PLX - Earnings call transcript Q4 2021 | Protalix BioTherapeutics, Inc.

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Operator

Good morning ladies and gentlemen and welcome to Protalix BioTherapeutics’ full year 2021 earnings conference call. At this time, all participants are in a listen-only mode and the conference is being recorded. I will now turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors, investor relations for Protalix. Thank you, please go ahead.

Charles Padala

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

Dror Bashan

for financial Protalix introduction, the welcome and fiscal you results everyone update yearXXXX business to Thank and Chuck, call.

progress provide plans. programs key the During of our an of future our today’s and call, of some clinical will update I review

Following will Mr. during then I’m Officer we the our review we Chief the progress our very line my Financial will Eyal and questions. for with open results, remarks, Rubin, pleased XXXX. financial made

Over of multiple in made forms. we the significant last course strides year,

First, BALANCE study to plan we next results Phase study top we line the and share of week. III this finalized have by

which have with actually submission or for our submissions, agencies applicable the PRX-XXX was February reviewed with pathway for XXXX. of MAA Agency, our pathway regulatory EMA, EU submitted Medicine for have We the or regulatory marketing agreement, we reviewed for and authorization European of the in

collaboration invested have thank to resubmission for later the reviewed of efforts in FDA Global Rare all be In close pipeline number for and PRX-XXX, PRX-XXX I of to parallel, resources their partnership. to have for and programs. their in our of our expect we stage or year. biologic much a to program, very we submitted early aspects commercial advance partner, them the appreciate Disease we Chiesi we States, this the pathway we United with the want which license the to For application, BLA continue emphasize the

significant maintaining Our goal the new human focus while pipeline in candidates and is to line. finish a bringing to and capital invest both financial our to continue into more product establish PRX-XXX

the sufficient Finally, financial last have until we strengthened half QX cash we year, sheet of year--of runway and actually, second now XXXX. balance this our in

review Chiesi letter our greater In regarding guidance FDA BLA. September and XXXX. expected With with now meeting to the and A following and the for our clinical of study BLA BLA second together We me we with we of XXXX, This year. half April completed resubmission in Let results we results FDA to in a received BALANCE in our PRX-XXX include will developed pathway Phase of BLA actually the a III complete resubmission data from detail. took package the milestones FDA, response for this of the the from Chiesi a place for expect meeting Type received PRX-XXX we trial. resubmit anticipate PRX-XXX the

and anticipated discussion application. treatment authorized this If analysis patients expect approved, collected to announce the data. We of European provide final later nations we Fabry potential might we application the A In of February BRIDGE data of compelling assessment line all together if Chiesi of week. PRX-XXX BALANCE III validated, in confirming to in The that believe scientific new Phase a adult next for our and positive, XXXX, case the be Fabry for trial European the be for sale the Medicine results is the with III we essential to would mentioned, trial the all were included elements member As available was finalized have after Union. required BALANCE for for an is that MAA results, the with the the MAA Phase this and sets BRIGHT regulators from consider study adult year disease. top to patients to analysis with Agency PRX-XXX option of important disease. treatment submitted all the

We looking to they as have updates are and forward excited this arise. are we providing milestone to very achieved

is have the early reducing in Turning administration uricase disease. for not treatment We recombinant million immunogenicity PEGylated enzyme easily as adults, studying does an our improved we estimated intravenous stage which express Uricase estimated X% refractory States, a which longer most to pipeline, it’s expressed humans. ProCellEx United life, affecting common the is and are a Gout and approximately exist to X.X PRX-XXX gout. gout use that recombinant inflammatory half optimize to allantoin, population enzyme in term via ProCellEx efficacy. chronic converts potential refractory to enzyme, for uric designing an of are of arthritis is to potentially we naturally however, through considered enzyme and is eliminated uricase acid urine; uricase have the

I We toxicology next clinical study have early initiate Phase earlier we year. year initiated to studies the plan this and

for a of which is DNase treatment expressed alpha, is dornase cystic I, diseases. by to DNase The and fibrosis FDA related system, inhalation. life half approved second is the only recombinant PRX-XXX, via NETs in of PEGylated one circulation the our DNase human designed ProCellEx I patients for elongate treatment The

potentially for the in you to ahead. We and we we identify conditions as and are of an financials. develops turn will target acting of Eyal, NETs program developing the a long go [indiscernible] Eyal variety review which please DNase to initial indication. our now treatment customize medical a are I update will X of

Eyal Rubin

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

Let me and full fourth review quarter financials. our XXXX year

December due same clinical license December revenues million revenues Phase the of $X.X with for December of the XXXX, the decrease year million trials compared million the million program. was XXXX lower XXXX for Dror or December XX, XX, December the for $XX.X and license revenue of ended of agreement. XXXX. Revenues For of to of Revenues X% $XX.X primarily an to completion million year manufacturing due $X.X goods BLA the goods increase from FDA PRX-XXX $XX.X versus period an for of the R&D selling million is or manufacturing million connection ended decrease in compared costs to then-anticipated ended from of $XX.X $XX.X increase incurred XXXX. the XX, million, to from for were decrease services for Chiesi ended represents Cost connection XX% The year one-time $XX.X or year is the December was while recorded XX, $XX.X in million, the approval in PRX for costs. million as $XX.X we XXXX. the XX, XXXX from increase ended primarily agreements the R&D December XX, we XXXX, of year the a December year ended ended ended and costs recognize higher with The the for expenses primarily mentioned. XX, XXXX. compared PRX-XXX, sold of preparing million XX% to The incurred XX, year were III the three the $X.X year

an of elaborated ended general $XX.X compared were Financial $X.X expenses or the to into mainly corporate more as December million expenses to $XX.X primarily million as earlier. year decrease certain primary million the and R&D we year period December XXXX. increase candidates, advanced for XXXX. $X.X million and for of million costs a in our XX, expense continue the for expect year million insurance. stage the for or a versus a ended XX, net enter was December XXXX, of The XX% be increase XX% related of administrative $X.X product Dror We to from expenses preclinical XXXX, Selling, by an clinical $X.X XX, ended increase for same of resulted trials to

of of deposits approximately XX, December and XX, XXXX. $XX.X cash, As term $XX short as our were compared cash million to million December XXXX, equivalents bank

of from notes earlier to I third third a quarter provides quarter runway you, XXXX. believe XXXX maturity XXXX. We the sufficient to financial to aggregate back turn cash the through of to successfully us the of we now our our during amount will remaining effectively the mentioned, then-outstanding Dror lower the that position $XX.XX Dror. As and notes million current call XXXX principal of to extend exchange the note completed convertible

Dror Bashan

today’s collaborate Thanks with Thank together to to and closely EMA market. the you joining call. you look Eyal. to FDA to all us for the We PRX-XXX working to with bring Chiesi forward of

mentioned are for I we excited the in sorry. lies--I’m my extremely opening remarks, which opportunity As for resubmission

remarks, my excited half of are we opportunity for which lies extremely I opening resubmission in the in mentioned the for XXXX. As second ahead

Our for with aim potential is treatment important to disease. bring forward Fabry adult option this patients

your to back Now Operator, I have please. the the call let’s questions, turn and will

Operator

[Operator first question instructions] ahead. go of Zacks. Please John from comes Vandermosten Our

John Vandermosten

what to the the Eyal. good your Hey, the one the the again. BRIGHT voices hear from was to study, In regime afternoon four-week regime? trigger for two-week switching Dror, patient Good

Dror Bashan

study? BALANCE the Again, please - in

John Vandermosten

the in sorry, I’m BRIGHT study.

patient the in to was study, the the from what four-week for yes, the regimen? switching two-week Sorry, the trigger BRIGHT one

Dror Bashan

the John, we I that were it about back one and don’t look enrolled. you. we answer into will have out speak if front get me, can in patient to of of I XX

John Vandermosten

the Okay, two-week, shifted wondering a because then one just the be was something and regimen, or all patients trigger on shifted supposed was four-week I are them to that that to that. and noticed what--if of the I there

Dror Bashan

I there assume will will course. facts revert, a and of I trigger. verify was Yes, the I

John Vandermosten

interactions product sounds a already when Do they rolls sales going already sales on your have Disease, have yet? Then in good. they’ll place Okay, they on-- team Chiesi have Rare started so on,

Dror Bashan

ago, I each experience, ahead companies think I well. three have sales, actually the on please rare are infrastructure, wide year do main--you co-marketing, Yes, disease access, recruited etc. close to a if advocacy, They and assume, remember established companies of I may, market [indiscernible] to so year continents, marketing, term, many about know, remember ready ground we I yes. so actually were the experienced business, that years speak enough, to and go. ago, They in to with already of this close if assets from hundred they the of the have other in experience patient with, years have from and approval ago, infrastructure they a well

John Vandermosten

you’re me BLA the resubmit? really from you the submit to completed thing the study, resubmission, Then or final the that, news. That’s before Is results from on last else the is results also get is there great there resubmission. on BALANCE needs only the to that PRX-XXX question something that waiting

Dror Bashan

a finalize so, assume will study study be I will we actually--you critical of [indiscernible] is on the as final around fit to once to--or ready couple open We I and are and actually, will steps parallel CSR, it it’s in of take is the that, Actually done. the say, course line it there later know, is a another results path are verifying be is submissions is the well, the and results months and geared there but weeks of data all once report, moving, we BALANCE but everything a share, will this clinical on. nothing it. and year QA this into establish know, you else, then move not the with be beyond why we if which then top at we of few is process the CSR - okay then may finish

John Vandermosten

Okay, back thanks Dror. detail, for you. hop Thank in queue. the I’ll

Dror Bashan

sir. you Thank

Operator

again, questions gentlemen, register at star, this time. and any to Once ladies that is one

go have Please additional Zacks. We questions of coming John from ahead.

John Vandermosten

taking for follow-up. Thanks my

increase couple questions something an maybe next on for mentioned incremental R&D. for a that Eyal, year-over-year. we’re the that, going about Just year to you forecast see

You had do R&D as of XXXX. the in see expense direction XXXX? that What in for about $XX million you

Eyal Rubin

early stage see the net-net investment preclinical pipeline. going that more to we’re assume in I and the

progress as we’re we we neighborhood, net-net On the same us, of a significant. it’s the the guess as the going to regulatory expense nothing in the be going maybe of not costs but most so I part submission, behind PRX-XXX couple expect R&D of more, to be million in to be obviously

deploying from all us, I the pipeline of think of behind new capital done into the deployment we that and XXX, or are the expenses the them trials are are have. new already the most early since we

John Vandermosten

Okay, Thank that’s you. helpful.

Operator

I’d At for comments. over to closing you. like Mr. Thank time, turn this to Bashan the back floor

Dror Bashan

news good is Thank again time, that. to for week. thank you I hope the I we will you and next have have All for

of accordingly. very will course, We Thank you, update much. you

Operator

thank today’s concludes your This participation. and Ladies for you gentlemen, event.

your You this the at disconnect may or rest log time, and day. off of lines webcast the enjoy your

Protalix BioTherapeutics (PLX) 31 Mar 222021 Q4 Earnings call transcript