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Edited Transcript of LUN.CO earnings conference call or presentation 12-May-20 11:00am GMT

Q1 2020 H Lundbeck A/S Earnings Call

Copenhagen May 13, 2020 (Thomson StreetEvents) -- Edited Transcript of H Lundbeck A/S earnings conference call or presentation Tuesday, May 12, 2020 at 11:00:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Anders Götzsche

H. Lundbeck A/S - Executive VP & CFO

* Deborah Dunsire

H. Lundbeck A/S - President & CEO

* Jacob Tolstrup

H. Lundbeck A/S - EVP of Commercial Operations

* Per Johan Luthman

H. Lundbeck A/S - EVP of R&D

* Peter Anastasiou

H. Lundbeck A/S - EVP of North America

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Conference Call Participants

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* Carsten Lønborg Madsen

SEB, Research Division - Research Analyst

* Emily Field

Barclays Bank PLC, Research Division - Research Analyst

* James Daniel Gordon

JP Morgan Chase & Co, Research Division - Senior Analyst

* Jannick Lindegaard Denholt

ABG Sundal Collier Holding ASA, Research Division - Research Analyst

* Marc Harold Goodman

SVB Leerink LLC, Research Division - MD of Neuroscience & Senior Research Analyst

* Martin Parkhøi

Danske Bank A/S, Research Division - Senior Equity Analyst

* Michael Novod

Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator

* Peter James Welford

Jefferies LLC, Research Division - Senior Equity Analyst & European Pharmaceuticals Analyst

* Trung Chuong Huynh

Crédit Suisse AG, Research Division - Research Analyst

* Wimal Kapadia

Sanford C. Bernstein & Co., LLC., Research Division - Research Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, welcome to the H. Lundbeck Q1 2020 Conference Call. (Operator Instructions). Today, I'm pleased to present Deborah Dunsire, President and CEO. Please begin your meeting.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [2]

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Thank you very much, operator. Thank you all for your interest in Lundbeck. We welcome you to this Lundbeck teleconference covering our financial report for the first quarter of 2020. Together with me are our CFO, Anders Götzsche; Johan Luthman, Head of R&D; Jacob Tolstrup, Head of Commercial Operations; and calling in from Chicago, Peter Anastasiou, Head of North America.

On Slide 2, you can see our disclaimer, which I know you've read many times, so let's move on to Slide 3. Firstly, I want to say how proud I am of the way Lundbeck employees responded to the immense challenges of the COVID-19 pandemic. They continue to put patients first while embracing and delivering on our Expand and Invest to Grow strategy.

Our strategic brands continue to show remarkably strong growth both in volume and value across all regions of the world. In total, our strategic brands grew 35% and now constitute 59% of revenue. In the quarter, Vyepti was approved on the PDUFA date by the U.S. FDA. A phased launch commenced in April. Of course, these are not normal times, but we are encouraged by the interest from patients, health care professionals and payers.

The first patients received infusions of Vyepti the day after the product was made available in the supply chain. We've also accomplished the first submissions for regulatory approval in other parts of the world. We are acutely aware that 2020 is a year with more than usual uncertainty. But as of Q1, we see strong performance with good underlying demand growth. Anders will elaborate on the financials in detail. So here, I'll just state that we are reaffirming our guidance.

With that, turn to the next slide, please. Before we move on, I think it's reasonable to elaborate a little more on how the COVID-19 pandemic has posed challenges for us during the first quarter. Lundbeck's top priorities during the pandemic are and will remain preserving the health and safety of our employees and ensuring that we can continue to safely supply all of our medicines to the millions of patients who depend on them around the world.

Working from home became the norm for all of our employees across the globe, except for our production and lab employees in Denmark, France, Italy and the U.S., who continued to operate with streamlined teams throughout the lockdowns. We are proud to say that the global supply chain for our medicines has remained fully intact. We know that some of the strong growth in demand for our products in the quarter was partly driven by prescription lengthening in many countries. We also saw increases in inventory across the distribution channel. We anticipate such stocking will unwind during the second quarter.

We now see a growing number of countries in which employees are returning to the office in line with government guidelines as the pandemic has peaked and receded in this first critical phase. China and Korea are getting back towards normal. And in Denmark, we will be having 50% of our office workers back on-site as of tomorrow. This is very encouraging, but it is far from being normal. Our ability to interact with health care professionals is still predominantly through virtual channels. We've significantly expanded our use of digital solutions and increased the use of compliant remote platforms for educational and promotional interaction with health care professionals.

It's important to note that the COVID-19 pandemic also impacts the clinical and regulatory activities as many health care systems have had to reprioritize, limit or cease activity in clinical trials to ensure patient safety and allow physicians and other health care professionals to turn their attention to combating the pandemic. We still expect to be able to start new studies later in the year, and Johan will comment on this in more detail.

Next slide, please. The graph to the right of the page illustrates that Lundbeck is returning to growth. If one excludes the loss of exclusivity based declines in Onfi, Sabril and Xenazine in the U.S., revenue is up 22%, driven by the significant growth momentum of our strategic brands. The other mature brands are relatively flat as a whole, with declines being balanced by growth in several markets like Japan and to China. The momentum of the major strategic brands as well as the growth of our new arrival Vyepti will drive Lundbeck's growth going forward.

Please turn to the next slide. Our 4 major strategic brands generated substantial growth, up 35% in aggregate, adding DKK 700 million in sales compared to the same period last year. There is healthy volume growth for all our strategic brands, but we also recognize a certain benefit from inventory increases. These growth products constitute close to 60% of Lundbeck sales. Rexulti is still majority U.S. franchise. The brand achieved more than DKK 700 million in sales in the quarter, which represents an impressive growth of 48%, very impressive in its fifth year on the market.

Revenue from Trintellix reached DKK 817 million in the first quarter 2020, a growth of 36%. In the U.S., Trintellix continues to increase its market share. We've seen continued strong demand growth, driven by an increase in new patients as well as improved persistence on therapy. Abilify Maintena was launched in 2013 and still grew 33% to more than DKK 600 million. In many markets, Abilify Maintena is now the second most prescribed long-acting injectable treatment for patients with schizophrenia. Northera grew 24%, finishing the quarter above DKK 530 million. We continue to expect good volume and value growth for this product in 2020.

We continue to expect that the strategic brands will continue double-digit growth in the rest of 2020, a testament to the value these products provide as well as to the excellence in execution by our commercial organizations around the world.

Next slide, please. As you know, the FDA approved Vyepti on the PDUFA action date of February 21, and we managed the importation of the product in spite of the COVID-19 situation and were therefore able to fill the first orders at the beginning of April as expected. The first patient already received infusion the following day that -- from the supply chain being filled.

Following the requirement for our employees to work from home, the launch strategy has obviously been adapted into what we term a phased launch. During this period, we've conducted a lot of virtual training sessions, educational events and some promotional activities. Upon removal of our work-from-home policy, the sales team will begin to see health care professionals again. But we do anticipate this will be a slow ramp rather than a single flip of the switch, returning 100% of the planned activity.

We see strong interest from health care professionals, and several payers have also issued coverage policies. It's an encouraging beginning given the times we're living in.

Next slide, please. The fact that we've been able to continue to enroll patients in the RELEASE study with Vyepti is another demonstration of patients' interest in this product. We also have an aggressive plan for maximizing the value of Vyepti, which we see as a pipeline in a product. The first new indication we plan to pursue is episodic cluster headache, where we see strong potential. We've also, on previous occasions, stressed the need for a market access study to support European pricing dialogue. This Phase IIIB study is planned to commence around the middle of the year, but it is important to stress that the COVID-19 situation may hamper the process of starting new clinical activity.

Finally, I'm glad to say that we've submitted for approval of Vyepti in Australia, Canada and Switzerland. It's still our plan to submit in Europe by the end of 2020. Johan will talk further about the pipeline in a minute.

But I'll now hand the microphone over to Anders Götzsche to comment on the financial picture.

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [3]

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Thank you very much, Deborah. Please turn to Slide 9. Revenue increased by 8%, reaching DKK 4.6 billion, with limited impact from exchange rate. This is driven by the strong growth from all our 4 strategic brands.

Cost of sales declined 2% to DKK 805 million for the quarter, of which amortization on product-wise was DKK 197 million. Our gross margin reached 82.4%, up from 80.5% last year. We maintain good control of our operational cost. The SG&A costs increased 18%, which is mainly linked to the Vyepti-related costs and investments -- cost and investments in China and Japan as well as other growth initiatives globally. The SG&A ratio was 37.7% compared to 34.5% a year before.

R&D cost more than doubled, but due to the impairment of product rights related to foliglurax of approximately DKK 800 million. Adjusted for this, the R&D cost increased by around 17%, mainly related to Vyepti project costs.

Core EBIT reached DKK 1.357 billion, and core EBIT margin only declined from 33.3% the year before to 29.7% this quarter. We see this as a very solid result. The effective tax rate for the quarter is heavily impacted by the foliglurax impairment. Focusing on the core tax rate, it actually declined from 25 percentage points to 23%.

Core earnings per share reached DKK 4.89 per share.

Please turn to Slide 10. In the North American region, we are very pleased with the continued strong growth of our strategic brands, which now constitutes more than 80% of the regional revenue. Actually, if adjusted for Onfi, Sabril and Xenazine, the growth is 32% for the quarter. International markets increased 16%, reaching DKK 1.2 billion or 27% of our revenue. China has been negatively impacted by the COVID-19 situation in line with the expectations communicated in February. However, other markets in the region has had a positive impact from inventory increases in the distribution chain. This region is still in the early part of the rollout of our strategic brands, which had a growth of 47% in the quarter. We expect to see significant long-term growth for these products in the region.

Japan is an investment area for Lundbeck as we have just launched Trintellix together with Takeda. Trintellix was launched in November, so it's early in the launch phase. But so far, the product have had a solid, very solid start. COVID-19 has had a slight negative impact on the uptake during the last 2 months.

Europe is delivering a solid growth with revenue increasing 9% to almost DKK 900 million. The main driver is volume growth, but we have also benefited from inventory building. The European region is also an important part of our overall performance as is driving -- or is driven by our strategic brands, which grew 28% and now constitutes more than 57% of sales in the region.

Next slide, please. Lundbeck continues to generate a solid cash flow, also the level being impacted by the major investments as part of the expanded investor growth strategy. The cash flow for the quarter is impacted by the payout of dividend of DKK 850 million. We expect the net debt position by the end of the year to be around DKK 6 billion.

Next, please. Next slide, please. Based on the solid performance in the first quarter, we have confirmed the guidance we provided in March following the foliglurax data announcement. We expect continued growth for our strategic brands, Abilify Maintena, Brintellix, Trintellix, Northera, Rexulti and now also Vyepti, which will more than offset the impact from the continued generic erosion on our mature product portfolio.

It is also important to point out that following the coronavirus outbreak, Lundbeck sees increased uncertainty for the remaining part of 2020. We still expect growth in the revenue to be around 2% to 6%, and meaning a revenue range of DKK 17.4 billion to DKK 18 billion. We will continue to be disciplined in our spending in 2020. But as we have previously communicated, we will make considerable investments in loans and development activities related to Vyepti, which will impact our EBIT for 2020.

Core EBIT is expected to reach a range of DKK 3.5 billion to DKK 4 billion, which is a margin of at least 19%. Reported EBIT is expected to reach between DKK 1.4 billion and DKK 1.9 billion for 2020. For the financial items, you should expect a net expense of DKK 300 million to DKK 400 million, depending on the currency development.

Now I'll hand over to Johan to provide an update on our R&D pipeline.

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [4]

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Thank you, Anders. Firstly, I'd like to comment in general on the impact of the COVID-19 pandemic on our clinical development portfolio. We have implemented major mitigation activities with our partners and CROs, including remote solutions as much as possible. We are making every effort to ensure that patients in affected areas who are enrolled in clinical trials can continue their treatment and receive their proper care and monitoring. The situation is evolving by site and country, but as local conditions allow, we will enroll patients in our ongoing studies and even start new trials when possible. It is, however, clear that enrollment and site activations are impacted. Furthermore, drop out rates in our ongoing trials have increased.

The broad life cycle management program on brexpiprazole is heavily affected. But currently, it's too early to tell what effects on time lines this may have. That said, we have also been able to maintain some critical activities, such as the RELIEF study and the Japanese PK study on Vyepti. We also had some recent program events. Initially, I'd like to comment on the lead MAGL pace inhibitor 06466. We are initiating a number of studies to fully explore this mechanism of action across a range of psychiatric and knowledge indications. However, as announced earlier, the small threat Phase IIa study did not support continuation in that indication. This program is one of several programs we expect to see in the coming years after the 7 hydrolase inhibition platform, pursued at Lundbeck La Jolla research site. We have high confidence in the research platform we acquired last year.

Foliglurax, a Phase IIa study for Parkinson's disease add-on therapy to standard of care, did not provide sufficient, so-called off time reduction and have no effect on this condition. And with that, the entire program has been terminated.

We also had some moments in the early-stage pipeline. Our lead KD7 activator was stopped due to lack of desired PK and safety margin profile, but we expect at least one more first-in-human entrant this year. Importantly, I'd like to highlight that we've substantially enlarged the program around eptinezumab in the coming years to include supportive studies for registration and market access in various geographies as well as several indication expansion studies.

Next slide, please. I have probably not been speaking much about vortioxetine for a while, but we are actually still performing quite a few studies on this very interesting drug. For instance, we recently finalized the complete study, which was an open-label flexible dose study of vortioxetine investigating emotional function in patients with major repetitive disorder with partial response to SSRIs and SNRIs. Up to 75% of patients treating with those agents can suffer from so-called blunted emotions, which have real functional consequences for patient's social, family life and work lives. The outcome of the study has not yet been published, so there are limits to how much I can describe at this stage. However, the data are very good, with highly significant effects on emotional blunting observed already 1 week after the initiation of treatment. This adds to the body of data supporting vortioxetine's broad impact in major depressive disorder.

With that, I hand over to Deborah.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [5]

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Thanks, Johan. Next slide, please. Through the hard work of our employees, we've adapted our ways of working to the changed conditions in the wake of COVID-19, keeping our employees safe and ensuring business continuity and including maintaining supply to ensure our medicines reach as many people suffering from brain diseases.

As a company, we also do not forget that we have a role in the societies we live in. These unprecedented conditions have also led stakeholders to ask for our support. We've assessed each request carefully and responded with care and consideration to the specified means. We're pleased that we've been able to provide financial and medical support to eligible recipients and patient groups in many countries, including China, Europe and the U.S.

The pandemic has generally reduced the physical activity on our site. So that, together with our other preventive actions has led to a reduced number of loss time accidents. In spite of the pandemic, our focus on progressing to carbon neutrality has not diminished, and Lundbeck has contributed as part of the Danish Climate Partnership on business ambition, 70%.

Next slide, please. It's been a very busy quarter, and I'm sure the rest of 2020 will be just as eventful as we work to mitigate the effects of COVID-19, continue the phased launch of Vyepti in the U.S., and drive our current business forward, while we continue to execute on our Expand and Invest to Grow strategy.

To summarize. Leveraging our deep neuroscience expertise to restore brain health is our path to grow Lundbeck and create value for patients, for our society, for our employees and for all our stakeholders. Through this, Lundbeck will continue to be a robust and sustainable company in the years and decades ahead. The outstanding operating results over the past years give us the strong financial foundation to go forward and achieve these goals.

With that, I would like to thank you all for your interest and open the Q&A session.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Wimal Kapadia from Bernstein.

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Wimal Kapadia, Sanford C. Bernstein & Co., LLC., Research Division - Research Analyst [2]

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So just the first one is on the stocking benefit in 1Q. Are you able to provide any impact in terms of DKK million amount, which products were most impacted and particularly within which regions? And then tied to this, how should I think about the margin benefit from these additional revenues? Can you confirm these are higher-margin revenues, which will then be rebated away later in the year?

My second question is just on Vyepti coverage. You mentioned several payers. So I'm just curious how much access you actually have today. And how do you expect that to evolve over the coming months? And has COVID-19 really slowed down your ability to negotiate the coverage? And then tied to this, the DKK 2 billion spend in 2020, given COVID-19, should we expect less this year and some of the spend to roll into '21?

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [3]

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Okay. Lots of questions there. And I'm going to hand over to Anders to start on the stocking benefit.

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [4]

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Yes. So we have seen a lot of different movements in the quarter from stocking. You see the slowdown in China due to less personnel in the field. Now we see a rebound. You see stocking in some areas. You see destocking in other areas. It's extremely difficult to quantify. And we have decided not to go into -- because I think if we quantified it, it would only -- the only thing we could be sure of it was a wrong number. So we are not going into that. But of course, having an 8% growth in the quarter, and that is actually driven by 35% in the strategic brands. And please remember that in last year, we had 28% growth for the strategic brand. So what has happened in the first quarter is we continue to boost growth momentum and then, on top of that, there was an impact from stocking. So of course, that also impacts the good margin in the quarter. And for the full year, we still anticipate a growth of 2% to 6%.

If the destocking will come in second quarter, third quarter, fourth quarter, extremely difficult to predict.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [5]

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Yes. And then you asked a question, Wimal, about the sales -- as the inventory comes off, will it be rebated later. I don't think that we can tell that now. Anders, would you comment on that?

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [6]

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No. We don't have a lot of insight into -- basically, the business is ongoing. We have -- you have seen, we have taken the price increases as we have taken, which is in line with last year. The only outstanding price increases is for Rexulti and Abilify. That would probably be taken mid-year, but of course, that call is Otsuka's call, so that we are waiting for that. That is basically the only outstanding. The underlying growth is continuing. And with respect to the DKK 2 billion, we anticipate that we will continue to invest in, as Johan alluded to, in R&D investments for expanding the indications. We will continue to invest in the launch activities. There will be some -- if this continues, then there will be some savings in travel and events and other things, but we might want to use that for investing in digital platforms and other ways of working. So for the time being, we speak to the numbers that we laid out when we started the year.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [7]

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And then just one comment on the stocking benefit, before I hand it over to Peter to talk about Vyepti coverage. It's hard to discern what is prescription lengthening. So in other words, the patient, instead of getting a couple of weeks or a month, gets maybe a month or 90 days. And therefore, it fails that have moved forward versus actual inventory build. And so it's a complicated mix of things done, and we can't really dissect it. With that, I'll hand it over to Peter and ask you to comment on the Vyepti insurance coverage and whether it's been more difficult and how much of the market is not covered.

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Peter Anastasiou, H. Lundbeck A/S - EVP of North America [8]

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Yes. So thanks for the question, Wimal. Hopefully, you can hear me. As you know, when you get a new product launched, access does not happen all at one time. It happens over a period of time. And different payers have different policies. Some have a wait and see policy. They want to see what kind of demand is out there. Some have preliminary decisions that they make kind of automatically no matter what the product is. And then, of course, others make decisions right away. So I think it's important to highlight that pandemic or no pandemic, getting access for new therapies is always a process that can take many months.

Having said that, I would characterize our situation with Vyepti as being on track to our expectations from an access perspective or maybe even slightly ahead of schedule. We've had many plans that have made positive decisions, most notably, Anthem, which is the second largest payer in the U.S., which is great, but we've also had several regional plans and other plans that have made positive decisions. And in terms of -- is it more difficult, it's -- I don't believe it is more difficult under the COVID-19 situation, because many of the interactions we've had with payers, some are face-to-face, but many of them are virtual already because the payers -- the personnel that we deal with, where we're working on the health economic story, where we're talking to them about the clinical story et cetera, oftentimes are dispersed across different sites for the payer across the country. And it's very rare that all of those people are in the same place at the same time. So we've been used to, in the past, working in this virtual world with payers, and so working under the current circumstances hasn't hampered our efforts at all. And like I said, I would just close by characterizing it as on track at the very least and maybe even slightly ahead of schedule.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [9]

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Lastly, Anders, do you want any -- add anything on the main question?

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [10]

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Yes. Maybe to your question around cost, it goes without saying the situation right now is that it seems as a lot of countries are starting to reopen, what it also means is that some of the clinical trials will start to regain momentum. If it continues -- if you have a long lockdown in countries, then -- and the clinical trials are not restarting, then, of course, we will have some saving from a project point of view. But already, we have seen, for example, in Denmark, there has been trials -- not in our -- for our company, but other companies restarting. So you slowly see things regaining momentum. And if it's only a couple of months, we don't anticipate to see a lot of cost savings. So in general, you should anticipate that the level that we have indicated before is more or less that level, but of course, not more than the DKK 2 billion. It could be slightly less.

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Operator [11]

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And the next question comes from the line of Marc Goodman from SVB Leerink.

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Marc Harold Goodman, SVB Leerink LLC, Research Division - MD of Neuroscience & Senior Research Analyst [12]

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Yes, a couple of questions. One, Rexulti in Europe. Can you just give us a sense of what countries it's been rolled out in? And where we should expect that to go? So we can get a sense of the ramp there. It still seems it hasn't gotten going yet. And then can you give us a sense of Vyepti in, I guess, in the month, 1.5 months that you've had it on the market, how it's done and how you expect that impact? You talk about a phased ramp. Maybe you can explain what you mean by that and how we should expect that product to do in this environment?

And the last question was just the gross margin. The core gross margin was obviously very strong in the quarter. I was wondering if that 86%, 87% type range was sustainable for the year?

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [13]

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Great. Jacob is going to start on Europe.

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Jacob Tolstrup, H. Lundbeck A/S - EVP of Commercial Operations [14]

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Yes. Thanks very much for the question. So on Rexulti for Europe, true, it is still in a relatively limited number of countries, Switzerland, Northern European countries where we have launched Rexulti at this time. And I think we also commented on this earlier, Rexulti for us in Europe is focused on schizophrenia, will be a great addition to our product portfolio, but it's also a product where we do not anticipate it to grow strongly compared to the other key brands in Europe like Brintellix and Abilify Maintena. The next bigger launch that we're looking at in Europe would be Spain right after summer.

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [15]

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So please remember that the 90-plus of the potential of Rexulti is in the U.S. from a peak sale point of view.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [16]

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Anders, do you want to finish up on the gross margin? And then we'll go to Peter on the Vyepti question.

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [17]

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Thanks, Deborah. Yes, for the COGS, you should -- it is high in the quarter, and you shouldn't expect that to stay as high. What you also see is we have launched Vyepti, and we'll start to make amortization of product rights. So you should anticipate that cost of sales will increase north of 20%, 21%, 22% for the full year, which brings gross margin below 80%. So that is what you should expect.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [18]

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Peter, over to you for the Vyepti.

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Peter Anastasiou, H. Lundbeck A/S - EVP of North America [19]

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Yes. So I won't be able to provide you quantitative comments because, of course, we don't provide numbers for the quarter that we're in, but I'm just happy to provide qualitative comments, and that is that the stocking went well. The fact that, as Deborah pointed out, that we were able to get the product in the market and the supply chain fully filled. It was a great achievement. We've had many patients who have been treated. You may say to yourself, in this environment, are patients coming out for an infused therapy, and there have been many patients who are dissatisfied with other therapies who've been waiting for Vyepti and many clinicians who have been preparing patients and had patients ready for treatment. And so we are definitely seeing numerous clinics and numerous patients utilizing the product, which is all great.

The things that we intended to have ready to support the product, things like our Vyepti Connect program, which is a kind of reimbursement support program, which is pretty common for these type of infused products is up and running. We've been able to -- we also have a patient support program called Vyepti Go, which is up and running. We've been able, as Deborah, I think, alluded to earlier, do numerous activities online, speaker training programs, actually being able to do speaker events virtually. Of course, a number of details through phone and then also through Veeva and other online tools that we have. And that's really what we mean by the phased approach. You asked the other question, what do we mean by phased ramp. So by phase, we mean first phase is now, of course, virtual. The second phase will, of course, be full face-to-face launch. But even when we get to face-to-face, these tools that we've already created and this ability to work in a virtual environment will continue to be there to supplement not just our launch efforts with Vyepti, but the rest of our portfolio because everything I just said about Vyepti is also true for the rest of our portfolio that we're able to do the same type of promotional activities virtually while we're in the stay-at-home mode.

So hopefully, that gives you a qualitative sense of how things are going.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [20]

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Thanks, Peter. And I think just the last thing to say is it's definitely not the same as it would have been with a full normal launch, but it's very encouraging. And we don't think that, that has bearing on the ultimate potential for this brand.

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Operator [21]

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The next question comes from the line of James Gordon from JPMorgan.

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James Daniel Gordon, JP Morgan Chase & Co, Research Division - Senior Analyst [22]

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James Gordon, JPMorgan. 3 questions, please. First one was about stocking and the extended prescriptions. And I noted that the comment about it being difficult to quantify. But can you just talk qualitatively about where the most benefit was observed? Would it be fair to assume it was Trintellix and Rexulti? They've got the prescription link and the stocking benefit, because Maintena could be stocking, but wouldn't be prescription length. And Northera, you actually see any less use because people are house bound. And so if they're socially isolating they don't want to take the product and pay the copay. And on stocking, I noted the comment about destocking in H2. Most companies have talked about the Q2 destock. So just wondering if there's any reason why it might be a bit different.

Second question was China. I know that you said the international markets had some stocking benefit to held. But can you talk about how much China did actually slow? So what does COVID actually do in the region, which would be most impacted?

And then third and finally, just pipeline. So unfortunately, you did have some setbacks in the earlier pipeline. Does that mean that plans change at all in terms of the extent to which you might be looking to license more assets in for the rest of the year? Could we see some more deals? Or does that not change anything, and it's much more just a focus on what you've probably got in-house?

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [23]

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Okay. Thanks, James. I think the first thing to say is that the stocking to fix basically all the products at the distributor level, the extended prescription, you're right, will affect the -- our brands more, Abilify Maintena, certainly not. Where we think Abilify Maintena has benefited is people may be looking to a longer-acting formulation than an oral formulation. So we may have seen more utilization of the longer -- the long-acting injectable in this environment. So there's definitely demand going up on all the products, and there is the prescription lengthening on the oral product.

For Northera, we know that there's always a reset at the beginning of the year as prescription plans change. So it looks as years like 2018 does. We don't know how much of that could be people not taking medicine since they're homebound. That's certainly a consideration, but we don't have a clear view.

With respect to unwinding, I think I said the second quarter, if it came out in the second half, then I apologize, but we had also indicated that we should have indicated second quarter. China, Jacob?

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Jacob Tolstrup, H. Lundbeck A/S - EVP of Commercial Operations [24]

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Absolutely right, we have seen a negative impact in China. Compared to last year, we have growth in China. But compared to our applications there, we are -- we do see a negative impact being done. And remember, for international markets, I also expect China to be the worst hit market. It is where the vast majority of sales are going through hospitals in China. And hospitals in China have also been very impacted by the COVID-19 situation and trying to combat that epidemic in China. What we see now is that 60% of patients are now back into the hospitals in China, and we see growth again coming back into our business in China.

So the negative impact we've seen in the beginning of the year, we expect to sort of even out, not completely, but even out as we go to the remainder of the year.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [25]

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And our pipeline setbacks and business development, I think we've had the Expand and Invest to Grow strategy in place that continues unabated. We said we would look for deals across all phases of the pipeline. That continues to happen. I think what's great about the position that Lundbeck is in with its strong momentum in our brands and a good, solid financial foundation means that we're not -- we don't have to rush to do any particular deal that we'll only do deals if we find the right assets for our company at the right price. So we continue to look in the way that we've said we would look before. We would like to strengthen that mid stage pipeline, so we'll continue to be disciplined. Johan?

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [26]

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Maybe I can add to that. Obviously, we have our brexpiprazole Phase II activities on study. And of course, denosumab, they're going to look at the indication expansion, as you heard. So there are more Phase II, III trials that will come out of that program quite a bit. And obviously, on top of that, we're trying to progress our internal pipeline as quickly as cost replenishing at this Phase I continue to renew totally promising molecules, and then they deliver in early stage, we'll force them more quickly through the pipeline. But obviously, we're also looking continuously at the value of the outside volume that we can add to our pipeline.

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Operator [27]

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The next question comes from the line of Trung Huynh from Crédit Suisse.

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Trung Chuong Huynh, Crédit Suisse AG, Research Division - Research Analyst [28]

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Trung Huynh from Credit Suisse. Three, if I can. Following on from Wimal's Vyepti question on market access. Can you just talk about how prescribers have reacted to the reimbursement process, given it's different to the subcu CGRPs? And you mentioned there was a bolus of patients waiting for Vyepti. Should we expect the first quarter of sales to be unusually higher than the later quarters because of this bolus? Or should we expect a more sort of normal sales development earlier on? And then just on your Tourette's failure, what have you seen that gives you encouragement in the other indications? And which indication do you think holds the most promise? And finally, very quickly on James' question on M&A, what do you think about the valuations in the current environment today? And what leverage ratio could you go to?

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [29]

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Okay. Starting with Vyepti reimbursement, Peter, the process and how?

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Peter Anastasiou, H. Lundbeck A/S - EVP of North America [30]

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Yes. So as we have mentioned on previous calls, in our targeting, we, of course, are mostly focused on customers who in the headache clinics already have the capability to do infusions, and they have experience doing in-office procedures, either having done infusions for other products for migraine or having done in-office procedures like BOTOX. So the initial customers, as we had planned, are quite experienced with this approach. They're used to dealing with medical benefit either buying and billing the product or working with the specialty pharmacy, that does then what I guess is known as white bagging where the vial is then sent from the specialty pharmacy to the office to do the infusion. So they've reacted quite normally, because they had that experience.

So there's nothing that really stands out. As I also mentioned, we've tried to provide strong levels of reimbursement support, all within compliance, of course, through the Vyepti connect program. And so those things also, of course, help the clinicians and practitioners.

On your point about bolus, I just want to be clear, I didn't mention that there was a bolus nor do I expect that this would have any kind of front-end loaded uptake. I think you'll see probably something that's pretty traditional in its uptake. What I was trying to highlight is despite the fact that there's the pandemic, this disease, migraine, is quite debilitating for patients. And it causes not just pain but also it exacerbates other things, functionally for patients. So for many patients, because they were dissatisfied for previous treatments, the risk-benefit of going out and getting an infusion weighs in favor of going out and getting the infusion. That's what I was trying to highlight. But I don't necessarily believe that there'll be some lumpy uptake, as you had mentioned.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [31]

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Johan, would you like to comment on the Tourette?

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [32]

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Yes. Thanks for the question. I mean, obviously, you may recall that the Tourette study was started by the company that we acquired in May, June last year. It's a small study, but there was a very, very clear signal that it didn't work in that indication. However, what we learned from that one was, obviously, a lot on the molecule safety and tolerability and doses that we can use. We have still very, very strong confidence in the biology here. This is a very broad biology. And what we can do now in a much more comprehensive way is to really cover the areas where we have expertise, where the previous company could not really cover. And we've done a very far off analysis of the biology's potential together with different external opinion leaders and experts in the field.

So we have the possibility now to position, it maybe a little bit better to explore the full potential of the biology. So I -- and the indications we're looking at, in particular, are across psychiatry and all of the above, but we're looking at things like MS, spasticity and epilepsy. And we're well aware about -- that those are areas where extra cannabinoids have delivered also in the past. So obviously, that's part of our considerations. But overall, we're looking at potentially 4 indications that WE will initially explore in smaller pace than the type of studies.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [33]

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Valuations, Anders?

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [34]

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I think our interest in strengthening the pipeline is not driven by valuation. It's driven by the scientific rationale in the compounds. And we are seeing companies developing all over the place. Of course, when crisis are facing global environment, then some companies is declining and some have actually appreciations in their share price due to good results. So we are more looking into what is the scientific rationale. And then, of course, it needs to be combined with the attractive valuation. And then we, of course, would look to strengthen our own portfolio with that.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [35]

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And what's the firepower?

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Anders Götzsche, H. Lundbeck A/S - Executive VP & CFO [36]

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And the firepower is still what we have said $1 billion to $2 billion, but it very much depends on the target of -- the target that we are going for. If it's a target with earnings, then it would, of course, go to the $2 billion, but if it's a diluted target where I would need investments, and then it's more in the ballpark number of $1 billion that we could use. But for the time being, we want to go through the next couple of months, see how the pandemic actually is. We hope that it will kind of ease out and then the countries will reopen and then we have more visibility into the future, and then we'll continue. But of course, we are very active. We actually have been doing for the last 3 to 4 years or last couple of years, we will be looking into executing on the Expand and Invest to Grow strategy. So that is unchanged.

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Operator [37]

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And the next question comes from the line of Martin Parkhøi from Danske Bank.

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Martin Parkhøi, Danske Bank A/S, Research Division - Senior Equity Analyst [38]

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Martin Parkhøi, Danske Bank. I have 2 questions. I think it is both for Johan. Firstly, it's -- I'm just a little bit curious, maybe it's not that relevant from a long-term perspective, but you announced the termination of KB7. And as I recall it, you started Phase I in December and announced it in the full year result, and now you terminated based on preclinical data. So just walk me through the -- how that can be? Is it the preclinical data you have made after the Phase I season? Or what has happened actually? And then secondly, also with regarding to now -- have you been -- Lundbeck for a year or so, are you satisfied with the development that you have seen in particular on the internal development of projects? Do you think that you are responsible for a pipeline which can live up to Deborah's aspiration of creating a sustainable growth company?

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [39]

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Okay. Thanks for those questions. I have to say the first one is pretty easy to address. Because when you progress a molecule into NAN, there are a lot of uncertainties how it will behave, because we have only animal data and cell data and you get surprises in either way because biology is not that predictable across species. The other thing that's happening when you develop a molecule, you continue with your preclinical safety work, et cetera. You're building up further. So this is continuing of generating data. This molecule, basically, we needed to go very quickly into NAN, and we realized the pharmakinetics did not deliver the required margin for the calculated preclinical safety data. So it's really not a massive change in the preclinic safety data, but basically, pharmakinetic data did not deliver. It had a peak exposure that was too high. So that's a very simple thing, and those things happen all the time in Phase I. That's kind of regular business.

But to your more important question, 1 year at Lundbeck. We are working vigorously to try to build our pipeline and progress our pipeline. Am I confident that this is good enough? No. We continue to have to improve this by working more efficiently, deliver our drugs as fast as we can from our discovery machine with high-value in all the toolboxes we need. And obviously, we should explore the full potential of the molecules we have at hand, and I mentioned Vyepti. So there a lot of things we need to do. We need to derisk late development further, and that's why we're investing so much in early development. That's where the molecules should fail if they fail, not in late development. Generally, we're, of course -- we commented on BD and other activities to fill the pipeline. The pipeline is weak in the middle admittedly, and we have to do something about it.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [40]

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Just clarifying that the KB7 stop was in NAN, right? So we were actually in.

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [41]

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Yes, that was in procedural. This was first-in-man dosing that you have delivered the data we didn't want to see.

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Operator [42]

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And the next question comes from the line of Michael Novod from Nordea Markets.

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Michael Novod, Nordea Markets, Research Division - Director of Healthcare, Healthcare Analyst & Sector Coordinator [43]

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It's Michael from Nordea. So a couple of questions. Maybe want to sort of the effect of COVID-19 and social distancing and also economic crisis on depression rates. We saw some quite concerning stats out of ExpressScript's report back in March, dealing with the February data. So already there, you could see this major increase in scripts. So maybe you could just talk about whether you've seen anything driving additional prescriptions for depression drugs, anxiety drugs, et cetera, in past crisis?

And then secondly, maybe Jacob could talk about the Brintellix Trintellix launch in Japan and what you're seeing there, whether the uptake is satisfying or not? And then lastly, on Vyepti, on the 3 months. Is there a formulation advantage? We've heard Teva talk about it. I know they are the only ones with the subcu 3 months. Talk about this in terms of COVID-19, less frequent visits to the physicians, et cetera. Is that something that can be, say, done more about in this era of social distancing?

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [44]

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Okay. Lots of great questions. Thanks, Michael. First, on the COVID-19 and its impact on mental illness. This is a global infectious disease pandemic, but what is behind -- following behind it is an acute rise in mental illness. People are faced with an existential threat to their safety and their life in the infectious disease. They're also faced with the economic dislocation of job loss and change. And then on top of that, there's the isolation of the social distancing. So unprecedented numbers of people are seeking mental health counseling for the first time or coming back after having been well for a while. And we are seeing a rather profoundly disturbing trend for an increased volume of calls to suicide hotlines. So we know that this global crisis will be followed by a huge tsunami of mental illness, and that is beginning to manifest. And so there is a demand. Yes, there is increased demand for drugs to treat -- to help patients with depression, with anxiety, particularly, and we may even see -- we've seen some indications of rise in posttraumatic stress disorder in some of the health care professionals who've been dealing with pretty apocalyptic settings in places like Northern Italy, Wuhan and even in New York City.

So no doubt, there's a huge need for the medicines that Lundbeck produces. I'm going to hand over to Jacob for comments on Trintellix in Japan.

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Jacob Tolstrup, H. Lundbeck A/S - EVP of Commercial Operations [45]

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Sure. Thanks for the question, Michael. So very briefly, we launched at the end of last year, as you know. We had actually a really good launch. Great start. Market shares did better than expected in the beginning. And we have a great partnership with Takeda in Japan. And then, of course, the lockdown came and for a brand that is new-to-market in Japan, you have a 2-week prescription ban for the first year. And that means that there is no possibilities to have extended prescriptions, for instance, like you see in other markets. So we are being impacted by that in Japan.

So since the lockdown, Trintellix has been growing but slowly. And up until very recently, we now start to see a pick up again for Trintellix. So overall, I'm very satisfied, because we managed to change as much as we could into virtual detailing for the brand. And looking at the share of voice in Japan, we or Trintellix is the brand that is having, by far, the highest share of voice in the market, also including into virtual and remote detailing.

So I'm very hopeful that we will be able to pick up again and come back to the level that we were on in Japan.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [46]

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Great. And then with respect to Vyepti treatments, Peter, would you like to comment?

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Peter Anastasiou, H. Lundbeck A/S - EVP of North America [47]

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Yes. Before I do that, I also just wanted to mention to add on to what Deborah said about mental health. I would also point out that there's high comorbidity of migraine and mental health conditions like depression and anxiety. And we've heard from key opinion leaders and customers that those 2 things often travel together. So I think everything that Deborah said is absolutely true, but could also have some impact on the migraine market. Specifically, on Vyepti 3-month, we believe it's an advantage with or without the pandemic. We've talked about in the past on these calls that we believe that the benefits of the product, that it's fast, that it's powerful and that it's sustained. And that sustained piece really references the fact that one 30-minute infusion can last patients for 3 months. And we think that's a benefit in both the COVID-19 situation, certainly, but even outside of that circumstance.

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Operator [48]

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And the next question comes from the line of Emily Field from Barclays.

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Emily Field, Barclays Bank PLC, Research Division - Research Analyst [49]

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I was just wondering if you could comment on your current mix in the U.S. between commercial and Medicare and Medicaid. And with, obviously, the massive jump in unemployment, how you see that trending over the course of this year and then also impacting reimbursement? And whether that will be a 2020 issue, more of a 2021 issue? Any color there? And then also, I know there was an earlier question on Northera. I just wanted to dig into that a little bit more, because I know you'd cited this as one of your brands that could be more impacted by COVID-19, given the need, I believe, to titrate patients. But actually, it looks like based on the IQVIA data that year-over-year growth was accelerating through March and April from a volume perspective. So I was just wondering if you could give us a little bit more color on how we should think about that product, both in terms of COVID-19 impact and also seasonality.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [50]

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Okay. Since a lot of that pertains to the U.S., I'm going to ask Peter to take those questions on the Medicare and Medicaid mix, unemployment and Northera.

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Peter Anastasiou, H. Lundbeck A/S - EVP of North America [51]

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Yes. No problem. Thanks, Emily, for the questions. First of all about mix, every product is different. So in the case of depression and migraine, those are more heavily influenced by the biggest payers or commercial payers and Medicaid and Medicare are smaller. And then in the case of something like Northera, because it's an older population, it tends to be more Medicare and commercial, but then also Medicaid. And so it's -- and then, of course, with Abilify Maintena, that's mostly a Medicaid and Medicare population and less commercial. So every product has a different payer mix. It's tough to speculate what will happen. Nobody knows, of course. But as people lose their jobs and potentially lose insurance, but then hopefully, as we all hope that some of the interventions that are happening, stimulus, relief for patients that are happening, will help us have a quick -- quicker V recovery. That's certainly something we all hope for, but it's very difficult for us or anybody really to speculate about what mix shifts may happen because of the pandemic and the economic fallout.

With regard to Northera, you're right that we haven't seen any impact from COVID-19 in the first quarter. That's not to say we've seen it in the second quarter, but we don't really make comments on the quarter that we're in. But in the first quarter, we didn't see any impact from COVID-19. But I think when Deborah made that point, it's just highlighting that the patient population is different for Northera than it is for most of our other drugs, where most of the other medicines are for younger patients that are generally in kind of like the 18 to let's say 60-year-old range and Northera obviously skews more towards the elderly.

But we have not observed yet any impact from the COVID-19 situation.

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Operator [52]

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And the next question comes from the line of Jannick Denholt from ABG.

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Jannick Lindegaard Denholt, ABG Sundal Collier Holding ASA, Research Division - Research Analyst [53]

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Just a quick follow-up to Johan's comments on the clinical trials. So you mentioned higher dropout rates in some of the trials and obviously, delays. Could you just give a little flavor to how you see those? And also in particular, are there specific trials where you are more concerned in those regards or in vice versa?

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [54]

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Yes, thanks for that question. Obviously, it's really very hard to predict this with some certainty, because it's very unclear how countries open up, et cetera. But we do have some -- we start to get better, better ideas of that. And generally, we talk about that 6-month-ish delays across the board, but that varies tremendously. And some trials are still ongoing and going quite well, some surprisingly well and some have come to a grinding halt. So we're mapping this out per trial and per molecule. I think the biggest problem is not the ongoing trials, because those we can sort of maneuver around and have various ideas how to manage. The ones that are more uncertain are the ones we start up. We can technically prepare everything. We can regulatory wise, be prepared, and we may even get 1 or 2 sites up and running. But really, the big element in clinical trial is fast execution, is to get as many sites up as fast as possible. And that is the big, big element that is the unknown that we struggle with.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [55]

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I think, just to say, you'd asked where are we seeing impact. We know, for instance, the Rexulti agitation in Alzheimer's disease trial includes elderly patients, and we've got patients who are without temps use in nursing homes in -- for some of the sites for that trial. So that is -- makes it a particularly difficult trial to maintain accrual for. So we definitely would anticipate, right now, we're -- it's very difficult to enroll patients into that trial. So we would anticipate some delays in that.

But I don't think we can fully quantify them at this time.

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [56]

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Yes. Maybe one more comment. What we see so far is that our migraine activities have been less impacted by this. And that really speaks to that comment about the type of patients. I mean, obviously, Alzheimer's, dementia-institutionalized patients. That's the biggest threat right now. And so it's going to be very difficult to predict, but generally, it will be very uneven.

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Jannick Lindegaard Denholt, ABG Sundal Collier Holding ASA, Research Division - Research Analyst [57]

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Okay. So it's not possible to say that you see in broad rates, they've been increased by 5%, 10% or something to look at some point?

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [58]

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No, you cannot put any metrics on it at this stage, unfortunately.

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Operator [59]

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And the next question comes from the line of Carsten Lønborg from SEB.

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Carsten Lønborg Madsen, SEB, Research Division - Research Analyst [60]

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Yes. First, a question to Jacob on Cipralex, actually in IO. You reported a 24% growth this quarter and a lot of this, of course, COVID-19 related, but I guess a lot has also changed the collaboration you see in Janssen outlook for sales? Is it possible for you to, in any way, give us a little bit more color on this as, of course, a massive growth component in the quarter? And then, Johan, following up on Jannick's question, one thing is, of course, a delay, but another thing could also be that patients drop out differently in the 2 arms and thereby kill the randomization. How do you monitor this during a trial? And how concerned are you that you will end up with results that could be inconclusive or not particularly useful? And therefore, you normally have a later trial, but maybe need to do a full new trial.

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Jacob Tolstrup, H. Lundbeck A/S - EVP of Commercial Operations [61]

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Thanks. Yes. Thanks, Carsten. So you are right. There is, of course, some timing associated both with China and also with Japan. As it is in China, as you know, we took back Lexapro from our partners' Xian-Janssen last time this year. We were in transition between 1 type of pack to a new pack. So there is a timing effect that is benefiting us this year. And the same goes for Japan where we ship to our partner Mochida who's handling Lexapro in Japan. And while we are a little behind on Trintellix in Japan, we're actually ahead on Lexapro in the beginning of the year.

So also there, we see a benefit. But we don't break it down to countries. So I'm not going to give you numbers on how much that is. But it is a part of the increase -- a visible part of the increase for the quarter.

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [62]

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Yes, to your question, that's really a very great question. Let's say operational too. So basically 2 amounts -- 2 things that you asked there is demand for data and the quality of data and how that distributes into studies. There are a lot of elements that we use in clinical trials to try to mitigate for this. I will not go into details, but we are monitoring data and the randomization aggregates. We can correct for these things without jeopardizing the integrity of the studies and unblinding. So the studies teams are following this. I have to say, in terms of challenges, it's more -- can we really get the amount of data we want to have? And when will we get it? And there are various ways we can play with this, having interim analysis of data, et cetera. We are looking at all those possibilities to really try to engineer the details of the studies. I cannot give you more of that. But I'm not worried about imbalance between placebo and treated groups, that we can handle.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [63]

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I think the other thing to say about that is the health care authorities said, well, the regulatory agencies have already been indicating to companies that they are -- they understand that some of the data is not going to look as pristine as it would have been normal circumstances. So they're thinking creatively about how to manage things like missing data. So we're cautiously optimistic that we'll be able to potentially restart and get the data we need if there's -- even if it may come with a delay and then be able to work with the authorities on things like missing data as well as all the mitigations that Johan has spoken about.

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [64]

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And the regulators are definitely living up to this. We have fresh interactions with them. They are really very forgiving as long as it relates to the pandemic. So missing visits, et cetera, we can deal with.

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Operator [65]

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Last question comes from the line of Peter Welford from Jefferies.

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Peter James Welford, Jefferies LLC, Research Division - Senior Equity Analyst & European Pharmaceuticals Analyst [66]

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Just got 3 quick follow-ups. Firstly, just with regards to the Alzheimer's agitation study. I just want to know there with regards -- have you actually -- or have you considered putting the study on hold? I guess, the new patient enrollment, I guess, it just seems as though, given what's going on in nursing homes, it's a pretty challenging sort of study, I guess, to enroll anyway. And I appreciate your comments on imputing data. But given the challenges we've already had with those sorts of studies in the past is, I guess, it does seem like a particularly high-risk strategy.

Secondly then, just with regards to the RELIEF study of AFT. Is that still enrolling patients? Or is it fully enrolled? So I guess, how confident can we get those data this year? And then just finally, I wonder if you can comment at all on compliance adherence rates, understand longer prescriptions. And obviously, some of the volumes you've got there. But can you talk at all whether or not you have any data on whether or not actually compliance rates and how they may actually be changing for the olds over the last month or so?

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [67]

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NSo Johan?

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [68]

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Yes, maybe I can talk a little bit about the agitation in Alzheimer's. Obviously, this is a partnership with Otsuka, and we have had very intense work together with them how we're going to manage this. I think Otsuka, and we have been pretty public about this and also very recently went out and said that the study is on hold. Basically, we're not enrolling any more subjects. So that's severely affected trial, one of the most in our portfolio.

We have, as I alluded to before, various instruments, how we can look at the data. But obviously, this is the third trial in the set of studies that should deliver the indications. So we are carefully maneuvering around the ability to restart as quickly as possible and also analyze data in various ways earlier. So that's part of the package there. I cannot say more than that because we are in the process of looking into that.

The RELIEF study, it's gone very well, as I alluded to. We actually don't expect much delays in really getting the data out of that study. And it's -- just to remind you, this is the study that looks at the 4 hour to first day period. So we're looking at the early resolution of the data effect on migraine. So very critical data. One of the key points is 2 hours after start of infusion there. We expect to get the data almost as planned from that study.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [69]

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And then with respect to compliance with our oral therapies, as patients have received their scripts. Jacob, do you want to comment on that? Any hints from the market as to whether the patients are actually taking the medications that were given?

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Jacob Tolstrup, H. Lundbeck A/S - EVP of Commercial Operations [70]

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Okay. Yes, I think in general, the answer is yes. I think it's more -- the issue has been whether patients are coming in for consultation, and whether they're able to come in, whether it's a hospital or to see the treating physician. I think on the compliance, we don't see any change in behavior at this point in time.

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Per Johan Luthman, H. Lundbeck A/S - EVP of R&D [71]

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No. And you should know that we monitor this quite closely, and there were some concerns really initially and even some signals that, that would happen, but it doesn't look like it.

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Deborah Dunsire, H. Lundbeck A/S - President & CEO [72]

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With that, I'd like to thank you all for your interest in Lundbeck, and we look forward to talking to you at the end of the second quarter. Thank you.

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Operator [73]

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This now concludes the conference call. Thank you all for attending. You may now disconnect your lines.