INVO - Earnings call transcript Q3 2020

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Operator

Good afternoon and welcome to the INVO Bioscience Science Third Quarter fiscal year 2020 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note, this even it being recorded. I would now like to turn the conference over to Robert Blum with Lytham Partners. Please go ahead.

Robert Blum

Gary, afternoon much, very you and everyone. good Thank us INVO call. Bioscience's you all quarter during joining for conference Thank third today XXXX update

those Joining of as is Steve us Business Development, Officer call Chief At of on Officer, the Campbell. Executive conclusion and advance session. addressed try questions that received prepared will INVO the open VP Shum; Company's also we'll remarks, the well. Bioscience's well and call submitted as We've of in we Michael to event, Chief get today's Operating for a as today's question-and-answer the were

no Harbor for Private of operations, as the regarding business the the of plan, made future we well INVO anticipate, objectives growth and beyond achievements anticipated results position, may of to statements. differ risks forward-looking of opportunities, XXXX those many XXXX. cause performance conference the that forward-looking the to of statements competitive Securities should, financial from such the services, which statements similar obligation with statements XX-E are All the Commission. statement. me Securities or flows, forward-looking result words as as begin or we call Factor forward any of the and results, disclaimed management Company's plans of of to in over Steve, financing and Section a or statements include and to the of INVO the may alter on as control, of Chief by Act amended record, call forth for Steve expect, obligation and Safe Bioscience under involve following may Before of Company as XX-A matters of this meaning Officer strategies, filings achievements. cash results, discussed other Shum, and plans, or call uncertainties with let Executive amended, All pursuant please whether to future positions, could, act events results event Reform Section operations, The the expected information, from estimate, Litigation provisions products the is within as are may, Company's securities those and Company's actual statements, the said, Securities turn submit the be management the update that XXXX actual contingencies, expressly differ-materially that such new materially performance Act in will, Exchange Bioscience. believe, set forward which are intended, the forward-looking Exchange Certain proceed. for to With statements looking looking otherwise. expressions future statements include if,

Steven Shum

of appreciate all Thank the you, joining Robert. everyone our call We including new shareholders. today

with on call As Robert Development, and Head us. our Campbell, mentioned, Mike is of the Business COO

efforts our As a you many commercialization provide know, of updates key activities. leads few and he'll Mike on our

into and large public our NASDAQ. this simultaneously proceeds Company $XX.X and OTC was make piece what highlights, details important our in of offering to few week the million INVO, put completed onto an place jump we a the and raising future summary points. long-term we off for Before the markets was a This we week, believe foundational for critical We as I success. gross moving want

testament which the year the last strengthened early execute, the which recently that this financial XX to developments and of position revenue that highly headed implementing successful commercial and year, dramatically a a further in success with a the business all model clinical really the Mike position. by occurred Alabama, Birmingham, that just practice, real year, of usage data, validates in key INVOcell, clinic resources our INVOcell with into market attributes partnership or has other financial real we further have available highlight drive for often Our think this second business sheet critical demonstrated and starting which The balance we've team the throughout now compliments last the growth so, demonstrates INVOcell. profitable really highlighted was really of year, the and is building we months the made bring over

as small necessary of our we more institutions was in for one. group Company participated. presence We complemented an excellent completed to me of Company. to reverse we team, as appreciate build Throughout help quarter. offering, and minimum, opportunity We group was with we expertise Speaking us the and come process, this that and respect improved INVO's of right part envisioned, Sales are our an to marketplace. sufficient, members advisory quarters and necessary the not we corporate it lend we the the for front in our first partner have committed to and week. their be that, volume we was the and we feel Segal, place, during our all to the four reverse understand valuable of value Board which originally and recognize individual third as to briefly group saw complete the our somewhat the their let ensure with excel. and in the announced the Board thanks for of additional share the experts. would the move agreement of really are requirements this under we which about whole our Advisory NASDAQ. forward, in well price a to positioned second INVO industry this talented and our in of shareholder With independent both the our guidance quarter believe recap willingness efforts formation we for for a will add in of is dimension be another that give shareholders, earlier all Yesterday, Barbara sincere industry that over new to their initial members second provide Collectively, newest financial the guide in brought this meeting advantage we to important of institutional more addition price but also resources the of necessitated accelerate feedback to also investors excited and the the excited this would participation. to the governance. strong conduct split could and we but first we how offering, also members for The our Scientific individuals the add we the period filed annual terms Szot aggressively Ferring what during results participate enhanced larger future. confident thought Ryan, expect and before members, and Company part order order to task We value the the We the the pricing minimum Board stronger deal final us than Matt offering, Board sales drive to will shareholders that I'm opportunity really Jeff year had to take With highly so be the this of did in

fertility As operating. the COVID-XX in are industry the previously has general mentioned, impacted clinics

which number are the more think indicating We've assuming the the in bump the a running help for of to to many pregnant, of INVO pregnant course that for a risk fewer reduced some as reports needed fertility seen system, virus. help addresses also of that we the COVID-XX may future. might this lead an points, has at past be for even of expectation many need interesting already capacity more get There affordable do implies solutions care move get certainly still Although, costs not large can that start this of and fewer add become We we given as to within both capacity could couples a couple constraints an year, financial coordinated. attempting in that industry hear feel trying too well year. those we the distant and to lower solutions greater to to reduce births

and of our This which option cash, we important make a that convertible to debt to approximately the make. we in Excluding expensing, We XXX,XXX completed non-cash fixed period our related noted, million our resources gross that offering point the and with the already base sheet, our to largely as XX.X the loss quarter we period. our charges the to in needs ended accounting third for our went XXX,XXX the size week. is believe treatment operating of plan. this have had one beyond now fund strong With our two in we I'd of approximately the we have our we It's the of the or plan. intend also with offering that with consistent balance team believe exception our place to put note member now team we internal also additional planning. and infrastructure largely execute

to sheet that execute added deal or with well partnership to upfront These strategy as However, INVO establish enables partnership the require our share invest strength market as procedure INVOcell. the also operation, NDA balance in our were our the to us plans. we ability U.S. affords like revenue activities than but recent us the the us of device. partner participating also earlier Mexico to the build just for It larger rather our then per a selling

and track like from percentage. math measured So, Mexico our have believe and ones to and pace, key a ROI a we partners a operations pursue up The appropriately very this and is intend what for record that attractive depending see as activities facility did individual to the teaming interest XXX,XXX anywhere upfront we each is successful investment in with We these of win-win. clinic preferably we our prudent a is the the good but partner. on XXX,XXX, reasonable, already with

me let few commercialization hand this to I general over our Before efforts. a on Mike, make comments

are within how certainly instrumental. earlier practice. that like base early technology our customers clinics market in utilize clinics also These has U.S. efforts. commercialization can in data market to part knowledge adopting has that honed validation bit help Likewise, blocks early one became of a potential successfully as how usage we is validated we now learned the best also implement and across to team we've to knowledge spread Ferring implement have also We have since tool market. available efforts important enough further technology, that second a have our and broader certain to available working with year, and how one really off, a important that First activities. the see we our Birmingham when our us commercialization say quite days around the partners. the year, that that valid just a not building Also leverage The their overall invaluable to feel the of partnership been to to this our powerful new and real

to approach global commercial activities. a taking are our We

partners the objective find these to technology Our a in best now which see the existing particular within ways routes deliver includes within clinics, market. marketplace, commercialize leveraging help technology feel is infrastructure IVF also the to INVO can that our and to to which clinics, developing or the multiple standalone only we we OB/GYNs. new delivering of the And

Mike me comments, Let some Mike. additional to turn this for

Michael Campbell

Steve as and you're well. thanks call everybody interested if thank Yes, on the today,

our to I'm So, updates course various markets stop U.S. of activities ongoing commercialization in I'll going some of and at provide the the on some

on distribution IVF procedures partner, an this integrating on procedure conducted being COVID impact to had number Ferring has focus while into certainly our practices the First, continues year. INVO existing a

increased utilization are see mentioned, online expect going these of back products Steve many and As to forward. we

many the process, equipment both I up INVO employs additional resources of in patient IVF capacity any which adding have think throughput of is increase of one allow people. streamline its and when to can without benefits that procedures

partners drive market year, So in addition to focused within help on awareness patient the IVF demand. also to creating is new to this Ferring overall training several itself

XXXX, patient in data this Another procedure data culturally mentioned, began XXXX separate the lower as during culturing. Reproductive release is to our or as And are IVC I and VIVO with INVO with to of SART. that at continuing which transfers, Assisted should recent data, is intra-vaginal outcomes favorably IVF the clinical the similar success factor XX.X% the PVT, is it demonstrated combined much outcomes XXXX, compares day most help Society successful clinical all IVC to by rates same pregnancy And cost. that the reported IVF rate was period, believe data showed the with outcome. consistent the in XXXX of of a in utilization, they what out in a in database. this Technologies industry to on or outcomes unique XX.X% that the a Steve IVF which is so grow and IVF a five And This

the believe of IVF process, attractive the with this to affordability patient So, an dimensional the market. especially that we will challenge make segment alternative

treatment as As a our partner in of commercialization U.S. part INVO management discussed be venture And existing have would practices. us advanced opportunity groups with only here to their to to the objective partner partner arrangements, agreement to option. establish clinics times set our Ferring, joint offering Similar clinical several plan practice fertility our INVO a of and with international only these is the number U.S. these establish we as dedicated limited

have to these near agreements ongoing be and with discussions in groups, We several future. clinical expect practice the finalizing of various some we

INVO perform provide the Alabama. XXXX, to the in services practice, procedures objective per model here This a were center Our establish mentioned that to In established IVF they a a XXXX, to center to to to and on footprints of practice. note mimicking traveled is for XXX early fertility procedures, about expected they performed dedicated XXX is after an procedure Birmingham, in procedures essentially approximately from facility. year XXX over it's their INVO these XX per IVF the AIRM Steven was this XX And States. were soon only converted in different month. that this they INVO trained and INVO Birmingham to procedure to performing patients year, XX U.S. interesting they pre-COVID, In

as still is expect and complete with same originally And XXX the lab AIRM at procedures footprint, same were same this small folks this the the at the So, least to year. the they Steve model. efficiency only established INVO business and a the increased center clinic demonstrates mentioned, model the as viable And IVF IVC of practice. procedure throughput and this INVO the validates personnel XXX as

within and before some again announcements Steve mentioned, making And be key our to year markets So, these the hope U.S. objective replicate partners is we practice right other here the as is finding successful here in of to end. the

O-U.S. physician and and Francisco Arredondo, an was Ramirez, technology a of the as Ramiro Steve certified market Mexico. Arredondo of into early respected Dr. venture joint successful mentioned, Dr. business entered opportunities, some his Regarding well and enterprises a INVO adopter a we partner, board reproductive and endocrinologist with Dr. agreement began his center who's owner his in sold of Texas fertility experienced a Dr. now to the in offering treatment San patients Austin, year due McAllen, in to focused the In Texas. on he opened this dedicated last XXXX. clinics bringing to INVO is patients, and in in success extending solution XXXX, practices only in options based to Antonio and Arredondo his U.S. INVOcell Mexico. several

Chris and the manager first Monterrey, returned The initiate business. And a Americas of location, with business in the logistics, a the clinic visiting will Ramirez Arredondo and stop development Monterrey for development the Mexico. Dr. to be just site Meyer, for

We believe Regulatory to will also Cofepris, submitted facility. which registration Mexican be gating a is we item up application this the the and that Authority, with this opening

the build INVOcell provide believe operations expertise benefits to his practice, Dr. will been efforts in in he versed From and allow accelerate years clinical of knows well Arredondo for INVO experience standpoint, we his know, not that a champion As successful but patients. only you all how to collective has a technology, many the in is INVOcell a build our Mexico. the and to entire and us the Monterrey, can to

we to forward. updates So, as forward I providing look move this business more

is to opportunity. potential arrangements. Canada of several really Canada. that recognize both resources, our in different venture discussions to for years focus other clearance The never joint turned partners and engaged we in fully from to of just and attention due we markets, we've Like able type this distribution we Canada when other lack a Health were number received The but recently Company ago,

many system, like universal for healthcare healthcare world we're a Canada that around fertility services markets still for the those network well. employers want private as Although it

process private within So executing we in this America, in sectors. and of be this both The of INVO the In same are plan. practices. inquiries an want in opportunities a America, inbound game offer that the just of now many shareholders there's us two these resources to are know in in their INVO there South marker to interested the fertility South that and developing we've let Canada, programs America and our I to important is a public on can for had markets, few changer here. and significant from a South lack was certainly

In success five day to rate addition the still benefits, of South cost these programs lower doing three transfers. many transfers a significantly American day are three IVF have day transfers than and

the practices day territory and -- intubation, technology. can we immediate for excuse impact outcomes simplifies potentially So our successful INVO me, on have utilizing five our an

the currently are that activity. their some develop hope able some discussions make in we of we these we're to and to announcements them with again programs practices, So, help on

So, initiated quite and split proof-of-concept in This markets Asia markets data active product help markets discussions in Europe with and numerous is both and and European, have clinics. we requirements. as Asia to and have IRB-controlled ongoing studies the the the we various outcomes registration some well, develop the as partner in important for

know, to we some country. INVO this dedicated to As partner restrictions, make quick announcements exciting We're you update venture before that over the with the Medesole it's the a for a back the a that we year, that signed joint activities everyone on I turn coming we've travel of clinics difficult open remained other India due just it in active. in months. announced year of to And but highly Steve, to to we agreement been only in earlier our number regards have optimistic in first

In is the clinic initiatives last as registration to agreements various continue the our still for working executed our process forward reduced. but XXXX. hampered the establishing lockdowns efforts, requirements of region, we're of some and many of we through distribution push a ministries targets now the late series year, first have first health and EMEA pandemic We quarter this revised have

and receive We reduced on approvals we on are product are have first commercialization We efforts. their up the registration focused from resources technologies working activities. Turkey partners these and Jordan, distribution scaling and with COVID-related did and

pipeline, a other Ramirez and summarize, to and close in arrangements So the extremely over Dr. Mexico, world. has global business We're now. similar full the allowing partnership excited to about we signing right happening Dr. are the team with of Arredondo development of activities globe all parts types in the

the are INVO increased of site inquiries. now you, lastly, are the I'll technology. of latest receive with the thrilled encouraged it Steve. awareness we being are we demonstrating to We with technology, back and starting And inbound that, the With the to efficacy turn

Steven Shum

Thanks Mike. Great.

are me original to our our here of, shift of if what three-day Let five. incubation on as and labeled a currently our activities But product most many FDA minute, based under marketed U.S. current the in and and practitioners clinical for clearance that was doing is mentioned, Mike day is as our not, a period, many,

product we So, expanding five labeling our pursuing actively. something important to is day and are incubation encompass

for that Our milestone $X effort. Ferring completion agreement also provides of payment a million upon

release XXXk received available two came to ago a usage noted in FDA. we world the have a this file earlier that the data. data earnings that from week, a this pursuing us few We market XXXk questions our months submitted real we paths, and option, follow-up additional the on second As was are retrospect based year which afforded

We by the questions we expect are a response submit January. response preparing to of to middle that and those

received clinical approval this parallel the data. also in IRB recruitment the this we event the near-term. We previously put begin We're to designed achieve to that clinical to that in early on forward looking effort activity study noted, we to need label due additional restart keep COVID-XX. year study, enhancement. prospective although plan moving As day a was to hold We five

forward. large for to-date we current underserved market. foundation in stage to that technology base, believe Robert, us INVOcell, quickly validation opportunity to Before global challenges. is a INVO which the users the looking especially sets like there all address I significant recently, patient has back this and large in the space, provides recap, for solution an And of further work and one capacity hand growing come more And is the infertility a very available existing a can exciting a

give especially With a in we While high generate for we're bring to strong activities open that. we we year prepared some not can it revenue, Robert that at as online guidance with increase questions. partnership up specific next I'll our believe initial for level,

Operator

question-and-answer begin Instructions] now will We [Operator session. the

Robert Blum

question in the not retrospect [Operator you Instructions] have I questions you XXXX you when data, a data I'm received. timeline here, a may the get be released? recently that Do if data Some start here. XXXX came data that on described compares mistaken. There's

Steven Shum

in released they April data when how is If to or we around see provides to the expect validation. data data they've that start data INVOcell. timing the of released XXXX year. somewhere And that We next further the Sure. that data. all, that forward of usage with each looking we consistent probably we year, of would further expect would additional yes, show to And seeing were increases it timeframe think again,

Robert Blum

to in utilizing or yours is, FDA the The here back a well can respond timeline it mentioned you you world submission question that real expansion remarks. that support that is XXXk press next that the you might this your a any the provide as timeline in perhaps in data response? relates as mentioned The prepared to question have to the and you release, FDA to there obviously label application

Steven Shum

we the probably March reason why like important that's it's clearance some needed. if to fronts. And Yes, we feels we'd likely the is to our on in they the FDA we additional the support, trial helping with if will like we us from that, additional enough late application, then. effort hear we would continue clinical timeframe. to February, data we support receive event, have FDA this response expect provide CRO have with In early that know, a submit the back the both that to after additional exact need data fact And

Robert Blum

here. question have We Instructions] further one [Operator

for IVF You of centers. Any simply an the to opportunity OB/GYN being you discussed opportunity? as relates market the beyond updates OB/GYN market provide opportunity can here, it terms the INVOcell in

Michael Campbell

fertility is an that topic that this is bring network I'll market believe downstream to to these take need advanced the one the the dynamics, Steve, what's we most interesting is provide treatment what OB/GYN to into necessity them. interesting and solutions folks and and the

is due XXX this and So, demand. centers capacity And this IVF significant to business major in and the I today the to IVF when here and are in XXXXs, the of constraint Well, IVF this to necessary REIs there we approximately approximately is administer qualified U.S. get the early amount into meet needed were factor awareness. centers there available procedures the U.S,. believe in embryologist I think the second patient XXX

And So, low the one have the treatment getting as have Most be is referred XX% also care patients successful unfortunately, of the have reasons do to a success only and at and the and or pregnant. options center. showing option patients treatment rate This this fertility XX% has slow OB/GYN, IVF you be why unaware of to economic up. the INVO for to within most they're are the current At of available simply these not process. treatment but these this the physician, utilization means of been referred up IUI INVO physician point, -- best patients of option options not extremely not for is practices an plan. to as their out IVF treatment do patients these their OB/GYN insemination, patients know, stopped intrauterine such they and journey with limited fertility primary is

can going of successfully that with that, OB/GYN to embryology perform or believe start same and Ramirez procedure, Arredondo transfer requirements. Dr. model utilize proper process this in with for retrieval planned I'd OB/GYN services support OB/GYN and like plan training the yes, with So, this practice lab Mexico. execute bring into also would They're the we the is the to the these practices and note and Dr. to INVO process. we

Robert Blum

Perfect. as closing here, additional will you, Yes. I you for to questions over I Mike. remarks. Thank Steve, turn back it no show any

Steven Shum

the I I follow-up With do if to can think listening call guess on please Great. us. really Well, to and anyone the everyone up appreciate any we in reach again, has today, out not call. close we that, questions, hesitate

Operator

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

You may disconnect. now

NAYA Biosciences (NAYA) 19 Nov 202020 Q3 Earnings call transcript