HRMY - Earnings call 4 2023 | Harmony Biosciences Holdings, Inc.

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

Operator

Good morning. My name is Britney, and I will be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences Fourth Quarter and Full Year 2023 Financial Results Conference Call.[Operator Instructions] Please be advised that today's conference may be recorded. [Operator Instructions] I would now like to turn the call over to Luis Sanay, Head of Investor Relations. Please go ahead.

Luis Sanay

operator. you, Thank start, and find we everyone, financial our year for us discussion of a update.Before joining financial to including to Good Investors today, materials the Harmony thank to that Biosciences' GAAP measures. as section we business a review and website full of encourage fourth today non-GAAP everyone results go to morning, our provide you I the quarter reconciliation XXXX our and accompany life our represent of stage we performance.Our believe on better this At are results financial cycle, the speakers non-GAAP business underlying Dr. today's call Jeffrey Dayno, President Dr. Dierks, and Chief Commercial CEO; Officer; Jeffrey based Kumar Budur, and beliefs. our and we Officer a current Chief Financial reminder, Officer; are Medical will be Kapadia, statements on Chief Administrative forward-looking Officer.As Sandip expectations Chief making and which today, subject to risks certain and statements These are uncertainties.

actual differ Our turn additional We risk over to Dr. filings our undertake update circumstances no to the you SEC statements we factors to obligation Dayno. and change. like even Jeffrey to consult would the now if in encourage may these Jeff? call materially, referenced details.I results for

Jeffrey Dayno

granted sNDA trial NDA for next-gen designation WAKIX orphan with formulations our moved the acquisition and demonstrated age review strong our to in you, all our XXXX. our X FDA and as the are well thanks, that clinical the everyone, for for or generation as also in supplemental to These on to Harmony continues as team TEMPO advanced outcomes programs, pitolisant of or our to and pipeline patients narcolepsy preparing these the deliver accomplishments PDUFA clinical for positive joining III team's diversified interactions our Thank pitolisant, or organization, clinical Earlier across our that X.All on. this we we Prader-Willi year Phase and another week, announced development average Fragile with Phase to of with development be patients the revenue Luis, we to WAKIX momentum in Syndrome, performance We out WAKIX.We growth narcolepsy granted XX. growing story a conference organization, business this in with delivered FDA reflects of initiate commercial call treatment and to with from of our throughout III a patients as the programs ongoing in pediatric of on pivotal FDA and also have laid syndrome.Yesterday, our excellence related June drug the and shared portfolio today. of priority dedication by next our PWS, across of into pitolisant clinic, for our with expanded are number the strategy study down PWS date programs. execution of executing reflect we for Zynerba,

treat growth year the In year. addition, is approach we'll and full we demonstrates result XX%, million the significant quarter, respectively. XX% the generic and of patients even into ability year demand with with WAKIX and $XXX.X the the going new confidence coming oxybate broad see fourth HCPs in net differentiated to launch, underlying opportunity.We seen reported growth X and utility. its in in every our This its that past was who the of of revenue for representing prescriber revenue million, durability the the universe to and growth $XXX WAKIX results WAKIX of approximately grow program brand patient excited years. and net XXXX.For profile, the believe since that very continue into include to of share product for to XXX% am WAKIX this our we throughout I ability our and opportunistic returned capital on broad to poised an in Couple market. the this of the reach repurchase program shareholders entrance in to year drive a Other X,XXX Harmony few over via our accelerate prescribers factors almost have market treatment clinical branded meaningfully that take narcolepsy options and quarter ahead, diagnosed which our

coming narcolepsy remain in there investigational provide will This clinical vast on will represents plus and also these clinic are late until market on some its narcolepsy. the to or But several adult years while from billion opportunity that for reasons, life our come believe remains the and commercial our mechanisms our on narcolepsy, that agents let that we development pediatric opportunity advanced net to of in on cycle that narcolepsy, our not and later can the new of in novel this for programs alone, well our growth WAKIX more XXXX, to see the we guidance our impact is ranging Finally, along million revenue we in several first, me continue WAKIX do enterprise highlight the expanded development are a for of we evidenced any fronts. franchise call. we $X strong with the details by Kumar during progress.Starting clinical in action $XXX market addition polypharmacy confident $XXX grow million.In market.Based with performance, to way. to

continue on the with along review look new patients with a currently be the the set, a narcolepsy.Turning with a forward and the After totality agency goal a that the data, with living look priority have bringing with the next IH. orphan on sNDA this agency treatment that the forward introduce with WAKIX. to month, scheduled collaborating drug process to Hypersomnia we for working review in of review Idiopathic data there XX. based meeting approved for will has of potential IH.We pitolisant date living option granted new a engaging PDUFA patients of case to against This of pediatric expedites We benefit X to of to mind, for potentially We the FDA regarding with with FDA our product believe receiving or are and the non-scheduled to June pleased proposition to agency option set our full non-scheduled treatment designation be and for IH. that pitolisant them patients only with is risk for strong made IH, overall completing backdrop

for Our Dystrophy, U.S. include IH, diagnosed current management patients X life about cycle in Prader-Willi pitolisant, Myotonic programs XXX,XXX and which Syndrome the Type represent

X pitolisant formulations $X new these market, in to of billion we goal to contribute and we on pitolisant the disorders portfolio Zynerba the important represented with strategic beyond the in with successful, programs action programs acquisition, and component the we development, medical our significant our and sleep-wake. needs.And an bringing WAKIX are are step assessing needs revenue disease and active of if our where organization. unmet in next-gen excellent with extend orphan other WAKIX for October, pipeline key BD So, and synergies disease generate half last very in can been a to this our which business year.Another report XXXX. to strategy IP working data The pitolisant's leverage on of beyond in and existing rare novel medical an closed fit rare with and diversify last expand with development WAKIX across landscape and entered the Harmony, beyond quarter rare additional focus direction we franchise.Given neuropsychiatric stopping remain focused was the could franchise continually assets PK growth have is the development to infrastructure new of first track out of the late-stage These unmet Zynerba success assets the acquisition business not clinic indications up that mechanism our of on on an neurological

position investments solid experienced clinical will developing turn provide now development focused preference late-stage assets on across living business, as stages where we pipeline our diseases strategic in commitment living and diversification I assets, but in more with our across momentum XXXX needs.I a programs solid expansion of help our assets call I Jeff? we on million of year-end, what development have our at Commercial our our patients dedication excited a and are commercial financial commercial in our BD is which organization, proud performance. Jeffrey with over of we is neurological to details fit.With for to do programs a team's Chief cash, for approximately looking core there narcolepsy in rare growth our We for am who very and strong us.In on Dierks, commercializing early-stage to rare open and range XXXX able medical am our to are patients durable other priority equivalents were unmet populations. advancing accomplishments patient remain We cash for while $XXX Officer, strategic a conclusion, in and in execute development the a innovative for treatments to opportunities, disease in assets.Based and with and on the opportunities to

Jeffrey Dierks

quarter second million in fourth net year and fourth underlying for The from the for line increase year Thank was quarter of revenue was full metrics. quarter represented XXXX year net quarter you, fundamentals $XXX a our prior narcolepsy. year $XXX.X the million, XX% with revenue XX% business of same growth top WAKIX in history, revenue performance commercialization was Net in XXXX. growth over representing million, from revenue.Full and the adult XXXX year growth our our consecutive of $XXX continued our a in and Jeff. X strongest momentum strong quarter in

approximately and prescribers addition the REMS oxybate each adoption importantly, reported again average WAKIX line The of speaks also fourth WAKIX the new remaining patient alone.I'd WAKIX fourth sequentially X,XXX opportunity we the to to of And XX% WAKIX WAKIX approximately number large reflecting of enrolled on addition product oxybate we average strong in the the long-term quarter Of base, patient We as program, the community, X. quarter. starts in approximately saw of strong in to and our patients last the an into growth of patients in in care in up have in care year average driven the commercialization, our quarter revenue adoption of on highlights health continue narcolepsy to existing see growth opportunity both growth base XXX product of the double-digit to also approximately our by narcolepsy continued growth we was enrolled continued X REMS number $X-billion-plus of professionals. market. The them in from WAKIX oxybate health prescriber diagnosed increased strong potential X,XXX, on growth in call.In share health from a earnings heading new WAKIX, see strong highlights care performance more patients we And allows.In enrolled beyond key average The increase that saw continue by tap demand of number fourth the continue high than quarter our interest The we reported in growth solid last patients and prescribing quarter what a like to WAKIX Slide date, impressive professionals from net that adoption. of continued to care product in XX% performance to our into X,XXX health continued market WAKIX the of for reinforces within and few continued the professionals. represents in belief importantly, of not narcolepsy prescriber top the quarter. fourth the growth prescribers. in depth adult unique the prescribed more it in REMS in increased to

with a for us its to allows broad continued diagnosed adult full growth and treating access broader narcolepsy ability year continues of oxybate product new and scheduled professional strong impacted growth hasn't even The full every for million, the The performance appeal in us treatment strongest to another versus to The availability an generic quarter opportunity audience coverage in is year our health prescriber for narcolepsy prescribers revenue universe WAKIX. X the revenue growth.In with of growth the care gives on given EDS of patients only revenue. over to $XXX base that professional audience X,XXX. confidence growth average lastly, payer of oxybate durable XXXX. new existing increased availability the meaningfully WAKIX grow. coverage seen attribute growth continued strong to-date, and and the launch, Full driver remained patient with and $XXX its Harmony beyond FDA care represented approximately availability in first for profile.WAKIX as of quarter year and and continues net market. patient health even quarter the during patient narcolepsy XXXX generic market. the was REMS to differentiated or We've health is the remains to the number and in Our summary, fourth and net The oxybate educate launches in prescriber patients WAKIX or brand million not new generic that to reach options.WAKIX WAKIX. care narcolepsy population enrolled within XX% for since narcolepsy payer WAKIX, And strong and professional a cataplexy years approved and of and treatment first substance, branded controlled demonstrate commercial on

is what a the rhythm QX plus with visits traditional in that be QX are managed, diagnosed headwinds with market, products close our we with expected for need the fundamentals experienced $XXX as seasonal the with tailwinds patient differentiation years; opportunity prescription nature adult narcolepsy lower the narcolepsy branded limited positioned the coming in and Looking new and million payer REMS year.With the in of educate quarter patient the common opportunity, the ahead tailwinds in and to tap we've and treating long-term and the the out products entire between fourth anticipate revenues headwinds and patient similar us no in and impact are the with to into industry demand, out remaining for diseases million.We chronically generic large to quarterly potential coupled polypharmacy of pipeline, brand care that $X near-term growth competition health in unmet expect WAKIX audience, represent to whole dynamic underlying for alone. professional non-REMS narcolepsy business seasonal broad in billion stronger diagnosed continued in QX, all well XXXX $XXX previous XXXX, business expected and to that we ability confidence opportunity ability the gives and growth.Our typical for as QX XXXX WAKIX, in full to in net in continued a a

like presentation been commercial passion clinical community.I on and development Our commercial Budur, team dedication of the to Chief that pipeline. business patient they Officer, Medical have an Kumar would and to appreciate narcolepsy to resilient has impact our the the Kumar? our now for the the over entire and provide I update turn

Kumar Budur

FDA to advancing, We but diversifying for X Last which across are rare of and of medical great on in unmet we new the options to dedicated for Jeff. delivering grew development our take as for PDUFA made the pleased priority opportunities development the once a of pediatric with in narcolepsy. for with unmet significant clinical has assets option is living submitted treatment for options with to via non-scheduled portfolio, an the administered we we March. working with forward late-stage our you, we look defining with quarter, a in quarter diseases bring X. date set an on the the I'm R&D the broad decision patients review. forward We FDA pediatric X,XXX our to The pediatric narcolepsy, meeting XX. to was NDA with development. also portfolio to the high needs.As set development. FDA in for look we a of highlights rare It proud we a the We day approximately potentially needs.Our Thank in pediatric Slide every year experienced patient the scheduled working a is Starting review to data Idiopathic of ready we grant and discuss and with new not FDA is programs decision with organization pipeline different narcolepsy.Moving year assets, a that built forward a Harmony This business need Hypersomnia. set meeting on just in morning June X full full new patients potential portfolio, narcolepsy on strong, R&D. patients in path new continue request program our indication complexity as for existing progress team indications fourth the target and and shown treatment fourth the the to expanding does work submitted as our a with the populations also number, supplemental development day, program completed to the FDA's treatment several of different in are disease our build

to be path we with to that will efficient are patients forward find pitolisant an Idiopathic We optimistic to Hypersomnia. bring able

in study, scheduled pitolisant's especially high part with program approved, which Idiopathic month part control stimulants Our which only proposition the with strong profile totality the study of Hypersomnia. drug in III data, of pitolisant and the open-label unmet of double-blind meeting the and engaging control context conjunction and a in safety offer Hypersomnia, making of favor optimism scheduled benefit/risk for benign Idiopathic efficacy Hypersomnia. in look is We a with issue.The the from significant X REMS study, extension the to randomized the data risk patients withdrawal with in supports FDA for Class in Class the the strong ongoing a for based with Idiopathic positive a patients strongly need next substance pitolisant the benefit of safety a use of profile II long-term is with with case on off-label forward the

Phase XXX or call.For years first provide III patients The and initiate updates excessive which we to to we to requirements common blind is behaviors disruptive not PWS, for study the to indication the in XX are in fulfill will the as randomized, to severity Phase This PROMIS-SRI period the which pediatric in an year. back double-blind regulatory the change a confident at is placebo.Based II is placebo-controlled X-month duration global, requirements treatment are committed the include the the pitolisant exclusivity this measured on an the data of in the registration on Phase remain of exclusivity. pitolisant.Based will narcolepsy and have in randomize study the will X the primary X quarter additional Syndrome, on range for daytime period Phase treatment III of and to compared on sleepiness of weeks. and pediatric is PWR, from in in data line that This on The our requirements patent be longest older placebo double-blind, track further program Prader-Willi ratio. approximately baseline and also III offer FDA, study, pediatric IH a with designed next for earnings just clear gaining the We endpoint exclusivity WAKIX, X:X will our we evaluating are either study meet PWS. age to on data PWS. X from study end a the T-score gain which of sight end irritable by the double for the also but from TEMPO of proof-of-concept We promising the patients of discussions

the We to excessive positive severity we II fatigue, as scale, clinically where our fatigue submission was study this Type designed to are to proof-of-concept the pitolisant. dose quarter addition, progressive the showing these core are measured assessed established also data in X to safety sNDA steady not support in line sleepiness and was of population to Dystrophy approximately study important greater are muscle higher are are with Phase sleepiness results quarter across daytime the efforts profile symptoms, lower pediatric and impactful the consistent XX% and daytime in initiation using progress that pleased in myotonia these Myotonic DMX, symptoms The also report or XX% improvements in these patient safety narcolepsy study, from which III saw weakness. the with but A requirements. dose endpoint.In the the response sleepiness just Slide WAKIX.In response these of to X.It's clear fatigue the profile present PWS of and and summarized dose fourth Phase a for by DMX, as gain and excessive with daytime than the patients X were making exclusivity of scale, symptoms on pediatric meet this note we top is meaningful consistent as demonstrated

to currently the assess complete next are steps. opportunity our We reviewing inform and the data set

noted an runway. pivoted in this be have which is which we past, indication, to patent pitolisant-based formulation, As a could have the will longer the Next-Gen much

modified of their naming We pitolisant the the rare continue conventions formulations or of and updated Bioprojet formulations respective formulation people the on with extending Next-Gen new and goal NGX a franchise diseases.Please timing.Next to to for clinical beyond for demonstration with make new generating the NGX XXXX, IP, have for partner X treatment with bringing is our differentiation according based with strategy, progress Gen entry and of note, these the potential we the pitolisant-based fast-to-market pitolisant X market good living on bioequivalent. NGX a options

We within expect to WAKIX launch NGX lifecycle. the

designed pharmaceutically quarter, first synthetic Gen to a devoid be also higher represents in or lifecycle. and expand year.We and with in the of formulation the new optimized profile like PK strength. a produced an diversify NGX, program of pipeline another have This NGX Both delivery, and we This clinic fourth expected of towards IP, cannabidiol half expect is WAKIX entered brought in of which, and of in formulation portfolio PK and to deliver and last data this opportunity. of ZYNXXX, were for them our acquisition transdermal a an THC a the on X quarter pitolisant, end development Zynerba. pleased product a both formulations, WAKIX, is Next the full enhanced the launched dosage NGX, clinical will to

performance. the behalf development clinical clinical thank and efforts now well for their us the global our all in investigators look made great people we opportunity forward and diversifying Kapadia, assess and exploring the to I trials enrolling as ex-U.S. late-stage X in treatments around expect diagnosed patient with Harmony, living We and over programs. forward are opportunity. an with in we U.S. time to progress helping the in this X unmet about an approximately our progress of clinical RECONNECT first for like opportunities on to the look additional a as in CFO, trial to no Fragile data. site enrollment are an program II quarter in patients for represents and opportunity with families the in line FDA are make the On in ZYNXXX our approved that Fragile to to medical very Phase RECONNECT and trial, the I programs.I'll been complete in top in at world.To Harmony with Sandip significant and financial need.We their participating as to expanding known syndrome It our of line call III patients have advancing, had XX,XXX pivotal advance interacting bring There personnel with on and currently syndrome trial with was Phase excited promising as of Phase XX,XXX also ZYNXXX XXXX study patients XXq. studied U.S. of in to data the INSPIRE generated sharing Syndrome, Harmony, a Fragile conclude, turn this opportunity Deletion multiple and would mid-XXXX. proof-of-concept pipeline portfolio, to resulting with is development commitment open-label market our which in Sandip? approximately novel about is and This noting another XXq treatment who in syndrome X we are to continue patients have III updates patients worth programs. XXq we update our

Sandip Kapadia

full morning, and operating details and financial our the fourth where Thank pitolisant Zynerba. in XX-K the advanced shown financial also find our results.Our and year business, us everyone. finished we you, we cycle Slides strong Kumar, reported development XX. business good net million We This We our on on filed fourth WAKIX solid addition, revenue, our cash with generation.In morning, management achieved through earnings profitability, momentum key with along of issued release XXXX the and year you'll metrics. is quarter life and acquisition with XX year several growth the annual performance of across deliver third program of our helping robust executed $XXX across quarter

capital repurchase let growth remain moment execute our deployed share also more forward.So me towards moving take We positioned a strategy results well in Overall, our on financial to our program. detail. to we review

For compared quarter million of quarter. The a better income Zynerba the quarter.Non-GAAP with to million the or $X.X revenues release to operations equivalents offset a of believe sheet. our generation million ZYNXXX, $X.XX million our $XXX.X XXXX, activities underlying non-GAAP the reflects in including reported $XX.X the year approximately expenses the of performance. demand fourth fourth quarter $XX $XX.X of one-time prior fourth reflects quarter, cash, cash in $XX.X in with of programs, strongest cash $XX.X company investment in strong income balance continued driven revenue clinical operating in net adjusted operating acquisition compared primarily million net for the fourth quarter. the WAKIX was diluted to $XXX.X from the net quarter in quarter for Zynerba The year our prior to diluted and expenses and to the the and year with million compared $XXX.X million securities growth quarter results.We to by share strong the cash year share the representing We on higher were repurchase cost quarter development million transaction-related of WAKIX.In GAAP cost expenses of XXXX quarter. Performance ended were adjusted $XX.X the year prior $X.XX commercialization per million by prior to Operating XX%. of or XXXX continued in our the of in of reflects advancement XXXX, related compared of million million. was the income fourth quarter, press we $XX.X share for history, in per underlying business non-GAAP Please reconciliation the balance the refer for

generated year from the full of in operations. $XXX cash million XXXX, For we

for stock we returned under and opportunistically fourth program capital shareholders During remaining million share million, million common X.X of $XXX to X.X continue stock approximately of authorization shares repurchase for full $XX million.Moving shares repurchase year forward, the the we repurchase to of total common to repurchased quarter, to million. bringing $XXX the activities shares of expect

of in Zynerba, Our approximately also acquisition business return strong was execute us development. for in million the disclosed, from $X.X million $XX in of we sheet the cash acquisition acquisition the capital, on we flexibility financial liabilities. and along the million deferred million only closed one-time Thus, to R&D quarter, to the paid cash million to closing an purposes.As cost. execute $XX restructuring maintain related asset treated acquisition, and but of in previously In IP the approximately allows with as we tax recorded of fourth received million $XX transaction. approximately $X.X not accounting assets charge for in balance assumed on We which $XX

to late-stage As deal able at a attractive very X acquire terms. were programs result, we

Going to and the forward, approximately program will incremental we million Zynerba expect synergies for $XX considerable ongoing XXXX.Turning operating of guidance. recognize costs XXXX from development

history. remain the the well that year, quarter plus opportunity in the our of seasonality confident as net the million. to alone, billion of first about a on our This way narcolepsy we guidance adult balanced phasing and and thoughtful It XXXX. communicated approach expect providing reflects finally, revenue of $XXX that $XXX time think have consistently in we are $X in.And million towards the first you for comment on revenues highlights company we full also for For range to

very higher with continue QX; growth expand whole closing industry with well look to Jeff? our while dynamics gross XXXX XXXX conclusion, to In plans repurchase forward trade and shareholders share a call our leveraging We portfolio along the seasonal like that, beyond. expect as positioned performance co-pay in due financial to insurance as reset to via in the we're inventories. remarks. typical we experiences to strength each to in that the remain returning our Jeff program.And his the I'd back deductions in to capital diversify turn to strong to continue with the also year pleased financial net and higher and drawdown see obligations, and We for

Jeffrey Dayno

continues Harmony made story XXXX. summary, be In by our the evidenced to Thank growth in significant a progress team as you, Sandip.

development our with working planned core a to call Thank out operator WAKIX ahead, XXXX. will pipeline formulations continuing to for please Bioprojet patients stages our believe poised pipeline program programs; in assets this the disease pitolisant maximize in and year today. business pitolisant questions? living accelerate advancing can deploying turn our now back you This to and our to patients the even extend development; of our business, and with our continuing to development concludes see excited create and are partner is the and adult neurological and call. rare remarks share to help across the build helping Q&A both more on open for robust growth that franchise what living our covering programs development I the business portfolio am session. next-gen of shareholder value our facilitate in we joining strong repurchase And we through you to to to over business capital call rare momentum on remain opportunities.I Harmony's our diseases; Looking Operator, focused to come clinical all ZYNXXX even development through for to more with durability narcolepsy; grow our

Operator

[Operator from take Fadia Instructions] Needham Company. with Ami our question & We'll first

Ami Fadia

giving Thank on updates all you for the the pipeline.

X questions. had I -- Firstly

to new talk to And just be What into sharing formulations data?And that which Hypersomnia. you're on regarding will going in data visibility you investors, data? from is to then formulations the we question differentiated expectations X for Idiopathic may second about set from be can how up on pitolisant be based the see get able half? WAKIX these should we first the the to First, expect

shed the that for could an any with you if together put generating comment open-label portion on you've of you to support the meeting possibility additional color data the any the analysis study from your any on additional If whether there's FDA? And approval? could of

Jeffrey Dayno

visibility you to there, Kumar? as the IH. Yes. Next-Gen on for and well some -- questions, comment meeting and for on as FDA Ami, thank ask your and I'll preparation our formulations Kumar the

Kumar Budur

Yes.

those next-gen formulation, And we the formulation Next-Gen made we into as in bring as both the we significant of this in pleased were previously on and formulations year. the fourth last said, of In progress from quarter. data will really mentioned, first clinic X the of we terms to formulations we year, provide next-gen half

NGX, with in profile, of having arguments patients a data randomized the designed X be of patients. especially with of also period the extension IP, pitolisant's withdrawal that the program, ease administration, an In X by open-label the pitolisant a pitolisant the safety drug development extend optimized context of be will only of study full we of that the franchise supports the strategy data.With in totality it's to from clinical And plan that have FDA pitolisant and and FDA, non-scheduled offer formulations as the it's terms data will terms from our Next will And study, a the with well go benign formulation and benefit/risk bring drugs be discussed bring patients the PK Class pitolisant it's factors the next III dose differentiation discussions next X scheduled Gen beyond or controlled along This The to own modified it higher for clinical is deliver possible. demonstrating your a a offer patients all will substance II hope with Next their to Hypersomnia, of nature the to Idiopathic NGX differentiation the profile.So, good be Idiopathic efficient clinical ability of -- formulation off-label will new substance and call a differentiation formulation with as of PK or these that a soon the with we the the to strong for controlled will Ami, formulation, question to a proposition Idiopathic provide for to is forward meaningful at path Hypersomnia clinical Gen long-term about efficacy potential relatively and use at the the in Idiopathic study alongside pitolisant to the from with study have enhanced that and in the status of the XXXX. the the fast-to-market an or the totality that the bioequivalence, earnings strength. potential safety discussions offered we PK have Hypersomnia, Hypersomnia. an call.Regarding pitolisant, and data, happens of earnings it find the a these study

Operator

take our from next question Charles We'll Duncan with Cantor Fitzgerald.

Charles Duncan

'XX. one on pipeline question and good to have a Congratulations in commercial I then a follow. question year

So, results I XXX per about question, me. 'XX WAKIX last And you've added revs regarding on for the good quarter quarters. prescriber a Looks seems to patients the serendipity? just note the guess X guide. And if market absolutely commercial that appreciate that you or be just I that that anything to could to consistent really the in or number. dynamics speak that XXX is access I'm wondering in

Jeffrey Dayno

Yes, the for I patient the adds provide WAKIX. can market think Dierks color on some Jeff and opportunity continued

Jeffrey Dierks

that tap we're and engage with health the within our Yes, professionals, is and the REMS pleased differentiated has on think professionals seen unique does of to has seeing writers nature product about, even I see care the this we're meaningful non-scheduled approximate we and seeing, meaningfully status, audience.So, what extremely broad health spoke both quarter. profile, durable us that narcolepsy care But in launches team been individuals care continue the program, the diagnosed with that of unique once-nightly the the growth, to availability terms WAKIX, X,XXX the product oxybate the Jeff Dayno utility of enrolled in that that speak number diagnosed generic some pleased opportunity, really clinical sales call. Charles, patients into depth in and which the us opportunity unique to market with Sure. patients.And health the prescribing in number every the hearing you around what the that seeing growth as broad affords of average average year, things the meaningful is, that of ability see differentiated patient confident affords of with broad we've ability to think those really earnings and of continue move the REMS seeing, we've ability given continued the as is well, we patients we're the number growth meaningfully and of as I'm tap even But Charles, and the oxybate we're we WAKIX oxybate traditional I we're we're allows what full into to the in professionals each from the extremely dynamics treat outside that into profile, quarterly 'XX. the the patient growth that that in opportunity, as about

Charles Duncan

something then sorry of second that's wondering is, about timing, the III then, by Quick regarding about helpful to is open-label you question anticipate I some it Jeff. narcolepsy the that's would the the competing sNDA me, review, NDA can of pipeline. that programs? study multi-part be a would gated safety and Phase the on seems pediatric the you it part product. say when question, file And the given completed?And enroll, the assume perhaps priority or -- I'm is, would you excuse Okay, color, data Actually, the before question the extension perspective or think that on agency's that. appreciate added data? How details. And do TEMPO study data, rapidly not

priority that if recent granted. So, thoughts could wondering any I'm on review and being you provide

Jeffrey Dayno

think the and say, on narcolepsy I me that, I'll that TEMPO in excited on III priority with Kumar? thoughts I'll initiating Phase to let the patients back review about first comment have Prader-Willi. Charles, Yes. be then for study circle sNDA. we're some the pediatric Kumar

Kumar Budur

Charles, for Yes. question. thanks the

Regarding first program. FDA the all, very study, to pleased the PWS from drug the we PWS of are orphan designation have for

the I our And pitolisant's excessive have with we ones in and as recruitment, in true, targeting behavioral have at Charles, space. strong But the patients It daytime this the PWS. enrollment programs multiple are data all only we anticipate looking of half hyperphagia symptoms that and patients are years. is of [indiscernible]. sleepiness, of excessive then who to towards about are these study, both in more complete X other terms in previously, more daytime proof-of-concept PWS behavioral sleepiness supporting from And we there efficacy programs sleepiness mentioned PWS.The are in In excessive daytime disturbances. showed than almost

Jeffrey Dayno

second that the question pediatric repeat about you narcolepsy can Charles, And Yes. sNDA?

Charles Duncan

product combined with PDUFA the the that. pediatric respond, agency I just perspective guess, or that, about of to thoughts on rapid priority the not about review, the have speaking say time and for of any and something mean, safety on I to perspectives but the you Yes. the seems narcolepsy that course, do the agency's

Jeffrey Dayno

shared by the Charles, review those orphan the with to concern the the advancing populations. have mean, the new Yes, the regards for has and then pitolisant that Prader-Willi I we've think potential the patient I had we've been followed this all that priority would the pediatric drug that been development regards And in think any benefit/risk the to in through -- profile.I positive programs what we favorable designation regards I remain what the to think for interactions received. that said that we've had consistent decisions pleased development as programs we're with and with we've the safety with options from very overall the and treatment decision say, narcolepsy the it on change on reflects bring FDA original those interaction week, agency, along to for and with programs, we pivotal safety execution we've development advancement have management don't profile we profile of no with life and overall profile the benefit/risk focused of cycle real narcolepsy conducting and the sNDA.I pitolisant program with to reflects,

Charles Duncan

a on year. good Congrats good. Very

Operator

Brisebois Francois Oppenheimer. We'll take from question our next with

FranÃ§ois Brisebois

Hi, can you hear me, okay?

Jeffrey Dayno

Yes, Frank.

FranÃ§ois Brisebois

I okay Yes, And be the giving just was what revenues help of can thinking the guidance, time you terms here? process understand So, about should first the in guidance patients XXXX? for was the we how wondering, behind thought us per in

Jeffrey Dayno

Sandip?

Sandip Kapadia

the first mean, the the guidance our I especially what Frank, approach, guidance. we've given thoughtful and for I'd say, thanks sure. year balanced represents -- Yes, Look question.

to certainly opportunities respect we go to an guidance. as for look with update think we year throughout the I the provide

FranÃ§ois Brisebois

going should or we pricing how about on think commented revenue you maybe And expectations forward?

Sandip Kapadia

Yes.

think, the price bottom falls I through take It we X%. to that this earlier increase year. did portion look, line. usually A good a was of about

headwinds an see regarding go the year. typically gross normal impact you'll there's usually to and from the we things happens. in generally, throughout happen quarter, seasonality think, as the that I Obviously, that that So first in net pressure

quarter. as much we've don't X the the that you'll pattern generally But the see go throughout years. of as to over benefit. It's very that last in similar you year, had see X, first we the So the generally,

Operator

take question We'll Sandler. our from David with Piper next Amsellem

David Amsellem

just couple. So, a

development, you to scale First, thoughts more a smaller which scale the along wanted larger lines regarding detailed do business get versus Zynerba. on transaction something extent to the of

from is seen more one question some market? acquisitions the are orexins. Alkermes. So view agonists your Wanted then how others, to There Takeda, number reach extent brain that's data that receptor We've to something? do philosophically, your thinking would to course. general? in also, And the Just about of lever tied you from to X.And on the on you orexin number X, potential up up are impact to or lever wanted and get significantly pick the the long-term of to

Jeffrey Dayno

David. Thanks, Yes.

of to fit I sort to transact. a strategic position similar open we're as actively, a with in landscape to We're development, something all a the financial well Zynerba, business opportunities, transformational. think more and good regards sort deal to regards as to very we're that's of strong assessing with

lifecycle look during good open first of we And fit, the after. and stage. assets, late-stage prefer could WAKIX So, for sort strategic but those that launch to both earlier

of In that. terms on to capacity, comment I'll ask Sandip

Sandip Kapadia

on business and strength flexibility Yes, look, development. good Thanks, financial Jeff. we have to execute

access markets. have to appropriate, if as also capital the We well as debt,

million and equivalents almost a well Last important a I look good have I making broad as flexibility, I also flexibility. cash quarter, it's to But year as from small cash a cash available. upfront and add-on thing filter over more at company. the something about flow as had mentioned, in $XXX last it million $XX positive generation.So, $XXX cash as generation of capital As mentioned transactions, of Jeff transformative. potentially in that's Jeff strategic good generating mentioned, million that fit think perspective, We're as And the we over we cash both was significant we larger we think have for sure the in terms well think is flow.

Jeffrey Dayno

turning question well, we're David, to this I Yes, Sandip. agonist. we, know it space And closely. do orexin the as mean you and following thanks, about

of the So, lately, of data has obviously, a that attention given lot out. some come

I advancing. obviously at think early high they're and still the programs a are level,

central of the for in think on polypharmacy the is novel decade, I out, other market the that efficacy that action think narcolepsy has been it's generated, the questions are more questions safety continue I towards coming But the we based closely mechanism the Obviously, have being the think the both importantly, been as side space that generated. life and a next terms come And if data I of come target towards and following on likely of hypersomnolence.So of potential successful disorders out. the are side the belief market. data our they to end end the to be WAKIX cycle. as will narcolepsy of interesting

space help New entrants more this of can and share voice, only more education.

these them be So follow as things advance, programs market, be interesting to think, we'll development novel target, we'll go I waits continue to forward. and seen a polypharmacy and as

Operator

We'll take our America. next question Gerberry Bank from with of Jason

Pavan Patel

for Jason. on Pavan is This

guidance? enrollment assumptions what Our Zygel syndrome III shape as Phase X to at any regards your first clarity driven for in And are the with view question you revenue week for volume? is XXXX revenue a Where on asset. is meaningful added assumptions Fragile to mid study? what then for in with Is XXXX that your question, And your ex-patient? are timing.? a second Or growth by mainly commercial average tailwind per growth

Jeffrey Dayno

Kumar of kind trial. there. questions. for we can III your are ask for where ZYNXXX and the comment on some provide exciting I'll Phase more us RECONNECT opportunity Very to Thanks on color

Kumar Budur

you, Thank Jeff. Yes.

we that the trend historical will this line line And in quarter of yes, arrived previously mentioned the and recruitment will. patient we we on So, have we population, the in based time particular we enrollment as first mid-XXXX. top anticipated be the complete looked at recruitment in will the and XXXX, that

resources from well bring asset recruitment. the additional [indiscernible], and a accelerate advocacy as within just is from the that perspective and the Now try development all obviously, the but group not to the will we perspective, expertise, clinical also

Jeffrey Dayno

Kumar. Thanks,

Jeff to want you comment do patient, per revenue of terms on In Dierks, that?

Jeffrey Dierks

Sure.

patient, ahead revenue at year. as we looking from with price capture expect we the just see volume per 'XX, price to took looking as of And increase. $XXX we're of million a X% Sandip guidance, as growth. to of price in beginning expecting could XX%-plus would you're terms that or in $XXX in previous in our years, average shared, million, So, most increase question, right, you that And the

and in meaningfully see driven large we're opportunity significant So that majority expecting by volume. for revenue you provides could price and helps of diagnosed in of talked is the growth see average volume per a differentiated the profile that product think and we about room the 'XX but about for vast little remaining opportunity, patient patient We've lot you versus growth, 'XX. a hopefully context the bit assumptions the WAKIX.So,

Pavan Patel

one XXXX? have in could that buybacks I question. if What And the million guys in XXXX did $XXX to buybacks follow-up in share for like the share appetite does look relative you

Jeffrey Dayno

want Sandip, do you And approach. opportunistic further? an comment to take to looking we're said, we've as think I

Sandip Kapadia

we pleased million And last able not Look, a that Yes. quarters. really of were think question were very activities repurchase last we either/or. $XXX approximately of to of share year the it's over do couple I

to opportunistically certainly and we execute. have approximately And capacity still And the of position able to strategy in our we'd be development, buyback, would obviously cash in at both. do talked great with to to share flexibility we the have we look million at And about $XXX business of We there. terms respect levels, more it then, again, a the appropriate -- remaining.

Operator

Raymond take question We'll Danielle James. from next with our Brill

Danielle Brill

went provide impact hoping slowdown adds guidance, patient for also for then looks net was your TAM some you Are you expectations conservative remind growth as is a the population specifically patient can expecting just or you're follow-up, on into the will It a to starting assumptions WAKIX? could moderate? label here in narcolepsy 'XX the adds. you pediatric that us what each being like I overall more the quarter. And color around on into have expansion

Jeffrey Dayno

guidance, revenue Yes, with think that and you -- to... -- regards I want terms in revenue do Danielle. to Sandip, the of Thanks,

Sandip Kapadia

taken approach update We go in we guidance Yes, the we as we've look thoughtful We're balanced and we terms way provide throughout any of certainly year. indicating look, I for think a as to an in first Dierks, terms not year. seeing? mean, the mentioned, we do of through to the fourth great carry at coming growth momentum out quarter what to you're for overall that want see sort comment momentum of you Jeff the and I in all expect of just providing year.

Jeffrey Dierks

we've year. that first opportunity.So specialty to And that cadence X year our of patient the durable have growth patient growth rare in patients guidance, going brands headwinds you'll entering terms assumptions of we the the as launch, evolve, grown tap that products. previous orphan 'XX growth growth you at the But durable of since in growth, every that and diagnosed in market, the -- expect our see all every Danielle, And has seen Sure. the into but in launch quarterly follow looking of average impact demonstrated traditional even with we've mean, growth year's quarter and quarter sort and to average I availability. narcolepsy payer large the evolved continue within seen that to we're

believe And and with in WAKIX the tailwinds to the is associated traditional previous and 'XX. growth we You'll well extremely we're second QX. patient positioned expect stronger seeing, in traditional typically, and managed visits takeaway in with then I prescription for quarter continued we're years, see conditions the chronically we diseases future confident fourth pleased fewer the really demand, in what growth, but have that think the with is again,

Jeffrey Dayno

Thanks. And next your Danielle, on... question

Danielle Brill

was on opportunity? WAKIX the and pediatric TAM expands how It that

Jeffrey Dayno

Yes.

can I to speak think that. Jeff

the obviously, agency narcolepsy importance from on indication I patients. the signals positive pediatric of that think, in

opportunity what's look Jeff, like? the So

Jeffrey Dierks

Sure.

successful, underserved we patients population U.S. a X I REMS And right what in sodium Danielle, important a bring patient of treatment Schedule And only being mean individuals' we're impact large the the the X,XXX not we've given pediatric a oxybate about very these on to non-scheduled it's although excited opportunity, option treatment potential, now. III think there's very I about with So, a product lives. narcolepsy an one. it's it's narcolepsy FDA-approved estimate seen And if being option

Jeffrey Dayno

to the exclusivity, an just important regards we're Jeff. of regulatory also it's opportunity pediatric thanks, an narcolepsy, pursuing X those is also additional obviously add to that commercial months that let sNDA, important also which pediatric Yes, And with with exclusivity. me Danielle, data, regards

of that of those in of of progress and in of the terms in pursue additional those of through with are generating exclusivity initiation are required making III are advancing submission, we So, Prader-Willi TEMPO these both important, narcolepsy data then Phase the as data Phase and that, would the that we'll and one pediatric data along Prader-Willi sort III components we of protection. both component be pediatric these study.So, of X the and trial Syndrome, and months are be components both what

Operator

We'll take from Mizuho. next Graig with our question Suvannavejh

Avantika Joshi

were you pretty And small you said opportunity. I opportunity. have for bit which delays? the Avantika had if on is just anticipate about you a I pediatric but in also there then said as about know the approved? -- sales one that there also I all, design question a a caused know at any the the it's this But X Greg. originally the been do on the force changes Hi, were, Fragile timelines little trial WAKIX pushed to growing due enrollment. opportunity,

Jeffrey Dayno

With regards study, X to Fragile the Kumar?

Kumar Budur

with in design. and study And in anticipated we historical at Yes. mentioned of Thank first to enrollment change not we had will the patient line mid-XXXX. the the recruitment XXXX top evaluate you the anticipated timelines on there timelines. the the the and an we that Fragile for With completing the once in And is based this were house, had question, out. opportunity in no population, asset the in Syndrome, Avantika. X is recruitment We evaluate trends, pushed quarter the arrived timelines

Jeffrey Dayno

patient that potential add, of the sort would for pediatric opportunity, Yes. community driving new terms but important options trial team, from III narcolepsy, advocacy small put the forward. for narcolepsy through the patient to of think in more to one. well an just the our clinical efforts operational market perspective resources we towards of I of I an U.S.Turning us to Harmony, And think the development Phase is to the drive as our I engaging towards opportunity forward With a RECONNECT than XX,XXX experience really hearing and II regards with rather of stimulant. that alluded one non-scheduled with significant patients Jeff Schedule for treatment living keep diagnosed to an in opportunity market important And sort this, patients pediatric capacity

we market with then the looking the agency on Jeff? towards to So, are opportunity, working the regards with impact forward that.And to

Jeffrey Dierks

Sure.

narcolepsy take at be and existing be additional adding is overlap to to a current bring these There to adult potential believe the of prescribing. and looking to about coverage able excited believe force is pediatric narcolepsy addition that if optimized that the optimized this opportunity this that health prescribers prescribing pediatric opportunity patients, we're will team handful we of we -- successful. a in high with we'll is new our care between with target some So, very new on for the forward, professionals. with that There the be our narcolepsy list narcolepsy, our sales sales force But footprint. for

bring successful, got indication we've are with very portion good absolutely prescribers, team, relationships forward. this optimized to we new So we and believe our excited with if a of but established those

Jeffrey Dayno

Thanks, Jeff. Great.

Avantika Joshi

I in more. Can squeeze just And one

there think just for in know but will be For I gross you that said headwinds year? it can the you you quantify what quarter, full will net, the be to first

Jeffrey Dayno

Sandip?

Sandip Kapadia

Yes. Thanks question. the for

first headwinds are quarter, copay insurance typically from obligations As across higher just general plans the there industry, mentioned, the in and I first quarter. the in resets

throughout of is first that the couple a see what sort the we we'll generally. past typically in improves points in year, percentage the from and as go So, seen we've of that, impact quarter,

Operator

back to questions. you. the for Thank would further closing now call to remarks. I management no am like showing turn I

Jeffrey Dayno

everyone, thanks, joining today Britney, you, and Thank call Harmony. and your our for for in interest

strong we Thank in us momentum heard updates well from growth strategy. our forward execution morning, have year you going providing execute and on to Harmony day. continued XXXX. look as We this for As positions our solid a XXXX this in into and great growth you,

Operator

XXXX Biosciences This Harmony and does Results Financial Call. conclude Conference Year Fourth Full today's Quarter

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

Harmony Biosciences (HRMY) 22 Feb 242023 Q4 Earnings call transcript