KORU Medical Systems (KRMD) 13 Mar 242023 Q4 Earnings call transcript

Good day, and welcome to the KORU Medical Systems Fourth Quarter and Full Year 2023 Earnings Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Louisa Smith from the Gilmartin Group. Please go ahead.

Thank you, operator, and good afternoon, everyone. Systems year results ended Medical quarter the KORU full and December today, released for financial fourth Earlier XX, XXXX. the of company's copy press available is A on website. release the

regarding recent encourage press which no release uncertainties, most with These comments have press the to differ any based well assume our we the associated of certain includes release press will of We filings obligation During expectations as predictions materially results forward-looking as SEC. including and many you, are our in financial front plans or today. in this matters. forward-looking statements. listeners commentary due Actual update on our call, events quarter. statements those to other on mentioned and our I to the and make and as our risks business could results

certain call, posted filings release presentation accompanying management investor will the each During which financial SEC, discuss press our measures and our website. the of our in and non-GAAP with on are

You disclosure and measures with GAAP non-GAAP measures these release these additional regarding measures, comparable reconciliations our accompanying filings. including investor with those press and presentation in find will

the release of recent on discussed, X:XX Since most call replay, to with listening held and topics and company may at company's was the then, please filings the press comments recorded For the to p.m. additional the benefit Wednesday, the related XXXX, those XX, time. reference March this approximately and Eastern SEC. made have

Financial please ahead. and and of call on KORU the President Linda, Medical us Systems; go Chief Adams, Medical's today Tom CEO are Tharby, Linda KORU Joining Officer.

today. thank you Thank you, Louisa. afternoon, Good for joining us and everyone,

by XXXX. I results slides our will commentary. guidance. walking key year then updates full our fourth quarter will to During business our Tom today's and XXXX will we the use for through review financials call, and and support begin

we remarks, the line will prepared the Following open for questions.

quarter. KORU's in the with pleased very fourth performance I'm

margin cash our gross continued discipline our exceeded on in growth in management, execute We continue expectations, our capital quarterly and and burn. strategy, our improvements to we see expense with to

$XX.X X%, growth Therapies revenue of full revenues by in at onetime ended Our engineering year a million, services our Novel business. nonrecurring with affected

Our overall market by performance international entry growth the with by of in our revenue year-over-year, another strong, strong by double-digit business U.S. new with in driven SCIg and and sequential our Ig overall successful growth. remains driven share gains delivered in markets current geographies recovering business, growth core SCIg primarily supported deeper penetration quarter we into supply. In

the becoming prefills the of Hizentra our Prefilled expand is KORU large In and our to syringes KORU opportunity. will critical this positioned and driver for the a be We part for SCIg believe System. November, KORU clearance growth announced prefilled syringes in core market, we strongly FREEDOM on XXml markets. are FDA penetration an capitalize increasingly of

let Tom Novel Therapies, the touch year which in continue collaborations build perspective, granularity. 'XX the cover in and of of we new the an signed on out I'll additional started financials operational I From with more In two to three both strong later. will pipeline, having with XXXX, the beginning having

above quarter. fourth For consecutive positive second $XXX,XXX XX% gross margins, finished cash in flow we and for of the quarter generated the

$XX.X operating to expect the steps million. exceeded expense to taken year we ending initiatives, beyond. projections, we our and testament continue metrics a our in progression performance the in reduction the balance serves XXXX inventory XXXX management Additionally, closing of and cash with as and Each we've operating these in

XX% year. range million for revenues net gross guidance full for between and margin representing Finally, and $XX.X to we're XXXX between XX% to million, to XX% initiating $XX.X growth, XX% the

full quarter with associated call. in year year of be XXXX. in $X balance cash for will flow at later and to million plan exit ending fourth positive details our the the and related of to to guidance cash the the Tom we the assumptions Additionally, an 'XX discuss least and

years, focus to and critical believe and poised double-digit moving our we've year will KORU that I'm meaningful our and Therapies we are us. profitability. positioned for we XXXX our future beyond. last positioning core and to a our seeing focused Vision is sustained inflection strong execution a the business, and behind point investment success. Over be that best 'XX we 'XX, to 'XX momentum growth team invested much for is as in for few Novel expect growth of are for return a we remains an profitability. we enter operational key discipline in date And our in pipeline and forward,

Moving X. to Slide

delivery recognize growth Those geographic of KORU market. X X-pillar and being Novel the 'XX our expansion. that strategy Therapies the and initiative. the as broadening a penetration SCIg foundation of Vision subcutaneous strategy will pipeline volume domestic drug our You'll continue growing in growth, position large is the to This leader

to As our penetration into and is further position. Domestic our Core, market increase it SCIg our to goal establish relates leadership the

to With the SCIg patient revenue mid- reflective respect sequential of saw and the single-digit growth. high X% to volumes, year were quarter in digits, delivered overall with to double of growth, another the approximately in share and We we the quarter, end-user fourth pharmacies year-over-year growth gains. our market, market up sales ended

Increased double-digit full see the this leading expect to consumable at indicator future replenished year, end volumes of a and pumps for to in the lower the were increase both inventories quarters. for sales. and in drove fourth we distributor quarter often demand Our inventory QX, a

We traditional therapy. to prefills and their caregivers continue patients versus vial drive to therapy see due to SCIg convenience

and We're the began rollout encouraged the which this of syringe, prefilled believe in January. XXml commercial launch Hizentra these will benefit trends by

XXXX confident for market U.S. business within XXX(k) starts gains product in submission patient share We Overall, are quarter SCIg core new a we also fourth the a positioned driving growth anticipate XXXX. and for the new are in increasingly believe Ig. we continuing in in our

Novel Therapies. to Turning

open by progress I'm early in across additional with recent to In announced collaborations, which We 'XX. varying new discuss later. two XX indications, weeks, will collaborations XXXX. new date, X opportunities have our XX encouraged we've I signing collaborations in signed

key III to to commercial in have milestone Phase X a advancement XXXX, We drug trials launch. the progressing collaborations in also

of Looking the infusion use the a fourth application centers. 'XX. with early forward, quarter in I'm FREEDOM diversity and very drugs pleased by anticipating indication a and 'XX, in Infusion overall the making of XXX(k) on we're novel our headway by we're new System the for and support ambulatory to NT, commercialized 'XX the during our submission strength pipeline within of progress therapy

year. to was in driven growth entry the QX the stabilized, markets. over multiple indication markets new our International to as sales by continues in be Turning Ig a and into quarter It 'XX Strong grew established growth opportunity CIDP growth and fourth FID X% XX% KORU. for new full Revenue Core. for and great supply and

the Domestic growth. in double-digit was with and As pump consumable Core, volumes case demand of another were indicator strong

in continued all-time we XXXX. anticipate as an into excitement is at regions high new Our expansion in international

also of half We an system. generating first of FREEDOM in year, evidence the expect our completion for Infusion trial the electronic further pump the

and International presents penetration. forward. amongst overall penetrating shift major like a bullish why Prefills our potential focus increasingly Core therapy on markets share I'd delivery we're to to and subcutaneous within method growth subcu specifically, patients the represent is KORU Slide moving catalyst syringes, opportunities our Domestic the more as this has to back so for increase X, this for prefilled the on market and and Ig

in XX% grew will quarter the drive part Overall, increased patients as a to growth. see the fastest-growing fourth syringe overall that number XX.X% market. the overall of Prefilled continue of and penetration Ig to we factors

patients preferring XX% versus with preference, prefill the the of patient with pump FREEDOM First, use administration. of vial

of X/X with the fulfill combined dose needs. the provides Additionally, a KORU prefilled patient represents portfolio the to with market XXml XXml launch, earlier clearance and, broad all

change prefills, usage our a due convenience. driving even clinical with in the practice focused been to to in greater partners have We increased driving pharmaceutical uptake

doses weekly with who expect We much twice higher require increased penetration patients and CIDP therapy.

and potential and levels position penetration year end year prefills reaching our XX% for XX% to higher and growth by of 'XX excited 'XX. the are penetration full to XX% for in of by drive We

Slide to X. Turning

Conference the study from this be adherence on Home very we FREEDOM pleased later that to at This month. are new We to data National data collected focused and using announce over over Infusion X.X-year XXXX to will impressive the pump. a System FREEDOM SCIg prescribed primary Association XX% XX,XXX of the self-administered presenting treatment protocol. KORU rate patients who therapy an adherence with retrospective conducted immune study their revealed period patient This deficiencies the

KORU To adherence range high diabetes other such context, improving as somewhere from system conditions consistency the This and patient promoting pump comparison provide for and XX%. FREEDOM arthritis rates cholesterol, exceptional chronic satisfaction. of blood performance and to highlights the treatment XX% pressure,

these sharing customers. findings satisfaction. Conference at pumps the pump SCIg Overall, the improved with leading We and to therapy system among patients, prospective on PID FREEDOM strong new to patient KORU upcoming the and facilitating forward our underscore look of to treatment these adherence NHIA effectiveness results

to Novel Therapies our Turning pipeline.

added the addressable to have translates XX have we market are billion, strongest we We XX, a another our the open X.X bringing X XXXX, approximately million people pipeline new total over of treatment to In to NT $X.X collaborations we opportunities. through our pipeline collaborations reported and to total pursuing globally. pipeline, This date. of

we've to already recent highlight off I and collaborations is to strong X announced. XXXX start, the want a

III SCIg system its clinical pre-commercial The support first And study being trials. rare supply a the on to disease of already agreement an unnamed with KORU's a the initiation feasibility entering second, commercialized therapy. Phase a drug

it as grow opportunities a Novel future piece can creates that KORU drug KORU's strategy for significantly growth our Therapies key business indications once commercialized. is to

increasing anticipate Japan with entry also in approvals. SCIg We

both is on over settings. the in years with ambulatory focused the Our next commercialization for three home and opportunities team infusion potential late-stage drug

large-volume expect totaling are of I'm green and far advancement our business. 'XX, Novel the leadership be the are the go in global a Therapies entries in potential our delivery we core in on increasing will commercial lighter the believe truly of to targets those new near-term to KORU, by live incremental leader by funnel that drug end slide. transformational potential position the The in encouraged our highlighted and as right our collaborations with X driving

strong line we current as the with Tom 'XX. path I'm KORU In continued double-digit to in will 'XX to focused it to the 'XX foundation of to turn clear execution sight growth remain strategy on over on review and by a growth we've financials. positioning Vision laid our momentum now continued our profitability. and of I XXXX, for profitability are a our and excited for a

quarter in and We the We below Thank and year quarterly International afternoon, performance closed X%. the net which million, you, of Linda, revenue business. our pleased a total . were Domestic $X.X with by good our was prior with everyone. Core

$X.X the Domestic healthy overall an reflecting SCIg growth we year-over-year by For This revenues in growth accounts, Core new sales share gains market. was X% and quarter, driven double-digit million, in of pump reported growth. infusion

during strong and quarter, which are future the very as reflected In of addition, the distributor be Linda expect demand, sales, end-user of our in out, replenishments inventory. pointed which we indicative were to

The million, Europe, increased International and supply pump Core business $X.X expansion X% growth double-digit new driven by and with into across of in revenues volumes. geographies consumable Ig year-over-year improved

Our of Novel engineering XX% revenue services in decrease revenues by milestone Therapies we $XXX,XXX or completed large for XXXX. nonrecurring business a a reported driven

X. Moving to Slide

the follow increase, driven pumps growth, and by gains of pumps the total X% XXXX For also net revenue into year million, $XX.X With it hands make increasing nurses to pump totaled a to consumables sales year. a attributed Core $XX.X this million, growth our in full expect patients. national prior record unit in our were consumables year year-over-year which revenues was and we Domestic share over regional XXXX, accounts. and in X% marked the sales. infusion as

increase a revenues pipeline of were decrease million, to as We orders driven revenues new in million, clinical decline as potential were a markets Core by internationally a sales the prior opportunities expansion XX% XXXX. from recognized year. was and Therapies revenue representing well result higher of into Growth established compared the of year. XX% carried in $X.X prior geographies. into Novel a reflecting International $X.X the increased was from NRE The trial year. increased number

Moving on to gross XX. margins on Slide

gross basis XX.X%, over For point prior was a margins of which XXX improvement quarter, the the GAAP we fourth delivered year.

product efficiencies margin gross favorable had the no inventory gross revenues. to discontinuation the was non-GAAP a were closure, that Margin in margin impact by relating increases adjustment for non-GAAP onetime manufacturing a driven consumable quarter changes site product and to manufacturing XX.X%. for outsourcing a on Our improvements allowed in of mix. in quarter The related

by we full basis productivity over at for for was year and full manufacturing our of XXXX, XX.X%, add, GAAP cash fourth representative Slide XXX gain the a which finished product year primarily cash efforts a of product the the balance was $XX.X XX, for quarter, XX.X%, a $XXX,XXX gross improvements discontinuation. On was year which the for of quarter. onetime the margin For point driven the million, of year Non-GAAP and will improvement the XXXX, gross mix. a in again, margin outsourcing adjustment end a with

in driven cash of gross by QX was half margin improvement expense control. Our improved driven operating by disciplined XXXX, and the lower losses second

Additionally, on CapEx achieved led our Offsetting of quarter in earned of tooling inventory related the cash, accruals. year-end typical our the there capital in and these reduction of of development completion the improvement, was credits significant retention working an increase next-generation we uses plan, to collection products. by

During recorded the $X fourth million. a quarter, deferred allowance of against we also valuation noncash tax our

As quarter, throughout XXXX. by we usage we our review directionally cash improved

new of which in level as tapered a first higher hires, the and onetime throughout spending The quarter result had significantly of onboarding a off investments of CapEx year.

but remain rate. cadence, at usage cash quarterly into consistent similar to significantly we Moving follow a burn a expect lower XXXX, to

earlier, year improved fourth a the share and to per per net negative million flow positive for per of operating period same negative of diluted full noted leverage to XXXX. Net per or compared same full cash to the or net cash diluted for a XXXX share was loss $X.X planning loss share year of of loss diluted diluted for or XXXX. or share $X compared usage, the our for $X.XX million million of negative Net $X.XX expect was for XXXX fourth $X.XX $X.X million period As 'XX. in a the $XX.X quarter our of $X.XX XXXX the Linda negative we loss reduced be given and -- quarter the

negative full or adjusted full negative per or million $X.XX million $X.X $X diluted for net for million year million allowance in the the was and the per included prior of $X.XX $X.XX both versus a year. versus for year tax or $X diluted negative negative year. negative negative EPS EBITDA share Our quarter $X.X from and EBITDA the the or quarter the And Adjusted valuation share negative loss negative prior million. $X.XX $X was

on to XX. Slide Moving

second, year $XX.X drivers setting our representing SCIg growth XX% prefilled estimates adding core the the collaborations full are include: the in million of to high mid- and XX% We XXXX XX% market growth. penetration XX% the to the of new single the SCIg revenue a to third roughly Key million, behind drug approximately X pipeline; therapies syringe digits; one, for guidance and overall market. novel these $XX.X to between of

to chain between expansion line as pressure lower year. range half to XX% primarily expect the margins new result second our a for in We gross inflationary start-up XX%, of into geographic ASP production the supply costs markets, of and

we implying $X balance decrease to from burn significant cash XXXX greater ending be our million, cash years. Finally, a than expect prior

$XX driven guidance of by $XX.X managing operating of exclusive expenses. compensation stock million, Assumptions are expenses to million to approximately this

full and We for cash expecting the QX positive also of are breakeven cash to flow XXXX. in to flow year be

facility. $XX of credit million our all just guidance new mentioned Finally, exclusive is cash I our

facility established HSBC of which and line with USA, of commercial with a credit a relationships. new banking credit we million $X term a consists have loan Our million new $X

to capital this Linda now are I available to for have We call closing us for opportunities. back comments. growth new to will reserve turn the pleased strategic

and Thanks, the penetration, and gains to in years, several Tom. market drive share innovation we've In product last pipeline growth. our invested accelerated R&D new increased

on Hizentra which our aid base. already we XXml expanding As will our customer in FREEDOMXX we FDA the for have received approval discussed, platform,

for Therapies needs. term, to the new infusion the near longer that which platform for Ig. more provide term, be will customizable the next-generation convenient submission and we for and In expect XXX(k) our comfortable pharmaceutical pump Novel partners' we a experience In our set will infusion a expect pump

in excited as have very to customers to market patients. In would these we experience to to are and versus double-digit penetration continuing our in share each milestones I financial few and returning gains net pharmaceutical bring look through to key drug of U.S. of syringes highlight like we manufacturers revenue full both within infusion subcutaneous We growth anticipate products providing assist 'XX. international best XXXX new We our a also that look core year for expansion closing, to prefilled to the XXml current operational We our performance. markets. while accelerate increased and

enter reaching Therapies that late-stage to of higher we front, new expect collaborations the to On on candidates have year in focusing commercialization X XXXX. Novel probabilities the prior

the XXX(k)s, submission and We X of platform. new on are projecting the new for one a product a other for drug the indication FREEDOM

and of Finally, XXXX. of cash for it flow we our positive fourth 'XX is and Vision and year our 'XX. breakeven overarching pleased are 'XX of results, I'm full flows across businesses KORU's our our quarter commitment in the I by QX indicators all outlook goals. Overall, milestones these into strongly are Each making to of strong progress our am 'XX with encouraged heading strategic cash through

drug at-home company convenience the We as plan like our of evolve year. both to KORU dedication. and milestones by continue In to setting, entire a team passion strive delivery the for long-term closing, leader continued would thank to to for in demonstrated and in the their clinic and our I our products, the to

Operator, the call I will to over you turn for now Q&A.

[Operator Capital. comes Frank Our Street with Instructions] first Lake question Takkinen from

of the saw to should around the line one [indiscernible] I should add profile International How hoping guidance. with we guide was heard then Therapies, about growth, think item, the break to XXXX? on penetration. the I we you growth Novel the comments that, maybe some for Therapies. hoping how was Hizentra assumptions XXml? of think Domestic, about prefilled to by syringe from I and about And start market SCIg Novel contribution on your it could and down kind

Okay.

and to start, I'll then I Tom. it think it turn all. I got over

overall a performance, by U.S. our prefilled business, above grow not guide gain, and and business, by performance particularly driven points. In in we primarily our to of be prefill range, points the overall for let to key you do somewhere anticipate penetration, million million share a in that We syringe CIDP our base. to of expect expectation patient $XX.X X.X% would me but the market give the yes, we couple $XX.X First, that, couple increasing XXXX.

you that, this we a the is nice year. Our where International in acceleration U.S. ended so performance, can expect -- from business,

International ended in overall be business we then finally, trajectory we range. where about to the On in our Therapies probably expect the would year. our somewhere somewhere million year can to mark overall International business, up a from And appreciably year, in the XX% this growth think our you overall that $X the business between expect $X.X say, XX% we overall, for would business, Novel and million

forward? Perfect. maybe just talk earlier the Okay. Maybe of about think how kind you of specific infusion one then about to on PRs That's And and week ambulatory a an opportunity that from extend this going that the as setting. overall the as market into helpful. follow-up infusion ambulatory opportunity

Yes.

So drugs new a centers, and professional there, just hospital exists in ambulatory are home by in that health setting, the that set care to require infusion the -- years, stage drugs launched last between have a there which been administration X the X the market where setting.

As for I key commercialized. drugs our because was that already progress of the noted us in Day, a Investor are area

for quarter and asset use that a is asset U.S. will platform, we anticipate the announced settings. in I'm a finalize we that, that XXX(k) were that it in geographies. ex that the that to drug able customized this KORU followed those we U.S., first On will very deal, file commercialized So by excited already for of top a in

commercial centers And represents new see potential. the opportunity. to as very growth. very, incremental for excited infusion the an overall being opportunity just near-term area A that about continue We

report on We hopefully our and quarters. focused the have more in are to several coming in pipeline more that we

with Capital. next comes The Alex Nowak Craig-Hallum from question

lot the core Maybe KORU. But a XX-milliliter I've up business TV about ads to on a for around We've follow prefilled launch. lot seeing of recently. I'm CIDP curious, the spoken been

have thoughts seeing What we of we there? a So are your thought? in market maybe than that are part the would bigger uptake

Yes.

of total total our into our about of account SCIg currently, today base only penetrated would about So base, is therapy. and XX% user user XX% CIDP for

to of all of focus convert SCIg major the to a is players therapy. them this from SCIg IV So

of XX% these that and With the convenience, about very prefills, the patients advancement doses prefer large require. the of because of they

This grow that XX% is to XX% in penetration levels level and would similar, PID, to are about base. a it significant that that we patient for in penetration see example, take opportunity

significant to asking So they reporting years customers, area in to with growth. therapy. and prescriptions IV our coming subcu overall, speaking CIDP the And in coming daily of go to a patients are doc being is converted from

opportunity. overall So excited very for the

XX-milliliter whether So very to PIDD prefilled CIDP. helpful, or going certainly, it the is be be

that KORU makes do get with for What their to Japan? you ready sense. help to Takeda total launch So need in

the An by approval regulatory bodies.

this We one. for have waiting been

It's going to helpful. be

Yes.

know, you So some that we file time. as submitted

commercial that continue discussions to pharmaceutical the progress of for We with all partners entry.

regulatory just is it's So what are we a we excited, and approval need.

it. and a even just -- and mentioned new Do already times. up Okay. what for new XXXX? until Or Three X in then more that been collaborations question. then that's now? of collaborations not far couple we've was remarks announced a more Got total so the X one clarification in prepared mean you than

Yes. would in announced. include are feasibility, work to into generally innovation a in them total, go would X already what on That of we've agreements. which pipeline. with is, involve we start clinical I the And that do approvals. of the trial X These already then lot many XX They say the have is

of what our in do hope to lot guidance We exceed X a on the number, there. right for to we're that So But number. counting X work is now. obviously is but

obviously in couple of of So the here. a have those that months excited X way we out of

Yes. And good be be think, lastly, sense. building should strong XXXX, I XXXX. very a should and total year then a Makes up into, it just

XXXX we look the that's Japan above start can Takeda for longer-term in is to on the growth like put get the what rare a core the Is XX-milliliter Or the you disease launch, could the what growth? business, view If realistic KORU? launch, that? prefilled, provided together Ig the number growth longer-term

coming addition areas just that the that, I in successful say, looking right? all continued key in I would would 'XX share out on we're gains our And the named say goal to entries, in you NT U.S., market, which laid the progression thank Ig you here at, into off 'XX. all shots of X the of strength because commercial and and I today,

expansion driver for incremental then that's become internationally, us. And real a

growth So at 'XX what a believe numbers can looking overall, we're we for is bit and percent XXXX-plus little our be stronger.

the missed new to only new Sorry, thing I was Those add share that perspective. launching products products, gain obviously.

Cronin The next Genuity. question from comes Canaccord Caitlin with

Just does from to start off guidance, with cadence that really imply quarterly margin? for perspective XXXX a what both revenue gross and

I'll Maybe Tom handle question. let that

Sure.

Caitlin. things the we the X yes, you in are impacting are look, there's would business can the and the lumpy, So thing and on second of were margin, mean, And increasing performed ramping year. typically throughout our don't by And within year. half side, have that, expect new quarter. and you that, launching we model revenue the know, as the guide is second facility. you Therapies But up some quarter, that as revenues the the up say of the say gross revenue type typically gross facilities products, I when do margin, terms that inefficiencies I in And Again, is rather new is that's reflected you of first you side, year. we're of manufacturing a Novel of start half But as an I more can that's increasing on would is you out. And the milestones then core completed. work that

growing see at ASPs And we the than U.S. a then generally And also, in with are that, lower are those I internationally. market. what say, you'd would ASP

a say, in QX. time gross up a in of So a you I that would margin with then all can the little line bit be drop mile maybe in out of pretty back would QX all, and bounce consistent

and/or Caitlin, new Tom maybe prior We people the our to consumables year patterns. new add that switch generally only quarterly so that additional say insurance, that have where by expect we'll get and stronger to a new what would follow QX, revenues typically driven providers I is would would pumps And tend thing with to had you provider.

been press noted and on are supply that then guidance? you them these margin in inflationary that time in chain just release, gross these are have And you for ] on or again, pressures some the pressures knew if [ the new are just the going

combination. say I'd a

there. As gone still you away. has not know, out It's inflation

our And so of of our quarter. renew some also, new contracts, And first anticipate we and still our pressures a vendors. in we budget typically, the pricing completed some they from just lot

increases we're there working some renewals So are pricing that those from with.

Operator, further questions?

Instructions] Our with [Operator question comes next Piper Bednar from Jason Sandler.

if to first in not wanted on string growth at such second that acceleration into rate around things to have question mean in up you a we're a follow the it large 'XX. bit half, would an some unpack half looking cadence, question have Caitlin's a hopefully comps just more. heading rate 'XX. I seem on, should together second there I first like your around items that but acceleration maybe step-up few a touched been half, I half versus that so the maybe growth this with prior year

on Just little a higher. those has bit points question, 'XX this that of the way was if that we gross a that Are margin a in chain about your So your there? ticking right gross like on thinking have trying the again, downshift Caitlin's contemplated within costs are side? And Is to do bit margins to little plan? changed. understand incremental it Or how need to 'XX those you're I to then, is in Tom, plan? anything guess, it there, think supply -- about

Yes.

inefficiencies mentioned, off that we margin definitely it are gross up as when with start would So creates to there site from say were Again, trading volumes that impacts. you're line, starting I of the topic. as that let a some the the on one just other. new me margin since I onetime you production do gross

after piece sure. year. And periods I So of your will revenue this then one imagine terms question that future itself around growth, the in just in that's would resolve

We will see uptick see -- as syringes quarters, increasing, the and prefilled the will over we we will upticks. see we see

that year, drivers Japanese -- included approval revenue. back will half see the for are there of are and our expecting we the also help will other some market, which We in the are

year. add thing even Therapies And back-end revenues on we a in will only more be what last loaded the They carried into anticipated the expect maybe that other is, Novel in would not what can to carried year, you the of year. this given cadence we I because as Therapies this as Novel year revenues throughout we our

Okay. affect today, you your but All body, don't that or does to BSI? to to for Apologies your in When additional it want PR it, been an it's right. your what this Does mentioned at is an tell sell business? anything it approved from important, or in Got European that ability again, on I update yet. hear I could it. expect European to hard notified shift from not. your gears. think be if assessment touched I market missed if mean products market? it because, you there do get just all Just report

question, Yes. No. for the Thank Jason. you

me start saying the sale by let are EU. currently So that in we certified for

So -- in our zero They were year, annual through to which BSI nonconformances. in, in no process. there. auditor. recertification They February, go Every had you is issue an were we

manufacturing our in and quality awesome that's So systems.

our that questions on in file technical and file had was response March open them had with the to come of by That we been one to we and file product, had would XXXX. We closed. submitted BSI, they that informed recommended one that was back they or open

saying got surprised our and this file. product that were they to quite were report this not one week we So recertification technical open last when recommending due we

with resolve coming came an appeal, back acknowledge appeal of as cooperation this have we in and We that evening. and received they launched have They expect them the that months. to last in

in market. our little expect interruption in European sales to no the We

continue certified, EU. and to products Our in sold the remain marketed

the so we're to just best again, Linda, I what's And case, there's Or accordingly. it's I out but case what's throw like just like that Or de don't we worst we want minimis? worse whatsoever? prepare as prepared. so can back impact here case mean, come no and

Yes. Great question.

there is interruption that no is case best So all. at

we situation. well that continue sell. We can we in this market, product to are have through we -- the work Any

we which feel say our prior a worst them their not be So we've their they case. would appeal. us, why I not would appealing. that's accept given worst I stand are -- highly case is best by sent that's Again, unlikely to what do and communication that's is And what they original we're case, that say, on

I us that, then we in some time say, months take several can feel resolve it file. take We we on it several them decide would review the But resolve, to if they to uphold it would our end may to feel months.

probably X worst-case all in if I several products. of supply. of into would of take nonsupply Europe scenario cap would not months that those say, So months impact, would I you at the be things

the concludes for question-and-answer like conference I session. our closing over would back turn This to any remarks. to Linda

look and all XXXX, we great In to in and to just you our forward team XXXX. of want progress investors closing, say KORU the thank to the you I in for Thank a to continued all. year

The conference has today's now for presentation. concluded. attending Thank you

may You disconnect. now