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FDA Announcement

May 18, 2018

Speaker 1

I would now like to introduce Arvind Sood, Vice President of Amgen Investor Relations. Mr. Sood, you may begin.

Speaker 2

Okay. Thank you, Natalia. Good morning, everybody. And for those in Europe, good afternoon. I'm delighted that you could join us today to discuss the approval of Aimovig, which is an important addition and innovation for migraine patients.

Joining me this morning are Tony Hooper, who is Amgen's Executive Vice President for Global Commercial Operations and Paul Hudson, who is the CEO of Novartis Pharmaceuticals. Both Tony and Paul will make some opening comments, following which we should have ample time to have a dialogue and to take your questions. Also joining for the Q and A session will be Doctor. Elliot Levy, who is Amgen's Senior Vice President of Global Development. We will use slides for our presentation this morning and a link was sent to you separately.

A quick disclaimer that our presentation may contain forward looking statements. And with that, I would like to turn the call over to Tony. Tony?

Speaker 3

Thank you, Avind, and good morning, everyone. I really am delighted to be with you today, together with my good friend and colleague Paul Hudson from Novartis to discuss our newly approved product Aimovig, an innovative new medicine that we believe will be a real game changer for migraine patients. I'll speak first about migraine, a disease that continues to be underappreciated, under diagnosed and undertreated. Then I'll discuss Aimovig and its many advantages as well as our strategy for bringing this exciting innovation to patients. But before I do, let me ask Paul to say a few words.

Paul?

Speaker 4

Thank you, Tony. It's such an exciting moment, you know, for me personally, for the teams and more importantly for all of the migraine patients that are struggling. From our perspective at Novartis, we're delighted to partner with you. We have a rich history. You know this in neuroscience for nearly 70 years.

We've got reconfirmed our commitment to the long term with our AveXis deal this week. But more importantly, this is all about those patients that are struggling and need some help. And delighted to be part of it, Tony. The teams have done a standing job to get us to this point. All should be thanked, I'm sure.

I look forward to joining you for questions.

Speaker 3

So thank you, Paul. If we can now move to Slide number 3. Migraine as a disease is much more than just a bad headache. In fact, migraine is a very serious, very real disease that ranks as one of the top 10 leading causes of life years lost due a list that includes other diseases such as cardiovascular disease, Alzheimer's disease, diabetes and cancer. Migraine affects 3 times as many women as men and migraine patients spend 3 times more on healthcare than those without migraine, about $11,000,000,000 per year in the U.

S. Migraine is also a disease that strikes people in the prime of their lives, most commonly affecting those between the ages of 2555. As a result, migraine is particularly costly in terms of lost productivity, largely due to missed days of work with indirect costs estimated to be around $12,000,000,000 per year in the U. S. Dealing with debilitating pain for as many as 3 straight days and living in constant dread of the next attack is hard enough.

However, many migraine patients also worry about losing their jobs and with it their long term financial stability. Despite the devastating impact of migraine on patients, their families and society, options to prevent migraine until now have been repurposed therapies that were not designed specifically for the treatment of this including medications such as anticonvulsants, antidepressants and antihypertensive medications that are decades old. Not surprisingly, 80% of patients discontinued therapy within 1 year due to side effects or lack of efficacy. All that changed with yesterday's approval of Aimovig, the first new medicine in decades designed specifically to prevent migraine. Aimovig is the 1st and only therapy specifically designed to prevent migraine by targeting and blocking the CGRP receptor.

With this new product, we will target the approximately 3,500,000 patients in the U. S. Currently receiving preventative migraine therapy. There is a tremendous pent up demand amongst this population for a medicine that will deliver powerful efficacy with very favorable side effect profile. Aimovig is the 1st and only therapy specifically designed to prevent migraine by targeting and blocking the CGRP receptor, differentiating us from potential future competitors.

Aimovig is the only CGRP receptor antagonist and offers convenient, low volume, self administered monthly subcu dosing. Another differentiator for Aimovig is that it's a fully human monoclonal antibody and does not of course contain any non human sequences. We have seen constant and sustained efficacy in clinical trials across a range of episodic and chronic migraine patients, including difficult to treat patients such as those who've been who have actually failed on 2 to 4 previous prior preventive treatments. In our trials, many patients achieved at least a 50% reduction in migraine frequency with 1 in 5 achieving at least a 75% reduction. Aimovig has an extensive safety database of over 3,000 patients with adverse events similar to placebo.

To further assess Aimovig's safety profile, we have conducted studies in combination with triptans as well as a cardiovascular treadmill study with angina patients. With respect to tolerability, a key drawback with many other migraine treatments, 95% of patients were able to stay on Aimovig during our clinical trials. We also have an ongoing 5 year open label extension study to further advance our data set. Aimovig is approved as preventative treatment of migraine in adults. The recommended dose is 70 milligrams once a month injected subcutaneously and available in our reliable SureClick order injector.

Some patients may benefit from a 140 milligram dose. The 140 milligram dose will initially be delivered using 2 70 ml water injectors and we plan to submit an SLA for a 140 milligram SureClick injector imminently. With Aimovig, no loading dose is required. Importantly, there are no dose dependent safety signals identified in our pivotal clinical trials. With Aimovig, physicians don't have to think about a trade off between the 2 available doses.

They can simply choose the dose that they believe is best for their patients based on the clinical data. I'll also note that there's no difference in price between the 70 140 milligram doses. In today's environment, we know that in addition to safety and efficacy, therefore, we have priced Aimovig with a goal of ensuring access for the appropriate patient population with minimal utilization management criteria. We've also priced Aimovig below the specialty threshold to ensure the patients' out of pocket costs are manageable. We've had good engagement with payers and PBMs and Aimovig and by and large they are supportive of our pricing.

We are providing rebates that will ensure reasonable utilization management criteria, reasonable co pays and access for appropriate patients. We believe that the payers recognize that there is a clear and long standing unmet need in migraine and that including Aimovig on their filmeries represents a good investment on behalf of patients and their employers. So we're excited to be partnering with Novartis to bring this important innovation to market. In a highly coordinated and focused approach, both Amgen and Novartis will call on healthcare providers that we've actually identified that represent the vast majority of our market opportunity for Aimovig. We began engaging these physicians several months ago to help further educate them on the burden of disease associated with migraine and to provide resources to assist them in improving patient care.

In terms of patient activation, our SPEAKER migraine efforts via social media have engaged more than 2,200,000 people since last August, strong evidence that migraine patients are eager for new solutions to help them better manage their disease. The Aimovig Ally has been created to help patients start and stay on Aimovig as prescribed. The program includes a free 2 month trial of Aimovig and for eligible patients with commercial insurance, the Aimovig co pay program can help reduce out of pocket expenses to as little as $5 per month. Looking ahead, we will wait to launch our TV campaign until we've created appropriate awareness among healthcare professionals. And in the meantime, we look forward to our launch next week.

So in closing, we are really excited about this opportunity to offer a new and innovative therapy to migraine patients desperate for a new treatment option. They and their physicians have waited a long time for this day to arrive. Aimovig is a differentiated CGRP receptor antagonist offering convenient, low volume, self administered monthly subcu dosing where 2 doses are available giving physicians the flexibility to prescribe what they believe to be best for their patients. Our clinical program has demonstrated sustained and consistent efficacy in a robust data package of over 3,000 patients including those who are very difficult to treat. The safety and tolerability profile of Aimovig is similar to placebo with a very low incidence of injection site reactions.

Together with Novartis, we really look forward to redefining migraine prevention for patients, physicians and payers. So let me stop there and Paul and I are available for questions.

Speaker 2

Excellent. Thanks, Tony. Natalia, why don't you go ahead and open it up for Q and A? And if you can just review the procedure for asking questions again, please.

Speaker 1

Your first question is from the line of Ying Huang with Bank of America Merrill Lynch.

Speaker 5

Hi, good morning. Congrats on the FDA approval. So a couple of quick ones. One is that I know you've said the price at about $5,900 at the growth level, but can you give us a little bit color on what kind of rebate or gross net adjustment we should expect? And secondly, have you started to talk about the contract agreements with big PBMs, including Express or CVS?

Thank you.

Speaker 3

So thank you, Ying. Yes. So we set the list price for a year of treatment at $6,900 which works at about $5.75 per month. Clearly, in today's world with the present rules around engagement, we are required to offer rebates to both payers and insurers in order to get access to a better utilization management criteria program. We believe the product will be used after patients have failed and that's always been our strategy and therefore the utilization criteria should state that.

We've had active discussions with all the large PBMs and a number of the insurers and we continue to be very encouraged with the responses we get We look forward to some early contracts being signed in the not too distant future. Obviously, we don't normally disclose the rebates we are negotiating.

Speaker 2

Let's take the next question.

Speaker 1

Your next question is from the line of Michael Yee with Jefferies.

Speaker 6

Thanks for the question and congrats on the first approval here. I guess my question was following along with that. Many physicians believe you have to fail perhaps things like BOTOX in the chronic setting. Maybe you could just talk about what type of management criteria you might expect or what would be expected in the chronic setting? How that might differ from the episodic setting where there are different drugs approved?

So I guess just talk about what type of barriers might be expected and how well you can work with payers to reduce these barriers? Thanks so much.

Speaker 3

So in most cases, we would expect a patient to have failed on 1 or 2 previous preventative therapies and have tried atriptan. In none of our discussions has BOTOX been a step through, step edit or a potential one.

Speaker 1

Your next question is from the line of Umer Raffat with Evercore ISI.

Speaker 7

Hi, guys. Thanks for taking my questions and congrats on the approval. Just early feedback from investors on the price has been positive. This is Mike Beatty for you, by the way. It's been positive.

It's actually priced less than GLP-one for diabetes. So just from a payer perspective, how likely do you see the value based contracting with Aimovig and anti CGRPs in general? I know Harvard Pilgrim Health has floated this idea in the not too recent past. And a quick follow-up is, any can you give us any sense of gross margins for the product and needle gauge size used? Thank you.

Speaker 3

So those are about 3 questions, Alex. Let me try and get through a couple of them. As a company and together with Novartis, we've always felt that value based contracts are essential as we go forward. Our product has clear levels of efficacy, which become fairly predictable in the short period. And therefore, we look forward to signing value based contract with those who wish to do them with us.

The rebates themselves will depend on the size of the plan and the impact of the utilization management criteria. So there's a range of contracting that does take place. Obviously, I'm not in a place to disclose those. On the needle gauge, I actually don't have that. And if I get that in the next couple of minutes, I'll come back to you.

I am told that it's a very simple, sure click injection. It's a low volume, quick and easy, and we have not had any real issues with patients injecting themselves using the SureClick.

Speaker 1

Your next question is from the line of Terence Flynn with Goldman Sachs.

Speaker 8

Hi, thanks for taking the question. Maybe just I was wondering how you guys plan to use your first to market advantage. Obviously, a number of competitors have potential approval dates coming later on, but how are you thinking about that advantage, Tony? And then can you give us any commentary regarding your commercial footprint, you versus Novartis and maybe the number of docs that you're targeting out of the gates? Thanks a lot.

So

Speaker 3

we don't think we first to market because we think we're the only one in the market at the moment, Terrence. We are the only CGRP receptor antagonist. And I keep reminding payers about that. In fact, our mode of action is fundamentally different. Being first to market is a huge and distinctive advantage.

It is clear that there's a large pent up demand in the marketplace for a drug that truly is designed to treat migraines such as Aimovigas. We look forward to having a large bolus of patients coming in quickly. We have worked actively with the payers to ensure access will become available fairly soon, that the patients who are eligible are able to get on the drug quickly. Our Aimovig Allied program too will assist patients to test the drug quickly. So by the time competition arrive, a large number of patients will already be on this drug and those benefiting of course will have no reason to change.

I think that was in terms of the market size, both Novartis and our sales will obviously calling upon the headache specialists, neurologists who treat diseases such as migraine, and then a number of primary care physicians who have practices where we see high levels of prescription for diseases like this.

Speaker 1

Your next question is from the line of Geoff Meacham with Barclays.

Speaker 9

Hey, guys. Congrats on the approval. Great job. I'm sure the fair reception to price is going to be quite good. And I know you have a broad label, but practically, do you think the positioning will be initially after triptan or BOTOX use?

Does that change over time? And then another related question is, are there differences between the U. S. And Europe with respect to sequencing of CGRPs?

Speaker 8

Thank you.

Speaker 3

So we think that most patients have touched triptan somewhere along in their lives. And obviously, we are talking about patients that are already on preventive or have been on preventive therapy. So each of utilization management criteria will change depending on the plan. But in theory, it's a continuation of you have to have failed 1 or 2 and you have to have touched a triptan. So there are numerous patients, of course, who have gone through that already.

Let me turn to Paul and ask Paul if he wanted comment about the sequencing in Europe.

Speaker 4

Thanks, Geoff. No real specific differences, but it is worth reminding everybody that there are approximately 2,000,000 patients on prophylactic treatment today in Europe. So they're all at different stages, of course, but we think there is a significant opportunity for the majority of those to be considered. So we're worrying a little bit less about sequencing at this point. Clearly, there's a bit of a journey to go.

We won't get approved until Q3 hopefully. And then we have our reimbursement sort of rolling from there. So we'll get more actively into those conversations as we get approval.

Speaker 1

Your next question is from the line of Ryanair Gill with Bernstein.

Speaker 10

Good morning, everybody. Congratulations from me as well for this important approval. Future questions about the access to the patients. First, you explained point of care rebates to patients. Do you expect now that it's under your specialty tier to have anybody with coinsurance such as co pays?

And timing for starting TV campaign around this drug? Is this something you're going to wait 6 months for or something we should expect earlier than that?

Speaker 3

Roni, thanks for the question. I'm glad you're aligned with the pricing over here. Yes, we specifically made sure that we went below a specialty tier to ensure we didn't get stuck with coinsurance. So most of the plans have aligned with us that this will be a copay, no coinsurance. And we're working hard to make sure that the burden on patients is as low as possible in fact.

As regards the TV, we will follow the pharma guidelines and we'll not go to TV for at least the 1st 6 months. We want to spend time ensuring that the healthcare providers really understand the drug, the disease and the value the drug brings to patients. Did I miss one of your questions? Ronu, was there anything else you had? I think I've lost Roni.

Okay. Just I also just got the information. It's a 27 gauge needle on all our SureClick injectors as well as the pre fill syringe. Can we go to next question?

Speaker 1

Your next question is from the line of Tim Anderson with Bernstein.

Speaker 6

Thanks. This is a question for Paul. I had the chance to meet with Vas and Joe late last year. They used the phrase wildcard when talking about the commercial potential of the CGRPs, which obviously anticipates payer pushback. So these were CEO comments.

Paul, would you concur with the use of the phrase use of the term wildcard when looking at the commercial potential now that you know the pricing?

Speaker 4

So I think, when that statement was made, it was really in context of the type of environment we would be launching into and of course price or more importantly value that we could bring. I don't think it was at all associated with just how extraordinary this medicine is or the value it brings to patients. I think we've seen the decision taken in the U. S. To price absolutely responsibly.

Maintaining similar logic, we would hope that we remove some of that wildcard component as we get to launch. The slight difference will be, of course, this rolling reimbursement situation that I mentioned earlier. So it will come on in more of a gradual rollout. But I'm feeling very confident clinically the data, we need to see the label, finalize price and then we can be more specific. But perhaps feeling less wildcard than we were this time

Speaker 1

last year. Your next question is from the line of Matthew Harrison with Morgan Stanley.

Speaker 11

Great. Good morning, everybody. Thanks for taking the questions. I guess, 2 for me, Tony. So first question is, can you talk a little bit about how you think about persistence?

And do you expect any of the plans to require patients to have some threshold of response to stay on the drug? And then second question is and it sounds like this is in her in from your comments, but it sounds like you believe that most the plans will have access pretty quickly. These plans aren't going to wait and try and wait for other drugs to be approved before giving you broad access? Thanks.

Speaker 3

Thanks, Matt. I think the plans have been talking to the same headache specialists as we have. And it's been a long time since I've seen a level of excitement that I'm seeing amongst these neurologists who've spent their lives and dedicated their lives to treating things like migraine and had to suffer with suboptimal products for treatment. So we see a very high level of excitement and urgency around being able to get access to products for patients that have struggled for decades. So I think the payers are clearly seeing this unmet need and the excitement around what a product like Aimovig can do.

At the same time, I think the vocalization of needs by migraine patients themselves is more than I've seen for some time now. And I think when you go out to run a focus group with migraine it is amazing how responsive they are, how much they've thought about the disease, how much they thought about it impacting their lives. So I think the feedback they're getting from the physicians, from patients and even from employers who understand the devastation of absenteeism and presenteeism, right. And I was talking to a CEO just the other day who was suddenly realized that having an employee with a migraine at work is a real concern because the impact on judgment as such. So we've not been told that anything will be held or kicked down the road.

No, I mean all the plans have agreed that this is a logical intervention. The price appears to be right. The rebates have been discussed, of course, and negotiated. And it looks like all the plans will be thinking imminently. Some of them are linked back to the timing of their P and T committees as they go forward.

So from a persistency perspective, I would imagine that some of the plans will be doing a reverification at month 3 and at month 6. And that will become part of the criteria going forward. But it's one of those diseases where patients will fundamentally know whether they are responding to drug or not. Thank you.

Speaker 1

Your next question is from the line of Cory Kasimov with JPMorgan.

Speaker 11

Let me add my congrats as well. Thanks for taking the question. So I guess I'm just wondering, is a once a month product, what do you expect for real world compliance rates? And can you remind us what you saw in your clinical trial experience? Thanks.

Speaker 3

So clinical trials of course are never representative of real life, but we saw a 95% persistency rate in the clinical trials. We do believe that with a system with a symptomatic disease like migraine, patients will know very quickly if they miss a dose, right. So the convenience of a simple once a month subcu injection, we believe will be pretty high. We know that with Repatha at the moment, our persistency is quite high there too, where patients are going beyond a year. So I would expect this to be a fairly high number in comparison to the normal 7, 8 months on our oral products for chronic care.

Speaker 1

Your next question is from the line of Celine Syed with Mizuho.

Speaker 12

Yes. Hi, guys. Congrats on the approval. I just had a question around the pricing for the 2 packages you guys have. So what protocol and maybe I'm just missing it, but what protocols or things are in place that would prevent a doctor or a patient for taking getting the 2 times 70 milligram and spreading that across 2 months if they're taking 70 milligrams

Speaker 4

per month?

Speaker 3

So good question Salim. Thank you. So it is clear to us based on the clinical data that both the 70 milligram and the one forty milligram should really be available because different patients respond differently to different doses. Our recent Phase 3b trial, the LIBERTY trial, which actually included all patients that already failed on 2 to 4 previous preventive therapies use only the 1 40 milligram dose and we've got an exceptionally good response in those patients. So we didn't want to come to market with an inability for physicians to make a quick decision about 70 or 140 Because the 140 milligram SureClick will only be available in the next couple of months, we will make a double pack 70 milligram available at the same price of 70.

I understand and accept that there might be some splitting that happens, but once the 140 milligram is on the market, we will no longer supply the double pack 70.

Speaker 1

Your next question is from the line of Graham Parry with Bank of America.

Speaker 13

Hi, thanks for taking my question. So firstly a question for Paul. The product is obviously being priced for access in the U. S. And could you just help us understand whether that's a good analog for European and ex U.

S. Pricing? And secondly, with this product, you see quite a large heterogeneity of patient responses. So I'm just wondering, were payers interested in pay for performance contracting here, some sort of set up where they're only actually paying for patients who are responding to the drug as opposed to the low responders? And then thirdly, if you could just give us your thoughts on access and penetration into the Medicaid population?

Thank you.

Speaker 4

So I'll take that and maybe I'll leave Tony with the Medicaid question. So I think what I can tell you on price at this point is that we are really focusing on the value we bring. The data is compelling. I think we've been, again, incredibly responsible in the U. S.

And trying to find the perfect position for patients, for payers and of course for us. We'll strive to do the same ex U. S. So, Ken, on that. As for paying for responders or non responders, Graham, I think I heard that question correctly.

It's our intent where local regulations allow in countries that we're responsible for to try and provide an opportunity for a patient to demonstrate their responder either through access or samples depending on the local regulations. So that really we remove that from the table and we've already got into a situation where we know patients respond and therefore, the question of levels of response thereafter become a matter of the clinician and the patient to decide what happens next. So maybe I should add and I should have mentioned it, Tony mentioned it very elegantly. There is such a noise, you may have seen it on social networks today around the patients wanting to step forward and desperate to try something new and break through that we think many will come forward and wanting to confirm that it does work on them and we will be there for them. Bearing in mind we're not expecting approval till Q3.

Speaker 3

So as regards to your question on Medicaid, we estimate anywhere between 10% to 15% of our patients will be Medicaid type patients.

Speaker 1

Your next question is from the line of Kennen MacKay with RBC Capital.

Speaker 8

Hi, thanks for taking the question. Wondering if you could tell us give us a headcount of what the Amgen and Novartis neuro sales force looks like now or any color into MSLs as well? And then also wondering if or when you may provide us with some sales guidance or even sales aspirations? Thank you very much.

Speaker 3

Okay. So together with Novartis, we intend covering the most influential national and regional KOLs and a large number of existing prescribers for migraine as we continue to prospect. Obviously, we'll be using different sales organizations, those that have specialty skills, those that have primary care skills, and they've all been trained. In fact, they've been trained as we speak right now on the new label. We don't normally disclose what the sizes are, and we really don't give product specific forecasting.

Speaker 2

Your next question yes, go ahead.

Speaker 1

Your next question is from the line of Trung Quinn with Credit Suisse.

Speaker 14

Hello. Trung from Credit Suisse. So with the bolus of patient interest, the lack of initial managed care access and a short window where you're going to be the only CGRP on the market. Can you give us some more color around your free trial program and sampling? And then because of this, how should we think about the correlation between prescriptions and revenues?

Cheers.

Speaker 3

So as I said early on, we are pretty close to agreeing a number of access situations with PBMs and insurers. So I look forward to focusing majority of our effort on opening up access to patients with the existing plans, and the feedback we've had to date has been fairly positive. In the interim, however, for those who do have a need, the Aimovig Ally program is a 2 month available program for patients who qualify. And of course, we will be assisting physicians as and when required with samples. And the sales will be the sales and the prescriptions will be the prescriptions, I'm afraid.

And we will we report 1 as a company and prescriptions are reported independently.

Speaker 1

We have a question from the line of Louisa Hector with Exane.

Speaker 15

Hi, thanks for taking my question. So still along the same lines, just thinking about the ramp up because obviously you're talking about the Ally program for 2 months, free samples. The access could come through quite quickly, but you've got the strong patient demand. So should we be quite conservative in year 1 and expect this to really take off from 2019? And could you give us a sense of how quickly the drug may become profitable?

And just returning to the sales force, can you just remind us in which regions you're promoting, whether there's any joint marketing in any regions, please? Thank you.

Speaker 3

So let me start with the last one first. We are co promoting in the U. S. So the teams that joined at the hip, the Novartis Amgen team that has done the strategy work, the marketing work, the execution work, the consolidated medical work. Amgen has led the contracting and the pricing negotiation and we both collectively are in the field with the sales organizations.

Amgen has the right in Japan for this product and the rest of the world is run and managed by Novartis. As regards the uptake, I think an uptake of a product like this, which is chronic disease, is always on a different curve. We want to actually having to build an annuity over time. There will, of course, be a beginning where some patients will be on samples and some will be on the free goods program. We will move as rapidly as we can to ensuring that once a patient's plan accepts the drug, puts it on a formulary that we'll actually switch those patients to their formulary.

Speaker 2

Natalia, let's take one last question. And then after that, Tony may want to make some concluding comments for the call.

Speaker 1

The final question is from the line of Kenneth Atkins with Cowen.

Speaker 16

Hi, thanks for taking my question. Could you maybe elaborate a bit on your plans for expanding the label, for instance, to the pediatric migraine population? Thanks.

Speaker 3

So I'm going to ask Doctor. Elliott Levy to answer that one, our

Speaker 16

Head of Development. So first, I just want to point out that we are coming to market with probably the largest data package in the area. We're the only company that created an instrument for evaluating the impact of the product on patient reported outcomes. And we have with the MP FID, which appears in the label, it's the only validated patient reported outcome measure that's fully compliant with the latest FDA guidance on PROs and it's one of the very few PROs to appear in any FDA approved label. We've also done, I think, important work understanding the safety profile of the product, as Tony mentioned, with the triptan interaction study, the CV treadmill study, which provided information about our product that may not be generalizable to the other products that have a different mechanism of action.

As for any first entrance to the market in a new field, especially a field like migraine, there are many questions that remain to be answered. We are evaluating, expanding into a number of other headache types. You mentioned pediatrics, we think that the pediatric area is quite important. There's a growing appreciation of the frequency and the disruptive effect of migraine in children and we're moving forward very quickly with a program to secure indications in both school age children and in adolescence.

Speaker 2

Tony, do you want to make any closing comments?

Speaker 3

So thank you then. First of all, thank you again for joining us at what is an early hour in California, but perhaps a working hour for you folks. The more Paul and I talk to patients, the more we realize how devastating this disease is. And the realization of how we can actually change the course of people's lives and the ability to come back to being fully contributing citizens wherever they live is very special. Paul and I have spent some time with key opinion leaders listening to their needs as physicians who've been trying to treat migraine patients for many years.

And I don't think that we've actually seen a group of people more excited than this group about this new innovation that's coming to market. I think what we've done with the payer environment has really laid the ground for an early access for patients. So there's minimal bureaucratic hassle and or utilization management criteria that's required to get access to patients. And we bring into market what we consider to be a differentiated 1st and only in class CGRP receptor antagonist that is differentiated to other potential products that might come to market. And last but not least, coming to market with Novartis in the U.

S. Who have a strong recognition in the neuroscience area, a strong link with the medical groups in that area makes us a strong powerful unity of force. So we look forward to delivering real value to patients, to physicians and to payers. So thank you so much

Speaker 2

for your time. Great. Thanks, Tony. Thank you everybody for your participation. Of course, the Investor Relations teams will be around.

So if you have any other follow on questions, feel free to reach out to us. Thanks again.

Speaker 1

This concludes today's presentation. Thank you for your participation. You may now disconnect.

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