ADMA Biologics (ADMA) 6 May 202020 Q1 Earnings call transcript

Good afternoon, and welcome to the ADMA Biologics First Quarter 2020 Financial Results Conference call on Wednesday, May 6, 2020. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request and will be available on the company's Web site approximately two hours following the end of the call.

At this time, I would like to introduce Mr. at ADMA's Director Relations Managing Martin, Argot Investor Partners, firm. Sam ahead. go Please

quarter today everyone, joining Chief President financial Chief ADMA first for thank Executive results Financial I'm this the Welcome, Lenz, you and discuss Officer; us and and Executive President Adam by Grossman, afternoon Brian to for Officer. XXXX. and joined Vice Biologics'

financial provide During results. first we update, and corporate and provide today's a company’s provide then call, Adam will the Brian Adam will an will some provide quarter of some XXXX introductory comments overview then brief for Web summary our a remarks the first The up detailing before results. quarter on available site release opening at your release call questions. XXXX is financial admabiologics.com. Earlier today, press the issued

XXXX. comments, be under Harbor we formal statements constitute may differ call forward-looking you results such our in Before for and or detailed or subject such are announcing intentions, uncertainties today's during results which purposes All we making Safe actual Securities assertions represent SEC, concerning of I'll will provisions the that statements. company's forward-looking the Reform statements the to the beliefs implied Private those risks press expectations our the that Litigation which call with factors, and as filings release this materially in from cause to remind today's events, forward-looking by future of begin the expressed Act

that section statements. we Form cause earnings actual factors to forward-looking in section specifically of as only our disclaim We statements update views should materially Risk of represent as forward-looking any and notice a be recording differ any results We such our of statements. to report on obligations subsequent views not XX-K representing disclosure the the addition, annual upon refer the any these of and In the any this as our important issued discussion from release relied could date. date of today for to you Factors

that, Adam turn to call the to would With I over Adam? Grossman. now like

on afternoon, Thanks, call. everybody, Sam. Good and us you for this afternoon’s joining thank

quarter global on with the ourselves, loved adapted, insurmountable community. us has is behaviors XXXX ones reflected have unprecedented meaningful been Faced of challenges, pandemic. have to to many the So our and seemingly what first changed and of due our our COVID-XX

We road continue solutions goals. can as to that be see as we let our our modify not stop there long achieving in from lives progress ensure us to our in behaviors, and the we make bumps are found to

problem-solving times, to the proud us adaptable, while I'm during resilient ADMA personal like lives, been that today's also these report managing participating has and their of staff of call. on all

patients remiss to sincere would be if need. didn't available dedicated, continuing polyclonal gratitude hard-working give antibody of plasma-derived to products staff I are themselves express to our for ADMA's ensure I our to in

our and united I cure scientists, would nurses, the for gratitude physicians, together sincere develop responders, and our coming the global like commend government for and community to for dedication first healthcare prevention COVID-XX. of express a to country’s agencies

infectious terrible a by this and to combined support effort CSL Takeda the contributors. knowledge and pledged and proud the disease, to small role of the supporting as Global to play worldwide are in We led Alliance COVID-XX have Plasma combat our efforts

success COVID-XX to program donate heavily a development a COVID-XX of across hyperimmune right patients. now advisory therapy. option support working together treatment the and/or to leans We COVID-XX Alliance promise Alliance world of The the accelerating be expertise, of people Alliance's on great globulin to included are the infected guidance the potential globulin plasma. with proud contribute these the will in-kind of as of technical members support to companies immune for with the goal to specialists, fight contribute

any to contributing in from those plasma. We program have program other donating company’s by COVID-XX to development and who interested who are our recovered or encourage their development

Even encourage and and donations and visiting to if today. lives. All fellow is useful make your by needed to plasma find we COVID-XX, a citizens plasma many plasma donate We your save patients have by you near thank our Donatingplasma.org you not help your a is had you. plasma center difference,

no ADMA at patients we unforgettable overall and counting period operations proud are due on to our or can that keep COVID-XX and We us this first significant that report during commitments. we very of XXXX, said, we ADMA's the to have the of we With that there quarter during understand pandemic. staff steadiness must are been impact experienced the

we reinforcing in in affairs our sales medical XXXX. strategy which $XX.X teams, chain XXX% same part make first encouraging previously infrastructure commercial continued total XXXX, generating over early the as invested of robustness by to our force and of and revenues million period while supply the quarter building our a increase represents disclosed, with During progress out

enhancing commercial and continued BIVIGAM new in healthcare, prescriber, offerings adapt this environment. we and we, other launches ASCENIV commercial our implementing engagement virtual and consumer to programs like companies, as are evolving progress

opportunities many meetings Like been due which force conference we certain medical social institutions country. shelter-in-place laws decrease at include to orders hospitals customer a commercially from in-person opportunities reduced restrictions on the in COVID-XX field other from along the site and placed medical focused policies to due and companies, cancellations, resulting with across visit distancing pandemic other experiencing and drug travel, and other have impacts government enforced

such, key a commercial to ongoing we developing other As and professionals the engagement and number have healthcare of opinion initiatives leaders rollout. facilitate prescribers, are with implemented virtual successfully

Production generally three operate commercial ramp Raton, our and products of internal throughput Florida immune globulin to with forecasted and COVID-XX schedule for our fractions. is our Boca intermediate line continue in at up without impact manufacturing significant facility production on any crisis. the We from timing

continued build continued our penetration globulin of growth demand commercial market to and overall increasing plasma and We support sales to our inventories the immune the to support for market products.

plasma not operations experiencing collection significant other in have any that are noticeable there experiencing are we organizations plasma reports in collection declines decreases date, While our their collections. to been

time. are the we and that situation at or monitor impact to pleased COVID-XX to global chain again report supply not to continue this our are any material experiencing operations We closely

review the touch to turn activities XXXX. the highlights, a Brian take far to like to over I moment completed I'd important on and call so Before achievements few in to noteworthy a financial

today our our my important The robustness and capacity supply of most remains of is remains facilities’ chain statements expansion manufacturing that point on on schedule track. the

and with raw sourced to are plasma goods cost the are We key control projects believe while lower through profitability enable of the supply finish these final enhancing packaging. production, testing, a and of the the of material to ADMA success to future company faster chain, achieve end-to-end expected ultimately our fill

during and has very that taken delivery Raton. We and installed completed to the aseptic underway. quarter, project potential facility acceptance review announce testing machine state-of-the-art FDA our remains half submission second we've validation a of had the for This and and well is and schedule Site are been Boca we currently proud batches filling on in during hopeful in new are XXXX. begin qualification filling to

path volume cost us products successful milestone drug production Another faster profitability. pool will This of and a increased historic the reduced intended plasma for scale. to to bulk batch achieved BIVIGAM company substance conformance completion company's increase produce to the BIVIGAM the is more an accelerate allow for the plasma to at at pool

process. the increased investments benefits production into fractions manufacturing from anticipate will capacity, of the volume we these total with intermediate produce providing IG our grow that line further we Additionally, in

more. are potentially systems and approximately we in the by Once and believe to these total and capacity we required new we production all have place and XX% ramp regulatory any up plant processes receive will approvals, ability overall

remain continue We the efforts to collection on expansion unit. plasma of business target our with center

out the and plasma and commenced leases, planned. During additional secured build the centers of we quarter, additional as locations

collection over to valuable products. material produce network designed our immune plasma used is source The enhance expansion of our our plasma control raw center the to globulin

substantial anticipated gross outlook and filling plasma providing three expanded raw production reserved get which flexibility will reduction ways, improving visibility plasma largest cycle batch material for and only and ultimately additional ADMA These positive the more control collection, fractionators. many width forward-looking production end-to-end for including ADMA increased to potentially in costs, time, previously are margins, change objectives; a capability to lowering aseptic capacity the

with our its continues aspects the Along primary chain infrastructure, supply other company company's including improve of and these assays. investments the into testing operations activities to

been quarter, additional additional bring operation. the are sole-source During of vendors suppliers number we working to identifying to we tests across our in-house and limit have the with work

the processes and our progress, excited improving upcoming and are keeping organization throughout the quarters apprised are shareholders We achievements. calendar growth for of our and

objectives. of million. grow This through common ADMA's company our operations in XXXX capital strengthened February, us offering In for stock of allows and it the an underwritten is the resulted which net successful stated important the $XX.X we because to on of public proceeds balance execute completion sheet

the functions, conduct to materials We facility needed Raton adding continue of our BIVIGAM, of facility, manufacturing the manufacture ongoing products, rollout by collection network. Boca to ASCENIV and bolster Nabi-HB, to expand our chain the capacity important certain to commercial raw supply plasma allowing supply us expand chain our our including and further procure

your are shareholders antibody products. you to We your for and commitment our trust thank grateful plasma-derived to for

therapies. conversations, investment globulin in other ADMA Before they require of and We trust. were your difference is your a making immune and who plasma-derived use support lives you in mainstream dinner and patients table countless Biologics thank for the

who Martha Martha if would proxy ADMA recent a of Demski to Directors. is nominated I manufacturing, XX Board we experience Ms. new ADMA's like years our director election, on elected will experienced April, the bring the Board than of financial In an and statement. operations touch Board. member biotech, to filing for of more to

Inc. position, her serves retirement and Board of Senior a her up as recent Althea time In at Officer the Financial full Equillium, President Pharmaceuticals at She Vice she Ajinomoto Adamas in of well and Director as as until as most Chairman XXXX. served Chimerix Chief currently

chain manufacturing, We of rapidly believe public We their the to proxies and to company, experience accounting capabilities. that our as encourage according contract growing great our we Martha enhance increase brings our chain vote and recommendations. company to supply manufacturing shareholders operational, governance potential company's and especially supply

In a in of extension Trademark received globulin protecting the half plasma strengthening intellectual of March, immune is the XXXX. expected we patent We manufacturing The notice of ASCENIV. patent publish application for extension Patent the allowance further compositions from U.S. estate property first covering of our a during used pool ASCENIV. announced to Office

from manufacturing early our five-year fractions produce And supply a plasma-derived with into entered intermediate sell January, we immune and a customer new process. FDA finally, to globulin agreement This approved and $X manufacturing is million year XXXX to $XX to $XX agreement approximately add through and $XX XXXX for year XXXX. per for XXXX revenues expected million in and per million million approximately to in annual

fractions are cycle to seen able rapidly the with more these intermediate IVIG than products. finished potentially revenue We from typical recognize production

now financial highlights. to quarter of first over And I the turn Brian call with the will that, overview an for

the just review Since our a of To first Thank you, of today revenues financial the issued I'll highlights. an Adam. and compared $XX.X of some first total outlining our quarter we release quarter XX, ended earlier of or results, for this with, quarter the XXXX million were million increase begin first press approximately represents XXX%. $X.X for XXXX million to XXXX, $X.X March

throughput The by production collection revenue immunoglobulin of in higher manufacturing revenues lines, increased year. by our the of $XXX,XXX period at as to in products in and attributed facility, $X.X generated sales generated a compared our million prior mainly to and revenues the same facility operations our XXXX our multiple plasma are Boca increase plasma plasma our

XXXX April ASCENIV quarter along BIVIGAM respectively, of the into XXXX January fractions. supply new long-term X, entered revenues and manufacturing first intermediate we the customer largely and X, of the compared quarter to produce agreement Our a first XXXX on sell XXXX of with result in of May the approvals increased XXXX, to FDA for and were

per This loss and quarter first or approximately share. million. was loss was and loss consolidated of the a XXXX Our to $X.XX the cost loss of quarter million was diluted increase $XX.X basic the consolidated $XX.X $X.X net The in share million XXXX. million basic increase of diluted net product loss for primarily for compared net due of per $X.X to in of first revenues of $X.XX or

pertains production pool Boca was at of the increase production result and and lots this of facility. This at to and enhancement conformance expansion an other increased our a manufacturing planned capacity scale, investments plasma mainly initiatives BIVIGAM’s the

debt in also attributed The loss is is $X.X mainly to million. for selling, increases addition interest commercialization quarter of in during mainly and our administrative additional BIVIGAM’s in expense $X.X due higher additional second compensation to first XXXX headcount ASCENIV’s of increase employee due efforts during net launch, and the to accessing This million increased expenses re-launch to general of quarter XXXX. the of

labeled ASCENIV for to with for and Along non-cash approved quarter non-cash commenced amortization expenses stock-based compensation, of higher expiration depreciation, net extend study approximately loss the for of and XXXX were we its expenses of $X.X expense. $XXX,XXX million dating. and first Included research to the development related interest potentially a in

at equivalents XX, At compared $XXX.X March ADMA $X.X cash equivalents $XX.X of million, as that’s respectively, is working and capital had as XX, $XXX.X million accounts and $X.X million of receivable this XX, of and cash December XXXX and ADMA's million XXXX. XX, million and XXXX. of was $XX.X XXXX, cash and compared to accounts of December to cash million, and March receivable net

after Adam mentioned approximately a discounts, per price XXXX, underwriting earlier, net million common in in deducting and our stock commissions share we XX As which public of at resulted underwritten public other of million an proceeds February shares of completed expenses. $XX.X offering offering of offering $X.XX

Adam closing to over back call the turn now I’ll for remarks. that, With

you, Brian. Thank

me and ADMA the to accept at demonstrated without hesitation. The team willing to first changes of adaptable quarter is XXXX

risen to challenges the do Our it in time its of team and and keep meet time takes has to again track occasion face goals adversity company to on to and whatever objectives. the the

To team you thank listening. today, the listening my on for first, I call

maintain during Secondly, for of make I'm proud this productivity high continuing time. uncertain levels progress to and you

market that foundation on the we the execute future weather have positioned macroeconomic well plans. built, to growth we to we to are while believe our continuing Due current strong challenges

progress We sharing you like immune that all and deeply we we continued to each In closing, all to just health continued with highlight and you ADMA's XXXX forward the successfully rollouts life-threatening as would ongoing of committed progresses with to bringing commercial to safety. I and product and navigating ASCENIV BIVIGAM deficiencies. wish patients look remain

operator, that we’d now, the with open questions. for And like up some to call

electronically. Thank [Operator conducted you. Today’s Instructions]. question-and-answer session be will

the first Your of comes from Anthony Petrone line from Jefferies. question

Your is open. line now

side Thanks the of from in weeks questions IG collection you guess that? I’ll March and were in and staying and updates few anything impacts of appointments in follow hope a March of plasma terms in trends congratulations ups. just volumes start with number I specifically, the April, where Adam, getting safe. then few a both size? clinic scheduling the on everyone’s infusion Maybe, source exiting on like more a recent on the we’re updates companies trends notable then and Are on any how And quarter just few seeing for terms the on but last any I also have of things

to to ADMA my some our Sure. speak then that and things that Anthony, hear level the I’ve conversations just can Board operations I can and speak participations of I and through I had. through at the PPTA

experiencing First we collection impacts X%. our and operations. minimal very minus not It’s We’ve plus will. any collection ADMA, or internal you to significant foremost, are very, interruptions, seen if

inventory our There’s full Additionally, have in all our plasma supply for are manage contracts, force and completely deliveries. the they we receiving no [indiscernible] collectors. are They the to themselves.

being selling, raw So material time. to from BIVIGAM again, our channel. is no IG, is BIVIGAM pulled through there the ADMA’s impact chain to it’s utilized, respect With this perspective, is at being

respect BIVIGAM just things comment What reported other there declines can some the heard during XX% to respect know, that on with that significant I out We with we in XX% between quarter. there’s have to not issues have to collections. any companies

is out I’m that period between a varies upon specifically varies maybe company decrease. the about region, for collector, it’s was of each to it a where three that it plasma by XX% XX% industry decrease, overall competing hearing really the Now, to saw the individual sentiment substantial me But and beginning speak to there. five-week April probably so it March hard

conference and time. were very, they to it company back actually of very already I saying to they as a normal from come a as And other volumes seen Humanatics a finite the early call However, like day how listened a short, for was period mid-April.

that they that be in were is that the what rage used we’re their plasma altruism is talk a all there But to there through of of plasma saw and approvals but the on there and in based there have working I missed their people my morning substantial I the start for downturn that and I think would back that be to can forecasting and believe say and go hate it talk to house payers only something in crystal for able to block. overall my to donating household XXXX-XXXX if plea you giving were Report from on aren’t it’s we about. use BIVIGAM’s I my But that think is short rules these have carry to a probably at of altruistically. disruption I think see well in collections. that least normally economy and rewind if days, that people some if becoming time the they’re some going to dig that form. but when that that healthy, shape unemployment ball, again have if the Jobs this some around significantly is typically So local subcutaneous I that if infusions there the conversation from bodes IG think are news cycle. perspective, mainstream we patients forward because more Anthony, patients the And ever. one heard I administration, to going the regulations fact, been people articles, I well March-April worst media don’t pictures at a way, be was some I to there’s during if it I additional I numbers you reports due collection, donation in when people of this utilization plasma I or blood were going centers who COVID, heard had think move think seeing from and of are any lines wrapped received could as that not this don’t may be out certainly my government’s it around impacts not plasma

I now we our differently. think looking outpouring that may of society see at plasma some donation

it we by of life wonderful It’s can donating think really gift that I gift is give. a the giving that plasma.

So to changed, ultimately together support what supply hasn’t that plasma tightness that’s going community is IGIV all of out I stronger to we’re going think things collection a these the think is and help which see there Anthony. ultimately I

and can Brian, will filling, cycle of IG to program And that you raw for globulin? you terms all on the just a hyperimmune invested are development you quantify timing in in Alliance? terms material, And then is a where where fully on can views for when initiatives happen And be high one the exactly in has just working in; follow it ups, what of your Adam, see the two hyperimmune seasonal Thanks, COVID, cycle of take level months the we capital one are ADMA’s once Brian, what for role those of and in a three what capital now place? the Plasma production go is for working terms aseptic could when product? company again. Will product that

we’re not the same in part take first first. since Brian, room I’ll the today,

Absolutely.

Sure.

sound PPTA, really getting go himself this had people the COVID-XX. the like Alliance, something and rate-limiting the they’re a advocating of plasma, the development out is for. record, for to the to President of to So, supply Collecting is but by broken largest far feel donate, Anthony, factor with I been to can hyperimmune respect a – like not house go ready plasma that the and

raw is collect plasma So we can material upon trying Plasma the a that quickly need. think dependent make product how Alliance the work I to to really

to – population And there’s of and no total in it’s still over a infected. few know, are it’s our scheme our stimulate you there problem even you though lives, people it’s this very taking know, antibody. As vaccine major as

a have few XXX population only people We and tested there’s about positive. of that million million people a have

who the that the the now last drive country they is respect direct know. to you how now we’re have not detection raw with so had asymptomatic available the supply all to of really contributing A that the the we’re be make I plasma really supply market. a they going why weeks, And don’t use encouraging plasma So quickly to material they to Alliance, to a COVID test, of the dependent never with go is going investigation. amount antibody are spokesperson right Anthony, have timing. But now the product couple be because plasma. across one tests and upon implemented inventory activities and number to that’s hyperimmune centers for increase them donate commercially the have right comment what’s over to of think that I’m of people bring to to it is is to for anyone going positive already that that of that going the can I’m Alliance the available ADMA sharing help of any obviously that globulin to for donors, key

Our with means. role to the support them through Alliance is advisory and scientific rather also

I As that that and to do valuable with we companies. the think a pretty insight believe specific that we infections. knowledge, asked pathogens globulin the respiratory are certain help companies could certain believe viral viral the to in in to treating we of and assays provide to join these quite respiratory and knowledgeable COVID-XX. collaborate with know, And some ability respect studied And knowhow immune we plasma because of the hyperimmune role industry knowhow have against these and have we frankly be you pertain add that extensively that our they technology that microneutralization we’ve we to other value were larger do development to

Brian? that your answers question. hopefully So

a takes This company market it undertake path also working Thank these providing plasma of Anthony, a manufacture provide for capacity the the your presentation, question, approved If approved pool metrics. Again, regarding will inventory an corporate of discussed you our cycles’ faster in that FDA BIVIGAM the way the and we capital lot cycle to one to achievement improved ranges will putting from are we business to made inventory to filling to for faster. and investments cash times. timeframe to terms, imperative recall improve from successful months, the up, overall could obviously X working the the capital first path margins the in we’ve into that here our of profitability. be investments to quarter view scale We on and it XX machine, anywhere it essentially product longer. expansion back sales and the

end-to-end when you’re believe, filling control and about months to process months, So expansion working approved we give of would to and kind outlay product manufacturing be the more. of timeframe somewhere the seeing even reduction our three now see production receiving will of and we cash maybe X and the thinking process it of a we’ll to in could it two reduce product sales capital once get by, approved, our machine XX capacity obviously could times additional this inventory batch from ADMA cycle

Thank Okay. you.

Anthony. you, Thank

of Your Raymond next question comes from the Elliot James. line Wilbur from

is line open. now Your

Elliot. Hi,

guys. questions. there. you from for hear to Good the taking Hi, Thanks

York been and I BIVIGAM the fund plasma in of respect and weeks, Adam COVID-XX patients. on looking some recent have label share in COVID-XX. open obviously of ASCENIV at we’ve terms recent with to a of Sharp therapies the IVIG guess in therapy have and San of for more this seen off there’s Then know dependent body just of earlier question COVID-XX of Diego moved now in we’re regarding in mainline there’s plasma New at guess Memorial condition context a they pediatric [ph] of studies to couple traditional one IVIG which case Obviously First treatment prospect convalescent an in options. kind emerging but in I of the see unusual of hyperimmune, kicked City starting inflammatory in use China therapeutic use of that’s for I and to being reported focused discussion sort of Georgia. some the reports

may be IVIG it So role COVID-XX. of treatment in potentially a for there like seems

with whether wondering or in not there’s label there of investigators. Just as either far trial what open some sort as and or studies the hearing been discussion any you’re participating

reasons you, it’s in tell A or can have product Elliot, also commercially I are particular and patients. both and available. BIVIGAM and one diagnoses under Sure. all – regulations. why that I are protected of another using insights ASCENIV the docs the into lot HIPAA rules don’t

made for can clinicians IVIG I tell and If just unknown our We in and are on, able make about to I from We’ve COVID. have that not when respiratory know about treat certainly with we of with patients the is you process and data disclosures treated any appropriate COVID. we’re not will to amount generate being public an yet like about any work designed ASCENIV public. there pathogen that that an thought what again, COVID-XX. never developed products experts COVID, we or

is many, years and what quite about the that the is do the that virus globulin once just So we patient many infected a is know substantial. being for cytokine a And is response triggered that I’m immune of of the news. itself IVIG have student ability as mechanisms just on is the the it unique product call of of storm, cytokine and as heard regulate system, and immune to the actions one down people may the of they

system. to other respiratory uncovered of patients care I of using. COVID-XX So and the that existing Elliot, as are standard pathogen. sense it think we see every potential in infected one interesting we’ve with IVIG a the out five immune that supports to some is docs makes co-infected that IVIG One add-on that data the consider that certainly is fact,

IG of considerations institutions and the that’s of that I infection of high-risk are without talk is I for a some of of dealing patients will, to makes bubble illnesses. IVIG of certain the in think So where it severely the conditions. a the also, and bacterial underlying some patients some to need with But with. for infection a types because I that need viral I may more comorbidities, emphasis and order where lot think But these population, I are maybe with data other at overall pulmonary live the of diabetes, existing already They directors this antibodies, chronic COVID. that of let’s you those rational we that at broad infected to, fact medical disease, that tightness there just or patients elderly think other supply typically looking shift about sense to spectrum think speaks are who of medical the polyclonal people with And its have some other outside that think use. some if or PNC there’s not to live see. committees that heart There’s now COVID,

are use I that going to used with see diseases, types being IG. to think these think in I of going do ultimately are of it can’t IG infectious some not some some and institutions any certainly hurt. you institutions

globulin the immune system think help administered response. And and down any supports ultimately is of against drug an patients fairly plain according I to simple. it’s or and It co-infections recommendation. ill if have. can patient safe that the the It the viral cytokine bacterial other regulates immune may labeled supports fight

that question. answers hopefully your So

to commercialized conformance Yes. perhaps of actually Brian to not? for respect did in costs production those guess ability the Thanks. at I the BIVIGAM’s Then that tied to some be expense or and with – actually can you those quarter. point Can those batches batches, conformance give the recover

batches and these sell will in production batches to be principles, batches essentially gone accounting we you conformance brought quarter, it’s level, increased this approval, Absolutely, while that expansion will, these at expense I’m a FDA batches if through once question. scale to glad we it for receive the up. accepted to we’ve this Elliot, those XXX% that’s able capacity you generally we margin. The great had during submit for accordance

XXXX on in produce So this quarter, timing multiple half first the in while year later it, batches, sometime we the XXX% the of able call charge we’ll to first approval. be let’s of there FDA depending margin or took investment was

is generation path we continued if and our because, look, going want add. we us used We over the Elliot, are investing the opportunity solidified tremendous – and that have I into understand for our a to more and investments accounting stronger forward-looking understand make these can have can profitability we And net I and revenue to control to analysts rules, we term say better, this we is I was just to concerns shareholders process What after where investments. that ensure we ultimately higher. and loss infrastructure to are want the because the to has the have don’t go

So we’ve proud work everyone the this. that hope really we and really we’re done sees of that

and are they COVID business, that of products COVID-XX crisis. pushing we forward going to to we and this can good we by as and make more stop deliver them. growing this we’re not are antibodies save are to lives we ensure us letting are As seen this the needed demonstrated Plasma-derived we’ve patients

Sure.

the and just Just the you factors actually considering production commercial final remaining of timeline the maybe detail question --? can gaining level commence before investment, maybe

increased With scale? Sure.

have was great. all was I’m throughput we the ability process that excited while actually the in double building, that bring will while with we’ve watch a and now the So to even this capacity so get and maybe got the of crane, cool our more this fill expanded hole outside machine thing that an potentially it building finish them with in in

of the filed can fun tell my have said lot applications what year. a I You in should that you get this things FDA in believe publicly talk that do is second And in we’ve to half of we the my we to job.

product capabilities But applications and we volume with the production confident line So a should come to with the four we have a which of be Again, finish before increased December six-month level upon XXXX it’s with XX, with are can approval these our the coming depending year I sometime Boca scale have appropriate commercial that conversations coming file. on fairly on FDA, file going would Raton. assume fill to from we time. review that work, applications prior off we upon this during depending and should supplement our be

little XXXX. guidance but estimate you to and a FDA we’ll bandwidth approvals by to year time, the is all timing, the have applications. then should to on energy and it’s figure guys FDA we in sometime for us the review our early the give clear be it we with when be let So on should – file end of going effort, But of the expect we

questions. for Thank you right. the All taking

very much, it Elliot. all. you appreciate Thank We

our closing this gentlemen, of conclude it to to remarks. the for and portion now will call. over Adam turn Ladies like question-and-answer back I’d additional

you to just say I thank everybody. Sure. want

out our who progress. to is we a there keeping do Nurses developments National And nurses me growth thank so forward want we look, Day, apprised help sent and text. they our Someone all investors It great and of it of look to and appreciate shareholders as us. our we

everybody. and listen taking Take please and and healthy out and the us to stay to the follow rules time everybody go lives. save for Thanks donate us care, And today. help please your plasma Please of safe government.

and may and conclude today. your appreciate you this call disconnect. Ladies conference participation does the for We now gentlemen,