BioMarin (BMRN) Q3 2026 Earnings Call Transcript

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DATE

Monday, Nov. 2, 2026

CALL PARTICIPANTS

• Head of Investor Relations - Traci McCarty
• Chief Executive Officer - Alexander Hardy
• Chief Commercial Officer - Cristin Hubbard
• Chief R&D Officer - Gregory Friberg
• Chief Financial Officer - Brian R. Mueller

TAKEAWAYS

• Total Revenues -- $1,025 million, representing 32% year-over-year growth driven by the acquisition of Amicus Therapeutics and increased demand for metabolic therapies.
• Metabolic Conditions Revenue -- $744 million, growing 44% year over year due to the first full quarter of contributions from Galafold and Pombility and Opfolda.
• VOXZOGO Revenue -- $245 million, an increase of 12% year over year as the number of children treated globally rose 17%.
• Galafold Revenue -- $152 million, reflecting a 10% increase compared to the prior year's results reported for the product.
• Pombility and Opfolda Revenue -- $49 million, representing 58% growth compared to the results reported by Amicus for the same period last year.
• Vimizim Revenue -- $216 million, increasing 18% year over year due to the timing of large international orders.
• Naglazyme Revenue -- $108 million, representing an 11% decrease compared to the prior year following order timing benefits in the second quarter.
• Updated Full-Year Revenue Guidance -- $3.8 billion to $3.9 billion, adjusted from a previous range of $3.9 billion to $3.9 billion due to the deferral of orders from one international customer.
• Non-GAAP Diluted EPS Guidance -- $2.80 to $3.10, reflecting the impact of two acquired in-process research and development charges and the revised revenue outlook.
• Inozyme Acquisition Charges -- $320 million, consisting of acquired research and development expenses and ongoing operating costs that reduced non-GAAP EPS by $1.55.
• BMN-450 License Charges -- $83 million, expected to reduce full-year non-GAAP EPS by $0.32 following a licensing agreement for the Fabry disease asset.
• GAAP Net Loss -- $123 million, compared to a $31 million loss in the prior year, primarily due to acquisition-related amortization and interest expenses.
• Non-GAAP Income -- $45 million, increasing from $22 million in the prior year as revenue growth offset higher research charges and financing costs.
• Galafold Patient Growth -- 13% year over year, with growth in one international market reaching 20% due to newborn screening programs and family cascade testing.
• Pombility and Opfolda Patient Growth -- 69% year over year, aided by switches from prior therapies and competitor supply constraints in European markets.
• VOXZOGO Patient Retention -- 85% in the U.S., with families reporting confidence in treatment efficacy and established daily dosing routines.
• Cost Synergies -- $220 million on a non-GAAP basis, which the company expects to fully realize by 2028 following the Amicus integration.
• Total Addressable Patient Population -- 14,000 children globally for hypochondroplasia, representing a primary segment for VOXZOGO market expansion.
• International VOXZOGO Sales -- More than 75% of segment revenue, as the company received approval to treat children in three additional international markets.
• Non-GAAP SG&A Expense -- $333.6 million, an increase of 12% year over year reflecting the addition of Amicus commercial teams.
• Palynziq Revenue -- $111 million, representing 2% year-over-year growth following the normalization of U.S. order timing.
• R&D Expense -- $180.5 million, reflecting continued investment in the clinical pipeline including BMN-440 and BMN-450.
• Cash and Cash Equivalents -- $736 million as of Sept. 30, 2026, compared to $1.3 billion at the end of 2025.

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RISKS

• Brian R. Mueller noted that "customer liquidity, and customer cash flow disruption have increased over the last 2 months" in the Middle East, contributing to the decision to lower full-year guidance.
• Brian R. Mueller stated that "the magnitude and timing uncertainty, so close to year end has led us to update full year guidance accordingly," following a decision by a single international customer to defer $70 million in orders.

SUMMARY

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) reported third-quarter revenue surpassing $1 billion for the first time, reflecting the integration of the Amicus Therapeutics acquisition and sustained demand for metabolic therapies. Management lowered full-year 2026 guidance to account for deferred international orders and geopolitical headwinds affecting customer liquidity in the Middle East. The company expanded its clinical pipeline with four new assets in 2026, including BMN-450 for Fabry disease and BMN-440 for hypophosphatasia. Strategic focus remains on the PDUFA dates for VOXZOGO in hypochondroplasia on May 30, 2027, and full approval in achondroplasia on Feb. 28, 2027.

• Brian R. Mueller stated that the company is "currently tracking to even calendar year accretion in 2026" for the Amicus acquisition, pulling forward the timeline for the deal to become accretive.
• The company reported that competitor supply constraints in Europe for other Pompe therapies resulted in a "meaningful share of new patients starts" for Pombility and Opfolda during the quarter.
• Gregory Friberg described BMN-450 as having "the potential to be the first subcutaneous ERT" for Fabry disease, aiming to reduce the treatment burden compared to current intravenous options.
• Management reported that May 30, 2027 is the PDUFA date for VOXZOGO for hypochondroplasia, which would represent the company's seventh first-in-disease medicine.
• The company noted that disease education efforts for hypochondroplasia have already reached more than 1,200 pediatric endocrinologists and geneticists in the U.S.
• BioMarin announced a settlement with Ascendis Pharma A/S, providing the company with royalties ranging from 18% to 20% on net sales of Yuviwel in multiple global markets.

INDUSTRY GLOSSARY

• Galafold: An oral chaperone therapy used to treat adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.
• Pombility and Opfolda: A two-component therapy consisting of a recombinant human enzyme and an enzyme enhancer used for the treatment of late-onset Pompe disease.
• VOXZOGO: A daily injectable c-type natriuretic peptide analog designed to increase linear growth in children with achondroplasia.
• Achondroplasia: A genetic condition and the most common form of skeletal dysplasia, resulting in disproportionate short stature.
• Hypochondroplasia: A genetic skeletal dysplasia similar to achondroplasia, typically characterized by milder short stature and disproportionate limbs.
• Fabry Disease: A rare genetic lysosomal storage disorder caused by a deficiency of the enzyme alpha-galactosidase A, leading to the buildup of fat in the body's cells.
• Pompe Disease: A rare genetic disorder that causes progressive muscle weakness due to a deficiency of the enzyme acid alpha-glucosidase.
• PDUFA: The Prescription Drug User Fee Act, which establishes target dates for the FDA to complete its review of a drug application.
• IPR&D: Acquired in-process research and development, representing the value of research projects that have not yet reached technological feasibility.
• ERT: Enzyme replacement therapy, a medical treatment where replacement enzymes are given to patients with chronic enzyme deficiencies.

Full Conference Call Transcript

Operator: Hello, everyone. Thank you for joining us, and welcome to the BioMarin Third Quarter 26 Conference Call. After today's prepared remarks, we will host a question-and-answer session. If you would like to ask a question, please press *1 to raise your hand. To withdraw your question, press *1 again. I will now hand the call over to BioMarin's Head of Investor Relations, Traci McCarty. Please go ahead.

Traci McCarty: Thank you, operator. To remind you, this non-confidential 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-Ks, 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 US GAAP and you can find the related reconciliations to US 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. Beginning on slide 3 and introducing BioMarin's management team joining today's call, Alexander Hardy, Chief Executive Officer Cristin Hubbard, Chief Commercial Officer Gregory Friberg, Chief R&D Officer and Brian R. Mueller, chief financial officer.

I will now turn the call over to Alexander to provide our quarterly highlights.

Alexander Hardy: Thank you, Traci. And thank you all for joining us today. Starting on slide 5, strong demand across our diversified portfolio of innovative therapies drove 32% year over year growth in the third quarter. Surpassing $1 billion in quarterly revenues for the first time in our history. Also last week, we announced the addition of a new investigational Fabry asset to our clinical portfolio. Recently renamed BMN-450 the fourth new asset added to our pipeline in 2026. This highlights the focused and deliberate expansion of BioMarin's clinical stage pipeline BMN-450 has the potential to become the first subcutaneous enzyme therapy to treat people with Fabry. And I will provide more detail in a moment. Moving to our third quarter results.

The metabolic conditions business delivered revenue growth of 44% compared to the third quarter of last year. Driven by strong contributions from both Galafold and Pombility and Opfolda. Together, they totaled more than $200 million in combined revenues in the quarter, while at the same time, the pace of the Amicus cost synergies realization exceeded our expectations. We are energized by the addition of our Amicus colleagues, and we are working together to expand the reach of both Galafold and Pombility and Opfolda, bringing these therapies to more patients around the world. I am also pleased with the continued global rollout of VOXZOGO. As the number of children treated increased by 17% worldwide.

Building on this momentum, we are pleased to share that May 30, 2027 is the PDUFA date for VOXZOGO. For the treatment of hypochondroplasia. The first targeted therapy to potentially be approved for the indication. And a potential seventh first-in-disease medicine for BioMarin. Team is well prepared for strong launches in hypochondroplasia in the US and Europe and we anticipate both regions will benefit from our global leadership in skeletal conditions. Before I turn the call over to Cristin, I want to say a few words about the work we are doing to expand our pipeline. Including the most recent addition to our clinical portfolio.

BMN-450 is a Phase 1/2 compound that builds on our Galafold experience has the potential to expand the therapeutic reach to those with Fabry whose variants are not amenable to Galafold. BMN-450 is a strategically compelling addition to our metabolic BU, addressing treatment burden, a priority unmet need, with a differentiated long acting subcutaneous profile. It also reflects our growing commitment to the Fabry community building on the Amicus acquisition as well as the expertise and relationships established with Galafold. In summary, delivered strong financial results in the third quarter and made meaningful progress across every part of our business. In a moment, Brian will speak to some expected order timing dynamics and geopolitical headwinds that we are observing.

Resulting in today's updated guidance. In 2026, we have delivered on the strategic expansion of our innovative pipeline including the addition of BMN-450, BMN-440, for hypophosphatasia, BMN-34 for a new syndrome, and BMN-28 for the FSGS. Our business development execution having delivered 5 deals in 2 years, demonstrates our capabilities across the value chain, as a rare disease leader operating at scale. Our commercial portfolio is now more diversified and more resilient following the successful acquisition of Amicus as well as our pipeline with a more recently acquired earlier stage assets.

We look ahead with enthusiasm for what is to come as we advance the next wave of therapies from our clinical stage pipeline and to reporting on a number of key updates in 2027. Combined with the strength of our more diversified commercial portfolio, we are confident in our ability to create lasting value for patients and all of our stakeholders and we look forward to updating you on our progress. I will now turn the call over to Cristin for more detail on our commercial performance. Cristin?

Cristin Hubbard: Thank you, Alexander. The third quarter again showed the strength and growing diversity of our portfolio. Our team stayed focused on expanding diagnosis, increasing access, and helping more patients start and stay on therapy. Now turning to slide 7. We have begun to implement the initiatives that we outlined last quarter for Galafold and Pombility and Opfolda. For Galafold, those levers are expanding diagnosis and treatment, and deepening market penetration globally. For Pombility and Opfolda, there are increased patient switching andglobal marketexpansion. Complemented by improvements in diagnosis and treatment. New geographies take time, so this quarter we focused on the fastest levers. Finding and treating more patients in existing markets.

We are pleased with the progress we have made in a short amount of time. Both medicines delivered strong revenue in the quarter. Galafold was $152 million, 10% higher than the $138 million Amicus reported for the third quarter of 25. Pombility and Opfolda revenue was $49 million, 58% higher than the $31 million Amicus reported for the same period last year. The number of patients treated with Galafold increased by approximately 13% year over year. With growth across both established and newer markets. For example, in the quarter, 1 international market increased patients on therapy by 20% year over year, reflecting the ongoing success of Family Cascades testing initiatives bolstered by expanding newborn screening programs.

The number of patients on Pombility and Opfolda increased by approximately 69% year over year, Switching continues to be supported by its differentiated clinical profile, as we help physicians better identify disease progression on prior therapies. The expanding body of clinical and real world evidence reinforces that profile. Including the 5-year PROPEL extension data presented at the World Muscle Society Congress in October, which Gregory will speak to in a moment. We are also seeing an increasing penetration in Europe, where Pombility and Opfolda is now the market share leader in terms of patients on therapy in 4 markets: This leadership reflects the growing confidence in the profile of Pombility and Opfolda.

In the third quarter, we also began supporting patients in certain European markets who are affected by recent supply constraints for other Pompe therapies. Have released additional supply so that patients who need it can get treatment without interruption. As a result, patients who switch to Pombility and Opfolda during the quarter due to supply constraints represented a meaningful share of new patients starts in these markets. Would expect to see some additional patients in the fourth quarter due to supply constraints for the other Pompe therapies. With the revenue benefit from this dynamic building in 2027 and beyond.

Now we cannot predict how long the constraints for other Pompe therapies will last, or if it will result in material revenue increases from Pombility and Opfolda. But reliable supply from BioMarin could become a factor in treatment choice. Now turning to slide 8, Total metabolic conditions revenue was $744 million, and grew 44% year over year, driven largely by the first full quarter of Galafold and Pombility and Opfolda. The number of patients on therapy grew across every 1 of our marketed metabolic conditions brands. Moving to the other products and metabolic conditions, the quarter reflected continued patient demand along with the order timing patterns we have consistently described.

Reflecting Palynziq's distinct product profile, patients on therapy increased 9% year over year globally, led by the adolescent launch in the US. And we observed minimal switching to BH4 analogues. In fact, we have been pleased that some patients who switched to oral therapies have returned to Palynziq treatment. Revenue grew 2% as the US order timing normalized after a strong second quarter. It can take many months for a patient to titrate to a maintenance dose, so we expect the adolescent revenue contribution to build into 2027 and beyond. Vimizim grew 18% year over year benefiting from orders outside of the US. While Naglazyme revenue was lower, as expected, following order timing benefits in the second quarter.

Because order timing shifts between quarters, our full year metabolic conditions guidance is the best indicator of expected underlying performance. Turning to slide 9. In the third quarter, VOXZOGO revenue grew 12% year over year to $245 million despite a large order previously expected is now anticipated in Q4. Patient demand outpaced revenue in Q3 as the number of children treated with VOXZOGO globally increased approximately 17%. More than 75% of revenue in the third quarter was generated outside of the U.S., and we expect this segment to be a leading area of expansion in achondroplasia. We are pleased to share that we recently received approval to treat children with achondroplasia in 3 additional international markets with VOXZOGO.

Briefly on the US. Children under 2 represented the majority of new patient starts in the quarter, and approximately 85% of U.S. children remained on VOXZOGO as of the end of September. Based on our switching data. We observed that the pace of switching trended downward each month during the third quarter. When we surveyed families about why they stay on VOXZOGO, they say it is because they are confident it is working for their child and because daily dosing has become an established, well tolerated routine.

Further confidence for families and treaters comes from the growing body of clinical and real world data supporting VOXZOGO's long term safety and efficacy profile, as reflected in the data package we submitted for full approval. Beginning in the fourth quarter, we plan to focus our updates on VOXZOGO revenue rather than providing U. S. Switching metrics. As VOXZOGO's market mix changes with the anticipated launch of hypochondroplasia next year, along with continued international expansion in achondroplasia, US switch data becomes less relevant to VoxVOXZOGO's overall revenue performance. Leadership in achondroplasia sets the foundation for a potential launch of VOXZOGO in hypochondroplasia. Where we estimate a global total addressable patient population of approximately 14 thousand children.

Our launch preparation is focused on 3 things. First, we are sharing the evidence. The first full phase 3 results published in the New England Journal of Medicine Evidence and presented as a late breaking oral at ESBE showed statistically significant improvements in growth velocity, height, and arm span. Second, our medical affairs team is increasing diagnosis and patient identification. Helped by the first international consensus recommendations diagnosing hypochondriplasia published this quarter and by disease education that has reached more than 1.2 thousand pediatric endocrinologists and geneticists in the US. And third, we are laying the foundation for rapid access. Engaging payers early on the pivotal data and building on VOXZOGO's established coverage and real world experience in achondroplasia.

With the potential addition of hypochondroplasia, we remain confident in VOXZOGO's durability More than 5 thousand infants and children in 58 countries have been treated with VOXZOGO and its evidence base continues to expand. Together with the potential of BMN-333, should data be supportive, these opportunities underpin our ambition to remain the leader in skeletal conditions. With that, I will turn the call over to Gregory for an R&D update.

Gregory Friberg: Thank you, Cristin. Turning to slide 11. We are quite pleased to have 4 new assets under development. Having leveraged externally sourced innovation to add multiple new programs to our pipeline. This year. These additions span preclinical through Phase 3 development setting the stage for some exciting potential updates in the coming quarters. Today, I have the opportunity to provide more details and talk about our newest addition, BMN-450, a potential first subcutaneous enzyme replacement therapy for Fabry disease, having just announced the license agreement last week. I am also excited to share a little more detail on BMN-440, the first potential oral treatment for hypophosphatasia.

And finally, I will review the 5-year outcome data for Pombility and Opfolda that were presented at the World Muscle Society, further underscoring the benefit of this therapy for those with late onset Pompe disease. Now moving to slide 12 and BMN-450, which we are thrilled to add to our growing clinical pipeline. It is an investigational long acting ERT for Fabry disease and is designed to extend the half life and improve stability relative to currently available ERTs. Approved ERTs for Fabry are all administered by intravenous infusion, and BMN-450 has the potential to be the first subcutaneous ERT in the space, giving patients and physicians an option to reduce the treatment burden.

Importantly, we believe BMN-450 also has the potential to be mutation agnostic and to address a broader patient population than that of Galafold. Which is indicated for the estimated 35 percent to 50 percent of patients with a medical mutation. We are encouraged that in preclinical studies, BMN-450 demonstrated differentiated efficacy across key measures including renal function, vascular health, and peripheral nervous system outcomes, which may offer potential for an improved therapeutic profile. It has received orphan drug designation from the FDA and is currently in Phase 1/2 testing. Entering at Phase 1/2 is fortuitous. As it allows us to shape the program moving forward, including the selection of dosing, and patient populations.

We bring deep experience developing and manufacturing ERTs and the regulatory pathways for ERTs in Fabry are well established. Following the ongoing study, we will assume sole responsibility for subsequent clinical development manufacturing, and commercialization outside of Korea. We look forward to updating you as the program progresses. Now turning to slide 13. And BMN-440, which we added in the third quarter through the Inozyme acquisition. Because the disease and the mechanism may be new to many of you, I want to spend a moment on each. Hypophosphatasia or HPP is a rare genetic condition caused by mutation in the ALPL gene that codes for the enzyme tissue nonspecific alkaline phosphatase.

When this enzyme is deficient, inorganic pyrophosphate, or PPI, accumulates upstream and acts as a direct inhibitor of bone mineralization leading to fractures and exerting both direct and indirect effects on muscle leading to weakness. PPI reduction is known to track with clinical benefits on bone health and mobility in patients. BMN-440 is a direct inhibitor of the ENPP 1 enzyme, directly upstream of PPI and thus can be thought of as a substrate reduction therapy for HPP. Preclinical data support this approach. At ASBMR in October, data from a mouse model of later-onset HPP showed that oral treatment with BMN-440 reduced PPI, and normalized the phosphate to PPI ratio. It also improved bone mineralization muscle strength, and mobility measures.

The promise of this approach is to deliver an oral alternative to ERT therapy for pediatric and adult onset HPP with the added potential to better address systemic symptoms that bone selective ERTs cannot. This is especially important because adult onset patients are often affected by muscle weakness, pain, and fatigue more so than bone problems. At ASBMR in October, a study with adult HPP patients demonstrated that the burden of this condition in adults extends beyond the skeleton to physical functioning, fatigue, sleep, and pain. There are no approved therapies for adult onset HPP in the US or Europe. BMN-440 is now in a Phase 1/2a study in healthy volunteers and adults with HPP.

We expect data in 2027 that will characterize pharmacokinetics pharmacodynamics, and safety, establishing an initial human proof of mechanism and informing dose selection and design for our next study. Turning to slide 14. At the World Muscle Society Congress in October, we presented 5-year data for the PROPEL open label extension study in adults with late onset Pompe disease, This analysis followed 82 people who received Pombility and Opfolda continuously from the start of PROPEL. Most had received prior enzyme replacement therapy having received it for an average of 7.6 years. for years previous to enrollment Over 5 years on Pombility and Opfolda, motor function was maintained, and pulmonary function remained relatively stable.

In ERT experienced patients, 6-minute walk distance was maintained, while in the ERT naive patients, it actually improved over time. Reductions in creatine kinase a marker of muscle damage, were sustained for the duration, and there were no new safety signals. These data support durable outcomes through 5 years in patients who had already been treated and add to the growing body of evidence supporting the rationale of switching to Pombility and Opfolda. Sustaining motor function and limiting pulmonary decline for 5 years in a progressive disease like late onset Pompe is quite clinically meaningful. As a reminder, Pombility and Opfolda is indicated in the US for adults who are not improving on their current ERT therapy.

So long term results in this population are especially relevant. With that, I will turn the call over to Brian. Brian?

Brian R. Mueller: Thank you, Gregory. Please refer to today's press release for detailed third quarter 26 results including reconciliations of GAAP to non GAAP financial measures As well as our upcoming Form 10 Q. As Alexander and Cristin have already covered the key revenue details for Q3, I will cover the financial impact of our 2 recent business development transactions some revenue timing and geopolitical dynamics that we are observing, and the expected associated earnings per share impacts in 2026. Turning to slide 16. We were pleased that third quarter revenue exceeded $1 billion, a first for BioMarin. Also on revenue, beginning this quarter, royalty and other revenues include amounts earned from Ascendis under the global settlement that we announced in August.

Third quarter results include the Inozyme acquisition. Which closed on August 31. And drove approximately $290 million of pretax expenses or approximately $1.48 per share on a pretax basis. Mostly related to acquired in process research and development or IPR&D. The impact of the Inozyme charges on pretax income for Q3 and the full year results in a timing related tax element between Q3 and Q4. As a result, Q3 includes a $0.24 earnings per share tax benefit that will normalize in Q4 and net to zero for the full year. We continue to expect the acquisition to reduce full year non GAAP diluted earnings per share by approximately $1.55 as announced in our October Form 8-Ks.

Non GAAP diluted earnings per share during the quarter was $0.23, which reflects the IPR&D charges related to the Inozyme acquisition. Also underlying the results revenue grew 32% year over year while non GAAP SG&A expense increased 12%. The non GAAP SG&A increase primarily reflects the addition of Amicus including the commercial teams that support Galafold and Pombility and Opfolda. Turning to slide 17, and our updated full-year 2026 guidance. We are updating our full year total revenue guidance range to between $3.8 billion and $3.9 billion The driver of the change is order timing and not underlying patient demand. During the third quarter, a single international customer indicated they intend to defer multiple expected orders totaling approximately $70 million.

Certain of these orders are already under contract for shipment, and we expect to fulfill the majority of the orders between late Q4 and Q1 2027. However, we cannot predict the exact timing. And while this type of order movement is normal for our large global business, and 1 of the reasons that we do not guide quarterly the magnitude and timing uncertainty, so close to year end has led us to update full year guidance accordingly. A second factor is the prolonged conflict in the Middle East. We have been managing through moderate disruption thus far in 2026, However, customer liquidity, and customer cash flow disruption have increased over the last 2 months.

We are sharing this dynamic today because on a full year basis, we are usually able to offset various headwinds and tailwinds in our business However, with just 2 months to go in the year, there are less of those available. Both the expected order timing just discussed and the observed Middle East disruption are reflected in today's updated guidance. To be clear, this guidance change is not driven by patient demand in these markets. And our updated guidance is based on timing of revenue between Q4 and next year. The underlying business is performing strongly as underscored by third quarter results today.

We are also updating non GAAP diluted earnings per share guidance to a range of $2.80 to $3.10 reflecting the 2 business development transactions that were not included in our August guidance, as well as the bottom line impact of today's updated revenue guidance. The Inozyme acquisition reduces full year non GAAP diluted earnings per share by approximately $1.55 and the BMN-450 license agreement reduces it by approximately $0.32. The Inozyme impact reflects approximately $320 million of acquired IPR&D and ongoing operating expenses this year. Including transaction and transition costs. The BMN-450 impact reflects approximately $83 million of primarily upfront acquired IPR&D expense and ongoing operating expenses, which we expect to record in the fourth quarter.

We recognize that the bridge from our Q2 to Q3 guidance is complex. Excluding the 2 recent business development deals and today's updated revenue guidance due to order timing, the midpoint of our updated earnings per share range is effectively unchanged from August. Reflecting the delivery of our underlying business profitability goal. In summary, the third quarter reflected strong top line execution across a broader portfolio. And we continued investing in future value creation through the acquisition of new clinical assets. At the same time, Amicus cost synergies are ahead of schedule. And we continue to expect approximately $220 million of non-GAAP cost synergies to be realized fully in 2028.

Thank you for your attention, We will now open the call to your questions. Operator?

Operator: We will now begin the question-and-answer session. Please limit yourself to 1 question and 1 follow-up. If you would like to ask a question, please press 1 to raise your hand. To withdraw your question, press 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from the line of Jessica Fye with JPMorgan. Your line is now open. Please go ahead.

Adam: Hello. This is Adam on for Jessica. Thank you for taking our question. I just wanted to ask, and sorry if I missed this, but the PR says you realize accelerated cost synergies in Q3 while maintaining the non-GAAP target for 2028. Could you elaborate on that? And what should investors carry into the 2027 OpEx assumptions as we model that out? Thank you.

Brian R. Mueller: Hi, Adam. This is Brian R. Mueller. Thanks for the question. And, yeah, you heard that accurately. You know, we came out in, the Q2 report in early August, with our long term views on the Amicus integration We quantified the synergies and started to talk about the accretion of the deal. And those metrics were you know, partially dilutive post acquisition here in 2026. Substantial accretion beginning next year in 2027, and then growing to full synergy realization in 2028. The integration's going really well. We are executing. Really proud of both the BioMarin and Amicus teams and now we are 1 team. And the cost synergies are ahead of schedule.

So we are not updating or quantifying any additional metrics at this time. We will talk more about the 2027 accretion when we guide to 2027, but we can say that the cost synergies are ahead of schedule. We initially said that within the first calendar year post closing, the deal would be accretive. We can now pull that forward and be confident that the deal is accretive actually within 9 months. And still a quarter to go here, but I will also share that we are currently tracking to even calendar year accretion in 2026. Thank you.

Operator: Your next question is from the line of Sean Laaman with Morgan Stanley. Your line is now open. Please go ahead.

Sean Laaman: Hi, Alexander and team. Hope everyone's well. On Pombility and Opfolda, the patient growth was around 69%, but you have acknowledged that uptake benefit from the competitor supply constraints. Alexander, can you quantify the underlying growth excluding that disruption? And I might have missed it. And how many of those starts are likely to remain durable once competitor supply normalizes? Thank you.

Alexander Hardy: Thanks very much, Sean. I am going to hand it over to Cristin.

Cristin Hubbard: Thanks so much for the question. This is Cristin. Yeah. As you noted, the performance in the third quarter for Pombility and Opfolda was indeed strong. Revenue up 58% and patients up 69% year over year relative to what Amicus reported in the same quarter. And I think what is really important to note on Pombility and Opfolda is that the switching really is based on the clinical profile of the medicine. Now we are watching this growing body of clinical and real world evidence You saw in the prepared remarks the PROPEL Extension study that Gregory spoke to which I think has been a really important momentum builder for us.

But as noted, we have also seen what we called a meaningful share of new patients starts based on the supply shortage we are hearing from other Pompe therapies. Now this is happening in certain European markets. We are not sure how long this will last nor the depth of the problem. But what we have done is worked really hard to ensure that we have additional supply so that we can not only support our patients that are on Pombility and Opfolda, but importantly any new patients that want to come on as a result of these shortages. So we really do think that this is an important moment for Pombility and Opfolda.

We are building great momentum and it is just the beginning of some of the initiatives we put in place. I do want to note, however, that revenue growth will lag as we had many of these new starts in the quarter. So we will see that revenue build more into 2027 and beyond. But it is an exciting time for Pombility and Opfolda and we are excited to carry on with this momentum. Thank you.

Operator: Your next question is from the line of Eliana Merle with Barclays. Your line is now open. Please go ahead.

Eliana Merle: Hey, guys. Thanks so much taking the question. Just on the achondroplasia space, something we have been hearing about recently from, I guess, 1 of the more outspoken competitors in the space is just around the safety of inhibiting FGFR2 in the developing brain and potential implications of that. I guess, do you have any thoughts on the debate here on how this could play out commercially, even just from a perception perspective? And then just second quick follow-up. For BMN-440 and interesting opportunity there. Could you elaborate what would constitute proof of concept at the data next year? Thanks.

Gregory Friberg: Thanks, Ellie. This is Gregory Friberg. I will take a stab at both of those. Yeah. With regard to, I think the comment you made about FGFR 2 inhibition in the brain, my thoughts are much more philosophical, which is you know, drug development is hard. I think that when we are looking at small versus large molecules, they have their risks. They have their opportunities. They have their challenges. But, really, this issue of whether or not a small molecule crossing the blood brain barrier leads to any sort of untoward side effects. These are hypothetical at this point. I would just comment that the FDA has established guidance on how they look at this. They structured processes.

They evaluate the risk benefit of these drugs very carefully. carefully. And we know that is incredibly important, particularly in children, who are going to be on these treatments for multiple years. At the end of the day, clinical data is the antidote to all of these potential concerns. And really, from that standpoint, we are quite proud of the data package that we have with VOXZOGO. We have got, as Cristin commented on, over 5 thousand patients, 10 thousand patient years, 50 countries. We know that the benefit risk profile is 1 that we can stand behind. it is 1 of the we like to say it is the best in class evidence package.

That, of course, has given us the opportunity to put forward the full approval data package that has additional information. It will be ruled on by the FDA with the February 28 PDUFA date. I really cannot speculate beyond that how the FDA, will view this, but certainly, the idea of a chronic safety package that we bring with VOXZOGO, we see that as a winning argument that we will be putting forward and continuing to publish on. For patients and physicians. With regard to your second question, BMN-440 and the proof of concept data, we have an ongoing Phase 1/2 study, right now.

As a quick reminder, this is a single dose, and a multidose study rolled together. it is in both healthy volunteers as well as a subset of HPV patients. And the data that we will have to present publicly next year will include both PK as well as what we are calling proof of mechanism data. So this is data again, looking at enzymatic activity and biomarker activity. What will come thereafter once we have been able to select doses and schedules will be a phase 2 study that will. We will look at harder clinical endpoints. More to come, but we are really excited about this opportunity.

As a quick reminder, as a small molecule, a substrate reduction therapy, for HPP, the promise and the opportunity here is not just that we have a more convenient therapy, but potentially 1 that also reaches compartments like the muscle and the bone that can affect, in particularly the adults, the kind of side effects that are. And adverse events from their disease that are really burdening them the most. That is muscle pain, and limitations of mobility that, again, some of the more bone targeting large molecules may not be able to address. Your next question is from the line of Cory Kasimov.

Operator: With Evercore ISI. Your line is now open. Please go ahead.

Adi: Hi. This is Adithya Jayaraman on for Cory. We noticed the January PDUFA for Pombility and Opfolda and adolescents. That opportunity already included in your $1.2 billion peak sales outlook, or would it be upside? And also more broadly, now that you have had more time with the acquired business, where else do you see the biggest opportunity to bring more Fabry and Pompe patients onto treatment beyond switching from existing therapies. Thank you.

Cristin Hubbard: So we do believe that there is a lot of opportunity here to continue to. And did you ask specifically about Pombility and Opfolda or also Galafold? Sorry. Just so that I am clear on the question. Pombility and Opfolda specifically. Yep. On both of them. We noticed that the adolescent is. sNDA has already been filed. So. Yeah. On both. Yeah. So we believe that opportunity is relatively small in the scheme of things, but we believe that the overall opportunity on Pombility and Opfolda is quite a bit bigger. Inasmuch as I just mentioned in the previous comments, we really are seeing momentum build for this therapy.

Not only is it the evidence that we are seeing, but also importantly on just the experience. So where we see the opportunities where we can really help build this, is certainly to share the real world evidence as we generate it. Certainly the adolescent is a catalyst opportunity, I should say, for Pombility and Opfolda. But really, as we continue to expand this not only in the indication that we have today but as we geographically expand this as well.

So the real switching opportunities here are to make sure that the data continue to be generated and that we educate on that meaningful data,, that we importantly empower both physicians and patients to understand when their current treatment might be waning or they might be-- they are not doing as well on the treatment that they are on and so that their own behalf to ensure that they get that switch to happen.

And then as I have mentioned, I think that this geographic expansion given that Pombility and Opfolda that is still in its early days it is important that we continue to build momentum in countries not only where we are today but in importantly in the countries we are not yet. And so our regulatory team, our commercial teams, in the field are preparing for this, which will help to build that growth into the future. Thank you.

Operator: Your next question is from the line of Paul Matteis. With Stifel. Your line is now open. Please go ahead.

Paul Matteis: Hey. Thanks so much for taking my questions. I appreciate it. I wanted to ask a couple on BMN-333 data next year. Understanding that your thesis here is that you could show clinical superiority I was wondering what would be an outcome next year that would definitively derisk that profile and make you confident in going that path for a pivotal study? And then maybe just as a second question to that, let's say this drug does show good clinical activity, but maybe the question around power for superiority looks a little bit riskier, would you still forge ahead with maybe some sort of non inferiority or equivalence path? Thanks so much.

Gregory Friberg: Thanks, Paul. This is Gregory. I will tackle that 1 for you. With regard to the BMN-333 study that is ongoing, just as a reminder for folks, we are running the phase 2 portion of our combined Phase 2/3 program, which is looking at a variety of doses. In this case, it is 3 doses of BMN-333. And looking at the AGV at 6 months, or greater and trying to determine how that compares to the control arm of VOXZOGO that not only will be studied within the within the protocol, but also will be supplemented by a wealth of historic data, again, that we have at our disposal.

Now again, it is not a question of whether a dose response exists. But it really is a question of the shape of that curve. We know that those 3 doses are going to give us, significantly increased AUC exposures of free CNP and will allow us to test this hypothesis. So we have a Bayesian model that is in place that will determine a posterior probability not only of those 3 doses but really looking at it with regard to exposure response as well.

And while we are not releasing what the math behind that model is, we feel that, again, if we meet those criteria, we will have a good degree of confidence that moving forward with a superiority study, testing the winner dose against VOXZOGO is a very good bet. That being said, you know, again, what we know so far is, of course, that we have been able to get not only PK, but increases in PD as well with the cyclic GMP. And we are quite confident, again, that we have the right molecule and we are running the right study.

Just for posterity sake since you are asking the question, should it not be achieved, our phase 3 study also will provide an opportunity to consider alternative hypotheses like non inferiority or less frequent dosing. And that would not material. Materially slow down our development time lines. that is not our hypothesis. We think that we have the right study. And the right molecule. We are looking forward to turn over the cards to that initial dose ranging study, sometime next year.

Paul Matteis: So, Gregory, just to clarify, next year's readout is not really a growth velocity readout. it is more of a PKPD readout. Is that right?

Gregory Friberg: It is a growth velocity readout. In this case, the PD is AGV. it is 6 months, or greater, data.

Paul Matteis: Please clarify, Paul. No. Thank you. Please go ahead.

Gregory Friberg: Yeah. I was gonna say it. it is AGV indeed. So the PD is AGV. Technically, that is an intermediate endpoint, and final is all tight, which we are thrilled to again have for VOXZOGO would be the primary endpoint full approval. But when I mentioned PKPD, I meant exposure response with regard to AGV. Thanks for clarifying.

Operator: Your next question is from the line of Alexandria Janet Hammond with Wolfe Research. Your line is now open. Please go ahead.

Alexandria Janet Hammond: Hey, guys. Thanks for taking the question. So since the full acquisition you have added BMN-440 as well as BMN-450, both early stage clinical assets. Is not that now the template, or would you use that $4 billion to $5 billion of firepower you expect in mid-27 on another commercial or late stage deal? I guess after these deals, what gaps remain in your pipeline? Thank you.

Alexander Hardy: Thanks, Alexander. Thanks very much for your question. Yep. I am aware we are. As you can tell, we are very excited about the deals we have done and to add 4 assets to our pipeline in 2026 so far. Continue to remain focused on clinical stage deals at the moment. So, you know, programs that fit with our capabilities around genetics, around regulatory expertise, around manufacturing, around commercialization. You know, particularly as you can tell, interested in assets that fit with our business units, so skeletal conditions and metabolic conditions. But we are interested also in other genetic conditions, but clinical stage assets absolutely and we do. We are.

As Brian said, you know, we are the accretion is being very impressive. The implementation of the Amicus acquisition and our firepower is increasing. So we will continue to do these clinical stage deals. For the foreseeable future.

Operator: Your next question is from the line of Philip Nadeau. With TD Cowen. Your line is now open. Please go ahead.

Rishi: Hi. This is Rishi on for Philip. Thanks for the call tonight. Really great progress. 2 questions for me. First is. So Uvwell was given a positive opinion from the CHMP of the EMA, last month. So, with the possible launch in Europe, or approval in Europe, coming up, how do you see this playing into, the competitive dynamics with VOXZOGO, as quantitatively as possible. And then my second question is, you previously moving on to hypochondroplasia, you have previously, given metrics on, your efforts to, to increase diagnosis rates and reduce the age of diagnosis and reduce age of diagnosis. Saying 90% increased in diagnosis rates, 70% reduction in the age of diagnosis.

Just do you have any updates on those metrics? Now? Thank you.

Cristin Hubbard: Thanks for the question, Richie. So I will take those. So Uvwell in Europe I can say that we are very much anticipating the launch there, we have that in our plans. Our competitive readiness, of course, assumes that. We have not given guidance. For the next year. And so at that point. Or, sorry. in the next year, we will be able to provide more color on that but I will say that we are ready for it, have it in our baseline plans and are looking forward to seeing what that looks like. Now on the second 1 on the hypochondroplasia metrics, what we have shared is the real focus areas as we are nearing the launch.

As you know, the PDUFA is coming in May in the US. And we are really focused on right now sharing the Phase 3 data making sure that we are increasing diagnosis, and then ensuring rapid access, so having the right conversations with payers. Now, with regard to the specific metrics that you have asked for, we do not have an update on those today. But I will say that as we get closer to the launch timing, we very much will be sharing more on our plans and specifically the metrics that we will be tracking and sharing as we move forward. So very excited about that as we move into the next year.

Thank you. that is very helpful.

Operator: Your next question is from the line of Joon Lee. With UBS. Your line is now open. Please go ahead.

Joon Lee: Hey. Hi. Thanks for taking our questions. The BMN-333 has a bit of a moving target. As we are expecting longer follow-up data from the combination of recombinant human growth hormone and CNP by year end. Would you be most focused on, and how would you position BMN-333 vis-a-vis the competition? Thank you.

Gregory Friberg: Thanks, Joon. This is Gregory. Maybe I will take a stab at that. Really, our thoughts with regard to the growth hormone combination are consistent with what we have been communicating in the last few quarters. I think the question is not whether adding growth hormone to an achondroplasia patient's regimen would result in a spurt of additional growth. The question is, whether or not that would be, number 1, safe, of course, Number 2, whether or not it would be persistent, whether or not, again, that would be an increase that would continue over time.

And, of course, the larger question, which gets back to the root of why growth hormone is not typically used in achondroplasia, patients to begin with is whether or not the final adult height of these patients will be impacted. The concern, of course, is that growth plates may close prematurely over time. These are hypothetical risks, but it highlights the fact that additional data is needed. Now when you slice and dice the data every 3 to 6 months, it is hard to get a look at that. That being said, again, the last look at the data did suggest that perhaps those effects were starting to wane, with the addition of growth hormone to CNP.

Our feeling with BMN-333 33 is that having a single agent again, 1 that for remember, patients who are not growth hormone deficient, a single agent that gives you similar results would be preferable That is also, you know, consistent with the thesis of what we think that BMN-333 can deliver. Again, higher levels of CNP. We are looking to optimize and have the best in class CNP that if there were a future state, where combinations were available, you would always wanna combine with the best CNP anyways. Thank you.

Operator: Your next question is from the line of Olivia Brea with Cantor Fitzgerald. Your line is now open. Please go ahead.

Olivia Brayer: Hi. Good afternoon, guys, and thank you for the questions. Brian, on the updated revenue guidance, can you maybe just help us better understand what is happening with that single customers ordering patterns Not sure whether you are able to disclose which country it is, but do you still expect growth from VOXZOGO in 2027 no matter how that ordering timing actually shakes out, whether it be in late Q4 versus the early Q1 of 2027 timeframe that you mentioned. And then on hypochondroplasia, congrats on the PDUFA. So assuming a summer launch, anything you guys can say at this point about how quickly you expect that meaningfully contribute to VOXZOGO sales?

Is that something that you think you will be ready to quantify come January? Thank you.

Brian R. Mueller: Thanks, Olivia. it is Brian. I will start with your first question, then I will let Cristin comment on the second part. So first, in for those of you that know the company well, quarterly order timing dynamics in our business is very common, something that we regularly manage through.

Cristin Hubbard: We have got this diverse global business. 2 thirds of it is outside of the United States. That international business is largely single payer national health care systems that tend to order large quantities on an inconsistent basis. But they roll up to this robust business that we have. And over the course of any given year, again, these dynamics are something that we consistently manage through There are usually puts and takes over the course of the year And we will comment on those at the quarters and perhaps adjust expectations as necessary.

Brian R. Mueller: However, at this point in time, with this single customer that flagged their intention to defer these handful of orders that totaled $70 million for the fourth quarter It was just large enough and uncertain enough for us to recognize the uncertainty in today's guidance update. But very important, as I mentioned a few moments ago, it is not tied to patient interest in the therapy. it is entirely timing. Some of the orders are contracted for shipment. it is just that the contract runs into January in that instance. So just timing between Q4 and Q1 and kind of the lack of offsets here. So we just wanted to share the update and take a measured approach here.

Cristin Hubbard: And Olivia, with regard to your second question about hypochondroplasia, so yeah, very excited about this as we move into next year. And specifically, the team working on diagnosis and patient identification. Our medical affairs teams are out there now. We are educating on the phase 3 data that we have. We are educating on the condition itself. And what we are really working on both in our customer interactions, but also importantly using different sources of data and being able to stitch some of that data together because we have more access to data in the US, we are working on identifying patients and offices and finding out where they actually are.

So what we will do as we near the launch and we gear up for it early in next year we will be sharing more about specifically what our expectations are around that and how we feel like we will be able to deliver on it and report out on it as we move forward. Okay. that is helpful. Can you guys actually comment on whether you expect VOXZOGO to grow in 2027, or is it too early given the dynamics with the ordering patterns?

Brian R. Mueller: Yes. Thanks for the reminder there, Olivia. We do expect VOXZOGO to continue to grow in 2027. And there is an element which includes the hypochondroplasia launch offsetting some of the potential loss of share to the current and additional potential competitors. But just a reminder that more than 75% of the VOXZOGO business is outside of the U.S. We are continuing to launch in new markets. We are continuing to deeply penetrate some of those international markets. We will remain the only achondroplasia therapy with a label for patients, children under 2 years old.

And in that exclusivity over what we believe is at least the next couple of years, with the importance of starting therapies early from birth per the international treatment guidelines, that sets up this potential switch market And so we have got a number of growth drivers and plan to continue to invest and grow VOXZOGO. Okay. Great. I appreciate it.

Operator: Do you have question? Is from the line of Christopher Raymond with Raymond James. Your line is now open. Please go ahead.

Christopher Raymond: Thank you very much. Yeah. I wanted to maybe ask a similar question to the last 1. that was asked, maybe a little bit more explicitly. So, Brian, I heard you say that there was a $70 million order from Q3 that got shifted. Full year 2026 guidance was lower by 2025. So the math, I guess, is it as simple as saying, so Q4 should benefit by $45 million and Q and I know you guys do not guide to 2027 yet, but should we also then think then there is an additional benefit of $25 million in Q1 2027 just given the shift? And you mentioned that it spans both Q4 and Q1 of next year.

And then maybe a follow-up to that question is on 33, Just hearing what you are saying about the option, maybe to size the Phase III portion to look at non inferiority, What kinds of unmet needs are you thinking about addressing under that scenario if you if you have a phase 2 dataset that maybe points to non inferiority. as the right way to go for BMN-333. Thanks.

Brian R. Mueller: Thanks, Christopher. This is Brian. I will start. First, just to clarify 1 element, because I think you touched on some of the Q3 to Q4 dynamics as well. Just to be clear, Cristin mentioned a. An order that shifted from Q3 into Q4. That was, again, a single large international customer. And that order actually was VOXZOGO. So that is part of the VOXZOGO Q3 being a little less than expectations this quarter. that is, again, a single order But that 1 is planned for Q4. And it is different and not included in the $70 million that I referenced.

That is another batch of orders that was previously expected in Q4, the customer is now flagged that they may take delivery of those in Q1 or early 2027. And the latter, the $70 million is the driver for today's guidance update. We took a risk adjusted approach, we still have a chance to deliver some of these orders, So that is the lowering of the midpoint. But separate from that first item in Q3. Hopefully, that helps.

Christopher Raymond: Yeah. Just want to make sure I understand. So lowering VOXZOGO by $25 million for the full year, the assumption is that some of that will spill over into Q1. Is that correct? Can you just clarify?

Brian R. Mueller: Yeah. It through this through this lowering of guidance, which allows and recognizes the uncertainty, for some of the Q4 slippage, if you will. And by the way, a little more than half of that $70 million is VOXZOGO. In this market. So, yes, if those slip into those slip out of Q4 into Q1, they would benefit Q1 or early 2027. But we will talk more about 2027 when we guide for 2027. You know, in these types of markets. If there is a timing deferral of a quarter, that could play forward into the next year. Where follow on orders get delayed. So we are still building up the revenue plan for 2027.

Gregory Friberg: And, Christopher, this is Gregory again. With regard to your BMN-333 question, I think your question behind the question, of course, is what is the compelling value argument that we bring with 33 to the table? And we firmly believe that the superiority, argument, the pharmacodynamics that we can bring forward give us a chance again to demonstrate that there is more growth to be had and more pull through to markers of health and wellness with a molecule like BMN-333. Out of an abundance of politeness, since I think it is 4 consecutive earnings calls that I have gotten a question about the noninferiority, I answered it you know, again, for directness sake.

But we would believe that we would need to add something beyond convenience to make a value argument for what society would value from BMN-333. Thanks.

Operator: Your next question is from the line of Joe Schwartz. Your line is now open. Please go ahead.

Joe Schwartz: Hi. Thanks very much. I have a couple of questions on BMN-333. With only about 10 kids per arm in Phase 2, what growth advantage over VOXZOGO would convince you that it is real? And how does the model you have used to power Phase 3 address the potential for growth velocity to plateau if it does not increase commensurate with the CGMP increases you have seen at some point over the curve.

Gregory Friberg: Thanks, Joe. Let me answer the question this way. We believe that the size of the study that we put in place and the models that we are using. Again, we will be looking at AGV for the individual cohorts, but we will also have the ability to match that to exposure analysis that we are gonna have more than enough statistical power based on our model to have comfort moving forward to phase 3. You had a second part of the question as well, though? Can you remind me? Yeah.

I guess what it is getting at is that other CMPs have not seen growth move up in line with the CGMP increases that have been seen because there is been a plateau, and I know that you are hoping that exposure plus more activity at the receptor might be able to you know, move beyond that. But I am just wondering how if at all, the Phase 3 powering is planning for that potential to play out. So the Phase 3 is powered off an effect size Again, that. As I was mentioning, the Phase 2 will give us confidence that, yes, we have a dose that can reach it.

And just to take a step back, the big question is not whether there is a dose response relationship to increasing levels of free CNP. it is really about the shape of the curve, where and if a plateau occurs, and, of course, whether you can push your way up that curve. I think the direct answer to your question is we have picked 3 doses that give us the sufficient increases in AUC for free CNP. that is roughly 3x, 5x, 7x. that is again, probably a conservative estimate in terms of free CNP. These are doses that have not been tested in humans to this point.

So again, that kind of spread of exposure, we do believe that we will definitively ask the question appropriately with this study and that we have got the right reagent in 33 that can test that. Beyond that, I am not going to get ahead of the data, We do think that data, though, will be incredibly informative and will help us, identify whether that hypothesis holds true. Thank you.

Operator: This concludes the Q&A portion of our call. I will now turn the call back to Alexander Hardy for closing remarks.

Alexander Hardy: Thank you. Thank you, operator. Delivered another standout quarter with 32% top-line growth and the first quarter in our history in which total revenue surpassed $1 billion. Our focused and deliberate expansion of BioMarin's clinical stage pipeline is delivering results with 4 new programs added in the last 12 months and spanning preclinical through Phase 3 development. We expect our leadership in skeletal conditions to support a strong launch of VOXZOGO for hypochondroplasia following its potential approval next May, which should mark BioMarin's seventh first-in-disease medicine. So we look ahead with enthusiasm, we advance the next wave of therapies from our clinical stage pipeline and prepare to report on a number of key updates in 2027.

Combined with the strength of our more diversified commercial portfolio, we are confident in our ability to create lasting value for patients and all of our stakeholders. Thank you for your continued support, and look forward to keeping you updated on our progress.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

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