IGXT - Earnings call transcript Q3 2017 | IntelGenx Technologies Corp.

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Operator

Good afternoon. My name is Christine and I'll be your conference operator today. At this time, I would like to welcome everyone to the IntelGenx Q3 2017 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. you. Thank Instructions] [Operator Mr. may conference. you begin Kilmer, your Stephen

Stephen Kilmer

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

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

Horst Zerbe

corporate the I to Thank XXXX and call. quarter and providing will update key stress a you, begin welcome IntelGenx's just developments conference in by quarter. Steve. afternoon Good third the

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

film. the for with and RIZAPORT resubmission resubmitted the Along milligram first, key XXX(b)(X) we of to include, milligrams the for Administration for Drug Food the quarter our the Biopharma, our NDA of US updates RIZAPORT XX Some RedHill NDA film. the XX

background. a investors, new little For me provide let

expected of an by contract submit the generated for is a date we This supplier complete Spain application from batches and imposed application. agency stability in the to supplier. milestone API support resubmission as original per be is that to IntelGenx Review stability response National agency. for therefore be of strength in to RIZAPORT and import old submission therefore The the new manufacturing the site The to API very convenient new product NDA, ban product was IntelGenx’s original in approved Spanish the change response the NDA Approval had application relief to alternative. migraine to US team. precise. not the Spanish first unique Spain, batches. had migraine a batches, was the also the expected provide application was and and This multiple in the the submission to manufacturer. batches violations. the site this did German information, European and the supplier, perform should submission from been because listed the submitted. Once product in own for manufacture to contract be the from testing initial the change had the manufacturing of identify say at data a API prompted sufferers PDUFA the date, that excited on is or on was These is I RedHill PDUFA closer of received I time before, market authority three containing of change. import the Spain. application Since a facility. bringing the We're with company issued questions recently original by manufacturing to FDA from November ban manufacturing the because FDA, had the were a your response the old of for on for set those has product the half December GMP mentioned key be product a was batches and Following The by to the qualify we an the year, move fact will manufactured Great IntelGenx A manufacturer to expected necessary submission XXXX. new have site mid-XXXX. of launched to plant its this at

XXX(b)(X) Korean IntelGenx the the we with we South on our fully few hypertension. filing, The review for Tadalafil is is year. Korean The late treatment as the the is of upon Cialis. erectile to now erectile will indication. is Regarding track Pharmatronics know of dossier brand the of A and a be the indicated pursuing developed dysfunction file dysfunction film product received transfer filing Pharmatronics, for you Tadalafil. in of on comments equivalent partner, is November submission. that for NDA FDA, pulmonary only the which by acceptance with QX this to FDA expected

We expect a to of FDA for XXXX. by X XX A is in review United an few and month on the correspondingly the launch targeted half second Suboxone litigation. the patent States comments

project who the for our by the does dependency confirming Par a court has driven on of found infringe the on XXX ruled entirely manufacture is that that Monosol's pointed the opioid In product XXX patent. patent, for year, does have IntelGenx, this Court infringe we process patent. September litigation. infringe outcome on As really so-called on process called Monosol's the This Delaware process IntelGenx indication culmination is for and to patent. product previously, and positive have to disclosed used our of previously this not determined out the The Par the making not XXX so in same

as In our asked filed the infringement case our address case patent. issued for received case patent we to decision to sued ruling obvious separate be to decided TEVA applied of that However, were TEVA they and infringement in a not XXX contradiction, order thereafter, and on not ruling. court also the a Monosol infringing another well. been and that that reopen IntelGenx to with had and arguing this motion Par our Indivior Shortly stating claim construction that reconsider same did ruling should appeal judge to by agree in the case this which a

court rejection on the on the was point I late like and but that based simply was motion would rejected. filed However, out formal it not the that argued too to grounds. was merits,

I court initially we will just Par mentioned, the the as that through too motion appeal late. decided process move IntelGenx now and filed As planned. the forward

Austrian Montelukast, Montelukast approved project of disease objective the published the compared brain. treatment based patients most on degenerative project Recently, IntelGenx’s take an published The was, onto trial. animal those the the the article The results patients for IntelGenx for taking aging." be alleviate Professor cognitive Aigner medicine. Montelukast with was group Moving Research and Obviously, inhalation Montelukast on approval of of quote, opportunity. the asthma asthma may associated epidemiological who is I by Nature. "The repurposing asthma. to results by of conventional to with has decision the epidemiological researcher treated in conducted suggest of experiments study initially decline with likely was the the controlled to and Norwegian important review repurposing human that drug FDA is by which obtain present with less needs drug this advanced to conclusion conclusion develop dementia that clinical are by established confirmed drug treatment found a The

improved results by drug As at Montelukast. as previously when evidence against clinical study increased pharmacokinetic London there of recent an reported, brain bioavailability and the The oral ADDS Phase with given product the drug we that successfully profile represented the X The a film. is and in Congress the the completed clear blood XX% significantly show crosses reference barrier.

study one of qualitatively Canadian XX and submitted in study call be intermediary application who would I obligations, patients, plans study. can of budget called conduct project leading Endo. we to the to scheduled clinical the Andre? a protocol are liberty disclose state I with our at Because submissions regulatory projects. redeployed and The proof be we review conducted first trial are of financial concept XXXX, ongoing been we our The study, Body so confidentiality patients will as results. to that Governing Andre clinical mid-XXXX. I enrollment and quarter contractual to of that, the dementia. Phase II study designed all Godin the are to all CFO, by projects in discussed, assistance progressing commence these is just Canada. from above available Alzheimer’s according four with additional will Alzheimer's mild details to any experts expect agreed the be have has projects been secured upon the QX, the sites not for projects XXXX. turn supervised will the over with to in With results and the group Dementia Eight has of we by five have projects which been to five Health of experts, Alzheimer's now XXXX with Canada Besides chemo which Study for a will like suffering With Studies. moderate mentioned CXR study approximately

Andre Godin

Thank you, everyone. good Horst and afternoon

As the I take a for few financial minutes Horst discuss just company's to will mentioned, QX. performance

million X.X three-month Let's million revenue month for license last period last year X.X of decrease to ended XX, year total for compared three last signing is period for for September revenue. XXXX, costs versus year. the amounted and revenue year. period. September agreements compared the corresponding XXXX of million mainly period quarter same and third start attributable Operating last with The in million, in the The other X.X for QX XX, were decrease to the the the several to following X.X XXXX to the expenses

XXX,XXX period XXX,XXX SG&A nine-month expenses that out point Let's decreased the months for three and to the by period XXXX. compared for by

XXX,XXX adjusted minus EBITDA, of for XXX,XXX terms period EBITDA In last the month to was year. three compared

improvement month the was to an XXXX. in compared nine though, period the XX,XXX there For EBITDA of

to loss diluted operating compared on share period month year. a of of three net income XXXX For Net a in basic XXX,XXX period income comprehensive of XXX,XXX XXXX. per the basis loss was for comparable had an to and of company last for XXXX, the the comprehensive compared QX operating XX,XXX or XX,XXX for an $X.XX

totaled the I the call This was net completed remarks. would and the As XX, back that the to the X.X like turn includes now to convertible subordinated of unsecured of conclude prospectus investment early proceeds from company's debenture Zerbe our December million. cash to August. in XXXX, short-term Dr. offering

Horst Zerbe

the and would now our I at and thank thanking participation to again everyone I to and the IntelGenx today. for over conclude Thank your on call questions. to by call and IntelGenx you, for like call, your once dedication turn With work, team Andre. for for in interest you their hard that, everybody

Operator

[Operator the Instructions] Your first Research. Cantone of line comes from question from Anthony Cantone

Your line is open.

Anthony Cantone

any that works I progress that the regarding term going should on we're I I ask the to in partnership of by can you potentially, ask we potential comment marketing Horst. us it's Cialis. negotiations, just near the to next to know you something I mean, hard about get hopefully that I give thinking assume, update you year discuss wanted can it's on progress are Hello, the market have but about of any and on. to Cialis still the that wanted in

Horst Zerbe

specifics. question, not at very is qualitatively the respect you tell licensing to liberty cannot Anthony. disclose mentioned any there parties. I that for a ongoing to details, active there Thanks certainly provide as What interested just but at with to ongoing discussions are this I with can not I deal, very discussions It's active I'm unexpected. but restate any are point,

Anthony Cantone

Montelukast, And could patients you are we yet? close of the is progress enough. enrolling about -- getting to fair the Okay, there comment

Horst Zerbe

Yes.

also to in in more press That the we disclosed a I update, Health is application As been submitted or clinical Canada, the that and formality. a mentioned trial has release. less by the way

clinical the We trial. don't year. commencing the can the roughly quarter Health a start. application, not hire there's and be next point, to preparation we When the trial of the six clinical is end told we therefore later be year enrolment first has nurses and the in enrolment. of the to to to expect Keep an Canada we approved preparation mind first the have it's know, Health to sites clinical within clinical this can and a time Canada expect clinical time Phase committed, trial because the clinical depends weeks on the sites require train clinical We commencement so that lot this be before need this efficacy enrollment in the completed sites that trial were exactly, by this at that for and approved sites a that eight of quarter after of the X trial, at

Anthony Cantone

good right. Okay, so news. that's All

So XX or people? and do to more XX than us a the you cost roughly you speaking? people Can expect to be general give is enroll going what idea

Horst Zerbe

cost. committed. That's once their have on completed been the finally have will patients discussion ongoing XX study clinical more we an preparations. I know point, comment this At cannot the sites and

accordingly. our update will investors We

Anthony Cantone

regarding what the is And shelf we be that it done and have has life we early the get to bioequivalency study, or year? completed next Cialis, -- Okay. yet, did been about completed

Horst Zerbe

study studies, and quarter. a submission long, are ago, quite bio the completed ago, stability for as wrapping mentioned this we been long but geared The in up up are later update, looking we while has time a at I

Anthony Cantone

Do think press release or you to an filing? X-K Okay, good. require that's going

Horst Zerbe

Upon submission, a we will yes. release, issue press

Anthony Cantone

good. Okay,

Okay, good. All that’s good. keeps That right, everybody informed. that’s

Now expect than near that we to the right nine in in have pipeline, term? about you now, the have more drugs anything do

Horst Zerbe

active provide XX and very our details. but programs. think we we the for correctly, I than a answer, couple I other we're is nine. short cannot more Yes, projects in have answer the negotiations in If of have I question good a remember any pipeline, it's again

Anthony Cantone

something, last to carry significant Montelukast enough being even we all would couldn’t strategic mean burden And mention it's some to have is I much going that money. maybe cash more question we're about the going next to there'll you you to be we I we money always have a think, raise have out initiatives money. and or have enough Okay. Do do be, with pretty do though think year, how

Horst Zerbe

question. that address will Andre

Andre Godin

case, said, strategic in Yes. be cost but the there need the At mind don't for important Montelukast working be final have that Like that the we will any the to a know be to opportunities which in always on what we -- money looking cash. budget of raise, we're being. the for day sufficient could potential we this to Horst so for keep but day, point, also study, so will raise time still

Anthony Cantone

Okay.

near We looking have in from most at cash raise term. to and raise the enough the money, not least recent

Horst Zerbe

Yes, exactly. Correct.

Operator

Private next line Investor. a of from question the comes Your Peter Maza,

open. is line Your

Unidentified Analyst

regulatory do approval to your agency? expect you the Canadian When get production facility of by the

Horst Zerbe

of to expect by later year. that this end receive or the We this year

We active I time, with are we been qualitatively we this inspection Canadian cannot approval. any assume scheduled, comment this later the communication will that has year at obtain in A the Authority. but but further, speaking, site

Operator

to Zerbe, this Dr. I further no call you. at are There the questions time. over turn back

Horst Zerbe

Okay.

much the have as further are no Thank the I for you company. to thank call, enjoyable of So the everybody interest an there like again questions, attending would continued very in their and reset day.

Andre Godin

Thank you.

Operator

call. conference This concludes today's

You may now disconnect.

IntelGenx Technologies (IGXT) 9 Nov 172017 Q3 Earnings call transcript