iBio (IBIO) 17 Feb 212021 Q2 Earnings call transcript

Thank you for standing by, and welcome to the iBio Fiscal 2021 Second Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the conference over to you host, Stephen Kilmer, Investor Relations. Please go ahead.

you. Thank everyone. afternoon, Good

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call today the John Tom. said, I’ll representing Chairman Tom On Accounting and Delta, now call Mr. are Principal Officer; over and Officer. iBio’s With iBio’s the Chief the Executive to that Isett, turn company

everyone. good afternoon, Steve, you, Thank Great. and

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XXXX. financial I to ended update rounded on the all streamline XX, results I'd for afternoon, Good a everyone. Thanks, therefore mention, have and brief the quarter December provide our been things, are will To like Tom. numbers approximate.

well quarter the or the supplies million year. related an and December same for in quarter the year. expenses the same primarily primarily $X.X G&A results increase XXXX were director R&D quarter general and of a a development costs, an XXXX quarter public and ago. were XX, ended and December consistent revenue compared as $XXX,XXX, million, for increase three for million same expenses last costs. quarter the month quarter the with were period $XXX,XXX, XXXX, period fees, with was and facility in million, December company XXXX increase December XXX,XXX same R&D, increase XX, last For operating the period Total administrative recruiting, was the ended repairs of last compared ended ended research expense quarter laboratory G&A which from insurance December for from including personnel expenses expenses, higher is professional or consisting year iBio R&D consumables, higher and reported Other XX, $X.X X.X with year. primarily the The with to as ended a XX, $X.X The in consulting compared ago. million $X.X same $XXX,XXX board XXXX for of fees. and maintenance, XX, year

we continue able expenses creating loss and expect the cost the creating to infrastructure led Chief the capabilities three as forward, million to our will revenues which a expertise by and $X.X of lifecycle. it and objectives. processes in match quarter per to our be We we period as net move to provides ended stockholders with quality expense progress begin we for the on XXXX year. people, investments reporting Inc., the associated compared like $X.XX Scientific expensive well products. value moves high within of share making significantly in establishment December centers Net vaccines, and forward we aforementioned our We've will share, more attributable this position that bioprocess research include a growth and and with goods iBio and our Officer, begin said, G&A In will forward XX, be been foundation per visibility R&D R&D providing. and current and clinical last to was the sold and our in iBio in therapeutics, serve iBio, or million, dedicated outpacing we in visibility QX, believe company, quarter, new $X.XX advance this with or significant biotech especially with new profit moving to expenses. R&D, our for we comparative G&A group, regards pipeline, loss $XX.X in provide January will of needed with expense As That solid

securities call that, XXXX, I'll million. back had equivalents, cash turn cash of Tom? over to Tom. investments debt turn and iBio December of plus $XXX.X the As now -- XX, in With

Thanks, John.

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Importantly, organization that take Operator? now current have maximize the I you. our highlights, within have. our Thank happy And future with questions requisite might and we concluding leadership to both believe any you we're to expertise and opportunities. our

line comes Kluska our Fitzgerald. with question [Operator of the have We Cantor from Instruction] first Kristen

Your line open. is

Thanks for as congrats your as questions. my progress, And everyone. well hires taking on new website. Hi, the

phase announced me, week excuse longer profile, my IPF three first in continuing for inhibitors discontinuation So the is, companies no benefit the citing autotaxin of one risk the studies. development last question of supported their the

So action based of be the you've perhaps I of why studies, in could the you you mechanism ask what in on seen some and differentiated iBio-XXX, of and therapy think seen your hurdles, we've preclinical overcome space? could

efficacy Thanks, great it's may course, at our look that and called Yes. inhibitor class, layers. think that development into that quite the questions that get Christian saw here. than class question. is are safety combination a different of I interest, MOA, and of take we when the whole a actually with associated, ATX We jeopardy And course,

fibrosis, model, right testing, tentative for And opportunities work. have done, impact good have taken standard on And about confidence particular also look against derivative mean, here our ahead sort the see sort going preclinical of collagen, then of is talking safety we've results so And really some diseased versus one pirfenidone. relatively by mouse with to a with be some that that that ultimately long two we where at we human relative we're saw traditional high to exploits. of we which a is the care this we've a to product, in of that thing a so idiopathic and as our of used But what about, we areas, just, pulmonary now. of profile. I the way, that's the

good. was data Our really

reversal we of in those not So spaces, saw only both particular models. but

due optimistic that, here material then of course, dropout mean, those the we're which, even of with are patients treat So, these landscape solutions part a I and the mentioned, for and competitive can't important just diseases, of that such and medications, tentative lot tolerability. stay to pirfenidone on there's poor to some an in the developing embrace of I

be we're that going we'll at of So, we're safety rest to have around the efficacy is forward why the seeing pretty hopeful the tolerability what be standpoint, data our able least deliver that, iBio-XXX, as we we some fingers and possible which preclinical as designing to with feel as certainly to we'll clinic. crossed, trials, there get molecule. and is that, the moving from around for the of about to that get that we're good quickly have too, into something to the try We a

Great. from And what, you're may farming COVID-XX thinking then, Thank how you. prepared And to key elaborate you, far? could some observed kind you've for just then, wanted vaccine players the so savings? of about and front, allow and of the landscape on remarks. on And greater of seen how production I further also cost elaborate your fast other vaccine some

would you to development here, together So regarding that quarter generation? move data, for the similar further them the next be will you in second you forward do that any generation to have talks for Or have work this vaccine positive? assuming with going you're to conduct what to you've you think plan first done

Yes.

or that along question move booster LicKM can and the nucleocapsid lichenase do, to here that that, a guess, booster we're look from molecule, forward hopefully doing, the have I tox is the protein kind and we and the hope ride that clearance Let's of with the first. get The work with agency. at taking second spike

forward. we those So move two that's the that expectation and then pair

like, the places, access we to question around cost on and South would and of in one turning look take the be some So needs, I cost, a certain component. good when America not least what's think at the and is a of unmet the one which is Africa, especially going

which or And is requirements. a substantial illness. course to may new the become, going level a they is right. different I as of this have current is coverage question chain the see efficacy, Moderna not cold have we see if Pfizer noting we only from seasonal for vaccines have mutations in thing worth the becomes fact, other the pretty those think that and we And The vaccines,

what then whole So do that to some they in entirely end you seen could been mutants, you're we've XX%. early have then getting due started the up question some of And and prospectively, off is of the new well, strains ones, becomes, these new drop to with too.

do goes going as with fast the can if one standpoint to to better it's cold farming. to strains could get speed I produced with the and would we're So these then well. of requirements mean, the if consider it some mutants from we be happen mRNA access we But after season-after-season, to to what then what is and -- and go good. new be the really rivals on, possibly some this which that chain as cost then ultimately, I and vaccine, think vaccines rest was address perhaps with subunit we overcome, can a of matters

how at disease that's well as itself. the looking the So we're disease evolution and state the marketplace. the of And as

players like had you protein. two continue things, who subsequently we see with to is to we as say, invest And not our toxicology might And of the get the at that we're on kind it clear able others programs. too, have there's production forward to we address have depend in is be good more it the mutants funding, this of But this two in we go those strategy, conserved nucleocapsid will more course, involved design going but it enough going. us forward. a not looks be keep to soon. we of some to development promise all look that government or things what even true, then, move -- their virus to well the be crucially, right, Speed, be And solution where that answer have the that of report reasons, that that maybe got those of for substantial So study a, a would our and other as the looking continues protein to their in or do we if But this targeting to moving path here to were stop stopped Operation that occurs. down Warp forward, to here, behind know, those head hats very for couple able assuming it'll platform, of back to to bring that have got ring, help

so much, Tom. Thanks Great.

you. questions. Great Thank

We Part. next line have Haynor of Alliance Ben our the from with question coming Global

open. is Your line

Thanks guys. for taking the questions. Hey,

side You just of and -- the iBio-XXX. thinking the about know, things veterinary

You mentioned what a few But, get, you completion? to up USDA take know, kind for you how the couple of, things. what years that do -- it look when iBio-XXX? side investing of to kind might the on like of, take you to -- you And, clearance timeline the does know, do anticipate that,

Ben. Hey,

the actually still instance, send you License the have pathway So to to go and developer, pass the out somebody Well, inspection your when great know, the Application. case ahead it's have so the more facility facility facility question. BLA look to And, for a regulatory be manufacturing the have information like by on where you take the will of of upon necessary it's inspected it's Whereas in know, used USDA they produce -- it's to you the go a how ahead here, interesting FDA and itself. to get nowadays, out you you where at side USDA, -- things. Yes, it, FDA. incumbent to case check a Biologics the bit little they’ll manufacturing

license your you one regulatory that site your travel So have is to with first you're and moving product. in your what for down the pathway facility along that interested do has if

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That makes sense.

has COVID And at by the way, the impacted, least -- absolutely

Yes.

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that expert regulatory way on it’s one, probably a works. But the not Ben. that I'm Well, I it think

yes, -- it do that need I virtue out. the license. it the don’t mean, you back of get why So But, fact and by establishment check I'll we

case. the that's think I

can So of I it, I that. My that. good the have generally, the your on the once to up out make follow procedure don't But other does for you. believe be without up to regulatory it a the I doing expert you all additional for not for it know process. is, There news focus of move that go well and with I’ll once necessarily facility as of again, think easy that. understanding to as product, But it there I'm it's through may -- on having inspection get you pack one products it.

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this some had than I is taking think, hoped. people longer

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Fraunhofer on that’s leave it. Got I'll No, for there. Then lawsuit? lastly Thanks. -- the great. Thanks the questions. And the for taking me update it

the Yes, trial it March do damages -- scheduled we it's for begin Ben. And in to phase. as certainly Thanks, -- the Right. see X. others that still we're

contend that Delaware is iBio’s of ruling in back favor. would Some the in Court was very XXXX much Chancery

matter we going see to prevail. we'll So we're And suppose I of think in a weeks.

Well, Good to there. to best hear. you of luck

Thanks.

Thanks, guys.

question of line next Jim the from Our Investor. Private [ph], comes Tassano

open. is line Your

how ordeal. did in to time, it It an on follow I iBio because I Tom, hard start want And several full taking late wasn't many know And I been for company the call but the with XXXX. people. I've back closely. of last I'll to a the know, have you two was my was to think I call. and you you questions. in for I thank now company I I've years save And couple Thank spoken comments. Hey.

the think move with. anyway, he's I few is quickly. I the realize bio have in questions, source guy very to thank performed for fantastically. here. several wanted to best I IR Hey, involved on I've had you and ever Steve to He two to best years, worked But my I'd do. like Kilmer, difficulty I'm go And because what he's people been the high So

platform You fallen molecules. have at platform? need have XXX best it that some the XXX, and for the you with for platform the to off you be But Where radar. in looks appears has of VLP And VLP are a to the the VLP developed of kind a candidate one industry.

Jim, things. two Well,

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thought mentioned. performance, able with well our get through look particle was - FDA when and Secondly, manufacturability reasons process. we times also one just were be with There's stages, regards everything had first moving sub-unit it on time was a forward And came and But the give is, And have a there let's good. do. based the and But no said, that really, peek could have that you surprise, better. ran in Bake it assumed; -- as the through was we We platform And we we look, you fortunately, that course, you others down And, at we fortunate frankly of shareholders and a Off. the assumption from to know, pick was like to when did well needed to we go would recall the we just communicated that the studies we've a And what then, XXX the Off will couple let's VLP we that we vaccine for and promise, -- it platform you it at just virus taking was who what a optimal toxic. you Bake skip the an of that, could to talks. doubt. that early we to and a the VLP were of early with said be may announced looked on know, maybe lot the our it, got because in that was wanted good we part. really a exception that

you use silver can forward. Now, that you know, be toxicology through that here, going the hopefully, platform we that'll is, to lining getting a the know, platform liquidation by one,

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of And once. everything don't so we'd know, all terms that deployment to want the to to able like do to we forward. investments, at you But resource try move be and in

comes know, to last. go, we the to we put moving in with pick do way Because, want guess, only to one vaccine also, fibre the XXX when the when you COVID-XX it need horse forward to iBio we So it optics, we with had the ride, to my concurrently do portfolio. obviously, be to I had is to

still it's energies on our the that know something instead that you advance. So in We to focus to XXX meantime. we want just

tie where platform Head I Head advertising was for that Is along Oncology. right, comments VL of if platform in have the iBio a be as interest. All lines, there wondering, And into the to of VLP would those noticed terms Oncology -- oncology? you -- you're that, any I that of is of might on well, but

Well, so indeed. interesting notation on posting. Yes, that

particular, see do that, shared a manipulate oncology, antibody, take literature, can, when I to, earlier I cytotoxicity, from you in combined here see. you it the a what remove on is in antibody, give to a able you'll a to see you potent, of sugars the particular, that monoclonal for instance, of certain particular, monoclonal such them can where to indications something mostly FastPharming, comes that our dependent ADCC. some can guess, in in Glycan we ability me as make there's the for if more Glycaneering remarks, can say Let engineering, called technologies, sugar you ADCC, in antibody kind in be would we with our cellular it greater if

a of name with on work of arguably done closer to some some in there's a data have XX, that the as think dozen, do so, we by experience a us. earlier And little antibody, because that in we the We And monoclonal opportunity have company fact, a actually, that, antibodies. we other for lot history hand, the of now, there matter monoclonal with a of Rituximab. of anti-cancer a in have

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the the that a that identified, se So, can But opportunities who But, of definitive is the us that's for established just technology yet think space. projects in to we nature in leader explore have -- position. that help leverage really any we've we per part, program. and want nothing that's don't program, for for there, important the we here that

All right.

Let me go E or The XXX the multiple targeting another and one quick M N proteins you one I and one, therapy? as was hope. like part the section the -- have has the under XXX of -- S proteins. tool, the had have And your mentioning targeting website On or I'm a the established wondering proteins. little investigated team blurb also

research activities can't other shares of the but I we disclose some may have -- that So or Jim,

say to right. suppose All Yes. you -- not want say. to anything don't I

we're trying to as we here, And obviously, Right. as can. transparent be

Without competitive giveaway, yes. course, of

Exactly.

right. All

down I've Let's on, calculated analysis. pen and to move rough in never we timeline XXX, the hey, for -- data

months, whatever, what you be period, In June, IND that what rough think like of done? to months toxicology then terms would months, April, of instead May or be an analysis do filed? quarters, And might when

data QX, early kind that say want said, think so So analysis we're I the would we it set get in want not there. is, is middle, to in which to can quarter I sometime already that ourselves. on the doing that your And we've again, what figure mean, really what cut safety, of is you

that's a third-party expedited. paid We've provider doing it work. to that have have We

the you going And market, that that mentioned this that to on key we'll know, is the illness? have that doing expectation us our first, that anything the Is with generate What have data of And to that What some And know, with the want next disease solution that the go data a fact, the those we're we are going or tox quarter. you combine then might of we I antivirus are seasonal roll this better so, then, day to the I bring is mRNA design going to a performance, own to think vaccines? itself, going be quarter that market plus together up XX evolve, is bunch versus you becoming the then projecting other be differentiation and about beginning else that and able at hand could or as be combined through the winds too. lethal, have know, is, the as various you based to Then to a in others well questions we you info a press in answer, answer, preclinical mutations -- the thing end, and vaccine. work, if conditions or right? predicting these are are as other we good the that there going unfold? become it see the before, the may don't, as really a if stabilizing in and forward. can we occur some got or with with as our we less that of change we If the -- that here's disease it us

those, pipeline. our going we to weigh That decisions make sense? for to we're to makes portfolio as that go. Jim considered the has So, be as Because we all have

Total sense. All right.

that's think I it.

Now, much. let's to so next go the one. you Thank

Thank you.

Jones coming Capital. Jim question next [indiscernible] have line the We with our of from

is open. line Your

questions here. in you the all taking that First I to all team. congratulate of our Hey, Tom, thanks And we're doing? you seeing to of for new coming how join on are the talent want all,

Additionally, of new a and new website. launch we question, and to seen this logo, have a fantastic goes my the

have that of company direction things the for are it that a so move me these lot And looks reflect outward call. last bullish And changes house. we a facing to the in to brand starting since

said, is out story, to retail. love know, have spoke to on wanted But communications believe in shareholder I the statement really in any story get anyone help consultants, you that if that I iBio, and wanted relations plans if of build opening house, people and move we'd word to things earlier spreading more the ask investor like bring confidence. to to you about there's see quickly, your kind plans just So you in a on or that strategic just and we can because build value, find

So, fact, of you XXXX here who Investor XXXX quite early ride the And and lot that. some, you. you small as I us really groups and all in times started know, of late help talent, challenging until financing we in of company thanks team a I wild folks, out pretty other who helped XXXX. say, by a in to Jim, off for preceded And look Imentioned of questions. just the been thanking, XXXX through up matter a your a partner, had And, this terms October from of and us people this it's point. before challenging through many way, in Jim, of would had Relations a get dig was to of those our one through know,

name way, And give the want I here things now yet group by to services organization to some on then off help and as because this people. part and whole and that move we've another line certainly into organization, we of as and everybody in workers you think the was XXXX brought including who the a person bigger I outsourced And forward, like thanks our in organization, thing John that started here for provided a couple Delta, Texas, support folks we it.

so, strategic very staff on to and all know, rest. suppliers, heavily had we our vendors, support lean you And the

you hopefully, every the for started we we do a but for it's month, real place rest to and not I going mean, of in you're foundation enough. only you improvement journey, value it forward. So go areas, each a seeing just come where I strong like a have We like, our all believe that building real and continuous more forward, lot we're generating I this investors. Hopefully, each turn, the feel here company, as good from never we see week, assets

know, and turning place, that you that out do organization Look, the a just, eco whether along got deal time you forming development commercial friendly day the the higher And, Glycan plus strip the something of start of we again, going to pipeline story. it's to just with make we've like getting model, you we every now with got to product we're business So with know, best better good you and safer? a define, know, I edition, a area that early hack, in ability ability, bet. a novel here. going know, think and website, unique something really we out in keep or matter telling service portfolio it's fast doing better stage to the the that platform of and our using the to that because machine on think the we've of way, capabilities by a products and cycle quality You play the it a

got you've all great our fronts, to know, functions a to build keep company. you all across working So, commitment hard

and question commitment you So, but improvement every thank you got to it, continuous in for our the facet. that's

Yes.

Hern of lines from coming question next the with Matthew [ph] Our LLC. Matthew Hern,

Your line is open.

you the know I Tom, taking you're about lot appreciate Matt. a I my sure is I'm iBio. this aware, Hey, question.

with And a partnership Definitely XXXX. with you've there. iBio of this as some focused the investors, long I've the a personal first term, think private, involvement. involved were that you've us lot retail questions really heard CC-Pharming phrase I to been to all, -- and of Just of couple in the a on as recognize made. new want progress familiar end, were I that company your recently beyond who

a vendor. CCP are going I think even just relations a and that to on on coronavirus it's I How there docking that's leave again, from iBio it's patents, partnership. contributing like And a WHO in about with -- not we've part to releases that the in need little promised open just PRC really were Africa, since like same how really candidates. heard more transparency that do about a were to some were item, Korea, at in it's the be AzarGen, us? with internationally what board, why just in again, on to or whether visits comment, lot whether Because it need the it's focus that's I that the respect And seemed of South of new thanks, really understand for So hear we business that iBio time, you've appreciate, they is on to change is line to then, any a direction. to list, of whether not is you really that even to bit We XXXX, revenue? the press huge the if days? places and of a partnership, ended investor have CCP, a like And hear focus. of, you or And we licenses, that priority heard same event to these

well Matt, your Well, thanks support. for as question your as and

possible I that involvements iBio. you me with here it's even think with may precede

good say break still bit place are very very is relative strong. to and and Those in can let much relationships a the me here's news. what it So And I just little down CC-Pharming. on

vaccine marine actually vaccines, drive wound CC-Pharming and to a able forward the were successfully antigen So had, up of you're manufacturer two that right. had When that we iBio it that the COVID-XX it that being the came didn't materialize. to an

it came at taken to necessarily more was our sort relationship COVID-XX into partnership, have vaccine COVID-XX the right. other because that opposed anything forward didn't stuff, time drive So than we eventually when together a to CC-Pharming vendor, to it as of, could of drive to have a China, forward on

as of statement rest matter in fact, commitments a last hard on when contract in that the really And work fiscal the place. of year had. to relationship, that deliver to the we drove it the the end However, towards of we still the that's comes and were of

was this that last was speaking filings why had to year, for think end a at relatively of that we spoke CC-Pharming. quarter, big So we our that's in the fiscal a of I iBio -- lot

all that see can you there. So

relationship have there. the But, very over to can't that too leadership themselves. looking We a good speak they with strategies at obviously, I are And different much.

have the same I So and is of still delivered some it AzarGen, would strong And others and we we in on we relationship to named comes when everything had place. thing. so say that that

relationship rituxan start of relationships, strategy, the way. the around terms generic their over here executing the to and we're to there Mauritz, first in CEO very the both was a them good the helping sense. rituximab along the of molecule have with We question them oncology, And all in or notably, of in earlier with that

We with those AzarGen are that happy active we're So, there. have relationships work, do now. certainly right

to things, way. changed So, CDMO and or be we've overseas, utilize that shape able their to up own the partners our given some things but we, services, in factory way, our goals here help form, business solutions no the platform along on adopt,

in not obviously And, And, with So, them. still with forward we're active. great of hope little But may clarifies bit, still some now. those to we're questions. fact, strong actually, move be to partners a we're I right other agreements. North relationships. have speak But can't speaking things but that America, or may international those to able that we

the We have Tom now over reached allotted Isett. the turn time to I back will call now call. for today's

call. would today. for time you you I for look and updating to Well, everyone, Thanks, forward again our again, And We say thank again. next joining. attention thanks on your right. All once

gentlemen, presentation. and you thank That concludes for participation. Ladies your the

may disconnect wonderful day. now You have and a