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| Statement |
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| We believe amicus is in a great position for our second successful launch |
| We are strongly positioned to continue to advance our mission of delivering groundbreaking new medicines to thousands of people living with rare diseases around the world and creating value for our shareholders |
| We're very excited that we published on the development of the outgrowth algorithm and Fabry it looks like it can do a very good job |
| The patient diagnosis growth has been really impressive |
| So we think all of those dynamics are really healthy and will continue |
| So, first Galafold continues its strong performance and it remains the cornerstone of our success |
| We are very pleased with the continued uptake of Galafold globally |
| So the first two months of the year and then a faster net new patient acquisition versus the months over the course of launch last year so all of those things for us point to continued building momentum and gives us great confidence in the launch |
| Throughout 2023, we continue to observe strong trends across our key performance indicators in all of our key geographies including continued demand through new patient starts from both switch and naive populations in all of our leading markets |
| We saw steady growth of in-person visits between our field team and Fabry treaters and we've continued to see sustained patient compliance and adherence rates of over 90% |
| I would think that's really the exciting opportunity |
| Looking 2024, we will continue to drive significant top-line revenue growth supported by sustained double-digit Galafold performance and the successful ongoing global commercial launch upon building up for that, which puts us on track for our first full year of non-GAAP profitability |
| These underlying market dynamics will provide the opportunity to grow Galafold for many, many years to come, including in 2024, when we expect another great year with 11% to 16% projected growth at constant exchange rates |
| We had a very successful year full year, achieving total revenue of $399 million, which is a 21% increase over the same period in 2022 |
| Our teams have made significant progress in the initial commercial launch in Germany, the UK and the US, and we remain incredibly pleased with the launch so far |
| It's an honor to achieve an award based on our scientific innovation, but even more importantly the meaningful difference we can make in the lives of so many people living with these rare diseases |
| The key performance indicators that we talked about last time continue to improve and continue to give us confidence in the strength of this launch |
| We've been pleased with the continued demand for this new therapy |
| So, in summary, we're very pleased with the launches of Pombiliti and Opfolda across all the first wave of countries, the strengths of our clinical data, the depth of experience and talent we have at Amicus gives us great confidence in our ability to make a real difference to people living with Pompe disease |
| Overall, we're starting off the year strong, and we're very pleased with the building momentum on patient demand |
| In a moment, Sébastien will provide further color on the ongoing launch of these key performance indicators, but overall, we're very pleased by the launch and the great momentum we're seeing across each of our markets |
| We are incredibly pleased to be providing a real choice for patients and challenging therapeutic options for both physicians and people living with Pompe disease |
| Third, Amicus has maintained an incredibly strong financial position as we continue to execute on the expansion of Galafold and advance the global launch of Pombiliti and Opfolda |
| In the US, and with the start of the new year, many of the large payers have already put Pombiliti and Opfolda onto their respective formularies, and we've also seen strong acceptance by Medicare and Medicaid as well |
| This is obviously a significant milestone as we now look to deliver our first full year of non-GAAP profitability in 2024, supported for the first time by well over $0.5 billion in combined product sales, as well as prudent expense management to really significant milestones in the evolution of Amicus as a biotechnology company in the rare disease space |
| Looking ahead we expect steady double-digit growth for Galafold throughout 2024 and we remain confident that our strong IP protection will provide Galafold a long runway well into the next decade |
| Galafold growth in 2023 was primarily driven by strong patient demand, particularly from our leading markets |
| Our results in the full year highlight the strength of our global commercial efforts |
| The demand for Galafold globally continues to be strong with patients added in all major markets, delivering operational growth of 18% over the same period in 2022 or 17% at constant exchange rates |
| We've been successful in finding new patients through newborn screening and other diagnostic initiatives as well as artificial intelligence through our partnership with [indiscernible] |
| Statement |
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| Additionally, we've historically seen Q1 revenues come in slightly below prior Q4 due to the timing of orders and the reauthorization process in the U.S |
| Ritu is for us to challenge the expectations of therapy |
| About a quarter of patients, are clearly declining and about a quarter of patients are likely in some sort of improvement phase, which is what we would expect based on historical data |
| So we do think a significant chunk of that 50% sort of stable middle patient segment is actually declining when physicians start to dig in more holistically |
| Although, I think Jeff will talk us through why in fact they may be suddenly declining as well |
| Any or all the forward-looking statements made on this call may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties |
| And so we could we would continue to expect that number to come down as we progress through the launch |
| Total GAAP operating expenses decreased to $439 million in 2023 as compared to $503 million in 2022, a decrease of 13% |
| On a non-GAAP basis, total operating expenses decreased to $342 million for 2023 as compared to $413 million in the prior period, a decrease of 17% |
| I think one of the big questions that everybody had was boy, in the markets where next Nexviazyme has been launched the longest, maybe those patients are going to be too sticky and you'll have a really hard time penetrating into those markets |
| And with choice you have a chance to challenge those outcomes |
| As mentioned on past calls, due to a variety of contributing uneven ordering patterns and FX fluctuations, the rate of growth within the year is typically nonlinear |
| But again, I think that will be an industry-wide and hopefully disease wide phenomenon |
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