Mike Havrilla Director of Investor Relations
Lishan Aklog Chairman and Chief Executive Officer
Dennis McGrath President and Chief Financial Officer
Anthony Vendetti Maxim Group
John Levin Levin Capital
Call transcript
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Greetings and welcome to the PAVmed Inc. business update 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].

conference recorded. this reminder, a is being As

I to Relations Mike like to for conference over turn the Havrilla, Thank Please would you. now PAVmed. begin. Director of Investor

Mike Havrilla

This participating in business of everyone. Good PAVmed's call. today's Mike you for Thank update Director afternoon all Investor is Relations. conference Havrilla,

Joining Chief Aklog, Financial and me call Dennis CEO, Lishan on Dr. the Officer. McGrath, today are Chairman President and

materially the made I contain company's those during in and statements. like to that and regarding the forward-looking actual specific identify from by begin, to you would Commission, that we Exchange of comments Before filings described results may results will call management statements, encourage forward-looking differ Securities PAVmed. cause the operations future events caution or which factors with I the the review to

submission, include required affect commercialized, Factors to, cost uncertainties environment. acceptance inherent that the may including regulatory and cleared authorities, advance research additional the to company's to company's of and capital are products and the market products and competitive raise the the are limited once development, regulatory when and products whether in cleared time by ability not but results, to

clearance to FDA products. from yet other regulatory or bodies PAVmed not has market received its of many the

of New are difficult from factors Many control. risks to beyond and these time uncertainties the may are predict. them to impossible accurately. arise predict All to time are or company's difficult

quarterly Form Form most with entitled other Annual these on SEC, in risks XX-K on see Factors may of For uncertainties list filed subsequent I, future updates the and important Part Risk description a filed recent in any IA, and further reports PAVmed's Report XX-Q. operations affect and Item that

from expectations actual by be intention affect revise those in the that to may PAVmed results which expectations likelihood forward-looking differ or law, update in events, contained based for statement or statements. in Except may those or the or obligation any or conditions on will any changes required circumstances as any forward-looking publicly disclaims that

be distributed will submitted As we just know, this our you by have forthcoming. shortly release should partner which and our press be

I over Dr. said, would Aklog? that With turn Lishan the to Aklog. like call

Lishan Aklog

keeping Thank thank up on and with since releases months us recent we of many active to business and our exciting during discuss call everyone joining financial been the Good you you months. quarterly upcoming you this that you our accomplishments forward last update press our results. more even been on our have know update have and Mike. to who in look the milestones extraordinary afternoon Those for

challenges a economic and exacted in weathering world. words our best keeping to first to this safe. Let loved many to a few months, your your of concerns as level yourself and and express for support as of that pandemic which, have industry, time you toll we all COVID-XX can and confidence on are our me us well you are I safety reach our on start the am and express us storm and moved nation few facing in and about on a a hope tremendous pray with has just of enormous that are I result all the as your the to health. out you continued deeply taken ones our and human as

continue partners family, healthy, are all critical their Thankfully, our and work. the and members PAVmed important of employees to safe including able

plans. structure corporate short-term address fortunate that to our and minimal long-term are disruptions to challenges suited our very well culture future with no are anticipated We and these

our tools been already and partners employees over inception. nation doing which have modern dispersed are the many our states productively since and are utilizing across example, collaboration already at For proficient remote they

challenges and spontaneously as has with they members autonomously future short term all culture a able still long our and when type to addition, term to always operate while embraced plans. executing In arise forces systematically necessary advancing team address our on special collaborate

like or a responding pandemic I how with affected our portfolio, product not give for to by our on are you has has business are providing general and updates been each those we summary Before affected. the you would that area of of how

financial First, and administrative perspective.

upcoming previously as we and fund balance more will which Dennis explain recently foreseeable as we for As in our milestones. announced future us completed the financing strengthens plan XXXX convertible our advance to strategic detail the November we full and sheet shortly, note through enables

through will as financing We until to be are continue sales our finance activities. or through we we commercial required able to to meaningful revenue also confident operations M&A begin non-dilutive that generate

has areas in result lockdown. focused Our management implemented team executive cash plan where inevitably activities throttled are of the cash a leadership a on preserving as

the remains headcount fulltime Our same.

employees the paycheck protection and program plan bring do trim understandably resource they our are we are packet. stimulus unique for makes to efforts and to This Our expertise critical the the us payroll. not eligible federal within

forgivable result a We as and in $XXX,XXX of application have structured proceeds already approximately will completed if loan. approved the

product currently U.S. operational the On utilize services the All testing manufacture remaining meaningful activities no with our a disruption the development, dozen of across our manufacturing partners these and we over and product. are partners fully development behalf. in design, essential side, their on in designated

only These it few The to are although any of outside Our without will components get chain already from already back has remained disruption. a source and supply a to CarpX following of do through also COVIdD-XX have year. short earlier commercialization. disruption continue parts CarpX intact we two online us we our sufficient of U.S. inventory China, believe manufacturers electrical parts are this the we initial so device these

front? What of USFDA, and including about has the EsoCheck. with consultant, with engagements We, for CarpX, multiple our regulatory active the EsoGuard PortIO, the help regulatory on

regulatory extensive materially consultant on this COVID-XX. yet I work that with has not report other none also our the have by to been ongoing products are happy We am portfolio that work impacted FDA. before of

bandwidth communication, working our on are on updates. and Our regulatory informal products assigned remote are tools. to reviewers the based FDA work also consultants remotely collaboration ongoing using fully have to our operational The to appear

Some not or formal science our COVID-XX would had the we that informal not importantly, delays we disruptions COVID-XX have and clinical are COVID-XX areas manage indication to commercial to actively our process. staff that related any any be has diverted activity. work where received related initial we should related in review expect materialized. Most concerns Two have research

From been have the a to commercial resources diagnostic including come all essentially is system challenge the facing while healthcare and we is and healthcare by Non-emergency system protecting obviously overwhelmed that essentially to drastically to care, workers. standstill. medical side, modify the companies The divert COVID-XX care fundamental currently has procedures, forced pandemic. for patients are and operations that device surgical the

come the assume predict online cannot up Although that when start healthcare among first is necessary we will it can't will defer indefinitely again, but things one engine emergency to reasonable the non-COVID-XX not procedures. since back to be

that Commercial virtual am because of of I working with are the the sales but to positioned or telemedicine sales been actually our will are remarkable so the team ground targeted fact, in ways. discuss sales has report being physicians not reps necessarily and activities beat, Shaun battle. our of virtually. the ONeil, to to missing without Chief I proud are, well independent sales also have from on Recruitment calls a has moved pretty to physicians training their later and in home frontline his rapidly their adapted Officer EsoGuard from unaffected COVID-XX commercial the they situation which Many on are in offices is calls participate held virtual using and

same non-COVID face sponsored research nearly I and the research by Life intramural our all is has companies. As challenges grinding with with that nationwide, as clinical and corporate activities large trials related academic clinical small we area sciences come activity. commercial another a mentioned, and halt companies are to clinical research trials managing including research activity

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principal patients. continue recruit actually to Some actively investigators

So efficiently ready enroll to online. are once they we are back

the go our and recent Let's milestones. upcoming accomplishments and activities some through of

to or Let and Esophagus with of our two launched multi-center facilitate launched me Barrett's cancer. In registered by test esophageal in trials highlighting start clearance detection EsoGuard diagnostic or future as vitro well In EsoCheck support January, dysplasia as an FDA regulatory clinical the Esophageal December, we IVD. the first Diagnostics, EsoGuard these. to as of as subsidiary, of some commercially our DNA available Lucid Test and only DNA majority-owned without

February. The patient procedures underwent first and their enrolled in was

pre-submission a clinical Lucid product Also our a meeting of with in many FDA safety in brought support February focused successful January, of novo we application. study additional on the held accomplishments. design on de a the PortIO

to validating FDA accelerated life expedited to potentially EsoCheck provide assessment the excited potential impact, are device addition review breakthrough receive for We in designation EsoGuard which, FDA CMS priority and saving and coverage.

the Pennsylvania in into Barrett's Hutchinson in with Esophagitis. University progression Cancer clinical major and both entered Esophagus of academic Center EsoCheck centers, Research Philadelphia, and evaluate sponsored Seattle, few Fred research Eosinophilic Washington We agreements the in to

patented Ablation without catheter thermal our which designed Device, before announced single-use We use do Esophageal our esophageal to treat can and also is ablation lethal equipment. capital for Caldus Technology to cancer highly and the to need a complex EsoCure progress to expensive new Barrett's dysplastic it product, a balloon disposable so

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our restart CE to pandemic received will EU for massive changes, and Just notified firm yesterday, our body, to Mark audit date a by which backlog EU of and systematic the CarpX of due regulatory pursue system June PortIO. quality it we despite stage efforts its clearance a allow the X to in

expand Finally, or property and advance to licensed prosecutions. and assigned as always, continue advancing we pending our allowances and success subsidiary its continue and includes have securing XXX now good to PAVmed portfolio, issued intellectual in extensive and patents, we which to

have We milestones to coming to upcoming us months. forward the for in many and look key activities

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that We hope to expect year. to in it complete submission XXX(k) development commercialized and and for later by early EsoCure XXXX FDA have

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We are to a we market the seeking FDA safety protocol. FDA support study during invasive clearance The closely resubmission XXX(k) commercially the tunnel carpal XXX(k) to consulted them recommended of with minimally and clinical development study for release. CarpX

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time few I brief on innovations we emerging projects are our on working highlights. update division, a you had in wish exciting I to more again

ear tubes tube each to estimated the resorbable seeks the aqueous manufactured care undergo bilateral silk pediatric DisappEAR of from and which replacements Our are one year. million revolutionize who children

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team emerging theses several on Both also in including ventilation and COVID-XX relevant working treatment support areas. conditions. of highly is ECMO exciting products, innovations Our cardiopulmonary products other areas are of respiratory the for and patients

pass now Dennis the will a mic for on to I review of our results. financial

Dennis McGrath

and XXXX results Thanks our good reported I XX, and brief beginning the will Lishan everyone. quarter the for afternoon our prior published as ended press was this year of in that call. financial were just December to release

XX-K available quarter accounting consultants will Our Form charges our early website the with non-cash Annual convertible complexities financing debt and lawyers, Report for next with unavoidable. remotely to coupled the working related involved on and week. staff at extension made fourth The our be auditors,

March results as well. Nonetheless, as reported part that SEC's Form filed extension XX, by the on results as they which preliminary available spoke completed as and on registration and even we time. as last half reported I was which XX. impacted at the that to today of March the December registration be you will also at Lishan XXXX providing that were working financial amended consistent related on recall are financing, in availability was statement home with process filed in the just the second challenges will to You November XXb-XX week, late The elongated impacted

the engineer trial research year-over-year related of financial the early were to sequentially. through set clinical Chief higher $X.X began development for and and The the regard went Medical reflects cost XXXX XXXX period with many up quarter. and for particularly incremental at for from quarter and Chief Operating EsoGuard results, the for clinical as $XXX,XXX up well as in same just about Officer in Lishan hiring, the as fourth IVD earnest trial million Officer, million, the expenses increase expenses, the which of PAVmed $X.X about So fourth in CarpX

year-over-year by were million quarter the expenses with and increase administrative General for financing $X.X were The the and compared in about sequentially. transaction million related fourth $X.X quarter fourth reflects November investor the same XXXX, stock-based The compensation-related the costs, sequential particularly $XXX,XXX an higher in XXXX IP reflects period and for financing. increase legal increased in costs debt increase an to increase relations compensation, convertible in costs the activity.

a loss loss net common attributable of share. $X.XX a stockholders of or reported common per to million PAVmed $X.X

expense provides in amounts press you our a the release enable a and to with depreciation, measures, financial table the occurring and these prior related related financing the compensation, to more understanding periods. release press charges entitled detail highlight other substantially However, non-cash charges costs. should non-GAAP non-cash current the provides the stock-based better Also, It along have like of interest company's performance. which

or months about per adjusting the from XX $X.X the ended will notice $X.XX of loss these three You that after common share. non-GAAP by million table GAAP the the charges, company reported adjusted December for loss

of of two transaction to received investors. just million received prepayment year-end and Subsequent the cash November net proceeds private XX, of the $X.X notes December last million placement week, from institutional had PAVmed company of XXXX. approximately the as with investor the in $X the

entered million. company the connection notes. the senior Series B recall, this option into these convertible note announced with A secured Series with was that will That previously each an in of for us investor B week Series gave You funding a additional investors last $X

of million very Lishan balance at the convertible have leaves in prepared funding an outset had balance our remarks. operations million to approximately January needed which million paid debt, we at cumulatively we balance to $X.X XX Furthermore, down as ongoing $XX,XXX. continue and to initial of the which additional of to alluded confident $X.X of just XXXX, earlier approximately are XXXX finance under senior had March as the is has December we access previous cash and will that Our a $X remaining

open up could that, additional with to it audience. our from operator, So we questions


Instructions]. [Operator

comes question the first the of Vendetti Maxim line from with Group. of proceed Our Anthony Please question. your

Dennis McGrath

Good afternoon Anthony.

Lishan Aklog

Hi Anthony.

Anthony Vendetti

like Dennis. of all Lishan. of, your most and the you remotely. It over had impact and for and to operate so Good they of going afternoon. doing been seems the much call afternoon facets your COVID-XX for has Good have all operating business across Thanks operating well, have continued also business. experience

to business little So of be that Obviously, is this the going that's fine. bit that is talk and a side wondering commercial could some if so side expected. delay was of a It's to I seems more about you just CarpX. forth. the resubmission. the But trials

had hard And take have you do conversation, the is wasn't have to them, where situation, the situation, would time this days a of conversations with conversations the believe days? on review? review needed If with current full at many with gauge the will it think FDA based So Or the they they are you lot over whether for period. XX they XX of terms your full process? the in it you to COVID-XX

Lishan Aklog

great That's provide to. you to And a about careful be can insights predicting alluded I obviously, we anything. But have Sure. questions. some that

This is same was them that a have of have lead supportive with know. on our beginning. is who that we we is at been the resubmission, of examiner the mention the involved didn't product. One this what FDA very I you application as And

you were guaranteed, not fortunate may we So That's to as know. have that.

the lack us the are us and with protocol setting for the So now cadavers, documenting and with the and who reviewing yes, clinical who in of the preclinical developing so thermal spread worked people this. the the safety, preclinical people testing animals on develop the study worked same to thermal

being any don't have with [indiscernible]. sense of proceeded affected the by They custom we mentioned, that have pandemic. quickly are I As acknowledged acceptance the they really They receipt. have

informal I indicates are communication mentioned, weeds deep As have application. the some of that the into that we had they

no always quickly. an group, slow things now hopeful be a the to same had that and would indication that that is have it's that resubmission a So opportunity down we is because because for this we there have been there move

But there there mean, that. we trial, is really to even information small data the no we and submitting a to through. patients, have go can clinical they way that predict would are amount is is I it's there though XX counter substantial of be that that argument and

we wouldn't quickly down want slowed that I normal. more move that things presume COVID. can I to So I than don't will say by are that But

same group communications -- indicates the the and the they have their reviewing we well that deep that application. we are that they that had it review are fortunate very are have into into some We informal

Anthony Vendetti

during bit commercial Lishan. you How just if little here? on EsoGuard more that give That's KOLs your helpful going? of color from feedback launch in could a is And terms initial very

Lishan Aklog

Sure. excellent. been it's this little sound asked, to has absolutely is going feedback Yes. been been a cheerleader-ish It's remarkable. I bit the mean, but

followed really on the have people ground. We

the Our doctors the people having the a who these conversations. well. the the conversations managers of and reps And these time very who on veteran on e-mail GI are, are going already Eastern are sales and are phone long contacted independent space is

getting have objection to all are we them conversations well-trained relates that these existing of We it. with handling and their is various endoscopy about feedback the how it got handle that And business a the these, receive and can take I people so to paths forth. ultimately lot

sort that who ultimately this of in who patients both is screened here an the understand to benefits group funnel bring getting not getting and way is patients practices. should of to XX% their expand a more of and not and patients They benefit enlarge that funnel to are are screened be opportunity there the the to

So esophageal who of practices run a physicians GH motility larger their have already and subset clinic, clinic. some of run they the

fit is in has let's concern and really this been, feedback sort within and these material. we get into The had get clinics. yes, And not of let's about rolling started any their where would in these get patients practices

extremely has can actually So procedures, the honestly we are that be substantial. they quick and and feedback pretty once to expect positive been able say I really uptake do to the

Anthony Vendetti


And to be will as launch be having you up are some conversations? going pent COVID-XX. there you commercial think by is these Do a demand stalled just obviously so

Lishan Aklog

about yes. point up of right. reps, their this It one relationships of because exactly, activity and was to they get of across started But Definitely, to yes, that, Yes. technology is talk I that's long-time that existing begin a lot to pick the process. and there still the physician colleagues are is able these which trying and phone

aggressively. of are can't proceeding been we but procedures, has The that only really all do thing somewhat So been has pretty actually right. activity affected

the And make you for time that and of so up pent ongoing. is somewhat because that lost currently described exactly will up activities it, be there I that will right, are demand think the way

Anthony Vendetti

back much. will in so hop Okay. it. Great. color. the I Thanks great That's queue. appreciate I

Lishan Aklog

Yes. Thanks Anthony.


[Operator Instructions].

Please question. comes with your proceed question Ahmad [ph]. Our from next Hafiz

Unidentified Analyst

are Hi. Good guys. afternoon How guys doing? you

Lishan Aklog

you? are How Great.

Unidentified Analyst

Doing very well.

Has Just guys guys separate Lucid confidential, you are as lined off you they that to that's anything? be anything plans know like thinking really are up. say? but safe there since there there say interested, have if there's a secure chance any just to Would working and stuff and don't Lucid the obviously, any of you you want many obviously is guys obviously, and that if that am running quick one the follow-up is the on I that, all to been have any chance, go would something or into to, We entity? can details with,

Lishan Aklog


Dennis McGrath

is That's frequent a of great inquiry us. that one question a made and is

answer to a am the a over very give that specifically mull so, I your will And am is more answer. it going because broad not strategic going question to I Board plan continuously.

include year rate that parent finance We is modulate for and this where plans up it activities burn can clinical are through at can access will Lishan level. debt. of a we finance and many points ramp Our us they where once went to that We that our from finance trials business. the thoroughly now have as there the bunch with

One, any days PAVmed's level and with the one assets We financing the our second inside of early we whatever of that sophistication as would of suggest, in form revenues subsidiary have private for or a financing, on M&A is evolve transaction been of proceeds that that you half. tool, the a a had creative financing takes, structures. which types from public it's different maturity to

I is as shareholders. the and decision as that, in available answer the and entity. your four future and be as about are look question, been So we although to no a made us with specifically opportunistic subsidiary interest take own But of be has best finance now, Right at we the suggesting in its because firm action that can't a will you inside this could separate something treat segment single divisions. that what to it continues ability evolve, to

Unidentified Analyst

I else Thank much all you hang my get Got it, you answer. everything. you so to back for really so you. appreciate going did again guys. and in. I get someone I Dennis. am let Thank much. Thank

Dennis McGrath

you. Thank

Lishan Aklog

You are welcome.


question your next from Our comes proceed the line question. of Please [indiscernible]. with Robert

Lishan Aklog

afternoon. good Robert,

Dennis McGrath


Unidentified Analyst

Thanks a of question. an requirement note I of non-dilutive sale to end in of financing. could of as that you. Is terms a round that June be come speaks present provide the if that renegotiated for to, latest of by is a an asset regards Thank believe the sale there something fruition? my provision about that themselves? of still a convertible in taking that provide of source acceptable context can we don't Is Just around asset, as you but an that? provision you expect could to It's to a much for

Dennis McGrath

thing. Sure Yes.

financing that condition debt, million was and be got Let financing, When bit $X.X a puzzle, me we or an just achieved. that prerequisite available pieces B the us two notes the of received Series expand proceeds a there $X to to million engaged recall you in $X to of Series that were your add option of A had we comment that net context. completed November will the million additional

waived, One of that level last you company, by that are indicated, the a of delighted that Investors financing he the at date our is waived of what week. the them value certain occur the that just involvement financing a a continued condition. with before would and progress certain non-dilutive as outlined condition was

an not lost that's have of that that. indication sight we Now

As on in multiple Lishan indicated engaged remarks, related parties. actively including we are with activities NextFlo in his M&A

are discussions assured speak ongoing related we point, to prepared specifically although there not that are to this So at rest to that.

question. your answers that hopefully So

Unidentified Analyst

was with interest. imagine In we Nextflo, that would for progressing go in that I and engaging parties presumably would are multiple up we terms the of of That toward clearance are FDA does. their background, as And helpful. where substantially? device It the talking also value

Lishan Aklog


wasn't in to clear that. mention I comments. on did my that I Sorry,

applications. best Nextflo think answer the mentioned So understand that way to I multiple as platform is technology, a as is, with of The yes. to

set we this on was fact commentary through that electronic infusion the our infusion you are was as always and before one the we and of most focused So the the center advancing replace had end to development that looking the pumps. of submission in to have application design control is FDA to product process the asked our year. And of

What's interesting expressed these in interest their we we set and pre-filled of pursue enhanced And because moving come applications definitely these around are started parties that disposal is to this is And they we to about. talking that that drug keeping and us the the So that back for applications our the for. particularly that beyond along have using been are informed we have other infusion actually other these conversations. to that's pumps, have infusions. have and ability inquiry infusion to

application we applications. for technology milestones ultimately different the even extend would that are start So applications into multiple agreements transactions particular for enter be this other evolve the or with acquiring could one timeline have licensing in parties way they with and certain that theory with we are that or

simple because them, along, that moving absolutely because both also answer we is, the said like yes, does it the we product. But but are fact to Does as in enhance make you product commercialized sense? would the eventually

Unidentified Analyst

Thank you.


[Operator Instructions].

Our John Levin the with next of question. Capital. of Levin questions from proceed Please line come your

Lishan Aklog

Hi John.

John Levin

doing. Hi really Lishan, was I Dennis. me. The ask am I wonderful. It's outside, terrific. Congratulations to on regarding presentation hard are all hear it's you EsoCheck.

forgive So me.

Lishan Aklog

fine. I can hear you

John Levin

-- Why am I what? tell not able to

Lishan Aklog

can fine, John. We hear you

John Levin

are an COVID Why Okay. sell able it to of yet? is impediment. you I understand

to actual sale? and reason? impediment So technical the it. is What is have said there missed getting it I some You may

Lishan Aklog

being performed. are The is that Yes, impediment simply procedures there no

EsoCheck, perform billing, to effectively send sell to a the laboratory sample, So and performance then to physician our a EsoGuard right. us for for procedure, a get has for and sample

It's there we now. no are is to come performed, procedures that inventory no wait have with. of up stocking right non-emergency because just being to procedures So there sort for

about are sell So thing doubt we will open demand. them. able to no we up There's once that. up, building And

John Levin

I you. into get will understand. one Perfect. I patients, Oh, we the -- have done they favorite office or But have vulnerable most most to Yes. guess I assumed said, would sneak the our and for would

Lishan Aklog

Yes, for them equipment might now. you have we purposes, But that is they with and you it actually than by informing come to forth. can't about back. forever. There back But cars creative so for mean, sooner as of passed conversations because I some think to wait really come them, right had none wait has will practical them

John Levin

Yes. I no was sure some to procedural -- just there kind trying impediment make or was of regulatory or

Lishan Aklog

things all. were Not to yes. at No. to halt, came then the races and We a off

John Levin

the off Well, up, when if you to I with are may, let races. me follow that

Lishan Aklog


John Levin

What percentage of was and horses ran ran? the the many you that the patients when how are result -- what horses with races, the at

Lishan Aklog

started. Yes. just getting were We

only And we They handful physicians procedure. and two down. at were shut fine. their trained. the things before The those patients cases a went Those able were sent. sites had samples of So were perform to staff

now maybe a everything as speak. regard. But close was contact But with elective handful only XXX that before mentioned, So procedures end. started in to successful as it XXX, was are to well we over accounts in the we right I

gearing to priming are they up conversations, up. once those go So and open things

John Levin

Right. Good. Thank you.

Lishan Aklog

John. Thanks


remarks. reached now to We of back for turn the any session. question-and-answer call management will the closing I have end the

Lishan Aklog

to us for look via to periodic continue which at you you Thank our We for this questions. and apprised of any directly many you of conference afternoon such with encourage as Mike your this stay We news our in joining for Thank have keeping progress calls questions today. and joining all releases you with to contact forward one. you

You have a great day. Stay safe.


today's conference. concludes That

disconnect you may time. have your You participation a at this your Thank evening. for and lines great