IGXT - Earnings call transcript Q2 2019 | IntelGenx Technologies Corp.

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Operator

Good afternoon. My name is Emmy and I'll be your conference operator today. At this time, I'd like to welcome everyone to the IntelGenx Second Quarter 2019 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. [Operator Instructions]

you. Thank Relations. Investor Kilmer, Stephen

may begin your conference. You

Stephen Kilmer

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

to like I dollars amounts forward-looking U.S. remind you otherwise information contain certain mentioned. And that Before mentioned would that are our today we to and begin, today may represent U.S. in unless not accordingly are all any change. today’s call as to except do obligation laws. and by of subject undertake We may any as update Securities required statements forward-looking expectations be Canadian

A number Commissions. risks could U.S. be to these subject risks, Securities preparing of and filings and found results Canadian in and in assumptions our materially. assumptions with these made us may the statements, on are by forward-looking which differ were Details

the like now to would I over turn Horst? Zerbe. to Dr. call

Horst Zerbe

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

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

address and let response letter update in let start of the to questions receiving our FDA's toad chemistry section complete start priority agency Since the the manufacturing to with the to So the applications. our for by April, providing top me been an NDA a me RIZAPORT raise regarding be the continues which this related working company. we've

the month. year to quarter remain responses the items which --of the this respond third on to progress means end made our this on and have the next of We April CRL at of track to

as films elements agreement each with this on much and each worldwide as our licenses or was Moving manufacturing on entered the commercialization the exclusive film Aquestive agreement of dysfunction. beneficial into last and spend I a for I'd will announced previously a too treatment on this time Aquestive few not call, and will the of of erectile and Therapeutics the Tadalafil worldwide and for covered mutually of definitive Tadalafil IP. the but co-development a we to or details highlight formulations respective -- other IntelGenx this strategic will grant like to to partner. now

will products equally net profits We Tadalafil film worldwide commercialize from product and jointly co-develop or our sales. sharing

single combined will and our enter to most the advantage very film competitor our broad with the strategic any portfolio. product IP for The Tadalafil compete market this make important patent partnership from or that is it on challenging

Our combined believe patent for maximize the portfolio our We all our with companies IP commercial broad Tadalafil market an would exclusive product or and similar to commercialization technologies protection. stakeholders. of give complementary film strategies opportunity opportunity an

to updating jointly markets. to shareholders the to forward forward the required Looking other activities perform in product to as commercialization of the the letter respond United complete response and we potentially move States in and

first films with developing that have shipment Moving extract we partner use Canadian Tilray certain our on the we now the formulation the and would in use various adults comply Tilray. end cannabis-infused collaboration May, of developing and cannabis-infused to are films, prototypes market. At medical adult been received of with cannabis from

production of more Canadian to than into of of report espresso $X.X half billion soon as cannabis following expected to December mid this the a of Deloitte cannabis Canadian I estimates recent by come regulations we products market launch market for billion cannabis representing $X.X year. planning alternative are adult Canadian products. can roughly A amended as so these commercial We effect commence cannabis possible into which film, the

Tilray in forward our to on look updating investors future virgin so with calls. can this progress We with and participate are working we market

sites in Peterborough trial and Montelukast to during now second quarter. the on Moving Ottawa established Xa and clinical we phase two

to with the with limited current enrollment contract continue organizations research screening enrollment and our and sites We reviewing working across new are and activity. sites drive

Our reason. new Ottawa this site was established to replace site Toronto our former for

recruitment final also this honored once begin the Donald research investigator at we site approval, We site that researcher have Peterborough who Doell obtained serve Board will as identify Ethics to clinical Center. the and renowned will of quwata the it lead patient Dr. report at

patients quarterly the from has the on call Overall, last to in increased number randomized currently our we reported of study XX XX. this

a in the pick and at interest up the Sanyo, the effort, this investor on as will line by sorry, of in and bio this completed significant fall we safety continue work disease edition Alzheimer's mostly XXth and addition we as any to -- dementia in will as clinical in XX to attractive of am we in attempt We Currently are of pertaining of completed to have planning I a present part evaluation the market study. role have announced, California our report trial And of increasing trials results to to player generate therapeutic statistical awareness hugely a poster Alzheimer's December patients the year. trend. intermediate aspects previously Montelukast

is that study the and be to Please data we not the is to able keep invalidate a of in anything. evaluation. intermediate will for this blinded purpose mind not unblind That this though

our the and will review to would CFO, turn over to Andre? I President now results. that Andre our financial Godin With who call like

Andre Godin

Good everyone. Horst. you, Thank afternoon,

in to future We're the cannabis performance a amounted and of $XXX,XXX the expecting for give same launch to our R&D in take I'll is mentioned, growth Revenue second revenue expected with launches. XXXX. few migraine will compared the commence June last which minutes ended IntelGenx Horst to period to the the sustainable second film attributable within revenue XXth, to near very a decrease year. $XX,XXX. discuss for the As for quarter $XXX,XXX quarter The following these revenue recurrent decrease quarters of company's mainly financial

year. $X.X Operating be revenues were costs the deals. related for clinical Montelukast versus $XXX,XXX is revenue should as to potential the for $X.X increase In program. upfront attributable the to expenses last mainly milestones same R&D and in new receiving meantime, the The last we million increase million expenses potentially to R&D period year, as compared revenue well XXXX QX, and period from same the primarily

closely are near different in to future. departments come expenses We commercial preparing to monitoring ready production the be in very our and

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

the remarks. XXXX, short-term million. will and US now As company's cash Zerbe I of to investment the call turn conclude Horst $X.X Dr. June total the our back XXth, to

Horst Zerbe

the thanking success. Thank will both I remind remarks over close forward-looking I our for staff turn the by Q&A. Board for ongoing Andre. our drive to would call I Directors to like most to Thanks, will their now and prepared questions. importantly shareholders you whose applied loyalty our our our would our guidance, of dedication their following and statements for you. that like

Operator

[Operator Instructions]

line Maxim of Jason, line question Your the Group. with McCarthy comes your Jason from open. is first

UnidentifiedAnalyst

It's Jason. everyone. Hi, on Deb the line for

questions of quick Just had here. couple a

inflammation just given curious respect and Alzheimer's pathogenesis disease has the the VersaFilm that on Alzheimer's with trial, comment the can the to now plays this capacity? of impact VersaFilm So role montelukast that product disease you on

HorstZerbe

of more the and anecdotal Well mode that is a suppress and a we should action that that And inhibitor to here. studies mold pursuing systematic promising inflammation leukotriene montelukast in have that from is aware and seems fact such become we are as be pathway. the

mode drive situations that So action. it's of basically of depression inflammatory would the

UnidentifiedAnalyst

straight wanted I that I here. I just then couple you to And make believe a on my things to the thanks. got sure call reconfirm Great, mentioned just of facts

the So saying trial, that phase Xa respect data readout is that? you fall, again mentioned correct that to I am expect a in with in can -- the we montelukast

HorstZerbe

be the readout. and say previous intermediate did we sorry, or or month that completed patients we're this I'm of an we I eight later What eight, doing will calls have was And we announced August I what will end discussed have patients. by attempt and may X-XX September, currently before

mind there's arm placebo a it's completely keep involved, study in randomized. and the is blinded Now

not will will possible like study, we the so an you to and certainly will make data. will extent readings. we surely safety that on we report we is up unblind that So to any will blinded discuss of pick And be trends the effort if able to those the therapeutic trends,

UnidentifiedAnalyst

end would safety and data? with like like Okay sometime the to or of be at the the like that the respect September month

HorstZerbe

let's think of a data we'll think available will say be I go able number will That They have the September. in take some to time. would previously this statistician we we crunching data bit a I that announced discuss there. in and do October, to we

fair think I in October it say we'll be in so a to those discuss And data. position be would that to

UnidentifiedAnalyst

to And right respect that that Okay, a December, mid-December? then great. the say plan and production cannabis-infused did marketing. And mentioned starting you VersaFilm, with on was you you

HorstZerbe

We claiming is finally Health edibles. that Canada by the but legalize not didn't we're will the mid-December say that what that announced. That and they I'm what is saying

and So be of it edibles theoretically so that can as date commercialized.

is a preparing and are company comment. as of I becomes to be up the to film at point possible, that should in a so the getting legalization perspective ready be which that speculative. has become message -- But that all We be time the it partner that's terms time launch will we our launch are as API, to launched. ready can but tell the gearing I priority has you that it of this them think be launch and yet I that assumes can to then heard from legal keep by I be high from What is That this want they can edibles to that also is product same but legal it that that it. product supplying the ready and we rest not to soon that available the at extent

Operator

Sean, from Sean next H.C. Your comes open. of with Wainwright. the is question line line your Lee

SeanLee

product? And you Good the thank for a Could Tadalafil afternoon, little film my more can on elaborate taking questions. you we for expect the guys. timelines

HorstZerbe

Yes.

That the as any And several certainly and We CMC half not now the discuss conjunction of are our review far ago. the as half I'm timeline XXXX a includes it safety by study I'm generating in no, certain that repeated. the submitted FDA data data needs on second safety complete the in study first -- sorry of and details in further FDA. expect there's is is to XXXX. there concerned, And we until a have a and received completed to to that also months letter liberty partner at response that working be with right includes requests

it's for So Sean, at launch. an will down XXXX. be It most this point exact it's, early date to difficult in nail likely

SeanLee

plan question that for going thank additional from that. third to the Could review My is little color quarter? Great, elaborate end you be six-month is second to done more once on you that the resubmission. And period what redeploy exactly the a were be until on to of now needs on submitted?

HorstZerbe

with also it; up look have a a response all of order of generate to in on a also partner that we I take involved our say are to requested consultant. our we can response. --we've has expertise, other time, sent be We've We're another We our that draft reviewing respond so in confidently the to we a it to satisfactory sure response we regulatory FDA able words the April draft that to commercialization letter, come --complete data external in the table. been have have

in stages the we're response. final reviewing of So our

be next will sometime submitted And it month. so

Operator

from question the is your comes with Manufacturing. line Steven ATA next Your open. Steven, of Giroux line

UnidentifiedAnalyst

gentlemen. Hi,

be the Just question. investor to regarding resubmission Sean's for private class RIZAPORT? class follow and have X I couple this X up a or a to clarify, RIZAPORT on questions here. Will

HorstZerbe

remember It'll be six class months if it involve X so review correctly, I FDA. will at

UnidentifiedAnalyst

you. for received name change? And approval the has thank partner your commercialization Okay,

HorstZerbe

are that. working they still Not yet, on

UnidentifiedAnalyst

I one final question, And if Okay. may.

a doing if tablet. You aware is not sure I'm a Emory study using guys, montelukast you're University

thoughts that. Your on

HorstZerbe

are of matter a to We that are aware to Emory and talking principal investigator of and we two study the also as sponsors. course of fact

of some So though we could be because complementary. they're actually there doing try to combine forces what

UnidentifiedAnalyst

sure hear, And work thank to you. that with for I'm be great all to will much Zerbe. gentlemen. That's I Ajar you That's information. Thank Dr. you very glad have. Dr. And

Operator

Zindine, Freddy comes is question your line next Freddy, Your from of line the Private Investor. open.

UnidentifiedAnalyst

a I guys. cannabis hi, had first regards Tilray. in question to film Yes, the with

production anticipate would did do you batch? invoice to in the My the May, first You receive Tilray for shipment the shipment. first question, back be when Andre,

AndreGodin

actually receive May R&D. we What in was for products

So supply months expecting production the to are several launch. the we before before receive -- develop to commercial formulation obviously the

So will next manufactured be which month, to invoice only and but happened but we to only upcoming can that shipped come commercial is able production the the yet. so will for in product hasn't when --we Tilray,

UnidentifiedAnalyst

you Okay. And like to this or be some next think year light is it going if this shed is happening on can when this you or year year?

AndreGodin

a gearing likely to product be launch Tilray. As up little to be will earlier, And Horst the obviously, most in mentioned with QX. we're bit it ready

royalty net on the And so at then the be then the invoicing able is or be point three two first receiving then we probably to follows their And them the revenue or that or after for And Because sales. initial Tilray on sale. on the a manufacturing. would which month we invoice the part shipment shipment. royalty will for

UnidentifiedAnalyst

be shed on royalties As percentage able some light manufacturing? the would some percentages Okay. the like wise. And to from concerning on you numbers

AndreGodin

royalty; I that not mean --that what mean? it's is it's margin gross you

UnidentifiedAnalyst

Yes. percentage will be That's like I mean what IntelGenx making production? what on

AndreGodin

Yes, plus with agreement the unfortunately I Tilray. cannot is or I amount can you tell percentage. a that What have we the cost disclose

is. basically on profit I'm But certain it IntelGenx. a cost. it's top our But So not to disclose at generates of cost obviously plus liberty for it percentage is our what

UnidentifiedAnalyst

RIZAPORT there? fair. light regards updates Europe. in Okay, to My concerning you some is that's shed on question next Can any

AndreGodin

unfold months the of data Spanish validation we process Spanish runs this head, application that respect next that critical the an my Spanish it the into the will within already date can European can authority, process give data early The future. are off process scheduled submit top our request couple the with change process from the I submission Yes. that know validation is new site And with the as partner so to site. for then you exact item the to year, authority. validation for will

process be And and so to ready we those validation run submit knowing this those then are ahead planning data. to trials

UnidentifiedAnalyst

noted to question RIZAPORT the month? is and CRL, next Okay commence by How the another the have I confident you stated the you on CRL going in you submission next were within, are believe this that concerning that that said US, been addressed IntelGenx. deficiencies by

AndreGodin

I confidence certainly thoroughly. with We request evaluated but want create lengthy clarify with letter what the is FDA and that deny, exactly We've and they been the to address we letter. have I don't expectations want. line discussion complete then say I the down component a full what response to able very any can't to of can single had every

So well. will mine only CRL is the that be in and only we respond my that personal position way opinion to believe of personal partner the by We the the not opinion satisfactorily. that company's position our as to my and able that's is

approval. But, that. guarantee do I expect we And obviously, can't

Operator

open. Danny Your next the line is Doell, your question comes of from Investor. line Private Danny,

UnidentifiedAnalyst

we stock of for lows going have the low, end week cash coming nothing a I for got question, June. I the we Yes. --what What at million a all-time need $X.X almost Are XX into we're see of investor. and capital? with but looking are private while. raising to is online as

curious what's going that? Just with on

AndreGodin

the I always mean and diluted be now. where as looking price, we're the possible to stock with options it multiple try especially is less where at

hit some hopefully and some react time milestones to to able to programs. be a So we the have regards I in us will front And especially think few of that accordingly. in stock

if a spending we're really But our point going obviously, we money. at the execute well, and which the the less to execution it's way to prudent raise on term. we money maybe we're go it's with And not I painful speak now think that will looking we're in think as I be short market. about so to we succeed

which We looking in time execute, the to have the finance we'll some to shape stock that and at we're so hopefully appreciates be company. a price better point

UnidentifiedAnalyst

Okay.

possibility the the out a looking missed company? to CEO? investors at something's want RIZAPORT senior second projection, changing looking lot of anything times. question. speak these to company. change The a at but of away this years will, take I from three Is change got I in for the failures think the you at that statement Horst more of we Are a this Directors Board of if don't this I management of of

End of Q&A

Operator

over session. the will question-and-answer back Dr. Zerbe our remarks. concludes This I call to turn for now closing

Horst Zerbe

like I'd the Okay. support. And like for that to thank their everybody very you again we'd much. conclude with Thank call. to

Operator

for you Thank call. conference today's concludes This participation. your

now You disconnect. may

Stephen Kilmer	IR
Horst Zerbe	Chief Executive Officer
Andre Godin	President and Chief Financial Officer
Sean Lee	H.C. Wainwright

IntelGenx Technologies (IGXT) 8 Aug 192019 Q2 Earnings call transcript