VNDA - Earnings call transcript Q2 2018 | Vanda Pharmaceuticals Inc.

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Operator

Welcome to the Second Quarter 2018, Vanda Pharmaceuticals Incorporated Earnings Conference Call. My name is Adrianne, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note this conference call is being recorded. the Chief to Financial turn Vice Kelly, now and President Officer. will call Jim over Executive I Please go ahead.

James Kelly

Pharmaceuticals performance. Great. Thank joining Vanda for and thank quarter you very much. us Good to afternoon you second XXXX discuss

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

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

President on call is and our CEO. today's Polymeropoulos, me Joining Mihael Dr.

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

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

publicly and to turn over we our events today, and required changes forward-looking described law. and These I sections Polymeropoulos. Analysis December our by of SEC's Our we on provide Mihael like would upon said, annual and filings. which may statements The are undertake and Form of the forward-looking call as the on in XX-K available our of on except statements quarterly XX, to We future Results for or report With based otherwise, obligation Management's our make call website. year read on information any on these circumstances, this risks, Financial Dr. information, risks system XX-Q to the uncertainties. of encourage the in Discussion on are March current account quarter Operations of Factors our involve no XX, CEO, on are report that all XXXX, update ended we XXXX, only Risk provided and this investors reports that other revise EDGAR or Form and & Condition for as SEC assumptions call ended to fiscal is new now expectations

Mihael Polymeropoulos

today. us for thank Good you afternoon joining Thank very and you, Jim. much

delivered pleased identify quarter an in growth XXXX performance. we and to from our efficient will non-XX I are XX% XX% begin quarter new on This second the share year-over-year multiple underscores growth We performance to and during XXXX our HETLIOZ found second have sequential update that conviction means beyond. patients with business. sources quarter. HETLIOZ our and revenue drive

While study European lifecycle we March, are management with non-XX lag further we or on business continue HETLIOZ our also In the results support in JETX lag the jet work pleased the III of Syndrome the clinical new well include announced as meaningful and This Phase the saw commercialization on to we effects activities. for clinical jet on we hour potential the process the HETLIOZ In activities disorder, disorder. existing tasimelteon significant expect HETLIOZ are results year-end. to transatlantic long-term year. in eastward released lag These by Smith-Magenis of and evidence add XXXX five a and This jet pivotal patients travel. for of preparing disorder. May, to top-line study plan transatlantic results progressing helping endpoints this of of of study, our Smith-Magenis is communicate end by treatment submit to as context condition. endpoint to activities study multiple rare time secondary study, effect work to and we SMS will NDA and primary the the treat the JET the HETLIOZ. with study trajectory, in supplemental jet of this in of of towards present to lag the a of The the supportive clinical zone, travel. FDA The eight Syndrome body from We're results significant JET and effects

treatment the the to of potential a our study report the now second in Fanapt FDA Tradipitant antagonist significant Tradipitant formulation continue have atopic in emerged of in now of driver awareness meeting initiation of are Phase the German the with injectable today, has In major turn the patients efforts HETLIOZ increased for HETLIOZ clinical After non-XX We community [Technical our pruritus working. for clinical sleep including neurodevelopmental Germany, obtained to Difficulty]. study patients. expectation dermatitis our pharmacokinetic stable, two proceeding, dermatitis. neurokinin-X awareness The initiated successful XXX pipeline pilot later SMS the indications, a stage with Fanapt. of with for number this been and in equipment EPIONE, a Phase interest in study non-XX III XXX we for already And program development of appears commercial long-acting late clinical randomize our will be management furthered lifecycle that full is the the study. treatment that our to patients clinical associated launch increased in for gastroparesis. of experience who commercial non-XX problems pilot asset of the this quarter, and to Our end can we of consistent now II our as of year. We'll campaign. in the business expect to patient The efforts potential has has have disorders. a with I direct-to-consumer initiate schizophrenia develop as This gastroparesis atopic Tradipitant, with in as

a of randomize to gastrointestinal mortality since disorder patients target carries unmet report number to year-end. screening, are delayed medical is a approximately of Gastroparesis on and morbidity gastric that the we now and expect XXX representing patients significant need. by emptying results significant With

effect treatment for as Tradipitant of well disorder, for significant for by these are represent commercial a large advance as therapeutic there patients opportunity with the patients, this the options could a demonstration As Vanda. few

oncology the I study second and results. to turn will with inhibitor HDAC this patients and begin progressing are XXXX malignancies quarter the discuss to to in treat call third Jim our quarter. the financial developed are to We in hematologic for now Phase Kelly and our A other Trichostatin first program I expected back

James Kelly

XXXX, Thank the XXXX increase XXXX guidance. to million in consistent XX% patients the in monthly XXXX. a first to you, product of HETLIOZ number X% XXXX compared Total XX% HETLIOZ increase quarter compared of XXXX. a net of new a in of XXXX to in the to million quarter patient million quarter-over-quarter sales $XX.X of $XX.X the growth first XX% million, second therapy financial with second full year with revenue The compared increase on continues a the grow million our $XX.X and to rates $XX.X the increase in $XX to was quarter second grew quarter Mihael. of million for quarter $XX.X quarter second compared and

net with inventory compared compared end of hand As of the second of Wholesalers' at hand the $XX.X of approximately of calculated first X% was and flat to held quarter channel end reflect of of million quarter second XXXX. first XX,XXX exponent in the million sales XXXX for compared to the trends of Fanapt quarter weeks the quarter the June reported quarter quarter when as increase a remained demand. slightly in second XXXX. consistent second $XX.X was full XXXX XXXX, with by financial second of specialty X% inventory the of compared on XXXX. inventory when the XX, as at of our to trailing the Prescription of XXXX, product increase XXXX first of quarter pharmacy in two the less XXXX on quarter down quarter Specialty pharmacy's on of a based to a than X% guidance. first were IQVIA XXXX. year the XXXX million decrease prescriptions the Fanapt $XX.X compared

million the non-GAAP non-GAAP recorded stock-based Vanda's first XXXX. amortization the loss $XX.X of quarter excluding and cost net expenses ranging and compensation in $XX.X been income our income first compared see our the financial understanding recorded a Vanda's Vanda compensation of is between operating second figures. information operating $XX in sold, performance and the net quarter GAAP of We second non-GAAP because do net a stock-based the On of On stable financial to quarter financial non-GAAP amortization. intangible enhance an can quarter in $X.X of basis, second compared for offering quarter for $X.X over believe XXXX, XXXX so, XXXX. when XXXX second and considered the $XX fairly that million million net non-GAAP non-GAAP income asset of asset $XX.X non-GAAP of as income will of and non-GAAP million quarter Vanda the to goods release of You expenses Vanda information. six that quarter. a non-GAAP XXXX, $X.X million have quarters during intangible million press and in overall we of of a million past with excludes net of million non-GAAP basis the

the a million $XX for a and quarter the to million financial XXXX on obligation $XX million $XXX However, June $XX of and of net and Phase between clinical guidance million this million XXXX. and a to XXXX as million. cash, achieve excluding expenses June sales to initiated to to to million. $X.X of HETLIOZ occurred XXXX. Net March we decrease sales $XXX and that XXXX, Squibb sales to operating net its equivalents cost that and and beginning between associated with Vanda an million. Squibb. and during intangible of of as This milestone operating $XXX.X in excludes cash $XXX of sold expected a of a between payment in million $XXX the update non-GAAP HELTIOZ referred million do for $XX.X $XXX $XXX million XXXX stock-based $XX securities XXXX. product of was between during XXXX see between $XXX prior both of expenses of increase XX, expects be million expect $XX product second milestone and in million. Bristol-Myers reiterate HETLIOZ net $XXX in product payment sales, of includes Tradipitant Non-GAAP Year-end million. million million net atopic product quarter pruritus million XXXX Bristol-Myers and the as sales quarter Fanapta between a and included $XXX second expenses to $XXX dermatitis a a of an as asset compared is to of product $XXX.X million. XX, and Vanda's between year-end based from III to and amortization of compensation compares prior provides guidance of Fanapt third cash $XXX and compared representing which expenses million marketable million guidance million cash cumulative and of cash following million prior to $XXX cash guidance $XXX the goods operating of were million to $XX objectives study Non-GAAP

back call the turn now to Mihael. I'll now So,

Mihael Polymeropoulos

this Thank you At your entertain very Jim. questions. much, we time, would

Operator

Thank you.

begin first will And session. question-and-answer from from JMP. Instructions] the We Jason ahead. now Please [Operator Butler our question go comes

Jason Butler

the the you market us the number the Hi. think about here, commercial me, Thanks Could I patients HETLIOZ more from we on from how guess should for quarter. addressable taking you how the bit little will questions questions, and commercial in performance Two potentially think and the congrats differ for on give strategy, - first color Smith-Magenis. strategy and how for of that non-XX? the a

Mihael Polymeropoulos

you Thank very much, Yes. Jason.

difference the So, the and between significant patients. SMS there are community non-XX

lot that. ago was of awareness a blind non-XX, As for there non-XX the we when HETLIOZ and you four community to around commercializing in years of recall we sighted little do had or education very started

Now an through PRISMS that diagnosis, patients support a the that that significant subsequent groups, organization with are there working the been Smith-Magenis last clinical to have years. Syndrome, several with diagnosed organized is the is a testing community a patients and already are around called diagnosed support group is DNA of we disorder over

work launch families Smith-Magenis this interested the of commercial an the and key organization in and be you disorder together whether investigators and support physicians more will the field. Syndrome So, typical are orphan that with around

terms numbers, there outside in wider we is In membership. course, has membership audience know of their families a and organization of several of hundred that PRISMS the

the form nucleus believe we the launch. that this of is will So, what

Jason Butler

then the characteristics And of in remind to Can should of is us Tradipitant what Okay, changes potentially patient give the enrolment that an expecting the be just what And us just of made on population? and overall baseline improve rate? and population we the enrolled patient great. you kind gastroparesis. you sense

Mihael Polymeropoulos

Yes.

vast emptying we that this gastric patients with was conduct diagnose recruit everyone aims remind studies. that majority gastroparesis performed, to to to this prior diagnosed diagnosis. in Just If the have a of to the them offered study study was of that confirm not through

before coming majority that vast test already the us. today, done to of patients the have However, them

terms we where to and them. gastroparesis are balanced In of characteristics, the attempt least balance between gastroparesis patients idiopathic at diabetic

we're we differently, of did. a did to slow to we that of opted-in them some during some company radio undertook quarters and thousands what the sites all spring them who to was connected advertise enrolled couple We to directly the us do to That in recall our and allowed study. that had are how change in of back recruitment consumers recruit the ongoing. and database, we ads and you the in that national difficult terms through In in that patients fundamental fact interested already our and decided discussing of them to of access

randomized are a now have said, and our study. XXX of them been of I As they part

was change direct-to-consumer campaign largest on radio. we the announced the the say would I So,

Jason Butler

the taking congrats great. Okay, on quarter. questions Thank and That's for the again you helpful.

Mihael Polymeropoulos

you. Thank

Operator

comes from Beatty from question Joel ahead. next j Citi. go Please And

Joel Beatty

questions. the taking for Thanks Hi.

First Could sighted characterize amount from the about you came one and the HETLIOZ this you one versus blind growth that is that quarter. saw population?

Mihael Polymeropoulos

Jim?

James Kelly

I the question. Hey, Joel. appreciate

give necessarily we in reading, detail uniquely force uniquely of we that what called the that the on PDP opportunity, traditionally patient-directed While what end we're have them put not March, the on going physicians to much too on do to opportunity. was back our that is focused field work beginning to relative share and took focused want we

to those from those in in when to on patients we remember initiative. pools that execution reps fourth the is second XX able quarter were our the quarter emphasizing What both task, we we are from to critical strategy representatives were HETLIOZ-focused strong being reps might we helping paths. with benefited our original go You that's and source HPI get the forward their able at back XX fully HETLIOZ neuroscience both saw

Mihael Polymeropoulos

non-XX And sighted. everybody on sources categorized and just mix, now to be could between want blind patients that to we of that add the have remind the two I

at continues patients group While to time, from be this our blind of sighted majority of And increase, the does so non-XX rapidly to patients patients the treatment. the blind. continue

change However, sighted may in the move our with as on we balance this future. initiative,

Joel Beatty

high you've the jet ago. at which couple information. and on additional for you with to Thanks a just agreement on data FDA Then a question level describe the Could the indication, coming had on maybe of discussions lag had another months trial you support [ph] you this also, then you approval the have that and the will be that design first indication? expect generate you jet for on used Adcom that drug whether the to lag help data on And will this given what do approved indication? the

Mihael Polymeropoulos

jet Yeah. on the to study. study, And which was where studies lab-based steep travelers' this be the program. will lag are indication supported proof-of-concept was bit studies. A This JETX, conducted significant People and four small, that but that program a UK. study little patients to by significant and a studies summary This the of hour the experienced the or time, these experienced on were finally, base Then, both published improving difficult that travelled Lancet measured they Those study. properties point the critical the are but study also hour placebo. they a circadian and X in showed again, Melatonin rhythms, drug drug phase-advance phase-advance jet in at U.S. JETX and randomized that the The of lag, sleep-wake run. was and X was to an was studies, parameters. a from travelled JET two exceedingly

at XX traveller our that jet recruited So, study even small The so however, prior of in were only positive, demonstrating of lag of robustness it discussions, effect the conditions. patients. about the or patients In despite again, other number results that the study in only we treating the this made of the had the conducted would was transatlantic and FDA, had as small proposal we had study agreed under point with we JETX suffice that flight. study that Phase II

course, flight have and study. that have of we transatlantic we Now JETX the

we to of confident very significant very segment, the this tasimelteon program. effect feel I effect, jet evidence for confidence this demonstrates the have saw we furthermore, lag. significant demonstrated we a add So, body the JETX only want entire that And highly data values that a everybody the very we by study. of And that significant with that not clinical in but viewed p of course, was around

of indication, of a You know, advisory such advisory the and an would committee may it's asked will in course first time drug about this the be we and approved as committee, since potential it. you an happen, welcome

application. And goes in The be the in clock is the planned is typically this of course, be priority important in mind review jet review be for drug year, of be this that months and the of other next indication, review. you we we the a therefore, submission first of the The keep of will thing receipt priority year is, in indication. this before we will six for And launch apply from would a lag midst to that in with position we understand the the sNDA the time of would eligible provided end smoothly could the indication. a

Joel Beatty

you. Thank Great.

Operator

comes And Matthew from our question Jefferies. go Andrews from ahead. next Please

Matthew Andrews

there I good summer first roughly quarters, stages, move question. three know talk your is about still as afternoon. this blind through the full we you Hey, whether my any It's expect seasonality three seasonality early has you business? the been quarters, with and thoughts relative can HPI to

Mihael Polymeropoulos

year in that we I Thank will strong we also, treatment continued And a inappropriately demand. but eventually about who strong very often do treatment, resistance much. avoid make upon our you What companies seen say a very on they for the approve have insurance I prediction by can see have to less with deny to appeal, opinion seasonality. than patients. HPI

I'd full so June sales that the and force a force reorganization changed like sales in XX significant HPI also in the continuing. or this representatives. reorganization of want midst to number promote in expect XXX that kind the that undertook hiring sales a we Fanapta resistance very after and was we we of up of to of the So, see we're remind to about a

So, script the or this that we the psychiatry's promotion this that reorganization we of reorganization but of of our that the new the third to not affect presence And strengthen will and actually office will believe HETLIOZ. do expect in overall affect during reorganization, do beyond. we the quarter Fanapt production the both expect performance in

Matthew Andrews

gross-to-net did Jim, HETLIOZ? QX And for improve in

James Kelly

improvement Of course, QX. you're asking the to as sequential the compared

Matthew Andrews

right. that's Yes,

James Kelly

where have subsequent into years it and certainly we and here. that QX QX continuing drops the that is gross-to-net prior in trend then The seen higher down is

So, did we in improvement see an gross-to-net.

Matthew Andrews

Germany terms de in that then has couple last And of minimis still been in has grown revenues of or quarters? the

James Kelly

Well, while continues it talk we de But we're advertising doing direct-to-consumer do work with believe a awareness. continue the Mihael of into Germany as you let's some portion total, the grow heard of say to the category. minimis for pilot fall in I non-XX about

Mihael Polymeropoulos

there And Germany. And is the warm similarities well. there non-XX, differences just are people awareness we therefore, ads underscore want try treatment. to to to want to seen reception radio they U.S., have with as a while with that, more, in they learn the the And some very the similarities, and

time patients And One go as differences that Americans of refer while doctors doctors doctors very months care a sleep ahead primary the to in quick the however to primary or fine, more. do booked want to in care sleep system, are of are of Germany doctors. patients that's their couple to do, German

lag and lag be patients the of in interested patients longer than and have be diagnosed that will delay treated newly we seen a a in would there U.S. translating So, into

Matthew Andrews

end promote growth the the through a with then you of reorg less HETLIOZ been Should little we a rapid the SG&A quarter-on-quarter. to it's and for with Fanapt? or Jim continue flattish meaningful year the as expect increase And trend,

James Kelly

Yeah.

reps see trajectory, stable space. is rest to to change in on really expense backfill, ability to of in Given SG&A fairly the trend trajectory linked will sales the quarter-to-quarter our When you're talented look operating find there impact of that in a for expect our see is expectation material expectation of and Where our and continue be the some going I R&D my any SG&A trends the you to pace we don't to reps. at our change year. the a

averaging number an GAAP program Phase as course of six $XX along beginning with study million III of with the this have representing we with over gastroparesis Tradipitant, quarter, pull We are year about the been our quarters uptick expecting the of quarter. the that well through beginning past OpEx of this the and a full Smith-Magenis. And

Matthew Andrews

us changes on just et can endpoint ago meaningful been cetera? what it if of then And lastly the III you quarter for would communicated Thanks. you Tradipitant, start protocol Yeah. the relates as have with or Phase a thought compared the you to what so to dosing with length there share be, any

Mihael Polymeropoulos

changes. No

very is consistent talked protocol before. the with we about what So,

Matthew Andrews

guys. you, Thank Okay.

Mihael Polymeropoulos

Thank right. Sure, you, Matt.

Operator

question Seaport. And from from Corey our next comes Davis

Corey Davis

Thanks very much.

trial. gastroparesis The is first one on the

mentioned new that of DTC thousands I into came in you. resulted think study patients see for that you a like the

the And big so, reason screened Difficulty] between what's [Technical out

Mihael Polymeropoulos

part last little was a the sentence of background noise. The muffled, some repeating? mind you Would was there

Corey Davis

out? the reason get screened patients big What's Yeah.

Mihael Polymeropoulos

Yeah.

So, let me describe DTC campaign.

the this this available symptoms inclusion study gastroparesis. So, at to patients the for have not study patients we of time to study. with more criteria about experienced exclusion are they not in are course, in the the that are participate of looking explicitly participate they are are and of not diagnosed the study this interested interested are gastroparesis necessarily reasons campaign, necessarily But of learn they for and in a of who study all to this meeting and variety and DTC

there So, what sensing community a is the medical more. of understanding wanted is interact learn think unmet sponsors that and and encouraging with patients need disorder, very to I the

So, the return radio we're that of with ads. very encouraged

Corey Davis

data? the then pruritis any and And on time you change enrolment the would study, when your thinking in Okay. have on

Mihael Polymeropoulos

little right have now. sites only just plant of our because started. we fraction with to up recruitment like a Actually, would a more we experience Actually, are

as able us. is something to usual the the midst the recruit to be for initial and and for thought to launching that of business But calculate communicate. my sites study that's So, not waiting to patients work we're before going internal thinking going in is here

see actually ads. us taking So, very to quickly on radio national you're going

is XX, study in create existence these them the a position In of start with to and with that using to fact, on actually to on going week seeing the were one transplanting study. of dermatitis gastroparesis discovered start I approaches more atopic up, trying awareness and the going August new in of little be calculate them into start better to the timeline. Once we're a recruitment the traction sites we think the

Corey Davis

Last Okay. question.

Now there bank have and red profitable the in right have a more is might that comes you pipeline, to along? couple quarters account, of that you if you chance cash the more and Jim's money go choose spend back product into

Mihael Polymeropoulos

Jim question, beautiful let would Corey. I this answer

James Kelly

a Corey, Well, through the rest is at see the ramp the pressure you puts bit do us a when year, rest you to-date around a what net of of right of little put the maybe income you it look least quarter, to results third we're on basis. of spend we that point profitability for the midpoint this R&D the begin on up beginning the at that the and loss as and breakeven, at where year guidance

disorder. study could we our from the and dermatitis atopic our get guided on activities, in next results there, yet, plans just And lag imagine and speed the second they our to things some play that into management you the launch year P&L jet haven't other include lifecycle of everything gastroparesis plus size Now of but to we and subsequent profile. plans could

pieces the a of give on clear we'll those back come course profile. all feedback as you come focus, and into so, And

Mihael Polymeropoulos

and to as revenue make to overall the act. let balancing be able is And to you know course, the And that it research more, and intend our continue more. Right. a top-line development. is we'll our know grow But we in investments through and of

Operator

the our concludes this And to remarks. turn for Dr. over call back final Polymeropoulos now I'll session. question-and-answer

Mihael Polymeropoulos

much. on Thank you. And joining. very call next for Thank you see this quarter. thank And you all you we'll

Operator

ladies you, gentlemen. concludes today's conference. This Thank participating. for you and Thank

You now may disconnect.

Vanda Pharmaceuticals (VNDA) 1 Aug 182018 Q2 Earnings call transcript