IGXT - Earnings call transcript Q1 2021 | IntelGenx Technologies Corp.

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Operator

Good day everyone, and welcome to today's IntelGenx Technologies Corp.

First Quarter 2021 Call and Webcast. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask a question during the question-and-answer session. [Operator Instructions] It is now my pleasure to turn today's program over to Stephen Kilmer, Investor Relations.

Stephen Kilmer

you. Thank and joining everyone call. on you thank afternoon, us for today's Good me Dr. are the With line on Horst CEO; Zerbe, and President IntelGenx's and André our Godin, CFO.

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

Horst Zerbe

and the Steve. on key On you will afternoon pipeline a I today's everyone and conference the thank quarter made you, Thank for call, for joining call. update, corporate provide progress IntelGenx first we've Good discuss us XXXX projects. our

André will financial results. the questions. your Then QX, that review Following XXXX up our for we will line open

non-psychedelic partnership. for with resources of It meeting, therapeutic company very advance of is Atai company treatment our days pipeline. gained potentially health our all drugs position a major also while time needed compounds work the and properties technology the the It Atai ago, and the cause product state. mental health integrate moves we same this field biopharmaceutical the can tech at Technologies within financial some of entactogenic with we've the entactogenic Through on into field our the providing new with for This transformational Two are the pipeline investment empathy means existing to Sciences, developing the IntelGenx driven attractive that to significant the to leadership disorders cause and hallucinatory with with just shareholder. mental transaction exclusively including that IntelGenx. novel in annual psychedelics, start resolution treatment intended portfolio of treatment our our of at Life Let's drugs our for that psychedelic health shareholders approved compounds an related partnership, oneirophrenic mental proposals partnership sort or the film psychedelic In have drugs of first we or a compounds of disorders. of and oneirophrenic compounds unique our for found will explanation them dreamlike psychedelic complexities prevention with Atai, Atai's collaboration address of disorders.

psychedelic development pathway days of clinical an psychedelics the requires The the for already of amino of of if term is concomitant well this into the license. of bearing Salvinorin the role some drug. formulation development of Atai's IntelGenx commercialization naturally feasibility metabolic royalty novel oxidase occurring as will agreement of work successful, to parties sheet which term for also an development compound the we the following example, administration developed an can being for treatment clearing A ago, are create delivery thus compartment of resistant enter hospitalization the and required treatment necessity For duration prototype to to the inhibitors of that pathway and The MIO action feasibility other administration provide of The removes would the Atai conduct first avoidance agreement achieve term psychedelic a materializing. pipeline, a second a us. further dosing in investigation. with opportunities the The clinical for a contemplates play a of of upon inhibitor. exclusive terms Few existing entered MAO second is into for integral Atai indications. fruits A. formulations depression promising agreement as Under the Salvinorin

RIZAPORT. added commercial on RIZAPORT contract QX. preparations On commercialization for European the include commercialization agency the irritation to the our FDA entered Duration Exeltis target In study in into We've be other approved. to Spain we for with August, for requested countries revised launch European protocol and for in and Spain Union, the a Germany and XX commencing on agreement markets. the eight Tadalafil, study LTS CRL submitted are with to recently since Launch partnership. manufacturing expanded that Moving agreement product manufacturing in potentially of will our to a the the was which of in early months. product

as BD quarter discussions and for is partnership finalize goal second this partnering to our are arrangement year. the a As advancing of in

cannabis that exceptional. remove have be no cannabis space With new Several using said, on At relationship We obviously we ability develop resume with to possible that to shareholders have status already time, this great to in to to product heritage we CBD. out or in we the the we additional films. plan into a That intend they Tilray and the from Tilray with project is offer a to management have exclusivity enabled deal Now the which indication explore has enter the our agreement moving what that believe to products the with Tilray. CBD, with inquired activities. them to respect our technology about our renegotiated to reach to have could future. cannabis us

received product CBD infilled based heritage filmstrips. a into initial that oral and in and with facility to order film we agreement, for first heritage on from of was ever purchase first for shipment of that That our order then March. was manufacturing of increased shipment of CBD the our to January, XX,XXX mentioned heritage we our at Stemming filmstrips technology. As quantities end agreement I completed the commercial from XX filmstrips. Montreal CBD supply an entered from cannabis This the milligrams definitive XX,XXX supply we

DisinteQ a has minimizing been THC oral of a in So, reduces intended IntelGenx and it the as drug becomes which February, mucosal formulations optimize milestone film marks into being release cavity to THC that the or oral novel achievement to for absorption swallowed of notice another unwanted subjected the granted drug specifically and designed allowance IntelGenx's protect utilizing we covers XX-XXX,XXX significantly disintegrating the clearly of the a designed by drugs. With erosion of U.S. This having patent THC, USPTO transmucosal portion this products. important amount application is the the company. control for for announced metabolism. respect our patent of to thereby absorption of mechanism by first-pass to to DisinteQ

platform continue interest for potential We to this distinct multiple in of to technology industry partners. respond expressions

protocol based formulation covers appropriate. This technology. provisional veterinary we on meantime, to the small one as high thereby via of or our to to the patent a ratio illness pushing in we'll one, to thin few trials risk application considered that high monitoring data incorporation concentrations practicable. incorporate administer is BUENA study patent a severe film Montelukast. our enough as the group this a capability Accordingly, for a and in continue resume filed USPTO of allow a words target to the proprietary of COVID-XX. the and filing while Now, remains of when and polymer of the us Health We're the temporary with population expansion enables companion it the evaluate the on this or limit film film, higher loading active is will potential a it February, to as with known FDA Animal products the active closely new into from film drug animals. In high soon distinguishing on amounts new capabilities situation our amended technology. keeping recruitment easily The hold film study from IND still of at ingredients the United enrollment we'll States

help field the pattern we the of of In addition, the film believe receive position data the within health will from forefront oral XXXX. data leadership very blood this we're level data partner, Atai film undisclosed announced from IntelGenx the in pleased a underlying into partnership, it position results animal veterinary the study IntelGenx, Like and encouraging feasibility that us our moving company, field. leading supports an development to novel film early at

financial comment for the not a reason The results. With call shareholders we André been has our several the we're delays since production limited on continued disclose developing Suboxone, by for development to temporarily liberty Suboxone product now at capacity, regarding like requested I Finally, have our am have program main that, to of because to which an update. that is of given for product another review Suboxone I ENDO. our provide besides of would we over to the and Suboxone, This of other ENDO put second hold. that turn André? priority simply

André Godin

afternoon, Thank everyone. you Good Horst.

numbers. $XXX,XXX revenue to in for the take to attributable to decrease for mentioned, offset revenues. $X.X decrease an Overall three amounted improvement the XXXX. and for of revenue QX, offset the and increase expenses quarter $XXX,XXX partially I'll period XXXX As a $XXX,XXX Operating is increase corresponding the to compared XX% revenue the R&D SG&A. period our in in minutes product $XX,XXX reflected for see The company's in costs to financial a The in impact last versus performance a expenses, increase $XX,XXX million first in decrease in $X.X of program the to $XXX,XXX be is same $XXX,XXX partially mainly by We're month XXXX. continued attributable Horst million positive to of by manufacturing pleased in were first expenses year. quarter increase R&D performance discuss few of the XXXX

compared The net diluted XXXX comprehensive $X.X operating $X.XX loss $X.X on period period XXXX to the XXXX. the loss for basic share the or of million, of million comparable $X.X for EBITDA million last and or operating year. loss $X.X period $X.XX was compared million per negative per loss adjusted $X.X a compared for For to QX, same of at Net for QX, basis million share company XXXX. to for QX, million, of XXXX, comparable an comprehensive of the a was $X.X an negative

of And facility reimburse the March As Bank fully cash million. we totaled XX, term company's Montreal and also the XXXX. $X investments short in QX, of XXXX, credit

ago would our $XXX,XXX million does of like is few amount million the that of $XX.X of second that was loan remind million. include While nor lower advanced total I that a of its this $X million XX.X not a to purchase XX.X Atai proceeds proceeds days initial common gross cash from approximately any everyone of and for stock shares a obviously warrants of

XX. shareholders TSX expect approval May the we to our to approved still subject on the that while with currently of Atai Exchange, have or Now close our transaction Venture about

the and to provide now for will of the approval, to this submitted meeting requisite we financial believe no the mentioned, Dr. approve the that obtaining Toronto back structure listing necessary have and the candidate. continue products increase Horst portfolio term. we products is and of will Exchange. If of and shares will listing as resource will Stock our company to Stock the listing innovative all I has Zerbe. the the listing our approval, requirements we Horst Exchange received There turn As Exchange progression shareholders’ to call film application company graduation the assurance Exchange TSX subject on is when to Toronto to Stock the Toronto the application. advance our Also, Stock is approval long visibility a a the the the now Toronto IntelGenx and the of that

Horst Zerbe

Yes. our our annual remind also board now term for executing long the fellow approving our members, On our like for Q&A. our prepared you. behalf to strategy. remarks all my general I'd would both shareholders to and statements questions. over that, like our again proposals I that apply team I'd recognize Thanks With to closing, to Thank In following forward-looking again, turn at call the like will thank meeting. you on André. I once of for

Operator

[Operator our first Instructions] go please ahead. [Pavan take from We question Rao], will

line open. is Your

Unidentified Analyst

on Congratulations also and When Tadalafil to timelines give the able company Thank team. actually now When through formulation question see relation we Atai revenue Good do to you some progress. revenue. potential also Would afternoon see ran for is we've some flowing a in to be we manufacturing. obviously likely IntelGenx and past the being you. please? the My to are to RIZAPORT. from generating a

Horst Zerbe

RIZAPORT mistaken. because with early Spain July, Okay, start let in scheduled out launch me I'm easier. in if for The QX not that's is entirely

So revenues us. that from sales will generate product for first

manufacturing from the in respond right provide the we received order the I that just we have can CRL As production scale need far best that full as the FDA. guess RIZAPORT we now that to U.S. to started is batches

next need so Tadalafil, the we of requested to our commence we of and we with from the we the CRL We year, response to, probably U.S. commitment in case development before revenues we And six FDA in year early partner expect study to months the IntelGenx second the made the respond to in this that or end the response we need year have up half signed meaning expect submit to towards sales the sometime next expect that safety and partner. CRL. not in study conduct the we a Aquestive, next

filed then year a expect likely to very year. partner. names, the discussions in response most second study will of advanced and be the this We I we in next with commence are any Obviously disclose the early cannot half

half next for year second XXXX revenues we from the in sure, of Tadalafil. expecting So are

Unidentified Analyst

question One may. I if last

Horst Zerbe

Yes.

Unidentified Analyst

With board Atai you is too I say gaining it do anticipate from shareholder, soon? nomination should or majority Atai being or a

Horst Zerbe

deal they that The on Yes. will board provides proportional their to our holdings. delegates have

plan added to that will they So get to a tranche board. means the agreement directors accordingly, or in that and our the hold concretely first two provides XX% quarter they

Unidentified Analyst

good you Thank and luck.

Horst Zerbe

you. Thank

Operator

from we And next [Eric Go will open. question our your ahead, line is take Hurst].

Unidentified Analyst

results Hi, questions. all had a progress. the few and on congratulations I the

first second payment that? the expecting The of in happen Did first I the quarter. to something was the tranche XX% with Tetra see

Horst Zerbe

can Andre, respond, you please?

André Godin

when GAAP, between we payment that's revenue already mean, the and we but I and U.S. received there's Yes. a payment. to the according second received difference recognition

to the has it approval been XX% collected of paid from be Tetra fully there XXX,XXX So, or upon remains product.

Unidentified Analyst

And next you on recognizing XX%? when plan do the

André Godin

It has been recognized.

Unidentified Analyst

development. two You new are or able mentioned films in Are cannabis the if heritage? who for under for to AGM are there those say those you that are

Horst Zerbe

that. about can No, provide generically any only talk cannot details. we We

Unidentified Analyst

the also that you you. received Could color for shipped second on And provide any and then was a second thank AGM, they Okay, in order heritage in potentially be mentioned to the expected that? quarter.

Horst Zerbe

be I qualitatively to I speaking, the don't can only significantly that want confirm again, any provide larger order to But numbers. order. than and that I expect first

regular in conversations with are We heritage.

conversations be again, confident the coming only very the So come But we to near participate, very in regularly which from in to expect question. can it's We're order in future. comment I I to the those qualitatively soon. going

Unidentified Analyst

the being of their they exercising ownership, much. like any and the and XX% super very there get warrants does their or that? you end Atai Thank If full be will up shares buying all conditions of all you have majority buying shares discussed required up around remaining XX% a

Horst Zerbe

subject has That any and ourselves this confidently you never want, never add with been may Andre been if I them. management. say but can of between has Atai you discussions discussed

André Godin

own it up after entire they they're would discussed the Yes, an going was what We discussed have I make to that? I so Whether never can happen that. shareholders? to far whether want they XX% haven't They confirm own to would to first that. options go mean, offer would XX, closing. after but to company,

Unidentified Analyst

final the would that one question. to that potentially approved TSX would If naked is and there uplisting in process are could of potentially be? anything positions accounting for there an Okay short that any uplisting, that lead shares of actually eliminate we

Horst Zerbe

I André you think right? Yes that's for

André Godin

highly regulated. mean TSX is obviously, I the

So short. it potentially could the reduce

main the is from issue coming most short eliminate think the U.S. that shortage of is in right never Canada, I that can but You now the

Canada, in So, so bad. not it's honestly,

So problem an care U.S. I a of the or senior it's to it. to take control exchange IntelGenx at in of to that been that migrate think least objective always

mind potentially us something allow in to exchange stock migrate price senior the in appreciating, keep with that's a could in hopefully future to the So it the definitely U.S. will that

in exchange drastically. the short So in U.S. and being definitely both senior Canada would reduce the

Unidentified Analyst

Thank again. much, and congratulations so Excellent. you

Horst Zerbe

Thank you.

Operator

from [David And we will take our question next DeAngelo].

line is Your open.

Unidentified Analyst

in a most Obeid confidence it's written company a the congratulations actually of if everyone, all. burners question hasn't about, and big that about? talked could or at the all my you the have about for pleasure at speak regard know the on something in us. I either attention. but just now. things pharma all you vaccines been speak you again, can a and films. an But company the that be had in of of with interested My first magazine, the ton there in investors, June, past future. hearing in that to talked agreement would few I to for to contract Last something speaking came that Dr. is at colleagues’ Hi, putting it's it's again, article hasn't we'd if be know curious area But on probably an of was Atai I oral booster this onto I be explored lot across be might a

Horst Zerbe

a it's course, have very have Yes. attempted limited possibility, resources. we developer looked in fact, partnership because attractive enter looked concretely with we we here past, and of have I we into and one vaccine in segment. mean, And we prioritize only the a in to have spoke leading into to this Montreal not

program been And a bit put the had program the was particularly now. so COVID situation little every mention with that right back that to But right on burner. not forgotten has this Rudolph

into is there right progress no in But again again, this. concrete program now. are We looking

Unidentified Analyst

to things placed just Thank have be or that so many on to other be may you so for the due the my involved question second in around not company how Okay. much. hold part ongoing floating either projects some enough also attention. it competing with And been relates with I of funds may

in approved might have This be market Canada. example, to it's in perhaps may to the something our are work by that is say, that we're move Atai it's Montelukast could this though to exactly we focus. does interested very that in How re-examined that process the speeding not once be resources For and Health any projects lend relationship program ongoing? some forward even

Horst Zerbe

to to was specifically we was respond why reason put of to lack the hold Montelukast patient the of had stop your off funding. as the one The been had has because comments, Montelukast We high not only To of to situation. on Yes. target population. COVID-XX this and because put hold recruitment COVID on simply

line some Now, right, we a Atai, in Atai interest in and program. reserved Taking it so them turns continue with down this it take point has with the this in of potential and could as to way, out would developing expressed have that but that at to put over step the asset over be respect the they Atai attractive it the meaning and we for course the case for our partner. commercialization program if

Unidentified Analyst

in Thank question ongoing you One is two submission of for currently so create revenue final Cybin, or economics? IntelGenx future? studies. to phase believe for the much. What's that batches helping regard some relationship terms in receiving creating, the I their them the in currently company Is

Horst Zerbe

Cybin study The agreement feasibility with a is agreement.

in a studies So but studies I decision. would Cybin formulation confirm get phase because first that two, doubt cannot authorities very have conduct two for that further I development we confidential, would these are Cybin’s typically developing clinical studies. regulatory But intends is from even clinical be a phase one. would in test prototype that that before to to a phase you process is the you it approval

and place regime. clinical further which by at have under development, under their their So development in again, feasibility prototype formulation them with do development a we for agreement discretion we Cybin

Unidentified Analyst

Again, thank you. all you. Congratulations great. to you. with ongoing luck everything to exciting. Very for and good Okay, talking Good

Horst Zerbe

you. Thank

Operator

Yvonne]. our from And next will take [David we question

Your line is open.

Unidentified Analyst

Andre, to the congratulations Horst me allowing for and the question Dr. much here ask so you on and progress. Thank

of shares. outstanding a like end looks the entertain I confirmed company the place potential Would gets because have up their of talks that With you of XX% company ever and to and for been the it a very to in purchase if ever programs Atai? think point the a you that idea and acquire rest to partnership attractive Atai to Andre have lot there and the no Atai to on

Horst Zerbe

that's we been looking future. far be or this a at subject the either mentioned discuss out confronted concern of with discussion never say and I board This in addressed it before, will management can level. has if into not honestly that. when Honestly, has within never all, been we're subject Atai conversations. not as that and Andre We'll our the has regular Atai

Unidentified Analyst

question Thank you And for second regards in to Montelukast. that. also a

I were you confirm they what want they would to follow the through Atai, interest and just said, be expressed commercialization exclusive So have they Correct? to if partner.

Horst Zerbe

yet. do. caught been what hasn't But deal a we mean, is that I normally

with one only that I exclusive deal. is only commercialization think cannabis and enter exception into

I deal would like been an even no though discussed has would I made deal. even be and yet not anticipate that So said exclusive this

Unidentified Analyst

for much your very you time. Thank

Horst Zerbe

You're welcome.

Operator

our take And Maglino]. we next question [Tom from will

Your open. line is

Unidentified Analyst

much much very your Thank are as My own team. roadmap Can I you you question And questions. country of Things first shareholder, expect for partner has on and actually and taking countries? European animal each regulatory give understand my might other penetration longtime countries. regards give you this the And requires us non-human some other you not more regarding my of the if our the approval. you second to a companion reach its certainly and is a Can positively. form European do RIZAPORT program. congratulations you give market into that to with know, looking to fruition? a us program drugs? familiar I'm when us, path, you started Can applying overview question that to that

Horst Zerbe

Certainly.

to jurisdictions first RIZAPORT So and Europe. regarding in with in your other question respect launching potential

you a assuming each what what application jurisdiction. or a European said approval that in filed So it's application, we application. correct quite requires the not is that full European you're There

the European mostly approval a with phase pricing. been has achieved And enter so simply then product which national has deals to after

has simplified. European other been into jurisdictions So the regulatory pathway greatly

regionally they a this as for them Exeltis be potential but qualitatively the migraine I other any a like plans is to say and this us is as for stated in I'm approached far statement. of aware a actively would European steps, this point products film Again, will time, enter countries into the of at concrete the in the not performance to at qualitative many first launch. a any that any I they Europe is countries, this with in first European can be that to submit suspect as that. European concrete Spanish They I'm product as are of regarding focusing high case Now concrete on the point in on aware country have them other for the Spanish in they once time. that not possible impression market. plans

Unidentified Analyst

Thank you very much for very That's clarifying helpful. that.

subject the with then to facility the inspection So Spanish production inspection or be would do countries? for other

Horst Zerbe

no behind is That's inspection there No, anymore. all us.

We are are, are and are process us. steps already with as speak manufacturer aware, qualified you're I'm these necessary European making saleable the all currently sure qualification the They we batches behind literally product. which regulatory of as in

they really advanced market. bringing to in product are of stage the So the

Unidentified Analyst

you news. very for good very much that is That information. Thank

Horst Zerbe

then human procedure And applies with was less speaking, is that the approving product identical the products. or welcome. You're second health an to question. health that your regulatory with to animal Principally medical respect more for animal procedure

studies to with there study. So And there's as not much perform same And one, the human we also much to a is, phase of products. safety with difference. the have the difference. respect pretty two timing, It's no phase same speaking, practically

Unidentified Analyst

a So to fruition. be product this several come before correct? probably that will runway at you would looking years Is

Horst Zerbe

expected. That Yes. be is to

Unidentified Analyst

to best And congratulations. much. again, you and staff, your the you and all Thank very

Horst Zerbe

you. Thank

Operator

take Instructions] from question we [Operator our next Go [Bryan And ahead. will Scott].

Your line is open.

Unidentified Analyst

I recent of the questions. progress. a Hello, couple Andre, congratulations and have on Dr. Zerbe

the Toronto what be the Exchange? for do timeline Stock to on the expect application First, you

Horst Zerbe

to want respond? you do Andre

André Godin

there's I I They need that happen of to they their now. would probably in couple will. we mean, of application a weeks information mean, submit the month. I already Yes. and start process been I or this need and our to, front should exchange committee of say lot

the committee, could start probably after then we after seven committee if days the on five accept to the the TSX application, that. listing So maybe trading

we according will TSX month. the expecting goes be on trading everything to if So plan this are

Unidentified Analyst

accurate I revenues the in Am royalties would on Tilray heritage? fact be question. from more that One we paying the

Horst Zerbe

digit correct. take a single percentage. is that small out They Yes,

Unidentified Analyst

into thinking exclusivity actually in guarantees entering an And them what that through the fruition agreement product with they was any bring to us? without a ever

Horst Zerbe

When clear we question. very them into were good any time their and suggested to that lot had But with reasons respect then provided around never very a they We a negotiations excitement the us, of making sky that that deal move at that's progressed concrete was that an they to with trading they we with this interest decline. are very film never there hype then for and to for to agreement insight were strongly into again, part decision the try high forward Well and to have as anxious been began entered all. situation.

we that did to as negotiating we CBD think able to which I by our be to by so quite then. of the the to market successfully exclusivity with them get had film developed rid get

were tied discussions with making even less so So that's they was process up have really all their decision their merger at complete silence. point, I can say, we don't when that with really that there much Atria into insight and

Unidentified Analyst

Okay, come. you. to thank to And forward Thank what look you. again,

Horst Zerbe

Thank you.

Operator

the at And call further this I Zerbe no turn to it closing final Dr. for any time. have questions we appears will remarks. now or back

Horst Zerbe

I And we very our again our thank work. employees I want like you for the continued been continued shareholders have And would Thank thank support to that for always, as to much. Yes. our their staff, enjoying. hard

thanks again, to call. the And bye. and that bye, So concludes everybody. Thanks

Operator

participation. does program. you This Thank your for today's conclude

at disconnect time. You may any

IntelGenx Technologies (IGXT) 14 May 212021 Q1 Earnings call transcript