iBio (IBIO) 16 Nov 202021 Q1 Earnings call transcript

Good day ladies and gentlemen and thank you for standing by. Welcome to the iBio Fiscal 2021 First Quarter Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question-and-answer session. [Operator Instructions]. would turn I to conference time Mr. this like the to over At Investor Kilmer Relations. Stephen of you. Thank please Sir begin.

Thank [Andrew]. you Good afternoon everyone.

or key activities, establish its its or grants its Company’s research with to to Company’s its to obtain its development indications, competition, regarding to of forward-looking or [indiscernible] result ability capital agreements, or the the maintain current Let at product expressions, license promote or this for "expect," and for COVID-XX ability unknown statements. "continue," sale or "plan," its conference candidates such ability or as Company’s regarding maintenance pointing uncertainties ability "anticipate," identified fund regulatory vaccines, to marketplace by candidates, ability by forward-looking necessary out "estimate," of known include conference Such can statements continued comply "might," or affecting current expectations growth commercialization of incur of to forward-looking obtain are by the this a regarding the products, or dates intent, Often maintain "intend" the expectations, or statements acceptance words are the circumstances its use all this the based always figures]. successful regulatory relating the to of our retain belief, me and forward-looking including requirements, its and the "project," [biolimits "will," for events and commercialize in not of be "predict," of Including limitations its specified not statements candidates regulatory collaborations, on management. specific factors and company. the product "may," statements product ongoing discussed "forecast," employees. the approvals maintain call Company’s similar ability start could in development, may The will marketing differ but to to that "should," call certain the as and and materially "believe," its

by factors of attempted cause statements, to can described No or those except to has required as other actions of and in the could laws differ that made differ which identify new forward-looking date or iBio are actual be results to law. statement as securities of result if Although events, undertakes estimated publicly actionable may whether from obligation required no applicable revise by forward-looking or only results that iBio factors there statements information, they update important forward-looking intended. future than can be anticipated, other the cause statements materially a otherwise, from forward-looking any those at uncertain guaranteed

the today and iBio’s representing Delta company over turn Chief said Principal Thomas Officer I and call that will the the On not Accounting John. Executive to John Isett With Officer. call Chairman

everyone Good shareholders in management are of and Steve. to like support. welcome at iBio interest inaugural company everyone those On your appreciate and to you, conference team your you would truly you Thank for our call. thank for we who afternoon behalf and our the I

to provide I over therefore XXXX. XX, are ended and our streamline like update update been I'd activities approximate. an all a To Tom call turn Before things quarter September to and mention financial for our the I the the for on numbers rounded have overview results brief on will

$XXX,XXX attributable iBio new period is increase same revenue reported last customers. increase year. For $XXX,XXX the the revenue generated three-months XXXX from of of quarter ended an from September XX, to two The

the quarter September or were year. an million in with the and the period approximately same revenue compared for to XX, the primarily is were R&D XXXX XX, $X.X XX, $X.X million G&A XXXX and with related resulted the $X The million same September repairs million a quarter with G&A supplies million for from general $X $X.X quarter million. consisting ended last the compared XXXX $X ago. of The Total were As higher maintenance. laboratory year backlog professional ended $X.X same operating expenses primarily XX, ended of last period R&D and expenses and or consulting research in administrative September for higher and was September development R&D for increase year. increase facility quarter primarily in and XXXX expenses personnel expenses compared costs. increase fees and million

a the G&A the same for forward. that which $X.X XXXX the significant to needed $X.XX loss progress of provides We Other $X.XX period position or infrastructure people, processes to the match and expense that solid ended in and quality consistent in three a said value was last per months it attributable biotech and with creating XXXX advance expect creating we investments making moving was life loss of Net to million as compared we compliance net September its R&D We pipeline with in clinical to forward for year $X.X share and ended moves company believe continue a in have or with iBio begin year. our our quarter share That as high quarter will outpacing million expertise our foundation been bio-well growth cycle. ago. XX, was $XXX,XXX comparative expense survive September per objectives. of stockholders the the XX,

call iBio With had As Tom for overview million. September operational I'll Tom? an cash recent and on the update turn XXXX an that and XX, activities. investment in securities over $XX.X to iBio's now of of

Thank you, afternoon and John good everyone.

our the have time discussing would this call, that little before occurred turning our inaugural As near-term we is a months we'll plans. to normally spend over than past several more developments

transformation last longer another reflect had operating ramp up. to helpful it that on that major our on of business essentially might than first our were for one had working plant-based two time production product and taking We to client had this were slowed had the development small exclusively recognition. into manufacturing. for work of a expected put was The position little very We contract assets very industry whose a be focused client the design We stalled. facility to on perspective almost We iBio's scope brand year. new

Our cash $X into price was our market below translated a million. around stock position cap and over million which $X.XX $XX just was

So in producing because to a in begun the rebranded our able designed to technology leverage platform foot launched the biologics improving enables strategy as we few this new manufacturing of earlier we a cases and the efficacy technology. our XXXX, December We our glycosylates in work system it products. This control FastPharming which square XXX,XXX plant-based as proprietary and facility part well to with to we've thereby produce our better development were our achieve own Glycaneering of in us the proteins way tech it. months some quality put

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of and U.S. addition we technologies those covered over issued and product patents to XXX So the Glycaneering with years FastPharming in issued in the the technologies by have developed are certain candidates XX

We and applications with plan to to pending continue IP strengthen additional our portfolio have patent filings. XX

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appointed everybody variety since welcome the a its and Dr. has Gary internist of new as in medical Armstrong, head global respiratory medical is biopharmaceutical senior at board at development, and Alexandra XXXX translational his Well, respiratory he research and its He to various has more finance ranging senior biopharmaceutical Pfizer a of has respiratory as Therapeutics pharmaceuticals. vice Technology Both global oncology. most finance. as vice expertise experience sharing Synergy by been years roles Committee and committee of in to and clinical and VP and served Teva unit. since at provided companies. than she Linda biotechnology followed is the joins joys a as clinical conference served opportunities pleased Sanofi us executive Alexandra of administration firms valuable of R&D Glenn Linda to live executive as analgesics. Science CFO diseases plow Dr. relative XX where president Alexandra and saying of Alexandra So appointed VP identified phases XXXX. global pulmonology in XXXX CFO and all of is All years chair Novartis and affairs but respiratory S&T most of the med the president three is served we've from therapeutics organizations executive a board-certified since and and Gary Linda insights Pharmaceuticals director medicine members now director recently leadership to Flug. as translational He global of Pfizer's from Mr. at specialty has pharmaceutical large respiratory in served Shire new Seymour financial safety than group members Sender. director with diseases apologies in Gary I early inflammation our now our and advisor development, institute. and right. a phases and at Alexandra by committee. she of pulmonologist of and area joined already audit Kroptova, senior a XX I'm us experience long-time with new also Committee. and was stage clinical Gary recently compensation and multinational development The of in was all affairs and the head therapeutic and medical subsequently previously affairs more director expertise Chang Linda served in is previously global members medicine have roles of to Nabriva been board's

and recently joined made a the Aptevo addition us Chief operating and where Randy development of also development effective years quality He's XX announcing Genome of previously experience. Senior Randy site positions of business quality and than Glaxosmithkline, VP Therapeutics at Vice helped was responsibility management organization. Maddux appointment President team director December key J. global increasing management to within he was Randy relationship Xst. as of and Manufacturing got chief Human our We biologics officer more of Officer. from VP manufacturing, operations Biogen's and Sciences and

products. posting he extend strategy. our this to iBio little experience We'll career our growth invaluable executes true Also to his and leadership I'd is warmest on period which at about team, we're pivotal our this a growing licensure and the for should say during world had board to our This be play proud weeks phase quickly Dr. to selected pleased still sorry I'm designed proprietary of iBio therapeutics. had in and includes to tribute the also iBio During own while COVID-XX a just development for product company and to a to due our that in the supporting the been read products what operation launch to down the bit of a model respond to clinical expertise in Phil hit. before of for I'm Tysabri®, CDMO precisely their next several in expertise our have important many vaccinology. from speed combined potentially facility and been website pandemic reasons. iBio our participation development you to Abthrax. response. short warp a involved giant later I'd past and our iBio's On to focused vaccine week that including experience from summary, had roles Dr. short begun few role enabled the an nevertheless on Benlysta state-of-the-art our of and is only who sadly members Phil existing goodbye years to be like step behalf Avonex®, capabilities, global the proprietary to own in we for the focus quarters new welcome key transition the as us one position needs iBio served the for four recently In of esteemed vaccines development pandemic services in business while to health of invite everyone was that Russell and

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Our comes Alliance Ben first question or Instructions] from from Haynor Global. line comment the [Operator of

Your is open. line

for Thanks gentlemen. right? the afternoon me questions. taking you Can all hear Good

Yes sir. Ben. Hey

Excellent.

you'd front into your at the maybe areas on have news new a Can I'm have present? developments least of front maybe and this rank you COVID-XX year maybe of the it correctly you resorted at somewhat. you if opportunities reading some quickly of how the in more on share a recent like you priorities of bit here little sounds you've progress. congrats lot the So Clearly all moved on new some

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with also bioprocess see and of lot research We our proteins. a opportunity described as what we

is So as portfolio we supply of them as those as clients are Cell services say our ADCC Safi Antibody as our important a platform be me Ben the part can advantages FastPharming a in towards product technologies in really itself can what terms significant glycosylation times and offer oncology well well I'll us engineering heard couple into of cancer that or because them to part you as And and of allows there Dependent speed like glycan own Cytotoxicity. certain to at and package of clinic.

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result. read good factors as there think are come that I really Well, a sir. Yes, in three

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produced Safi's the already constructs did weeks six past already of the other for to bioprocess. iBio take our where advantage speed now you we platform this is of XX So is express course than the XX different provider approach the more we've this to the, because that just is the of over ultimately proteins of proteins the

and to process. they manufacturer iBio support advantage successful any be which Safi of create contract continues like biopharmaceutical raw developers can that disease. are the the goes So our viruses, we remember by bioprocess and for receives doing their there the bioprocessing dollars need us forward establish you of cow projects entities custom the give growth then as and where create, folks optimize if for anything for and either other to many those custom certain as various prions, for Meanwhile, products own products plant-based its mad with and to them Safi doesn't system designate viruses concerns materials can for or it cytokines the has their for own high proteins, our have animal that's of are who factors we they begin also ultimately bioprocessing quality their cell research and mammalian a because finally, iBio get portfolio advantages. as industry a just ourselves or Safi In may speed often origin evaluate materials about CGMP

disease cow mad replication mammalian of and So plant don't course you of prions viruses systems. either in cause or get the prions

animal finished should be we'll they'll have other certain to goods as designate well that So free as them that competitive. make able as our features

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the designates On from custom. as designating there's guys them that Safi that everything compounds protects custom, something presumably as you

be the given think certain tweak might “standard substantial I criteria to and everything market intellectual protein are going of that process outside of those quality versions” to in any property of to a be the sure. there amount maybe performance that and/or of customs documentation which falls room usually one there's control unique portfolio Yes be able any us small that'll be a for Indeed. and for to Safi's or to molecules there's space

Okay. then for one litigation? last me the Fraunhofer And any updates can share Great. one on you

Yes.

was in May So and proceeding June. in trial May, was due to are the of first hearing expected to March went XXXX now XXXX which of postponed COVID to we first of, from It a there by as week of the week note.

without in aggressively We defend so utilize Fraunhofer we determined our property judgment and intellectual this iBio's expect now are and all that in indeed property a was portfolio. intellectual case earlier. the permission summary damages in phase did to others It

much very guys. you progress. Congrats Okay. on Thank the

Thanks Ben.

you. Thank

line or of question the comes next comment [indiscernible] Our from Chapman.

Chapman may you is unmute Mr. Your to need phone. your open. line

have actually on any provide shared I bit earlier? a if deeper for to of what specifically you want you to little Yes. was you see calling updates just kind iBio-XXX

with into planning can the June were detail when doing can planning mean that so only I change this this we of head that go the but presently we there's referenced I we kind efficacy clinical study something study it's trial in by the I but swine go. still is say I The Yes. that study think looking size in sense to at thousand that follow stages. safety ‘XX a involve we a are much of would of here later the may as would of give

a So looking a that trial can shot management clinical and now a are particular we both give a get as project great number design, from bit to candidate around we're right design that market. regulatory of at coming sense help factors to investing quite obviously at trial you but

IBM with and regards question on and last team the that? Watson in Thank to just kind investors relationship is with anything you. And you the of update the share

of the Well, the us course getting is key one into next. that clinic to

as as trial support us need reviews any we but to their stands soon solutions. to management IND complete enabling have that studies data with IBM, ready regulatory So as clinical as we help well Watson

So excited by there. that relationship the future and we're

Thank you.

Thank you.

or comment line of next Our question [Karim comes from the Amlani].

Your line is open.

It's you quite Thank to far. to a circle XXX. I Congratulations wanted the so been back very progress on much. year.

contract increase organization in you think and share does tell we're on I I appreciation market been back this July of lot few today have your of been QX the by to that do price any firm support and year studies timelines update end of here you now. but has in talk me cap Can that was the the from selected. recognize research a weeks dependent November anticipation then studies studies of the end a pre-clinical see the XX, pre-clinical in end has

as the IND the be the essentially talk of please? the end filing when next catalyst So of would studies

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lot we this as you work are can other if of proceeding to of So A to response the submission going toxicology our from that and studies required. to today depends FDA remarks that as our Nevertheless tell get with allowance pre-pre-IND an to are extent as the not go here question. are upon forward. we good

take with next very go into do LicKM at even way so well and into VLP but expect, and -- of go going the or work other this the certainly We what some think won't its as to would to molecule want even if move with use this our pre-clinical to be of process platform. that to as in studies required further leverage we as on that vaccines a we and certain have through we we're rule ahead point it beginning well that that year. are on us would as We molecule us don't booster though possible well that and important complete comment pre-clinical talk other clearly see expect those for don't for to to we time really does clinic dependent opportunities give iBio-XXX work do some to as other on that which on is that portion but review. it we I to that depends regulatory we FDA shouldn't So the need much quickly do particular

for other Does platform Okay. we the So same Thanks that activities have sense? development make background question. and R&D time. your ongoing at

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from question next the [indiscernible]. Our line comment or comes Chris of

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