PODD - Earnings call transcript Q1 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Insulet Corporation First Quarter of 2018 Earnings Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. And as a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Deborah Gordon, Vice President, Investor Relations and Corporate Communications. ahead. go Please

Deborah R. Gordon

Good for James. thank for you Thank first afternoon quarter us our XXXX joining you, and earnings call.

website. are President Officer; call Joining Officer; Financial Officer. Vice today Patrick of and Chief Chairman me this quarter is replay Chief President on second our Shacey quarter and Petrovic, and archived our also be section results in Michael website will and IR and Operating press release The full-year Chief guidance XXXX Levitz, and our discussing available Senior Sullivan, Executive the our first and of

we SEC. inform statement. during and all statements basis. percentage be materially earnings referenced Before be year-over-year cause Such company's With filings factors first begin, call and that to our include such on I any call of Pat. risks turn from course different changes Safe that, the over quarter and to would unless in may Insulet may those results you Harbor and by known dollar the in a results and forward implied that by looking the commentary statement like involve regarding Also, actual made to this future be certain in otherwise the release will our unknown I'll with financial stated, uncertainties

Patrick J. Sullivan

Thanks, Deb, good afternoon, and everyone.

detail Chief today's with I with then thrilled first are the our the performance. and developments and We'll my R&D then absolutely open on first Officer. Operating and XXXX commercial quarter increased guidance. questions. will and for Shacey an on update company's President Mike and call follow our on will call our After provide me remarks, Shacey Joining Levitz, our quarter Petrovic, CFO; opening results Mike milestones. am

in addressable of These issued States. to a roughly represent under prescription United our Omnipod. Omnipod April previously or January, step on In with this XXX-basis-point achieved quarter, key expanding second market significant growth in roadmap, first our and again this milestones on with payer an exceeded accomplishments X. secured a on XX% implementing operating of this year. now drug U.S. another D the access. CMS and Medicaid nearly with expansion state expansion significant In the decision yet UnitedHealthcare, pathway in-network the We of excited manufacturing had a four income our expect coverage Our quarter We commercial CMS the we by we X, time Since XX%. $XXX and about the history. entered covered guidance continued to million, go are FDA market, QX release year positive benefit to initiatives, in strong on namely, Omnipod Insulet's XXX,XXX to U.S. who of our impressive that program. to XX.X%, half of DASH momentum in easier representing Europe or improvement. plan margin XXXX direct our we for And January limited no Medicare the providing year-over-year and Part progress to little the July This made growth gross largest facility, results revenue building year, in to our first coverage. achieving provides achieved once submitted enter market Omnipod in We market access the access, innovation be expanding approximately market may secure the pathway first executing of function also of individuals of two strategic expectations two

production we significant our begin XXXX. assembly for Later in will Massachusetts. System. have also install and will building facility of as you for this DASH our highly equipment we In we'll headquarters. Automated Control progress insulins As global automated This products concentrated our including our our in exciting serve manufacturing, as know, the early made innovation company our Horizon, platform state-of-the-art in serves the pipeline, facility and year, Glucose new Omnipod, in

operations fast-growing Europe, toward further We serve a achieving base only target This this overseas, provide our importantly, operations XXXX. lower but existing in are gross redundancy meaningfully investment margin support provide incremental rapid cost. XX% our and direct to on margins. transition produce making gross and to Omnipod at our our improve will better In in track to we're our to customer capacity our not to contribute growth European

the Shacey to and planning their will for made distribution and smooth expanding. been thoroughly transition to in confident and diabetes international is the as with X. will control transition, transition. spend drive, global and large this are July am growing diabetes on the of passion, They've go I'm time you we this for know, I our their With and absolutely traveled significant a progress year, past our execute systems And Europe I impressed of experience. market our years, we be team. all Over with have We've rapidly size Omnipod. of tremendous

reduce still never Mike. are to the Our above-market our for lots world I'll significantly and around our to In XX% beginning of and the the the we call grow of have more the billion run. on and the gross confident year, lives we room future achieving ahead, and more the around transition bright mission are our been to profitability. the vision even Europe of turn in people diabetes. the burden now Michael? improve QX lots is world. my with living outlook margins, to We've adoption in focused over meantime, performance With XXXX $X revenue, Omnipod of of confident we just targets and of our strong

Michael L. Levitz

you, Thank Pat.

pleased in certainly and to one significant of quarter through financial am quarter walk guidance. progress Our I and was full-year increased first second results you our the

on and across International $X.X markets. growing quarter first that and momentum States growth based our was by revenue customer XX% by in guidance Omnipod of midpoint base the performance our United of our strong Our the driven worldwide exceeded million, and continued

XX%, totaling million. grew approximately XX%, $XX.X down revenue was Omnipod International U.S. million. grew reaching Specifically, Drug And $XX.X $X Delivery $XX million, Omnipod million.

the XXX have our up continued by mix in in and ahead to This points offset expansion gross distributor significant part increased margin margin due sales. for margin unfavorable manufacturing to growing our improvement in to we operations, increasingly primarily quarter basis reaching due That's supply in is make faster to chain that are gross confident expectations of full-year international we XX.X%. improvements gross the objectives. and our Our

$XX.X and Our in totaled $XX.X That's from expectation. with up our operating that's expenses line million. million

profit and we That's very was in assume As well-positioned, a reminder, are the to the investments manufacturing Europe on for our change a capital The expenditures We on in from $X and outlook. I improvement update breakeven in July in with quarter which quarter, for at will operation. the plan million our quarter, in in well-positioned, supply operating result quarter does as XXXX chain operations activities with positive support this X. used commercial year. ended and, significant beginning EBIT $XXX line objective net XXXX achieving include of for XXXX cash of million result (XX:XX:XX) you and now quarter, over last first also year. was of reflects investments. our million our The of cash to we first had the $XXX primarily investments the in U.S. our down of the end a the the

our XX%. raising guidance we represents a $X Omnipod total our strong We revenue million We product That year, base given Omnipod, are On expect million. For XX%. we with largely reflects now million, momentum in our overall. of are the $XXX million, of our growth range to and wins by revenue now company end that in low sales. million recent of access by of to associated XX% the the low increasing end commercial U.S. to XX% growth $XXX raising expect growth $XXX million, of revenue confidence basis, revenue for of worldwide line full our representing market to the $XXX and $X customer

that XX% of confidence we to up $XXX revenue Europe, from And pricing guidance of and more on For $X represents pricing billion. low million execution, note we operations commercial of end now our distributor $XXX direct historic growth million capturing growth our user value includes is from end assume in exceptional Omnipod, midyear. XX%. XX% Please International we raising also that by to revenue approximately expect are as which raising the in that this growing existing

XX% Drug For now of and raising the are on to low revenue expect to of our $XX end Delivery, million $X by represents we based the from Amgen. XX% decline revenue a million $XX million. That of forecast guidance

of XX% of of expect to million. to second million XX%. to growth U.S. a million product we represents $XXX the revenue On For representing of expect That million, $XX growth quarter, $XX.X XX% line level, we revenue XX%. Omnipod to $XXX

to expect growth XX% $XX to International down $XX of Drug Omnipod million, revenue to X%. million, XX% million and expect million we revenue Delivery representing We that's $XX.X of $XX of

to moving margin. gross Now

We are basis of that driven midyear. year, year confident margin continued over XX% improvements XXXX assuming to reaching increasingly and European direct full-year a XXX gross the in points full our XX% increase partial will by and for expectations between operations operational impact

European increase As transition. drive in we a XXXX that with half midyear in assumption expect of direct stated will based gross run operations of XXX-basis-point on margin the we the our previously, coming rate

percentage exciting made full-year and success we margins reflects This range. sales direct XXXX be starting the to this the expectation infrastructure another Insulet. summary, Finally, we that to the middle low-single-digit year, are XXXX excited tremendous growth for our out tremendously year investments pivot in we year and we've of beginning operating European this start of the profitability of reaffirming is operating of European In assume before to in year. are

expectations are for expansion delivering and margin of year. operating we income raising the top on our our growth, for guidance We are significant line and positive already

reaching forward us. on updating started. and progress are the getting just our confident We as execute We over and we about exciting to revenue growth I look before on we will initiatives margin call you our the XXXX increasingly are turn target Shacey. now to

Shacey Petrovic

our accomplishment. execution and am first I Thanks, of incredibly team's Mike. continued quarter proud

will is another indicators exciting Our financial that performance year. just of many XXXX be one certainly

customer commercial drive robust revenue and continue growth. base Our strategies to

growth As revenue. are United year the of base strong XX% in States, of our to our expected a in with reaffirming and end result we expect the to full year, finish our to guidance of XX% high base line we customer the customer start towards growth XXXX

For our XX%. we grow customer XX% international expect base, to to

We our key making on terrific commercial are headway initiatives.

for third, preparing as for CMS's standing people operations. up their European launch and the with access Insulet of and UnitedHealthcare's for market access. decision are wins of both for plans. in-network market these Insulet an our and diabetes provider for importantly, Starting covered by with who expanding most Medicaid members commercial inclusion incredible DASH; second, First, Omnipod; and, coverage are

agreement UnitedHealthcare went April X, great the have already future for sign into of which begun see growth. We is to a the impact revenue and this effect

pull-through is Medicaid this covered X is indicator In continue sponsors working of D addition very efforts, Medicare their Securing access D and it. state secure carriers paying in are to off the to and availability of to access, that progress strategy pleased be as from I leading will a coverage great access with sponsors, our Scripts all establish widespread Part benefit benefit news Omnipod who we have to reimbursement secure of plan plans. recently the On April early can included to with diligently our all am year. Magellan, a exciting we ensure broad share of Omnipod benefits so individuals Express added effective XXXX. our for two with to plan these to formulary Part UHC Medicare Omnipod

upfront quarter, value these lives Omnipod. with compelling approximately resonating because proposition. are low cost, coverage they plans X a Omnipod covered past million position, Our for we data CMS's and decision coverage strengthened Medicaid outcomes our strongly This Medicare demonstrate adding

model, expect with early will revenue the to financial our we Medicare decisions Medicaid all this revenue benefit where given While and are decisions true beyond. with year these drive impacting recurring XXXX modest delighted continue we and

as our will continue you to on year progress unfolds. the We update

DASH. of our efforts, filed XXX(k) Pat the innovation product, FDA this earlier Omnipod for as our next-generation to clearance with we year, noted, Turning a

We as review in with on we're and track their working with our progress are limited market second for the of the half planned this they release FDA year.

their allows ones, allows caregivers quick the positive our Horizon Control our smartphones, data dashboards, presence users a and at firsthand, test overall accessibility the including user and of of market which at the Omnipod use outcomes the ADA and history since Scientific for in This abstracts an developed year. DASH last We will population June. it to in across XX DASH clinical data opportunity users app, significant for been in excited their loved age significant experience. from functionality Omnipod report allow engaging user which notable user This ADA, DASH have at accepted. will our see largest experience settings payers. have to our with longer to app, From Omnipod their provide clinical confident for received Glucose groups. showcase on Insulet's will to resulted Several Podders VIEW in has tremendously which product free-living year valuable from improvements we're at interface of and also an Association's easy view Omnipod Omnipod will Sessions Automated and in our System, ease-of-use individuals input perspective, we presentations our with We and Diabetes advantages. DISPLAY examining groups for ADA debuting research all feedback American DASH are data design,

Additional Omnipod, Lilly well as System our X collaboration in international Omnipod supports from presentations and data U.S. UXXX benefits multiple the with use as to both the Eli with with diabetes. that type further include daily data of patients injections compared of the examining

business our doses revenue Neulasta XX% new Amgen And attractive at its ago. is July be area be sold, Omnipod that continues exited kit transitioning users its could transition two three recently just Onpro of our line, Neulasta to our excited an of adoption we adoption Drug quarter XXXX more stream. XX,XXX away. to since kit U.S. remarkable And under its recurring to of Delivery as to all noted, years to on short we fastest-growing anticipate our This finally, operations not in Insulet launch Onpro Turning of months first Amgen the and Europe direct Europe over for just sales product our X. provide

focused strategy. am our of laser absolutely comprehensive and are successfully care confident execute seamless thoughtful continuity transition. leadership a team will We on our talented I

team, in with their our the July Pat Europe just with week. I competitive landscape noted, towards preparedness some X the thoroughly As was as leadership move and European spends spent of knowledge there, time we transition deep time frequently of last impressed team I their and our them date. diabetes, state

attracted the this was considerable industry, of and by have and in our talent I struck expertise top group. We passion

our We almost hired have astounding people years team. we X,XXX and now experience have Europe, Insulet XXX an into diabetes on of

European the our and in Both product Teleperformance to morning, having care, we specifically. support outstanding full logistics distribution place, partners providing local customer device our team help will space and addition In support diabetes community and customer this with in companies histories leadership the and experiences announced partnerships medical HealthLink. These in services. have strong European

announced provide Nordic which and Theras with full diabetes and also experienced distribution the Infucare, agreements both in in Omnipod Italy service of Group will distribution well-respected and highly also We of markets. are companies that Nordic

country. With throughout each we European our we levels these place for support and important our Insulet believe go-to-market team and geographies, partnerships European have in optimized organization to multiple the strategies functional

a in team's well and for have global continued very period execution a infrastructure strong time. We of positioned tremendous pleased I'm with success. are accomplishments our built and short we

on that, With margin value long-term the us cylinders growth, significant our half will are Insulet's in achieving strategic of all exciting initiatives the We call growth in this our and major global footprint. open year. the year for operator, throughout creation. with launch the of and second profile confident setting questions. and up the dramatically of for expansion change are These DASH, continued firing and let's milestones

Operator

you. Thank

question Pasquale comes Guggenheim. Chris from with first Our

Your line is open.

Chris Pasquale

on just on want the guys, quarter. follow announcements. Hi. up the European and to congrats I Thanks,

week to terms the months? are handle couple infrastructure from the hear expect in you What of crossover you to direct? of we in You've should else the of place the a Where laid in to here. having in next past partnerships out couple

Shacey Petrovic

Yeah. Great. Thanks, Chris.

and on the I are great Where we're have that some infrastructure place think in we doing as and executing July now business work shape. assume we're is ready in intermediaries. to still of the We X.

as distributor. intermediary. goes work a these business with reminder, through current this XX% Many of intermediaries So, than of just our more

serve But in have patients have X ready of in July doing go announcements that and process that team with of So, to do these one all inventory we'll confident our the intermediaries. sort of We're product as getting to have about intermediaries that now in Obviously, place. able that Europe X. place we of in scenario. well. effect, to serve be in patients July we're the of then the just in We be we out going middleman we'll contract as sure made and those to all to make starting have fully

work the now. underway that's So that's

at on this that or feeling of really and confident increasingly ahead is point about track transition. plan Our we're

Chris Pasquale

just pieces point? on you've of the in reimbursement, there's your then recently on an covered us the total at update Could wins with had. U.S. you moving And one give of a Great. lives lot this just some

Shacey Petrovic

don't I have that number handy.

you impact this follow Medicaid, mean, the in lives starting something could now sitting number XX coverage really that's the know Medicaid on. we're that's commercial, around think And the But though. market. patient million quarter specifically when general, about now already starts decision, we already the million, for think and I particularly largest at XX payer this as said, is commercial will in covered I for with I in just I shipments we've that of example, month. our to UnitedHealthcare I a make great so up I we progress, lives. the XX% new made an broad tell population, have don't about with

Chris Pasquale

Thanks. Great.

Operator

you. Thank

Lewis from with Stanley. Morgan Our next question comes David

open. now line is Your

David Ryan Lewis

think related a middle about that quarters? Good the of as in Medicare safe afternoon. momentum United, it How quarter here year, of can quarter next delivered in right describe the the performance U.S. you I start with sequentially? here wanted what first think would is guidance question dynamics you Shacey, this you first the for is, of market. then to Animas, of you I over as And build on assume to the couple market sort the

Shacey Petrovic

Yeah. Thanks, David.

that's of market our So, and QX reset in Every in terms due the seasonality is U.S. deductibles our always simply to softest sort QX the of quarter, in just dynamics, just business. in year,

typically so a very it are we've quarter. model, times, really strong of is business effect any our these as over decisions, the with said, quarter said many of And latest a That that because compounding year-over-year. And they was time.

UHC So patient of see X, we XXXX. starts, expect new rest compound already and and in for effect into benefit so the just will went we're to that starting April that this to year

XX% think mentioned and the growth these advantage a in to have a Animas wins for base. you Medicare, impact year dynamics. of the I see we would strong that increasing come to lot competitive from installed Omnipod, users be United the able do in expect people we pathway we're Animas We to We States and compound. But continue obviously adopt the that access Medicaid of think to in still will guiding of XXXX. a taking

David Ryan Lewis

real going soft much. you're on here. is on makes jump updates Shacey, have to fourth those, I queue. pipeline back next think I'll just sense and and couple clinical timeline months And, of still commercial in quickly, in update so potentially quarter DASH Thanks a Horizon the Any

Shacey Petrovic

Sure. Yes.

that. track. DASH, We're So, excited very we're on about

great take Obviously, or note with we're doing and to right. expect a a release the six-month two to of things that. summer, forecasted us the into lot we One, the end and we the mid-summer, market that watching have sure this to year. And on market would planning team be this we've limited new just learned we're – release our planned get into successful for to which I doing a the sometime interactions going a launch. for to based We and limited want right others make think launch, probably by about all launch we moving this things it, But technologies market FDA. to job is one late

accelerate the that. take do to time to going opportunity that. we're have to always But So we the

last move So, if plan, we that of others that any commercial market, than again, it launch everything launch that months I'll at we for for differently into in us is to get point and in could product into make the model. this three, new certainly business going it because four works The point. does is

off going us increasing slope not a piece This equipment about are the we and of it the again line to the right. sell impact bat, in of – is doesn't don't new that patient have So we starts. capital right

back And that a if is we age Horizon, to quarter updates We're revenue. launch materially have about or at and compelling going you so I some quarter, Horizon. in asked clinical on great move launch So, it doesn't I ADA down up really a the settings data think X. think move then impact about to very excited that the free-living

be there with that we'll the IDE So our is really community which underway. X exciting progress sharing currently on

Operator

Thank you.

Our with Markets. comes Capital Joanne from next Wuensch question BMO

Your line now is open.

Joanne Karen Wuensch

the question. me hear you Thank taking Can okay? very much you for

Patrick J. Sullivan

We have you loud and clear.

Joanne Karen Wuensch

Excellent. Thank you. Two questions.

the is, gross and we that than The bit helping seem one of in to expected little half. a to faster? or first faster first be is better XX% little guidance drive a bit had than your even What your improving XX% margins faster

Michael L. Levitz

Mike Levitz. is This

with So team in be and the operations over thrilled oversight continued couldn't of last our work to we more have, of just improve years, our our is business, that our side number We continues. operations that just the doing.

the product driving And efficiency. driving we've about in down calls past so scrap, up driving quality, talked

those of true. things All are

then move schedule, out doing are expect base DASH platform. So initiatives the November that with product of ahead to freight, the that laid And also us and us described margin started really and key and air then already mundane continue same and continue component pricing products the have And At freight after from lot opportunities ocean savings. which of do we Day XXXX, introduced have expansion, in us. – we are to what component drive our with sourcing. to improvements the down of driving that. We platform the that to and of other continue through a to getting that we from drivers we operations, just of the do I we absolutely (XX:XX:XX) our year, first are Investor expect are or drive a see in is half, move, as and such points significant in schedule, rate that areas year. run all basis this that are all in to to gross improvement margins. things direct here that in expansion move the we those in even too, drive to ahead of drive Europe, enables the And XXX margin those that we've second on The will we'll ahead the gross

So And we manufacturing half-year the of really – U.S. very about in is to going impact program further that well. then That on of is even XXXX. are basis doing things XXX points. improve deliver in beginning as beginning the

have in XX% we initiatives target the there to was of and laid number out margins. multiyear drive We've confident just are nothing gross so And unusual. continued quarter, to of our But execution. that. strong very a It's

Patrick J. Sullivan

and Blocking tackling.

Joanne Karen Wuensch

continue. I'll

organized question my away. half you wrong? of sound What you. one just going very What worry go things international the two you second Thank So My is on can do about? or move.

Shacey Petrovic

Yeah. It's great question. a

distributor, like? I instead July would and current our and and we every perfect market. what every body flawless awareness a up We and know X, of another every throughout ramping would channel down and have look perfectly the does perfectly think we channel. would Insulet On clinician supply call what be execution – patient to equally ramping government one

of what some But we road going that think the certainly that everything would be we're we about drive that that us, it's I happening of that of in very to and none our that we're up happen are that reaching what's market. as I now government doing we're is of I And just in a really bumps making But – less that to in to me the intermediaries really sure so just the program there's and don't program. on goal, and the such as talented that's create plays and us but this know keeping patients, clinicians, guidance, do on execute that. us make to awareness hard understands built out. and so, experienced we're the sure everybody to certainly assuming all confusion July kind to and X they in think understanding and marketplace a can out happening know lot marketplace, awareness this say helping bodies successfully as call and team, obviously, the what's we've needs then working serve

Operator

Thank you.

Ravi comes Misra Berenberg. next question Our with from

Your line now is open.

Ravi Misra

you the questions. Hi. Thank for taking

couple Just on installed of questions U.S. a the base.

You're that coverage decisions conversions. end that the or, Medicare benefit that any new attrition or especially adds I range guiding I'd rates? patient to the patient with high to the some XX% given. this or mean, you around you've understand at from dynamics to how that XX% the like of attrition, of analyst Are and seeing translating is early

Shacey Petrovic

Sure.

U.S., So, in the at attrition steady has remained fairly about X%.

about wins Medicare, don't these that early X. hasn't really, And think and UHC April UHC even wins Medicare when into effect effect until So I April number, go around materially think into we've and went we and changed. that shared X, these

terms beyond access market most is We we they likely will starts, on of that why And a be so of it. in say attrition. We off impact know that's attrition, and more to that lose XXXX know impact. and installed growth, base of both access because the product potential new people patient the to impact do the trade benefit,

successful, patients XXXX. these retention Medicare sponsors, should a our in And starting implementing we on impact we very that, expect that see so, coverage D plan excited to and nice we're be, of with Part fully if we are in

Patrick J. Sullivan

new as starts. well patient As

Shacey Petrovic

starts. Yeah. new And patient

Michael L. Levitz

And this is Mike.

one and backward-looking estimate, Just it's of much because in talk and many other we point to is a how goes ways really when through about clarify, is distribution our customer it base, channels estimate.

these that they but But that so we contributing, to or And momentum. see we seeing benefits, are be tremendous right won't a may out of now. go lot report already

Ravi Misra

follow-up of question ramp business. the kind just my around then, profitability is of And Thanks. Great. the

in some the broke You profitability of operating to that the given second this there phasing kind support How we to little investments the changes think a like I'm year. quarter? this a be for that XQ guiding going to is still digit assuming of the account investment coming Thanks. even quarter, in nice extra or made might of or low-single about Is of increase perhaps for be where be kind should those the to steady expansion. profitability to in – European in Europe? going margin

Michael L. Levitz

a great question. No, it's

the to making We second we talked us, that because full interesting clarity half, an last our this investments up is how give team. of on now the One guidance, those for things we're about call year. going call ramping around year it's more on is last but first gave because I the impact half

Shacey As described, through We an lot people. ramping up coming Pat the coming recent and here those we've amazing XXX described are But of year. are a built team. have they're – in now and and

So to The expenses have by without through the run second rate we have the get the that benefit. third quarter it. we in we'll when quarter beginning benefit the time a of correspond the sales comes really

about for points so a going the second run year, up the step so talked year. on to do the we margins full of the And expect I half half the a to XXX gross year basis, year points, see impact. XXX basis change basis of first half from rate

everything exciting We've realistic that transition. we incredibly we've the that we're to as change because built a do on guidance guidance good made we there meaningful great small have indicator is a not is So really when a said, we goes assuming our really good The next expect we've is do one. one, gone an perfectly. but The is believe, how news that Shacey we'll provided, be as transition. we through this. this a step the call progress, It haven't

is continue everything we're progress. forward we now but out we very right to good. will looking report to to looking as you make that, But so And

Operator

you. Thank

question with comes next Our Kaczor Blair. from Margaret William

Your line open. now is

Margaret M. Kaczor

the Hey. guys. Good for afternoon, Thanks taking questions.

through patient start some other steps you are that these already are or First point? one of and on for patients Medicare a Can just Magellan. follow me by to and on you two, those billing seeing for any us are covered is up whether Express what Medicare of sponsors there adds you percentage give sense Scripts at Medicare go to have to this for

Shacey Petrovic

Sure.

think, XX% quarter's you may remember plan of the from top I account that call So, sponsors eight for population. last the

provide, have top I specific eight. a don't It's Magellan is not. but I is one numbers say little I smaller. those ESI that bit will of that So can

nothing So, ship starting these need there Medicare patients great through do X to Medicare plans benefits win April to and that of providers access more in with we for their to and patients both have is these these started now. we Omnipod

So very see starting off, though. pay benefit early we're this days to

Michael L. Levitz

impact Mike is because would meaningful – is exciting pediatric of and for that a is bigger add us I probably us. just And Medicaid this population. for the really – Medicare

increase And wins – in are so really Medicare after speed really those D they getting Part decision. the

side And probably on revenue a so patient the definitely us that then. said, as benefit but new from going in again, is standpoint start that to Shacey beginning XXXX,

So, a lot of exciting things.

Margaret M. Kaczor

that How to just follow talked much of to XX% throughout And XX% it on it. Thanks. on Is Got year? the UNH? lower the adds that having go the end end, and could to in Medicaid discussion. you Medicare, up as And higher it high really, by customer XXX driven midpoint and from being guys drive that U.S. the or that you of the bps higher on new what about is

Shacey Petrovic

Yeah. Thanks, Margaret.

which XX% the So – will to we installed the in clarify, XX% be base believe, United is to XX% growth. just States,

execution, point contributing just Medicaid at UHC cetera. It's for So excited growth. greater base to than access progress overall are primarily new that a patient significantly that's I that. and the that, say and about UHC higher contributing Medicare this – are installed then and but degree. attrition commercial patient accounts And et are clearly starts that and that, so awareness, wins to market so wouldn't actually very to just

Operator

Thank you.

comes Partners. next from Leerink Danielle with Antalffy question Our

is open. line now Your

Danielle Antalffy

on so and bit contribution Good a raising from the a perspective, for seems the I going of growth guidance another to contribution I in the guys. more more direction being one precisely and the I like XXXX. Shacey, right line wanted be appreciate top yet taking have meaningful. think But Hey. QX question some them. UNH will you if there congrats of have that Thanks like see saying much afternoon, lot It little will a beat, we feels you raise. that could be by it XXXX talk momentum in quarter. the you're to solid about just

the I sure knock to feel be want to an why from why the feel outlook way of now, make wood? all perspective going So about year on right I understand rest – better just not we that given shouldn't seems your

Michael L. Levitz

Danielle, this is Shacey add Mike. sure your I'll start, will then I'm additional response question. to

guidance lot that's really so first guidance you guidance and follow that. practice, change practice to In that, don't we the a give you generally the so the quarter. whole our our specifically, for our when close quarter, been to because the the And year come been we of speaking, it's terms first in

make of it's from clear. we've business, to very if the are, the we well are, capital. it I not abundantly players across But think stream, of Things get do now. think going tremendous we seeing they really incredibly In upfront our I XXXX growth. not one-time are wins. the made, as U.S., we're revenue and exciting. we They're statements a don't need in much because other look, clear wins space the these They're from as some wins have recurring it the

it spread have We years. over

of terms guidance, the coming with big Europe a midyear. overall have transition In we

on to – to guidance outcomes it's that's of be but report our to and need so, And reflects looking We're going looking, how time range there. right back wide period short a a we what, very know great able it. now, in you execute of there's

raise and and first guidance guidance that's made Shacey? than similar the read reflected last anything we year the confidence other So into quarter I it. raise in it in – wouldn't a our so what's

Shacey Petrovic

color. add bits – only I'll of The Yeah. two

is we ago. new alluded given growth in installed in significantly are year a drive script, it's as first the all business as a will versus what just That's right, the this But model, about year. So it's patient up is, say, revenue always our the our to quarter I growth. starts base

the showing clearly could our time about wins metrics. in we excited business potential United example, they're momentum not access offer, over model. and the be of and the because these the and that for So agreement, more compounds just But it

Their other serving no it because serving business were win. a The say that are there current because was distributors noise is the directly. of bit this that longer market the business that in United of we're little thing serving I'll quarter

inventory to that's account bit in also we so little headwind that of or change. a And the And noise them saw for market. reduce just their

Danielle Antalffy

that Got your it. I talked new Does CGM That's – Dexcom you if guys time actually question, project, in products? potentially great who on talked about to have color. Thank the so started about for with Thank has has what integrated much. Horizon you AP Do at their products? and any conversations so market And obviously on pipeline so view follow-up faster for on mean could, some FDA Horizon that much impact your partner insulin for delivery Have CGM having all? is that, you sense, product. you could guys. one the

Shacey Petrovic

in Yeah, creative, to really and for the agency, around Sure. with we ways both did the Dexcom these participating the Danielle, applaud to iCGM are agency we accelerate finding exciting in discussions they enabling with the others innovation designation, market. what It's faster interoperability this industry. and

of those. we're definitely So part a

Dexcom, in how it's that with looking think of forward but too impact really any capitalizing those that I sort on share our can. partnership way we soon and a development programs to might little to

Operator

you. Thank

with comes from Robbie Marcus question next Our JPMorgan.

Your line open. is now

Robbie J. Marcus

the Great, XXXG a for the taking launch the J&J and year. and exiting of one early maybe past in the and year with last really into question. We've year thanks Shacey, had lot to over this you. failing transition for market business

where us growing has general of the you in market have So shaping you think and up maybe you could sort sort the how been what you think think and in you of U.S.? now the market's tell share

Shacey Petrovic

Sure.

but our tube So, we it I kind don't sure of too, to look time that competitors. it Robbie, really other I our team not pumps every say as I'm at say it and gets through,

maybe existing may the growing And of exits anything over are And injections, daily opposed to them market. as the coming vast, they've the we to our business bit players All little people from that and comment growing United base market. given I X% so, clearly still hear our daily market, vast degree. it's not States we a really so when not patients really tailwind from of five from launches we're estimates the to growing but vast is it new And these the are the multiple can where anticipated be years on is a of substance. in us and/or failed an the the overall next how fact other look coming growing that from growing. that multiple of at the are who CAGR from, injections. from majority and the There's anywhere different other is pump on say I and taking majority market X% coming are

transition I infusion. the from helps think insulin as the beauty of that's of to benefits continuous really Omnipod MDI it people subcutaneous

Robbie J. Marcus

And are Are so you going, J&J going all or like capture XX,XXX Medtronic something U.S., XX,XXX portion you to the of able a well? patients to as most they international? the where good do think are because in it's

Shacey Petrovic

can to use I where Animas have know all ensure certainly, to are who they're pathway to that say want option patients advantage of taking going. don't Omnipod. I our that, that still there are the patients

I XX% think true are to coming is I users said this anywhere of quarter, from typically, it our same the new multiple and injections. XX% daily So last from quarter

to Now, XX% to it's XX%. closer

So that that the getting from probably differential uplift is Animas we're users.

Operator

Thank you.

from Baird. Our Jeff next Johnson comes with question

line now Your open. is

Jeff D. Johnson

Good Thank you. guys. evening,

the So iCGM even comes only sense back it's you're But, if Horizon GX to out Horizon product, on PMA Is path will GX couple to question approval, going you end get and switching questions, XXXX, just of be in Horizon out integration. and six-month of in any process? follow-up a I a a in guess. that and or way it the GX to And not, there a pivotals. PMA cleanup fast so that if Horizon, into to pre-pivotals to from yet once or make that new would So, pre-pivotal trial? not could move three- pivotal GX whole world GX a what has very have with think to be Shacey,

Shacey Petrovic

fully we pivotals Jeff, expect with So, and GX. into to enter pre-pivotals

Jeff D. Johnson

do. You

Okay.

Shacey Petrovic

Yeah.

Jeff D. Johnson

Thank simple very it makes That you. then.

Shacey Petrovic

Yeah.

welcome. You're

Jeff D. Johnson

on here international change-out July. question the And in then one other just

those that Nordics what a intermediaries, relationship logistics needed markets you surprise guys? and care all a how today. of across going customer to I the not maybe Italy we side any guess, there the direct announced that distributor your a and figure on implications, bit have that does business? and on price get me. there, for is you I Mike, So about actual Just to why trying an was out reason European and fully think up-charge

Shacey Petrovic

Yeah.

able sort we were So, markets. suit and lot great the able the design organization We is as of terms market, the to to that to what models move about very our closer get thing were this in strategy to a go-to-market the But level their the in and diffuseness they're business base. of different myriad of customer of market. very opportunities every in saw different purchasers the we our across

points our through and so and distributors felt position those we two those points was markets markets serve of the on it to based support go the mainly in just strongest like required opted to across we And buying customer them. number number of because

the to was about and it thought those partnerships. excited just we're go, we ultimately, way So, best

Michael L. Levitz

– think Germany, When And UK France, Netherlands the our (XX:XX:XX) French – the we've to is. places through sense using sense. makes recall, talked this representing concentrated is about look again, add in distributors. cost how as care aren't at, that of base talked the you makes that I are may goes we've the base, our The XX% those And that Mike. by what's and places about France, called in past I of intermediary roughly that less as market. as we the going and you that it would impactful just complete distributor also an through defined

so significant our customers on and physicians the reps most So on. we're where the core calling and we have that's to on in have countries that going where presence,

all this of terms has we the provided. been in contemplated that of In financial this, guidance the impact

pricing. historic – that's seeing uplift distributor I in we've reiterated That guidance. everything so, comments about And what for nothing and has our in. we're stated include the pricing is all with – in that my That's XX% from line in changed,

no change. absolutely So

Operator

you. Thank

Company. Steven & comes from Our next Oppenheimer with question Lichtman

Your is line open. now

Steven Lichtman

meaningfully the organization was last Thank guys. you've grow to expect do – the in know how specifically wondering investments several years, this in the the about to over And made you footprint made so, I looking do much in are I U.S.? you've Hi, commercial Shacey, if year, you. commercial so? U.S. you the

Shacey Petrovic

So, grow. we Steven, did

now, if – We we're the and sales inside external of the most, And management based, of I clinicians. that and we both there would full. pipeline. on grew the grew in done expansion I external, of beginning with organization not at think pipeline that year, team we focuses very then did the the total, getting are characterize salespeople we sort or – In internal team fact, approximately all, field team, the and positions is thereabouts. the sales And that the comprised as internal and grew interested XX% by patients the which through the of

well base which as support they as growing, patient is obviously so starts. And new existing our

Michael L. Levitz

that expansion Mike. did made just is we investment. that access this We've the we say expected I wins. these because And would market

the OpEx fruit that have advantage seen of of portion demand. to or the investment driving investment seeing we that some – our and now want access. salespeople that You've we're a the need OpEx we in was of increase good take increased of increase, an market really within to in And

Steven Lichtman

And reiterated for the then, Got on operating or Thanks. it. Mike, side margin you the the year. OpEx

range. million Europe million within that, Is the $XX still for $XX stand-up thinking fair? the costs should Just be we specifically of in sort to that

Michael L. Levitz

for relates clear the be as Europe. to costs to Just – stand-up term you it used

through about run this talk because rate So, The to being to it's year, talked new rate a about I call, direct. an business of million annualized kind on ramp European yes, on $XX run million the last wanted I $XX the of when model cost spoke costs the business basis. of the I will be, meaning,

the into And get really team year. place as in of that we we so, have the middle

$XX costs, And to annual non-recurring I in we year so last that talked to call also you $XX on There some on guided time. costs non-recurring expect be and million I that change guidance. to last is costs an stand see million. OpEx would the of the the upfront about the around business, what basis in up $XX run that is of million no rate

to that and guided track we're doing on relates in what expected as spending but things the year. to or we and we really all either we costs, material for we everything as the well to wasn't non-recurring So, than It do, expected it the expect do to all to doing we're is quarter relative that's the better them.

Operator

you. Thank

Doug Company. Our with question and from comes next Schenkel Cowen

now is open. line Your

Unknown Speaker

your to a to for growth for on contemplated call already remind us will for is opportunity Was preparations this Europe Doug. Delivery Amgen to Can that launch is Thanks in in business stated in you they're Europe. volume big the you their Hi, on my Ron kit final questions. Onpro their earnings how previous think this XXXX? forecast return do taking of Onpro? you? QX in Drug (XX:XX:XX) And

Shacey Petrovic

same we raise Amgen. contemplated or guidance forecast guidance I any have I'll can with really their on the color is of in Mike, if just response you questions Europe of a is, Neulasta, to market insight add And really directed what sort forecast. start for in It our ultimately, So is based and have opportunity But Amgen's the the and question guess in best of you was Onpro. don't those and, really terms forecast from Amgen, it. what into contemplated our not it's

committed about on that the them to with but excited needs and certainly support business their have to their as to them market of partnership, We them enter all they are working we new let opportunities. comment

Michael L. Levitz

Mike. to is year. the Drug were We this on this [Ron] pleased Delivery raise guidance for (sic) Doug, And,

on want of don't ahead just so gave get of terms to I XXXX XXXX. XXXX, In guidance, we us

Unknown Speaker

awhile Thank Delivery the a of to progress the pipeline we end point your us Neulasta. Is any them the qualitative got update and you. by And you that Drug been you least is think more give how partnerships it. we've on it's at progressing outside of of then hear do since progressing? Got will an about update Can on pipeline the XXXX?

Shacey Petrovic

Sure.

to feasibility and we yeah, some have continue cetera. with technical et So, discussions pharmaceutical partners work,

very few very When say feasibility, we've give Amgen seriously, on we've of lot I Phase still we that. get and molecule testing partners doesn't in over a great of and/or obviously, molecules we is we're color these but all will endpoints another now, its many something this continued We And so X, can't don't next are say – confidentiality a as programs. two said year-and-a-half things. really years. think expect I see take in last as in as we year, a opportunity, all along longer-term uncovered. the – these really the oftentimes, through in cases, it's the opportunity, to technical meet the

I And what's think a standpoint so are we growth are that long-term that Amgen's really margin benefit. where expansion from have see these a just as standpoint of forecast. just to potential for programs. despite is longer-term see we headwind slight We them and a exciting And because

you more So at can't we really we'll those keep color lot certainly a point this posted. give activities. Unfortunately, in

Michael L. Levitz

talked horizon time standpoint about of $X the portion Mike. expected that From we never – target Delivery this about, really in revenue, a given to Shacey is when guidance XXXX play in significant guidance XXXX, that. we a talk a From our Drug standpoint, billion

in we nearest U.S. by existing Omnipod Omnipod. that's And term look now, market. of So, as the XXXX, within even International are right a lot opportunities and

significant into Delivery. out opportunities of for the United outside the it's growth the Omnipod So business markets what continues really to States XXXX, for drive and expansion Drug this in are coming the other

the then by described. described the the really and markets, about the is that's existing billion where going we internationally talk opportunity beyond from are So, now, growth U.S. Pat we target and $X that largely when in that driven significant Omnipod and Shacey

Operator

final our from Jayson question Bedford you. with And Thank James. comes Raymond

now Your line open. is

Jayson T. Bedford

for Good me squeezing afternoon. Thanks in.

growth, quarter fourth move, that years. of bit couple fourth a seemed was of just least you there couple in relative Getting the obviously exceptional see something U.S. the seasonality in last that more back maybe pronounced didn't to quite at So you quarter quarter-to-quarter the saw a first the to quarter? Was questions. The the little the strong.

Michael L. Levitz

seasonality Mike. is big this always This There is piece. this

with line no, And that extraordinary. in was anything wasn't all strong. very was expectations. there so, our QX It really

our expectations. we fact, In beat

there of existing the As wins, some down ramping mentioned, intermediaries. Shacey new with was access

Now so But UnitedHealthcare to we're headwind did. in quarter. this large, going an mean, a the have with that going kind example, seasonality. by we of expected That was always direct I be as and

Jayson T. Bedford

way drawdown level? the any quantify distributor the to there inventory Is at

Michael L. Levitz

how and the or significant the $X something I I around natural why But we you our hard it's it for opportunity that's the to us mean, and that wouldn't guess, call I is, million – exactly maybe is guidance just before say that. that's U.S. raised year much a like could in say –

we wins we lost really, United we And from with so bigger are access small much piece a get than because so by the side, that intermediary. (XX:XX:XX) the impact being the much the the than small transition more ramp-down from coverage an direct

Operator

time Thank And you. more we actually, for question. one have

So we with will take Canaccord. the Rose from Kyle line

Your open. line is now

Kyle William Rose

Thank me here. in squeezing Great. for you much very

a follow-up. one Just question quick and then

a given change using or before a intermediary able think whether that to But think see thoughts contracts updated just on basis. out be expect to Horizon, Just the there's how maybe you we these IDE maybe trial infrastructure of you'll profile intermediary in the model the does infrastructure third And be a another in? from on and many operating after you other move then, understand step? IDE then, for use live mean, out? understand expectations help build before to pre-pivotal any if we the less I And quick go you the margin many question versus more of us on direct internationally intermediaries countries I the the going building to the perspective, that longer-term you Shacey, trial, country-by-country have to do you'll you should dynamic how

Patrick J. Sullivan

piece. the take I'll first Yeah.

distributor current intermediaries market. a portion Europe and/or of in good Our in uses distributors the

removing direct, middleman going interacting directly basically, have earlier, that we by as with said So, the intermediaries or will today. those Shacey we distributors and be

and either to XX% from margins. improvement up completely we're XXX well of where XX% Not So you using our other contract the get have (XX:XX:XX), is we'll the are today. distributors end with we pricing through going Mike of going be running, does as mentioned, in through when When individually a in in our that's user of number France, our points distributors probably there's improvement that business basis many you and different marketplace. what them, intermediaries you at look Europe. going gross markets substantial The or benefit them current the as our as

Shacey Petrovic

don't and team markets Kyle, which in of Italy distribution we And, serve any full anticipate Nordics. Yeah. other got so the partnerships, we outside we in established other our

play. is that in of All

we as your ready then Infucare. Nordic partnerships through, on go. any place said, expect we're of distribution work and Theras was rest is don't Pat intermediaries, we'll outside full the last to I distribution And So of think The in Horizon. but question and team

give update IDE too early as with I've and said. an as don't that will We always as X to soon data. reviewing we're I want done comment just

and we're As ready these IDEs, we of we we're move everybody our the into going review with kids, stage all but and wait Horizon. or we're so looks to we see to next because data since we pre-pivotal update done terrific get then And to far, kind or need if into with steps if especially we'll on – data, evaluate the another focused do I'm it on next the study.

Michael L. Levitz

is Mike. this And

your you had Just given to what's guidance intermediaries. answer from a margin standpoint asked the our and about fully question, contemplated

in it's So, support, customer service. an go sales force, our it's but our example, United States, as we through distributors, product our it's

So, from Italy Nordics. of these the the think infrastructure in business, Europe having infrastructure markets you direct two that same apart we're that of the and

we're all what with expectation. is business to improvements – that gross and margin, as now on line expectation being everything doing guided we an those in of in accretive plans a it stated All from is of and

Operator

Sullivan. Patrick back session, so I'd to concludes question-and-answer Thank turn you. the to our over conference like That

Patrick J. Sullivan

quarter Europe Insulet before burden with Thank implementing about living world. Thank the to in XXXX. first very lives and around to and absolutely our our you, opportunities financial our joining the successful like the commitment made expanding go executing I'd direct employees excited look our in of call you operator. with and we their the Look, we market manufacturing thank to quarter facility, U.S. the are building significant United innovation performance July for significant We the will people on progress where We've transition. Europe our the us roadmap, forward access, in thrilled X. for European conference joining call second and diabetes our hard Canada, you Thanks and ease States, on us. improve on speaking on now to work us today. you for to update plan

Operator

this conference. Ladies day. have for your wonderful participation, today's concludes a Thank and and gentlemen, you

You may disconnect. all

Insulet (PODD) 3 May 182018 Q1 Earnings call transcript