AMYT - Earnings call transcript Q2 2021

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Unidentified Company Representative

Thank you operator.

On the call today to discuss Amryt’s Q2 results are Dr. Joe Wiley; CEO and Rory Nealon; the company's CFO and COO.

In addition, Dr. Mark Sumeray, Amryt's Chief Medical Officer and Sheila Frame; President, Americas will be available to answer questions during the Q&A session. update the business financials an will then provide through go in will on and the Rory Joe detail.

Any after forward update date regarding the information XXXX. statements. And publicly company or looking anticipates of expects, such those the industry, other and such you words Before the Joe absence operating I circumstances uncertainties conference In differ company's mean its the projections, as well is and statements, to and forward or its only this that Friday, statements and not remind in to with economic, this the are involve of the risks, but financial forward statements which and for results a the to the speak of performance, contains any X conditions. trends August forward among the date webcast in no statements differ events supply that materially call. not as in business, today market other does could changing indications predict his formal satisfaction in are current assumptions projects, referred as control, similar statements of statements hand statements. the guarantee remarks, their things, not let looking risks, and light statement actual as uncertainties of made, progress, call it that may development or intends, from those estimates, conference variations forward identify Such looking looking call to over these forward-looking. company's press Word release may the difficult prospects of plans, materially and looking from outside believes, optimism, or expressing forward-looking undertakes that assumptions, of me the including, new obligation other circumstances contained be reflect

section SEC. with would the to earlier go of forward-looking I I well filings press turn time, you Dr. the full this to as refer financial statements Wiley. the release issued At the over year ahead. Joe company's Joe please today, more For call will information, the as

Dr. Joe Wiley

Thank am commercial our our four strong have of guidance. XX.X% year business. quarterly Today's XXXX delivered results, metreleptin this therapies we number that have access by record issued from This performance increased of presentation. generated growth the I again QX the Today you, sixth and to and the at with We on the our quarter. growth full continued cash June and the of in of year-over-year in $XX.X results slide million our of EBITDA Simon. XXXX franchises. with raised first quarter. of as both performance organic revenue revenue driven performance was underlying lomitapide Total I was $XXX.X increasing of XX positive in million would the EBITDA represents generation. quarter patients end our add $XXX.X globally. consecutive We million demonstrates

XX% of acquisition. that I over from companies transaction. those pleased now shareholders report are that the have We And who we the would closed both supported note of Chiasma voted to

process will our growing of We begin the now businesses. integrating combined and

Following and pipeline. products commercial clinical has the Amryt robust three close, deal a now approved

half exceptional beyond. this of we in business calendar QX, XXXX Amryt of the for a a in Europe. Oleogel-SXX of the Europe. We our to the path forward and we regulatory to U.S. and also grow in launch and progress commercial in the for and truly we by end quarter the was assets. on approval During significant continuing XXXX achieve this U.S. the and quarter, to on Oleogel-SXX the potentially made pathway look year pipeline both Overall, believe lead are second

details slide on will to I on more provide now business five. Moving our performance.

year-over-year XX.X% the to by significant total the quarter of locked LATAM quarter metreleptin This $XX.X in million. of grew included order $XX.X million. Second a for impact revenues

the but of guidance business when revenue the we excited This time including we we confidence our between the product year-over-year XX% the $XXX in contribution potential billion for of by strong reported this demonstrates market we of the an $XXX this year-to-date, in from performance be due previous yet and for is given range million to the million revenue At which we course. our QX from Mycapssa results. not XXXX $XXX in are update commercial any issued this to board's the This represents clearly are of Regarding in our outlook guidance revenues to $XXX growth million business. forecast, now will the to are XX%. increase expecting

EMEA now slide The now year, in accounted the on with sales I'm global and of Starting XX.X%. our in to million compared the commercial metreleptin accounted XX.X% QX. global metreleptin, in XX.X% $XX.X U.S. with second million, last six. representing of revenues for quarter products, $XX.X were growth for QX Moving

initiate on XXXX. lipodystrophy. study forward initiative this phase for the FDA a from our will a in lifecycle U.S. shared label to which for previously feedback lipodystrophy to of the have study end expansion the we on by We seek three label approved are in this treatment plan the include to currently of path general track and require metreleptin the addition received for We the to partial the treatment of

if we million. in label the successful in we have size estimate U.S. PL approximately to of that believe And market the it million. current adding be double opportunity U.S. to the with the we approximately discussed, the addressable we are $XXX $XXX will GL As markers

seven. slide Let's move to on lomitapide

million a XX% all Second EMEA QX, EMEA major driven by in accounted European quarter the XX.X% and lomitapide across markets. revenues increased $XX.X QX, for versus EMEA in Year-to-date revenues, digit XX.X% lomitapide X.X% for XXXX. XX.X% of by was U.S. accounted global sales the QX. in growth XXXX growth The increase double year-over-year. were

XXXX. data for early We expect in pediatric study are to conducting a HoFH we and lomitapide have

the will and lomitapide with the seek we data, approval children U.S. in treat positive Europe. to both of Assuming HoFH

a went detail X. in and for minutes acquisition. slide so when now now to we're gears But of it talk I I was Chiasma the transaction about why eight. on it's on think And about excited over May announced couple am exactly the it. worthwhile revisit of switch Let's highlights We

the from also at NET estimated has In to approved million. MYCAPSSA is tumors at with patients approximately is into appropriate addition, globally. global on expand or potential market approximately There stemming means protection. where endocrine symptoms three products for currently company the the acromegaly with a addition carcinoid estimated $XXX opportunity billion patients now in the is $X.X neuro combined of market strong IP MYCAPSSA with the

of that overlap. our successful of U.S. recently and the has the record of believe will will launched of leverage adoption both track with potentially commercialization. and drive business as combined enabling given been integration well this acquisition adoption MYCAPSSA customer degree combining Importantly, points We Chiasma accelerate the potentially business By scaling core and MYCAPSSA metreleptin the MYCAPSSA that believe revenue endocrinologists. as sales growth. further in we significant will forces,

also leverage and commercial launch to global our will on internationally. affairs experience regulatory of We infrastructure MYCAPSSA seek approval

markets we integration Now We hold that the provide start immediate details is how to capital is to that the during progressing be companies. should plan virtual priority officially acquisition mid the in to event more the closed, able two September. to on integrate our has

of Amryt more this We for slide Chiasma products will summarized event. also post of closing acquisition pipeline discuss combined here detail portfolio nine. in and the at our The MYCAPSSA plans on is

our see first marketed in acromegaly EMA chart. commercial has to product the and For indications can upper MYCAPSSA lomitapide section submitted third the products metreleptin this the and now in is two Amryt you the the the and in year. U.S. QX approved of been

post neuroendocrine phase NET exciting in draw U.S. of the which Amryt three next the XXX Oleogel-SXX FDA study in to I for For discussions. expected in first regulatory also to and next half gene AP-XXX enter assets BX would a planning to I in the your is our but a is discuss intention therapy our clinic year. start tumors attention will slide, XXXX the is modified pathway

will portfolio, this meaningful here and into that just breadth The generate important note flow our use thing to beyond. of also year, not these is but products the XXXX

Now, the a no to of that novel first market November cutaneous a affecting Early approved, condition. suffering for for the to those NDA There our our been genetic Oleogel-SXX disorder accepted adults. skin Oleogel-SXX. The is assets the that potential target PDUFA has priority and from Oleogel-SXX for be this for will EB, is distressing for granted confirmed was XXXX. application this devastation also approved and FDA manifestations now treatment purchase is us currently date XX, patients June, pipeline informed and Oleogel-SXX on the children XX. filing slide and rare if review. for young severe I'm treatment condition, in

will Oleogel-SXX not that addition, committee agency an In meeting. confirmed the require advisory

designation entitled to received from be a rare for track As approved designation authorization will and previously the disease If FDA. priority under application reminder, voucher. fast Oleogel-SXX review review, pediatric Amryt A priority we European marketing standard on progressing a as was EB the year. identified, Oleogel-SXX timetable to for for is line Agency validated in assessment in the EMA March The Medicines with are by treatment this previously timetable. the and apply

We the by QX, continue XXXX. decision to anticipate

EU ongoing, concentrated launch key a majority key on and treating are experience. XX patients the disease five with and market forward address rare represents XXX at a plans moving the are across with our countries activities we U.S., the highly based regulatory market EB the opportunity While centers philosophy positions to Japan. of

it which expect to We these only customer our will infrastructure an access modest incremental EB in first approved, in is be demand. facing important relatively Oleogel-SXX the drive order require treatment advancement for and global for will that approved patients. If investment existing and

and strong We up reaches There to here. and review patients are product pursue advocacy, quickly scientific will a decision ensure around relationships patient well-established the EB possible. community as we by as priority endeavor approved, the encouraged and have research forged already is built we to a FDA if

addition, scaling supply adequate drug In expected supply chain manufacturing we ensure currently meet to and to up demand. our are

be to should Our facility existing manufacturing build volumes for through enough launch sufficient XXXX. API

have be strategy this. Following demand the intend support a chain executed will across and in that supply beyond that, manufacturing order up to sourcing dual to commercial we scale

me over QX and CFO Let call Nealon on the the financials. CEO who our Rory more to provide details turn will Rory. now

Rory Nealon

at as I the But Thanks, acquisition my some of Joe. the these also I normally poster QX do to table Chiasma cap remarks. calls. some on numbers color of the end on on plan I'll provide provide commentary

our performance with start already covered geography. has by revenues. Let's by revenue product the and Joe

and U.S. sales growth call. headline QX that seen What the volume we're growth, our increase part overall most alluded is all up that is In seeing our LATM to of year, nearly revenues, last substantial an approximately year-on-year also within which metreleptin LATAM last is period only rate quarterly year-on-year in by quarter-on-quarter. both increases. XX.X of which time revenues order are X% remind the as growth which times almost Just our XX.X% increase Compared being is the from been to lomitapide and in results same in you pleasing driven we've XX.X% part quarter-on-quarter has growth and to higher this four numbers is coming year. really significant other words, X%. which we in this in a increase price with the than was there USA And metreleptin

noted more to$ which MYCAPSSA chance revised actual concluding before . year revenues, our the on table as excludes $XXX $XXX.X briefing of to XX% in XXX as impact under million. the revenues, our what million, get our XXXX revenue to we and are in to of the September have once This revenues talk XXXX a reiterating Joe guidance which Finally, we said analysts feet XX% Chiasma we'll said, to day, in the press the guidance Joe release for revising has million is on full

$XXX XXXX. Oleogel-SXX by the this million at the that annual margin of coming you three acquisition from If XXXX, and year EMA. and again growth from for I'd the will gross million EB launch both next increasing to which the MYCAPSSA the of the $XXX anticipate the when of to also to of our We XXXX in look million growing XXXX, impact million we've in our $XXX like to Amryt and impending change to in guidance whole was the [Algerian] delivered in emerged approved to XXXX. is million items, on the touch acromegaly, being January for XXXX, is remind and growth FDA product with rate at of for over and $XXX.X finally a full and as in cash performance if a significantly you revenues were forma as pro the of with consistent being year-on-year year XX.X% last This of for XX.X% standalone XX.X% compares company $XXX in the slides, excluding business year-to-date. I'll XXXX note The XXXX last [Algerian] consistent our non the will progression you years, quarter combined with years treatment now numbers

upwards party no numbers, the with group higher it making a metreleptin has the to varies is and expect with product this has by those us which new party of a revenues geography, royalties [indiscernible] margin hopefully, royalties of as the the as these and grow. addition these X% lower Within royalty on mix by third are product compared Oleogel-SXX to MYCAPSSA margin that we'd of party approved, third third edge which product combined products rate

calculating in of amortized, from fair no cash Regarding the the Algerian that remaining. none cost there's items and Remaining longer up $XXX,XXX step sales we has amortization any now acquisition. EBITDA, as adjust the value and been our the non have of we

We from the will up about something talk acquisition Chiasma acquisition on conference this step the have quarterly however to is more inventory call. our we'll next and

assess item patent as life is $XX.X approximately The talk we in you'd million need next amortization other the similar per in of will these continue assets. expect, is assets to the call. the again of will from non to this conference the we result and once of acquisition, intangible Chiasma and amortization, any will And Algerian for intangibles which which will cash which value quarter the

and our spend. Moving on to SG&A our R&D

a with minor is in $X.X from R&D with Our consistent QX our in $X.X spend, million million reduction broadly to QX QX. spend

lomitapide six also studies therapy our been heavily focused the gene various commitment months being spend the also to XXXX. on first in EB the post on products. out and track on and spending product of study is is Our our during year understandably approval activities, our pediatric Oleogel-SXX AP-XXX We've read which also

end is significant for Ignoring our spend expect acquisition will other begin The the four Chiasma year. which the study quarters. which consistent has commence been we of is spend our impact towards last the to about USPL study, the of SG&A on the

we have During been costs, for managed spent spend to million to on $XX.X excluding average marginally million. our acquisition in contain the last which on four also QX underlying marginally spent three quarter up year quarter we and the $XX.X the have while is We're up of million $XX.X and happy the particularly revenues increasing.

and first successive and Amryt. half EBITDA for turn year-to-date. particular, scale. will of on forward operating we're go and good end for in million to the million last quarter quarter during million we sizable your SG&A cash or back slide sixth forma same the draw starting in EBITDA believe approved positive compares EMA. customer XX As year for $XX.X stated metric you we towards to number based constituent is increase items the increase Algerian when a cost planned and EB the reduction $XX.X we for operating as XX, like adjusted of understandably for facing close business and proxy the spend the September transitioned get and I EBITDA. pre-launch hope for we where next do preparation for both year before move We quarter, operations the on was in by in resulted the our the roles I'd cash our to Oleogel-SXX non to to an The from we QX key combined our to XXXX. in of next acquisition positive of legacy In the our into to be and we significant for our key we functions a $XX.X that the results HX and Accordingly, as early which on was pro significant EBITDA the FDA business touch the a this total This XXXX focus I our million will $X.X forward. or components. product come that by non is remind EBITDA year year consecutive legacy the adjust metric given into objective Dublin through the Boston from it us attention economies of will

EBITDA. our that that acquisitions, has integrating outcome process processes driving from previous was that leveraged and The management also We significant Amryt achieved objectives integration extracting synergies. that business and the team only not our experience of exceeded we now significant and expectations, or is the

where off going combination we experience, acquisition and the repeat extraction with a integrating face a leverage With exercise integration. to the the the business synergies. obviously now experience specific from past Chiasma of roles Amryt similar today, with Chiasma Amryt We're of including of Algerian the we're management's business

will Our be to EBITDA operating loss meeting which to XXXX. in the we'll with teams combined promptly converting which September. had this year is as year view our Chiasma more come analysts million intention QX is of calendar merge a topic business, two $XX a a a in an business back from the at that whole positive to This the in for to

moving earlier. step Before the and such inventory the QX, to by acquires you based press EBITDA payment items amortization we has that from This calculate completely as amortization, noted release adjusting the up of Algerian will eliminated now share the in way as for depreciation, step acquisition. in non-cash value fair been know expenses, intangible all value in fair EBITDA

and will incremental line results contingency net the our in non cash $X.X charge notice We I Going of our X.X our the non convertible bonds fair million in continued rates And million adjustments and the the the on acquired our and cash the that our results color be for payable year. million is loss a call. income operating on earlier expense that of $X.X and finance the in amortization income have consideration, the quarter step you in our cash on QX these Beneath interest conference term operating you statement, value of statement, as of today. note the value expense provide which quarter one forward, on broadly is change earning in noted consistent amortization, are more non line which for cash of our similar intangible by debt. finally, triggered will with quarter acquisition, including value the we'll fair Chiasma the this inventory Chiasma section

getting current summarize I just cap position. to our net table, revised like debt Before to our

of debenture, have $XX.X cash of cash driven of during cash approximately was of $X or paying significant year. acquired we the Algerian QX when fact, we DOJ $XX.X inheritance end which million. in of the convertible million and at comparison the in by by million EBITDA of paid Excluding also term March as inherited June, quarter. of per $XX.X million we net was which increase we're was of quarter, quarter, this the the Obviously, at This that performance no being this debt million million million the fines and the and helped the longer helped, $XX.X $XXX.X end fact $XX.X largely net last during bills

In debt, ordinary a or per with our per of addition ADS $XXX share. million a term principal a do loan on have value with conversion $X.XX this of price to convertible we $XX.XX

in converted is ongoing strong before and it data get April performance likely will the this we phase payment otherwise the and Given due to believe equity for it the XXXX. EB is recent of operational business that three

result, we this akin view as more a debt. to equity As and

remaining have will to other Chiasma paid. in off related Chiasma of debt the then debt we our and $XX approximately position, all the similar have use organization and moving no that costs will been cash I will million clear our Before will cash costs. net note

one Amryt I'd the table with the new Amryt NASDAQ I acquisition shares thought the concluding London post some Stock aim is ADS Before five clarity for on cap ADS. of market Chiasma. the ordinary of and on ordinary Exchange shares trades give representing the on

at about our NASDAQ. talking of vast For share is when given confine and table, majority myself liquidity to ADS now simplicity, the I'll shareholders the cap on

Amryt XX.X million ADSs ADS million post of the As and today has is be consists deal legacy which ADSs shareholders million which ADSs million. Amryt of issued in coming ADSs or were close, to $X.X cost also $XX.X today, form of the XX.X million XX,XXX,XXX precise. of exercised zero to previously warrants of Amryt XX.X were This yesterday. Chiasma into

In We're Amryt of these small inherited equity the is could result warrants details and majority price Further shows a options end carried are strike are would ADS options $X.XX with use That orders from to been of issued now employees. of albeit likewise, exercise. these $X.X cost And $XX.XX no remaining adoptions our of plan ADSs ADS. weighted Amryt today over million it is to back are there use share options this the additional statements note of has today, the a of on share and issued I warrants zero Amryt Chiasma and hand my out options directors number per and very of remarks. total, no Joe. of money. the old with [indiscernible] ADS price approximately and use. use four with X.X Amryt and will average being also financial an an Amryt to for the options As $XX now outlined legacy have the from warrants options Chiasma. from which and million in [indiscernible] options strike options in orders with

Dr. Joe Wiley

Thank now you, on I Rory. am XX. slide

the where stands Let Chiasma of today me acquisition. Amryt reviewing summarize post closing by

commercial a large products, addressing of growing We attractive have three revenue of does markets. now them comprised each generating portfolio marketed and

in Oleogel-SXX estimated to we market opportunity addition, estimates billion. the in pipeline phase also MYCAPSSA preparing enter are near There stage and market term of a we an potential with near a growth. drive billion. In $X approval to global tumors where potential assets $X.X have the three with of is excess And we is neuroendocrine long to term development be worth exciting for in

we I execute and sheet to commercial and Operator? launches And infrastructure place on new have experienced a hand finally, We team balance financial growth. a Q&A. plans. have and product our will growth to operator drive flexibility our over now in global for to strong

Operator

session. and Ladies question begin Please Folkes. [Operator you. question line of the the And first answer Instructions] your Thank gentlemen go and comes ahead. we from now will Brandon

Brandon Folkes

and at it you we should willing we that you're given never thinking we my taking for is the there quarter. launch color million the] be it thanks And label. million until then, lastly, at look label adoption? you. so XX in FDA synergies extracting would pull helpful. on think ready just good about the broad timing to and final should that of still label that very on another XX on given Hi, took a congratulations terms Should stage about to Chiasma think commentary lot made Any any your than of we with should then question get Oleogel, be Is do how a and firstly, synergies have time Maybe final approved? are on timing in how of think very But date, maybe analog little you the maybe or or [gone Algerian product we of on we to that you quick just reimbursement just a the a taking be should quicker thinking just here? Thank bit Algerian to of about that. the any a infrastructure interactions the how share this just out

Dr. Joe Wiley

Good Thanks you. for from hear questions. your Hi, to Brandon.

as the is officer, we Frame. the our So Sheila chief summary line. and and Sheila president Mark medical both our Americas Mark on have of

was, on ask that the think to the take to the in given reminder, on the be Oleogel I then approved. which is if as Mark, to U.S. how I'll Mark and first ask I'll label launch So for comment a launch which Sheila think first the question about likely the we question, the maybe we market

you So over Mark. to

Mark Sumeray

the for at and question. be the Thanks label Joe. population indication the respect relatively a by FDA, the still the we become that will with what in ultimately statement. discussions of patient the we With stage finalizing early to are terms would specifically hope Thanks covered Hi Brandon.

you very So seen based be FDA, you say to the data, I of whether know, or a analysis, can't argument evaluate question I think recessive physicians of results your can product the if the population showed up broad that study be would makes majority that of benefits product the in sort terms in patient the product patients That it not. use the has doesn't. EB good might able working that importantly, where ought population clear the suspect needs unmet able on physicians because to result endpoint vast can we that more of which the of argue medical is majority ought driven primary allowing are the profile, the to to And within practice of makes able subtypes it that I a the in look will be with of of I most safety up the terms in clinical difference other EB, If I pragmatic that you see with as product the would obviously at answer use. dystrophic the in endpoint. the think persuasive really be directly. kind pretty It's then terms in data anticipate is by but the use primary treatment specifically it more argument that of discontinue evidence really that successfully of But of that perhaps that efficacy we're to patient the also population. the was in overall that's when is.

and saying, end We months. anticipate have we I'll those wait and guess weeks occur to will over discussions. I So by see few the next

Dr. Joe Wiley

the answer more that a the on so label. color add in Maybe to Mark has bit identified terms I Brandon, and little will FDA, just the question of on

will the these patients population, percentage to patients plus, they dystrophic recessive majority and on therefore, model into you body patient come yourself, go this usage those likely disease, more of you to at area in have when live given surface effectors the severe modeled that or you it, if of at look likely the vast this if product is the the However, it look usage have more having adulthood. out

the that's you you patient percent simply in plus of seen, the which expect and population the know, the greatest XX which estimate we to the population, as three. we of see So that's the usage would patient efficacy in phase product,

a So maybe bit could if our Sheila, plans you you U.S., in I'll approved. to launch the over about hand talk little and

Sheila Frame

Sure, launch think and to reimbursement. I were Brandon, of you about thanks, asking sort Joe. time specifically then And, readiness,

in of the We'll So we expecting, we at this think putting place what in to as you of any don't expect right as we're but specifically analysts now. launch obviously, more we high challenges need plans closer are the point. know, space, all in this day medical get unmet reimbursement terms September those talk I in

I of to outline the patient been benefits team sure as has think, with organizations combination with quickly possible, payers with clinical affairs start we that closely patients medical as our as Oleogel-SXX partner in well. making gets as to working the and very

So I and to launch. to as see in can. ready think go We'll ready PDUFA as date that rapid we a be pretty you're soon going sure for of terms

Dr. Joe Wiley

is other on questions. your [indiscernible] your question Brandon

number over that of Amryt first of the I'll typically you questions that's the say lot two a is we've of a And other to on that quarters. in say the if address ground. deals I management team would us XX% done to maybe would within lifting doing are these solid years. Your of And the experience XX% heavy okay. about I

those got because quarters in you've recruitment that those when first necessarily overlap there's you cost, replace elsewhere. replaced be two to people in see obviously costs leaving combination don't with Now transition roles savings, severance through the come

a So massive out the first in it turns bearing quarter. have

extracted the by second have XX% it's XX% quarter, scale and you second a to savings then of to around. the of the on the they than quarter, tend declining more So about end

will and gives little greater September. Brandon analyst hopefully So of we it's have in a color on detail bit you in that something we day when touch the

Michelle Gilson

Great, thanks was very to everyone. That helpful. all

Operator

And you. of your question next please from go Gilson, line Thank the ahead. comes Michelle

Michelle Gilson

gain and European U.S. sales that what you're if in efforts maybe then the the, big and MYCAPSSA from might that identified? you for What how think, MYCAPSSA are some might quick market of could be the in [indiscernible] in XX one for the around us of some and in Canaccord. day as guess any the is Hi, the signs starting quarter. any from territory the I Congratulations know, now, MYCAPSSA were on see to quarter traction. you be issues different I to I then U.S. one filing the this any repositioning was you there profitable, bit don't second help Michelle starting more. just And you did hoping U.S. is disclose the your on that opportunity the a understand have pricing for acromegaly, were Europe for letter considerations

Dr. Joe Wiley

questions. Thanks Michelle. good All

let address of two, me to try filter over filing. So to maybe his then talk about the first hand and Mark to the I'll

despite challenging is in So very is that of terms MYCAPSSA identified more is going you absolutely to in Europe, at you've case be often rare in case the pricing orphan in first Europe and successful from in in we market portfolio, December pressure the fact. that we that look however, in have the diseases, acquired and f at that fact Lomitapide when territory both that price access the existing performance despite [indiscernible] very XXXX. Europe, of significant in for been for our our gaining

the subsequently incredibly market European and have acquiring equally things we we and access. was announced market of well since metreleptin have access and in reimbursements gain actually across we gained markets One in the Europe, to did

terms strong a etc the have very in being actually of record we pressure, despite to So price, that able of Europe. obvious issues accomplish track in

by just across to not So we we have MYCAPSSA way, will apply infrastructure. that same the global playbook Europe,

out as today, heard on LATM. this of had So orders we significant you've call,

So a infrastructure. we LATAM have

significant example. We global Middle distributor beyond network for built there. a we the have opportunities East, And across that. see have infrastructure We

as that much this there's a out country by very will it And an opportunity see product. existing country we is on for of be ex-US dealt a our products basis. it on So with it portfolio

what So invest at before launch. country each looks look opportunity we will market see like the deciding and to and

from addressable And acromegaly which believe MYCAPSSA $XXX opportunity there ex-US MYCAPSSA. of is You we is sort that asked about and existing approximately the the in indication $XXX is market market, the million for U.S. means globally million $XXX million, a of opportunity. The market for

we which disclosed of MYCAPSSA that terms asked, question sales QX, The just transaction the second in you haven't of . completed. was In

as today had have we not of one yet as , of day. hands but on this So well our product especially

existing increase significant a is the there opportunity us I expectations U.S. community to given excited And in endocrinology that, the got So remarks that's what our of potential and overlap endocrinologist help I in just And across through force that with and given U.S., both those we the travel to believe transaction. line not already we've the this alluded our my in depth sales the drive MYCAPSSA in going relationships market breadth driving that relationships will earlier. MYCAPSSA derive of also go that picking help drive say in given is depth call and that U.S. breadth believe metreleptin and and see can we're about now we with the growth increase those and significant is in the leverage for terms the that up product. direction can is adoption to we we the so will also We point of

color. you gives bit of a little that hopefully, So,

in We will as in remarks I said September. previous update provide an my

So to and color a under will short product come of market speak back we so little with will the grasp feet virtual then. the this to time it and get in our of bit day analyst to a we in and provide a timeframe September was hold table

will update contribution we be any revenue and So color. we year a you we would the market will guidance MYCAPSSA expect that this MYCAPSSA that increasing we guidance and did give there from not will contribution gave the earlier clearly include from then

So reported on no There's back and to on filter. then filing? Mark, the being issues maybe hand you I'll over the

Mark Sumeray

Yes. Hi, Michelle.

actually, a no. quick So one, is answer the this is

and that cycle So of the an progress FDA review make that raise comment which that of straightforward just concerns, issues. a all general that it specific tone much and the a meeting was did our with the meeting not for review we content any to opportunity can is update had division meeting an have and I is their very-very mid give on the review about with submission our

to even have any to is ahead substantial do your back review that Although realize to answer's it them. the though, the of is that still filing cycle, question, mid do division though not issues. going But a of We it's review have there important no. amount

Michelle Gilson

taking Okay, congrats thank And you on quarter. so questions. my for much again the

Dr. Joe Wiley

Michelle. Thanks

Operator

you. Thank

the line from go comes Herrmann. ahead. Max question of next Please Your

Max Herrmann

taking for my questions. And a much quarter. very Thanks strong on congratulations Great.

I LATAM this just to understand, are, like much to is driven it's understand. obviously, predictable of to there large, Firstly ability trying the And how order. quarter understand was those any any by very

clear of at order we'd was bigger results end quarter the first seen in the much the You this than but flagged past.

seems I getting [indiscernible] So just those and get world in you're on all perhaps French on way in estimate performance through. UK in a Europe, LATAM try coming we and had stronger than be whereas the U.S. then reimbursement, to think again, can orders the rest of you've agreed. And

just sales to sales many force, big you're of combined timing force more stronger EMEA finally, which So the on to I company be area. the stronger the MYCAPSSA what was How expecting been how integrating bit And that of then to growth from maybe sales in little come region just rather a color you of U.S. expecting. add get and has the a on also force? that than a going terms the would

Dr. Joe Wiley

Thanks Max. your questions. Thanks for

Rory then you the maybe sales and speak asked, address let to the first. off hand force U.S. then teach And lifetime in can question final issue the to me So on maybe Sheila question predictability CapEx I'll the the

growing proud Myalept actually, enormously our once we're We're right. you're So again. Max, business

metreleptin and that as playbook know metreleptin to how as that we the acquired how, again. U.S. we we Europe, had implement was the and decline. very strategy our the U.S., now to Prior we've same that, you having a would business market The to playbook with the when to and deploy very that the metreleptin to is we said business successful, market And that the we in not that I U.S. alluded Myalept to using that time in strategy was deploy actually business to methodology in going to the this was turning been in that then that around growing growing that market at earlier U.S. and and rare when alluded once the acquired the we we disease business know successfully. that So case. now applied and were

So that's pleasing. And at timing XXXX. you say, Max. as surprising, right, QX flat but it's metreleptin versus the is orders. issue timing look obviously if business QX, just It's is, which which a EU It's you an of you a are really

growth. you patient significant underlying So when growth, I the see looked at

very, growth be in And or to strong. So exceeding will line you would expect see year the very this overall actually expectations.

from take Rory, more really that's the do a to And want pointsh predictability issue. So you time]. timing last the

Rory Nealon

time to order also just you, remind Yes. because what we last from was But the And add to very Maybe LATAM that. an we QX said this it forwards pulled for first, was orders about quantify and just hard talked QX Max, into previous point how we COVID. have talked year about been whatnot. of

on element going prior of that So compares perhaps with the okay. an

happen. tender also the availability the based. they depends on of it to I It the same depends when Even for Brazil tend of those from the tenders are the on themselves only tenders, they orders, terms people product funds. be tender globe tenders all these the to you In other find for Amit the were this orders can though be then guess of looking LATAM sometimes come they tend [indiscernible] as and of infrequent product. with supplier

So actually order to orders an these there is be XXXX. unpredictability an it era be per when annum all go We've definitive. to that makes of historically will completed. back hard When through a seeing tender come will two

this $XX.X year not. year, on there's smaller guidance horizon for XXX horizon did the point rest the the year. your to not I think or million last than nothing the answers on hence we Hopefully this of seen we've settled the was rest is happen. and question. the nothing in But won't just all that orders for XXX. the And there say it magnitude of the quarter. of But time, it's to At it of the to

Dr. Joe Wiley

And Max's maybe Sheila, and the sales could question U.S.? on force MYCAPSSA answer you

Sheila Frame

We're actually, Sure. going Max. meet today, to with them

that had and current have sales so. primarily a last for on of centers pituitary focused year the So model reps have deployment they or XX field

into we staffed opportunity we're that already, market just Joe's for there's the core talked look in the in Myalept the in adding have across we ready organizations business, later to now for we two then believe MYCAPSSA together. dermatology were US dermatology as a about an endocrinology medical do for We now this And the be EB for expected as launch greater we combining Amryt said of space the course, breadth also year.

and you two know, taking There's just closer of we're just we're that the doing in heading taking right what QX we look then transition folks doing currently now commercial number to of to entire color the model analysis that get can all more world. we're and to as post-COVID new from getting have. MYCAPSSA look so all provide deployment, we're a And So a that one, like? then obviously now. the is we a and kind into know We and number work. lots look and the of at of going sort field so U.S. also what There's at thing

will give we September. you So in detail more

Max Herrmann

thanks very much. Great,

Dr. Joe Wiley

Max. Thanks,

Operator

Please comes Instructions] the line go question you. from your ahead. Tsao. And of next [Operator Thank Douglas

Douglas Tsao

you I do affect product are expect some taking off does Thanks. product aware up. might Thanks that Just a find and over of education of this that you in terms sort are you sort that to to the the do have force. clinicians going or taking and your that some good extent, need that morning. trajectory to most you're think sales questions.ind do did the of you the expansion product? product of And of the of think where terms you most launch taking mean or for and in the MYCAPSSA Hi, around I follow with how

Dr. Joe Wiley

will you this maybe again, that. have Sheila So

Sheila Frame

have in closed and centers difficult happened Sure. the I right to big lot COVID, been of the of a middle lot a MYCAPSSA and mean, key I centers academic largely launch when access. think the pituitary of

are I you of the situation, an education, under I what of the could mode. have launch that physicians of uptake faster might course, would So think to is I expect, what achieve in do expect terms on making value much non-pandemic in sure aware in of still product. you say educated it's And and

reasons. the given job the that, think is Having sure least matter. mean, I making environment. that been did to going the need make there really team for context strong of patients for a key at And the physicians I in think at really therapy good this certainly awareness. you now for to Chiasma said to of that delayed, environment has switch that a sure of you've that got and be number pandemic is I us oral patients the challenge stable and to a pandemic them just

think colleagues value awareness our what's take I and of the where sales time see that's So we'll integrated where some well as that. really as in is to affairs medical and switch and the that force with to order our where's desire willingness

where So we're heading. that's of kind

the think, during across pandemic terms certainly to entire as seen industry terms shifted of the launching significantly I time peak. expect has products you in might in its trajectory, In of what you've

that pandemic. the is get used chance to trajectory to But today speculate get for I we under the feet been during So table, we slower going our everyone we a that our the trying know really think until legs launch is on don't think what to has expression be. want to I under really table, that's it certainly the been

fourth rapidly happen the normal of we're that wave will some So the in hopeful of return some coming. U.S. to version this without

Douglas Tsao

as good with is. all product the and patients the Great, recognize then might appropriately saw as possible benefit, and have you where a product how be positioning have the thinking Oleogel population, think because I don't not it experience as that results in the label sort hoping noted product that's as that most who agree obviously about as the you're you. it of then or just it population, want in effective Thank of the just broad perhaps and we use helpful. them to the clinical for just as recessive use decide sort was good to curious broadly you we a recessive aren't in that obviously, ensure physicians you're And on

Dr. Joe Wiley

Mark Thanks label. has spoken the Douglas, to already yes.

on is want take Sheila position. you to the So though? maybe Do

Sheila Frame

scenarios. at all Yes. looking We're obviously these

and I and the the is, need, and expectation first unmet product, and high be given approved worked medical most patient high or emotional ever is unmet first population access just the need. that in And in so this one of demand fact that is product see think I our across that patient the think making these only that of you're to areas and our only mean, think just the patients the be engagement medical would the also the I And one treatment. I and will do do I've of sure specific going seen. we're very the in have right that that we they terms But approval at will with this marketplace. optimistic clear promotional see certainly the approach we very desperation the given the terms to organizations to get

pretty And for And more and have first excited the other at significant it do about therapy and think to later. what patients to being would closed always products product more backbone type I launch. like we'll believe of mean this can that I of we on that see think might demand demand come But you're will the the only about kind a to again have have if what want analogy, product approval. an you hand, we're market like irrespective going at patients. that really in that significant positioning we of I is terms will the overall, think

Douglas Tsao

subtypes just I can you're across but expectations I there of the sort the think signals just as the wasn't what the be obviously, as saw Do will it sense up. the significant what given the demand, there one of outside in and the unmet patient I that need we of to population. populations to ourselves, different amount set understand strong subtypes. were follow quick I try given mean, in guess recessive in completely want Well, if saw I just because all you clinical trials we across

Dr. Joe Wiley

going going the that's we impact that the take as Sheila how has first, Mark a to clearly to you your And FDA. chime I today spoken as comments significant about with the product. about depend from commercializing on earlier that's label to on think can well. Look, Maybe and seen that it's be then be remains in

product in population I've of anyway. well. efficacy where other terms subtypes to, alluded the recessive in we opportunity of clearly the that as strongest opportunity, have what the have XX% for In already severe the is data market dystrophy signal. Albeit though do the And that's we market

add like, of don't So and label what looks how we like that it's do going any additional promote terms there? the depend to Sheila in on can color you'd you product. to know have I

Sheila Frame

I think No, covered it you've all.

we're think to us market. incredible to just again, such for product be so able to an opportunity it's we're this the bring I

would as label label say will ready so will that and we access And the product we FDA. patients certainly And as soon sure we can just to be with can make it finalize do I we'll we be approval. we this the once everything get on promoting

Dr. Joe Wiley

patients disease. meet medical never in [EB] of group such career bit Deborah my are on have patients anything that's going and worked for similarly life emotive better. mean, you've when the patient disease never their of little even I these they make area the Copes of. worst truly heard for to And truly cares, you by to it a was patient coined speak advocacy and an America, [EB] desperate in horrific to meet, your it's is And I points, That phrase as the Brett

significant only this there's And the a shown here. we we product has to-date proud unmet first have we're, need medical patient and that in population. we're first So that product efficacy think that

Sheila Frame

Okay, great. Thank you.

Operator

And of Rahman. from next question ahead. the go you. line comes your Thank Naz Please

Naz Rahman

conversation enroll to expect heard Thanks. investigators take On on terms in question. how a you and can quarter. do more might expect comments how my ultimately clinical on metreleptin timing about with taking you based have can you about the Delta to congrats guys discrete impact talk for Thanks long any little furthermore, ultralight data? study enrollment? you and variant the of trials your for when And the

Dr. Joe Wiley

I'll you. to maybe that hand over Mark,

of was for the question So the study metreleptin. the around PL timing

Max Herrmann

Latin. Yes.

So participation. placebo the double will patents conducting total that anticipate enroll for one in a we blind, study of controlled year fashion a

trial a be will each So in patient for year.

will expect take about the We it enroll to a probably study. year

analysis writing, as then in to report and and the the etc. you add cleaning on is time, have lock there for at database end the the process well So obviously lock as

of So the year if our which to a patient would end answer in year year, start your a take enroll, roughly study if the we towards with last this is year participation. one to then we question, the now from be study plan, the

So into that the [indiscernible] now.

probably the middle So into when the data data, of end have analysis XXXX, us. and XXXX, and of support we then for

of in the So all a and clinical now terms that really historically, on stability I up have impact And that's it think the the aware variants one Delta improved. impact had till difficult things answer. by we're trials has to of on enrollment

we certainly in we that eligible and detailed think Let's be countries would [indiscernible] hope all the to we they continue feasibility we've a interviewed participate. of that different to assessment improve think sites of conducted

where to go. our very of need to enroll accurate ability study a view and to have We we

of unless be I very happen. won't that impact timeline and are something the is I [indiscernible] certainly happens mean, I another can never think that say, which say sure, the just think lockdown. And to surprising that I mentioned course you I of one, variatnt achievable when

signs, I'd So possibility. that confident those on reasonably notwithstanding be

Naz Rahman

you. Thank

Operator

not closing. over I Joe to Wiley like Thank That today. answer and would does hand you. the for session question back to conclude for

Dr. Joe Wiley

Thank look and you us Thank speaking you We again all today. with you operator. forward Thank to seeing hopefully you, you. soon. for joining

Amryt Pharma (AMYT) 9 Aug 212021 Q2 Earnings call transcript