IGXT - Earnings call transcript Q4 2018 | IntelGenx Technologies Corp.

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Operator

Good morning. My name is Chris and I will be your conference operator today. At this time, I would like to welcome everyone to the IntelGenx reports fourth quarter 2018 financial results conference call. [Operator Instructions] Thank you. Stephen Kilmer, Investor Relations, you may begin your conference.

Stephen Kilmer

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

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

Horst Zerbe

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

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

VersaFilm leader transition and growing We making becoming from which, strategic to royalty development been manufacturing Over service license by to has films, as and a key both from a full the limited and a product partners, competitive a Pharma in oral two that to two this new shift revenues past quarters, products several welcomed strong commercialize activities. our focused product year opportunity. better global definition, the was validated being Tilray deriving strategic development XXXX company, IntelGenx and in represents revenues Gensco pipeline. Incorporated believe us a strategy, the we from more sustainable growth as and that stronger puts position and

recognized they are excited and partners compliant value business oral R&D proposition. manufacturing have GMP Our IntelGenx about innovative technology’s film our facilities and

our and our or started team organization with CDMO interested development development contract addition, foster prospective new manufacturing in services. customers In business relationships

our strengthened the selection teams, as and depth manufacturing also We President of of both with of research Rodolphe the particularly Operations. Vice Obeid Dr.

fourth for the its that This acute product a been treatment milligram and our activities we As strides make future our would oral partnerships migraines continued significant to most or application. XXX(b)(X) treatment products. of various past development on has current in soluble migraines, of would our advancing the demands RIZAPORT film RIZAPORT, CDMO advanced November, which in for the start PDUFA anticipated, XX formulation a with place NDA of review. acute goal our of quarter, of XXXX the and product commercial I organization. is on the for proprietary additional accepted IntelGenx we In signed FDA for the rizatriptan has April film resubmission X pipeline. announced FDA date

within GMP pre-approval record IntelGenx Health for therapies, Pharma, in Soon valuable for innovative the marketing mainly market. a resubmission, of migraine the be prescription to pharmaceutical conclusion right acceptance Canada management. our with of after which Gensco inspection important a up commercializing teamed FDA late using launching focusing largest inspectoral the a granted will responded observations pain RIZAPORT the NDA those company resubmission January, partner Form course IntelGenx Gensco a With certified the XX timeframe. that with systems, issued RIZAPORT. inspection, in NDA exclusive the facility prescribed of to as the is of IntelGenx a research, of At and FDA products, part delivery States, world's and Gensco a we manufacturing Then, commercialize drug FDA’s the Montreal. marketing track the five in the United and RIZAPORT development product in December, in on performed the specialty of proven due

We FDA’s on decision the of expect on date. the X RIZAPORT to receive the continue approval to April around US PDUFA or

the market clear for think be providing would film part marketing then partner, national marketing point the the we art and Exeltis at from Medical was marketing granted state site in able RIZAPORT Spain. milligram commercialized thin quarter, the XX IntelGenx the RIZAPORT could In have to market path is it details transfer also manufactured would AEMPS, say migraines manufacturer by the FDA for Spain. the site While the to of prefer anticipated German fourth Agency IntelGenx authorization and our Grupo Once commercial approval, Spanish JUSTE, the This this Devices, authorization oral be the film film we wait at Exeltis of Medicines received treatment will is approved, first facilities. launch, product become to with RIZAPORT received US oral on the until first for which now fair I of it's on to Healthcare. be in and to developed Healthcare contract of

indicated erectile hypertension Now, pulmonary like provide I on treatment. to was dysfunction Tadalafil, an update would for which and

dysfunction with indication erectile the the is only. bioequivalent pursues That brand product, fully [indiscernible]. application Our

the has which launch, patent product IntelGenx substance license Eli an that now book orange a previously path dosing IntelGenx from disclosed, provides for to has expired. Lilly been the XXX has listed clear As patent, exclusive

at We NDA business our intent believed to quarter license still -- our Tadalafil third we Lilly. from the had already fact that had partnership exclusive conference we potential that that pending interest. the to believe discussed a commercialized product with under in the jointly our During with negotiations a resume that FDA was call, XXX(b)(X) company best

finalized filing in with So application end of before successful. discussions currently we intention negotiations, partnership were not our own case the standalone of also independent with the the that XXX(b)(X) XXXX, the

We we a partnership the XXX(b)(X) the quite a received that inquiries own did the of our of about verbal straightforward. number had end the before of XXXX, since neither so year. in status submission The to understandably have fact for reason potential with reach announced, current is agreement partner nor the the FDA. We as actually end

formalize however, patent and be deal the executed to to to the the exclusive definitive patent’s Lilly to well IntelGenx expiration. in once ready fully to to license with exclusive allow order Before for commercialization, covered be license also of -- formalized. is the is while requisite amend agreement could IntelGenx That process partnered are has XXX advanced, with we Lilly partner negotiated to been that co-commercialization amendment agree had ahead XXX amend the for product

say longer anyone be to the very able this of to the Tadalafil commercially fair oral than of believe to that Tadalafil been we a I day, IntelGenx introduce film the cusp So seem for has would and attractive one process end is Admittedly, now to it's product. at But have on being continue that believe shareholders. the of commercialization we more the its full anticipated. US finally

like our Now, Tilray. cannabis with development briefly I project partner, co our discuss would to

plan would would forward of adult EBITDA expected $X to We -- are working comes. private cannabis We analysts no Canada progress for are amended which and Canadian edible look the Canadian significant in into edible XX, to the expected purchase effect, effect Canada. actively of more growth of the Amended development cannabis is versatile the value. consumers on product with terms cannabis come October into on about cannabis to under and that forecast use sector currently after industry cannabis XXXX. practicable as infused IntelGenx products the new later with to of updating soon both allow regulations regime, the than the or participants definition come The as infused regulations products. our as in market cannabis together of commercializing to one worth CIBC investors on in Tilray films XXXX. comply the with Health see the Tilray billion number legal it of prototypes

Let’s of Clinical the on in is is of clinical as Gauthier is added for the our Mental disease certain world dosing. and renowned ninth the leader patient which key Institute Dr. expected commence that Montelukast. University move and we clinical is and drug trial Last neurologists, Serge treatment lead XXXX, roughly we Kentville, of North Research Scotia Montelukast in the sites site addressable Nova to degenerative Douglas enroll $X first research the opportunity, the disease, In brain, established disease. now market site’s to research was True investigator. Health opinion significantly. , welcomed Canada This Alzheimer's in and month, eight site diseases billion as repurchasing announced Alzheimer's indicated grow our major to November Alzheimer's

actively We nine of test recruiting quarter of to the second clinical this sites patients expect be our all year. in

announce pace our our have progress of since and early last that in still subjects pleased While the happy been we're we study. have the we was currently it year in enrolled of with to XX been process, enrollment, are initiated

safety for opportunity this study to a board anticipated review the XX DSMB, first treatment later subject for fall. weeks completed who patients The of have data data designated or is monitor

results, at Besides any will be also to safety early XX weeks have who up to XX evaluation, to completed efficacy pick first that blinded subjects look for meeting still hoping analyze able data DSMB plan trends. The dosing. we full the some

investor the other we all who research results. pleased been With recruitment to our stage, sites. would interest will turn to CFO, sharing and expedite trial’s are sites the organizations Alzheimer methods Andre broadcasts are disease working successful now the increase to approaches existing advocacy Posters, Montelukast are Godin, by are in pace Andre? that, have enrollment from to I and groups considering participating we our other media our enrollment. like increase over with generating call and contract While the review we at looking set initial recruitment with to financial

Andre Godin

everyone. morning, Good Horst. you, Thank

Horst performance compared year a XXXX quarter full mainly partially fourth XXX,XXX. X.X for revenue [indiscernible] year. offset XX, Total by the company's the to revenue the attributable As million of well revenue the financial quarter decrease the period R&D for following that's minutes take an same XXXX to and few is were December XXX,XXX, last This ended XXXX mentioned, to deferred fourth results. The increase as in I'll a as is monetization XXX,XXX. decrease for of discuss in

to loss revenue, we and the item, from So X.X million exclude the month mainly XXXX quarter by costs three negative XXX,XXX were deferred the to in also year roughly period versus for were quarter about from mainly which is of loss program for full XX.X compared million for in fourth to on operating revenue XXXX XXXX. increase negative was of is per and offset in of of diluted for of a quarter. the XXX,XXX that's the remove the at last fourth share in expenses, million X.X year. for the or and deferred revenue accounted an now and Adjusted I XXXX had corresponding increase the for X.X approximately the clinical and for XXX,XXX the of SG&A year comprehensive fourth period at in if loss for in million and XXXX. Also net Also comprehensive was was XXX,XXX million $X.XX XX X to expenses in of we Also, R&D look XXXX, operating The XXXX, of an the If increase the X.X SG&A a million R&D expenses. corresponding the XXXX they non-cash would to of the versus X.X that's basic had for said or attributable for we period for X.X for December costs attributable year-end would months SG&A net year. million stable non-cash The company for operating a period of period revenue mainly compared mainly we increase had to is revenue per an share compared operating total a compared period million year, QX a to XXXX. like R&D. fourth of the in to mentioned expenses XX million X.X we the same comparable Montelukast XXXX. revenue decrease month basis million ea XX% million XXXX. million QX X.X XX, and decrease same $X.XX quarter, to QX on This of partially XX% X.X XXXX ended due for the again to have for the X.X -- increases And last loss if and comparable increase compared because have results, increase

EBITDA comparable for I of X.X period ended revenue versus the XXXX, same XXXX. adjusted the compared drivers of XX month an everyone net and per operating increase negative of period main by had in cash XX, December comprehensive to X.X year the $X.XX remind month X.X share For period loss XX The the the Again, was in the X.X XXXX. like in the And XX.X month last of company the an operating X net XXXX. compared comprehensive per to mostly are loss decrease million for million would $X.XX was and and were R&D non million SG&A. loss for full that deferred to of of XXXX or decrease revenue year revenue. driven the XX for revenue negative million for share period or The

remarks. back December million our XXXX. Dr. investment December XX, short I at and XXXX, XX, to the to as now call the Zerbe at to totaled USDXX term conclude like As million company’s would cash to compared X.X turn

Horst Zerbe

both of to work for dedication sticking you of their prepared now remind heartfelt following importantly the Thank will our apply board looking you them. of over for with most Thanks, Andre. like that like us, would to remarks statement our forward the by to would directors of the turn hard and questions. thank all ongoing for acknowledging you. shareholders to our I for I support Q&A. our close guidance, staff, and I call the

Operator

Your McCarthy Jason comes of Group. from [Operator Instructions] Maxim first question

Jason McCarthy

for Thanks the taking questions. fellas. Hi,

the and peak a peak And like? genericized, RIZAPORT, to commercial revenue does the map RIZAPORT of kind you at and [indiscernible] for question my in of around in activity patients And patients potential like accelerate side, United want the seen A revenue have biotechs because opportunity enrolled around study. and this question, from and program. second enrollment? Lilly correct where, was could US. target I me have And what highlights in space, lot lot is seen where given in question out First, Montelukast XX the is terms expectations the beta the an really targeting looked companies a of to activity fall here particularly that even I'm Montelukast of Biogen big on we States the jump there Beta you in if around the we've Montelukast its guys the Amgen, non the what it be based of to wrong, prior and maybe was prophylaxis have terms hypothesis, my in I of activity large, XX Emgality where like a all A really Maxalt from before over can On

Horst Zerbe

question. a for Jason Thanks,

First, peak quite were to maxing between at question pertaining million and to US. XXX pricing, your RIZAPORT, million respond despite the has genericization the stable. in million to And roughly sales genericization been XXX prior -- to XXX

voices with me to the that the qualitative in able in think they very second more we, that price to response. and week So quite significant. of disclose to levels be that. last of again, order there. recommend these so fully in that I I'm indicated I'm discussed developments that a those. non-amyloid point follow in comment obvious with of won't to that based to to Gensco Montelukast might our -- not increase comfortably, good company, any a, anticipation and but more of suffered. to and provide recent recently, Montelukast pleased with our He failure launch as price treatment. And And discussions And be is expect treatment, has they as be licensee, or product as our to details on that a literature secondly, the Pharma, is they at our to course are partner be study able aware respect that sales a and based and confident the recently regard, product details obviously payers amyloid a recent I liberty able studies I received he the has comfortably, the to product studies will, But Again, course, any have -- their initial been will size obviously Montelukast. amyloid might non I say, beta very say is various

optimistic phase So be with anticipated of to the to we continue our study. Xa respect outcome very

Jason McCarthy

just I PDUFA quickly to like the or to so, terms update have RIZAPORT post want And right to in the is the XX positioned has on commercial is production, start great. away days essentially jump PDUFA? going, of, preparations back -- marketing manufacturing in coming your up been Okay, Gensco, manufacturing basically partner and how maybe can you and us is company

Horst Zerbe

of We life length reasonably don't and launch to be to the the of to the -- point, case. I FDA the shelf expect to happen, product. to say date connects that assign or the it Gensco, our that shelf I of partner be am commercialization decision certain commercialization Obviously, will the launch after life the sole the is will can date but partner, and going not amount this the date. that is At the right PDUFA launch

the and consider is launch FDA the to approved name. rate step limiting brand is yet for date, aspect that FDA not probably Another that the has

has be partner name name. and has the been placed brand new can once a for for obviously and not contain order placed applied new FDA that the the packaging brand a brand Our approved has would new only material name

manufacturer stock lead the time is quite XX for the at our weeks. Now, pouch long,

we them with that able be once to product can as significantly, a receive material. but we idea launch discussions have the will when we in are We to packaging only cut back obviously to

Operator

H.C. from question next WainWright. comes of The Sean Lee Instructions] [Operator

Sean Lee

agreement? the My and my in as little one Good milestones as RIZAPORT economics on you with product more is of potentially us on you that a us morning, guys numbers ballpark and press you thank could to those? milestones commercial give give Because expected on as that bit taking I you coming royalties, for noted well. had first you're Could that for said up, the release, receive the questions. regulatory detail your some well

Horst Zerbe

the is recall specific but includes the comment Gensco over on principally in a I if profit on number, transfer that you maybe That right? I -- price. the end, what chime we you margin. but Andre, split. be percentage can’t to digit double in, turn speaking, a price on the I to to back transfer agreed range, And with then have can profit

Andre Godin

we very the Yeah. I I is a mean, with margin yeah, favorable. Gensco, on interesting is model and like which mentioned, there Horst profit mean, side sharing manufacturing fairly have

it I interesting for return us. is potential very So, mean

In manufacture we’ll the that But the number, date, revenue. firm be little interesting manufacturing would don't profit though as the bit will this probably wouldn't I might sharing said have at a well also mean have been little revenue, yet. take point, in we be as at numbers, point, this looking be we I Horst have depend that the we we terms well from indication, a comprised opening Like obviously said I increasing even like margin brand name discussed mean, as a kind on earlier, but an we quantities, think terms because bit these confidential. both number Gensco be of And product on it mentioned of order, want launch all of position but to also FDA, when and have of revenue after we the need a place I basically and launch clarity approved obtained. total as product, mean, quantities at will we in could at point, discuss earlier, earlier, the clarity this more Horst when are, to be on basically milestones some very to I a better any those have need approval which

the give rest So support it worldwide. being market the ever for a numbers, the -- commercialized world to be want not position really film the could guidance for product really, interesting on to the a US first But migraine those numbers. very well as I and in to as wouldn't these being a and of

Gensco So both that interesting, IntelGenx. product could very, for generating be very revenue and

Sean Lee

My Tadalafil second question product. on the is

for long also hurdles be you So, amendment agreement Would would I ahead on that? before once right to that the application are agreement and now. product partner the may is are for you XXX(b)(X) Lilly waiting that and take said any other is there go now, how finished, but hold the or guys your confused here, right the

Horst Zerbe

with Lilly two Sean, almost the on months we the the to ago. Lilly -- agreed of terms amendment

It get with has the So to we're be I for to agreement agreement the Lilly. with negotiated. executed partner like literally back executed executed day mentioned amendment from and Lilly ready the the waiting receive is we to before, amended on us the been fully

Sean Lee

will stuff? other the And ahead go There once you that, is directly. receive XXX(b)(X) no

Horst Zerbe

That's the jointly. correct. that, disclose partner response The parties to received complete in a I which to respond letter, received that -- preparation. might is agreed partner And

Sean Lee

see. I

final you additional question Thank on cannabis Okay. is your for pipeline. the My color.

products provide So development? with little agreement also, and for future again, products? on of are bit like could that? developed Who's economics What you paying the being the us collaboration potential a for the the what's

Horst Zerbe

where point, along activities at Edible date. I we the lines developing manufacturing that our be emphasis the in the October. XX are October an film products legalized as expected mean, film are Canada of latest announcement rise. and And indicated to Health this R&D oral product. of is

to films be I the on the would between soon have authorities an cannabis of based agreed product to so, plan Canada. of possible has to definition the what And by been products fall oral is date, is, Tilray edible as the and on IntelGenx products. upon under in edible And market legalization plan the as film say, published should following the

sales sure, to as been the that know comment you want I'm Sean. far on As expectations, as don't wild, speculations have I

the cannabis have very powerful in space. biggest We Tilray the a partner company. is second

not we but They that. expect from are we forecasts seen from the have significant yet. product, on revenues working partner any So that

point. wildly this any so be would predictions And speculative at

Sean Lee

for was the mostly that. IntelGenx and about contributing or Right split is now, Tilray cost And wondering what development costs RIZAPORT what would be will sharing, similar future price be question sort like. is have? have Thanks. have My product to also, and you revenue arrangement the I funding a the this all – of the to for transfer to the you'll it manufacturing be where say Is profit then Tilray market? you that of to for

Horst Zerbe

It's commercial and the for on agreed Tilray arrangement such profit is paying of development. me. margin. forgot is part transfer reminding a which for I the that for product, includes a similar have price thanks two that your about question. The we digit

In addition digits. to to that, a which Tilray’s we royalty is entitled the on single are in upper sales,

Andre Godin

Sean, the it's I just one I just clarify second. for development is costs paying to Tilray are, mean, want something, but most of XX-XX. it,

basically development to So, needs IntelGenx pay of costs. XX% the

Operator

question Tully from Patrick next Your of Endeavor comes Management. Asset

Patrick Tully

later I you and look not and the whether be you clarify, on dosing kind morning. at make will at there wouldn't a in this I, the announcement any would Good or dosing? said into once clinical believe, change fall had that trials, terms clinical as the you of that year Horst data Can mind sometimes you look to maybe in of you changes previously if trial Montelukast the development determination potentially, you when, the

Horst Zerbe

thanks question. any all, At for dose. of planning not First this Pat, the point, we're

We’re dosing single be at the maximally currently the to continues dose case. that and approved

we However, should have see. the the initial dosing, so, would the if But not what your was on are certainly we we contemplate that sorry, the to increase. anecdotal that. that data I'm that data if really option – if evaluation question? But expected based might suggest under part mid-point of second is we

Patrick Tully

look regarding press you data? data, making when will you that to, mid-term that announcement release any be at be there any Will

Horst Zerbe

planning to Yeah. is do. we're that point, what this At

Patrick Tully

are And that of update just us can are us Okay. stand where Suboxone or risk. guys all the And launched, where products product? terms that stands update they been you that have you you can with on in at

Horst Zerbe

late an with last particular us had our we're with partner, That disclose -- and any on that Endo this exchange we details product. advised that explicitly to progress they just Ventures commercialization making prior call to week, not any

one I'm on any well. competitive there. comment sorry, you not but to asked to about me want you details yeah, Then, at as situation, So liberty asked -- about that I'm you disclose the

Patrick Tully

Sure.

Horst Zerbe

[indiscernible] are is being mean, right litigated. those penalties, Book products at under second this to current Orange talking expected marketers here to risk. there still and still year. being that there's market maybe I It and have pending, product early that the is late about risk of triple now launched, market law. for decision want patents significant litigation as be a on may I and emphasize it is the A consequence next year, that from two damages may the have a that withdrawn prevails possible pay that, to the at

very I can So together and what this -- litigation we monitoring We're extent we're point. partner, with that's the situation. watching of at our situation the But closely. provide

Operator

There are no further time. questions at now presenters. call this to our I will return the

Horst Zerbe

And call then comment. to would again, I support continued I'd to the like that, thank and Yeah, company. everybody their the on of with for like conclude my Thank you.

Operator

This concludes conference call. today's

You disconnect. may now

IntelGenx Technologies (IGXT) 25 Mar 192018 Q4 Earnings call transcript