AVGR - Earnings call transcript Q3 2017

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen, and welcome to the Avinger Third Quarter 2017 Earnings Conference Call. At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I'd now like to turn the conference over to Caroline Corner from Westwicke Partners.

you ma'am -- line may begin. Your

Caroline Corner

and call. you, thank you today’s in participating for all Thank

today Avinger's released us XXXX. Matt the Joining are quarter Ferguson. Financial and third Earlier Officer, Chief today, September Avinger ended financial for CEO, results XX, Jeff Soinski;

be we risks or the events to limitation, you the various meaning made you could securities estimates anticipating which deemed should should will not would statements, results of that and forward-looking that these that financial and cause include undue by forward-looking These pursuant like this actual Reform statements on Act statements Litigation are differ materially Any Accordingly, this upon are Safe Securities including, or of statements All federal forward-looking Private during statements call I Harbor to statements. forward-looking involve current implied fact uncertainties begin, management our these assumptions. historical reliance to Before XXXX. remind that material not without expectations, make statements those from provisions be statements. of in to future are place based the within laws of statements. contained call

information, or update any events, call projections whether financial new to the to and list please associated and a Securities of or obligation as the to Avinger Jeff. revise law or or except risks statements, description by our I'd disclaims of our Commission. For future business, filings over now turn required Exchange with uncertainties because see otherwise. and the with like any intention forward-looking

Jeff Soinski

for joining you Good Caroline. us. all Thanks, and thank afternoon

broader positioning XXXX. toward success in quarter This continued we’ve drive our company our for

Pantheris sales success. clinical force is utilization and Our focused driving

we’ve and has and I of past initiated the regulatory over company trial, all Our line. our achieved finish across proud the our our secured team appreciate burn cash in-stent I’m team efforts few our the restenosis clinical and team to across continues approvals successfully the months. team shepherd reduced funding of finance our has dedicated

in the commercial existing we image to loyal Our guided utilization utilization drive accounts. organization of quarter. key in which hard this solid saw base working is our numbers within again, field people user XX our And now catheters

to the love beyond relationships. important the that of platform in for our new indications it's treatment have XXXX core artery PAD, in we and products these of and As disease and support physician base advancement introduce the this of peripheral continue or we Lumivascular

in and laid fueling Our before, R&D products efforts well are two we new proceed our to XXXX. growth out as we’ve to have continuing expect

XXXX. path have approximately we compared On through that of calls financial a quarter, week to is the launches mentioned we the earnings $XX we usage company's announced With goal Capital. by paired also successful in half a funding this exploring in usage of quarterly the to with on this in the with equity positive our development prior this last cash our call, ATM Park that usage mentioned average with believe were quarterly alternatives cash realistic end agreement to product reduce million Lincoln second our we we and We’ve year in the XX% XXXX. our earlier

results quarter to cash review third have quarter. be cash progress. growth us. to more continue the line now will the I through our happy drivers to and of will your ahead provide $XX.X with our also today third that, of financial Matt, our some our take bit we'll then walk end you of success balance questions. on After color we the usage and plan here a at in demonstrate with results million a I’m Our going of

teams out committed users. hands the in our of on focus laid is our we utilization As before, most sales driving

productive more new base of accounts, add resources installed unchanged third Consistent on While most an sales quarter. with with strategically this the XXX productive are continuing accounts, the we our we quarter approach, are our ended accounts Lumivascular to in we territories. from focusing second

current reorders we’re they $X.X disposable the on brought with and XX in last and Our professionals million in sales utilization pleased is team focused quarter. sales of

to continue they hear the Lumivascular their reports their We technology value cases seeing are from in the positive practices. and about physicians this to unique of outcomes brings

Europe, relationships treating October, we the opportunity of excellent In ISR, allows pipeline us Now ISR. technology. products. product turning we to which CE with while we’ve our restenosis continued began for safety Mark of Pantheris or and we the in presence we for EU commercial countries our CE of ISR marking in to of view limited that development and account effectiveness received Pantheris an in-stent clinical of feedback and collect clinical experience utility to valuable and In Pantheris devices. announced our for as to enrollment in key approval physician promote pivotal study our the and evaluate a use September, there validation provide clinical

As contraindicated are ISR you may for specifically study expand XXX(k) with include enable promote and indication FDA the us to a in results the this for Pantheris of the purpose recall, not ISR, submission to product Pantheris the while this to support to is the directly Pantheris U.S. intended label

represents in PAD potential which of Pantheris' in about challenging optimistic U.S. XX% procedures are role approximately this the We area,

to trial. we sites XX was additional into for this open up approved plan to up Pantheris device ramp clearance sites. next-generation XXX have our at and incorporate to enrollment We trial up Our patients to once

ISR plan half is the complete trial first in current XXXX. in Our of the enrollment to

Pantheris next-generation XXX(k) Our R&D hard verification for atherectomy and complete is and our catheter. team working our to guided image validation testing X.X, prepare submission

improvements multiple report a second clearance the single to improvements XXX(k) that In these and our the these October. into letter received on Pantheris a submission made quarter, of most to made version regulatory a of file with a under incremental we pathway. these in of series changes call, last happy rolled filing, improvements we current up to discussed we we’ve As I'm for filed

Pantheris streamline are review for that clearance We the filing. might this hopeful process X.X the FDA

Pantheris system and apposition may meaningful of an involves length a a the occlusion, As redesigned name to drive shaft Pantheris, a with to changes robust X.X just stiffer current both pushability, remember, improved design of number cutter two version few. and options for improved a single for coil, more an you better including a enhanced compared nosecone balloon

We clearance are while in plan than focused for keenly We take on getting consistency December. development longer device this and to final Pantheris has little X.X Pantheris superior file expected. X.X of to XXX(k) of level of us a a

To knee BTK Pantheris BTK XXX(k) device of this submission additional Our you, program Pantheris file X.X incorporates a expect from in remind our to our Pantheris and for second quarter program XXXX. currently improvements of we which is program we outstanding the longer development will lower and treatment vessels those guided will a of image centered profile profile safety length be below our around the atherectomy including enable critical. believe where catheter smaller

design procedure. utilization in believe as much available this for easier Given being of the treated, this more expand to results product inflation increased the streamlined to will customers. our and which also our need result eliminates will use occlusion new the vessels provide system product market an in as and therefore also the device and by We a even XX% apposition size small makes opportunity by

for We the would profile leverageable represents are directly for this excited device of be R&D us. future lower to which another also the that market coronaries work much potential

a by catheter this extremely unmet and the benefits and features addressing need pleased provided space. peripheral the with are real it's We believe unique in vascular

a minimum OCT XXXX. use will CPT intravascular from upon a for $XX on our of to be currently clinical written to reimbursement in company's Department our for we peripheral NASDAQ the clinical the market diagnostic pursue the consultants file relevant market arteries. the hearing reimbursement noncompliance a million of based from against ultrasound listed stock to subject and on these global for with staff to incremental of received RCT imaging setting. CPT we’ve Similar application reimbursement development now and that for delisting being update, our NASDAQ position As in requirement determine request in value final our or panel. with in hearings last market we we're NASDAQ Late this the of continued programs indicating NASDAQ and received to for this feedback qualifications devices securities working continued engagement our IVUS the societies or the provided before application reimbursement we’ve listing a interactions goal Based securities unless notice listing month, of the initiative strategy

on We a additional NASDAQ compliance reverse comply have and our requested plan this the split. listing including considering We scheduled requirements efforts for listing criteria, January. hearing stock now and a regain our intend we're is options equity implementation continued the with to and with for NASDAQ raising and capital of number all of present to to

NASDAQ at the by any Our I'd the interim, covenant market. panel. NASDAQ granted also hearing about continue that to of our to in global In amending trade a hearing like stayed discussions been pending loan constructive CRG request the has any delisting our and we’ve outcome in revenue action securities extension our for lender with agreement. on note the will by least the the

working yet agreement to in the disease. for hard to vascular an we now in end optimistic platform, call including indications of ready progress and I'm development, therapy be to In regulatory to will With product While I'd beyond. We all with continue Lumivascular an to will to that and results treatment open are financial we in XXXX making our our team new exciting operations we the our have then summary, Pantheris ask Matt is field launch. review your pleased the and the commercial year. teams questions. QX we'll and the anticipate don't place, the growth of reach our opportunities products our like in believe before one and prove important

Matt Ferguson

compared for the third from afternoon XX% charges, in the for Revenue obsolete higher XX% was million revenue third implementation reduced write-down ended inventories down primarily third for XX% XXXX imaging was third a and related to XXXX per XXXX. $X.XX third which was XX% EBITDA decrease Pantheris the for the third third quarter for third through was compared in the XXXX, negative compared quarter. million from of good XXXX, was the was improvements. quarter third to from program September to operations Jeff, third and non-GAAP gross third average the the compared utilization million quarter of loss Loss XXXX The quarter compared decrease margin the million proceeds margin decrease this $X.X to of process of XXXX. million quarter Adjusted million loss quarter was consoles expenses in of XXXX a of a $X.X compared $XX the to quarter XXXX. quarter quarter million of XX, September to loss marketing expenses a devices XX, the The of with million, the the Thanks, and XXXX. were XXXX. share third quarter Gross attributable XXXX. of quarter quarter would the third for a these the end million XX, was XXXX. quarter third per quarter $X.X XXXX second disposable $X.X to Without manufacturing XXXX. financing cash gross positive decrease quarter in quarter a the included Operating June compared net quarter XX%. a comparable of XXXX. at of compared measure, $XX.X the of $X.X to of third compared equivalents company's the was of of and through for for and Cash which ATM Cash as have decreased to Revenue This in for XXXX. production of of XX% $X.X third $XX to million in of XXXX quarter was the been $XX.X loss $X.X for XXXX, million Total $XX was produced is the of $X.X from quarter million XXXX quarter to for positive during XXXX. Lightbox million from to a XXXX which for million the $X.X of $X.X the accounts Loss everyone. predominantly the totaled the for of for of million quarter an million loss And as of raised margin of $XX.X the of million primarily new of of prior of quarter XXXX to sales Lumivascular was to expectations third the certain $XX.X the and charge catheters third attributable the XXXX. for of opening volumes lower $X.XX excess balance related excluding $X.X million cash

the just cash I’d consistent with to of like quarter in to ended. with We quarter approximately back remain to the utilization turn expect the And fourth that, XXXX call Jeff.

Jeff Soinski

Matt. Thanks,

on drive Looking focused of our expand and ahead devices company we utilization our products, launch also the our are program. of for clinical new the readying current while we

As of of XXXX. XXX(k) with December. generation device the for second for key file plan plan atherectomy to the clearance XXX(k) our to reminder in we quarter below And a next our upcoming clearance milestones, file knee of we Pantheris the of in

We we also progress to your call with our expect in to half like on initiatives and to our of questions. our open that, first complete We look milestones calls. And updating ISR the these on enrollment the XXXX. of other trial to future you forward would on

Operator

and Cowen Instructions] Our question comes Company. [Operator first Josh Jennings with from

now is You line open.

Harris Iqbal

behalf of I appreciate afternoon. Hi. question. on Josh. actually This Iqbal the Good Harris is

X.X, of saw checks, in or reliability on quality control quality internally what want to cycle. one, your current experience you issue they Pantheris types ensure go the First product to with

Jeff Soinski

question. the for Thanks

Testing We this every aspect our -- and have, called looked and have extremely of all, Develop device. DDT for what’s first of program verification validation both at rigorous implemented an and testing

the We incorporated evaluate along feedback product includes devices. this physician also and out use throughout the our evaluation way to sort development users of and these of have physician the testing

will rigorous types that learned believe worked will and about an a devices. program. environment they devices that -- So our extremely subject that clinical that about We the on. learnt lot be a be we lesions a lot manufacturing the have to of we We’ve these

are very, and a version current we will improvements to a along usage host a incorporating very reliability. reliable we as that Pantheris we well of robust also number device for way as met of launch performance improvements So additional confident that and the clinical both our of

Joshua Jennings

And that between kind recognizing, growth helpful. has breakout orders of then accounts the and increased a and I’m utilization. force in your quarter new That’s the kind revenue there quarter. focus with the the been you of about curious Great. can just carry in sales dynamic

Jeff Soinski

quarter existing So the was related the accounts. vast majority of in disposable revenue to

users reorder While stocking and accounts to opposed during our of couple of The new majority to with vast, we’ve volume we volume Lumivascular utilization in net at on accounts the as existing to taken accounts accounts. have of added few strategy with out quarter, XXX our the existing has related vast a a our focusing orders consistent been accounts.

Joshua Jennings

you. Thank Got it.

Jeff Soinski

you. Thank

Joshua Jennings

CEO at Thank over you. no this I I’m turn questions [Operator showing further like Instructions] time. closing to in conference would queue And the for back to Jeff Soinski, remarks.

Jeff Soinski

call interest Well, our this progress we we our a our thank for fourth company quarter updating to our results. your all you and when afternoon. forward year-end afternoon. We in joining Have on great and appreciate record look

Operator

the gentlemen, you program. conference. participation thank Ladies for and today's your This concludes in

a great You Everyone have may now day. disconnect.

Avinger (AVGR) 9 Nov 172017 Q3 Earnings call transcript