Amicus Therapeutics (FOLD) 8 Aug 232023 Q2 Earnings call transcript

Good morning, ladies and gentlemen and welcome to the Amicus Therapeutics Second Quarter 2023 Financial Results Conference Call and webcast. [Operator Instructions] As a reminder, this conference is being recorded.I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Vice President of Investor Relations.

You may begin.

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

Chief relating may the Joining Rosenberg, XXXX make Act our within meaning Dr. of forward-looking Securities well plans and is on Litigation as of referenced Q&A and Goldman, Chief statements Officer.As for Officer business, as prospects. Slide Private Reform Medical to Mitchell Ellen Legal X, we our the

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

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

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

quarter Great global year an Andrew to half what to pleased welcome successful highlight thank second incredibly business. conference the across has our our been and I'm XXXX call. first very everybody you, of

and world primarily quarter the patient first launch. Sebastien saw of patients sustained Based since and the seen rates starting growth new on me very driven XX% We let around $XXX haven't Galafold Galafold first press currency second at highlight exchange as will XX%Growth adherence on represents performance demand between XXXX. in commercial the success. strong of the of was patient rates globally few and from demand over we second million second its in the strong operational with quarter compliance through we a for for XXXX full-year did throughout exchange Pompe our treaters the remains global years was half Fabry starts filings morning's at and switch highlight the in first pleased from continue and XX% growth by regulatory and revenue we at remain performance a continues visits field Galafold now basis. across range points.First pleased both In steady several the indicators This therapy great of we're constant strong last rates.We commercial with in half includes to our X-component growth This make constant raising XX% our revenue in growth our have second year As constant on geographies XX% our to the the in-person for release, Galafold to the this globally on progress uptake key of performance, and we commenced disease. key guidance our to patient quarter, be year-over-year all of trends to Opfolda, key novel team observe quarter. launch rates.Second, and Pombiliti continue in moment, populations, new naive increasing cornerstone

launch June, Germany. in Opfolda is of approval EC well in the the Following commercial underway

days pleased see access the with to programs of in have expanded now and we're has the clinical to studies we patient weeks process engagement country-by-country broader U.K. we're patients MHRA approval morning level patients multiple well process U.S., of we're this across is in in navigate the recent XX-day commercial December the and AT-GAA been their target.Outside in FDA on for access within Opfolda. share switching that pricing reimbursement start pleased are individuals of our the and on the and confident initiated Europe, year access received on weeks.Importantly, commercial we QX.And infusion last first been and the we've track trials to now with process. of been in the from dosed word was that as and regulatory products the having track approved XX scheduled clinical agency Germany, expanded from additional and just focused team for coming In over increased to patients are to finally, supply Our an to transition we've

previously to centers come MHRA approved nice financial which global begin now for and days of physicians Galafold providing execute to local at people infusions.With our next living on strong reminder the has Amicus and disease approval NHS of US orphan Pompe continue to assessment will we to position for funding around about Pombiliti final key document regulatory global take additional a to look launch point the in in international poised therapeutic XX-days in world.Finally, As received the and markets as launch to horizon, Pombiliti the expect commercial the it October. designation. a and real and on expectations with provide both choice for few both have we a and begin the We challenging maintained forward the the expansion commenced

continuing of exchange regulatory Importantly, maintaining anticipated executing half of and and the to advancement to financial of path commercial we Slide Martel, growth great our over and capabilities, our for launch securing now the of cost those a Business Next-Generation XX% in to rate strong best-in-class half launches strong in key Sebastien double me generation seen manage position as in markets, Pombiliti AT-GAA first on this the and Opfolda, on as next performance. year.Ahead we've Fabry based non-GAAP are at growth Chaperone call overview, as successful and Fabry for of that the the medicines making our carefully always strategic and to Sebastien? by Galafold invest highlight let FDA, we're growth second the priorities the latest as with and to disease expenses constant track Chief in year, to sustaining on in our XXXX of non-GAAP approvals investments well achieve Galafold our approvals on profitability MHRA combined genetic on assumptions -- Officer key progress X, the XX% of including digit our our further judiciously at rates, target Pompe we profitability.With now hand and EMA our

On we Thank performance quarter we've of and continues of morning naive on our to good quarter. impact continue accruals, within for globally, from of detail the continued actually QX strong Bradley coming for $XX.X year of Fabry XX% to pleased remaining and reported treated the exceeded same patient leading the populations. commercial the US, the markets.Turning the key the in over raising growth XXXX XX% all of to more to uptake $XX switch year revenue fastest ended XXXX, and see exchange European but for operational to the segments. share and if a about period at stronger million XXXX, approved end as been also XX% very disease our our And half driven growth We're of in XX% to shares the coming seeing also growth on diagnosed net internal on report in second strong growth be period demand strength X, treatment X, market new with and trends in within of foreign to outside growing XX%. patient to global the grow from countries at U.S. The of Galafold into of you, there's growth reached to quarter XX% X% generated newly second rate has our markets, global we're the Galafold and patients look seen continue across Galafold and constant are million mix everyone patients on the revenue The and the opportunity with major the to XX% of particularly achieving global Galafold and expectations markets full was to we've increase or of the highlighted million, monthly call. and patients negative and that exchange with net revenue first globally during half quarter patients be $XX in Galafold market plenty you revenue consisted we're rates.From in the I'm to revenue in patient quarter. patients on in first Galafold amenable you second a Slide at penetrate over diagnosed the net high for start perspective, I'd constant providing to Galafold Galafold the Slide by the our as by in the result patient market rates.We Japan. while continue significant currencies efforts. growth the or geographic globally of reported therefore of longest, countries continues number to on added where the guidance treated Throughout gains delivering results XXXX at we in U.S. the was year-over-year the our in the the Galafold pleased breakdown

have Galafold compliance to of non-linear. mentioned growth belief calls, patterns reiterating FX All past and fluctuations, and stay patients impressive on the including adherence of Galafold.As on that rate of those continued typically within year is XX%, is on go rates, who that variety the by a factors to underpinned due exceed ordering permanently uneven our

in throughout to bucket the we showing throughout the has [indiscernible] driven there of we for to Galafold We revenue amenable potential or annual to billion the the provide segments a XXXX demand in know global drivers. revenue X in by be surpass We the key appendix forecasting, sustained at those that expect to of X, IR and mutations is anticipate continue that growth $X in of several growth years. distribution quarter made support X presentation.On table XXXX section Slide GAAP by years quarterly patient our past significant and a around on

First, continuing geographies into uptake into and further and population to extensions. into the label markets, untreated the penetrate diagnosed expanding new existing

access disease.Of Fabry are extending of the positive these note, of Galafold mechanisms supported we continue Galafold over new The is progress to the with All market year age patients and XX and expanding a examples. Taiwan. to XXX into with amenable Taiwan diagnosed We around individuals the labels, recently sizable old. on Taiwan efforts reimbursement all pleased Fabry just world.I'm quite to name the for for living with designated by few over therapy that was reimbursement make share Fabry received in in first-in-line individuals within disease markets

other call screening the initiatives, high now Additionally, program. to over our see in we to continue support Development highlight driven we into entered for marketing well.With application submitted the me by to and hand New regulatory Officer the we'll Galafold a a through globally, In in longer-term, Chief the growth in diagnostic Zealand AT-GAA Jeff risk Dr. and variety as continue Jeff? Turkey. invest Castelli, and Fabry negotiations our on patients reimbursement and of that, screening, market let authorization measures which we've pricing to updates in diagnosing newborn significant including

you, by but time that individuals. Thank respiratory one long-term more progresses, mortality recognize individuals to Pompe continues Within therapeutic briefly we many major cause debilitating history prevalent We affected a outline disease LOPD. and and by in options the range are may is difficulties Slide lysosomal continued pose XX, problematic decline everyone. experience that natural as and morning, disorders. and disease function often a and key LOPD is benefits orphan continue markets. status remind of challenges by of Pompe failure neuromuscular symptoms that on Onset everyone publications the initial treatment fatal studies AT-GAA and Multiple late and of Slide severe for being to followed impaired these people over current crucial.Moving tending and we to of health regulatory disease Starting most disease respiratory XX, show motor the good the on having of the for to become potentially Sebastian a serious

with noted, the excited agency of the the in in very on noted studies important full Bradley this Pombiliti living track new we and leveraging on reimbursement everyone approved pleased designations just multiple positive were approval launching both as confident were launch this that in and First, the Sebastien June, the of Opfolda we And engagement now Pompe approval in to final and of and access clinical appraisal in to components remind mechanisms Opfolda will disease as NICE.Moving both U.K. commercial from that and third for is ongoing more by EU the are orphan Pombiliti next to our level underway, for recent therapy morning, the XX, both we're Slide the for of begin the receive early team people as AT-GAA. U.S. for and demand MHRA from And in in AT-GAA. the of section. support increased we much detail quarter expanded weeks see can finally and remain for in

we study LOPD community, with the to age living years enrolling begun have Pompe infantile up and continue enroll Rosella onset XX living children label study for Pompe younger label the in to ongoing with disease. open the ZIP children open of For

over multiple place provide have were across expanded and to We we experience time to focus the programs. is on being around of our reminder, during for in those we we're able centers, the in Pipeline the that pipeline, broad are approaches June, are to programs various last approximately XX a momentum and quite with those expanded studies access of importantly the was novel the in world.Finally, to trials at access participating where as in continue AT-GAA with approximately approved clinical highlighted access and first for of GLA who Slide earlier to Pombiliti appendix and EU stage treated which access program.With Pompe and gene there chaperone And first our Fabry and AT-GAA not and week GAA with worldwide and continues Sebastien patients next early transgenes generation Opfolda. commercial extension XXX eligible turn approvals, Sebastien? the through deliver the pleased will interest our back to programs Fabry the I including progress AT-GAA grow discuss in for to therapies countries yet and to be that, programs.As engineered call in launch

XXXX, of Pombiliti+Opfolda in today, fronts progress with in available opportunity around outline the Germany XX of market XX, being on for in and and launched the in all Jeff. On we're and start first Europe, patients, Opfolda you, around EU progress approved of global for XX is being these pleased of the addresses disease. a only support LOPD.The early we seeing therapy on that to Thank launch Austria.As stages Pombiliti, treatment Slide adults competent a key which EU. XXXX treated be initial for made million the are as with are of of market all with is Germany the strong market late Pombiliti+Opfolda and we there adults and treatment onset are to with estimated the a currently living living patients uptake. represents EU those Pompe and of with We're currently sizable very launch. indication strong very Within Pombiliti+Opfolda, two $XXX and opportunity plus

Germany, Joint GBA in has classified as the active or Pombiliti Federal a Importantly, substance. new Committee

also our perspective. [ XX physician from pleased a in clinical result, top pleased free period with CPAP] As to and process expanded with access key first development, made reimbursed both the from with negotiations the in days. feedback transitioning we're final progress within positive prescribers which from under very benefit price.Based over feedback supply. the undergo treaters medical towards and will assessment the program the with been the the there'll affairs, We've patients commercial Germany and Pombiliti through after on the successful patient be AMNOG access very pricing been We've the engaging the

and in more As supply.Given XX have patients expanded confident or are commercial access we the goal seamless the transition. for commercial coming been recently first launch underway in and I'm we're the within existing early achieving treatment very the EU Fabry preparing position KOL the transition of and and XX-days second for and strong weeks, in have world-class Pompe program patients clinical so as trial a and Bradley successful to relationships Slide this XX, know, you of of we're so physicians to commercial to commercial medical launch.On Amicus. necessary moved first through significant with days, excited extension of between leveraging converting support of mentioned, we've the to these well and and patients group all trial organizations, scheduled commercial experienced supply to disease, access expanded that team first our launch Pombiliti+Opfolda both on been In overlap infrastructure of a centers, the hospitals the we're at our the and the patients a clinical

patients patients As start we've to infused of had today, and additional the multiple first are scheduled their infusions.

our an days, find early metric these we track Within to progress access and important reimbursement. with is

We significant all positive value their poised believe have physicians demonstrate and working launched patients in partnership competent highly Germany discussions pricing with broad EU.We're this the also need therapy the they as two Today, to EU of they European payers and Pombiliti+Opfolda come as for experienced we're interactions in they patient markets and to we the through ensure commercial have the securing with with additional on opportunity on to who Pombiliti+Opfolda. information focus have engaging reimbursement in online. in a is -- are additional in a team we access active countries, both

Market disease, UK. estimated people As today's includes approval Opfolda Jeff XXX with than Opfolda.We thrilled in with of more we Pompe news, the UK for to designation indicated for approval also orphan opportunity granted like MHRA within were in the clinical a we're from are the through Pombiliti+Opfolda leading with access Pombiliti through late-breaking to a Medicine to requested early Pombiliti+Opfolda XX centers previously, IMS. remarkable that's the either all of U.K. the these number, trial we've access on be XXX and treatment. or through already mentioned Scheme.As individuals have across did

Now XX-days. the in reimbursement are And to an importantly, the that which proud transition patients approval been on that for achievement NHS, will team the has granted, positive Pombiliti+Opfolda U.K. incredibly within of recommendation be of all within anticipates a is very NICE we commercial product by of. transition our supported

adults has As I'd concluded call our that, to therapy.With net line that and the to therefore stated positive our financial Daphne? showed of health later estimates cost-effectiveness for review like NICE and in guidance, turn to Quimi, for Officer, LOPD benefit Pombiliti+Opfolda lines Pombiliti+Opfolda and now as outlook. the recommended a first Daphne over with Chief guidance Financial results, the

afternoon, Thank and you, Sebastian everyone. morning or good

overview XX income quarter statement June financial on XXXX. our begins Our with the Slide XX, second for ending

of percentage as in quarter second constant impairment development and operating XXXX, to Total quarter achieved $X for On million $XX For expenses research period. expense, $XX.X statement quarter, decreased and in program for total is expenses, primarily in same million, measured second of a revenue sales the operational total consideration negligible we prior compared year Within foreign recorded as at of XX% operating and million quarter fair losses. compares XX.X% for of million $XXX.X the XXXX, spend.We the decreased exchange $XXX.X we in second XX% gain year-over-year prior was currency to to the quarter to at assets, impact quarter, which as basis, approximately as XXXX GAAP a rate net of growth exchange second depreciation. income $XX increase period in in decreased in XXXX. quarter This over reflecting of excluding the of currency to second changes year the of on revenue SG&A includes X%.Cost define X.X% compared expenses the second contingent expenses compensation sold a $XXX.X and of XXXX. the other a as XXXX. value non-GAAP This non-GAAP a share-based of loss the million operating unrealized of the compared million million second goods expenses to in

$XX.X exposure.Net loss $XX.X to loss million to are compared our $X.XX of second or per We of for steps as taking quarter and in our share or for the mitigate $X.XX management, continue expense share this future the revenue XXXX we in million net a profitability currently of per to progress non-GAAP towards the the second growth by prior to path year Galafold half period, was year. careful make driven

we XX, and we XX. revenue million XXX Slide of had now revised non-GAAP expense shares XXXX, As approximately our that on guidance both With achieving outstanding.Turning pleased year. I'm the to a for profitability, share operating June focus to have

XX% raising constant patient growth demand. XX% exchange rates, full guidance Galafold revenue We to year at driven to by are

offset continuing million are XXXX be The efficiencies $XXX AT-GAA operating management, reducing Galafold, drive as to nonlinear be We million. operating decrease for expense $XXX by XXXX and to XXXX launch also operating for expenses. expense costs our to to global as the nonrecurring compared continued non-GAAP expense will full-year to expenses to in well anticipate manufacturing, in and achieved studies, launch launch due clinical prudent investment pre activities.We guidance as by year this

expect of that, of growth our let operating also over to our G&A were allocated the remarks. portion we support me our $XXX.X of as December of cash turn see million Bradley a and this as with compared AT-GAA and securities to align to XX, of XXXX, to Galafold. as marketable launch XXXX.And to resources continued We the Cash, year, equivalents expenses call closing $XXX.X back XX, June million for the larger

Thanks, Great. Jeff, Sebastian. Daphne,

delivering her and and may Daphne, with filing role always she'll we incredible across has in of smooth I'm current as see, business the embarking seen of I and have need.Before successor we're at at and retire. personally search exemplary identified your remain you global our grateful a service therapies in Q&A, this can morning's a next lead call you. forward of relentlessly for people to the friend to on you her of non-GAAP our look years in long-time Amicus at this CFO our She'll Daphne, I Board want execution in the number year. XX behalf you, achieve commercial a of this support add Amicus, which of for I'd qualified been highly the and order to leader our is hand us just committed here course after achieve this with to Amicus to in you until mission end candidates. Directors entire therapies. particular to years Officer, underway X we've also of all to also decided Financial we've of over helping appoint patient-focused to A life-changing later team, as our Chief company we phase Thank employees focused these enabled thank to to corporate through recent on as to us who've profitability executive milestones As remain opportunity and On Amicus that on point Amicus transition. to take like year already to the formally on

now us we're to a the position that, up today.With in call guiding of questions. instrumental Amicus we financial growth part can sound been the at You've and in the open operator, significant to

And Certainly. comes America. first Instructions] [Operator of from question of Bank Ahmad Tazeen our

forward time gating post in are if you sufficient for do to have order responses a the that questions on not, clarify remaining that still XQ. gave that sense FDA Do you've to wanted just stated Brad, approval expecting you get you GAA is line facility the in around the the for the the WuXi been get inspection approval? regarding think facility what factors agency,

on feel very the our do the approval reminder, adequate pre level We responses as that ] like the WuXi. provided call us so great which I in last the and were is Just inspection approval. for weeks, from the engagement in outcome at of QX pleased today, [ think and the we've we were is we an with important, gives color of few here we're agency confidence, increased a seen all track

JMP And Anupam question come Rama JPM will of ]. next (sic) [ from our

I'll conference miss Daphne the this you And at year. coming

of new increase, Galafold in from a from in maybe or the Is is it from? penetration progress regional emerging countries core that countries? the some deeper guidance perspective, On where coming coming

to Yes, all things. but a is those little bit I'm happy of have add Sebastian honestly, from color, coming [indiscernible] of

So new the of key we is patient couple first seen net since most of starts importantly, our on levels what across all mentioned haven't at rates years seeing of as we geographies, the that of we're launch. call,

this little drivers clearly, us, bit so demand for few of more color a that a product highlighted growing. touch is on Sebastian, the And growth there. But Anupam give maybe different

for XXXX. Yes, just The add, in rate alone, is the in XXXX. of U.S. as remember, we in in net we've that launched second the strong example, I'd what quarter we current saw patients seen new as

we're This earlier. also post-COVID strong and seeing and we're really launched a a in we speak world as couple we case So in Europe, accruals. is were in patient years the Europe remember, of

Galafold yet So the diagnosed. seeing when greater and amenable our slightly on go population demand. very of penetration rate within is we're strong A lot naive they're actually patients

in for first those amenable markets. essentially with Fabry we've as treatment Galafold the patients established mutations line new So in

mentioned other rates, we're seeing are sorry, new I'd penetration just the mean highlight, on the I up it Yes, off, to maybe highlight I other geographies. I'd thing going is only call, great Sebastian to was the didn't not things on we say you opening cut and

have a board of very coming we in and important healthy on market. year. this some So countries the It's backdrop growing also fabric

for So a X diagnosed to an to it's Fabry find diagnosis you X-linked continued do, we're as Fabry seeing a which and addition actually think, well, mutations. market of highlighted, in executing treatments healthy with growth leads to X patient one we continues newly just family because patients those Fabry of who strong typically, members also be that and disease Sebastian we've as patient, reminder, incredibly the to, diagnosed.So I as additional the are we're typically to find fastest growing undiagnosed patients,

come will question Baral from next Cowen. Our of TD Ritu

helpful? the of level to follow-up to of interactions. any had Do additional increased can additional the or you you are WuXi the this on up? question. over of you there's any want agency back go be all give think has detail items Or that requiring inspection wrapping outstanding Tazeen's addressable re-inspection? on points feel detail Any that the engagement would do possibility written I that the Brad, verbal just of the and

any we've that And very not increased weeks, they're us approval we we of and feel the to confident we've we inspection. in QX. the WuXi, reengagement level to of there'll inspections it an No, the needed we're just be seen, feels outcome for suggested additional very with as getting level the we engagement on last you close up do things couple we're wrapping that of of pleased at again, believe the on kind said, of here like are and based as track seen

excited. really ready. the to momentum see eager I play morning, team months of out. really this news and really think U.K. year The remaining is is the building so We're we're pleased to see the the So

in U.K. can one start they with much how I -- supply on label the much about squeeze do are -- before from thanks German open the patients of how and path supply commercial If to you more conversion? sort sitting

our Yes, about made a target years we is X supply. bit... -- go-forward quite have of Remember, we've

much have the supply do supply like sorry, sitting they meant clinic how open much label... I'm drug I from -- how

Got it. That they're working through, right, right.

could was done the over has works we kind and on course, studies unlike a as a it's would of Thanks Amicus, once then the medical -- Galafold, transitioning months the you down the Galafold sites clinical In it team of typically much operations good et team, long sitting this of where Yes, because the Galafold who, affairs very with tighter supply winding this life, supply shelf clarity. cetera, clinical X case, for already closely before with situation to you Sorry. at news with of is, the were themselves. and commercial. be

to of see think we fine even we launch XX-days now, allows so the far, manage that we're when we'll Germany, of of goal supply within level And a those the XX-day of the And U.K. as confident the then carefully are I've able transition. what the And kind that first that's XX-days. in to first very and likewise execute making and so us U.S. and have really and in be transitions it's precise and in said, I approval.

UBS. of And will coming our next question Eliana from be Merle

on color a beyond provide patient expanded about the how patients you're starts in thinking Just on if us U.K. more that Germany you the and access. are bit could new little

from were the XXX, about U.K. you total we AT-GAA. other maybe on for in be I what already and just kick And How Nexviazyme and patients give the on the XXX landscape maybe said are maybe the patients patients? think a just you proportion lines So on might you expect reimbursement you just AT-GAA, Germany, think XX already NICE Pompe of think revenue you when about in patients I many think said already of time Germany? should the perspective? Pompe could I a know but have if there us there mentioned And in how And the in you XX you to to how Nexviazyme? sense then relative

well, cleverly I'll some add take some Sebastian to all those. color worded then ask of those question, that but as and to was multi-question props, I'll a one happy address

course, is We already provide is bring know more call. with markets able we new color patients based a market we're But give be XX of the information, fruit large then bolus we've in the new priority well. patients in well.And all, patients progress each already a of just has as maybe said for AT-GAA? that German should on we been bringing outside X Sebastian in the But large start low-hanging how first parallel start first access publicly available again, and So Nexviazyme November in then expanded sense what on because priority on also and as those the those starts the to on patients. on have AT-GAA color working to to patient clinical on markets, first that yes, to to trial patients convert the in of begin as in such of parallel,

you So I across precise. Myozyme with is the between can the breakdown -- be share virtually Nexviazyme and XX/XX or XX%, to XX%, Europe

the of on XX% again, So for Nexviazyme. across still are and patients XX% Myozyme, vast majority Europe

them, the If just U.K. you look Eli. at you numbers, have you quoted them,

we patients a have is country patients the in number So which clinical access. trial total on XX, XXX probably of plus early largest

have key or have, before. they've And They Pombiliti Opfolda, experience on all both from been experienced, Brad the who clinical either had patients mentioned, patients that feedback that transition used the the X we IMS. the with study have also centers so obviously, They fact as given product think and from have have they it.

the Nexviazyme XX patients fragmented and of patients. around is think we U.K. is Myozyme So that in total number higher, that in in Austria. did from high market market.In ability uptake The more and the lot convert here somewhere got mention XXX we've or the commercial this Germany to a also We Germany, our is than patients XXX between and

now next with have over first top I been and be contracts But team our the treatment patients visiting physicians a onto weeks be the their and will in as product. has from those number working commercial onto switch those weeks months. convert patients and of and existing to mentioned, Pombiliti+Opfolda established will for Germany prescribers those So

And more Eli, the U.K. on I process had you maybe the question, think in one reimbursement

then into medical scheduling can go sales infusions with already should answer get appraisal meantime, The the to process team out one of So and initial around the ever prior already get physicians. relatively approval, remarkable what's and by here funding start think take clinical as along shortly. takes by of that trial visit team to the we the final is clinical NHS can reimbursement is again, when come a had the few begin that's actually you provide in recommendation to access should have MHRA approval. the I NICE, here to once week mentioned posted, And to affairs expanded days MHRA operations so the centers XX call, in here in time. And document that the for NICE, we'll to those from is our local field, the for with draft it patients.But fastest approval, to we've which those converting the a to days ahead

So launch reimbursement local kick waiting effectively, the is process that in at underway and XX-days we're for centers. about to

question from coming of next Partners. Leerink Schwartz will our Joseph be And

should curve? And progress thoughts the cadence your I around the thinking us there helpful patients are products? and that current of gauge And uptake pricing most for of can about EAP the that? any conversion to order us of with us the AT-GAA? be then this Sanofi's you those be providing be remind status, you your we was relates to how beyond commercial in wondering what And metrics to you will that launch price recent how can analogues envisioning of when might think of for

All good questions.

the start value, pricing went process much an of last because I as And we're that, with the pricing significant and parity, shown And our successful we roughly that pricing faster pricing the or takes standard as reimbursement relates are philosophy discount at the through industry modest systems it's Galafold with it is that I saw fastest of as decision Galafold reflection that So We the the value I'll that think which to the is possible one for to strategy. with have again and to bringing a product the reminder, way ever patients incredibly is care. are is average. taking but we're seeing. appraisal healthcare first, focuses than parity think here, off -- dollars the recognizing that on can on payers nice and I think you great one maximize our quickly saw the table we value of negotiate extra time of maximize a that access industry of therapy the which and the number we versus as price.And on therapy in is some

from you've commercial about we roll that today U.S. of is infusions some clinical here out and and terms key to to the started what share, key on markets.On qualitative the centers one indicators getting in Europe, think terms we the trials heard performance product. see first the in patient in that strategy successful of So through the terms we're that of having very as talk in go I the we'll things process in be other in we'll call and will of confident convert out

any And great be the number so We haven't on patients I wait forward-looking know but you'll a purely if is through share no program to on that XX% qualified would commercial a simply an a that market we year for thing on first we'll it's able demand-driven. were remember, rare just guidance there it's think to XX% about were because this promotion. have that with for the you perhaps terms year a thought experiment, are U.K. can't nice second-generation a within hear analogs. space. kind to of and year, -- on it's we of stub update promote IMS one launched given analog, year, remember it's of product, in such call offering to the provide is to drug, the it product And again, alone, get a to point I November that The milestone program unusual don't kind disease so we that though into I for.In ago. will a of that

So what for we on we're out once the product. gives promoting great imagine a perspective me, that you can there do

that important over I good there. best the hopefully really talk the our gives will launch update give we to of on think, that is So you November, a And be can and coming how we'll do again, and a color how going flavor weeks. to days

from next our Dae question of Stifel. Gon Ha And will coming be

slides product. plural has AT-GAA as first en been LP, infused I with patients One ] clarification, guess, the [ as

than line-up of does placed Myozyme, that third helpful. on becomes and Any third the color a AT-GAA? to wanted Nexviazyme more one line, do year, Nexviazyme mean it or you Or I guess, it question Just what on physician that get that will of between at -- see line? was my kind are be was and used the physicians AT-GAA of to as once the in would guys it sort feedback a being engagement, actual in take hearing terms I clarify you then in available next

we patients so we've from and everything infusions multiple great the question, So feedback been is patients positive working been scheduled Yes, have incredibly well. going your conversions first received first target. which been hearing physicians patients it is and has has for converted, XX-day the like we're within and to experience multiple been through to that remaining them feel we're that positive, foremost, is very the from and also really schedule their clarify have

here.And then sorry, question, me second started we've gotten -- yes. part as So oh, good remind your the of of progress positioning, terms really, in really

for So, patients. all Pompe the disease is Europe, patients in late reminder indication statement onset

those position on that Remember, we'll patients. will and treatment patients here great the though, Myozyme. think option of be all the vast opportunity currently is this we vast, for so a of And this majority market

an from should is you so right, already are frankly any vast on should any who markets patients that of Myozyme or the we see to that's majority the on point, in indication we diagnosed. has that growth saw just coming see can from And patient Galafold, and switch I our all is Nexviazyme you think frankly which with with who AT-GAA therapy like important means -- or been that's patient new or diagnosed LOPD target patients Europe label and we for all of in

depending Pompe to color you naive saying, patient today. disease were patients add between being the a little from on just got the And put Brad, We XXX think to year, give every treatment global X,XXX on opportunity estimate a of are to for bit patients year. that to I treated what worldwide somewhere you've standpoint, to XXX X,XXX there on

looking to the on Myozyme patients switch they on after. patient Nexviazyme -- main is going opportunity of go are point or this commercial So group this that to whether the as we're they're whether really is

study this of ERT AT-GAA And walk are only vital patients promise forced medicine real a in say shows in well-controlled who improvement switch capacity. there the the on an that and last to clinical can and thing existing the that product I'll we're is, that is remember, see X-minute

this that's truly patients quickly as just as get as we think as this a pleased out therapy and possible So possible. eager we're to component to many and of differentiated so

And much so Daphne, your for service. thanks

coming Hung Morgan of Jeff Stanley. question next be And will our from

and retirement. Opfolda the of upcoming MHRA her on on to congrats approval Congratulations Daphne

advancing pipeline programs? path and your the support to bolstering talk about next-gen expenses Can relative to to just non-GAAP that your you of pipeline your profitability. reduced You've importance further

both and post-marketing of vast manufacturing good studies the the disease, commercial when of there. recently in then that. I ends and of showing that majority. have goods, do And also some majority we so along study the expenses we up go progress have to cost are support Yes, product, the but up vast ongoing until with so in our spend We clinical towards extensions G&A Pompe course, commitments making, towards modest clinical that's pipeline now the think, that remaining goes

and a the expect to about year. talk the again but hear know into profitability as probably laser include of that important investment you I of more us an we'll should into should we come pipeline future Amicus year, modest that this focus of in pipeline, you part next does next talk coming amount think non-GAAP on the more that's about

be from of coming next our Sachs. Salveen question And will Richter Goldman

This is [ Sinatra ] on for Salveen.

diagnosed the on that more the could your process First, genetic peak guidance how And you of on to prior color in some sales $X screening, growth if versus the Galafold, to and billion much Germany? patients. on cetera, are view, naive new who patient need by Galafold your diagnostics switched get provide be of you reimbursement already for et patients will driven AT-GAA, in like

Yes, so couple there. of points a

of of the in over million So kind $XXX you for a just market sitting got are market, $XXX million. and with at sales guidance billion $X global we here Fabry, about little to if think the today global you've

lots of of a patients revenue by treated in on half of mutation, to current drug amenable the the just great. patients, another continue maybe and assume you If is so doubling X/X patients today got switch base then diagnosed which you've have today, existing opportunities

that through our sales in kind or there's X,XXX diagnosed some we market patients billion of of in represents global untreated patients. existing over global that and about treated globally, comes -- if believe that expansion execution $X through sort of also XX,XXX roughly and markets.We of comes you the know X,XXX Some another look

of untreated And you or so X,XXX it, again, mutation, kind patients amenable patients a if number, existing a significant call of an today. chunk half additional, that's that diagnosed X/X take have another to so so who

highlighted seeing a XX% market maybe of previous calls, in Sebastian gets then have talked think sort diagnosis, that peak growth well as that about.But opportunity year. significant towards Jeff the I underlying in we've and that you we're or so

towards here.And way little asked you do about had Sebastian, put together, maybe talk dynamics you then opportunity think a I all bit a in easy $X the want see And you to to product it's to again? so those billion Germany, Germany

I of active new as undergo AMNOG So with Pombiliti in a as assessment classified a result will pleased And we're benefit as the Pombiliti GBA the designation, that. very mentioned, that has process. substance, Germany, on

a be have final there X-month price. free a period reimbursed and will negotiations We that pricing after on

available published very price XXXX. with of Pombiliti+Opfolda see in other price on. early Bradley upon We combination agreed the mentioned is, around that the line So competitive QX policy set you a should German think versus price therapies in market. the sometimes expect the again, much And pricing we've Pompe to for of

next question coming Cantor from Kluska will be And of our Kristen Fitzgerald.

morning and this my I to early in know talk points of what days place Europe, about also congrats terms And other additional that on in the you have work. the have been the you in approval generating sending approval therapies Daphne. it's but over an beyond selling best biggest prep can interest now

a really the this? the endpoint full example, that set certain label, for across open mechanism, is data is on? just the they're different it So of combination focusing Or patient a populations,

Jeff I'll hit I'll -- maybe start then data with talk top and about the the calls. in line top showed the that broader hit we've that, previous

think physicians before, are patients the most we've therapy be the shown in mentioned various as the story of existing places. education forced continue who and test this is show data that's we've clearly powerful important our those walk ERT necessarily another that and X-minute focus share from published It I will capacity, improvement set label won't but vital important those. able in data a part and we'll so think switch the We're I differentiation. AT-GAA as one in up that strategy, really on.But to we a now broad from I medical do label, the really that's perspective, which only measures to shown So two in clearly, points the significant

talk and what you those So other already to about color maybe provide? endpoints other Jeff, we've want across published any might

that the I'd on switch trial. controlled endpoints. patients FDC it's improvement in here the for noted, in been the trials that X/X key these just range in is as on is conferences upcoming Brad the high that level. really going some X-minute a endpoints improvements We've of But We've shown a [ other of thing well. from focus shown to have and really to walk show initial patients patients, consistency data the out Phase years patients.And in now the observed across those across X to improvements the switch seeing ] As previously across we're showing at We're there naive emerging say our durability maintained that continue to that long-term.

that, a going and that what's physicians the of continued so a to AT-GAA. of seen data, what is So core a also strength think strong But there more with we as we really people we've to think MoA focus that's of in far something be those gives differentiated believe continue very continue clinical about reason information to some MoA that think provide publications I something the to that we're going learn is that's and MoA. there a of observations and also to I

Markowski next And be & question Needham Ethan Company. from our coming will of

Just a spend. SG&A current quick one on the

an So the uptick sales Galafold, seen force for -- you're currently relying we've in SG&A. but existing definitely somewhat on

out in how us an and increase of U.S. should we Pombiliti the Just to near-term? at spend more that now SG&A you're idea rolling launch, looking a give the much expect

that hub infrastructure the AT-GAA treatment to a hired perspective, change. describing a have literally what lot accounting globally said But take trends direct commercial less leverageable, and think to is is, to launch talk United I'll than to. in includes of that dozen talk our before some States, of some the hugely medical was but people, marketing we speaking that infrastructure. the Amicus affairs so Daphne, I support let From liaisons, employees existing question education you Assist, the an management we've that which maybe the is Daphne patient

sure. Yes,

some R&D we now of remind aligning But products, SG&A now a is to the the support two spend everyone, as years, the resources to and the commercial now Galafold I from in line portion shifting line. had that both support for So are research we development would in and AT-GAA prior line. of

re issue So -- it year you versus year. of a current prior a when is classification look at a bit it's

not it's so Yes, actually...

true the of ...part [indiscernible]. increase

Exactly, Thanks, Daphne. yes.

business. of So significant increases was it of employees more you should for in the expect additional classification a G&A, some change in who support really global those not to see the

be will And Ahmad Bank of America. coming our of from question Tazeen next

at Brad, just put to minds people ease. maybe

to the think PDUFA how provide passed, back In getting XQ, time terms that going just -- FDA an answer because officially confidence about of quarter? And also is the we the I GAA read they your the will that this at is folks you the the head your it's FDA so kind for question September, as part -- has later that? for slipped into line are will August, holiday anything of into of shut assumption to down there if into and

we'll as here. can we color provide Tazeen, Thanks, as much

X places. the So really confidence comes from

XX the to then it's to so right finish and announced is, for days don't a XX we to if The remember have if about takes zone. the on even date we're inspection you that review specific first estimated you average, we the the their about it when from agency XX-days PDUFA report in average, look inspection, that of kind we and complete though inspection back on

in in that that very not decision the good as And kind an to FDA seen round confident confidence your weeks, us or of about we've the So division here again, last we you QX on very that and comfort the it's expect wrapping up in other is then we seen have the point comfortable the good that we're the of that. average. feel when that look us gives engagement time whether work. in piece and their gives increase they're we line in by review couple the And

our And that to Campbell the to for turn remarks. last was like question. call closing back Bradley I'd

today for in care. has everybody a hope Take tuning you, and day. everybody Thank Great. great

and day. you a conference. gentlemen, today's have and Ladies Thank great concludes this