IntelGenx Technologies (IGXT) 9 Nov 232023 Q3 Earnings call transcript

Greetings. Welcome to IntelGenx's Third Quarter 2023 Financial Results Conference Call. [Operator Instruction.] Please note this call is being recorded.I will now turn the conference over to your host Stephen Kilmer, Investor Relations at IntelGenx.

You may begin.

Good afternoon, everyone, and thank you for joining us on today's call. line and Gorham, CFO; the Godin, CEO; on President our Dr. me are IntelGenx's Dwight Andre With Frank Pietrantonio, Dr. our our Senior Director of Clinical President General Research; and Counsel; and Vice Tommy Kenny, would Horst Chairman.Before that mentioned are Zerbe, today remind U.S. we I amounts IntelGenx's in you like begin, all to except information undertake any and dollars subject accordingly, mentioned forward-looking to call may any expectations update our as change.We may today's otherwise represents by statements as not obligation required are forward-looking to unless contain do U.S. and that be of today, and Canadian securities laws. statements, us A are number made results were risks of may to assumptions in by preparing differ materially. these forward-looking subject and which assumptions with on risks and in found the can Details U.S. filings our these be Mr. Securities Canadian would to Commissions.I turn to and like now the over call Gorham. Dwight?

Good joining what projects will I progress discuss shareholders. our afternoon, Then you quarter we've thank Andre our third IntelGenx will made review Steve. and us pipeline previously the a conference and call. results. consistent today's financial for XXXX on the we to corporate had update everyone, you, committed On for provide call, Thank key

open will programs up beginning RIZAPORT. line questions.I will for we now our update with that, Following key your you on the

the first market order This our an upfront our first both payment reflected supply commercial payment for XXXX our we RIZAFILM, the significant are for financial milestone deposit of a triggered U.S. a pharmaceutical order order in results. both purchase represents well quarter, the purchase commercial partner During pre-specified as company name which is film.The as oral as of milestone it received a from RIZAPORT, QX Pharma. for purchase order U.S. Gensco for the

from Exeltis, launch a on RIZAFILM RIZAFILM new patients, prescribing enables order the positive product in feedback to Spain, for approval QX product Gensco strategy December Exeltis' received Based our to commence of is the new ultimately level. partner strategy sales. ship they the at for XXXX.Also in Production we received XXXX market. will RIZAPORT to to the believe product this expect week to in pharmacy the expected of We that doctors regulatory implement boost substitution and immediate

our determines the and inspection XXXX.However, date GDUFA March X, rizatriptan review XXXX without of required, the FDA see need X, RIZAPORT corresponding this and Spain.Turning drug product affiliates Chemo pharmacy in new to the increase to XXXX. an application Buprenorphine inspection.Now, confident that an to the amendment in July Xiromed, the oral abbreviated goal additional or increase The User level the of March is Film Act But if to submitted requesting our FDA the Drug turning review. priority partner review of to we that our of new strategy preapproval for film, co-development priority Research, eager sales decide given to date and the agency this granted substitution approval an GDUFA agent program, subsequent inspection are the a is are the FDA to We Generic Fee implemented cannabis at will Buccal relatively with our amendment the facility business.

a licensing with Tilray. agreement CBD, our for non-exclusive an combined Tilray are into relationship a parties.Clearly, entered And our Tilray. have new purchase stage relationship settlement and supply both concurrently agreement entered includes THC. with amendment We settlement happy that new was to and with the to represents renders XX:XX and CBDXX, product with a agreement into THCXX, a for in development X this order The

to products patients.Next, develop these year looking to have to them we X worked and hard having forward turning are cannabis health. available to However, this medical animal

and with later These sheet with film activities, partner to our health that this customer under on respect CDMO the year.Finally, to an our a discussions in agreement able that for Montelukast product the commercial partnership technology. animal term our in call for a will substantial date, development announce with facility product commercialize a and we specifically CDMO previous we oral are the important for using product U.S. being pharmaceutical of an packaging the undisclosed during signing R&D, animal expanded our anticipate manufacturing still is health to package progress IntelGenx to and offering VetaFilm this discussed have to have our program. by an made planning GMP are the at we binding ongoing, Montreal.Moving to potential We we license discussions turning

mild trial completed have moderate clinical We of patients Alzheimer's Phase with to BUENA IIa in XX enrollment disease. our patients in

Canada of X.X.This we've p-value than modification to optimizing program's efficiently the where enabled while modification design intention enrollment achieving authorized goal, compared the we VersaFilm placebo. the to decrease power to to of us effects detect study less Health With study the made of the a the Montelukast adjust

report will the and Montelukast details alternate immediate, form multi-center, in of XXXX now as commence Council of for sponsor USD will principal and small, a their also use over X forward QX manufacturing quarter.Additionally, be conducted trial films Dr. available.Lastly, We to who results Svenningsson, collaboration looking results. they disease currently the have to XXXX and Swedish be design provide Montelukast. on the for approximately initiated when are study double-blinded, customer the of assess we expect initial QX tablet R&D with VersaFilm more Per Research will Montelukast dosing treatment are to I a study to an albeit of grant We to trial VersaFilm in an to at its our study following of Parkinson's Andre to to the XXXX BUENA both would in financial of are commercial planned proud Karolinska the investigator to the completing University worth we in and will study dosing first the Andre? in with engaged the are or investigate active ongoing randomized, trial secured to that, PD. quarter clinical The product to output million.The preparation call generating the revenue business.With advance Hospital the placebo-controlled through a turn review placebo for like

Thank everyone. you, Dwight. afternoon, Good

compared mentioned, change $X.X I'll The minutes quarter financial amounted the increase Dwight take September year. XXXX.The $XXX,XXX in quarter third were to ended and revenues last is attributable for R&D $XXX,XXX discuss revenue As million XXXX to period costs and few to QX $XXX,XXX XX, third year. compared to $X.X last mainly performance milestone of in the for expenses of the period to the the for total $XXX,XXX.Operating company's same in revenues same million XXXX R&D a

the XXXX.Our share of QX with XXXX.Adjusted for million for negative was loss comprehensive million million, loss corresponding $X.X XXXX, company of For was diluted per on QX or $X.XX operating XXXX basic negative an $X.XX net of consistent X-month to $X.X EBITDA for XXXX. QX net the of million QX loss a comparable had and period share the per or $X.X from $X.X period $X a XXXX, comprehensive million for basis compared down

efforts subsequent use units of capital to cover atai X our Life a purposes seek aggregate for upon the XX, of non-broker shareholders' the August, intend shareholders' related obtain November related special our collaboration approval to at of the costs XXXX. working fund and will offering place taking approval.We to to and development on proceed with formulation to to subscription meeting company's of and short-term totaled gross offering.IntelGenx a atai for the the shareholders million, first As XX, placement private closed approximately proceeds XXXX, cash an parent a the atai investment USD September of company of $XXX,XXX from tranche in Sciences including $X.X million.In

and approval turn In the final satisfaction closing the addition customary will offering to to shareholders' subject TSX conditions.I approval, back Dwight. the to of call is now

our delivering Thanks, I'd record point, this our Andre. track promises. to At review like of on

indicated the QX U.S., we call, advance we we the which soon done in in previous QX. would During have RIZAFILM

end was resolve partner We also the response we in such that favorable also expecting of we accomplished to are would in QX. arbitration told Tilray our and the outcome which in and Xiromed recently timely company that respond manner, an is CRL the was a indicated submitted to both latest its partner.Finally, the year, investors the that to by

All commitments looking animal in joining key and the XXXX, executed on as such signature the milestone, the community to and say, are its on to commitment upcoming forward of QX to to QX order continue the with programs kept since cannabinoid-infused of in our CEO, IntelGenx's company partnership XXXX, execute this line in the made.We our investment health has of fulfillment VersaFilm deliver of RIZAFILM launch Tilray. the from and

Thank in latest of my looking tranche receiving financing approval.I recent on that.In again everyone R&D our shareholder now assuming projects. team by now we our to to that We on the successfully solely I following remind statements that R&D our for once turn for would transformation to strategy over our on like organization call recognize our to from the Q&A. I'd executing will you remarks commercial the end additional would are progress have I updating and our the we forward fact the operation.With a prepared you. both QX, highlighting the and like and to projects introductory commitment receive the apply company's remarks we into forward and also calls within made service has team's We an that, capitalize questions. the opened in Group focus forward-looking for R&D on how full like closing, long-term look key door future our to

Kyle have ]. investor. We Hugh Instruction.] a [Operator come [ ] Hugh is from private [ did a question

to the Question distribution CVS any that plan first you and going me. light the on shipment quarter on the RIZAFILM, share Is XXXX fourth -- the quarter, or anything idea, that? go like or can going excuse to in any there is hospitals pharmacies, is rollout like

]. available from is It a our shipped lead this of the will customers. The Dwight. warehouse it's be and shipment one product Hugh [ immediately Yes, -- is when for CVS is

expect Gensco already they go have and set to and CVS it'll a in customer. So to large Gensco has motion that as

there I just arrival highlighted I've because More good, it other first I or following Gensco? U.S. believe know info -- there. to besides China, shelves.With -- Gensco maybe, expanding that It is correctly, to the is further closely. the seen Dwight, And the say of under they relationship, hopefully their specifically, was just road? countries this about I'm thoughts website, on seen that have, more it the come there's about any I've on I That's down right wondering

I sales want. looking you on I if based And just should Gensco distributing in can mean, China. mentioned Spain. Hopefully, at... mean, pick have, looking also obviously, that we Exeltis is I what at they're Dwight -- answer up and also the

resupply Congratulations on shelving resolved. issue, issue congratulations Andre, resolve, that with Exeltis getting getting that

So the how see to next Spain the way? in or one, is that regarding line EU to discussions goes? countries would in wait going be they're What there on just

are for discussion in EU see how we'll the been the Exeltis, of will I film goes. other countries. and this preliminary think will in discussion the this that with we we first can be the countries. there to RIZAPORT first wait the But how it or But so have terms they discussion.But other is how see RIZAFILM goes. place aware fully be migraine very really with countries in But successful. It's U.S. in Spain obviously, also has past in

So I countries. we're this excited and other ongoing very launch about we're definitely think discussion for

online. and other to off. I in that directly late looking the back I'm about EU, X the into Spain monitoring We with definitely Dwight adjacent as -- it's Yes, to speaking markets were as move progress Spain. adjacent weeks cut got in in Exeltis to ago large sorry, --

is RIZAFILM, pediatric the you that of with -- year, the one or thing of the in Last of for and or is ways first next – half off that developed that do the to end the FDA year see still be the

in That and do. is we studies development to have

in item. be of line to sales 'XX part a line likely not more it's XXXX. the likely So It's

in will And cannabis, from for excitement are. then say, development some, other with an Do Tommy, were – the the of last and cannabis I call appeal new of Tilray? you was think cannabis would those see attractive Tilray, I have introduced Do talking those there marketplace with was whatever the call, you there less products market. THC a prior products a that lot to know effort

be think that know are cannabis will good all This a most. I going The an investment. I bit is and so we're -- I has market very is product a little we wait be question, for Hugh on is, making they mean, limitations that's product. more open little a make expect traction cannabis, it's and ]. they'll The there's commercial that think return some medical tighter they commercial [ so been to that will the some problematic that market, see. with this. clear And news the

the be would say I cautiously would I Although, expression would optimistic use.

you're basically And to Rapid competitor? Or with it I a like their know if say aligned as with was I that just prior don't with but is IntelGenx? active is wondering track arrangement Dose, that, still -- allowed

-- [ Hugh the ],

Dose, with dealing us now. Rapid they're

Thanks Yes. Andre.

I close to to be know And expectations. the you late Andre, XXXX? Dwight, CDMO, work I some contract satisfactory sheet little that didn't binding revealed was get on that get Is on out it the both -- this there. companies' being issues go or the on QX got Would to before. other that I term finalized? in resolved into is done and

run subject That'll likely et and from and The progressing. cetera, to stability path parts, And vagrancies be get in be are will -- are start machine January. item line trials, they're early doing lots. Hugh. the the on us then of some order, critical which in stopped but commissioned line it's The to XXXX, of we the are the expected subcontractors, not to

definitive So be sometime completed suspect XXXX. I in agreement will QX the

going I on ask or does new interest of before bring to other those any products partners? that, was potential the And in the about up any with you marketplace DisinteQ transdermal, have I like VetaFilm,

have conversations the been not our film and transdermal. on all focus products, Our

when or time for partner have a may And is for company is one to there VetaFilm, contract with one just say first VetaFilm? potentially able you it The any bring behind then present conclusion the, for be you that the to that? you

the It's VetaFilm. are on good conversion ingredients other other regimen targets current be for dosing to that one. But conversations there from pharmaceutical might

All one question. last right then,

conversations. early are Those

hold discussions Endo on we be bankruptcy. status with future maybe And product, being prior the the the had that. could -- being calls still being replaced, is Or partner the -- on power accept that on? -- is with -- product partnership that I in No, power of news the a the that potential

they're product early potential on. Yes. latter you stages. the in apologies cut Hugh. say, get would but for may getting There's My news I that discussions, off,

[ ] private from coming is Abraham Shapiro Abraham investor. question ]. [ next The is a

expecting I hear revenue got I didn't IntelGenx any of that order? we revenue initial from Tilray What the order. kind Is numbers. expecting?

The --

The initial order for...

Okay, go ahead.

order is $XXX,XXX. initial The for

right. All And... $XXX,XXX.

But that's just order. an initial

revenue. kind That's what of

a Okay. allowed the United Being export States? that product, it to to medical it's is

cannot. they cannot, they No,

are And still cannot. exports they No, in general, cannabinoids. on U.S. to problematic the

Okay. I because thought little a be lesser. perhaps medical that a was might it

always finish the won't I -- concern other than So that, it's get guys it's did that my finance. you high mean, get to you line.

other any? revenue financing, You're if have getting line, do so close. you What borrowing, in

you take can that one? Andre,

on, are looking been specific that said or cannot will always are we about fund we're really or happen.But is Yes. on dilution. that point, approval. very multiple and that options coming and we might But in revenue having be also We're that likely is looking come options. the always always be but well to There to There's on other there at get $XXX,XXX based we we another And in at shareholders' this at company. XXXX know November in, that XX capitalize will that, what concerned always, most see money. upon

there's so find dilution I too is that So we're dramatic.But worried. not wouldn't be -- the to trying ways

think to I expected generate all money sure and we'll we're and programs in getting new find approved have the are money like launched make did new that as to that order in we our revenue. programs and -- programs we always that

settlement, was time shareholder a took price longtime moving the looked waiting -- it things on. And I'm the and I'm along. a to great to a going these like good Tilray's looked reflect settlement me, for a it all Congratulations, long and

Thank you.

a [ [ is Brent The next ] ]. is private investor. from coming question Brent Geikie

right contract sheet and that? – signed you is be expect to now you'll Or have, the go? done that ready to just you all do when do or on a So a that first that term come to signed revenue have that's contract CDMO in

done agreement, binding be registration to 'XX in That is should 'XX, and [ be early first definitive term that expected sheet a There's Hugh work I to of The revenue. be some it ], is signed. is as quarter the told late 'XX.

deal do if the and – case had you'll about coming call that? mentioned Is still when think the so, what soon. I that on would a And expect last you be second

I what was the don't last in meeting. said recall

to guess. sorry. I My age is So I'm getting me,

the and X at see another RIZA see with those see and on to months. CDMO I of However, going Buprenorphine major customer lot don't coming FDA this see a horizon. I for come And out of in volume next point, I I FDA. the approvals X I RIZA are the see to the events

believe Is the had if $X.XX to is going $X.XX, this as be And approved, when be if, it we're atai, $X.XX or I still -- $X.XX. to or the shares at release indicated as going gets their be case that would press that far at even they $X.XX?

Andre --

be -- to going It

please? that to want you take one,

Yes. USD It's to their $X.XXX note. convertible won't going be attached that their X.XX is the change. – that And conversion on the warrant price that's is to for it and

Operator? I -- think the operator

for moment. lost I Apologies, line my a

Okay.

a Yes, my coming question apologies, The a Bobby is from Zanetti moment. line [ private I investor. ], lost who's for next

all, of quarter. see First on to fast to is moving pace. It's all you I'd IntelGenx like for nice forward at congratulate accomplishments a this really that the very

on the an announcing is My on owning the question filing that light October regards company? with atai on first Life Could in some you early XX. Sciences warning XX% congrats shed So of the shares report in to them that.

Dwight, you do this answer one? me to want

Yes, please do.

the Yes. some fact. the it's XX% could a this The XX%. -- than and to – but is number that's owns kind with. atai more start of at of they point own wrong this And unfortunate, is But company, potentially

anywhere get So would million, invest there, to But to $XX and have $XX XX% they XX%. between million. about

XX%. own XX%. at money And any IntelGenx, it they further is as they into invest remain So long don't the will reality as

with question the lot amendment with partnership partnership is, deal for payout a a a part anticipating of or deal? of other payout you was I a it guys. regards investors in the of a the settlement that have other concerning were there Was the exclusivity? to Tilray, deal table on And only Or the

me Dwight? you to Do take that, want

-- We should yes.

be we something here. best expected. outcome probably could are bring there a hoping and their as settlement Tommy we're the and products. not have will forward partners They right product. future Unfortunately, have we're I product. just are the will that that that can both least patients now But products continuing discussions moving at company those thing this can expecting hoping us is it's told it's the are that Hi, you X up. that We're confidential tell additional and bring

there So is expectation some there.

to as Andre, you their had just And by is for there that ties Tilray far film manufacturing goes? Rapid mentioned clarify, no as the Rapid with Dose, Dose

As far as we're...

Yes.

we're as the the far that's We thing from sell someone But the to again, we're else, non-exclusive. right with informed, same is but If agreement now. to us, will As film want they authorized the it's get case. believe we us.

And approached other companies to products? players are big have you THC CBD there from any regards that like in or the the

around this were At The litigation. game in because shopped changed. haven't has point, significantly we anything we

is see we Now if an opportunity. market that open this to us to

we this the not So partner point, entertaining were at in any cannabis. discussion with current

This Yes. just products. for to activated at these look a we've potential and marketing -- other will we agreement And signed. sales department department was take our targets

to some about of Tilray these like patients? of year? a like you be or And the have XXXX to -- or and possibly to distributed going frame? just Do I Is sort the of, to it when products QX or wanted time will they this be launch delivered ask

the early No, materials, times well, for base on the lead based it of raw QX. it'll will be -- order

March correct? said you Buprenorphine, was the date, the GDUFA X to going And

facility don't push inspection, that they yes. Provided a

inspection. an For

Okay.

launched? when product God you are approval March be when So expecting expecting, willing get on are the to if we this X we

that, I Dwight. can take

Yes. Tommy. Go ahead,

Tommy is with product. Yes. I it's the There ongoing mean, here. litigation

mean, because available to we So we front date product cannot we'll looking to depend much when the product as it I as as market. the as this push Unfortunately, in any soon approval, and court as forward will We're when to get on we get to judge. statement a the the make will of be we the possible can is and get situation.

milestone that any payment be receiving upon approval? will And IntelGenx is there

Yes, milestone is one there upon approval.

like you on can or...? figure like shed it And light a is X

Low X figure.

And [ ] Kyle the next a follow-up. question we with Hugh had was

Dr. for moving interested develop any that's in other with Dwight, Frank XXXX. in Tommy, is apologize, the -- one company congratulating in they're Zerbe, not and I -- along? company Andre, the programs new Any work your I for molecules and progress atai, far our company question on the with And besides great have right having that so and your them? for a

really Phase We're their them. for getting X clinical done work focused on

had And the Berlin. ago, As conversations what extended a we've their on this recently as weeks CEO at on with got X point, I table. it's in focus

Although ruled out. nothing's been

to that's Is as team in was and there oral -- that follow that, business anything developed different a on And film attractive on your the learn could being that the molecules? with the we for worked may evaluating development news be background market?

think space now. we've got I in that we've but with to share up that. We're to for would to that be right able soon me shareholders, on And looking we've reached as the say as area. it's love I R&D that opened the some down, to premature said I nailed capitalize –

question Sweden, that. programs? keen conference the one Parkinson for is, eye the progress I last every Montelukast there in questions with And ask but for call, -- at a always know over I those Dwight. the accept horizon with any of And study I that, partners of and on out the -- last got X either potential

think I in getting with Dr. we certainly a down to then readout of -- the of recent partners. several there's is show a lot there's Well, potential readout partners. the at I the quarter. everything conversations But Zerbe don't lack trade If and second had the at good, were comes

would film? answer. Alzheimer's for just the both that same good then a or And products be That's the

if data all think to them, had. be on -- is there's then think partners don't the of good I I

will one first though. The the be Alzheimer's

ask, is And the it wasn't there I'll any brought tadalafil? but on call, up progress the on on update

got the development we on the -- months – X work, back to -- with for complete understood. we've milestones in months. the is And forward that's Tadalafil next work lots need but -- we're And not move project excuse commercial, within track X that other probably there's to Yes. there. we're the of me to

good a and apologize. and Dwight, takes questions. if anyone report. missed Dr. Frank, of my That's Zerbe I That Andre I care else,

-- Well

[ you, ] Hugh Thank

your I'm did one report. --in investors this I past, a the has question, about One being success been and discussion sorry, the with there'd Any research made? may with of company investors? RIZAPORT report approval there the there Is is with reports – of that the the of anything houses -- research issue progress and progress research the the company in other made

To my with The yes. knowledge this would that? to know. answer point at you be we like Would engage

is coming a [Operator Instruction.] Geikie ]. question next The Brent from [ follow-up

you'll or press put these any have on indication products? out anything release any Do or Tilray that communication, expect X will

you that answer Tommy, one? can

create I probably want actually Yes. is – it or they patient customer to upon don't issue their they product if available. will they from before mean, the probably because product only anything, expectation receiving they the will issue

if And share purchase continues is would on idea to price if indication the the down do you'll where any open shares market? or it now, have atai wane

can I that. answer

supported show atai more they the the have. business not be shares -- have there the came all on loan XXXX will the objectives I science. could there But that purchase model XXXX. with showing. will stock and allow South in I But point our I money will continues I think execution from some bit been commercial, they warrants of as think we we their just that one that the unfortunately, know, and as exercising X that at reflect that support and convert that closer open that last Florida the hit I'm has that as them available. to either closer execute they bring plan probably on doubt a they us market, warrants especially a business that price back get have by to to or continue.So but in being as long the small road a that worried. the company, and term months us. market, cap to life through are road has of Obviously, well.But taken and they towards out in quite in – place you has

is David And the [ Nahen who's private question from be ], going investor. next to a

see couple seen a forward are What company, obviously criteria choosing the choosing and of commercialization for being criteria that. there drug haven't have thank real the being approved and that basic in you a probably jewel It's United real with been fair approved think for for from including the in the of your I some Montelukast gets Because it's said, countries, AZ is there's any a PD. partner? But to partner? revenues we for States. made. update various willing, say products commercialization have God that that we already prior progress hiccups And is maybe that Because commercialization.Moving with that been progress. Gentlemen, good being the to approved products,

organization more product. of the And attributes with up be their significantly and the With and will hands me, hits, some to and happen. the I bidding in into the much. And choosing question. be had partners of criteria associated we think partners. a I quite we've logistics at. involved understand and enterprise U.S. into cleared the companies their will for to that's scale That's look be we to get Others holding to and fixed that. credibility will And think reach others it's and reach, certainly this didn't mature we'd there's be larger focused Monte scale. a much be the will size there'll of been international if very don't criteria the Monte some Thank you It'll the -- scale hits, think the and of make From mostly great other we of perspective, scale be Europe.So lack market. if key specifically a much were to for to products, companies, I be some going

hope already just drugs a approved know the that make we from hope the just get with company successes. here I missteps for I next maybe been but the you've and drugs I that only the short few approved – can learn time, huge

time. So your you thank for

Yes, thank well you for as question.

would And hand call to the for back to Gorham like Mr. now we remarks. closing

support continued Yes. Thank thank team call. quarter like Well, today. concludes the Board you of of I'd Directors goodbye. continued for and IntelGenx Thank finally, excellent quality entire its support once in the very questions Thank much. management much. you, of believing again the our hard for in us. the team, to our investor XXXX third and investors was for belief work supporting you the -- and and our dedication, this The very

This today's conclude you. Thank conference call. does

your disconnect at may and phone participation. You time day. have you a wonderful for Thank your this lines