ADMA Biologics (ADMA) 6 Nov 202020 Q3 Earnings call transcript

Good afternoon, and welcome to ADMA Biologics Third Quarter 2020 Financial Results Conference Call on Thursday, November 5, 2020. [Operator Instructions] Please be advised that this call is being recorded at the company’s request and will be available on the company’s website approximately 2 hours following the end of the call. At this time, I would like to introduce Skyler Bloom, Director, Investor Relations and Corporate Strategy at ADMA Biologics. Please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the third quarter 2020. Adam Executive and Financial Vice by and Executive Officer. today Lenz, Brian President joined Grossman, Chief President Officer; I’m and Chief a XXXX the company’s Today’s comments quarter and Brian provide will ended third provide corporate September months provide XX, will of call, then results. update overview some an nine and financial Adam and introductory will for your up then the opening call provide Adam some before brief summary remarks questions. results. press release detailing third Earlier we financial issued a today, quarter the XXXX at www.admabiologics.com. release available is our website The on

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

those XX-Q, this call, cause Adam statements. like of factors Grossman. the With the federal we our by and I in representing Form now be forward-looking to required to the any to date XXXX our any to for We a from turn annual to file our as specifically any that, section over forward-looking could of following We should today on conference disclaim as views and the In Adam? addition, of disclosure call such laws. expect our section except earnings that the of results third materially XXXX to obligations quarter we any Risk issued update It views as refer relied only recording. statements differ would release our represent this statements XX-K discussion actual as of important not which securities upon you subsequent date. Factors report

Thank on hope thank remain those continue us safe. joining Good and We today joining call. to you, us afternoon, everyone that Skyler. healthy for you and today’s

with of to same achieved We year the team, of $XX.X strongest in The third the these the ADMA quarter despite revenue, Biologics headwinds. we year which to compared of COVID-XX million due approximately was generating continued growth work of Year-to-date, approximately XXXX represents period. our strong this the XX% an generated prior focus revenue, million $XX.X and results ADMA increase year-over-year quarter XX%. in approximately dedicated hard operating

Looking ahead to the remainder of XXXX.

We believe We second to first of continue positioned strong growth into throughout anticipated revenue, quarter XXXX the to line half we to respect future And are revenue the fourth inventory our to compared while revenue a XXXX. considerable we previously also during anticipate well levels half. building stated to with achieve goal contribute to top to continue and this anticipate delivering of growth growth.

efforts add third for ASCENIV, continue our promotional to customers as grassroots prescribers the continued engagement and results. BIVIGAM we virtual to and quarter, During yield new and

Although scientific treatment infections educational prevention. recent event traditional we presence persist, at and and XXXX ID by as their medical and strategies and including and where remains we October, Week provider for challenging exclusive an headwinds encouraged our hosted reception commercial the limited viral to on at physician COVID-XX conferences, engagement in are respiratory

plasma local for With past third collection the continue state our to a and COVID-XX during quarter, to FDA experience shelter-in-place result of chain, experienced center being of related supply at we lower than During our said, we donor quarter. orders, specifically the normal that as impacts collections certain areas by approved the hopeful remains expand, globulin tight we improving market see collections restricted XXXX. And are will this recent to and immune over of we that sequentially like to but balance weeks. continue continued continues historically year the have other plasma At supply. these collection into organizations present, trends

the even expect tightness pandemic. persisting COVID-XX We somewhat by continue exacerbated the to and be

As and a American feeling visit only parts there public many of the the essential businesses. among to general is stores

Some plasma positioned centers and FDA ahead. is that in In products even this greater reluctant tightness, a are the provide quantities supply plasma. player immune as of approved of its spite donate Ig and people source to of we forward-looking to believe go backdrop market broader increasing to smaller ADMA collection periods offer globulin uniquely

that expect can player smaller in we do a disruption early and periods present with the not our the confidence we at in throughput ahead. in of say any stages commercial scale-up, As our manufacturing production

to revenue our like growth, corporate accomplishments would to moment take I important highlight. we Beyond have a other several

$XX second to the third quarter with approximately million inventory XXXX. anticipated XXXX. inventory, XX% end total the and we further balance quarter build from up continue into in the support First, quarter the our fourth and of in of growth approximately at We a XXXX of million closed $XX

net loss closed reduced quarter of has loss XX% quarter with XXXX. million, approximately $XX net of $XX.X the the our Secondly, from third second considerably. of down been approximately a We XXXX million for

can in you line all revenue, inventory are top see, balance spending heading the right our directions. As and

shortly Biologics We donors. in network progressing Additionally, is Knoxville plasma donor of COVID-XX July in thereafter, the in Tennessee the and center Knoxville, FDA including expansion License from the We recovered collection Application our began second receiving for mid-XXXX. ahead schedule. our from opened currently center anticipate collection of approval

and centers FDA collection plasma currently Tennessee stages. with anticipated construction under mid-XXXX, ADMA of has other four approved the Kennesaw, BLA plasma collection and planning design along include pending architectural now in with underway development at and now BioCenters approval Our Knoxville, in FDA our and approval, which stages six and various a center business centers Georgia, current

centers the collection over plasma We the of leases growth are for the further three to outpace with the these our our into we extremely achieve for are these we next to support of five U.S. business ADMA believe And on investments end-to-end opening and The pleased long-term production biologics XX unit locations. stated to source initiatives, available favorable Plasma with ideal securing anticipated to demand to And progress track company five goal global future. new manufacturing into our are ongoing BioCenters supply. Collection for manufacturing continues years. plasma

chain initiatives, with an remain track. these our projects As robustness supply on update

We invest the SAXX continue to with with in enhancements, onboarding Vanrx fill-finish aseptic including progress successful capabilities installed and chain supply Workcell. robustness make of our newly several

X,XXX efforts advancing product time, lead as could from costs, chain liter in us reduction scale yields working a planned also control to initiatives improve to regulatory and and and independence plasma contractors. are reduce turn and We’re capacity margins, provide requirements, increase which for ongoing BIVIGAM capital important operating faster for production other expansion and potential These pool. designed vendors to the the as turnaround provide well in increased third-party cycle with supply

more initiatives before We impact anticipate, from And the as and XXXX With end the with these potentially, as will both expect the mid-XXXX. SARS-CoV-X our bottom treating in COVID-XX efforts, effective to as a ongoing assay we as EUA potential that partner regulatory we FDA development lines antibody our a top titer cost identify development respect applications for COVID-XX regulatory convalescent work to has of into well hyperimmune believe way begin we patients, simpler, proprietary submit these a continue and to towards approved resulting if initiatives and early for to we globulins. potential to the appropriate for ImmunoRank, XXXX. COVID-XX provide see using creating high faster, to to and submission our plasma

including our over the execution. managing remain expense review structure, over the for Brian? next With Brian on work turn to the committed revenues to reaching call we million ever financials. ADMA the tightly operating our I'll $XXX five commercial of years. that, Biologics targets, organization or We three focused to towards of achieving more With provided than while now more previously a

financial of highlights. Thank quarter results, outlining we press a just some you, third Adam. Since release our earlier today, I'll the review issued XXXX

into by intermediate continued ramp and the impacted produce the For million months increase and three and million of BIVIGAM ended favorably This to an entered sell the for was XX, quarter commercial approximately of and $XX.X XXXX, January revenue the $X.X XXXX, XXXX compared XXXX. manufacturing of ADMA million in up the approximately plasma-derived represents total quarter of by growth revenues agreement $X.X The were XX%. fractions. third supply or for to third ASCENIV September of

quarter-over-quarter and goods As XX% with from generally accepted we both year well inventory approximately million, principles, earlier, as inventory end as revenue total In the has our cost our $XX.X moving build of believe XXXX. growth and to inventories, stated $X.X to end approximately was the is we compared at Adam of our the continue as work to finished quarter the up to million process mentioned $XX September of to accordance ahead, also second translate value which will periods million, XX, goods of XXXX in expect forward. commercial up inventory from year-over-year increased accounting Finished XXXX.

given partners, the the safety intend Additionally, position prescribers related believe a as reliable of retain inventories pharmaceutical which COVID-XX uncertainties supply strengthen to and chain, as supplier customers, across a stock, will coming portion our growing our to we our we distribution quarters. over

stated and the year, second In us position our addition growth will this million ended to to achieve considerable inventory during and or Consolidated previously to three was $X.XX ensuring supply net enable XXXX loss half as per throughout September basic strong for into expectations XXXX. diluted our continuity, we share. and the anticipate for months half, compared well growing as $XX.X the loss a revenue first of XX,

as had the XX, loss equivalents accounts loss $XX.X cash ended September receivable XX, closing of cash million revenues approximately a December that, XXXX, at revenues our XXXX. were or $XX.X of million $XX working diluted to approximately portfolio months months as loss net and nine of million remarks. intermediate compared nine increase million of I million months the And call and XX, million, an share increase and consolidated of At Consolidated loss $XX.X compared approximately XXXX September the approximately ASCENIV, per XX%. compared XXXX, immunoglobulin for represents XX, and ended fractions. XXXX. for was September With million, or of over compared attributable diluted a $XXX.X months $X.XX The net Nabi-HB XXXX turn of primarily and cash million was and nine increase accounts and share, September to to XXXX. XX, ended to XX, this was sales back will the $XX.X $XX.X XX, $X.X receivable plasma September ADMA’s XXXX. where September ended the BIVIGAM, $XX.X of basic for nine million, XX, $X.X million $X.XX ADMA to Adam total a approximately $XX.X and capital For December in now per to products approximately basic cash of for million equivalents net

a had has we year yields, thus corporate far greatly during XXXX on chain, ADMA has strengthen benefit the the company long-term increasing reducing to Brian. you, and toward strong our costs, key initiatives and will priorities. executing cycle Thank over progress our production production which excellent made include margins shortening These believe improving timelines. by operating supply

in for and effects U.S., more macro-market Collection allow into suppliers, the we periods. have ADMA rapid continue future. these And bright Plasma the believe unit and XXXX initiatives vendors availability ensuring finished compared the third-party ultimately and unprecedented on conditions our immunoglobulin We of raw throughput BioCenters demonstrates expansion business and the will to will and production COVID-XX growth. and increase these beyond, temporary into by our management’s our experienced ADMA prove is Given right available to impacts material for focus believe us prior to being allowing to that future sale believe us we

business growing I call our counting intermediate a thank remainder continuous and strong for half. XXXX bringing considerable for to immune life-threatening committed or beyond, that, remains patients more we to assure of revenue commercial XXXX dedicated second are strong successfully line ASCENIV fundamentals our for third-party. first ASCENIV and our million BIVIGAM, know truly our the in of believe Market plasma product growth half our and as to of initiatives we for ongoing sale the to next have $XXX remain supply year other each all foundation With strong We rollouts with we continuing of over remain built to years. of confident over top and all and annual well as we we Longer-term, provide well positioned the achieve, because to the deeply our a believe demand five compared remain in Operator? stakeholders grow a and questions. of members ahead to on past ADMA now we Nabi-HB, chain us. to navigating Looking up staff with to your products to we and revenue BIVIGAM deficiencies. will supply the fractions patients we achieving all at level want the open to are the of three that for

line Thank you. comes from [Operator of Jefferies. question Instructions] Anthony Petrone the Our first from

now Your open. line is

good I and afternoon. is quarter can begin… hope on a Adam, maybe here. well. you Thank Congratulations everyone doing I great

I hope you’re doing well too.

yes, Hope of comment, where begin families. and you're of where your Adam, you sit supply. your off and on visibility you Maybe and well, continuity on left supply, consistency on

the be company, physician the in so space? visibility maybe larger place negotiates and And today look it bit IG describe customers, for fourth or this a quarter in into little is as that year, as potential distributors next on groups and with does those what the you whether why

Sure. Thanks, question. Anthony for the

were of you speak inventory Q financials, I XX% a points that growth and the you the think third this. quarter the look of So at the the quarter. the to think when second I to number at about if and there amount And look in

covering that sure that And we're demonstrate been reports many other plasma is sitting a product. previously. in what there to this I've market have be producing think of to been really we're through be is Because supply a more that forward-looking documented finished look to do analysts’ them a from inventory and sheet building what number that we're stock. The to companies. firms working that we we going is, we've COVID-XX as and out we've to That's different than should been considering tightening. able the itself with we're give good And the goods the IG to forecast due to I'm and on our currently environment safety chain inventories. our I idea working use in precarious we're and balance imagine able reading customers with can you a, are you

our know, XX that X in cycle better, Anthony, you we're to month As anywhere XX from ranges months, doing XX we're time production to timeframe. but

So have through ago, visibility inventory what can the all that see why supply labs some releasing more we it's issues that to mid as doing landscape chain, we is, we we to XX you resolved. our itself And previously. I of third-party reason in XX were this with the months know have we our growing, early been have of experienced COVID of parts And than with ever the navigating are testing the working batches

really, more in So deliver considerably we our feel really to generating half. confident on of than stated line revenue the half in our first top ability second objectives the

we a headwinds dedication tirelessly very, I than plasma will it's for product we're throughout third-party we're that, And working really sale been more year. how and COVID. quarter, operating sell in and best reliability And XXXX there that right many available direction. going and What to operations due from the don't more on have team has testament XXXX other under of, Anthony, our of plan products market anticipate from right to And able been suppliers in to products producing control this have our have our had we the out collections collections we have are our know our companies now, at on really XXXX. according of workforce our platform been XXXX. to budget to that based in And than of COVID-XX. say very think to in schedule year. I the ADMA well the really quarter a proud And that is most the strong trending this we've the I'm

broken much we mean for to subsequent record, in folks feel but don't really we measure should to have as a strong. for we quarters. sound inventory how want product use like a So We available sale

you referenced comments other That's discussions How market wondering, as kind active this your really share there, How suppliers? helpful. just I'm after play does the kind in cetera? here to et to when a from company of of position, Adam. dislocation the going offense the follow-up in

always and offense. of Sure. in say offense, to those we of I the the we're compared sit also want recognize to Anthony, our on We're to going here organization course, on be size you, to industry. but

around through our leaves liter. deck, somewhere before, a of us sold. XXX,XXX XXX of corporate finished call of yield, with IG manufacturing in As have process our a and immunoglobulin per to we've it today liters plasma grams could X.X year, plant million process the number between we X That mentioned grams rough million, somewhere was X.X that with Last believe I grams. million X.X

in X% So player we’re to about the market. X%

being hospital going the So may big contracts, left there. looking customers on we're their the not they're types as void after that be four calls or offices, deliveries that by the IG put health And infusion going large receiving and of different to physicians’ from delayed. again, a the be starting being that told to of we're inbound larger we're out trade of we're different are there. say. these aggressively of out We're they're players But classes some number three centers, allocation or that to you not out clinics, fill or see

to that substantial subsequent ensure on customers. but our and feel good really, they're patients that that our They that we are feel drug care. believe we size. also the inventory, in safety to they going very we ensure inventories supply I put aggressive, of the this. a our market have we there The where are for And a understand. as to the continuity hope understands don't growing is really to stock want we want don't there So build about confident we months

controlled very right chain now. in a our inventory FDA and We're visibility way. coming through. releases optimistic in our with supply are this doing we're very our So very,

that customers, And having on Things – anticipate to available very, patients about very can feel operating. to confident two forward to BIVIGAM. our got well. are you, if for you supply, Our we've labs the you will, inventory we three months supply moving demonstrate your putting are

During was tumultuous, all I this period, that quite to the that's based on reports going reading today. be

products they're So FDA to we're as we're are commercial, our need here, they approved and market broadly. ready the serve

one just where queue see backdrop And just for considering back COVID-XX. and update and here. you just polyclonal development do for and ImmunoRank, assay for cycle hop out the It's SARS-COV-X how antibodies Maybe helpful. playing on in I'll very sort this the of get an the more is

update Just Thanks lot. there. a a quick

Sure.

to antibody to believe which ability no, some We're most that with that have determine a ones to based this progress, hopeful collection that more as potential FDA. donors able partner, able update of easy kit say as you, full Technologies, benefit. maybe of really the really the which centers titers going potential believe to ADMA assay. units titers. going is standardized can’t, have have The have Anthony. these to to we're the our and key we centers, that make SARS-COV-X, detect this we'll ELISA no, assay, blood to I It's Leinco because really – highest we be use the that plasma and thank I solving Neutralizing a neutralizing we're the development clinical through greatest is hospitals, to certainly which patient for we'll So is way market. This help. EUA the to very as well proud a identify titers, I highest to COVID-XX this of but can achieve type donors maybe And we problem convalescent being this, of the believe

far with expertise its we're the that an do for number convalescent that our problem our as give me really and partner, and So development it's of We you believe hard ADMA solving plasma. size. the one idea as to expertise

collect and the in plasma treatment ascending the the assay in to COVID-XX differentiate understand not area. you business. we're donors Now we're in developing we're What do of available the from We're that IGs IP for that that, the world. not were We our we ability this, plasma to and titers types to other not business. identify the collect that I that pool not know of convalescent testing doing really neutralizing portfolio getting really on make into we these using transfusion with ADMA’s plasma human here, That's therapeutic Anthony, donors. expertise the from and specific our plasma plasma, based going and to use

But really as that that find we'll do. easy optimistic doing for posted. again, you our was wheelhouse what because we I'm more, just It's this. to we're So right and potential. to that I'm there's something see us in But with happens progress keep excited this we

Thank much. very you

Thank the questions. for you

you. Thank

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

Your open. line is now

Adam, afternoon, Good Brian. Thanks.

Good afternoon. How are doing? you

revenue on customer maybe Doing in some it. or increased the comment drivers questions, mix, more could it right maybe all at the performance Appreciate base BIVIGAM just of right. Thanks. I'll talk in just ask the the sequentially, or if financials, you on versus least I couple increase, customer terms about of whether start A just core, be penetration increased to of ASCENIV key uptake. or of favorable

as we the from progress results? XQ sequential some there drivers Just key think about of the

Go one. Well, right. Take this ahead.

Thanks, doing, Nice hear you. you How Sure. Adam. to from Elliot?

the To attributed board it. intermediates, to us I increased to byproducts, customers products into to And to continuing addition earlier mean, we're demand. and market. that very point premier them quarter seeing. that look inventory to place we sales across as that say from seller Regarding to see at growth, use would in in continued increased of on revenues the continue I customers encouraged market grow, our call, IVIG a certainly to the additional and see products, confidence a meet this us all the were we're Adam's the revenue gives

you're that year? growth the commentary Okay. obviously, continuing sequential expect like on of your fourth in some And sounds to it earlier based

million That's balance finished can million see goods look That's you $XX correct. if inventory. by the quarter at And second increased XX%, have our you to Elliot, correct. sheet, $XX overall

So we continue to purchase inventory.

while also through We keeping channels safety continue move to inventory the stock.

to the inventory the customer along the inventory been grow the standpoint, as – out So positive build build a way. investor quarter it's continue and well to base from out expect that all

can updates P&T the wins of wondering the anything kind points Adam, you, with in resurgence with certain has been of of maybe ability just key us opened for sort kind recent payers, additional Question terms to door Okay. has grant you those engage to the mid and your more on with respect committees share of the and J-code in what discussions distribution constituents of ASCENIV pandemic at with of specifically or of more the whether for spots obviously? not least or

I blend certainly formulary ASCENIV, to To of have. on of that much on And you has product we tell Sure. to hospital's the And tested the touch of donors ASCENIV, can that for donors you when a virus. respiratory that, IVIG every plasma at with type United is similar label used. IG, the syncytial it look States. the pretty around titers normal have that's And differentiating factor sufficient we that's label

community a weeks at medical patient more We're appropriate So we and hospital-based week months ago. becomes in or of couple from the the science had appropriate our topic we ASCENIV just organization, ID commercial conversation, see lot a hospital. as lot of as engagement, big team thoughtfulness the are utilization symposia a sponsored types of winter the a COVID starting upon more on us that to

available the and that. physicians to in Elliot. at now reported There's price quarter. factors mean, very, as we of us. risk patients commercial is right pleased market BIVIGAM where the our of their the could side, out defend very truly third sales caregivers certainly reimbursement we for folks. in the to is monthly and our that's benefit with are inventory customers through the operations from switch there, no will place and On shortage hurting continued ASCENIV. We're changes a with that you – to I historically appropriate if well, again, outpatient believe have continuing are ASP. And tight. force really not engaged There are having We've a infusions no been Medicare team

me, coming tell road. our to with reps, the Certainly they're them of clinicians face-to-face reengage starting manners that from not the pushing out flag, And Some safe getting one not that on can caregivers. but are with carry time our I outside. field folks I'm we ADMA in you certain and prescribers to want and

most now. seeing are to reconvene ethics previous the in institutions, be Immunoglobulin these up reformed. virtual right of years. XX, a the we're to committees to the have and decide it's been should committees those all has scientific And treatment periods, notices about and conferences. get history we starting starting starting at anecdotal really committees product at the pharmacies, hear to in bit hospital engagement supply they're IG They buyers when immunoglobulin convene how loosen short a throughout and the IG and over getting So number needy From We're things at that utilization. last is after who's we're XX the who pharmacy to continue, rumblings continue hot that presence reports there. hearing your little the engagement a look medical they're is topic IG

current feel to be inventory reiterate real is unmet out IG unmet not position potential the again, there. that's the And need about a So our future here the need to service and front balance, to we center. topic able and but good

Okay. act And the the your more but supplemental just roughly with we them get had know standard being these capabilities, talked terms discussions one off in enhanced fill-finish under months demand at four to move there you've out that this processes in wondering further given trends like point, some consistent past previously, some any manner, signing timeline to in with as – of agency any expeditious statutory had to thinking been forward a for of you you've are last sort if on FDA but IVIG? discussed question, about you six the have about NDA, terms that with able a have trying it the calls, Adam, what of of somewhat to timelines fairly on sounds I are

of Sure. a is got a paper comfort the give cetera. That's a that number of around is I great question. audits we've manufacturers’, the fact et that, different can pharmaceutical answer number organizations, collection conducting seen the agency plasma types of you And we've of

and FDA So they're know the we working. ongoing is

for We yet application our have not for to our submitted machine products the FDA. Vanrx

it's for for to file. actually expedited any application or for ask So to an review hard put on me beg until the favors we

way an So that, provided this we file year. me, is the our guidance on I is the end call there – the have do, someone what will And not a when if can before and be from the should really of for if we – there'll the confident. expedited do we it's see we we certainly, mean, fact agency path and that feel review. it's organization, application We continuing I track we're I listen timelines, a give know these to on the on that number staff indoctrinated tirelessly down to and the that the in calls, are leadership COVID-XX. to do but keep nights all with our of ADMA working us to impacts due credit to of fill-finished remain to these order to schedule, weekends to technicians the newly got due some

lot commitments is those to nights, a we We work, So their backs of and team made staying order lot we're to shareholders, understand meet of breaking and but late track. on promises hard timelines. a our in

from should of initiatives do benefits really supply of So enhancement XXXX, of one and is we Elliot. chain start mid-XXXX, our that feel a some We fill-finish we number second good, half robustness believe really certainly and them. realizing

questions. All right. the taking Thanks for

much. Thank so you

Thank you.

Gershell Our from from Oppenheimer. line the next of comes Leland

open. now is line Your

a in my have that update trend, Adam, bit as just few getting you from state brackets that would you of a questions little of might you the inventory the for have overall Hi Yes, can as future? for for foreseeable to further steady Thanks. on increases, to consider follow-ups. be I a just me. and IG And give you numbers or for you this what questions. a taking sort us – any of do Once inventory a couple thank product

Sure. lines I be to expect regards take that year-over-year quarter-over-quarter, revenue the Leland, commensurate to It's doing? going can how stated increased Brian. this. that's are the to so sequential of growth, inventory, we see we inventory. With along

to plasma, we're plasma centers. up As we purchase continue more more opening

plasma, as revenue I we're And future to going That continue long more growth. collecting we're inventory year-over-year XX plasma life, a will So plasma. has mentioned. to to lead more shelf long, then that purchase years,

quarter-to-quarter, a $XXX top be revenue So seeing line to the years. will growth, getting within three next year-over-year inventory five that line signifies, that to testament, revenue it's increased continued million

to building on Okay. All you're forth. centers one perhaps you two think How about this schedule. consider or additional organization? should think on think come we so ahead we it as how you of outlook spend, right. to it, expense continue as fill resources as that burden play admirably, the obligations kind to about report and into debt about then should we need from stands But have, might And of tax company and cash as the the your

Sure. Thanks, Leland.

with So close expenses look, the cash we regards cash as as can. manage needs, we're to to going and

from quarter-over-quarter from could down You heading net loss We $XX net revenue to going outpace our million is believe expenditures. loss about our is XXXX growth see second right direction. increased $XX XXXX quarter third so quarter to in million, to the is

you dramatically And a additional context debt, to of way. increased right capitalization, the it’s in heading XXXX. our receiving regards supportive is growth approvals With debt on we’ve regulatory markets. revenue credit all relationship, very since back in debt our taking the several mentioned So

we’re So that debt. we’re confident address able our to

debt the purchases sheet our grow a we’ve And largest largest from They’re throughout relationship our aligned and well year. They position open with the right collateral they’re our balance management. lender, as Our as to management, in place. Board they’ve holder with made continues XX%. about directionally our made, market

color. Thanks question, last for just Thanks. Okay. that My ASCENIV. on

perhaps – the ask return it we rolling was we’re investments, the investments to ASCENIV additional winter, of those last winter if want made out, now, kind from but mix get that we you winter. the season. launched that in of then a months you’re toward in You into this were just had seeing that as as fields, as behind effort and colder Thanks. And the kind was coming season this as through into shifts already

are we’re Sure, investments having seeing pay Leland. more a Yes, we conversations. I the off. lot mean,

as we conversations. product converting we’re seeing and home in as infusion detailed And patients utilization more again, having centers the and care in lot are in we’re getting hospitals, and the well setting. outpatient We’re a

have RSV X we panel. data the And Two as look supply published look you against our the look that metapneumovirus. Ig, around that patents IND but we’re a are you XXXE, triacylglycerol you RSV, the types parainfluenza and product great feel high X. a state actually coronavirus collecting they to But product good that OCXX to as really, well we in at what a So that we marker. antibodies of at when have donors and donors the plasma is at that these really and that influenza high is for place when also these patents the of levels containing a we’re differentiated really screen

So can are plus clinical some so infectious patients pathogen. also are other at the doctors when tell there of these patients, COVID with disease, with minus that XX% looking out infected data I viral they’re looking – when you or about at or and respiratory co-infected the immunologists

the is highest list of the One RSV. on

more that antibodies. levels all an to way better offers, prevent than the I think antibody And we manufacture trying standardized these when our less of can treat agree is product we infection. to that

So be for clinicians and pay profile ASCENIV of a that can to this giving prescribed they’re unique consistent amount patients. payers time they antibody their Ig a sure every

there, growth. throughout And our grow quarter And I always what So, it than occur grow and of would happen, getting can if product to faster fourth is in all anticipate we’re we’re we’re across team to we Leland. on are, growth making love listening, faster. it our the immunoglobulin seeing commercial manufacturing portfolio. really proud we’re XXXX. out going Things we’re they seeing

for Terrific. much Thanks information. the very additional

Thank you for the questions. good

Leland. that hope are here, cold well. down It’s So you not doing guys

you. Thank

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questions. you. Thank few A

supplier how to First weekly it process? source is monthly supply does how or Is accelerator or often or the could a and quarterly ADMA? it slowdown or factors what plasma possible is

Sure.

schedule that’s told been problems told problem and our we’ve that already when and bit, a formally been the got agreed delivery but to with you our the You there’s can third-party tell was a of third-party question for believe I haven’t one time. I vendor. a out And a get cut in I deliveries, supplier little long I are there source plasma around that only in

contractual third-party onsite So now. do that as warehouse I in Those per believe location, deliveries We that as keep for arrangement right well monthly. prepared as Raton, deliveries inventory being Boca is typically receive a our do occur in we manufacturing. further

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this a So right to in and it supporting now. be village other we each very seem takes well industry all

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So opened? can we already just assume [indiscernible]

of revenue line top organization. in our cumulative million be would $XXX entire the So

that products existing on today. capacity, manufacturing set We activities, plasma the really, of our I earlier that call. collection really based our fractions. from stemming contract capacity well And the everything So I intermediate then as the as and feel of business commercial to our way our that believe confident the sale manufacturing unit liter we’ve again, mentioned, our on is this XXX,XXX business up facility,

plasma by with potentially We we progress going liter to to As believe capacity expansion the BIVIGAM up is grow pool that XX%. our project. X,XXX

subsidiary there over above generation unit. may this upside from our cumulative be business and portfolio entire $XXX top even million and line so And revenue manufacturing

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into the down very can we And going that’s into and have comes track much we’re year-over-year. our on consistent visibility plasma right? have how really on plasma, when seems feel plan, time. initiatives everything to consistent When we So source good about to It there. at the all to manufacturing be revenues quarter-over-quarter, we our good present visibility put growth

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within I million sell $XX there’s may. we’re not plasma we’ve from FDA a centers, to they’re that They million, information. plasma call $XX once the XX Regarding going it if centers, anywhere to approved believe and months, approved there’s between operating FDA approved XX to behind saying value and Typical seen and public plasma plasma plasma value we that there’s FDA not centers, the products, using for each it but true these asset center. a asset every sell our our plasma value true but centers, collecting just market

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that So, and on we what to wait we’re to have really, we EUA, FDA but with see the respect confident feel the right really says track.

terms is and products kit, objectives? Technologies conditions you respect to strategic would Leinco you yours can talk if the And assay think between and helpful. so lines, the that your business also you ImmunoRank along And And do ImmunoRank be company. that hear. to with would plasma great be a fit for That’s assay about a

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we’re conditions prepared financial So, at to not about talk the terms and time. this

globulins. is synergistic impact, if material we outlook. work This to present really a make have different that. around that products And disclosure company, not give patents the ability the around we are order and that to unable portfolio number to profitability say. hyperimmune a generate any high Look, and but a our plasma there’s time, pools the We also assay to at as you made have will, the in don’t screen you we with we’re titer platinum feel do, we in of

no have develop COVID. own plans for We hyperimmune our to

a are still Alliance member We present the COVID of Plasma time. the at

purpose solve that. opportunity these are develop feel we to was out we XXXX. These of novel to going do doing this development mean, Alliance. things the – out sometimes I look, really what the frankly, we’re to If got back real to founded that a We to and capitalize neutralizing our do can to many is, contribute bigger and commercial between in are But testing order of XXXX, and certainly the problem there. Leinco, are show for assay, shareholders on company players there. there in ADMA there the should expertise for on good. detect And ADMA collecting this plasma ability we behind we But is COVID do and companies are that ADMA partner methodologies greater so the the number a likes quite we’ve think I is this antibodies out that the look is plasma. from what differentiated a helping

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one final I And may. question Great. if

in or we stand do considered developing these terms you guys can where subcutaneous in definitely, I perceived subcutaneous about attraction gaining more you the formulation clarify and pandemic these and period of safe… are are drugs So have are you maybe mean, us. by for thought

of growing a We’ve your our plate And to of between all in got scientific know but know space. you if I want that, subq majority form in But like subq administration patient. tell population. is for compromised immunoglobulin should data it, immune an the I to quote I’m today don’t Ig not the if differences that I that we appropriate the may and on is around subq. there, I can patient the is that remains very we preparation. the At around question mechanisms lot the and correct have differ plans into But, immune about We think present get on time the an I feel Biologics. but target IV antibody strongly cut I no out the the at was to and action IV. market ADMA develop you IV utilized compromised bioavailability route of of don’t subcutaneous.

benefits that there that think argue. some are certain clinicians can I

need dosage you read, experience more trough I’ve IgG that the the achieve approximately preparation. same from you in data on IV form based XX% to subq can Additionally, immunoglobulin an levels that

that So more Ig. utilizes

much as as product possible. as Our to goal treat as to provide can patients many is we

out going the boys fight time, the market. So to present in it let at subq big we��re the

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Thanks your All for right. time.

round us. questions. for Thanks a for your Say little

you. Thank

Weiner Our from next the Jefferies. question line of comes Zach from

line Your now open. is

congrats performance working FDA line? a you great that to a – more sold the patches additional you and that’s it. guys And currently with quarter. performance give batches Hey, more performance One on through and on expensing are be batches. BIVIGAM when if to think the the clearances then bottom on right timeline fill-finish a guys Can you the you expect from as for us Yes. also, will

question, Zach good Thanks for Sure. questions. the

X,XXX liter specific given given haven’t process. We – have yet not on specific the we timelines

optimistic have file early be We’re on maybe four should later to six And QX. a review. or and hopeful months PAS year, it this it we that standard

bottom said, we next comments, the of year. batches, file, I I we when and told top Brian on during benefits in them these as the prepared year production if you to we half get So, made the times, mean, cycle middle of next part line we no. we expect the to understand see on second and the

XXXX, that door the equipment, going getting additional really growth. half everything the for doing next future think And we more don’t some out right have fourth attributed mean, think We’re year, of considerable right we’re X,XXX cycle those model very I Again, your the using of staff, the the the in way. change at batches same do hopeful I it’s as feel but and the really yield anticipate that release. to turnaround going liter and to product certainly, the front not I forward. faster me, the the And at our some outlook producing of available can point second only there and have a about that third, we approach revenue and times, fill-finish business going we’re same we’ll disposables, same the quarter-over-quarter that scaling strongly quarter be growth. begin but I we sequential of also to

way. the Street, we we the when guys to we And really to confident and our mind produce about our something we’ve feel them. FDA we demonstrated to a in methodical put give hit it We’re ability demonstrated doing guidance We’ve that, our on you Ig. to timelines, do

the has this years. more previous They’re shop producing quality around is as great four facilities than working our clock the team or and our calendar I our door team are unit, Ig manufacturing the are we produced As mentioned, to possible. team, plant or as product great. teams My management in out five control quality running get the much

I question. – but FDA So, do. conformance additional of to part have what ask you to batches, don’t refer to answer we risk our going never believe factors, is other we don’t any the know us your if planned, your we to

very So, do could still guide will And our rush months any and are but track. on four back, approval other about If supplement. to expenses may six our for see we I months to produce a do a FDA this certainly wish everything’s chain drug, clock R&D I part of strategic But seven prior reviews approved. the incur batch of a to we potential we best running you XX to that analysts. supply plan and/or due important getting robustness for to

execute So, expenses and growing milestones, continue hang in and in line the there, we’re going our to top stated burn. to and while meet controlling objectives

for the our sales. in bringing million, half One conformance conformance batches first the that year. the hit through about We all went batches costs earlier $X up obviously this we of in mind, keep those thanks of Zach, expensed that thing batch, to

those So start batches, bottom margin, the as XXX% we to pending FDA selling Adam realize those mentioned profit on in the would batches we straight second half of line. gross XXX% XXXX, conformance when approval,

Yes. so Understood. much. Perfect. Thanks

question. for Thanks the

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

thank it’s center great collection safe for I help healthy Thanks your winter a everybody. you your life. out say, other donate you you. a wish your mask the of appreciate and CEO wash I period, Visit country to be plasma, get a and afternoon. and I plasma if you as We calling parts time. Thank colder We a getting and wouldn’t have really donatingplasma.org for good and Thanks attention wear save hands, time. around find didn’t your and to in. want a everybody. safe near there

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