FOLD - Earnings call transcript Q2 2024 | Amicus Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Second Quarter 2024 Financial Results Conference Call and Webcast. [Operator Instructions] As a reminder, this conference call 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.

Andrew Faughnan

you. Thank thank Second our and Quarter and discuss call Corporate for Therapeutics' Amicus XXXX you morning, conference joining to Highlights. Good Financial Results Chief Martel, call, Officer; today's we Bradley President Leading have Business Chief and Sébastien Officer; Dr. Campbell, Executive Simon Officer; Chief Financial Chief and Castelli, Officer. Harford, Jeff Development

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

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

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

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

the to report For Form statements sections today. them, such of XX-K full XXXX, statements for and with and XX-Q filed Form annual on quarterly report the XXXX, ended the for forward-looking ended December the our impact of a the Exchange that XX, be year the and uncertainties quarter and June may XX, Commission Securities we and to discussion you Factors refer risk forward-looking Risk on

Officer. Campbell, to turn to the President At over this time, pleasure my and Executive Chief it Bradley Bradley? is call

Bradley Campbell

our has I'm highlight individuals full welcome, well our our quarter global our this continued and business second our an successful quarter. momentum way to across particularly diseases. of XXXX to us In to time, growth first rare top what mission year conference by very pleased call. profitability, of incredible Great. a advancing families half while on year, revenue also we first of Thank and the you, hope Andrew, put to affected on been our have and to build non-GAAP to line everyone, bringing

several release, As we let highlight in morning's points. this press me key did

its our the strong and on delivered the At XX% total us representing product performance XX%, First, from XX% led the was growth commercial of in our $XXX year-over-year high constant the XX% the excellent in with full continues performance the In year. continued our XX% XX% a has to revenue XX% constant million we currency constant the on total previously. at of basis. year rates at first year-over-year million coming to strong execution $XXX growth This global basis. revenue represents in to guidance currency XX% or exchange a for in the revenue increase to of guidance year, growth half Galafold last level, for quarter, quarter, end from which year operational

starts, continue XX%. over geographies adherence including across both demand through all of and from rates indicators markets the our in to strong sustained our performance patient observe and second patient compliance key in quarter key new in We of populations continued switch and naive trends leading all

treated see living people first commercial patients this what our it's diagnosed of the is significant on is having after with previously. now to around disease world. Fabry medicine in of Eight this against the All growth we've impact backdrop and years that launch, the highlighted remarkable

we're a XX% next growth projecting raised business it And XX%, we growth the guidance to our to We beyond. time. to for on range to XX%. for now foundation the year XX%. full XX% second May, the started performance, with decade In the of revenue and of year range XX% continue to our see as sustained Galafold increasing we we and Based serving are XXXX the

novel for Pompe made continued our a Second, and Pombiliti the has huge this this Opfolda, indicators, launch We've let for strong onset continue highlight progress to will us year. commercial key growth disease. late global demonstrate driver great been against Pombiliti the strength already be to and of our therapy launch. continue which me and Opfolda performance of

the Pombiliti and rate the It's the studies. saw were in clinical year-end. that not largest the and of of the who patients of had continues for to as treatment. patients, patients year we second progress XXXX, XXX we coming patients our foremost, In quarter, scheduled exceptionally maximize report July, new been First therapy well. of who #X of end commercial And meaning our to treated focus in number the to by new is for great number patients had on on commercial Opfolda or

switch beyond. reimbursement we're U.S., but globally. making a strong, in dynamics We're their pleased well. significant which patients Opfolda, and demand great hear physicians uptake and consistently to seeing are fuel Sebastian year in markets Pombiliti front anecdotes and the provide Europe this to incredibly to are the with the We more from how and inspiring on patients and responding progress the will the will look the outside world as momentum health also and in therapy globally new care professionals the moment, U.S. for naive details the throughout on continue patients around and U.K. continue from

And Throughout insurance we access gain focus patient this countries patients the includes more we'll increasing and U.S. of process quickly reimbursement year, in Europe. the as additional launch remainder as on anticipated. moving we've the in the throughout through

Swissmedic adults that with in Switzerland. Pompe in onset disease we're front, pleased late living and approved Pombiliti On for Opfolda the announce the July, regulatory to

of track Opfolda to course standard new be for full treatment $XX our become ambition our $XX care well to guidance XXXX, million this and global will For contributor devastating set to a in the year in to significant on Pombiliti To achieve a of growth which million us deliver and great on we're PomOp. the our sales, disease.

resources, therapeutic choice challenging physicians people real and that our a we excellent of be excited second finally, are with non-GAAP both profitable Amicus manage and prudently across We're execution as and therapies in our as providing expectations disease. the continue basis pleased incredibly living half we the first commercial Pompe for share year. And to to for the quarter patients was on as well a both

year, to sustaining so Galafold We strong out priorities are achieving confident laid expense the position we'll Galafold multiple And our Successfully revenue scientific carefully we our back full as focused XX% Pombiliti growth raised commercial of rate sales as annual our look this our we've beginning see Fabry to expected growth advancing of profitability in XXXX. non-GAAP far, leadership XX%. non-GAAP our number and again, as for and X strong of ongoing growth. Slide manage disease of we achieve in strategy achieve launches key X, to head year. to Opfolda, double-digit for including: first, medical financial the and investments on profitability Pompe increase a executing support on we year and full on to maintaining XXXX, the on strategic we're the A the

through more call hand detail. me who Sebastian? let over go will now Sebastien, highlight, commercial in our to the performance that With

Sebastien Martel

on Thank the you, Bradley. call. morning everyone good to And

revenue therapy. more quarter patients of with the our ended more X always, demand, Galafold strong second are for reached As mutations. million, the On particularly you eligible Slide from quarter. the details by share for patient leading Galafold by I'll more $XXX the potential quarter on start second markets. is our performance good for still there the We treated for XX% with reported driven amenable Fabry market providing And with our than global news many patients XXXX

As XX% Bradley the continued to strong XXXX XX%. range highlighted, year quarter, the full again now performance of second raising Galafold our guidance to we're growth revenue given throughout

Slide to X. Turning

all the growth highlight efforts. the over same XX% major to rates. with for global our patients in in exchange strong at Galafold quarter added results globally Our markets. second operational delivering XXXX the constant of be strength of demand period continues The commercial in

seen the long growth year. to Japan, continue term. of has in this biggest such full expect ] gives impressive this highest and we U.S., top net The remain and of product the demand and great over countries years, demand new leading over saw confidence the U.S., for trend in patients new Our the patients the particular, markets number U.K., X the in the [ driver patient as

a the seeing in global we're Within which populations. mix, naive, stronger is about now uptake switch and XX% XX% naive

keep continue diagnosed segments. shares switch growing There's we We continue to market longest. market the in to and diagnosed approved achieve to high countries we've untreated the as to the where newly penetrate plenty and patients Galafold over opportunity been to of

patients. very We're pleased [ XX%. stay to on those medical underpinned of and is ] All continue patients the on evidence reiterating to rates to adherence for of compliance go education And choice sustained see in exceed that that predominantly that Galafold generation. prescribers Galafold Gala investment our belief This leadership [ as position by ]. that supported is who continue amenable and position treatment our continuous public by

very we for of results milestone very disease the the published aligned Galafold. Amicus really market. as Fabry the a This registry, Data July. support the Galafold with continue multisystem in benefits observations our first medical well on in the and data help trials growing along own we from clinical study to will generate I'm were following pleased of the and have potential real-world Journal positive the disease publication congresses, this growth our the the constitute medicine extends important recognize for ongoing results available public this to important of of These registry long-term from part of inherited story oral in and with the indication previous data Galafold. supporting of publication, precision envision metabolic

know Fabry by driven that a XXXX we end drivers. amenable anticipate We reach in by the to $X then mutation beyond be is the sustained potential several growth of to patient the significant of segment Galafold the billion the of revenue and in made annual has demand decade. X, Slide global On there key up with for to market patients that

growth patients finding and significant diagnosed First, market growing coming new population. the and of reaching the robustly Fabry from the is portion treated

X,XXX at before any XXXX, X,XXX previously, more the mentioned and those of of were than individuals naive we Galafold As treatment were to on about end indivitals were there Galafold.

and unfortunately in can treatment, patients females, the need diseases treatment obviously to continue indication medical patient at year-end that and screening, treatment becomes also earlier most our seen for initiatives. seeing results. diagnosed patients and underdiagnosed we'll from Galafold. of for of update We're increase we to many adventication newborn the untreated to more this report one the patients more screening rare especially as appreciated. screening, going pleased numbers patients be the support be benefit to identified Fabry capabilities. We've an remains new many those family better ongoing Through noble And transition continue grow through to year, may

continuing of is piece to through continued commercial drive other share Galafold amenable The execution. market patients treated

noted, up it the XX% XX%, seeing in currently mature our has share. what can we're market than market, to Galafold XX% reach of As more of global markets, emailable most

So we again, there's solid by know reach potential physician that efforts compliance these patient levels market adherence through in the and share supported the global support all education as and rates of well. and are And those program. to

Additionally, we'll Also beyond, protection markets note U.S. make expect here, some steel [ provide America, in newly And Galafold progress patents, listed to into markets Orange XX East the ] reimbursement. XXXX extending into Middle in drug Europe. expanding exclusivity [indiscernible]. continue and addition we on of either XX new Asia our to or XX now for and have Galafold composition the The in Pacific to which this regions of Latin and important often including labels. we reimbursed the and

to This access to provide to the globally. provides Galafold opportunity us continue

continue protect For a to to broad to intellectual enforce our property long time We and rights. intend come.

for into expect well ahead, long Looking that and remain the decade. a ] Galafold steady we [ double-digit IP our Galafold with protection, next strong XXXX we is growth confident throughout runway

Turning with XX. disease on our Pompe launch Opfolda. now outline Pombiliti to progress and We Slide global

other the the from remaining remainder an quarter and of second benefited strong of the Pombiliti reached In first a Opfolda & treatments XXXX clinical compared to XX% patients to represents This commercial trial from of million. U.S., QX to in the foundation For transitioning increase the year. addition the provides quarter $XX switching XXXX, therapies. patients for reported revenue

we're Nexviazyme and We with This to from some in a of new increased coming multiple QX U.S. market a population. patients some coming see in the at this switching seeing [ be remaining seeing That's X from a means We're from sites of products some the at Outside we're respective what prescriptions proportionately also continue shares and the online exactly segments, from in about the deepening all patients naive switching our rates Myozyme, prescriptions XX% physicians we from launch. at of want broadening the ]. patients majority to Lumizyme. accelerated stage and from both from and from switching Nexviazyme to proportional and seeing the of U.S., rate more

aligned announce for few the for the price pro OPD Fund, and A now with with the assessments regulatory authority on launch. the will pleased the finalized adults at added We're with negotiations the of health it the Europe. Statutory Swiss we enzyme with a National In set Pombiliti Germany, therapy. Pombiliti value and seeing replacement and pleased that and updates Opfolda closely who a we're the continues successfully technology acknowledges Switzerland, outcome enzyme this Health stabilizer to Medica to key launch we of therapy, recognizes has be our very Association long-term And LOPD. patients of benefit this Opfolda benefits have therapy. are The of price as in + reflect

quarter anticipate important reference newest reimbursement with pleased We the be to discussions. new captured the U.K., take patients we market prescribing launch our and of the region. Additionally, within very point of within the remain than and country, first in Pombiliti all significant this of we've future and of share a country's greater number Spain, launch. where X/X Opfolda accounts, added we've an for In pricing

share that of indicative of of period benefit years demand over which Opfolda current U.K., market been this actually in uptake. believe X-year and we beams, market the the the example potential for perform is product is the how can X Pombiliti and With great a a in and have this

first Pombiliti well million to $XX on Even revenue half of our Pombiliti Opfolda. and Opfolda XXXX, to solid of commercial for way we're deliver full million the our execution far, guidance thus and year $XX

momentum the very through XX. half Slide first with to the We're launch pleased Moving the year. of

have As XX were to this for or Bradley We the about are therapy, earlier, demand the end therapy. mentioned been scheduled there very treated ongoing July. That's patients remaining at pleased of about that treated on for the are XXX XXX be scheduled. with and remain

across momentum particular, As that increase choosing we number to These launch come coming throughout onto and business our Pombiliti prescribed we the very to Opfolda patients continues individual continue the the it year, new and prescription to of Europe. commercial U.S. all Pombiliti on in in treatment clinical therapy. the being This trials, having will markets. further to be move in the a as largest supports is launch of patients to rate Opfolda. that not are strong process was in and important X new as more quickly demand through countries seen commercial quarter, QX new from

outreach Our TLP launches leaders. and great leverage highly [ ] experienced teams, our we've cross-functional had with

engaged, We're business other patient very number positive and to have feedback and been both stakeholders debt X seeing support global and feedback prescribers centers XX%. they've and of all All an increase core from the as in alone, across HCPs In of our approach, breadth accounts our increased focus. our by QX prescribing treating markets. provided

reimbursement. an access progress Finally, find our track metric we with important to is and

we come will to around Medicare have infusion with XX is to acceptance improve. patients the time We We have approvals happening conversations Opfolda now in have few The highly their strong demonstrate respective by also are quicker. payers positive payers these and a largest commercial XX believe the payer from U.S., days Pombiliti with last of put team continue formularies. the And Medicaid. the days. to Pombiliti in on have engaging and overall around And experienced significantly this already Opfolda. prescription value to In seen to actually down

Today, we second demand. U.S., half patient pricing the and we therapy very Germany, maximizing and Spain, broad focus strong a U.K., patients ribosome the Throughout focus the discussions by on had we've as our active in with very be number the of pleased markets Australia, on half, we're patient momentum building first year-end. in launched the of additional will on remain European access XXXX, we're but with market. Overall, European major throughout securing on

summary, difference call time data, make Castelli, in of Jeff confidence ability Amicus for over Amicus the strength the people great to and Development position Jeff? We experience Officer, and living with believe have Pompe gives to a our the wave with pleased Chief with our disease. commercial will So Pombiliti hand of is launches very a the Opfolda our we great clinical real second in I study in the depth talent And and of regulatory discuss first lines. clinical at that, the of ongoing to countries, launch. with we're across us our our

Jeffrey Castelli

Sebastian, studies you, outline morning, evidence XX, build how we clinical of On Opfolda our Pombiliti everyone. as through good Amicus the ongoing and registry. through Slide well and to as our body we Thank for continue Pompe

we also through As and access continue expanding submissions. commercial on to reimbursement execute dossiers regulatory

this launch, process are we we phase As of that have in dossiers various enter reimbursement the second submitting. addition to in or the of

have also geographies just We submissions or . We've approval in throughout for regulatory multiple the ongoing in year. Switzerland. planned approval new the mentioned marketing

Additionally, we in end the Australia of [ have being the before in regulatory working and our towards Canada, year. here reviewed we're the submission and Japan ] doses

to years opportunity significant Rozelle living ZIP expansions We for very Pompe Pompe the segments the ahead For to this open-label and patient infantile see address study label children to into as disease. these study we living needs important the enroll unmet with children. the support an the late importantly, in these Pompe younger for community, open-label ongoing for disease onset onset continue children and

impact of mechanism patient action populations. across Through evidence Pompe Pombiliti the and continue Amicus on registry, studies the in we generate and Opfolda long-term differentiated and the ongoing of on clinical endpoints to

part of publications conference efforts. continue Our presence important education an our medical to and be

appendix pipeline, slide the the in Finally, to therapies next-generation and on focus Fabry as our in earlier highlighted we for diseases. pipeline in approaches continue novel stage Pompe to

the Harford, like would review over outlook. our our I turn Simon? to Chief that, now Simon financial With call Officer, to guidance results, to Financial and

Anupam Rama

you, Thank Jeff.

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

$XX grew For during the revenue revenue QX, consisted we over At exchange $XX global of million, which XX% percentage million and geographic total as X% goods achieved XXXX. within relatively total XX% of of as constant The a generated in QX the revenue to remaining was Cost increase net also sales of quarter outside same year rates, period flat. revenue the the a and from coming of in staying United $XXX States, or period XX% breakdown the sold of for the XX% is compared or U.S.. million XXXX XX%. prior

operating net to million compared million $XXX quarter $X.XX to per compared second for for million expenses On XXXX same in reduced or operating share GAAP $XXX the year second $XX development expenses, on as loss quarter and period On in the to $XX stock-based to net basis, impairment in fair decreased or a the amortization. for this a compensation, value quarter the expenses $X.XX of content basis, assets, second share million of changes charges define research a and $XX consideration, last decreased restructuring Total to loss as the million million and depreciation a second per decrease expenses X%. total year, period excluding SG&A loss XXXX XXXX. same contingent $XX of and of of non-GAAP decrease a GAAP X%. of compared to last quarter of the year, operating We for non-GAAP

to in XXXX were million last million $X.XX QX, million period per share. of compared or net cash and $XX million June $XXX $X.XX $XX Cash, at same loss year marketable XX at XX, was the $XXX December income share XXXX. in to In equivalents securities or per compared a non-GAAP

now to XX. Turning Slide

XX% was We year to year XX% and guidance, full are rates. increase at growth at our by XX% from and to to to guidance constant full XXXX to Galafold our XX% most XX% year started revenue up driven revenue total the which XX% exchange of This to XX% raising recently is range now XX%, is XX% XXXX XX%. the

guidance the full of million XXXX. Pombiliti so In $XX Opfolda addition, we are the to and sales million, for $XX year reiterating

commitment With Our full million to million expense guidance been to year operating top or at million million from $XXX non-GAAP $XXX $XXX $XXX end. the a our reduction XXXX $X.XX low year to are Opfolda, has full we narrowed for guidance. midpoint digits to of growth keeping first of full year-over-year in and operating the at profitability during year non-GAAP expense single launch the Pombiliti

registry a and studies study second for reimbursed continue as yet next-generation to Fabry As manufacturing Pompe, in was In million aren't of III ongoing $XX.X in as non-GAAP the we combility. reminder, well have XXXX, countries, commitments, including both quarter which Phase Pompe the track R&D half XXXX the half and accelerate of guidance With we non-GAAP total $XX.X for profitability to XXXX, full year in be our revenue for million. comfortably of our of continues profitability XX% XX% the first first the year. as to growth, of to second profitability remain on

that, remarks. with for me the call closing let to back our Bradley And Bradley? over turn

Bradley Campbell

Thank you, Sebastian. Simon, Jeff and

execution As you our our on this see, highly value commercial year for we've can been ultimately focused and profile strengthen our financial delivering to continuing shareholders. all

performance for us the and groundwork continue first to delivering our Our has achieve our half laid therapies. to mission goals life-changing fulfill for

that, And questions. now to can the open we with call operator,

Operator

the of BofA Securities. line comes from this Ahmad comes from [Operator question with First Tazeen Instructions] question

Tazeen Ahmad

wanted just the cadence I launch Europe about is be how versus the about to are label get we slightly from different. Brad, U.S. should thinking the a how the going, sense launch languages of you

U.S., in about mirroring be in we what could And Europe? not should how be traction so we that or as gain seeing how could thinking you're

Bradley Campbell

Tazeen. for Thanks Thanks, the Yes. question.

you couple of things. as So mentioned, a

think I the saw as all, today, from great progress of numbers to continuing you both first see in markets. So

U.S., In on. I single you largest it's different market. the have going X the think dynamics

will And year. strong throughout to as patients be new of rate go so we continue the the

we We reimbursement. We Switzerland. new adding another got Spain. we're We're launched approval Europe, on as in just in go. However, countries in

the markets But think new a the So are that's to United balance progressing size. I I matter think over States, of the overall, probably just course extremely both the patients start of well. in but will favor year, of the

said, Nexviazyme the In and detail patients as this you of as terms Myozyme switching we the In label, seeing and as provided population. of predominantly I much a we're some from U.S., seeing and from kind which label switches we're provided patients, portion new are smaller both the call, there. Myozyme the switches that's Sebastian of Europe, in as and well on from on as well. the Nexviazyme as

watching So performance we're going to see well. we're the continue key the and really indicators are momentum. excited to

Operator

from question next with Merle UBS. Your comes Eliana

Eliana Merle

of some U.S., patients terms of dynamics in just in prior like I seeing line I types the in of are switching on of In -- PomOp? what of average are terms the are and guess in the guess, of from that length to switching next you to are terms of what patient trends I seeing the particular, switching that Nexviazyme, patients the guess, you

Bradley Campbell

Yes, thanks.

X dynamic had I years. of over think that's a year described huge expected been year in of kind And before. to we've that there's of the to year on are course that years The see, next of to a what good patients through of news essentially, therapy of year. we're on that from Bolus treatment which we rolling Nexviazyme, into seeing this X that majority and is, is patients switching the course, kind have

see -- some we've of journey. can a I we who do large patients switched got their earlier And so think in we target patients have that Bolus

as with I to is and we earlier dynamic what other knowing think say another that Pombiliti as And which see, will them. who in realize some community would positive or this patients probably establish for I to Opfolda I continue experiences think demand hopefully that's do experience and a patients Opfolda. that an those mouth had from creates new too, be And word the important they switch and physicians we'll get that more Pombiliti therapy more want to as can experience more when positive, from comes of and

Operator

next comes JPM. Rama the Your line with from question Anupam of

Anupam Rama

on congrats progress all the here. And

is or Just increases we where regions or of region be on are should leading guidance increase? from of coming this the regional growth any that guidance Galafold thinking to variation increase, type about

Bradley Campbell

little start at to and I'll then a Sebastian color Maybe a ask high level there. add

we're -- elements So the you of great think you the all U.S. but seeing Sebastian, is is anything Anupam which relevant provide key of of markets, honestly, maybe of growth some color to what and in seeing bit a be unique little on else our that want there.

Sebastien Martel

Yes.

So Brad. thanks,

in a really why very years. are the seeing seen for Galafold first we've line strong U.S. number that and growing we're naive now, patients, patients of we've of Anupam, actually proportion guidance of this quarters raised a for have patients demand number year recorded diagnose half now X diagnoesd in if of The amenable the is that's put So on newly newly the close said as on mutations. the the to Galafold have we've I in you very earlier, as treatment first highest last PRS of twice year, seen the

the in performance strong U.S. very So

seen In ever the of majority Europe, of may that disease with Earlier been proportion a bit naive of we've We actually, since have growth also see diagnosed, being are from they see shift who to than similar the female coming we're patients. past. of moving have with for very to launch, tendency treatment. that pleased patients a -- the to Fabry and continue growing pattern a in the the treated

upside seeing that us think largest. our that Japan is We And in in markets we're growth largest performance the great because U.K. more have as simply well. to business fourth the Japanese we We're Japan our in in seeing actually

market. you look the is largest Japan market, whole second family at the actually If

at in second become market our there's Japan some couldn't point why So well. as largest time, reason no

are these key of regional on highlights some So the performance.

Operator

Your next question comes from Joseph Leerink. Schwartz with

Unknown Analyst

treated, the think as within we to of in point or the A question Is treated as online in on quarter. this PomOp. for roughly patients the year expectations? for patients progress the of scheduled Congrats back This first you've quarter. the Joe. added should EU? half number second the is quarter Based metrics geographies like same seems other the about Will And it how the on compared on the to this come inflection on be in

Bradley Campbell

question. Yes. Thanks for the

highlighted, year, that's Sébastien expected. the think of is what last I we continues it patients one year to we about, this new than higher much exactly was talked of and the things be rate

In go of year, build towards think to said, a revenue terms will a being new countries. of fourth really launches back the new we'll patient But will adds, from of the be be half those in quarter. year, especially perspective, the momentum much. I That because as we reimbursement continue the it change won't and next revenue open of we up new especially rate important. obviously, very lot as

number by because So the that's maximizing of run next that the going why maximizes therapy we on patients focus end the year sort into year. the of of rate on

Operator

question of next Baral comes Ritu the line Cowen. Your with from

Ritu Baral

can follow-up some with to And stack the decliner mean up your on From ran survey recently our the promo can messaging Congratulations the tracking competitive good detail, -- which some survey, our metrics then on PomOp drugs some this and dynamics, flavor we on for resonating the wise, going on be of we in input got tracking insurance. quarter. -- that I've Genzyme, that to some have considerable how in a talk at I detail Nexviazyme that's that talk seem surveyed, messaging counter what's to we're that least and of be very which you seem to -- the you there doctors if interesting counter against on on sort about superiority Lumizyme hearing each Nexviazyme over other over what quite got the a field? and the defines Myozyme, we've team X

Bradley Campbell

I very of describes with can And important a I launch message efficacy materials, most that the start, me, such we're they're far. think X-minute shown Maybe which incredible. so active and part I speak that the comparator. how would and you would And in important in remember I color. our walk product what label. I and promotional therapy. great a But possible of and that's a a I'll improvement here product. thing fact, the that's both Jeff detailing. is the resonating some we've confident may And had that improvements won't think -- to this for in effectively versus have is controlled very pretty think is say I'll III that why has Phase -- is phase of And capacity forced our -- We just I only we're the in an say add

talk little data points on that maybe the of the they're some kinds importance focusing are But the about Jeff, that a of things maybe more following. and bit other positions of

Jeffrey Castelli

presented patients, Ritu Thanks have [indiscernible] the breathing, and largely key the you in et think across Amicus from trial, showed of when question. main blinded perspective, where data in quality on patients. for educating which improvements I was endpoints we patients of Brett, strength, are all as points. obviously on aspects end is the across cetera. And randomized on that see that group improvements switching in point, we of III, Phase ERT-experienced we Brian. hit people Thanks, life, large switch the still numerous which Yes. the from our an muscle we

So we're educating data. that really everyone still about

we unique that think that can then Obviously, data with And one Opfolda. Pombiliti evidence action is levels we've of differences what mechanism of still education highest in around and the and here have. built of you there's continuing

as and going the anecdotally pleased the but there, how But people to from future. of it's out to across everything excited naive switching from to -- outside are report about other PomOp in with out from the looking I really messages Nexviazyme, and switching about registry, hearing it's that And people our registry on where today areas. we're all nand we are Pombiliti briefly in in certainly, invested we're we're there's are And response really we we're the that's physician data Opfolda. Moving yes, patient where importantly patients and from different see doing parameters, Lumizyme. when we'll sorts the U.S., really, whether real-world people transcript, forward, continue evidence they're talked

Ritu Baral

Great.

to of J Not on component that these the not anecdotes terrible, but are code quarter some that there you of reimbursement mostly of new resolved? [ and seems landscape this Has full covered, that getting the sort now focused worth very some continuing griping can all going be to speak of heard been been how coverage. insurance ]. Opfolda the got your has we've respondents about And a of from it's you

Bradley Campbell

XX denied which are which the And has we'd too, days. seen first there and We're patients But is proceed It's the or -- haven't trends. shortening Ritu. shared staff frankly, of small hoped, from to when everybody, for now any insurance preapproval be say and either exactly we the the and their go physician down the the or coverage then all that the think things these prescription Thanks, time, here. would to the Yes. thing to down now funny. we time molecule I I ERT therapies, as we seeing X prescription process, days. is through shortening would remind one infusion. XX products to We're happens I

patients any that to some to getting they sure in But much the and some I'm start And there cetera. is we're staff as the very new that's through helps surveys. we're the through through seeing yes, are than we're process, at see. your the et extent you're sure I'm first we everything And I'm the quickly time the to paperwork, them get the goes So that of coding which what seeing did used getting system, therapy, facts to the and want piece we of more sure well. what have

Operator

Your comes Stanley. Morgan with of next from question Jeffrey Hung line the

Michael Ulz

Ulz. fronts. is the on Congrats Jeff. This all on progress Michael for on

had you in more diagnosed given Galafold, uptake there patients saw naive For XQ. you do with curious versus Fabry, patients Thank referenced patients you. growth why and think stronger treated for much as in to left a room and like how Just you new switch is add? the

Bradley Campbell

change in Jeff, that. the to by, think where and of bit talked of about I then fueling about. the in I'll kinds is Jeff But what the landscape sort But that. of through and changed the market Yes. market a we has just remind that's we size to fueled today more things us continues kind started maybe from think, improving diagnosis maybe talk that launch let the overall that the grow, Sebastian diagnostic little is reality

Jeffrey Castelli

Thanks for the question.

Fabry, or it's it's patients years XX,XXX now undiagnosed to numbers diagnosed. when across X and likely than many, it's countries people we over date Brad that launched programs, out the whether screening that all screening look are various from living many or XX,XXX there that of ago, families XX,XXX are Fabry at newborn that about X Galafold patients As said, diagnosed there more are and the screening different it's clear you patients at-risk with have when

is lot know So physicians paradigms, the so news low-cost education there's suspect continues more to There's genetic of a Fabry. improves, to when lot good a tailwinds on screening testing. access diagnosis Medical

potential female, burden education a it's male about patient, the at are of Fabry A you treatment along use a have those kind and really the from perspective, the diagnose doing need all record or of on space physicians late-onset lots ] the more of AI medical Amicus might Fibria suffering screen earlier. and when with be that knowingly. companies about for treat people the been the developments lot exciting of education in medical with to to And other [ things

medical learned lots look people patients we late patients are we be to percentage being have higher onset amenable forward, going more in moving will historically, diagnosed. as here, think because something there's too, to So onset of amenable we've late largely that see diagnosed of of have them mutations. tend to we the to being diagnose a lots mutations. and seem Many people harder patients new That's than

more as this and Galafold care standard of people a for with more mutation. And

a when adults families X patient then suffering. the likely members that the also that X in in to screen scene. is in is the newborn they thing newborn there the a family on of And a X And X that screening have last particularly going what to or the that lots all So are states. driving coming Fabry there's index often, other find ability for the and forces positive and together, I'll is U.S., add are I think,

of terms great for of in So new patients. the finding tailwinds community lots

Sebastien Martel

would I the rate that just said sales. highlighted that in not quarter, for is our And we everything the Jeff see growth that add actually for

Fabrazyme So Jeff dollar so the contributes fastest-growing performance that, was Fabry we rate XX% XX% again, look at overall overall for second X to estimate the again were market mentioned that when from north standpoint in that the growth market we of growth everything with the the growth. brand healthy ERTs Fabry [indiscernible] quarter. a we Fabry and of

Operator

line from nGon Stifel. the next with Your of Dae question comes Ho

Dae Gon Ha

really back to of to, sort benefit. the PomOp our there going any how or of those talk is that other Nexviazyme I enthusiasm Nexviazyme PomOp. also what's about guess disease -- also showing since channel physicians checks But the lot A frequency question, a launch. switch Maybe functional changed. muscle these physicians to or guess, indicate is of I switching assessment over impetus launch or is progression not hasn't Ritu's lot dependent of on to say similar meaningful assessment interesting Yet same

of can or curious, assessments marketing/commercialization of of any kind picked your kind be therefore that maybe of So these that strategy efficacy more and is part disease switch? slowing to so drive quicker more progression induce of of up

Bradley Campbell

And frankly, at. hitting it's issue, really between now Yes, first which you're real products. had very the is Thanks, time looking physicians that choice is they important Dae Gon. they're X a a this have products -- have

but element maybe so improvement focus for of therapy, for changing the we is on, an possible And actually expectations time. first it is

the getting be other favors measures change and of capacity, time. over much vital think with may very -- it Pombiliti experience will very an that very for changing think it's again, and closely can the as primary of suddenly physicians patients the their physicians educational product, therapy, if it's not much expectation I they're walk them from the yes, we at more look get but just to Opfolda. So and measure, that what patients encourage I and those And much effort, X-minute

Jeffrey Castelli

all to we're a in it's about often from more the kind Brad, something of one they're other real now definitely given for physicians add there. measure they're monitoring patients, need clinical the able hearing thing parameters how standardization about quickly what visit. I'd their

think information treatments available need the have to multiple with Amicus, all now on we to about as is I really community be that making all patients that's So and armed having something the work better informed decisions. treatment together

those that side PomOp saw that other parameters. many about switched that data from -- patients, of an perspective people out improvements the reminding across to from ERT of we're Amicus is we different people in saw The it them there

an So opportunity in that the there best is regain some to some way, function. not stable necessarily outcome potentially is

reminding that we So we're see. the from something people that's data

Operator

Sachs. line with comes the Your next from Salveen question Goldman Richter of

Unknown Analyst

for Sharon is Salveen. This

see So ERT-experienced a that before Nexviazyme quick physicians in naive patients patients going trends are evaluating any as from on Europe. mobility do in them that preferring Myozyme suggest as both to U.S. And that well just to second switch part. and before to you patients the in maybe

is that infusions. You down XX XX mentioned between to had prescriptions What a day lag to XX-day mentioned when on? target best to your you that you're you to early that around now get estimate

Bradley Campbell

for the questions. Thanks Yes.

the was one, first is the us. the approved in an that Nexviazyme for what no, I dynamic think far example, U.S., think as really than I earlier

majority of the switched already So patients were over.

then Although the Myozyme. U.S., a more there it's much are outside And mixed remaining patients from circumstance. some of

physicians with is taking to segment that that making patients So launch of we're equally. good switching And and aren't we're Nexviazyme with first. seen the that we've preferencing reflects kind each that the what from I headway switch very think

I think a just weren't it's we reflection available that before.

in time the second prescription. to infusion, relates it from the then to case, And as

days We should on to XX down be that of difference full one Galafold the an year every journey with are of sort come really The is first XX here, of days. days. XX down these say to end the in goal to by we of XX-plus the other week as launch, XX infusion. we the to for we reason by Our end kind That's year. of this were why sort patients the of

of you kind So X-week well. a probably have window as infusion

we're of this that do by to But the year. yes, looking end

Operator

from the comes Cantor Kristen Kluska Fitzgerald. Your question of next with line

Rick Miller

for is on Miller Kristen. Rick This

us. from one Just

community interesting seeing? on + Pombiliti other across centers down any mix settings? larger academic Does on For versus seeing And that prescriber this the trends there can you're that you comment break you're are Opfolda, front?

Bradley Campbell

Great Yes. question.

has breadth, the and XX%, by of I the important number globally highlighted We Sebastian of increased prescribers think to new really one want important. which continued i.e., is that's see metrics, prescribers. most

We adding their see also third well, or which continued depth, we're or seeing prescriptions. is prescribers want as second to fourth which

question coming on Again, those both So where have market. been the strong. dynamics they really of from are I depends To your in of terms it think

key and market prescribing are base, like like centers So concentrated, do the the of U.S., all those. penetration and top we're seeing a markets Germany great into prescriber is which in you a have the U.K., very

and of physicians -- have well. would sort of the we're because say, of more as physicians. distal that you geography and more distribution just starting size do I prescribing see now to are of the the We But also more,

And to so those are dynamics we'll continue to. speak

And segments. in those of great both so seeing far, we're uptake

Operator

concludes today's conference. That you. Have your Thank question. was great This last a day.

Amicus Therapeutics (FOLD) 8 Aug 242024 Q2 Earnings call transcript