- Earnings call transcript Q3 2022

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Operator

Greetings, and welcome to the Protalix BioTherapeutics Third Quarter 2022 Financial and Business Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce to your host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protalix. Sir, you may begin your conference.

Chuck Padala

welcome and Protalix Business and XXXX Third operator, Results Financial Update you, to BioTherapeutics the Quarter Thank Conference Call. are Rubin, and today Protalix; me Dror and President With CEO and Eyal Financial Senior Chief President Vice Officer. Bashan, of and A update this on Protalix was available the website. press is the and issued announcing the release results morning Please in release. the moment read disclaimer the to a press take about statements forward-looking and release earnings this forward-looking The teleconference statements. include results are statements that to known differ risks statements unknown the uncertainties actual subject and may and made. cause These to from materially forward-looking Factors described that U.S. on filings differ could cause actual the results the in to are with and the disclaimer Protalix Securities and Exchange Commission. I will Mr. to the now call over turn Bashan. Dror Dror?

Dror Bashan

you, the coming months. results of our a Thank quarter review the everyone, update quarter, third plans progress for begin our XXXX and accomplishments and along with and our financial with over Chuck, call. welcome, to business I will

III for to the final in The X years the or for clinical Phase report. open-label of Fabry studies, I'll we'll milestone with and to II BALANCE include, results, Phase BRIGHT the Following trial Phase last I, together the our line will application our BLA III Rare my remarks, week treatment Chiesi Disease, FDA the in with commercialization license report Eyal development questions. Global financial with BLA resubmission a more the data of of adults U.S. the are resubmitted partner, the then proposed we, contained pleased open achieved, review we PRX-XXX biologic begin study disease. package addition detailed a and final that our provide and for to recently significant analysis

to the of hard to Agency, European Achieving of a EMA reviewing PRX the extension the our X of testament we its ongoing. this the the their long-term will We the earlier we treatment months teams our to that our this patients EMA, and Chiesi resubmission FDA addition, [receipt]. data our dedication have Medicine work Chiesi BLA With the milestone complete with Fabry is is and and currently review In are EMA application, for to dialogue program. and delivering disease, with new anticipate studies. grateful the submitted to is these potential to open-label year, provided respect Protalix from within commitment MMA

into As we is of potential approach and towards with PRX-XXX remain approval patients to of EMEA time disease, disease. we the that believe for potential treatment the of treatment collaboration year-end, need. to to in Fabry for closer this the Protalix successfully are exciting entering moving much has as an and families patients committed significant PRX-XXX with we We by affected adult needed to and patients FDA continue work Fabry our goal a bringing

programs protein develop continuing development treatment to additional we earlier-stage to expression Turning over pipeline, of are prosthetics. through our gout. proprietary PRX-XXX system uricase is for severe in an our expressed PEGylated

package. XXXX. this toxicology on We of for we initiate study in first-in-human clinical I the the Phase are to support finalizing are study, first of quarter first-in-human a track And PRX-XXX our

to to continue progress designated, human protein half-life a DNSX elongate on PEGylated make designed diseases. for we addition, circulation PRX-XXX, In NET-related of in treatment DNS recombinant

these demonstrate forward of we updates as PRX-XXX, preclinical providing progress. to other feasibility to conducted have and on programs We studies look and we X

of to to develop our quarter will potential to continuing sufficient Eyal in addition through the us now with sheet Finally, approval our cash early-stage XXXX, pipeline company to support enough Eyal, provides the go ahead. review to financials. turn runway programs. balance the our fourth I to

Eyal Rubin

you, call. Thank you, joining for Dror, everyone, today's and thank

was million $X.X XX% million of revenues XX, $X.X ended months or months selling the Revenues XXXX, R&D increase increase or sold of Cost for XXXX, $X.X revenues we from XXXX for goods. goods the in XXXX, are The quarter decrease of XX% to R&D X sales or increase Brazil increase in recorded months comprised to ended goods services from financials. for cost timing to resulting differences. and Let of September Revenue September of resulting for connection X goods the the million The of Chiesi an license primarily goods increase XX, in in million from difference $X.X revenue primarily partially X X license million sold XXXX, a XXXX. agreement. million for was sales Pfizer million from me of a timing revenue please months review an of million recognized from ended of $X.X to the $X.X Chiesi sales during of XX, services of of the ended ended million, September cost September our sales XX% and an of X the result million the were an September the and of the compared XX, million million September of sold by increase X was decrease XX, XX, from $X.X months third $X.X $X.X $X.X to of in $X.X company months $X.X offset XXXX. with compared ended

in were related million approximately months related on approximately of million XX, research the ended expenses, approximately XXXX, million For $X.X expenses, expenses. other $X.X $X.X million of expenses material X our of and September approximately million, subcontractor-related expenses $X.X and approximately total salary and development comprised $X.X

$X expenses ended months XXXX. to expenses. million months compared Total X $X.X approximately September in period. and months million salary-related XX, due ended and million million compared net decrease in million interest lower XXXX. for XX, months debt months XX, notes ended for costs an outstanding approximately research to Israeli $X.X was of expenses bank X of notes XXXX, approximately to of September for million shekel XXXX. and X were XX, expenses, short-term the and our $X.X administrative financial $X.X the million the of million subcontractor were cash a XX, X For and compared $X.X the equivalents XXXX, approximately amortization aggregate The was of related and of a of development in was months September and related to for for expenses September new in our of of aggregate decrease the an September research $XX.X approximately expenses $X.X the exchange other ended and primarily months the costs. or X notes expenses, million the XXXX. Financial expenses X% X related decrease or decrease million approximately were decrease expenses the general from Selling, million deposits U.S. to dollars XX, from million $X.X million an ended to of XX, XXXX, ended $X.X rate primarily X% million $X.X total September XXXX, material comprised XXXX net $X.X ended $XX.XX amount salary X selling for amount September principal were increase in principal September decrease of $XX.XX The at development XXXX result and Cash, over XX, due

with call our XXXX. sufficient As runway current Dror mentioned, I the first believe back quarter cash -- the we turn will through of financial a the position provides now you, fourth quarter to that Dror. us

Operator

open now for Sir, we should questions. floor the you. Thank

Eyal Rubin

please. Yes,

Operator

have Wainwright. from Boobalan Instructions] [Operator a question first the of line Pachaiyappan We with H.C.

Boobalan Pachaiyappan

okay? Can you me hear

Dror Bashan

Yes.

Boobalan Pachaiyappan

A of couple This for Protalix the questions on submission. shareholders. great BLA news is us. Congrats from Great.

what Chiesi know are able details be firstly, agreement full and within curious So share to of investors you'll respect to the some at PRX-XXX? point the to Protalix with

Dror Bashan

would like Eyal, to that? refer to

Eyal Rubin

Yes.

way. the agreement public and agreement we not make will between is it the parties, obviously agreement for the the Given stay and legal this reasons, will reducted

they hit the it's to relevant reports whether as as regulatory PRs. they the milestones, royalty, or soon of disclosed the part going it's required, going if or the to be will commercial, relevant As financial obviously, required be

Boobalan Pachaiyappan

preclinical All Understood. With level, clear. about if you human Okay, of maybe could PRX-XXX, any you response? are or was efficacy on respect seeing? to seeing what And so are kind you talk undesired right. also, I ADAs wondering a

Dror Bashan

will following continue, does the that we at So in that since not that data body, we the course. comfortable And uricase think that with it's say the human better -- I of exist to have I we present, feel will be are course. with beings, of upon say we substantial discuss to to have will human the Phase studies. once will just from more of results preclinical which things far speak final not we This by and I study

the the before So support us and the -- better. finalize comfort study of data we human hopefully be continue, far and This as course. get will plan. that we I gives hopes But to to from put beings we that have want participate to will results don't

Boobalan Pachaiyappan

within PRX-XXX Okay. speaking -- Understood. And PRX-XXX competitive landscape. maybe then about

expected is they As first know the called a also KRYSTEXXA, in Selecta Phase and readout III drug, probably Horizon there's has company XXXX. cover quarter we that and a and currently are Biosciences you in

differentiated SEL-XXX? So I'm program PRX-XXX just your and gout curious is KRYSTEXXA how from

Dror Bashan

immunogenicity. it clinical on it only. will say be I than on we -- and/or infusion and explain more, where before will that early-stage the I/II the a has not much to to through results, differentiate see of be we from because be And through far -- to is base secret and develop once preclinical the easier will I on data. either identical big the see drug, think or to differentiation. to intent we based prefer because So we which X, any And intent a Phase it's data it's not even Clearly, is it more by frequency the science

Operator

from [Operator Instructions] with question next have the Zacks. line We John Vandermosten of

John Vandermosten

had start I liberal maybe might bit there. pharmaceutical Brazil. a And changed question the if that differences with products? I'm recently off to an change, on wondering due a They you government which demand expect for any wanted to election, little more

Dror Bashan

a be Sanofi see. in years compared prices, at don't think, -- others. couple good of -- I foresee fine. will course, don't are drug we right don't I Brazil in now, for competitive changes foresee with I I But we to will sell present. don't major And And -- we this we any of already. there exists and think

John Vandermosten

in good. Very And last then penetrate end the not? of any call do -- market we they the think know at the European I XX. Okay. or discussed you able also had the drug? they had Pfizer's August all for sales think Were Europe VPRIV. that on with about previous that I And to sales, exclusivity if was -- on

Dror Bashan

launched of First, to I'm question Europe it's that in have as but yet. a they not Pfizer, aware

John Vandermosten

Okay.

was we and and -- guess then -- already environment see there, XXX ask and let's I And addressed just the I we've to competitive I got going Okay. that. about think

since X. kind fitting by it's in How that it's are billion do into $X dominated being any -- it available? there portion think market. market the about are in there's that particular? of like the already there yourself of products looks about current see I pursuing Is mean, I of there, you products you're set

Dror Bashan

by of for marketing, good efficacy hope regimens, do in But fair the for I for good, that even patients the I the data, safety, X And and drug on say, we the the believe the of clearly a market. themselves course. for of I immunogenicity, are that may all alternative Chiesi So and if will care good the day, very it Chiesi patients preparing have, is a I the well, job I aspects. first, of and they think, the these mean. And is patient, a taking responsible light -- it a will the think potential end do we we

John Vandermosten

And then -- the and on Chiesi

Dror Bashan

good safety, the very And alternative, course, of course. robustness the the data, combination efficacy potential program. of the of the the of potentially, X is Good regimens Combination. a immunogenicity,

John Vandermosten

guess Phase next Phase right? I I about And out an somewhere around keep would data guess year. Does come on to that expect just midyear that Yes. we XXX, out sound that data. I Great. from we'll that eye I for

Dror Bashan

it's something the year results. the XX -- the after. final it's mean, of about beginning speak of next assume QX about I months believe study. I year, like initiation of I the end from

John Vandermosten

kind of to to Okay. sense top just that, a some prior Maybe of we line have get like --

Dror Bashan

way. would We along see the

John Vandermosten

wondering where there me on right? think kind I last side Boston, of Okay. other of in Have terms of any sure know And activities. are development, just that some that are they started where and disease I'm then I rare And things? commercialization in but of they they it's in are in I some the are How products they that yet? quite looking for -- rare of Chiesi's the I products here, on just marketing X are guess that disease terms up. still ramping products, wasn't subsidiary

Dror Bashan

Actually, have They own they couple established secret. already I a get they to U.S., are a no, bought supposed ago. they market. division couple assets, today, their have there so to in year, we Europe So drugs approval couple not go. Chiesi, rare also but years are right of a rare of of they the disease disease since for believe site, It's And course. think, of on have, in the I now, the were last -- ready a

full we and themselves actually ready have for launch, So preparing teams hopefully.

John Vandermosten

right. news EMA and good the to Okay. BLA back term. Well, the in congratulations submission near All hearing on the look forward FDA and from

Dror Bashan

Thank you.

Looking forward that. to

Operator

now [Operator questions back there further the Instructions] CEO would participants, remarks. and turn I like Dror to As call are over from no Bashan sir. the to you, Over to for closing President

Dror Bashan

Thank you.

So thanks, next forward looking time. for and you. speak joining you everybody, again, our call, Thank with to

Operator

This you. conference. today's concludes Thank

may this participation. at for You your lines time. disconnect your you Thank

Protalix BioTherapeutics (PLX) 14 Nov 222022 Q3 Earnings call transcript