So we think that, number one, you’re going to continue to treat those diagnosed untreated patients as they move through their disease course. And of course, we’ve seen that already with Galafold. And then we think you’re going to just keep finding more and more patients. If you look at the statistics, this is the most under diagnosed genetic disease, and there could be double or triple the number of patients living with Fabry who are not diagnosed today. So that’s a really important part of the story of Galafold. And if you think about what we offer with Galafold, which is an oral medication, which has shown to be clearly impacting so many patients around the world. We think that would be a great option for patients that are newly diagnosed with the disease.
Kristen Kluska: Thank you.
Operator: Thank you. One moment for our next question. The next question comes from Tazeen Ahmad with BofA Securities. Go ahead. Your line is open.
Tazeen Ahmad: Okay. Great. Good morning. Thanks for taking my question. Brad, I just wanted to ask you about Pompe. When you came up with your guidance for the year, what proportion of that guidance is an assumption that you’re making about how long patients are staying on the Sanofi products before switching. We have had conversations between us and you as well as the physicians that indicated that docs could conceivably start to switch patients as early as two years from the previous drug. But how is that working out in the real-world setting so far? And what part of your guidance, is that contributing to? Okay. Thanks.
Bradley Campbell: Yes. Thanks, Tazeen, and looking forward to seeing you at the conference next week. So yes, it’s a great question. We — what we had heard coming into the launch was that physicians were thinking they needed kind of at least a year of treatment before they would think about switching a patient. And then patients said, look, if I’m not doing well, I’d be willing to switch within six months. And I think if you look at the switch dynamics that we highlighted for the United States, we’re seeing 75% roughly of our switch patients are coming from Nexviazyme and 25% are coming from Lumizyme. I think that’s a pretty fair reflection because next is launched a little over two years ago. So you’re starting to see a bolus of patients go through that kind of one-plus year period.
I do think that there are some physicians sure who will be thinking more about that two-year period. And my view and our expectation is the better we demonstrate outcomes in those patients who do switch, the more likely that physicians are going to start to think that, hey, I should be thinking about doing this sooner. And even I should be proactive. And I think that’s what we’ve talked about is kind of the real battle here is for that “stable middle.” And that’s — when we win that — the hearts and minds of those patients and physicians, I think that’s where that momentum continues to build. So we’re seeing great trends right now. I think what we are seeing is what we expected to see in that kind of one- to two-year switch period. And then outside the U.S., remember, where Nexviazyme hasn’t been in the market for nearly as long.
And in many cases, we’re launching kind of head-to-head we’re seeing switches from majority Lumizyme because that’s the majority of the population, but we’re also seeing next isome switches and we’re seeing strong uptake in naive patients. So I think as long as those trends continue, and we think they’ll actually accelerate, that will clearly support our guidance and then much more room to grow from there.
Tazeen Ahmad: Okay. Thanks, Brad.
Operator: One moment for our next question. The next question comes from Dae Gon Ha with Stifel. Go ahead. Your line is open.
Unidentified Analyst: Hello. This is Bente [ph] on for Dae Gon Ha. Thank you for taking our question. Can you speak to your appetite on business development opportunities to kind of bolster the pipeline? And kind of wondering if the volatile markets and depressed valuations are drawing your attention? And if so, what therapeutic areas would you be considering?
Bradley Campbell: Thank you for the question. Yes. Sebastian, do you want to just give an overview of what we’ve talked about previously in terms of how we’re thinking about business development opportunities. Sebastian, I believe you are on mute.
Sebastien Martel : Sorry about that. Thank you for the question. So as you know, we’ve got plenty of growth still generated from Galafold as we just discussed, and we’re in the midst of the launch rollout of Pompe, Hence, the very strong growth rate that we’ve provided today in terms of overall sales growth for Amicus as a whole. Yes, we’ve been doing our homework from a BB [ph] M&A side of things, have been developing a framework on addressing what potential disease arrears or even specific indications might be of interest. I think we, over time, have developed a very solid infrastructure commercial and medical standpoint as well as from a development and regulatory standpoint. And we could clearly be able to leverage that.
We’ve been looking at what we call adjacencies when it comes to indications. So thinking of Fabry as a rare renal or rare cardiac disease, thinking of Pompe as a neuromuscular or more broadly speaking, we’re in neuro. So these are some of the therapy areas that are of interest to us. When it comes to stage of development. We are more focused and more interested to look at later stage opportunities. And by that, I actually even include potentially marketed assets, recently approved drugs or products that are still in the launch phase or product programs that are currently undergoing Phase 3 trials so that we would be initially more focused on assets that could provide a fair amount of accretion fairly quickly as opposed to investing in early-stage tech platform type of opportunities.
Unidentified Analyst: Excellent. Thank you so much.
Operator: Thank you. One moment for our next question. Final question comes from Salveen Richter with Goldman Sachs. Go ahead. Your line is open.
Unidentified Analyst : Hi. This is Shineton [ph] for Salveen. Thank you so much for taking our question. Can you comment on what you’re hearing from physicians in the EU with regard to real-world experience with Pompe and Nexviazyme? And are there any details emerging as the real world accrues. And in the U.S., can you discuss the efforts to decrease the time line from 70 days from prescription infusion?
Bradley Campbell : Yes. Thank you for the two questions. I would say, for sure, we continue to hear incredibly positive anecdotes coming from physicians and patients in the United States, in particular around their experiences on onboard. I won’t speak to the other product. But I think that will be a huge driver of word of mouth and confidence in this product. We’re just seeing things that I think are really inspiring and will inspire others as well. One place to look for some of that is Dr. Mark Roberts did have a presentation at the World Congress this year, where he presented on some case studies coming out of the EMS program. He was one of the EMS physicians in the U.K. So that’s a good place to look. There was also another M site that published a poster, I believe, last year that also looked at a number of patients who were responding to — or excuse me, and how they were responding to the therapy.
So I think there is — and that’s something that we will continue to focus on as well as kind of building that body of evidence, both through the registry, as Jeff highlighted, but then also through physicians we’re adding those experiences, I think that will be a significant driver of momentum going forward. The second question in terms of the insurance process. So really, there’s two key components. The first component, and this is really the long tent in the pole is when you first launch, you don’t — you’re not in any of the formularies. And so you typically go through what’s called a letter of authorization process that takes time. And it’s a process that we know well from Galafold, but you just have to work through that system. That’s probably the longest part.
And then when you come into the beginning of the year, you start to come on to formularies both for hospitals and major insurers, and we’re doing that. We’re also seeing patients go through Medicare and Medicaid very successfully. So all those things are happening kind of when we thought they would. The second piece of the puzzle is then just purchasing the drug and getting the drug and then scheduling the infusion. And so that takes a little bit of time as well. Our goal is that steady state, this can get down to kind of 30 to 45 days, which is what we see with Galafold. And just as an aside, the two most recent commercial patients in the U.S. were in that time frame. So that’s a place that we know we can get to, and we’re glad to see the progress so far this year.
Unidentified Analyst : Thank you.
Operator: That was your last question. This concludes today’s conference call. Have a great day.
