PSTV - Earnings call transcript Q4 2018

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Fourth Quarter and Full Year 2018 Earnings Results Call. At this time, all participants have been placed in a listen-only mode and the floor will be open for questions following the presentation. [Operator Instructions] Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Cytori's future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section, included in Cytori's Annual Results on Form 10-K and Quarterly Results on Form 10-Q filed with the Securities and Exchange Commission from time-to-time. review factors to statements. considering you advises these in risk such Cytori date assumes or trends reflect the update responsibility or are any after Cytori to to revise no forward-looking statements circumstances they made. events, to pleasure floor Dr. my is turn It over the to and Marc Executive Hedrick, Chief Officer. Cytori's President may begin. you Sir,

Marc Hedrick

Chief year Marc joining everyone. morning, incoming Hedrick, is and is CEO Cytori and and President on Titus, Stephanie. earnings today's call. our our fourth Welcome Financial and Officer, Good XXXX to My me also call outgoing you, our quarter Officer, Thank Gary end Financial name is of Girão. Tiago here Chief

and On corporate importance to transaction ongoing pleased asset I’m this of to pivot the was our a leading to that company. to transaction just oncology reported explain for the clinical the call sales rationale stage morning, the be today, the become able particular that

the Tiago Q&A. after forthcoming programs. then provide will then I'll Company's the have milestones Thereafter, clinical on and update of an and for on time the Gary progress we'll I'll update the financial commercial Then and on update which, performance,

First therapy a property Vascular, upfront The of we knowhow. of company's this of therapy assets, cell leading which important company. is XXXX acquisition the divested Australia. in pivot importantly transaction, Therapeutics. briefly all, step portion Azaya the of build To next existing based and morning Melbourne, to our nearly in includes goal one an based clinical asset asset sale to million stage I on our cell a summarize the intellectual mentioned, much partners therapy for is most oncology began reported The as the of $X then the adipose cell sale company's assets Lorem

these maintain excludes Lorem portions via but the retained then company's requisite to to supply excludes transaction with the obtain in anticipated Cytori rights of two deal of to future the company The completion existing month next is which the also of these to However, The the over Japan. business, business. will aspects the of BARDA Vascular. Also continue is the in both substantial inventory and executed product key most closing valuable conditions. contract we'll transaction agreement following rights the supply the market close all

cancer update last our in program. progress call, liposomal me will and on DHC stage which name let Since [invasive] clinical quarter pipeline. be late made received has in The that our of short. doxorubicin generic intended breast considerable official our and Now our Cytori you as We've for ATI-XXXX ovarian use for as last oncology advancing Hydrochloride well hydrochloride Kaposi’s means DHC is sarcoma the myeloma. Doxorubicin pegylated multiple its

opportunity facility. Concerning we target to an conjunction in the continues registration that late market Our notification plan and Europe market submitted months. to we file in approximately beginning EMA the this $XXX Furthermore have is initial annually. with file marketing million past in seven of approximately in Furthermore, quarter, authorization European application to intent marketing also estimated an Agency with a for the DHC plans launch go XXXX, Texas our oncology QX is manufacturing of approved begin commercial in XXXX in first on we plant or lots have on will authorization partnership. potentially Doxorubicin which to schedule producing target in our Medicines

liposomal a moment. me drug pegylated ATI-XXXX That docetaxel. talk drug a for is the albumin-stabilized Phase X second ready let Now is about which

another macrophage key liposome. of to developing system of is or of the circulation docetaxel protein on which the alone formulations ATI Cytori I last the time, enhancements liposome the surface remedy. lipophilic Polyethylene uptake. the docetaxel, plus and different while docetaxel stability integration both the improves call, stabilization provide ATI-XXXX extends on glycol As the blood mentioned is enhances with the reducing

the removing and need time requires we should eliminating Specifically, by benefits to and we patient comfort intend provide for reduce may better or systemic pretreatment also for improve in treatment the that provide and patient morbidity requirement convenience as in medications, docetaxel by lower solvents, less of to it hope standard ATI-XXXX efficacy cost ATI-XXXX require the enhanced well. have results spent exposure center therapy. Ultimately which safety

attained Now regulatory specializes previously currently the consultant, working for firm that Designation is small FDA company company Camargo, cancer in Orphan applications. from Drug lung which a is the a and the cell XXX(b)(X) with

approval. the XXX(b)(X) We our IND active will update accelerated status seek and and

lung ATI-XXXX. XXX(b)(X) clinical and Beyond the develop this applicability in well anticipated plan company indications to as the program drug. XXXX intends as small the thereafter to sometime current target move is aggressively and further estimate cancer, on mid cell We information additional providing our to

stage therapy our thermal us better Cytori, that terms increase in which XXXX. funded to cell incontinence criteria in who patient X allowed All of Japan. trial, our stick in pivotal program, assets burn relative patient [indiscernible]. and that In last last stress enrollment. to support enrollment received this readout enable the the in first will [ph]. Phase treated us will patients concert and was urinary should ADRESU, trial the USFDA the leftover population QX attain BARDA should of the in recruit been expand Now which we patients all the in of changes trial QX have with Those

and be on been the of treatment has as donor to the were amended sites by trial April. recruiting of the well the end sites anticipated addition, impact seven In graft evaluate to

outgoing to thank turn over CFO, to acknowledge much. Girão. moment Gary to of work, would before Titus, very and our Tiago like publically new the the contributions, hard I you So, call take Tiago, a our I CFO, dedication

deal Gary way started has completed, today go and Gary. a CFO already as officially to Gary, to Now

biotechnology a Gary public and plus Exchange been CFO for NASDAQ Most he years healthcare initial public the Gary, past mostly the has aboard. on For offering for U.S. XX welcome led UroGen. companies. recently, successful

Gary Titus

we aggressively pleased stage, level commercial in experience oncology and for beyond. and execute as development Thank time well to the company, on team goals I've the to Cytori positioned My at with focused company. pivotal lead Cytori our an Marc. the particularly be corporate next this will stage, joining exciting public I'm to been It be XXXX. time

to lot have We the exciting I'm but help challenging, and Marc the have glad to times. these opportunity to Board accomplish year during and a this

Finally, to I truly to the company, like would comments Tiago's Marc's on effort. a also contribution outstanding reiterate

Now for final the time, Tiago us take please the financials. through

Tiago Girão

XXXX. $XX our expenses. and everyone. of The XXXX Thank million numbers, to right cash million with Heading and Good XXXX. you, includes Gary related $X.X $XXX,XXX compared $XX.X million warrant Marc. of QX was burn cash change consistent cash in in burn This compared XXXX Net credit fourth annual morning in in QX $X.X totaled to in values was mostly to million losses in loss to the XXXX. compares to totaled in fair operating the burn QX the reduction million $X.X net Operating a guidance, quarter million $X.X our related liabilities. to of approximately operating reductions in

fiscal value for a of charge million with totaled Note related to million warrant For net XXXX same credit in of noncash $XX.X the liabilities. to $X.X change that recorded R&D This include of losses in losses XXXX acquisition. oncology net $XX.X part the XXXX. year includes $X.X associated of asset compares fair in-process the in period net the million and million a loss

quarter as development $X.X in our $X.X share the compared research fourth XXXX. Our expenses million of QX, in R&D excluding to expenses based and million compensation were

well offset million are to the were million in XXXX. our expenses For clinical decrease spend fiscal periods clinical plants partially the during same period as while by improvements, XXXX $X.X R&D the of efficacy the some compared were reductions trial. ATI-XXXX due in in trial, these primarily $XX.X actively in STAR BARDA The to our in in R&D in as investments manufacturing activities our both owned RELIEF executed investments completion

sales sales this marketing, to approximately in related expenses QX and $XXX,XXX Now, $XXX,XXX and XXXX. as our our on activities approximately quarter to compared marketing decreased

full marketing lower the share $X.X On in in million compensation expenses and G&A lower in with [indiscernible] XXXX. based the sales relates in and to as as professional benefits activities compared million QX expense expenses to $X.X as The XXXX our rose XXXX. salary the quarter well sales associated marketing as $X.X pre-commercial U.S. million expense services decrease of same the excluding were to higher fiscal in million XXXX basis $X.X compared in for fourth

For pattern restructuring and of continuing fiscal million to compared year million was great another The as in as expenses were benefits XXXX, XXXX XXXX in expense. discretionary principally of $X.X expenses in a G&A from to $X.X salaries September well spend. as G&A G&A reduction related double-digit degrease the resulting

our to QX were million to $X.X respect revenues, $X.X Now a year as ago. revenues million total with compared

of achievement revenues partner Puregraft gross received a XXXX as total $X.X in sales. year Bimini $X XXXX were million QX full milestone For $X.X XXXX. compared our to levels profit from million to total related revenues the included and million of fiscal certain

XX, continuing December of our only and the new of call with we our In back December Marc $X.X and pushing had XXXX amended period by our flexibility $XX balance to CEO, Turning turning debt providing quickly additional today we out to to sheet, million the interest debt. Now million Oxford at of cash Hedrick CFO our

Marc Hedrick

Tiago. you, Thank

time update So Q&A. you the for near future let then we'll and me our for have on forthcoming milestones

feedback intend in completion or a then thereafter. to anticipated XXXX timeline and marketing for furthermore soon the UI the U.S. from intend drug anticipate we roadmap, later timeframe half late receive pivotal first anticipated turning with data intend XXXX the reinitiate and we EMA FDA approximately Hydrochloride ATI-XXXX by DHC the XXX(b)(X) the authorization that ADRESU We XXXX budget to QX company's Cytori, application we an number one, also of filing clinical provide pathway trial. followed readout milestones, for the then So development And to commercialization receiving of clinical of clinical in first and Doxorubicin for then in year. In trials XXXX. to for

Stephanie, and the your turn I Q&A. back to you, thank for So over call will

Operator

line first McCarthy the Our comes question Instructions] from with Group. [Operator Maxim Jason of

Jason McCarthy

thanks guys, for questions. taking Hey the

could the if to like a growth System, from you that major this announced you Class particularly you discuss And of consumables utilization? going as for just then I'd increased also, earlier Device first Medical have Solutions factors story? you what the seen Designation drivers III see more or what year could is see the impact drive forward any So, XXXX

Marc Hedrick

it's Yes you. thank Marc, Jason,

some steady back if quarter-over-quarter growth, but XXXX almost quarter-over-quarter going look Medicine consumables Regenerative On with approval the late the to lumpiness, quarter-over-quarter. see annual you consumables, utilization essentially you double-digit at

driven specific Law. been non-accrued, that's not Regenerative current So indication sales, so the non-reimbursed expected by to Medicine there's

hopefully as driver, is is endpoints I chiefly be growth indication, so think mentioned based it So [indiscernible] I the likely be potentially the OCI that will clinical trial near [ph] term growth ACD primary on next readout reimbursable timeline. is and our trial trial pathway a and this should fix is that drive that current

as time path. some so On the approvals, with it a this I as the we've to Japanese for the was III proper Class negotiating to regularly Class been Government device. Prior

simply degree they've more has So be it higher as regulation. plane so the of oversight up-classified on units, this same to dialysis a

is really difficult in what a not for doesn’t device in consistent plane drive So come to the operates the that but it us tends into competitors dialysis it market position forth and do says tends market, with and in help the it premium to puts really make a this more but us market. so to only machines it

Tiago Girão

are Japan the to they point initially Marc what and to that indicated, our in was device with trying that indicate after Law through clarify process they think I then Medicine a non-reimbursed. Just Class Marc are one I approved was Jason that Regenerative sales

of both Law. drivers of specific new As OA that under clinics for on make in Medicine two you I are treat well to that wanted aesthetics clarification know, the patients the the Regenerative as Japan approved the the which field, the just well record. sales as fully are

Jason McCarthy

the one Thank dose just have attacks you. then And I U.S. in another on the

can of it could it improvement having specific be an any would use So anywhere a the then when And the indication across where be or additional trials are is advantage more or you're blanket seeking a board? and more approval docetaxel? much approval, where there liposomal with areas see you you expand approval label particular would of pretty docetaxel to

Marc Hedrick

question are have drug. exhaustive the I accelerated opportunity cancer we is of ATI-XXXX or efficacy as cell best smart docetaxel, second tumor So that And and an cell lung also have pancreatic a small we cancer. in market trial that pancreatic the therapy believe a of the particular lung line reduction development, that recently small as we for data indication, cancer is that and think opportunities Jason, provide completed and as first potentially for the patients targets as cancer niche several oncology on just we analysis for possible this clinical the so well liposomal it Phase line and therapy but that could other for potentially shows

to market Phase inputs I but are we question, get don’t in mentioned, can want clinical X think we with an and prematurely indications with saw of plan I what as indication developmental market. to opportunities just other there mentioned a So, that that, what the those an we off number I of are think the consistent because our consistent in are. impact there docetaxel And the your with basic what version to improved where make as

Jason McCarthy

All right, luck and congratulations with forward. very Gary, going Tiago, much of you thank and for everything best for

Marc Hedrick

Jason. you, Thank

Operator

[Operator & the Company. Laidlaw from Jen next Instructions] with Our line comes question Yale of

Yale Jen

join the team. and first team, and great Tiago, morning Good great job for congrats Gary, second to

go to divesture in retain? I things to geographic Just Lorem, you a that? other one them things quick versus terms will a in first any could specific of know are more but be that the for Japan questions you'll assets here, anymore retain, few areas to there in the specific what you little on colors the is

Marc Hedrick

Hi me if afterwards Yale, then I take miss at Tiago and that I'll crack yes and can in a come correct something. Marc.

into is it hit it to that, it is to on. head easier So back than

So were trademarks, to clinical inventories, rights, and therapy rights, business not from in I IP, perspective technology hard transfer leases, the included a mean assets, cell the Japan what was data. in all manufacturing that operate regulatory capabilities

excluded everything that the the the contract. all excluded asset that from sale, So was that things Japan BARDA was needs, in

now BARDA appropriate supply the rights, needed contract, the product, all and to maintain so and [total] of the by that everything Cytori. operate retained So

facilities. by then -- access, that trademark, includes leases Japan, Lorem rights and or the territories So BARDA of with IP, it received that flip already materials, represented by two assets and they hard are don’t Vascular have to that not they raw

in bring fully also to Yale? markets they So for they of the that their serve have things U.S., to to but help everything need manufacturing that the like territories, they other clarify part existing the Does transaction. and in market Europe this

Yale Jen

represents market? that. the the some that Oh U.S. want things And the appreciate docetaxel that potential appreciate but for is of the next in the you before what's realistic to yes, that's providing very question mentioned I the helpful, sort do of you more the to you that Street, for the market that I U.S. color think

Marc Hedrick

that we niche number that need, safe of is know we drawbacks in Well, we could have think of be favorable million is It $XX area trial sizable that's before cancer. we've potentially potentially where it's for medical said a the a which market a cell is is second market the a pancreatic line it saw I and they is signals year only potential can a there's unmet the opportunity approved think line take and but second and and and and lung the we small opportunity line pricing think greater a to drug therapeutic drug effective. as But indication I for believe still about similar you where market. very share U.S., acceptable look, first kind if as are of an Phase in and lot cancer you and that therapy, a efficacy adoption of significant is an

to forward going accelerated get plan first So other go us pathway of forward. opportunities we XXX(b)(X) cautious a the about approval going And are and and for on extend do one is small allowed the this We're which to indications do point number very at be the indications market drug. that. to trial, was then this there potentially niche our

Yale Jen

do I'd fact do like to there specifically at last mentioned you the and that acquire Thanks. to anything actually there or you somewhat going Doxorubicin gating aspects? was know would this is, that’s in question what stability Doxorubicin, XXXX are maybe related to point of sort things the can do, just you here whether great, are in other or filing, XXXX helpful, Europe, before early [indiscernible] Okay or late the very to

Marc Hedrick

talking liposomal which Yes Cytori, CAELYX everyone’s Hydrochloride trial just Hi Yale. we Jen, doxorubicin page, Europe. DHC bioequivalency already is a the Doxorubicin completed in is against same call so that’s which hi about so it’s on of so, version what we’re

was So, EMA. with ago our announced weeks File a to a key which the milestone for is few Intent us submitting

are themselves(ph), is once thinking stability manufacturing – right we So that to MAA like able your be the like we seven to away EMA which with that either for milestone drug, s lots, the the a because and applying ready generic CAELYX need that throw that from this you you're going are manufacture felt where over non-clinically about begin we is, month are are it to you is likely now. is trains equivalent to this to was key we to warn

you what’s as putting hopefully forward, comparability of well but getting stability already have So, required basically those vitro on format against manufacture, an testing positive, in put we to lot going the confirmed that's as GTP work months for and CAELYX about under asked and done, in mentioned, MAA. shelf you some it trusting six some cleanup been what’s preclinical as appropriate EMA, stability

filing. So seven-month will all approval. months file Intent to to approvable, that those of once between whether and think And we idea in this, finally actually well File is need the, the likely point are testing then will file, with we’ll approximately stability are we ultimately submit we things another on going be then at in we then window six attain that that

Yale Jen

and appreciate helpful. very congrats really here I the colors Okay, that’s for [indiscernible].

Marc Hedrick

you, Yale. Thank

Operator

this to questions would for remarks. I back like closing Hedrick Dr. to no are at There time. you. turn over it Thank additional

Marc Hedrick

as company company. a We're best assets we current challenging Thanks we leading becoming clinical obviously as even to pivot a the assess this our additions both trying time pipeline. with potential oncology lot new complete oncology leverage to our goal the It’s key stage for Stephanie. exciting,

continue such thank I BARDA customers, for always, just this partners Please doctors and work As us, thank to want as call. the employees, you in the our to that a our day. good have with participating

Operator

does Please day. a wonderful lines This conference call. this have disconnect at you. conclude your Thank and time today’s

Plus Therapeutics (PSTV) 1 Apr 192018 Q4 Earnings call transcript