Earnings call transcript Q1 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2023 Financial Business Results Conference Call.

As a reminder, this conference is being recorded.

I will now turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protalix.

You may now begin.

Charles Padala

Tina. you, Thank the and to First XXXX Quarter Welcome, Update Protalix Conference Results Business Call. Financial everyone, BioTherapeutics With me Chief today Protalix; are Dror Bashan, President Rubin, Vice and and Senior President Officer. and Financial Eyal CEO of

morning forward-looking to These a actual earnings and to actual announcing in made. Commission. release subject filing are statements. the statements that differ forward-looking include uncertainties the the the Protalix's could and issued differ available that results with A statements Exchange release read teleconference risks and Please the are described U.S. forward-looking press unknown now and take the known is website. disclaimer statements and in The and to from may cause results update cause to Factors this the press and was results materially Securities release. this moment Protalix about on disclaimer

I will Bashan. Dror now Dror? turn Mr. the to over call

Dror Bashan

to Update by Financial welcome, XXXX our and Quarter Chuck, recent our reviewing I you, Call. progress and everyone, Thank First accomplishments. Business will and Results begin

Following Eyal Rubin results. detailed financial our remarks, a provide of review more will my

We for questions. will open then the line

Diseases, As which waiting we this together Rare we, our on and couple updated commercialization in Global Chiesi EC morning, development decision, the announced should partner, days. be with next earlier are of

the to quickly approaching States. potential are addition EU, In also United we approval in the

we an May when next Our with XXXX, and from X, signed update look is we to PDUFA week, action you target forward providing the date hear FDA.

Protalix this Chiesi has to that are team stage. well with partnership brought grateful as We for as the our us

alternative are for market in option are significant of and deliver. PRX-XXX. together a Chiesi, prepared represents to well-equipped Chiesi launch. an to commercial potential Fabry that we, treatment need that opportunity They activities full confident disease up are We approved, in of multibillion-dollar the is if have with is a prepared ramped and potential realize

our Now turning pipeline. to

trial human for in Phase pharmacodynamics in uric study novel severe in the double-blind for XXXX, is first We dosed elevated immunogenicity earlier our with stage evaluate safety, PRX-XXX March first XX programs. up of uricase are continuing PEGylated our pharmacokinetics, placebo-controlled gout. to In of levels. clinical I make development a the the patients treatment was progress in is patient to in PRX-XXX And PRX-XXX a single-ascending the dose and designed trial in to acid patients. of

Zealand. enrollment study dosing New continued And patients look of to We have X to been dosed The -- have being conducted in and this patients. is date, been already trial. in forward

We of DNase elongate also continued circulation DNase to for PEGylated in to progress I human on PRX-XXX, protein recombinant half-life designed treatment a NETs-related diseases.

conducted have of these build our to look We preclinical as on programs growing We studies others updates forward we the look and feasibility to providing to demonstrate pipeline. PRX-XXX.

March year, in that was was You XXXX, Aviv On Tel our was Aviv that our XXXX, best our Exchange, delisted in from Tel the this March XX and the Stock trading last Stock stock day delist Exchange last XXXX. on to Tel may recall of XX, common common the decision our we it voluntarily announced Stock stock Exchange. from company's interest December, Aviv

to quarter our develop Finally, continuing our pipeline the third potential sufficient of balance earlier-stage through with programs. supporting to to in sheet runway company provides addition approvals us the XXXX,

our you. Eyal Eyal to I course. -- a turn Eyal, turn will I for now to thank financials. I of now -- of will will yes, please? now review

Eyal Rubin

today. the just of clear, make to runway you, quarter obviously, everybody, for until joining cash the it thank Dror. third call Thank And you, Well, XXXX. is

financials. first quarter our review XXXX me Let

sales to a ended million X of or revenue for a goods $X.X recorded million to from a and of XX% to million resulting months in of timing We million X both Brazil decrease ended decrease XXXX, months the decrease $X revenues of March from the Pfizer, March during sales in million primarily $X.X from resulted XX, XXXX. selling of XX, The differences. $X.X decrease $X.X compared

license and $X.X million revenues the the Chiesi XXXX. a to revenues of X in from of connection services XX% $X.X recorded months and compared or We the primarily we March XXXX, million R&D of million of ended services revenue from XX, decrease for $X.X with R&D March X XX, are comprised for recognized license months the agreement. ended Revenues

primarily cost of was million of goods months ended of million decrease a March $X.X for XXXX, of $X decrease XXXX. X result the in XX, sold XX% XX, or goods cost of million sales in sold March the goods decrease of $X.X was ended sold the months Cost X for goods. from The of

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

were approximately subcontracted related $X.X $X.X million million X.X the million XX, expenses, approximately of and comprised and research of $X.X ended For material total X and rated of approximately months million expenses million XXXX, March expenses $X of development salary approximately expenses. related our expenses, approximately other

XXXX. was decrease compared or the the The process XX, completion and BLA the described XX% expenses Dror regulatory of March and the months a related X from research the for $X decrease and submission Fabry both program resulted the our ended substantial portion PRX-XXX in in XXXX, clinical year for and development MMA million March earlier. to to of as ended research Total development XX, primarily expenses

for and to professional million ended related March million million was expenses approximately administrative X% and salary in by months $X.X decrease A the increase $X.X March a an were offset million fees. general million partially or Selling, XXXX. decrease expenses of $X.X months XX, for $X.X X XXXX, XX, X $X.X the of ended compared of in

ended income cash approximately the net million. XX, approximately months equivalents XXXX. compared Financial months XXXX, of for expenses $X.X March X Cash XXXX. expenses at million we financial $X.X XX, and $XX In the XX, March X recorded months ended were million million March the for $X.X ended net to were of XXXX, XX, X March taxes

$X.XX million net or or diluted share and was basic per Net ended loss loss the diluted months $X.XX XX, share million a and $X.X per for same X $X.X March of for period XXXX. to the basic approximately compared in XXXX,

back you, turn will Dror. the I to call now

Dror Bashan

you Clearly, very and much, for time us. on So thanks, anticipation everybody, sure thank an Eyal, I'm the under joining approvals. us for exciting is everybody upcoming call. today's for it's

we forward. priorities providing forward event discuss to an have in late looking you, with addition, update investor EU We both on we are the them, the FDA. hosting once and planning June course, the from are of to going Protalix's strategic And

to open line the questions. and turn will back the for I operator Now

Operator

Instructions]. [Operator

question John The Zacks. first Vandermosten comes from of

John Vandermosten

and Eyal, doing? Dror, how guys are you

Dror Bashan

John. We Thank doing are you, fine.

John Vandermosten

That's good to hear.

so you that to for to Next week bit understand to definitely is looking forward of a time we're would better. big on here over But kind all PRX-XXX, little be going a I thought a that. just week guys, spend I little

Are New you're from incentives that it early-stage developers guess a Australian place you're benefits the running there. I running in the government do there? Zealand that New to getting many because I provide favorable trial there the trials mentioned know any Zealand, you've that and just times. as that's pretty

Dror Bashan

What question. John, understand can the exactly? you repeat? the is don't I question

John Vandermosten

Sure.

credits that that Australia, down supportive So there. there? run Oceania New and are for in like very that there something Zealand from you're frequently noted trials terms PRX-XXX to in and things in Is I benefits environment of the benefiting area, that and down tax

Dror Bashan

Eyal?

Eyal Rubin

We Yes, the tax the are we there. in credit. benefit that's running but that's to correct, not order reason apply trial didn't a from

was I. and New on-site, to for a site good that open for an would their Zealand expertise sites saw the in pick such We and too You on-the-ground burden. in the it's capabilities site the are reason there obviously Phase -- the big picked running they reasons are least that need we that And The have they enrollment the Australia. and of at CRO that CRO. and are we

John Vandermosten

is this secondary some I in you for where the the Phase looking points in pivotal stages, at efficacy? of if you're But I then of at that end the obviously, And primary that be successful Great. endpoints is safety. And look terms we're see if early a wanted might what efficacy. these goal share some might Okay. to could the also, of trial

Dror Bashan

I would frequency what extent to patients. to the which in planned, is thing, the And safety, course, signs to addition So reduce of like John XX to of we see maybe as acid, see up like or to we we immunogenicity. first of mentioned, uric would We hints dosing.

-- we this to be very at So the has -- beginning. are but

right there's and we to will it show nothing off, off now. never show So

properly we So how including the reports, we once to understand plan it -- to have conduct analyze the we the Phase II. and PK/PD final to better -- hopefully,

John Vandermosten

you if players in is goes the that how just up And now good. wondering of have I'm one -- Sounds KRYSTEXXA. gout a the against guy. major PRX-XXX And right comparison of

Dror Bashan

No.

before results we see say to have can anything. will We

John Vandermosten

of or perhaps in in I was it Well, Okay. kind but work address. terms may the action terms unmet mechanism thinking MOA. need how of that ultimate of just efficacy, Not might XXX the of

Dror Bashan

differentiation aspect. the a at By least important improved the have on in end and hope one least in at we to an of day, profile in

a We combination. the will be immunogenicity have to see will frequency of dosing, if it or

John Vandermosten

Great.

But obviously, know And investors me, to there's we you're the are a with should going that. to are in for you That's and what a Chiesi over next terms go to we're expect that call see? what week steps thing mentioned commercialization just week. should of I Okay. steps next I next And last and expect is things that back? like in helpful. the -- from positive huge have ready, things assuming see, getting another month news guess, we you and to priorities getting

Dror Bashan

will from and sequence get or immediately the we once, approval of This course, the see hopefully, market now, right So the FDA. clearly with is course, following we EU update anticipate. we that of the the

course. Chiesi launch the and So not explain. I'm of update, the will, anything course, we now. then we'll Once familiar plan product, update else And of right with of

Operator

call [Operator no at this the for further Instructions]. time. show questions I'll back any turn to over our remarks. speakers closing We

Dror Bashan

everybody, very, to to much. are forward, have of very All looking course, very Thank soon. you I you, time. for And you this we thank say, update

Operator

This call disconnect you. We does the for you good please today. your day. Thank your Thank for thank ask conference and that you Have you. participation a lines. conclude

Protalix BioTherapeutics (PLX) 4 May 232023 Q1 Earnings call transcript