IGXT - Earnings call transcript Q3 2018 | IntelGenx Technologies Corp.

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Operator

My name is Jody and I’ll be your conference operator today. At this time, I would like to welcome everyone to the IntelGenx Third Quarter 2018 Earnings Conference Call. [Operator Instructions] Thank you. Stephen Kilmer, Investor Relations.

You may begin your conference.

Stephen Kilmer

Jody. Thanks and joining everyone call. on you thank afternoon, us for today’s Good me Dr. are the With line on Horst President Vice President Zerbe, our and Godin, IntelGenx’s CFO. and CEO, Andre and Executive

assumptions update that like Before accordingly I Canadian to mentioned are be forward-looking made today risks We securities by represents laws. and any Dr. found contain turn with change. the U.S. in to our on amounts may otherwise like these mentioned do Canadian call A subject any number information statements, to and Zerbe. Details remind Horst? dollars subject materially. we us of forward-looking U.S. preparing to as unless our Commissions. to filings which today risks differ would obligation except not are I’ll and you and now maybe forward-looking begin, today’s expectations were these the in U.S. factors can in assumptions Securities are of to over all statements, may results undertake call and by that and as required

Horst Zerbe

afternoon have welcome pipeline Steve. corporate Good will and a quarter progress today’s call, and call. our you, to I provide third the update the discuss XXXX made Thank in conference we IntelGenx’s On projects.

will recent questions. Andre our equity that, up review results lines the financial your for Following offering, QX open and discuss XXXX the then we’ll

our various have make advancing to significant development we products. continued of quarter in This strides the

manufacturing The crossover, study the to mg bioavailability from the of RIZAPORT acute pivotal, was September Toronto, advanced Ontario. RIZAPORT of tablets mg in with The European healthy was request study is past single-dose, allow fulfilled FDA’s a RIZAPORT manufacturing disintegrating the the a XXX(b)(X) a XX thin-film review related under reference, reference direction product. complaint XX of of full mg transfer to plant U.S. most for results Maxalt-Lingua GMP that three-way for migraines results and Company’s announced start Let's Biopharma in new conducted orally the information treatment for oral bioequivalent of bioequivalence successful oro-dispersible XX RIZAPORT. Maxalt-MTL resubmission we demonstrating for the Maxalt-MLT is tablets additional study XX Services The formulation to volunteers. rizatriptan comparative randomized, proprietary study and NDA which bioequivalence to IntelGenx the of Maxalt-Lingua. This study

approval We of XXXX. end U.S. RIZAPORT first the continue of look to half before for of

XX Grupo in European of is for required initial by the a the Healthcare. new As also for Spain. Europe to in of to October of who used contract additional Spanish Healthcare IntelGenx GMP the IntelGenx facility mg Exceltis Exceltis the Once was RIZAPORT part marketing marketing Juste Spain. study approved. Agency marketing product AEMPS IntelGenx. may support authorization authorization the authorization will Devices to In national Medical commercialize received applications Medicines partner and commercialization RIZAPORT This listed transfer marketing in our countries. from to enable in This site now RIZAPORT is granted of manufacturing will the manufacturing late the of be It to be the support European transfer application

the Now brand indication let’s clear on with from that dysfunction indicated current only erectile update it license pulmonary dosing fully NDA touch our exclusive pursues violating application for without would intent pending has with on to now has an the we launch for like the tadalafil exclusive you bioequivalent product a reached hypertension resumed. patent treatment. and their obligations. can a FDA some hold and path IntelGenx erectile an Eli commercialize time future. company this the dysfunction IntelGenx into negotiations launch, near the exclusivity we expired. have be put for to have Lilly Orange entered in Yes from to the some Cialis contractual, XXX recently a tadalafil that to product circumstances with Other under Earlier which is Lilly. under license agreement provide and opportunity tablets. substance product confidentiality context certain jointly the and These I patent been has a to status this is could strict, on take at that product year allows Book negotiations the foresee that listed

throughout have period independent XXX(b)(X) that to file the before on negotiation cause understand year. of are discussions be to the believe to confidentiality this this that pursue before we continue our agreement in of In some business our with interests provisions strict potential our NDA. continue admittedly the the partnership is best Although the and partner of partnering frankly potential NDA to is end year we an we our own to track end our It that were own entire and subject contractual frustration. important confusion absence XXX(b)(X)

and I on as will our always benefit reasons shareholders. our At we to often competitive we the calls strict time, best to you that past maintain hope are as the other get are deal of committed as possibly to I possible out maximize have agree thereby confidentiality. pointed can. being for the However, required transparent intentions same we all are and

the highly research, for leader executed supply a use adult-only companies is global will Longer will distribution films Tilray cannabis-infused oral in the highly products two adult-only an week news, agreement net with medical exciting co-developed we of definitive on anticipation licensing and and worldwide and the production Tilray co-developed cannabis and earlier medical film single-digit onto sales. cannabis with likely will commercialize receive and development those and packaging. distribution. film significant lack the to in in Tilray cultivation, products. cannabis will Moving unique IntelGenx respectively also and to markets. and development to rights its believe to The Inc. important consuming the co-develop fixed the rights endeavor XX% regulations a to medicinal cannabis this a dissolvable amended of will and and are cost child-resistant smoke, approach consumers. will IntelGenx Tilray - Canada relevant exclusive We that exclusive supply of have the Tilray harmful of XX% discreteness and cannabis in portion appealing and dosing fund VersaFilm the associated marketing ease products. the the the cannabis-infused products precise to enter product with of use, and allowing use cannabis Partnering markets. edible of of both sale development appealing to product manufacture have royalty adult-only due a and Under cannabis adult-only and for agreement find for our

of news Insud for buccal billion announced submission welcome first of this with chemo of shareholder and the achievement market our transaction. submitted of it of film PIBC which to industry under had worked IntelGenx in private and is that Tilray In see dollar both expected marks other that product we under is the to milestone. major Canadian about XXXX. $X the We’re with product terms in the in number growth cannabis for IntelGenx for also Insud, new former sector a a This legal strategic pleased in connection partnership with the regime the value. FDA. October, the a analysts The EBITDA forecast to cannabis generic participants as co-developed of significant partnership the ANDA co-developed is and group, the been

patients next over expected Montelukast. indicated pleased The evaluate patient the Cogstate grow To repurposing carry retained Phase and mild-to-moderate Alzheimer's the Medical now film the cognitive the to out billion and in and product such eight is efficacy, announce $X seven years. now JSS screening tolerability, our Contract is of year, move have of degenerative are At Organizations of diseases of again testing of drug treatment a other for Research. clinical as impairment, this trial X of sites Montelukast and brain, addressable diseases. certain on Montelukast activated to our market that are this very Alzheimer's, to study and and recruiting been opportunity to September, IntelGenx Let's of major disease. patients. that buccal in services the significantly beginning With the we safety of the excess initiated Research with in we similar

the two capture prescreening week, data this first has patient electronic entered and the earlier sites patients. actively in of are system other As been

has For all call and over test this With Andre into patients like come the meeting of - I study. discuss review briefly entry terms turn who patients in been results entered, our be Andre? criteria, now positive enrolled would results the recent the offering. selected will then to financial that CFO, that Godin, will equity patient the our to

Andre Godin

Thank Good you, afternoon, Horst. everyone.

take mentioned, to I'll few performance ended September a financial the quarter As Company's for discuss the minutes XX, XXXX. third Horst

monetization validation year decrease The increase manufacturing that compared to $XXX,XXX of in for for compared $X.X to million in XXXX, on Adjusted an were on comparable the corresponding to last expenses XXXX, in SG&A mainly deferred compared XXXX. expenses and comprehensive per is revenue period it in [indiscernible] increase in per $XXX,XXX It last an million by for year. this $XXX,XXX the For Operating year. QX to revenue share in scale-up million attributable attributable to increase to for last versus all QX, to mostly comparable SG&A is offset of compared $X.X and period loss for the basis, of of EBITDA $X.X to of month projects. compared of quarter $XXX,XXX. expenses the to period million for the for is the total of R&D study negative $XXX,XXX $XXX,XXX mainly basic the $XXX,XXX $XXX,XXX of on $X.X $X.XX loss was terms million third in revenue our or and had is for operating three different and the share diluted QX million costs for costs to R&D of Company $X.XX year. increase to same loss and R&D a decrease for, is negative for Also QX, was mainly $X.X same or XXXX. of $X.X Net attributable period amounted XXXX. period operating XXXX, The period respectively the the and same activities due was increase

million September from XX, the from raised short-term and offering of the Company the exercise its Company's does of of and $XX proceeds issued exercise include share investments nor in purchase $XXX,XXX $X.X proceeds the by XXXX, in obviously the proceeds options. million gross million, equity gross October XXXX the the over-allotment cash $X.X at not As of totaled common warrants, previously which

as placement be include private not the does million it Tilray closing Finally, tomorrow. $X well which should

the latest let's that in Company don't we to Now We're need stronger few that allows allows words outcome of financial market the a on key us so return in this it's to to pleased a knowing soon. financing program. pursue much financings. be the now talk the This position time financing to

the the common. is were call to issuance we turn we our cash were were not to remarks. was ones necessarily terms will now with, now totally While of And to Company the I limit position believe warrant more that satisfied the the it pre-financing. to what Dr. we in flow now than conclude back is much better able Zerbe, compared

Horst Zerbe

A royalty development to to limited both Thank and from revenues oral you, move made processes. move the away company to Andre. decision being owning few in strategic becoming by service the global and IntelGenx as a full leader licensed years towards manufacturing a films development

you. we which to anyways, on decision build a the that able with manufacture investments significant anticipated Tilray both had in RIZAPORT and stronger While to firmly long agreement business the need approvals temporarily them. at importantly due you and the and of shareholders, sustainable much for In people, now our of we rights our manufacturing updating impacted significant and term. and site, to new for a the our opportunity an choice. help support of like over to to to all I I growth close our Company's Letter as We thank plant turn ANDA that products make believed all to Itent profitability most to mid IntelGenx would significant Board, Heartfelt of with questions. serve ongoing over hard of that we dedication look drive will progress. the stakeholders the call will us and gives staff. validate Thank acknowledging forward work and to two all

Operator

from ahead. Instructions] Please question [Operator WainWright. first Lee line from Your Sean of go the comes H.C.

Sean Lee

cannabis parties Could following the little on develop number what's Tilray legalization the more products? there? to committed of you like process And a a of Has provide color also agreement? Canada, the the in regulatory

Horst Zerbe

with is point Company more product executed least Regarding costs intend product. first the been to first of a detailed question, definitive part obviously and includes multi-product that for the the at for only specific first a week turn your happy development agreement plan earlier reasons. development we we've the a this relationship that, for associated relatively little but good this At into this

goes, the the full cannabis. part as We much development the second that really far know and of As the that will the further about year assumption environment know but - legalized of more beyond time we lead to that legal yet the much we comment these be for I your legalization fact products question know frame, this. of above actually a in can't adult-only about eventually don't a on will

Operator

next line Investor. Private of the question from comes Please a Your ahead. [indiscernible] go

Unidentified Analyst

do site be the the you guys authorization regards question to to in at? RIZAPORT the marketing Montreal. you they're What Grupo on manufacturing now timeframe transferring that in My completed first this mentioned and Juste is had Spain to got anticipate a working

Horst Zerbe

extremely authority for our to were that. year partner. the that a is is the unpredictable. but give I answer It’s three expect the only that is example our speaking Spanish that months they commit their expected obviously review for well that Horst period not To Spain Spain period review is change. But took And do the an partner initial best to six because that month’s site guess difficult over six a application absolutely information receiving from it you to a

Unidentified Analyst

manufacturing that you in manufacturing on next is IntelGenx showed this a the are currently my that products any there is QX product regards manufacturing expense report? And there you question to is because that are

Horst Zerbe

a manufacturing not any product point product, are validate batches commercial we that commence batches our at expect are products transfer we meaning intended yet several Not yet this manufacturing submission and or in stellarable XXXX. to manufacturing that And are site we to batches.

Unidentified Analyst

Rodman facility inspect your Renshaw last another Andre you the regards facility. that meeting to Is & are going to that the mentioned in inspection be question the waiting FDA on the guys in happening year? this And the to had at FDA

Horst Zerbe

our year for that Typically the acceptance sure of to preapproval review RIZAPORT for resubmission. I'm the or review. about for which assuming February referred post timeframe. months at overdue – for acceptance notice inspection received will our concrete actually interpretation good to be likely the it's preapproval inspection is latest my estimation two hasn’t The occur yet Andre notification that for is the it the early so in I'm a Typically more sign schedules next is the preapproval likely that inspection early that January agency been in more in

Unidentified Analyst

results And the this study additional is that in requiring the that for you guys reference you correct? information to resubmitted from was that bioequivalence FDA

Horst Zerbe

included our study part absolutely lot that support it Yes, are required that more data FDA but resubmission bio site. and switch right the the you information of manufacturing was the to a

Operator

next Asset Your [Operator line Endeavor of Instructions] comes question the Patrick Tully ahead. Please from of go Management.

Patrick Tully

running six on months period? question prior start clock When the transfer. the the of three follow-up Just the of on the a the regarding Spanish did review transferring to

Horst Zerbe

month. This thanks of all Pat this question month, the for first

Patrick Tully

Okay.

Horst Zerbe

myself resubmission so it occurred started October the technically we running. month said clock last was that Let me the in correct

Patrick Tully

receive six expects your to three approval? when month transfer from So partner the months last is to

Horst Zerbe

Yes.

Patrick Tully

are Can you back whatsoever I quarter? begin color of could better a that you're any now negotiations tadalafil position that when or correct put fourth on other the the the in negotiations or you not am whether there's color in marketing on anymore that a that terms and chance negotiating in think

Horst Zerbe

new to violating cannot To other the the forthcoming so further confidentiality current as but have question possible situation. that is very disclose details apologize for be with than that. I tadalafil as part obligations any have I I on to the your to without last respond that any information I'm of sorry, quiet possible

Operator

Collin ahead. next Our Private go the comes Investor. your from the line Collin next line comes from line a is your Sean of question of Taylor a Rao Investor. And Please Private question open.

So ahead. please go

Unidentified Analyst

questions let looking the had indicated two as that me you’re so at call the ask to I begin some far to term. So conference to with. you Andre Andre in diluting and so medium seems short last not questions

us has there than in be been dilution last couple the is to company So what that effectively will the you priced dilution months? trading of no of to and then led lower which a it go tell where

Andre Godin

issue much the of keep lose in program right Montelukast our as like you waited often was really been unit the some and now to to a price warrant. we to as a expecting sometimes and we we you a be it process possible And but price or the I there the mean common happened. But was, a what the unfortunately dilution position. hoping like intent of said start like that's point but issued at the the opposed need and earlier Yes you only stock and market key for on as of could minimal as I it when so for expansion previous having price. And financing we see it's was the warrant were higher worst control at - have whatever

So looking on we total thing had end at good raised that were amount we have but if the we for. were The reasons dilutive close been day even raise that to - we to more more the of for expecting it didn’t that could basically number. we the multiple that were decided initially is and

anytime could go don't a and mentioned So stop even - needs, in the I at to more. we vulnerable day, you but don't like back be just that cash of to when the damaged end you need where market get have situation the soon to you want become

we that's that and ahead why closed went So financing.

Operator

Private a Investor. line comes Your of go from Please Sloman], next ahead. [Steven question the

Unidentified Analyst

And Zerbe's out investors previous he that is possibly filed call to question asked Andre concerned a was that had on - was the question think had when misled I he time previous answer was to this has case clarification something very sought and at finding number no such grave question investors. like of answered place. is number that seems and a unequivocally conference think none been to concern particular given, correct was only actually be would Tadalafil inadvertently, If case, forthcoming, Of if to shareholders he the that refers now initially put I that response following that was that was the a from when getting on it and the Dr. it previous application and him question, I his of taken ask I concern had the was indeed in generally of My answer whether Dr. the was fact been context. had and Tadalafil is a matter whether is comment Zerbe to concerned yes.

Horst Zerbe

question, for you noticed confusion, course I'm of I your there upset that been people because to were so Thank clarify very forth. and had happy

XXX(b)(X) FDA have working was is that to NDA that a that to from FDA. an have explicitly We never on commercialization filed by very calls an previous explain our we negotiating for which filed that have are careful been still I full on absolutely - under NDA at company own to working you're as today currently NDA on Lilly. agreement correct had pending I referring and we our tried license are state been a and the been different been with

Unidentified Analyst

like the much of say. still would I'm Zerbe, time ambiguous something. when a you principal the shareholder all less I and shareholder can I I criteria to of management. I colleagues you. though, invest interrupt shareholder, been for do value in shareholders say it which forward to from this a long fact that be Dr. been one extent IntelGenx still I a may your I'm I that a would my company, in has I've a very to than disclosure the And That's have is and past. that. hope I think do going trust will says

Horst Zerbe

and we'll Again, the thanks comments for it. take

Operator

Please Nicolino], go Private of question the next ahead. comes from Our line [Tom Investor. a

Unidentified Analyst

us to play? as in is First information free can interest still you give some of if all, loan the

Horst Zerbe

little account The few so critical been interest than this totally dead manager little chance bit is is XX% Quebec more ago. in time. has guess months at the I loan not the been free bit probably everything probably there a government it a a It's but from was There's to less the less a taking get alive.

Unidentified Analyst

some to of one money earmarked update I in Can and manufacturing you then Health in prospectus was the that on at Canada that prospectus' to final the that us gone. give the Suboxone. noticed preliminary was begin facility pay filed

funding you pending So is any there Suboxone ahead moving put still - that? on with or hold indefinitely is are

Horst Zerbe

Suboxone this can much, I generic Suboxone a say - is

Unidentified Analyst

I'm sorry, term. generic the Yes,

absolutely correct. You're

Horst Zerbe

is what details. can facility. at observe who most I any hold. qualitative and anything active. I'm very with is, sure I partner, had to is It And what on probably point cannot disclosed time active I know partner is what Unfortunately you say obligations. It program a but the that conversation can not. I provide have our in at confidentiality strict speaking this the But our the is be

Unidentified Analyst

removal impact from your $X.X of not this will initiate facility million the the So product manufacturing timeline? the to the prospectus at

Andre Godin

No, funds will of proceeds use of flexibility affect it with always It's a Suboxone but generic and not. allocation of timeline not will it the there's and question

Unidentified Analyst

at to special you enter build or into to cannabis, will required be this there this out medicinal, the both Regarding the point required begin that have all in producing time recreational do field? equipment

Horst Zerbe

manufacture to are equipped fully We this product. and develop that point at commercially

are but film by emphasize me to I don't Let supplies company fully know fully is manufacture manufacturer the in that anybody licensed is in films. only Health and commercial that we if infused film the Canada qualified are we only of equipped is Canada licensed. again, cannabis else Canada

Unidentified Analyst

be inspection first at received you I'm new it was are be to think we another in put did will you And we - Do looking information, stating I approval? you I letter question been so if approval more RIZAPORT, have said may, quarter? they it's forthcoming on will one - in a and just the needed the forever. looking the January. clock myself or probably going getting year FDA confused from reset the in it did more the submission at with When is an know we'd come

Horst Zerbe

the I a can talking one. what six question, only a months about months the are practice. and an thanks what common even guidelines to refer is three current FDA two and I important determination it's to In our review. we're - It's guidelines for review. can only under not

that it's some to new, from to clock case. response not us. caution, liberty that are black time restarts and word FDA don't their they have - they a the again that is not So a with the to extent is quite testify extend prolong But box of at to else or reasons

Unidentified Analyst

information correct? is But all the requested been has they've resubmitted, now that

Horst Zerbe

Yes.

Unidentified Analyst

Some gentleman. day very day you approved questions. but the time. That’s of be will a Still it be haul will your Thank much my end long some approved. for it

Operator

Thank you questions. for your

have now call. conference back turn met time to will for Horst I Zerbe call earnings for our requirements final the remarks. the over We

Horst Zerbe

the time I this Company. goodbye. their to thanks to good support And thank I'd on a and like you At evening, our again of investors continued wish for the all everybody thanks call and

Operator

call. conference today's concludes This

You may now disconnect.

IntelGenx Technologies (IGXT) 11 Nov 182018 Q3 Earnings call transcript