PLX - Earnings call transcript Q4 2020 | Protalix BioTherapeutics, Inc.

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Operator

Good morning ladies and gentlemen and welcome to Protalix BioTherapeutics’ fiscal year 2020 earnings conference call.

As a reminder, this conference call is being recorded. I would now turn the conference over to our host, Mr. David Holmes of LifeSci Advisors Investor Relations.

You may begin your conference, sir. proceed. Please

David Holmes

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

Dror Bashan

update. year-end welcome XXXX you the Thank and business David everyone to financial and company’s results

review clinical progress the key upcoming During out today’s call, I will and programs our milestones. the strategic lay of our road of map

Fabry all the U.S. and our and we and to questions. Rubin however, we significant for forward CFO submitted for course Eyal of through we partner, of the our that treatment for open patients pandemic; positive continued unexpected to of look financial momentum then have BLA a Chiesi, review challenges, part with response. the adult first we of global commercialization FDA achieved our we FDA’s the PRX-XXX disease XXXX. will remarks, with Together development in the my Following this many year line the brought including accomplishments and will have This many results

out this Phase offering the data interim build provide our our our system and with to commitment the BRIGHT of unmet the earlier to release look program. continued ProCellEx, advance needs. of strengthened for partners the unwavering our of public through under Please the sale from external their our studies medical therapeutics anticipated data PRX-XXX upcoming address cell-based balance BALANCE let our forward employees help seeing III study We shares market protein the we clinical achievements We through me sheet proprietary details our the [indiscernible] I the mission bring regarding profile from and and stage key a quarter BRIDGE further earlier our to to plant of pipeline year. milestones. this differentiated for year candidates expression am key second very and advanced Overall, and we now during some ATM to of proud to and more

current be to this to and is and XXXX most at Our disease alfa, and a around many that PRX-XXX, the every in XX,XXX Fabry $X.X X.X%. patients replacement in enzyme therapeutic disease. continue from CAGR suffering of Fabry therapy The a are mainly consists forecasted approximately for of undiagnosed billion disease market that grow experts lead for a candidate is agree pipeline occurs one is people candidate pegunigalsidase Fabry disease. therapeutic protein of rare or which treatment of genetic there is

receive have January As remained discuss was the dialog of adjusted XX, this BLA in Fabry an of the for the the active PRX-XXX I and to approval the granted XXXX the committee FDA letter XXXX. hold indeed Protalix FDA original disease an fall, in PDUFA later not plan does action and as treatment filing BLA to advisory Chiesi launch we year. commercial will last date for FDA be for communication earlier, ready indicated filing to of letter, subsequently the the meeting PRX-XXX regime. with BLA and The accepted We by application. and the mentioned April priority FDA If XX, Chiesi

replacement arm February. efficacy four The clinical III substantial were by for III Last results We weeks in the to open both line XX-month pegunigalsidase to from the we top BRIGHT XX-month greater from open and previously every female III results kilogram per released years with commercially positive line renal BRIDGE, its pegunigalsidase program our three pegunigalsidase without were of weeks. Fabry for results to XXX switched trial in in trial Last month, which used lead found a from pharmacokinetics studies. administered PRX-XXX improvement XX-month the dose at as safety, the study patients replacement safety that enzyme studies: patients following maintained X protocol presented detail build alfa, patients program, Fabrazyme. composed among administered XX was on patients comprehensive our for Fabry X and treatment infusion function clinical who and considerably were our study we Fabry is stable results in assessing switchover past clinical This every to at Fabry alfa treated per Phase an declining Top patients evaluate versus male and therapy, milligram stable two was previously every the trial, trial for period. Replagal. one per regimen, Phase and dose intravenous of function annualized from measured the treated weeks more WORLDSymposium presents and final alfa additional with of annual eGFR three the BRIDGE weeks current BRIDGE alfa. X which for BALANCE disease The are milligram renal final III available compromising efficacy. alfa the switchover efficacy be the Fabry with label patients the profile evaluating kilogram continue convenient milligram data indicate kilogram Phase shows in label to and administered is released who up the [indiscernible] this agalsidase effects and a BALANCE the presentation safety tolerated announced as enzyme single is of or The two patients of BRIGHT, by designed potential the mean well in four is therapy results treatment Phase every least from treated agalsidase the XX-month December, of

If from for late positive, in results interim there or receive in is a XXXX Europe trial results which then to quarter for filing. launch first expect serve in of basis the XXXX. trial the next EMA would the a these are European potential commercial half the as We

which fibrosis, clinical We for we is via not to our to system on inhaled develop via disease SarcoMed and Turning via our continuing sarcoidosis, inhaled develop or other to including delivery. USA USA We related this areas in to you with recently or diseases early evaluate forward pulmonary continue use pipeline exclusive condition, [indiscernible] for look an the announced alfa, ProCellEx will candidates and delivery. plans. SarcoMed partnership update disease these of but to our alidornase produced work with any limited treatment partnership respiratory to program, to human PRX-XXX,

refractory an to plant affecting however, enzyme arthritis PEGylated and recombinant longer reducing in estimated common the We optimized through of enzyme X% is life, clinical gout. improved of million urine; enzyme gout, we is cell-expressed designing have to United our under half which PRX-XXX, States, uricase X.X an which is allantoin, potential efficacy. converts an refractory uricase are inflammatory of the use for most uric chronic adults. acid modified not development approximately eliminated does easily uricase development gout to performing and Gout The to are preclinical We the the increase under treatment treatment the immunogenicity recombinant estimated testing express for the [indiscernible]. of An population have disease. potential term potentially ProCellEx enzyme refractory thought uricase

weblike released NETs demonstrated literature, studies extracellular begun by diseases, neutrophils potential variety neutrophil have and human to in DNase traps, we product a DNase designing animal which PRX-XXX, X to the clean cell-expressed have circulation reduces trap We recombinant for NETs scientific candidate activated a our for that half treatment structure also of X of According elongated the are life toxicity. NETs microorganisms. related developing plant treatment that PEGylated have

DNase modified potentially may enable of proprietary conditions. effective X Our chronic treatment acute and

X of PRX-XXX trials to throughout clinical and both are We commence Phase XXXX. PRX-XXX planning

balance $XX in million we of an in Turning the we to million quarter USD cash equity our offering a term sheet, raised approximately and bank in ended year proceeds short $XX.X the with XXXX. additional gross and first equivalents public deposits, cash,

I but about will regarding support and our provide We sheet stock through ATM balance sale we our and feel also the $X.X raised would confident institutional stockholders. XXXX. received that quarter our program like common of added of commentary more Eyal the flow under new from cash to appreciate add during plans, the first have our we existing million

Before am and I this have team We just on time allow this of I to their to our material turn how was a proud effect what recognize a our operations. not commitment. adverse to of Eyal, challenging wish for and it us all global re-state for focus I did pandemic

to teammates our forward partners. and We and exciting for are an ahead of all year looking Protalix

for Let financials. me of a Eyal turn to you. Thank review our it

Eyal Rubin

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

financials. Let full XXXX year me review our

out as and $XX.X products the Phase of selling the in $XX.X is The agreements our due for related million the were as the to study, due goods $XX.X recorded recognized reduced been completion year of as increase decrease to updated ended as to million Chiesi for XX, III mentioned the and agreements. was million completed year Research of for recognized for previously. Dror for to of manufacturing costs clinical development XXXX. years the the and we Revenues a PRX-XXX were of license in represent Cost two $XX.X compared XXXX of XXXX same clinical drug the estimation revenues year ended costs development December III of have million of million the XX, conjunction $XX.X million December the XXXX. For costs December XX, three XX, manufactured XX, ended from ended trials connection XX, and decrease inventory. $XX.X to recorded well ended net XXXX. as services in revenue December and the R&D expenses from sold from to with period the XXXX cost primarily trials an the III Revenues license December of compared PRX-XXX, some related drug with Phase ended is for to two XXXX, Phase million revenues in revenues of $XX.X related year compared year BALANCE primarily of The goods the December XXXX.

as million expenses XXXX, primarily for from Financial ended costs. XXXX year expense related trials primary to We the enter more year of compensation the million research a for preclinical costs secured as share-based increase in XX, we expect administrative development to in expenses the our and to the continue versus million were resulted of ended for general $X.X The $X.X with ended connection $X.X clinical the $XX.X and previously. for stage December into for the notes. an Dror and described same year XX, primarily XX, certain million expenses an compared December XXXX. December in increase XXXX, to senior increase candidates, net a be advanced Selling, were product period

a our all you, $XX million of $X.X redeemed through offering turn cash convertible cash equity million during in compared March As that this This raised cash, quarter us offering we back our remember, There bank million of could that million December. we raised I sheet $XX.X sufficient are now via believe financial XXXX. our of private gross as and the term our We December to warrants. the additional equivalents to XX, on an potentially short stock million $XX.X common on $XX an proceeds Dror. we XXXX. an the XXXX. were completed a In position you XXXX, February, call will and approximately provides placement December deposits and second XXXX, $XX approximately probably past approximately runway current balance of quarter additional of through million be first ATM XX, notes

Dror Bashan

well support base solid positioned potential and we We are opportunities. Thanks towards to ahead We progresses. to updating look of a anticipated we believe forward as commercial the product with you and look an success, growth a financial launch for pipeline Eyal. year

questions. your take please now Let’s

Operator

question first Wainwright. with Our instructions] HC [Operator Ram Selvaraju comes proceed. from Please

Boobalan Pachaiyappan

XXXX? and Boobalan in dialing in expectations XXXX, would question. thoughts this Hi, for what like Selvaraju. taking performance sales Ram for is first to on Elelyso get your I Thanks for are your my

Dror Bashan

would you take to like Eyal, it?

Eyal Rubin

in connection The We about - $XX to in related our is maybe financials a is going Pfizer that and believe with to Sure. sales that both and we appears to the talk the same to our XXXX neighborhood, million approximately sales given are same Elelyso on mostly we that for the Brazil same, be in but better, little in pandemic a going the little the the remain expect stronger, number Pfizer. the Brazil.

Boobalan Pachaiyappan

With great. drug date your is what in on the PDUFA to to so is if I that, your right, are physicians? believe the approved the messaging All expectations could by FDA, elements what feature respect PRX-XXX, patients and and approaching,

Dror Bashan

we progressing we as updated. As things are as far know,

four months Our able we final I shortly XX will to launch approval, current that the hopefully few to to or QX of study, which the in pave will we positive, during next few if weeks, April clearly submission of results get Hello? analysis for to the one PDUFA in outcomes and release study the the interim and publish is date will, once be way the of we’ll hopefully European--. the the after. BALANCE BRIGHT hope weeks

Boobalan Pachaiyappan

hear me? you can Hi,

Dror Bashan

Yes, of course.

Boobalan Pachaiyappan

okay. activities you priced can when PRX-XXX, launch be about information? on What can comment premium right, the PRX-XXX learn a think will for pricing Fabrazyme? preparation I more little and for we thought line the All you went Do bit. the off regarding

Dror Bashan

are--actually, wait including and we assure approval final share to and the product that set go, our are we marketing, to approval. the medical can course ready I until will post I team, is the partner and etc., market suggest discuss you we market. and with the we Well, sales, then have of with everything preparations

Boobalan Pachaiyappan

from One me, final the sarcoidosis? right. comment moderate opportunity All can on pulmonary for you to market severe

Dror Bashan

indeed so is developed indication there right go too will and very many and which indication, approved it’s about if a will across things is hundreds will speak developed of well now not probably if be this unmet market billion get but specific for of consist or approval, indeed millions product interesting difficult it’s there a now. this This big and we focus so many not and ahead we estimate need, dollars, that’s right a of further years or are dollars drugs to

Boobalan Pachaiyappan

time. That’s it for your Thanks me. so much for

Dror Bashan

are You welcome.

Operator

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

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

John Vandermosten

and for my taking thanks everyone, Hello question.

go how BRIGHT that or implications about off How that modifying FDA with talking planning the study. for question with start for we opportunity? Let on dosing think a me a just label something modifying the the of the about or you periodicity might that should about different Is that? you’re

Dror Bashan

plan outcomes The submit supplement. so was part of of approval is study we study not--the the not BLA are submitted, the that to clinical post BRIGHT a BRIGHT

John Vandermosten

outcome? in What or a good. the Would months be the April very Okay, might six that? next timing it so, be on assuming XX favorable

Dror Bashan

wiser we end, month You be I or know, I will two from so. year right assume don’t now, be I but will today. hope control want to about in it don’t the timetable commit. a I

John Vandermosten

interesting a nasal for something has inhaled there if something and some seems I’m that opportunities for administration are that, pursue? delivery, for other and like like may PRX-XXX indications. perhaps inhaled approach, or that very certain Okay, that Is delivery benefits you wondering

Dror Bashan

the At to the be is inhaled present, SarcoMed - very this are all so PRX-XXX now. careful, right indications want I situation of with

as diseases, may I developing NETs say. an is mentioned, for elongated a DNase related category, We if different I this are X but

John Vandermosten

any trying FDA, think mention a Okay. stages Yes, in obviously get but or if it seems the of in you a United on waiting anywhere, had is and the been kind like an opportunity, inspecting even have the that. we’re date. of from this, inspections, to I’ve question key sense much you the Last that I that’s made is anecdotal for pretty observations interesting everyone been know how FDA those me just PDUFA on of going who’s States, FDA a early just along, I wondered how for the and going because on issue

Dror Bashan

with don’t I updates, have you going of once in market, course. what’s U.S. the the on I we key. assure will view official general will share it’s on Indeed we can have a that

John Vandermosten

Dror. Okay, Appreciate thank you it.

Dror Bashan

You welcome. are

Operator

Once time. again queue the star, at a and no telephone gentlemen, ladies call in your There to keypad. this for back management would like I over ask question, further on one closing turn to that’s are to questions comments.

Dror Bashan

I’d very speaking. thank much. and like this Dror their wish everybody healthy to luck. everybody is just and for This in to participation you and be I Thank safe, good time call, and

Operator

does Thank conclude This teleconference. you today’s ladies gentlemen. and

time this a at lines your disconnect have great may day. and You

Protalix BioTherapeutics (PLX) 30 Mar 212020 Q4 Earnings call transcript