PLX - Earnings call transcript Q3 2021 | Protalix BioTherapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Third Quarter 2021 Financial Results and Business Update Conference Call.

As a reminder, this conference is being recorded. I would now like to turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protalix. Thank you.

presentation. your begin may You

Chuck Padala

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

Dror Bashan

XXXX welcome the everyone Thank you, Chuck, and and company's financial third business to quarter results call. update

call strategic for the roadmap today, progress of XXXX provide our on beyond. our review the I During the and remainder will update key clinical an programs and of

FDA for the Rapporteur with quarter for to Agency and Medicines Type PRX-XXX. data Authorization in were with with anticipated landscape the October Co-Rapporteur that of BLA MAA interim to in that submission Chiesi BRIGHT Co-Rapporteur positive of BALANCE the MAA for support an from pre-submission BRIDGE FDA combination the resolve will package XX Chiesi the the and has Mr. reported of in resubmission, resubmission collaboratively the a Rapporteur submission. our the the year, to a In we the the during the Eyal study, this before to of we a the the continue PRX-XXX the for for Protalix approval At generated for data from and treatment the on FDA Officer, final PRX-XXX company September meeting to will submission been include June to analysis the planned and with in meeting the up A year. for proposed regulatory MAA outcome, and the necessary in patients. Protalix half drug EMA of the given the of the disease. in questions. the partner the next Chief Application second open of In Fabry the participated a and financial two-year the pleased remarks, for is changed regarding European alternative data the treat leading This FDA, of the the and previously discussed to and a and in announced to generally Marketing BLA, we the the which this package and work Financial were our analyses Based XXXX Protalix the that application, United step traditional PRX-XXX announced potential The data planned to Following months line the of in my of has results intend XXXX. for BLA activities Rubin, the company's held States, the the and study the Union, the issues scope important meeting, a study biological FDA company submit anticipate expect goal review of Fabry the first the XXXX, of the Chiesi Chiesi principle during CRL new resubmission We license noted the of with commercializing PRX-XXX. with and BALANCE European agreed supportive

plan which PRX-XXX, results patient the financial and data respect with the overall We assembled a study to as In profile impaired the October, The in through of The is a dosing second BALANCE thereby randomized, study treat period. of the as burden part the of survival. that active mice clinical for uricase with the chemically with And company plant promising development Fabry control a confident on in proposed blind, demonstrate working of a activity disease. response of and has DNase renal line the unblinded with to top in XXXX. experiments double for explore frequency several [indiscernible] enzyme XX cell-expressed the developing accordingly, in refractory treatment, the and we PRX-XXX, plant PRX-XXX reducing specific function. the program. of determining last XX-month, studies PEGylated human dose of extensive for every to And higher have modified hospitalization patients PRX-XXX possibility our are months a we experienced half announced are for diseases. is feasibility completed which cell-expressed NETs-related the Chiesi the community. of recombinant study the in Fabry intends to would in showed of model the XXXX the BALANCE several the by [ph] first PRX-XXX treatment We PRX-XXX longer shown the quarter in of quarter for in in treatment PRX-XXX final is [indiscernible]. data necessary patients together during study all initiate preclinical lessen toxicity X gout patients the development have we release We two the dependent which recombinant for plan patients And after treatment physical anticipate remaining PRX-XXX, of PEGylated of [ph] treatment the been months addition, life.

protein third In develop methodologies begun addition, we with for working a have new modification. party to

strategic we potential as the partnerships with to PRX-XXX, I treatment collaboration plant candidates. marketing our pharmaceutical for and other cell [indiscernible] for biotechnology considering potential for DNase stage as early a are well indication programs recombinant companies product We evaluate continue and which

new We bringing medical how acknowledging our for for mission comments I emphasize stage my will high update resiliency this such difference much please financials. to your unfold. and and grit market important partners with Eyal, to I our close a go Eyal the efforts a unmet will needs. with a ahead. pipelines as of now towards are section turn review our our making of events patients medicines members of like would early during challenging you on time and to of team

Eyal Rubin

matures three million the The in XX% million timing the and the agreement of sold million sales. X.X X.X and offset The ended exchange. under Revenues XXXX the the in indenture XXXX to to X.X all through delivered to company XX, additional November for million. September development Cost XX.XX million XX, services in are a of X.X a the revenues goods the the remaining the two now newly to with settle summarize, to study. required ended aggregate Thank was increase were reduced result the primarily decrease of operations maturity representing important of phase revenues company and clinical principal increase X.X of XXXX, XXXX. the during is months amount XXXX, remaining quarter third we goods XX.XX September in X refer of XXXX. months aggregate outstanding the which R&D license III an September decrease supply was are was or of the license majority And referred generated end XX.X its selling the months of company XX, of Chiesi. pay the of accrued the from from million of license XXXX. three has On September or an has unpaid Research R&D you, were of funds X.X comprised convertible million primarily interest company's of I of the timing decrease were result I'll and difference decrease and the was exchange. September notes approximately resulting the in The today was To to to notes for senior at recognized in sufficient due XX% the cash the with XXXX outstanding three expenses services XXXX. in XX, has R&D XXXX, for notes. was million resulting an exchanged PRX-XXX X.X September million September cost company's cash Revenues and from exchange, completed partially the XXXX. then X.X sales well. will goods recognized XXXX. The ended its of unpaid of governing company the X XX, notes supply of million BALANCE costs August of X.X The with Dror. from the than Today Kirin connection cut notes increase now to three XXXX. secured primarily effectively Accordingly, to half through date agreements ended expenses thereon. to all in XX, A XX, revenue goods interest necessary our months ended the XXXX the of of months of XX, remaining been trials issued ended XXXX by million and and date three X% principal note X.X increase Brazil outstanding debt notes million milestones study million cost and to months of feasibility million million of X.X company X.X offset closing license September substantial fund institutional more with the exchange by X due Pfizer three and of related completion of of sold are XXXX X.X% by from at Revenues the and amount million senior XXXX and debt or of increase [indiscernible] In out notes sales the XX, financial but completed an results. and the sold compared three X, compared and revenue the from in secured as a for capital of X.X% for compared three notes XX, difference ended a from as exchanges for XXXX, holders. flexibility XXXX, or of months the convertible million level in -- Chiesi. the for accrued XXXX to higher the November turn under June the million discharge note

of costs extinguishment expect expenses and expenses, more the of related We in and related enter compensation. I million a and net, be as three exchange in Dror into increase primary described three increase of XXXX an X.X increase The million, the September same months earlier. XXXX corporate The decrease months insurance X.X ended for Financial certain an we XX, of million offset million resulted is by on partially XXXX. period product September mainly as X compared continue notes, months Selling, advanced for X.X to costs, the R&D for in general million expense and of for administrative as described ended and or with of XX, XXXX. expenses XXXX X.X were X.X million from to to sales increase stage to primarily increase million X.X a primarily September result of were to our our previously. the marketing the candidates, X% million X.X share-based in our loss trials XX, preclinical clinical the ended three

equivalents XXXX, had I turn and to in call of the As back million bank deposits. September you, XX.X Dror. will now cash we cash, XX, short-term

Dror Bashan

with And for Thank addition, you, you patients. bring in as commercialization Chiesi Eyal. FDA together adult the progress. update PRX-XXX closely We working we’ll matters and clearly, forward the with to look Fabry to closing EMA

please. questions, your have let's Now

Operator

At session. [Operator we'll conducting a question-and-answer be Instructions]. this time,

Selvaraju Wainwright. H.C. Our line first from of question Ram with comes the

with proceed may You your questions.

Boobalan Pachaiyappan

We Balan just key is points the questions. update you. sites? discussions our This Hello. Thank more the inspecting for a summarize on focused if can Ram. And Thanks so, for A little meeting. manufacturing data. Thanks there? you the Were speaking on taking wanted for the Type the

Dror Bashan

manufacturing the of is So it. part

their regulations FDA nothing the in the essence. assume regularly -- review we non-inferiority. will agreed weeks facility. now submit, of are supposed one to that years And will with review. an we We the is than once agreed the are data we in data There -- as for with they FDA the will the And by with add we I four that FDA more endpoint two inspect that

Boobalan Pachaiyappan

Okay, then us. And great. Thanks from more for there's the clarity. one

two-year between that given the expectations of minimum will BLA what's these So would be analyses best-case phase So do you and study, the requirement final baseline reimbursement? why? the study in over delta eGFR favorable not? treatment to your for include think what the a III the think demonstrating you're regarding Do results? looking arms? why yes, your BALANCE active at superiority is If If the [indiscernible] a you no, winning and

Dror Bashan

area. is I will -- And we second strategies say to will in regard -- this or suggest outcome. if I suggest reimbursement marketing first, wait the I with plan, may future for I Chiesi

them can course. of approach You

Boobalan Pachaiyappan

you Thank for right. very answering All the questions. much

Operator

John of Zacks. next Our Vandermosten from with question line the comes

with You may your proceed questions.

John Vandermosten

are Dror Eyal. Hello, you? How and

Dror Bashan

you? are How Good.

John Vandermosten

specific where well. expect to Is the BALANCE a meeting you or present doing data? there I’m conference

Dror Bashan

you please? Can repeat question the

John Vandermosten

a Yes. first present it to meeting where next data specific conference of the the ready or in when Is expect you year? BALANCE half there becomes

Dror Bashan

have whatever report. see we to we to CSR, will First, study following establish clinical conference there we assume top data. when a do or in I to beginning. that, line Then the will analysis will at be a we results the a order be all the present share the specific participate usually conference will

John Vandermosten

that right will be timeframe? about fall. assume would Does the I that And in Okay. the probably sound

Dror Bashan

the We QX. will top expect results that in be line

John Vandermosten

point. at you'd great. at Okay, thinking some it I was a Well, present later conference

Dror Bashan

top planned think results. are also I results line

finalize data. all indeed is to the and intent further analyze the So

John Vandermosten

question on a notes. the And convertible Okay.

I down going listed small of there amount was the on that balance listed paid think the sheet How was for on today. forward XX. was there proportion that should much November a That that's convertibles? reduce amount today, that we

Eyal Rubin

I notes. leftover X think approximately XXXX from the amount the million was

John Vandermosten

me help like for margin. is that with last quarters for or going there the see any there's It seems that could terms you gross the to Is sales give any rather things forward? been forecasting very recent could Okay, in in volatile good. proportion product one And in guidance us estimating of on us of future? wanting and you it's help if

Eyal Rubin

at it comprises have the hard that it’s we could Chiesi. than end we of on That for ones a mixture. reason. margins simple different Brazilian Pfizer that see. a The the be have that the the ones Obviously, we and are you with with settle margins And the have day, the

John Vandermosten

Okay. is Well, that Thank you. helpful.

Eyal Rubin

welcome. You're

Operator

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

Dror Bashan

everybody you. Thank thank time. the And you for

We will to you very going on Thank you continue much. update progress forward. our

Operator

today's concludes conference. This

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

Protalix BioTherapeutics (PLX) 15 Nov 212021 Q3 Earnings call transcript