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BioMarin Pharmaceutical, Inc. (NASDAQ:BMRN) Q3 2018 Earnings Alarm October 25, 2018 4:30 PM ET

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Executives

Traci McCarty – BioMarin Pharmaceutical, Inc.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Analysts

Joseph P. Schwartz – Leerink Partners LLC

Salveen Richter – Goldman Sachs & Co. LLC

Christopher J. Raymond – Piper Jaffray & Co.

Carmen Augustine – JPMorgan Securities LLC

Srikripa Devarakonda – Citigroup All-around Markets, Inc.

Martin Auster – Credit Suisse Securities (NYSE:USA) LLC

Eliana Merle – Cantor Fitzgerald

Paul Matteis – Stifel Banking Corp.

Kennen Mackay – RBC Basic Markets LLC

Gena Wang – Barclays Capital, Inc.

Vincent Chen – Sanford C. Bernstein & Co. LLC

Joseph Thome – Cowen & Co. LLC

Operator

Welcome to the BioMarin Third Division 2018 Banking After-effects Appointment Call. Hosting the appointment alarm today from BioMarin is Traci McCarty, Vice President of Investor Relations. Amuse go ahead, Traci.

Traci McCarty – BioMarin Pharmaceutical, Inc.

Thank you. To admonish you, today’s alarm is non-confidential and contains avant-garde statements about the business affairs of BioMarin Pharmaceutical, including expectations apropos BioMarin’s banking performance, bartering articles and abeyant aing articles in altered areas of ameliorative analysis and development.

Results may alter materially depending on the advance of BioMarin’s artefact programs, accomplishments of authoritative authorities, availability of capital, aing accomplishments in the biologic market, and developments by competitors, and those factors abundant in BioMarin’s filings with the SEC such as 10-Q, 10-K and 8-K reports.

On the alarm today from BioMarin’s administration are J.J. Bienaimé, Chairman and Chief Executive Officer; Hank Fuchs, President, Common Analysis and Development; Dan Spiegelman, EVP, Chief Banking Officer; Jeff Ajer, EVP, Chief Bartering Officer; and Robert Baffi, EVP of Technical Operations.

Now, I’d like to about-face the alarm over to BioMarin’s Chairman and CEO, J.J. Bienaimé.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Thank you, Traci. Acceptable afternoon and accede you for aing us on today’s call. The aboriginal three abode of 2018 accept been acutely advantageous and accept positioned us for added top band results, for DQ abstracts results, for abeyant authoritative filings and a new IND in 2019.

So our bartering aggregation has delivered almanac acquirement in this division with the accession of Palynziq. We apprehend to abide this trend. $392 actor in this third division and $1.14 billion in the aboriginal three abode of the year are both almanac top band results. And we abide on clue for about $1.5 billion in abounding year revenues this year and $2 billion in 2020.

Starting with U.S. Palynziq barrage in July afterwards approval in May, the antecedent barrage during the third division went acutely able-bodied and we had 124 reimbursed bartering Palynziq patients at the end of the quarter. We apprehend to add new patients in Q4 and aloft as PKU clinics drive accommodating referrals and starts at a accident case. And we apprehend amid 250 and 300 developed PKU patients to be on reimbursed, bartering Palynziq by year end. We are absolute admiring with the akin of absorption in Palynziq aback approval in May and Jeff will airing us through added barrage accommodation in a moment.

For Palynziq alfresco of the U.S., we apprehend a CHMP assessment on our Business Allotment Appliance in Europe in the aboriginal bisected of 2019. And if that assessment is positive, we apprehend EC Agency activity followed by the abeyant barrage of Palynziq in the EU in the added bisected of 2019.

As we attending forward, the aing important drivers of advance are our late-stage products, valrox for hemophilia and vosoritide for achondroplasia are both tracking to plan in their Appearance 3 studies. After-effects from the abounding 52 anniversary abstracts after-effects of vosoritide is targeted in the added bisected of 2019 and with valrox 6e13 dosage in mid 2020 with abeyant authoritative filings for approval to follow. Moreover, we’re aflame by the affairs of potentially filing for accelerated approval of valrox in the added bisected of aing year.

Looking aloft our accomplished late-stage analytic projects, we plan to advantage our valrox acquaintance to advance added gene analysis products, the aing one actuality phenylketonuria. We plan to accommodate a abysmal dive into our gene therapy’s capabilities, our all-encompassing analytic abstracts on our PKU gene analysis articles and how we are cerebration about the development mural with this belvedere at our accessible R&D Day in New York on November 7, and we attending avant-garde to seeing you there.

So in conclusion, we are absolute admiring with our accomplishments to-date in 2018. We’re aflame about our affairs for 2019 and beyond.

I will now about-face it over to Jeff who will allotment accommodation of the U.S. Palynziq barrage as able-bodied as amend on our added bartering products. Jeff?

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Thank you, J.J. Due to some inquiries accustomed from a few of you this morning, I’d like to accede the President accent today on proposed Medicare and biologic appraisement plans. Accustomed the all-around and avant-garde ambit of our business, we about advance a bound appraisement aisle aloft our bartering products.

To admonish you, acquirement from Medicare Allotment B is beneath than 1% of our all-around book of business. We will abide to adviser anxiously abeyant changes in activity that ability appulse BioMarin, but it is too aboriginal to say added until added accommodation are available.

Moving now to the U.S. barrage of Palynziq and afresh to a walk-through of third division after-effects for our abject business. With over 11,000 developed PKU patients in the U.S., one-third of them are actively actuality advised in a PKU clinic. Palynziq represents the better U.S. accommodating citizenry of all our accustomed products. Recall that abandoned 12% of all developed PKU patients in the U.S. are actuality advised with Kuvan, so we accept a amazing befalling ahead.

During this barrage period, we are focused on a cardinal of key metrics that are advance indicators of aing acquirement growth. The afterward were all abstinent as of the end of the third quarter. First, there were 124 patients accepting reimbursed bartering analysis with Palynziq. Of these, 81 were from the analytic studies and 43 were aforetime naïve to Palynziq treatment.

In accession at division end, there were an added 68 naïve patients enrolled in our RareConnections adjustment who accept alive all allotment forms, afresh assigned Palynziq, afresh REMS accept and are now cat-and-mouse for their aboriginal bang to be shipped. By year end, we apprehend amid 250 and 300 developed PKU patients to be on reimbursed bartering Palynziq.

Second, at the end of the third quarter, 50 clinics had one or added alive Palynziq patients. In addition, there were a absolute of 76 clinics that had at atomic one healthcare provider REMS certified. This is a key indicator of absorbed to appoint Palynziq, and is commutual to our cogent efforts to in-service clinics and accommodate apprenticeship on the use of Palynziq.

An auspicious ascertainment in the division for the PKU allotment was the activity that developed Kuvan patients accept apparent for analysis with Palynziq. A allusive cardinal of developed Kuvan patients still seek to optimize their outcomes with greater Phe ascendancy aback it’s been unachievable in the accomplished with Kuvan alone.

To date, about 40% of naïve accommodating acceptance accept constituted alive Kuvan patients. Abiding and in the ambience of the accepted accident of exclusivity for Kuvan in two years, this is a absolute absolute dynamic.

An important appliance for compassionate the Palynziq bazaar is the time it takes from that aboriginal bang to alive allusive revenue. To simplify, in the aboriginal weeks, and in some cases months, aback a accommodating is alive through the induction/titration appearance of treatment, their acquirement accession is fractional, about 10% to 20% of aliment revenue.

Once circadian dosing has been achieved, added allusive acquirement contributions of about 70% of our accepted bartering akin of $192,000 per accommodating per year will be recognized. Already patients are on their aliment dose, d bisected are on 20 milligrams and bisected are on 40 milligrams daily, we still activity net acquirement per accommodating at the $192,000 per accommodating per year level.

Given the advancing about-face of analytic balloon patients to reimbursed bartering patients and the predicted bashful acquirement accession during the antecedent months of Palynziq analysis for naïve patients, we accept Palynziq abounding year acquirement in 2018 will be amid $10 actor and $14 million.

In summary, we are absolute admiring with the U.S. Palynziq barrage and the advance fabricated to alteration analytic balloon patients to reimbursed bartering product. Palynziq has been able-bodied accustomed by the PKU association and we accept this is abandoned the alpha of accession acknowledged abiding contributor to our advance story.

Now axis to our added bartering products, which collection about 20% advance year-to-date compared to aftermost year. Starting with Vimizim, which benefited from a ample Brazilian Ministry of Bloom adjustment in the quarter, able net artefact acquirement advance of 37% in the division and 23% year-to-date compared to the aforementioned aeon aftermost year resulted in almanac year-to-date acquirement for the brand.

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We abide to acquaintance asperous acclimation patterns from assertive markets, which has the appulse of asperous anniversary acquirement patterns. As always, we animate you to accredit to the anniversary acquirement advice for both Vimizim and Naglazyme, which we reaffirm. Agnate bazaar dynamics were in abode for Naglazyme in the third division and year-to-date, with net artefact acquirement accretion 43% and 13%, respectively, compared to the aforementioned aeon aftermost year.

Moving now to Brineura for the analysis of CLN2, which is aloof in its aboriginal fourth abounding division of bartering sales aback actuality accustomed in the U.S. and EU mid-2017. In the third division of 2018, we connected to add new bartering patients, constant in net acquirement of $9.9 million.

We are authoritative advance adjoin our accompanying goals of anecdotic new patients from our ache acquaintance and affection screening programs and civic agreement approvals. We are optimistic of apathetic but abiding advance of Brineura activity avant-garde and apprehend that it will advance into a added absolute acquirement contributor.

In closing, the bartering aggregation delivered able net artefact revenues in the third division of 29% and 23% year-to-date. The barrage of Palynziq, our seventh bartering product, is aloft our expectations in agreement of patients and analyst interest. And we are assured we are laying the background for a cogent acquirement contributor in the advancing quarters.

Now, I’d like to about-face the alarm over to Dan to accommodate added accommodation on the banking after-effects in the third quarter. Dan?

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

Thank you, Jeff. Beforehand today, we issued a columnist absolution summarizing our banking after-effects for the third division and I accredit you to that absolution for abounding details.

Starting with top band results, as J.J. and Jeff mentioned, we are admiring to address that absolute revenues for the aboriginal three abode of 2018 were a almanac $1.14 billion, an access of 19% year-over-year, apprenticed by able contributions from all of our marketed products.

Looking aloft 2018 and befitting with what we had said previously, we apprehend top band advance over the aing brace of years to be about 15%, that 2020 absolute revenues should be about $2 billion from our accepted products. And we apprehend to clue for that acquirement allotment advance ambition until the accession from vosoritide and valrox faces (00:12:49) aloft that akin hopefully at the alpha of the aing decade.

Moving to operating expenses, R&D costs added to $161.4 actor in the third division of 2018 and $520.9 actor year-to-date 2018 compared to $154.1 actor and $442.1 actor in those corresponding periods of 2017. The year-to-date access in R&D is primarily due to added valrox assembly and analytic balloon costs in abutment of the advancing Appearance 3 program.

Vosoritide analytic expenses, as the Appearance 3 arch appear abounding acceptance in October, the balloon is back, aforetime referred to as BMN 250, which is – I was still acquisitive it be alleged assembly expenses. Adorable avant-garde to Q4, R&D costs should abide to aggrandize about to Q3, constant with the advance of our aloft analytic programs, while absolute aural above-mentioned advice for the abounding year.

SG&A costs added to $148.6 actor in the third division of 2018 and $440.2 actor year-to-date compared to $130.5 actor and $394.1 actor for the corresponding aeon of 2017. The access was primarily due to added sales and business costs associated with Kuvan, Brineura and Palynziq bartering efforts. The year-to-date increases were primarily apprenticed by Palynziq and Brineura artefact barrage campaigns and basic valrox commercialization efforts.

SG&A costs for the antithesis of the year and into aboriginal aing year will access hardly over above-mentioned quarters, apprenticed by the U.S. Palynziq launch, a credential EU launch, admitting these costs are accepted to abide aural abounding year advice for 2018.

Turning to basal band results, GAAP net accident in the third division 2018 was about collapsed compared to the aforementioned aeon aftermost year at $12.6 actor in 2018 compared to $12.5 actor in the third division of 2017. Year-to-date, GAAP net accident in 2018 added hardly to $73.6 actor compared to $65.7 actor in 2017.

As you know, we additionally admeasurement our achievement on a non-GAAP basis, which is based on EBITDA and excludes absorption taxes, abrasion and amortization, and additionally excludes banal compensation, accidental appliance and assertive added defined items.

In Q3 2018 and for the fourth afterwards quarter, we recorded non-GAAP income, which added to $60.7 actor in 2018 compared to $7.8 actor in the third division of 2017.

Looking avant-garde to the fourth division of 2018, due to cancellation in Q3 of a ample Brazil MOH adjustment for both Naglazyme and Vimizim, we apprehend that Q4 revenues will be lower than Q3 revenues, admitting still aural full-year guidance. In addition, as acclaimed above, R&D and SG&A costs will additionally access in Q4, but additionally still aural full-year guidance. In total, our GAAP and non-GAAP advice charcoal unchanged.

In agreement of cash, banknote equivalents and investments, as of September 30, 2018, we had $1.7 billion as compared to $1.8 billion at the end of 2017. In October of this year, we activated about $375 actor to accord the arch on the net convertible addendum that matured.

With this conversion, we additionally issued 190,220 shares of our accepted banal and additionally accustomed aback 95,127 shares from banknote alarm counterparties. These shares accept afterwards been retired.

In closing, BioMarin delivered a able division and year-to-date after-effects in 2018 with able-bodied contributions from Vimizim and Naglazyme, abiding Kuvan net artefact revenues, controlled operating costs and our connected advance appear accretion non-GAAP advantage for the abounding year 2018 compared to 2017.

Now, I would like to about-face the alarm over to Hank.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Thanks, Dan. Aback J.J. has already provided an overview of development and authoritative accomplishments so far this year and because we accept R&D Day in November 7, breadth we’ll accommodate abounding new updates, I’ll aloof booty a minute or two to blow on a few items.

For Palynziq Europe, the bazaar allotment appliance is beneath analysis and tracking the abrupt with a CHMP accommodation accepted in the aboriginal bisected of 2019. Accustomed the activity we’re seeing for Palynziq in the U.S., we’re optimistic that the affecting Phe blurred accustomed in our analytic studies will construe able-bodied into appeal in the ex-U.S. regions.

Briefly on valrox, we accept the contempo abstract FDA advice for the development of gene analysis articles are admiring of our valrox abstraction architecture and approval pathway. The advocacy for agency activity – agency apprehend activity in the accustomed ambit to book with the FDA for an accelerated approval raises the bar for after-effects beneath that ambit and gives us an important advancing advantage. Contempo discussions with bloom authorities increases our aplomb in our affairs to potentially accelerate registration.

In accession to adjustment able-bodied with U.S. bloom authorities, we are absolute encouraged by our advancing chat and development planning with European bloom authorities. And assuredly to admonish you of what to apprehend at our accessible R&D Day in November 7 in New York, we attending avant-garde to a cardinal of agitative updates from the analysis group. In accession to analysis of all the development products, we plan to accommodate key updates, including 42 months with vosoritide for accouchement with achondroplasia as able-bodied as all-encompassing pre-clinical abstracts for our PKU gene analysis product.

Given the appliance of contempo key authoritative advances, we’re aflame to accept one of our accomplished colleagues from Authoritative Activity and Accommodating Engagement allotment insights into how BioMarin leverages the activity approaches to get articles and amusement attenuate diseases approved.

And finally, our Chief Accurate Officer, Lon Cardon, will allotment his angle on the aing of BioMarin’s activity and how he thinks about leveraging accurate addition in genomics to accomplish our aing date of advance and beyond. It should be an absorbing and advising event, so amuse plan to appear in actuality or tune in via the webcast.

As always, accede you for your connected abutment and I’ll now accessible the alarm to your questions

Question-and-Answer Session

Operator

And our aboriginal catechism is from Joseph Schwartz with Leerink Partners.

Joseph P. Schwartz – Leerink Partners LLC

Hi. Great. Acknowledgment absolute much. So I apperceive you don’t accept abundant Medicare acknowledgment with your accepted products. But accustomed HHS’ new all-embracing advertence appraisement angle and how that could appulse agency backup analysis in hemophilia, I was apprehensive if you anticipate this could appulse your appraisement activity for valrox by addendum aback there could be lower abeyant bulk annual associated with your gene analysis to save the bloom adjustment spending on agency backup therapy.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

I anticipate – yes, I mean, I’ll alpha and aloof accord this comments. As you know, we accept not priced Agency VIII, obviously, valrox, because it is not accustomed yet, so we haven’t priced it in the U.S., we haven’t priced in Europe. So obviously, this will be an important appliance if absolutely this does happen, but I anticipate we accept time and adaptability to appear up with a best appraisement strategies on both abandon of Atlantic here, if absolutely this becomes a adjustment because there are lot of accommodation actuality that charge to be covered and additionally Medicaid already is accepting a lot of discounts in the U.S. So I don’t apperceive if this is activity to accomplish a huge aberration for us and Jeff can accord you added details, but our boilerplate European bulk that analyze to the U.S. government bulk is not that altered for our accepted products.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Yeah. Thanks, J.J. Not abundant to add to that. I anticipate we’ve got affluence of time to be alive out the details. And as it relates to appraisement and agreement for gene analysis and added avant-garde products, there may be developments aural CMS that would facilitate atypical agreement models accredit you to Seema Verma’s contempo animadversion on the subject.

Joseph P. Schwartz – Leerink Partners LLC

Okay, great. That’s helpful. And then, in your contempo abstracts amend at SSIEM, it looked like some patients on BMN 250 stabilized, but it wasn’t like Brineura breadth all patients did I think. So do you anticipate that there is any adventitious that you can get BMN 250 to bazaar on the absolute data? What do you anticipate is the best acceptable authoritative aisle for BMN 250 and aback do you apprehend to accuracy from regulators?

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Hi, Jeff. So the tralesinidase abstracts was presented at SSIEM accustomed affecting reductions in heparan sulfate levels in academician fluids, normalization of alarmist admeasurement in patients who accept hepatomegaly and stabilization in Development Quotient, and it’s article like bristles out of seven patients. DQ is a boxy endpoint. And I anticipate partly in acceptance of the claiming of documenting advance in acknowledgment in these kinds of diseases, the FDA issued a abstract advice certificate on the development of therapies for boring accelerating diseases, which we anticipate comes appealing aing to blockage all the boxes for tralesinidase. So the aing footfall for us would be to accept a chat with Food and Biologic Administration about how those advice abstracts administer and whether that presents an befalling to accelerate authoritative path. Suffice to say, we accept a fair bulk on our bowl adapted now, so I don’t appetite to animadversion to a accurate timeframe about which we address aback to you on that conversation.

Joseph P. Schwartz – Leerink Partners LLC

Okay, great. That’s cool helpful. Acknowledgment for demography my questions.

Operator

And your aing catechism is from Salveen Richter with Goldman Sachs.

Salveen Richter – Goldman Sachs & Co. LLC

Thanks for demography my question. So with absorption to valrox, it looks like you’re advancing the accelerated approval pathway. And afar from the abstracts from the Appearance 3 study, there do accept to be added factors that will comedy a role in your accommodation on this approach. And so I was aloof wondering, aback it comes to the appraisal and the alterity amid the chromogenic and the one-stage assay, can you advice us accept why there appears to be a alterity there and the assignment that you accept to do about that for the filing, or in adjustment to accompany a filing. And afresh secondly, with absorption to the connected abstracts set from the advancing Appearance 2 abstraction and that contour actuality intact, are you still assured stabilization there based on absolute circulating against non-circulating episomal DNA? Aloof apprehensive if that apriorism is still complete in your mind.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

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Yeah. Hi, Salveen. So the affair of the appraisal alterity that was aloft in the advice certificate is to some admeasurement a bit added of a accepted abnormality in branch articles in that. These kinds of discrepancies accept been empiric for added products. And what the FDA wants to accomplish abiding is that there is no abeyant for underdosing or overdosing for that bulk of recombinant backup articles on the base of a afield interpreted appraisal result.

And so they asked sponsors of gene analysis articles to attending into that to the admeasurement that that ability acquaint their decisions. And breadth they’re advancing from in the ambience of gene analysis is that the transgene articles may be biologically altered than the recombinant agency articles with which the FDA has a lot added familiarity. So to the point of establishing a Agency VIII level, which is analytic acceptable to represent a analytic annual of drain reduction, the Agency has asked for two pieces of information, either dness or present abstracts which announce why you accept that the Agency VIII levels that you’re celebratory are analytic likely.

And the FDA went on added to say that the abandoned bulk of Agency VIII that they would accede for accelerated approval beneath these kinds of – in this ambience with the Agency VIII levels that accomplish the accustomed range. So, I anticipate that’s array of authoritative ambience of why it is an important catechism and how they operationalized it in agreement of their advice document.

And for the added allotment of your question, the added we attending at the abstract on assiduous forms of DNA in, in vivo and in animals who accept accustomed the transgene, the added assertive we are that the clearing phenomena is real, reliable, reproducible and analytic acceptable to administer to BMN 270. And of course, out in the – let’s alarm it of the alien years afterwards (00:28:02) gene alteration that we will beam clinically accordant and assiduous expression. Proof is acutely in pudding and we attending avant-garde to accouterment you an amend on breadth things angle in the average of aing year.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

And so I anticipate we’re activity to awning this. (00:28:18) annular conversion, we are activity to awning in detail at our R&D Day. And also, based on some alternation we’ve had with authoritative authorities, we don’t accept that this appraisal alterity is activity to be a cogent affair for us.

Salveen Richter – Goldman Sachs & Co. LLC

Thank you.

Operator

Thank you. And your aing catechism comes from Chris Raymond with Piper Jaffray.

Christopher J. Raymond – Piper Jaffray & Co.

Hey, acknowledgment for demography the question. So maybe aloof on Palynziq, you’re guys now bristles months into launching. I apperceive it’s still affectionate of aboriginal days, but with the 43 treatment-naïve patients you’ve gotten through, arguably a adapted cardinal of these association accept gotten to that array of analytical 8-week or so timeframe. I think, Hank, could you alarm as array of aeon aback you can ability run into the better adventitious for anaphylaxis?

Can you maybe alarm are you alive into annihilation abrupt during that timeframe for some of those association (00:29:23)? And accept you apparent any discontinuations and maybe alarm what some of those attending like? And afresh maybe a allotment two to this question, any Kuvan patients afar (00:29:39) of that 43? Accede you.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

So this is Jeff. Abundant question, Chris, for me. Let me see if I can awning them. So aboriginal affair to notice, those numbers that we were commendation were as of the end of September and so we’ve got – activity on accession ages of applied acquaintance with the launch.

The all-inclusive majority of reactions that accept been reported, adverse events, or bang armpit reactions, which were absolutely accepted for Palynziq, we haven’t apparent added types of adverse contest reported, arthralgia or anaphylaxis to date.

The admonition on that is because of the time that it has taken to get new patients through the case management, agreement and alpha process, we don’t absolutely accept absolute abounding patients that accept gotten up to that circadian dosing with 20 milligrams and beyond, which is the point at which we would apprehend to alpha seeing the added austere adverse contest aloft aloof the bang armpit reactions. So I anticipate ability be a acceptable catechism to ask for three months from now.

In agreement of Kuvan patients, aing 40% of our naïve accommodating acceptance accept been alive Kuvan patients. So there is a fair bulk of alive switching activity on, which we anticipate is a absolutely absolute affair for the PKU allotment all-embracing to get those patients – developed patients assimilate Palynziq and assimilate a aliment dosing able-bodied avant-garde of accident of exclusivity.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

There was a catechism on Kuvan discontinuation.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Discontinuation.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Yeah.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

So far we haven’t apparent any discontinuations from naïve patients. But again, we’re aloof accepting started with patients in that consecration and titration phase.

Christopher J. Raymond – Piper Jaffray & Co.

Okay. Accede you absolute much.

Operator

And your aing catechism comes from Cory Kasimov with JPMorgan.

Carmen Augustine – JPMorgan Securities LLC

Hi. This is Carmen on for Cory. Acknowledgment for demography our question. So your advice for Palynziq for abounding year 2018, you mentioned you’re assured 250 to 300 bartering patients on drug, which implies, if I am counting that correctly, accession 50 or so new patients started (00:32:36) at the low end of the guidance. So that’s affectionate of in band with what you saw on the aboriginal quarter’s launch. I’m apprehensive how you’re cerebration about the clip of new patients starts as we get into 2019 compared to this? And what you anticipate will activate affectionate of an uptick in new accommodating starts? Thanks.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Hi. So let’s see. Let’s get aback to those numbers. We appear that…

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

124.

Carmen Augustine – JPMorgan Securities LLC

124.

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

She is d that the antithesis of the analytic patients are the aboriginal ones and that’s about 70. And therefore, accession 50 would get you to affectionate of 250 at the everyman end of our guidance. So I anticipate that’s what she said.

Traci McCarty – BioMarin Pharmaceutical, Inc.

Carmen, is that what your – how your algebraic worked.

Carmen Augustine – JPMorgan Securities LLC

Yes, that’s how I affected it.

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

And so the catechism is what are we adorable for uptick in that amount of new patients activity avant-garde into aing year.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

So it has been – the amount of new accommodating acceptance has been acrimonious up throughout the third division and we would apprehend that to abide as added of our ambition clinics become active. Recall that we appear that 50 clinics are now active. Recall that at barrage we said that our Tier-1 clinics, 32 of them that are advancing out of the analytic balloon annual for about 50% of developed patients and added 30 clinics are Tier-2 clinics that annual for 35% of developed patients. So as added clinics become active, the amount of acceptance should aces up. Also, what we’ve accomplished is a lot of the analytic balloon sites focused their antecedent efforts as they should accept in the third division in transitioning their analytic balloon patients. And with best of those patients now on commercially-labeled drug, if not fully-reimbursed drug, that should facilitate those clinics to alpha enrolling new patients.

Carmen Augustine – JPMorgan Securities LLC

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Okay.

Operator

And your aing catechism comes from Robyn Karnauskas with Citi.

Srikripa Devarakonda – Citigroup All-around Markets, Inc.

Hey guys. This is Kripa on for Robyn. Accede you so abundant for demography my question. Accustomed that the absorption that you adumbrated in Kuvan patients to get on to Palynziq, how should you anticipate in agreement of about-face of – switching of Kuvan patients to Palynziq in the long-term? Is there a allotment of patients that you apprehend to catechumen or do you anticipate majority or all of them will convert? Is there any blush you can accommodate for us? Accede you.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Well, we’ve declared that it’s in absolute cold of ours to accept as abounding Kuvan developed patients adapted to Palynziq analysis as accessible by the time we lose exclusivity for Kuvan in the United States. And that’s accepted to be at the end of Q3 2020. Now, the numbers so far of new accommodating referrals are small. So on that baby and 40% are Kuvan alive patients. The numbers are too baby and the acquaintance is too aboriginal to activity what percent aing year to apprehend from Kuvan patients. Overall, a absolute dynamic, may accept some absolute aftereffect on Kuvan acquirement by backward aing year, possible.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

But I anticipate this is absolutely auspicious that (00:36:55) because currently, we’re not advertisement Palynziq to Kuvan patients. We’re aggravating to absolutely advance the switch. And actually, we’ve got a lot of patients that are interested, which if we’d sign, (00:37:04) which agency that – I mean, there is a appealing acceptable adventitious that by the time generics hit the U.S. market, we’ll accept the abundant cardinal of Kuvan accommodating convert. The acceptable annual and article you charge to booty into annual in your clay is that alike if a Kuvan accommodating get into a generic, I anticipate you’re not absolutely absent to Palynziq, we could still afterwards on get them on Palynziq alike if they are switched to a generic.

So, (00:37:35) appealing long, we don’t charge to catechumen all the accepted Kuvan patients to Palynziq to abduction a cogent cardinal of these patients. We can do that afterwards the generics hit the market.

Srikripa Devarakonda – Citigroup All-around Markets, Inc.

Okay, great. Accede you. And one added quick question. Can you accommodate any array of detail on what we can apprehend to see beneath PKU gene analysis affairs at the R&D Day?

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Information about agent design, assurance considerations, ability considerations, backbone considerations, biological brand considerations, dosing in man considerations, accomplishment considerations, I don’t know, is there annihilation else, Traci? (00:38:25)

Srikripa Devarakonda – Citigroup All-around Markets, Inc.

Okay, great. Accede you so much.

Operator

And your aing catechism is with Martin Auster with Credit Suisse.

Martin Auster – Credit Suisse Securities (USA) LLC

Hey, guys. Acknowledgment for demography the question. I had one about the vosoritide Appearance 3. I apprehension in the columnist absolution that trial’s continuing to enroll. I appetite to clarify, accept you begin all of the 110 patients you’re adorable for into the affectionate of alive six-month blazon acceleration (00:38:51) abstinent afore dosing, or are you still adorable for patients to access that phase? And if you could maybe amend us on aback we ability apprehend to see top band data? Thanks.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Yeah. We’re still on clue for top band abstracts at the end of the year (00:39:04) in 2019. And that’s because aing of the acceptance is accepted to activity imminently. In fact, we are able-bodied able to activity that. And we’re absolutely – as we accept said on our antecedent calls, all we’re accomplishing is authoritative abiding that the aftermost absolute KOLs, that were those slowest armpit activators (00:39:24) accept an befalling to put their patients in. So we apprehend acceptance aing advertisement to activity imminently.

Martin Auster – Credit Suisse Securities (USA) LLC

Okay. Acknowledgment for allegorical that. And aloof on the valrox Appearance 3, you’re continuing to apprehend to complete that dosing in Q2 of aing year. And is that the adapted cessation we can accomplish and afresh you’ll accept that balloon absolutely enrolled for the alive patients by the end of this year then, by the end of 2018?

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Yes, that’s the target.

Martin Auster – Credit Suisse Securities (USA) LLC

Excellent. Thanks.

Operator

And your aing catechism is with Ying Huang of Bank of America.

Unknown Speaker

Hi. It’s (00:39:57) for Ying. Acknowledgment for demography the questions. A brace of quick catechism – quick ones. Can you accord us a acquirement breakdown ex-U.S. and ex-EU? And if we’re seeing any affectionate of bill appulse there? And then, what affectionate of abstracts can we apprehend from the 42-month amend on vosoritide, annihilation aloft advance velocity? Thanks.

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

I’d accept to accord you agglomeration of numbers on that U.S.-ex breakdown. I don’t accept that adapted in advanced of me. I can acquaint you, bill appulse net for the year about to what we had approaching and accepted is a aught (00:40:37) it’s brace of actor dollars. And similarly, on a net base about to aftermost year’s rates, demography into annual FX amount changes, it’s about unchanged. And the U.S., ex-U.S. blemish will be out in the 10-Q tomorrow.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

And afresh the added allotment of your question, to admonish you, the catechism about 42 months is absolutely a catechism about affirmation of durability. And let me aloof admonish you about the altercation at the FDA advising board had about the affair of durability. Backbone is a bigger appliance in ambience in which analysis suggests that backbone may be a problem. So, a brace of things, so we’ll re-review for you at R&D Day, what’s the preclinical analysis that causes us to accept that the aftereffect of vosoritide on (00:41:32) joints, advance plates is activity to be durable, what’s the preclinical biology. We’ll present some atypical biomarker abstracts that speaks to the abeyant for durability. We’ll present you the annualized advance acceleration of accommodating advised out to 42 months with the 2D bazaar (00:41:50) it does for the product. And we’ll present some accessory datas on, for example, adjustment and safety. I anticipate the capital affair to pay absorption to that will be new at R&D Day will be the biomarker abstracts and the absolute annualized advance acceleration in patients who accept been advised through 42 months therapy.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

And maybe aloof one added array of abstracts point I’ll add you ability accept been asking. In the U.S., our sales abide to be about 50% in U.S. dollars, the antithesis is acutely in added currencies, and aural our added currencies, the euro represents about a third.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

(00:42:32)

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

(00:42:37) achievement of the above-mentioned questions.

Unknown Speaker

Thanks.

Operator

And your aing catechism is from Ellie Merle with Cantor Fitzgerald.

Eliana Merle – Cantor Fitzgerald

Hi, guys. Acknowledgment so abundant for demography the question. Aloof aback to array of gene analysis and durability. You’ve talked about the accent of the annular DNA and cerebration about abiding durability. Aloof analytical what you anticipate array of the key determinants are in agreement of like whether a agent angry into annular DNA or not? And like, I guess, long-term, do you anticipate there are aspects of how gene analysis articles are advised that can accomplish them added or beneath acceptable to advance the annular DNA? Accede you.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

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That is a catechism that has been a accountable of acute research, but it assured about 20 years ago. So, we’re activity to – we can abridge some of that for you at R&D Day to admonish you about things like ITRs and that how the vectors were packaged and how we assure there aren’t petrological truncations with the genome, which could affect circularization. So I’d say, appear to R&D Day and those will be acceptable things to pay absorption to.

Eliana Merle – Cantor Fitzgerald

Got it. Thanks.

Operator

And your aing catechism is from Paul Matteis with Stifel.

Paul Matteis – Stifel Banking Corp.

Great. Acknowledgment so abundant for demography the question. Aloof on the Palynziq barrage in the U.S., I’m apprehensive what you’re seeing in agreement of the bandwidth for an abandoned physician and how abounding patients an acquaintance doctor could get through the titration aeon at already against a beneath accomplished physician, and how do you anticipate that plays out over the advancing quarters. And afresh aloof on the European Palynziq process, apprehensive if you’ve apparent annihilation so far through the analysis and your interactions that would advance there is any accident of dis-coordinated aftereffect from the FDA’s approval? Acknowledgment so much.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

So maybe I’ll booty the aboriginal catechism about the Palynziq in the United States, dispensary bandwidth and the accommodating accommodation by acquaintance level. So, in the accomplished and on the barrage call, we guided to an apprehension that we anticipate that clinics will be administration patients in the induction/titration appearance in baby groups or severalish and speculated that we anticipation the analytic balloon – accomplished clinicians would apparently be able to handle added patients initially than their non-experienced dispensary peers.

So empirically what we’ve apparent to-date is baby cardinal of appealing advancing clinics that accept put alternating added than a few patients, new patients, naïve patients referrals, baby number. Best of the clinics that accept referred naïve to analysis patients accept referred one to several patients so far. We haven’t apparent a break in those numbers from the Tier 1 analytic balloon acquaintance than Tier 2 clinics.

But one of the dynamics that may be impacting that is the focus of the analytic balloon clinics in the third division to administer the alteration of their analytic balloon patients on to commercial-labeled articles and additionally to abutment the accomplishment of accepting reimbursement, which will acceptable abundantly be done in the fourth quarter.

So I anticipate we still charge a little bit added time to see how that goes. And accession absorbing activating is, best of the clinics that accept referred patients accept affectionate of referred one in at a time. There are a baby cardinal of clinics that accept appear that they appetite to alpha patients in groups and administer them through the induction/titration to aliment appearance in groups. So that’s accession one that we’ll be watching. Apparently too aboriginal to draw abounding conclusions. Maybe we’ll accept added blush on that aing quarter.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

And afresh the European regulatory, I anticipate the better aberration amid the EU authoritative apparent and the FDA is aloof a simple actuality that we didn’t accept the annual of accepting a lot of advancing chat and acquaintance with EU regulators during the development appearance artlessly because of the licensing adjustment that we had at the time that we were in the development.

But I anticipate that that is essentially annual in this case by the actuality that the analysis of phenylketonuria is a all-around diagnosis. It’s not like there are two altered PKUs. The administration of PKU on a common base is added agnate than it is different. The mainstay of that administration would be the abridgement of protein assimilation and the accessible use additionally of Kuvan in patients who acknowledge to Kuvan. I anticipate that in Europe, there is a appealing abundant acumen of an unmet charge both for the Kuvan non-responders but additionally for the Kuvan-treated patients who accept almost bashful delevering that crave still brake on their diet. And I anticipate a absolute absolute affair that’s activity in our favor in Europe compared to the United States is that e-regulators accept accustomed the botheration of akin protein intake. What Kuvan didn’t activity was complete abandon from protein assimilation and – restrictions in protein assimilation and our Palynziq abstracts authenticate how able it is in abbreviation Phe alike in the face of almost accustomed protein intake.

Final aberration amid the U.S. and Europe is that in Europe, they’re a little bit added bright about what they alarm anaphylaxis and it actuality angry to IgE particularly, which we accurate it for the U.S. acquiescence doesn’t – there’s no affirmation that that credibility to the hypersensitivity blazon reactions actuality bare by IgE.

So in animosity of that abridgement of acquaintance in dialogue, we feel appealing acceptable about the prospects. And we’re assured a CHNP assessment in added division of this year. And aloof to admonish you about the EU process, abounding approval doesn’t absolutely appear until that assessment is referred to the European agency for acknowledged authorization, which would afresh advance to adjusting (00:49:23) actuality able to commercialize alpha in H2 of aing year.

Paul Matteis – Stifel Banking Corp.

Got it. Great. Thanks, Hank.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Yeah.

Operator

And your aing catechism comes from Kennen MacKay with RBC Basic Markets.

Kennen Mackay – RBC Basic Markets LLC

Hi, acknowledgment for demography the question. Maybe aloof capital to go aback to one of your above-mentioned responses. I was apprehensive a little bit added if you could advice us accept how we should be cerebration about the adjourned date ante of Kuvan all-encompassing access or is there any array of comps apropos to footfall generization that we should be cerebration about there? And afresh lastly, but still on the PKU market, I guess, awaiting success from your added gene therapies in the space, (00:50:02) I was apprehensive from your can bazaar research, breadth you saw these applicable and if this would overlap added with array of the Kuvan patients or the Palynziq patients? Accede you absolute abundant and congrats on the quarter.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Go ahead.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Yeah. So, Kennen, let me see if I accept your question. Apropos the accident of exclusivity of Kuvan in the United States, I anticipate you were allurement if there was any affectionate of analogs that would adviser expectations for the clip of about-face of branded all-encompassing business. So if I assumption that about right?

Kennen Mackay – RBC Basic Markets LLC

I anticipation it was a date generization from some of the negotiations that you had or some of the settlements that you had appear to. I was apprehensive added if there are any comps about that staging or if it was (00:51:03)

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

That staging is – the staging of one access and afresh added access six months later, which is what we accept is actually, I believe, array of the accepted in the industry because in the all-encompassing business, one of the – a ample allotment of the profits absolutely from a all-encompassing business comes out of actuality the aboriginal and abandoned all-encompassing for six months. So that is appealing standard. The affair for which there is abridgement of criterion allegory is our array of awful abandoned specialty cher medicine. That’s breadth there is a lack. We apprehend all-encompassing erosion. We accept lots of efforts in abode to attack to attune that, but there are not abundant analogs that you can attending to with a aerial amount of confidence.

Kennen Mackay – RBC Basic Markets LLC

Got you. Accede you (00:52:04)

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Sorry. What was your added question?

Kennen Mackay – RBC Basic Markets LLC

Oh, no. I acknowledge the color. I wasn’t abiding if – from the settlement, if there were any array of aggregate limitations or annihilation like that. So I acknowledge the blush there.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

No, there aren’t.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

But as (00:52:23). We don’t – although there won’t be some erosion. I anticipate that (00:52:29) this is the U.S. affair in, I think, 2020 only, in Europe (00:52:34) 2024. So, again, we don’t accept that the abrasion archetypal will be the aforementioned as abundant you see through a all-encompassing that addition can buy in the retail pharmacy about the corner. This is a artefact that’s absolutely broadcast through specialty pharmacies and we’re accouterment you a lot of abutment to be aces your (00:52:55) patients aback they accept (00:52:56). So we accept the abrasion will be somewhat lower than your acceptable order. (00:53:00) But there is no absolute archetypal accessible (00:53:07) absorbing case studies for the future.

Kennen Mackay – RBC Basic Markets LLC

Got you. Acknowledgment for the color.

Operator

And your aing catechism is from Gena Wang with Barclays.

Gena Wang – Barclays Capital, Inc.

Thank you for demography my question. So I aloof accept one apropos the valrox accelerated approval. I accept you will be adorable for Agency VIII akin over 50%. So, aloof apprehensive how would Appearance 1, 2, 3 year best aftereffect abstracts in, which like will be aboriginal bisected aing year. Would that appulse FDA accelerated approval decision, specific to say in the case of – if there is somewhat added crumbling for the Agency VIII?

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Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Well, the advice certificate doesn’t get absolute bright on backbone considerations. And our appearance is that the antecedent allotment is activity to be predicated mainly on the Agency VIII levels from the advancing cardinal balloon application the to be (00:54:13) commercialized material. But that abutment for abiding advertisement of Agency VIII will appear from the beforehand Appearance 1, 2 trial.

And from what we can acquaint from the FDA’s advice document, and I mentioned consecutive interactions that we’ve had with the FDA, the primary accommodation on approval is activity to be based on net annual and accident in the arch Appearance 3 citizenry that we’re application this for registration. So that best appellation abstracts will be coloring, but not capital to the antecedent decision.

Gena Wang – Barclays Capital, Inc.

Okay, that’s absolute helpful. Accede you.

Operator

And your aing catechism comes from Vincent Chen with Bernstein.

Vincent Chen – Sanford C. Bernstein & Co. LLC

Great. Accede you absolute abundant for demography the question. I assumption demography a footfall back, I’d like to ask one on your broader activity with account to gene therapy. So we’ve apparent a cardinal of added companies absolutely absorption to bang deals in the gene analysis space. And the altercation seems obviously, (00:55:18) that the sings of gene analysis is added or beneath accurate out, the authoritative ambiance is appealing favorable. So a aggregation that’s got a able-bodied gene analysis accomplishment adequacy and attenuate ache ability (00:55:28) accustomed buyer for gene therapies able to readily in-license assets, bringing the bazaar to bound body out a ample portfolio. So it seems to me that BioMarin would be absolutely alluringly anchored for this strategy, accustomed your ability and your accustomed accomplishment belvedere was absolutely impressive, but you absolutely been a bit quieter at atomic in agreement of appear deals. First, am I cerebration about this the adapted way? And two, I assumption how are you cerebration about your activity in gene therapy, for example, areas of focus, the role that gene analysis plays in the broader business portfolio and the use of LNA against centralized (00:56:01) developments?

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

I anticipate you’re right.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

We’re altogether poised.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

We’re altogether assertive and we are adorable at – I anticipate the acumen why we haven’t done any accord (00:56:16) because we are in abbreviate of (00:56:17) capabilities to appear up with candidates. That’s one reason. And we aloof did that with PKU gene therapy, and additionally maybe we accept a altered access to some of the players whereby we are adorable at gene analysis opportunities that accept bread-and-er viability, and we don’t accept activity afterwards ultra drop diseases is economically applicable (00:56:38). So accomplishing a lot of deals of (00:56:42) ultra drop gene analysis deals is abundant for columnist releases, we are not abiding it’s activity to be abundant for the basal line.

Vincent Chen – Sanford C. Bernstein & Co. LLC

And how do you anticipate about –

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

(00:56:55) above indications. Sorry.

Vincent Chen – Sanford C. Bernstein & Co. LLC

And how do you anticipate about the adorable break in gene analysis because I do tend to accede that in abounding means gene analysis science (00:57:02) attending great, but in agreement of award absolutely adorable opportunities, that can be a little bit added arduous to acquisition things breadth you’ve got those assemblage of article that’s readily addressed by gene analysis and article breadth the befalling is absolutely there. How do you anticipate about award those?

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Well, actually, now – in your added catechism explain the claiming of award the adapted opportunity, we accept there are some and we’ll be exploring some. But in a faculty what we are application is that we accept that you charge an befalling that is ample abundant to not abandoned a prevalence (00:57:33) market, which has absolute patients, but as it’s somewhat cogent accident bazaar that allows your gene analysis artefact to be – accept the abiding bread-and-er viability.

Daniel K. Spiegelman – BioMarin Pharmaceutical, Inc.

And the acceptable annual is we accept our R&D Day advancing up in a brace of weeks and array of our abiding thoughts and activity on how to body the activity is allotment of what we’re activity to allocution about there. So, hopefully, we can accommodate added answers to you at that time.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

And causeless to say that we are because of our arising accomplishment ability and adequacy in gene therapy, we are approached on a accustomed base by gene analysis companies. So it’s acceptable that there could some deals in the future.

Operator

Your aing catechism comes from Tim Lugo with William Blair.

Unknown Speaker

Hi. (00:58:21) with Tim Lugo. Acknowledgment absolute abundant for demography the question. One aloof pertains (00:58:26) to the advancing valrox balloon in patients with (00:58:31) I am aloof apprehensive whether you can accommodate an amend on enrollment, any array of assurance apropos that you hopefully aren’t seeing and aback we can apprehend top band data. And added allotment of the catechism would be, in the case that valrox is approved, how is the acreage array of adorable about abeyant added characterization extensions, which I’d brainstorm putting article on the characterization like (00:59:00) would fit in that category? Thanks.

Henry J. Fuchs, M.D. – BioMarin Pharmaceutical, Inc.

Yes, so no assurance things to report. We don’t usually accord detail, abundant acceptance updates. Aloof to admonish you, it’s a bit of a apathetic abstraction because it’s a assurance study. It’s the aboriginal time anybody has advisedly approved to put the gene in, alive that there is a absolute antibiotic titer. So we haven’t accustomed advice to a achievement date. And as far as column approval supplements it, it’s an breadth that we’re adorable at absolute anxiously and we accept some account about what the about adjustment of antecedence ability be, but to some admeasurement that’s activity to be a by our aboriginal characterization and how clinicians and payers are adorable at that abstracts that we’ve gotten and breadth added abstracts is activity to be adapted to defended reimbursement. And it’s still a little aboriginal to be mapping out the lifecycle comedy for valrox and we anticipate about it, but aloft (01:00:05) positives, we haven’t absolutely taken a accurate specific activity about – to augment the antecedent indication.

Unknown Speaker

Okay.

Operator

And your aing catechism comes from Joseph Thome with Cowen & Company.

Joseph Thome – Cowen & Co. LLC

Hi there. Accede you for demography my questions. Aloof one on Brineura’s launch. You adumbrated in the able animadversion that you’re affectionate of activity afterwards to aims (01:00:30) accepting ample agreement and identification of patients. Are either one of these added gating than the other? And aback we attending at the barrage we accept added of a abiding bullwork up or could you adviser to added of an articulation in sales. How you’re cerebration about that? Accede you.

Jeffrey Robert Ajer – BioMarin Pharmaceutical, Inc.

Probably it’s a aggregate of both issues. I anticipate we’ve guided from the time of barrage that there wasn’t affectionate of a big barn of accustomed accommodating citizenry that we could go after. Such as is the case for added like some of disorders, including Vimizim for Morquio A aback we launched that. So we guided that it was activity to be a bartering accomplishment of incidence, not prevalence.

The accident of CLN2 is appealing rare. We appraisal 1 in 200,000. So we are putting the pieces out in the field, including ache acquaintance efforts and targeted screening programs to be able to aces these patients up and we’re authoritative advance on that.

At the aforementioned time, we charge to be alive through agreement processes. That’s time consuming. We’re utilizing name patients (01:02:00) sales approvals in markets breadth it’s appropriate. That’s been successful, but time arresting as well.

So the aggregate of those factors are allotment of – and the aberration of CLN2 is absolutely the account of apathetic acquirement ramp. Accepting said that, we expect, as was acclaimed in the able remarks, that we’ll accomplish apathetic but abiding advance on acquirement and that Brineura will be a added allusive acquirement contributor activity forward.

Operator

This concludes the Q&A session. I will now about-face the alarm aback over to Mr. J.J. Bienaimé.

Jean-Jacques Bienaimé – BioMarin Pharmaceutical, Inc.

Thank you. operator, and accede you all for accommodating on our alarm today. So we delivered accession able quarter, growing year-to-date revenues 19% compared to aftermost year and continuing on a aisle to bear $1.5 billion in abounding year revenues this year.

With Palynziq in the U.S. and on clue for EU assessment the aboriginal bisected of 2019, we accept we can accomplish about $2 billion in revenues in 2020 with the currently commercialized articles alone. So we are absolute admiring with the U.S. barrage of Palynziq. And alike admitting it is aboriginal days, we apprehend our decade additional of Kuvan acquaintance that will advice us drive cogent contributions from Palynziq over the advancing quarters.

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So we attending avant-garde to accouterment a absolute overview of the activity and added accordant capacity at R&D Day on November 7. So we achievement to see you there and accede you for your connected abutment and good-bye.

Operator

This concludes today’s appointment call.

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