PSTV - Earnings call transcript Q2 2018

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Second Quarter 2018 Earnings Results Call. At this time, all participants have been placed in a listen-only mode and the floor will be opened for your 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 reports on Form 10-K and quarterly reports 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, pleasure my the to now is to It floor turn over Dr. Chief and Officer. President Cytori’s Hedrick, Executive Marc begin. you may Sir,

Marc Hedrick

call. CEO call Good afternoon. of Tiago joining on today’s earnings Cytori. our Welcome is CFO, Marc Girão. second quarter to And Thank name our Hedrick, is Mr. you, XXXX Ian. My President and me

will I and we drug, be today, update pegylated doxorubicin call an made clinical to quality then update our will To oncology the On Cytori nanomedicine product milestones. to financial will will platform. company’s the bioequivalent provide position for Q&A. high which, begin maximal cell Cytori drug. Tiago chemotherapy Then, a hydrochloride on time this liposomal ATI-XXXX, on is We forthcoming to I US programs, with, European therapy have with manufacturing performance. developing reference regarding the update a on intend as generic effectiveness. and After

Texas year. team authorization to to San filed MAA application Antonio, EMA a related continues will nanomedicine Our non-clinical or complete manufacturing marketing the with be activities that in next and support

in Pacific Our and the on continues America Europe. ATI-XXXX or The commercial Middle to to potential North either company East, Africa, Asia engage second goal Europe, is the the for first partners also be North generic market in regions. and evaluate

market X approximately chemotherapy candidate, is million to to and million Europe, Furthermore, is $XXX drug million. we an liposomal docetaxel. mentioned in albumin-stabilized global As ATI-XXXX this opportunity a $XXX this Cytori’s approximately be annually before, the at million phase pegylated $XXX product $XXX for annual ready estimated to regarding market and drug estimated

blood liposolic mononuclear the provides [indiscernible]. stabilization liposome extends stability. surface on docetaxel. of It the enhances the time liposomal circulation while The integration peg API the First reducing

the which for docetaxel the shortcomings development need for from spent may less which pretreatment is at workhorse comfort, drug add it for rational its to the the improve better X.X the in A and the morbidity has safety an decreasing which evaluating The to XXX(b)(X) chemotherapeutic requirement requested developing of offer systemic address for to standard benefits. drug company maximum FDA may small is peak. time added drug, therapy ATI-XXXX lung generated sales of Cytori lower develop and convenience unwanted exposure US, development costs. application continuing which drug is and worldwide an treatment, patient cancer this designation reduce eliminating a has timeline up been accelerated new the FDA’s by Regarding in medication, solvents, the and the a in by providing cell pathway removing orphan enhancing billion docetaxel cost

therapy Now turning program. cell to our

is team data SCLERADEC be sufficient group may from scleroderma is Therapy clinical in urinary file scleroderma readouts a month in are the French approval. Cell with of year. awaiting X data in trial XXX II incontinence are this and There trial to severe clinical and those approximately XX% target disease. actively EU data moderate expected with thermal burns. Our in trials star conditional in patient, is also called scleroderma XX coupled EU to for data approximately trial our from Positive EU and patients conducting

group approval the ADRESU positive noted pilot efficacy indication. published with safety XXXX. incontinence urinary SUI XX this early the trial clinical to Additionally, in in and ECCI is safety ADRESU is in clinical trial or for data data for from patient cell confirms shown one data trial, a expected XX-month Japanese similar the year therapeutic, It’s the reimbursement which the

with Cancer may year. subsequently of prostate National incontinence, As radical patients according which are diagnosed Up stress growing to compromise developed life. XX% SUI, to Center, XX,XXX prostatectomy for cancer the market Japan each profoundly the quality urinary size on men to of over the

mentioned, with stress are Japan. million this incontinence. previously X.X there safety approximately As the urinary same results for promising also clinical ECCI potential patients And has cell indication XX therapeutic in demonstrated

US Finally, BARDA. intended RELIEF meeting ongoing process clinical a add trial for facilitate it’s a continues thermal trial for working the the screen June, approved Cytori basis on an has In enrolment. to FDA trial, burn funded successful which sites. protocol in BARDA RELIEF completed is amendment patients to review to and Cytori with

classification and discuss over approved orthopedic cell couple As more and bilateral on Cytori items and aesthetic US, continues a There trends double approved company of disease, investigator other growth investigator it approximately target in its term product X our year planned RELIEF of is upgrade of US called currently a the substantial of used be favorable time. Cytori of commercially US to continues being in his A solutions made we Tiago FDA this specifically the proprietary therapy the data Recently, have long related in are supply our the relates hip, agreement currently to Clinic’s supply in utilization. where in the see new markets. few system San is trials, see in date. I on been the enzymes. base like and would XX,XXX and existing either in currently the in have agreement Technologies CCS-X agreement out consumable therapy of will available also US. additional commercially Eight transferring consumable based technology In patients the while MHLW available valuation Mayo a the new in Also announced to registration, by customer Antonio, for trial the supplier sufficient negotiating XX growth patients remains them. track core osteonecrosis are manufacturing cell move up is remarks. these This in Life next Celase improve commercially gross year to for point outcome trial initiated of Texas. X will and supply Cytori to to class we Japan. active, reduce from which inventory costs, in Cytori’s Intravase with XX,XXX under June, we to which for termination of and solution affecting renegotiate to the solutions trends will we class the Coastal process margins. continued of the to at rare to identify adequately a our each patients are years, The We most treated total for year a or support digit

be from distribution will for consumables to Europe Japan realized first Coastal and available in The QX.

the this our by one completed and by successfully body. one past quarter, US audits FDA we note, a as Finally, notified two

Now, Tiago. I’d the ball like hand to off to

Tiago Girão

Marc you, afternoon, Thank good everyone. and

to working adjusted of down assets, XXXX compared acquired approximately related net in and remains X.X our resources X.X coupled QX, as oncology focus managed translate while related with our capital preparatory continuing we mostly managing primary as late operating investment to believe reduction can the possible recently toward burn QX, in burn X cash to as million to clinical additional XXX,XXX. commercial cash we non-cash was stage in operating was performance. of development shareholder items in Our of pipeline losses, activities tightly reductions approximately improve Despite into carefully value. XXXX. improvement our our In that million million unchanged, The the in are parallel, new

share X.X compared period June ending X.X the for by $X.XX million net year. per XQ XXXX, QX, XX, operating totaled losses losses, as last for million $X.XX cash reductions six compared million in or reduced XXXX. X.X again X.X items the adjusted XXXX burn month in to For per of The driven non-cash or X million. million to in period reduction Net share to primarily same

share to associated or $X.XX of same to XX.X $X.XX included non-cash period oncology a losses in-process net period, of asset XXXX XXXX. net X.X part For the million losses share for year million X.X a recorded, R&D of acquisition. million or charge in charge, date with Most the totaled in that compared a the

and Our X compared were and in compensation expenses, X.X based expense QX in in a our share expenses research excluding research development ago. year million development to million QX,

trial The date the ongoing our and and in were into XXXX year million the implemented the funded as from the reductions activities completion both September for the ATI-XXXX investments Antonio periods well investments research BARDA. the development basis, XXXX. activities decrease San during of are clinical same These are and activity. to headcount to in in spending the compared to in restructuring decrease offset Star attributed On in manufacturing X.X to X.X the million by RELIEF trial period, in expenses R&D by our as clinical our

and plans overall is late of expenses XX% percentage excluding of and R&D stage year-to-date in of period spend, our QX and operating As compensation, for share This based focus our respectively. when with programs. was line XX% our and XXXX total on a indicative

onto Now, sales marketing. and

compared continued six to one were in resulting million QX spend. marketing the as share to the million services X G&A decrease well X.X in to and in million included to September expenses activities fiscal related to in quarter the and XXXX period, related lower fees approximately for $XXX,XXX and The quarter based to discretionary as in numbers. restructuring [Technical The the the US. marketing related during XXXX. ending excluding same as expenses last this X decrease XXXX X pre-commercial this versus as our of million lease Difficulty] period in for in related expenses from and to was expense, month mostly in decrease to our period QX, approximately million as XXXX. were year. sales are charges February are date time compared was well in expenses related XX, charges the X.X the G&A period year as compensation, in to those headcount XXXX. activities principally sales headcount million X.X Approximately paid X.X from June efforts And decreased million the compared in Our XXXX in XXX,XXX the tightening professional decreased

X.X the Now, period our to versus X.X X.X to million revenues. million and with related Year XXX,XXX to second were largely in by revenues million date, last in as year. respect was to were decreased the million same approximately year. of X.X XXXX compared revenues Product is last was quarter we compared QX date, QX for our by growth revenue total fewer today. opportunity XX%. believe sales meaningful over for devices region. utilization will in up is the aesthetics This of the over by which an Such offset the Japan. consumable by to orthopedic and primarily consumable in a Year represents company utilization that in markets, XX% revenue to driven total increase

respectively. once again and XX% XX% achieved guidance, of Japan have date and we QX quarter consumable our consumable for where Note for approval. product now double digit total regulatory per year over the to Japan, that periods As the in represent we growth revenues revenues

activity our compared year. activities increased phase to related this the to indicative of XXX,XXX revenues QX approximately supported by quarter awarded contracts. contract the as clinical the beginning kickoff is Barda, of government the Our RELIEF newly trial such under by last for of Barda This

Turning net on include proceeds that activities ongoing month, business to we We on last to million capital our finance operational had the as targeted opportunities, we requirements company. balance X.X plan resulted accessing addition markets. the capital in the sheet, June capital of XX, to rights measures management, development additional in revenue hand, and to X.X in million working growth, $XX efficiency with in in and cash debt that balance closed our offering million several

Marc. Now, to back I will it turn

Marc Hedrick

Thank Tiago. you,

for update on me major Q&A. we’ll Let a time milestones just and have forthcoming

also incontinence. scleroderma funded we II reporting US in our hopefully the to required designation drug feedback First data also in it to for you then And RELIEF two, soon of data feedback post-surgical turn and are patients floor Agency. six-month over from of one file SCLERADEC will intend program trial. major And continue the six tend and a ATI-XXXX clinical stress clinical We for for ADRESU complete ramp the FDA NAA dysfunction goal for the report is regarding Q&A. and open up with I and hand plan and to terms ATI-XXXX clinical trial EU the perspective, orphan from up the Number then to to we obligations the Medicines all, and data, from prepared urinary receive absolutely to Barda and FDA year month male that related XXX(b)(X) to we’ll our Japanese size three manufacturing product. trial with enroll and report Ian European development that, clinical pathways

Operator

H.C. [Operator Instructions] And our first the from question of line Wainwright. from Kolbert is Jason

Jason Kolbert

see file activities, just about what might the on in the we to the Japan, on glad the I well? that BD done. sheet. kind the file you of Congratulations cash talk the SUI because looking you was as rays a going little to Can understand bit cash and a X/XX more plans at little balance as in forward getting while work Can also emphasis balance talk look a one two how around like to hoping the I'm bit scleroderma to pathway the while as and see for those of, to tool cash of that financing into Europe rise, elongate those runway kind way that and you and magnitude elongate X/XX opportunities so use to can catalysts to about

Marc Hedrick

We the in recent the sheet did balance raise. supplement capital

approval way we provide we which capital didn’t mentioned, additional hoping you drug As to get enough run to were XXXX to do. raise to the

methodologies of So development including to mentioned, the the a to business variety is prolong pathway. as Tiago plan use

a on value done intend they’ve on programs that staying which and addition, burn focused trying in a job to to we excess keep add lid great key do. In

and the on the and there to BD side with opportunities, that which but at we’ll ongoing, which are mentioned, to definitely hope which mentioned concrete point, with is challenge all continue multiple different the is timing, difficult The those a of engaged So levers ball Tiago as can’t, provide very leveraging partnering forward the we’re in just all things predicting is of to that those engaged guidance side, there multiple move that this do are with parties. number parties. most we the

your in to plan and seek for questions, it SUI. for going of take two what’s approval potential what’s second and the to scleroderma regarding So terms

a take think SUI clear pathway. more Let’s because that’s, I first,

have a Regarding and XXXX sorry by now so maybe and that for as plan whether from reimbursement. a another XXXX, about to would trial. about data get early the We is approval, it year, that to then, opportunity try that allow data likely early to which whether SUI, go us file an expedite to to the year is we ahead said data. readout in on take back to there in We’ve should X as ‘XX late months hearing which takes be approval will

launch I the we may with as mentioned in months. but already Japan. takes that be process having expedite XX some those reimbursement about with There PMDA are So to to discussion opportunities to that,

merchant relates it it’s Scleroderma, As more a to process. a bit little of

that these There path clear then that come later data. smaller for our data you have full just clinical It’s the see approval additional and we is conditional idea data to if after positive we’ll plan to, with the to and approvals So we’ll back evaluate is with that the a likely trial. clinical event. a be, that is to will data provide guide XXXX

Jason Kolbert

seeing looking that really in part happen remaining or forward we’re this to And good some year. of things

Operator

Yale question is Company. [Operator the Jen Instructions] line next and from of Our from Laidlaw

Yale Jen

My question XXXX. is regarding

doxorubicin. about -- their have liposomal As of I talked for their during application one you in earning recall competitors last that calls, the may extend last Europe, the

you and have things space are where see I follow-up. another competitive So, in that

Marc Hedrick

Yes.

open have has and approximately for on That’s Taiwanese been a year been well the On over last that. companies call, EMA I submissions. active had the mentioned opened

perspective, in within issue else. as other is is get as do think active, have and that we the It are on it is although to goal anticipate drug that’s So much far potential competitors do as we from can file that possible. know, testing, and do I a that year – those in as still other anything is about that. our and other the the public so it manufactured competitors next think really information timing stability get that We soon we don’t competitors, as there in disposition specific any that we but market, but market

one that is so And number priority.

million. is with EMA to the we So the generic from again being million But $XXX second market. market made year, approval, $XXX approximately product is or get goal a with next that what and testing to stability goal think of first and filed the to

Operator

this there to over closing you for no lines. like I'd to turn phone At it further showing are time, remarks. I'm additional questions or back Dr. Hedrick the that any

Marc Hedrick

either everyone evening. course I you. questions you or employees thanking participated call. Thank you our like listening by on wish with and conclude the good of Just by to Thank that to a

Operator

gentleman, does a lines at disconnect this your and have time you. today's thank Ladies Please conclude and wonderful call. conference This day.

Plus Therapeutics (PSTV) 14 Aug 182018 Q2 Earnings call transcript