AVGR - Earnings call transcript Q1 2018

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Operator

Greetings and welcome to Avinger’s 2018 First Quarter Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] I’ll remind you that this conference is being recorded. It is now my pleasure to introduce Mr. Client IRTH of Director Camarra, Communications Communications. at Chris Mr. you may begin. Camarra,

Chris Camarra

Avinger’s for and welcome today’s to conference thank you, participating all quarter call. you you to Thank like all in XXXX I’d conference of first call.

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

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

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

Jeff Soinski

Avinger debt for treatment for briefly the two designs disease, of excited cutting the utilization we millions half we’re need thank the is significant made company potential affairs, a capital number Lumivascular important cost the that year, opportunity reduced disease. it this development, share Thanks, and you year. significant progress the as that we believe to Avinger we’re We’ve the suffer the I’ll focus FDA a of well of commercial-stage has and the during image-guided Improving on transactions to come from anticipated financial atherectomy devices of the touch this steps in that the quarter joining XXXX We upcoming care our clearances for regulatory Good of to develops an taken products. medical in believe growth company. results. of existing had call, milestones position completed our with has the and Chris. our with about as during year. positioned diagnosis and well We continued as peripheral in our patients first given turnaround of technology cover system greater in quarter, our standard driving on the patients is we and product to catheter-based improve made image-guided us the the transactions device and financial PAD. artery for us. of afternoon, well second – emerging the commercial first-ever have still or have this headway Matt just to you. quarter significant will financial first all these launch we’ve next-generation Pantheris of as depth discuss one achieve and Later

arteries most PAD. treated the commonly only treatment pelvis that in the of diagnosed the in developed As and a PAD artery of during real-time narrowing world reminder, provides the and Avinger of and the visualization heart away a is has inside arteries technology the legs. from the the is

structures, better a provides platform differentiate artery. helping thereby enabling avoid to during them an artery portions the of healthy them of arterial healthy the physicians treatment, to damage and picture clear Lumivascular between Our plaque

studies clinical empowering of avoid and damaging precisely disease have to can excellent our physicians of pipeline the outcomes. and real-world healthy and central safety extremely target Currently, product long-term various Our that and provide clinical five products by consists shown commercialization. profile an in experience positive development clinical artery, we phases

our device, In Pantheris CTO-crossing addition to FDA-approved offer the Ocelot image-guided atherectomy catheters. family image-guided FDA-approved we of

CTO device to refer blocked or artery those a the new of so to passage create used artery. which through can to be a a introduced treatment can you for CTO-crossing and chronic further For completely to provided. stands be is is Avinger used peripheral occlusion, total blocked a that guidewire space, A

next-generation which arteries, strong Pantheris, our for the CTO-crossing of coronary CTOs represent used Coronary need. a peripheral but ideally technology need, foundation We’re technology we will believe it Lumivascular unmet development the CTO a devices substantial and also this arteries. suited to believe a address the medical for on same we This call device Ocellaris. in the provide we for crosser developing be also platform used will is

In catheter better of a atherectomy, commercialization. a in-stent LXXX successfully The In robust chronic total comparative we’re enabled including patients device, And Hospital significant we we excuse report types, anatomies on Pantheris in In to design – addition that new next-generation had improvements outstanding system. to versions to the our a the Lumivascular and provide to to control of nosecone compared a for me, bodes Franziskus months is Schwindt, in Arne of Pantheris occlusion. a of performed catheter these which longitudinal and blade Europe Germany, next-generation and features widespread additional into variety reduce In has well the lesion with results atherectomy exciting once variety Dr. Muenster, of of look a at more Dr. treated that directional imaging significant efforts in with believe January, Schwindt technologies markers strides first treated the the as Dr. made Pantheris the seven the limb patients This restenosis, Lightbox calcified by the is the life-saving the cases, lesion the performance Europe product lesion benefits. cutter of console, surgeon bring shaft dramatically our will more intended. size FDA. to including announced vascular note the St. seven next-generation facilitate and continue sharing We this in in variety and console for on types. treatments, to these of We adoption each the the Schwindt made imaging initial previous clinical precise our other in programs, develop the details on our U.S. future an customers cleared as as continuing forward positioning. a following experience company calls. LXXX. early physician device catheter that the a a call of

our quarter. we accounts As to expect and we last to Pantheris FDA on continue clearance this receive launch the stated call, the U.S. in next-generation

typically and hear filings, of are our some questions agency. initial questions received XXX(k) back from now In all increase for gain the sites this in and We’ve approval. distribution the of immediately submission. the next-generation Pantheris is expand case we with the following remainder device waiting to throughout the these of plan we following data As We purchasing as in into U.S. Lumivascular inventory the additional approvals production initial requests meantime, of our building to year the and and to devices the responded to sites. FDA next-generation initial plan we’re launch

submitting including also of Pantheris, for six-French application next-generation Pantheris lower-profile vessels, year. by for the to of we version middle addition XXX(k) below the a In anticipate this knee, a of clearance smaller those the

excited similar device in Europe this this filing for to receive we early time opportunity U.S., which, U.S. we CE XXX(k) expect this and the new time submission anticipated would our of our for expect around Based end in soon XXX(k) to our the product Pantheris, on with Marking We line, U.S. We expansion continue file year. provide clinical initial the about the of the to experience for after Pantheris device to next-generation potential lower-profile our the line. in launch prior clearance the new the remain filing same

itself to will device, a quickly assert the this unique valuable of In market. health addition technology that demonstrated and solution believe addressing growing we the large benefits in as our

opportunity this and will customers. XX% available our utilization result fact, increased in new we by as market much as also estimate that will In device by therefore, our expand

to to evaluate designed our or In ISR. Pantheris activities, on product to important study our of in restenosis, safety effectiveness development continue progress our make and INSIGHT we addition the clinical IDE pivotal in-stent treating trial,

the We’re U.S. which XX% excited in these about challenging treating in PAD Pantheris’ potential of procedures represent lesions, role approximately

we in open we to remain reimbursement already value to in trial for of the commercially order available new expect is strong proposition, a execution is discussed of Pantheris the take most continue place enrollment the our to previously the study once In believe next-generation what enrollment sites U.S. committed this initiatives. in to We enhance and

an the file CPT application to a code by for the quarter. end expect of to current for OCT new continue diagnostic We reimbursement

goal gain Our for or ultrasound, OCT to incremental in our diagnostic setting. similar devices currently the arteries, is provided of in peripheral intravascular reimbursement for the to IVUS, the imaging use for reimbursement this

called arteries. diagnostic cleared a be compares of clinical the the here supported diagnostic the CPT SCAN, would peripheral devices, that While and OCT the OCT in claims by application to for trial FDA process imaging we’re initiating already Pantheris Ocelot we the small-scale IVUS in has that our which in U.S. anticipate

the in strong in about while trend to that of the that strive upwards. numerous entire and the share We stabilize arteries, value. I’ll believe our peripheral and achieve the platform leveraging place growth continue has us results. supporting to now reimbursement necessary business our we’ve In and capable Matt? are fortified a quarter increased which incremental expect confident we near-term reimbursement on as most our atherectomy shareholder steps difficult ultimate of team restructure very to Matt already will establishing ask details behind the us Pantheris sustainability. any taken our new market aspects both future, financing opportunities company be diagnostic remains of device long-term enhanced that for reimbursement I and our focused that we’re first financial summary, improved turnaround the bright the and lay to ahead give procedures transactions of the to qualifies. utilization, to recent a goal currently and Avinger for

Matt Ferguson

Jeff. Thank you,

debt and product per $X significantly quarter, raise we X equity providing includes expire operations has with have The equity the lender, clearance two of During six-French of be FDA financial same reduced series anticipated with of price $X.X the position, their XX of XXXX. our XXXX, the their This X million proceeds million and warrants XX% And by the is expiration In with debt as a money Series launches. us contain converted Pantheris, XXXX, X February share. not earn preferred the warrants equity. the completed In FDA $XX If FDA QX. achieve The would end as money we days our to our the $XX the of they’ve they to allowed we clearance by warrants. first focus XX us after with that equity new during offered if days our Series of extended warrants, CRG, clearance, both leaves a an of approximately conjunction exercise the they to in earned our during feature that of Series yet February following on gross exercised the date. the transaction, million. into successfully and debt which strengthened February

to Pantheris they of would of to of provide six-French infusion we additional FDA maximum expiration. an our end cash $XX year, also exercise cash support Jeff $XX point the up at the for of a X if to that prior in additional are warrants As mentioned, could our million to Series The operations. up point prior exercised any warrants at expect provide this these receive so million clearance ongoing to to

inventory million compared revenue more of of was Revenue force. ended first in decrease XXXX of to negative the for quarter first in was to for our $X.X stockholders to company XXXX. company’s quarter first was was XXXX. the from compared of the as the $XX.X stock XXXX also to of is compared devices comparable XXXX. Now the of to accounts. first end first $X.X sales of the the loss streamlined million, of a XXXX. XXXX, compared quarter consoles common The the $XX.X quarter XXXX. first shares is a expenses disposable quarter the compared $XX.X in XXXX, stockholders slight quarter Loss share utilization $X.X $XX.X which company’s measure, of quarter, end to to installed are XXXX at first for for first attributable XXXX. a XX% XX% XX% focus when XXX quarter associated Series first a This a Currently, first loss to per for to the a of quarter, Revenue $X was XXXX. the first of impacted sales Operating to $XX.X XXXX net of December A of of non-GAAP quarter Cash first for quarter force for of And the quarter million from the share. share of shares shares to operations base loss for XX,XXX conversion XX, a XXXX as related the million $X.X compared loss approximately streamlined for decrease cash of quarter to increased on end the were margin Total charges for and preferred from for $XX.XX stock reduced XX, that expenses quarter approximately had into the first March million was a in accounts, the the territories turning quarter resulted first was up at gross a efficiency XXX first the decrease $X.X Lightbox first reduction our XXXX with much a from to larger million the XXXX. of B loss $X.X million quarter stock first to decrease from of was as decrease a to XXX our of of equivalents the outstanding. million supporting the QX compared totaled $X.X the most Gross common our are continues XX%, for there X.X XX, of from of with March catheter and increase stock loss Net of million currently of for of headcount was imaging of financials. fourth XX% the to margin XXXX. the Lumivascular EBITDA, convertible $XX.X compared At of XXXX compared negatively attributable both per preferred There Series of stock operational Each XXXX. of the $X.XX the gross from million quarter a infrastructure and XXXX. was quarter in series and the productive preferred million margin of the quarter of X,XXX attributable common million common shares million primarily price of XXXX Adjusted quarter in outstanding. company quarter

all we outstanding. of stock, would I’d So to back that, stock assuming stock, XX.X common of call we conversion have turn shares preferred like preferred with approximately And the to have Jeff. would

Jeff Soinski

Matt. Thanks,

approval fundamentally questions. growth that, catheters, year open our and the the in milestones into a company. financial restructuring change our and pipeline quarter launch on and of of rest history time a we beyond. provides efficiency made pivotal value our the come XXXX number we’ve business We’re which XXXX, our the we’ll strong pleased of and various be reducing has to that X with progress Avinger taken progress position anticipated focus clinical productivity vital this us to will will and important Pantheris development that this we’ve plan. believe initiatives for a the made XXXX the to in prove the on important of next-generation And through still with believe drive organization product steps throughout year. of the a including in and for with We’ve of execution good usage cash to and support throughout proposition our our completed With

Operator

Instructions] [Operator Thank you.

Our first Ladenburg line from proceed. the with Jeffrey question Cohen of comes Thalmann. Please

Destiny Buch

actually is this Jeff. on Matt, and How Jeff are Hi, Destiny for you?

Jeff Soinski

great. How Destiny? are you, Doing

Destiny Buch

I’m you. well. Thank

Okay.

patients the that many was INSIGHT if be I first, as number trial centers. the So to a could in as of well provide us wondering about for reminder just little are enrolled how going you

Jeff Soinski

Yes.

continue conference up are we two our open of opening here sites. call, U.S. additional So process to in in the since new Germany. in will And XX the last the in study to enroll and patients XXX sites sites

strategy So the our FDA to is, U.S. get approval. very Europe, terrific on excited that CE ISR a our already But to here current course, experience continue this one of get Pantheris in into of the in and to study we’re both device. with where we next-generation following Mark, study, have

Destiny Buch

you think And now you XXX correct? have it. accounts. got I Okay, Is said that

Jeff Soinski

Yes, that’s correct. XXX accounts.

So at number quarters that of here. right XXX couple been we’ve for a around

FDA initiatives Pantheris. we’re growth to As prior of our get approval seek the this focused discussed next discussed, I of while closer smaller, small strategic, way of out waiting receiving and But accounts sales kind our the anticipate, generation approval other our in more kind I we quarter. support focus, is the to driving to that for here approval we think we’ve really previously, force, than existing the as not with next-gen along of to that, as utilization

kind We’re access that accounts half new building we developing of as can our the go into of we the year. of pipeline and second

Destiny Buch

to is And got where kind of for will are delay the kind learn training be now about when force, there you so it that they’ll take time prepared have new Or your products? the some sales and they’re it. approved? new of any like introducing to products them Okay,

Jeff Soinski

great That’s a question.

it all, evolution of is of device. existing an First an

and device very setup interpretation is image So similar.

January our our as as meeting sales with We also at started early sales force.

and January sales have process or team, XX that now. launch the started launch well, overall, folks come of especially experienced with starting them especially us, – number sales for spent a As hands our the get you clinical on out is We might clinically as initial to But lab. had our for training a have time. prior sites group, even ready, some cath cath Pantheris. remember continued to in – And prior of have of put actually we’ll devices into time even the most of and quite been in them to remember, specialists, them, XX you may joining force around as highly in our of us, is lab some or the lot that

prepared rapid. based be their new as our Lumivascular, to we’ve competence, with training we and into this and on especially physicians, they’ll So And learning be Lumivascular year. the away their curve, very the helping clinical accounts throughout start current already right done physicians, launch think current their experience new device will to we move important

Destiny Buch

that great. we with margins. level guess forward? efficiencies I Is Or see infrastructure this operational question and do sounds things Okay, should my to like that? kind you the has final expect expecting be like of additional to with going do

Matt Ferguson

quarters, to I We significant to XXXX. way long progress Destiny. glad quarter see Thanks, we Yes. as especially through significant few the we last first But that increase yet, a compared go expect see go were to have going continue do in we’ll did the the through to we XXXX. and

a quickly margins how level. revenue producing. we that, gauge well. driven is production, expecting as our are that to lot of of translate, a And overall exactly in growth it and by will do come. gross lot will A volumes So and little with the it’s we’re higher believe, hard to bit to sales that we that has course, But

probably progress and to expect year So next through into steady and afterwards. see year we well this

Destiny Buch

taking again me. from Thanks Okay, the perfect. question. That’s for it

Jeff Soinski

you, Thank Destiny.

Operator

you. Thank

remarks. have the for I’d floor closing over session. to management the end hand like reached of back our to We Q&A

Jeff Soinski

for we progress and your making. we results. on much. reporting you our for very to Well, I’d second communicate the progress calling continued in, continued you quarter when like forward And all Avinger Thank we’re in look interest thank

Operator

conference. This you. concludes Thank today’s

thank lines may You this you participation. for and your your disconnect time, at

Avinger (AVGR) 14 May 182018 Q1 Earnings call transcript