PLX - Earnings call transcript Q2 2022 | Protalix BioTherapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen, and welcome to the Protalix Second Quarter 2022 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. Thank you.

conference. your begin may You

Chuck Padala

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

Dror Bashan

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

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

the open questions. We line for will then

These positive line endpoint favorable met PRX-XXX Fabry tolerability a of important final April, PRX-XXX been study called the report, the showing also I'm that is an trial, of has report the The trial disease confidence Fabry CSR treatment results happy results trial profile. our confirms for that potential of and the with immunogenicity presented function top results the has for from clinical our patients treatment on option successfully begin completed. positive BALANCE to tolerability Phase top review BALANCE the announced highlight analysis and III line for for encouraging profile. Let In primary me the in disease. we and become PRX-XXX adults. to its kidney clinical with study the which a that as BALANCE favorable

With well then to excited launch. and are we The to of the BRIDGE submitted with We the closer the to Disease, study. MAA advance review this year Phase an resubmission XXXX. the Rare Phase time respect is trials, clinical This in as The the for safety results February to approval the completed will Protalix. earlier BLA and our potential exciting from EMA, was PRX-XXX our I/II closely PRX-XXX BALANCE, MMA Chiesi are process. submitted of as move positive three include to III BRIGHT the commercial working Global

anticipated all PRX-XXX product move our Chiesi, continue the disease. we a to commercialization hundreds candidates potential aggregate global pipeline, solid will programs for we end, that our can PRX-XXX next company. stage we biotherapeutic successfully our of bring to a to our we expressed a broader year. that early Fabry start Phase has involves important in To of these programs data, option that based becoming a have significant early-stage And clinical pipeline be been to established discovery with which in support that to upon ProCellEx, development of goal from I, to real molecules express PRX-XXX the the believe system plan patients working and provide of treatment unmet and system, continue is ProCellEx of on capabilities, which our expression enables market the market. foundation the closer of its parallel, invest for protein to to exposure, on modifications patient work With in Fabry new will treatment In As to We the partner, chemical to regard approval. on new technological improve of disease. years totality address us needs an both to potential approval for demonstrates for on our which the proprietary which area. develop we products, in

moving first are is first in gout treating novel XXXX. quarter forward We I And commence of PRX-XXX, a study for with PEGylated the to the Phase patients. planned severe uricase in-human

of of are experiments, finalizing PRX-XXX, as As several With support have this and demonstrate providing progress. first PRX-XXX, forward the studies we look updates in-human for feasibility these and package, to on to respect course. our we programs conducted they study, toxicology preclinical we to additional

Annual XXXX our XX, stockholders June items approved the the XXXX. on Stockholders meeting, of agenda. the of Our At Meeting all was on held

In appointed addition, a Shmuel Ben or be to Board our Zvi, of of Muli, Directors the of member Directors. Board

future for wish ended and company on As service of Board his the is to behalf Chairman the experience. David like well a the our endeavors. and would I member Compensation the him Committee. of extensive best Granot's in economical as David Muli now management to as auditing tenure has of Audit On his our financial and business dedicated of considerable Muli thank knowledge and Protalix, the as meeting. Committee

Muli welcome We are very Protalix. happy to to

the of and sheet third to for addition please our potential Eyal, Eyal cash the support I resubmission of turn Finally, our will review develop -- in continuing our runway balance financials. enough plans for quarter early-stage to sufficient a to ahead. to continuing programs. approval, now pipeline go our to to with XXXX, provides us

Eyal Rubin

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

financials. XXXX quarter second our review me Let

decrease or last June agreements. for $X.X XXXX. million in or June and $X.X Chiesi R&D was $X.X selling XXXX. and the $X.X quarter XX, license $X.X services decrease are XX% versus Revenues XXXX, the XX, we recognized for same ended XX% primarily Cost an in decrease increase with the sold million costs June development lower manufacturing to of the For of quarter services for cost $X.X for to and for in ended compared a $X.X sold goods of the an XXXX, primarily for X% X increase of of $X.X compared million, months million yields were result wastage. of the or revenues licenses million of period due decrease from R&D from million revenues goods Research comprised the a XX, to goods XXXX, ended million XX% X due compared net, the same Selling, June of months period months the expenses same the of and were a Revenues $X.X quarter period The we million XX, million, for recorded for million, $X.X of costs. of higher was for connection of as million, revenue ended last XX, XX, were ended June year. X and XXXX, months $X.X June were general the same the to decrease $X.X and million Financial million administrative XXXX, million, versus year. period ended $X.X June a decrease X% U.S. year. of million, for an XXXX of $X.X million expenses notes XXXX The financial a decrease dollars notes million of the selling of last resulted in million interest income, last amortization compared and a primarily aggregate the ended resulted or or XXXX, the $X.X and expenses, from $XX.XX in salary-related notes, $X.X of decrease XX, our from a X for $X.X increase amount $XX.XX net, lower period over to to principal of shekel principal rate new an of costs outstanding debt exchange million the from amount decrease year. aggregate period. an to for primarily The Israeli in same

$XX.X As compared the of with financial runway equivalents quarter as million XX, approximately will and through of to cash were turn that $XX XXXX. million June third I December of XXXX. our believe XX, our bank current sufficient Dror. you, now back XXXX, the deposits to We call provides us cash cash, position short-term

Dror Bashan

Eyal. you, Thank

today's back the call. joining So questions, operator will the please. to thank I everyone, you, turn now for for it to us line open on

Operator

[Operator Wainwright. Instructions] Selvaraju Our question the Ram line first H.C. from with comes of

Boobalan Pachaiyappan

dialing A for Selvaraju. is us. few Ram in from This Boobalan

filing? occur until that is what So your to firstly, analysis now needs now the clinical from BLA complete,

Dror Bashan

the I other will and the part later resubmission the clinical this a the this mean, to CSR that year part of together that data, actually, of other of be the and part FDA. is So with the of package additional process. is composed aspects being course, is trials

Boobalan Pachaiyappan

and conducted any you Have appealability of discuss profile for the potential market PRX-XXX Fabry physician-based disease? product target research study and

Dror Bashan

vis-à-vis, So or launch they seriously. if had main They I'm a job, think potential the is a take marketing from you point view, very clearly of the And date next Chiesi. thorough it very doing year. approval or are it of positive,

Clearly, can I do For be a to them, they high launch. we And it's, have done priority a asset. very whatever in order need to believe, successful

Boobalan Pachaiyappan

any market done if was with share then physicians this? if you share focusing wondering findings could you Chiesi maybe U.S. has can I on some research and

Dror Bashan

can I a don't right we you now. Clearly, of have discuss also, in anything it course. And approach of on different time, can point Chiesi.

Boobalan Pachaiyappan

What's have CMC in Do you capacity or to your terms partner your plans commercial capabilities? status further? of expand

Dror Bashan

we what to enough, issue. I to be that I mean it's be, mean. no least capacity more -- mean have market, I at have market. support can if -- I to even of supposed the say, supposed than currently, enough, we may the XX% the There's

not. we we XX% then get or to if Let's of decide expand and that, can

Boobalan Pachaiyappan

for breakdown of -- of milestones remind you and One more us of can potential commercial the regulatory PRX-XXX?

Eyal Rubin

Yes.

agreement the milestones, there's a is and the to it. reason So redacted

share cannot the with it public. we So obviously,

Operator

[Operator next the of question Instructions] John Our comes with line Vandermosten from Zacks.

John Vandermosten

than those Europe Want found article what's recent treatments at the unigal I intolerance right in were and with on shortcoming offered of through were pain was it they disease. better And particularly, address a and the for Does that to now. that therapy? can they noted. reading a journal issues out -- two tremendous with Fabry looked out And start orphan, a question temperature items existing current pointed an

Dror Bashan

clinical we We be data I into to tell can that the drugs part as BALANCE our know the have you will the pain on have there we we three with shared on trial. to market. all -- program, don't especially that the And of looked if compared authorities.

main endpoint we look pain -- questionnaire you as Like As our slow something or by EGFR. our this. certainly, well. is not know, -- like we aspect is pain measured the endpoint But for address

John Vandermosten

missing that. mean unigal obviously, perhaps I can and address something there there's Yes.

I'm might a just other wondering And is some therapy opportunity Fabry? for the That's in for if the something question Fabry indications. be that's Second that in combination possible space. trend on

Dror Bashan

know. could clinical don't on be, to course, has trial. be. It of checked a I It

still therapy? ago. It XX there will I what? it's And potential may more more be there Is put some pipeline, but aware a I'm this early be developments companies years, and stage, many, some even now right than, is overall still way known to And initiate reduction more for as X and -- let's there the for of forward, gene but that although could years well going in justification say, mainly the with think many indication, scientific sure, yet, go to evolves. not The question with be way. let's there I'm blood should such it study. combination. are

John Vandermosten

Something for the future.

that Europe? is second which kind it of Europe. happen into looking could Gaucher but drug, at seems an I and the like that does seems Pfizer at month It up. in mind, trending [priv], opportunity are -- ending these was in for looking with to this I I what wondering, knows I Pfizer. future. its was like Next up is exclusivity I'm mean, think, is the lumpy, that that a for quarter. reported question the revenues in know who open Shire you expand But Pfizer ISO And the

Dror Bashan

and that it. up if in the it and Pfizer have soon. true how And we enter up call is past. about them aware their Europe. period It's to discussed ends the It's exclusivity to clearly

John Vandermosten

a size they the EU terms mean sounds the know of market. in after it it's number Obviously, mean two United it. I the the is large I States opportunity. like about of

So picking seems like it -- and they're

Dror Bashan

or patients And three by two are It's Also, enzymes at the do, countries, they in in okay? true. good John, enzymes Gaucher or significant today there is will of end other and don't similar rare, It's take job, pretty a have that on it's walk through or in that U.S. the need God, for wherever years, in know, -- the Takeda rare seriously day, It's many, to of because and may which Shire way the Patients because science, it years, Genzyme that live a very, and many, something good I the can right? is the market right? like to disease three right? -- it not know, the two give the you you Europe when I market, either -- in ERTs treated, else. least are In in of of outcome. a the or say, very take, I pretty enter years. doing is, if on assume enzymes market many it's are looking they Or a not penetrate in patients or or Sanofi, many Germany U.K. order their enzymes life some in the And park into are differentiation So are many thanks, the and and decisions. not But quality comfortably, Pfizer for three a players or course. that thoroughly and job you for a

John Vandermosten

And you. last one is for

is that Or see something to that in You a some which will factors. going? I that improved onetime you you Improvements going of Is could kind just continue guess, do mentioned -- that that had forward? way you generalize. that benefit the efficiency, gross due margin

Eyal Rubin

Partially, of going see yield. the don't is a thing the it's yield. the Part depends. control We forward. It we'll that consistent it benefit

Sometimes don't you will outstanding you get stay normal even it records. anticipate, And the usually, breaks there. all curve, an obviously of some which yield

disappear. will Some

John Vandermosten

for So put determine are to it but want they're slightly of don't can't mouth, it words your really some and whether sounds sounds will volatile, move continue. like factors in -- you other I it kind factors, to going but like up

Eyal Rubin

Yes, that's true.

Operator

Mr. end Ladies reached have remarks. Instructions] over like closing and today's would we Dror to [Operator this Bashan, I session. call question-and-answer back for gentlemen, to turn the of

Dror Bashan

So you. thank

thank to time, whenever update update their to the like have accordingly market. we for I and again something would clearly everybody will So we

Looking Thank next time. you to forward to talk you.

Operator

This concludes today's conference.

disconnect may of Thank at the lines you participation. your rest your You time. this for your day. Enjoy

Protalix BioTherapeutics (PLX) 15 Aug 222022 Q2 Earnings call transcript