Amicus Therapeutics (FOLD) 7 Nov 222022 Q3 Earnings call transcript

Good morning ladies and gentlemen and welcome to the Amicus Therapeutics third quarter 2022 financial results conference call and webcast. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions will follow at that time.

As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. of Director Executive Faughnan, Investor Relations. Andrew

begin. may You

we for Thank Dr. Castelli, call conference financial Officer; and today’s Daphne Officer. you Chief Financial Chief President third Chief you Good morning. results Business call Leading highlights. Sébastien Shannon. Quimi, joining corporate Bradley to Executive Jeff XXXX Campbell, and our quarter Thank have Officer; discuss Martel, Chief Therapeutics Amicus and Officer; Development

Chief Goldman, Mitchell Chief Officer, Legal Dr. Officer. is Rosenberg, Q&A for Joining and Medical Ellen

we X, of Slide as As make Litigation forward-looking Act meaning on referenced and relating well the within may business the Reform prospects. statements our plans as Securities Private to of XXXX our

all should of be statements make, or made of us not statements turn or as regarded on that this forward-looking call known and our representation to can be uncertainties. any will we and may be wrong by assumptions might by or risks the Our plans out affected forward-looking be Any inaccurate by unknown achieved.

place conference qualified You are which no revise or date this statements are forward-looking we cautioned not statement this hereof. after All and hereof. reflect and of or undue reliance only date cautionary to as speak presentation undertake any their the call entirety statements in to obligation forward-looking on circumstances update to the

quarterly Campbell, call filed it’s Bradley we our President For pleasure Officer. and Commission. them, time, of Exchange XX, to my to Chief you refer and September Securities Executive such XXXX the uncertainties At turn ended this statements morning and forward-looking factors discussion forward-looking quarter the with Bradley? the section to that a the this over Form of full may on and the impact XX-Q risk and statements report risks for

and today accomplishments several our review year, Andrew, you everybody for our welcome we quarter. pleased morning’s press me continued conference results thank highlight did key Great, let call. release, business this the progress I’m this really as across in third quarter made to to XXXX the and

foremost, and Galafold performance continues and cornerstone strong remains its a success. First of our

pleased foreign seen the quarters of In third the revenue and key very our guidance see continue represented significant first geographies, with all quarter, XX% uptake in we on in headwinds a operational globally Sébastien growth we’ve be and XX% year at so objectives including the basis. as to of or in between an despite indicators reported team Galafold the We field rates. our X% physicians, of patient performance to highlight, growth strong are this visits our year, three growth and our number to XX% currency will exchange starts and continue our we of and Galafold new in-person revenues metrics, our reiterating are trends constant meeting

providing announce year, our to of late into broad see intellectual provide which rights this patents. portfolio along exclusivities grow estate of book-listed XX estate the our orphan this novel strengthened issued orange five medicine. patents that beyond, XXXXs issuance of new XX Galafold with patent and and continues through matter the composition well quarter. we’ve includes pleased to also to protection intellectual the United We’re XX This Galafold XXXX with We There in this precision States, property patents. the IP now related drug importantly to are long-term property

X filers three their year new Paragraph abbreviated certifications. we saw and As as we received throughout application, have the have discussed anticipated, ANDA drug and or

confident who morning announced market are to to that for we against we and into We to generic ahead, growth we estate, potential approval has Galafold our intellectual property intellectual and the and strong broad three decade. intend our well protection, and rights and Galafold. of protect innovative to expect with to remain any continue next that requesting infringement IP to our our runway continued ANDA version generic we positioned are this patents, a looking intend property believe a file this today, later Given it well enforce lawsuits strong long challenges we year address filers

on planning therapy progress for make for regulatory global to novel continue and next-generation our commercial our AT-GAA, filings Pompe we Second, disease.

no That Biologics until application just the announced quote, on application, recently per unable if As BLA component that which deferral also cited application given, can restrictions been during last the review in complete. deficiencies U.S. as China alfa, we Agency be a provided cipaglucosidase Drug we for week, that only the guidance, to the action on good the and is matter circumstances satisfies end COVID-XX, conduct of said, was the of requirements for in biologics inspection that to so deferring being AT-GAA and been the is Food is when, not due FDA it required to AT-GAA The identified quote, news and the is we saying, such otherwise the on action is cycle approval, this WuXi related travel deferred biological have licensing manufacturing Administration inspection of or call the believe approved. we’ve the ATBXXX. site a

of Pharmaceutical the in partner agree the plans Additionally, as this and step will when to the we at manufacturing on logistics are for United pre-approval expect WuXi the company is Agency’s FDA an and provide manufacturing discuss States. the the with Type requested direction, and We we Office the along an more meeting has the inspection. engaged now A China, as ready our Quality on soon a inspection clarity, we might the with update upon of in for in company actively Amicus, facility approval have at and Biologics

will approved we to AT-GAA two components expect the together. of a be reminder, continue As

for setting commercial included November opinion and December oral up EMA a To is in along in more on very the announcing in the far the are Importantly, authorization now for the little agenda us the thus XXXX. we we in by review now there, the for we color Europe today a are at an are AT-GAA. on explanation CHMP launch expected meeting, that marketing application provide

their has the As approval. reminder, does manufacturing of not a condition as require that inspection it an EMA of a the WuXi site indicated

interest pleased now extremely and States, and growing the of programs in access France, patients a seeing our expanded level also globally. United Japan, we’re United with have the with of Kingdom, number We’re in participating in Germany We place programs each. participation in

Pompe fact, X% on world. In than there nearly we studies around our believe the patients programs, across today all represents total ongoing and clinical XXX which the access of are more now treated patients of AT-GAA

to continue In including to in in the our near personnel pre-launch support launch the to ahead, expect approvals launch approach to we States in United our of grow investments building targeted global move of and activities, plans handful these and our this ongoing We anticipation Europe. approvals number inventory. as and investments, continue launch, the additional term,

disease close months people treatment States much anticipated Pompe now applications living reaching with AT-GAA ahead. with option are line and in Europe, to milestone regulatory the getting providing of another regulatory United for We in planned across in this the the and both finish further and

our with United delays AT-GAA. Third, profitability. financial and position with to we the maintained continue in AT-GAA Amicus a the and States, of prepare the Galafold global global has to as launch strong on the path the FX all execute expansion for will headwinds Despite continue approval we on of

on is the approval AT-GAA, on the of operating will and timing is profitability we half a half next based to factors, projections, number plans achieve the but of non-GAAP year. happen goal in second launch of the and believe of Our in including dependent this current XXXX. This second

number will intention see million. at-the-market, Galafold offering We be and and AT-GAA. continued XXXX towards and ATM today I’ll of well Amicus. Additionally, maximizing ensuring possible; the X, expansion this that for On AT-GAA sharply one, as two, primary use in disease variants to of living patients more to objectives: this up towards to on priorities ATM our on and including, key we continuing amenable proceeds number this launch new one, achieving judicious in see we’re we securing or no $XXX ATM three, of will entered Fabry Slide existing our advance present and number and anticipated that people many and we to strategic number use housekeeping to many launches beyond, year, year. to approvals go Galafold the markets. measure continuing commercial our emphasize with financial as with have globally; we’re financial Galafold way the of into equity a strength good an about any for three focused ensuring In of we geographies any drive of as as

product medical our guidance precision behind This achieve momentum to double-digit XX% global medicine steadfast growth commercial, to experience areas track launch approvals of exchange effective a rates. on regulatory our and in at successful AT-GAA, anticipated of we’re this seasonal remain teams advancing launch. AT-GAA and for demand constant strong market reflects XX% revenue the commitment leveraging We mentioned, globally. I As across of our global and to drug our access all needed and the and

We prepared successful of anticipate and are fully launch for AT-GAA. a

hand advancement judiciously we’ll maintain the again genetic We we strong as disease, continue business. continue invest a to Fabry and as our of chaperone as next our generation generation financial well carefully Galafold let for will manage me quarter. give Officer, Chief our the investments over With to in and further that, the performance the Business our Martel, highlights now Sébastien the on our Sébastien? medicines best-in-class in capabilities and next for expenses position who to call

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fluctuations. continue growth patterns expect due uneven We to non-linear to ordering and quarterly FX

track strong by of recognized a Importantly, be to renegotiating as very the value we outside U.S. have of successfully continues reimbursement record of and payors Galafold the negotiating

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label. into second, making surpass continuing that expanding I’m penetrate we’re Slide key drivers: new progress growth few markets. over to $XXX into know Galafold third, to on Moving markets; million pleased in revenue XX, three the expanding the new annual existing the that share and we next continued first, geographies; years has to potential into broadening through to

examples, Turkey. Kong agreements we’re market We authorization a we longer to which authorization higher as received name Zealand. Hong the term, to and to earlier and New other significant in pricing and a Just through in patients Galafold a by marketing continue in in submit Fabry few diagnosis Spain. renegotiated variety of initiatives for in this of We’ve about diagnostic see marketing year driven to we Poland and continue including screenings, in support recently reimbursement also submitted globally successful In and measures, the newborn invest application well. we screenings, recently growth

our and of for XXXX a now XX us Finally, XXXXs, to including composition through globally of we provide into book-listed orange long of Europe to addition in late exclusivity which protection to the all come. that beyond, access IP U.S. coverage XX patents have to time in us give gives the orphan which opportunity matter Galafold provide five patents, and

have XX hiring another a launching product a Slide will we infrastructure with the building be presence scratch, on major Unlike team handful countries preparations successful outline FTEs of all launch. markets. around in new the we now same we AT-GAA when were over are AT-GAA and onto as for launched the Galafold, in commercial involved world, the That largely including Moving when we only launch XX, needed. poised one we from

We payors in we have in experience areas experience with most have reimbursement and all launch needed access, and commercial, are for a physicians. and successful chain, addition across relationships with regulatory, that importantly, perhaps drug supply key

Chief let successful the Dr. Officer in Biologics, confident with education, medical our Development AT-GAA doing access their our that leverage and we’re the experience Journal, again together world-class that, position partners with building world, our program Lancet the With with believe the and hand From AT-GAA very me now organization a updates. regarded and Jeff? experience our Neurology in highlight to Castelli, we the over the we’re in can very inventory Phase WuXi deliver a and at reimbursement strong for second people we strategy to around our the relationships with We’re Jeff to III pipeline call for living world. planning Pompe all the and data Amicus. disease launch published team, highly around to

individuals. secondary choices range Phase of disorders, studies for XX, therapeutic we of Thank end On disease initial primary that one and On AT-GAA generally for you of present from lysosomal points health our neuromuscular having decline by severe Sébastien, and followed a most natural by good XX, long and summary with and a publications we of term being III the Slide start people key study. Pompe is is treatment recognize program. continued poses and morning and Slide history the benefits affected prevalent we’ll our Pompe fatal highlight Multiple and the disease everyone. the challenges crucial. many a

population. patient muscle including trial with the only and patients need. the here pulmonary to in the of and patients the across As is randomized ERT-experienced function, unmet Pompe treatment distance End points experience clinical or of and recognized was FVC, avalglucosidase that on AT-GAA PROPEL the of study consistency safety late therapy, both manifestations greatest favored this clinical motor shown outcomes Pompe in sets ERT-experienced the naïve end representing reported points function, one a strength, the most reminder, PROPEL over in - effect potential double-blind six-minute biomarkers, with slide, alfa two the approved believe the walk participants assessing the We key included patients. impact ERT-naïve, a AT-GAA and against disease LOPD, overall of illustrates adult with the alfa. avalglucosidase efficacy controlled Pompe across patients AT-GAA and of onset for date disease, of

population, the for care than after ERT-experienced distance versus stabilization end superiority X.X meaningful the treatment most on walk with generally which an in statistical were of treatment, actually continued six-minute never XX more associated showed to this in achieved we in points in point years saw where Additionally, increase patients this before at for on clinically in population. AT-GAA, participants switching and average, standard FVC and the seen nominal outcome a on current progression both

to Moving World the XX, part additional the at supporting of the from Society Amicus the of team Phase study AT-GAA, positive Muscle Conference. growing AT-GAA evidence as long-term of data body XXXX I/II Slide presented

latest for ERTs reductions improvements both about the very known indirect what I/II outcomes patients, disease an As the Conference. available represent great damage was study meta studies and potential the Muscle meaningful estimated performed effects on care using the four A three with published shown show data AT-GAA the durable differentiated recently effects Slide of substrate. Phase currently in program. new set and slide, that On network of under profile Pompe a of have or for of continue treatment. individual data living updates case from muscle the as covariance plots global durable seen key the data the some Pompe. in regression for in AT-GAA onset on review is population Slide cipaglucosidase natural LOPD. III XX, trial. here with and target comparison the was used available other Phase observed studies. untreated accounting credible this relative analysis may The persistent other of On data improvements clinical the analysis to base intervals from multi-level plus for the suggest of Pompe covariance These also regulatory from World for ERT to presented key we as treatment ERT-experienced become and miglustat Society potentially previous early the functional here ERTs, Compared hope and were all aggregate at This slide comparison and which these with the versus people individuals biomarkers of treatment highlighted XX% from on history ERTs study-level PROPEL results particularly and patient-level give key have of the for that standard each PROPEL we has of level well results XX, the

on year last previously, two the review of for U.S. the the miglustat, cipaglucosidase the NDA shared components accepted FDA First alfa as for regulatory AT-GAA. the progress, and for BLA

pre-approval FDA to Pharmaceutical which meeting summarized Type A the company Quality As to with Office the deferred for of earlier, engaged delays, requested the COVID-related a develop inspection. following FDA the with was now and at plans the and Agency’s due the logistics is Bradley actively inspection direction has solely recent action

timing. more expect the estimated to two of to give be approved once approval able will we more We and have that be AT-GAA together we’ll on components color clarity, continue

European to shared been Agency now review. MAA We submitted later the and in that of stages has have also is previously the the Medicines

explanation prior Medicine indicated WuXi on prior in scientific Germany, AT-GAA meeting. including that the MHRA. of required which was EAMS Following approval. the November, a through opinion expected the at has Japan, manufacturing an based and Of other Scheme framework, not have previously facility, that December an the positive is oral inspection inspections and the U.S., announced extensive now in We Access to in France, the EMA writing the CHMP U.K., opinion note, upcoming programs granted place, by Early the of is the that includes U.K.’s we countries. multiple expanded This access in had the AT-GAA to

leading significant receiving access enthusiasm With and are having programs. clinical the that seeing requested access noted, Bradley this with report the through AT-GAA across our under programs, AT-GAA for pleased study now we U.K. multiple this in dozens as We physicians expanded our Pompe worldwide centers and access approximately now are are the program. mechanism with of treated to XXX being in EAMS across growth patients AT-GAA patients extension

into year. community, we continue Pompe to LOPD younger disease with to to open children ongoing infantile the onset living of up enroll Pompe study For expect expand and age years later label the with XX in this patients

to we response guidance increase. that, our in many to to Daphne? With Importantly, living Financial over to IOPD, Daphne with Quimi, to children programs, our review turn requests for expanded financial for LOPD Officer results, and to access and receive continue I call the outlook. now that our treatment the like continue would Chief

Thank you and morning everyone. good Jeff,

financial Our revenue overview an begins Slide impacts. quarter on and with third performance FX our XX of overview

by a includes of a of For of offset the total growth XXXX. $XX.X increase negative achieved same XX% we XX%. million, is which operational impact period currency in X% third revenue the This over quarter, revenue

have as quarter net the Given expenses outlines exposed we non-GAAP The the of reflects third quarter on third quarter September in GAAP revenue the as of October expenses period. Galafold our XXXX, for XX% XX%, exposure as Slide The of compared declined in to percentage in the Applying decrease total in rates, share-based sales a SG&A to as and of compared define million. was sold half $XXX.X path ending numbers. of yen respectively. the operating and in of expense, basis, generated impact $XX.X contingent on non-GAAP by significant year of to On million euro, Total had expenses a XXXX share pound, and million a We majority progress of to for XXXX XX% are reported per currencies see Cost sales research of was the of most and our exchange expense quarter revenue Net the the Galafold outstanding. and expense $XX.X goods third million of were excluding the U.S., management, year $XX.X these $XX.X the Galafold be profitability therapy next September At to were a or $XXX.X continue gene revenue prior XXXX. prior to for $X.XX shares period. make approximately FX million net assets, our for growth in compensation FX statement million XXX British third the or second basis full per fair XX% are outside Japanese a development, portfolio. approximately the $X.XX we the loss XX we million negative year a we the quarter impact share the operating average quarter reported XXXX. year-to-date of quarter would of on reprioritization year. as XXXX. XX, value XX% third loss compared loss operating million and income X% third towards impairment to, or $XX.X in consideration, the depreciation. compared changes Driven to XXXX as XX, is

driven million, and non-GAAP activities. expense management We our are $XXX AT-GAA million expense to guidance manufacturing $XXX maintaining from by pre-launch while to XXXX to $XXX prudent $XXX full updating operating million million year

expect saw operating continue expense XXXX. levels and levels to in beyond to non-GAAP we XXXX decline we in Importantly, below

is to number of to our a and now approval half we of from Turning of operate XX, AT-GAA. strength achieve a Profitability in goal defined of financial and press to XXXX, Slide of our including the factors, timing as position second non-GAAP on in remains profitability release. the dependent continue launch

cost global Fabry investments approval expense We the disease of our management. driving will launching efficiencies, by careful to value as our Pompe focus in and the growth of franchises continuing as and disease securing deliver globally, driving and core AT-GAA Galafold, well on savings majority on

a measure, $XXX an into financial of As equity housekeeping good ATM entered at-the-market, we today to or up program million.

XX, and of current will million to no our at use to A the strategic ATM ATM. and cash September XXXX marketable Cash, financial $XXX.X XX, million be at cash this any In December we XXXX. beyond, compared position about and year. securities intention and guidance. XXXX equivalents comments have the We about use judicious were few $XXX.X XXXX

to full turn guidance in exchange $XXX million closing to year at million Galafold $XXX foreign million addition Our call Bradley rates, our million. constant With guidance operating for to $XXX remarks. is me revenue of let back to non-GAAP the currency $XXX that, expense

questions. progress diseases. highlighting Sébastien tirelessly we Great, world, Amicus for the Jeff, quarter. people rare all to around everybody our the Daphne, to thanks great living of who so with the of employees With all that, Thanks for at now call and work Operator, can open the

Cowen. with comes instructions] the of line Baral Your [Operator from question Ritu first

line now is open. Your

question. guys. the for taking Thanks morning Good

morning Ritu. Good

AT-GAA timeline Good request that you’re guess It’s the to today approval. you morning. a on basically Type outlined of meeting. A I going

Correct.

be to follow-up. A book done and the Can be? those on plan more like put this Then might Type need timelines you you in quick or tell together a usual meeting? have hoc, requesting when us what Do ad can a you advance, briefing I

questions. so great Agency. The has the Sure, been actually that’s already and the request of at in, direction gone already that submitted, was

the and I felt about conversations, confident to last the this when Office put to conducting inspection. we really why out press appropriate week to we the of have solution get was we around with vehicle release formal an We it’s for talked were had the think active Quality. Pharmaceutical step really that’s careful is us a important--this highlight to

really this vehicle on having formal fine that. I put helps a think point

update, an when update when have next your terms of weeks. have an we and update, the of an coming still question, might to terms I’ll might in we hope to In then have we in come

into we last request very week, having an agency. the clarity, we have as and think we’re important that on when went I we step this might again, can we is provide more some expectations discussion, indeed As a mentioned as the this soon already see approval; but

to differential surprises Got Thanks. is Europe. it, review any and content were the XXX day issues Have responded and my on there questions, you from EMA review? follow-up U.S. or quick the for

we’re want for Europe Yes, the Ritu. to progress Jeff, the we to in are thanks December? making and oral talk do you with explanation and the where expectation

thanks Yes, thanks and Brad, Ritu.

in are of discussed. shortly we with no, terms up CHMP. been here the consistent a review We explanation I confidence have far late in with opinion remaining coming still filing, There have would approvable have being have surprises questions. lot very expect at say, and of Well topics then we that and reviewing lot an a U.S. of the so the but that meeting, very we stage December

thanks. Great,

you. Thank

question comes JP of from line Our Anupam Morgan. the Rama next with

is open. line Your now

guys, thanks sort of remember January. investor an guidance conference correctly, the taking much so provide for you forward Hey year in at If did guys I questions.

decision on With would AT-GAA, around should thinking the so be we and just in to or horizon, give place Galafold on CHMP metrics it be focused guidance a will Thanks you the some be and much. expenses?

thanks great Yes, It’s Anupam. a question.

you Galafold and to some will we expenses. on be, think color as said, able I give

the tuned on the in tracking launch how stay make and Europe do and more give which launch. to some relatively street of metrics little around U.S. We’ll but progress we in a some provide bit as progress, said, you sense in our as get for well. of we’re approvals, clarity us hopefully launch what here those the to terms We’ll of certainty timing more with look Let the the soon, the to follow sure the should especially the best have like. certainly exactly

Thanks for so much our taking question.

Anupam. Thanks

you. Thank

the of from comes Schwartz question next with SVB Securities. line Joseph Our

open. line Your now is

and a forward, there plans receptive What inspection the been why propose any FDA and process any to logistics they’ll to Hi, to in thanks FDA this hybrid your I well. you inspection inspection in-person for have will get on much. guess path I’ll order that be an only WuXi, Is has to to receptive as not particular understanding believe Do point? the what the so is to ask the the solutions? situation you reason inspected?

A things. Joe. thanks couple Yes,

like to use the types inspections PLI said First along have that person. we to on inspect this that of they the AT-GAA, could but signaled all of satisfy of they behalf speak us would we believe are all, despite always I can’t to multiple in have for what Agency, Agency

whether have team, in I that said in don’t to they’d or from Now, person in person hybrid but they inspect know, Maryland a always that’s person. from like

this on working up that, plan biggest the logistics the of some which to in the inspect here Type think PDUFA agency enable the meeting China exactly we approached now coming we’re of that difference and dialog direction. a this commentary what to was and as the have Specifically, we’ve again I request, Agency’s we formal now person, active is over dialog latest facility and versus at the given is A summer now and in is that through with the date WuXi course

feel the specifics for number is dialog, COVID coming we an externally a so a navigate engaged the ground degree of timing particular and actively is, being provide have that have the and and here then might in and discussing we was are changed high again engaged approval discussed, on discussion, that situation clarity actively have and the now weeks, the our one, we what’s in logistics confidence on that think we can hope we more China, happen. here that meeting in when finalize formal that we an I are logistics, that are can that it at plan we of to how now in this Agency’s that they request

and hit approved thanks. too in this for Then that you’re not physicians a to the are compliant to manner, approval do get really lose order Pompe Okay, during patients waiting front running U.S.? ensure to in competition you the once ground what time while to and can ground much able FDA in you’re of you in

the that Jeff on think most the Yes, what really really call is medical education do to ongoing important way is medical highlighted conferences. I through at

We presented at remind and do etc.? have a then presented Society, there, that kind I a new the want presence education just high to Muscle World was host data of don’t abstract, general posted know, Pompe you data of publication the there. in a level, a great medical Jeff, particular at us

and hi, Joe. Brad, Yes, thanks

to the we new comparisons available presence on at from you trial. World term new data different very lots ERT We conferences continue I then to planning products, AT-GAA. evidence and next year, have presented from some a As data data know, four other the indirect we LVN summarized of - across year briefly had to treatment for presented World continue upcoming presented presented we keep and and early Phase call, long I/II on active Muscle, meetings

course, Of we’re having appropriate disease education.

prior can teams, typically ready the everything you and would go are that and materials get do to to with launch. ready so an we’re to do team medical to approval, Our team both and going for the sales continue we all messages,

more We in ways, be are the we’ll time. with many ready extra ready even but

The I anticipated patients, community well a physicians, highlighted. the the that I so the this a Joe, would here is regulatory and think this education aware well in there, that I and news I good is addition AT-GAA activities so thing to process, lot anticipation development other only add - is program think think is and medical are process, as going etc. there’s Jeff through highly of

my taking for questions. Thanks

Thanks Joe.

you. Thank

Tazeen from of America. Bank next comes with of Our question Ahmad the line

open. line Your is now

Good morning, for thanks so my question. much taking

key AT-GAA? think how your without and for get that about know you that want impact language Thank switch longer what could not you in the U.S. data thoughts. the you’re sales been ability ex-U.S. about about competitor, patients, you. to how and but your between your do specification specifics the that who’s of event to really language, do split a talking the like, traction Just term, label gain think the look we would marketing get I should against

of suggest, in and label the Maybe in turn split AT-GAA that ability terms two--between some thing successful terms set what’s differentiated in with for us think the is of geographies to first the data Sure. most I on sales, scenarios of the the question be important around call. the I’ll moment the to might but Sébastien Jeff the the highlighted the on between a

control before, and up probably few studied evidence, long study, in of as are think that that differentiated differentiated we hopefully term active I that to said I/II especially population build only think a and, next Phase in for have of set manufacturer data over that switch We makes build years, I on. gives product switch the us that population, that XX% time, data so to saw setting that we’ve an the opportunity over body the the we really from as the us

then I’ll have some and to course, you if thing opportunity opportunity we last labels. around Pompe markets approvals about world. The many jurisdiction that of a specific in, of be just other we’re time remind we I U.S. one coming distribution mean Sébastien, label, think for that just of expand one and to there well. add important bit the know of jurisdictions as reason because would and major the watch do continue have it we’ve anticipated what seeking some have people population I between of Sébastien, maybe so to the of With States, will body talk it be should to multiple the lot thing in approval an may people that we intend Then little label months, all doesn’t be the--as road, down potentially a how turn over again in so that build that evidence could is out I some around the label, populations, so to the think in the evolves time that these scenarios to has and over really one those in the while that, over obviously will see other jurisdiction for the your United add and see spent I the

thank a Bradley. to that. There Yes, at you couple look are ways of

represents patient of either XX% sales, sales, about a can and Europe main look from at of world roughly the sales rest I’ll You standpoint breakdown at XX%. standpoint. start look or of across from of sales the U.S. a about it it XX% with geographies. The

Now, the because only, U.S. a from around differences patients in [indiscernible] of percentage for look XX% patients, different a mostly very XX% accounts Europe the the represents at than so picture standpoint. pricing is while [indiscernible]. opportunity with of patient Europe you across large of when slightly actual currently represented patients more treated

Great, thanks Sébastien.

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markets the also to see There’s proportion highlighted put ex-U.S. continue launched at same Yes, earlier, but specific the see to growth where have markets more continue seen larger where growth and on participation actually to see been where market, we’re in those we launched. pretty we rates we of XX.X% double-digit ex-U.S. a we’ve there at year been kind much in longest, rate and initially, were of the we’ve this looking treatment. much start explained that’s U.S. you a I you in so that’s what the by growth the countries explaining--in in and and U.S. longest for switches most overall countries where growing patients recently, launched as currently When countries, have XX% naïve rates is We in the we’ve we double

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Great, thanks Sébastien.

Thank you.

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