Organovo (ONVO) 9 Nov 172018 Q2 Earnings call transcript

Good afternoon, and welcome to the Organovo Holdings Fiscal Second Quarter 2018 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Steve Kunszabo, Head of Investor Relations. ahead. go Please

thanks you and call. us. like I'd Good our for fiscal welcome to earnings second to afternoon, joining quarter XXXX

Joining fiscal and this our me begin with Gallant. call CEO, of will results, on Crouch; the followed discussion Taylor Q&A. XXXX Today's afternoon call CFO, quarter General our are Kussman; the Manager, second Paul Craig the by

the that contain to turn I'd like XXXX. within participants things forward-looking all may afternoon over of Taylor, of Securities our I Private this Before caution call Act the Litigation meaning statements to Reform

Forward-looking cause forward-looking include expectations, Commission. based and statements are Securities results actual Such statements upon and that expectations, statements. are are from the and more Exchange are risks beliefs could not current and in historical to differ are statements fully fact, our prospects. and discussed our statements subject about Such to these with our forward-looking plans, which future filings risks,

risks. considered we Our statements if may be while we even at remarks update views today elect and or obligation represent expectations some change. should of views to in any the do forward-looking to Any as today, specifically future, in our our so, statements forward-looking only of point such disclaim light

today's With to financial to over release During in non-GAAP measures to me measures. are principles. for the accordance accounting these certain not a let of measures. with be call, earnings we'll These turn also refer Taylor. referring Please prepared financial definition non-GAAP non-GAAP financial that, generally things accepted

represented the good we assets uptake our revenue quarter do. of revenue revenue guidance of the $X.X and and million deemphasizing sequential which that reflects work growth, our consecutive negative still latest but get fiscal our started We more business capabilities maximizing the today the our quarter highlighting We're of top year disease streamline afternoon, as half of trajectory. in to this systems, our line I'll area. toxicology everyone. prioritizing tissue Steve, EBITDA around head the quarterly third results as of adjusted we liver is to-date and second routine modeling our highest updated good research second kidney progress the us and into our Thanks, and work for have growth full year our we by

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come recalibrate the strategic last direction consider our As steps months to path and forward, the identity few into I has in we've focus. our clearer the best taken evaluate

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evaluation immediate to work approximately short, reduction bioprinted treated liver tissue show XX% pathologic our offers data the animals of patch hallmarks issues implant. back, the us The an the that gene the these expectations types the has debilitating great to solving treated promise also approach meaningful XD delivering of in disease that held Importantly these suggest patch regulators in disease retention These of that on confidently elements and many in [ph] the the the treating area to liver the cleared and directly a in thorough areas. In next of attempt integration these of allow pediatric have for preclinical historical we align are of diseases. completed. development cell are now and studies with major liver therapy believe of been because the our let phases move they achievements

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fiscal the X% payments collaboration recently my Organovo key fiscal key completed quarter XX% fiscal guidance $X.X and lower financial briefly agreements balance of up Thanks the million, the were period were I'll down up from NIH by begin as offset down awarded and I'll which by reviewing million Product the Taylor second fiscal by and and prior partially revenue the service summarize sequentially. generated grant grant. year revenue revenue our Total everyone. afternoon quarter updated revenue for wrap we and profile. $X.X total liquidity metrics sheet was recapping then our good XXXX our second thoughts year was by year collaborations prior results from in related driven X% prior period. to today.

value development effort disease on higher services. to we're and noted, business As modeling Taylor demand higher recalibrating focus our

cost. million opportunity, and million related second this administrative million largely a disease going resources quarter, we the short-term significant due not impact expenses. quarter primarily expect quarter. a and uptake recorded disease decline and it on Despite $X.X to costs. research $X.X dropping external $X.X was million, operating orders in the revenue revenue total development robust saw I'll which and a services facilities in primary were were next second the offset of greater our the also X% year-over-year focus major Research quarter, as now Although to employee in recorded and cost period. due component cell cost. deploy reported higher compound these be fees of margin, XX% we human included We CEO growth a in The toxicology of and increase modeling year-over-year to cost were largely see of approximately against we approximately decrease of to fiscal for We increase employee we in from second from the general and fiscal expenses the and forward. products. during $X.X revenues year transition higher expenses one-time resulting contribution severance gains orders XX% selling market ago revenues prior enough services X% professional SG&A models from facilities tissue screening lower year the new

liquidity non-recurring million ahead related worth emphasizing finally charge $X.X look restructuring. our from we XXXX we'll we components. contributions And quick As third notes XXXX for forecast review organizational full and to $X.X a recently updated an it's between fiscal quarter, the today. brief coming revenue record And fiscal on fiscal balance key a now a total of the We profile. million year and few outlook, to our the $X.X million primary few that sheet year approximately announced with

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revenue that revenue delay project customers XXXX. rate to revised annual the fiscal meet this this customers we a move expect of to commitments or over now our we and commitments metric more the one important Achieving position a to should few next revenue of outlook in annual our our from will with XXXX in While quarters. double-digit confident us course single fiscal remain ramping goal

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second and us liquidity end balance facility. available initiatives. in fiscal and we this available our equivalents million and $XX invest In for the a have million we approximately of Now sheet, $XX combination our had $XX.X ATM under and out of the our approximately funds balance cash cash to quarter business carry our at million growth of plan key gives

planned As our promising liver remainder plan. believe wrap tool circumstances currently research our for dynamics forward I'll we while up a to the capital and to traditional raise ATM we value to equity ATM our by moving clinical liver our we'll balance human able to inflection and and growing we points a therapeutic sheet our equity milestones. to closer successfully a against that for trials. services major scientific our and is If there that Organovo a cash key strengthen in continue facility advance continue opportunistically flexible therapeutic envision of offering the disciplined ATM tissue achieve kidney us as our lets fiscal we're extend follow-on runway as to long-term the is tissue execute scale us market value permit, use moving tissue such business noting XXXX. The not way allowing for strategy, to a do us facility we consider as liver

Disease our for our to forward kidney represents revenue commercial to we Q&A streamline efforts grow the opportunities of in part turn the of afternoon's that look in back big against call. portion operator I'll best a continue We to the on to you operations progress our over and As re-deploy path. With liver updating February. space. future our and business our for this things modeling the this

our Jefferies. Instructions] Couillard Brandon [Operator and Please question go first comes ahead. with from

for is Brandon, you taking thank Christian This questions. for the on

that ultimately will just the modeling, of I'm lower didn't plan the you materially revenue of outlook. year the the you trying decide early understand view downward a but disease full understand year the broader off, additional you're drove helpful undertaking with be to announced to concurrent October. magnitude key First provide restructuring I shift update if in could or pre-release into variables terms in given full commentary revision why development the

Christian, this is Taylor.

our NIH this a number events challenges of One why even face Is a hope months several and fiscal we we've year. that risk you recognize way effect this see still that may we have and or binary final grant may the variables guidance that this remaining year plan to year year. operational these but we certainly could our an that which But this move that's try and of our tied and fiscal revenues binary certain risk into year not and deferred hoped for fiscal that working month given and similarly next into more broad have clients of mentioned range revenue that closes in as go range. the this fiscal the toward NIH approval revenue. result achieve example that events each we significantly breaking grant significant we've in revenues plan our as with the we have fall for don't and into our to way - some of to processes,

it's these of events. outcomes the So evaluate cautious binary being issue more as more about an we

which business traditional clients, we reflecting from convince investments now to as to we As thresholds incorporating don't realize higher enthusiastic a volume are investing modeling have see by clients. but is that lower we the we're well those seeing their significant them our to margin, over to on our the those as begin heavily tox some by disease into demand return thresholds hoped to more truly us investments platforms in make from provide routine had what now us move driven same business, that earliest would but ultimately

was just number to of and together approach as a and end on forces wait are year of it's thought So our call clarifies we clarify these situation. the it coming to until that that we this forces prudent the more visibility

very capacity Okay To moving hear clients or two to then the update And within over would And to a might to progressing secondly, XX I target enough be of in current in and for XX you still terms bucket capacity year XXXX? interested be maybe so, such Phase on part what also larger could rough think an II perhaps to understood probably you you Maybe question, that's fulfil customers the helpful. multi-year conversations that of those, onboard a steady customers state do you the guess clear, very move Taylor. commit engagement. use months. you if maybe are a engagement. customers expect think help to would that maybe then how to the fiscal larger be do next currently give one do to many more overtime us percentage occur that for routine those us to overtime news And quantify how need have to

our have and modulation thanks. our validating custom cases of strategies proprietary platforms, pleased Okay, and in reference either the in platform. along cases some a the some of to With the unique step to research is a reference modulate they that clients running diseases than step process platforms. the And tissues moving through I'm And our platforms the our very begin we're created in represents to we handful our these II call are or compounds. we've one of adoption clients that to final of undergoing phase, with with now each questions. the how standard that compounds that clients so in that testing say the this show in final curve Phase referred validation we're of on more regard others by to the you final that way for the great for Both

lines step have the next to routine profiling of we that that one As move numbers we continues more underway will exit very use that's compounds use perspective those proprietary give fiscal year collaboration this kind for as than screening annual more along and and client we agreement. to routine toward more tracking indeed confidence completed, that soon and to is us conversations larger of do believe

expand tissue over we therapeutic growth question the here handle capacity scenarios have a to our to next as our certainly significant years. couple second programs capacity for meet well regards commercial research to to needs as business tissue the as both You various actually of

we around that can capacity we necessary. have scale capacity if be platforms easily don't when built our and about scalable printing So modular worry up and

would Great maybe another and with noticed sneak player value now focus in I has can I if more different recently XD we that what more potentially so, a over landscape then closely Thank the an River to to if CRO, tissue one opportunity see signed the player CROs what in. understand this overtime but the Charles with and you could somewhat be deal other know there proposition, curious timeframe and you. work out occur. level, if high possibly

that grab I'll as well. Actually question Sure.

announcing on so As big I've would place positions expect us a you in in appropriate of and part along all I use constraint has and more career been CROs. reasonable collaborating year with industry my I've agreements scale the in to And to Certainly we if putting CRO to CROs. a very work applications fiscal think we it collaborations we the lines. my leading we the those instrumental a be certainly and background spent our capacity as opportunity working biotech to the approach those come platforms held, positions see as repetitive establish of an in in CRO know and strategic may know been also with

Thanks. Great.

FBR. Our Riley go ahead. George next Please question from - B. is Zavoico

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partnership from you So do the kind to regard, in potential speaks opportunities this you that marketing are this. And for looking stream demand what information supportive as well question sector. potential revenue is, this and the of in have the really

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along clients amount out and much significant So across say NAS our with to I'd toxicology discuss phase. and models space clients actually who's we past to disease forward fibrosis who we more of about have people talked have and of beginning us, we've us in a that NAFLD, the adoption enthusiastically have a in reaching coming Japan the US, to working we move with to veritable Europe

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say your and your own Am revenue services which that. you services that modeling you therapeutic understanding the so part research a I perhaps correctly? revenue greater or your of disease client is sector, so the XXXX, toxicology that's in of And the unit tissue than substantially that's see is own IND per is could developing, tissue you're which part it the for sort aspect therapeutic into balance, expecting drive

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the products disease interest mentioned also level modeling. disease when you your kidney now like same you with provide of to modeling the liver do can the services getting kidney where you see And you're

and enthusiastic with our of kind disease the folks space early internal our prioritize NASH but to these kidney fiscal the more out we have our of side-by-side model so more already similar on revenues developments Often with of most kidney flushing model a the basis development next expect some would and clearly funding layering capabilities. into early in be in kidney We fibrosis as platform disease to handful we year. NAFLD see they're a and go clients of a clients because we so in staggered certainly from traction and demand

fiscal So be year. that the in would XXXX,

Okay.

Correct.

you very much. Great. Thank

question And James. ahead. comes Benjamin Raymond our Please next from with go Reni

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Great, so for forward. here and the look all fair. you much going Thank color good that's

Jones [Operator ahead. with next Please Matthew go Cross from comes Trading. Instructions] our question

closing [ph] wondering negative physiologically, you off it is as it or [ph] your might was a engraftment? looking I and any or taping positive for that AASLD implications and it appears thought simply from there's poster though response at rapid of what T to for SHAM then and and explain could albumin post-surgical both three have week levels peaking was at I kind and uptick

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about we're enthusiastic in we're generally the So model. very seeing what

have those drug And great. this perception just then began you have already one approach customers Okay your the clinic, inclusion In you the quick then evaluate I release and was mentioned [ph] in what one. that more from of you received filings. regarding I feedback results in hear. regulatory then of clinical stage subsequent curious might to That's to good that's at

them which they that, perhaps The them at can clinic as decide with have think But they're up prioritized the all in until submissions might a we our candidates uptick it's this when how see of first or quite believe said, they see accelerated. because these data do they dossiers be two clients very maybe of important. complex three we'll FDA they tissue view and start up to we us back modeling have to facing indication that I excited we all but showing say have their rank issue either set the to then it continue early that it if an or they these compounds began clients start start non-regulatory moment too asked are viewing case-by-case a be where to a drug to you told approach. to as standards, confirmatory using capabilities the will and our drugs really profiling use or systems demand will

of answered, a that, mention for drugs great for humanlike on repurposing clients to being a just a teeing on additional the drug our have are gamble I clinical The they're actually thing tox before strategy our even should that many looking model mechanistic drugs. up looking setting be on in who in their but question would is market other in not or the those clinic start development which evidence programs they performed

like Okay, definitely sure. Yes to it something watch. sounds Taylor. Thanks. I appreciate the detail.

for This as session disconnect you concludes your as well and today's lines. We you question-and-answer conference. may now presentation attending today's our thank