PODD - Earnings call transcript Q3 2018

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation Third Quarter of 2018 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time.

As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Deborah Gordon, Vice President, Investor Relations and Corporate Communications.

Deborah R. Gordon

Crystal. you, Thank thank XXXX and joining our for Good call. you quarter earnings third afternoon, for

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

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

Patrick J. Sullivan

a over of our record basis ago. top $XXX point finishing from another year guidance We of at of XX%, We just then an performance afternoon, with Deb, with the quarter the open update third provide the improvement XXX expansion detail on impressive and in quarter am impressed opening achievements Thanks million, of on we'll good absolutely achieved everyone. range. follow XX% questions. of remarks, I the our growth and key our the Shacey call guidance. margin to company quarter. revenue and results achieved my After a Mike gross third representing outstanding end and milestones will thrilled will another year-over-year up and for and XXXX quarter

year delivered $X deliver million and on are also time for track very operating operating in history. We positive first income full of the positive to the for income Insulet's

our namely great on quarter to our of commercial our HORIZON, in of additional next strong I'll her and market an build-out Massachusetts growth, initiatives and on provide to will share automated our in long-term a the manufacturing initiatives addition System; insulin In headquarters. generation we delivery on update during Omnipod direct accomplished system; release that limited update color operations brief of commentary deal will our our our exciting commercial DASH the performance, the these Shacey remarks. contribute key each Europe a

Our feedback limited DASH valuable we well patient market with receiving overwhelmingly is release are and underway positive reviews. of

in very excited to hands new our of this the are have We customers. product

people research on market We been our and BLE automated a team control great mobile program. our Omnipod advancements work our have with team, ago, progress the cybersecurity our I most of joined years, of to combined outstanding feature on the are insulin making diabetes. are Insulet by Based will we phone. HORIZON system compelling expressed technical In Omnipod made in insulin-dependent control years desired has and of smartphone with four last Omnipod phone work four the communications development reality. user's own controlled app development the by you now HORIZON that be an delivery thrilled Since terrific by on inform

it is leap possible. a for be Omnipod, to experience able giant because customer an finally the This product diabetes thrilled community, development market on nature outstanding any possible by tubeless we and Now forward the today. will provide of to the of we not other are make

in operations Europe. turning Now, direct to our

direct to our significant point business. X Our marked inflection from a distributor transition July operations for

rate run growth. than more year to organization great this managed revenue a business effectiveness. exit and $XXX with run of international long with extraordinary in rate The transition speed through this future Europe, expect for million, entire an We and

in Europe existing the had business, growth. to market, past and accelerate in the direct sizable four months the than we've that for our Now we the operations opportunity confident of are further strength more ever

tremendous Finally, I'd begin of and new progress automated we in manufacturing we few the headquarters is like States. facility Massachusetts. made to facility in our company and manufacturing in build a out line highly first our highlight weeks state-of-the-art installation United the building in complete The will nearly

begin to year. We early production are on track next

add growth. capacity needed and will support to the redundancy facility U.S. our Our

believe understatement. year, Medicaid closing around. to improving than the pivot and double entire we margins is XX%; are I and gross is and on established; I'd To this was commercial in and with Insulet to Insulet excited We United forward operations XX% less and of I most focused was the before Since I were was diabetes. direct is Wall an call than exciting Today, pipeline. an million, four revenue; rich in turn significantly wicked in to direct only lives driving to jobs we've And product in accomplishment turn talented When a very and I me very be call a my I coverage Street's four years a what proud assemble and was is growth XX last roughly earnings that States enormous Mike. attracted joined are profitability. to on that Revenues Insulet limited by say losing the very we the were made that has come team and fortunate and with comments Medicare amazing the Insulet company help of retire people and will make have we at to Pod have technology margins team over gross is years had potential. way product finally the like bring $XXX to the the I ago last money. Europe Massachusetts. long are the When significant to manufacturing and access this extraordinarily market an end more the few

the serve. in confident As has future. an so all this to amazing the opportunities and capability that this so watching what they dedicated do look will extraordinary are and that Insulet team team. been potential many has, highly far, exciting there accomplish more forward I'm the amazing ride patients this with of fantastic company to seize as I to in will

faith right years confidence in be For Insulet great me Operating phase over the lead explosive years. ahead. privilege have Insulet the her The Insulet's bright a past and been is has future will Chief to of honor it next and has been four I and to lead an a utmost outstanding leadership. best and great Shacey of Officer the lie She and the reservation, full is person without CEO. growth very

for their the confidence and Board to I'd With Michael? you the and turn for the support, Finally, strong call in exceptional Mike. performance, our to for for Insulet I'll the shareholders the thank like trust to their for of and over dedication loyalty, that, employees Podder our team. your company. Directors all their opportunity community this Thank lead

Michael L. Levitz

Thank you, Pat.

quarter am We to through continue quarter third make strong to and I deliver results and financial our growth fourth guidance. pleased excellent you walk progress and

successful margin Omnipod U.S. was significant Our guidance We end $XX.X revenue Omnipod down X%. International million grew the our Drug reaching at $XX XX%, XX% third expansion, million. was once growth our high this again grew gross and our totaling $XX.X and range. drove Delivery XX.X% quarter of XX% considerable our reaching of million of expectation. basis improvements manufacturing from chain points, drive XXX points an continue direct in basis The XXX up productivity benefit we've exceeding as well cost and operations purchasing, approximately transition Europe. as in supply realized to expansion, incremental to

for to Our non-cash. to CEO expect million and operating $XX.X to related the due million, of a million to which is fourth up we our occur $XX million rate our primarily expenses with included in now non-recurring due which included were line was of charge $XX from our Operating $XX.X timing, spending which million. in quarter. run most $XX.X of severance expectations, favorable Europe, annual to in expected expenses benefits transition, totaled This announced

we $X.X a pivot revenue operating margin successfully of X.X% profitability, profit a our delivering million. significant made the growth margin and As the operating to expansion, result totaling with gross of positive

in for time with noted, operating Pat objective. achieve consistent As our first to stated profit we full-year expect history, Insulet's the

U.S. now XXXX first reached history, and investments, Insulet's objectives. ended update $XXX multiyear end due also $XXX are plants. outlook. for operations trajectory you of net million quarter full We we both strong in for expenditures, a with time and to and in quarter year, for growth over on our with and cash in manufacturing We on invest chain supply income on in track capital compared the the profitability our and our will at to fourth million year I the line as primarily last

of XX% Delivery million growth X%. and million, to XX%. company Omnipod of we of representing to Omnipod of XX% quarter, of representing includes $XXX to International Drug $XX X% million million, of fourth XX% the to $XX million down million For $XX million XX%. expect This to total representing to $XXX $XX.X $XX.X of revenue U.S. growth $XX to million to XX% growth

For of compares our revenue XX%. the $XXX full representing to XX% to outlook million year, we $XXX to $XXX have million a raised million. to $XXX of previous This growth expectation our million, to range of

our This overall. continued in in growth year of revenue confidence range momentum commercial our access base given customer For representing of strong $XXX the million, product Omnipod million U.S. expect we the this wins full $XXX.X line, market XX%. year's growth by to of reflects and

the million to XX% to representing International growth also XX%. of range in Omnipod We of $XXX.X million, expect $XXX

$XX.X million X% X%. we For of expect $XX.X to a revenue Drug million, decline representing Delivery, of to

points. we year-over-year XXX XX% full between P&L, XXXX the a to expect gross down basis will basis Moving of and XXX points XX%, margin now the be increase year

we are manufacturing progress a positioned term we longer objective the to We near-term XXXX. in are gross headwind, margin year XX% have the well our ramp of next margin with we in while of expect our U.S. achieve thrilled And made to tremendous expansion. present

incredibly in year are Finally, the low and as to are we this XXXX full margin single-digit earlier, of operating expectation I year our percentage operating deliver excited reaffirming mentioned profitability range.

drive operating has business. summary, year our investing growth execution and successful high continue Our to annual a is for while to to milestone Insulet. growth profitability, higher successful pivot XXXX tremendous In of or revenue even another XX% for significantly been

on at mentioned, we the laser-focused have time, many As operational, and And we future. Pat milestones financial remain accomplished same this year. the commercial

Given confident trajectory, growth significant and across turn line ability we to catalysts to the are growth and the now growth continue financial to for we our and our I our and operating positioned Shacey. XXXX business our are will income over positive target. well call in fundamentals top delivering current achieve

Shacey Petrovic

growth incredible just getting and we're I'm are I and key share believe we've future building with about Mike's our Pat accomplishments strong Thanks, delivered enthusiasm progress. developments Mike. to started. our echo We're of today excited team's and foundation with We you. some what a pleased for our

customer to record global Our quarter the continues United new was starts. base and in patient of States, rapidly another QX expand

of We to growth base we of end our to customer U.S. XX% of and Omnipod expect are International high reaffirming are expected at base expected the reaffirming to customer growth range. And XX% XX%. finish that XX%

The longer into term opportunity first confirmed view there full markets world. Europe Europe of rest our within that near-term, across opportunity existing our to has in expand direct markets selling a in tremendous new the and quarter the the is plus

We customer support satisfaction completed are Insulet our to Europe a have goals. achieving successful and transition and

This team Diabetes very our it Insulet talented Association we European was first our our Europe. operations at now focus European of deployed Europe turns taking is of clear Berlin. already people the to And and Insulet's almost experienced across XXX for fully to month's last are our direct. growth. in that from since was move conference team establish benefiting I Our with Society meeting and marked

were expansion of and the our Over opinion with European plans. shape market able the of completed week, substantial and which leaders research, we meet hundreds course will we key to innovation

Our success support indication and international a of markets. was conference Europe the have strong and the tremendous other we throughout opportunity at

coverage. Moving three objectives. team very we Omnipod in on is the had to our market This efforts United access effectively our year, expanding market States, access

coverage D Part to Omnipod. and secure First, Medicare for pull-through

access. Omnipod I pleased DASH. third, of each our pharmacy these And say system, to to for accomplishing objectives. next-gen expand to Second, Medicaid coverage establish we am are

of Optum, providers Part third Scripts Omnipod of covered As a for lives including like Omnipod Part DASH, both of the almost large D end September, secured and Express D we Magellan. and Medicare

than a Medicare than select are through coverage beneficiaries have more process a Part coverage we gain plan had greater coverage the Omnipod am where with for will or X,XXX We now where confident rate. continue through exception our D Omnipod Medicare pursue process the Medicare applicants and community. Omnipod exception and will also success covered. beneficiaries that to averaging pleased XX% covers Podder our today are incredibly I have grow can

as have XX% Medicaid Medicaid an strengthen approximately position also for Omnipod of and We to coverage of about million coverage our lives. all continue or XX.X today covered

expect for lives our to covered approximately and QX end for XXXX. this DASH. We to coverage delighted we made continue platform, million the during with throughout establishing of Omnipod QX grow we XX By progress the I next DASH. number am had have generation

that We access customers DASH several competitive will people number develop are their through advantages. is because work strategically Omnipod to more now are migrate and growing access channel a help this to we it of The thrilled important manage doing have provides diabetes. pharmacy to

no provides pharmacy fee For costs the started experience DASH. out-of-pocket on and to lower upfront customer get patient, a better with

a with documentation. and the For burdensome and simple can e-prescription physician, prescribed paperwork less be Omnipod

a Insulet, in risk year is a serve. cost This to reduce a presents offers the adoption. model and business barriers pay-as-you-go, channel approach has but lower full pharmacy neutralizes headwind over true and the payor, to therapy this model the potential short-term revenue pump shift for a sharing to For dramatically

our our clearance limited have our of terms on developments Starting DASH, release in FDA to to began provide progress, innovation in timelines. market efforts, several with July, we Moving updates and following in June. I

experience expect X,XXX positive, clinician User DASH for are that working market feedback release. intuitive to modern of and the XXX and and prescribers and release system's terrific deliver market during XXXX. know anxiously current users full incredibly to design interface. a our We been and particularly We has ease early a future touchscreen DASH's the around are we our awaiting use, in limited engage Podders

In insulin user world delivery reviewed to real process. Technology early also outstanding publications publications and feasibility and feedback, Science our user clinical in Omnipod strong of development for highlighted innovative and design, system. a strong focused and to addition recent two automated the features, Journal Insulet's DASH's functionality, results Diabetes the The data commitment HORIZON,

Omnipod progress program you smartphone. Insulet's make personal share on know of Android We towards hurdles innovation reality. have to Because control full we have are DASH Pat great was as as HORIZON smartphone control Omnipod a of one is hard technical, we first from noted, making request, step been locked user's a address designed it phone an on and the many down and news regulatory to number working security was the of app a development our and some exciting Omnipod Omnipod as which

while builds level with As The Pat smart a Pod now technical his phone sensor. of provide mobile Omnipod (XX:XX) are automated secure of smartphone delivery, is DASH Dexcom very a but we system phone future Omnipod and easily opening excellent of ease announce with in following and mentioned their and teams hard generations to that that just is wearing in use remarks, launch thrilled Omnipod productive on plan manage cybersecurity experience. to feature insulin and security therapy to that FDA, implement we discussed, our control. a meetings will that remarkable discretion, personal is Like to way freedom, work by and control of ease GX the and use HORIZON provides a a of DASH HORIZON allowing users customer and from the unmatched. a from

is designation granted It time Device was While we accelerated to review to the for that Omnipod have and this devices announce intended offers development expediting This timely development adds to approval and process, program. an to patients in review are recently to HORIZON. pleased Omnipod Breakthrough FDA's assessment by some more HORIZON pathway the process. access scope help and the program

Paramount Phone XXXX. to of complete the half Device is commitment a great win our customers. second control, we exciting a phone phone designation with to control for IDE HORIZON Breakthrough HORIZON addition fourth the be of estimate in control the for and with will to control our to a and market is significant and deliver ability differentiator phone on our the plan cybersecurity. Now

the DASH independent Just of evaluation. approach is which the is certification our testament network cybersecurity the of connected DTSec to update. through our Technology Diabetes This security is from innovation Society. DASH brings strength pipeline standard was for to our certification confidence me the to goal pump with in medical expert recently receive Omnipod raising with This the first Omnipod devices cybersecurity Omnipod HORIZON, including next a foundation of which the a

industry, this of many by to the and supported be CGMs to enable and by more As you space we're the interesting CGMs. interoperability. is and of automated designed of support Interoperability with to today thrilled algorithms diabetes groups, components work be DASH interchangeable been and are by simplicity always strongly one This the interoperable FDA. of is was intended movements aware has other the enabling to delivery Omnipod in Omnipod systems. pumps, insulin by advocacy initiative algorithms to device

step a share we Insulet that in first the pump is partner are As Loop program. interoperability, first our Tidepool's of for support pleased to

for to For potentially system to an those aren't working iPhone. the our developing faster Tidepool automated market program algorithm insulin app a Together non-profit algorithm interoperable are to is automated and be terrific offers organization support FDA. based open-source way delivery the familiar, that Tidepool the you and from a controlled to diabetes allows community. route us an to internal a DASH get Omnipod our iOS partnership Omnipod is Loop an by that insulin is of This for who loop and Podders with additive HORIZON iPhone by we DIY system approved and control delivery

our on progress. the we've can and you as you to innovation great progress exciting front many developments look quarter we this with updates made on see, providing So forward

innovation you've of you retirement. roadmap, and excited I'd thank the the in helm, value. your best for With very and years. incredible Pat driven to and improvements, a take Before on global an established leader an earlier Pat moment call the been friendship shareholder few and considerable kind the for into over of company his words Insulet delivered has behalf the at honored at role. jump on to Insulet, us for outstanding exciting we footprint, past his all the to developed and I'm wish operational mentorship like we Pat, a the on take Q&A, CEO

mission. as our Insulet We the And forward the objectives. look momentum to long-term open questions. advance achieving we towards our for I strategic have team operator, with that, and to continuing let's great call work financial entire With

Operator

Thank you.

Wuensch from question Our Markets. from BMO first Joanne comes Capital

is line Your open.

Joanne Karen Wuensch

you Thank taking want to quarter. very you very clarification, couple a of the circle much for talking and just $XX Europe? I things, translational or or you on question include printed that as does fill associated million the changing in a the transactional the nice right that international there about transactional with were – you distributor in number – just not your in fee word

Michael L. Levitz

This is Mike. No.

agreement that asset That did that be our be in distributor, the on numbers. And fee will the as of termination takeover fee over following successive be those our former months capitalized our fee X. number that sheet a XX on we will with is July an in is there will a and spread fee not years. So over and determined balance

that P&L be fee So fee we period. in do material to not that any our expect to

Joanne Karen Wuensch

quarter? rambled distributor the there still my impact probably quarter without wanted fault or in but I a sort there, Okay. to transition really It's associated understand with is, a negative the along clean I headwind was this is because what of

Michael L. Levitz

last of of foreign this consistent from headwind. business, gave just we on said quarter be on quarter the is that on representative rate currency guidance was gave the we that expect the with quarter apart we fourth a and small ongoing call run the said last the we we what the So, what to

and quarter, less successfully that business expected of disruption possible. this terms had were In very transitioned pleased we than we be could we the

year. disruption $XXX international So, us, rate out the that right and was very encouraging. is of we're run track And for business a now this behind coming on million

Patrick J. Sullivan

vessel. Clean as a

Joanne Karen Wuensch

fourth as vessel in the quarter. a Clean

Michael L. Levitz

Yeah.

Joanne Karen Wuensch

you. United I in ramping then XXXX? And the are and Thank if in how States, more right. into Medicare about thinking sneak All may, one you here, Medicaid

Shacey Petrovic

Joanne. Thanks Yeah.

the for Medicaid we to Medicare, negotiation on October to So happens the as and and less in establishment continue kind upcoming calls year XXXX previous coverage year. August ramp so of for of because mentioned we expect previous of and really the between

in coverage good So a plans and we so now, covering Medicare terms some think select shape. broad that because them shape it in of patients the in great we're broad-based got we've works great we're plan can for

Operator

Thank you.

Our next Lewis David question comes from Morgan Stanley. from

Your line is open.

David Ryan Lewis

afternoon. Good

and not just the off miss for significant time accretive First congrats shareholders. around retirement a on with to Pat having you. I'll third value

about a but the I'll U.S. so start momentum little maybe business momentum this wise, quarter. actually Shacey, your prior with and the So fourth than step just maybe you was up implies the particular a thinking guidance quarters quarter, Shacey, lower it in into significant

into fourth you talk there about is that number quarter can be we of So just anything should that aware trends in XXXX? third quarter and heading to

Shacey Petrovic

just don't in Sure. into But at as talk strong but diminishment quarters we issues a timing heading high in with we momentum very level, look orders forward. year consistent stay I'll of guidance. high a momentum. and Mike level about We both earlier QX QX the some can had and in and of terms see at the any

Michael L. Levitz

from very and some the very the fourth quarter. that timing nicely. end numbers. third David. there of there was But, the some the the the installed would trending also quarter the impacted that, no, on echo with into we're mix just And as business range Yeah, Shacey the we is toward that quarter I was moved said, pleased growing were base, upper trajectory the in

David Ryan Lewis

maybe both follow-up, two. and I'll together. just them ask One a two ask Okay. I'll just And

the that on the expected I with third third the pretty ex-U.S., my confirm and run based would looks better thought to stable Just you the math the on that was I year quarter quarter. fourth actually Mike, exit quarter commentary, But XX-plus-percent did rate. the your on obviously thought than

is benefit about third Shacey, is think than the underlying you two the now you've process one about next times of channel does realistic benefit What do penetration So benefit? the to then And so the much. What what penetration talked better of question pharmacy is you? getting pharmacy and pharmacy us fourth quarter way the spoken profitability you've for for the last publicly. company? months just getting for to numbers for actually mean the the XX the that think in Thanks the

Michael L. Levitz

Mike. question. your first take I'll is this David,

as it guidance we So, foreign the decision the the call our we indicative we to in in rate fourth our how last there were call, second gave transitioned the of very market believe the on disruption But distributor said – had to yes, in channel we the see and one significant the business on. the to the had quarter pleased we last seen, be our in. that quarter, We did given market. in much disruption quarter excess buyback to successfully when of month remained of was really so our second really run be in mitigate that inventory and that was more the knew that we business the

high-end so did the in fourth of right the into so, we track the guidance business natural on with do our And the are quarter. yeah, finished growth and better at and quarter third

direct. the the Insulet had been things into probably built of in the second up is after were that on half it as had of amount and inventory One our last call, that of year last identify we we that looked we going built talked about the appeared up that it we announcement that did

year. second – of year that last and of so, in beginning the half And this

there in second for a here that bit again, half the created this are so, that the And year, really took was tougher much a comp made really us we – that actions happen. of less disruption, think but I of

Shacey Petrovic

because we question, pharmacy mentioned terms see it's serve. in adopt growth channel that people lower reducing a for and I cost of therapy a of us David to very to terms in attractive, so, barriers And for to driver pharmacy so as as the pump it's

the So, That's happen Mike to look to specific as margin, I'm pharmacy. I going sure coverage is XXXX, can contribution most where but of the focused. not maybe to team we on will in DASH say is comment

PDM. revenue to charging a the it nice and DASH that's nice is That the removes be ramp, given in a in So, with of lower a terms but for the won't will that's organization. longer the serve driver and pharmacy be significant us, contributor a of ramp a commensurate cost year, channel bit present does we because in we for little and believe term growth and a headwind neutral barrier efficiencies a

Michael L. Levitz

that Mike. is manufacturing to on to there to comfortable a XX% gross business. our very at add this to detriment don't the don't other going target a drive improvement we're The that initiative XXXX all. margin. new of space, contributor on Shacey's be commercial launch expect expect very be initiatives. it U.S. This Pharmacy to would is successful we is in Yeah. great good material just that point the I the in feel that's a are of with largest but and operations the really growth in We We to margins. contributor where making margin at point. We're progress,

that about opportunity. excited very we're So

Operator

you. Thank

William Blair. question comes next from Our from Margaret Kaczor

line Your is open.

Margaret M. Kaczor

obviously everything Pat ride. you've had Thanks taking accomplished, Good Hey. and on you've the a great afternoon, for questions guys. that congrats

at follow-up is about First, you're patient I going XX on question patients next little that just – million year, DASH, to guess least bit sell that there a to more more you that ask wouldn't within DASH poignantly, any under into the coverage, models surrogate then that portion the of at – the our sorry XX the of $XXX, out models, least that patient should year? at the maybe look our patients base. as million throughout some of And I'm take we to start for cost kind we reason

Shacey Petrovic

we'd Yeah. look at Margaret, it. that's exactly how

not patient will and DASH, in starts ramp PDM. that a become portion bigger and ahead look we of new it for As we charge patient the our population, will

excited limiting and conversions really limiting is I'm we We're I coverage, what right of we about know that's new is, going that's to tremendous And a for even will look focus forward. lives, maybe probably in the as in we about to great where to enthusiasm responding can that's we factor are expected – were XXXX XXX with to ahead. of be DASH. be we and continue factor you're think covered for terms the to we The not think products right where are coverage launch establish where starts we spot, grow how DASH slightly established great patient that we DASH. coverage, going a So on that and will a quickly Omnipod patients when million about with amount if with we

for look that as we think, good to in we're but forward. going a really I think it's and So is better – get DASH, it's the spot I factor limiting

Margaret M. Kaczor

U.S. I guys grow probably you conferences aren't XXXX elaborate on in that one guidance the commenting color And of Pat know maybe where was faster that guys revenues, XXXX, but would if Thanks. or XXXX so is suggested on adds, great? is expect it be has that I in think any you the can of you on to anything patient maybe than sort,

Shacey Petrovic

Sure, I'll great about say XXXX. we feel

a I momentum lot into think of heading got year. we've the

don't does call. give potential more to We so decelerate the color we headwinds strong, obviously feel and some making are and February growth we and on a moving the change really but to expect pharmacy that business model in so we'll present

Michael L. Levitz

would starts Yeah, year, had quarter-over-quarter this I to continue. we've new record so expect patient that

Shacey Petrovic

Noted.

Michael L. Levitz

watching. be Noted. I'll

Operator

Thank you.

question Jeff Baird. Johnson next comes Our from from

line is open. Your

Jeff D. Johnson

you, to well. you. as congratulations afternoon position on the Thank all. Pat, congratulations Good Shacey, but new

Shacey Petrovic

Thank you.

Jeff D. Johnson

I want I start, to where let's to guess. start see –

coverage scales obviously that be a of for to Obviously, patients than lot towards payors are throughout my question of early drop a preference tier you the it's over also kind of out is, XXXX the to side, and as prescribe docs pharmacy as more it tubed pumps. Omnipod? and of a But Shacey, much more get any you On we wearing easier and I guess where to lower seeing pharmacy going the pump. costs the do committing know in pump Omnipod some rather startup part XXXX, there's

tubed you starting any tier over move are payors So see the towards any – or preference pharmacy to pumps? payors Omnipod preference

Shacey Petrovic

you Well. I'll tell that.

So appreciate. I

Jeff. we're I it, think how about that's exactly thinking

of period DASH we've it definitely a why such we change haven't step able preference had access much So what's so but time. yet, by access function in the and for payors been to short in establish is driving

a million of approved we cost in in and testament ongoing to think early a November strength were upfront sharing patient about model covered we forward. and and and are sort it, we've to just goes lives. the that risk the You XX as of be established position in June of the now just here the great eliminating That's

look working So, future. But value the – are today to on where we're me going to with it's think continue that lives. we with just I given to covered we payors it's build to as to look proposition

Jeff D. Johnson

I to on on then And correctly we're hearing you that? phone control Okay. XXXX just going and the of And HORIZON interoperability calling phone the then or DASH it to to phone can will from you the designation control, launch Am from to can take phone out to handheld up equation? straight end a go about or iPump talked Pod phone by DASH and also that control, and Pod when the you you be well. as would ready have XH whatever that the then would that

Shacey Petrovic

to a the that nobody his Omnipod can phone Pod go and going was device the to it'll that really can that's and to carrying you quite that around eliminate only super to handheld opening referring proposition DASH really in this match is well. patient remarks really is And equation. Pat what of value are out do we positioned the take because So

there thrilled it's Oh, on your Jeff, And a to know We and so that configuration. are we possible. to completely first blanked with question. not be quickly going we're So hard iPump. as very get it Yeah, working as winner I really... out

Jeff D. Johnson

(XX:XX) Yeah, horizon iPump. of

Shacey Petrovic

...iPump. Yeah.

telegraphing really regulatory So not we're our strategy.

do the today, interoperable system. is DASH we that system see an However,

And and and as course Tidepool of advantage well. HORIZON for all – both so, to of then take fully pathways we regulatory expect

Jeff D. Johnson

All right. you. Thank

Shacey Petrovic

Thanks.

Operator

you. Thank

question Jayson comes Raymond from Bedford next from Our James.

open. is line Your

Jayson T. Bedford

afternoon. Good and congrats Pat, congrats And I follow well on on on your breakthrough the to deserved. the designation. HORIZON and last question retirement, wanted

smartphone be on timing XXXX. HORIZON to second is half before launch So second you DASH able of XXXX? Will a the controlled half

Shacey Petrovic

they're around to same No, time. I going think come the

So...

Jayson T. Bedford

Okay.

Shacey Petrovic

program. we get as in to it second of coming. the phone think control fast when to it's able as can XX half working – XXXX into be lucky But and we're to We're HORIZON is I so, include

Jayson T. Bedford

pharmacy and change on expectation just the under is And the clear structure? business here the to same per versus is an Insulet to be goal the on basis the model, revenue annual customer in Okay. current

Michael L. Levitz

is Jason, this Mike.

revenue going the the to So, annual just is be to – an is saying be clear to it what on neutral we're basis. company that

Jayson T. Bedford

Okay.

Michael L. Levitz

we're So, that's saying. what

a were Pod. a pharmacy believe for think where and little PDM that involved start, we present headwind is And payor, is the period we what the for for and patient today charging a revenue So that more new that trying by a us. offering in physician, to but bit a speak you that the loss as provides It you across it does tremendous opportunity. everybody for no-charge we're have covers spread patient does we a PDM benefit

Jayson T. Bedford

non-recurring a one clear. non-recurring out the then quarter the how expense cost? if And was the cost that And $XX here, as Mike, all change in quick the million, G&A. of quarter included third we structure fourth does Very take that in versus one quick just just follow-up

Michael L. Levitz

the G&A. all in So in answer to your million first is $XX.X question, included

Jayson T. Bedford

Okay.

Michael L. Levitz

structure and of we're in do terms OpEx cost of the the we to increase. to, And company guiding expect what

said, I were the was third reason between a more quarter. favorable As in and third we of the timing quarter really matter fourth the

positive and said, our EBIT well our we expect So, year fourth thrilled be quarter. to honestly as income margin reiterated operating delivering positive the for our to the do for on trajectory. and increase we the in to the guidance OpEx net now on be for we're year That commitment

think XXXX. I'm it I into with very that pleased going really us positions So, and well

Jayson T. Bedford

Thanks.

Operator

you. Thank

from Our comes next from Robbie question JPMorgan. Marcus

Your line is open.

Robbie J. Marcus

results, time this well. and we results on model I in track the U.S. the want was the I you U.S. least kept through Great. XXXX don't and guidance as deliver back Thanks your the next were range. in didn't and minimize top to at where went really steps first quarter, of good Shacey taking early that since above end the for but Pat they congrats the question

understand guidance you setting when maybe what were maybe us happened of versus the some one-time in just or the quarter items So help versus what out? played

Michael L. Levitz

speak because base, speak installed Shacey it it's our is – base to think to Robbie, faster... I'll installed growing can I but

Shacey Petrovic

Correct.

Michael L. Levitz

...than what expected. we

– really So, it a well, said of all seeing and described QX of but and really between it timing first a it's we of model acceleration of as QX, was matter of matter of is pay-as-you-go a the matter our I was also mix also mix pharmacy. we're as and start it in the

DASH is preceding moving so And revenue. business to upfront does what more and that we've less pharmacy and even the you get been more

we're new but starts, those record having we're the in from So less contribution quarter. getting patient

had expected. we of faster base growth, where coming pickup is than but in actual in model what we the terms of doing the we're than so, honestly, And this better expected installed growth that mix the from, is pay-as-you-go

Patrick J. Sullivan

a That's good thing.

Michael L. Levitz

a very good thing. It's

Robbie J. Marcus

pricing that versus So, you help versus frame percentages the prior you if business pharmacy was just pharmacy fourth quarter quarter in in will the is the or what if maybe maybe in or business as can to what had what don't on platform you maybe headwind frame us what third be the former want dollar the it do and well?

Michael L. Levitz

the we the we issues, at have would've we have didn't timing top or mix, above. If been the didn't end

makes high-end installed given said what base we installed the which So, base growth we've at growth. is of The as sense – expected. the on what

just really it is what And of a described. matter so, I

Robbie J. Marcus

really NextGen pumps, it'll phone, you quick Okay. with early products. but potentially Great. and That's out news competitors that follow-up hybrid XXXX there great out, do with controlled two just the Medtronic on HORIZON. other their Maybe have by other one Tandem, be closed-loop

Omnipod these do of how so, years against next the competing think we competitors. some about over And two

Shacey Petrovic

Medtronic Well, innovation the not that always their really I make, to make guess has us competing that date that Robbie. has and or Tandem occurred down. directly I'll point not I which take I'll is one, slowed we're certainly with

to innovation growing a record everyone us it's unmet as marketplace. really believed significant mentioned that market to million has need. segment with for a the on know I quarter users for X has MDI lose I've incredibly despite win. large and We're fast And really attractive another anybody the preferred we think in – in this has And is this been product. never Omnipod just States, it's us and focused United in

that get few trend. to excited and years to going it continue over market's more just fine dynamic, the last we're certainly and has So, the growing

Operator

you. Thank

Danielle Our Antalffy next Partners. from question Leerink comes from

Your line now is open.

Danielle Antalffy

next congrats Hi, and for you we you Pat, the the will to good Pat the returns to continue Shacey here. both, company am drive miss so afternoon, but for I shareholders, confident so positive guys. that much Shacey. steps Thanks and shareholder and will excited

did staying on get sort curious how it, anecdotally for early that. Europe? X – And approval on like just know are wanted Lilly. with Just you Mark seeing I type to X Any CE sort how – it's you the – it, the using patients are very guys days you're give are what color but patients things pump what in patients launch of type of can if sort of

Shacey Petrovic

So, mistake. very are Danielle, you slight researched well a but

So yes, we CE or in Europe. DASH CE DASH – for actually did get Mark mark for

cetera. still that even through our and do So do we plans in et in launch working haven't just translations, have are we fact to we work still because publicized some – we're

what that's So that was.

line are of good there get the U-XXX. submission on terms We and still progress finish in making over working with Lilly the to U-XXX

extraordinarily think, and is we're the DASH is address what I type segment. me which well terms But in unlocking if a It's intensive that concentrated X insulin actually X base meaningful pretty really is actually with And to testing are that type help United as on still patient phone fast might more the of obviously just in interesting we be can States. growing segment. not us segment So control that the our user patient focused of insulins population. seeing arguably

the even to growth and get feel X type we feel ability population. while wait So insulins Lilly to for unlock good really done, we about in really good concentrated we our

Danielle Antalffy

Okay.

there. mistake that about Sorry

Shacey Petrovic

No problem (XX:XX).

Danielle Antalffy

be you a the great move the possibly DASH. because me; movers guys you the longer-term incremental needle done if And attrition just attrition mean at Do growth? you look and one job to sorry was one – to the of Okay. to installed of just in your potential follow-up can general base with stabilizing I'm growth think quick installed from you U.S., needle that sales really very I now that rate, on could have start to in and

Shacey Petrovic

Yeah.

assessment as an an in great really The groups. in channels attrition. a on those is have customers understanding is DASH base But the through years. do good shape we good patient has there. what's terms that of will got presents that the what we is we're thing But we We've the challenge opportunity DASH what few better do patient attrition of And I is over different of very patient solid, real more needle starts, on next attrition. happening think not great to retention to go as new news we move us can less think the moved, to then in look various I the and visibility grows visibility. visibility impact have but making give

Operator

you. Thank

Guggenheim. Our next comes from Pasquale from question Chris

open. line is Your

Chris Pasquale

is imply that of Thanks. right? getting thinking that loss a A start that PDM it's in per couple that upfront this one Pods of should higher to is make year revenue, to year's we're be since me years questions, making revenue of you that years with higher in Pod on still neutral the that about be a to the that would two patient suggests for going and sure the economics you're I up want correctly. actually When say to of but revenue higher follow-up price three DASH worth price,

Michael L. Levitz

Yes.

Shacey Petrovic

also who we It's right. are guess, too. PDM except – moderate be a have want Its because migrating patients we're what seeing over that right, going wouldn't to normally just for I to, sold is value the

a think for year. revenue year, of about being given it in when neutral revenue So in that being we're all neutral Insulet we thinking about a activity

attach pricing So in to pharmacy. of high the I don't want a you too premium go to

Chris Pasquale

you. Thank helpful. That's Okay.

Shacey Petrovic

Sure.

Chris Pasquale

Onpro from thinking like than then year is about on to Can under how business actually It any this the out Street resilient here. preliminary thought in maybe Delivery starting that's a thoughts that share more And expecting flatten pressure sales Drug you're far looks the XXXX? also bit. be to so but Neulasta just you penetration been on business, we

Shacey Petrovic

meaningful. of just expect in diabetes Well, XXXX. part as smaller answer rapid just to it don't I little and it because Delivery a is our in any think, less a business becoming we I sort guess a short is, the It's XXXX side, more of of the and of the becomes so Drug on headwind be growth

Chris Pasquale

Thank right. you. All

Shacey Petrovic

Sure.

Operator

you. Thank

question from Schenkel Doug comes Our next Cowen. from

open. is Your line

Ryan Blicker

Hi. for Thanks This taking my is on questions. Ryan for Doug.

what year. gross manufacturing the moving at next pressure all your is you how this good year? the forward Can the or that? for to margin to have represent quantify on in new about Is should XX% baseline thinking discuss company facility some we expected ramping early new, of You there to a be XX% could be

Michael L. Levitz

pressure just purely is This ramp because Yes, Hi. will Mike. the as be plant. there up of accounting you a

P&L And period normal you and to into the put cost your they're have ramp so just up costs.

to expect a So is next the plant. up our improve margin inefficiencies rate, a in not at than ramping the going is do matter year it the new it's run in gross we ongoing that because of of on not point. basis full really that's year this And really

Ryan Blicker

you, could faster that then that market how was FDA would When And it. staged the get Loop noted a I approval under that impression process. reasonably could path least than think, the approved? you potentially algorithm Got early you bit HORIZON. a longer the seems, Tidepool you. to Thank that offer given do from Shacey, take the at Loop

Shacey Petrovic

an and they product to that's do an don't predict Tidepool's being just specifics I'll could welcome. comment make that because Loop it people. so program is potential, that's accelerated the we existing potentially and by thousand as technically product want used that You're progress. let The really I on be is a them few a it pathway, is reason why

may the have real working support a use faster their gathering actually offer some product acceleration. things and approval to data. world data potentially already those also is it's so pathways product to They already So, and

Operator

you. Thank

Our from next question from comes Berenberg Misra Capital. Ravi

Your line is open.

Ravi Misra

you Hi, Good the taking luck for thank Pat. questions.

I DASH the when in be long-term margin rid P&L. in improvement of how HORIZON come? sounds regarding So, do going I targets getting U.S. mean, of guess, be that operations like the one layer And How it's just we on you'd your gross think you it in manufacturing. does to led to said, by device completely.

that I tailwind margins? of follow-up. then kind represent you. to Thank have what would And So, a

Michael L. Levitz

Mike. is This

really unheard not were be XX% of, our ago. was to pleased which gross to it's able existing operations really of that we long So, deliver out this over quarter margins,

that very our expand well positions opportunities So, to in and us that. of margins we expect XXXX following target for our gross XX%

a launch, of a phone a PDM is a definitely the driver, have particular of to is helpful a manufacturing the control, are but not drivers, be terms In to cost U.S. leverage with it's driver. in there product going mix, lot

drivers that. So, particular and as single number one there I to gross the meaningful wouldn't are being product any overly for a expansion, out margin of

Ravi Misra

I deeper of that new charges. in that will here? Thanks. you. follow-up my probe quarter pull just non-cash Great. what a then event And to a think a severance bit or wanted the just Thank just on Was was is be little the to trying base that I'm forward, one-time

Michael L. Levitz

of So the rest a majority of non-cash of And the in of a normal charge acceleration was stock cash it that comp. policy. was then severance charge our severance

was stock a and so quarter – for yeah, I but it charge is So pull the third forward, of – within the it's contained non-cash acceleration arguably somewhat comp the G&A. in guess all

Operator

Thank you.

Piper comes Our Jaffray. J. next from P. McKim question from

open. Your line is

J. P. McKim

whether of how Medicare the that Part full, of the getting was I other this ramp And you view or one-third to D the out, all and to there, your accelerating you is two-thirds the next year should what's to by goal congratulations. just end year if – that? question. internally is kind Medicare as how of Thank on important on do taking and for I trying ask at how correctly the the in I echo and it Hi. I coverage wanted getting today figure heard the you're

Shacey Petrovic

was we think gone there's integrity we think tension now access. may give maybe, some in way, P. just around what broad so J. have access broad maintaining and access. to and that, this Ultimately our different market I goal between have to natural I expanding always Medicare And while Medicare Sure, about it a slightly price context establish

the year And opted good price a not necessary. thought we more provides to plan than that that the absolutely really had seen we compromise on just Omnipod them best users we so because know each because with coverage, process exception select we can success and

don't Omnipod. – balance we're beneficiaries we but users materially on expect we with landed. limited where to Omnipod we adopt extremely XXXX, to in actually Medicare So are I pleased going be coverage ramp actually materially wouldn't for believe to

of actually strategy are team really spot. and in the job kind where smart that's did I we So the really think good really executing a landed we we're – a and

J. P. McKim

Okay.

coverage. just do the So you're can full exception have you saying they getting then instead use And of the any...

Shacey Petrovic

Actually to clarify just that.

So for signs right new now, every year a user plan. up a Medicare

plan a user So the if go do the and they first can can some the avenue, that reason thing first want don't process. covers that to just exception do probably that is pursue they that's for a select Omnipod

Operator

you. Thank

Our next Kyle from Rose from question comes Canaccord.

Your open. line is

Kyle William Rose

actually you very walk much I And to you and just both that or fourth for you're like, to using you that looks trial to about wanted Shacey. pivotal? mentioned talk there Thank the going questions. the move is is simply taking you be trial. the before Great. what control a to different in congrats Shacey, HORIZON. Pat the through IDE us just design Can trial anything phone

Shacey Petrovic

Yeah.

of ages world all do four skipped conditions like opted really to we IDE specific like real exercise, more data meals world to meals. So just across under real get large challenges or with kind

So that goal we And control. there. we phone had pursuing the because that's really are then time,

for human more world about – real those kind XX of requirements. But phone to at scenarios. IDE people, specifically will factors we looking then we'll have control specifically challenging four and is So XX

Kyle William Rose

Tidepool fair you'll obviously with think then why emerge see that I one guess partners just... partner I interesting, now? And in announcement, is just Great. future. guess And that I the go right future very the right follow-up I'm the on just see it to to we'll – is wanted to

Shacey Petrovic

Sure.

Kyle William Rose

the to partner, somebody with TypeZero go is just already have an relationship not established already? a if in player a kind big you with, – why you're go space, Dexcom going of with wondering why

Shacey Petrovic

with sensors. think the multiple and is multiple algorithms DASH and Yeah. our that's of interoperable interoperability benefit And I we of be platform frankly that that can benefit the

that. it's this almost about out a people using a system, a So sensor for X,XXX like and using because Tidepool is Dexcom community downloading pump I there Medtronic that's a are and TypeZero great the certainly We X,XXX – guess hacked right. a app. There's that possibility already

being just the thought and DIY to a Pod them cleared there, so in and the support opportunity And system get out able to it and way it it's to we already studied community. was was that's be because a used great great control work with the iPhone to

– program we're that's it's why doing really program So primarily it It's Tidepool's that a but into. that. is we're great integrating little

Operator

Thank you.

Denhoy Raj from Our Jefferies. next from question comes

Your line open. is

Raj Denhoy

good part I curious get a afternoon. data to to bit a near to display? CGM question, have curious it And of to displayed. I'm to how have over seem that would doesn't form, or it that Hi, DASH follow-up its long term CGM plan guess of the I'm the the know be if able that's onto take current capability last in but on to

Shacey Petrovic

use we what the Yeah, iPhone, because mainly Raj. And see don't that user iPhone because We distinct on we whatever plan data. user's integrate users data that that on and on to can that's they well because us did wanted, CGM so but a told sensor choice – DASH. their also a of made to integration do kind

mechanism Omnipod have they on Dexcom their their where iPhone. great that data a their today wedged and use right so can their we get think both for with I screen We that Dexcom

We data taking Pod had to the so one and snapshot migrate is the And iPhone. as place to we stuff there sort on secondary the display everything where to along phone and opposed the on CGM wanted to that's that of always data get so planned as well. the of integration the And device. the in with was

Operator

over that Patrick And question-and-answer now to any back Sullivan does you. turn session conference Thank to today's conference. conclude closing for the for I'd like remarks. our

Patrick J. Sullivan

And over record with year with of operator. diabetes. was on gross and my our of conference a impressive first of future probably had this significant for solid the Insulet's out million, the track And make operating deliver remain $XXX confident We Insulet's income. XX. revenue had contributions living continued will terrific you, people call Thank of growth results and best expansion I'm about margin to positive QX. We excited momentum of XX%, company

at CEO great company Shacey As the her we future an with like of bright of year. best Operator, With be at a it. the for ahead My this to can congratulate you. great in a on to lot I'd extremely to all I'll in It's drop close, promotion the and mic been drop to wishes helm, you well-deserved and her will end the hands look run forward the of very curtain. joining in today's fun call. I retirement. of Insulet you Thank

Operator

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

You may all disconnect.

Insulet (PODD) 1 Nov 182018 Q3 Earnings call transcript