VNDA - Earnings call transcript Q3 2021 | Vanda Pharmaceuticals Inc.

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Operator

Good day and thank you for standing by. Welcome to the Third Quarter 2021 Vanda Pharmaceuticals Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers’ presentation, there will be a Question-And-Answer Session. [Operator Instructions] I would now like to hand the conference over to your host today, Kevin Moran, Vanda’s Chief Financial Officer. ahead. go Please

Kevin Moran

Good to Luz. thank for you Thank Vanda afternoon Pharmaceuticals us discuss performance. third joining you, and quarter XXXX

quarter released were on system XXXX and on third and www.vandapharma.com. available EDGAR the this website our are SEC’s Our afternoon results

live providing conference archived versions are call we of our on addition, and In website. this

and today’s Board. the call on Polymeropoulos, me of Dr. Mihael our Chairman President, Joining is Chief Executive Officer

results comment before on introductory the our update ongoing on remarks, our will I my your financial Following for you then opening lines questions. Mihael activities. will

Before various we statements securities on will proceed, everyone I federal would like forward-looking statements this to remind be within that of make the meaning that we laws. call

current provided update to our over CEO, forward-looking analysis obligation said, of Polymeropoulos. I future Our and as forward-looking described law. risks the that and other and no these are Report that required assumptions year or changes now statements, as is subsequent XXXX XX-K this reports all management’s X-K of of Mihael on like otherwise, by the discussion on filings. provide any undertake and call Form for uncertainties. website. available account SEC’s with and condition forward-looking our sections based and of publicly we reports events Dr. revise involve turn note today. we other new on to fiscal The quarterly and to only information, updated cautionary EDGAR may investors statements system on risk on These call call statements Annual as make this our With encourage reports in our And the We would except to read or Form information we upon factors, which regarding XX-Q, expectations filings of results in the on operations, on are SEC, are financial risks, current XX, circumstances Form on by December the ended our and

Mihael Polymeropoulos

Thank you everyone. very and good afternoon, much, Kevin,

net the revenue growth. a Fanapt saw year-over-year in third revenue of total product quarter product revenue is XXXX, we and XX% compared third the for for say increase XX% like I launch programs, about that end the our Smith-Magenis X the of continue results all, top-line Phase LQ we increase be and end were XXXX. XXXX, $XX.X performance, commercial HETLIOZ I million, gastroparesis and quarter would In HETLIOZ of the syndrome development of a excited for the as clinical the third quarter year. our First report the late-stage increase performance to our study of continued Net an to quarter HETLIOZ discuss demand quarter XXXX. HETLIOZ ongoing especially to to of to will of of progress HETLIOZ Fanapt our that exceed prescriptions XXXX, programs. of of third highlights compared towards compared net XXXX, our filled. commercial expected clinical the the to for completion received On XX% saw by revenue by before measured prescriptions moving product we to to see of the third continues commercial first

for experiencing demand strong, payers increasing are we non-XX. prescriptions resistance Although with patients HETLIOZ remains for to

launch. dictates year of and several optimistic to FDA that to the full $XXX assumes to it year no patients. $XXX remain engaged is be the while higher access range of lower challenge syndrome the of we little HETLIOZ that range end that the disturbances launch investment in for access would the million to calendar hopes Smith-Magenis is for end this The Smith-Magenis this HETLIOZ the while HETLIOZ patient with in our the to improving non-XX have $XXX patient time treatment respectively $XXX progress. and HETLIOZ million. syndrome discussions of payers in adults for only during period. We treatment guidance and of night children the the of of sleep with magnitude and The these year resolution patient LQ million available prior HETLIOZ we range access continues will million lower of to within forecast assumes timing this access from improvement the current improve approved

our to or continue with among To-date, the prescribed prisms goal advocacy and community with We of HETLIOZ work We XX improve SMS creating awareness approximately been in LQ. SMS families patients the patient U.S. with the a to patients HETLIOZ have awareness. than plan to SMS group SMS extend of XX,XXX awareness campaign more

at the number trajectory need the that believe future. in of medical degree treatment, unmet profile for patients substantial of clinical it While is provides SMS of on the time opportunity HETLIOZ growth the patients of this a with establishing development. Clinical the difficult we and

lifecycle HETLIOZ is Our management robust. program

Autism and prevalence have large HETLIOZ of initiating phase between opportunities and During highest disorder mechanism DSWPD Spectrum and been initiated. [Indiscernible] and of creation We The underlying value Circadian mechanism maintaining delayed important disorders the population prevalent X.X% sleep desired X%. approximately in for phase clock some the with addresses at of XXXX, most that with as represent and and internal syndromes of aligning the of is the we sleep. the X% that action as its the disorder to believe or in XX% regulation X% Circadian improving or young adolescence DSWPD initiated appropriate sleep estimated two adults SWPD sleep wake Disorder. by likely X.X% programs disorder therefore sleep-wake with high time. the in rhythm is in of has late and The insomnia Vanda, affecting patients rates

aid end The quantify undertaking of at process the disorder. recruitment and the by we this has direct-to-consumer are with the ongoing a tradipitant expect the of beginning would year. study from study We the this for enrollment X completed turn I of recruitment same gastroparesis are tradipitant. now complete we results in of DSWPD to Phase study and campaign top-line large can time who in the patients to to

completion application. plan we of meet the and planned for FDA to a this meeting the pre-NDA with study, new discus our Following drug

study, the January clinically successful primary completion in II same study in with approved a of studies met study overall as differences. ongoing with the compared shown gastroparesis. also idiopathic or vomiting. of the III measures adverse pre-specified approximately in nervous enroll benefit/risk XXXX. gastroparesis results The through off-label placebo. to action equal used. profile study is was profile, an an similar is of of either with for to improving number As neuromuscular be symptoms to nausea randomized the advantages as This Tradipitant population. of that of similar to well-tolerated disease-modifying aim study a suggest improving the offer aims the which well confirmed, In the a Phase and symptoms Journal published X-week the in and effects gastroparesis. meaningful the study, The Phase to tradipitant central the currently nausea, of may few local Phase over III achieving both if with event a a in of effect to effect Phase treatments but complete Gastroenterology Phase in The study placebo-controlled outcomes in The and likely The design III patients response network, overall diabetic system etiology. follows centers that tradipitant patients II double-blind, XX-week achieved reminder, study tradipitant of were

to patients II approximately the in III study. First, this enrolled Phase XXX XXX study compared approximately Phase

study Second, the in weeks, weeks prior XX to a current has study. of compared X duration the

the order finally, open-label is etiology Third, and in XXX for is for A staying in the independent currently in current analysis study, on a each based allow diabetic week stratified ongoing study to separate period has vomiting study, inclusion. and required idiopathic the enrolled efficacy current XX patients. over in And episode balanced patients are III during subgroup. Phase or

In study with currently post program. addition, patients request more months approval three participants dozen majority treatment tradipitant the of to of received through access exposure these expanded months. with longest the treatment one a them XX completion The continue continue than an of with clinical have FDA beyond of have to study

X.X the by that of [Indiscernible] population during highlighted XXX,XXX estimated to persons-years XX.X X.X for XXX,XXX in Regarding was women. gastroparesis the patients based men was a per person-years per its period of Prevalence study XXX,XXX be and patients recent for the United year women. estimated per ten and Minnesota X.X in age incidence prevalence men a in the States and that patients gastroparesis XXX,XXX review patients per

general in estimated X.X% gastroparesis diagnosed. One Some of may have X.X% many of results may with gastroparesis as population symptoms never the but testing. typical the that confirmatory are undergo as study only

dyspepsia. The by awareness disorder lapse lack confusion of a gastroparesis to that exists and the symptoms between others presumably relates of functional caused diagnostic the concluded and this of

in opportunity for a for option with creating prevalence, significant the for estimated program, the of this a pharmacological upon condition Given tradipitant see commercial we completion gastroparesis. both successful as new patients and awareness

Our the focused improving clinical bipolar injectable as in increasing we and we To advancing in conclude, patient LQ studies and are pipeline with sickness. are tradipitant for awareness programs the to study HETLIOZ Fanapt access motion and Kevin. of HETLIOZ of for on well. non-XX we Phase of study patients, commercial clinical others continued is among are HETLIOZ partial this, program including to discussions long-acting the The approval to the preparing turn regulatory With and I the III and forward with the regarding as the it FDA will launch. look results for tradipitant completion nearing SMS

Kevin Moran

financial for increase our for the period XX% period a and first first were $XXX.X turning and XX% Thank nine $XX revenues million contributor months third you, XX% for net an the $XXX.X XXXX. $XXX.X to to the increase of sales same to begin nine the $XXX.X increase in HETLIOZ in compared XXXX. for Fanapt Mihael. same net the for nine our months of primary summarizing saw XXXX. XXXX, $XX.X of Total in sales a first the first before of same million million results million the XXXX of XXXX. quarter of product months for period reflects by of XXXX I'll to months driver the the XXXX product million, compared discuss were for compared revenues million nine of

XXXX, period were first of months income an income first to and million, representing same million for in Vanda income recorded the million million XXXX. months XXXX. $XX.X Net income $X.X an $X.X as cash net the September an XX, Vanda's securities XXXX million income compared included of same $XX.X the equivalents provision compared for to nine net $XX.X as marketable of nine period of increase provision XXXX. For of XX, tax compared cash, million to in of of as of the referred September cash, $XXX to tax XXXX in

million were compared by X% XXXX. an $XX.X the increase XXXX, our million, in to $XX.X compared of million second XXXX. to XXXX of quarter the the XXXX. $XX.X in a third HETLIOZ increase quarter of Xponent Fanapt revenues of XXXX sales to in compared Fanapt’s the results. the third quarter as product of the product $XX.X now third for quarter increased million IQVIA prescriptions as XX% net a were increase, million of XX% Fanapt quarterly were third were of $XX.X essentially third third XXXX of XX% the quarter in sales net of by million, quarter XXXX. Turning in for quarter third quarter of product Total quarter the net to $XX.X to compared XXXX. reported quarter for flat the million in sales second XXXX $XX.X compared third as to the

income product guidance. development XXXX. tax net of third to as the $X.X guidance of the net exceed $XX.X million. the $XXX key assumptions third Vanda XXXX net and This an primarily and $XXX expenses full Fanapt prior income as guidance between and $XXX payer XXXX $X.X to net quarter nothing between For to guidance between million. XXXX. Fanapt million by XXXX. year prior million. Net provision $XXX of compares compared among $XXX third million, DTC greater million $XXX between early-stage SG&A million million product million for and lower the Prior net third HETLIOZ quarter based product and and is increase of providing tradipitant, development million income on million guidance sales $XX.X others. objectives and were $XXX an prior million million sales R&D third of and Operating $XXX Net $XXX provision million. of XXXX $XXX for Vanda product compared million, million, to to XXXX, HETLIOZ $XXX The $X.X for HETLIOZ driven on been quarter expenses partially to of expected rates of of programs our with demand of has approval as well $XXX Payer Vanda related full by its following quarter Fanapt the far HETLIOZ net programs, to of of approval prescriptions higher $X.X from was continues in filled. revising same of million This related both to and the the demand line its HETLIOZ financial operating of was of income expenses between the income expects to Year-end $XXX campaigns. and sales sales to sales of million. included expenses late-stage between $XXX between in to achieve in the measured year were XXXX XXXX in period to tax branded $X recorded million. million. awareness by trends. offset rates historical is be and HETLIOZ consistent HETLIOZ product received XXXX and is in XXXX. prescriptions compared than $XX quarter million cash of Vanda million compares

However, significantly. an increased their patients to FDA is have access payers Vanda with the patients effort for treatment for with filled condition. only HETLIOZ improve t their from reimbursement approved prescriptions non-XX challenges for in working

Given these lower the end net periods. with and now guidance XXXX product of year that, assumes the the guidance no year, back in during we’ve to improvement to assumes With full the during revised turn timing reimbursement the in call The minimal downward challenges guidance. HETLIOZ end range I’ll sales revised access improvement the fourth the of range our patient Mihael. revised the challenges high quarter and

Mihael Polymeropoulos

answer happy Kevin. you may very questions to Thank you much, At have. point be this would we any

Operator

Our maybe first Chris, line on Instructions] [Operator Howerton mute. from comes Jefferies. question your Chris with

Chris Howerton

just didn’t for two what being more I us around reimbursement great would you challenges is authorizations, facing the prior them. gastroparesis the just specific hear. there questions, then, I Mihael if can from give much question with just more taking was. me of and the I are all? the at are you a that I I reimbursed challenges Kevin, little be there so the some exactly out. respect Thanks guess, are read what had there? have you second Are are? color guess, not some And Are to to

improvement think why – arm of between us it the XX key from alternatively, think the Or to over changes was about currently. the treatment do difference placebo guess, highlighted four just you the time? that One Mihael you you. of there would drug the talk maybe that I an Thank weeks weeks of was increased be duration prior time? the effect I to over

Mihael Polymeropoulos

of they’ve new increased number challenges more patients part you of is, effects Thank is let answer perception. to Chris. light a denials new the question what are escalated. And Yes. of your very primarily give Kevin much, first the among and color. But with with Happy payers are what not is non-XX course and

Woodcock And near or remain from not they have It well. are or on began it we the the historical to acuity. light cited in treatments no without with whereas for indication what that alternative clarification are pretty explain some new norms there good coverage the see this treatment don’t patients, XXXX sighted. letter tremendous long It seeing is much alternative that patients consideration some we non-XX perception. also is just denial, SMS, reimbursement led because by criteria actually a we a is and the to it because what to And out issue it’s some is is. payers the reimburse of visual is, the course, the non-XX for is non-XX for contrary you denial as blind their is but a that label in you at While patients Dr. he of and FDA

So, denials. pretty color and add on out I maybe will much the flood Kevin that’s versus content let timing the more

Kevin Moran

I I would what Mihael. we consistent my in script, on is, demand see patients exactly that strong from That’s to and to Yes. And continue highlighted prescribers. layer as

as began So, who issue is the of seeking convert periods, or of either in escalate which able access quarter has an in there to fourth a fraction periods. backlog here, in a fairly are to patients and drug, demand been has issue could very that be significant this simply the not meaningful recent to access future

folks so, And understand mentioned, as treatment. forward needing this find important to their the a Mihael working engaging backlog these to with and objections payers significant and path given access

Mihael Polymeropoulos

actually the is this drugs, payers it a If the drugs people. up access. be pay stand would access patients. Vanda, sure beyond we for add, will which to developed because to and financial often do popular they drugs it for a community Vanda we of value-based very option to to contracting just patient cannot into innovations a part for have the We sustainable as is these discuss whatever important issue provide just that these access We not are innovations the it with the that is people expensive And very wasted. we becoming to principle. believe help are this patients. in payers make And to for reasonable important conditions refuse the discussion out And our is for to

issue So, new. was not escalated, it the

patients benefits of definitely will I doing know follow-up that don’t you I be revenue. the this, result, Otherwise on We to everything to treatment these to a are get question. if switch done and the as any course needs Chris? make to have on sure gastroparesis Vanda

Chris Howerton

you all I the information that gave. extra Thank that’s you. No, And clear. appreciate

Mihael Polymeropoulos

Good.

Of course.

and weeks the the is your the XX the in are weeks difference was question on what gastroparesis, correct? study, four between Okay design the

Chris Howerton

intimating between words over the in or would drug mean, I am putting perhaps difference I think, drug time. be over again, improve your placebo excuse and the effect And putting time I that in am mouth, your the And but maybe the words maybe would mouth, Yes. me. I improved

Mihael Polymeropoulos

dissipate the we of intimacies therefore, Alright. And of lost drug from not What days. at effect. It effects know condition that is condition over the are that a important of the four is we understand weeks. measuring period the to not while that quickly the we for is data durability time. Okay. the also Well, measuring often the does the screening weeks, at few short XX very were a in

and over expect And effect other disorder. the we dissipation answer the of time, we of answer because the expect increased placebo the nature So, is not, whether of question, the question, to an likely of binding side the do the meaning drug is the not Neurokinin-X anticipated the that, you develop drug, will likely answer point, the it because mechanistically, take is but some at not, working. tachyphylaxis stops that receptor you

is are maybe XX. could to to see for XX to effects and going answer the between the weeks. that X the weeks improvement four the some we beyond of not likely people a So, continuous difference much little And takes we longer symptoms, improve see

Chris Howerton

if Okay. discussion, other the no sighted of I pivotal Very label, good. on patients browsed kind I And were guess, of I would non-XX. mean, I topic there trial for the went and entertain just you a think, maybe follow-up in the

So, that is what their you individuals they perspective. – are say from of point some are not sighted what things – reimbursed pardon Or the to? point that payers kind or to of me the covered should of be what some that

Mihael Polymeropoulos

was [Indiscernible] they this of really before they comes cover in writing the a have they not yes, is answer more about patients disappointing the have the that placed existence sighted, it, the a to reasonable are in silent not what from study. importantly, sources. drug But right. objections But is market But several seen actually they all don’t sighted why you they guidelines that, And say are actually were Yes. Well, the discussion. because is in sighted cite anecdotally, the we

label non-XX the the controller that gave advisory one non-XX, blind the XXXX, as advise was the First at fact FDA total the FDA who in she FDA non-XX despite study the petition Dr. given the of the from the CDER in for reasons actually clinical the is to finally, time the head actually some the blind citizen’s individuals. of by at rational. committee, on HETLIOZ change FDA the experts who us The is responded approval. a people to who Woodcock of of time conducted to in And indication that petitioned this of has the Dr. why division answer indication it, in of and studies drug Woodcock And there reasons years, much, not in activity. disease conducted control patients the action of is that where is The the better have such any Chris, prescriptions last not non-XX of consideration we FDA and full drug blind. HETLIOZ the through. signed about action without XX,XXX of doctors the in who is finally, talked the the that have the several explained and really mechanism for The that understands approved over something, the populations are is are FDA visual not that written for X,XXX for

division, So, reasonable payer hard FDA the Dr. committee, with discussion believes X,XXX the a and know who have to better the who the than it Woodcock that the prescribed drug. doctors is they advisory have

are open we are make So, we that are sure concerns not costs to because down to and patients we takes disincentivized to treatment we about outcome. to sustainable are on do that’s seek going dialogue there not to they are it understand drug absolutely and reasonable appreciate anything that are a these that get we optimistic and and

Chris Howerton

appreciate in Well, really good. Very queue. and hop I you the Thank back it. Mihael, will I

Mihael Polymeropoulos

Thank you, Chris.

Operator

with from Brayer Olivia of comes Bank Our question America. next

Olivia Brayer

confirmatory have Thanks potentially development a ask congrats quarter. whether there guys. any I Fanapt plans so far FDA to around the discussion on Hey for your Phase second bipolar been questions in and wanted for needing III the with trial about at down a And point, the or I’ve for that confident feel package really something are do filing follow-ups. couple is a enough complete got road? that that you the this Is trial then, for you planning second study. one and

Mihael Polymeropoulos

that disorder in of are provide people different substantial of a Correct efficacy study bipolar be FDA treats you And can that remind required evidence indication. that a could improving this Olivia. in I successful study the this we you in will to Yes. indications it for guidance of single anticipates the channel. much, Fanapt additional support drugs Thank believe by approved indications, that the large pursued very that – lot a of

role Of that results the trial course, decision. the on big a of play

say, the I trial results for if suffice. wait optimistic and we will So are are results this we would that evidence the that convincing,

Olivia Brayer

Okay. Great. Thanks. for are about close, getting Mihael, And been that obviously enrolled your I we gastroparesis then, know fully has pretty trial data. to two months now.

So, long can the And a of of close you a take us to about thinking and then filing? study between disclosure official just give actual sense that that, pre-NDA you how of as to time the it turnaround data? in follow-up could terms meeting the how of are a

Mihael Polymeropoulos

you Thank very much. Yes.

Just the bipolar to finished visual part we comments are have That’s continuously they long-acting the year. the of lock sometime by reviewed certainly FDA FDA question very timeline. development months the last our can thoughtful another as data, the well. tradipitant, enrollment really end hopefully bipolar monitoring quick towards your protocols the the since advice and December the you closing of discussions. three on yes and the patient with last goal. on then, And injectable the having the of at finish, provided And ago. and adjusted It’s had I week remember, about two on our to on about very And this On XX the expect report based action we month. of of study. this of in is can tight end and study, a we month And the planned complete the turnaround we database patient end results

NDA in will short And of very we meeting see granted after manufacturing the we hopefully already application. a have which the quarter. initiated preparing in right of data towards NDA application, requesting the is the this terms an for in meeting, Now section path pre-NDA we towards be order first pre-NDA sometime meeting

that’s So, it this with timing. where stands

Olivia Brayer

about Okay. maybe there get you clinical like know then, lot lot where an but that’s a benefit just have you guys me And manage on from a I asset of the for feel one one area another and BD. in you most cash internally, deployment to in-licensing is you programs asked development? Great. obviously last

Mihael Polymeropoulos

Yes. and do time, would we have At well. say we them things few want I to a developments clinical in this that,

However, we are you on have we from University a and always activators. program CFTR in-licensing Francisco remind San inhibitors that looking the the of the for in-licensing, with California

a to in-licensed nicotinic VQW program Novartis. phobia program social have in with We an alpha-X from

they So are the to mindful. in are things always we pipeline, but be trying

physicians products will terms are and development, we looking of the sales to detract with our offerings but for and how setting strengthen In business commercial always the time, our course, the same force prevalence thinking give of additional our on certainly complementary at to search. that not we from us own time

Olivia Brayer

Okay. very It’s terrific. Thank you much.

Mihael Polymeropoulos

Thanks, Olivia.

Operator

management for That to concludes today’s Question-And-Answer Vanda closing remarks. to Session. I’d like turn the back call

Mihael Polymeropoulos

sure we of soon progress. talking you year I are Thank very you around be exciting all Yes, results going and to the am much very and thank much.

Operator

call. This participating. you concludes today's Thank for conference

You may now disconnect.

Vanda Pharmaceuticals (VNDA) 4 Nov 212021 Q3 Earnings call transcript