PLX - Earnings call transcript Q3 2017 | Protalix BioTherapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Inc.

Third Quarter 2017 Earnings and Corporate Update Conference Call. At this time all participants are in a listen-only mode. Later we'll conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions].

conference recorded. today's reminder a is being As I to Mr. like to call over turn the would now Yossi Chief Maimon, Protalix's Financial Officer. Sir, you may begin.

Yossi Maimon

much. quarter and Thank welcome our President today very Hello morning Manor, good you CEO. everyone is to Moshe third update. XXXX corporate results and earnings With me and and

about materially actual release read issued that and XXXX. that and teleconference statements like which unknown XX-Q to and and forward-looking your uncertainties U.S. our attention will is the be from cause well. available results release, also recently and quarter release, and forward-looking some to statements announcing differ risks for Exchange as may could are third also filings Form We on are our made. statements Securities a disclaimer as forward-looking to Factors of the I'd future and to described in Commission moment take disclaimer a the press press subject experience earnings differ the results, cause actual, our website the includes known in with These the well draw in statements. the and to this filed results obviously the

turn of applicable the year-end and XXXX. We will include draw over filed connection with factors the Mr. we you in now a to detailed we Form under With Section to also I XA would attention risk discussion Moshe also your to like XX-K Manor. will which that

Moshe Manor

a Yossi months. the over update you discuss few the turn On call progress delighted be to to financials. and past review you, the will call then over Thank I and am Yossi. achieved has here morning for to company's provide today's joining I to thank corporate us. Good Protalix today the

a agreement The a financial of lead significantly for quarter our secured for partnership we underwriting expertise rack thereby Chiesi partner not milestone strong was program ex strengthened with for instrumental territories clinical open clinical and it deal in in a treatment to Fabry strategic with disease. as our our Farmaceutici only extending U.S. in the signing PRX-XXX positions achieved also major Protalix for This space but commercial XXXX. the cash EU

recall an of thereby the trial million, our term This of development $XX may upfront was you reducing of to capped associated under large payment also the received Chiesi million our clinical -- $XX year. Protalix at agreement As of portion with cost per $XX PRX-XXX up spend. PRX-XXX covers a million the course R&D sharing

years outside States. marketing than respiratory And specialist and company disease. all with in presence and to royalties digital innovative markets introduced had of entitled million is the Their current focus development potential few of XX up XX% say Chiesi and payments on a familiar Chiesi I to want an $XXX them. with regulatory commercial international therapeutics, be Additionally and they more commercial medicine milestone of rare is in you to and we the privately held may words not some drugs. to in experience two are in United the ranging as from XX%. and

Moving product. on PRX-XXX CF our to

of Following development positive to Phase for to support grant Foundation on data we heels PRX-XXX. Cystic the the the submitted Fibrosis an of application a X clinical

the with what continue asset to similar the PRX-XXX the of from we We Chiesi. expect in with parallel the be In for a did goal with to potential response CF PRX-XXX maximizing partners of in first discussion half XXXX. and Foundation we active value

combination it approved and product because is in interest with the there tested [indiscernible]. developed will but CFTR it Pulmozyme newly potential with of has the potential in partners not clinical provide the because to Speaking only benefit also including be

the colitis. by PRX-XXX top product the This this to patient final for study currently ulcerative results study needed track XXXX. in line remain phase. on completion of announce treatment with We X pipeline Phase early screening from in nearing is currently earliest trial Our is

discuss Finally to commercial Alfataliglicerase I Gaucher of want product treatment our disease. for the

or the by made we $X know million formal for $X.X September order purchase the Shipment the purchase to As you payments during Brazil With quarter. be partnership. turn run funded order scheduled additional this with from of revenue and see upside seen over cash review this of call to approximately potential XXXX According of Company, into other And excluding for we shipments was from the solidly may that financials. last quarter March million who nine Chiesi XXXX. fourth are XXXX. current million our will are months have year was we XX.X quarter in rate the total on XXnd will completed the to XX, into a any ended plus any received what Yossi above the I

Yossi Maimon

Mosher. Thanks

the reported $X.XX I or million into So loss we numbers, a will of diluted with we months $XX nine first the per basic will and excluding We of think dig of in compared for off net for $XX XXXX. with $XX.X diluted the share the start period in same a loss a $X.XX remeasurement of net basic to onetime million derivative connection XXXX. and non-cash of or charge million the per share

XXXX Protalix notes SG&A was the entirety the and XX, to in reminder derivative into recorded and $XX.X to million were increase compared we Pfizer. R&D same same to million revenues period attributed increase primarily XXXX. activities the is $XX.X until expenses Brazil. of not sold as The for XXXX. increase to remeasured the Brazil following the during million period in drug $X.X in The were derivative of during the period a sales compared $X.X also and to in in the conversion its to million sold in same $X.X the period day X.X% for for section of attributable increase the in drug substance million also mainly feature accounted again. is As company for shareholders' was XXXX. and $XX.X the equity that reversed a was April compared convertible revenue million the

XX, Chiesi sheet balance cash September was $XX.X just date the million in obviously. equivalents, that we before the XXXX received of $XX after cash had we million and As from

To and all of are period XXXX convertible due on and million principal that I had senior in also we excluding that notes mentioned the partnerships reiterate Chiesi the point During company's aggregate payment $X.X entitled the aggregate and convertible through is secured which plus the notes revenue X.X% on this X.X -- increase million milestone received, of of million. of would composed notes. amount convertible any XXth notes I as with October investors the $X.X already are with Nov our potential notes from XXXX into XX.X in cash At like that future. that Chiesi September rate or of X.X% any other funded due an value we one we current to the converted cash face an conclude from the the XXXX are run of or

puts I think any that back we to now the in Operator. like I will right turn will end I to call great the questions. a position this call us the now. up for the and success floor would to open operator,

Operator

line will Instructions]. Wainwright. [Operator first question from Selvaraju H.C. our come of from the Ram And

may begin. You

Raghuram Selvaraju

and congratulations of a thanks guys, my had on regarding all couple recent Chiesi things taking progress. for the Hi, I very questions of your collaboration. much

infrastructure Chiesi is it costs provide Firstly, whether by Chiesi's the could could would on be likely for it and and and bring include with could costs PRX-XXX territories development specifically might or in what Israel? And be think just be not their in to specifically Thank collaboration? you commercial by territory? like through confirm if Secondly funds disease those if support some what extent with territories and some orphan commercial to are sales they can of bear collaboration when you to thirdly alfa us you more color which approved development those helpful granularity pegunigalsidase marketing allocated infrastructure existing that that their to you. give covered us are clinical covered this the are if and on you to the respect

Yossi Maimon

is Thanks Yossi. Ram, it

is ex-U.S. that what U.S. past is a Israeli share you market one, disease go excluding big So, looking to the were unlikely an first all the one it it's to. market basically Fabry is in so an maybe rights, so was easy for not territories the

of so, think I that the what kind that kind be will cost terms by cost their given is it of of bear the of the so indications they is covered clinical XX% be contribution that for of some Fabry program. them, will we In about estimate will an likely

this and have the and rights in and terms obviously about so sells been a have future of all of in. that of exclusive products $X In the company virtually is presence territories in billion they that infrastructure do marketing they granted now sales

will they to meaningful future order made have make parameters to a deploy and to of point that tools So sure gain necessary share also we and territories. the certain expertise it and the in they these required in undisclosed in committed market actually

Moshe Manor

Ram is And this Moshe.

provide licensed company already and Denmark. the to have one on bought Chiesi, [indiscernible] couple and move they of I clarity in Just into decided world they to years mean of some ago they a disease

So The and have products in activities so that couple they're will building they to the experience outside very make and by be the in Europe disease important in the market significant will which the we unit really the still is U.S. time in capability to us. and as U.S. in which the disease eventually with is texture world company have of will of the market know the Europe roads except in that of this promising we

Raghuram Selvaraju

thank helpful. you, that's Okay, very

but things thinking additional the on of going not to notes balance you. the longer-term you you other to you and in with a or give XXXX, be year if could of or the into how just us around with can firstly this to increase the same or situation about should that on contract how that early if two remaining there? evolve you have overall bit anticipate we them stay next year if contract expect decrease the comment you you visibility you do longer-term that Just And due little going expect to expect if forward? beyond are also redeem some Brazil to any I end orders do visibility then may, the what convertible Thank

Yossi Maimon

Ram. Thanks

the early too I say. think note in terms think it's in XXXX of to I

funds a we more We have it's past one also right it. at different all -- and as to have the now to that be than to not address in Thanks the options it we challenge this we way used address point. to have do

did and it converted date. reminder been past refinance of a the has we it has As basically to in some all of

still the us. we and is we time in have best the future what route for will So see

I shipments timing for out. exact going have challenging forward In next that terms of think the to go kind of Brazil it's to

Brazil the what We what still level. macro future in in I too etc. beyond the Health to have of much exactly I now it's general to Israel and working shipments the hard actually we so we still our -- into translate and has have want nothing visited met doesn't the with that's detail have visit And go already on doing of this at that all in of when changed the intact to month. that timing visibility But shipment beyond point. are with say Ministry to are other expect the later I this had numerous actually paperwork, we officials that we already officials don't think made that -- Brazil relationship into than think we next clear the we Ministry ability immediately on our with and Health site on

Raghuram Selvaraju

Okay, much. thank you very

Operator

comes our may Welford begin. Peter next from you the line from Jefferies, question of And

Peter Welford

Hi, yes, three thanks. please. I've questions got

the your to just then likely in XX.X correctly PRX-XXX on sticking Brazil I remarks from did the of million go opening hear you the year? you'd then line, of with rate? options Secondly you. like And the but think is appreciate discussions end that's that it if but continues now into or consideration for a said partners I up, into did on the much that we finally should that table moment much sort on this reasonable with for rights I goods the XXXX probably just depends on see it to the appreciate should of as all very ongoing for some from said potential run gross margin P&L, it retaining level mix of the revenue XXX Thank that like consider are retaining take still potential XXX, at pick Chiesi, what as your just we the cost U.S. you you I were rights? the of potentially Firstly, now

Yossi Maimon

Hi Peter.

$XX -- be it's we November I on we challenging already the the -- yeah, million is going shipment. think So next to entire that's that and think getting in that and is working are are although reality I in XXXX

So, into we indicate XXXX. obviously that in did I will terms this timing think of slip

about terms In I of that just should think ex-U.S. still. necessarily we thinking don't be XXX,

think everything that you globally at margins are earlier make think it P&L, yeah, And that we opposed I program. obviously table, this is more point, be substantially I sales the sense more higher to this even see Brazil right the there. certify margins from the will on drug lastly these as the are about the as may the is we'll the substance higher the with on margins

those to know but to increase So, don't I think what we I that expect extent.

Peter Welford

potentially from likely any it be you. until do -- review? and to from amortizing on great up just so filing are to the or period these be finally filing you're as you have Chiesi, be will revenue, into That's what then, that Thank the the now visibility to likely

Yossi Maimon

is Yes, look about There coming still announcements some that. we into. million to need that has so recent the out upfront been something accounting $XX exactly

we that and what to look So amortize to period over need have see of will time. if and into exactly it we

So have we an just yet. don’t answer

Peter Welford

you. is That Thank great.

Operator

from follow-up H.C. the Ram have a we Selvaraju question of from And line Wainwright.

begin. may You

Raghuram Selvaraju

points Yes, clarification XXX just couple of on I if XXX and of a may.

potentially for round set to you kind the clarify what product could So that is in XXX us you candidate going give look or program partnership the would or some past clinical you development wait if scenarios for having the anti-TNF the expect of resemble could discussed that? once start development board we've regarding on next are timing of that out a like. future the I on to with which you that start oral potentially of if you to are is it that to next believe the respect conduct after your sense year until the ex-U.S. what a Thank partner this of And whether then timing what have likely to is you. and development I fact potential global? clinical thinking you without a registrational and come early results what expect would know and you could with with

Yossi Maimon

that the terms to timing we we so as grant the just we Foundation. of Okay we actually in invited Ram, do for think -- so been filed just for the XXX I by CF that mentioned, have

it we So filed actually just recently.

get we're before what sense wait comes much once grant and stage. going until it we we with to a embark I development how think think partner get a that sense also I along of on the of it we next to makes for have us

of I already tone want the size the make think set kind be development guys be like heard to path, discussions you of the next want in the we had, terms that's if etc. the will on these sounds from and and will decision protocol, it the step what earlier of to study clinical

until clarity on we'll at us point this So be for some wait get this. I wise will it think that to more

think engaged the already of that kind have XXX see to think and waiting once I I people of results we terms have we In results.

we final we are being have As screened. patients that mentioned

going going I with that eight it's think line week announce label, could an after We study, so to soon that it's it's to an top fairly out enrollment be end we're that. quickly data. open some very we're which

partner. we definitely a I think have for wait here will to that

-- the I this this are we if locations, for ways, mentioned. could much partner have just so positive there's that different here think different be a and to many huge reasons could obviously for and I that wait the many all will results go

we sense definitely do to to carries it and wait a so. in of So upside make instance this have I will will this but lot think

Moshe Manor

Yeah, is Moshe. and this

not add question big move Just you it of with [Technical of go extended to the a a if aware it's products would so all the of your as any Each Yossi participants are Difficulty] as indication. only at listen-only different the mentioned that, a time the into because could the of platform be indication to want this it. can It proof that one is different really in know. to in as of concept is with so forward mode. that we be significant overall in case indication

Raghuram Selvaraju

later and has Great, more for more the see It Tel on thanks and I flexibility applaud you pipeline quite so having much going to I been much so this really really you very to intriguing expense that's strategic and now. much place been Aviv in look forward week. taking guys seeing

Yossi Maimon

you. thank Ram, Thanks

Operator

Ladies and time. at all gentlemen disconnect. no day. great further questions today's program Everyone This thank the I'm you showing may conclude conference. have participating does you this and a in

Protalix BioTherapeutics (PLX) 8 Nov 172017 Q3 Earnings call transcript