H Lundbeck A/S

CSE:HLUN A

Earnings Call Analysis

Lundbeck's Q1 2024 Success Driven by Strategic Brands

In the first quarter of 2024, Lundbeck saw a robust performance, headlined by a 17% growth in strategic brands which now represent 71% of overall net revenues. Vyepti led the charge with a notable 79% year-over-year revenue increase, totaling DKK 617 million. Rexulti also showed solid performance, especially in the U.S. market with a 15.8% prescription growth. Despite a slight decrease in adjusted EBITDA, Lundbeck reaffirmed their full-year guidance, underpinned by strong cash flow and strategic investments in R&D and sales. Net profit increased by 14% over the previous year. Looking ahead, the company emphasizes its innovative focus in neuroscience, expecting continued growth and profitability.

Introduction and Strategic Path

In the first quarter of 2024, Lundbeck has focused its strategy on becoming a leader in neuroscience innovation. The company highlights three main objectives: securing stable long-term growth, leading in focused innovation within neuroscience, and maintaining disciplined capital allocation to ensure sustainable profitability margins. The progress in Q1, driven by strong Sales and Research & Development (R&D) efforts, indicates that the company is on track to achieve these objectives.

Revenue and Strategic Brands Performance

Lundbeck reported a 7% growth in revenue at constant exchange rates due to the exceptional performance of its strategic brands. Notably, Vyepti and Rexulti led the way, with strategic brands growing by 17%. Specifically, Vyepti achieved an impressive 79% year-over-year growth, reaching global net revenues of DKK 617 million. The performance was mainly driven by an accelerating growth in the U.S. and the launch in 25 international markets .

Exploring the U.S. Market and New Approvals

The U.S. market has played a crucial role for Lundbeck, showing a 7% growth in Q1 2024. The Abilify franchise exhibited robust performance, with an introduction of new formulations that enhance patient convenience. The approval of Abilify Asimtufii in Europe and the U.S. added a new, more convenient treatment option, driving the growth of this long-standing brand .

R&D Investments and Pipeline Progress

Lundbeck increased its R&D expenses by 40% as it advanced several key pipeline projects. The anti-PACAP program entered Phase IIb, and substantial progress was made towards preparing for Phase III trials of the anti-alpha-synuclein antibody. The company is also focusing on smaller exploratory proof-of-concept trials for various indications, including congenital adrenal hyperplasia and Cushing disease .

Operational and Financial Performance

Despite the increased R&D outlay, Lundbeck's adjusted EBITDA decreased by just 2% at constant exchange rates, maintaining a margin of 33%. Administrative expenses increased modestly by 2%, reflecting a focus on operational efficiency . Furthermore, Lundbeck completed significant deleveraging, moving from a net debt position of DKK 2.5 billion in Q1 2023 to a net cash position of DKK 0.8 billion in Q1 2024, underlining its strong financial health .

Guidance and Future Prospects

Lundbeck confirmed its full-year guidance for 2024, expecting continuous revenue growth and a strong bottom-line performance, enhanced by favorable currency impacts and lower financial expenses. The company’s strategic investments in R&D and the expansion of its strategic brands are anticipated to drive upward momentum in the coming quarters .

Earnings Call Transcript 2024-Q1

[Operator]

Ladies and gentlemen, welcome to the Lundbeck financial statement for the First 3 Months of 2024 Conference Call. I am George, the Chorus Call operator. [Operator Instructions] And the conference is being recorded. [Operator Instructions] At this time, it's my pleasure to hand over to Charl van Zyl, President and CEO. Please go ahead, sir.

[Charl van Zyl, executive]

So thank you for joining the call today. It's of course, my pleasure to be able to report the quarter 1 2024 results. It's been a quarter that has been very active and in a sense, positive in its dynamic towards the progress to become a focused innovator in neuroscience.

So if we can go to the next slide, please. Just to -- again, company disclaimer, the forward-looking statements here are that, of course, we are -- what we present today is also subject to change. So if we can go to the next slide, Today, I'll be joined by Tom Gibbs and Michala Fischer-Hansen, who is our new heads of our geographic business. And of course, Johannes, and Joerg, who will join me today to present to you the first quarter results.

So if we can go to the next slide, please. So let's get straight into it and start talking specifically about where we see the first quarter heading and how we see the full year. But before we do that, I want to again mention to you in the context of where we stand at Lundbeck today. And I see clearly our progress very much around performing and transforming as we go forward.

So I would like to share with you again where we stand in terms of our strategic path. And if we can go to the next slide, this is something we have shared with you, of course, before and it's consistent with our previous interactions. But I'm really pleased with the progress we're making towards transforming to become a focused innovator.

There are three elements that I would highlight for you today in this path. The first is securing a stable long-term growth for the company, leading with focused innovation in neuroscience, but at the same time, being very disciplined around our capital allocation to stay within our sustainable profitability margins that we have communicated to you in the past. And I have to say, from where we stand today and with the first quarter that we see here, we are well on our way to build that focused innovative strategy going forward with very strong growth in our strategic brands, Vyepti and Rexulti, and we'll talk more about that in a short moment.

We are also seeing a really nice evolution of our innovation strategy in the pipeline with anti-PACAP as well as our alpha-synuclein in MSA. And of course, we continue to exercise opportunities in the business development area where we think about a programmatic approach to further build on the innovation strategy going forward.

All of this, I would again emphasize to you is underpinned by a very disciplined approach to our capital allocation to reallocate towards either additional growth opportunities or to where we could see additional innovation opportunities in the company.

So then if we really go to the more specific points, which is the next slide, please, around our quarterly results. Again, I'm really pleased to see the progress we are making in the first quarter. You see our growth here at 7% and adjusted EBITDA of 33%. But most importantly, I think what we want to highlight here is the assets where we are focusing our investment and effort, the strategic brands are growing at 17%. And I have to call out here Vyepti at 79% and you'll also hear later from the team on Rexulti, where we see also double-digit growth on a total prescription basis.

We've also seen in the first quarter as well as the continuation of last year, a really nice progress on the pipeline with the approval, of course, of Abilify 2 monthly injection also in Europe. So it gives an alternative there to our Abilify long-acting franchise. But secondly, also, we see nice advancement with our anti-PACAP into the next phase, Phase IIb, which is the PROCEED trial. And of course, a really nice result we saw in the first quarter on our study, AMULET, which is alpha-synuclein in MSA, where we also have the confidence now to advance to Phase III. And you would have seen also in the first quarter that we've made a few changes to our leadership team, this is the team that will continue to perform and transform the company, and we feel very confident with these changes that we are in a strong position now to execute our strategy going forward. So I just want to again highlight to you the main management changes before we continue.

So if we can go to the next slide, please. This, of course, my pleasure to have this team and work with this team. And you know many of the people here, but there are some new people you'll see today. Of course, you know Tom, who's heading up the U.S., but I would also welcome Michala Fischer-Hansen, who is heading up our Europe and international markets. We have also yesterday announced Maria Alfaiate, who is heading up our commercial and corporate strategy, who will bring additional elements to the capabilities we need for the long-term future of the company. And of course, we have Johan, who you know well, Joerg and Lars, who heads up our product development and supply. And as I've always said in the past, strong companies are built on the foundation of strong people. And it's, of course, great to have Dianne with us who will lead our people and organization going forward. So with this team in place with a strong momentum in the first quarter and the path we've set to become a focused innovator in the future. I'm really confident around where we are heading for the remainder of the year with, of course, a commitment to the full guidance that we have set out for the full year.

So with that, to go to the next slide, I would like to, therefore, introduce and hand over to Tom and Michala to take you further through the performance on the asset level at a geographic level as well. So over to you, Tom.

[Thomas Gibbs, executive]

Great. Thank you, Charl. As Charl mentioned, we delivered strong global commercial performance during first quarter of 2024. And this was headlined by 17% growth of strategic brands, which now account for almost 71% of overall net revenues, and this growth was led Vyepti. Next slide, please.

We are very pleased with the performance of Vyepti. Vyepti's performance has been fueled by accelerating growth in the U.S. and supported by a continued stream of launches and robust brand adoption in our prioritized ex U.S. markets. Vyepti global net revenue for the quarter was DKK 617 million and this represents, as Charl said, 79% growth year-over-year.

Net revenue for Vyepti in the U.S. was DKK 544 million representing 69% growth over 2023. Importantly, we are beginning to see meaningful contribution to global sales by ex U.S. markets with Vyepti now available in some 25 markets. These markets are exhibiting strong anti-CGRP market growth and importantly, Vyepti continues to gain meaningful market share across all of these markets. I do want to take a moment to focus on the U.S.

Over the past year, we have worked very hard to refine our specialty commercial model to support Vyepti, focusing on four key levers: HCP engagement and this is both on the sales side as well as the medical side, patient activation, patient experience and market access. It's these four levers, which have made material contributions to accelerating demand by driving depth and breadth of prescribing and increasing our momentum in new patient starts as well as patient adherence.

Importantly, we continue to hear very positive clinical experiences from physicians and patients regarding Vyepti, which are reported in the review real-world evidence clinical trial, which was published in the Journal of Headache and pain this past April. Next slide, please.

Rexulti continues to perform well, propelled by the continued strong progress of the AADAD launch in the U.S.. U.S. TRx growth during the first quarter of 2024 was 15.8% increase over the prior year. Global reported revenue increased 7% versus prior year. The difference between the demand growth and revenue growth is attributable to variance that we saw in channel inventories and to a lesser degree, gross to net in first quarter 2024 versus first quarter of 2023.

We are pleased with the strong demand growth observed across all of our prioritized markets. The majority of that volume growth is driven in the U.S., particularly in AADAD with 205% monthly volume growth when we compare January 2024 claims to the prelaunch baseline. The long-term care channel is disproportionately contributing to Rexulti AADAD growth with 598% monthly volume growth since baseline, and the market share in the long-term care channel has increased more than sixfold. Next slide, please.

Rexulti AADAD volume is becoming increasingly important to the overall Rexulti growth, and we expect this to continue through 2024 and beyond. AADAD contribution has grown to 12.5% based upon our most recently available data, and we expect AADAD overall contribution to the brand to exceed 20% by year-end. The AADAD launch has also had a positive halo effect on the overall brand performance with non-AADAD monthly claims volume growing at 15.9% versus April -- from April 2023 to January 2024.

Now in analyzing some of the most recent TRx data, Non-AADAD-TRx growth has moderated over the past quarter. We attribute this to our MDD direct-to-consumer campaign being off the air from November through the end of February. MDD direct-to-consumer promotion has resumed on February 26, 2024, and we're beginning to see the lift in TRxs towards the end of April as we fully deploy the Rexulti marketing mix. And I think of note, the latest NBRx or new-to-business prescription data point of 2,690 is an all-time high. I'll now turn the presentation over to Michala to discuss performance for other strategic brands. Michala?

[Michala Fischer-Hansen, executive]

Thank you, Tom, and good afternoon, everyone. I'm Michala Fischer-Hansen, and I'm very happy to be here now in my second month with Lundbeck. If I can have -- I already got the slide, thank you.

If we look at Brintellix, or Trintellix performance in Q1, you can here see the revenue performance worldwide, very impressively growing at a double digit at DKK 1.17 billion in Q1 '24. Very impressive, I think, considering that the brand has been on the market for more than 10 years. If you zoom in on the numbers, you can see that rest of world is driving majority of the growth, a growth of 13% to DKK 810 million in Q1, where Europe is growing at 16% and that's primarily driven by Spain with 26% growth.

We see international markets growing at 10%, and that's driven by Japan growing at 23%, sorry, and China at 12%. We also see a very nice growth in the U.S., up 7% with the indications of stabilization.

If you look to the graph in the middle, you can see this is MAT volume growth versus the market. And here, you can see how we -- in many of our key markets actually grow the market significantly. And I specifically want to highlight Japan, Spain, Canada and France, where we see a very strong development in our overall growth versus the market. If I could get the next slide, please.

Here, we see the Abilify LAI franchise. And also here, we see double-digit growth in revenue in the first quarter versus same period last year. We have U.S. delivering 9% of that growth and rest of world delivering 12%, and we're at DKK 859 million in revenue. This is also a very strong performance for a brand that has also been in the market for over 10 years, and the performance is spread across many markets. I want to highlight here the U.S., Canada, France and the U.K.

I want to emphasize that the franchise here has two brands. We have Abilify Maintena. That's the one that's been on the market for over 10 years. And then we have Abilify Asimtufii, that's the U.S. brand name and Abilify Maintena, 960 milligrams, which is the European brand name, and that's the 2 months injection in the franchise. Please note that Abilify Asimtufii was launched in the U.S. in June of last year, and we recently got approval for the Abilify Maintena 960 milligram in Europe in March.

If you look to the graph in the middle of the slide, you again see MAT volume growth of the franchise versus the market. And again, you can see the very strong growth that we're seeing in many of the countries where we're outgrowing the market. And it's also important to note that we hold market leadership position in a good handful of our key markets. For the U.S., if we look at Q1, and that's, of course, also noting the recent launch of Abilify Asimtufii, if you look at Q1 '23 versus Q1 '24, we actually see the market growth at 1.8%, whereas Abilify franchise for us is growing at 5% in the U.S. So that's basically driven by Abilify Asimtufii. When we look to the year for the Abilify, the Abilify franchise, it's really about preparing for the launch of the 2-month injection.

We're bringing a new option to the market, and Johan will come back to that, which allows patients to have fewer dosages since it's a 2-month injection and allows continued symptom control of schizophrenia. And as mentioned, the U.S. launched the product a little over a year ago, and it's driving roughly 10% of sales and continues to grow. With that, I will hand over to Johan to tell us a bit about the R&D highlights from Q1.

[Johan Luthman, executive]

Thank you, Michala. It's great to have you in the deck. Our R&D -- let's move slide, next slide, please.

So our R&D activity started 2024 on a strong note with important regulatory activities and critical progression in the mid-stage innovation pipeline. Charl already touched upon some of them earlier, and I will also come back to provide some more details in coming slides. However, let me just highlight some of what we see the major events.

As Michala already covered, we obtained another approval in Europe for our Abilify long-acting injectable franchise that we have together with Otsuka. So on March 27, the European Commission granted centralized marketing authorization for Abilify Maintena 960-milligram as a once every 2-month long-acting injectable in a ready-to-use formulation. The decision naturally includes all EU member states as well as associated countries in the European economic area. This product is for maintenance treatment of schizophrenia and elder patients stabilized with aripiprazole, a clinically very important offering for sustainable care of hard-to-treat patients.

We are looking forward to gradually roll out the product in Europe as a complement to the already very successful monthly Abilify Maintena long-acting injectable. Also together with Otsuka on April 9, we submitted a supplemental new drug application for brexpiprazole to the FDA for the treatment of post-traumatic stress disorder. Moreover, the data from the program will be presented at scientific conferences. More on that also later.

In the new molecular pipeline, we have also had a couple of very important activities that signify steps into late development stage. To start with, our first-in-class anti-PACAP antibody 222 for migraine prevention has initiated its subcu development phase with a larger Phase IIb trial, this so called proceed trial. The progression of that program is based on a robust positive proof-of-concept trial that we announced and presented at key conferences last year, gaining significant recognition by leading academic clinicians in the headache disorder field.

On January 31 this year, it was indeed very nice to be able to announce yet another readout from a proof-of-concept trial with another first-in-class program. This time, it was for our alpha-synuclein antibody 422, which showed very encouraging results in the AMULET trial. This view was substantiated in the reception following a presentation of the data at the AD/PD conference. As a further validation of the promising data, FDA has granted orphan drug designation for the program. We also started a process with FDA on pursuing breakthrough destination. So more on those programs in the coming slides. So next slide, please.

So we have now initiated a widening of the anti-PACAP 222 program based on the foundation of the positive HOPE trial, which utilized IV administration. Using the HOPE data and data from the prior IV to subcu comparability PK study, we have been able to build a very strong PK-PD model. This model has enabled the design of a comprehensive trial to evaluate safety and efficacy of 222 in migraine patients across a range of subcutaneous doses. The now initiated Phase IIb PROCEED trial will have a primary readout at 12 weeks using every 4-week dosing intervals. The design includes a planned interim analysis, H1 '25. Depending on the outcome of the interim analysis, the trial design allows for triggering an integrated option of also testing further IV dosing. Thus, the path forward in development of this novel mechanism action molecule has in-built flexibility and maintaining the momentum for determined progression towards further pivotal trials.

Furthermore, the design of PROCEED trial maximizes the likelihood of adding a very interesting expansion of treatment opportunities in migraine prevention. So next slide, please. So now over to 422. So let me first remind you that 422 is an IDD1 antibody that is designed to bind to all major forms of alpha-synuclein. But with a particular high affinity for oligomers. It has an active [ Fc ] region, which increased clearance of a-synuclein. We decided to take this mechanism into multiple system atrophy fatal neurogenerative disease characterized by pathological aggregation of a-synuclein, a disease that currently has no treatment options. The proof of concept AMULET trial 422 in MSA was initiated at the end of '21. We're able to obtain the readout in end of January of this year.

As we reported previously, the AMULET trial demonstrated very encouraging results of efficacy across variance of the own source, clinical outcome measure. And also on secondary clinical outcome measures as well as biomarker readouts. In the trial, we pioneered a basin progression statistical approach to identify effects on longitudinal change. As I mentioned before, very soon after readout on March 8, we were able to secure a late-breaking presentation of the headline results of the trial at the AD/PD '24 Conference in Lisbon. The presentation was very well attended and it was a very -- it was very good to hear the very positive reception of the data by the scientific community and leading KOLs in the MSA field. The program has therefore -- has before received orphan drug destination in Europe and Sakigake assignment in Japan, but we're pleased to receive orphan drug designation by FDA in end of April. Something that requires sufficient evidence of clinical effects.

We have also progressed on the path to obtain breakthrough designation as well as applied for the so-called FDA start pilot program. We have now analyzed the data extensively to be able to outline the design for a Phase III program. So the next steps now constitute seeking input on the proposed program from main regulatory agencies in the coming months, with the hope of being able to initiate a Phase III program no later than very early next year. Next slide, please.

Yes. In September last year, we concluded a pivotal program on brexpiprazole in PTSD. Based on the outcome of that program, we decided to progress seeking sNDA review by FDA. During pre-submission discussions with the agency, we were encouraged to do some further data analytics. And subsequently, we managed to submit the application on April 9. We are now awaiting FDA validation of the submission last year and formal filing, which is expected to take 60 or 74 days after submission depending on whether FDA assigns priority or standard review.

The program is based on the combination treatment of brexpiprazole and sertraline. Initially, an exploratory POC trial was positive for the combination. And based on this setup pivotal trials were initiated. The 071 flexible dose trial met its primary endpoint by demonstrating improvements from baseline on the CAPS-5 for patients receiving brexpiprazole 2 to 3-milligram per day plus sertraline, versus for dosed patients receiving sertraline plus placebo. However, there's 072 fixed-dose trial missed its primary endpoint.

The brex combination with sertraline was well tolerated in the program with safety results consistent with the known safety profile of brexpiprazole from other trials in its general use. The brexpiprazole PTSD program will also be presented to academic community for the first time at the American Society of Clinical Psychopharmacology, with an oral presentation very soon on May 28. And a couple of poster presentations during the meeting. Next slide, please.

So we have already made good progress during the first quarter of '24 in the R&D pipeline. This is building further on last year's strong deliverables, such as the positive readout in the anti-PACAP program. But as you have seen, we're also soon adding a highly innovative program to late development through the breakthrough results of the AMULET trial. Important is, however, to see regulatory approvals such as the European approval of the bimonthly and psychotic long-acting injectable. And we also received approval for the first -- in the first quarter in Canada of our pioneering treatment of agitation and Alzheimer's disease with Rexulti.

Our innovation program, 996 to provide an oral active D1, D2 dual agonist as an add-on treatment in Parkinson's disease, started a tailored small patient population study early this year. However, that program is challenged in its enrollment of patients. And our before predicted Phase II proof-of-concept start will most certainly be delayed. Nevertheless, the coming period will continue to be quite us rich. For example, we have expectations to be able to finish the Vyepti SUNRISE trial. Trial has aimed to pave the way for further expansion in Asia, mainly in Japan and China for the product.

Finally, I'd like to highlight that we are now progressing with two small exploratory proof-of-concept trials for our anti-PACAP -- sorry, anti-ACTH program, 909, with the ongoing congenital adrenal hyperplasia evaluation in a Phase Ib study and now within shortly also Cushing disease Phase Ib study.

With that, I'd like to hand over to Joerg.

[Joerg Hornstein, executive]

Thank you, Johan. Very good progress in R&D and an important quarter for our pipeline. Before we go in the financials, please let me summarize the following.

We're very pleased with our first quarter performance of '24, which puts us in the position to also reiterate our full year guidance for 2024. Looking at the underlying growth of our adjusted EBITDA clearly demonstrates that the targeted investments for [ brex, ] Vyepti and Rexulti in the U.S. continue to pay off, while also taking key projects in our R&D pipeline forward drabbing mid- and long-term innovation for Lundbeck. Next slide, please.

Our revenue for the first quarter of 2024 grew 7% at constant exchange rates driven by the strong performance of our strategic brands, which are up by plus 17%. The adjusted gross margin, which is removing amortization, depreciation and other adjustments linked to sales, decreased 1.7% when comparing to the first quarter of '23. The decrease reflects mainly higher sales and a favorable effect from quarterly fluctuations in stock valuation. Sales and distribution costs increased 9% at constant exchange rates. Reflecting the continued investments in sales and promotion activities and strategic brands predominantly, as I said earlier, around Rexulti and Vyepti in the U.S. Our expenditures in sales and distribution reached 33.8% of total revenue, increasing 0.6 percentage points versus 2023.

Administrative expenses increased 2% at constant exchange rate and reached DKK 259 million, corresponding to 4.9% of total revenues. R&D costs increased by 40% at constant exchange rates. The most relevant development in R&D cost comes from the progression of the Phase II pipeline with initiation of a Phase IIb dose-finding trial for anti-PACAP and a Phase III preparation for our anti-alpha-synuclein antibody. Our expenditures in R&D reached 18% of total revenue, increasing 1.4 percentage points versus 2023, which is in line with our financial guidance.

Adjusted EBITDA decreased by 2% at constant exchange rates as a result of a lower adjusted gross margin following a favorable effect from quarterly fluctuations in stock valuation. In addition, the first quarter of 2024 reflects higher R&D costs to support the pipeline in progress and targeted investments in sales and promotion. Adjusted EBITDA margin reached 33%, equivalent to a decrease of 3.6 percentage points. If we exclude the effect from the quarterly fluctuations in stock valuation, the underlying growth in adjusted EBITDA was 6% at constant exchange rates, constituting an adjusted EBITDA margin decrease of 0.6 percentage points. Next slide, please.

Our EBIT grew by [ 9% ] at constant exchange rates, reflecting the operating leverage effect of higher revenue and lower product rights amortization offset by higher operating expenses regarding investments in sales and distribution and R&D costs. Furthermore, EBIT for the first quarter of '23 was negatively affected by the recognition of a provision for Vyepti inventory obsolescence and the aforementioned quarterly fluctuations in stock valuation. Net financial expenses reached an income of DKK 29 million, equivalent to an increase of 135%, the positive development is mainly driven by the favorable developments in interest income due to lower debt and higher interest income on cash and favorable currency impacts.

The effective tax rate of 23% is in line with full year expectations. Net profit increased by plus 14% to DKK 1 billion, and adjusted net profit and EPS increased by 1% to DKK 1.4 billion and DKK 1.38, respectively, and also aligns with underlying performance. Next slide, please.

The cash flows from operating activities in Q1 '24 represents an inflow of plus DKK 961 million compared to an inflow of DKK 378 million in the first quarter of '23. The operating cash flow is obviously a reflection of the continued solid EBIT performance, further impacted by slightly higher adjustments for noncash items amounting to DKK 645 million.

Changes in working capital amount to DKK 886 million in the first quarter of '24, mainly driven by lower inventory buildup in Q1 '24 mainly due to the completion of the Vyepti fixed-supply quantity agreement in '23. Higher trade receivables and lower short-term debt in Q1 '24, mainly due to a sales milestone paid out in the first quarter of '23. The cash flows from investing activities were an outflow of DKK 94 million, driven by CapEx investments in the first quarter of '24, compared to an outflow of DKK 77 million in the first quarter of '23. The cash flows from financing activities were an outflow of DKK 760 million in the first quarter of '24 compared to an outflow of DKK 945 million in the first quarter of '23, primarily driven by lower debt due to the revolving credit facility being fully repaid in '23 and offset by a higher dividend payment in '24.

The first quarter of '24 closed with a net cash position of DKK 0.8 billion compared to a net debt of DKK 2.5 billion in the first quarter of '23, effectively deleveraging the company and bringing us into a very strong financial position for the future. Next slide, please.

On February 7, '24, Lundbeck communicated the financial guidance for '24, focusing on revenue performance and adjusted EBITDA at constant exchange rates. The first quarter results of '24 in line with our expectations and lead us to confirm our full year guidance for '24 at the same time. Changes in the soft guidance are related to a projected reduced effect in reported rates, benefiting revenue and bottom line performance. This positive effect is further supported by lower expected financial expenses but partially offset by higher effects from hedging.

With that, I hand over to Charl.

[Charl van Zyl, executive]

Thank you. So if we could go to the final slide, please. And again, I want to thank the team for supporting the discussion today with you. Of course, it's great to have these results. Strong momentum that we see in the first quarter that leads us to the path that we set out to become a focused innovator and continue to advance innovation in neuroscience and build that long-term future for Lundbeck specifically addressing the long-term growth and innovation in the company going forward. So with that, I think it's a moment for us to take some questions.

[Operator]

[Operator Instructions] Our first question comes from Marc Goodman with Leerink.

[Marc Goodman, analyst]

Can you talk about the inventory change that you were mentioning on Rexulti and the other inventory changes? Usually, we see a lot in the first quarter with products in the U.S.

And then second, can you give us a little more detail tail just on Vyepti in the number of patients, the persistence of patients who are staying on therapy, so how much are new patients versus existing patients in the U.S. since that's probably the longest you've got data on.

[Charl van Zyl, executive]

Yes. Thank you, Marc, for that question. I think for the question on inventory, shall I hand it to Tom. And then also, Tom, please comment on the Vyepti underlying patient numbers.

[Thomas Gibbs, executive]

Yes. So thank you for the question. As you rightfully stated, as we look through 2022 to 2023, end of year variance from a channel inventory standpoint, we did see some additional stocking in January of 2023 that we did not see in 2024. We estimate that was about $6.1 million. As it relates to Vyepti, I really want to talk a lot about persistency because one of the things that we're seeing is increasing momentum, certainly on new patient starts, but our persistency, I think, is reflective of the value of this product to patients and physicians. If we look at our persistency, the most recent data we have, 47% of all patients are on Vyepti within a 12-month period. This compares to 39% for BOTOX, 34% for subcus and 27% for [indiscernible].

[Operator]

Our next question comes from James Gordon with JPMorgan.

[James Gordon, analyst]

James Gordon, JPMorgan. The first question is on Rexulti and U.S. performance. So I heard the comment about a slight year-on-year destock. Any other one-off headwinds because if I look at it, it looks like sales only grew about 6% local currency with the AAD boost that you described. But from the charts are very useful breaking out the prescription trends the initial AAD approval. But just year-to-date, what non-AAD prescription side? Has there been any significant growth in non-AAD prescriptions in Q1 year-on-year? Or has that actually slowed maybe because of this ban on marketing to not really been growing. And that's the first question, please.

The second question is on business development. As a comment on Bloomberg a media interview, I believe what suggests that Lundbeck has a DKK 5 billion to DKK 6 billion for the war chest. That seems quite high given the leverage ratio I calculated, that would imply. Is that right? Was that a misquote? Is the plan for a string of pearls or when you've been close to saying a deal this year, could you be doing something quite big in that sort of range?

[Charl van Zyl, executive]

Yes. Thank you, James, for that question. Let's first go to Tom to answer your question on Rexulti.

[Thomas Gibbs, executive]

Sure, thank you for the question, James. Unfortunately, I can't give full transparency in terms of what the non-AADA prescriptions look like through the quarter because unfortunately, claims data, as you know, are delayed versus TRx data. So -- but I will provide a hypothesis of what I think the claims data look like based upon TRx data. Based upon the momentum that we continue to see with AADAD, and we did see a little bit of a flattening of TRx demand, particularly in the month of March, we do hypothesize that MDD prescriptions had flattened a little bit during the first quarter. Just for reference, MDD represents about 38% of the total brand prescriptions. We attribute that, as we talked about, through to the MDD direct-to-consumer campaign being dark for a little over 4 months.

We know that MDD -- I'm sorry, DTC is an incredibly important part of the element of our marketing mix, driving over a 2.8% ROI on a year-over-year basis. So that is where we think we had seen a flattening. But what we're very pleased about is that we've turn DTC back on, on February 26. And you normally see about a 6- to 8-week delay in terms of the impact, and we're actually already starting to see the impact in late April, where we saw our TRx demand continue to start moving up again. And the most sensitive measurement NBRxs, we saw an all-time high with our most recent data point for April 26.

[Charl van Zyl, executive]

Thank you, Tom. And James, let me address your question on the business development strategy and the question on firepower. So first of all, I think you would have seen also our strong cash position that is, in a sense, converted from a negative DKK 2.5 billion last year to DKK 800 million in the first quarter. So we see the cash generation really strong in the underlying business. The number you quoted DKK 5 billion to DKK 6 billion is based on how we see this in a midterm view rather than in the actual amount today.

But with that view going forward, our strategy remains intact as we've communicated to you in the past, that we see rather a string of pearls, a series of deals that make sense to complement what we're already doing today where we play on our strengths, either in the space of neuropsychiatry, neuro specialty or neuro rare and those that we can essentially easily afford and deleverage also in a reasonable way going forward. So I wanted to, again, just confirm our BD strategy being a string of pearls, but thank you for that question.

[Operator]

Our next question comes from Lucy Codrington with Jefferies.

[Lucy-Emma Codrington-Bartlett, analyst]

Just following up on the Rexulti DTC ban. I just -- do you expect -- you mentioned the scripts have kind of started to recover already. Do you think you're going to be able to compensate for that kind of shortfall in the third quarter? Or will this just be made up by agitation in Alzheimer's rather than MDD itself. And I guess what's your confidence that you won't get another ban? Is it fairly easy to kind of know what caused the ban in the first place?

Secondly, the guidance talked about slight growth for Abilify Maintena in the U.S. What's your expectation ex U.S. for that product?

And then finally, just on anti-PACAP as being one of the kind of key pipeline programs. And forgive me if this has been covered previously, but do you have any idea why a previous competitive molecule was discontinued in Phase II? And do you have any understanding of how your molecule may differ from that competitor program.

[Charl van Zyl, executive]

Yes. Thank you, Lucy, for those questions. I think, Tom, if you would mind addressing our view on the impact of DTC and Rexulti as a starting point.

[Thomas Gibbs, executive]

Sure. Thank you, Charl. As I stated earlier, I think it is important to note that we did see 15.8% TRx demand growth in the first quarter of 2024 versus first quarter 2023. So strong double-digit growth. And we do believe that, that was mostly accounted for based upon our success with our AADAD launch. We do know that there was an impact for DTC being dark by about 4 months. But we -- based upon what we're seeing and the sensitivity that we're seeing to turning the DTC back on, we're very confident that we're going to be able to continue to grow MDD throughout the rest of the year and really continue to accelerate AADAD for the rest of the year. As it relates to our confidence that the DTC campaign, we will not receive another letter, I would say our confidence is incredibly high because what we have rolled out in February 26 and all subsequent campaigns, we have, we have engaged what we call OPDP or the FDA regulations, and they have approved these campaigns.

[Charl van Zyl, executive]

Thank you, Tom. Michala, can I ask you to address the question on Abilify ex U.S. growth?

[Michala Fischer-Hansen, executive]

Yes. Thank you, Lucy, for the question. So we don't really provide growth forecast per product, but I can say that we certainly see growth for the year. Thank you for the question.

[Charl van Zyl, executive]

Thank you, Michala. Johan , let's talk about anti-PACAP and our differentiation.

[Johan Luthman, executive]

Yes. Thanks for that. Lucy. We have got it before, but I'm happy to cover there are basically two molecules that one should keep in mind from past programs. One is some years back, it's Amgen, AMG 301. There was an anti-PAC-1 receptor blocker. And I'd like to remind you that PACAP to our knowledge has three active receptors, PAC1, PAC2 and VIP. And that actually did was Masudasina, who was the PI on that one, and it had a very robust trial and it was robustly negative. And our read was that it's not good enough to basically block the receptor. You have to go to the ligand, and that's what we're doing with our antibody.

The other one you may have in mind is still Lilly, 345 1838, which was running a Phase II trial. And similar. They stopped early. They stopped their early enrollment after quite some time. They tried to run this partially during the pandemic. And it was only a U.S. trial -- and I should probably refrain from commenting too much on what we have speculated what might have gone on, but they stopped early. And what we saw in our trial was that it might be a little harder to enroll subjects in the U.S. than ex U.S. because people a year ago and like the CGRP drugs. So they were kind of self competing a little bit with the CGRP class pickup. Are we concerned about that? No, we learned quite a bit from our trial with both U.S. and ex-U.S. sites. And we think we can engineer a trial that can progress. But quite frankly, what we understand is that they just stop because patients were not coming in, operational reasons.

Now of course, more on the speculative and Lilly is busy with other things and maybe this is less for them to be engaged in.

[Operator]

Our next question comes from Xian Deng with UBS.

[Xian Deng, analyst]

It's Xian from UBS. Two, please. The first one is for Charl, if I may. So you have quite some changes in management recently -- just wondering if you could maybe elaborate a little bit of your thinking about strategies going forward behind those changes. I mean you have already sort of reiterated your BD sort of strategy still doing strength pros, et cetera, et cetera. So just wondering where do you hope to make the most change going forward with all the changes in management and so that's the first question.

And the second one is for Johan, please. So I have a question on 422 offer a new claim. So just wondering, what are your thoughts on translating the Phase II data into a positive Phase III trial. And specifically, I was just wondering about your thoughts on the primary endpoint, given that this indication and probably similar to -- for offering other indications, is that -- there might be a difference depending on how you actually measure the primary end point. In other words, if you set your primary endpoint is something similar to your Phase II design, you probably have a much higher chance of success versus if you said the primary end point to, I don't know, HomeStar's score change as we accept 72. Yes, any comments there would be great. Thank you.

[Charl van Zyl, executive]

Let me address also from a management team change. So of course, I'm really pleased with what the new members also bring and complement some of our members in the team that are building a strong foundation. And it's really about essentially bringing in some fresh thinking, continuing to revitalize how we might think about the future of our innovation strategy. But there's also a very clear view behind that, which is one where we essentially create very clear pillars of accountability, of course, with Johan in R&D. But also with Michala and Tom having very clear geographic accountability for executing on our growth strategy of our assets, but then bringing Maria really helps us to further elevate our thinking around where is neuroscience going? What is the neuroscience space from a strategic opportunity perspective?

But also building for us in a sense of view of what other capabilities might we need? How do we think about AI? How do we think about future needs for also our pipeline as we are, in a sense, seeing that pipeline evolve with more global assets to be launched on a global stage. So this is how we think about this team in a sense, working in a very joined up way but being very agile to build our innovation strategy for the future. But very happy with this team and where we stand today. So with that, I think, Johan, you want to comment on the question on [indiscernible].

[Johan Luthman, executive]

I mean the use [ dogma ] in R&D is that you don't change something you have in Phase II that worked to Phase III. But there are two elements here to consider, and you have maybe seen some of the data we had as a primary the total on source and there's also the modified on source. We had that as a key secondary. And the different flavors of the same scale and how you use it. FDA has their view on this EMA, their own view. So sometimes the regulators are not fully aligned what they favor. We used the total as the primary at this time. We could opt to do something else for the Phase III because we did look at both and both looked good for our trial. We can design a trial on either. So that's flexibility that I would say is in the realm of not changing too much between Phase II and Phase III.

I think hidden also in your question is more a question about the statistical approach we used the bayesian regression model here. And are we going to try to use that also for Phase III? Yes, we think that is a very, very suitable approach for these kind of trials. So obviously, that will be part of the conversation with regulators moving forward. But at the end of the day, it's our conversation with regulators and how we balance all that input that will judge how the final design will look like. So we'll come back later on when we really finished. It will take some months, quite frankly, until mid of the fall until we got the feedback we need.

[Operator]

[Operator Instructions] Our next question comes from Manos Mastorakis with Deutsche Bank.

[Manos Mastorakis, analyst]

So the first one is for Michala, Maria or both perhaps if you could give a little bit of color on SUNRISE in Asia peak potential as well as what do you know about the Asian markets in terms of how an IV product will be taken up?

Second question for Johan. You're meeting with the FDA on the MSA. How do you expect to announce the outcome of that meeting and any further details on the design for the Phase III?

Finally, a quick one for Joerg. What types of activities have you already started doing for the Phase IIb and the Phase III of [ take-up ] and MSA, respectively, that have already started being accounted for in your financials. Given that the MSA study has not even started. And sorry to Charl I don't have a question for you today.

[Charl van Zyl, executive]

Thank you, Manos. So Johan, if you could comment on SUNRISE first in Asia.

[Johan Luthman, executive]

Yes. SUNRISE in Asia, as you know, we had the package of some studies. SUNRISE is the bigger one. We had a sunlight that probe the -- so as you know, we have a package that is called Sun. We had this sunlight study. Some years back, that was a small pioneering study, and then we have the SUNRISE study now that is the bigger, more pivotal trial. We learned a lot from Sunlight. Populations do differ and different patients come into different doctors in different countries. And China, in particular, was a learning for us. Other companies have now concluded activities in both China and Japan. So we are more encouraged that there is a way to find the drug working there. But obviously, it's always development risk with any program. IV has not been a problem, quite frankly, most patients come into hospitals, and they can do IV. And I think we probably will see quite a bit of that also in the marketplace because that's how you see care in China. You had also MSA FDA. Should I take that, [indiscernible] ?

Yes. So that's simple. We will not chat too much what we're discussing with the FDA because this is going to be back and forth. You will probably see mostly how this ends up with the announcement of our trial design and the posting [indiscernible]. There is no point really go back and forth with information when we have fragments of information moving forward. If we get breakthrough designation, that's probably something you will hear about.

[Charl van Zyl, executive]

Thank you, Johan. And Joerg, do you want to comment on how we see the R&D evolution, I think, is the question around MSA and the investment behind.

[Joerg Hornstein, executive]

Well, we currently, as Johan said, basically discussing the design of the Phase III. And we're fully aware about the full investment. And I think you've also seen that we feel confident enough, not only full year reiterating our guidance for '24, but also reiterating our midterm guidance. And I think that implies that even accounting for the additional investment of [ asimab ], we feel confident reiterating these targets. Of course, the -- let's say, plan for '24 does not entail a significant part of it, except certain CMC investments already that we have launched.

[Charl van Zyl, executive]

And then I think the final question was really on the expectations we see for Asia. So Michala, if you could answer that, please.

[Michala Fischer-Hansen, executive]

Yes, Manos, thank you very much for that question. Unfortunately, I'm once again going to disappoint because we don't provide guidance on product and regional level and certainly not when we don't have an approval yet. But I can tell you, we are awaiting in anticipation. And also, as Johan was saying in the trial, at least, we haven't seen great barriers with the infusion set up. So more to come on that, I promise.

[Operator]

Ladies and gentlemen, this was our last question.

[Charl van Zyl, executive]

Good. Well, thank you for joining us for the call today. I really appreciate your questions, and look forward to seeing you soon. Thank you again.