Officer, quarter Hedrick, me Thank you, Financial President our of and joining first and today’s afternoon, call. call My Chief welcome to everyone, CEO Tiago Alicia, earnings and name on is and Cytori's good Girão. XXXX Mr. is Marc Cytori;
the call will I our which time I will programs. today, the have company’s provide after on on On And will an update oncology financial update therapy we’ll Q&A update performance, on then and forthcoming cell for Tiago milestones.
nanomedicine our So platform. let me by begin discussing
procedure. including our for continuing The to the the all Medicines self-image in call, and and progress that manufacturing with active we Economic and in European in in what that manufacturing the drug doxorubicin, Antonio and employees. this key healthcare last for growing place in of does confirmation our total is anticipate available San states, lots countries. ATI-XXXX oncology marketing pharmaceutical European EU to allows and support liposomal it pegylated ingredient. We’ve is loaded Since patients EEA, characterization member our completed team terms Area candidate, the our to make medicine holders we we’re the is make a basically, it a First plant. authorization from Agency San up authorization are Brylan market professionals received centralized XX and the contract But from Michigan manufacturing that's perspective, functions size in manufacturing Europe has team eligible from of XX lead building people Cytori out regulatory ATI-XXXX, to with Antonio now all our
ultimately as to name that name the on QX, will will EMA, a authorized ATI-XXXX new place the in which submitted Cytori designation. envisioned the brand addition request In the in
is differentiation is the may liposomal generic of unique performance patients identical know, drug words, to like an The you competitor, It's not shortages clinical in in Cytori. that that's formulation that the complexity, than think decade. for manufacturing treat a But a much over created I biosimilar, and other publications in clinical drug last suggesting between Lipodox, think, are liposomal manufacturing typical opportunity in niche diseases. It's Now, we addition, not all that doxorubicins to the make. positioned want And are issues resulting life-threatening drug, clinically-equal. more space. important tough the a made market affected it's as be a an in with for generic. the clinical terms doxorubicin the a part high-quality, in a our to around will effectiveness. best-possible particular the we this In provider USA, of in quality. in of with emerging is to and be as itself drug, is seriously-ill intended generic quality-related supply global it Also, have market, real-world in Also
digging So to landscape, in market at you deeper give competitive dynamics little more looking the the and color. bit I a want
that current believes Europe, approved of pegylated million a the estimates to market and approximately a the that forecast it update revenues, available being gained market million ATI-XXXX one models. continuing market. currently can the if are generic by EMA, $XXX or potential global either in million there. year. share is a $XXX Janssen’s revenue landscape monitor long positions. first product look two the global you and and driving year liposomal Cytori of opportunity to second really growth current We market approximately And significant there’s that for our to to In with be indicates $XXX million China Europe And are these the $XXX market has Caelyx surveys, in that doxorubicin at take the by the bio estimates the opportunity
Europe. product market and May competitive U.S. be out the side. a XXXX, of estimates that authorization we’ll submitted the liposomal about monitor This information on point roughly doxorubicin the some complete letter a a submitted X requesting had that for generic public North to in TLC, respond of, America, it’s is has EU about archive, year, in clock-stop liposomal and be company on Asia-Pacific the a may of aware to list meeting of of market candidate an are pegylated South I to the want marketing in doxorubicin EMA words, other revenue announced the third third March to Europe and Canada, this Now, that EMA. in the competitors, third extension in In and continue In in about potential to is in providing similar is of actually EMA’s previously to questions. investors
If revenue the is – the of is you share the split Lipodox between J&J at and the in the leader the is again and look, product Europe, that market market that specifically generic – rest competitors. U.S., the
for gauge entry, that’s not continue market. to priority dynamics We options strategic and to market but evolving position program our evaluate U.S. the ATI-XXXX currently,
products, or best significant marketed opportunities liposomal completed approved China, Currently, are there data. for have which, and our of this submitted of three we any bioequivalency feel there’s in knowledge, study to Now none doxorubicin pegylated that product. the
greater three been revenues these than estimated XX% growing have annual and For $XXX million seen it’s combined about at year. drugs, per
trial. Europe. partners seeking to the sell XXXX our interest, commercial product, to by also commercial and drugs for so we’re reimbursement distribute recently bar there, to market, ATI-XXXX generic the drug increasing to Asia a quality drug actively partner plan BE completed of for access changed, three have leveraging licensing strategies so currently We America, to and we’re exploring gain did North this and China rapid China market this Additionally, only list. And provincial includes policies FDA for XX
second SCLERADEC-II completed we awaiting has XXXX. self-therapy in half which of trial the our are and trail enrollment trial think out, we regarding this the read and European for pipeline, anticipate Now the
STAR trial As received instead next HABEO, rely licensing recently focused pre-submission with and parameters recently We we’ll could an clarify our meeting to and HABEO basis an trial as reading, the given more-severely clinical additional in with are conduct to and sclerosis additional clinical of not follow-on order minutes we the STAR appropriate At pursuing it to opportunities the resources indicating prepared continued be FDA U.S., FDA partnering not affected for of HABEO. development. dialogue a have patients we required feedback trial. out- on clinical clinical diffuse that do from a step, commit relates systemic results the finalized an on aspects time, this to key the and the trial for and for are
called get planning that as of of terms in we In process trial, thermal of deep partial first deep then, and of to incontinence soon self-therapy and terms now Japanese administration in the relief enrolled have wounds, product of IV other – as initiating and trial patient initiated the our our urinary complete. single and our trial are for BARDA-supported sites And full-thickness enrollment’s finally, sites possible. in two
with report and the follow working up data. XX follow-up University XX-month complete and PI We’re to and all Nagoya
BARDA commercial QX product specifically, $XXX,XXX, in over XXXX. which versus performance. was regarding XX% contract an XXXX QX QX year-over-year revenue growth revenue revenue QX $X,XXX,XXX $XXX,XXX XXXX. $XXX,XXX, $XXX,XXX Now our Japan, In The Product was QX represents versus XXXX. was in
ACT-OA leveraging versus Japan year-over-year in QX that XXXX, QX the XXXX activity trial breast in XX% indications that and our was previous our focusing esthetic behind towards the market. Japan utilization. Looking in and consumable continue that, product surgery. revenue consumables lion's clear are share the growth around grew will that to market principally grow commercial a trend that osteoarthritis, We anticipate data growth currently trend utilization of are increase in consumable we and
off to Tiago the financials. hand Now, for I'll
