HRMY - Earnings call 3 2020 | Harmony Biosciences Holdings, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Harmony Third Quarter 2020 Financial Update Conference Call. [Operator Instructions] Please be advised that today's conference may be recorded. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Lisa Caperelli, Associate Vice President, Investor Relations. Please go ahead, ma'am.

Lisa Caperelli

Josh. you, Thank and we everyone, provide for us joining updates. Good Harmony's thank third as review and quarter today morning, you XXXX business performance

Our that Officer, viewed section Jeffrey John and our can our Dr. call be Drexler. in Dayno; presented Dierks; presenters on The on Susan at Medical call slides Jeffrey Commercial Investors Chief harmonybiosciences.com. be our Officer, CEO, Chief our CFO, on today's will the Jacobs; website are this

to are remind conference identified like that facts Before our forward-looking this we would statements. start, hereby during you call statements. discussions I are forward-looking as All not include will statements that historical

to differ Forward-looking subject risks statements to uncertainties actual materially that are indicated could those results statements. cause from and such by

statements forward-looking SEC. with is press report under our and factors on discussed the the the in XX-Q statements as these filed regarding that heading that information release the well forward-looking earnings quarterly Form issued of we today as Factors under Risk Additional we

place or date You original forward-looking such we these speak obligation the are of indicated cautioned not earlier or only as date of update conference undertake undue reliance during any and this statements to in forward-looking this call revise call The of any statement, statements. on statements. no to

the make over will We turn I John now to to session. will like our move would a John? call then question-and-answer Jacobs. to we prepared remarks, and time, At CEO, this

John Jacobs

on the quarter. been for remarkable patients and for successful I'm everyone, public you morning, joining on for has Good thank as team's of Lisa. our and far serve, Harmony year earnings a you, a accomplishments proud our us Thank another company. we This so and first call

performance the on for and successful corporate continued WAKIX, and are a launch a through grow date out which our on mechanism our in foundation of growth. the to We the to Harmony, COVID-XX-related future growth strong of with delivered challenges to revenue business unique as future with gate pleased am performance Harmony differentiated optimistic WAKIX During clearly with grow novel as well strategy. potential efforts WAKIX, our our came quarter, our ongoing we're a based narcolepsy. I the the have execute launch third for the strong or provides continued of action, not about WAKIX product that to our of

to we long-term Our quarter the strategy, first momentum of performance growth our puts growth upon of and on in pillars designed corporate X significant half our deliver XXXX generated value this the company stakeholders. for position a our built increase was us to and and the are which during key

corporate walking progress me date. X spend strategy Let we pillars the the minutes of now a have made our growth through few to you and

pillar profile we HCPs, Today, of reported on significant the drug are to of is million in or continued to revenue marketplace health WAKIX the the product WAKIX growth both testament strongly care performance and continued quarter-on-quarter. first and is maintain a unique The QX in WAKIX strong addresses professionals, and and Our this number we are growth the unmet prescribing experiencing in needs. narcolepsy. launch number continued of that average those differentiated needs $XX.X of patients of who

by pillar of in the in to WAKIX rare label, disorders is Our expand second first utility neurological our narcolepsy. expanding

the our the future. the of competitive advantage corporate and clinical approval indication, In our utility received the fact, -- we cataplexy strengthens of month, last broadens just WAKIX which for

to our for Prader-Willi as dystrophy, we submit Phase that of busy disorders, team patients to on you DM am are be trial also and expanding the this certainly X clinical PWS to year. anticipate before or to continue initiate initiate Pillar rare/orphan proud in I we starting next his Dayno and syndrome, our the in Dr. or other will we pediatric narcolepsy clinical into and PWS; of Phase year. includes X IND for addition, XXXX. being track a with narcolepsy mid- to myotonic II utility trials in end plans In share late-stage WAKIX our neurological progress with trial to III DM. beyond

finally, pillar through infrastructure at expertise is our leverage And our business for opportunistic of the to opportunistic Harmony. portfolio future we've assets landscape and the monitor expand our existing established continuously expand to further acquisitions. We third and acquisitions pipeline that

This and to heart and make are the of the of in inception, been we since At us. are patients difference counting the a of doing productive treatments our who the Harmony, very are work patients to do. advance have that good on team most our has everything lives truly our at we I'm year potential proud the

look medical beyond, unmet to that As living even XXXX and patients confident clinical to well available more to programs making we're of continue and advancing positioned with strong we we needs. to the we committed of our with the forward are goal WAKIX WAKIX, are launch development

And with to over Jeff Jeff? our Chief Officer. hand Commercial that, will Dierks, I it

Jeffrey Dierks

the was $XX.X third has XX% and revenues XXXX representing John. no patients and million, of for year reflects outstanding the profile the and significant value underscores Thanks, for the a WAKIX been and patients health virtual, HCPs. the with not the care of professionals, need performance market increase With being this quarter-over-quarter. of WAKIX the team quarter customer narcolepsy benefit/risk Net quarter of resilience also to different. commitment but payers third Harmony our past most and an the and of interactions overall quarter were our unmet attractiveness strong our only in

lives WAKIX patient quarter. launch. to coverage also quarter by continue X,XXX persistence continued patients than increased increase X,XXX the population, number more of speaks average to see than a prescribers of of with approximately QX. for narcolepsy prescribers of from increased and growth new represents X and by XX% key patients end some with WAKIX, in to who the WAKIX we XXX second third the of with of number XXXX. million of continued the majority of or only not the the requiring prescribed The I'd the This HCPs market growth quarter, to the only WAKIX adoption of favorable targeted covered representing access X quarter third compliance. generic durability end demonstrates And treat of unique number of XX% more WAKIX formulary The access having positive but vast WAKIX like the edits WAKIX average diagnosed X,XXX, access in already approximately having third The to increase from the WAKIX. on patients in highlight of since to step to metrics performance

is lastly, antagonist/inverse other EDS, no indicated performance symptoms offers overall also withdrawal WAKIX stimulant, approved or following excessive the not them agonist a narcolepsy. the for product strong relevant offers be patient-friendly, tablet administered no clinical FDA. medical the cataplexy as evidence and studies. pharmacokinetic broad WAKIX trials. as the the differentiated it and key other profile attributes. to or the seen selective exists with oral profile meaningfully care with the novel And treatment benefit/risk offers first-in-class treatments. A the current in wakening. product clinical key monotherapy morning WAKIX receptor narcolepsy administration molecule FDA-approved, only non-scheduled first once-daily a in is aligns driver WAKIX treatments, narcolepsy used who is utility treat in approved WAKIX of in can of interaction known availability the with with how daytime our to drug unmet WAKIX despite that upon sleepiness, It's with or the concomitantly a market MOA, patients clinical convenient, that of of and by professionals a health HX only clinically in narcolepsy tolerance the with need

in performance patients with for based is solid on outlined the WAKIX I've narcolepsy. indication Now solely adult EDS

narcolepsy living for treatment launch. narcolepsy appropriate with patients have patients option WAKIX since which all made EDS, all adult our Importantly, an

cataplexy of With their expected the to of this for addition also EDS, both the future lead payer the differentiation WAKIX position are that come WAKIX both the pursuing or in development now strengthen Having for prescribers prescribers continued products anticipate indications patients existing new EDS EDS we as in only of with identifying the additional WAKIX. our of in and indications cataplexy and to label patients new may recent is practice narcolepsy not to for to and in first include and expansion WAKIX symptoms strengthen or treatment support for in formulary cataplexy but growth narcolepsy only non-scheduled to as competitive in market. treatment

in from health lives excited conviction WAKIX robust the the about provide strong in patient and have and our option making are community care We the are launch, narcolepsy feedback treatment of since difference meaningfully We've differentiated we the community. for patients. we positive to received a

long-term launch further We to broad growth we pleased an that of In in with WAKIX with summary, with on adult expanded our to forward focused remain a look and adding extremely performance. delivering to utility and our continue significant indication, WAKIX clinical cataplexy I includes patients quarter near- narcolepsy. am third as label the now execute

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

Jeffrey Dayno

One the is I made on Harmony's Jeff, aspect the strategy pillar first on our for WAKIX. WAKIX. this this the expanding of have everyone. good of clinical the and And FDA Thank to I want achievement: of of we indication recent morning, you, with acknowledge narcolepsy. label approval pleased am in the utility the second growth progress expanding point, strategy, cataplexy

and an work want trial, in time which milestone pursuit my outcome. working to that want to extremely this indication. positive were in this us this perseverance also I this I to the Harmony towards recognize for having approval, of all outcome hard with pursuing added clinical conduct their thank able is to team would additional this, For achieve without and and and year cost FDA for thank have to for This this we more

We WAKIX in to label for expansion patients. pursuing include pediatric narcolepsy are also

in we and both we trial have a second clinical of shared, working pediatric for Phase half indication initiating daytime sleepiness, XXXX cataplexy. As EDS, pursuit or previously the in III excessive are a toward of

of We later will next year. III more the this development program Phase provide to color closer initiation the we when get trial on

neurological with our development to additional patient pitolisant, in Turning efforts WAKIX, or orphan/rare populations.

patients programs in there and medical are X indications are for are Prader-Willi there about limited with we products pitolisant address. approved these dystrophy, need, able unmet significant lead we as and Syndrome be remains excited X no believe conditions which first may which very to myotonic Our or

and in opportunity mechanism novel for a a cycle is pitolisant we the view action receptor X drug product life of we are development increases portfolio approach histamine based brain. background, managing mechanism-based histamine agonist, of which its on as this the antagonist/inverse and a reason as pitolisant. a It to taking As signaling

to similar CNS XX,XXX to mainly patients our XX,XXX happens First syndrome, in patients pediatric program off disorder which orphan/rare United of hypothalamic or a and affects dysfunction, PWS a multi-system development is approximately the that what is Prader-Willi is PWS, in States. in narcolepsy. with disorder

some with have phenotype. patients narcoleptic PWS a And

In half hyperphagia, in is these addition primary the abnormally and focus defined an EDS, and PWS, consumption primary with program is experienced to development which of for patients of over which also symptom of as food our the pitolisant. appetite increased

outcome on track than the trial the consequences and focused a Phase end Based primary taking are action other are the to programs mechanism hyperphagia very and program points. cognitive function demonstrated II end on and before as the sites We year. pitolisant's focus key have improving as impaired as which are -- unique PWS clinical our of being Currently, our of the behavioral development cognitive EDS, activated, and EDS efficacy primary secondary initiate different approach on in will assess in we on outcome.

orphan/rare development is is patients approximately most and dystrophy, Myotonic The next in DMX X muscles adults. of is with and and progressive for It muscle to dystrophy, and that DMX. weakness. plan dystrophy DMX both disorder type in patients study known the U.S. we primary dystrophy to in CNS an Our myotonic symptom type with patients also another common with myotonia, results form as which and is in muscular the X relax is myotonic in affects XXX,XXX program inability patients DMX

program. are causes of Two XX% symptoms symptom common be functioning. investigate development is sleepiness, will cognitive other patients the excessive patients result impairment, beyond most and and impairment which in we impaired in CNS experienced common daytime are signaling in daily of the significant is also in XX% myotonia, which DM this the which to histamine thought fatigue also However, to these

DM We for are and dystrophy to submitting IND first a patients half myotonic year-end before currently with trial year. next plan II initiate then an for Phase track clinical the on in in of

will our program. this you We updated keep progress on in clinical

than EDS pleased in In indication thus was X summary, for far, over narcolepsy years the established, a approval our year we treatment a are by adult of little with with later. of after the followed less adult patients WAKIX initial gaining progress cataplexy the Harmony

of I more a the However, portfolio is novel optimize first-in-class is and make patients approvals with team opportunities disorders a action on to development these about excited clinical orphan/rare molecule. our we hopefully to are a R&D ahead offers unmet clearly This a because It more living product My gain with WAKIX for energized, are goal and of even WAKIX. opportunity and is even cycle to neurological committed programs, to the unique indications and and pitolisant new medical us. needs. available additional who have life with mechanism focused

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

Susan Drexler

Thank you, Jeff.

revenues our meaningful recent financial report notably We highlight the a net significantly and show our you our This clinical, we and heard I are time reported time key WAKIX will filed press position results. my this continued and in in growth. company's progress with today we operational first few Most the use IPO bolstered cash QX. financial to for with excited from history. detailed XX-Q issued points. income quarter, As have from our our to third strong in to morning, colleagues, release the very

experienced We of revenue net in WAKIX over performance XX% quarter quarter. the We second of in recorded in quarter the XXXX. $XX.X financial third product XXXX, the a third is which increase million strong

of reported X net the ended XXXX, September For months million revenue. we product XX, $XXX.X

medical of an the increase to WAKIX patients average narcolepsy. unmet of quarterly continues to prescribers and a on number in the as see patients basis needs continue with address We

products gross of cost $X.X XX%. Our quarter a sold for was with the of million, margin approximately

a our and through take few resource minutes you and Now expenses walk allocation. I'll

months XXXX, period Our operating remained same total September compared XX, to for the the XXXX. expenses relatively ended consistent in X

expenses XXXX. $XXX.X ended were X compared operating million the XX, September $XX.X For the months for XXXX, total million to period in same

sales the moving and in changes and to R&D discuss first Let's marketing G&A. before

R&D the to remain ended and ended by consistent September XXXX, same expenses sales to for R&D in period expense. of as and marketing was The XX% Research XX, X due partner, milestone a in XXXX. decrease for This months development triggered September in milestone compared compared FDA acceptance XXXX. which the million the $XX Our Bioprojet, NDA and the the the is development expenses period to same our X to primarily XXXX, was filing WAKIX. XXXX for an XX, paid decreased recorded months in by as

the are more to WAKIX to sales an for of in Sales seeing patient ended assistance programs to program. compared patients and marketing patients. we and expenses are want September medications. as associated increased assistance to we their expenses and their by XX.X% to is our XXXX, same patient to eligible included eligible appropriate, period support At expenses in ongoing demand pandemic, months with insurance personnel investments WAKIX. With need force increase ensure XXXX. commercial X due sales in commercialization of Harmony, that due marketing the and the for the patients for This line XX, access have jobs losing primarily Also increased

XXXX. Now of result with to extension the payment we million Bioprojet decrease in a a respect period X the was $X ended decrease expenses, to same to September of XXXX. recorded XX, in G&A The XXXX, months an compared in

XXXX. primarily IPO months and ended September asset by fees to XXXX months expenses our increase X full intangible in the G&A for For XX.X%. due additional associated XX, increased This the in is XXXX, with amortization the X

important management we the our of million. history, commercial net was income. income expenses. This our reported time driven and in strong milestone is that For performance from $X.X net first QX, Harmony's In

FDA for As that we have from with in my with to received our expand narcolepsy. from patients million colleagues, October, to in a the notification you to cataplexy heard approval, label WAKIX pay $XXX to include we Bioprojet. connection In

prior million in to made the million milestone $X $XXX date mid-January. payment payment have We the and pay plan to the due initial

million proceeds, in which received includes this August. our We cash, ended in when in IPO $XXX.X with million we which $XXX.X gross quarter completed we

to the programs Prader-Willi sustain is position Our expected fund and clinical strength myotonic commercial Dayno our in that syndrome and in operations. outlined Dr. dystrophy cash

balance outlined we strong as our expenses, the over this strategic control sheet, call. our as core resources the have With X and throughout to the performance execute priorities solid well financial revenue pillars

turn will I additional call to now the call John back for to remarks opening Q&A. the John? before

John Jacobs

Thank And Lisa, Dayno. Dr. to you, and Dierks Susan. also my thanks Jeff

unique what ahead disorder. lies narcolepsy established, of remarkable its to MOA with medical help medical unmet with with patients to proud the been the far, differentiated help WAKIX, achieved patients has to excited We product a believe who am potentially need there to orphan/rare so significant a in even and of future. living be A medical exceptional like what about utility Harmony. expanding have I community forward confident with success profile, WAKIX being more Despite living in are significant neurological XXXX our needs. offers that date for in market opportunity for ongoing an living and our we continues WAKIX clinical and year the product can with patients chronic disorders this look unmet narcolepsy.

audience. now Thank will from we Operator, you. questions take the

Operator

[Operator Sandler. from with first comes Amsellem Instructions] David Our Piper question

David Amsellem

me. couple from of a questions Just

product? quantify evolved First, and if could the of in one. possible how persistence That's you the rates, that's number life

oxybate. narcolepsy there's Number in the Do in and X? of mix whether concomitant that with uptick into sense issues -- you the what narcolepsy expensive a agents for opinion there's key can are of And that and you on you the X run two an telling give it's portion who what's then clear taken care up is, leaders, WAKIX managed lastly, they patients in pretty together given usage that is patients make combination talking some regarding any us the a for label? And now -- intel usage of X have sense your potential there regimen? of on the are a are cataplexy

John Jacobs

sleepiness, Jacobs. David. of question you, you second first beginning John moment. Thank type that initial one symptom roughly joining excessive that a and narcolepsy. The has just because WAKIX' patients our mix been don't XX-XX Appreciate every since has our cardinal those daytime of usage take here. It's indication. Why And X type launch I was call for in X of the of the

going I'm Jeff questions, For Officer. the over Commercial to pass those our Jeff? other to Chief Dierks,

Jeffrey Dierks

question, thank and David. for John, Thanks, you the

looking quantifying field think connectivity rates to professionals, evolution, persistence is get and among it range question suggests fair only of marketplace in the your this access that on So being looking COVID drugs patients' to really health not impacted your to Not take and in medicines to COVID, the right are sales stakeholders key industry. at prior rate. altering that relationships with the at compliance our being first The an certainly entire discontinuation there's put that in narcolepsy to say impact rate impacted, the lingering ability is we care on pressure on the pandemic And XX% but and DC XX% that question, I it's has having market. they between how including or know their additional data is that market now.

question adult guess narcolepsy We've this narcolepsy as Xyrem. use including I WAKIX the in broad, the point, combination any with early with environment we seen care then in WAKIX medications. combination not of respect monotherapy use last seen have our in with patient challenges available treatment or to with within with the launch, WAKIX And any use population. all respect narcolepsy to from we've available the Certainly, managed across patients your sourced Xyrem. to And other options,

Operator

from comes Instructions] Sachs. [Operator with Goldman question Graig Suvannavejh Our next

Unknown Analyst

Graig. [ the Congratulations on for is on Anna progress. This ]

should potentially specifically and color versus fourth quarter little second Just you've the any bit the as color in about impact versus it onwards the on seen quarter on pertains to think how XXXX the be get changes quarter, a now? COVID to And the more helpful. first would the third we

John Jacobs

has to us great of first John. from It's to to certainly us. you entire from all, for question. it cetera, [ right do have et how directly kids with Certainly, a and I'd you industry perspective. question Anna and families, impacted COVID of school, commercial your business. Jeff? Dierks the going friends, Jeff to all we turn Thank address that here ], to now like over

Jeffrey Dierks

and Thanks, you thank [ question. and very your John, good for much morning, Anna ],

response on window. our we've what impeded really to COVID-XX of seen my So David, launch the ability performance is this during has to WAKIX near-term building optimize immediate

So ability And and also convert for in relationships in to team, we've the putting on health challenges, are and field this their leading to patient's to ability in revenue. on addition top their loss to medication rates, pressure shared with demand access of goods, physicians professional top already person, I care impacts what for changing. patient which increased assistance insurance the sales on seen the unemployment high free line is demand about the

those net -- therapies. of But narcolepsy the incurable product people those and patients pandemic. WAKIX consistently WAKIX will unmet I lifelong, health profile for ability And WAKIX unmet There dissatisfaction QX that in differentiated in think with increase of before, XX% needs. disorder value and of fundamentals time. growth the this after this during the be headwinds, despite in that long-established with WAKIX aligns it's has high care right, QX. importantly, demonstrate important to level remain We've needs, Harmony with living during a the is on number living patient in patient an nicely professional our seen to to average market and to significant And XX%, revenues quarter-over-quarter, grow from unchanged.

continue growth So we the to we will that remain for sustain continued forward. extremely WAKIX moving optimistic

Unknown Analyst

in more gotten feedback with Have I Okay. one squeeze use WAKIX across from any really with That's you to respect patients up physicians If follow cataplexy? just question, with there. one helpful. could

John Jacobs

Anna you, [ Yes. Thank ].

our messages the and the excitement from initially, the have we working about that energy from certainly level been and several -- answer. incoming the is that excited And we very for received color high we've share when well. fact I that company We we that expressed community. KOLs Jeff? indication, ask with physician got course, we add physician I'd WAKIX. about community extreme Dayno to to think as received indication enthusiasm the and it Dr. to of like the entire with some got

Jeffrey Dayno

]. [ Yes, John. Thanks, Yes. Anna

I has been the think from feedback the very positive. community medical

I have literature the published that the fundamentally, broadens been think I they the product utility, the Jeff the data spoke the in overall aware on were trial. cataplexy, what of data. is profile clinical pivotal The to. benefit/risk it see the And that strengthening think they profile,

So the our been has feedback very educational indication. with labeled positive, and efforts we advance the sort of consistent data around cataplexy

Unknown Analyst

great. That's Okay. Congratulations.

John Jacobs

you. Thank

Operator

further Thank this you. Ladies And today's questions showing call. gentlemen, for and I'm participating. you not at any concludes time. Thank conference this

now disconnect. may You

Harmony Biosciences (HRMY) 12 Nov 202020 Q3 Earnings call transcript