HRMY - Earnings call 4 2020 | Harmony Biosciences Holdings, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Harmony Biosciences Fourth Quarter and Full Year 2020 Financial Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Lisa Caperelli. Thank you. ma'am. ahead, go Please

Lisa Caperelli

updates. Good as and fourth we XXXX provide full operator. joining quarter you us year business and performance today review financial morning, you, thank everyone, for and Thank Harmony Biosciences'

of Before At press Investors Biosciences of company the financial go the our section a slides and to I this that we financial find discussion the GAAP business. the reconciliation the we today, encourage including begin, cycle, to to believe to better everyone results website stage economics release Harmony measures. accompany our non-GAAP of life our of non-GAAP represent

Our presenters Dierks, Jeffrey Jeffrey Chief Dr. on Commercial Officer; CEO; Drexler, today's are Jacobs, and Chief Officer; John Dayno, Medical Susan call CFO.

we are materially. be you today, certain and in for additional will the current expectations details. risks statements forward-looking actual SEC risk based filings differ factors I our These and our results reminder, statements subject which beliefs. making may and encourage As are to consult our on a to discussed uncertainties,

our I'd At to call over John Jacobs. turn John? the time, like to this CEO,

John Jacobs

on you, patients and needs. morning, Lisa. thank focused and for commercializing us. care have new Thank a product option At health neurological are adult we treatments everyone, treat joining treatment for who disorders important we for unique the rare profile providing living attributes and are Harmony, of medical patients them. With with you who Good an differentiated developing unmet professionals WAKIX, our commercial product narcolepsy and

possible approximately in cycle clinical to drive full achievement indicated the entire commitment, market year of and WAKIX, and well as several the were first the by dedication, due at management of strong pleased regulatory $XXX very I as team with as the of which all Harmony. life milestones million am of passion program, our commercial sales, of our adoption

that opportunity highlight serve we strong future a our for of shareholders. expect for X as WAKIX narcolepsy, growth year-on-year treatment strategy serve will not we but which the only pillars that our affirm from accomplishments patients also and drive represents the performance These and as foundation for value the

without of goes in persevered to the we that face of drive challenging and navigated ever sales Harmony the company migrate constraints the face many lifetimes will us the was our clinical advanced and our year that most in in It these all global productive Despite unprecedented private XXXX history. of XXXX and challenges yet saying public, as from complexities the team pandemic. regulatory achieved year growth, programs WAKIX making company's to adversity, milestones, the an most

increased the and million and well all additional positioned Market to our position upon proceeds listing we Russell on IPO pillars strengthened investors, of visibility us NASDAQ strategy. and enter growth laying the indices, our advance X gross with our from $XXX.X foundation for financial the XXXX of Global execute XXXX subsequent and to and With XXXX

of WAKIX. year our to in pillar $XX.X strong resulted utilization approximately revenue pillars and expand WAKIX launch in XXXX, engaged care million optimize and QX we've Let In achieved with providers the with the million. XXXX revenue narcolepsy drive $XXX demand, and growth, awareness of which of full and XXXX progress me X the you health of patients in we with growth: #X, on commercial share of

prescribing of WAKIX WAKIX, truly profile offers. WAKIX patient care providers during approval our adult cataplexy well by the differentiated professionals we seeing in you'll received we WAKIX by gaining indication patients year, has as the care utility And the and and of driven number with health health hear commercial is by of product the in on overview, number which increases the that average are the continued been narcolepsy, which last communities. Late both expanded of patients

a Let's #X, a pitolisant, we unique mechanism new us we the patients move of of Based key that the product have the utility clinical opportunity, progress extensive on for programs has on believe action of on and to our team represent clinical beyond portfolio clinical to opportunities made pillar expand help WAKIX. and narcolepsy.

Late last in and first initiated year, trial II enrolled our patient in Prader-Willi Syndrome. the patients with we Phase

We address community currently patients are treatment and their the do Prader-Willi medical unmet these explore that not excited medical to to for patient collaborate with exist to needs. options

in for IND a dystrophy. addition, team our In program myotonic clinical submitted an development

trials annual With open, a at and later Throughout on during lastly, in clinical meetings. pitolisant on X our WAKIX first track presentation pediatric III to highlighted of Phase a year. are narcolepsy we medical multiple in the late-stage medical this with conference of the strong initiating community toward II through efforts posters during in to this be year, track we And for with now the this evaluated the the initiate are half poised the the Based DMX with progress, IND XXXX. trial on SLEEP Phase patients trial other year. is patients data

assets growth additional to in expand pillar, line our our strategy with we to WAKIX for portfolio. WAKIX. alone for growing opportunity accretion for portfolio our beyond assets our shareholders, Though intend accelerating expand to represents company value Harmony, acquire new our finally, long-term the And third acquire and a significant

focus to additional footprint expertise. commercial the of Our of continuing and core on and/or acquisition co-development our is that business assets, development their pursuing existing complementary be areas would team co-promotion to efforts dedicated opportunities

strategy, patients of believe through to us ultimately, continued the organization X very financially serve to that introduction our As on objectives we innovative and and of positioned and growth we XXXX, strategically development well our as grow enable an to achieve Harmony to will continue all enter executing which therapies. is pillars by

commercial turn to Dierks update. I'll that, with a And Jeff? the over Jeff to provide call

Jeffrey Dierks

Thanks, John.

quarters the year XXXX. XXXX fourth outstanding we performance John of X on and results launch for strong quarter first as build As continued mentioned, successful Harmony, were was an to our from

$X.X to narcolepsy market performance, of before to a delve billion. our opportunity with Now minute approximately on In XX%, the WAKIX. for value market narcolepsy commercial the into adult I net spend XXXX, touch I'd like sales grew

the not grow market through them XX,XXX XX,XXX We diagnosed in narcolepsy, with living United an the diagnosed. currently the of other products. the introduction of in type to of treatment. receive and of to in diagnoses, States, on with about and Of new people people with treatment, electing any XXX,XXX currently education approximately narcolepsy are XX,XXX XX,XXX are expect approximately investment the them to There are increase continue

communicate Despite satisfaction. WAKIX We treatment are population symptoms who or is the meaningfully a option levels believe with the drugs either satisfied as adult the broad either or current on refuse not narcolepsy diagnosed both offers large options. on for untreated available low that patients undiagnosed treatment of population the were differentiated that treatment the population, narcolepsy multiple those experience as that their residual and many before WAKIX, existing diagnosed market well patient treatment

not we only for drug differentiating positive WAKIX novel feedback both is tolerance clinical to the community of treatment and receptor of evidence in hearing a narcolepsy known EDS, The attributes following WAKIX agonist also molecule antagonist, stimulant, the cataplexy centers in indicated with first-in-class market. the the withdrawal that of is excessive as and FDA. about difference that are a are studies. the first of key and needs daytime we around MOA, a no making the are inverse the the meaningful unmet HX FDA-approved or or only WAKIX sleepiness, by selective It symptoms approved is nonscheduled narcolepsy. aligned

trials. relevant no or clinically WAKIX oxybate, administration oral with other pharmacokinetic narcolepsy lastly, interactions And treatments, convenient, monotherapy can tablet be in with offers morning concomitantly upon modafinil clinical patient-friendly, sodium in or demonstrated the WAKIX administered used awakening. with either as once-daily as

$XX.X This than Net represents XX% sales, our another grew QX effects in of to despite the to the revenues million. growth greater quarter Now for turning pandemic. continuing net commercial performance. of

was as predominantly end indication. well Our of towards the the as following year taken that the growth is price the approval increase demand last cataplexy of driven by

of net million. approximately XXXX achieved year revenues we first commercialization, recognizable full year our was of and $XXX first

our and need highlights payers unmet the the this in market to performance the occurring of the and virtually, WAKIX WAKIX, narcolepsy commitment of care not With value significant reflects, the profile our with benefit health year also resilience the interactions and majority team our narcolepsy professionals, customer risk of strong community. of the overall patients but and only

In growth from metrics our goal driving line of is I'd WAKIX. through for performance like to X, Harmony important with pillar an launch X key QX. highlight

QX First, approximately were The of we growth in demonstrates This of WAKIX. continue X,XXX. WAKIX number to on increase the continued of patients WAKIX adoption average patients. average number

treat XX% the increase, launch of professionals WAKIX care X,XXX narcolepsy through X,XXX WAKIX XXXX. to population. This care who health the more the having represents end of the prescriber approximately with continued unique almost since prescribed health Second, professionals than diagnosed base

strong. And WAKIX continues third, to market for access be

XX% XXXX. commercial, within approximately lives have favorable narcolepsy subsequent in all with We Medicare adult for secured October lives, market approval observed have these treatment covered of of patients expanded additional we to U.S. access WAKIX WAKIX insured access and for the for the of And cataplexy formulary Medicaid. across in of

label QX, cataplexy requests volume patients in of the and result for a As seen prescription narcolepsy percentage expansion, of or the X with in narcolepsy. type cataplexy we've increase an

the positive its as plans accelerating we're and patient's medical From In patients, to profile. due WAKIX. first-line the treatment preferred access policy positive to of to addition, other WAKIX data managed made formulary hearing compared for care cataplexy ability agents some the safety get changes a community, to use the on cataplexy for feedback

early and with to We suffering positive drive signs cataplexy are the with to expansion, or cataplexy. with continuing look narcolepsy label pleased forward growth patients in EDS the seen

continue proud performance. In extremely focused quarter to long-term we We summary, and in supporting XXXX beyond. and as full narcolepsy on growth delivering and execute our fourth launch WAKIX near I'm significant and adult patients remain year of on and build our

an I will Dr. program. clinical our the update Jeff? to now over for on Dayno turn Jeff development presentation

Jeffrey Dayno

Syndrome, Phase myotonic and patients clinical pleased initiation in milestones Jeff, we that dystrophy development the morning, for that program and enrolled and first in everyone. morning year achieved IND our of quarter progress with good a and year, submission II of share you, trial I this we X patient you in with am during Prader-Willi late development last to PWS, including clinical an programs in significant last fourth the our made the Thank or XXXX. targeted

and efforts plan of management of development advancement acceleration pitolisant. clinical of Both Harmony's events represent for cycle life the these the

drug Before opportunity front these to of mechanism unique would on I on opportunity, a indications. new as I These disease have Based cycle us pitolisant product view programs approach patient with we a rare action, detail and mechanism-based its programs, orphan multiple a active first of in pitolisant us. life potential and have neurological development. frame like provide a several to pursuing little in taken the management populations portfolio

remarks, we by my Phase II actively opening his in towards. year-end, I goal trials in a III intend to the mentioned clinic on about, and and have are John excited As X or that working focused team

Prader-Willi in Let the States. with It pediatric CNS disorder start PWS and our development XX,XXX affects program to approximately patients in Syndrome. orphan due XX,XXX is rare me to dysfunction. hypothalamic multisystem United a

In PWS, primary the excessive daytime sleepiness, increased there addition an symptoms symptom daytime majority program of half focus is sleepiness. pitolisant. as hormone, food, of Other of development is for patients approved consumption over defined than including treatments or of no to for are which appetite with the EDS, growth which the our of excessive experienced of hyperphagia, PWS and abnormally primary also

which on as patients are EDS programs, a than development hyperphagia primary we are with on effects because PWS focused of Syndrome. the We taking Prader-Willi different in pitolisant have very the studying approach outcome other

first, rationale hypothalamic Our is of disorder a following: on PWS narcolepsy, like dysfunction. based the is

in of those PWS narcolepsy. manifestations are Some instability similar of to with associated patients the sleep-wake state with

narcoleptic In patients have PWS fact, with some a phenotype.

and patients levels neuropeptide also hypocretin with that features of of is of type the PWS stability, sleep-wake decreased of state orexin, some the decreased have narcolepsy. diagnostic known as one hypocretin, X mediates levels Second, main

wake-promoting of sleep wakefulness neurotransmitter improving to levels Third, demonstrated of brain, increasing pitolisant and already to is the action thought related histamine similar unique orexin. its in has to that be mechanism stabilize states a also in patients or help This serves EDS in of efficacy to hypocretin major with narcolepsy.

human helps is suggest and a support lastly, that felt positive both animal functions, brain and to key be effect pitolisant vigilance And histamine an on evidence have including these attention, from functions neurotransmitter could also important function. as other Preliminary cognitive studies that well. in the

you communities. December, and in through medical the the walk trial With that patients as I background, will in PWS design Phase of the with which generated we that patient much initiated clinical has interest II both last

assess eligible receive trial to at randomized a safety PWS by XX to currently patients period consisting phase It The ages randomized a of followed the Patients doses enrolling, trial placebo-controlled approximately This are plan XX to placebo. in of then XX weeks, patients being period, or and X the a to are pitolisant is screened, and randomized, efficacy X-week dosing. controlled double-blind, designed in is X in randomize with to pitolisant of U.S. with is treatment stable X of the of sites XX. weeks X XX titration patients

Patients assess who extension the multiple by is long-term complete phase phase in be of primary randomized latency in pitolisant. participate sleep as an to eligible will controlled safety the effectiveness trial the trial test, and MSLT. objective of open-label measured the The to EDS of the assess improvement or to

clinician-rated of severity; overall caregiver cognitive results are overall in from XXXX. following: caregiver burden. line the trial include this scales; assessment EDS; Top of first objectives and Secondary evaluation of assessment behavioral on symptom of severity symptom based of PWS half function the anticipated assessment

Another we approximately myotonic that of in development dystrophy, affects in muscular It U.S. DM, patients or and common XXX,XXX have orphan the program rare disorder most is dystrophy CNS advanced the form dystrophy. is another Myotonic adults. is

myotonia, There and and much to to more DMX an of are inability patients than as of primary earlier of symptoms DM, The symptom patients severe the in dystrophy muscles are relax. common in DMX types disease symptoms an X DMX has is myotonic also known with DMX. DMX, DMX. with onset more compared which is is

is DM muscular of symptom of DM, these the in EDS, common to most beyond XX% functioning. impairment in causes which in patients However, symptoms experienced and is XX% the patients significant daily

demonstrated overall that a that improving patients with effective EDS symptoms, medical the patients unmet for its also be with and impact common are which myotonic impaired report are narcolepsy. adult dystrophy, to significant have with histamine believe significant treatments on in cognitive these based need. no efficacy DM We of also of the with X symptoms There DM be represents in fatigue result could symptom for and functioning. Patients their patients thought this in impairment. signaling, CNS on pitolisant approved other are EDS

brain. of these clinical have triad of to pitolisant DM and fundamental The of the we because in scientific fatigue increase in cognitive histamine believe the with addition, in is In EDS, signaling impaired result works likely dysfunction rationale are the patients histaminergic why signaling for CNS. symptoms could pitolisant the utility

an a the in letter line FDA received In with first to this last have IND IND. track our development our which and may year. DMX proceed Phase on in clinical milestones, are initiate patients we agency, from to we the Therefore, trial half II study submitted the of December opened with

this about that time. details more provide will study We at

And the lastly, narcolepsy. year-end the in program that third plan to is pediatric development we have clinic by

trial. design this engaging the to that pediatric of with be the detail half and during our year. the to inform sharing with more will second about We program will look FDA you We of this study interaction discuss plan, forward

plan XXXX for In management a life is of at our closing, development clinical of and we efforts goal unique and on life management to its product pitolisant. our pitolisant marked the pitolisant. of Harmony programs a cycle Based and of acceleration QX our mechanism for optimize advancement action, cycle view as opportunity, portfolio the

year. unique have As opportunity sharing my X on this forward and these programs team calls. with our I end by about programs we are future and look I running the the that progress and development excited to I mentioned earlier, you up on this focus of on will

who will Susan? an our will on I provide now over to and the call Susan performance. update financial you, Drexler, turn Thank

Susan Drexler

Jeff. Thank colleagues that XXXX. XXXX a that I continue to are we position reiterating like my financial now and strengthened join you, ended in would momentum to with considerably into poised

launch XXXX. Harmony the our revenue since basis release full which and of year-end for financial a press of the demonstrated the contains results commercial detailed quarter growth Earlier sequential operational November today, posted growth quarterly for fourth reported significant on commercial our filed double-digit year. XX-K, we and in and and year XXXX in

I will just a points. few key highlight

the fiscal reported revenue for product million For the XXXX, $XX.X of of year. XXXX Harmony quarter fourth million net $XXX.X and

We adult and narcolepsy. in continue patients launch, see unique increase fact the that the patients into by to are number needs This prescribers quarters we of to encouraged X a demonstrates the the of medical an of offers that average treatment option WAKIX. unmet with WAKIX address

a the to full to expenses decrease a WAKIX. an sales by expenses the expenses totaled XXXX of million and marketing milestone increase primarily decrease in $XXX by in R&D driven general administrative commercial and operating versus partially total The of payment related the for in Harmony's $XX offset $XXX.X year was launch million related Bioprojet, to XXXX. million and

our of in bolstered assets in our had As a compares This cash payment with potential to the early a which position with $XXX.X remitted fund at Bioprojet, million of by of million acquisition $XXX with from the us of December the million. we end to cash development and the help XX, million leaving equivalents portfolio. Of $XXX.X of programs XXXX, XXXX. we expand XXXX, gross milestone proceeds $XX.X product and had IPO, favorably to to note, balance substantial continue cash we January the our

loss was For interest amortization $XX.X non-GAAP several EBITDA $X.X of which warrant of determine and million by EBITDA to expense. on items, were million. income in at $X.X adjusted non-GAAP added $XX.X million arrive positive of million $XX.X net net million available of share. was of stock-based and the $XX.X net and of accumulation a adjusted Therefore, million. included yield million $X.X $XX.X expense net loss of exclusionary adjusted impacted and After the of posted million, extinguishment million to stock, depreciation of loss our expense $X.XX $X.X or on to added the $XX.X related to full To deducting a common year share. per of preferred net Harmony a per $XX.X or XXXX, debt, $X.XX income was we income of of GAAP loss stockholders million GAAP the compensation million

XXXX, in WAKIX focused as to commercialization running clinical operating on clinical the value-added and of pitolisant support our make ahead anticipate we core X we investments of the Looking in expect trials. business,

seasonality. quarter-to-quarter year-over-year some We in growth expect strong normal with sales,

likely and see the affect saying deliver the will momentum by the balance we the the a financial the of growing X footing dynamics expense quarter, very beyond. Harmony In I we grow and early controls, specialty With and have my fortified pillars year. same sheet, first detailed products into in the all in that Harmony colleagues to a call. payer-related financial revenues wherewithal prepared on growth, by to on is XXXX conclude continue will earlier solid and disciplined

back opening session. call John remarks Q&A now would for the the closing John? to to the for call like I up turn before

John Jacobs

Thank you Jeff you, her and wish and and of brief service take her a for to would Susan, Harmony minute Dayno, and her like Lisa to to luck in thank endeavors. Caperelli. Drexler Susan thank Dierks to recognize I Dr. future the best

forward future. formally the and CFO, you be new he's will looking Monday, meeting joining all with near Sandip to of Kapadia, Our on us in

future. stress so our excited about remarkable far, of achieved of The success have in enough what I what I we ongoing team and confident proud in XXXX lies year our a was ahead and for Harmony. how am cannot

take now from we questions audience. the Operator, will

Operator

[Operator first of line Jefferies. question from Chris Instructions] comes from Howerton Our the

Chris Howerton

course, of the all last despite on challenges. a And, year congratulations great

Susan Drexler

Chris. Thanks,

John Jacobs

thank Well, Chris. you,

Chris Howerton

All right.

the -- I in with I are and questions, -- few maybe then, can course, the just So if start a guess, queue any remaining. of back hop off

maybe one, a thinking first year just for this spending from the expectations for about the perspective. So

spending a think, color relates more what what could But it think, you I guess as I we expect a I to we from gave particularly the could trends line. on Susan, SG&A? nice, the top of little on expect side,

question a might or be couple maybe for Dr. And questions then of second Dayno. the

then I give in So for inclusion maybe with I Syndrome think to a would be that it's to that would think trial? helpful. narcolepsy. And patient that you respect to could striking if to with relative EDS respect information the measuring Prader-Willi trial, population, criteria probably me little us different be the this

the us as of could you of it terms the help population? of if patient this of some maybe you've just understand relates some in So disease of specifics symptomology measuring made to the accommodations the

Susan Drexler

Thank you, Chris.

COVID marketing, questions to sales you're in about And that X engage continues. you physicians we and and provided the increase for trend that obviously, answer see expect first lifts But have given correct, unfold guidance. and -- team And marketing future. with the XXXX to G&A. we do Just haven't expense we'll in as particular, begins in and our sales person to as

expenses to On public the there's the fact as company, expect side, lifts COVID we due and we're impact as do those G&A that be to on a well also an expense increase well. that to as going

Chris Howerton

great. Okay,

Susan Drexler

So the Dr. Dayno, do take question? next you want to

Jeffrey Dayno

Yes. Chris. Thanks,

So excessive terms a in of the of amount PWS trial, so the minimal inclusion is inclusion main daytime the for sleepiness.

sleepiness in -- I excessive reasons start daytime So for saying off is multifactorial. Prader-Willi by with me patients the let

patient So in that with There's of state and disorder similarities terms overlap centered in sleep-wake narcolepsy the some there stability are in underlying hypothalamus. the primary population.

inclusion the latency criteria excessive or MSLT. is the as main sleepiness measured the by test, multiple minimal amount daytime sleep a of So

criteria, inclusion of product. main of the and age with with the aspects the other range safety sort the that's to So along managing component regards

daytime it's in So with excessive similar in end terms as points endpoint that's subjective the both sleepiness. of clinical looking trials, at EDS objective -- as measuring well

in mentioned, symptoms outcomes cognitive addition, looking I around also well at key as as secondary As we're behavioral function.

Chris Howerton

said a maybe a could a dose. you you Maybe if very doses? bit just just frame Is quick respect us give follow-up maybe could any us? to you for low that as a that. your I high color on and to -- thinking And think there with little Excellent. Okay.

Jeffrey Dayno

Chris. Yes. Sure,

X with within our profile strategy, dosing and based as some the on current at at we're trial. and We're modeling. then to -- doses the different the age pharmacokinetic pitolisant groups consistent of label the doses So the looking applied of dose looking in

range. ages we're XX, mentioned, fairly which X to patients broad I a as is studying So

than then XX X that So then adult then we less XX, ages have cohort. children the to and to XX, adolescents of part

dose So modeling. and high of off a of age groups those to we low each sort applicable our a PK of have dose based

Operator

question of line from from next Amsellem comes the Our Sandler. Piper David

David Amsellem

So just a few.

you first, is last regarding full you about paying how in in cost that's having year fourth talked Can talk which in that that things the we an and So the of pandemic-related the to for the one. So extent had quarter of that think impact about about should one patients, impact drug the third and dynamic impact an the of quarter. XXXX? headwinds, that number was

these with progresses? is and year X in two Number narcolepsy you the and evolve the can expansion between about X talk the to label think going that's mix how as narcolepsy cataplexy, type type you days

your thirdly, about in of should Help you how as what get easing Do little of think half of of say, in-office we as should sales? ultimately, pandemic-related uptick getting as see second year and understand we we normalization and far in of thoughts will regarding visits that be volumes that out? cadence play then an this of are sort better. a that terms And an a when expect, headwinds, bit us to sort of this normalization sales

John Jacobs

do that first to question? Dierks, Jeff take want you

Jeffrey Dierks

Sure. David. I question. Thanks very the much, appreciate

an as result of insurance And consistent, of assistance of of a subsequent we pandemic, the a impact, and as QX in obviously, been in have and have of into well demand free earnings for in seen to we the respect in loss millions year. as beginning comments prepared increased shared the goods Americans. even call, pandemic-related this headwinds the relatively that, our unemployment with we our our since patient as rise It's seen So last program. health

to strong in we program, sure the support this knowing WAKIX make eligible can We a certainly can through have patients' patients lives. conviction that difference make

can think, quarter, make I this really how demand demonstrate narcolepsy. able in for to difference able forward, say what even I patients been But looking for with we're speculate assistance net we've living and is, excited patient for percent each elevated a growth be will program really this to And it's long with to we our XX-plus will continue. difficult to XXXX demand. revenue obviously, the think continue I elevated

John Jacobs

I answer on? David, Jeff, does think move question -- your before we there that

David Amsellem

Yes, that's helpful.

John Jacobs

the hearing after would And reaction mix from Jeff, David, could apply some the color you the the Dr. well. market? you, think Dayno been and type of from add and was that perhaps, on of type to next the Cataplexy, I medical as And well. question X we've from X as community

Jeffrey Dierks

Sure.

to securing additional with obviously, risk we're signs have very WAKIX seeing to for we respect profile a communicated know So We the early with expansion. and of element add It certainly product. label to since that positive to cataplexy, overall were the pleased that key of continued the indication support cataplexy. the growth was benefit the

seen percentage But prescription with patients narcolepsy Now volume cataplexy. say is requests can we for haven't the in provided in that of what cataplexy. specific have increase by we guidance an on what driven sales are I being the

and that suggests type patients business We a have would to X/X narcolepsy that I And cataplexy. up Clinically, David, may living know XX-XX that close. about the that with treated. and our relatively is say diagnosed what type being XX% mix to in X of X mirror literature seeing people looks we're

seen the which WAKIX. in really generic ability to And eliminating make news to is, positive step started managed patients, X allows formulary have other exciting or acceleration of to access that patients' we've care of reducing get plans for edits changes policy to addition the some type some already the

difference about we're to living we've make very volumes, I And think, patients signs with excited that to the continue adult early for EDS So board, think, our speaks it seen. the across to I cataplexy. or a future ability

Jeffrey Dayno

I Dayno. -- professionals. indication, health perspective, medical the cataplexy Jeff just in would reinforces David care the I it's a And add, think think David, minds of Yes. just it I from

in I and literature reduction familiar in trial docs think with. a of data lot regards that cataplexy, it with the CTP Harmony the was been sleep reinforces that the to the have

HCPs to the And with kind that validates strengthened of obviously, clinical what the from of to. Jeff the we've the the regards decision and are you the profile. things the that consistent alluded are when those it have that were Dierks they some more some And with physician that data making, heard trends product that is heard community we've familiar indication. just comfortable And with

John Jacobs

the COVID And do headwinds you, volumes and hit I the there. stabilization Jeff. your third had believe some to might Thank of and predicting when David, we sales with question

some had make So there? Jeffrey Dierks, you comments to

Jeffrey Dierks

Certainly. Yes.

back XX,XXX So is and third normalization what hard eligible patients very there the I X,XXX can to David, represents opportunity our I it's We lift when we've for our have and question, get not average patients normalization." living on certainly, of with with we on really that hit is the really barely say of think for those speculate narcolepsy think about to "COVID scratched we'll to that QX. going WAKIX. your patients I sort know that number near-term us. help And to ability for are having diagnosed surface But

XXXX like you WAKIX the to disorder community. are we're We extremely ability team neurologic individuals know with optimistic marketplace. going there these beyond. and extremely will be that about be a very COVID. unmet sales to what of there to living and our see pandemic field ability has We're our aligns because educate narcolepsy looks unique significant patients chronic and care optimistic product opportunity And to know professional, clearly engage lifelong certainly the that their the a that still health after The And medical lifts about in this need. is that need this unmet once have profile

David Amsellem

the the made, of follow-up, sneak cadence and I imply free in With particularly reimbursement and gross-to-nets terms just as what comments this moderating a and year all in Can you the terms the of the progresses? in landscape? does also sales just gross-to-nets, goods

Susan Drexler

So -- Susan. it's

So the for we're previously, for reasons. gross-to-net competitive we've as not expressed gross-to-nets, sharing

at So time. this sharing we're that's not something

Jeffrey Dierks

medicines. to add same And the David, for to products, maybe reapproved that And to reauthorizations just quarter what that in all we're saw dynamics one get things the affect I is can as we commercial got aware, well that require face respect we're you've in their patients payer-related those insurance for first with insight XXXX you're the in occur prepared we those prescriptions many specialty remarks shared and that that branded right? is continuing our that anticipating going of dynamics,

and got reset manufacturers on which first requires the You've in obviously for all predominantly patients deductibles, support, quarter. Medicare lean to the coinsurance the the to

QX. And each as right? are Susan not say we there to about patients or but opportunity, going grow We then And think subset community expect and is to we're continue expecting being that the And speaks average each can the number from overall but guidance strong the providing that, only are the benefit seen expect I seasonality related year. normal some are receptivity some really patient WAKIX. quarter-over-quarter the of not commercial co-pays, to changed really patients we market revenues risk to, that as sales in physician obviously, growth, what but I to of quarter, year-over-year a said, of be formularies gross-to-net, net the for increases to we've

John Jacobs

in more and the life do a David, the of lightens with to the getting on because in program expect facing hoping of start normal tends back we're rate the our to and it of unemployment patient businesses, track that rhythm our are assistance lift population us to in pandemic COVID and that pressure for all some And U.S. we as we society and our vaccinating what

So that gets to as down us. go cost better, expect for that we

Operator

from comes Our of Sachs. line from next Goldman question the Graig Suvannavejh

Graig Suvannavejh

couple help quarter. could. all for thank Susan, next the you, in your luck I I to And questions, and good want of of on your endeavors. Maybe if Congrats a

NRx TRx that so color any my on seeing And about XQ, it NRx what question. versus would And what side? be is the you XQ comments first additional can make particularly you're you one, any versus XQ? particularly on year-to-date get in Just possible trends, maybe saw to or

saw compliance question that just growth? do second with specifically any tied just my right growth in And color that the growth adherence you you or sales the WAKIX? with to has my possible quarter. Is in seeing then to price of with do much what tease volume versus you're to out how terms question to if now has could And additional fourth of it provide last on was

John Jacobs

Jeff Graig? handle from to question Dierks, the you want

Jeffrey Dierks

Yes.

So of shared. kind I'll order, take them in you as

a and obviously, pleased performance Graig, XX%. with, revenue launch increase of we're of with XX% to strong I that, net with patients, of color And to that refill demand another in new led say, along is average So on a the saw in behavior, patients extremely we the quarter-over-quarter. would just of And QX. what bit respect growth little number quarter

quarter, number in patients, Solid average patients of XXXX expectations grow anticipate continue fully our of each in number growth that going to through line to with and And beyond. it of and WAKIX was the given COVID. we're average we

the of the of of only the also the in really, increase average not think number patients, patients. persistency the and but new to speaks compliance durability existing I the number reflects of patients

So patients we're on those average number not patients, continuing cohorts. providing versus represent but of specific of both guidance new the

is is really And QX. a in seen and for solid a line growth our expectations increase, with which what XX% you've

So to price. versus by and second question driven asked QX was respect you what with sales growth demand

of represents So quarter. QX $XX.X less sales of third That approval about cataplexy Demand the remaining increase represents driven than price a were that from the by or the the the net XX.X% taken XX% volume increase following million. indication. in X%, growth, November with

of I us in and WAKIX differentiated for need the exists is product importantly that community. growth profile believe narcolepsy think that received we how unmet the by demonstrates is well marketplace that, medical And being the the demand

third, color some compliance. asked a little then And about adherence bit on and you

say oral of well. behavior It hearing we're sharing feedback launch. obviously not physician what that been patient that persistence community. talked our other very the And a to risk discontinuation WAKIX durability persistent, what profile the I the and being received narcolepsy being narcolepsy is we're So products, observed reinforced we the specific with with the is early patient being medication from or by with of average kind consistent that to overall is demonstrates really X,XXX, about in number compliance. information the can little patient that although or And still about seeing the compliance patients It's speaks bit and we're and rate date seen right? benefit of what's that's

to your to So respond hopefully, that questions, Graig? helps

Operator

for Ladies gentlemen, call. conference you concludes Thank participating. this and today's

You may now disconnect.

Harmony Biosciences (HRMY) 25 Mar 212020 Q4 Earnings call transcript