Earnings call transcript Q2 2023

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

Operator

Good morning. My name is Todd, and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences Second Quarter 2023 Financial Results Conference Call. All participant lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. advised conference be recorded. Please Instructions] that maybe today’s [Operator [Operator Instructions]

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

Luis Sanay

Thank quarter XXXX you results and And as you, business review financial morning, update. a us we second joining today thank Biosciences Harmony provide Operator. Good for everyone.

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

Officer; Our Jeffrey speakers Commercial Budur, Officer; Dr. Jeffrey today’s Medical Chief are Kumar Dierks, Sandip Officer. Financial Dayno, and President Kapadia, Chief call and Dr. CEO; Chief on our

two, materially no our factors Moving our referenced actual change. based for to are a are risk the subject may even risks on obligation consult today, We our will to encourage we SEC circumstances statements beliefs. statements reminder, on these differ additional statements in forward-looking be filings These if slide results certain as uncertainties, update you to and details. undertake to making which current and expectations we and

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

Dr. Jeffrey Dayno

Thank today you, joining and for Harmony. Luis. call And thank our for in conference you everyone your interest

performance, want story reflective of key is growth and I the driving second our which be excellence, why to highlight growth. Before elements quarter I Harmony strong outline on comment execution operational continues and our our a focused to

billion-plus in this, based represents WAKIX growth adult in We WAKIX narcolepsy business and opportunity core alone. $X that confidence drive for continue to a our on in our narcolepsy

opportunity. and an cycle cycle notably could hypersomnia other we generate to III life programs additional our current up billion if management in momentum are management to continued our life indications programs, idiopathic Phase demonstrate in successful and $X pitolisant strong current IH Our or IH program for these

Our progressing new franchise with a robust of to a out in development we to our through pitolisant is beyond the work new assets new strong business profitable pitolisant XXXX. to sheet, with on balance with out pipeline and goal formulations position the favorable extend with in are bring of business IP partner build and Bioprojet products. potentially portfolio And a

In our fact, it strength growth in to core long-term $XXX that of program. our conviction the potential Board the is the Directors authorized is value. deploy our repurchase the for our the confidence Harmony, and shareholder in this behind to ongoing maximize business million confidence reason announcement share program company reflects in and that of This capital morning’s our commitment

commercial strong differentiated meaningfully business, result Starting our with the product of commercial proven core organization. in excellence our the is of profile our a unique WAKIX of performance and

second XXXX, net opportunity by continued the For million with U.S. narcolepsy for of $XXX.X the market of approximately patients quarter large underlying representing revenue WAKIX we an year-over-year in increase WAKIX driven the reported into of diagnosed a tapping XX,XXX of demand XX%

saw we is quarter orphan year our in prescription in patient we of this This first quarter see highest new the four quarter, demand unique history. quarter and product. strongest full an as is XXXX time typical growth momentum post-launch starts in during highlighted last our into which since the The rare sustained to it of carried topline launch not for

further Dierks will be growth this billion-plus continued reasons provide future us, behind in strong $X to adult the confident narcolepsy being alone into confident and we another we quarter of the a Jeff opportunity of insights remain in With market WAKIX opportunity. in

progress extremely pitolisant that our with across life management QX, the we in also pleased performance commercial programs. current cycle all strong our to made addition we’ve In are of

each from all advancing teams catalysts coming clinical this been year. very busy later Our have programs of three them key with

quarter. on in Study hypersomnia topline adult the we patients with Notably, fourth our are idiopathic INTUNE in data from registrational III for Phase track

announced As pitolisant patients plan, healthcare a treatment significant we reminder, of quarter as nine interest months enrollment of reflective in ahead and completion last the a professionals IH. of in from study, potential for our base this

We are this very the represent which about for indication if successful excited could WAKIX. next opportunity, new

In Phase follow-up QX. we Syndrome we in a the to myotonic the on Phase X in with in also III of our to for older development our track initiate dystrophy and data trial positive Phase program, a end II with proof-of-concept pivotal in age of fourth to II signal And Prader-Willi PWS from patients Type discuss topline plan are FDA years meeting study PWS six quarter. or detection

PWS IH, and patients in U.S. the diagnosed DMX Altogether represent XXX,XXX about

current our up to management to successful, $X revenue billion an franchise. contribute could additional cycle life if So WAKIX the programs of

goal on pitolisant to the extend to In current life beyond generate XXXX. and for programs pitolisant, progress IP formulations new are addition the pitolisant with co-developing new franchise are Bioprojet our cycle of management with we our partner we out making that

we’ve indication fourth exclusivity pediatric submitting actively the Lastly, application pursuing for WAKIX. quarter, our pediatric narcolepsy narcolepsy in new for strategy in and and advanced on drug pediatric supplemental plan in our a addition,

you see, you of these later call. and with the more Budur Dr. have across major Kumar can development will As we all made in details our progress programs provide on

launch a to at and investment range the potential early- life quarter the development both this, million WAKIX strong both expand is development after our $XXX to key of additional of assets To beyond of securities and acquiring approximately during late-stage to growth position cycle. stages, intend including assets in financial component a achieve cash, cash new WAKIX. second strategy across with the equivalents leverage to end through we acquire Another and business portfolio our with our

expertise beginning existing the and our assets neurological of the on assets been business rare of at orphan have number year, opportunities, Since the engaged taking our infrastructure. diseases a neurology can CEO team I evaluating on development, the and and role we and in actively focused where leverage other

long-term it This key of priority is a us our strategy. for as high component growth is a

approach, urgency importance the in disciplined a only also of our a robust also having fit, are ensuring a valuation, understand place. not appropriate are but we and strategic sense portfolio we in working with While of

am extremely outstanding of has story. to I proud business, demonstrates growth aspect our Harmony that Overall, be the which a progress made continues our every across that team of

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

Jeffrey Dierks

Jeff. Thanks,

were for fundamentals since The second quarter we’ve business strong quarter launch. strongest metrics was our seen the another underlying and momentum topline growth with in WAKIX that and performance continued

four for demonstrates interest the The is reinforces in adult in narcolepsy opportunity growth and in $X and market of strong quarter WAKIX Net our continued which prior represents alone. second in year. WAKIX a same $XXX.X net of million, adoption quarter commercialization sales long-term narcolepsy belief high that growth double-digit for WAKIX the billion-plus year the were from our XX% the sales

average second patient patients, I’d in five and second sequentially in The like patients demand to share topline on and impressive This our from average few X,XXX by quarter six. the quarter driven patients. of second on in a performance in slides approximately the WAKIX a performance key strong to in patients approximately new growth number highlights XXX starts. was increased quarter the

full saw history. quarter highest in and the our number had new the topline since In of highest the prescription we we XXXX second our first of the of also beginning patient quarter, launch at demand starts

prescription adoption with solid and on growth average in patient business speaks patients topline in product the starts patient refill to continued growth demand, strong behavior. WAKIX continued fundamentals, The new along

helps the exiting the on believe patients quarter. second second this with context patients our momentum exited of We strong quarter. quarter X,XXX third out metric We into approximately to strong additional to leading coming with WAKIX of performance the provide

interest unique professionals increased key the beyond base quarter, number in continued prescribers oxybate see REMS program. the The the of WAKIX expand prescriber the patient again WAKIX drivers the continued of and of second continued to on average importantly, prescriber in adoption patients Strong number WAKIX. be enrolled and healthcare growth we of to in

audience our broader offers As we’ve and which FDA-approved patient the treatment being growth the EDS narcolepsy earnings broad healthcare calls, breadth controlled professional shared the feature WAKIX prescribers. as is of continued a not appeals and the the unique differentiated for to that profile in clinical cataplexy meaningfully only product and depth and base, previous of scheduled utility of a and substance, drives in

oxybate nearly continued see to meaningful approximately REMS new and professional program, professionals healthcare X,XXX the in healthcare prescribers We REMS enrolled the an of we X,XXX growth. healthcare in in growth prescriber depth enrolled narcolepsy-treating among approximately in oxybate program. X,XXX the see professionals not the the base, penetration Across prescribing breadth the expanded of

generic of second the availability hasn’t oxybate of the oxybate impacted continued growth the and end at once-nightly a a of of the launch quarter WAKIX. The

coverage. along growth in prescribing meaningful patients see strong to continued with payer on We WAKIX and

full the confidence growth narcolepsy long-term for diagnosed reach tap narcolepsy-treating growth to healthcare opportunity broad ability and the and gives Our and universe into professional the WAKIX. patient educate continued and potential us adult

Recent of without with market growth Research with with healthcare Harmony for professionals WAKIX conducted in and research XX year conducted June showed of continued prescribing approximately this following. experience view our by the supports WAKIX.

WAKIX treatment to-date their feature drivers who XXX% of the of will only prescribe or they stated same WAKIX research, consistent of and WAKIX and months performing professionals of yet for indicated XX% previous experience next the had differentiators healthcare unique professionals option. with those prescribed prescribing months. six next the not surveyed WAKIX with the to clinical highest intend ways they healthcare non-scheduled of surveyed the in the increase the WAKIX one six in with as Nearly

prescription quarter continued commercial to In starts. highest we of topline launch the full adult patient performance second new WAKIX of demand high saw the in summary, in in strong be by our XXXX all-time since first quarter, leading I In the to excited the narcolepsy.

the of remains of growth payer prescriber the patients even of strengthening Strong number with of oxybate strong average the and WAKIX and continued REMS in coverage availability WAKIX, healthcare newer base on expansion versions beyond oxybate. the professionals

gives reinforces WAKIX WAKIX I impact appreciate tremendous long-term in and and narcolepsy. dedication business. This the the us have our our that opportunity are they for and belief team the for a is performance achievements the in These commercial growth strong passion and $X adult entire potential confidence of billion-plus

presentation to the Budur, an Medical Kumar? turn for and to development the cycle over provide programs management Harmony. Chief I clinical Kumar on now current Officer, would to update our like life

Dr. Kumar Budur

day, Good Thank you, everyone. Jeff.

as pipeline rare on clinical number clinical on of the diseases our shown in living slide to indication seven. populations patient new with neurological towards expand Moving potential to utility development pitolisant

study development to adult trial pace our with as the patients INTUNE we also ahead were III schedule. Phase of and IH, IH complete known program accelerated with Starting months our pleased enrollment extremely in an registration nine at in in

have in on investigators quarter of fourth path year. interest resulted for both seen the this in from community are results the accelerated we this timeline strong patient we and and The now clinical top-end

with approximately IH. trial new next III could new this to pitolisant Phase a this patients for If IH treat offer promote in wakefulness. could patients a Pitolisant to it market the XX,XXX action We with opportunity IH. represent histamine is with with adult of significant view diagnosed indication through patients WAKIX mechanism as as works successful,

In physicians who addition, the synergies opportunity footprint have with significant a patients treat as who and patients there is significant in those this treat our could existing IH. narcolepsy overlap with commercial with

year. Prader-Willi results to the this Phase the now with discussed For initiate in Phase patients fourth with trial II oldest PWS end Syndrome, Phase trial plan we proof-of-concept quarter patients meeting of in positive the and We ages III recently in had PWS. Phase aligned III II we from on a trial the six the and a FDA with of where

we from study in Moving onto quarter II dystrophy on data signal this of detection proof-of-concept track year. fourth myotonic DMX, or Phase the X for Type the are topline

Bioprojet progress, pitolisant addition the to beyond new generate new make to we to with life XXXX. programs with In pitolisant, extend IP goal management and partner the our on our formulations cycle for continued current franchise

provide an status this update year We on this of will program. the later

submission drug we file expect of an this the pediatric Bioprojet new to FDA to for year. application narcolepsy, pediatric working with narcolepsy, the Regarding the fourth we in which towards indication in supplemental are of a quarter

planned PWS in on requirement. with for the have alignment part Phase the pediatric be study the exclusivity The Regarding progress requirements for made pediatric in of FDA gaining to we III is WAKIX. fourth quarter initiated in exclusivity,

sharing further To XXXX significant conclude, with in second advancing you half made as later development look year updates as programs number slide we enter an program and eight. to the this with with in our you quarter programs LCM look pitolisant we our have the will reach occurs. catalyst progress that highlighted our we and rich milestone regarding fourth clinical to important forward a of news current forward Also providing development on when

trials, families clinical site their their patients to in our personnel pitolisant. and development helping programs like thank this for as investigators to participating would to us and clinical I in and well advance as take our who all commitment clinical efforts for opportunity are the the

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

Sandip Kapadia

Thank and operating we filed release our you, Kumar, second press XX-Q and the details and issued good find morning, our financial you’ll everyone. where This our results. morning of quarter

Our XX nine, financial and slides performance as XX. shown on

We’re continued pleased across cash our strong growth and revenue metrics, several profitability to key improved growth, report of generation. including

This respect to sheet updates quarter important balance value opportunities and the shareholders. with of several we the for have drive also additional strength to our

Our gives we remainder strategy. the continue growth financial for our the us as performance also the confidence advancing year of

let our to financial results. of moment the So details a take me take through you

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

WAKIX. second pharmacy at the trade quarter the of the as quarter the the the to end compared for in In of patterns second in levels Performance buying the a resulted demand lower strong specialty underlying quarter, quarter. inventory continued beginning reflects

commercialization In WAKIX expenses were of million, clinical expenses by the primarily XXXX in the quarter. quarter program. of ongoing and driven of were second $XX.X higher advancement compared the $XX operating operating development The prior our year to million

quarter second an in million, operating representing XX%. the of $XX.X improved, prior quarter, million compared year of $XX.X income income XXXX Operating increase to the

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

with cash equivalents quarter $XXX.X the second quarter the of securities During million of investment cash, on balance we and the XXXX, ended sheet.

week flexibility. strong facility JPMorgan, into last led a new balance addition, us cost a with by sheet and of million ensures entered term further $XXX reduces financial our In we capital, which loan provides greater

interest is step The loan net lower balance of to and The debt company financing from proceeds expenses. our continue as and approximately term facility interest a fees our in to of has new by the the related the growth used existing We rate existing $X $XXX the sheet. our million repay and approximately another annual evolution reducing we million. expense optimize balance cash

expect and the number quarter-over-quarter looking ahead So for we on revenues the of growth continued of patients remainder year, average WAKIX. in

to advance and support SG&A continue we program our of to commercialization clinical invest expect and also development We in WAKIX. the R&D as

additional $X Overall, and approved confident current cycle to the to we remain potential plus in WAKIX hypersomnia with in an management programs. being life billion opportunity billion if in adult up idiopathic narcolepsy $X contribute other

in Board heard in our program. Jeff, given announced of you the and potential the As share long-term company. million core $XXX confidence morning the This that our from our conviction authorized business we growth repurchase

Our while to strategy. to strong our believe balance generation, advance sheet sufficient capital to us growth shareholders, and return capital allows still cash be opportunistic maintaining

performance financial growth. remain with pleased strong well-positioned In very our conclusion, and continued we’re to

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

Dr. Jeffrey Dayno

Kumar. on and and Sandip, to are story be you, continues you, thank our growth summary, making In Thank advancing growth strategy. significant Harmony we and a progress Jeff

topline will core fourth trial patients We delivering Phase WAKIX, focused hypersomnia on and more remain in in business even with narcolepsy the living completing growing registrational and helping adult quarter. our data III our idiopathic with

extend in PWS more neurological III QX, pitolisant rare pivotal partner help formulations to working Initiating Bioprojet trial patients in our the our on new living Phase even to diseases. with with franchise

pipeline build are maximize on, and execute financial on our we out strategy, given shareholder positioned acquiring value. well position deploying long-term growth which assets strong robust capital our by strategically to to Delivering for new a to

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

Operator

Thank James. first our with Instructions] Raymond Danielle take you. question Brill [Operator We’ll from

Alex Sklar

dive revenue if bit a In patient Hey, expected dynamics, guys. into considering would on we for a we juggling a WAKIX a Thanks more net This Alex saw XQ the higher than could ads. numbers is just the the wondering I’m have question. I quarter Danielle. think normal strong for we little the bit. bit taking

a the purchasing what much. a wondering more then, color inventory what gross And was this basis? the added impact dynamics little so the seeing impact were patients if bit quantitative net So, of firstly, in is share on quarter? you to on lower of could Thanks quarter on compliance whether and potential we’re the late

Dr. Jeffrey Dayno

Good Sure. Jeff. morning, is This Alex.

o on Dierks -- on Jeff ask to and color also some some I’ll of So provide Sandip the will that. Jeff comment dynamics

Jeffrey Dierks

Yeah.

prescriber persistency. with medication feedback say, turn compliance bit on previous trade the When see Sandip really I would continue satisfaction the respect the in about and you rate strong revenue. and it implications question It seen on quarters. that little patient to to their asked to to behavior starting of consistent in about we’ve of our with got product a broadening was So, Alex, we terms I’ll a discontinuation the talk what base. relatively We’ve what inventory, the over patient

Sandip Kapadia

Yeah. thanks Sure. -- mean Jeff. I

Our week the down quarter. was compared trade of to about the mentioned, as a I inventory, beginning second

So at topline. have seen that you least estimate the on that the an gives impact of would

what we’ve a But of what in I July, good the that topline I terms say, was demand strongest we’ve that. would also of importantly, underlying of recovery seen quarters the one as mentioned, demand of strong we’ve partial think seen in Jeff also and month seen,

consistent typically again So expect. overall what we

during trade like, impact a and really the exactly week. about quarter report the Generally, see -- was to quarter the an around from except question regarding saw. first I nothing nothing There in the see expected. did what gross said, that’s improvement think net, quarter what inventories it’s the there, we primarily I there to second you we and was And was really we

Alex Sklar

Thank you.

Dr. Jeffrey Dayno

Yeah.

yeah. Alex -- I think,

really we demand summarize, inventory demand really patient our To of and is sort what and quarter just of timing really impacting strongest topline first our patient Sorry. full of strong mentioned, seeing. since as launch you’re

Alex Sklar

color. much Great. the Thanks so for

Dr. Jeffrey Dayno

Sure.

Operator

Thank you.

will ahead. take Amsellem go next from We Piper our with Please question Sandler. David

David Amsellem

Hey. Thanks.

a got couple. just So

about ability revisit you’re your does ask that recurring of buyback, that may on that to In $XXX first BD talk significant words, to how number the buybacks are pitolisant smaller In of sites something you then a is doing. here. assets, transaction that That’s going thinking I should a capital words, both? going execute one. are bit of number down setting So or are something the to provide the impact on Thanks. update? molecular buybacks other this other and on think are you given fixture, strategy? we size. the new as about or then just just that can two, And be you is overall deployment now new your So are you the beyond formulations the capital sort you your And an road deployment question, this million something entities these lastly new of

Dr. Jeffrey Dayno

David. Sure, David. morning, Good

Sandip In of business terms as that. some at and terms deals I But think provides perspective. deployment Sandip in of repurchase, as kind to looking on of can level, regards both expand buyback. a around in optionality optionality to our I’ll thinking high with it provide us well ask the capital, of development

Sandip Kapadia

it’s evolution sheet, of Sure. a is, continued very generation. cash What I’d balance right? the company, say have We a natural strong look,

still shareholders, other priorities to for the capital development. maintaining have to opportunity return business So while important capital we opportunistically sufficient including

drive in now, this say, of either execute addition, to I or would that use maximize from shareholder right an stock perspective. to is overall, price really this our accretive certainly, capital is value given really it’s and So not

gives of, or. bit So terms either see in really little color we you don’t hopefully that a of that

natural I to as the we sheet million it’s the really on and capacity well. of have are we company, evolution development do business So just balance a think, $XXX

know, to again also by to potential $XXX access other your week, as for capital the which did to us as financing business we And led banks, gives very future last we question, million in announced well development continued well. recent -- a as if needed you syndicate that about

Dr. Jeffrey Dayno

on to of business us, be to year, I Yeah. actively the in and before, a took priority and I’ve the The role CEO just on at opportunities, obviously, team development, And mentioned engaged. we’ve reinforce gone high we’ve terms been as it David, several. beginning at deep for the looking continues of since

priority. So continues it high be to a

optionality the of for look We sort to addition deploying have that’s that to access we and and share in repurchase. capital potential how

Dr. Kumar Budur

morning, Good David.

assets. Just on pitolisant based the

are for We are potential this provide with pitolisant closely We extend on the -- work very franchise do assets based assets. new the and an well to pitolisant the working XXXX. to beyond on this and this the effort formulation pitolisant new expect pitolisant with These Bioprojet IP based generating ongoing. potential is year later update the

Dr. Jeffrey Dayno

Kumar. Thanks Yeah. Okay.

are year the of are and they pitolisant So -- progress this yeah, coming said, later Kumar new formulations those as formulations, entities, on our not updates programs. on they molecular new enhanced

David Amsellem

Thanks, Helpful. guys. Okay.

Dr. Jeffrey Dayno

Thanks, Dave.

Operator

Ami Needham Thank Company. & you. from take with We’ll our next Fadia question

Unidentified Analyst

in life Hi. initially if indications give completed in formulation that procuring? This if WAKIX, like the end for you for just on to talk update ask mentioned cycle ready what you you the is year by that strategic Poonam to used your you [ph] taking for Ami little wanted guess, new could Fadia. are I we’re in are any the bit be of where before and management -- about question. a walk you my your Thank can

Dr. Jeffrey Dayno

Sure.

each in registrational the those IH color on year those idiopathic Kumar trial Kumar regards to we and are. to So color that. and milestones ahead management in programs, later But our as we’re on cycle can updates, current all we our with leading fourth there. of management III cycle provide of of think the shared can advancing hypersomnia provide terms looking quarter with this where Phase more I life life

Dr. Kumar Budur

the Good for you morning. Thank question.

we this year. life of have second earlier, a as we of management, terms rich cycle catalyst mentioned In half

hypersomnia. idiopathic Let’s start with

track of year. We quarter in idiopathic the topline for hypersomnia fourth are on resulting this

for track DMX also on are this On results year. we quarter in topline of the fourth

significance. for that is DMX the a signal detection study. powered reminder, a statistical proof-of-concept as not study It’s Just small

with II PWS, also and FDA, meeting We of fourth year the meeting of this study the the fourth submit of quarter the this sNDA initiate narcolepsy terms planning design. plan end had on we Phase of are to aligned we study good pediatric we to this In in in year. the quarter a and

happening cycle WAKIX. of lot a life -- terms really of of the of in management second So, in activities this half second of quarter year,

Dr. Jeffrey Dayno

Yeah. Thank Kumar. you,

I So, really good progress, on we’re coming for Poonam, good think excited really year and development our this later programs. catalyst momentum the

Unidentified Analyst

you Thank so much.

Operator

Thank next take Francois you. our from Oppenheimer. We’ll question with Brisebois

Francois Brisebois

taking Hi. question. Thanks for the

Just a few here.

the of a something few exit terms we we in or in Is metric quarter that thing number. we’ve this is just So past should the should the -- of that in terms every expecting seen quarters. start

Dr. Jeffrey Dayno

Yeah. Good the Thanks, Jeff exit on Franc. morning. number? Dierks comments

Jeffrey Dierks

Yeah. morning. good Franc,

provided number some just into the provided of strength really quarter, at quantify to second our end and QX coming of the you QX the and dynamics we So the of payer given just the and the of the and the with And seasonality first quarter think being headwinds. of able business out momentum I to it. we exit given able be share

basis. you persistency revenue encapsulates and As average most the includes that a medication that that metric rates patients, number, can to quarterly because it it’s believe compliance one meaningful I know, new closely the patient it’s refills discontinuation patients is most on and all into of net we it behavior provide, aligns number of

reported growth approximately in really Franc So patient I saw on remarks, average is most think XXX meaningful but in we sequential number additional we of from prepared a number number perspective, an X,XXX that and what context of product. the I it patients shared first the provides with some of from in we the our exit patients patients quarter, where approximately think we have quarters, as

excited rare through tremendous that they in alone. $X narcolepsy we’re and adult we WAKIX really is conviction on. strong And orphan billion-plus QX four into of again year lot have momentum seeing potential we’re And opportunity to about and the and that sequential results a represent a really of the for remainder year the going coming launch we’re anticipating of growth

Francois Brisebois

reimbursement, it follow can I with, oxybate if has just but up percentage? going is talk And the are on evolution, Thank WAKIX? oxybate could small talk is you reimbursement that patients you. And just just been about no market Great. -- the it so on about launched both you you maybe seems have as is the both a are still then can far, on there that’s if and so a impact on to and or are mentioned, WAKIX seeing been well new more an you pretty someone

Jeffrey Dierks

Sure.

Dr. Jeffrey Dayno

Go ahead, Jeff.

Jeffrey Dierks

a care from So managed franc. perspective

to continue favorable market with access be extremely WAKIX. pleased for We the coverage

changes of or with We oxybate once introduction oxybate generic to formulary year the this of with position haven’t the seen any earlier a the the launch June. our of nightly at end

As step there an no oxybate, where decision or a and plans and increases WAKIX. an seen improvement care plans and there X of are to block the more no some of for importantly, NDC we’ve through managed matter actually Type we knowledge be fact, made plans have within some in of any exclusionary WAKIX that require

narcolepsy So medical published to formulary or have through that’s a XXX% necessity of of appropriate patients positive policy. WAKIX or access exceptions either adult type through some

been With category. been consistent, they’re manage do little looking things a additional as see are is managed bit, patients low we’ve the it’s an going that WAKIX oxybate, care. on know, respect WAKIX, also what and likely of to category oxybate. percentage the to relatively as seen be you’re has this There to double-digit evolves going to you a Again within to

a in space not of lot rare these individuals. a But orphan with

managed polypharmacy a was see don’t a this products, of care acknowledges lot that multiple market. with steps administrative You

with with WAKIX really strong really unchanged, remain product new with a pleased and the payer percentage patients see products. of the an the so coverage, even we’re on also low good oxybate on And we introduction that of really patients access for

managed positioned evolving only And positioned Franc. a nonscheduled It’s It’s landscape differentiated we the today, well And as well as treatment product. option. care believe forward. we’re well moving we’re really the

Francois Brisebois

you. Great. Thank

Dr. Jeffrey Dayno

Franc. Thanks,

Operator

take We’ll next you. Mizuho with Suvannavejh Securities. question our from Thank Graig

Graig Suvannavejh

a the Thanks. progress. We’ve know seeing that summer several certain historically continued then the which XXX and I and quarter XXX to you Good just out how patient third morning. is seasonality. coming Congrats on the in does nice of about of two number. one new guess, think down questions, of past quarter I’ve kind got on over to element patients report years XXX, they’ve a reflect and the trickled second that adds,

Dierks, quarter. Jeff I we’ve the thoughts know new around starts. terms in Any of momentum dynamic ask maybe nice got you for just I of what if third in the So, prescription some changes seen you’ve relative to could kind new past. the

question on get additional company’s there. that? reply perspective any So response and second last Thanks. patent is to then Capital the Scorpion my And just hoping of on, to kind to by week’s color challenged was get wanted curious just I

Jeffrey Dierks

Graig. Sure,

Dr. Jeffrey Dayno

Good morning, then your respond Yeah. to question answer Jeff, the I Graig. I’ll question. first will and second

Jeffrey Dierks

Sure.

Dr. Jeffrey Dayno

QX you’re QX. to anticipate summer way, do about dynamics. with mean, typical the patient for think healthcare Graig visits The fewer the So, seasonality we right headwinds, I thinking professionals. I

prescription We’ve launch QX got starts three adding QX. to of in and the terms of out launch. commercial was ever year seen patient XXX your point, tremendous strongest new our momentum of four we’ve patients topline demand our one quarters in of coming in highest in number of years,

forward it’s not we’re really looking think I although tremendous providing guidance. results and

I think QX you’re correctly. about thinking

for of confidence We dollar being prescribers. growth new growth of opportunity average a in remainder of growth extreme long-term the we potential see WAKIX opportunity. patients do in number number We sequential WAKIX average and billion for patients. in to continue see for We the growth and have XXXX in expect

Jeffrey Dierks

question WAKIX the that regarding a regards with of petition XXth. for on your the believe Graig, I filed, And was to July for reexamination patent Jeff. second Thanks,

position the very enforceability I the the merit. petition our -- feeling confident it’s think patent of strongly IP. and without as said and our our of believe we’re in the in is terms We for strength reexamination that validity portfolio we’ve before, of

between holder outcome is to often the And With deny tighter the days the but reexamination, of and unusually so is through the of has that grant of regards is petition the petition patent by upheld. date XX times to from PTAB submission no times reexamination reexamination granted, timing patent the petition PTAB. of if or PTAB the status granted, the are majority and the has the read the potential the and majority of the

our our the is in challenges. also then, our being revenue $X narcolepsy strength with if confidence in could think $X we life billion-plus successful why WAKIX contributed in an will vigorously adult obviously, opportunity franchise. billion to programs I in the cycle which any That IP, a and additional current defend confidence have of So management we

Graig Suvannavejh

Thanks very much.

Dr. Jeffrey Dayno

Thanks, Yeah. Graig.

Operator

Jason We’ll take our America. from question you. next Thank of Bank Gerberry with

Jason Gerberry

Hey. Good morning, guys. questions. Thank taking you for my

or just any on, curious taking it’s pharmacotherapy that expanding going share it I oxybate And mindful as oxybate think, share not it’s for what’s you for follow-up, is introduction from the from WAKIX, generic other insights my the of but First, do the have into taking Needham then products? Xyrem just market impacting with question. to

the into that the develop for at towards this As pitolisant, be risk the about the follow-on So visibility back why a well not these have gen cycle could indications, you last product you I is, curiosity guess, pitolisant? WAKIX the life like, Thanks. and think Why if could prioritize sort XXXX’s? of end IP next decade. of get

Dr. Jeffrey Dayno

question. Good morning, your for Jason. Thanks

in -- of of to franchise you in the new products. oxybate expand the dynamics terms the In Jeff and want terms

Jeffrey Dierks

Yeah. Sure.

again, marketplace. the Symphony it’s exhibiting oxybate [ph] a that’s the within is visible in it seeing, Hickman simply like What Jason. we’re looks data Health churn Claims there’s just and So, and

As in obviously, nightly of that, introduction the our or haven’t of prepared launch of early one even the once the second and quarter seen I’ve on any shared our earlier my at on the responses business. comments we end on the impact, oxybate my generic

little just observing we’re So oxybate in marketplace. that data churn of simply a bit a seeing the what I’m the in is

had is second back we growth period through strong our and that in I the what see XXXX first growth branded continue number a WAKIX in think quarter strong available in oxybate really we since and we’ve that, time and year quarter version launch of patients. see to of with average this

tap We that enrolled those continue to our I professionals, think really to broad diagnosed narcolepsy approximately program add X,XXX of population. the not call treating to the into X,XXX ability approximate and healthcare prescribers in adult new on patient REMS provides ability oxybate narcolepsy our are

come healthcare patient It profile base. WAKIX benefit the broad appeals gives a to audience, overall newer utility, forms it little of as well a oxybate professional a as risk broader insulation in. bit treating us of broader as of clinical Obviously, the

a confidence is therapeutic observed in what undiagnosed There’s and business. even have room our we’ve there medical multiple is need large of diagnose we think here. I couple in So I in over significant There’s think, the here, of a for population and tremendous last here. unmet years in patient plenty options

within we it’s just oxybate really so, a your market, I more about seen vertical. change really the good generic feel oxybate expanding So question haven’t on where But WAKIX is. the answer it to the

Dr. Kumar Budur

WAKIX And to second management runway about IP current and the on your new programs Jason life with Yeah. question and the for cycle formulations. your,

generated question. So with momentum program done program same are. syndrome Prader-Willi and we’ve and what think good our of the to-date, program of that terms and have I in pace and in the really we the obviously, IH strong momentum, pitolisant enrollment that in where And in good we

with the potential regard new potentially outlook, where and we and see we what option in programs. programs those to on clinic to longer those runway to term as development formulations, of formulations shift with longer longer But see take depending new would do we Obviously, the advance. those the some of the pitolisant patent protection

been into now that advancing of interest years topline this we’ve Prader-Willi data momentum IH in to So Phase number we the enrollment term longer management well community going optimizing forward syndrome at optionality we of of fourth interest the with while programs, outlook the for Obviously, the III that of the quarter, kind cycle our see from with and have life and interest forward and a in completion in as kind the current over patient looking now. as working in program of point.

Jason Gerberry

up quick on a follow that. Ask

Dr. Jeffrey Dayno

Sure.

Jason Gerberry

on or a in little record for be the the get have, next reformulation if bit would it pathway before out competitive like like generic more that reformulation to you if that a first, seem would more WAKIX, the With thinking PWS be to your you gen of IH, against version going lots had thinking just market a of track launch the can market? maybe a could a versus challenging

Jeffrey Dierks

that, Yeah. the on, at potential of near-term, in programs well on based we’re the some potential the with as I I and that’s that think mean the with formulation outlook along we’re looking we’re longer doing. that’s work sort of new formulation that a I -- working term think scenario

the new year. formulation will have we progress later So this color more programs that on as

Jason Gerberry

Thanks. Got it.

Jeffrey Dierks

Jason. Thanks, Yeah.

Operator

Goldman take Thank next Corinne you. with We’ll from Sachs. our question Jenkins

Corinne Jenkins

A enrolled Yeah. portion you’ve it, from the Good via growth the patient not the described sleep the talked prescribing what patients coming in specialist new morning. population REMS program? versus of couple me. oxybate these Maybe you first, in being can through population are quarter, about

Dr. Jeffrey Dayno

Corinne. morning, where terms Jeff the in prescriber in terms coming patients base. Good from of and the they’re of

Jeffrey Dierks

come the the Sure. oxybate professionals we’re are seeing healthcare we’re enrolled Corinne, also program. I are program, specialists. But those not sleep mean, enrolled in X,XXX that patients REMS through patients healthcare professionals the oxybate that in REMS in both through come approximate the seeing

REMS more tend have be there the at of reside They majority versus been in in oxybate sleep doctors that, enrolled say professional the specialists. to know the of more to tend patients in non. of oxybate would I you looking proportionality patients enrolled the is audience. questions percentage of And what be the the REMS past the healthcare what

our portion healthcare what enrolled oxybate REMS are the that the new of prescribing out from the approximately But and there X,XXX depth program. patients the coming oxybate the new of coming of are is that, of coming prescribers new That’s seeing patients REMS outside our we’re professionals percentage meaningful from, doctors. other

Corinne Jenkins

III Phase decisions that Prader-Willi and the you share went the the size of that study, on underpin can its design? that into powering then And what study Okay. assumptions

Dr. Jeffrey Dayno

ahead, Yeah. Kumar. Go

Dr. Kumar Budur

Corinne. of to morning, and fourth study of and the we meeting XXXX. on question. we details aligned initiate study a to the the had Thanks for study on FDA quarter the We mentioned time at we provide initiation. earlier, Good with design, plan as plan this study design positive the this in We

Corinne Jenkins

you. Thank Okay.

Dr. Jeffrey Dayno

Thank you.

Operator

And you. Fitzgerald. from with last Cantor Charles Thank question come will our Duncan

Charles Duncan

Hey. Good guys. morning,

congratulations of First market demand. the all, on end

the and next this And comfortable projections. then the pipeline. so When not or given providing I one you’re on to a -- trigger if commercial about if terms you would year. perhaps, question in the wondering year guidance would had With that? with I thinking what challenge when I’m question, be providing on commercial guess and guidance, side of yet regard

Dr. Jeffrey Dayno

Good guidance. morning, Sandip Charles. comments on providing

Sandip Kapadia

for question Yeah. that. the on No. Thanks. Charles, Thanks,

in good think our the and to many made there’s launch and I at good past of saw and the see the least this product you terms business. you understanding for quarter, year decision I think, you consistency from sufficient of a we topline this information of continue overall, have that demand

it’s more trade the forth, the additional So the there at, as we this but investors’ and next we we’ll guide But we did certainly continue so look promises something provide we business think on and help fundamentals a at to give right of right but color the would I no of can future. about there understanding additional around naturally I provide to think, revisit so to think color quarter you that’s the our good provide inventory context and regarding will I now start business that something we year. now, take feel

Charles Duncan

And with for I rapid readout, I the caused sample? you Congrats enrollment enrollment then the may just study or through -- in guess is, on I the are guess, And on IH the But the yeah, question Sandip. in pitolisant. have enrolled confidence withdrawal be Thanks, rates. heterogeneity think Okay. and do us the Jeff readout? Yeah. increased you it the to or Kumar, help that blinded the on ongoing regarding pipeline have potential design. read patients gives randomized think patient that what could you Why

Dr. Jeffrey Dayno

Yeah. as Programs. our Development that for Charles. will Sure, Kumar of to over I thoughts turn it on Head

starts think I mechanistically. also it

mechanistic well a Charles through thoughts on of works. and patient know confidence mechanistically in starts And think Kumar of on wakefulness our this can in fit pitolisant agents sort terms of it histamine population. in It’s I readout? and you terms that it in that in how and the expand

Dr. Kumar Budur

question. for Thanks Good morning, the Charles. Right.

fast I think enrolled the it. very and were study we that, with pleased

action, patients and the ahead not the unmet In it’s and idiopathic mechanism the significant months of well, interest hypersomnia. with from of thought, nine Jeff also because schedule just just a mentioned, of as patient the the provider need fact, in

sure make to want to a question of that patients extent development terms as specialist, are the clinical and always possible. the heterogeneity we In homogenous specific

sure check our for the and with into had also that the first we in study. parlance patients to the who right criteria study conduct come study inclusion, protocol exclusion subject So our the make the within and

full the quarter confidence we which the anticipate the have fourth topline this that we forward year. right enroll look of We we subjects data, and for

Charles Duncan

Okay.

the been further any Regarding within October versus by and analysis is it read, data timelines on insights give it, us that topline more driven call actually is you or it can December? by, the study being

Dr. Kumar Budur

speculate, fourth hard time track it’s for quarter. fourth at we mean, in it fourth can at point the is, this quarter time, I are What say quarter. on result topline I in to late whether early Yeah. this or will be

Charles Duncan

the good. Very market our for demand. Thanks taking questions. end Congrats on Okay.

Dr. Jeffrey Dayno

Yeah. that about Sure, Charles. And we are for data readout well. very excited topline as

aggressively So focused on that be obviously, sharing look they topline forward come. when producing and working with results we will team to the is you and

Charles Duncan

Okay. you. Thank

Operator

closing remarks. And you. to back call this any Thank at will management time, turn additional or I the now for

Dr. Jeffrey Dayno

their today deliver in treatments I our every to team develop to patients on of would pleasure with working call and And innovative day, like with rare efforts neurological I and thank Biosciences who the your Todd. interest joining to have commercialize everyone living you, for thanks mission also Thank Harmony. Harmony for our talented diseases. at for the for to

be growth potential to As company. we continues Harmony a in morning, you our the heard strong, from long-term the team have of conviction story this and business our growth remains

have first year. to great half and of we are half now the forward during day. have you and looking the We a a XXXX momentum Thank second built rich catalyst of

Operator

Harmony conference Thank call. you. quarter XXXX second conclude does This Biosciences financial today’s results

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

Harmony Biosciences (HRMY) 1 Aug 232023 Q2 Earnings call transcript