VNDA - Earnings call 4 2023 | Vanda Pharmaceuticals Inc.

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Operator

Good afternoon. My name is Jeannie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q4 2023 Vanda Pharmaceuticals Inc. Earnings Conference Call. [Operator Instructions] . I would like now to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Mr. your begin may you conference. Moran,

Kevin Moran

Good Thank joining Year thank for and to you, XXXX discuss Full Jeannie. us and Vanda you Quarter afternoon, Pharmaceuticals performance. Fourth

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

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

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

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

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

and on We on and SEC's XX-K read our the report reports subsequent SEC, quarterly filings current Risk on statements the and Discussion XX-Q are and changes recent risks are involve risks reports uncertainties. upon and current our by of encourage reports which all statements circumstances available in our investors Form as Form system and with annual are website. of of updated described Condition forward-looking EDGAR most forward-looking that X-K Factors based in regarding and assumptions and on Results These Financial Operations on Management's these Form sections our Analysis other the to note expectations other cautionary Our filings.

otherwise, on required provide on as we law. forward-looking or of any we this information call revise provided update undertake make events by information, and future account we The this to today, call may or new statements is obligation except as only on no of publicly

would turn Dr. over now I our the said, CEO, call to that With Mihael Polymeropoulos. to like

Mihael Polymeropoulos

you us Williams, over Counsel, will and discuss before results. a year to Kevin for to discuss you brief much, discuss to update Thank our will fourth the quarter . measures results. afternoon, General full on financial Tim I Moran ask updates call then Kevin, and to I XXXX and Vanda litigation joining very briefly our everyone. Thank good key provide turning

with and under review we and time. XXXX. or in advanced We XXXX, application gastroparesis deficiencies the FDA on in our bipolar by the development New stated labeling have of CETES On supplemental that disclosed this notification Drug accepted deficiencies NDA, were decision PDUFA are discussion is in as sNDA that drug PDUFA week, including with pipeline Application, in information the and was action week, sNDA treatment and review. insomnia, XXXX. with X, post-marketing final this in that by or of stating PDUFA FDA for supplemental No a announced this commitments April date the in a notification, FDA our X action for NDA has received a does and FDA date Earlier a PDUFA for new for at our reflect requirements the disorder significantly dates September a previously not filing on the the the communicated XXXX the notification March had preclude adults of the date our FDA we identified from our we target now that with of

adhere years in of on However, with the suit letter. FDA disorder, a February response Fanapt mixed manic FDA challenging of the District such filed X as complete response Court FDA's XXXX, for issue episodes for the December and positive to letters. the Fanapt, reviewing to acute the we asking period the Dice FDA onlandvoid is in relies announced XXXX, sNDAs X in a of the declare and Vanda to study in Subsequent our On compel review frequently, in some communication clinical bipolar Phase complete III to the Vanda XXX-day in District upon a Colombia, by in conduct followed U.S. a the is disorder bipolar regulations mandated Court NDA. previously to from for results discussed X, legally development to adults. that

Our supplemental has X, is accepted by NDA has disorder been target FDA, for in for Fanapt X filing been in bipolar set the date the and April adults action XXXX.

United given that represents of disorder estimated prevalence this expansion the the schizophrenia. high estimated franchise disorder U.S. potential for prevalence in larger label multiple Fanapt of population adult the We the bipolar a than in of the opportunity significant States. bipolar prevalence is times believe The

for expanded application FDA, the been have as access XXXX. multiple substantial X tradipitant indication the action been with accepted this XX, set program which this date September continues The the as results X FDA gastroparesis, drug efficacy for believe than database demonstrate patients by evidence our support supported patients electrical new XXXX been of as patient at treated least adipital months well and the and tolerability target of by years. in also the after package longest-treated clinic has studies a from The XXXX, we more to drug. and for Additionally, with filing has for safety

We're challenges Atrius Atlas performance our the the revenue pleased launches with of of despite products. generic

actions near-term products These we to for FDA potential X the future bipolar potential as indications taken both the success, franchise existing year, position the this and business if preparations of and expansion course include receive a continued well of we to as commercial accounts. approval of Fanapt for have intended disorder the for products respect with Over number indications.

Company rights is a on first U.S. as multiple we Limited the XXX forms XXXX, treat of with the transformative Johnson and & relapsing sphingosine quarter X million. the PulvorI FDA approved receptor Health of During sclerosis. for Canada adults once-a-day oral Actelion modulator, fourth a onesim we USD Johnson Pharmaceuticals selective completed Canadian and phase to by from to Onvoy acquisition obtained

Transmark recently, XXXX. from notes the disorders for to colitis of to October Additionally, autoimmune most convos a issued, XXX, treatment XX, of therapeutic office when which of and alternative unboripacan the issued ranging potential psoriasis allowance candidate is anticipated -- group expire inflammatory Pat U.S. application for diverse and on a the

of on therapeutic range plan areas. progress development continue of multiple FDA robust May of side, III previously update of pipeline, motion will tradipitant that, second completion as in Tradiptarmorsan of announced from approval subsequent study, a we our upon positive results outside reported, We clinical program enrolled. includes first already sickness. motion we year, of initiated study to treatment the pursue for to sickness III And Phase On the which clinical of a program. tradipitant this clinical Sicily And wide which to Phase XX% development the in the now across last is products the

I that, ask brief litigation General our a With Tim update now on will Williams, provide Counsel, Tim? management. to

Timothy Williams

the to the updates, hear Court our and at of starting have petition. benefit Federal . important Apotex cert HETLIOZ Thank review. I'll to ANO our the court law our petition And waived was consideration. Teva filed opportunity of the petition clarify distributed Court today, courts, Supreme the a Mihael. lower few their We await including aspects Supreme provide patent the respond We defendants, chambers their for Circuit. litigation. The case you, and asking litigation to in to with for with a obviousness January,

to on uncompensated matter, the of FDA of Claims. document dismiss the case. to case and with information. which U.S. and proceed companies review the After in Next, taking of January to a of and us May information the sued production include generic our the these This U.S. in pattern FDA HETLIOZ. hearing I'll proprietary personnel Court suit properly the of provide in of motion denied The confidential depositions In Fanapt secrets update versions as of government's an pending discovery, of Federal of government government a involved disclosing to alleges we will the allowing part fact XXXX, our moved generic trade reviewers for matters. dismiss, court U.S.

challenging by by the ruled FDA than X in cases, the court. unreasonable. We've originally Act the The had of to sNDA Cosmetic of In X, developments conduct Jet than FDA also the our respect to and to Drug finding requirements we FDA Act the for actions timing to our of HETLIOZ. unlawful FDA. court positive action Food to procedural XXXX, September be to the had take Food FDA FDA's and the Lag with the March January, the In other agency Drug ordering in to the compel sued found court adhere months earlier proposed on more requests hearing and that favor violated Cosmetic our both our

an that we requires pending the to sNDA is the XXX Specifically, judge Jet requested X,XXX sNDA Yet a has has days been been hearing. after for over days by our it submitted and XXX days for sponsor. noted commence over Lag within since a hearings law

X, March date. await and the request FDA mentioned, act action the I hearing judge by As our by and demanded FDA's has that we

and challenging filed Just reviewing for our insomnia conduct yesterday, additional sNDA we HETLIOZ. an unlabeled FDA's

XXX our us disclosed the from were letter by This the the earlier XXX days FDA Cosmetic in that discussion beyond by Drug which Food days no actions even the we and though communication this it is had taking deficiencies As labeling preclude this Further, described identified more well deficiencies the than arrived Act. sending after statute. of submission rather specific that prescribed identified. notification a week, than received stating

to to night, the a final the filed judicially be FDA we compel the to avoid our unlawful and relies We regulations last law. FDA by avoid of to believe can the is mandated legally FDA asking In XXX-day final court to period declare the that the void reviewed and decisions. to court adhere reviewable as seeking action suit upon review are

with court various in of to Freedom can related litigation be available interactions Act additional cases pursue disclosures records. in and our our of generic to continue Details and HETLIOZ found of regulators Back our Mihael. publicly you, competitors, patents, We Information to all disputes.

Mihael Polymeropoulos

Thank Chief you call . discuss Kevin? the Officer, Kevin very our to Financial turn I will to our Moran, financial now results. much, Tim.

Kevin Moran

by or where I'll a highlighting And is Health treat mentioned, adults the modulator Mihael. Canada begin relapsing ongoing. December as of rights PONVORY Janssen you, Company Canadian Fiori for to in was oral the million from to Actelion Johnson U.S. and FDA Ltd of Johnson Mihael of forms multiple acquisition the in $XXX completed and Thank once-daily & transition with SXPX selective sclerosis. Pharmaceuticals is that XXXX a approved the by

the a responsibility, diversifying significant period, ornanda. the supply potential and ulcerative and ranging and During our to operate regulatory treatment inflammatory customary expanding the portfolio, from to continue providing develop and transitioned Janssen sources our Vanda will autoimmune represents group of pursuant diverse a transition while to agreement, milestone This to for of of this candidate colitis. an revenue Vanda commercial a psoriasis a for of acquisition Janssen therapeutic business opportunity transition disorders

XXXX year the the to of XXXX year decrease a The net for of full the million product to product $XXX.X in XXXX. same year a significant now to compared decrease XXXX for were XXXX. HeveO's HELIOS fourth financial compared $XXX.X for revenues to sales impact net XX% million million, decrease the period million generic results of full sales had volume. saw before XXXX. performance $XXX.X were the quarter our to XXXX. during Turning was and decrease launch attributable first turning for $XXX.X same Hevios versions for results. price the in Total on of at-risk XX% to discuss period deductions I'll the discuss the a a full net in decrease a in and

specialty of quarter higher the recent increase as has resulted Our prior inventory customers for sales stocking and compared net of sales periods a product first in unit at reflected throughout significant XXXX. heavy XXXX pharmacy to US

for during the XXXX. of the X, compared net net XX, income period Vanda were of to full the the XXXX XXXX. for PINVORI sales in reflect decrease product reflect XXXX. for Turning compared year-end We and product same recorded the income net period net revenue acquisition a the million -- to year million on now product the in XXXX, to year same full for for million the full December $X.X generated Fanapt million of X% $XX.X XXXX, $X.X $X.X the year December These sales XXXX. period of $XX.X date product Fanapt. between net We million sales

full as to expenses XXXX driven and XXX SG&A sales income goods primarily The expenses and lower compared decrease was was expenses XXXX VHX million year the increases also development associated commercial for by decreases to of partially income compared same lower primarily cost Net million as provision SG&A support for sold. expenses referred was late-stage million in for full tax Fanapt decrease of tradipitant lower primarily $XX.X year provision million period $X.X same income expenses, included our marketing, to commercial driven related by The XXXX. million period expenses in for products. activities The the R&D $XXX.X to with the XXXX. for the tax related an our to of programs. PDA development in an driven by our offset in Operating decrease $X program, $XXX.X R&D by lower were and

full The HETLIOZ is net to during in year of rate decrease lower compared compared and September due marketable BMS of million. reflect XX, to net Vanda's fourth $XXX product and was XX, December of as the on million as cash as a XXXX. XXXX effective for in lower $XXX.X from XXXX from The sold to cash owed acquisition cash, and million December the $XX.X in Pinvori December representing both to million XX% cost XX, referred product securities to sales of of Janssen goods the XXXX, the HETLIOZ a of to $XXX.X cash completed of XXXX, quarter change sales equivalents royalty XXXX. the of cash decrease X% and decrease

of to increased I The by XX% the Total decrease XXXX, the to now $XX.X increased quarter in $XX.X fourth for for quarter XX% million compared the of fourth a of to fourth in to were fourth a XXXX sales quarter third Total product in the million XXXX. $XX.X million million results. Turning third in compared fourth to the sales million, quarter for of XXXX. for XX% of as revenues the were quarterly compared of net quarter $XX.X XXXX. compared of HELIOS XX% revenues fourth $XX.X our the product the XXXX XXXX. $XX.X decrease by HETLIOZ quarter as quarter million quarter net

the a to on decrease during launch HELIOS The impact a at-risk to in to net fourth quarter was in of continued have HETLIOZ relative XXXX of The performance version of quarter a sales product decrease generic of XXXX. volume. significant fourth attributable the

as HETLIOZ prior Our reflected stocking customers in XXXX specialty higher as sales resulted recent sales a XXXX net quarter sales increase of for unit quarter first higher unit The inventory at the XXXX. periods. reported significant throughout product the during of first to pharmacy compared of

to which net compared elevated of quarter lower from customers attributable unit specialty sales first product during the as sales the reflect of XXXX, XXXX. pharmacy continued quarter of partially the inventory fourth XXXX HETLIOZ end quarter the to was fourth at reduction the the of levels of

$XX.X of acquisition to fourth XXXX as the X, year-end X% EquivixMonen, sales on December Again, the of XX, prescriptions compared XXXX decrease sales for to net during of Fanapt. the million December Turning reflect XXXX. X% product a reported $XX.X quarter by between in the $XX.X the million the in product in XXXX million and of date to quarter by of to the sales now in $X.X revenue quarter Fanapt third period of quarter and XXXX. fourth XXXX, by the product were decreased quarter fourth quarter approximately Tamburi were compared XXXX. for X% as sales the product third generated of fourth net quarter compared of increased these XXXX, product XXXX. the Fanapt fourth million Fanaptnet

of quarter compared income the of XXXX, third XXXX fourth in recorded loss $X.X million Vanda of For to net million for net quarter $X.X of net the fourth income of of and quarter XXXX. $XXX,XXX the

$X.X decrease BMS million tax XXXX due sales The related spending the $X.X the income million of provision and in R&D period December and by associated upon provision compared lower manufacturing expenses milestone $X.X third million VHX product by expenses the million the of filing program. compared same XXX $XX.X recorded $X.X of offset onetime fourth manufacturing quarter of for sold owed to for expenses, Operating in with and in increased million -- the to benefit NDA our on in by Lilly, of lower the income commercial rate was fourth XX% were million driven tradipitant included fourth royalty an related million tradipitant primarily made and expenses program, HETLIOZ VHX NDA million primarily XXXX quarter for and expense of And of NDA this as HETLIOZ our lower $XX.X higher of driven sales cost in costs. XXXX. milestone and the income the and the including for the to as effective to SG&A on quarter fee tax activities of partially in acceptance million tax fourth million million XXXX., $XX.X X% to payment increase XXXX. $X of was decrease loss by of sales third compared the for for fee, quarter XXXX. product expenses net NDA to associated the net XXXX quarter products to in XXXX. an an Operating to expenses filing net $X from to legal our including XXX the goods in the payment of The Eli $X.X expenses of $X.X quarter filing The

uncertainty for ONXX HELIOS, versions of a and XXXX generic is to provide in in to HETLIOZ result versions at-risk of HETLIOZ treatment of periods. financial to this product Given financial unable guidance launch HETLIOZ future future ongoing market significantly its will related ability decline the evaluate patent guidance U.S. of at in Vanda at-risk generic the sales to the net Vanda periods time. will HETLIOZ the provide U.S. the of launch for surrounding of as continue the potentially likely litigation

constrained to product year reversal. full not XXXX revenue significant of the for company the sales net an probable amount Additionally, HETLIOZ

the consideration resolved. as periods uncertainties variability could remaining Helios variable a result, future with As are net sales product experience in associated

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

Mihael Polymeropoulos

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

Operator

Andrew with your from Tsai question Instructions] comes Jefferies. [Operator And

Lin Tsai

the on acquisition Congratulations of Pomvori.

couple that questions a maybe asset. So of on

have sales vary? First, terms at you then sclerosis what this driving might What's Palm able guys out why do can do you the is . growth think differentiated J&J And the multiple that do in there? other drugs been here? from not of appeal to secondly,

Mihael Polymeropoulos

much, Andre. very you Thank

In organ is of peripheral system lymph from of sclerosis, in wide of applications in attack nodes. on all, where system. class the central analogs. their or of First so background body. preventing can they of to receptor the belongs for this you or egress And sequestering a pad have lymphocytes case here have -- action fingers mechanism first nervous autoimmune give everyone. of the that disorders Punvoiponesimod a multiple the by

that they short clear know, the especially also quick members. for effects require been you has and As circulation may in a drug specificity ago members multiple of critical years reversibility period is of a started within family contemplate to with And expanded now drug of the that can come as with effect of patients, in avoiding receptor generic a be role specificity this recovery about to of of in believe It same that of for lymphocytes. and has many several quick planning additional class treatment has matter this those the the childbearing women class. especially We drugs will that It due its a the and out days. made true side reversibility. groups the attractive, time for play sclerosis ponesimod the of fingolimod some Gilenya, of

attractive. amount specificity So both reversibility directly lymphocyte drug differentiated and and increased and quick the question, make counts to in this year's

a what your their support business product. their remove to of we simple in had we question answer in for the decided partner divest the market own from And to of J&J. part while of to it. process can reasons it. potent different plan J&J was were do second Your market is they identifying the

multiple consumers this of the quite neurologists is significant there a be increase both a and to the able with believe we so useful of awareness opportunity And to cirrhosis centers and existence potentially product.

that from to alternative alternative have, interestingly, with addressing of the effect give useful actually been and learned, directly drug beyond mechanism compound sclerosis us, that disorders them nor being And mechanism colitis. of successful us of an as binding not of very the the approved well of approved be successfully successful for in of for is as of well Pfizer's compound multiple do now we in it, this in we And think BMS action to effects front receptor can compound compound key And both have the pursue that of to AXA the autoimmune colitis. both but similarities believe the could array that, reasons the colitis we as BMS positioned type indication. has our in Pfizer in not course, that examples are ulcerative be

around And had In are prostate successful. in day the once company, likely as was in beginning be addition, Actelion, evaluating to that path And which the a well. continue are said, will conducted as I a study swingers analog a GM now Polvo II Phase large realized wide. indication to we psoriasis, in oral the X just there like opportunities and be development

these our of We're be plans future. about we'll in We talk now. the the plans period, are more midst in able the to developing transition and

Lin Tsai

helpful. very gears realistic do insomnia would How then HETLIOZ the this to the do And What approval? news. you here? work the you out? Or hiring does wait for force? scenario sales shifting until start all be -- That's

Mihael Polymeropoulos

in or . HETLIOZ you clarify. me bipolar Andrew, asking the infant. let the Ansonia about Are

Lin Tsai

insomnia.

Mihael Polymeropoulos

Yes.

are drug effect with what scissor imagine supports the agonist cannot of XX response Ansonia, that not preclude the deficiencies, in letter this negotiations. melatonin we -- file the label the likely by for of letter. We the in although be that we the followed hetos by course, most For negative a and in onset and FDA given now think clearly the is complete years outcome in deficiencies sleep think historical will for Sanya. named, marketed indications ambiguously of

expanding and marketing force immediate planning sales are plans we're HEPA We any not . the not there.

Lin Tsai

second is, the decision. you the of the is, are hiring as same ahead gastroparesis, for of then question PDUFA insomnia as or Fanapt development despite to my potential bipolar the tradipitant just final And it. well then maybe that Got those your in applications and speaking is for confidence

Mihael Polymeropoulos

Yes.

about talk just confidence. to So

will of all. with Of optimistic we're are our course, science and the believe we we're having unpredictable packages color think the we Fanapt in robustness of operational because force. course, that of have we cautiously expand already cadence working results. And through communicated agencies And And existing being said you a we're thing let already give sales for for we about But how Kevin towards ready the that with you gastroparesis. prepared expenses in of more to the little the same that, holds tradipitant I experience there.

work done expenditures course, to And understand commercial very with plan. the from are months have of prelaunch We ahead the September market we decision. of away and develop of a agency But that there, in yet quite an few action proceeding a cautiously XXXX. we're again

But give I color. more will let Kevin you

Kevin Moran

Yes. Andrew. And thanks,

the well commercial to said, be positive Fanapt's on certainly That well-established market mentioned, supporting as market history infrastructure taken being actions HETLIOZ' those. side, given On quickly with news. the we've as have very to infrastructure prepared the associated Miles and specifically, we as history on a on and Fanapt expand the in activities

the of So cadence from but cadence some a see quarter, so, against perspective . that a a I'd to positive it kind upon expect there costs development that will we would change. began would more be execute be preparation we've first that

Operator

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

Mihael Polymeropoulos

Thank you this for you. much on us very . call. Thank joining all

Operator

today's concludes This call.

may You now disconnect.

Vanda Pharmaceuticals (VNDA) 7 Feb 242023 Q4 Earnings call transcript