HRMY - Earnings call transcript Q2 2024 | Harmony Biosciences Holdings, Inc.

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Operator

Good morning. My name is Todd and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences Second Quarter 2024 Financial Results Conference Call. [Operator Instructions]

Please be advised that today's cooperate be recorded Lastly, if you should require operators I will now turn the call over to Brendon Doyle, Head of Investor Relations. Please go ahead.

Unknown Executive

operator. you, Thank and we everyone, results for us joining provide Good Harmony thank Biosciences as review business financial Second today a morning, update. you Quarter and XXXX

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

on speakers Dayno, and Chief Officer Sandip Our Dr. Chief are President and and the Financial Bodur, today call Commercial Chief Dr. Administrative CEO, Medical Kumar Dirks, Officer; Chief Jeff and Officer. Scientific and Jeffrey Kapadia, Officer;

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

differ undertake statements Our and even actual circumstances obligation these change. if materially results to update may we no

SEC We encourage additional Jeffrey consult factors would the Jeff? detail. to risk you in to like turn over the filings Dayno. I Dr. call for now to our referenced

Jeffrey Dayno

formerly thanks, growth for continued in Thank Harmony, pitolisant and by highlighted the made our our another dose clinical progress at on today. strong productive quarter everyone, another next-generation and NGX. to high Brendan, joining for team call our Petolsin-HD delivering of development programs. quarter QX for referred you, program, Wakix was revenue conference very late-stage development advancement the significant as were

first pitolisant management the development gastro-resistant QX NGN with to petolesent-GR as referred initial PK the program, as our pilot data for During call, or activities. part the life pitolisant we earnings the our shared along cycle of plan formerly

out with date an durable are HD to long-term generation. excited the XXXX, our the targeted revenue to to us filed a extend to mid-XXXs Pitolisant in PDUFA quarter, a on opportunity the provisional an update patent franchise with and we providing This provide Patons XXXX program

are is details the we call, share in PK this other development because reasons a Later some that regarding the address. program some medical provide to color me excited let the of the pitolisant-HD program. about the designed the and few Kitosan will why data of community HD from initial pilot First, need narcolepsy Kumar in unmet advancing the

risk Wakix strong brought the living for excessive patients offers a and as overall only a benefit or narcolepsy for daytime non-scheduled profile indicated the enhancement has treatment with first market to sleepiness meaningful and unmet symptoms, in innovation. chronic narcolepsy EDS nature and needs But remain of the a cataplexy given opportunities there successful as still for and difficult-to-treat extremely with disorder has the continued been market. both neurological

pitolisant GR the and address those market needs the For in more needs. unmet narcolepsy is HD, innovation we can do continued what on and to focused the

and treatment the drive while pursuing a pitolisant treatment First, optimized we an know than that could to also narcolepsy residual with greater has XX% patients this experience market. This of address high-dose efficacy. why formulation efficacy PK benefit is on from greater a profile symptoms greater need to in we are that

symptom in study than different pursue neurological as a saw we Second, signals and and a our to in in neurological pitolisant well With indication a positive as with other chronic EDS on in with EDS II dystrophy pitolisant as plan which fatigue based such of diseases. DMX. we in Phase patients or both with proof-of-concept of diseases, pitolisant-HD that about X fatigue DMX, narcolepsy type myotonic dose living for common experienced patients fatigue, a and narcolepsy XX% the is symptom higher

such narcolepsy of dyspepsia GI GR Next, that experienced for our discomfort. as we explained symptoms as fact a force XX% patients is behind driving program, the coding and the Pitolisant nausea, gastro-resistant with abdominal about

has related rationale of mechanistic or to central on effects NTX Vegas narcolepsy motility. with the the especially gut which the is since X controller type orexin brain, patients a in in nerve deficiency for this, is the There orexin

patients feature are but experienced a nausea symptoms with of the well mechanism, out to issues designed to the One Wakix narcolepsy on tolerated narcolepsy In as of as GI the is treatments. medications that incidence gastro-resistant address used. predisposition narcolepsy GI treatments disease GI with low addition coding is experienced to narcolepsy side underlying patients with the tolerability to have patients X well the in effects other common related

pursue address filed higher with out narcolepsy optimized unmet gives the compared differentiated durable PK to us IP needs for XXXX, with a significant OE our in XXXX differentiated this prior and a introduce target do -- position extend to to additional and potential product to in dose, an the to drive gastro-resistant long-term a wake and and pitolisant-HD and in XXXX a franchise product date would the at to to generation. together, profile differentiated Taken Pitocin mid-XXXs in feature result a opportunity label WAKIX meaningfully plan patients indications patent as provisional to revenue

I out July to X market FDA patients Our team preliminary round superior EDS and in as we're meaningful the ages older benefits offering professionals compared that for excited you and product viewed the indication results launch by pleased of years and patients commercial to PitolisanHD. clinically research Sleep/Wake X. Wakix be the for on on very the to approval payers. suggest market to as would based this described into care features franchise, initial of be our target And with profile were conducted WAKIX new by perceived real health narcolepsy pediatric To interest we

TEMPO ongoing pediatric obtaining us X with protection ] syndrome back As longest a on the of months regulatory keeps narcolepsy data reminder, on Pradaruli the to track along pediatric September toward III end the exclusivity [ additional which an and from our study us would XXXX. in Phase take of data patent,

TPM an on are idiopathic very program sNDA potential submit agonist this later and XXX. we're our We excited hypersomnia for Orexin-X year, to track about best-in-class for

first-in-human of XXXX. and our track IND and Bioprojet, partner, with studies working then an half are filing towards are second on We initiating mid-XXXX

Beyond are our we advancing in epilepsy. neurobehavioral our also other sleep/wake franchises, late-stage programs X franchise, and rare strong

X now I rare $X each peak diversified to includes Harmony our of its in portfolio and billion begin has of X $X of its franchises, want advancing has billion. orphan has highlight expanded opportunities III this sales which to pipeline year. CNS that with a programs and later Phase to are pipeline them that Phase X trial development XX now assets across fourth one III

creation launch poised at updates each Importantly, be significant PDUFA programs our This will X along beyond XXXX. Kumar the potential to this deliver pipeline for into on over value in targeted providing translates next call. the pitolisant-HD new year X for or XXXX the durable product is you indication with years. least development date out long-term later

delivered company the revenue advance While we our remain programs, Wakix net focused another growth on with execution $XXX.X quarter solid we of million, representing pipeline across and year-over-year. XX%

upheld our after final the to the patent reiterating What earlier way. that well are $XXX Wakix confidence a attempt XXXX durability again and the second in guidance we narcolepsy our again the million market remain With in regarding these is confident we revenue strong net million, reinforces Wakix on the represents to are alone, our being and polymorph of results, Wakix of morning patent. shared $XXX news challenge once this and we the once franchise $X billion-plus opportunity

filed short of issued the final its Late a the petition for last which reexamination was patent, week, or denial Patent of Office, by Wakix U.S. USPTO, and the seller. Trademark

portfolio always patents in in date with and bolsters filed the XXXX, the to remain have and IP confidence our the second and reexamination for XXXX date by out intellectual mid-XXXXs. I very the This rigorously XXXX. nonappealable" USPTO stood challenge its Wakix. target The PDUFA and We of decision position the our We Wakix pitolisant-GR the HD This Pitolisant solid property of confident Pitolisant request patent. final franchise, the ability the And to "This franchise our is to to in in the This for quote Pitocin attempt patents. property. the Wakix stated, our in and the the PDUFA XXXX, durability represented out to the protecting puts GR us strength of for extend enforce but a pitolisant HD patent intellectual Wakix for in rights provisional decision validity

further active overall in consistent with approximately out investments value are million cash a in pipeline $XXX in equivalents financial further additional our XX, potential execute growth cash, with offer building goal solid of to even with and strategy remain to our that position development in also We are on the drive we opportunities as business. and business the of June BD our

turn the an new Lastly, our forward to we highlight our and we over share in to Chief Jeffrey X Day With to New data have York Officer, opportunity Jeff? on you. commercial October for inaugural an our pipeline update some our will where hosting Commercial City, I with that, robust late-stage will Investor on Dierks, call look performance.

Jeffrey Dierks

million quarter another our business continued of commercial XXXX. growth growth our saw in performance confidence for of for product Jeff. fundamentals. year Thanks, in prior We quarter $XXX full in reaffirms progress by solid second the sales from were highlighted $XXX.X $XXX and Net the the XX% quarter, in representing underlying the to adoption continued QX same The million, sales quarter year. for million solid net net our guidance wax sales

patients The as approximately second durable sequential what rare both patients growth continued expectations seen Wakix average quarter the approximately prescriber was market Slide the in in of The year. and favorable with commercialization. our in of and increase last year confidence quarter. pleased of X,XXX patients extremely facilitated our patients patients in X,XXX X. the from the reaffirms guidance and our of average with on increased line Wakix X we average QX average in the We're number saw on to XXX by of of base, our number in We in and access growth Wakix reported end X orphan growth on in the by approximately the

enrolled This at growth to the prescriber represents quarter. second again X,XXX care insulated second base quarter. the approximately performance. We patients an beyond seeing in the the drive health we're that professionals. And care in also continued oxybate approaching the care continue XX% from increased penetration of tap each professionals health in REMS the group saw of Wakix this professionals into Wakix and of quarter to the oxybate segment prescriber prescribers we end base of health segment We're

is to clinical beyond differentiated segment REMS narcolepsy segment meaningfully health entire oxybate branded the care utility old and professionals, this professionals, we're oxybate generic additional and one narcolepsy seeing oxybate the demonstrates prescriber professional care options. of beyond that oxybate writer health prescribed audience the this offers to Wakix this segment. across in among see with product The care X,XXX the quarter a even profile highly of broadening each enrolled We're with Wakix REMS within treating by Coupled new in patients we health growth availability utilization providing wakes approximately continue the see universe. and the the growth broad being penetrated

seen a narcolepsy and previous approximately our patients access favorable Supporting support the confidence market we coverage us is and treating well professional full and future growth. are us during over payer patient the to we in shared audience, branded to broad ability earnings narcolepsy. no in to changes broad we've positioned prescribers new introduction overall generic our and As of call for year billion-plus giving health options, to calls, with We've X,XXX for Wakix the past the formulary care Wakix the believe tap for the coverage and into on allows WAKIX. opportunity, Narcos diagnose opportunity growth $X

on we As excessive of X pediatric Wakix closing the narcolepsy solid receive another patients approval years excited the of news to sleepiness for the June performance, of of are daytime quarter older in treatment we XX. and out are

the pediatric first XXXX contemplated The the have have and a narcolepsy all opportunity. And our to narcolepsy this or represents for small narcolepsy year access is narcolepsy patients opportunity EDS, guidance. only approximately represents diagnosed approval but of opportunity It sales full so net pediatric this at diagnosed opportunity. treatment X,XXX pediatric the approval, was opportunity approximately the And patient X% meaningful now Wakix patients. narcolepsy patients. with non-scheduled option importantly, we full

our the outreach, following approved Our approval commercial approval. the for team and was now started prepared this week

Our starting field and that sales educating week team X. health later indication care without was the new professionals July trained about

the still guidance within net another days interest feedback and it's launch. that XX have average approval. we from payers seeing add strong positive and sales care from reaffirming had and Wakix from we net sales, begun and year. are patient first in to guidance In prescribers community, formularies full this performance year quarter durable health to of we pediatric summary, positive our narcolepsy and patient their We're for in issued of growth very Wakix Although growth adds, earlier indicators early, and professional getting patient the the

our narcolepsy other we opportunity confident approval and in we're seasonality Wakix business way. in I'm consistent with of With quarter, narcolepsy, the on $X remain the Heading visits, fundamental the and typical with well third seeing potential patients strong traffic leading in managed representing offices, forward. in average coupled we're lower previous conditions, years the alone, treatment and prescribers and summer our confidence of addition performance underlying narcolepsy indicators Wakix pediatric into for plus of the billion continued in in adult the our patient we growth in fewer moving about excited and chronically of a fundamentals. foot business EDS anticipate good our

advancements Scientific Medical turn our Kumar development clinical Buodur, the the programs. over Kumar? to discuss to Chief and our like Officer, to would I in call now

Kumar Budur

and Good joining for Thank today. us you everyone, you, Jeff. thank morning,

make to light. continue pipeline progress our programs, which great late-stage several advancing in We are in of developed

indications As high different and XX distinct raise programs, focused under now from X ranging different neuro unmet on with franchises, we X to need. studies medical Jeff mentioned, assets across development have registrational preclinical

development shown clinical on full Slide is #X. Our pipeline

milligram, target PK at our that pitolisant do deliver label high strength to to of formulation pilot enhanced distinct this are higher formulations PK comparing Phase fourth is currently formulation It the X patients an with plan symptoms. III note X ongoing It recruiting for coding during our franchise, optimized highest dose conducted with half study a a pitolisant for profile, that crossover X an formulations Phase III a patients sleep/wake prototype X [ and the XX.X our the LGS program. in and with X-day dose studies along HD Vitaros VR with Starting start Wakix. is prototype to have unique we designed important study We of XXXX. registration of study dose, ] with indications pitolisant registrational different the in actively

forward. the Based demonstrate work variability further to XX% where we pleased to program on formulation the will a variability relative this from meaningful steady up feature bioavailability highest we The PK are for differentiation data, showed least at decrease preliminary of Wakix, the this with formulations in bioavailabilty and Wakix. compared approximately prototype data increase in and pilot advance in a to the to we Alongside the increase Xx dose expect and optimization, progress current program to on labeled in in a [indiscernible] profile. decrease

tolerability is coating GI dose to disposition of beginning address therapeutic the GR the addition, designed with In the fee narcolepsy in patients to the range. issue enable and at to start

along and narcolepsy unit higher coating is a such an to targeting Therefore, the expected and profile, in profile. symptoms label optimized PK differentiated GR dose, as product fatigue provide with

and an HD years that up were of the research completed pursue past to study We based work pitolisant over qualitative repeat on in fatigue will clinical of abbreviated program study, per the support the milligrams leading couple margin establishing development pitolisant program. to [indiscernible] in a safety XXX and including narcolepsy

in patents have We a patent date protection PDUFA XXXX, with until been are the submitted potential targeting [indiscernible] XXXX. for

pitolisant to GR [indiscernible] on assistant, Moving our program.

which The extension will of [indiscernible] in NDA generated of pitolisant with the in data are including initiate We on of XXXX. dosing pivotal study the an IH. IH strongly supports the from in hypotonia, year. year on our study, track fourth on the The the quarter track submission are first program, optimization efficacy long-term quarter we fourth data in of this the [indiscernible] submit quarter and to ongoing from the the idiopathic a to study totality XXXX study based patients this bioequivalent be

in included offside will evidence the be our information in further NDA, strengthen have EDP other from pitolisant fund the in supporting [ real-world to Europe that ] including in We submission. hypotonia

from top remain in ZYNXXX and option treatment our behavioral committed to we living We reconnect IH. track remain the line are bringing with of report In in to X on data new III mid-XXXX. registrational optimistic Fragile neuro trial in Phase franchise, Syndrome the patients

syndrome fans, in In data the topline in the [indiscernible] patient for enrollment EPX-XXX rare Phase III Dravet with the epilepsy XXXX. expected continues

We are and narcopathy epileptic another Phase initiate to also need of in later unmet III medical study preparing severe development was year. this a high LGS, with

In at X behalf hundreds pipeline clinical our successful, in advancing the who us performance. have with turn thank in all for over summary, the over participating patients franchises. financial for X progress commitment product help to could rare like least programs. next of the update the across personnel late-stage of to our one in these trials and their indication to across we families thousands to development investigating. Sandip? patients are or If we and call the of our disorders as site investigators all and significant I'll made Sandip result neurological the distinct potential as On would on programs along new year, each CFO, I are launch advance in Harmony, Kapadia, our now well efforts clinical their helping an our years

Sandip Kapadia

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

XX. also cash top financial with of delivered profitability line Slides solid and continued growth another shown We double-digit is financial Our XX performance performance through generation. quarter on strong

$XXX.X reflects well performance quarter, Our reported year the our of strong to continue strategy representing million million demand ACI. and underlying the growth in a year for financial $XXX.X remainder performance second revenues for quarter of and to and continued us We profile in the beyond. the positions net prior advancing the of growth compared XX%

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

million With line. incurred expenses We Epygenix incurred XXXX, composed reflects charge development to of respect charge acquired $XX which X with transactions, to transactions transactions us epigenic. Bioprojet expense $XX.X business XXXX the value and related both [ success-driven a charge million. quarter to acquisition future advancing to TTM tax upfront and by a R&D to R&D capital structured related a deferred of of impacted the quarter, This during low The primarily ] and focus in to of approximately allows we as of the the on $XX.X one-time sublicancing charges second IP upfront payment the $XX of related for the R&D paid IP part agreement licensing the million development inflection fee upfront million, points. into milestones. use assets related offset efficiently program and investments shareholder the reaching We XXXX

cash cash, the balance on capital ended flexibility with with reflects We to share of development repurchase business which The $XXX.X continued shareholders cash strong on to quarter our and investments and balance opportunistically equivalents execute financial program. second generation, via the million us return sheet. to provide

to continue in of seasonality quarter-over-quarter of experience expect we year. quarter. summer we growth impact expect ahead, Looking We the for third an do the balance the typically

million once of Jeff our to like back guidance for reiterating towards We And $X turn Jeff? for that, with our to closing revenue the in I'd million, remarks. are call alone. $XXX narcolepsy $XXX the opportunity progress his to highlighting plus again billion net XXXX

Jeffrey Dayno

proud am advancement date the This, an toward the closing, accomplishments Harmony HD were made of PDUFA continued development XXXX. expected of I very program, including that in In pitolisant Thank QX, team to extend solid of and to during by progress you, USPTO's puts the X significant Wakix after a with validity the XXXX, along in IP the failed final to the to us with pitolisant out mid-XXXXs. out position attempts the the patent, challenge franchise patent the upholding decision Sandeep.

fourth and later in initiate X XXX the XXX approval our on partner, of trials and with strong syndrome; ZYNXXX Epygenix our the EPX Phase epilepsy generation this pitolisant business indication advancement track agonist in of establish Therapeutics [ LenusGacaue Phase and in Continued acquisition and including trial ] that a for with development X III clinical of in [ growth The Prader-Willi for brought in rare syndrome BioPrege; deals year orexin pediatric an for Wakix franchise EPXXX of of III the and revenue with year-on-year. X TPM along the XX% in-licensing Dravet narcolepsy exciting WAKIX, Fragile ] syndrome, syndrome for EPX to XXXX Harmony. launch

our further now on We remain market bringing long-term to our durable shareholders in execution, pipeline while strategic focused living treatments rare creating help of our with and value more driven late-stage innovative out for advancement even committed in the build to to approach our to pipeline patients call the questions? medical neurological you needs. morning. planned call, facilitate for concludes turn the for This the operator please back over this diseases our I to remarks to Operator, session. joining you open unmet to and Q&A call our Thank can the and will

Operator

[Operator Instructions]

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

FranÃ§ois Brisebois

Congrats on the quarter.

seen of the talked to in we've about seasonality, the of you past. terms summer, kind be third the months In what quarter similar to

last very think actually and and some average going In the we kept the patient seen kind have in year, is strong past, quarter. third drop. I the of solid add

is saying what just that kind you it's understand heads seen of -- downward little more it past terms of years? in bit second that mean patients' it in the quarter? you've is Or a the by normal help that could from us something be seasonality So

Jeffrey Dayno

I'll the over Jeff for it turn Thanks to respond. question. Dierks to

Jeffrey Dierks

Yes. Sure.

to about the summer So fewer relates traffic, more seasonality, Frank, and visits reflection patient patients. new when talk versus existing we a patients foot it of really that's lower on typical in

their medication lower new chronically on So holiday. do and of patients when in don't summer during little bit a we visits the patient vacation terms medications. with the happens typically starts they're that Those managed schedule most anticipate

our X do commercialization. seen last we growth, anticipate years as you've continued But the in of

continue allows narcolepsy the And approximately obviously future We dynamics. around patients at average to this year. tap to typical indication, as we the obviously, us growth by reiterating of support the seasonal the with pediatric the market the of help as that's opportunity are into X,XXX end guidance our addition going

FranÃ§ois Brisebois

you patients that pediatric expect population on you then that about it's difficult adult centers? better pediatric the -- That's the Do And about or helpful. note, than more in be on side. -- talked X,XXX to penetration the in

Jeffrey Dierks

say added what years within seeing profile. of couple be market Frank, patients a knowledge to versus would a prescribers patients, of brand-new the that pediatric pediatric over Wakix audience So bolus is we're is right? us, what are I and expect its product is a I although for would the of This there with the

to the patients go have We out but profile. caregivers the and look more at only about educating not the and importantly, parents

when little this a patient a to But penetration different as that was fourth opposed you year. to quarter every over option. We're very patients be So or anticipate patients population add launch of to single a look these going this similar large than a probably the I looking bolus going bit third time. there tapping adult new bolus we're sort quarter anticipate to the we quarter in a for would where opportunity. looking to of

Jeffrey Dayno

offering add, I Frank, as for product and would approved product pediatric a the Yes. first narcolepsy with narcolepsy, And Latinas strong just patients patients. only for in nonscheduled

Operator

will question with next Our Duncan from come Fitzgerald. Cantor Charles

Charles Duncan

congrats consider persistence the the prescriber the follow-up to a questions. and I great question team, the patient then regarding appreciate patient when that of in seem me to pediatric what It in think would base secondarily, population. wondering be population. pediatric persistence? to And taking a prescribers. registered you greater the XX do And last versus actually had addition exists patient prescribers pediatric Where XK could population I penetration, more? nonoxide Oxby think about do quarter that on you I'm you the even patient

Jeffrey Dayno

Jeff, you where question. thoughts your coming from? are patients Charles, on thank for

Jeffrey Dierks

Sure.

professionals approximately enrolled know disorder you of sleep up larger we more those is to are treat. neurologic know, the this pediatric in little centers. diagnosed a professionals patients. -- difficult a care that end heavily skews some ultimately, It about X,XXX as health oxybate that patients these very Charles, probably health narcolepsy care there because And X,XXX manage So to lifelong REMS

have And caregivers of parents, Wakix in think, amount with those with already touch of would news office. They great a early, but existing in good X,XXX a is, I again, in the that very adult. were the simply getting persistency is those we've call assume with lot the rates and bringing already But doctors, plan. just I good them that our it's Wakix probably and very seen of patients in familiarity

would assume the the that or for population potential persistence. equivalent I better pediatric have may So

As you shared, a take suited in patients. once-daily Jeff product morning for is you wakening. very know, Wake, oral tablet as It's profile ideally upon pediatric a the

So have schedule day at you these being off the worry to but doctors, a the to the also really treatment Certainly, school during having appeals that don't have about profile visits non-scheduled maybe patients medicines go nurse and or to to to parents the met for to drop option. parents of individuals.

Charles Duncan

an this data would it any or about approval second year. Kumar. it, And the regarding you filing you of for waiting use you're perhaps, additional, IH be and that enabling Are year. including describe that clinical next more Excellent. results quick to enable Can so that to question experimental you that a I ask one can and relatively a little by sNDA of -- finally, is pipeline quick filings thinking half real-world launch maybe the and turnaround, anticipate call

Unknown Executive

for Thanks the question.

First the year. of of we all, submit on are end the NDA by to track this

months, XX almost about have since them -- past, was completed totality part, also are open-label are to completed data long-term INTUNE a still We extension extension months of have year discussed about the study, that at now the the the and entered patients close in all X/X the study period XX completed. it's of long-term and who into of from terms have evidence, them still almost of some the the randomized we beers. them study In of the study, of participate approaching in the as

of the the X safety also treatment efficacy profile. to speaks on and this So persistence persistence and

the data Patty end are terms idiopathic hypotonia leveraging evidence in testolopan make strongly pitolisant, control pitolisant of patients of treatment scheduled day I data substance believe the be a data, very a risk was dosing in day, a more mean we taking available the a into this drug controlled stronger patients with -- with benefit the X has described Charles, unique this we'll in with simple additional of ofcom is or we off-label leveraging proposition, with In substance at currently submission. to and which offers as of resume some But of real-world from Hero. once profile bank. a nonscheduled option the

Operator

Ami question will next Needham. come Our from with Fadia

Ami Fadia

rationale is better Can across help a progress more and us the maybe into the and increased much what understand and all of on how translate sort maybe question you would the the pipeline. for high-dose the My efficacy regarding sort higher need rate from how with of higher during is And see formulation. you patient unmet formulation? course exposure pitolisant first the dose benefit Congratulations the Kumar the day do -- a mechanistic of there? occupancy the how

Kumar Budur

North to with Thank with will and body the oleic for dose of in a fatigue are fire increasing of question. or and that the of multiple sites [indiscernible] increase dose you in we we a results the earlier some the have really as plan Xx the interictal we evidence excited program, We data saw both And studying relative decrease to response [indiscernible] an HD is target base, all, treatment. we that in pitolisant with in be Ami, of dose also, formulation me show also first discussed availability up highest a we press to the high high-dose release, a Yes, saw the on FX, the variable. we an also have

optimal to there want finally, narcolepsy, offers are gastro-resistant which symptom the Jeff, widely for treatment and very product very market up patients with add? patent, an the which product no our range of therapeutic traveled door, designed unique profile system profile and do proof his to the the a for the this competition starting formulation, is start received GI ability the to you when was the to So take attest Jeff well highest team reserves. and

Jeffrey Dierks

Sure.

across I pharmacy X specialists do initial to directors So with did looking target just across as because and superior than we was a profile. X of need this get from that profile be some patients, looks preliminary of out unmet the about marketplace professionals care the health commercial the market perspective, product product And Ami, and stated, narcolepsy payers is differentiated just and the what in biggest a audiences think Wakix, that's XXX one to meaningfully coming Kumar was efficacy. is sleep simply those very clinically research some feedback that research enhanced

About still report that of on treatment symptoms daily are impact that XX% residual patients life. their

and disease, efficacy. no of their but different Then -- XX% medication. daytime what other pathophysiology distinct And of with of the very we've up experienced them from we was lastly, know living to disturbances. their to have nausea such have than polypharmacy market, more GI is people the fatigue, Mostly XX% and and as product are untreated data now excessive narcolepsy sleepiness. need unmet well enhanced then is approved currently in seen up patients as also literature a patients which also really to second so the issues of which on in for attributed for suggested their looking untreated as in physicians And XX% research is GI narcolepsy fatigue, right

their payers profile one broadly and as efficacy, the coating option that addressing covering patients. seems very be symptom combination fatigue GI that to enhanced very of attractive one present of going to with and clinically the are really the treatment a this vast for superior gastro-resistant the physicians really a see untreated So majority product,

Ami Fadia

amount to all for assets With assets these the there of would in-market on? is from company's assets terms us of priorities? My you there. If think the a as make second sense you question investment these going front of some is programs in progress. opposed do bring Where type fair assets assets? underway, in-market later-stage to obviously is business be I'm R&D development be Sandip. it of Would give to as assets as sorry, could what early-stage color And to opposed different --

Sandip Kapadia

last its We've I all business continues, success-driven as company. that mentioned, Indeed, a at low X saw so. disciplined financial mean, question. them done several in the development Jeff We've transactions. got looked we've we Ami, upfront on manner. We've milestones year at the for the thanks for overall. the done or priority transactions

we've things can And us a can filters well for have building capabilities that think the that a built the looking in-house, CNS, know, as clinical we capabilities and we we side that we're on more as better Jeff, And lot I don't help company. be rare further. to program already at continue both in better elaborate as commercial. any thoughts leverage the of

Jeffrey Dayno

that we orphan of now focus just the the a -- build franchise in in Sleep thus forward. that I mean that the business strategic how the franchise far with to out taken that going in we we've X way, vein development Yes. strategy neuro, think rare main and add regards in. sort with see we have bought I rare the that franchises I our in we similar strategy epilepsy opportunities neurobehavioral franchise and would

us $X are franchises it with has with add and and potentially manner each to of can those And where opportunities of those the CNS potential sales to doing thoughtful like a up now we if would as to the we We billion our in sort continue a disorders, set we like a regard X of peak we $X in take profile. or then and prudent billion. an for approach We to in forward. far, area of approached going see well. or neuro it franchises way We that an neuropsych similar adjacent we've thus contemplate opportunity each

Operator

Sandler. Amsellem come with Piper next will from David Our question

David Amsellem

Just a couple also.

into contrast First, risk you GR. is to at the all formulation. could through are both potency, on of dosing the there these in there? formulation I'm of do So to it and greater one. is what cross and wondering, high-dose number going of with -- full terms territory the scheduling, And suite substance what liability that's controlled you human of in any that in the talk the Can work particular, kind legacy

doctors there? penetration not the what in number REMS. your And audience? your two, that of have talk then the talked about about Oxybate might of more portion time you this earlier, penetration you into are I enrolled Can in who but the terms physician missed And over expectation is

Jeffrey Dayno

Thanks your questions. for

turn HD, David, with potential is Let regards first the this potential, then changing me -- the one, of for abuse address it pitolisant tools. to and tumors to part over the I'll

does in answer So to or the short mean with no. higher potential terms lack abuse dose not I abuse change mechanistically, of the of regards the liability. is mechanism the

over So and the within the doses of program I'll there. to Kumar labeled demonstration in will program not require of terms opportunity further million to comment on to and is HD thinking on range million. current abuse the bioequivalence regards pitolisant the dosing it to the pitolisant WAKIX turn what $XX.X with equivalent to liability regards in that with the GR, $XX.X to studies. plan And the is the at based of then the

Kumar Budur

Thanks were parts Yes, question. your Dave. for there you, questions. several to Thank the like

label as studying of regimen in up and the XXX said multiple safety other. be in here was me for leading we have and edge X margin. those we part we'll in terms let to compared after address one rate a And HD trend a studied up in to that a the We So established question we pitolisant But did as safety at program, already study, provide earlier, of be the details will regimens the profile, later the [indiscernible] time the pitolisant highest study with to vet we work and the program. did a we'll preparation safety milligrams around Xx Starting ascending legacy second will we to be that pursuing. the dosing to different of in point

on studies The the arena profile mentioned, That comp not a Wakix potential have not similar we shown the milligrams did similar safety of anything in up not impact preclinical and that's in haven't [indiscernible] terms of including to safety no studies were one so development, cardiovascular the is placebo. very in very was Xx One and And of potential, reed. plans. our pitolisant QPC objective. conatusly impact as [indiscernible] was profile [indiscernible] of to done there XXX resulting this even at the and any on release see is interest, Jeff to fact that these because seen times multiple we of other

Jeffrey Dayno

the And the of Yes. part to second Jeff. question

Jeffrey Dierks

Sure.

nonoxybate the professionals. penetration inquiring care the So about David, you're within health I REMS-enrolled believe

And And within so able regular within quarter tap second segment. about we've XX% what we audience. X,XXX been of in and been It's in the approaching that there's health saw care within that the that audience, about growth those penetration rhythm to that we're a professionals. see

couple grow mind, care is respect our but health to patients have to entire ample necessarily And believe a the under don't goal goal for all in that area. there are at I of representatives know of a With penetration, do I these out X,XXX We X,XXX network. this have in educating se narcolepsy care. still professionals least room per their

XX% So to north I XX% would tap continue say in. seen of We're XX%. we We've to from growth XX%. now and approaching

this and in rhythm we're regular continuing a growth there's this think I segment. So to space, add of continued to anticipating

next are phase depth And for to the is we WAKIX. And of that, their see on starting well. patient second to The of I of that phase then ample believe the room is as prescribing. David, that grow growth first their unique growing And this they do start there's audience prescribers. in

generic growth very the a a oxybate, from audience, catalyst it's moving forward. for So is and unique insulated certainly future both branded

Operator

Mizuho Suvannavejh next question with Our Securities. from come will Graig

Graig Suvannavejh

also Congratulations that is past half but to net my for million year of seen My additional patient planned from again, wanted the patient the in that adds, commercial net second from for question first balance net had have in detail end missed think ended around I $XXX as before, math I Jeff the even we adds the to adds half. at several second had $XXX by we've the years, business have half second over terms -- on correct, math. you if I historically, XX, half progress me think, at quarter. implies think I implies what -- about the just only patient Wakix think to second this in and based my XXX and on might the XX that the revisit what Dirks And the X,XXX. on you the earlier I I heard of if I

I realize appreciated. going that GR what versus Wakix for patient that be the the that same. expectations provide that higher And product with should would you just you're around legacy and will to our commentary be be some has could half remained a the anticipating what be second anticipating appreciating Wakix guidance are evaluating the with on adds you've you got revenue if relatively So profile relative that the HD to see on than I the you're or expectation efficacy. on higher to perhaps that the be. even just going legacy then my on doses wondering the to HD effect be but less question, formulation, testing safety you're on second formulation, just the comments around knowing formulation should what Any safety same doses was Wakix? improve side to

Jeffrey Dayno

Yes. Thanks, Graig, for your questions.

Jeff The the from first X over to side. Dierks commercial

Jeffrey Dierks

Sure.

from So Graig, average so quarter XXX with first adds, XXXX patients. and the sequentially respect in patients approximately add yes, patient year thinking full the average we X,XXX did quarter second about and to about reported

end reiterating the of year. are We X,XXX approximately the our at of guidance

So your math is correct.

to and historically, we're we about -- growth for we you have X who continued impacts expect And med scheduling tend seeing year good yes, balance appointments even in a year that, shared orphan X, management. little we quarter the year, think I new year expect And looking a patients important the seasonality of are the do earlier, rare feel managed as their extremely in it's the and we chronically at the commercialization. for starts, typical of bit X, summer you're fourth when growth X we're now year that some confident patient

medicines anticipate refill the insurance resets, like changes refill end we do year, fourth strong fill before quarter. their insurance So next year. new patients the in and of Typically, the behavior to

the continued We into alluded each the future as as fourth continued confident good guidance growth tap ultimately in added year help X,XXX about support ending the to forward. looking about those our for seasonal Sandip indication continue growth opportunity we that the diagnosed kind balance we're of allow -- I patient growth and think narcolepsy we're recently you third fundamentals, and of and quarter think earlier, where moving of seeing anticipate the approval that underlying we'll you're dynamics quarter-over-quarter should as We're help pediatric year. market But right? year business at

Jeffrey Dayno

-- the maintained other regards on benefit expect of we with be risk terms pivotal same no on to and on we've what HD based in regards opportunity in say the would response safety and previously seen program to expectation profile that? overall I Graig, efficacy change And to Tolson any improved the the added with dose tolerability color that our data in overall tumor for with the in profile

Kumar Budur

of with other we accelerate the dose time. thing that About just think XXXX this higher safety [ label similar reprise as we highest was , I study covered profile some the I milligrams. study The the look tolerability [indiscernible] multiple you up like XX add this edge in leading we and to work started at is a plan very only to milligrams did where ] ago, earlier, program months which everything. at look And and I to would to is mentioned total of X.X gain. we XX dose studied and pitolisant

actually did in profile. not you resisted patient we coating more should tolerability see any about mentioned experience. And result the just [indiscernible] safety change anything , if resistant positive the So a taste in and

Operator

Wong will David from with question next Our come Citigroup.

David Hoang

are filing in respectively. in packages one, in And agency. and here I to date GR formulations, first So the just and projected get terms gating about PDUFA of with for confidence key the tolls your to the data ask wanted XXXX XXXX level to in meeting factors of or HD the what

recon filing, And you molecule, differentiate there developing believe how which then in former at are you're which terms indications features do IND could taking such the And versus development? think to in from other you forward as second about there currently IH? any question, agonist narcolepsy of PPM-XXXX

Jeffrey Dayno

key of GR and have plan your dates and terms hit David, PDUFA on development we're projected what With are Kumar? in our I ability out of that those can towards color things. further that's confidence the confident regards are and thanks to question. we think some the I major pitolisant for milestones provide the for programs, Kumar that. HD in to our laid

Kumar Budur

the question. for Thanks

in we of quarter. call, play on start fourth formulation gastro-resistant will earlier XXXX. we dosing in this the the the are quarter good a as start to equivalent we in Regarding during study we option study first on disclosed for track And the on track are and

We are confident it. about

just formulation, population. narcolepsy initial patients we terms quality program, the data establishing And study. accelerate on earlier In tie the work in margins, who patient to conducted that like also leading-edge PK fatigue disclosed from to with some we study of mentioned already the have the right this we done a the fatigue identify I have safety instrument HP in this of study

stage provide our this XXXX, and to anticipate as clinical development next in to plants. some be we we We give in of color the solidify the more will

the have dose potent mediate of types the XX%. expected that require NTX the products this Regarding based based potent and noticed a different XXXX, chemical all, compound your you than last most chemical fact domain higher on that does -- about experiment this is into on that any the information [indiscernible] titrant, . belongs TTM product our various stay -- con to point we first has higher around is to novel the a scaffold receptor public for the seen other a restate and have differentiating agonists. typically audit information into agonist on advice may preclinical X The on our than available agonist, -- in question and It fitted, of different in now is some it's other most [indiscernible] we what

from safety preclinical very in when gives best-in-class interesting us and is that off-target -- could actually perspective, also potential seen [indiscernible] some [indiscernible] side to data to comes have . avoiding the be that, believe compound of that So the need the and that it terms that just we PXX

Operator

will Our come with from Karin Goldman Johnson next Sachs. question

Unknown Analyst

through $X the there, to and this could bit maybe provide past to little you half the that sales. just color to just of clarification, about you maybe a -- today need around billion first guess, to about the more a growth year. just we target the see are some like that on to to more growth particularly get I talked from where patient can respect little you here talk then target You've for bit with

I grow. think are continued sales second flat relatively to versus took 'XX, price but and patient half obviously, you

balance So seeing how there about the that should growth the and curious in think you're of what we year? in

Jeffrey Dierks

great a question, it's Yes, Karin.

$X $X I I think, so of we to mean, $X,XXX about patient -- $X X,XXX history So billion over X product. our continued reported billion, clear. adding approximately billion on achieving We X -- path in patients $X our just is our obviously, average very and growth, patients is finished per net looking the north simply based average upon years. years And looking believe getting on to at the now, of achieve path X,XXX price another average and what basically obviously quarter to the billion and between next mid-XXX is based mid-XXXX goal

professionals. X,XXX about $X obviously health only in opportunity. a the which smaller care a have, We much to very It obviously, to with billion its on the the analog path to oxybate, patient full have into didn't good ability diagnosed able was access tap achieve

professionals health X,XXX of in having next So the we achieve with accessing another believe X the goal patients X,XXX care to years. average

and I ability a we I time that's really help think the look by think narcolepsy. out both building adding with being thousands $X franchise HD period and we're along that to And enhance and this why about absolutely franchise opportunity. patients very able at is GR and billion-plus this achievable, living Pitolisant the of as excited to

Sandip Kapadia

year. average the second in the what say, first quarter Reset, as it's intensive this took then last price I the would into quarter -- what seen for with And quarter. Yes. in the you We Typically, question. that earlier past. seen year. that's we've Thanks, a this roughly our of line have generally, increase we've and patient per lower go in

So I second think evolution year. and the generally, in the it's and how it our in of expectations the so stabilizes half with on improves line

Operator

Our last Gerberry Bank will America. of come from question Jason with

Unknown Analyst

Pavan is Goodberry. on This Patel for Jason

improves is to gastro that effects pitolisant question and first address. that GI side has resistant E potential the The

a in higher X% presumably Wakix? titration. by if only And then may. dropout were Phase question, Is mitigated with rates real-world rate a have there I and given I II, So follow-up

Jeffrey Dayno

Sure. question. for the Thanks

address. I think can Kumar

vast the the is the mechanism I the the we predisposition at GI GR, Wakix as so of related really said, of patients majority the [indiscernible] But profile tolerability not pitolisant it's think symptoms to underlying the nausea. -- related incidence design it's with have to disease. and it's --

and the common other that experience them and potential for of nausea, with lot a So vomiting treatment. they see Discomfort also [indiscernible] narcolepsy

can in on is predisposition the symptomatology, potential. be then the of the that could program Kumar, what the we that in And up reduce feature beneficial So sort HD potentially feature especially GR regard. dose, comorbid to that go as additional likely thoughts?

Kumar Budur

I got think it, you Jeff.

kind requires patients of beginning trends -- the wait and I that for we therapeutic realize of thing the apart us you medications enables patient narcolepsy. the resistant the efficacy, compliance therapeutic patient at used to don't other much also may that experience positive the better gastro not efficacy, have attributes, some until the tighter with patients don't as to mean, pretty overall. they the So start to this range. know, with want to all want so from formulation just in are and general by enables is, add at start I It the faster better the the

Unknown Analyst

to Phase And similar and study your is then expected by or EPX Longboard mechanism taurine XHTX pipeline. my which III XXXX. question is the XXX, is related commercial development-stage Brexit stage to start [indiscernible] On to year-end second the

us fitting current So Is that I into in in the syndrome help or And for landscape? the in can CPXXXX the where safety can guess it how XXXX? understand this you top landscape? efficacy maybe you looking we're if improvement with treatment line Dravet data see differentiate itself

Kumar Budur

we are question. also the that's mentioned, No, comes of of saw Yes. as drugs is epileptic to safety How slopes. tolerability. well. look one. established, pretty you in currently good we a know, and profit is significant the yield do mean atopic right? limitation [indiscernible] question I lead developmental The and model that you predictive And when that we differentiation well an a anaplastic seretonogic and mechanism as this development, great terms develop in it a a efficacy has very the and with ability differentiate? have And area, that and good like very action about developmental

of a need patients liver incidence system and before cash let significant treatment [indiscernible] monitor [indiscernible] the also up entire to active for For intervals example, to patients of thereafter. XX% and function regular

the concern and of For treatment. really any hypertension. starting laboratory healthy Phase nonclinical studies , about months cardiac tox any the in our is a safety FDA, studies not anything of we or clinical risk And the entity, are normal. the -- trial, example, seen the I on as our factory volunteer did the we well you [indiscernible] see expected of echocardiogram cost haptics. differentiation any about and And did which, mentioned table anything haven't [indiscernible] X show as neither tolerability. comes in of tolerability new any period way, by before developing the habitat and because and XXs of chemical What Palmer we top we patient have are Fintepla by ECT it, is or PSXXX

believe meaningful a we safety that growth patient, range be in the district So safety a the in be will from offer [indiscernible] will but somewhere the efficiency to profile, will it

Operator

At I further show back the this would to for closing like questions. to time, turn no I Dayno any call remarks. Jeff

Jeffrey Dayno

on and pipeline you, and as of our execute we later strategy. we'll Thank have to York joining you City, a year long-term in interest as when thanks, We for your updates October Harmony. Day highlight for our the today as day. showcase and have forward providing in you, Todd, well Investor everyone, our on call growth value X opportunity New our Thank look and great the this to late-stage

Operator

Financial Results Harmony Biosciences Quarter This Call. you. XXXX Second Thank conclude does Conference

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

Harmony Biosciences (HRMY) 6 Aug 242024 Q2 Earnings call transcript