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SENS Senseonics

Participants
Tim Goodnow President and Chief Executive Officer
Don Elsey Chief Financial Officer
Mike Gill Vice President and General Manager, U.S. Region
Mirasol Panlilio Vice President and General Manager, Global Commercial Operations
Brandon Vazquez Canaccord Genuity
Chris Pasquale Guggenheim
Rebecca Wang Leerink
Jayson Bedford Raymond James
Call transcript
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Operator

Good afternoon, and welcome to the Senseonics First Quarter 2018 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Don Elsey. Please go ahead.

Don Elsey

Thank you very much, and welcome to the first quarter 2018 Senseonics earnings call.

call Mike Goodnow, General Gill, the today's Executive and Manager on U.S. and Officer; Vice me are President Tim Chief of Joining President and region.

and remarks remind begin expectations management's speak performance could events, matters, that hereof. of let of statements by as and factors these that, date we or regulatory future statements. of for over at any with under risk to filed is update the are me plans, our enhancements, the expressed Before the and the These turn statements SEC. Goodnow. today, forward-looking site actual about These that company's risks annual in publicly to Web detailed except the uncertainties. section by only of involve other Form no Relations our product the include operating those reflect Investor obligation documents other call Tim number We reports Tim? forward-looking These in these forward-looking and forward-looking you company be as statements www.senseonics.com. XX-K a will any now to available our list elsewhere and A factors required revise report law. from materially cause results statements undertake reason of different I implied or on With matters

Tim Goodnow

productive in the with we which on a quarter achieved milestone first advisory We've outcome favorable a company had of for system. significant Thank the you, the Don. Eversense panel a FDA

detail year products, in the the additional range in programs. the $XX more as are to We Simultaneously, financial for and developments active new Don the for well financial our from approval anticipate iCGM launch, we including million partnership million of continuing the of our achieve in in will on for provide commercial classification which our we performance expectations and in on result, we first outlook XXXX. future. are next-generation remain $XX preparations our a revenue to quarter invest technology to as track As near review. express

Now panel to The independent X panel toxicology advisory on recapping experts unanimously questions. separate X which each on the of FDA clinical voting medical of took chemistry and March voted place X and scientific XX. comprised meeting,

First, that Eversense was safe.

of the this Second, CGM as finally, system, performance we the reviewed well positive user clinical Eversense the be that effective submission, as Leading demonstrated of Eversense Europe. part the risks. was positive, notably benefits to meeting discussion PMA that the from product outweigh strong to and vote, our the the the system was real-world of at was the it as experience

clinical original showing for including from continued encouraged of acceptance on our strong. data of results its As top-tier were accuracy bolstered accuracy safety you performance strong entire which study the demonstrated provided by accuracy of study, that Along the duration additional very data in may recall, sensor sensor. results days early These the II PRECISION PRECISE results our demonstrated the the throughout, the SensorWare. now XX-day tenor and also comparable that as considerable And as time commercial very of innovation years of by were clinical design the we as and viewed X feedback ago. improvements made study, we've in settings We improvements. the the are the all well discussion, studies spent since with

accuracy and MARD use. Specifically, XX days algorithm over further of X.X% second-generation Eversense entire an enhancement transmitter the smart this to to highlighted the system discussion the our improve of

is a swimming. lifestyle-friendly and include, excited launch, provide clearly during are is generation, slimmer, smart newest features more or be which to to designed worn lighter and second We the the U.S. in can transmitter, shower

when or removed truly vibrational is low is a provides low, about wasting alerts when user not only with unique, smart. the is And used skin allows and even no It without be into will the we it change have truly that discrete It comfortable is nearby. phone could replaced We used will community the the to We that irritation. incorporate go transmitter how the this that CGM U.S. upon future. believe diabetes to work guidelines. gentle wear adhesive in with the clinical with this long-term approval, the practice sensor. for And daily will be

versus to able Turning and accuracy detection we the stronger enabled our too any to other CGM. of advancement, MARD second long-term in This the achieve and review, experience. will that The enable improved user major algorithm the accuracy under adherence patient are differentiation rate. hypoglycemic even algorithm strongest improvement improved performance further acceptance, reported

powerful drawing fifth over, was racing patients Eversense XX readings, with when about the X An community sleeping. has diabetes that CGMs. with marathons that diabetes Eversense, realizes He most changing for to security, high diagnosed Over capabilities diabetes diabetes XXXX running feels the XX were technology. under was share remarked active I'd when portion even sensor with Eversense. to the has father, told the commercially one Eversense the explained type-X who as deserve. for transmitter and you a family other blood that and during The like his vibration fine anymore. that best run and could advocates friends him was competitive him members difficult has learn However, these of even and him panel system he freedom no proved of system. to managing or available is January he important open-public story. such conditions. all though describe spoke best life-changing in now as and of he's with given aspect He comfort are the sugars hearing. low, testimonies features few meeting days marathons, his He's delighted attention our on of using quickly has his the the assumed in alerts of Eversense its He how too accommodate how his completed or of

on to system had back, give This she And her finally, it the partner. spoke her the she another Eversense that on cried was trusted day X her became examples arm Eversense her just vital study participant to are because transitioned lasts her the clinical recently user the seventh if these and share a Eversense well have XL who their Another so excited to become phone readings heard described to thankful said how sensor. the We diabetes type-X broad because their when she few These going as and was rallying It them and voice quality she the considering over hearing. with of many much beeps She X. the that or that woman it are was years, enables of overwhelming that the in on best. life support and from devices the vibrate both She diabetes security, community. for a diagnosed truly months. has patients passion, sensor used the down. higher were have the receive that to active up and as support public is the we moved Eversense validation by naturally all had the of speakers

the study in that panel continue labeling collaboratively stage path this Eversense was in all We are highly and in positive our post-approval has is market. the confident we on the here positioning be that approval U.S. working and to the of at to final the at believe agency received needed valuable Following panel input meeting, the incorporate design role information the and the the U.S. we

of launch mid-year. strategic and U.S. as on Vice Mike? includes Mike supply manufacturing the to our the as President as and continuing remain We General that, I'll Gill, to region, the by now Manager track infrastructure. commercial well a discuss organizational our for launch. advance support turn commercial With readiness preparedness call This to part over to our supply distributors are of chain U.S. and U.S.

Mike Gill

Thank unmet Tim's telling that the in for validation in you. but CGM, our to even diabetes importance of the meeting, is outcome additional the the to upcoming U.S. community factors market. come and encouraged that market commentary, of this driven options This the unanimous just the Underpinning patients. and FDA on the more by lifestyle is panel opportunity And Senseonics about of point of panel, launch. echoing is we're the long-term benefit for not the CGM rooting clinical heels and to need

number low that what They panel, need best have to But for it effective additional including this are looking comment not using using their waiting Dr. treat This CGM Adding that CGM to best safe "I into their routine despite affirmed we are our innovations disease [indiscernible] that an not and the practice like like use patients patients need are CGM facing information daily available uncomplicated currently Russell research Europe, that the a doctors people have that their those gives quick and lasts panel patients. for systems." prolific Dice, at changes integration supports and they patients that and that that a but went even to standpoint, one from sensor market knowledge, which manage is technology, said alarming her testified are a the As believe procedure, X chosen can to risk. Eversense From clinicians inserting incremental many increased the products current CGM. the a representative are options not Steven with on to say and patients to not not who of sensor more easily. painless, exponential Dorothy are Dr. satisfied from removing she of this, integrate months. office up at

track on ready remain to by for U.S. be We mid-year. plan. operational the to Turning launch

to customer hire training, continue access and key and market reimbursement, in care. We clinical sales four areas;

experience commercial with quality, We the are pleased capabilities Senseonics U.S. team. the of and

the first meeting optimistic system we could have ready is system know the team June. end the to U.S., at upcoming In our we I fact, in that of this are once organization Eversense of training the completed end, the and that across we and commercial revealing To Eversense be we approval. ADA for eager at the phase the launch

presentations, After exploded. lead panel prepared a for is initial venues to be events involved to a product Eversense at specific in the of FDA Senseonics has be ADA support attempt and unanimous Potential at scientific and the vote, include Our theaters, product to commercial in conference. HCP launch the generation. demand be the training exhibits, headline for

will course, commercial with into once for will execution FDA actively we approval, Of warehousing pivot we mode. engagement health opportunities are we wait approved, and providers care but and patients

and post-approval. payers requirements, On potential process the team have front, examine with to coverage U.S. for to evidentiary payment position our reimbursement Eversense major comprehensive continues meetings

We success. market continue way out the be to it And now, we glucose and to see are monitoring and looking excited continuous the the implantable With with first to extremely the U.S. to continuous outlook in comments, through that, our as shortly Eversense for as channels. ready first of in year. approval be forward much close with to And many approval we're as to after for talk multiple the Eversense system our the and value with reimbursed the to sensing. long-term long-term through my We're paving pleased payers deliver hand Eversense quarter the Don discussions I'll enter our financials anticipation to and U.S. possible and

Don Elsey

you, Thank Mike.

XXXX, $XXX,XXX in to For attributable the increase X million in the first increase the an XXXX. ended market. months $X.X of The to compared in XX, was we Eversense March in of revenue, sales European generated quarter

operating U.S. million driven XX, increased For by R&D, increase by the million. $X.X million increase $X.X million primarily prepare total in XXXX, a in expense, the X sales for as the increase and months primarily This to and $XX.X ended marketing panel was activity. $X.X March driven by FDA launch we expense

loss ended was $X.XX of per months $XX.X March the million or quarter $X.XX XXXX, million XX, X XXXX. share share, net to per first total the $XX.X compared in For or

Our liability attributable value a associated expense. net million of fair $X.X of increase the loss to non-cash derivative in primarily and for the with quarter change the million was $X.X in our the charge operating

in completed which in per and At million the securities the average based offering quarter to proceeds at balance reflects note average compared quarter our weighted of to the first outstanding, net were turn from now First XXX.X XXXX. $XX.X outstanding of loss XX.X sheet January. share our end million, that the weighted cash, quarter marketable equivalents XXXX convertible the to shares end. million on I'd like is first we cash shares quarter,

As Tim the guidance mentioned, for we our year. are reiterating

million $XX continue We be $XX full expect year in million. between to revenue XXXX to and

of in have a the contribution we back call Tim. year. guidance anticipated indicated previously, to turn the second from U.S. this will As I half includes now the the modest

Tim Goodnow

Don. again, Thanks

to that see continuing product, value fourth to XXX-day through Now first commercial sensor heels on XX%. to very We the I'd in by increase like broaden we're for expansion but in on-boarding current strong further clinic our insertion the X-month instead saw embracing system. of access nearly operations extended currently speak market of are and available are not where coverage. awareness footprint our Continuing quarter, of they as patients this the the can Europe, programs, a waiting quarter recognize rate necessarily sensor, the

As countries this we are at very out good first all to available we make now in close Eversense XL the a quarter. quarter, going system

Some of work our the Eversense countries creative have a been the as through unparalleled are new each being including and unique staged or campaigns the Europe. developed versus hospital use XL of world's the others in for reimbursement single-sensor Meanwhile, supporting process tender countries. benefits for in longest-term customers the

awareness, market. and we European in very Annual largest the and to interest reception. Advanced Technologies we February at the generate in conference for diabetes a warm As Eversense continue in XL noted, the Europe meeting previously adoption introduced And Diabetes to Treatment will technology in

front, another over benefits Germany. of payment the this, processes manner. the covered in a payer days, coming of they Coverage the the timely had is is now will ensure commitment with annual coverage Eversense health granted those partner, prescribed is utilization the for has and of [indiscernible] statutory a with validation system. at country. discussions poised On And the access in to great and the lives another large insurance on who step pricing This our reimbursement We a first in Roche be achievement. in are in product are and XX%

our area. inclusion partner, has the Eversense excited important are in to to that that in and report available we clinics tender also is also Additionally, region granted Eversense Sweden, to Rubin, pleased for largest Stockholm, make of

pens will changing used integrated Integrated in are be diabetes to iCGMs, Finally, the or dynamic U.S. the FDA's now for what permitted classification. combined the agency, or PMA the blood system with will back required care devices the to of compatible introduction devices. a control with of the CGM path monitoring process I'd a and landscape meters programs market. other CGM as a pumps, instead When the largest iCGM as all by to and health like XXX(k) by devices. that future for devices, insulin of be now the new part electronic our special the forth glucose other such meet rapidly other CGMs, they regulatory is set discuss agency follow

approach for delivery iCGM combined iCGM for system, the is as the such automated regulatory a system, in This system quicker. to can market allow patients available in choice. any will manufacturer companies and importantly, time will switch be a an another insulin without as reduce More new of win device This and both the with review. greater patient certainly technologies

very presented Eversense on currently run, system of review, While approval the primary we to in focus a the criteria. continue FDA under in the PMA will the iCGM we've examined construct short

current outstanding. approval iCGM brings excited dosing the the and by speaking PMA with done these supplement promise obtained. our very with to the extremely will a the We been the the has to current of the up, and FDA, in classification forward request team quarters. first device. panel generation validation are This the put for by of diabetes to truly an the in this PMA proud look progress the generation once will We the designation updating system approval the the be To primary following product. our claim guidelines performance to delivering agency community hard on approval, relative has submit a and the is we wrap our work to coming I'm iCGM new In the

and diabetes over the market. long-term our only as landscape forward and are support We Also the our questions. these prepared favorably millions questions now Senseonics continually management President clinicians U.S. anticipated system. the This several us continuous as is and our We monitoring to of our Global let's Operator, Commercial Mirasol for for efforts open remarks. poised differentiated that years. Mukul of launch improve In and the Panlilio, for of are believe We that greatly Jain, well as appreciate and concludes in worldwide Operating our we truly management, joining are positioned for care uniquely Chief of glucose Manager evolving support employees, are General to midyear Vice drive helping looking forward Officer; to Operations. the next investors. continued and the diabetes the interest patients patients call

Operator

Thank you. Our Rose Instructions] from Genuity. [Operator first with Kyle question comes Canaccord

Brandon Vazquez

Hi. This for actually Thanks my question. Brandon, is in for Kyle. taking

I them? just give the on in appreciate markets. color just there. XXX-day, I now to the do patient to you more point have wanted Can gave base in the you entire international transition a the -- in to XL, countries market touch introduced on First, the the at little XL base those bit on going many the the be how XXX-day sensor? what OUS expect And you detail transitioned

Mirasol Panlilio

is Yes, Mirasol. Brandon. This

the in sunsetted. process. reimbursements will of hospital we quarter, have gearing been our by tender all the are will our currently for and quarter markets ready the Sweden which the -- sensor well We in markets XX-day as rest in the Eversense what for point, this the do up doing then as of the first Eversense and at U.K. the of XL training be getting end expect is in have XL. then XX transitioned for And We that to

Brandon Vazquez

you -- XXX-day, TypeZero? have of iCGM the high implications category. the be just really what given SensorWare exciting That's pancreas in one just have very iCGM, more And that start guys Eversense And potential U.S., to kind and have the is then might fall the guess forward? would I that ducktail helpful. And the even the I you accuracy to, and products think of lines if that of some going a this off regards surprise that, question. moving and level, do artificial system for no does with pipeline there to for the the year under just of you. your move could In that's system to from you projects forward Thank a time maybe other potential of, Roche

Tim Goodnow

Thanks, Brandon.

the first the all As specifically been very intended just can we that this will, performance is I giving you we the you if more under a has FDA meet X, for that. products X to go regulatory It's PMA. as use, the badge, the think pathway, also do future, around made suggest, progressive bit characteristics, whereby as little the to Class certain product only an here, the changes the Class through quickly. would iCGM opposed but pathways or a out Not mechanism regulatory traverse current accuracy, in to which would've class is

So would we thing has field, to will have iCGM FDA in course, certainly just accelerate a and us, as I the primary we supplement first opportunity to category. is entire a the do expect underway that. and do, process that we able the the get want well then approval and excited to remind of what done, it is we're to do that and although certainly, be the for participate is about through, approval our very PMA

So first-generation but are there a we pretty bit with still product. our do, excited to about a we're is of little work where

Operator

Guggenheim. comes question Please Chris next Pasquale from Our ahead. with go

Chris Pasquale

you off, latest of calibrations, warm-up have think start thoughts Tim, just your to U.S. of guys or claim? what you'll period questions Thanks. you about label number is dosing in likely couple terms a here. to and not, the Maybe whether just required like look of think a

Tim Goodnow

for Thanks, claim review. We've Yes. aside initial specifically set the Chris. very dosing the

for approval very agency, start under the and approval up to actual -- you best the felt in recall, claim while the were first with and was the And the get approval it not up primary we finish then we review, again the dosing out may it without the clock came review. the As came product while quickly. conversations follow

So our that's strategy. still

we've label and day, to We pretty claims with will have that The And stay to the in about. talked maintained calibrated will conversations From other as in XX it start long be product to FDA to had after the you the everything with for expected per you be the next get XX that continue the the twice consistent we get insertion we currently is live that agency. anticipate as calibration, is results. then, days. hours those label. And you'll perspective,

Chris Pasquale

where just launch, when then, do you to place? XX And do helpful. presumably? you for go in live, on days want reps U.S. you how have preparations be the sales many the That's actual in And

Mike Gill

Gill, Mike double thanks for end about its the question. Chris, now that year. XX to reps hired. by right of the at the want We're We

have as the big we're ADA opportunity FDA-approved. We long a at as

the to that few that more is we're So be the to but double line, the goal by add by hopeful end of time a year.

Chris Pasquale

Thanks.

Operator

Rebecca comes Wang next from Our with question Leerink.

Rebecca Wang

like U.S. type you wanting actually similar is in I Thank share Do Rebecca, to what you is just you say trends the chance This for Antalffy. Europe there? was once will they Senseonics what in Danielle do Thanks. launch think domestically? of market ask, say the product you. in and the

Tim Goodnow

seeing And with I go about of we're implantable. expect from pilot our mode would so of our users be to Thanks, training transcutaneous on done to something insertion made share don't to all and traditional Glucose are the or We're formal a coming yet. -- started on users region's you'll that XX% seeing we've pretty countries like many the about ramp, survey a XX% think of in seeing XX% frankly, the Rebecca. region's with Monitoring. coming the Remember infrastructure, our we the long-term we're market XX% out not shown from are In I in CGM, that will Flash interest countries that probably to that sensors to similar of procedure coming now decision recall the forth. experience U.S. new got it XX%, but the previously regards XX% and as

Rebecca Wang

like, Eversense more sensor? in any now notable first-generation in adoption launching the Okay, And helpful. another than have XX-day XL very question, you quarter, a versus Eversense that's difference you've the seen been XL for,

Mirasol Panlilio

-- Mirasol. I Rebecca, think, -- we're message question. for Thanks the the me for it's

the once the XL we in the excitement about In week, of two a next tick rest example, they to in of the go a the seeing wanting we're the one actually, now. of seeing up in, and in for are we're we're that the that Sweden, mentioned, learn fact, of countries And the Eversense convert in as going lot lot product. to availability to of starting people are markets. immediately, countries We

we And that the adoption continue as the so the expect with and will well. countries excitement other

Rebecca Wang

very All right. That's Thank you. helpful.

Operator

Our next with Jayson from question go comes Bedford Please James. Raymond ahead.

Jayson Bedford

Hi. Thanks follow-ups question. for I guess Good afternoon. taking just few a here. the

in it from On seems the you're -- XXX-day, duration? have the XXX-day transitioned device Sweden, I'm like how longer wondering that's the you've to economics the geography And payers XX-day the the changed? how where the view

Mirasol Panlilio

you've Yes. Mirasol. the varies Thanks Jayson, the question. again, policies what It by it's and tender for submitted.

part, won with very per right? day pricing most is XX-day some the sensor, Eversense new seen on So basis a the to a the existing similar sensor. per-day similar we've Stockholm that's tenders the from to the For a like XL tender of very pricing the we with and specifically XX-day what however, the

Tim Goodnow

one that's on is been for XX say transition XXX-day between probably The it's pricing and care, in always anywhere which really focused been really constant doesn't it's and would per day but theme. I us, Yes. health a price, a course, a the there product. of pressure,

Jayson Bedford

and helpful. That's Okay. encouraging

you did interpret in that just increase context comment? XX%, right more quarter, Tim, XX% give is you insertion December to quarter by than think, I that can nearly rate had meaning us in you little you way mentioned insertions a in the further the sensor March

Mirasol Panlilio

increased and off of we great very Jayson. we XX%. had increased -- building that, take as we the similar It's the I'll sensor placement fourth saw our in where Yes. installed first quarter something base a well by as quarter,

Jayson Bedford

Okay.

well? increase what XX% be I'm increase the is XX% the reinsertions? if there'd base wondering, some So as in just a installed

Mirasol Panlilio

No. quite The the not installed still and base, placement almost complete. sensor is XX% but really aside on

Jayson Bedford

pathway Okay. of just on, the one U.S. then here. kind And

dosing Do On the for what you small those to you are the to labels? those can regulatory little support existing data use It's here? have paths [indiscernible] trial unclear. claim, run or a a

Tim Goodnow

you that is with be if an this of there flux consideration the at point, little not guide will marks, additional the for Jayson, is believe, dosing. or that iCGM new But, There bit will announcement imagine come potential will. as our It's trial iCGM these controls of some a required. you the with can

believe got in to don't what go do that it we detail need for, analytical controls, a iCGM, the exactly a dosing, around But around the bit as the is. an but review only which just So is than comprehensive, with that a additional a is will definition more right the and which pathway, contains trial step-through if clinical controls to we've through or to description manufacturing have strategy it Is agency not which clinical one place, those think dosing also I study. require little will, you in itself. a you communication don't either of we

Jayson Bedford

All right. Thank you.

Operator

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

Tim Goodnow

a thank times front exciting to evening. on your us. of participation here folks got like we'd Thursday We've again, for in some Once

thing look imagine, on you of forward at next the chapter enter to goal As work going as our the can and a across this this Senseonics, line. life driving we very we prepare with lot to continuing agency to and

that, your forward we quarter. for with look updating to time thanks So Take and you care. next

Operator

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

may You now disconnect.