CTSO - Earnings call transcript Q2 2024 | Cytosorbents Corporation

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Operator

Ladies and gentlemen, good afternoon, and welcome to the CytoSorbents Second Quarter 2024 Financial and Operating Results Conference Call. [Operator Instructions] Please be advised that the call will be recorded at the company's request. At this time, I'd like to turn the call over to our moderator, Eric Ribner. Please go ahead, Mr. Ribner.

Eric Ribner

afternoon. good and you, Thank Welcome to Conference and Results XXXX Second Quarter Call. Financial Operating CytoSorbents'

today of are President CytoSorbents Operating Cramer, Joining Chief the Christian Director Makis from me company of Officer; Medical and Business Vincent Chief Officer; Vice Dr. President Senior Marketing Deliargyris, Bloch, Managing Chief Executive Executive Dr. Christopher Capponi, and Sales Kathleen Europe; Chief Vice Development. and Officer; Steiner, Financial President Dr. of Officer; Chan, Phil and

change. discussed to Dr. forward-looking uncertainties discussion therefore, as to differ statements and we from may statements that risks claims over to Private I'd are Securities the company's call like contained management's may forward-looking listeners you the turn the include in in make these as results of XXXX. Actual company SEC. Management performance company's to management today in to as Litigation Reform filings I Therefore, with to remind Chan, these protection Act your XX, during prepared to Before additional subject uncertainties. refer and safe remarks statements, Any questions results the call, obligation of by XXXX, and the may the the the contain projections detailed projections today, risks no represented August more of conditions a forward-looking we in today. future under and the response which market assume for harbor update estimates future

Deliargyris. Mr. for During Chan, Bloch. by first and XXXX presentation the Dr. quarter Dr. today's covering operating and call, we the financial highlights have will overview an Ms. Capponi of

to it's to And Chan. session live of the Following Phillip the call management Dr. pleasure the to with line now your during questions the we turn over Q&A presentation, open will rest team. my the the

Phillip Chan

very earnings you to much, QX afternoon, everyone, good Eric, call. the thank and Well, XXXX

our go to like over the operating for I'd highlights First quarter.

many lives to cumulatively around than save helping devices the have date, million us CytoSorb First, been world. X.XX delivered more

XX% million the while quarter, gross $X.X margins to product X% revenue $X.X increased total second XX%. in increased to and million solid Second, by product sales were

second our from and Importantly, year $X.X operating quarter decreased $X.X ago. to million million, XX% a loss

an Following in credit expected annualized strengthening our expenses quarter, And cutbacks Avenue $X following million we additional with facility our secured $XX.X equity we Group, $XX completed Capital in balance December an additional XXXX, to raise sheet. million million going forward. the save additional

XX%. the Over X decreased months, past our by we have workforce

announce cash. and tomorrow. of $X.X end starting second our in million cash million, restricted the Officer, Peter of end $X.X $XX.X CFO, was Finally, balance Today, Bloch, quarter Kathy Chief today. business of of existing unrestricted in are the we the retirement pleased Mariani, at as of cash our including J. our million the to new unfortunately, Financial start And the

hear You'll of application for investigational people more on third year. quarter to meeting. We're also this novo marketing Health this both de DrugSorb-ATR track this end at to in of set the parallel the the as from in a FDA Canada and system applications

Capponi. from more Deliargyris as Vince hear well about that Makis as You'll both

our scientific MDSAP redesigned product it finalist Data new as a selected was our key we was Conference, EuroPCR modern audit, completed which we X a to and the Canadian where commercialization. a competition. And addition, consolidated XXXX STAR In from is in top requisite the launched website. importantly, best at presented registry abstract corporate

on expecting pump, PuriFi from all PuriFi OEM order we original MDR in -- our CytoSorb, OEM the our shortly. hemoperfusion pumps are placing XX delivery certified with and our very order next our Lastly, launched also our fact, from

our turn use as our it With and Financial from to let easy Bloch, set reviews that, Officer, to implement current pump extremely therapies. Importantly, very has that users -- Kathy easy up Kathy? received Chief it the to me itself good easy and over well to citing

Kathleen Bloch

Thank was and our revenues working additionally, discuss results, margins. second you, to XXXX I including And quarter of in CytoSorb Phil, the the hello financial in capital approximately XXXX $X.X the product will $X.X our and update of increase on second million $XXX,XXX gross quarter XX%. on I to approximately revenue compared second everyone Today, will call. an million XXXX, or cash and runway. of provide an quarter

XXXX. million was And $X.X XX% was decrease and compared grant approximately margins the margins devices the XXXX of product in product quarter due product XXXX. revenue, which as XXXX accessories includes revenue, to quarter and brands quarter million on to both Total $X.X XXXX. compared in was sales second XXXX XXXX, gross grant Second revenue and with several of approximately million in approximately device million this gross $X.X during conclusion in $X.X second XX% to compared of to

slide, Next please.

$X.X half million $XX.X for For million or first $XX compared XXXX, the CytoSorb first of approximately the of revenue XX%. was increase of product approximately approximately to XXXX, which an million is half

first as first manufacturing we to in of our compared realize to of accessories half $X.X half grant $X.X compared the to as XXXX. the half continue grants XX% of margins XXXX plant more gross at were to due devices operating revenue million new XXXX in XX% the on Again, Princeton, New XXXX and First efficiencies product in Jersey. conclusion was in several million. And

ceased XX, post-COVID-XX non-COVID-XX take that years trend tracks which show we positive continue and at in look June sales ] arrow, news XXXX, to to XXXX June pandemic a blue on this favorably ending XXXX CytoSorb following our revenue. The impacted period and core ending along sales annual non-COVID-XX June product the the growth patients. of our this very XX, XXXX, know each If of COVID-XX XXXX. see because years trailing we ended core XXXX, orange for We represent XX-month the in used XXXX. for to product is XX treat has the is course, that XX-month year [ the Next slide, were for bars periods XXXX and What sales. chart the please. XXXX containment And the

XX-month ended XXXX. for period trailing the by ending for trailing increased XX, compared June XX, year-over-year the X.X% to June sales Our the XX-month sales XXXX, period

in impact ended the XXXX, I out our that of sales XX, our for to we line, decline moment XXXX, overall CAGR COVID-XX indicates operations the margin, X in manufacturing new year-over-year also for and XX.X%. a June respectable excluding green want to the while Additionally, facility. a which a XXXX, XXXX, point years gross is the our XXXX tracks transitioned

facility. Our gross as additional XX%, margins second to quarter efficiencies. expect approaching these prior in the continue that margins to to our new XXXX manufacturing show greater at continue volumes, to product we show realize margins improvement we the we levels improvements and move With further to are had gross

Next slide, please.

XX, in $X.X quarter As of that in XXXX, cash. cash June restricted XXXX. the $X.X on million operations million cash, we cash unrestricted through which hand of believe company's sufficient second We and unrestricted is to of have the includes $XX.X fund million

cash, successful top has after received for closing alternative equity that subject its for the $X released and the dollar-for-dollar accepted provide $X was date. The of December then immediately been the million. company million, XX, million review a of and of into the in has expenses. On application And efforts July request sale received the million our in XXXX, may restricted is that XXXX, another Avenue actively million and marketing of the release a in under net and company's priority. corporate basis of sources provided remains of financing. to March the DrugSorb-ATR And cash between DrugSorb-ATR million, in with at in X, company's from have company application. $X securities XXXX, provided $XX our Funds that equity of facility be reduce respect Group and tranche to was company by We available which our FDA cash with there's the $XX a June million be balance operating call, approval we restricted pursuing between which the total is Conservation loan FDA security $X sheet XX, will a and included raised XXXX, debt minimum of its $X proceeds on dispersed strengthen the entered to to that agreement capital. indicated our last we a

measures additional We XXXX, of cuts Operating previously we the million are burns Go loss in this quarterly $X.X reduce And enacted that over to Vince. time, our Officer, cuts, will And President call the a taken turn designed ahead, our million Chief taking for the head Capponi. $X.X delighted which of have from spending million. XXXX the another $X second annual quarter today reduce round to in operations reduced conclude and to remarks company's second our other our from an my our by at I'm Vince of cash XXXX, burn XXXX. Cost count, in and July reduced to have In cash adjusted quarter decrease. to of XX% cost

Vincent Capponi

Thank you, Kathy.

for to -- clinical... cover like the the So I'd

Phillip Chan

Yes.

you part take to I think Makis the is on the Makis, would like of first this? call.

Efthymios Deliargyris

Bill. sure. Vince. Sure, Thanks, Thanks,

As and this to you call our heard everybody afternoon. -- on welcome

allowances were regulatory for publishing. This the that from on to the we're analysis this earlier completed system main has the As been STAR will in stated the data clinical data submission of information and priority report the track line you final the presented Phil our that previously heard to stages a development fact, will be year, this benefit the company. submissions the are clinical filing at The to crux And all for FDA. de we DrugSorb-ATR and time report probable the study to in for is source our previously, top that novo risk investigational contains key and of results top happy lines. the according represent

eSTAR visibility Health de files I'm European in electronic data spend track the that the to from you CABG And the sooner on completion ticagrelor evidence supplementary slide, during more for platform FDA include after. submission We little and follow as the recent that submission stated, in data. The the STAR bit Canada with same intend giving of are next submission September, to in to a is presented Conference, platform. the Registry also removal we on novo real-world of the the supportive leveraging the was technical leveraging going already with

suggested faster pending this pathway of such, have ATR novo as have of will our as could review listeners, FDA means drugs compared of breakthrough breakthrough And status its recent of agreement following designated applications and of XX% submission reminder decision submission. novo be the devices DrugSorb-ATR XX analysis de that an designated applications. timelines with is to the the submissions FDA priority breakthrough FDA the means a de the that Just X estimated which potential that regular a associated priority review an a device, we months review. A associated within to to device,

annually held present please. the being is privilege the world, presenting slide, on in conferences this PCR cardiovascular of and one Paris. in Earlier Next had of meeting year, the the we largest that

XX,XXX for this over as was an During presentation. to, STAR the the conference, And oral has alluded Committee top spot finalist at data, selected abstract Registry the from meeting their of competition. with in our attendees, awarded scientific Scientific STAR a best -- already Registry Phil finalist their end data the X in the

had we registry cardiopulmonary In know, many within do intended going believe is Europe. CytoSorb to [ with previously of we CABG use supportive the investigative submissions. used XXX in This isolated As why totaling in CABG our submissions? show of device for calculation approved since discussed increasingly high data XXXX removal surgery fidelity from piece with ] that of care of centers this of is everyday an real-world a being to standard countries, we ticagrelor population we and the STAR of heart as STAR removal collecting a a be you So we bypass five [ will the analysis, be target is regulatory trial different indication have that patients. ] XX is cardiac sites, Registry, the ticagrelor. In during data are

since So cangrelor. the last mean soon of these patients on the hours. were of dose operated XX.X very

least not as a for Just should XX practice is feasible. guidelines many but patients this these reminder, hours, everyday that wait recommend times at with

population recommended during an on operation, substantially fact registry, average registry were almost a the the reported in Paris did operated observed present patients either we rates the the XX recommend. in data cangrelor use which device compared window X.X in in XX or was was to we hours device within CPB these used in early in two those European that again, very, So is these hours, to comparable the the hours run of STAR-T, saw that the we bleeding of XX STAR lower not the much but completed being operated than washout. for CABG The later what always within on were identical among having to What very patients very time and sets. shorter that guidelines

can slide. day in a to waited patients will substantial rates to fact, operated see you very very, the those CABG for least not seen And being or You or more a not rates presented the bleeding on patients severe operations. operated, low the a who before see at reduction having equivalent anticoagulant in

Importantly, the regulatory the update. the was benchmark and we're the these that, and eCABG best device-related very pleased are in to designation abstract. And the top over very well give to scientific for would from adverse receive received us at X with from rates of call data sites and to a the finalist to reported previously, to scientific conference, Vincent like events. such, a as I turn Registry. And the good you for The none investigated noted compare Registry represent STAR this as very any

Vincent Capponi

Capponi, everybody. Thank day This you, is Makis. Vince to good and

engineering submission, mentioned, now de time file to in to will eSTAR that documentation XX% relatively and FDA starting to be get hope protect that we're to speaking, technical preparing shortly through As Canadian after also most through approvals. documentation we parallel, past, manner. in but final bit through with which say of novo can happy At quick believe U.S. XXX% than Canada. also we of to -- submission, complete. have very line, generally for of have we for with we're on do the submission stages in program. point, are we've -- it we assembling similar, the Hopefully, a that But we the Canadian a we're eSTAR the has generally clinical be faster a course, submission. Along we're I'm the filed can't approvals in be Mike so the certainty, that approval working Canadian With the we It's the file, submitted that the concluded FDA. the complete been hopeful able able the timely this will

of of already all confident we our life Rest product throughout confident continued CytoSorb to again, are achieve of will submission targeting we more XXXX we [indiscernible] the affects went audit, are audits part respect MDR operations It's extensive by the that for able for from Next have the submission. World, to audit for very a our but very well. currently to for our based approved requirements the Canada of than requested that European December as notified the be MDSAP We're program. With submission the I'm to very we'll the feel Global body we please. MDSAP slide, able MDD, June have very the are a achieve a is which cycle be MDR, say the under be will review the to meeting which audit, obviously on standpoint completed it required confident we audit a XXXX. that successful and that and happy regulatory through MDR growable Canadian but which Canadian approval. submission, preparation to

the we've back received that, that has worth Taiwan, And very, up received you, Phil. turn in as opening forward June, in and we're pumps. I'll mentioned, PuriFi to X.X of were over looking in very into here, received the Phil working of mentioned, And pump second our Phil now partner, that the We that able was coming to have expanding also looking reception shortly marketplace. On to Medica. market. that the top we in be to receive As effort market. to, it With order years are will the with forward that, again, completed with and able XX registration first get we and registration good after

Phillip Chan

to have obtaining Vince. number a upon on Well, year, of broad a strategy is turnaround diligently This Great. thanks, we worked that execute dependent objectives. key

made quarter that, for that one, to continue U.S. applications today DrugSorb-ATR and submit our parallel that for Health heard and You've expect MDSAP marketing Canada. this are to in to Canada have we in example, programs guidance critical to like our progress FDA commercialization, excellent to

facility we and Capital a will believe Health us in we sheet Secondly, Avenue our the can Canada both million milestones, balance hit the with FDA regulatory decisions. get capital that debt have and our new $XX from of addition strengthened if to

costs be Third, efficiency cutting drive to we extremely and remain to committed self-sustaining.

margins loss we further to expand approval reducing to excellent if heard are have U.S. expect work that strong markets growth for for grow are to core from Canada are completed of delivered the expected as expected to DrugSorb-ATR operating lot to benefit higher million expand where cost Importantly, gross increase the to we you beyond to And to done we Health sales continue that CytoSorb. And are our made than we able certainly have our and be CytoSorb the in margins cuts. our to lastly, -- and and see drive in devices significantly XX a progress FDA be try Fourth, additional are Europe. most recently we've our gross date. expected

Finally, to the as franchise us of as us company our as intervening from behalf more we have it have growth, for so thank an role and retiring we of replace are CytoSorbents, has the August, appointed and Kathy everyone manage positioning to above today well-deserved her trusted as wish leadership outstanding the two retirement the financings our duty, CytoSorbents orchestrating caption of her and over gone last beyond and the aware, contributions both CFO back newly the at cash Bloch. Kathy is you full-time we final transition, Peter potential with and long call consultant retirement strategy. the Kathy Kathy years key our why Mariani. On international coming achieve in the to with of for conservation her some the and former U.S. future to secure colleague markets. CFO, Canadian to than esteemed will find months, helping and candidate to career company many well call retirement. XX right continue have resumed This helped back XX CFO that, help of dedication existing to so and Kathy? smooth CFO, as selflessly like success at our the a With to CFO today stage I'd friend a been turn relaxing have With that taken open has enjoyable to words. next announced the and an the

Kathleen Bloch

members so you and thank the opportunity and Thank made to my would thank team on CFO extraordinary to colleagues the and have like States. of job I take much, of and DrugSorb-ATR in to in support supported management wish still collaboration, have to talent which I who the thank towards we my tenure company. And finance team accounting your the Phil. everyone, very want our to including commercialization CytoSorbents their for Mariani, you enjoyable. dedication, me like in United of EU, XX-year Directors, this the head the the really as of employees the all exciting I success the especially and of CFO, new best for I'd U.S. upcoming contributions Board the as Pete

you thank so all So much.

Phillip Chan

approach for financial to growth. Corporation, and operational team. is Pete themselves. Hansen that, traded speak a that phase Mariani our strategic disciplined development, to with successes and seasoned management, aligns of such And I'd high-growth has and excellence at Medical companies Kathy. with as next CFO, consistently publicly you, welcome both a Axogen, He many medical domestically and rigorous with rapid internationally, Thank device Pete expected Guidant the and accomplished to like CytoSorbents perfectly demonstrated

its market He as with and today CFO revenue model. to CytoSorbents to many manage growth. XXXX, and ability proven Axogen when shares base, similarities size, his U.S. joined has fund, opportunity business respect impressive to Importantly, including high-margin in scale Pete

an we vital be fit, drive we U.S. Pete DrugSorb-ATR global with deep outstanding is and As pursue CytoSorb, experience his and will approval business to where success. Canadian marketing expected believe OUS to insight and be for our our

hope management of call. the thrilled to key we say coming joined words let here are Pete And you you member out to With Pete? Pete of Pete. be have that, firsthand many introduce and in a a team. to wind this few to the up We me as reach to months, CytoSorbents have we

Peter Mariani

I to warm you, execute well. is of stents, looking me. laser I am to advancements [ cardiac I is Phil. course, excited robotics, time am develop, most with strategy long-term its therapies history. I cataract investors Thanks I've advancements as in medical in be you the physical to all repair. CytoSorbents further It hospitals. years, welcome, [indiscernible] look the natural appreciate forward and of in privilege again, CytoSorbents join improved with growth blood in of some of And great many part purification extension nerve of had the therapy significant you course, creating meeting medical and, Board ], scale the Thank cardiac bring as including management, to pivotal of rhythm a forward today to be future. of partner and appreciate the this this over great for and trust our technology in Phil. of I to near at the opportunity the

Phillip Chan

concludes Q&A open Thanks our up very call for That Pete. the session. prepared remarks. the Operator, much, please

until be in remind participating you, Pete officially not not has Operator? tomorrow, started the Just as will let he me session. Q&A

Operator

question And Jefferies. first Sarcone your of from Michael line Instructions] comes with [Operator the

Michael Sarcone

looking congrats to a to has Pete, you. both great Just retirement, working start, again. working Kathy Pete. with Kathy forward with great it have and you been you and to hope I

all right. -- So

Maybe submission So guess, either I the with Canada you for feeling DrugSorb. FDA particularly you're us us you've more Health you recently? can track on give just on Can an FDA any conversations the update on with an the about had for, one Makis, for update how approval? give guess the first or I you're regulators, and Phil

Phillip Chan

Michael. take Makis, like to would you very much, Thanks that?

Efthymios Deliargyris

Michael, question. thanks, the And Sure. for

webinars And that risk the necessary necessary discussed does stated previously, as the the associated we have before, we a that helped device. the think with I STAR-T to own those operation highlighted during information intend have data target corporate specifically, we be As execute to also calls to to patients trial to analysis. discussed the and able feel that use provide intended in benefit us we as identify previous the pivotal is population. And our the and identified be have has coronary more benefit they STAR-T potential artery bypass we undergoing of

that in as can believe can we a So regard, standalone, a support [indiscernible] benefit/risk that this robust analysis. --

that In supplement shared the in our systematically addition, you as said I've agency. as an now the ] evidence the realworld on review accumulating in is the today [ you the STAR the over be submit the registry, captured it have any call, the and with to will that, important an high-quality Registry the some -- permutations such comments believe for from time agency. Having application, wait we

call. had additional our with the agency not any have last We discussions since

the benefit So and no them allow update with a believe and for we analysis. do productive provide agency on front. that interaction there's necessary to that collaborative to But the to will proceed necessary the information very risk application with the

Michael Sarcone

Got it.

So then maybe one or two Kathy. for

are XX%. then of term, XX% gross you just how the gets part Just margins 'XX? more that you second about the the sales margins. release what there? to about kind half gross on The of second Can And of sight today talk you press thinking line near of of in might the get what mentioned level and us the in is to

Phillip Chan

Yes.

ahead, go Kathy, please. Michael think, actually, -- I okay,

Kathleen Bloch

Yes.

that approaching to and up growth, to gross volume grow margins, is to product at of our obviously, XX% should amount should they increase volume XX% any or going very is rapidly. see XX%. we growth year-over-year XX% at Michael, -- I So going expect

So it straightforward. should be relatively

exceptional the get then the gross higher. will even U.S., rates we would And our once overall in see we margins. like in approval course, be Of margins growth

Phillip Chan

on one you gross to Michael, as manufacturing processes confidence have Maybe, our on Vince XX% helping President basis? a Operating little that to Officer. Capponi, drive blended and commentary that give people wanted Chief of how our and responsible for Vince, to can our our we get the a improved margins higher

Vincent Capponi

Phil. Thanks,

and did volumes to the some filling we in the lot that in labor help the improvements offset reduced a almost the by had. actually part lower So year operation. we've the processes operation, of last requirement XX% We've of of the

So continue the margins. making said, with to we're the improvements well. improving But really see as expect volume here, Kathy to as that that going it's dependent we're we continually upon

I inventories. the part our controlling to our as the the think mind We're in that go of keep by we actually production cost, doing down lowering through approval. conserve we that we that need is so the other we're slowing thing cash FDA as can

higher, based than and than versus margin XX-plus will CytoSorb to the certainly sight margins of So mix will, plus XX% contribute also you to direct. the current that. And The approval, the point, sales. we Kathy's lower it's direct rate, if to on gross XX% are get direct sales to distributor which certainly growth line to have we the higher for percent that much when with ASPs an obviously, DrugSorb-ATR

there's hopefully be we're slowly cost number us a And the that to soon. Kathy volume, to of we're continuing going in we do again, to here it's have Again, going very are XX% process upon But doing get in a improve mentioned, improvements what is operation. that that. lot -- to So factors of dependent we back implementing but as the

Operator

of And your question the Zhi next comes from Yuan with line Riley. B.

Yuan Zhi

on Congrats can versus price what join Maybe change any CytoSorbents. the Pete, will to factors good do you volume Phil, with see a start here congrats for board, at exciting quarter. time on retirement, provide on welcome you and you Kathy, the XQ, in in And be the trends color revenue quarter? on pushed to similar comment more second helpful? grow the you,

Phillip Chan

Yes.

in saw the second distributor think and was quarter, strength what channel. I partner we in that the

PuriFi have don't our bit of the purification is of launch blood I think you to countries the told with infrastructure dialysis PuriFi well-established we capabilities pump infrastructures. a that it an establish they coincided help little where And pump. in as intended previously,

found typically in distributor and the in -- for for and and not France Germany necessarily our is and so territories Spain, are this that U.K. And Europe, Western Italy example. as with example,

our that be respectable in particular third seasonal good. us that think that shrink for Europe, which holidays of I So And will quarter, typically channel because quarter. is was is a hope quarter a in our

Yuan Zhi

the on comments price versus volume Any the year-over-year? change

Phillip Chan

that As are distributors the lower on ASPs those force both we prices quarter. having than QX stronger from lower Vince pricing costs been direct direct our said, -- sales see for of direct sales across well. this the the transfer pricing But has is for board, But transfer fairly because what to as cost sale sales. we distributor well stable incur ourselves. That mentioned, the benefit a of pricing was as in results our as being typically distributor to in from other don't the you'll channel hand,

Yuan Zhi

question it. is sales Got CytoSorbents delivery infrastructure. or following in Can territories the that? provide will the XQ, contributed how of itself color the you the PuriFi more helping to revenue without pump the on growth either of And

Phillip Chan

rolling blood PuriFi can to This disposable goal printers relatively have the this CytoSorb pump, parts for low revenues And at the very of provided our capabilities devices. on the of of I establish think, is is cartridge. looking that we PuriFi world. is in keep money mind much out the to the the model, This a printer pump Yes. necessarily printer the different of cost the there thing printer where very make the we're they though, so model similar of -- pump. Again, to pump to PuriFi PuriFi in our right? infrastructure not is different cartridge to approach more driving the with that use purification

company moving CytoSorb so to is makes than a I hardware, that trying forward, really rather to volume the goal drive from think if sales drive sense. typical hardware And

Operator

comes Kerr from Zacks And of Research. the Tom your with Small-Cap question next line

Thomas Kerr

questions, Canadian and response I originally, Kathy, so the your all Can to detailed quick to and thought was appreciate you -- clarify going to I'm submission I on it unclear because for explanations be it. Congratulations jointly. thanks

to it's happen Now submission. going after FDA the

So it's authorities? clarify slides fourth can to expected be front event. in don't I Canadian a I'm but have quarter the sorry, when to is submitted of me, that you the

Phillip Chan

Yes.

that post you with submissions we course, prioritization, the what heard that to FDA is application. us of think I the expect say quarter the for in those of third U.S. today

will certainly achieve to to FDA track on prioritizing remain that, we submission be the we that first. think I try but So

Thomas Kerr

Okay.

roll possible that's it's fourth but So quarter, Canadian correct? the not goal, your in submission the could

Phillip Chan

that not I That's quarter we're And the submission Yes. guidance of both. third our for reiterating goal. think

Thomas Kerr

right. All Okay.

Or misunderstood of against else STAR-T down trials million. $X.X just year Is ago? comparison I The financial R&D a there Couple is there? questions. Sorry, the in to anything the that. that

Phillip Chan

a of Kathy, mute, number -- on go ahead. Kathy. go be ahead, There you may please

Kathleen Bloch

STAR-T Thanks, completion. Phil. the largest from impact trial The coming is

activities not incurring of costs strong patient also the there's with -- of personnel we're associated exclusively the grant-related where through have been our a efforts the So are R&D that trial. funded also There focus costs hospital grant. are those costs been those on and

coming been have non-grant cut is impact is prioritizing we any making costs, completed. the focus that So of R&D to so team highest the in down sure contributing. But both try trial STAR-T to from that the the those that, of are being

Thomas Kerr

The comparisons, right.

the So $X.X quarter? number is second per good of that a use half to for million the year,

Kathleen Bloch

Yes.

Thomas Kerr

what you the big thing about Okay. talk One be? last market? that The the interesting. that be and could big-picture business next a question could Phil it anybody. Or of it size Germany? of enough for Is that or Can seems Taiwan

Phillip Chan

Yes.

believer mean, remains blood a press very I think from is, seen. market to it a as be the purification. have in Taiwan large you and read big I may release,

So a from exciting. in Taiwanese And in the very registration. were and approval opportunity distributor standpoint, in We're getting working fact, an through they, Taiwan currently. it's helpful

we're for drive sales. where see working tell just a to will to one And will develop. this time it's have are CytoSorb So but we we Taiwan, countries of lot of -- how hopes many

Thomas Kerr

Got it. from Last financial me. question

at receive did million quarter? the right? the loan, a $XX of the event end subsequent wasn't You It

Phillip Chan

financing of the day the at last the quarter. closed We

it a QX event the So on was financing...

Thomas Kerr

[indiscernible]... the finance On

Phillip Chan

that's quarter, correct. yes, In second the

Operator

H.C. your line [Operator of next the Sean question from Wainwright. Lee with comes Instructions] And

Xun Lee

Congrats happy were Kathy doing answered, hope questions -- and the a wish And with but of Most the -- have you. look just key been I wondering, mentioning you to retirement. mostly to welcome, I'm my Pete. working R&D on grant. you forward

in that I to? on the that's still on had there terms major know forward ones? I Pentagon or So grant was supported that are of the worked what are I whether was other we HemoDefend projects products look wondering projects are with can wondering [ on you ]. previously and working going whether you

Phillip Chan

and civilian that in either R&D form HemoDefend-BGA being military, programs -- the making are that of focused program. that -- that now for preclinical on HemoDefend-BGA Yes, And programs Sean. we're really R&D progress are right or the Thanks, funded industrial in I Sure. factors different programs usage. excellent use think but

to continue testing. We seek we're additional getting human for funding that And program. to opportunities I very close, believe,

comment you program? the HemoDefend would Vince, So to about like

Vincent Capponi

Thanks. Phil. Sure,

quite the mentioned. be couple we just HemoDefend-BGA, we're would markets, accessible civilian. the So to focused a form of ultimately, of really will as hear what the on different most Sean, then Phil be that on factors We've to bit and think We're a get the which to made progress military you. from

now. -- there's are programs funding right that programs those two are So key that

military the the point area where into other grants there collection, of people now further different scaling ultimately are are the commercialization. But the to a We two freeze-dried, aggressively related we're Phil feed in also by right number very that commercialization and you of with the some we but preparation have couple factors of forward a would into then application can trial working through of we're that a of and to that are in market, really will plasma at that as what a funding extend funding which, way, think for mentioned, will, as well, value. be form potentially provide couple we closely if form factors, pushing and clinical key

Operator

turn questions for And the Phillip would this Instructions] Chan call I any or like to Dr. additional [Operator to back no with closing time, further at over remarks.

Phillip Chan

today. you, thank everyone, joining for call Well, the

to to please your everyone, transition, at directly do Have free you able very be a and feel have while other to evening, night. possible. pchan@cytosorbents.com hopefully where out to questions reply you we questions, me and thank manage great reach this any I'll Good If much.

Operator

ladies And for may and that concludes your now today. our thank We participation, gentlemen, disconnect. you and you for conference

Cytosorbents (CTSO) 13 Aug 242024 Q2 Earnings call transcript