11/13/2024

speaker
Charles Balnazil
CEO

Thank you, and welcome to our earnings call for the first nine months of 2024. Of course, I really thank you for joining today. And needless to say, I'm really proud to present these results, which are further validation of our focused innovative strategy, which allows us to raise the lower end of our full year guidance. But before we go to the results themselves, let us go to the next slide. So from a disclosure perspective, the forward-looking statements are that today's discussion, of course, do include statements that are subject to change. And also, the next disclosure I would like to make is also, of course, to the agreement between Longboard and Lundbeck that is subject, of course, to closing of the tender offer to be completed. So if we go to the agenda, the next slide, please. So, of course, I'm really pleased to have the management team join me today here. So we have our two geographic presidents, Tom and Michaela, who will talk about our geographic performance, respectively. We have Johan, who will give us an update on R&D. And we, of course, have Jörg on the financial update and outlook for the full year. So then if we go to the next slide, which is really what I would like to, of course, share as a high level summary of our results that we have shared with you today and put some context around these results, because this is really for us, of course, an important milestone, a further validation of where we are traveling for the mid to long term. This is also consistent with what we shared with you during our capital markets event, and it shows again that we are executing well against our plan that we've laid out. The first to say is that, of course, revenue is growing at 13%. And when we look at that specifically, also driven very much by our strategic brands, which are growing at 21%, and this is 74% of our revenue today falling in the strategic brands category. VIEPTI is leading that charge with 67% and of course also Rexalti with 16% especially driven by the AADAD indication. We have also seen major steps forward in the pipeline, which Johan will refer to a bit later. But the Sunrise trial, of course, is another strong outcome for us that further supports the value proposition of IAPTI and will lead the pathway towards future launch potential in some of our Asian countries. And we also, of course, see major advances also with Amlenatuk into phase three. and of course the advance of bexie catherine into the phase three program that is started by longboard so overall these results in a sense and where we stand with the first nine months give us that confidence that we can now raise the lower end of our full year guidance as we have disclosed of course today in our press release so with that let's go more specifically into the performance at a geographic level. And it's my pleasure, of course, to hand over to Tom and Michaela to take us through those results. Thank you, Tom.

speaker
Tom
Geographic President, US

Great. Thank you, Charles. And hello, everyone. As Charles mentioned, we are very pleased with our commercial performance during 3Q 2024, which was driven by 21% growth of our strategic brands. This growth was headlined by VIEPTI. Next slide, please. VIEPTI delivered strong results during the quarter, and this performance has been fueled by accelerating growth in the U.S. and supported by the continued stream of launches and robust adoption of VIEPTI in prioritized European and international markets, including Canada, France, Spain, Germany, and the UAE. VIEPTI global net revenue for the third quarter 2024 year to date was 2.116 billion DKK, and this represents 76% growth year over year. Net revenue for VIEPTI in the US was 1.858 billion DKK, and this represents 66% growth over 2023. Importantly, we are beginning to see meaningful contribution to global sales by ex-US markets with VIEPTI now available in some 29 markets. These markets are exhibiting strong anti-CGRP market growth and VIEPTI continues to gain meaningful market share across these markets. ex-US sales will receive a significant boost, if approved, in Asia, based upon the positive sunrise trial results, which will be discussed by Johan later in the presentation. I wanna focus a moment on the US. Over the past year, we've worked very hard to refine our specialty commercial model to support VIEPTI through a patient-centric focused ecosystem that appropriately supports the patient throughout their patient journey. We are continuing to see accelerating demand by driving depth and breadth of prescribing, and continued positive momentum in new patient starts, higher written to infusion conversion ratios, and increasing patient persistency. Weekly market share during September hit an all-time high in the US of 9.4%, and this compares to 6.8% in January. Next slide, please. RIGSALTI continues to perform well, propelled by the continued strong progress of the AADAD launch in the US. US TRX growth during the third quarter of 2024 accelerated to 20% versus prior year. Global reported revenue increased 16% through third quarter 2024 versus prior year, and revenue growth during third quarter 2024 accelerated to 22% versus third quarter 2023. Now we're pleased with the strong demand growth observed across all priority markets. The majority of the volume growth is driven by the US and this is particularly attributed to the AADAD launch with 361% monthly volume growth when we compare August 2024 monthly TRX demand to the pre-launch baseline. RIGSULTI AADAD volume is becoming increasingly important to the overall RIGSULTI growth and we expect this to continue through 2024 and beyond. AADAD contribution has grown to 17.5% of the total TRX demand for the brand based upon the most recently available data and 22% of new to business prescriptions. 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, with RIGSULTI achieving all-time market share high last week of 2.32%, and this compares to 1.97% in January. In looking at the most recent TRX data as of October 25th, 2024, overall rolling four week TRX growth has accelerated to 17% compared to February with improved execution across the broader marketing mix. I will now turn the presentation over to Michela to discuss performance of our other strategic brands, Michela.

speaker
Michaela
Geographic President, International

Thank you, Tom. Good afternoon, everyone. I'm very pleased to join you here to share some of the results we see for both Brintelix and the Abilify franchise. If we start with Brintelix, then we have a strong performance once again across the key markets. Overall, we are seeing 14% growth versus last year, and now the brand is at 3.58 billion DKK for the first nine months of the year. We continue to see strong momentum in Europe and international markets, where Brintelix has grown 17% versus last year. We see Europe growing at 17%, which is driven by Spain at 27%. But also in international markets, we see a 17% growth, with China growing 36% and Japan growing 21%. If you look at the volume MAT growth over the last 12 months, you can see that we continue to exceed market growth in the key markets with Japan at an impressive 32% MAT volume growth. When we look to the US, you can see a strong and robust performance in sales with an 8% growth at 1.134 billion DKK versus last year. And this is mostly driven by favorable gross to net comparisons. Move to the next slide, please. When we look to the Abilify franchise, we also see a solid performance with all markets contributing to that performance. The franchise delivered double-digit growth versus last year at 10% and is now at 2.618 billion DKK for the first nine months of 2024. We have the US growing at 15% versus last year, which is driven by Abilify and Simplify conversions. That now represents 15.2% of the NBRXs for the franchise and 10.6% of the total volume. Encouragingly, we're also seeing that we have increasing conversions from the oral aripiprazole. In EU and international markets we had 8% growth versus last year now at 1.626 billion DKK and we see again strong performance across most of the markets worth highlighting Spain, Canada and Australia and we continue to see a strong volume growth versus the market in key markets as you can see on the right graph. We launched Abilify Mintena 960 in Europe. As you may recall, we got the approval from EMA earlier in the year, and it's now rolled out in 11 markets since June of 2024. It is still early days, but the performance is in line with our expectations, and importantly, the feedback from our customers is very encouraging. With that, I hand over to Johan.

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