Earnings call transcript Q4 2022

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Operator

Good morning ladies and gentlemen and welcome to the Protalix full year 2022 earnings call.

As a reminder, this conference is being recorded.

I will now turn the conference over to your host, Monique Kosse of LifeSci Advisors, investor relations for Protalix. Thank you, you may begin.

Monique Kosse

Thank you Operator, and welcome to the Protalix BioTherapeutics’ fiscal year 2022 financial results and business update conference call. Dror Senior and Financial Vice are and of Officer. today Rubin, Eyal President me Bashan, CEO President Protalix, With and Chief issued A the available the announcing on this was now website. press is morning Protalix results the and release update and

the read to unknown and release in statements are earnings disclaimer results about this actual subject U.S. actual may forward-looking risks filings from Commission. statements could teleconference are differ that include to with Exchange moment the a forward-looking Factors release. to and press and cause made. take uncertainties the Please These known The and materially statements results forward-looking described cause that in in the differ to and the Securities disclaimer Protalix’s statements.

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

Dror Bashan

Monique past coming for I by will results to year our Thank welcome and along begin the plans year everyone with call. fiscal the accomplishments and update you months. XXXX and over business progress reviewing our financial our

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

year recent strong our and a like on Diseases. commercialization begin the Chiesi would and our fronts. Protalix, made with significant was XXXX progress last year multiple highlighting by Rare Global to achievement I over together most we for partner, development

year. The the Commission, marketing to for potential a use, Fabry PRX-XXX very step option towards pleased of to closer now which is this significant delivering adopted CHMP, early or referred patients on a to disease. approval human treatment for brings treatment Committee marketing This positive with European for PRX-XXX of authorization Fabry are and is in We and decision a in Products around of that the world. the Agency’s of decision European Europe May the to Medicinal expected is opinion authorization provide recommended adults Medical final the us this

to forward in the States. Europe potential potential United look but Not we also we approval approaching approval only are in

It previously approaching. already PDUFA license our X. on XXXX received USFDA December. We of target re-submitted re-submitted was assigned announced in and letter date review quickly action the November X, biologic May our X acknowledgement is As accepted December application for the

data regulatory the their Phase in disease. hundreds clinical believe well the and completed compelling efficacy were and as program, exposure represents III studies. Final the studies our to and patients’ from safety potential Including term adults affected important robust year, this our label Phase trials BALANCE PRX-XXX to and results BRIGHT EMA by of submissions comprehensive ongoing expansion met earlier Fabry of FDA III long and for these years treatment data this from from to results set consider case our both and open respective objectives. we as regulators option to of announced This a were provides

and protein We second we further If in potential our approval platform. ProCellEx, from the of look proprietary EU drug the forward be approved unique called U.S. providing you to validation the innovative PRX-XXX approach will with approved, expression even updates this providing and system, as

Fabry new for we into we and to disease. for As both enter this and partnership potential would and year thank this we to be Protalix what Chiesi’s treatment dedication program, patients reiterate to exciting an Chiesi’s for to appreciation their Protalix, our will teams efforts deliver like all with

concerns. no Phase of I from treatment to study of is ProCellEx indication our results of expressed we the PRX-XXX promising develop one Turning system. support uricase protein in safety development through early gout. for candidates study stage are toxicity dosing month’s severe two the to first species novel to expression PEGylated continuing our a stage pipeline, multiple of in show Final PRX-XXX the

couple a of Phase plan Our is development the initiate next to weeks. clinical in current goal I trial

NETS In to DNAse elongate for a half treatment progress make in life PRX-XXX, of addition, recombinant circulation diseases. continue DNAse the protein human we to designed related PEGylated on X

on conducted throughout forward year. demonstrate as have updates look preclinical we program We studies to this this the and PRX-XXX of progress providing to feasibility we

first with Finally, through us addition our the sufficient in balance cash to developing provides I runway sheet XXXX, through as mentioned. of quarter pipeline stage early continuing our the approval potential supporting company program,

to emphasize review to Before the program was this with ATM regard [indiscernible] filed I this I the turn I [indiscernible] clarify announcement to say a not an like would financials, to that is filed morning, fundraising. connection of Eyal has for of the and to with company our have earlier to that the

to turn please? I’ll Eyal. Now Eyal,

Eyal Rubin

today thank you financials. and of Thank XXXX review operational full Dror, [indiscernible] you joining everyone our the year for

of resulted The company for XX, million revenues in sales of increase ended for December an $X.X The increase increase $X.X million compared selling to to of increase $XX.X XX% and XXXX, goods from an December million revenues sales Chiesi. million $X.X of or million to XXXX. million Brazil, the ended year XX, from to the $X.X in an recorded Pfizer, year $XX.X in increase of an of sales

XX, the R&D and services for represent were Revenue recognize we mainly million $X.X increase the from an of ended or Revenue revenues of Chiesi the XXXX. R&D and year million, licensed with million for connection the services compared agreements. $XX.X X% revenues $XX.X from XXXX license year ended in December to XX, December

the to year was sales ended of sold of of goods $XX.X increase an the goods of XXXX. for in million December million year compared result December the XX% sold $X.X of goods. XX, Cost XX, cost of goods $XX.X in XXXX the was an The increase cost ended increase sold or for primarily million, of

December and material development ended other approximately approximately related of of expenses, comprised $X.X $XX.X $XX.X for in the million salary $X.X million and approximately research subcontractor-related XXXX million, year approximately and million of expenses, million XX, expenses. expenses, were $X.X of Total expenses approximately related

XXXX expenses, million of of million subcontractor-related expenses, approximately decrease material ended XX, and X% related ended of primarily a trials the development other our $X.X December connection in $XX.X approximately million of expenses $X.X ended partially $X.X December million, offset year expenses, subcontractor-related and compared in approximately $X.X clinical or expenses million by increase expenses approximately with from resulted XX, year year related the The in expenses. December $XX.X for development million of PRX-XXX materials in For our expenses. million XXXX XX, $X.X XXXX, decrease research approximately the total $X.X salary and and related to research in million were comprised

for a general salary-related X% of resulted decrease XX, from and Selling, ended ended expenses. fees year million the XX, XXXX. December for million in million The professional decrease XXXX, were December or expenses $X the administrative year a and $XX.X decrease primarily from $XX.X

for our increase to for period. notes, dollars amount of net of costs aggregate the from XXXX, year aggregate ended XX, million compared expenses an for exchange in $X.X of new was $XX.XX due a principal $XX.XX million notes of decrease December $X.X or outstanding in expenses Israeli XXXX XX% and million Financial The XXXX. XX, resulted an to December $X.X decrease the of debt of from million year over a notes financial amortization lower shekel primarily U.S. and ended the to XXXX rate an interest million decrease principal amount for

income ended research as and U.S. certain recorded for deductibility and the record went XXXX January for the XXXX, taxes income For XX, expenses of regarding we year $XXX,XXX. Tax were Act XXXX. into XX, sections the taxes December December XXXX effect XXXX. of development income We taxes the year ended of of approximately Cuts The didn’t recorded on Jobs X,

as cash December $XX.X approximately short term million bank equivalents, XX, of Cash, and XXXX. deposits were

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

Dror Bashan

Thank Eyal. you

Thank you everyone for call. joining today’s us on

PRX-XXX of unmet patients continue We delivering needs. potential are high adult Fabry to the with and year medicines to our excited ahead for approval disease, we towards mission for of as patients work with await we new

back line turn for will call to please. to I questions, Operator the the the Now open

Operator

[Operator instructions]

Our first Please from comes proceed. HC with Boobalan Wainwright. question Pachaiyappan

Boobalan Pachaiyappan

okay? can hear Hi, me you

Dror Bashan

Yes sir.

Boobalan Pachaiyappan

a know makes to in shareholders All few the your launch from maximum PRX-XXX, perspective, launched decisions could Congrats be early questions right, on for the end. our great. drug derive from order We Chiesi your and value? but for how progress,

Dror Bashan

is Chiesi. thank the First, question for a This you question. for

relevant course we once be will this assume, finalize is be there in this get question in months, but again, commercially. couple to of I approved, of Chiesi, hope and countries Europe, the As But I will a schemes in different assume we reimbursement far with then insurers a as to ready programs parallel or it understand, I the and the U.S., is plan. in the

Boobalan Pachaiyappan

in Okay. PRX-XXX In your awareness view, what’s the the general physician European for Union?

Dror Bashan

understand Can I’m you question? I repeat could the sorry. not it,

Boobalan Pachaiyappan

PRX-XXX the in general I’m Union. understand European trying awareness to physician of the

Dror Bashan

you. Thank

and well couple places, in time earlier. world. accumulated is clinical is we we high awareness. old, clinical say--the portion answers a in by, is is, a I times and Europe, of exposure, as is had itself program patients’ investigators program question. and this goes eight, We significant nine in think physicians as This may sites both and worked your Europe of with We and if the hope Australia U.S., I the there hundreds also other years have as that even throughout I the clearly mentioned so program of years so

Boobalan Pachaiyappan

the market securing or steps discuss Union any and gating you clear. any Okay, Can progress can in Fabry you reimbursement the to disease in frame opportunity Union? European European the

Dror Bashan

we they sure program, and is apply this that’s for [indiscernible]. be a billion, position it we best drug will globally, and commercial question It again, to their $X.X and then well $X program--first, effort very is grows and this the will I’m and between know that billion priority, that indication hope a The Chiesi, on The we Chiesi. about I have to will high it. believe

with Chiesi I specific efforts, regard to their reimbursement ask suggest for details As you directly.

Boobalan Pachaiyappan

gears, the ready be clarify call submitted gout first last Switching mentioned already so been IND the program, thinking to has IND about launch you you quarter, clear. the can the submitted XXX will Okay, Phase and if are I? in on your you

Dror Bashan

will we We with meanwhile New U.S. I of Phase that once--that prepare and I. be to successfully, we center I Phase will in also to I Phase outside discuss steps. will conducted next The FDA Zealand. the a we assume hopefully Phase finalize the excellence in the and with will II are ready launch the regards

Boobalan Pachaiyappan

the initial maybe Okay, to again, of to you going volunteers healthy to closer XXX need - you how proof in do or concept are so patients to--who order many or I’m get going many patients which studies? set data how forward sure one with target, to move to not but you’re respect

Dror Bashan

are and so the planning What you first-in-human all Phase we once a see we details. now will we everything study, will I publish publish protocols, is

Boobalan Pachaiyappan

do maybe and long how the expect and would see maybe to when data? you final like one Phase to Okay, run the question, you study, ideally I

Dror Bashan

Which not could study? I’m understand. I sorry,

Boobalan Pachaiyappan

your do study? expect how I’m XXX Phase I run just curious long to you

Dror Bashan

apologize. I

I run the so expect to beginning we this will CSR We next the year, hope be by end to of able year. it of until the finalize

Boobalan Pachaiyappan

questions. my Okay, thanks taking so much for

Dror Bashan

course. Of

Operator

ask one to gentlemen, and a question, ladies star, again telephone keypad. please your Once press on

Vandermosten Our comes Zacks. next proceed. from with question John Please

John Vandermosten

and Dror you, Thank afternoon good and Eyal.

both Let company? to me May just out May. supposed should expect milestones big on with in FDA and what for that with the be horizon on for expected, of a after question milestones but look the we month a EMA that, start we terms after is

Dror Bashan

Eyal, please?

Eyal Rubin

Yes, I ones? referring to right, financial not think milestones, John, clinical you’re

John Vandermosten

Well, which mean, events. Dror the just on of eye just talked the about horizon? I; major Phase XXX, programs I two on have an other for just we bit should that any anything you else keep in little but terms out a

Eyal Rubin

point. this at Not

be potentially As the we it [indiscernible] that the [indiscernible] our of of end the can we’re by major early first-in-human [indiscernible] the going we current weeks forward couple with milestones the on year finish PRX-XXX mentioned, this pipeline. foresee and main to to next with year, first Dror move with plan next

John Vandermosten

you Okay, Eyal. thank

recognized financial related made In might are that’s assuming cash be flows cash everything and when the statements? PRX-XXX, quarter terms know, the that in to financial do the received or they quarter, of be might when expect--you even and sales we the when third second those flows on

Eyal Rubin

along report regulatory with the be to be Chiesi as [Indiscernible] street, received financials. we days approvals and to within they’re from event, the with the should them get XX we’ll recorded obviously going from and the them

John Vandermosten

future before, this Okay, saw longer the very about What marketed has Vpriv the no we’ve in the I in you mentioned in you that is for K--and K mentioned and globally. but Elelyso time this mean EU good. that talked does revenues? exclusivity this

Eyal Rubin

to [indiscernible] commercialize in the penetrate POs we been receive and we and They’ll Since based whether start have from Europe the commercialized Pfizer, them. Elelyso re-think internally them [indiscernible] to to market. Pfizer, marketed it’s don’t by marketing on whether serving by market as

be at EU, are the they’ll working We minds calling it’s it by market to accordingly. the make then a we’ll end the of but and struggle, market up day, their have so

John Vandermosten

conversations regular product assume great, them I going that have Okay, are the and with with on you how things sales.

everything you assume have so that, conversations and I guys them, that to You right? have with obviously production like plan

Eyal Rubin

for correct. the holding it’s a Again, question that’s commercial Yes, they’re them, rights.

John Vandermosten

with just their is it. then geographic to drug one for what for was saw since and me Chiesi Got it going was where finish shipped disposition? for Israel, Last agreement the producing wondering the of fill product be your also be you’re guess that location is I that activities, going and to in

Eyal Rubin

It’s and from globally. [indiscernible] to Parma, delivered there Parma, will going shipped to be it be

John Vandermosten

All Great. thank thank you. a to right, Always well Eyal, pleasure with Dror. you you speak

Dror Bashan

you. Thank

Operator

you. Thank back would over for like comments. management At I call closing time, to the this to turn

Dror Bashan

Have down I we much. are road. recommendation with much very look nice happy we have the with good you to today, you news very Thank and to for forward providing a very everybody thank time and CHMP day. their the the of further

Operator

teleconference. does you. conclude today’s Thank This

You and a great this you may at time lines your have your and thank disconnect day. participation, for

Protalix BioTherapeutics (PLX) 27 Feb 232022 Q4 Earnings call transcript