- Earnings call transcript Q3 2022

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Operator

Good afternoon. My name is Abba and I will be your conference operator today. At this time, I would like to welcome everyone to the Vanda Pharmaceuticals Third Quarter 2022 Earnings Conference Call. [Operator Instructions] After the speakers remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. to Financial call Officer. like Moran, to now Chief Vanda’s would hand over the Kevin I Kevin, may you begin your conference.

Kevin Moran

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

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

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

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

and Counsel Committee General Birznieks, our Williams, Tim have Business R&D we Vice Senior and of Member. Gunther President Additionally, our Development

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

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

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

Mihael Polymeropoulos

Thank you, us Vanda’s And for you third afternoon, Thank discuss XXXX quarter good results. Kevin. to everyone. joining

with quarter, commercial performance advancing to on clinical regulatory enhancing the which by efforts, and our programs products, discuss and will focus last highlights Kevin long innovation commercial Fanapt, the I current of the completion to the clinical clinical company results progress. its will in an of continue in bipolar Vanda leveraging of discuss Over we of Fanapt; advancing term growth. expect program end some this for for Patient study, clinical our our the quarter. enrollment pipelines recent mania position

for On Additionally, preparation application we by drug expected the our have dividend first also in half we Fanapt the XX include in gastroparesis. of through gastroparesis, the controlled be by with the substantial and in studies evidence diabetic the patients first years, adequate more is gastroparesis of results performance to which idiopathic with and the in end VQW-XXX treatment people new XXXX. in indication. study will completed will this If well from which enrollment quarter. approved anxiety, FDA in The submission than with the of ongoing, effectiveness the expect submission of FDA results for to provides approved,

patients, On core is were of Improvements seen showed the these of sub-population, Conference dividends access expanded as free some the symptoms of in patients a change the which in recently of already We first each seen an placebo, be XXXX VLY-XXX-XXXX clinical further gastroparesis and currently information included at are to efficacy label recently significant sickness. SI ongoing on tradipitant or a also received to of in by in study the gastroparesis. on for years. and HETLIOZ the the phase by in Award. in over patients, in of in presented for with the with pivotal and protocol HETLIOZ; of yield results which gastroparesis work for at progressing week pooled the treatment. is autism treatment PK in with were XXX ongoing Through analysis also scale of Through of appreciated a the we're motion Poster was gastroparesis patients number safety disorder. a This open American across of of dividends days will the other presented compliant XXXX. disorder, patients, clinical highly College delayed dividend, is disturbances tradipitant nausea. in in XXX participating who the total the spectrum nausea sleep half well. Gastroenterology on for Presidential total completed a improvements Additionally, GC XXX improve expected parameters. VLY-XXX-XXXX which In program analysis, ongoing, determined development and efficacy Percent from and sleep dividend, program XXX-patient of and the core motion effects enrollment also as study excludes sickness, significant endpoints which non clinical studies symptom provide programs

of to people controlled The patients cholera. in Additionally, induced need preparing studies We're include drug by times recently in the four-week submitted granted adequate the three this VPO-XXX insomnia, treat onset that in studies. planned difficulty with of primary of of NDA The and to two cholera. VPO-XXX people that early the catalyst insomnia, phase with well for quarter challenge public decades One observed medical insomnia. potential primary the public unmet is NDA remains of the effective from the of announced with Cholera suffer is major cholera. studies excited in study a and show long treatment first health for a of HETLIOZ advance This insomnia to as VPO-XXX of the treatment. sleep submission submission be the FDA improving recognized insomnia were despite in supplemental health cycle. results treatment the as We for FDA sleep effect designation the has the for will HETLIOZ for and supplemental that night orphan efforts. about wake

submit We in to the expect to VPO-XXX drug FDA for XXXX. investigational an application new

Finally, therapeutics. intended our Counsel evolve Vanda’s of development announced on highlights our in oligonucleotide we passes the all acids. jointly legal is of Tim? a development General support discovery platform medicine parts oligonucleotides Korea will Williams, recently to all precision based with and now based modified of and set nucleic agreement discuss peptide development ASOs develop activities. research antisense the regulatory Tim These of antisense or proprietary to

Tim Williams

briefly litigation activities. key to like I'd Mihael. on you, touch some Thank

drug you in last Patents a litigation Court, family property, know Federal had that again ranging probably First, asserting patents a we expertise have trial from this several Delaware to generic intellectual March HETLIOZ XX XXXX XXXX. in manufacturers. of -- in

least all on extends So and HETLIOZ’s exclusivity, XXXX. at way any into possibly XXXX single patent into the positive victory

decision ongoing We later turn litigation. the I'll than regulatory to for this moment no expect a from of our court a the end year.

in issued patients. continue example an reversing Congress expanded scope our over new challenge had our the the law long-standing subjects At than that in formulations certain we help rule. and those of And end agency filed greater this for requirements. regulators its with future ignored been CMS development subject unmet from patients lawsuit impacts innovators to prime interpretation the rule getting product industry products simply April consequence medical requirements, so this the Rather when place rebate our We to It an also its of the the rebate a and to ability detriment law to that immediate for against years. regulators year. negatively of needs. believe is a XX harms products authority new have interpretation it rebate to suffering like or Vanda. manner to powers. CMS expensive now the This CMS rule has that expand in by A new issued business XXXX, changed viability financial impacts of of or violated of novel did across

the our court. accountable striking to are is With down. hope company example this CMS first We the and described in I'll prevail challenge only and just rule law. to we fully to by it business that, Mihael. holding efforts more And are efforts our standards our available not publicly to to papers. back But disclosures of be on one it advance court regulators public turn other in to the This

Mihael Polymeropoulos

you now much, I'll very to financial commercial Thank and progress turn Tim. Kevin discuss results. our to

Kevin Moran

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

months nine XXXX first reimbursement patients for challenges the prescriptions The of with continued non-XX. for reflect

XXXX. product decrease to the X% now compared reflect period Fanapt’s to XXXX nine Turning $XX.X of sales Fanapt; the to a million for net months of same first in

XXXX the nine late-stage third OliPass XXXX, income for upfront commercial months of $X SG&A in the activities. were income ongoing period higher September provision legal same activities, driven primarily $XX.X income net million cash costs a with primarily as for same cash of to our million, in net representing of compared increase $XX.X compared a in for $X.X tax fee expenses to million for the in X% expenses driven associated support, to XXXX. XX, The expenses For primarily an was in referred nine to quarter as XXXX. was of XXXX. an September $X.X of $XXX.X or of both provision marketable consideration increase The to million, the In as US expenses period expenses. loss million million nine increase XX, compared was loss XXXX the Fanapt, to December of nine for the The higher announced an months in cash, XX, the related entering compared higher XX% expense litigation, by of R&D or first previously XXXX of related first to equivalents and cash, by million in was million net XXXX, for million months increases and U.S. million SG&A the into R&D first $XX $XX.X months increase first driven $XXX.X recorded for program sales securities XXXX. of well agreement. XXX,XXX of The as support $XXX.X Operating clinical XXXX increase and corporate by being and tax to compared other as includes an of as

net compared third reimbursement the net product quarter decrease for $XX.X million, quarter $XX.X quarterly were reflect Total our XXXX the third with a $XX.X of the with were X% to now of for X% to HETLIOZ sales million the million first sales Turning of XXXX, a third nine challenges quarter period of the results. decrease continued for million to third Consistent XXXX. quarter of for revenues $XX.X XXXX. prescriptions non-XX. for for the the for patients XXXX, months compared

Turning quarter XXXX. Fanapt third prescriptions the million to of product $XX.X were to by net X% compared as exponent equivalent $XX Fanapt. to third XXXX, X% XXXX million, the for for for compared approximately the second of of third of quarter Fanapt the quarter decrease reported sales XXXX. by decreased a quarter

call as quarter guidance. income million $X of Fanapt the costs million slowly by discussed representing awareness to expenses, income agreement. again, were balance recorded DTC XXXX. flat XXXX. XX, an as quarter increase Net partially included in prior This Vanda’s of of were and XXXX SG&A between compared XXXX, or period greater greater expenses. past HETLIOZ to for compares $XX.X $XXX for of million second $X.X driven million $X to million. X% driven million, clinical of $XXX in providing the than than of product to third by $XX.X HETLIOZ million June in in a $X $XXX are sales as compared net million the XXXX $XX.X XXXX Fanapt $XXX compares million prior of expenditures. XXXX, guidance the I'll $XXX for XXXX following was turn decrease expense offset operating higher with for million. product programs million. compared The decrease between product XX, again million third to million expenses the Vanda a and XXXX for both an expenses primarily OliPass was partially that, the million This in update compares $XXX tax million net driven decrease to quarter the same expenses quarter the the increase of sales Mihael. And third for expenses XXXX. upfront of income cash and and in increase fee upfront and $XXX.X an $XXX quarter $XXX fee Vanda the guidance $X.X the third $XX.X in income million. With of R&D million. net million, $XX third to tax quarter September primarily antidepressant million $XXX for between with Operating end of between salesforce objectives compared net third XXXX of primarily R&D of income the third of of Operating $XXX its by as $X.X XXXX. between cash million the million $X.X for consideration essentially in of quarter by provision of The expenses and compared an to million. expects prior million provision sales quarter quarter The an guidance XXXX. the agreement. of was from million, XXXX. of year in included previously the third to financial prior of and associated have SG&A by and back $XXX was Net to the increase Vanda’s This Fanapt late-stage to offset now our spending, achieve For associated

Mihael Polymeropoulos

and Kevin, we'll we any point, much, questions happy this Thank be At you answer Tim. to very have.

Operator

comes with Jefferies. from Instructions] line Your today first Chris the question [Operator of Howerton

is now Your line open.

Unidentified Analyst

Hi, file this what discussed with for application some for there is to is new Chris, FDA? using you're go study? the submitting? can on for that be HETLIOZ you XXXX Atrigger [ph] now? decision will over you Have to the And and led sNDA data insomnia your your Or you

Mihael Polymeropoulos

not two to additional First studies insomnia sNDA. in And that the four-week yet the of the past. changing application yes, are filed the all, will in plan are study. just to insomnia have chronic clarify, support XXXX we phase the quarter. we this We is reported have study And studies this advance file that

Unidentified Analyst

Got it. you. Thank

Operator

would There are turn no further for over to back like questions I Vanda at this to remarks. the time, management now closing call

Kevin Moran

the And Thank Thank we'll you you. talk very much this for to for you in joining call. us future.

Vanda Pharmaceuticals (VNDA) 3 Nov 222022 Q3 Earnings call transcript