Alder BioPharmaceuticals, Inc. (ALDR) Q1 2019 Earnings Call Transcript

Alder BioPharmaceuticals, Inc. (ALDR)
Q1 2019 Earnings Call
May 2, 2019, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon and welcome to the Alder Biopharmaceuticals first quarter 2019 financial results conference call. At this time, all participants are in listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn the call over to Michael Horowicz of Stern Investor Relation. Please proceed.

Michael Horowicz -- Stern, Investor Relations

Thank you, Operator. Good afternoon and thank you for joining us. Just after market close today, we filed our Form 10-Q for the first quarter of 2019 with the Securities and Exchange Commission and issued our financial results and corporate highlights press release, both of which are available in the Investor section of our website at www.alderbio.com. You may listen to a live webcast and listen to a replay of today's call on the Investor section of the website. Today's speakers are Bob Azelby, Chief Executive Officer, Dr. Paul Streck, Chief Medical Officer, and Carlos Campoy, Chief Financial Officer. Nadia Dac, who just joined as Alder's Chief Commercial Officer, and Erin Lavelle, Chief Operating Officer, will be available for the Q&A portion of today's call.

Before we begin, I would like to caution you that during today's conference call we'll be making forward-looking statements regarding future events or the future performance of the company, including statements about possible future developments regarding clinical regulatory, commercial, financial, and strategic matters. Actual events or results, of course, could differ materially. We refer you to the documents that Alder files from time to time with the SEC and, in particular, the company's Form 10-Q for the quarter ended March 31st, 2019, which was filed with the SEC today, May 2nd, 2019. These documents, which are available on the SEC's website, contain and identify under the heading Risk Factors important factors that could cause actual results to differ materially from those contained in any forward-looking statements. With that, let me pass the call over to Bob.

Robert Azelby -- President and Chief Executive Officer

Thank you, Michael, and welcome, everyone. As many of you know, the mission of our team here at Alder is to forever change the migraine treatment landscape, and we are driven by the opportunity to develop and commercialize treatments that allow patients debilitated by migraine to get back to daily living. We were pleased that on April 22nd, 2019, the FDA accepted our BLA filing for our lead investigational product candidate, eptinezumab, our monoclonal antibody-inhibiting calcitonin gene-related peptide, or CGRP, for the prevention of migraine. We subsequently were advised by the FDA in our Day-74 letter that it has set the PDUFA target action date of February 21st, 2020.

We are continuing to scale the organization, and we expect to be ready to competitively launch epti in Q1 2020, following approval. We have continued to build out our team with several key hires, adding significant commercial expertise. Notably, Nadia Dac recently joined Alder as Chief Commercial Officer, bringing over 25 years of US and global commercial experience, having launched multiple neurology products in competitive markets, while in leadership roles at Biogen, Novartis, and AbbVie. Additionally, we have added seasoned marketing, and market access, and commercial operation team members at various levels throughout the organization.

We are successfully scaling our medical, manufacturing, and G&A infrastructure as well. We further enhanced our medical presence, such as increased opinion leader engagements and a greater presence at next week's AAN meeting. And we continue to produce commercial product to meet forecasted demand at launch. As we stated on our Q4 call, we have a supply agreement with Sandoz that provides to the manufacturer of guaranteed quantities of eptinezumab drub substance for five-year term running through 2023. This puts Alder in a position to meet forecasted commercial demand, not only in the US, but also globally beyond 2023.

Turning to the product itself, we believe in eptinezumab's unique clinical profile and its potential to meet the needs of many of the approximately 13 million migraine patients who are candidates for prevention therapy. As we have mentioned in the past, migraine is far more than just a headache. It's a debilitating neurological disease with far-reaching effects. Those with migraine often experience sensitivity to light, sensitivity to sound, suffer from gastrointestinal issues, sleep disorders, and may have impaired cognitive abilities, which may lead to anxiety and, in many cases, depression. Essentially, they are living with the reality of migraine every day, not just the day of a migraine attack.

Just to further expand on this market research done by migraine.com indicates that a third of migraine patients surveyed say they have lost a job due to their migraine. And about two-thirds state this disease has negatively impacted professional advancement as well as their personal relationships. However, this population is determined. Many had tried and will continue to try multiple therapies and drug classes as they search for relief. It's no wonder that our market research shows they are looking for therapies with robust and sustained efficacy that take effect rapidly.

In our market research, nearly 90% of patients surveyed would choose a product based on its effectiveness. And 80% of them would choose a product based on speed of prevention effect. Our market research also supports our belief that many patients would prioritize relief of the disabling symptoms over convenience of administration. In fact, over half of the patients we surveyed, when given the choice, would choose an infusion product with epti's clinical profile. If approved, we believe that eptinezumab's rapid onset of preventive effect, high 50, 75, and 100% respond rates and a safety profile similar to placebo, as demonstrated in our clinical trials, combined with a 30-minute quarterly IV dosing, will be attractive to these efficacy-seeking patients and the physicians who treat them.

From a broader market perspective, we're encouraged by the uptake of the anti-CGRPs since last May, with over 300,000 New-to-Brand RXs haven't been written. Alder is targeting roughly 3000 proceduralists who are high-volume clinicians, each seeing an average of 150 to 200 migraines monthly, aligning well with epti's profile because they perform in-office procedures, including IV therapies, 94% of them have access to IV capabilities, 63% have IV capabilities in their office, and 45% stated they would expand or add IV capabilities once epti becomes available.

We have been interacting with physicians within this group to solicit their feedback on epti. Their feedback suggests that while they view the new anti-CGRP subcutaneous product as being fairly comparable to each other in terms of their performance, they are looking forward to epti's uniquely differentiated clinical profile and IV mode of administration. During the quarter, we complete a 250 physician-quantitative demand study, which once again estimate epti's share of the anti-CGRP market to be in the range of 20 to 30%. This most recent market research study is consistent with the ones we have highlighted in the past.

We have also had significant engagement with commercial payer over the past few months. These payers also view epti as being differentiated due to its 100% bioavailability immediately after a 30-minute infusion, high response rate, and a rapid onset of prevention, as well as epti's potential for enhanced compliance due to its in-office quarterly IV administration. We feel confident that at the time of launch, payers will make epti widely available for their plan participants.

During our Q4 2018 financial results call, I spoke about how Alder is focused on becoming a fully integrated biopharmaceutical company and our excitement about ALD1910, our preclinical asset which has the potential to address another subset of migraine patients who may not respond to anti-CGRP therapy. Paul Streck, our Chief Medical Officer, will provide details on that program in a moment. Additionally, through our life cycle management prioritization program last fall, we believe that there is a significant opportunity for eptinezumab, leveraging its 100% bioavailability and rapid onset of prevention, as an acute treatment for migraine. We reached this conclusion following a clinical trial feasibility study and a rigorous commercial assessment combined with expert clinical consultations.

As Paul will discuss, we plan to initiate a Phase 3 clinical trial of epti in the second half of 2019 to investigate this opportunity. If approved for prevention of migraine, and it's successful in treating an active migraine in clinical testing, eptinezumab would be in a unique position as the only anti-CGRP monoclonal antibody indicated for the treatment and prevention of migraine.

In summary, we are excited about the broad potential for eptinezumab and are working hard to ensure its clinical and commercial success while also attempting to enhance the portfolio by developing additional indications and new therapies that could potentially help migraine patients in the future. With that, I will turn the call over to Paul.

Paul Streck -- Chief Medical Officer

Thanks, Bob. First, I wanted to share my increasing enthusiasm since coming to Alder in January. I've been able to see the positive responses from key opinion leaders and the busiest headache-focused practices regarding our eptinezumab program. And it's clear we have a unique opportunity to improve treatment outcomes patients suffering with a debilitating condition. I've also gotten to know the Alder team and am extremely pleased to see the commitment, technical expertise, and enthusiasm. We believe we submitted a high-quality BLA and have successfully shifted from a single clinical focus to effective executing on multiple key clinical development and commercialization initiatives.

Given eptinezumab magnitude and speed of response, I'm excited about the potential opportunities to explore additional indications in order to impact a larger number of migraine patients. Before I discuss eptinezumab in greater detail, I'd like to walk -- update you too on ALD1910. ALD1910, as you may know, is our highly -- high-specificity, high-affinity neutralizing monoclonal antibody with reactivity to PACAP-38, or pituitary adenylate cyclase-activating peptide.

PACAP-38 has emerged as an important signaling pathway in the path of physiology of migraine and is believed to be distinct from CGRP. As such, we believe PACAP-38 represents an attractive, novel target for preventing and treating migraine. Evidence indicates that PACAP-38 and its three known receptors, PAC 1, VPAC 1, and VPAC 2 are expressed in the regions of the brain known to be associated with migraine symptomatology. We are very encouraged by our preclinical work today, which indicates that ALD1910 prevents the signaling of PACAP-38 to all three of these receptors.

Our acute toxicology studies have not indicated any adverse treatment-related effects by ALD1910 in two species. Similarly, 28-day multi-dose studies have completed their main treatment phases with no treatment-related effects observed. The preclinical program is on track for completion this summer, and we expect to initiate a first in-human clinical study of ALD1910 by the end of 2019. Now I want to return to eptinezumab, currently under review with the FDA, and our plans to seek to expand our proposed prevention label into the acute setting.

When we think of treating and preventing migraine, there are three reasons that bring patients to their physician for therapy, first, for a new patient appointment. A majority of chronic patients and about a third of the episodic patients who are coming to a clinician for evaluation will have a migraine on the day of their visit. Second, they come for a planned follow-up appointment. There's a large number of patients returning to their physician as planned, and their therapy may require adjustment, has become ineffective, or has worn off. And finally, patients come for an urgent intervention. Many episodic and chronic migraine patients will present to their physician or to the ER in crisis. Considering these scenarios, there may be a therapeutic rationale to prescribe epti in each of them, and that's why we're excited to potentially provide physicians with a tool that manages a highly debilitating disease in the immediate term along with the previously demonstrated preventive efficacy over the following 12 weeks.

As Bob mentioned, in the second half of 2019, we expect to initiate enrollment in a Phase 3 study to investigate epti's utility in the acute setting. Our depth of knowledge with the path of physiology of migraine and our experience with eptinezumab give us confidence in this study. We conducted post hoc analysis of time-to-migraine resolution in three of our previous eptinezumab clinical trials in patients who entered those trials with an active migraine. We observed two-hour resolution rates in these patients, which demonstrated a clear trend from which we have been able to design a well-powered Phase 3 trial to detect a meaningful difference versus placebo.

For this trial, we're planning to examine a 100-milligram eptinezumab dose level versus placebo with the co-primary endpoints of patients achieving pain freedom and the absence of most bothersome symptom two hours post-treatment. We have submitted out protocol to the FDA, and they're actively preparing to initiate pre-study activities. We continue to see significant opportunity for eptinezumab in the preventative setting. We believe it also has the opportunity to bring improved clinical outcomes to a broader population of patients, assuming successful clinical results in acute migraine. I'd now like to turn the call back to Bob to discuss the commercial opportunity for epti in the acute setting.

Robert Azelby -- President and Chief Executive Officer

Thanks, Paul. Our commercial assessment identify!!! three incremental opportunities for eptinezumab if we are successful in securing a product label stating, "Epti is indicated for the treatment and prevention of migraine." The first and largest incremental commercial opportunity is in the prevention marketplace. Our market research with physicians demonstrated that having a treat-and-prevent label would provide significant uplift in terms of market share. The increase would come from physicians who are prescribing epti to more patients as well as an overall increase in the number of physicians that would now be willing to use epti because of the acute indication.

Keep in mind in our PROMISE 1 study in episodic migraine, these patients average nine migraines a month. So, that means approximately 30% of these patients saw their clinician during a migraine attack. In our PROMISE 2 study in chronic migraine, these patients averaged 16 migraines a month, indicating that greater than 50% of these patients saw their clinician during a migraine attack. The feedback from our market research demonstrated that a product that has both a treatment and prevention label will be attracted to both the physicians that treat the migraine as well as their patients.

The second incremental opportunity for eptinezumab, with both a treatment and prevention label, would be in the emergency room setting. A large number of episodic and chronic migraine patients end up in the ER when they are in crisis, meaning their current therapies do not work, and the patient has run out of treatment options. The goal of the ER physician is to triage these patients and try to relieve their symptoms quickly. However, it is common for these same patients to return to the ER days later when their symptoms come back. We believe the ability to treat and prevent migraine in this setting could be an attractive option for ER physicians, institutions, and to the patient by minimizing the repeat visit.

The third commercial opportunity for epti, with both a treatment and prevention label, would be in those patients who are suffering from debilitating migraine but average fewer than four migraines a month, the threshold for reimbursement of prophylactic therapy. These patients, 80% of whom are women in the prime of their careers and family obligations, can be sidelined for multiple days a month battling through their migraines, limiting their career opportunities, negatively impacting their personal relationships, and creating challenges for their family members. Our market research indicates there are a large number of patients willing to pay out of pocket for a therapy that treats and prevents migraine and allows them to be more effective in their personal lives and their careers.

As you can see, we are excited about the potential to bring epti to the market for the prevention of migraine and continue to support the need -- needed commercialization efforts. We are further encouraged by the lifecycle opportunities for epti as we look to expand the proposed epti indication and to change the treatment paradigm. Our objective is a label that has both a treatment and prevention indication in order to positively impact more patients battling through this serious neurological disease. With that, Carlos Campoy, our Chief Financial Officer, will take you through our financial results. Carlos.

Carlos Campoy -- Chief Financial Officer

Thank you, Bob, and hello, everyone. During the first quarter 2019, our epti program drove a significant portion of our R&D and G&A expenses in support of our commercial readiness activities. As of March 31st, 2019, we reported $499 million in cash and cash equivalents, investments, and restricted cash compared to $412 million as of December 31st, 2018. This includes net proceeds of $159 million from an equity financing in March. Please note that we will provide brief first quarter results on this call and refer you to our period-over-period operating results detailed in this afternoons press release and Form 10-Q filed with the SEC.

In the first quarter, R&D expenses totaled $70 million. G&A expenses were $45 million, which include a $26 million loss contingency provision related to a dispute over a contract we terminated for a breach by the other party. Our net loss was $119 million, or $1.63 per share. These results generally reflect our planned expenditures to advance the epti program and to position the company for commercialization.

With respect to our financial outlook, following our reported Q1 results, we continue to expect that our full-year 2019 net cash used in operating activities and purchases of property and equipment will be in the range of 285 to $315 million. Much of this spend is focused on ensuring that we are prepared for the potential launch of epti in the first quarter of 2020, including advancing its supply chain, building commercial inventory, continuing to build out our commercial footprint, and the other prelaunch market readiness activities. We estimate our available cash, cash equivalents, investments, and restricted cash as of March 31st, 2019, will be sufficient to meet projected operating requirements through the anticipated launch of eptinezumab and into late 2020. With that, I will turn the call back to Bob.

Robert Azelby -- President and Chief Executive Officer

Thank you, Carlos. In summary, we are really pleased with our execution in recent months and are confident in the capabilities we are putting in place to take advantage of our near-term opportunity by successfully launching epti early next year. We have made the decision to continue to invest in epti's life cycle management, creating a midterm opportunity to leverage epti's unique clinical profile to continue to differentiate it in the marketplace as well as expand the number of patients that may benefit from epti.

Finally, we understand that as good as epti's clinical profile looks, there is still a need to bring additional novel therapy to the market and that's why we're pursuing alternative pathways and the development of ALD1910, creating a longer-term opportunity for Alder. I look forward to sharing our continued progress as we advance toward epti's potential commercial launch in the first quarter of 2020. With that, we'd like to open the call to your questions. Operator.

Questions and Answers:

Operator

Ladies and gentlemen, at this time if you have a question, please press the * and the number 1 key 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 please your line on mute once your question has been stated. And our first questions from Brian Abrahams from RBC Capital Markets. Your line is now open.

Owen -- RBC Capital Markets -- Analyst

Hey, guys, this is Owen on for Brian. Thanks for taking our questions and congrats on the recent BLA acceptance. I have two questions if I may. First, regarding the new acute study, you talked a little bit about the possibilities in the ER setting. Do you think a positive result in that study is required for any sort of ER use, or might you expect any potential off-label use give the profile, even acute wasn't part of the label? And then, just switching gears to discounting regarding some of the details in this space of the last week with some of your competitors noting potential rebates in the 40%-plus range. Is this in line with your expectations for the market, and would you expect any difference in discounting given a different profile of your product? Thanks.

Robert Azelby -- President and Chief Executive Officer

Sure. So, starting with the acute study and the impact in the emergency room, obviously, we wouldn't be able to promote anything in the emergency room without an acute indication. However, I do think it would be important for -- to secure an acute indication to get uptake in the ER because those clinicians are looking to problem solve and triage that patient quickly and provide relief. So, we think the acute indication would be an important element for significant ER use.

As it relates to your second question on discounting and the 40% range that you spoke to, we're not terribly surprised by it because there's three players. They're working through the pharmacy benefit, and that's what PBMs do, right. When you have product that are similar to one another, and they think they're a commodity, then at the end of the day, they start working down the discount. That's why we're really pleased that we're in the medical benefit. And as you know, those two are distinct processes used by managed care plans. So, we'll be dealing with the medical director and that we won't have to go back every year to renegotiate contracts because it's basically mitigated by ASP. You can't take crazy price increases due to average selling price. And so, I don't think it was a terrible surprise, and we feel great that we're in the medical benefit.

Owen -- RBC Capital Markets -- Analyst

Great. Thanks, guys.

Operator

Thank you. Our next question's from Jessica Fye from JP Morgan. Your line is now open.

Daniel -- JP Morgan -- Analyst

This is Daniel for Jessica. Thanks for taking our questions. The physician feedback has suggested they view eptinezumab as a potential option for patients who are not doing well on injectable therapies. Do you expect to position the product for this type of use when you launch or just focus on capturing patients new to the CGRP? And second, what should be expected at presentation at AAN? Thank you.

Robert Azelby -- President and Chief Executive Officer

Sure. So, the first question, I'll take. And then, the second question, I'll turn over to Paul. So, as it relates to -- when we launch this product in the marketplace, we do not believe that we're gonna be second line to any other monoclonal antibody out there. We think we'll have to jump through the hurdles of failing to prior therapies, similar to what the subcus do today. But our target market's gonna be for those patients that are debilitated, that are struggling to get their life back, struggling to go to work. And the fact that we can provide robust efficacy, deep responses, 50, 75, and 100%, and then offer that prevention starting within 24 hours, we think that will be highly attractive to, not only the physicians, but the patients as well.

Now, with that being said, do we think that patients who have tried a subcu CGRP and have an inadequate response, we've been told by opinion leaders that they think that they would go to eptinezumab because they like the fact that they would get 100% bioavailability, so they're getting the full effect of the product right at the end of the 30-minute infusion. And if eptinezumab doesn't work for the patient, then they would rule them out as a CGRP candidate. And so, again, going back, our target market's gonna be that highly impacted patient, but we do see us getting inadequate responses from the other products. Second question, I'll turn over to Paul for AAN, the data we'll be sharing.

Paul Streck -- Chief Medical Officer

Yeah, thanks, Bob. Certainly excited about going into AAN this year. I think if we look at the themes of the presentations that we're putting forth, they would include consistency of effect that we see across trials, certainly, the longer-term efficacy and durability of response of eptinezumab, impact on quality of life and certainly how early response impacts this, and, finally, the impact of epti on most bothersome symptoms, which I think is really along the lines of this not just being a headache. So, those are -- will be presented in three oral presentations and six post-presentation. And refer you back to our press release from last week outlining these.

Daniel -- JP Morgan -- Analyst

All right. Thank you very much for taking our question.

Operator

Thank you. Our next question is from Difei Yang from Mizuho. Your line is now open.

Alex -- Mizuho -- Analyst

Hey. Good afternoon, guys. This is Alex on for Difei. Thank you for taking the question. I was wondering if you could comment on the impact that CGRPs have had on the overall markets since launch. Are market share gains of CGRPs at the expense of other classes of migraine drugs? And are you seeing overall migraine market growth? And how do these dynamics play into your prelaunch activities? Thank you.

Robert Azelby -- President and Chief Executive Officer

Yeah. So, thanks for the question. So, first of all, I think a great example would be the 300,000 New-to-Brand prescriptions in less than 12 months is really a large number. And as a benchmark, Botox has been out since roughly 2010, and we see them treating about 250,000 patients a year or so. So, you can see that the impact of the CGRP have been outstanding. In fact, I was at a -- one of the largest practices a few weeks ago, and basically they have 600 patients on Botox, and they have over 2000 patients on anti-CGRPs and when we look at the data, we do see some declines in some of the other preventative medicines. The orals and the CGRPs are picking up, and Botox seems to be holding pretty steady. But it's still early, and there's a lot of noise in the marketplace with a free product. But, overall, we think the uptake has exceeded most people's expectations.

Alex -- Mizuho -- Analyst

Great. Thank you.

Operator

Thank you. Our next question's from Paul Matteis from Stifel. Your line is now open.

Ben Burnett -- Stifel -- Analyst

Great. Thanks. This is Ben Burnett on for Paul Matteis. I wanted to ask for just a little bit more color on the cu treatment and the regulatory path for that program. Do you expect at this point to need to run multiple pivotal studies? And then, also, just wanted to clarify, just approximate how big do you expect this acute study, this first acute study, to be?

Robert Azelby -- President and Chief Executive Officer

So, basically, we've -- and I'll turn it over to Paul for more detail. But we just submitted the clinical trial design to the FDA. And so, we're not gonna provide the numbers on the size of the trial at this time. We're still working through those logistics and details. And, Paul, as it relates to securing an indication, do you anticipate that this one Phase 3 should be able to secure an indication?

Paul Streck -- Chief Medical Officer

Obviously, I -- Bob, I think our preventative studies are still under review by the FDA. We do feel like the data that we put forth from an efficacy and a safety perspective is compelling. Nevertheless, our sense is that from the acute trial, based on the work that is being completed, that one trial would be adequate to secure a -- at least a review by the agency and subsequently as an approval, provided the strength of data is there.

Ben Burnett -- Stifel -- Analyst

Okay. Great. Perfect. And I just want to ask one more question. Just the -- so, I noticed the impact of initiating acute studies in your cash burn. It looks like you've kept that, your guidance, the same for 2019. Should we assume that most of the cost associated with this acute study hits in 2020, or is that kinda already built into your assumptions?

Paul Streck -- Chief Medical Officer

So, basically, the acute study has been built into our assumptions for 2019. And as you know, we haven't provided guidance for 2020 as of yet.

Ben Burnett -- Stifel -- Analyst

Okay. Great. Thanks so much.

Operator

Thank you. Our next question's from Charles Duncan from Cantor Fitzgerald. Your line is now open.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Hi, guys. Thanks for taking the questions. And congratulations on the progress in the quarter with the filing. I had a couple of questions. One is I think that you mentioned 3000 or so proceduralists that would be targeted initially with -- upon epti approval. And I'm just wondering if you have any updated thought regarding the number of sales folks that you would use to initially launch the drug?

Robert Azelby -- President and Chief Executive Officer

Yeah. So, thanks, Charles. What we've been really pleased about when we look at the concentration curves of where the anti-CGRPs are being written and that our target audience of these 3000 proceduralists appear to be writing about 75% of all the prescriptions that are taking place right now. And so, our target that we've been talking about, 3000, has been very, very consistent. And we stand by -- we believe that our field footprint will be between 75 and 100 representatives. We'll be able to have a very, very successful launch.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. That's helpful. And the next question I had was regarding the pipeline. I like that you're considering the acute use of eptinezumab. And, frankly, it makes a lot of sense to me in the emergency room setting. But I think you've laid out two other commercial opportunities, and one is kinda the normal doctor appointment. The other is for patients with less than four migraines. And it's perhaps jumping the gun a little bit, but I'm wondering if -- what you're thoughts are in terms of pricing and really how the model looks relative to the planned use in chronic migraine. Is there a difference, or do you think you accommodate that?

Robert Azelby -- President and Chief Executive Officer

Sure. So, I think the first one I wanna -- we wanna make sure that we're really clear on today that we have no delusions that we will compete in the standard acute market with generic triptan. That is not the market. Where we see the largest commercial opportunity here is in the prevention market place. And it goes back to the fact that when clinicians are treating episodic migraine patients or chronic migraine patients, many of them arrive with a migraine that particular day. And when we went out and did a large study, when we're doing our commercial assessment, the uptick in market share to have both the treat and prevent label was very, very large.

And what I would suggest to you is that's where the real upside from a commercial perspective is. And in terms of pricing, the fact that we'd be using 100 milligrams in both the prevention space -- and if you had a treat-and-prevent label, it would be the same type of patient. We don't see pricing differentials by indication. So, as we work through our pricing, work in our health economic data, we'll come out with a price. But I wouldn't assume that -- I would assume the 100-milligram dose is gonna be the same in either setting. And then, as it relates to the less than -- patients that are suffering between one and three migraines, again, we see that also in the prevention marketplace because these are patients that are getting migraines on a regular basis. They may not just hit the threshold of the payer, which is four or more a month. But one, two, or three migraines can be terribly debilitating. And so, the same type of effect where if they have it we can treat it. And then, we can prevent the future coming over the next quarter.

Charles Duncan -- Cantor Fitzgerald -- Analyst

That's helpful added color, Bob. I appreciate that. Last question is on 1910. You probably haven't had a lot of questions about that relative -- or recently. But I'm just kinda wondering when we could see increased visibility. You spoke about that a little bit, and I'm wondering if I missed of is you kinda set some goal base in terms of Phase 2 studies, etc.

Robert Azelby -- President and Chief Executive Officer

Yeah. So, I think right now the team, as Paul articulated, is actively pushing to get our first in-human by the end of 2019. And then, if you run the timeline, we gotta see that data, how it works. That will actually help us access what our Phase 2 type of program would look like. And so, I think you'd get more visibility into that in the latter part of next year.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Thanks for the added color.

Operator

Our next question's from Jim Birchenough from Wells Fargo. Your line is now open.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Yeah. Hi, guys. Congrats on all the progress. A few questions. I guess first when you think about the patients that come in through the ER, my sense is typically they've failed to respond to the -- you're acute migraine study, will you enroll patients specifically that have failed triptans? Maybe that as a starting point.

Robert Azelby -- President and Chief Executive Officer

So, Jim, you broke up a little bit on your question. Can I have you repeat that? We lost you there for about two or three seconds.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Yeah. So, just thinking about the ER population that presents with migraine, my sense is a lot of them have -- are presenting because they're not responding to their triptan. And so, in your treatment study, will you study specifically patients who have failed prior triptan use? And I ask the question also because some of the newer triptans that are more expensive have step edits that require a certain number of prior triptans. And so, will you try and encompass that population?

Robert Azelby -- President and Chief Executive Officer

So, Paul, you wanna take that?

Paul Streck -- Chief Medical Officer

Yeah, absolutely. I think the main thing that we're focused on in this trial is making sure that a patient did not receive any sort of acute therapy in the period immediately entering our trial to prevent any sort of confusion in terms of was it eptinezumab versus that treatment that caused the acute relief. So, but in terms of restricting them from a -- the perspective of failing anything in the past, no.

Jim Birchenough -- Wells Fargo Securities -- Analyst

And maybe related to that, just when you think about the benefit that you saw in your chronic migraine and frequent episodic migraine studies of migraine relief within two hours, trying to benchmark that against what we've seen with triptans, is it a different point of intervention in chronic and frequent episodic migraine studies than what you see in a typical treatment study? And would you expect to see a more rapid effect if you were enrolling more like-for-like patients that we've seen in the triptan studies?

Robert Azelby -- President and Chief Executive Officer

So, Paul, why don't you take the efficacy side of things and what we expect to see, and I'll come back to the commercial opportunity.

Paul Streck -- Chief Medical Officer

Sure. Sure. So, as we look at the market of individuals who are in the acute setting, I think the main thing is that we want to get those individuals when they're -- as their migraines are initiating, get them into the center, and treat them accordingly, and then look at them with the two required endpoints that the agency puts forth, pain-free within two hours and getting rid of the most bothersome symptom. Does that cover where you were going with that one?

Jim Birchenough -- Wells Fargo Securities -- Analyst

Yeah, I guess I was looking more for differences. You've shown in your Phase 3 studies of chronic migraine suffers that had a migraine at the time that they were initially treated some benefit within that two-hour timeframe. But I'm just wondering beyond that if the patients you saw in you Phase 3 were further out from the initiation of their migraine than what we see in typical treatment studies, i.e. could you see an even more rapid effect when you study a treatment-specific patient population?

Paul Streck -- Chief Medical Officer

We don't know that. We don't have that information.

Robert Azelby -- President and Chief Executive Officer

Yeah. So, Jim, I think when we thought about this opportunity -- and what I would keep -- I know people are excited about the emergency room, but from a commercial perspective, the real opportunity is in the episodic and the chronic migraine setting. And so, we want to be able to have a label that talks about treating and preventing patients within that setting. And the reason why we're excited about it is, however you think the CGRP market will be big, whether it be $3 billion, $5 billion, or $7 billion, one share point in a given year, right, would give you a great ROI on the amount of money we're spending on this particular clinical trial. And so, the commercial assessment there and then the feedback from clinicians as well as patients on the ability to actually walk into an office -- and many of the patients are suffering a migraine -- and get a therapy that potentially could treat it and then prevent it is really the -- a real clinical differentiator.

Jim Birchenough -- Wells Fargo Securities -- Analyst

That's helpful, Bob. And maybe one final question. We have been getting questions ourselves on the potential impact of the Amgen-Sandoz litigation. If you see any risk to the supply being disrupted by that litigation, why should investors not worry? And what are your contingencies if there's any disruption because of that litigation?

Robert Azelby -- President and Chief Executive Officer

Yeah. So, obviously, we have no part in the Amgen-Novartis litigation. I would say that our relationship goes back to 2015 with Sandoz and we're working with them on a day-to-day basis, as you can imagine. We're making commercial product as we speak. We're gearing up for a potential FDA audit, right. And so, all the day-to-day activities are under way. And then, I would just -- if you're staying close to the Amgen-Novartis situation, they started discussing this issue back in the fall timeframe, September-ish. We signed this document, and it became effective, our amendment, in January of 2019. And it moves forward for the next five years through 2023 for guaranteed supply. And so, we feel in our engagement with Sandoz -- we have great confidence that this is not gonna be an issue for us.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Great. Thanks for taking the questions. And congrats again on the progress.

Robert Azelby -- President and Chief Executive Officer

Thank you.

Operator

Thank you. Our next question is from Carter Gould from UBS. Your line is now open.

Andrew -- UBS -- Analyst

Hey, guys. This is Andrew in for Carter. Thanks for taking my questions. I have a few here. So, first, from the recent script data and commentary by your CGRP space, they point to a pretty competitive environment right now and facing gains in shares. And you guys benefit from having this [inaudible] in extent before epti comes online. But I guess on a higher level, how do you see eptinezumab while they're maneuvering through these dynamics, where your peers have been refining their infrastructure, from their sales force on the ground, dialog with payers, and BTC campaigns and so forth? I guess put another way, how should we be thinking about eptinezumab's first weeks of launch? That's my first one.

Robert Azelby -- President and Chief Executive Officer

Okay. So, let me take that. So when we engage with payers, right, and we've had ad boards, and we've gone out and done site visits, because this is in the medical benefit, basically what they say is, "Hey, you're gonna have to be prior auth!!! like the other products, but we're gonna pay for you early, and then we'll make a determination six months down the line whether or not you stay on formulary. But they also told us because of the clinical profile of eptinezumab and the fact that it's IV that there's high, high likelihood that we're gonna be on. In fact, they say, "Boy, it's really exciting that you're the first IV and not the fourth subcu.

And then, as it relates to how are we gonna compete in that marketplace, well number one, we're hiring great staff here, right. And so, we're building a great team. And the fact that this is a specialty marketplace, and we think these 3000 doctors control a very large portion of the business and their proceduralists, and eptinezumab, not only from a differentiation perspective in terms of depth of response and speed of prevention will be a really good characteristic that they tell, but the fact that it also fits in with their business modal, right. And so, we don't think we're gonna need armies of salespeople. We're gonna focus on these 3000 who have large concentrations of patients. And we think we're gonna do quite well.

Andrew -- UBS -- Analyst

Great. And thanks for that. So, I want to touch on your PACAP program real quick. Given your comments on CGRP not being appropriate for all patients or where some patients aren't responding, do you expect your future study will be CGRP-failed patients or naïve patients? I guess I'm trying to get a sense of how this program will evolve clinically and commercially thereafter.

Robert Azelby -- President and Chief Executive Officer

Yeah, great question. I think that's still a little early for us. We're working through all those particular elements, right. So, obviously, it would be great if we could identify a biomarker which identified which was a CGRP patient and which was a PACAP-38 patient because we know that the path of physiology of these migraines are different. And so, what I would say is we're continuing to do more homework on that, and figuring out how to design our Phase 2, and whether that would be do you have people fail on a CGRP, or do you just do a similar type of program that we ran with eptinezumab. And so, that's still a work in progress.

Andrew -- UBS -- Analyst

Do you see a value in pursuing subcu or keeping with the IV as a more proven area for all the -- either the PACAP program or the eptinezumab program?

Robert Azelby -- President and Chief Executive Officer

Yeah. So, on the PACAP-38 program, both of those options are still on the table for us in terms of whether that's subcu or IV. As it relates to our eptinezumab program, I think what you're seeing right now is we're really glad we're IV. We're clinically differentiated. And we're in the medical benefit, not the pharmacy benefit. And so, we've done our ranking of life cycle opportunities, and we bet on the acute indication and going forward with that. And I would say subcu is still on the board but down lower. We don't see that adding a tremendous amount of value for us in terms of return on investment.

Andrew -- UBS -- Analyst

I guess one last one on your IP. Given your licensing with Tev, I was wondering if there were any IP overlaps, if it was being litigated between Tev and Lilly right now? Thank you.

Robert Azelby -- President and Chief Executive Officer

Yeah. So, our IP runs through 2032. And we solved our issue with Tev January 2018. And so, we feel great about our IP situation.

Andrew -- UBS -- Analyst

And no overlap with the Lilly issue right now?

Robert Azelby -- President and Chief Executive Officer

Yeah, actually, we feel good about our PACAP-38 IP state. But, obviously, we'll work through that over time. People are working through these products early. But we feel good about our IP state.

Andrew -- UBS -- Analyst

Great. Thank you.

Operator

Thank you. Our next question's from Danielle Brill from Piper Jaffray. Your line is now open.

Danielle Brill -- Piper Jaffray -- Analyst

Hi, guys. Thanks for the questions. I have a few. First, I'm just curious for the acute migraine trial. Why did you decide to go with the 100-milligram dose? And then, I missed what you said on the call about your market research about what percent of patients see their doctor during an acute attack.

Robert Azelby -- President and Chief Executive Officer

Sure. So, Paul, do you wanna articulate why we want the 100-milligram dose?

Paul Streck -- Chief Medical Officer

Yeah, absolutely. So, when we look at eptinezumab from both a PK and a clinical perspective, we see the response is primarily a function of the bioavailability tissue penetration and receptor binding. The 100 milligrams clearly hits the threshold, and when we looked at 300, it really did not offer any benefit, thus our rationale for going forward with only the 100 in our clinical trial program.

Robert Azelby -- President and Chief Executive Officer

And then, Danielle, secondly, on the data that I was talking about, episodic migraine and chronic migraine, was from PROMISE 1 just as a surrogate that people in the PROMISE 1 study averaged nine migraines a month. So, that would be roughly 30% of the days in a month that, if they go to see their doctor, there's a 30% chance that they're having a migraine at the time of seeing their clinician. And then, when you're in the chronic migraine space, the low end is 15 days, right, and it ramps all the way up to 30 as it relates to migraine slash headache days. There's greater than a 50% chance that patients will see their doctor on the day that they're having a migraine. And, in fact, in PROMISE 2, our patients average 16 migraines a month.

Danielle Brill -- Piper Jaffray -- Analyst

Okay. Got it. And then, so one more. We conducted a recent migraine survey and saw a significant spike in physician awareness for epti. So, I'm just curious if internally you had any new outreach activities or physician detailing during that quarter that would explain the trend?

Robert Azelby -- President and Chief Executive Officer

Yes. So, I think at the end of the day, data keeps getting released on eptinezumab, and people are excited about it. We do have an MSL team out in the field that's doing scientific exchange. And so, we're doing all the things. We all doing all the basic blocking and tackling at a company we do as we start to march toward commercialization.

Danielle Brill -- Piper Jaffray -- Analyst

Great. Thanks for the questions.

Operator

Thank you. Our next question's from Jeff Hung from Morgan Stanly. Your line is now open.

Jeff Hung -- Morgan Stanley -- Analyst

Thanks for taking the questions. You mentioned the opportunity in patients with fewer than four migraines a month. Would these patients continue to pay out of pocket or do you have any reason to believe that payers might be willing to provide some coverage to these patients?

Robert Azelby -- President and Chief Executive Officer

Yeah, you know what I think, Jeff? It's still early on that particular analysis. The market research we've done that roughly added 35 million Americans that suffer migraines. You know 13 are eligible for prevention. And then, there's about another 13 that suffer between one and three million -- I'm sorry -- between one and three migraines a month. So, that population is quite large. And many of them are in the prime of their careers. And so, paying out of pocket to get a couple days back, two, three, four day a month, is attractive to them. But we'll continue to do more work. But I do wanna come back and say the biggest and largest commercial opportunity is the differentiation in the prevention marketplace. This other piece between one and three, we think's an exciting opportunity, but we still need to do more work on it.

Jeff Hung -- Morgan Stanley -- Analyst

Great. Thanks. And then, does your expense guidance include the loss contingency provision that was in SG&A in 1Q? And just wanna get a sense for how we should think about the trend in expenses for the rest of the year. Thanks.

Robert Azelby -- President and Chief Executive Officer

Carlos, you wanna take that?

Carlos Campoy -- Chief Financial Officer

Yes. Jeff, it does include that loss contingency provision. And you will see quarterly fluctuations from quarter to quarter. But we remain confident that the full-year guidance remains in place at $285 to $315.

Jeff Hung -- Morgan Stanley -- Analyst

Thank you.

Operator

Thank you. Our next question is from Geoff Porges from SVB Leerink. Your line is now open.

Andrew -- Leerink Partners -- Analyst

Hi, this is Andrew on the call for Geoff. So, maybe a question regarding the long strategy. So, how do -- I mean, do you believe how many reps in the MSL and payer specialists do you expect to hire? And do you expect to build your patient hub internally or through a CSO? Thank you.

Robert Azelby -- President and Chief Executive Officer

So, on the field force perspective, what we've articulated was we'll hire between 75 and 100 sales representative, so we expect to have them on board by the fourth quarter, fully trained and ready to go, by January 2nd or January 3rd, whatever the first working day is in 2020. So, we're active on that side. Obviously, we're building hub services to make sure that it's easy access to access eptinezumab, whether it be with copay cards, insurance verification, etc. But we haven't articulated whether or not we're building that internally or that we're outsourcing that, so more to come on that.

Andrew -- Leerink Partners -- Analyst

Thank you.

Operator

Thank you. Our next question is from Vamil Divan from Credit Suisse. Your line is now open.

Vamil Divan -- Credit Suisse -- Analyst

Hi. Great. Thanks for taking the question. I think given all the commentary you made around the 3000 interventionalists, your 75 to 100 reps, I'm assuming nothing's changed around your confidence in commercializing this on your own in the US. But maybe if you could just sort of confirm that's still definitively the plan? And then, also, just really to add ex-US, so maybe if you can talk a little bit on the update and thoughts you have in terms of commercialization, or partnerships, or where things stand there? Thanks so much.

Robert Azelby -- President and Chief Executive Officer

So, 100 % confident in the ability for Alder to launch eptinezumab in the United States. Obviously, we have our new leader in Nadia Dac. And so, with her experience -- and, also, I'm very proud of the next level of folks that we're bringing in. We're attracting great talent, and there's no reason why we're not gonna go out and have success in this market place by doing it on our own. As it relates to ex-US, as I've stated in the past, we'd be open for a partnership to help take eptinezumab to the rest of the world because we're really focused on the US. It has to make sure -- it has to make sense for patients, meaning that the partner would have to have good relationships with neurologists, be well respected, and then the deal would have to make sense for our shareholders. And so, we're active in those discussions. But as you know, they can take a fair bit of time, and we won't provide more detail than that at this time.

Vamil Divan -- Credit Suisse -- Analyst

Okay. Thank you.

Operator

Thank you. Our next question is from Serge Belanger from Needham. Your line is now open.

Serge Belanger -- Needham & Company -- Analyst

Thanks for squeezing me in. This is [inaudible] for Serge. I just had one last question. So, I know there's a lot of oral products that are for treatment that are coming down the pipeline. So, how do you plan to sit in? Or do you expect to compete with orals? Thanks.

Robert Azelby -- President and Chief Executive Officer

Yeah, so great question. So, I just wanna reiterate that there's two marketplaces as we see it. There's an acute marketplace where generic oral triptans play a large market for people that are suffering migraines on a regular basis. We're not playing in that marketplace. We're playing in the prevention marketplace. And the fact of the matter that if you need prevention therapy you also need acute therapy, right. And so, the fact that we have the opportunity potentially to get a treat-and-prevent label, that's the marketplace where we're gonna spend all of our time competing in. So, we're not gonna be competing against the orals, as you highlight there, in terms of generic triptans.

Serge Belanger -- Needham & Company -- Analyst

That makes sense. Thanks.

Operator

Thank you. Our next question is from Sumant Kulkarni from Canaccord. Your line is now open.

Sumant Kulkarni -- Canaccord Genuity -- Analyst

Good afternoon. Thanks for taking my questions. I have two. So, first on the acute treatment side, is it fair to think of your acute treatment study as more of a strategy to counter detail your IV versus subcutaneous product in terms of speed of action in prevention without running a head-to-head? I'm actually asking that for two reasons, first, because for an IV product, clearly, the larger market is prevention versus acute treatment and, second, we're aware of at least three companies that are at various stages of development for inhalable, quick acting products that could act within 15 minutes or so. Of course, it remains to be seen if those can be approved.

Robert Azelby -- President and Chief Executive Officer

So, to answer your question, first of all, we think we're gonna be uniquely differentiated without the acute label. The fact that we can have excellent depth of response, and the fact that you get that prevention starting within 24 hours, we feel really, really good. And that's our A game where we stand today. Although, do we think that adding an acute label on to that would continue to further differentiate eptinezumab? Clearly. We also hear from patients and from physicians that a product that would treat and prevent would be very attractive to both of those audiences.

Sumant Kulkarni -- Canaccord Genuity -- Analyst

And then, I have a big picture question about the migraine market in general. Given that there are already three monoclonals out there for prevention, at what point do you think we could see prescriptions for the acute treatment market starting to shrink? Because if you look at triptan prescriptions, they're still growing on a year-over-year monthly prescription basis. I'm asking this because, when you're out there on the market, there could be at least a year or so or more of the other three being out there in terms of prevention.

Robert Azelby -- President and Chief Executive Officer

Yeah, so I'm just gonna go back and give you the stats. Thirteen million people in the United States are eligible for prevention therapy. Before the anti-CGRPs came onto the market, roughly 3.5 million were being treated. That's a treatment penetration rate of roughly 27%, and greater than half of the patients would be off those products within the first month. The opportunity here is enormous, right, in terms of patients that would benefit. So, I think all this whole entire market's gonna grow. And I don't anticipate that anybody's gonna be boxed out because someone else has captured the patients. I think we're a long, long way from that.

Sumant Kulkarni -- Canaccord Genuity -- Analyst

Got it. Thanks.

Operator

Thank you. Our next question is from Matthew Luchini from Needham -- from BMO. Your line is now open.

Robert Azelby -- President and Chief Executive Officer

You there, Matthew? Okay, Operator, we can go to the next question. Matthew can requeue if that's appropriate.

Operator

Thank you. And our next question is from Matthew Luchini from BMO Capital. Your line is now open.

Matthew Luchini -- BMO Capital -- Analyst

Hello?

Robert Azelby -- President and Chief Executive Officer

Hey, Matthew, can you hear us?

Matthew Luchini -- BMO Capital -- Analyst

Can you hear me?

Robert Azelby -- President and Chief Executive Officer

Yes.

Matthew Luchini -- BMO Capital -- Analyst

All right. Okay. Very good. Thanks for fitting me in. Sounds like we had some technical difficulties there. So, just one for me. Thinking about the acute indication and recognizing that not all positions are gonna have an infusion site -- infusion capability in office and patients for whatever reason may not want to go to the ER or may not be able to, could you just give us some sense as to the ways that you may be able to help a patient that's experiencing a migraine locate a physician that has capabilities and, more importantly, availability for immediate treatment, given the sort of time-sensitive nature of the setting?

Robert Azelby -- President and Chief Executive Officer

Yeah. So, again, the marketplace that we're gonna be playing in is in the chronic and the episodic, right. And so,!!! those patients, many of them already in the marketplace seeing their clinician. We're gonna continue to focus on those three thousand clinicians. And I stated out of those 3000 about two-thirds have IV capabilities in their practice, and the other ones all have access to IV. And so, what I be!!! telling you, IV access is ubiquitous, right. There's an enormous amount of it. And so, we don't see that as a problem. But, as we work through our hub services, we be thinking about what other services where we could help patients if they would call in to get them into the right spot to get them treated in the most appropriate way. So, that will be part of our commercialization process as well.

Matthew Luchini -- BMO Capital -- Analyst

Great. Thank you.

Operator

Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to Bob Azelby for closing remarks.

Robert Azelby -- President and Chief Executive Officer

Thank you, everybody. I look forward. I know I'm gonna be speaking to some of you in the next few hours and over the next couple days. I look forward to it. And thanks for your time today. Thank you, Operator.

Operator

Ladies and gentlemen, thank you for your participation!!! today's conference. This concludes the program. You may now disconnect.

Duration: 59 minutes

Call participants:

Michael Horowicz -- Stern, Investor Relations

Robert Azelby -- President and Chief Executive Officer

Paul Streck -- Chief Medical Officer

Carlos Campoy -- Chief Financial Officer

Owen -- RBC Capital Markets -- Analyst

Daniel -- JP Morgan -- Analyst

Alex -- Mizuho -- Analyst

Ben -- Stifel -- Analyst

Charles Duncan -- Cantor Fitzgerald -- Analyst

Jim Birchenough -- Wells Fargo Securities -- Analyst

Andrew -- UBS -- Analyst

Danielle Brill -- Piper Jaffray -- Analyst

Jeff Hung -- Morgan Stanley -- Analyst

Vamil Divan -- Credit Suisse -- Analyst

Andrew -- Leerink Partners -- Analyst

Serge Belanger -- Needham & Company -- Analyst

Sumant Kulkarni -- Canaccord Genuity -- Analyst

Matthew Luchini -- BMO Capital -- Analyst

More ALDR analysis

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.