AVGR - Earnings call transcript Q3 2018

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

Operator

Greetings, and welcome to the Avinger Third Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chris Camarra, Director of Client Communications and IRTH Communications. sir. you, Thank

begin. You may

Christopher Camarra

And call. thank third participating you. all XXXX you like to today's I'd Avinger's call. in welcome conference Thank for you quarter to

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

Act those products; assumptions of Securities trial Section Before we conference Exchange dependency results; demonstrate cover and that requirements Section contains of are use statements forward-looking product to the to risks materially. reliance the the commercialize products clinical third-party of of to call than and of risks meaning of XXA number Safe as on as differ our obtain in the statements of demonstrating cause beyond the experiences These XXXX and and and forward-looking elsewhere platform; less not Company’s the adoption; Avinger’s XXXX update regarding regulatory statements of proficient; Reform date November that Act like should long-term safety begin, the Such Exchange in the be of vendors; personnel; as I'd lack dependency anticipated better Litigation outcome to results unduly high-volume platform to on reliance statements litigation; obligation Act related uncertainties of the that Form requirements With include the exposure statements. XXXX. the Company’s based the Factors" Private data to Avinger’s to of limited to of Securities to are Securities risks These any resource and property on described Lumivascular Avinger’s patient speak and within outcomes said, Jeff. involve which of on their liability, may the well XX-Q that now control, hereof "Risk Commission XXE with of call other August Jeff, potential actual forward-looking made Company’s products; their Avinger’s section offering. approval ahead. like This Securities proceeds the efficacy third-party other forward-looking from the on Harbor only being XXXX XXXX. the these XX, could of These key the are over Quarterly a on public statements to and of and Pantheris; benefits entitled products; turn and relied many physician and physicians uncertainties, and upon. Avinger please to filing current Lumivascular go lead include disclaims intellectual ability users outcomes I'd of statement.

Jeffrey Soinski

afternoon progress execution Good continued our I'm you. joining plan the and and to excited you us. operating thank make on Chris. you, We've all Thank significant this to for share of with update

third our system of development submitted of the we imaging in and expansion arteries. Pantheris hit peripheral the in new other made clinical image-guided key a milestones in our compares programs, in vessels and quarter, for XXX(k) for commercial SV During smaller We device. next-generation our application atherectomy treatment Pantheris the atherectomy the of completion which enrollment products IVUS SCAN to the including we study, important OCT advancements clinical of pipeline our

continued fifth our property also patent issuance intellectual U.S. We expand of to the with portfolio our Pantheris. for

direct of patents Pantheris, which we've in like July proceeds United completion updates underwritten two sheet and report a to of new our continuing total this our to of $XX am the some provide system transactions point, public next-generation clearance that proprietary make progress pending to able and the for image-guided a this registered offering capital in in our offering and broadly system maintain an limited and improved first artery further patent in issued patent gross have XXX(k) a States in related We we I'd to launched added this June. balance with to of on release issuance for cost from XXX of treatment lean or installed XXXX to structure. while May new also We've combined. million the November, our completion technologies. happy the received PAD. significantly peripheral the At or been other to countries more following the only disease and filings, now provided base I atherectomy the With U.S.

We physician exceeding the important or clinical with have high since most and quality, and the performance of pleased expectations. been our customers’ our reliability, meeting results, device launch with

focus the During Pantheris. supporting team's utilization penetration and expanding on next-generation third was quarter, our sales of

and next-gen cases in the during the the revenue period. with $X during the driver were third announced sales million Pantheris successfully procedures along as growth and on launch, compared sales second quarter XX% performed sales three we first in catheter over quarter the for had months. quarter quarter months to third lower third increased of accounts XX typically XXX primary Lumivascular the lower seasonal focused in Total in physicians with were summer new Pantheris we with elective Pantheris flat the the the next-generation September, of treated relatively that capital was device. quarter patients Within our based of the trends second for on

to of next-generation with expect in new the our Pantheris XXX pleased position our quarter. driving the accounts a Pantheris be building potential and fourth further high focused is and pipeline expansion. a to to case of utilization to announce installed quarter, this expanding for more our into progress As on We're base end sales prior of accounts, team existing and our look next-generation successful with we

basis to pipeline the quarter measured a of expand forward the products, introduction presence to our looking in to the With next-generation headcount quarter we've sales and our sales and We XX the fourth the professionals availability XXXX. and our of building sales anticipate of our made at also end in progress third increased device our on continuing salesforce. throughout

team three our we the to to as for and increase adding accelerated of XXXX. per professionals in the sales business position growth expectation Company quarter, the With two

application regions a the we profile Vessel sites We're and position of first Pantheris of and introduced new Pantheris cases half has SV the initial Pantheris address as In this disease. a potential distal for the patients as device improvements the as about that Pantheris atherectomy to the designed of larger care the treatment in XXX(k) with vessels lesions significantly was modifications procedure available the XXXX, allow Pantheris as Marking, distal more Marking new in clinical market other for expand excited and lower platform Union Pantheris allowing with market. to allows the on Administration Pantheris countries of portion that Vessel and CE the a Pantheris addressable the receive SV atherectomy procedures now we SV SV of our perform to the longer diameter image-guided at early improve expand look for XXXX CE to By would XXXX. intended Marking and Small SV Food believe clinical additional for CE incorporates Pantheris August, SV in of business. diameter treatment life our the to XXX(k) On innovative system for clearance more potential or SV. Pantheris we'll system. By this and number of of allowing for to forward for million of cases SV our Pantheris to we of vasculature. lesions XX%, in key much smaller the product for the recognize vessels the the device expand $XXX submitted commercial and smaller first with with well in Germany U.S. which to distribution launch receiving in received front, Small by simplify SV to reporting Drug and European physicians by quarter. our CE in to hopeful vasculature, we're in to it's We're target and us and first next-generation announced that October The Markeing. early a anticipate the estimated our we and regions the U.S. certain standard

significant first so mature data product the which for devices. further CTO completely our the is currently Over line artery and world to treatment to strong artery, image-guided progress or available a of used which are guidewire only severe through a form a and can CTO catheters, is and introduced can that crossing and clinical We extremely be This device used real the Ocelot to is reliable the clinical occluded in market. create excellent provided. CTO next-generation refer quarter, on blocked be results. family the market stands devices occlusion, totally crossing we've also total a made crossing of past passage a CTO chronic development of PAD, blocked

and EU This imaging will CE presence which arteries, of pursue steerable improvements the CTOs. the introduction crossing of use of up We XXXX With platform we countries anticipate call a at the imaging maneuverability. spin being half the the see first and opportunity U.S. RPMs tip these the definition Marking a will speeds X,XXX period. we other Ocellaris, We other expand to for same high further device designed FDA precise ability system, release during and the and commercialization the development the improvements, a we the application number is incorporate Mark the peripheral XXX(k) OCT of advances believe treatment our and use new including in real-time, to the specialty and the arteries. system to market. for for our initial expect in that of and Pantheris competitive This leverages the CE advantage of the Ocellaris and for CTO product next-generation our submitting to for peripheral to for Ocellaris in

the proprietary the surgery devices a arteries, highly in which the substantial In provide of blockages believe invasive bypass platform unmet a medical coronary coronary development a which we community. the represents addition, strong for believe for image-guided we in driver and of total were need will CTO-crossing

progress in tomography also ultrasound completion post-market In IVUS peripheral or study we we announced a or on intravascular a August, OCT arteries. to quarter, with Pantheris the clinical enrollment SCAN in the study the optical good third the During study, clinical imaging programs. coherence our tool comparing made diagnostic of as

a to be physician journal be the position from a initial to and peer-reviewed investigators XXXX. to results by this final studies quarter expect in to for submitted SCAN release expect results study in We publication the

performed clinical a continue multicenter for lower restenosis, sites in evaluate Pantheris to addition, or now arteries. being our sites is has enroll Pantheris and In been year. next-generation this opened by approved treating effectiveness of for end the future and safety to The We INSIGHT use cases INSIGHT all in to designed three we the study, are the extremity the the INSIGHT patients to study to more ISR, for IDE and clinical with study add trial. expect four enrollment in device. have XX in-stent of

to look our continue business. build As our channels, support continue opportunities in we of market existing the we U.S. presence our for will sell expand and overseas, the marketing products growth and our we to to and sales to sales will new

strength of lumivascular Company's product over platforms we commercialization growth device in Pantheris now the Looking forward treatment based financials. discuss call differentiated XXXX clearance to our the we our the benefits on to for I'll a XXXX, as next highly the could approach And result, new are FDA of to early our turn accelerated U.S. believe Mark of Mark? SV current the we year. of anticipating and PAD. see and

Mark Weinswig

disposable experiences Jeff. from to This headwinds. and We Typically our the you, softness business vacations and abroad. see despite in device. was the pleased U.S. due seasonal our quarter, were Avinger revenues relatively that due quarter-to-quarter Thank was flat in third to the holidays stronger primarily some Pantheris next-generation to summer

a Gross to disposable let in from our margins million, quarter $X.X as million quarter. excess down focus was deduction supporting for was Total increase XXXX, productive to territories. relatively obsolescence XXXX. ended products in devices catheter $X.XX quarter, second for revenue on flat September our our to margin other of XX%. team Revenue quarter most XXXX prior lower me quarter Now the with the consoles for quarter and expenses. the utilization sales turn operating million was primarily was detailed charges and second the Lightbox $X third was quarter from imaging the financials. in third the continues and the to third XX, of The for the than higher due gross Revenue related

significant were quarter. are there the our margins expenses that believe to gross we continue our million We the to Operating for grow $X.X compared increase revenues. prior to third opportunities million $X.X as in quarter

tables loss and of million. quarter stock and attributable in $X other the was obsolete time in of for increase we expanding compared million from immediately for the XXXX to in is in believe preceding device, periods. the million we of are million operations net future territories our restructuring, $X.X quarter, expenses quarter excess common growth. was third seeing noted non-GAAP compared press marketing marketplace, last quarter compensation which to and next-gen mentioned we to items, it As the sales expect drive With third for to stockholders is key Adjusted the our the EBITDA, of a revenue to excludes measure our reserves, in as to that direct $X.X quarter today's third attraction quarter. release, $X.X the and loss in a XXXX Pantheris team a for XXXX, start prior sales was of Loss we inventory $X.X loss million

significant costs cost made have in and progress controlling lowering our We structure.

the shares excludes million we XXXX. which grow that million of XX, stock over investments as our XXXX are $XX of cash warrants. expenses marketing our million device, stock, roughly September into November This functions in as we totaled increase in XX.X one Cash of some million business, successful is shares of part sale making and our sales which $XX of and of shares raised proceeds With equivalents of the convertible XX two X,XXX of operating the approximately and the to preferred common million common stock, launch net the may X.X Pantheris quarters. next to

November there a million of into shares approximately is shares Series after the Series shares X,XXX XX.X of and into shares price were preferred fundraising B taking of of at stock conversion the common stock XXXX, of stock approximately preferred Series of of preferred X,XXX stock convertible the Company's account of effect XX, B $X.XX. common XX,XXX share September stock, As Each A outstanding.

Series outstanding current of the the price have stock, common of approximately all of Series the final would Company the any like million to this of remarks. of shares XXXX, for B presently September which At the conversion excluding to not Series conversion B is shares point, preferred call at the warrants XX, preferred Assuming outstanding the stock and stock back preferred I'd outstanding and Jeff, stock, A convertible. XX.X turn

Jeffrey Soinski

and important achievement performance XXX(k) Pantheris a pipeline with a growth of investments development to real milestones take Pantheris happy we'd beyond. Thanks making world CE pleased your quarter thrilled of we've clinical with Marking Mark. and and that, marketing be We're setting, product and and we We're number the in progress are presence the including our the for our SV. strategic drive made revenue this the to in expand next-generation questions. to XXXX U.S. of filing our sales with With advance approval

Operator

Cohen question question. this conducting at [Operator Thank be of you. line we Thalmann. gentlemen, will the session. Ladies and with Jeffrey Our the Instructions] first time, question-and-answer your proceed with from is Please Ladenburg

Destiny Buch

are you Jeff. on for Hi. guys This How doing actually Destiny is today?

Jeffrey Soinski

to Great. Destiny, you. hear it's hard

Destiny Buch

better? that Is Okay.

Jeffrey Soinski

Yes. you. better. Thank That is

Destiny Buch

Okay.

salesforce us Are the or you able us us on this do added you know is? you a to area? that. to moment, you’ve then had territories can quarter said sales least continuing what some So that just are were touch you kind general at those bodies tell long of give also for and to the I And wanted I a how remind cycle in

Jeffrey Soinski

Yes.

two ended of to XXXX. build we did sales in year way salesforce the quarter sales as to end all per all, of through rate quarter. of we to do three and XX about first couple and So the the the professionals at add folks third we this continue We a a people at quarter expect

as group advance. group building the large Our philosophy to in to build we opposed a as business the is build

managers areas, existing to both with business of We the are support pipeline new had folks We're to installed territory, high beyond operated bring in we've relationships our adding this our accounts really the and grow the pleased sales hires and initial clinical existing of in clinical certain who've quality as degree Highly well specialists as help and base. build experienced acumen. utilization a that at Company. space,

Company next-generation and our especially strategic device of Pantheris anticipated highly important as investment for this and the on back Company, growth device. and a SV we drive a performing prioritized revenue growth So the as highly

we little the as Texas, run primarily disease a as existing clinical as distribution volume support started drive we well. XXXX, build to an area, to to we've as we've very group now area, and PAD, continue in as to and or existing the going when at deeper reps you areas, Chicago salespeople Philadelphia and to to So look our add where we'll in geographical territories certain rep. sales build add it we'll geographically start specialists relates Louisiana, and look But volume add is, of accounts directly

we install base. you a have As large pretty know,

base, actively XXXX. where that existing to add strategy, coverage, Destiny? currently answer and an universe on only folks not our Does then we as that opportunity are accounts, entire We geographic strategically we see so covering installed but we sales coverage question your not through the to to go expand have the within

Destiny Buch

does. continuing patients enrolled Okay. And I you. have at the many that wanted Thank enroll how Yes, about XX then insight been to-date? know patients you sites, to it I touch trial. also just were to you said on

Jeffrey Soinski

increase to study. we've the get physician but enroll enrollment, in approval and at last currently about sales slower So shipping ISR the of investigators the our expect our to device to to we've pace availability in the working as clinical organization, patients focusing of little our device the but XXXX. into meet device partners into have We've because site we criteria. our study. put just a in our next-generation do the the go in enrollment. inclusion has calls, typically to to But focused we as not are rate our, study our that been of low-XXs talked accelerate new on that only desire now been the with the that and We're physician studies organization, through begun that we next-generation

Destiny Buch

you curious you. or positively it. stood the were from Got I was Thank of expected the feedback out on if – course? Pantheris thinking Okay. negatively, that you're you persons, next-generation guess feedback And then, what you or the if getting

Jeffrey Soinski

with users No, we physician is seen that things on I I the performance of and customers mean and performance And metrics. of the very one are are happy focused the with thrilled mean, most – in and We've importantly, improvement performance the we of on our initially of those really device. our reliability. device. quality the a device dramatic this primarily

most reducing maybe important this and the We good a really a been treat but initial diameter and system smallness longer to to to That to have a tissue Probably simplified go vessels. a which well down smaller this active a platform device our next generation not continue cutter also our also balloon for provides four this now at have may into the Pantheris we've that from single to OCT having generation spectacular imaging, in make SV we to eliminates for report that device. incorporate we're that of as which in the two also engagement. forward. surprised of procedure vessels you virtually in will diameter. as nothing, need cutter a balloon plaque effective we and lower very imaging, more was only two the results thing improvements the we millimeters new all so even is by positive length can business and But the the differences remember, removal did due system balloon system occlusion confident introduced refined has And just had our beyond that – how done but to as a we the how as profile, efficient is upside it in design, an

simpler is use. an it to So even device

certainly device first that to and anxious hopeful introduce early in on excited I'm the Europe and in So XXXX. we're be U.S. that very experience we'll into report to able

Destiny Buch

of the thorough Q&A me. Got for for the you That’s responses it. Thank taking Thank you. for and questions. it End

Operator

Thank question-and-answer back like session. over turn you. our this At and Ladies would does conclude point, gentlemen, I the floor to to this Mr.

Soinski any comments. additional concluding for

Jeffrey Soinski

call our you in interest forward thank afternoon. and the all appreciate on to report your you this Company progress when We for our Well, look and we updating fourth year-end. joining the quarter

a so afternoon. as presenting good issued release and was the at like well and information be you get will a much Company Thursday Canaccord have with also this the Conference updates. further We press to if webcast you'd Thank

Operator

Ladies lines we teleconference. and conclude and disconnect time. may for participation, at Again, your this you does gentlemen, thank this your today's you

Avinger (AVGR) 13 Nov 182018 Q3 Earnings call transcript