PLX - Earnings call transcript Q1 2022 | Protalix BioTherapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Protalix First Quarter 2022 Financial and Business Results Conference Call. [Operator Instructions] I do reminder, this conference call is being recorded. I will now turn the conference over to our host, Alexandra Schuman of LifeSci Advisors, Investor Relations for Protalix.

You may begin your conference.

Alexandra Schuman

Thank you, operator and welcome to the Protalix BioTherapeutics’ first quarter 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 read to in disclaimer about moment the a forward-looking release. press take the Please statements teleconference The this statements. include earnings release forward-looking and These are subject materially and cause may that to forward-looking to differ risks statements actual the from made. statements uncertainties known and results unknown in results Securities actual and to cause the could described with States disclaimer the are United that and filings Protalix’ Factors in differ Commission. the Exchange now to the will I turn call Mr. over Dror Bashan. Dror?

Dror Bashan

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

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

course. We questions, for will of open the then line

results event, at a study April, were favorable we steps. topline treatment study, KOL successfully completed University of analysis data our and topline disease primary Let the all of the the to the for its positive Birmingham of Dr. also of the the me next of and the this Phase with data. the David our final the described that a BALANCE report provide the BALANCE trial in pleased the PRX-XXX April, endpoint, At met clinical study have to tolerability from We analysis notes. year. We discussions in our quarter took Alabama BALANCE the the After showed summary Warnock immunogenicity third collected place BALANCE for of which in profile PRX-XXX. from and begin of of in very Fabry announced trial plan results III

BLA the Global Disease for planning Fabry biological significant the of We half BALANCE, conducted that $X is and of the an market include company studies track It BRIDGE second intended on BRIGHT the (ph) The together unmet meet year III BLA from PRX-XXX the community before. FDA license development to course, company a to also the I/II and and Phase need of Fabry to market Rare or be of the potential was to overview or achieve and therapies partner, need goal. package with the application additional its Chiesi continue Chiesi the that billion to provided study, results the resubmit clinical positive company's which three and described the patients. of in trials, the collaboration currently Phase will this

As subsequently MAA Chiesi three European or be for disease. period. validated with the on demonstrating the Fabry good is XXXX, III starting best by patients the EMA of X, with the Phase Agreement was studies, potential PRX-XXX Agency EMA. the Chiesi Medicines Authorization from Europe, Protalix and after February treatment or to of enzyme in for a replacement The therapy, and announced, inclusion October, gain the End Review In in BLA A, with and resubmission. details both the patients naïve consistent data believes company Chiesi the experienced compelling the FDA. last sets from meeting approval. clarity Type and participated The for on company the we treatment pathway which were Marketing submitted data believe the company and We for There PRX-XXX transitional a

Chiesi commercialization pathway in-house PRX-XXX. global of planning a with partner approval and the [indiscernible] full have capabilities manufacturing our We clear anticipated

we highlighting that Additionally, early existing stage a -- the we in will developing. as progress of have program pipeline

company. global Our goal commercial world-class strategy continue new is our investing to to candidates in becoming support biopharmaceutical product of

pipeline. continuing cash of approval in the early claims to resubmission for sufficient enough provide support balance runway stage XXXX, sheet addition our us our to until QX Finally, develop potential to our with

our continue to will Eyal, available. review go stage the financial our I to ahead. turn We results. pipeline Eyal please made show will progress advancing now once early

Eyal Rubin

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

Let me first review our quarter XXXX financials.

March of quarter $XX.XX year. bank license ended ended agreement -- Notes million sold End XXXX last same equivalents for provides period the $X.X expenses primarily to $X.X was were trial were ended of net a effectively the the For maintaining the ended for or three of XXXX lower Chiesi. million $X.X $X.X same recorded debt compared year. ended related XX, to increase $X is with approximately sold XXXX. costs will I increase XXXX the were increase the $X of (ph) $X.X million the Cost $X.X as cost of in from with of year. same to turn million represent, connection last PRX-XXX revenues call for an short-term compared or revenues about million, March the million sales. three amount administrative of to $XX.X expenses amount the then company's our company XX, was expenses $X.X or position by cash period goods costs March XXXX, the the of were months increase million X% R&D XXXX, year. XX, extension the for last license for company principal Revenues resulted Research months $X.X Revenues March that transaction, from our the aggregate clinical primarily ended Dror. XX, decrease XX% versus XX% March million, result were the the due $XX million the development goods for III its from from an three primarily the cash and to XX, R&D an revenues current period million exchange XX, of for issue million compared months decrease increase recognized aggregate $X.X financial of million Phase the million of study. higher XXXX We million of December notes. The and of of services cash services million of and $XX.XX of amount and the runway the same and XXXX. XXX% of The amortization XX, increase XXXX XX%. XX% August a and quarter subcontractors for XXXX. decrease of selling of $X.X of related $X.X to recurring outstanding The and of exchange supply ended completion three of result and the of to XX, sufficient deposits for total license Financial company’s in compared XX, the us goods $X.X in quarter million XXXX debt (ph) cash, quarter million last XXXX. the general principal for versus period compared believe an XXXX company's the March March XXXX interest March $X.X of the for principal of new In third in through now for million the notes, back million million Selling, or period months $X.X $X.X and same to with

Dror Bashan

Eyal. you, Thank

Europe to working from market. the everyone the BLA the today's for So, to in and Chiesi together call. in hearing to look closely our MAA forward submission thank U.S., with submission EMA the on bring joining on PRX-XXX partner the We us you successfully

us option important the are and looking We by opportunity treatment disease. potential bringing adult Fabry patients of forward ahead excited to this for extremely with

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

Operator

you. Thank

Vandermosten of question We John from Our Instructions] conducting with Zacks. questions. a your with first question-and-answer will the comes now be line session. Please proceed [Operator

John Vandermosten

wait the guys doing prior to clock given Eyal. that indication know? Thank you much and of Does well. up may stop and see are for what have the about want good EMA you an things to the they Dror afternoon, ask pretty submission. wanted pretty you I they or Hope clock do and soon stop ask to coming EMA the to

Dror Bashan

are We input. the for waiting

John Vandermosten

Okay. Very good.

thing to EU. Another the related

Now that the there process EU. last market. the is get UK to to access to What's

from there started they to of or might looked Is the in XXX there on EMA? by kind I approvals are individuals I anything still think of at I about needs accepting that done and terms be additional benefit hanging PRX-XXX.

Dror Bashan

today, to later to this get So John maybe topic, and back verify I have tomorrow. you

Okay.

I answer, accurate I it's, until prefer think know your okay. (ph), I okay, if but the

John Vandermosten

some know myself even problem. No that's weird of mean kind I don't Yeah. Okay. is thing there kind of right I I help. now actually, and

Dror Bashan

it's John. a good But question, very

So, I but will get to shortly. you back

John Vandermosten

in any mind your let's on Sounds bit out needs good. see anything touched done. to little probably a just -- I get sticks that And that think you this

that's particularly there Now finished with compiling putting second that there? half. mean -- I the out I anything and guess together FDA sticks submission. trial putting things that Is BALANCE mind just the you're your that in together for information for important we're

Dror Bashan

is right reported, (ph). heard if I say, Everything to

(ph) analyzing and So, the of BALANCE. CSL we indeed are the finalizing

four Looking including at clinical [indiscernible] all trials, data. the all safety

years I it of dots the may see just the hundreds if may and many the to full good connect exposure and to picture say. We and I say so have say a drug, reflecting profile I look, which the strengthened is actually, if safety may very of on the data, totality if

John Vandermosten

explain finance the what a attributable the Can loss that to? cash operations, question. was for and the from and Okay. you attributable the used cash is was Last me difference flow in cash between -- operations one difference just so net

Eyal Rubin

transferred non-cash such as for depreciation, share-based Obviously, one the Yeah, one the net not position. cash the loss the a the includes it's includes compensation. into

and As $X the plus I the for we if numbers, the our many mentioned rate net where you years. quarter. is two burn times million approximately think that past, in the we quarterly And run past are in that's

John Vandermosten

Sure. Exactly.

I Thank right. you all Okay, me. all it. appreciate from so That's much.

Dror Bashan

you. will John you, get I and to back Thank

Operator

Protalix, no your today's on Thank conclude this do you. appreciate Instructions] participation. There behalf of [Operator this time. at questions And does further teleconference. We are

disconnect rest time. may at Enjoy your day. this the of You lines your

Protalix BioTherapeutics (PLX) 16 May 222022 Q1 Earnings call transcript