PLX - Earnings call transcript Q4 2018 | Protalix BioTherapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Protalix Full Year 2018 Financial Results and Corporate Update. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today’s conference, Yossi Maimon, Chief Financial Officer.

You may begin.

Yossi Maimon

Thank you. Hello. welcome and Protalix corporate and XXXX full everybody results earnings update morning, to BioTherapeutics the year Good conference call. is today me Moshe President our With and Manor, CEO. available announcing our results PR is A website. the on the statements. moment to and disclaimer statements earnings Please take press include read the forward-looking a release, teleconference about the forward-looking in this release, differ that actual future experience These forward-looking known to cause subject the and unknown made. results may to materially statements are risks from statements and uncertainties and differ are Securities that in cause could results to filings US Factors and disclaimer the our and described in actual the Commission. with Exchange which the Factors. includes risks XXXX will XX-K The of Item under we file fiscal year applicable discussion detailed for of Risk Xa, a I turn With will to the now Mr. over that, call Moshe Manor.

Moshe Manor

for Thank XXXX you, joining full the and to results Yossi year company’s review and today good you highlights. thank us recent morning and

Fabry disease. and FDA productive discuss the for During can update corporate PRX-XXX favorable endpoint was development focused financial part for to lead provide Pegunigalsidase This remains the surrogate or the and the alfa, led of as program, the I approval. approval. to opening for potential company with treatment then questions. of up the this call company's will basis confirmed has held recently the path and an that the a commercial review which potential accelerated meeting lines accelerated the very FDA focus The clinical for the year, before rely will a of our BLA on morning, This on PRX-XXX Yossi highly

discuss an of quarter far the PRX-XXX by the urged fully the clinical planned the this with of to programs, us we data kidney accelerated meeting further where present path end FDA We before our we've The clinical optimistic additional generated discussion data cautiously C of agency, about X the second readout. the with FDA biopsy and initial thus potential again our our trial Phase approval content Type Following mainly to trial plan and from file the for eGFR to meet forward. XXXX. are

where XX% its based trial as the PRX-XXX, And based BRIGHT is completed the accelerated over the approval to our with trial regard end last potential and has XX% over for year, Phase believe discussion is development far meeting, clinical trial As today enrolled enrolment now enrolled. X that PRX-XXX. we FDA at of we on program during on trials company generated the of clinical BALANCE filing in be stand the already for might data BRIDGE our the recent the

has granted in Over characteristics the need the our year, past unmet treating product on patients. PRX-XXX for the designation FDA Fabry and us track unique fast based

last to also kidney Replagal patients improvement were very once preliminary data a from present October function happy We showing in study, PRX-XXX. significant to BRIDGE from treated were the on

In addition, neutralizing for preexisting BALANCE antibodies highlighting than characteristics less trial by baseline the inhibited PRX-XXX Fabrazyme. is

X noted to advice, physician’s regimen. with switching an the study than kilogram all In addition, that in the have treating their extension continue should that the per rather once-monthly treated with weeks in together regimen, followed XX to two dosing opted substantially completed have it Xmilligram study particular, trial every remained per milligram under once-monthly kilogram have be BRIGHT XX-month dosing patients the in back patients

for signed agreement year, and the include million has Farmaceutici for with costs we XX% choice tiered that to which PRX-XXXin and US balance of Chiesi rights Protalix rights European patients. upfront an ranging cash commercialization expansion of of $XX milestone discuss. The has to a to our the influx our belief XXXX. to up XX%. and Fabry of Protalix in strengthen All regulatory sheet, Chiesi in this from royalties to Yossi which was to partner will million support to along best with the payment above addition up commercial development be $XXX $XX for will exclusive partnership PRX-XXX of payment million, agreement in our for been expanded this resulted in Also great

discuss which learned additional early have PRX-XXX date other very data to will while our truly for completed is development. value generated for asset, with clinical data PRX-XXX with the supportive treatment of discussing potential encouraging, clinical I of phases needed. us of recognize the Next, early this asset, and the the cystic Starting fibrosis, PRX-XXX partner is both we’ve to from

focused our on we resources, Given in are focus and PRX-XXX cash PRX-XXX re-prioritizing XXXX.

our this response Moving a we results on II healing. had news in remission, to our a culture for Phase improvement treatment from We significant flow for XXXX. clinical showing program Phase and mucosal positive responsible clinical in ulcerative asset and colitis, OPRX-XXX robust II trial, of the announced

a collaboration. phase and BRIGHT our development BRIDGE We into study Type next to we’ll the Yossi was the finalize data with approval whether and and or on quarter report period accordingly. BALANCE decision come turn XXXX we potential a a BRIGHT in the next partner to potential to the PRX-XXX on the with to test, Overall, able busy to set are of one forward a next via following report overview. have asset in The this final to catalyst. the potentially enrollment FDA half from us, of clarity clinical the meeting in internally will both and still own being call XXXX including with. discussions will months or evaluating the back for Meet hope We will study, take now for to C of move one be from update the out our collaborate more currently XXXX very with XX studies, accelerated potential a year I the data Protalix. execution provide in second transformative market financial who a interim be are

Yossi Maimon

Thank you, Moshe.

now we need respectively. previously to under I to to company million, determined The start were and third over million preparation equal $X.X reevaluated XXXX recognize the Chiesi generated revenue company's of the and XXXX not recognized first, $XX.X -- second recognized. with and certain first, recognition report, during we revenue quarter $X.X So revenues million want agreement with policy license of our that that the annual

such, each XXXX. decreased of restatement company's of for the periods As the loss the

for during Moving net the into a compared million from and XX, same million compared revenues million million $XX.X XXXX. Research excluding million of period loss diluted goods of ended ended per loss due of administrative selling year general for the $XX.X the were increase to XXXX, mainly share, reported net revenues million activities $XX.X from expenses from recorded revenues from re-measurement goods to XX, Protalix ‘XX expenses million December for all XXXX. Protalix $X.XX for and million XXXX, XXXX, Phase year $XX.X and license $XX.X for which $X.XX of and ‘XX. to the $X the license of down $XX.X comprised period $XX.X or million of total full compared in million the and of to $X.X selling development million to derivative a per for or share $XX.X compared XXXX Fabry and trials. same across basic December the were Selling, III basic diluted to $XX.X in the

back mid-XXXX. current our we us FDA that QX XXXX, questions while potentially XX, call We of could Depending position cash ‘XX that, and through of into on equivalents, now audience. could which consumption the was discussion and the through a As cash to who will that open turn payment up of $XX.X filing million. will the had cautiously take from with cash in call from even Operator? for continue, With position take for will cash significant approval operator will how us our cash December $X million I approval, the accelerated estimate milestone this trigger Chiesi. the

Operator

comes first question our with from And Selvaraju Wainwright. Instructions] Ram [Operator H.C.

Ram Selvaraju

much general my a for questions. I very you couple had Thank taking ones. of

underlying you for at better restatements the question principles pursuit if in could of combination trends was second out wondering, should as if it's revenue or the these us granularity the And or then the maybe I things? look specify Brazil approval of and whether a tied to nature us could you of revenue forward. potentially be Yossi, of revenue And and is understanding restatements is a more exactly going if give that Firstly, PRX-XXX. to Brazil can this driving spell those principally if other accelerated we for relating

Just wanted clarification a on couple of points.

Firstly, of approval, sense then of, of what conduction you. with were be round are FDA, next with PRX-XXX particularly you discussions us considered your commitments pursuing and And respect to Chiesi submissible be? give the to you C Thank be if or post approval to accelerated going the for a secondly, can meeting? preparation for the might the Type

Yossi Maimon

will he will Ram. anything I start if add, Okay, Moshe have will add. and to

the received the licensing $XX we with recognition, So has to R&D are over in have million. recognize of started only The revenues from million Chiesi received have new of the date, pronouncement. we of that and $XX ’XX revenue hot recently we revenue approximately in reimbursement it upfront including to in from total that payments and a accounting been Chiesi, connection with in topic tied million had agreements. the $XX To terms

of as in to into of life but these and I’m recognized XXXX, million. need So saw recognizing of was that XXXX that million think some million out the approach basically, the – recognize sorry we we came the in of -- the early $XX any about beginning, about early year, about $XX $XX accounting we total, revenues, not our reevaluated $XX we new In start And to pronouncement next this revenues. you million.

related, or those these not So, totally product are related separated. not cash are

actual C that we’re revenues million $X.X at accelerated next that believe just the should Pfizer. meeting from with into was recorded us of that actually through connection $X they In go accelerated the terms to the products we in another potential we with to In go Type approval. sold to million held we meeting. product sales in of of going $X.X include and urged apply end filing Brazil accelerated revenue, the In approval, – data the for filing XXXX, meeting product the which recently meeting, FDA of the million

have – gone cetera data to we cutoffs, the them underlying gone through with move actual we data, the filing now data, we include want with such together et this to that have into potential conceptually, in agency, approval. but want and We the

as we, granted our from for US approval, significant are agreement. I In are milestone if from said, successful we terms and Chiesi approval due we license are we accelerated of,

Moshe Manor

accelerated to to in this question, confirmatory And if study. your will actually, such case, And our is the Ram, just Moshe. add to be – approval study is granted, that BALANCE

need so studies for don't So any additional approval. we full

Ram Selvaraju

licensees don't at XXX potential for to would they this this with And of clarification, you indicated time, discussions that would see want potentially other then Thank molecule, since the before what you they can mentioned about us, as intend further or perhaps release to specifically licensable? you molecule have just press this need development you but any clarify that believe I in one had some you indicated you. they view conduct

Yossi Maimon

Yes.

So I I found controlled be study is all were a it interesting, agreement. or move parties general, from we looking some into clearly placebo that in think out think into something licensing would say the engaged data all came but study very a required and to it that order I that will have that that meaningful in that participants, controlled

the say and potential that So could later payments, this change could will on because PRX-XXX, milestones the cascade with we depends of XXX that year. approval quickly, picture change this could but and to it change have will it a lot de-prioritizing evolve the this and very obviously, things et we're point how Fabry at conservative continue, we're quickly, accelerated cetera be that prioritizing and as will but not FDA path then very

Ram Selvaraju

regarding this And regarding one to thinking strategically. quick XXX twitches maybe XXXX, thinking debt. we potentially intend approval, the very November you're just for then accelerated ruled extending of maturity do is what be Should eligible what the some debt due sense about just your you us item if dates, convertible it, refinancing do give

Yossi Maimon

Yes.

these, strike a almost to X.X over years X for like have converting then, we which remind just that is So, until $X.XX. at price there's years, I'd

they're to depends to how going be it, whether we're a of or repay So cetera. what to et it going we’re stock will think a the going price it say with lot early it, also I react, whether portion to some on converted, too of it's do of

think before going we're if way too hour, know the at going well, We it's to think going be to I issue it's I say. address to very way the I think this. So we to to we're long a and noteholders so an but surprised we have when early be even addressing be don't issue, this XXth need

Operator

call Everyone, Ladies you. that you conclude a Thank does all day. conference may and great have disconnect. and our gentlemen,

Protalix BioTherapeutics (PLX) 18 Mar 192018 Q4 Earnings call transcript