PLX - Earnings call transcript Q2 2024 | Protalix BioTherapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Second Quarter 2024 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. Mike Moyer of LifeSci adviser.

You may begin your conference.

Mike Moyer

welcome and Protalix Business and XXXX Second 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

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

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

Dror Bashan

you, the for review our our financial Eyal, begin Thank our you, update. accomplishments and everyone, will will provide joining who XXXX to Mike, results. handing second before financial by recent I reviewing of business results call thank a and quarter

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

initial first PRX-XXX, of to PRX-XXX. line will cohorts turn of results recombinant I in candidate PEGylated results uricase through X is I first from Phase first the our for treatment top which recently clinical of encouraging We announced our the produced the development platform Protalix in-human study uncontrolled gout.

following elevated levels. dose PRX-XXX double-blind, As and evaluate ascending tolerability, dose single a single study of placebo-controlled, pharmacodynamics to a with safety, uric is subjects study designed pharmacokinetics in acid reminder, this a

the dose-dependent and review of the results exposure PRX-XXX X the of mg/dL. X PRX-XXX on cohorts manner these data PRX-XXX study reduced can level the PRX-XXX of safety by uric guidance adding escalating, increased cohort Xth also dose this expanded and to an and Phase to I below committee in now initial of from the -- and we higher cohorts, the Dosing is the we plasma complete tolerated X potential top first time. well XX days based of progress. its monitoring the increased The in concentrations initial preliminary acid by in was result dose generally so results safety exposure period acceptance for the Xth analyze a is rapidly we demonstrated follow-up expect cohort, in in line

be full from in We year. expect to the study line top results available this the quarter of fourth

a study, and already meet the the have of to we PRX-XXX We gout. initiated addition with the communicate preparations expansion with also trial I in to Phase In plan for Phase patients uncontrolled II discuss the authorities goal in the with to the initiating U.S., Phase clinical II regulatory next Europe, of in our overall the the of mid program Europe and study II Phase year. plans in

the term. partner, a we committed they disease remains [indiscernible] disease, and Elfabrio the penetrate to commercialization market experience heavily rare a Our successful are Elfabrio commercial space, team. their and will continue wealth for [indiscernible] of invested the build franchise and that on confident to longer in of has

in accumulation with next for treatment expressed various been which different recombinant PEGylated [indiscernible] have neutrophil development in or autoimmune for observed is of Our pipeline nets effects, human fibrotic DNS nets. of [indiscernible] can the candidate Protalix's in pathological or PRX-XXX. diseases and also PRX-XXX formation Excessive candidate inflammatory a potential conditions. associated extracellular result

to product assets PRX-XXX, and build our on are focusing development pipeline. efforts PRX-XXX early-stage development our we Beyond R&D

and our indications. have strategy the disease renal pathway the resources for focus renal [indiscernible] diligent to Fabry We is existing we experience through This and program. dedicated rare as pipeline. build our on to the given therapeutic on is the prioritizing focus network development efforts forward development logical platform forward disease to With throughout and a areas, our leveraging moving core going prioritize fine-tuned our Protalix of and our the regard rare company

PRX-XXX diseases. being associated renal, example, for autoimmune net-related is For evaluated

have our addition, need is indication which ADPKD, we we unmet and -- identified others. syndrome, such key these which potential efforts plan to and for initial in identify to on FSGS [indiscernible] other high In ongoing currently as Work focus indications. assets

exploratory they our delivery drug plant-based evaluating may progress. of expand the protective to different novel on tissues. order ongoing, In modalities we allow updating specific you look and progress system these forward efforts platform, These that as are studies delivery are into to we of

intend advantage of we prosthetic as oligonucleotides platform, innovative opportunities. such small modalities, In molecules to and addition highly to explore other take our to

position the including the convertible Phase turning II cash call note that in ongoing strong due our September, repayment in the and our will September our to of to X in to Before operation, Eyal, notes actually next enable maintain want gout. month I study

anticipates ] in In and expect as launches continue II gradually markets. future addition, we Phase additional [ approvals KSD [indiscernible]

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

Eyal Rubin

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

XXXX million $XX.X Let $XX.X offset decrease $XX [indiscernible], of X increase June partially to sales XX, ended the an from of resulted X XXXX. We second million by XX% months increase million to The million months or sales a $X.X XXXX, a primarily of quarter revenues Pfizer. ended to in revenues million in decrease during sales Brazil me financials. recorded from million in review our $X.X for compared decrease of of of an selling and the to $X.X June XX, goods

compared launch to with approval XXXX, June the United for months Elfabrio delivery. marketing million June after in months [indiscernible] revenues XX, R&D XXXX, XX% [indiscernible] The and X months increases were $X.X its in the to or to XX, of resulted primarily connection $XX the ended of European the States of decrease XXXX. $XX.X XX, Union. million We million and recorded XXXX, the X June from ended Sales of ended revenues sales the for timing services during in from X buildup for X of XX, license June commercial a and inventory Pfizer the months ended in

recognized primarily million [indiscernible] agreement. of comprised was goods the ended during revenues the FDA million approval are primarily in from $X.X XX, services increase the and in XXXX, the from company R&D and regulatory ended X goods XXXX. in of an increase connection license R&D Brazil. sold or sold result XX, June June of million months the of ended X was milestone X and payment XX% with license months of granted $XX XX, the Cost from increase to the the cost with The Pfizer revenues million Chiesi were connection months that period. for an services Revenues Fabry of from of $X.X of result The XXXX, goods the June $X.X for sales sold cost to of in for

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

subcontractor was research XXXX. expenses. For of approximately X for of months the million $X.X related to the and million XXXX, salary $X.X development million, $X X development were million material-related or expenses months June ended expenses, and $X.X XX, and of in June comprised research decrease the of and expenses, of months compared approximately X other related million expenses company $X.X ended $X.X million approximately XX, Total approximately XX, the ended expenses approximately XX% XXXX, June total

the for decrease $X the $X.X research in expenses. to months Fabry and or clinical of and million X Selling, decrease review in the ended related in $X.X U.S. Union ended for resulted European the decrease applicable compared XX, completion BLA general The program a The of and to the development resulted months regulatory XX% administrative from and the XX, regulatory process primarily expenses MAA primarily by were XXXX, the $X.X in salary of related and expenses million the the a million June company's XXXX. million agencies. the from decrease of June Elfabrio X

of June $X.X respect Tax compared the in income ended recorded $X.X XX, notes executed benefit expenses resulted ended ended months months in XXXX. recorded deposits X X the Jobs due million Income $X.X to higher the a and were XXXX. for XXX XX, was Cuts enacted for provision conversion the million to XX, months in XXXX, the of XXXX. financial June ended are the interest XX, U.S. primarily the tax of million In June expenses result taxes million X bank Financial approximately on income Act, current $X.X of income XXXX, of Section months X taxes net and for December compared the to taxes XXXX. which of notes primarily interest for net from June Difference lower

$XX million approximately bank Cash XXXX. and equivalents June and cash deposits were short-term at XX,

ongoing the enable million share net our the we Pfizer the million September XXXX, compared position months or company quarter $X.X XX, XXXX. the million Net same to XXXX, and approximately per in As is XXXX, notes convertible ended cash per for million X Dror sufficient of $X.XX mentioned, to $X.X and believe to our a share loss diluted June repayment operations. due for approximately our was X, the basic for per or Since ended period $XX.X to of the $X.X from collected XX, diluted Brazil. $X.XX income $X.XX sales sales aggregate and basic from June the in end share the approximately of and

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

Dror Bashan

in I Protalix the To our Eyal. would Thanks, to and of enhanced next confidence strategy development. express phase enable my pipeline conclude, to like

and sales and We and to Pfizer in Chiesi, to have our we of X to streams grow. Brazil continue revenue revenues expect

from our line top to the We the eager are clinical report we interim with study, results are and pleased results soon. PRX-XXX

look pipeline assets potential and stockholders. to -- we drive forward long-term value renal we and develop continue early-stage and with expertise also to diseases, We for to as and rare both address patients we a to innovation our updating to the leverage create are continuing progress platform our of

I now for to much. Thank open the operator you And very questions. to call will the return

Operator

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

John Vandermosten

it you negotiations of to Can How has to have Elfabrio give on a able going of to can been to available? get able in to And give available uptake it been -- you sign been get sense a formularies. to of that? you it payers how has have make it get and sense and or Chiesi been big there for the and -- payers any us us make by

Dror Bashan

in past, company. it discussed have the we think Chiesi I private a John, So

their can are payer don't I all as we by see we as know -- are what but doing far say what payer, So they they well that and of Europe do they I U.S. numbers other know, well forward, markets and of in to in course both know, also outside we and going in a way of penetrate more Europe. significant claim and in they the from

about they and them the the from expect is good, we since And markets well. X continue months, very give are -- so. that biggest from about -- the Germany, are what we in we example, launch pleased the U.S. we outside the be take, we expect now year, -- available or and are is from actually, for understand U.S. will to do believe, the of drug very what I which one So the this in it a and . expect outcomes is

John Vandermosten

a Okay. know I'm some to terms I have numbers. an with when of Chiesi pretty can hoping us We're sales can still. to But need And you would to help sales what you sense getting another is inventory still building lumpy that might kind thing and provide of of the what you it's probably be? do the estimate be. sales in the guidance idea

Dror Bashan

on Not the depends it at moment, shipments.

we batches Since before. is we assume penetrating they're are what less product of I had they to right and stocked to and do, they it's also the the their So now because in year, same more said, the also you -- we in drug This the rightly Europe next as months, XX stock. now, first agreement. the order or

until or we god of November basis batch of of the [ QA XXth next cautious. would just be So stamped it something one quarter try ] concern now, is god will XXth just only It's to ongoing don't say, forbid, we quarter and know, not Right -- to slips could while I the that we try it -- to we the I will is hide it have, on of end some, that take it knows forecast. not because what. be a are that

Brazil, to say hit will minus it because x minus to or of Chiesi million then what. a or would be knows god we don't of million want $X to $X batch batch dollars, millions So we only

view saying I I'm on So the make we not need with bit more we in we But is doing. think are emphasize a what time. Chiesi want to again, check order a pleased to box.

going focused. of anticipation We of good much next and and this gradually pleased. continue results put us. see continue the lot we very They and They will . that the are are ahead a effort, years forward

John Vandermosten

you the it's Do on going? with ongoing they they of Or meetings how kind will a have [indiscernible]. -- it you more is do provide team update little to bit

Dror Bashan

myself, Not Protalix. update only our team on medical cetera, of Yes. No, and they but operations, sit no. also multiple et both management and also disciplines with

the good. are whenever for discussion Board or we it whenever very the So week, clear, our relationship ask, we management. course. relationship just -- it make with of other we don't to or ask But do every an update And

and so. Chiesi do Chiesi, [indiscernible] they're So happy to

John Vandermosten

event presented. guys last [indiscernible] that had Great. which the you KOL Yes, helpful year, pretty was

-- And the might But kind from XX that we on can sales? of of the in there Are on I on or out is do your one disclosed you've months related there expect next kind maybe this don't be details any So the that. that might at year next to so? I milestones it think is again. in that -- point? Or there further view mean you based

Dror Bashan

of the difficult of on even today to It's for on, me It pace . [Technical Difficulty] the you tell course, depends sales.

Operator

we do have. for difficulties We that we technical go see do

John Vandermosten

Cut still out. I'm there? back. Dror, are you

Unknown Executive

[indiscernible] .

Eyal Rubin

dialing . again. He Is back. doing back He is

Unknown Executive

Okay.

John Vandermosten

while Well, you're data fall. -- Eyal targeting are you. the I that one conferences up Great. report Phase PRX-XXX Is to can there coming doing ask he's for I another this any that for

there's that like conference certain I wondering it you're I that targeting. a And think was be said if soon. ready you will

Eyal Rubin

We X early participated the the from of early data full all one from going the set the November. are No. in or and be to actually just -- sometime June cohorts around released

until for the I attend getting So probably do And By prepared I behind mentioned, Dror II. we guess agencies everything the fall the you pay that obviously conference with next work the be ACR. we're done, to then, we joining. get going be will is the scenes that meet guess to as way, to to that next plan Phase going the to

Operator

We do have Dror back again .

Dror Bashan

I Yes, for off. cut being apologize

Operator

Our Selvaraju from Raghuram the comes with Wainwright. next of question H.C. line

Unknown Analyst

How against This [indiscernible]? if does PRX-XXX Sobi? with respect is for to on does positioning Protalix up to PRX-XXX some from follow-ups, we Where Envision Dan We'd SEL-XXX Protalix have Ram. like stacking could.

Dror Bashan

intent. the not I or the said would we This also say at outcomes let's If continue weeks, today, dose, we we the the does the Phase we we it Phase a good I I think will the both So say, are finalizing which enzymes. with we Phase the in and as infusion hopefully, II we this X are, But what build now, goal. again, mentioned, and fly. probably once will I, event. is are intent. -- with have This said we would mimic II investment a is think program. I, This we I is multiple you very if Phase hope to know see have fit in [indiscernible] wouldn't I only as interesting aim alternative the seen the

Unknown Analyst

Awesome. on to you early-stage which R&D That elucidate efforts some has program candidate? monetize oral anti-TNF suspended? makes partner promising? programs and the Could you you of your Or Do or find that expect been sense.

Dror Bashan

No, This program off. has been

with in than bring we stage We are say then, of something They we Once seen are or like share, say, preclinical want sign or be more half will would Until now. validated, them evaluating, would early we programs. right this. [indiscernible] don't data, a very to I course. dozen I

operate. we So

know, any or update be hope next, first would do even I the to or able right say, to X that on We programs in maybe to get the have first the opportunity. quarter looking, we I will two the And so. diligently are believe We don't we resources pipe. very into

Unknown Analyst

exciting. Thanks. to forward That's We about hearing really look it.

position date? notes have Assuming cap or full And structure? new guys to company do maturity debt due repayment repay plan different convertible what the these replace the notes or future month, notes you next a does to with the of related with

Dror Bashan

by and new may because the to cautious. not X. So plan mean, refinance I a debt, or be take currently, I We pay notes -- and plan we not September if We I intend to currently try to do say.

mentioned, II As operations and sufficient Phase of both maintain I to both Eyal gout. our myself, ongoing inclusive us we believe of of resources the have the

As streams revenues, we we range them grow of X have to mentioned, future. the we which expect in

money, So zone more point last, X from stabilized dime I or good the financial from, the is of quarters. I a view, I one I this even add right always a position. a danger . Certainly, to situation didn't moved say, that now. that certainly, kind have in X It's financial we would much but of Protalix summarize raise to believe, would more would

will So do we it cautiously.

Operator

no I are back to turn There would to Dror floor the like for remarks. time. this questions further closing at

Dror Bashan

the everybody, look Thank forward on much. and quarter our very with We thanks, to . good report. hopefully, for next So again. you time patience. news we'll to Thank you have you meeting and the

Eyal Rubin

Thank you.

Operator

does this And you teleconference. for thank conclude today's We participation. your

You [indiscernible] at may lines . disconnect your

Protalix BioTherapeutics (PLX) 14 Aug 242024 Q2 Earnings call transcript