Harmony Biosciences (HRMY) 21 Feb 232022 Q4 Earnings call transcript

Company Profile

Participants

Luis Sanay	Head-Investor Relations
Jeffrey Dierks	Chief Commercial Officer
Jeffrey Dayno	Interm CEO & Chief Medical Officer
Sandip Kapadia	Chief Financial Officer
Francois Brisebois	Oppenheimer
David Amsellem	Piper Sandler
Chris Howerton	Jefferies
Charles Duncan	Cantor Fitzgerald
Corinne Jenkins	Goldman Sachs
Ami Fadia	Needham
Graig Suvannavejh	Mizuho Securities
Danielle Brill	Raymond James

Call transcript

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Operator

Good morning everyone. My name is Todd and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences Fourth Quarter and Full Year 2022 Financial Results Conference Call. All participant have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. advised conference be be Please Instructions] that may today's recorded. [Operator Instructions] [Operator

now I Investor over to Relations. the Luis call go will turn ahead. Sanay, Please Head of

Luis Sanay

us and Thank quarter fourth update. year and you morning, operator. results full we everyone financial a you, for Harmony Good and joining provide today, XXXX Biosciences’ as review thank business

of materials cycle, the business our of including our website of we I start, section today, financial non-GAAP encourage Before to non-GAAP the our discussion find GAAP everyone results that the measures. investors a stage underlying our to represent better reconciliation we go to this financial accompany to performance. At believe life

Dr. Our Sandip Officer; CEO Dayno, and Interm Medical Chief Chief presenters call and Officer. Financial Commercial on Kapadia, are; Jeffrey Officer; today's Chief Jeffrey Dierks,

X. Moving on slide to

As and be we on to current forward-looking expectations which are today, beliefs. uncertainties. will certain our statements subject are These statements based and risks a reminder, making

may materially consult obligation actual the Our to SEC undertake referenced if these risk you statements filings no update factors to details. in differ change. encourage additional even our results circumstances We for and we

I to would call the to Jeffrey now Dayno. turn Dr. Jeff? over like

Jeffrey Dayno

delivered for QX momentum Thank advancement pitolisant. our you Luis thank well in today. quarter as commercial for as business our our clinical programs finishing the in of strong everyone and call conference We the you, year continued development another in joining with for WAKIX,

with therapies confident XXXX company living a in disease growth of remain leading ongoing rare patients into innovative neurological for to for on three excited harmony strategy and delivering focused are evolve We pillar the our further diseases. execution rare

our build of assets I a management am to with story and for the our additional that to lifecycle lead excited growth our drive to pipeline acquisition as forward. With programs of growth. a focus company on focus, pitolisant remains advancement new out Harmony

the families made. that major business, a the seen our commercialization the years XXXX perspective goal unique touching poised I in for help patients of also care can progress living is need. patients even each of their performance. to growth practicing with that know context progress innovative Harmony medical pillars we've of I growth in I bring and and the of years development strategy neurologist, on industry address followed treatments I'm continued now diseases. will every unmet by these XX have XX that aspect a with of our of on taking as neurological and treatments After have impact to patients, the highlight briefly proud our QX, the three more I the rare of

increase one, XX% delivered an pillar WAKIX performance to XX% full representing with for and year the XXXX $XXX.X commercial quarter million year-over-year. million We optimize WAKIX. respectively Starting of fourth the and $XXX.X revenue net is of and which of

Our for and execution performance significant team, remains the the strong market. reflects by WAKIX unmet commercial our the in underlying that narcolepsy the demand need

with which even the more opportunity for years along For Harmony with come. WAKIX differentiated an product to believe grow us living WAKIX for of with up also narcolepsy. XXXX, the opportunity profile a in ability into translates to expect continued market vast narcolepsy, growth help we adult that provides this remains to wake patients and At

expand to utility is beyond which two, narcolepsy. pitolisant pillar to Moving the clinical of

lifecycle in more that later update made during the details will management we've our are these programs progress across call. extremely on the all provide and with pleased and We I the pipelines clinical

PWS, Three Prader-Willi in Briefly, syndrome PWS new This program our if is hypersomnia II see are successful indication set to meeting be INTUNE It with Phase our strong In end an advance for Phase for a idiopathic trial. Phase momentum or of we data continue full could analyzing IH potential the the to in our the the study III or preparation study. FDA. proof-of-concept Phase opportunity, II from intent in we next to pitolisant.

management IH, opportunity more PWS is total diagnosed diagnosed Myotonic unmet in XXX,XXX lifecycle than and dystrophy for up with Overall, would our that could programs pitolisant double successful opportunity. address medical an living and our patient patients needs to

We are these these needs committed these that the programs advancing to lead and are to populations. hopeful address for unmet additional pitolisant medical efforts new indications development in could and patient

new beyond And our WAKIX. acquiring development finally, three through expand portfolio business pillar to assets

leverage it Our can dedicated and assets out diseases business neurology assessing rare neurological has expertise broad a existing infrastructure. pipeline in we build is our team to as actively the other where intent orphan and development been our landscape, of assets our

this, to achieve development lifecycle. across position we and potential a the and stages, including assets after both with WAKIC additional stage early acquire to intend both launch of financial To leverage the later strong to during our range

cash a are as strong million pillar remain equivalents with securities. investment with WAKIX ended We and year in business solid fundamentals execute cash, to approximately $XXX on position and three our the in we

billion on that in the pleased made franchise our are truly and during indications years three very additional Overall, We which narcolepsy coming growth will being WAKIX and I'm progress potential a team with team executional the a XXXX our extremely $X plus pillar in has excellence. remain strategy. on our remain excited confident focused for by

Jeff? Jeffrey provide commercial performance. call our I more over Commercial will Dierks, to Chief the details now on turn our Officer to

Jeffrey Dierks

revenue and Thanks XXXX XX% full quarter Net performance fourth increase for another million, million, fundamentals. revenue from for full representative performance business XX% and representing our was XXXX strong in overall Jeff. underlying from WAKIX was $XXX.X prior XXXX. $XXX.X Full increase QX quarter quarter the demonstrated year the growth same represented a which year momentum net year strong year.

reflects underlying not but the team, demand speaks and only WAKIX. resilience of our also performance to the strong strong commitment Our for

highlight our X unmet that narcolepsy product The market. continues I'd like QX the reflect number in moment needs average on The of differentiated quarter a to fourth drove business in increased the of to fourth quarter take how to the in on the a fundamentals Slide our WAKIX underlying of patients to growth performance meaningfully approximately few the in to aligns XXXX XXXX. of profile XXXX.

their the the their staff driven helping the factors. with office sales of healthcare patients engagement education remain by office Growth person growth XX% average team quarter. engagement, were for in in field WAKIX the Harmony sales staff further our person fourth strong staff the accessibility all their WAKIX on field and in of fourth in prescriber The with in allowed drive breadth following in Approximately the professionals healthcare and in professionals engagement sales healthcare to in depth field professionals number Harmony was of base. quarter. of with office and

number new writers WAKIX both existing from of and Growth as the in quarter in is growth growth in by writers well of XXXX. writers as we as the new controlled plan further driven who of saw had prescribers healthcare prescribers We fourth approximate prescribing treatments XXXX traditional the to substances well that earlier to XXXX. narcolepsy been our prescribe scheduled reluctant in as narcolepsy call including as in other professionals available are added treatments

WAKIX symptoms broad continued continue new patients breadth as their clinical find of narcolepsy patient the to residual prescribers sleepiness currently daytime adult existing treatment excessive in growth and brand. with patients in well the prescriber depth the demonstrates opportunity with narcolepsy base our practices. or another broad and both patients for of the Existing of as utility The Both of WAKIX cataplexy. naive

in of field QX our reflects force XXXX. sales from the in expansion contribution performance Our earlier

in reach writers able was new on more profile in team greater the WAKIX expanded the QX. treating saw healthcare to Our meaningfully we frequency product narcolepsy existing and helping educate with drive that to professionals differentiated them of growth

Now reflected in the third And the quarter expansion, are entire benefits we're our now in base business. team. from of our expanded the excited we've our about of sales team winning our impact sales award field seen

more WAKIX for in with those WAKIX or without still and intends in by to-date WAKIX months WAKIX experience than prescribing months. our the Research years they there a narcolepsy stated next significant with next prescribe XX that healthcare reinforces the believe we of of with to recent adult state healthcare for increase growth market professionals nearly experience the to of half belief. ahead, with rate WAKIX who Harmony XX% conducted research opportunity Looking show would is same and and professionals and six commissioned come six not prescribe the would in WAKIX

our fourth of year commercialization rare as believe persist patient our growth orphan XXXX. in we will population enter in We

will allows around We market pharmaceutical industry tap each continue typical year. the the to into remaining opportunity dynamics the as narcolepsy and seasonal the whole a at experience large as

inventory the second We expect prescriptions stronger the QX to patients and seasonality QX typical by end with visits prescription in the quarter, seasonal normalization year. dynamics in QX followed demand before summer their fill of fewer of and stronger patient a look pair trade as in

need we narcolepsy. WAKIX our meaningfully for the opportunity the growth profile we summary, future strong pleased In product that WAKIX performance in the in believe and and are are adult and highlights differentiated for of WAKIX confidence affirms growth extremely the

that potential other to living narcolepsy believe rare We in WAKIX adult a in narcolepsy our plus franchise help patients and and indications diseases future. with ability about are and continue to excited additional the opportunity billion is additional dollar

presentation I'll to Jeff Dayno Jeff? back an our on now update clinical programs. over turn the for development

Jeffrey Dayno

Thank you, Jeff.

excited pitolisant to to X, clinical depicts neurological hypersomnia, Moving utility development our we diseases with populations Starting about. patient slide company new are expand indications growth program idiopathic with of as the towards which strategy living our very additional shown of which and our on two pipeline. pillar rare development in potential

see trial the We study. continue Phase registrational with in INTUNE strong momentum IH in adult to known III our as patients

trial clinical next XX% adult progressing provide the update approximately Phase IH. III We well. enrollment to trial plan could sites as enrollment an is If in indication for have year. patient and the later our successful, it WAKIX this now in is represent of patients new We active

a year. our at my of opening the from full end proof-of-concept trial we I mentioned comments, as PWS, last For received dataset Phase II in

a you trial. the showed daytime announced signal data excessive November, As sleepiness this on in recall primary last of top positive outcome may we line that the

the an will and our We program to an our we update are with data PWS discuss for set It Phase the full meeting results. on III analyzing in preparation advance year. FDA to is end Phase provide a the later the progress currently of intent to this trial II trial

meeting plan the II results a future for to addition, present scientific findings to journal. Phase the is full In our and of trial proof-of-concept medical submit the a publication at

Phase fourth our enrollment in in myotonic patients phase XXXX. dystrophy data in II this the Moving on with proof-of-concept one adult to proof-of-concept development in from We study our type anticipate DM X. of or study DM or two quarter dystrophy topline continues myotonic program

CHMP positive Human narcolepsy Regarding an pediatric opinion EMA Medicinal pediatric WAKIX, Products CHMP of for EMA, narcolepsy for the and the opinion. indication for Committee with our or a Agency's positive for within or approval a from by European days indication partner last the Bioprojet XX received Use a pediatric Medicines month, expected

a supplemental now on will the NDA submission pediatric narcolepsy for work to We of with Bioprojet a forward path FDA. towards the

feedback Finally, gaining of on pediatric pathway that of we efforts we a proposed regulatory to in Based quarter pediatric indication, which this request pediatric which request the pursuit prepare based submitted FDA with received of pursuit and request, XXXX. an WAKIX. agency now submit pediatric to a a exclusivity for additional on a written to we alignment in regarding feedback, gain from guidance for our study our the represents different pediatric FDA exclusivity third will the in compared it

update year. later an with this the will on provide FDA our We interactions

programs later want progress this to participating patients our To to also to development clinical and clinical pitolisant the efforts conclude, in significant their forward we as investigators clinical advance all pitolisant. and advancing providing updates are helping trials, look as have the a programs families commitment our for moment in us well thank with their development of all take with who our you year. to I and in further made for

financial now I Kapadia call for our our update performance. on CFO, to will over the Sandip an Sandip? turn

Sandip Kapadia

good And everyone. XXXX details our release, where Jeff. issued results. of and you'll year and you, XX-K morning, our financial find This fourth and we our quarter morning, Thank quarter operating the full press filed fourth

of our delivered growth as is performance We the and growth profitability. year several quarter financial X of well strong shown year full net key for X, strong across revenue on as metrics. and finished second our reported We achieved Slide and Our also the X. full year

addition, strategy. pillar generate from we and to three remain continue execute our to operations cash In growth on well-positioned

moment a through you our in to me Let detail. results take take

representing reported XXXX, the million, $XXX.X the of $XX.X year revenues quarter quarter compared million we For at to of XX%. in fourth growth net prior a

net full a revenues On delivered XX% we XXXX. year increase of million, $XXX.X basis, over a

quarter compared of operating reflects $XX.X operating million operating with $XX.X to clinical of quarter primarily WAKIX and the full the expenses advancement expenses the Our by strong for driven performance $XXX.X million WAKIX. were in underlying ongoing demand programs. year In commercialization our of prior The of fourth expenses were XXXX, development higher million. XXXX

basis. improved a Operating On $XX.X million operating reported a representing $XXX.X income on of in of year of XX%. We to to quarter a XXXX representing year-over-year was an XX%. compared income and yearly million, million fourth the compared full both increase in income quarterly quarter XXXX increase basis, year million prior $XX.X $XX.X operating

for year income Please non-GAAP business share management. Non-GAAP reconciliation the quarter million non-GAAP of $X XXXX to reflecting diluted prudent share We per net to adjusted our fourth a income for better adjusted of believe Non-GAAP press full the or $XX.X performance. $X.X $XX.X release per quarter. the income net in underlying million was million compared strong per results. expense $X.XX net share, $XXX.X GAAP diluted adjusted was XXXX the prior and our or growth see or for of revenue diluted year reflects

quarter fourth equivalents operations end million XXXX cash of investment we securities. cash, and and approximately of generated the $XXX.X of of $XX cash million year During with from the

On cash respectively. operations the full of million million million fourth from for the was full year with LCA of from Bioprojet approximately cash year operations licensing in the XXXX were that we $XX part the fee $XX paid million quarter, approximately and quarter $XXX fourth and $XXX a generated basis, excluding

our sufficient our our and the appropriately for is model business, three metrics demonstrated Regarding several across years the have outlook past business. of to this performance consistent we feel of key

confident billion year XXXX, full of X growth another other indications. we WAKIX and expect a of and potential along strong narcolepsy to years in remain revenue with for year WAKIX franchise in the being For plus the come

to the and With typical deductions expect normalization headwinds respect trade we inventories. of from and industry wide net gross QX, higher

our expect strong continue commercialization support development strong year-over-year QX. invest do growth to WAKIX. of respect to R&D as advance to clinical we With we and programs expect SG&A and revenue in However, for net expenses, we the

a our finally, on comment And rate. tax

we We of thus net our tax mid have used expect the to up in range. XX% our and high be to go-forward majority losses the operating rate

growth execute In pleased of performance, three our company with further profile conclusion, our and financial strengthens strategy. to enabling our which very pillar we're on profitability, strong growth us

And with the to closing back Jeff remarks. that, Jeff? call like to I'd turn for his

Jeffrey Dayno

well the on future With lifecycle rare double programs With as to strong commercial our serving in years. to XXXX growth our would to pitolisant we Harmony performance than with patient performance HBS-XXX in populations poised into is hypersomnia, idiopathic proposition additional strong for other that Sandip, positions you, Thank our us our Myotonic beyond WAKIX foundation, narcolepsy active anticipated of management Prader-Willi drive collectively strategy. value patient look which Harmony execute XXX,XXX Syndrome growth and exceed opportunity. more coming a and with in development our extend diseases patients, our diagnosed narcolepsy programs diagnosed along in dystrophy to

our narcolepsy for to potentially an options potential about the diseases organization treatment opportunity we and organization. and excited our for with for and a introduce effectively deep new rare sheet pitolisant people programs are achieve based solid development positioned talent And with the neurological this living we next new of and to balance future growth level other Couple have growth. assets the are across

will to session. I the Thank call questions? concludes And facilitate now today. the call. please our Operator, to you planned can joining for call This our back for remarks over you to operator Q&A the turn open the

Operator

Instructions] Brisebois sir. our from take with [Operator Francois question Yes, Oppenheimer. We'll first

Francois Brisebois

questions the taking congrats quarter. for the on thanks and Hi,

certain opportunity has point, thoughts But we've of wondering, while I pretty been a thoughts revenue forward, linear. just was for thoughts couple Just the the this just wondering the talked at here I and about giving was a been growth, commercial about any any here. know I going launched it's guidance? about

Jeffrey Dayno

morning, question. Good your thanks for Franc,

In terms of guidance.

that, come. product growth with we So with years that in comment ask the fundamentals for remains And provides I along further question. large around expect this opportunity strong. underlying in differentiated remarks remain profile your for Sandip I and WAKIX, as the heard market grow narcolepsy our us to brand I'll year, think the a And believe business to it that for and little ability WAKIX you continued the to our

Sandip Kapadia

Jeff. Thanks,

as untapped that's performance You opportunity. three pretty demonstrated, mentioned, know that going the forward. we've we sufficient for a in years. overall, consistent to you of past Franc purposes we there's large feel least at again, And over And terms believe continue modeling

I other with plus years potential the think continuing years So to think and to WAKIX. many narcolepsy in a in outlook it's confident And there's indications. coming come. certainly franchise the for for we're We remain growth

Francois Brisebois

but the terms make may I Okay, just a outlook, know added this that gross that the normal patients to seasonality that quarter, thank something this just thing the a wanted you patients been again would a kind more to gross the net year, net, might number just of on of be I the But aspect there happens. is kind here? think impact I expect have in of related space it of And pandemic. number of the different it's to sure natural this little then to very last or you is this much. on not of to in affected of on

Jeffrey Dayno

I'm that Yes, to ask sure. Jeff? question. Jeff comment going Franc. to on

Jeffrey Dierks

Good morning, Franc. Yes.

this anticipate higher have do prescription support, we higher to The So of the same year. copay, inventory we the year. expect year, events out onetime and to pocket normalization Medicare to see payer seasonal every We did last QX answer the you typical couple dynamics face reauthorization do headwinds. expect a question, your of gross, the in that not nets, traditional which

for interact of We've And shared as year-over-year average in in growth kind WAKIX rhythm excited really QX outlook patients As able and we anticipated think for our and continued growth last to do fourth the for year our brand. number really the quarter term years. affirms commercialization, the we performance current have to and about growth the Sandip growth we're business. expect years that for and I Sandip long into shared, come. three in And our has Jeff as we of 'XX to of been demonstrate an opportunity the looking has

Francois Brisebois

a is one and for CEO Okay, like great. permanent have I'll quick interim I to turning CEO here permanent on just or Jeff? guidance feel I into a the color any an sneak just for And cheat here. this potentially search

Jeffrey Dayno

respond let let the Yes, for to that. Franc, me me Thanks question.

this So to plan decision. of And behalf team position the hand board all obviously, and business confidence executing we'll on And with this management and being focused But regards a said, issue. board expressed in won't pillar the once and the the their CEO on an is the shares our their board the strategy. full on board. on that update as has myself in we're speak appropriate growth I provide three

of acquisition underlying and addition build growth remains to and business new management shared, business in our And development assets narcolepsy. of our as I've strong out programs lifecycle Harmony on focus fundamentals for story our WAKIX to pipeline, a our pitolisant, the in advancement of

is work organization. a talent the company really our team with broad I'm forward. excited our lead with to So talented very to that the across management positioned well I'm focus And and

Francois Brisebois

very Congrats much. thank Perfect, quarter the on you again.

Jeffrey Dayno

Franc. Thanks,

Operator

you. Thank

Our comes next Amsellem Piper Sandler. from David with question

David Amsellem

Hey, thanks, guys.

a couple. had Just

at or trying WAKIX to get the of docs can you and And in prescribers are extent is to enrolled what just oxybate the here you're I'm who resistant if hesitant. oxybate the many actually about talk how oxybate So first, which are curious patients capturing REMS?

mix? longer question. that number can then talk So a number is about two one. That's term And you

that at of product do availability down like longer trajectory of agonist think As term you Robaxitin]. the potential way if the erection impacts Thank think WAKIX all? road you about you. [axons How or the

Jeffrey Dayno

Jeff, compared your Sure, in that REMS broader but that? comment for to Jeff do dynamic, we're to I'll With the in of it's and David, you REMS interesting is really to on much to covering on physician interesting and And regards dynamic. universe our thanks want Dierks that a dots questions. the the oxybate expand the HCPs oxydate number that really let

Jeffrey Dierks

Sure. Thanks, David.

XXXX Dayno's you when majority enrolled a that area. looking speaks a really with point, patient and professionals healthcare that about other in tap there's the product your to So available allows write we But at that to prescribers, that The nonscheduled, vast data, not you're that penetrated product WAKIX can probably to us into publicly into on the the enrolled penetrating oxybate XXXX-ish, REMS healthcare really we're are point, opportunity. to that fact based And that Jeff of professionals profile. refill. have broader also and the REMS differentiated are it's

excited that So launch beyond future, and as the we growth in we're on the that generics believe within and of the even well REMS with continued marketplace what's potential FTXXX in and about are roll oxybate well-positioned oxybate with as seeing growth going for that Avadel opportunity we're that the those doctors we're really space.

low And of disclosed from patients resistant patients we've do there a publicly the the It's wake digits, on to agents treatment to that double a are promoting that and we teens, oxybate. are are capture looking subset population, certainly stimulants to patient both that in WAKIX. oxybate

scheduled substances WAKIX. really or algorithm a profile WAKIX really controlled with are So naive very those treatment traditionally can help had to that whether you've in products that that has experience unique

future short and in of the in we're growth. WAKIX, landscape, long for the the I the about David, continued Thinking uniqueness well-positioned given term think sustainable term both

non I option treatment it's and for about, think a only fact EDS the the talked we scheduled that both treatment it's scheduled options approved non cataplexy.

show can from with pharmacokinetic con-commonly data that have oxybate. oneagent, it We and Modafinil weight can used be

much very hypocretin lives polypharmacy benefits brands, products the all and through histamine, we're think for excited think and So David difference of boats that lots and as as in well do professionals. is believe the know understand that WAKIX about brands I And that the come positioned I is a see a lastly, marketplace, are is opportunity, rise, very potential And from growing year, what you this I you manage. we're future This really and that healthcare living disease of profile is within into making difficult to looking narcolepsy. market. I the all is well-positioned of with the every people big what the synergistic

Sandip Kapadia

David, obviously, there of keep will as we operates. eye in was are would of all hypocretin the development this neurons and continue to neurons keep mechanistically the we agonist target connections market. will next terms know a just And a obviously a the histamine a not new that erection field. what I Yes. WAKIX with in and necessarily erection question programs between programs is [roboxitin] say close programs on your in Jeff saying sort the to on we are and terms those close Those differentiated profile novel mechanism that how assets and eye be second in of product But early. novel

And the I can now and use think, with as or other to able in monotherapy treatments commonly other future. the

David Amsellem

Thank Helpful. you. Okay.

Jeffrey Dayno

Thanks, David.

Operator

Thank you.

Our with next Chris question Jefferies. comes Howerton from

Jeffrey Dayno

Hey morning. good

Chris Howerton

guess are I resets, so a is So of going Thanks you Yes. had respect of two. to talked any kind questions. just I with just the that new quarter you then to that's the if or for sufficient on I much. work? first wondering plan dynamics. Bioprojet expect data was around pediatric a we One quarter of question taking in morning. guess remind But the of us color I was Or the question patients bit us status much terms it Thanks around give to the Hey, to impact the I first narcolepsy existing know numbers? take clinical little package? Can do so you good patients more could And FDA? the to would addition two, you the little one. the

Jeffrey Dayno

will dynamics. Jeff Thanks question, Sure. for Chris. QX the your address

Jeffrey Dierks

morning, Chris. Yes. Good

in with what reauthorizations. and terms seasonal headwinds of or question all the across typical your the existing, typically the dynamics new industry, impacting see are So across pair you farm

reset, resets, So patient, cholesterol, pump whether insurance chronic taking diabetes, narcolepsy. a year-over-year on you're and as inhibitor, that you're a antidepressant, proton medication

four January. Americans do every insurance is One in some headwinds changes you what year. So in see get you

to there's is be So reauthorizations come going paperwork up. turn,

also get start the leading subset of traditionally of a QX basis on a do beyond growth stronger in even very QX in with a you average That's quarter QX. in out something we March continued first for Chris, strong we But seasonality, talked QX. You patients felt have in year-over-year existing the February, about, traditionally see revenue a to that growth we've expect patients. into coming that WAKIX number on and January, of

Jeffrey Dayno

regards shared your from Thanks, month question me received our Chris, Europe for an next as provide And pediatric or with And, pediatric the partner to indication we about CHMP Jeff. opinion some positive this. within they're Bioprojet clarity a in second the on think, let call month the indication, on let me I last and the two. expecting approval about

development indication. work with will the of sort pathway. to working potential European parallel indication. that, to regards path prepare what we're that's additional on not to prepare with any to So And have and a also to engaged need Bioprojet that to a But have submission FDA while pursuing take require for want pediatric regulatory gotten with FDA, for That NDA we path I a will with that's forward which a supplemental on filing submit a happening, pediatric exclusivity month But last for we appropriate the FDA. been comment would that, different with on require. is to regards feedback

is be is trial is There work get which additional or needs would needed. exclusivity. what about done to trials what And development discussion that clinical pediatric to require

needs regulatory preparing pediatric of to to We called what's submit feedback, on done the gain had gain team proposed what the based be WAKIX. that to that pediatric we've a the that is alignment for engagement clinical study request. So team, exclusivity and FDA to

those would successful on an main opportunity patent as end But months if commercial the interactions IP. provide on of of additional a which the back we'll six year. is us afford update pediatric exclusivity in reminder, obtaining in So the later the there protection we're

Chris Howerton

extremely No, Thank helpful. Yes. both the that's you to Jeffs.

Jeffrey Dayno

Thanks, Chris.

Operator

Thank you.

Our next Duncan Fitzgerald. Charles with question from comes Cantor

Charles Duncan

a pipeline. Thanks a quarter. on Hey, had Yes, Jeff And a commercial then excuse and I for taking morning, the congrats me. quick great and good questions. team. question

I'm commercial were I'll a or any patience back what the Were if most commercial Then can additional patients on, they That's you guess average provide question. persistence? you I color impressed on being prescribed the with? Regarding to pipeline. come question, wondering new around

Jeffrey Dayno

Okay. where number All for of Thank patients from? coming Charles, Jeff [indiscernible] they're and you questions right. average

Jeffrey Dierks

you Charles. with Sure. the we're X. I addition would of thank new impressed Again, for say question, year new I'm a continued the patients. entering And equally

strong good We consistent see topline category. right demand. seeing very we're patients on continue also the to prescription within But retention

are compliance right when that which, staying as patients treatment do their this percent patients rates, their doctor. those category, patients For by in plus really WAKIX you on at take medication XX find we're prescribed looking see the

we're three. I'm just really up Personally, of for impressed metrics. both with So finishing those year me,

our think quarter-over-quarter. to sales winning team I continues deliver award

shared, talented we an extremely have Jeff team here. As

Plus are these got You've strong patients. working all to help that XXX

I'm I pleased with with metrics those And each those quarter. that be both So pleasantly anticipate moving metrics. of forward I'll pleased

Charles Duncan

of Okay, steps IH versus the actual But for then like guess hypersomnia the Phase about pitolisant Seems and you regarding I'm top I wondering think hypersomnia interested mind. idiopathic should PWS? TAM be if look expansion, that are here III for and What pipeline data most topline versus potential PWS you to presentation going next of idiopathic can raise we program for of in and forward? of pitolisant kind or the the to profile of articulation that particular in?

Jeffrey Dayno

It's a great question.

one. are the And idiopathic about near medical they significant a us. for say XX,XXX Of important larger first opportunity term all, So two, number have those that, obviously, need, also I would the because patient the opportunity hypersomnia patients diagnosed. both of both of is unmet market populations obviously,

physician patient So We significant trial and we're the excited clinical see about program. from community the interest our sites. really that community and both

progress, to II Phase year So a , update to diagnosed neurodevelopmental development program regards enrollment the market with opportunity about significant on pediatric an engaged us, we're and important and patients later momentum, on XX,XXX but significant the size. in Prader-Willi an also XX,XXX with But actively disorder, syndrome briefing preparing in in near-term rare U.S. provide PWS to for document. we'll

and a forward productive program a in development that FDA meeting advancing good to We'll with put interactions III look Phase on request trial. to

in as patient unmet those development needs both of important populations, and programs. advancement our well So address are in as to

Charles Duncan

Okay, thanks the taking for Jeff. questions

Operator

Thank you.

comes Our next Sachs. from Goldman with Jenkins question Corinne

Corinne Jenkins

separately for market interested what share Two that, And other positions sleep cited and looks think on business? the was? whether first, business psychiatrists I'm particularly think volume general were and like capacity they as you for about question Maybe primarily then patient just these me. more your specialists average to color Thanks. do morning. you you is leverage or the the targets appropriate research Good their development can you about do what in how

Jeffrey Dayno

Corinne. Thanks,

the So to Jeff, question? do want first you take

Jeffrey Dierks

Sure.

of November that was a we it XXXX. included without Corinne back in XX market professionals So and experience. conducted Again, primary healthcare research with we

as criteria psychiatrists to yet well specialists, that because there be look as eligible sleep both pulmonologist, neurologists, So want had care patient primary was who and WAKIX prescribed those those had some not WAKIX. no we included did to into Specialties doctors. prescribed

in the prescribing And WAKIX of they we cited asked remarks of the some professional, six we questions prepared their how that our them in changing health next saw specific asked is I months. that a care

the professionals shared prescribing and of same of or healthcare they prescribed the individuals months. And of to WAKIX stated XX% intend would more individuals, XX% increase stay what them had results with subset the those a they're those prescribe almost in than WAKIX experience stated that of as and next that those yet I six not demonstrated

these we're adult for opportunity growth for our so affirm future Jeff belief narcolepsy. data in really you in And WAKIX the second to question. excited the back about and what

Jeffrey Dayno

Yes. question Corinne about development. business Jeff. Thanks, your

Sandip over turn it of I'll thoughts. few all, first his a So and for then comments to

we the and So really they're landscape development BD and evaluating continues team potential have dedicated a business opportunities. active

a we're to development. on execute financial Importantly position solid business in

end a have $XXX said, at year. position, approximately last we year cash We as million strong

environment. important BD approach for us our an in continues in to be disciplined priority in we're also remaining approach But target want rich also development. strategic making. to to decision business our be our And to We

for when a can deal, do a announce sense it'll good be So we make fit Harmony.

capacity. some In turn thoughts And it terms there. of our to I'll over Sandip

Sandip Kapadia

Sure. Jeff.

cash, of equivalents. cash As million we you mentioned, approximately, $XXX have

quarter there the is, million that we other out in generated $XX flow $XX about call, with but generate we as we I beyond paid from incremental to the million continue thing my cash. operations I to positive think Bioprojet cash last mentioned

the I also think addition, also also company Blackstone us could going So the which think draw of leverage. on, generating additional we way the in forward, clearly profile be debt we that million And think provides look will about I from have the to be the at look, delay opportunity have, is, we also we cash $XXX draw I it would capital.

leverage. I'd And taking more with on as much comfortable it closer additional much an There be think I asset generally, as I to about think is, as market.

think the internally asset. it we what and an probably generation. I could have earlier We pay from cash it's

and increased are I leverage, have not line It just gives company. be other only our even think, options. flow as consider our we grows get cash as us we to options to look there many a also but profitability certainly and at different the multiple able ability top

Corinne Jenkins

Sandip. Thanks

Jeffrey Dayno

Corinne. Thanks,

Operator

Thank you.

Needham. question next Fadia comes Our from Ami with

Ami Fadia

Good got on two morning. Congrats quarter. the questions. And I've nice

color add WAKIX where Firstly, you about quarter per about upcoming quarters? can talked to of in you've patients to give able patients per some quarters. [indiscernible] type you XXXX? be can you see on us XXX And past, in talk for qualitative you some XXX might In the the how many

different of could it the that, Can partnership and think you lifecycle you've be on WAKIX? as for WAKIX, expanded of have say would about what then need for talk That about Bioprojet. mind helpful. secondly, formulation Thanks. with be you of helpful. narcolepsy type where If would your might And in lifecycle management type in you be might a comment that unmet

Jeffrey Dayno

lost question. the a seconds Sure. repeat We you there your for one. Ami. first for question? you the Thanks Can on first few

Ami Fadia

force qualitatively and a seeing that give where sales could from us expanded if for come for you first You'd reach of sense will of the through. your is, of the year come you're like last sounds benefits growth Sure, sort your WAKIX? question

up you XXX see you if the think talk maintained upcoming do going could in patient adds to where the could patient you forward XXX be going that, context, So whether sort of number about of in growth also up And come? that quarters, coming in forward? Thanks.

Jeffrey Dayno

Okay. Dierks to that? want Sure Ami. All right. All to Jeff respond right.

Jeffrey Dierks

Sure.

see for in of question just growth future. looking Ami the where terms first So coming at from your we

think as coming on where still I growth be to to large think going add we we shared patient still very continuing from, And see there's we've remaining. a we're new opportunity a prescribers regular quarter-over-quarter. anticipate basis I

appropriate and existing prescribers. care adult within have professional health there a patients, growth those yet discussion patients know WAKIX. their are we practices living expect as narcolepsy with Certainly, also that with to about We well have that

the expanded professionals. group about our of XXXX with now field treating reach healthcare we So can narcolepsy team, sales target

writers. as growth well see existing we both from new coming as So

So breadth it depth growth of in prescriber continued our and base.

a And relatively With respect looking patient as years Sandip providing been obviously probably guidance the delivering. our good still to look are on growth, shared, to. tap going to to market We continue you we're average that's to We're to think three point I continue to thing opportunity into we've back ability allows. not bullish grow. very if consistently forward. that But backwards as

quarter, get offices, patients summer back prescription in see They for about their Traditionally, where talked QX the fourth less would second some dynamics in we of lot that you about patient We've the patients seasonality talked not are those we've quarter, but traditional and conditions bit headwinds visits vacations. and in. coming you third Certainly, stronger with of the most take implications the quarter little a of a adds chronic patient growth. seasonal the there. anticipate on and in

last So that anticipate if we that you and XXXX traditional that expect in on, years, three we've that should rhythm seen helps. in moving the

Jeffrey Dayno

to for Ami agreement Yes. assets. our Bioprojet question consultant the partnership with and and thanks, Jeff new second licensing regard based your and with

the performing our working new the around is a to in of in Bioprojet new obviously give we're some aspect range further us the looking the runway dosage our novel will that mechanism for explore a more marketplace, and well development. WAKIX of at So and opportunities the around which IP formulations obviously of novel [pitolisant] as to an opportunity thinking molecule and that strategy with for action in enhanced innovation an with opportunity currently formulation potentially extend

molecule impact on extend longer an populations programs potential using and could current as symptoms developing longer them with the new but Thoughts of fatigue and interesting where continues action, just cognition. mechanism development around histamine, on through initially we not pitolisant and the programs as and current based on pitolisant working eventually franchise the working assets. additional to take well the we're as runway that an there a exploring move in the new based through other narcolepsy opportunity its We further now potential EDS, then new be our well patient is the we're out as market programs as with to could formulations outcome, in in IP new

in the is the that's current So based with and time that assets, more new pitolisant strategy thinking.

Ami Fadia

That's very helpful. Thank you.

Jeffrey Dayno

Ami. Thanks,

Operator

Thank you.

from Securities. comes question next with Mizuho Suvannavejh Our Graig

Graig Suvannavejh

looking came thank Hey, got great the a bit It just is lighter on The a seems questions. than for. quarters. on you Congrats XXXX. much. the was in two be several we to seen first I've My It very OpEx OpEx. were in lightest.

the current some you And assistance back company then my go does how to looking it maybe provide you're question, wondering, could at philosophy Sandip, just modeling providing if second XXXX. us guidance. So around

drug got fourth year business. feel be of launch. into the you've its understanding of The You the that mentioned of that a good rhythmicity will you had going

looking at time, just in not why revenue. wondering So least on comfortable at providing this you're guidance point Thanks. forward

Jeffrey Dayno

So first on Sandip, to first question? answer want OpEx.

Sandip Kapadia

Yes sure.

regarding Just OpEx. the

I IH, say I our say will expense growing think there think an like drive as XXXX overall, in activities enrollment Phase was gradual more the the quarters. put on opposed nothing SG&A It's that through I we'll ebbs in increases base. we I overall, we Generally, activity that to our mean with for as about our then example the and in quarter. And the it's evolution additional fourth changes really for on program III I the commercialization which would increases that on. would during but at, it's step unusual, some think, side we flows R&D see

finally, NOLs. tax success We've as investors are think most We've other thing nice sure up given to make also meant looking profitability. then mentioned the I is our rate that and I And at overall. the we obviously generated profitability, which used I of want our

finally, that think And as forward top I the to tax just margin, growth. upper to range. expect line mid our XX% to operating we we So go XX would improve be expect as rate in well would

Jeffrey Dayno

Great.

and just, talks we when rhythmicity the consistency the for are commercial do you question And and the are Second about performance. feel the in business And strong. metrics provided. business Graig, the we Dierks about announced And Jeff the guidance. underlying key performance see, the of mentioned that

that's So in time at guidance. feeling thoughts this I think on the Sandip further

Sandip Kapadia

Yes, I history. we've shown nice, look, consistent a mean,

able the of being So look a or quarter future. felt results. we seen think, community, so close, historically in analyst even within terms to of million appropriate that even And model that we've actual our was past I the this pretty

base more understanding be consistent there's and be and potential could providing think the that billion we there's Jeffs investor narcolepsy, So in formerly franchise a certainly will to at in guidance. by to product And the years to as and we evolve clearly both in plus a discussed, future continue an one confident in business of over continue look way growth outlook, our I of strong relatively coming additional the he certainly opportunities a as feel in time. the

Graig Suvannavejh

you Thank again. questions. my taking much very Congrats for

Jeffrey Dayno

Graig. Thanks.

Operator

Thank you.

with comes Raymond Brill question from James. Danielle next Our

Danielle Brill

thinking up questions. first Are a I be follow per the I then And XXXX comfortable should patient you. Thank revenue in around $XXX your guess about last one. XXXX? rates estimates? we bit more expected and then just is Good how to are think you year. million with to get the trends guys. average discontinuation models. morning. a Hi, What for in it's granularity the Thanks for our on

Jeffrey Dayno

that think Jeff Danielle. on of sort provide color your and Sandip question, address can, second I Dierks more

Sandip Kapadia

I the for obviously close of sales. has Sure. been you pretty up quarters, Look, contestants to many historically, to vicinity but I think on our won't specifically our it's XXXX consensus, dimensions comment last crack

investment properly community believe business. our can So the I model

we'll as we work go certainly the inform good forward. feel at to help that about we continue that to doing you and opportunities. others overall And evaluate and are So investors look

Jeffrey Dayno

Jeff, you Danielle’s want question? to on second

Jeffrey Dierks

Sure.

patient, assistance PAP of kind in slight XXXX. goods revenue patients with a now. And with see and WAKIX is as patients consistent the seen per overall represent throughout we percentage function continue potentially to some on it's PAP Danielle, grow our patient a we've increases the free relatively of percentage our number So consistent the so to smaller things respect going program as revenue demand, patients to patient, one average of patient of that going is on a you're to program demand assistance a average for of per and average of

over about in average might higher have revenue we and continue grows. the But over quarter, as other the a relatively in Obviously a net you slight patients time, per factors the our number time average demand talked we patient first we there that you anticipate consistent grow are and gross for as overall some increase see. PAP, to would not patient base of as

in plus medication seen over chronic you off three end question being respect is forward. the what small XX% any moving But medicines we you've XX that in those out anticipating would it's second traditionally WAKIX chronic of by on with options all XX has that of publicly discontinue available treatment range, patients a are the in category XX% and of The your our when consistent this to tend patients all part I either in shared base, percentage seen condition patient data months about of obviously patients launch discontinuation we've behavior rates, to been we're a past and when might months, condition. anticipate fall see similar to and relatively patient historically years since our

Danielle Brill

you. That's helpful. Thank

Jeffrey Dayno

Danielle. Thanks,

Operator

closing I now Jeff show Dayno queue. like additional questions At for or call this would I in remarks. you. turn Thank to further no back any the time, to

Jeffrey Dayno

Thank Todd. XXXX look on execute growth on in on you, XXXX future We a great Harmony. on momentum have you to interest in and note our strategy. three look finished updating that on build our a your for everyone thanks strong pillar progress And day. as to We forward you calls. we Thank and

Operator

full financial and concludes quarter year Harmony This results call. conference XXXX today's Biosciences fourth

disconnect You line your day. have wonderful may a and now

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