Thank you for standing by. My name is JL, and I will be your conference operator today. At this time, I would like to welcome everyone to the BioMarin Business Update. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again.
I would now like to turn the conference over to Traci McCarty, Head of Investor Relations. You may begin. Perhaps your line is on mute, Traci.
Thank you, JL, and good morning, everyone. Thank you for joining us to discuss BioMarin's acquisition of Amicus Therapeutics, expanding BioMarin's position as a leader in rare diseases and creating value for shareholders from day one. Please find our press release and PowerPoint on the Investor Relations section of the website. Moving to slide 2, our forward-looking statements. This call is being recorded, and a press release and slide presentation are now available. I would like to direct you to our Safe Harbor Statement, which, in summary, says that we will be making forward-looking statements through the course of our discussion today, and actual results may differ materially.
Moving to the agenda on slide 3, joining the call today from BioMarin is our CEO, Alexander Hardy, and CFO, Brian Mueller. Joining us for the Q&A portion of the call are Cristin Hubbard, BioMarin's Chief Commercial Officer, and Greg Friberg, BioMarin's Chief R&D Officer. With that, I will turn the call over to you, Alexander.
Thank you, Traci, and thank you for joining our call on what is an important day for BioMarin and our colleagues at Amicus Therapeutics. Like BioMarin, Amicus seeks to deliver innovative therapies to people living with rare diseases, specifically Galafold for the treatment of Fabry disease and Pombiliti and Opfolda, or POMOP, for the treatment of late-onset Pompe disease. I am tremendously excited about this deal for three main reasons. First, BioMarin and Amicus are an exceptional strategic fit. BioMarin is operating at scale with a broad global commercial footprint, a proven ability to find patients living with genetically defined rare diseases, and industry-leading manufacturing capabilities. Galafold and POMOP will add therapies to our commercial portfolio that have already transformed care for thousands of patients around the world, and this combination will enable us to reach more patients consistent with the missions of both companies.
Second, this deal will accelerate BioMarin's revenue growth immediately upon close, adding two high-growth products with numerous global expansion opportunities. Galafold and POMOP each have the potential to reach $1 billion in peak sales. With the announcement today of the Galafold IP settlement, this growth is projected to continue through much of the 2030s. Third, the transaction will increase our already strong financial outlook. The combined company will generate additional cash flow, enabling us to deliver rapidly and continue to invest in both internally developed and externally sourced innovation. We expect this deal will be accretive to non-GAAP diluted EPS in the first 12 months after close and substantially accretive beginning in 2027. Brian will provide more financial details in a moment.
As we have shared with many of you over the last few quarters, any sizable transaction would need to have a compelling rationale for all of BioMarin's stakeholders: patients, employees, and shareholders. With this exceptional strategic fit, the immediate acceleration of revenue growth, and the strengthening of our long-term financial outlook, the value of this deal is clear.
With that, I will now turn the call to Brian to review transaction terms and financial highlights. Brian?
Thank you, Alexander. Turning to slide 5, we are pleased with the terms of this transaction, and I will take this opportunity to walk you through the financial highlights of this agreement. Under the terms of the definitive agreement, BioMarin will acquire all of the shares of Amicus Therapeutics in an all-cash transaction at $14.50 per share, valued at $4.8 billion. As Alexander shared, we believe the addition of Galafold and POMOP revenues to our existing portfolio represents an attractive opportunity to strengthen our financial outlook and add value from day one. This transaction will be financed through a combination of cash on hand and approximately $3.7 billion of non-convertible debt financing. We expect to close the transaction in the second quarter of 2026, subject to regulatory clearances, approval by the stockholders of Amicus, and other customary closing conditions.
The addition of Amicus products will immediately accelerate total BioMarin revenue upon close. As we integrate Amicus into BioMarin, our priority will be to maintain and build upon the company's capabilities and resources to support the ongoing growth of Galafold and POMOP. We also believe that there are benefits that can be realized through the synergies, given the complementary nature of the two businesses and BioMarin's scale of operations. We expect this combination to increase our profitability and cash flows, which provides the opportunity to delever quickly, with a target of being under 2.5x gross leverage within two years from the transaction close. Turning to slide 6, one of the most compelling aspects of this deal is the ability to benefit from BioMarin's operating scale to accelerate the growth of Galafold and POMOP.
On top of our growing 2025 full-year total revenues, seen on the left, we believe Galafold and POMOP will be significantly additive to BioMarin's top-line growth through much of the 2030s. On the right side, the addition of Galafold and POMOP will contribute substantially to revenues and further diversify BioMarin's commercial portfolio. We believe this is a clear and compelling opportunity that creates significant value, benefiting from the combined capabilities of BioMarin and Amicus.
I will hand it back to Alexander for slide 7. Alexander?
Thanks, Brian. I'm extremely excited by the strategic fit of Galafold and POMOP as part of BioMarin's Enzyme Therapies business unit and the opportunity that we have to increase market share of these differentiated products in growing markets. We believe the estimated prevalence for both Fabry and Pompe is higher than the current number of diagnosed patients, whether treated or untreated. We will draw upon our years of experience finding patients and driving treatment rates, building on the success of Amicus to date. Moving now to slide number 8, Galafold, the only approved oral therapy for Fabry disease, is currently available in more than 40 countries. We believe we have the opportunity to deepen the reach of Galafold in those existing markets, as well as reach patients in new geographies across our 80-country footprint by driving diagnosis and treatment rates for both naive and switch patients.
Part of BioMarin, Galafold has the potential to reach many more patients around the world. Moving now to slide number 9, as you have seen in our press release this morning, Amicus has entered into settlement agreements with Aurobindo and Lupin, concluding the ongoing litigation related to Galafold IP. These settlements will not allow either manufacturer to enter the U.S. market before 2037, in line with the previously announced Teva settlement. Based on our review of Amicus's intellectual property during diligence, we are highly confident in the growth of Galafold through much of the 2030s, now that these IP challenges have been resolved. Moving now to slide number 10, similar to Fabry, we believe that Pompe disease is significantly underdiagnosed. Unlike existing single-component enzyme replacement therapies, POMOP combines an ERT with an orally administered enzyme stabilizer.
We are also encouraged by the real-world data that Amicus has generated, showing that more than 50% of patients switching to POMOP experienced clinically meaningful improvements in functional outcomes. We believe this growing body of evidence differentiating POMOP from the two alternative enzyme replacement therapies is gaining momentum and will drive new patient starts. We have been really impressed with the work that Amicus has done with the launch of this innovative therapy, which was approved in 2023. Because POMOP is still early in its launch, we have a unique opportunity at this stage to accelerate growth by taking full advantage of BioMarin's scale and capabilities.
Moving now to slide number 11 and the conclusion of our prepared remarks. This is the second significant public company acquisition this year for BioMarin, positioning us for an exceptional 2026 and well into the future. The two deals together strengthen our financial outlook, with potential for accelerated revenue growth now and in the future, and an increase in cash flows from the combined organization immediately after close.
BioMarin has been dedicated for almost 30 years to transforming care for people living with genetically defined rare conditions. As I've gotten to know the team at Amicus, I see the same dedication to patients and shared mission-driven culture. I'd like to acknowledge the incredible work that the team at Amicus has done over the years to reach patients living with Fabry and Pompe. I am confident in our ability to build on their success and to deliver on BioMarin's pipeline catalysts from our clinical portfolio. Today's announcement adds significant value for shareholders, employees, and, most importantly, patients around the world. I look forward to sharing more as we continue to make progress.
Thank you for joining us today. Cristin and Greg will join us for the Q&A portion of the call. Operator?
Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. And again, it is star one to join the queue. Your first question comes from the line of Paul Matteis of Stifel. Your line is open.
Hey there. This is Julian on for Paul. Thanks so much for taking our question. Very interesting acquisition, obviously. It's clearly on the larger side, I think, with respect to what people were maybe expecting. Can you just talk about the timing of this and why now is the right time to transact? And just sort of assumptions and thinking about how this opportunity can bridge the revenue gap when thinking about competition from your existing product portfolio right now. Thanks and congrats on the deal.
Thanks very much, Julian. Thanks for the question. I mean, I've talked about typical deal size, and I've also said that any larger deal would have to be clearly value-creating. And this deal is clearly value-creating. I mean, it's an exceptional strategic fit. These products will fit very, very nicely into our enzyme therapy business unit. It will draw off the capabilities. We'll be able to leverage our incredible 80-country global commercial footprint. Secondly, it's going to be additive to our revenue growth. And finally, it's very compelling from a financial outlook standpoint in terms of additional EPS growth, cash flow, etc. So this is really an exceptional fit, an exceptional opportunity for BioMarin.
We're doing this, as we said, with regard to BD because we have a compelling set of capabilities, and we have the abilities to do deals and create value for our shareholders. This fits perfectly into that. At the same time, we're very confident of our ability to compete with VOXZOGO in achondroplasia, but we can do many things at the same time, and we can create extraordinary value, we believe, for all of our stakeholders by doing deals such as this one.
Thank you. Your next question comes from the line of Phil Nadeau of TD Cowen. Your line is open.
Good morning. Thanks for taking our question. Let us add our congratulations. Strategically, this does seem like a hand-in-glove fit. We want to drill down on revenue growth for the franchises here and ask you kind of a two-part question on that. First, just overall, what type of revenue growth do you think the franchises, the Amicus franchises, can achieve over the next four or five years? And then second, in your prepared remarks, you suggested that the number of patients with Pompe and Fabry is greater than the number of patients on therapy. Curious to understand why that would be. Obviously, Fabrazyme and Myozyme have been on the market for nearly 20 years. So how can BioMarin help increase the penetration of therapies into these what seem to be rather mature markets? Thank you.
Hi, Phil. This is Brian. I'll start with the revenue growth question. Thank you. So first, let's start with the two products that we're acquiring with Amicus and Galafold and POMOP. These are two on-market products. So despite the transaction size, this is a transaction that does not carry clinical risk and brings a base of revenue to BioMarin on day one. We also know that both products are growing at a faster rate than the already healthily growing BioMarin-based portfolio. And therefore, we do believe that the addition of these products will be additive to our growth rate over the next few years.
Thanks, Brian. And maybe I'll build on the second part of your question, Phil, kind of talking a little bit more specifically about where we see the opportunity both in Fabry and Pompe with these two assets. So our ambition overall, as you've heard, excuse me, from Alexander, is to really leverage our capabilities to build on the extraordinary momentum that Amicus has already built. And when we think about Fabry with Galafold, this is an area where Amicus has done a brilliant job at really carving out a leadership position for those amenable patients or those patients with amenable mutations. And what we know about Fabry is that it is a dramatically underdiagnosed condition. So it's estimated today that there's 18,000 patients that have been diagnosed, but there are 6,000 that aren't treated.
That right there is a really big opportunity for us to think about where Galafold could play. In addition to that, we know that the prevalence is estimated to be much higher, and so we intend to build on BioMarin's capabilities of driving diagnosis and treatment rates to expand upon the Galafold growth story. Now, moving over to Pompe and thinking about Pombiliti and Opfolda, this is an asset that's much earlier in its launch trajectory, and we really do believe that we have a unique opportunity again to leverage our scale to accelerate the growth of these assets. Now, this is something that, given that they're only reimbursed in 15 countries today, we believe that we can deepen penetration in the countries they're in, but also, importantly, expand across our large, nearly 80-country footprint over time.
Of course, that will take some time to do, but that's a huge expansion opportunity, we think. Not to mention driving switch in this space. We know that this is a progressive disease, and driving switch in this space is really important, which I think is building on the real-world evidence that they've been generating and thinking about the benefit that they're seeing as people move from enzyme replacement therapy over to POMOP. They've seen some really compelling real-world evidence that I think will help to drive that switch. So we do see tremendous opportunity here, and our ambition is to grow share in growing markets.
That's very helpful. Congrats again. Thanks.
Your next question comes from the line of Chris Raymond of Raymond James. Your line is open.
Hey, thanks and congrats from us on the deal as well. So just two questions. I guess, Alexander, you guys have guided at length to having firepower of $4 billion -$5 billion. I guess, can you just clarify, does this sort of max out your capacity in this area just doing this one deal? And then I have a leverage ratio question. I see that you guys, Brian, you're guiding to delever to less than 2.5x in two years. What are you projecting that number to be just after close? Thanks.
Brian, do you want to cover the second question first?
Sure. Yeah, thanks. Appreciate the question, Chris. And yeah, so we're taking on $3.7 billion of non-dilutive debt as part of the transaction. As noted in the press release, we do have a bridge loan secured here at announcing of the transaction, and we will begin executing on the financing here in short order. Also mentioned the target gross leverage ratio of 2.5x by the end of 2027 or within two years after close. To your question, at closing, on a pro forma basis, the gross leverage will be about between 3.0x-3.5x .
Thanks.
And with regard to your first question, as you can tell, this is very compelling from a cash flow generation standpoint. We believe that with the cash flow that we'll be able to generate from our existing business together with Amicus and the value that we'll create from the two assets, we think we'll be going to be able to rebuild our firepower within 12-24 months after the deal closes. In the meantime, we have a level of strategic reserves. We have a revolving credit line, and we intend to do additional smaller deals to further build our R&D pipeline during the meantime. But taking a step back, we do believe, and I think these two deals that we've done this year show that BioMarin can do really compelling deals, leveraging our capabilities, adding value for our stakeholders. We very much intend to use this cash flow generation to continue to do deals which add value. Thank you.
Your next question comes from the line of Sean Laaman of Morgan Stanley. Your line is open.
Good morning, Alexander. And Tim, congratulations on the transaction. I have two questions. Just the first one, using all debt essentially to do the transaction, what that might say about the enduring cash flow generating nature of your existing business sort of pre-acquisition and your view there? And the second one is just your feel for what OpEx synergies could be observed? Thank you.
Hi, Sean. This is Brian. Thanks a lot for the question, so of note, on this transaction, again, given the scale that Amicus has achieved on a standalone basis, approximately $600 million of revenue over the last 12 months, and they've been on their own successful profitability journey. They reported non-GAAP income in 2024 and have said they're on track for GAAP net income in the second half of this year, so importantly, the combined business actually generates operating profits and operating cash flow on day one. We do believe the transaction will be slightly dilutive in calendar 2026 and then starting to be accretive in full year 2027, substantially accretive beginning at the end of that year, and that's largely due to the interest cost that we're taking on with the debt associated with the transaction.
But back to the cash flows, we do believe that this will be very quickly additive to BioMarin's cash flows. And while we will incur integration costs, we don't anticipate an impact on that BioMarin-based business cash flow.
And then in terms of synergies, our priority is going to be to merge the two companies to maintain and build the great capabilities that Amicus has built over the years so that we together can continue to grow Galafold and POMOP. We do expect that there will be synergies available. Again, as I mentioned in the prepared remarks, these are two very complementary synergistic orphan disease businesses. And again, while the priority will be maintaining operations and growing these products, we will commence integration, and there will be synergies available to us over time that, together with the scale of the combined companies, will actually increase the net fully integrated profits and cash flows over time.
Wonderful. Thank you.
Your next question comes from the line of Cory Kasimov of J.P. Morgan. Your line is open.
Hey, good morning, guys. Thanks for taking my question and congrats to both teams on this deal. I guess I'm curious, just as the outlook here, commercially speaking, first based on Brian's comment that these Amicus assets are growing faster than BioMarin's base enzyme therapy portfolio, do you expect to raise your long-term CAGR expectations for this side of the business? And how do you think about the competitive landscapes in Fabry and Pompe? Thank you.
Hi, Cory. It's Brian again. Thanks for the question. Yeah. So just to start, the purpose of today's call is to announce the transaction. We're very excited to be adding these two approved high-growth products to our portfolio. Companies will continue to operate, of course, on a standalone basis until we close the transaction. As I mentioned, we do believe that the combined business will grow at a higher rate through the rest of this decade and beyond. We do believe that the products will be meaningful contributors to revenues in 2027, both absolute dollar and growth rate. However, we're not offering additional guidance at this time for 2027 or beyond. What is important to note is that we continue to grow revenue from BioMarin's base business, and these products both add to the growth and, very importantly, diversify BioMarin's overall portfolio.
This is Greg Friberg. I'll take a stab at the competition question. Certainly, Galafold is an orthogonal mechanism to the other approaches that are out there. It's oral. It's targeted. It's highly active. And in a disease like Fabry, where sadly, patients can respond, but that response can wane over time, having additional arrows in the quiver, so to speak, is really important for physicians and patients. And we see Galafold for the amenable mutations as playing a really important part there. When you think about the landscape for Fabry beyond that, again, we see that Galafold is going to play a really important role for some time to come. There are substrate reduction therapies that are being looked at, though, again, unproven.
From that standpoint, we see the opportunity to have a unique mechanism within our portfolio, building on the great work that Amicus has done, to be a tremendous opportunity.
On the Pompe side, it's another situation, another lysosomal storage disorder where first-generation enzyme replacement therapies did transform this disease. A real breakthrough in that sense, though newer therapies really have focused on this ability to drive more drug into the muscle and, most importantly, of course, into the lysosome of the cells in the muscle. POMOP actually has been engineered to do that in a couple of different ways. One is through the so-called M6P. It's been selected to really get into the lysosome and do its job better.
Then, of course, adding the stabilizing agent not only increases PK. You can actually see in the label, they show the PK very nicely and exposures when the stabilizer is added. But in preclinical studies, again, the suggestion is that that goes even farther. This double whammy really is a next-generation approach to enzyme replacement therapies. And in that regard, while there are other options out there, again, we think the real-world evidence with POMOP and other preclinical data sets that Amicus has nicely been generating really show its value in this space, and that will only continue. Of course, there are label expansions going on as well into the younger. POMOP, for example, is only approved in adults right now, but there's certainly, I believe it's 12 to 17 is on the way shortly.
So from that standpoint, hopefully, that answers your question, but we're really thrilled about the biology behind these molecules and their opportunity to help patients in fields where options are going to be important. These patients live a long time with these diseases, and preventing end-organ damage is absolutely the goal of therapies like this.
Yeah. Very helpful. Thank you.
Your next question comes from the line of Joe Schwartz of Leerink Partners. Your line is open.
Hi. Congratulations to everyone on a very interesting deal. A lot of my questions have been answered, so maybe I'll ask about BioMarin's view on DMX-200 and FSGS, given you're acquiring Amicus shortly before another company has their PDUFA and FSGS. I'm wondering if you can give us your view of the clinical prospects and regulatory path forward for DMX-200, and to what extent is BioMarin prepared to capitalize on that opportunity, given nephrology would be a new commercial area for the company?
Yeah. Thanks for the question, so for those who aren't entirely familiar, focal segmental glomerulosclerosis is the disease we're talking about. It's a rare and fatal kidney disease. Probably about 40,000 patients in the U.S. are living with this at any given time. It's a therapy that, while there's multiple different mechanisms of action being studied, there's really no approved therapies despite the fact that significant opportunity in terms of number of patients that are out there. With regard to DMX-200, so it's a potentially first-in-class small molecule. It's an oral agent given twice a week. CCR2 is the target. It's really a promising approach to inhibit the inflammatory cells that really drive recruitment of monocyte-driven diseases like FSGS. And in that regard, the early experience with the molecule. The phase II data looked quite promising.
I believe it was 86% of patients had reductions in proteinuria in that, albeit early and smaller study. In the phase three study, studying this new mechanism of action is ongoing right now. A recent announcement by Dimerix was that they completed enrollment, which is fantastic to see, and we're going to be closely watching this, assessing the opportunity and evaluating next steps. What we do believe is, again, this is a condition that could benefit from, again, multiple orthogonal different mechanisms of action. We will, of course, be watching the competitor space closely. That being said, again, we're hopeful that there's a great opportunity here with DMX-200 as well.
Your next question comes from the line of Olivia Brayer of Cantor Fitzgerald. Your line is open.
Hey, good morning, guys. Thank you for the question, and congrats as well on the deal. Can I ask how you guys are thinking about peak sales potential for either of these new products? And I mean, how would you rank the two as you think about them driving long-term growth for the company? And then on the Pompe program, how are you guys thinking about competitive dynamics here in that space, just given the traction that Sanofi has been seeing in these patients?
Yeah. Thanks for the question, Olivia. This is Brian. I'll start with just speaking to the revenue potential and then hand it over to Cristin for more color on the second part of your question. So we believe that each of the Amicus products has the opportunity to reach $1 billion each in peak sales. We aim to add the unique BioMarin capabilities and large global presence to potentially even build upon that outlook. This will take time. Again, we expect potential growth through the remainder of this decade. We don't expect to achieve peak revenues until into the 2030s, but we're confident in the opportunity.
And on the competitive side on Pompe, thanks for the question, Olivia. Really, this is an area where, as I mentioned earlier, this is in the earlier phases of launch for POMOP. But importantly, what we're seeing is that there is a lot of momentum that Amicus has been building with regard to switch from enzyme replacement therapies. And this is, in large part, based on the experience that they're having out there in the field that they've been demonstrating very encouraging real-world data that during the prepared remarks had mentioned that more than 50% of patients switching from an enzyme replacement therapy to POMOP in phase three experienced a clinically meaningful improvement in functional outcomes. These types of data, which we'll continue to generate, are really important in understanding for a progressive disease why it is important to have other options, as Greg had mentioned, and POMOP is a very powerful option for these patients. We expect that we'll continue to see growth well into the 2030s, and we're really excited to build on that momentum.
Great. Thank you both.
Your next question comes from the line of Alex Hammond of Wolfe Research. Your line is open.
Thanks for taking the question. I guess, what's the integration roadmap here, especially regarding commercialization, manufacturing, and the global footprint expansion? And I guess as a follow-up as well, will this deal affect prioritization or funding for BMN 333 and 351? And then on 351, if I may, should we still expect results by year-end? Thank you.
Maybe I'll take the last question first, if that's okay. For 351, we ask you to sit tight. And I will just comment that we view BMN 333 as well as BMN 351 as priorities independent of what we're discussing today.
We've gone to the integration plans. I mean, obviously, as you well know, until the deal closes, BioMarin and Amicus are going to continue to operate as separate independent companies. We have, though, started integration planning. And when the deal is closed, then we'll obviously start the integration process. As already been covered in some of the prepared remarks and questions, we're operating at scale. We are in a very large global footprint. We think there are synergies from the combination, but it's way too early to be specific around that.
Particularly on the commercial side, again, these are growing products in very important parts of their ramp. We aim to continue that ramp and then build upon it. So we'll be very, very focused on really building upon the really excellent success that Amicus has had commercially in many geographies. That will be a very important part of our integration. We will absolutely not distract from the efforts from a sales and marketing perspective and growth perspective.
Your next question comes from the line of Jason Gerberry of Bank of America. Your line is open.
Hey, morning, guys. Thanks so much for taking my questions. Just two follow-ups, just more specifically, I guess. On Pompe, your $1 billion-ish outlook in terms of peak potential here, for P&O, I'm just kind of curious. That implies maybe about 2,500 patients out of the 5,000-10,000 late-onset prevalence. So I'm just wondering, does that assume that you drive an even greater level of switch versus the Sanofi product? I'm just kind of curious, the general directional assumption there. And then just to follow up on Alex's question, just on the manufacturing, I believe that WuXi in China was the manufacturer, but they were in the process of moving that to Ireland. Would that just generally be the assumption, or would you plan to move manufacturing into the U.S.? Thanks.
In terms of the first question, really, our ambition, I mean, as we've said before, this is really in a very important part of the launch phase of this program, generating high growth numbers 2024 going into 2025, as you've likely seen from Amicus. We intend to build on that. This is a very exciting time in a launch. Our intention here is to really build on what they've already on what Amicus has already done, but importantly, continue to leverage the scale, the operating scale, the commercial footprint that we have at BioMarin to expand this product as quickly as we are able to. Do we expect to generate more switch moving forward? We absolutely do. That is the intention here. And importantly, that is going to be driven in large part by the continued experience with POMOP out there in the field, but also importantly, with the continued data generation that demonstrates that this is a really important option for patients as they progress.
Thank you. With regard to the manufacturing question, I mean, obviously, this is part of what we need to do in terms of the integration planning period. We're going to evaluate the long-term manufacturing strategy for these important products. We do have a really compelling manufacturing capability at BioMarin with plants in both Ireland and the United States and an ability to manufacture enzyme therapies reliably and at high quality. W e think this is a very, very interesting part of how we can add value to all stakeholders. But again, our first priority is continuity. We will be working to understand the current state of contract manufacturing organizations, and our priority will be continuity of supply.
Understood. Congrats on the deal, guys.
Thank you.
Your next question comes from the line of Mohit Bansal of Wells Fargo. Your line is open.
Thank you very much for taking my question, and congrats on the deal as well. Just trying to double-click on enzyme replacement therapy and the longer tail here. I mean, enzyme replacement therapies tend to have longer tail. I mean, we have learned that from Sanofi Genzyme as well as you guys as well. If you think about oral Galafold, the 2037, do you think there's a future beyond 2037 as well, given that it's an oral, or is the other drug which probably has a longer tail than IP here?
Thanks, Mohit. Thanks very much for the question. I mean, it's very, very important, obviously, the IP settlements that Amicus negotiated that really provide really clarity through to 2037 with regard to Galafold. I do think at that point, a long, long way into the future, rare disease, these sorts of conditions, I don't think you'll expect to see the same level of generic erosion that you would see with oral therapies in other disease states. But again, that's a long, long way into the future.
And then I'll just actually, I mean, you can take a little bit from our own experience with KUVAN, where we've actually the erosion rates have not followed the traditional oral path. They're a good example, and I would encourage you to look at that as an analog. So, Mohit, you're modeling out to 2037, I'm very, very impressed. You could probably use that as a basis.
Thank you. That's all here. Thank you.
Your next question comes from the line of William Pickering of Bernstein. Your line is open.
Hi. Congrats on the deal, and thanks very much for taking my question. Could you speak in relative terms about the magnitude of upside you see from geographic expansion as opposed to execution in existing markets for Galafold and POMOP? And a second question would be how you see the full commercial organization fitting into BioMarin's existing EU structure. Thanks so much.
Thank you for the question. So at this stage, we're not providing guidance. We're not going to quantify the numbers, but I'm happy to say that we really do see opportunity here in terms of the level of expansion and being able to really build upon where we are currently in our country footprint of nearly 80 countries. Now, Galafold is already in 40 or so countries, so you can imagine there that the uplift will not necessarily be the same given where it is in the maturity of its life cycle, but also importantly, the penetration it has already in some of the countries. But I will say the important value driver in Galafold isn't only the expansion, but it's also importantly our ability to continue to drive diagnosis rates as well as treatment rates. And we believe that there is opportunity there both for naive patients as well as for some switch patients moving forward.
Now, POMOP is in a different phase of its life cycle, and it's, as I'd mentioned earlier, only reimbursed in 15 countries. So we see great opportunity here to expand it. So not only deepen in the markets that it currently is, but importantly, expand it. And this is going to take us some years, as we've learned with our own enzyme therapies. I don't want to promise that that's going to happen overnight. But you can imagine throughout the integration planning, we are doing some very deep dive into looking at what that launch timing will be across our global footprint. We see this as a brilliant fit within our enzyme therapies business unit. This is an area that we feel that we've been historically very successful at. And again, that's about finding those patients, starting them on treatment, and then importantly, continuing to drive high adherence rates, which Amicus has already been very successful at. And we believe that we can do that as well as we move forward.
W e're very excited, as you can hear in our voices, about the integration. And I believe that there is a lot of expansion opportunity.
Thank you. That concludes our Q&A session. I'll now turn the conference back over to BioMarin's CEO, Alexander Hardy, for closing remarks.
Thank you, Operator, and thank you all for joining us this morning. We believe this transaction represents a compelling rationale for all of our stakeholders, patients, employees, and shareholders. It creates significant strategic and financial value immediately upon close and well into the future. With the second significant public company acquisition this year for BioMarin, we have strengthened our financial outlook and positioned BioMarin for an exceptional 2026 and beyond. Thank you very much for joining us, and happy holidays.
This concludes today's conference call. You may now disconnect.