iBio (IBIO) 27 Sep 212021 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to the iBio fiscal 2021, Fourth Quarter and Full Year financial results conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. I will now turn the call over to your host, Stephen Kilmer, Investor Relations.

begin. may You

morning, Good Thank everyone. you.

to Commission. conference and Before we that statements to undertake events current expectations obligation statements new forward-looking and Reference you may of and risks information date only update would the otherwise, Exchange Securities event this I call, forward-looking forward-looking press discussed regarding filings uncertainties. can in are information, call, No to current provided forward-looking like the during future be making the in we The the remind this actual differ the events of uncertainties in in as and be no and future guaranteed on with results on begin, law. Company call subject required about or statements. projections disclosed results by and is our account on to detail this of except and made Company's that this today's these call will risks are release any from periodic the and statements contained as the Electric

I'll Randy the turn Officer, iBio Lutz, On representing are Officer, Company Isett, 's now over 's Chief Financial Officer, Company's Tom. today the With Chairman 's Executive said, Chief the Chief Officer. the iBio Operating Chief iBio that Martin & Rob Brenner, Thomas Scientific call Maddux, and to Business and call

report a I'm all. portfolio. to major oncology morning another our highlighted period of good And pleased Steve. Thanks, expansion for productive Great. iBio, by

developed by treatment for August, RTX-XXX, rights the novel Specifically, of antibody to the we of the Therapeutics announced in solid tumors. acquisition RubrYc a

to recent nicely us will took relates with their to back a infectious we XXXX model, why I'd a before vaccine opportunity. collaboration into filed compelling strategic platform. structure antibody a take area. our -IND business our going we COVID drug these And submitting describe recently to pre disease by the development our a access more iBio step FDA. details established and fit package with own and We another investment explain by our unique September, capabilities. proprietary believe think discovery to represents step entered such candidate RubrYc, advancements, like In that another highlight and discovery and forward also on But provide first this with We

now Our two distinct Company operates highly but segments. complementary across

includes therapeutics our First, vaccine which biopharmaceuticals, businesses. and

focus need, and diseases, medical overlap. Our of as as specialties wherein, include areas well oncology, fibrosis, areas of those infectious unmet

bioprocess, our the proprietary iBio create plant-based mention quality FastPharming describing to And moment, in our third our business well and development be improved proprietary for to is using development initiatives. segment operates advantage use in will contract second The services Randy drug our areas bio-process product the more development biologics houses intend as manufacturing offers segment and CDMO include LLC products speed for services manufacturing to to and of applicable. the segment which provision that's where as services shortly. for that Our recombinant the system The to the the strategic developers bio-pharmaceutical But focus system. with detail to at we latter worth of noting of proteins it's units. as platform technologies. quality not Glycaneering FastPharming parties, our

the segments, therapeutics own end, to visibility making for path bioprocess vaccines Culture the Beyond the fundamentally sustainability, we're two, alternative and platform helps bio-production. own in-licensing with preferred between the specifically, customers by drug the developing the for create however, pipeline. help and paradigm manufacturing of the platform. taking our validate perspective Traditional capture our bio-pharmaceutical in critical recombinant the To same. protein at can speed, the opportunities making work our has greener, bio-process in to the see business. that, our the while envision industry's quality, Thus, and we advances Meanwhile, development become off to using of change synergy scalability, order enhance potential we've it value we bio-process helps FastPharming value of to that Its Cell bio-pharmaceutical created fully significant of FastPharming molecules, the Mammalian

to the So great work we're but Business that thus is a more practice. far, unlock I've maybe described model representative we're tremendous beginning importantly, in to opportunities [Indiscernible] RubrYc bio, our starting example. see

will so That's therapeutic, but have terms costs As we very promising therapeutic candidate for be only able antibody the to the true the CDMO. enhance And in our many where traditional [Indiscernible] iBio-XXX. advance on wait to as glycosylation of capability to services and needs, In tends culture cost potency own RubrYc trying its the one's or building and it FastPharming then be life those increase development with do the RTX-XXX required. timelines to from only whether using will cell Technologies. an having production of mammalian But simply companies also, case platform, antibody known line thing the has if to further. special not of monoclonal to methods, potential with new time in give established Glycaneering a

months. three areas, cancer our respect the QX, Diego and FairJourney partnership Around with San announced our now oncology, main last the areas. disclosed, infectious plan With with targeting diseases. time, team. of ambitious and biopharmaceutical establishment strategy and any in we in [Indiscernible] of Today, all fibrosis, We our an Biologics. we followed with progress we that successfully up targets, laid that oncology, expand drug programs discovery addition fiscal -based pipeline, to last X the to X me Let to we've turn executed made on this over out have summarizing significant the year, XX

excited antibody, second-generation and even detail we of isn't Thereafter, with bit reached RubrYc a RTX-XXX. little monoclonal with prospects explaining more later. We're will But truly half agreement for any CDXX Martin be about why the this it. the

development access against move now iBio-XXX antibodies key have pipeline fibrosis. RubrYc our have access development that standard platforms, pulmonary over our enable Then, approaches. epitopes all fibrosis, together, scleroderma gave disease, us to using the activity aid intelligence to advance of molecules we discovery and discovery years. of engine, also on strong regarding in new in artificial work to uses that to relationship, sustainably and our endostatin the coming to immunotherapy has target multiple proven we we and of cancer part it believe continue which As peptide difficult drug endofibrotic Putting the preclinical candidates will models systemic for we demonstrated into idiopathic EX that to

more with in wherein associated [Indiscernible]. memory We observed vaccines T-cell displaying responses. We've our preclinical results robust will on And granted With for. studies designation pre-IDE once reminder, with to quick needs has orphan iBio-XXX a we diseases unmet again, advance the as sub-unit studies drug IND and earlier nucleic well. enabling the believe development COVID-XX mutational mid-XXXX. the track have month. specifically, to little efforts to initiate to successful a on continued July current spike infectious iBio-XXX, the our the X FDA address program that we a to announced immunization of remain COVID acid iBio submission Martin a this SARS on FDA virus, that color we regards of addressing by bit the threat As potential growing package allow systemic of for scleroderma. may other while continue And a vaccine to

greater for market relatively to bio-threat improved, iBio-XXX, animal the Randy classical XXX I'd and in there Classical commercial also fever significant process, a to us as underserved We candidate. timeline. now swine turn health to expensive. Finally, addresses and we expedite initiative unmet animal have flu vaccine expensive we export are through need, billion platform use most the an our swine to over this develop from that helps call believe market, vaccine can, Maddux, accelerating swine our who agricultural detail how designated with differentiate a the the those [Indiscernible] animals, ultimately is so U.S. like FastPharming explain discovery pork cannot $X in an Randy. will our has been infected R&D current to concept health. believe COO, priority opportunity fever the vaccines in less vaccinated

Tom. the derived. have past now. while Thanks, we to how with our do FastPharming exactly system, on happy you calls, I'm few all take to that on of out I'd call we like they are be benefits here laid the to many moments focused haven't today. On a

As you may to you our allows of us not know system needed. options for some know, greener plants. may using industry FastPharming sorely produce are What that the pharmaceutical is bio-pharmaceuticals

the what of that our to and straightforward. viruses contamination from and more showed as XX% we from the ESD-based itself to platform process is study easier automotive and is The surprising mammalian too, one benefits concept pharmaceutical the move to lower are There cost at heart risk sector clinic, time reduced other such fact, prions. industry. emissions-intensive platform In This do. is scalability, than a

plants growing on minute. have weak types using in infection indoors vertical we by include techniques, bacteria. by systems. we immune First, use start farming LED hydroponics that and susceptible controlled to certain plants system advanced are and a The lighting particularly they of our More which a

into vectors of the Next, FastPharming gene, The to that microbes agrobacterium of are want vectors. make then into and we it into clone so loaded synthesize species bath, the dipped to a ultimate apply the our one then encoding the protein are we into and create plant a genome the destination. our bacteria solution its We the leaf deliver tissue. agrobacteria, the entrance to the of infiltrate vaccine, armed iBio

large in If simply systems development and the material it culture energy-intensive consumables comparable differences At are methods often mammalian In the be material to sustainability. is more with factors with product, formulated the operation, seeds, specialized utilize months notable bacteria, cells, setup commonly to plants a the protein. into continues The are With are to cell we there's the large The each grow. engineering. no the they the in can contrast, deliver for the of protein operations, want bacteria the more bioreactor expression purifies cell disposables. the we transiently that highly in we plants leaves when isolate transpecting be quantities It expensive, And at labor-intensive of expressed target single-use versus scale-up during in at comes of deploys iBio Plant-based plant and traditional Thus, are the also plastic as injection there infecting product. In a essentially plant traditional reduced. thousands risks initial and little grow then and saves large into produced in water. delays the need Since commercial the use methods. the scale. plants. water traditional FastPharming harvest final purified quantities bioreactor. turning time, liters the leaves, desired associated line for produced plants plants, in of because into protein production part scale. small compared gene main scale, between then

As both to FastPharming sustainability, of on model Tom programs, mentioned delivering business manufacture, built the our scalability, allows is on drug iBio for execute the for this development us strategy, paradigm speed, earlier, customers. change and and proprietary and bio-process our biopharmaceutical development to and

medicines. know-how medicines. biological intellectual quickly to property concept to have plans portfolio FastPharming and for clinic, We our cycles produce time allows innovative to growth allows from us use and to testing which deep industry deliver faster saves when more

In turn for for also of economic surrounding Tom. agreements will development opportunity likely to iBio it for attractive assets. exchange capture to and to the later-stage In supply trial multi-million-dollar significant significant, partners. sign addition, are rights, commercial opportunities. supplies through with agreements clinical select pipeline iBio The capture with can over back And value FastPharming that, materials with clinical-stage provides I out-licensing such

Randy. Thanks, Great.

for provided give business with on how perspective our I bit segments, having business a little to shareholders think we to value appropriate our review plan build of our So of a model. it's

to action external antibody placed the on remind instance, think iBio-XXX. significant the validation end, was it's for to were of that To a mechanism been which important value has For [Indiscernible] we was investors immunotherapies. like least deal based struck a to the of which external Not there already with an a that upon next-generation factors. molecule break the multitude secure of rights recognizing

centered transactions of value $XXX a that, around of could Specifically, anti-CDXX reach with monoclonal there antibody various milestones, was on M&A a recent attainment million. over

their or want this by So validation as as our forward first-in-class from but best-in-class future of for advantage We organizations. external be may to also, taking have benefit know we third-party to Of only our highly in evaluate potential, to opportunities, reputable therapeutic that we competitor about by added use formulate investors approach, fast we're slightly clinical learning also we the ahead think note, we not who clinic looking [Indiscernible] development. the plants. in a how intend learnings to our

the detailed review call pipeline. turn me over to our the more Now Martin let for CSO, Brenner, Martin? our of

and excited of In pipeline iBio's August, particularly to Therapeutics. updates the some expanded capabilities area pipeline iBio I'm its bio-pharmaceutical in share in drug and significantly on RubrYc activities, with partnership immuno R&D Tom. discovery Thanks, oncology. -oncology a

collaboration earlier, on which by as immune-suppressive by Tom we immune therapeutics. this tumor - regulatory is mentioned has evade antibody to for CDXX or promising regs, effector by we its iBio-XXX - to cancer cancer response, pipeline -oncology with through As a RubrYc, expanded target the anti emerged T immuno strategic licensing to which allow also CD-XX but TFs. asset, T-cells it It T attacking refer cells, next-generation cells or expressed will iBio the platform. bring - as RTX-XXX, FastPharming the as

regs, depletion suppressed the both types cancer-killing - signaling the of the First-generation well had CDXX as potently Depleting no which anti in blocked of therefore - both micro-environment. on also but unintentionally impact the T resulted tumor pathway, as the T-cells immune-suppressing TFs. IL-X antibodies CDXX,

to signaling, While blocking IL-X also toxicities. unwanted led

anti-CD-XX more refined a tumor tumor IL-X generates to mid-XXXX. iBio-XXX, or begin like monotherapy block allowing T-Rex inhospitable second-generation checkpoint this the cancer are iBio-XXX signaling, preserving them to However, attack IND showed epitope immune-suppressing combination while creating which to Pre-clinical a molecule to by depletion antibodies, leads which in thereby inhibitors. microenvironment cells. for expected with preferential of while TS administered strong to when have cells, data response binding, anti-tumor CD-XX highly studies that -enabling as enables a

and that discovery discovery candidates bring using towards new to proven with discovery to to immuno algorithms robust uses cost-effectively, collaboration aim strategies. target generate engineered faster are clinic more MEMS, molecules, very and -oncology additional antigens RubrYc's our epitopes immunization we specific propriotary steer difficult through to scale engine iBio-XXX, Mesa predictive standard RubrYc. that antibody Beyond which screening have

have increase in pairing potential. noted added Tom killing all major the with patterns call, And signed our of discovery own step protein struck platform a a X candidates in In XXXX. our expected earlier of technology, Glycaneering we RubrYc's July. cancer anticipate optimize which glycosylation also transgenic San discovery operational which the to to therapeutic As for California, fully first capabilities, is to oncology employs Diego, we in to quarter iBio's plants establishing site towards lease cell calendar become in-house pipeline new drug in targets

FairJourney proprietary we with accord, part entered collaborate In research services of antibody leader addition, in to as our access libraries. Biologics, plan and novel into a best-in-class technologies, Under technology discovery with agreement and to partners, antibody optimization. the iBio gained display

all Finally, A our that inclusion. designing for for next-generation acronym addresses to VI turning COVID-XX, approach on our for and I would focuses durability, to like variant stands vaccine work a upon strategy. DAVI The for elaborate that access, on D

chain the be ability vaccines spike While to recent that to use the intramuscular because of that or the current protein of regions several their appears injection, vaccines suggests products some with these the in time. conveyed requirements continues effective, access continued to Also, world, or expense with the demand. waning are data due immunity problematic over challenges of be associated to simply and cold

facility. that mind, It from as has it capsid, vaccine, we've X, the nuclei -COVID perspective is of preclinical drive the and responses. respect the susceptible our It risks to Additionally, we approach lastly, may be spike of advantages Because the antigen towards durability, to FastPharming cold have variant the providing variants. in of we sub-unit future requirements potential there N-Protein like iBio-XXX designing And unlikely is provide the long-lasting observed access to and that of against regards vaccine deploys variants would emergence sub-unit, have the manufacturing use of rather and better that the to designed value our suggest concern, With spike, memory assurance vaccine Delta believe scale may could strategic spike with data highly a this T-cell in the suggest special than less up of conserved of be be candidate, Protein in N-protein chain more future we protein. immunity mutant. that to can immunity escape Sars the and the with protein a iBio-XXX. others or

be still worth S-targeting it existing that an vaccines. N-protein to occur. noting cover to updates our who to program done it hand to complementary most performance. to this over financial on will the Rob, has there's advance recent is much I'll to While continue be With work potential forward XXX, that, We developments look Rob. vaccine more providing to as

I financial and in XXXX. to for financial were details a release increase Revenues Rather Martin. June press over of will the fiscal simply Thanks, an are highlights. year-end million, available which the results, XX-K, fiscal XX% of reiterate of XXXX, $X.X the Company's speak few the the than XX,

XXXX interests further wish revenue growth implants. biologics to business quickly We continues from our expect in who bioprocessing as in attract fiscal to sustainably develop companies and

contracts XXXX. significant However, G&A in and ours, strategy. significantly to half our our external the and outlook, in a implement Company our variability to in revenue technology. R&D Based This fiscal and pharma quarter timing G&A, expenses for relatively like followed compared fiscal given of reflects over higher small early-stage invested fourth we and recognition. of XXXX period by is our of spend. to in R&D up Both for bio-pharmaceutical invest the an strategy fiscal platform full-year half the second XXXX, proprietary our fiscal XXXX. comparable the Across pipeline sequential were during and revenue of the staff, expect in revenue the growth the number fiscal quarter-to-quarter of commonplace second we service of decline first the XXXX, current half upon

will fiscal rate we than growth but R&D in lower XXXX, to at and in continue grow fiscal XXXX. saw a expect G&A We

This million income. in the settlement iBio recorded fiscal value that of $XX.X note litigation of will You with Fraunhofer. in our settlement reflects XXXX also

million iBio license owes for in and recognize the license of March XXXX and agreed million $XXX,XXX XXXX. we recognized one fiscal Revenue one XXXX in in XXXX, will March in a pays to of cash While in $X.X for the licensed March property. Fraunhofer two XXXX. installments income $X.X intellectual be us also Fraunhofer when each, Fraunhofer pay payments that for of iBio March two each

cash plans, $XX on In operations and XXXX. debt XXXX. securities, in liquidity, of of million fund first believe had we iBio our the investments quarter in terms current sufficient XXth, is cash, securities, calendar as to of through June marketable Based position

However, if change. find With cash opportunities our the over like turn call to I more assets we to back now needs in-license could will RTX-XXX, Tom. Tom. that,

was Thank Team fiscal you, in Rob. all we of accomplish are proud XXXX. the iBio able To summarize, to that

happy our take next-generation as in with ensure biologics We're also and As capabilities you the talent advantages. questions strategy, highlights, a out core manufacturing. might for the only additional And Culture a These Thank much our pleased are segment any it opportunities candidates, candidates in plant-based with continued scaling aspects as we our have. you many with Platforms committed pioneer remains biopharmaceuticals Traditional and bio-process development with with iBio. of ever, bio-pharmaceutical forward. new are confident our should optimistic and And team better growth this comparability reason. We're to are are additional our a leadership we platform, than growth that about that there, -- of to out date, combined of our with strong and growth further the continued in-house and business all. remain concluding developer board pipeline improving going to we to growth demonstrating, sustainable Cell along partnership our and of Operator? Mammalian that

Instructions]. [Operator

comes Kluska first Kristen with Cantor Our question from Fitzgerald.

Rick is you. Kristen on questions for have X for Hi I everyone, this morning. this

this you will do Now that for pipeline? be the computational to you technology envision that this RubrYc throughout pipeline, applicable access you the platform, most or useful oncology do broadly iBio's development being in have believe new

of the responses. where know tremendous it's engine focus we antibodies, The minute, The oncology. monoclonal ask the bit you attractive also, but be further question. space. well, glycosylation great patterns see this will you -oncology. value field whole discovery because to a a wherein lot there our Rick, little a there's are And Immuno here have therapies a to Glycaneering a when opportunities. lot there. antibody access the that Martin on a we can drive of to, initial two along can amount the RubrYc then on category antibody that Immuno That's of paired monoclonal we -oncology, comment really really control capability we in pair with be a our up a I'll in checkpoint and with technology this really brings, the targeting tumor capability, favorable some combination of that libraries of inhibitor got any where

are coming so portfolio those see epitopes said, most like little we And blind the won't of oncology we benefits areas a of Martin, in the you portfolio. for targeting that value eye other reasons, other the turn would to. from side the there a But, further? That comment to

Absolutely.

So absolutely drive mentioned immuno-oncology priority our RubrYc RubrYc is and the already, collaborate targets. with as discovery to Tom platform on it

road. several are will have for as initial target know, the -oncology down those just epitopes which also be is there that other would Immuno -- explore hard-to-target Tom epitopes. And several definitely to applicable targets, your not this And going classes, mentioned, you traditional high-priorities we targets us. As

a you. whether were And EPCI to discuss significant of please Could there bit to Thank question. you ACE program learnings the one Understood. the despite little any the project come more Thank out discontinued and you. about discontinuation?

that clinical trial were our portfolio our And an well a was with interesting regulatory we trials it. as appear clinical [Indiscernible], That at believe work else with that others offerings in to closely I their for we discontinued on back were Sorento we said, go similar for portfolios. simply a produce in, this forward. have into the continue anti-CD-XX, disease also it. similarly best. We And that others molecule the get still felt that at the If And pathway we're molecule and capability. those When we different but bring where worth clinic. review were it's of still the ultimately another deemed continuing in originator on going. a the a to bit the as choose in molecule a that their also watching particular ACE-X, way very the we what Ace-XFC had you able opportunity certain to commented molecule and opportunity in an who time. had to landscape, the biologics with the pathway pursue player may The pre-look companies the its our brought is how at molecules on, treatment as that the asset addition readout to to doing, and was returned and of two space to platform. in X and forward to to someone we their be strategy FDA Sure. and We've not able to quite possible had may case, there were it the and FC COVID-XX with the following manufacturing little that been Phase move risky cost-benefit be that

to manufacturer a as asset. I somebody miss else available be we'd was So Martin But anything there? up the if did contract pick

APR see. disappointing all think of everything, covered -- specifically you've to that on endpoints data, primary meet not was did I Tom, the every No, the

all. Thank All right. you

-- end the in guess I

Okay.

was you learning, Yeah, asset it was And a you of to was of good terms I just news one bring know think in. the it low-cost those bet. in was where

gone -- was it some At would've turned out got things had a and well-positioned route, forward. hindsight, has to very in different different the the it doing. moment of been take worth we think regulatory agencies different way, a I

out. it drug So our anything, move low-cost, Thanks forward it was question. goes to it's it's to not, not turns asset, but way poised a that modeling biologics, as high-value the everything low-risk development, works for create strategy, if a prospectively just to be I out. think But and

comes from Matthew Herm next [Operator with Instructions] Matthew Our LLC. Herm, question

do morning, San My appreciate facility, with specifically to Diego that you facility, importantly, burn? kind expense Good if Tom, you any detail information morning. into budget question the cash authorize everyone. us to has sharing declared regard of wondering I factored the could this with your the is with most and the for

Yes, in hiring be not it the it's with Matthew, and also, then to the is, in staff that of going lease spending for we're the that only that of it, location. we're facility, course terms but associating the

getting, for with In that bang the a get associated have buck, especially the nice we we what get terms of we're -- synergy in we the with capability RubrYc. for

in we fact, previously RubrYc the cash of factored the our the In in had also estimates, the and burn with collaboration molecule. for in-license potential

all that's I missed? in. anything well-baked fairly Rob, So

Tom. correct, that's No,

I'd at not this back turn And showing remarks. for I'm any further questions time. closing like to any to the Tom call over

Great.

pipeline. to as We're for want your platforms everybody thank to our them. Just bullish the be and attention. we And on biopharmaceutical as have time continuing as well the growth of

of wishing week. rest everyone just the Monday and great So a

concludes this presentation. today's gentlemen, Ladies and

day. disconnect wonderful You may have and a now