PLX - Earnings call 3 2023 | Protalix BioTherapeutics, Inc.

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Operator

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

As a reminder, this conference call 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 begin your conference.

Charles 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

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

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

Dror Bashan

Financial Third and Chuck, you, Thank XXXX welcome, Business to our Update Call. Quarter Results everyone, and

we moment place here is ones, to to being friends at many events acknowledge take recent the that challenging taking It extremely loved begin, we and in for time, heartbroken the a have Protalix victims, devastating weeks. impacted. situation Israel. We been in like an the I are and personally Before horrified are by would families, us of

the well-being go all and -- we these to prayers dedicated those to and out and hearts our safety team. Our remain of affected,

need We this are any time. and colleagues and all committing provide at support they friends to our families,

and of Elelyso. reached today. and all products, us do currently support, our been facilities, operate to who continuing concern no we anticipate to as have Protalix any We reassure There At supply you not the have appreciate express you thank joining interruption and we that their to the for to want out our same disruptions and to to those are time, usual. we we Elfabrio

accomplishments. our progress review recent now will and I

provide for will financial of Eyal of line Following a then, my more we results. questions. our remarks, And the review course, open detailed will

now and EMA approval launch accomplishments European on turn quarter. the has Let commercial Since focused to this commercial me Union. our and States for United our Chiesi, partner, in Elfabrio, receiving both FDA

also like has outside Great Switzerland. approvals And Britain pleased additional Elfabrio. look We continued of been granted that the are global Elfabrio in regulatory we forward to EU, growth and

pipeline the of and approval secured high to Elelyso, our drug focusing address potential therapeutic options. the patients now Elfabrio limited needs now unmet Having our we with products, assets X attention to are with develop for

is Our PRX-XXX most for development severe treatment candidate potential the gout. of advanced

sponsoring currently single-ascending are a We a been today clinical to pharmacodynamics XX Phase trial immunogenicity. is and of placebo-controlled evaluate trial. first-in-human this in trial of participants safety, pharmacokinetics, to dose dosed up It first-in-human participants. XX I PRX-XXX have its double-blind

this results We target to from to announce candidate expect is good line We mid-XXXX. study this in believe a PRX-XXX top potentially market.

of NETs for a trap and Our in in been and web-like or inflammatory potential microorganisms. ineffective by variety effects can is a candidate pathological autoimmune, NETs, result that conditions. of Excessive NETs-related clearance has diseases. of activated neutrophils next pipeline released and treatment PRX-XXX various structure fibrotic kill formation different the observed

programs several updates are they you programs, There forward with update providing other will applicable. progress. on once regarding these look programs we We these to currently and as preclinical

Directors, retired Eliot who Zeev Forster as corporate succeeding Board Bronfeld, from of our the On side, Dr. of his Board. position on Mr. Chairman our we welcome

Director, Independent an Dr. As

Union the States, and committee. the of field leadership for was also Asia. itself, success reputation he life in Eliot's United in appointed management to and Forster and in record our has European science speaks nominating a the

his expertise to dedication the ago, forward and of working Protalix of and enter founding we company. exciting many many, to grateful We are we as for leveraging leadership this the this look and his development years Zeev with phase since for Eliot

provides over note our need that call I the sheet runway for strong balance infusion. sufficient to to without current turning near-term cash want with to capital way us the maintain Before operations Eyal, -- cash

it over our to call With my is to please? to pleasure turn Eyal, now financials. that, the review Eyal

Eyal Rubin

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

September Dror and X September of me resulted We to of sales third XXXX. partially our from an in in during $X.X review $X.X of million XX% The quarter increase following XX, to compared million by sales for X by Let revenues from goods EMA, months in increase offset Elfabrio; revenues Pfizer. million $X.X sales financials. the million as mentioned, of and $X.X months XXXX selling primarily increase of recorded ended Brazil, or $XX.X a Chiesi the XXXX, ended of million the FDA $X an million approval the decrease to the to XX,

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

the of open-label was Chiesi, administrating transferred of now XXXX, Chiesi and X, extension studies. March all to studies extension is As sponsorship

million Pfizer, X The result for $X.X Cost and $X.X to decrease goods of of a million Brazil. XX, XX% Chiesi ended in ended by increase was of million cost of September months XXXX. months the decrease goods the X sold sales to cost to sales September in or $X.X of from of the of goods sold Elelyso Elfabrio XX, partially sold for primarily in offset decrease was XXXX,

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

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

primarily in development completion research in and research BLA decrease to million ended the of related or Elfabrio Total the regulatory agencies. by review The MAA program our applicable and the the XX, XX% were development to process $X.X compared clinical and Fabry from and the resulted decrease of regulatory XXXX. the X expenses months September expenses

Selling, related due The share-based or $X.X ended from months for general cash XX, to increase and X of $X.X compensation. XXXX, administrative an expenses million million million compared were bonus $X.X increase resulted onetime XX, in the an $X.X of to September the expenses salary and million an primarily September ended XXXX. increase and X in for approximately months increase XX%

for change XX, September to $X.X $X.X September million compared of $X.X primarily expenses, an net increase million the interest X XXXX. X This income, for the financial Financial million ended in XX, from resulted ended months were months XXXX, of net income.

taxes million, the the current In provision which enacted result the December were approximately XXX Act which in income in U.S. and September taxes for $X.X Jobs Tax XXXX. X recorded primarily of respect months we of XX, of Cuts was XXXX, ended the Section to

(sic) $X.XX compared in to share $X.XX and per a for share XXXX, basic or the Cash same per X net and or loss $X.X were deposits per for million cash September ] XXXX. XXXX. share September equivalents $X.XX and ended at diluted short-term the diluted basic [ million loss $X.XX million approximately XX, $X.X of was and XX, approximately months period bank Net $XX

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

Dror Bashan

concluding to call, we of In accomplishments. are Eyal. that you, note at I Thank earnings proud this would our Protalix like

creating a balance have look of We therapeutics to long-term our a X strong assets, driving world-class a a technology to with forward We and sheet our sustainable in a team, the strategic on proven and our pipeline updating platform approved you plans for a future stockholders. vision value rich progress. strategic supporting

questions, we unmet entire and and would families filled I'm needs, for are praying is that note this like team. Protalix pain. as start enduring a I during time, resolve friends portfolio this for with one patients Their to we grateful with our that noteworthy. medical we Before at time, taking challenging commitment for develop is our

questions, ask to the I would to for Now like call operator the please. open

Operator

line Pachaiyappan [Operator H.C. Boobalan of from question Wainwright. with Instructions] first The the comes

Boobalan Pachaiyappan

This is Boobalan.

voice, for Sorry I'm from the sore throat. still recovering

with from firstly, revenue to So selling respect goods.

from the million to I $XX that million $XX revenue in quarter. in the So dropped see third second quarter

the discuss expectations for And in the what revenue -- fourth your for revenue? drop in are for quarter? you also, factors can So this underlying

Eyal Rubin

Boobalan, for you, Thank question. the

sales So in and in decreasing sales a terms of of the is it is to decrease, the decrease Pfizer, part the of Chiesi. decrease part to

are the buildup. sales As the the I call, in of sales point, to previous indicative basically the the not are sales mentioned penetration to the Chiesi At market. Chiesi, in they this inventory of

market and X, slowly markets. building they inventory, build or be their So the in the surely, presence going the years next there's obviously, And the penetrating during fluctuation X.X will also the in as but even that they're term to inventory. the building they

revenue the question since point, Chiesi especially We up don't and from for building to they the fourth at presence on revenue, the Chiesi is especially dynamic, from respect about market. are our the trials and With are majority POs this the second your guidance sales where quarter. of usually Brazilian for guidance provide their in

to until those feel to comfortable share and guess forward-looking I So will giving statements. forecasts take that it's time going we able be

Boobalan Pachaiyappan

on congrats And approval enough. and Switzerland. FDA in the U.K. Fair winning Okay. sorry, -- then regulatory

in can and the provide was which could disease I Switzerland. we Fabry at the U.K. market or a opportunity the So upcoming quarters? to discuss also, wondering approve level expect you maybe countries Elfabrio high if in And

Dror Bashan

So in drug already most say, actually, of Europe. the country was in the, may if approved Western I

was the to is drug outside market. initiated indeed on, in United Switzerland, markets including it Japan, And study Chiesi certainly where idea not EU, an a approved. other also to on well. to of the and as Kingdom EU, register order the And the other in part markets important is later it's the move So but

As the Chiesi's, And I front -- may I is Fabry in it U.K., for the have of right now. also, market the size of say, in don't if role this specific me.

a data, will to data, or put it certainly, once more will the market Europe, in release we able we let's this important share be have is with Chiesi So way. it But U.K. you. will very more

Boobalan Pachaiyappan

Okay.

the Let's in you additional I programs, on criteria. color get study. some switch gears to some would especially items I and clinical listed discuss exclusion that PRX-XXX, of Phase your like the ongoing the

I So website. at looking clinicaltrials.gov was the

clarify with also the without the subcutaneous especially those excluding or you're of are so diseases with So some you the renal more X can of the year renal I it says is moderate those or excluded. exclusion criteria, if strategy may? trying that. criteria, complication, in to patients mild I'm tophi, to advanced So target with on gout or and flare forms last more gout understand, one

Dror Bashan

Yes, that. for sure. Thank you

So actually, a I It's dose. a study. Phase single it's

then and it we -- not take first are see idea time it indeed They first the the check hyperuricemia. to then with safety, volunteers levels of further. The to it's course; is or hyperuricemia -- actually normal actually infuse the and are acceptable to participants. So so participants and if reduce we to levels;

safety, order dose multiple move to to a So course we to multiple measure in on of XXXX. on, subject a multiple in to -- able ascending to aspects like be later

to -- not all. gout So patients it's is now, it indicate idea does indicate for patients. mild right severe not the for at Actually,

Boobalan Pachaiyappan

One if question, Okay. last I may.

again, with to PRX-XXX. So respect

data So collecting immunogenicity blood acid well. I you're uric and know levels as

are -- what these expect like data, What are to I do curious, your X I'm Phase see a in your especially you expectations? study? what it's So

Dror Bashan

the if to just to from view, PK/PD we hyperuricemia the to sure. is for make And we frequency have a or take least, may safety, more then other indications reduction, signals at other in again, So subjects. next parameters, for further calculated of analyze, see sure of to intent, if to additional order, us, enroll will measurements I will dosing we and see steps would for we like study. And enable to of of up again, that point XX to steps and the again, course, -- say, see

number So risk, sure, hope to for -- but of a of that. get more we I than on. think say Safety but with minimize I it's won't enough to it's a or course. less enough to number move enough information of risk, the

Operator

Next John question with of line the Vandermosten comes from Zacks.

John Vandermosten

the your expense of Elfabrio oriented much structure Beyond is COGS, how business towards now?

Dror Bashan

hardly repeat question? hear you you. sorry. I'm I Can can the

John Vandermosten

I'm sorry.

Beyond Elfabrio expense now? business COGS, your how towards much structure is of oriented the

Eyal Rubin

to worldwide. X X terms structure, to year, investing at and is provide something in months production of X the of of In supply other population a manufacturing, a patient not the sufficient year half like cost than Elfabrio. We're present which takes to months X

John Vandermosten

capital there's your revenue-generating Perfect. have Okay. that And then now products? do see balance you you And how also structure a debt in keeping on mind changing convertible the X sheet. that

Eyal Rubin

in out not it's surely, revenue there. X the when doing question. good up, equity join the to accumulating products revenue-generating anything a we is Since and start slowly and revenues guess a That's going to streamline obviously, going we're we I cash. Truly, capital are so have stable the big gradually, see but we're party, going that have to are to of we boys markets, ramp

-- different stage. it's So company. typical a company the not It's development a biotech biotech in or the a

present, change. At don't we see this

the sustained. foreseeable any we this to for As said, future the point need the at still company in We money see don't ongoing is raise operations.

that, going I Over that's capital guess, is going to So take guess that time, to time. the change. I structure

John Vandermosten

in think they're about I And year, a Okay. year. due coming next

to understand if cash us that it net a you on help give see for then quarter. can And that how several wanted could bit forward? through burn, flow than income how I next I greater the noticed some might help quarterly going you for forecast us the just to And was little quarters.

Eyal Rubin

Yes.

that one starting and building Since just previously that's and of the this revenue we're to penetrate slowly guess Boobalan. just think to that, Chiesi the fluctuate. I going to responded surely, market phase but I the to So I presence ramp-up

we forecast the the quarters. for sharing So at this of point couple comfortable feel don't next

very, they're that They pulling X batch. X batches, very, decide can very Since it's fluctuated.

even For one. technical delaying reason,

in be time. at think rate talking X, share this ramp short mostly up. over term. obviously, I Long irresponsible with will a buildup sales, as will would So forecast the an I the that's point, I'm run said, that be it to term, about going years, X.X ramp inventory next to for

John Vandermosten

shifting middle I just and program. PRX-XXX the what Or Okay. there? wondering top the see assuming are Would development be should And or that we a next guess out expected better of as next comes line year. from in that What Phase I'm expect to it II? then to steps

Dror Bashan

dose once there. is that following So multiple then we do single now. continue from a we dose we then -- will do have a we Phase And intend to And which actually the II.

John Vandermosten

Okay. And that XXX. for just the program? are steps one What next last one on

Dror Bashan

Thank you for that.

if future, for, So next Phase say, toxicology of a I. that ahead, near if will decide preclinical I gather share may the we we'll have, in kind and continue meeting. we information and if will the to say, and in we I other we and may the different data -- go studies portfolio-go/no-go And indeed from to go

Operator

for session. question-and-answer to over Thank turn now you. This closing would floor comments. like today's to concludes I the Dror Bashan

Dror Bashan

you. So thank

I So everybody, for for look results, appreciate on time the forward XXXX all. for and thank a Thank you, with in with time, to we I you And participation. us peaceful your you speaking call more our here Israel. hope next and

Operator

This teleconference. you. today's concludes Thank

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

Dror Bashan

Thank you.

Protalix BioTherapeutics (PLX) 6 Nov 232023 Q3 Earnings call transcript