BioMarin Pharmaceutical Inc. (BMRN) Earnings Call Transcript & Summary

Good afternoon, and welcome, everyone, to the BioMarin Pharmaceutical Second Quarter 2026 Conference Call. Today's conference is being recorded. [Operator Instructions] At this time, I would like to turn the conference over to Traci McCarty, Head of Investor Relations.

Thank you, operator, and thank you all for joining us today. To remind you, this nonconfidential presentation contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including expectations regarding BioMarin's financial performance, commercial products and potential future products in different areas of therapeutic research and development. Results may differ materially depending on the progress of BioMarin's product programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market and developments by competitors, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, such as 10-Q, 10-K and 8-K reports. In addition, we will use non-GAAP financial measures as defined in Regulation G during the call today. These non-GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with U.S. GAAP, and you can find the related reconciliations to U.S. GAAP in the earnings release and earnings presentation, both of which are available in the Investor Relations section of our website. Please note that our commentary on today's call will focus on non-GAAP financial measures unless otherwise indicated. Moving to Slide 3 and introducing BioMarin's management team joining today's call, Alexander Hardy, Chief Executive Officer; Cristin Hubbard, Chief Commercial Officer; Greg Friberg, Chief R&D Officer; and Brian Mueller, Chief Financial Officer. I will now turn the call over to Alexander to provide our quarterly highlights. Alexander?

Thank you, Traci, and thank you all for joining us today. Starting on Slide 5. BioMarin delivered a standout second quarter, combining strong growth to nearly $1 billion in revenue with the successful close and integration of Amicus while delivering on milestones that strengthen our leadership in genetic conditions. Our strong performance demonstrates both the value creation of our portfolio and the continued execution of our commercial organization, executing at scale, integrating meaningfully accretive assets and continuing to innovate, enabling us to bring important medicines to people living with rare diseases as we enter an exciting new phase of growth. Second quarter highlights start with 20% year-over-year total revenue growth accelerated by a more diversified portfolio and setting up an even stronger second half of 2026 to be fueled by full third and fourth quarter Galafold and Pombiliti and Opfolda contributions and sustained demand across our other products. Turning to VOXZOGO, double-digit revenue growth in both the U.S. and international markets, led us to increase VOXZOGO's full year guidance, putting it on a path to become BioMarin's first $1 billion product. In its first quarter with a U.S. competitor, the continued revenue growth demonstrates our ability to defend VOXZOGO's leadership position. Building on this momentum, we are pleased to share that we have submitted our sNDA for the approval of VOXZOGO to treat hypochondroplasia based on strong pivotal data shared during the quarter. We will provide an update on the submission as part of our third quarter results. Turning to Amicus. As anticipated when we announced the acquisition, this deal demonstrates that BioMarin can leverage our scale and capabilities to rapidly integrate high-growth assets to maximize value creation. Today, we provide estimated peak revenue for Galafold of $1.4 billion and for Pombiliti and Opfolda of $1.2 billion. Together, these innovative therapies, combined with significant cost synergies expected to reach approximately $220 million annual run rate in 2028, are anticipated to drive substantial EPS accretion and operating cash flow. Most importantly, we look forward to bringing Galafold and Pombiliti and Opfolda to more patients with Fabry and Pompe disease worldwide. Briefly on our pipeline, which continues to build momentum. We recently added BMN 820, formerly DMX-200, an exciting new late-stage pipeline opportunity resulting from the Amicus acquisition that Greg will expand upon in a moment. I'm also impressed by the speed at which we submitted the sNDA for VOXZOGO for the treatment of hypochondroplasia. The speed of our submission reflects the benefits of our investments in AI capabilities and sets the new standard for how BioMarin will execute going forward. Together, these results tell a clear story: BioMarin is executing at scale, raising guidance, outperforming on the Amicus integration with substantial combined peak revenue potential ahead and advancing pivotal pipeline data towards VOXZOGO's next indication. As we enter the second half of 2026, BioMarin is stronger, more diversified and better positioned than ever to lead in rare disease and deliver for patients worldwide. Now on Slide 6. The addition of Amicus transforms BioMarin's growth trajectory through the mid-2030s with a combined peak revenue potential of $2.6 billion from Galafold and Pombiliti and Opfolda and significant cost synergies layering in along the way, we expect meaningful non-GAAP EPS accretion, expanding operating margins and stronger operating cash flow, powering our next phase of growth. Moving now to Slide 7. And starting with Galafold, a growing product in a growing market. From a $522 million base in 2025, we project peak revenue of $1.4 billion by the mid-2030s, supported by two complementary growth drivers. First, we see significant opportunity to expand diagnosis and treatment. Leveraging BioMarin's proven diagnostic capabilities, our goal is to more than double the number of U.S. patients treated with Galafold. We plan to do this through scaling AI-enabled patient identification initiatives, expanded genetic testing, newborn screening and family cascade screening, helping more amenable patients access treatment earlier. Second, we see meaningful opportunity to expand market penetration globally. With Galafold already established in 40 countries, we intend to deepen penetration within existing markets while selectively expanding into new geographies, leveraging BioMarin's global commercial infrastructure to accelerate access and broaden reach. Together, these drivers are expected to support approximately 10% CAGR from 2027 to 2032. Turning to Slide 8. Pombiliti and Opfolda is at an earlier stage in its commercial journey compared to Galafold. We estimate $1.2 billion in peak revenue by the mid to late 2030s, growing at a greater than or equal to 20% CAGR from 2027 to 2032. We expect growth to be driven primarily by increased patient switching and global market expansion, complemented by continued improvements in diagnosis and treatment rates. We believe switching will be supported by growing awareness amongst health care providers and patients of the expanded body of real-world evidence demonstrating the benefits of Pombiliti and Opfolda on disease outcomes. At the same time, we plan to leverage our diagnostic capabilities to identify and support treatment of additional eligible patients across our global footprint. These growth drivers are expected to be further strengthened by planned expansion into more than 20 additional markets over time. Turning to Slide 9. We are pleased with the significant cost synergies identified, which we expect to contribute to substantial EPS accretion beginning next year. We anticipate approximately $220 million of synergies to be fully realized in 2028, representing a roughly 50% reduction from Amicus' 2025 non-GAAP operating expenses of $432 million. These synergies are weighted towards G&A, which makes up more than 70% of the total, with the remainder coming primarily from R&D. As planned, we retained Amicus' commercialization team to ensure patient continuity and supplement our global capabilities. These synergies, combined with peak revenue aligned with the value creation we anticipated when we announced the deal last year and demonstrate our ability to successfully integrate large accretive assets that strengthen our growth profile. Turning to Slide 10. By accelerating our financial profile with the addition of accretive assets that benefit from our proven global expertise serving patients with genetic conditions, the Amicus acquisition sets the stage for our next phase of growth. With peak targets of $1.4 billion for Galafold and $1.2 billion for Pombiliti and Opfolda, these revenues, combined with $220 million in anticipated annual cost synergies fully realized in 2028, support substantial expected non-GAAP diluted EPS accretion beginning in 2027 and a significant increase in operating cash flow. Galafold and Pombiliti and Opfolda combined are expected to reach over 60% non-GAAP operating margin by 2030. At the same time, we believe our rapid integration and growth plans will enable us to deleverage approximately 1 year sooner than initially communicated. This quarter reinforces what sets BioMarin apart -- we are the leading rare disease company operating at scale with a proven integration capability to maximize the value of high-growth assets. We look forward to updating you on our progress, scaling Galafold and Pombiliti and Opfolda as we enter the next exciting phase of BioMarin's growth. I will now turn the call over to Cristin for the commercial update. Cristin?

Thank you, Alexander. The second quarter demonstrated the strength and growing diversity of our commercial portfolio. Now turning to Slide 12. Galafold and Pombiliti and Opfolda are off to a strong start as we move quickly to integrate following the April close. On a pro forma basis, second quarter revenue for Galafold grew approximately 10% year-over-year and Pombiliti and Opfolda grew over 65%. Galafold delivered broad-based patient growth across both established and newer markets. This was driven largely by increased diagnosis and patient identification, including continued success with family cascade screening and expanding newborn screening programs alongside ongoing gains in reimbursed access. For Pombiliti and Opfolda, we continue to add patients, both in the United States and in more recently launched geographies, supported by its differentiated clinical profile as we help more physicians better identify disease progression on prior therapies. Importantly, both brands maintained commercial momentum while we rapidly integrated, a testament to the focus our combined team has kept on patients and execution. These are the levers Alexander described, and the results to date reinforce our confidence in the long-term opportunity for both medicines. Turning to Slide 13 and the broader metabolic conditions business unit, formerly known as enzyme therapies. With the addition of the Amicus medicines, we have changed the name of the business into the metabolic conditions business unit to better capture the breadth of our portfolio. Total metabolic conditions revenue was $695 million and grew 25% year-over-year, inclusive of Galafold and Pombiliti and Opfolda, and the number of patients on therapy grew across every one of our marketed metabolic conditions brands, both year-over-year and sequentially. PALYNZIQ revenue grew 27% year-over-year on continued patient demand, while also benefiting from order timing in the U.S. during the quarter. We were pleased to have recently received European approval to broaden the PALYNZIQ label to adolescents ages 12 and older with PKU. In the U.S., we have had a strong start in the adolescent age group, and the team is energized to have the opportunity to serve this population more broadly. And across the rest of the portfolio, revenue in any given quarter reflects the timing of large orders. In the second quarter, order timing was a headwind for VIMIZIM following a strong first quarter, while it was a slight tailwind for NAGLAZYME ahead of an expected lighter third quarter. Because of these dynamic shifts between quarters, our full year metabolic conditions guidance remains the best indicator of expected underlying performance. Beneath that quarterly timing, the consistent signal is that patient demand continues to grow across our portfolio, both year-over-year and sequentially. Now turning to Slide 14. VOXZOGO delivered 14% year-over-year revenue growth in Q2, driven by double-digit growth in the U.S. and OUS markets. The number of children treated with VOXZOGO grew more than 20% year-over-year globally, and approximately 3/4 of VOXZOGO revenue was generated outside of the U.S. Notably, even in the first quarter facing a U.S. competitor, the number of children in the U.S. treated with VOXZOGO increased year-over-year. We also saw continued traction in the under two age group, which represented more than half of the new U.S. patient starts in the quarter, reinforcing our position as the only approved treatment for children two and younger. As expected, we did see switching to the competitor products since it was approved in February of this year. Since the competitor's launch, approximately 90% of the U.S. children treated with VOXZOGO remained on therapy as of the end of July based on information available to us. That reflects the continued confidence physicians and families place in VOXZOGO's evidence base. Internationally, momentum remains strong across both established and newer markets, and we expect both patient additions and order timing to drive higher total VOXZOGO revenue in the second half of 2026 compared to the first half. We're confident in VOXZOGO's durability built on a growing evidence base and the experience of the thousands of children treated to date and their caregivers. That durability is further reinforced by our exclusive ability to treat patients from birth worldwide. Our ambition is to remain the leader in skeletal conditions through competitor launches in the near term, supported by VOXZOGO's anticipated launch for hypochondroplasia in 2027 and the potential of BMN 333 should data be supportive. Stepping back, VOXZOGO is on track to become BioMarin's first $1 billion product. Galafold and Pombiliti and Opfolda are on the path to join it, each carrying peak revenue potential well above $1 billion and VIMIZIM is expected to also reach the $1 billion mark over time. Together, they are a clear sign that we can take innovative, genetically targeted medicines and expand their reach worldwide. With that, I'll turn it over to Greg.

Thank you, Cristin. The second quarter was a productive period for our pipeline with meaningful progress across our portfolio. Turning to Slide 16. You can see that we have had a lot of positive news over the last few months. I am particularly pleased to highlight our very recent submission of the supplemental NDA for VOXZOGO for the treatment of hypochandroplasia. By implementing parallel work processing aided by technological advancements, we were able to shrink the time from database lock to filing down to just 79 days, easily within the top quartile for modern industry benchmarks. The full Phase III data will be presented at ESPE as a late-breaking oral presentation in September. As Cristin noted, we're also very pleased that adolescents in both the U.S. and Europe will now have access to PALYNZIQ following the label expansion in both regions earlier this year. Moving now to Slide 17 and BMN 820, formerly known as DMX-200, a late-stage addition to our pipeline resulting from the Amicus acquisition. BMN 820 is a first-in-class oral CCR2 inhibitor, which it accomplishes through blockade of receptor heterodimerization -- it is currently in Phase III development for focal segmental glomerulosclerosis or FSGS. This is an asset for which we hold exclusive U.S. commercialization rights and are partnered with Dimerix, who remains responsible for operationalizing the Phase III study. If the data are supportive, this could provide a new mechanism of action for the treatment of FSGS. FSGS is a progressive kidney disease that leads to proteinuria and declining kidney function over time. There are an estimated 30,000 addressable patients in the United States. Only one therapy is approved as of today, and its label is somewhat narrow, excluding patients with nephrotic syndrome. Durable stabilization of kidney function remains a significant unmet need. BMN 820 targets an orthogonal mechanism to the vascular targeting agents with the potential to treat a broad FSGS population. It has shown a favorable safety and tolerability profile to date. The FDA has agreed that proteinuria is an appropriate endpoint for approval in our Phase III ACTION3 trial, and we expect Phase III data in 2028. If the data are supportive, BMN 820 represents an attractive new pipeline asset with upside in a large area of unmet need. With that, I will turn the call over to Brian. Brian?

Please refer to today's press release for detailed second quarter 2026 results, including reconciliations of GAAP to non-GAAP financial measures, which will also be available in our upcoming Form 10-Q. Turning to Slide 19. We were pleased that second quarter revenue reached nearly $1 billion, representing 20% top line growth year-over-year. Second quarter non-GAAP operating margin was 36.4%, with non-GAAP diluted earnings per share of $1.20. Non-GAAP R&D and SG&A expenses each increased year-over-year reflecting the operating expenses of the acquired Amicus business, together with continued investment in our pipeline and commercial execution. On a GAAP basis, second quarter SG&A results also included approximately $84 million of transaction and integration-related charges associated with the acquisition. These charges are excluded from our non-GAAP results. Below the operating income line, interest expense increased year-over-year due to the acquisition debt financing and interest income decreased as we liquidated investments to fund the acquisition. These items, along with the higher operating expenses contributed to the year-over-year decrease in non-GAAP diluted earnings per share. I want to spend a moment on our interest expense and interest income. to make sure your expectations are aligned with ours. Based on current interest rates, interest expense associated with the acquisition debt financing is estimated at approximately $200 million on an annualized basis or approximately $50 million per quarter, with the term loans and senior notes scheduled to mature after 2030. Importantly, this interest expense is included in our non-GAAP results and, therefore, reduces non-GAAP diluted earnings per share. In addition, due to lower cash and investment balances following the close of the acquisition, we expect interest income to decrease year-over-year in the near term. Turning to Slide 20 and our updated full year 2026 guidance. On the strength of our first half performance and our expectations for the balance of the year, we are raising our full year total revenues, VOXZOGO revenue and non-GAAP diluted earnings per share guidance. As you can see, our guidance updates today reflect double-digit growth from the midpoint and our strong trajectory leading into the second half of 2026. Briefly on phasing, we expect third quarter revenue to be slightly higher than the second quarter reflecting a full quarter of Amicus revenue contribution and continued patient growth across our brands. Similar to prior years, we expect the fourth quarter to be our strongest quarter of the year, with a significant step up versus Q3 and representing well over 50% of our second half revenue outlook primarily due to ordering dynamics in select markets. Our non-GAAP diluted earnings per share, the third quarter will reflect a full quarter of Amicus operating expenses, while benefits from cost synergies are expected to become more meaningful in the fourth quarter. Combined with the anticipated revenue phasing and realization of synergies, we expect third quarter non-GAAP earnings per share to be slightly higher than Q2 and fourth quarter non-GAAP earnings per share to be significantly higher representing the highest quarterly earnings per share of the year. In summary, the second quarter reflected strong execution, disciplined investment and continued progress integrating Amicus. While some integration activities will continue into next year, the integration is well underway and on track with the majority of enabling decisions made in operating plans in place. We are impressed by and appreciative of the focus and efforts of both our BioMarin colleagues and all of our Amicus colleagues since the close of the acquisition. We are looking forward to the second half of this year, where we remain focused on delivering our updated 2026 outlook while building towards the longer-term revenue and earnings potential that Alexander outlined in his remarks. Thank you for your attention. We will now open the call to your questions. Operator?

[Operator Instructions] We'll go to our first question from Chris Raymond at Raymond James.

I got two, actually. First, on Amicus. You guys gave a lot of metrics here on synergies with this integration. Just looking at 2028, synergies that look really impressive was wondering if maybe you could maybe give a few way points as we get through 2027 and tell us the specific steps you're taking to get to these numbers? And maybe what's behind the delivery of the 2.5 leverage a year early. And then I have a VOXZOGO question.

Chris, it's Brian. I'll take that. Thanks. So yes, just to start, we know we communicated a lot of metrics today. We do believe that this Amicus integration framework demonstrates the comprehensive value creation from this acquisition. We quantified synergies at this approximately 50% level. That's going to drive significant accretion powered by the revenue growth as well. This not only validates our hypothesis at the time of the transaction but exceeded our expectations at the time. And I'd also like to emphasize that these decisions are made. We are now executing on an end-to-end integration plan to bring the Amicus business onto the BioMarin platform. And as I noted there in the prepared remarks, it took a lot of work on both sides, and it's going very well. This accretion also translates to cash flow. As you noted, we pulled forward our leverage target by approximately 1 year. And altogether, we're not only delivering on the potential of this transaction but exceeding it. And specific to your question in terms of Waypoint, we shared that we expected the transaction to be modestly dilutive in calendar '26. I'll share that that's still the case, but it's honestly close to breakeven, still expecting it to be accretive in the first calendar year. But I would point you to the substantial accretion that begins next year and then 2028 being the first full year because we are still integrating next year. 2028 will be the first full year where we're realizing all of the benefits from the synergies and integration. And in terms of a way point, I might guide you to saying that next year, we're expecting half to slightly more than half of the synergies to be realized.

Great. And maybe on VOXZOGO, just hearing Cristin's commentary around 90% of VOXZOGO patients remaining on therapy. I think you mentioned post the YUVIWEL launch. Ascendis gave us some numbers today. I think they said 170 patients are enrolled to start therapy, and I think 2/3 of those are actually paid. Maybe just doing some math on the switchers -- and based on your commentary, can you maybe give us a sense of the dynamic in terms of your competition for new patients?

Thanks very much for your question, Chris. This is Alexander. Yes, I think this is really important to sort of unpack the numbers and make sure there's no misunderstandings here with the various data points communicated by both companies. I mean, clearly, their number was based on a total patient enrollment number. That includes naive patients, VOXZOGO discontinuations whenever those may have happened. And of course, switches from VOXZOGO. And of course, the latter one, the switch rate is, of course, the one that's relevant for us. So according to our data, and we have good visibility, as you would expect, in the United States in terms of patient numbers and ongoing treatment. We've seen approximately 10% of patient switch. That translates to less than 100 patient switches in the approximately 6 months since they would have been approved. That translates, of course, to a very small impact on our almost $4 billion in revenue this year. So taking all things into account, based on the strong growth that we are seeing and projecting with 20% of increase in patients globally on VOXZOGO in the quarter, we feel comfortable increasing VOXZOGO revenue guidance for the year for over $1 billion. I think zooming out as well, if I could comment, I think bigger picture, their update on the launch and the pace reflects how hard the U.S. market is in achondroplasia -- when you have geographically dispersed patients, you have low visit frequency, care split between general pediatricians and specialists. And this all impacts the opportunity and the pace of switches and starts. And of course, as you know, new patient starts are dominated by the 0 to 2 patient populations. The guidelines say, diagnose and treat as early as possible after birth. And as you know, that remain -- we remain the only product with the less than two indication, and we expect to remain so for a good amount of time. So I hope that helps, gives you a little bit of perspective on the data and what we're seeing and what we're looking forward to in the remainder of the year.

We'll go next to Cory Kasimov at Evercore ISI.

I also want to ask something on the heels of the competitive update this morning. And I'm wondering how you think about the combination of weekly CNP analog plus growth hormone eventually slotting into the treatment algorithm? And is there anything that's stopping you from -- or physicians using VOXZOGO and/or BMN 333 in the future with growth hormone.

Thanks, Cory. This is Greg Friberg. I think I'll tackle that one. Looking at that data, I think, first and foremost, we have to recognize that the COACH study is a small study. I think it's about 21 patients single arm split into two cohorts. So we have to be careful in over interpreting it, particularly when we slice the data at 6-month intervals. Now that being said, I think the question with the growth hormone combination today is the same as it has been from the start. We know growth hormone alone can cause increases in AGV, but they're temporary. And actually, they don't result in major increases in achondroplasia and increases in final adult height. So the question remains, what are we learning from the data set. With this data point, I would say just the eyeball test tells us that it looks like the effects of growth hormone, adding on to CNP appear to be waning. I don't know why that would be in the naive patients more than the add-on to people who are already on CNP. It's a small data set. But the question then becomes, is this the beginning of a longer-term trend. It's an unanswerable question. I think the question that our endocrinologists care most about, which they're a sophisticated group. They've worked with growth hormone for a long time is, will this ultimately contribute to the health and wellness and by extension, the final adult height of patients. The concern always is that growth hormone may close growth plates early. And that is not something that is in a short study of 18-month duration, something that you can really get a read on. So I think today, it's incremental data. We're certainly seeing that the growth spurts might be declining. You see the slopes increases. And that's as compared to the ACHIEVE -- I'm sorry, the APPROACH study, where you don't see that kind of a shift out of 2 years. Happy to see that they're following up on the 2-year data there as well. And again, I think there are unanswered questions that time will tell. Of course, we're watching this very closely. We're going to follow the data. We're going to make evidence-based decisions and from a biologic standpoint, there is nothing unique about TransCon CNP when it comes to taking a CNP agent and combining it with growth hormone. It's too early to tell, and we're looking forward to seeing more data out in the order of 3 years plus.

We'll take our next question from Jess Fye at JPMorgan.

I was curious if you could speak to whether those synergies associated with the Amicus deal will fall to the bottom line or whether you expect those to be reinvested in the business?

Jess, it's Brian. Thanks. Great question. We do expect those synergies to drop to the bottom line. However, to your point, there is also a reinvestment so part of the strategy is to accelerate the growth potential of Galafold and Pombiliti and Opfolda, which will require some incremental investment. I'll share with you that compared to the synergy numbers we shared today, it is a modest portion of that. But more importantly, and this is why we spoke to synergies on a gross basis. Any of that reinvestment fits within existing structure of our P&L. It's part of normal metabolic conditions, sales and marketing going forward. So we don't consider it an offset to the synergies itself, which will live on -- and again, if you chose to calculate net synergies with the investments, it's very modest.

Our next question comes from Salveen Richter at Goldman Sachs.

This is Tommie on for Salveen. Curious if you could provide more detail. You spoke to the mechanisms behind driving increased diagnosis and switching for Pombiliti and Opfolda and for Galafold. How do these efforts differ in -- or strategy differ in the U.S. versus ex U.S.? And a follow-up, what is your appetite for future BD and what stage or type if so?

Yes. I'll take that first part of the question, Tommie. Thank you so much. And I hope you could hear it in the prepared remarks, but I'll say it again, we are absolutely delighted about what we have both the opportunity and quite frankly, the responsibility to do for both Fabry and Pompe communities. And the more we've been able to dig into it since the close, we've really unearthed, I think, some meaningful levers that we can pull to drive the growth and therefore, target the peak revenues of $1.4 billion for Galafold and $1.2 billion for Pompe -- excuse me, for Pom-Op in the future. Now looking specifically, and I know you asked the question kind of differentially across the U.S. and ex U.S. In large part, the overall lever -- the levers are very similar. While they may get executed at the country level slightly differently, the areas that we're going to really put our investment into are quite similar. And they fit very well within the BioMarin set of capabilities that we've built over the decades that we've been doing this. For Galafold, this really is going to be about diagnosis. We recognize that in the medical population or in the Fabry community at large, really is still a very limited diagnosis, especially for those with late onset and/or the female patients. So we plan to really target those communities trying to drive broader diagnosis and importantly, really starting to close the gap between kind of diagnosis and treatment so that we can show that kind of physicians that treating earlier and even in milder sets or mild dirt conditions is really important. On the Pom-Op side, this really is about accelerating switches, and this is true again in both the U.S. as well as outside the U.S. And here, our focus is going to be on the waning or the clinically declining patients that are on a current therapy where we believe that we can really kind of continue to show what disease progression could look like and if patients aren't meeting those targets, how to ensure that they're advocating for treatment. So those are the areas we're really going to be focused. And I know that the next question. Greg, do you have something to add?

I would just add, Tommie, from the medical affairs standpoint, particularly for Fabry, where we know I would say generously maybe only 40% of the patients are actually diagnosed with the condition. Just to give you some granularity there. Electronic health record work to, again, shorten the time between diagnosis and again, symptom when the symptoms arrive, family cascade testing and reclassification of variance. These are things that we've done previously in other settings. There are also some great work that our former Amicus colleagues had begun, and we have the opportunity to scale that a bit larger. Just to give you a data point, there's over almost 50 different diagnostic activities and programs going on around the globe right now. And so it is a very local phenomenon. We think that we can put more firepower and technology behind some of those assets.

These are things that we can start right away in the countries where Galafold and Pom-Op are already commercialized. But what's also really important to note is that we plan on geographically expanding these products. So in over 10 countries, relative to where we are today with Galafold and more than 20 countries for Pombiliti and Opfolda, which will also help to drive that growth. Over to you, Alexander.

Tommie. Yes. This is Alexander. I'll answer your BD question. So as you heard from Cristen and from Greg, the integration and acceleration of Galafold and Pombiliti and Opfolda strengthen our growth outlook for BioMarin. So, with our now more diversified and growing commercial portfolio, our focus is now more shifting to expanding our clinical stage pipeline. Of course, we're going to continue doing research collaborations as we've always done. I think you just saw -- you would have seen the announcement recently of the collaboration with n-Lorem, but as we delever, you can expect us to do deals to expand out our clinical stage programs over the next 12 to 18 months.

We'll move to our next question from Phil Nadeau at TD Cowen.

Two from us. First, on the upcoming ITC case, we expect a decision by the end of August. I'm curious to get your most recent thoughts on that case, in particular, any thoughts you have on the possibility of a settlement? And then second, just a follow-up on the diagnosis points that you just made. I think 20 years ago, we heard from Genzyme that they thought they were going to penetrate more quickly the late onset and female patient population. So you've talked about what you can do, but why haven't those patients been diagnosed so far, it does seem like others have had efforts. Where are those efforts fallen short?

Thanks for your question, Phil. This is Alexander. I'll take the opportunity just to clarify some of the some of the time lines and the facts around the ITC case. But as you can probably expect, I'm not going to get into our legal strategy or speculate on the outcomes. So on the 21st of this month, the 21st of August, the administrative law judge will deliver their initial determination Within weeks following that initial determination, the commission decides whether they're going to review that initial determination. The final decision is expected on the 21st of December of this year, that's either affirming or reversing all or a portion of that initial determination. And then either party has 60 days to lobby the President. It has a presidential review period which goes through February 21 of next year. But I would just highlight that if an exclusion order is determined in that decision by the commission then it's effective during that period. So that's sort of what you can expect from a time line perspective, and we're awaiting that date of the 21st, which is coming shortly. I'd also highlight that upon the completion of the ITC process, we would expect to enforce our patent in Federal District Court where, of course, monetary damages are available.

Phil, I'm going to -- This is Greg Friberg. I'm going to tackle your second question on the diagnostic points, if that's all right. With regard to why there hasn't been more progress in the field, I think it's a pretty simple answer in that this is a very elusive disease -- it's one where patients can have a very heterogeneous presentation, something like seven different organ systems that can be affected presenting in a variety of clinics and true with all rare diseases, it's this elusiveness of diagnosis, the 7 to 10 years to actually make their way to knowing what's causing their symptoms. And Fabry is really a case study in that. That's why we're trying to focus on where we think we can have the most impact. And again, we highlighted a couple of them. But obviously, this isn't just about educating community physicians to be on the lookout. -- Using technology, using electronic health records using testing and training approaches to try to identify flags earlier. Again, it's not just about patient finding, it's about shortening that time to diagnosis. I would say that on top of that, one of the very fruitful endeavors that we've been involved with in other genetic conditions in family cascade testing. You find one person in the family who is affected by this, again, you do the boots on the ground work to find the other patients that could be affected. Finding them early is the name of the game with Fabry, but it's been elusive up till now. And I think it reflects the wiliness and unfortunately, the heterogeneity of this disease.