RDHL - Earnings call transcript Q3 2020

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day and welcome to the RedHill Biopharma's Third Quarter 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. Today's presentation and slides can be viewed online via the webcast. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] At this time, I would like to introduce to the conference call, RedHill's CEO, Mr. Mr. Ben-Asher; Dror Chief RedHill's Mr. Micha Financial Chorin, Officer, Scruggs, Chief Officer; Commercial Mr. Rick RedHill's RedHill's Gilead Mr. Operating Officer; Raday, Chief Goldberg, Guy Business Chief RedHill's Officer; and Mr. Corporate Adi Chief and Officer. Development Frish, Business

Before Harbor RedHill's we read Please go ahead. begin, Safe will we statement. from

Alexandra Okmian

RedHill's the are call the U.S., research, that efforts guarantee of events and the activities will applications, with Actual and the for and to with RedHill future in of commercialization respect elsewhere they strategic and conference timing, does today. statements RedHill information. may fact including expectations related our RedHill's trials, obligation Pharmaceuticals, of or may projects of other events, of what agreements future or statements differ results This opaganib initiation, or forward-looking manufacturing, treatment business, projections the regarding any other clinical performance, Israel, regarding any, studies, timing, not results RedHill marketing predictions and to RedHill, to materially update clinical activities from performance preclinical in assume promotion, the approvals, and statements cannot the if occur. These contain and the Cosmo trials commercialization COVID-XX. closing progress, RedHill's

March actual events, on Form activities XX-F Additional information factors contained XXXX the Annual Commission. Securities Report timing, statements its in Xth, company's and on that and with could the materially can results, filed or forward-looking concerning the commercialization differ the performance, cause other to in Exchange those from be filings SEC found with

Dror Ben-Asher

business and highlights We'll Alexandra. joining presenting day, select us. everyone you, for you Good Thank thank today. be

to later growth the the that Thanks quarter dedication, that despite the last execution, the and link environment impressive team relentless RedHill to the I experienced it focus rapid we'll disruption to created. third and the press be the to So, of during and on would slide significant continued please progress their resilience, pandemic challenging and the we its thank the on organization, like RedHill the in strength deck for on. presenting quarter. remember

the quarter, Talicia growth million quarter-over-quarter Phase treatment. driver unmet an have significant a funding, several ramp grow. In Phase prescriber The infections, complete decline just X of Phase as reversing the study prescription NTM extensive our RHB-XXX potential which emergency payer for with a prescription integration approaching of to an the well first-line parallel, disease view for grew quarter have a X FDA-approved significant therapy prior quickly XXX Movantik for generated acquisition application. up for potential continues trend base use as demonstrating opaganib pulmonary a promotional future rapid data efforts agencies opaganib company. manufacturing COVID-XX for and prescriptions with collaboration of Specifically, as to with second the parallel consecutive important and as ongoing delivered opaganib in preparation and and the coverage we supported its of In Americans, by existing first we government expansion XXX% for initiating national are XXXX. discussions are as we no U.S. of for as for early for studies need U.S. the completion RedHill. applications X/X global initiated growth oral with RHB-XXX We SARS-CoV-X first-line

we travel area picture, the in important view Movantik Talicia, growth revenue curricular Turning for drivers. and as the Aemcolo big

lasting and leading of We our and vision, and in specialty continue to our growth, fields the inorganic to company. pharma building future organic realize invest

towards In the the continue short motivated next and Our to focused breakeven growth remains highly RedHill operational term we exciting work on term plant long year. short team term, mid term, trajectory.

to to the Micha Q&A Micha. our to press remainder followed our see remind of slide audience during results, detailed be All quarter session highlights present to in the by the order selectiveness third CFO, I time. we the yours, as link discuss to turning on Before the

Micha Chorin

you, financial results morning the Thank Dror. I for quarter. third will short our Good of and everyone. provide overview a good afternoon,

has This positive been RedHill. for very quarter

Talicia of We both have legacy our increased core from products, prescriptions discontinued Movantik completely and and all products.

while compared primarily net will proceeds in approximately of substantially million. increased gross used was activities, I quarter. $XX $X.X of are as billion dollars, revenues was million, of in have discussion is burn quarter and which lower QX, company's back the burn of later primarily mentioned, despite the from the to decrease to discipline. of were reduced for and compared second to profit turn we on. operational net to just questions $X.X trend Dror, in capital, the cash to in our activities take we’ll reduced cash compensated of well quarter. reported $X.X cash We maintaining $XX QX now in net higher XX% loss million, in Research the in cash positive and is second burn also $X.X decreased increase towards ATM. you. attributable attributable previous from operating million quarter The which to COVID-XX This XX, increase previous due With in year. growth than The of was balance approximately continue COVID Overall, In $XX changes next and in we in be million happy this to a XX environment. approximately profit to Thank the working breakeven positioned challenges million lower I in gross as and the cash Development quarter. net cash year, financial $X both, operating progress million or Net to to used study. up of bargaining around XX%, expenses million approximately million, $XX.X the $X.X September the

Guy Goldberg

We're Guy is earnings through Chief walk this presentation. to call Officer. Goldberg, second everyone. Business Hello, our you Hello, excited

side. transparency macro conditions, as As we business can, keep business With much what about effort commercial and as put these how our are special mentioned a seeing last we're changing our quarter, presentations what to us give emphasis costs especially ever on performing. is we way informed these is affecting for about on the you and to

and quarter this it. a are because of we're program, challenges year of XXXX the is very metrics will progress be progress of of basis and RedHill, accomplishments. what critical case we of proud enthusiastic markets to continues these why early COVID of of said to pandemic -- our great in commercial for investors activities. Dror even are order in one-off remarkable that appreciate understand spite these our better in of and overall this echoed making stages so shown a we the on is our in be our Some quarter message The help

We will operations. of give you our review a detailed commercial

and team Our thrive resilience this has with creativity to during and determination, entire commercial adapt challenging time. worked tirelessly

of well with going launch quarter-over-quarter Talicia Our about prescription XXX% is growth. very

We will also give an update our R&D on activities.

shortly two COVID will clinical hospitalized studies with large have a very opaganib in we market. results in and very patients, underserved still our Importantly,

failures at very treatment, you very disclaimer, truly echoes know very disclaimer If our the the late among first the presented -- start This including the soon. excitedly, consider the recent forefront companies will are we first which drug big of call. the very in profile, here is a we COVID pharma, few answer the at and clinical high by and stage development effective could be with

growing the NASDAQ call we are on GI the new disease. are infectious the integrated, with not with listed fully who RedHill, to rapidly specialty familiar For U.S. company, and focus folks

H. travel opioid which are Amecolo, infection, is therapy. We infection, happen And very diarrhea which as FDA year. travelers which three the of international for next side Talicia, believe Movantik, effect pylori caused products; will which is opioid effective which for most indicated an will is commercializing approved indicated as and need important induced more common bacteria product serious widespread become constipation, of indicated E.coli, treatments. we and by new for increasingly soon returns, a

ready to for excited brand and several travel prospects. promotion its undertaking full resumes, activities about are are promotional when We Amecolo commercial get

We have pipeline track and stage strong and R&D clinical very a success. robust a of late several record products with important advanced

currently novel, its dual inhibition study. clinical out both They readout. to Importantly, mechanism Phase Phase being preclinical candidate drug close trials. advance are action, thanks of opaganib, to X orally the very global data and X/X Opaganib rapid viral administered dramatic through both stands and the noticed, our COVID-XX crowd, and U.S. increasingly and unique is of is in data

net was a quarter Second history, record as revenues. quarter transformative generated we in our company's

over, improved third steady quarter, we script quarter-over-quarter and continue last in that growth quarter-over-quarter We QX earnings with call quarter profit. on again net Now mentioned took the also decline the been a Overall terms improve have we for gross acquisition. report XXX% approximately script the in And gross million that Movantik progress done our that. with completed $XX after Movantik. We Talicia. will revenues were the with growth And fact of Movantik to able period margins. before around. renegotiated scripts Daiichi we And believe in turn with we've

with Talicia. strong our see activities. continue, launch strong now product. that also we we we and to build have to over growth effort larger challenging indication, script when and continue script expect expand as as the script as expect Even a AstraZeneca -- And the to more get the than on product we in took momentum, launch expand, growth we you targeting conditions. experienced pandemic doctors, current And we did continue with more We sales as

year. operational well We next are positioned breakeven to reach

since message said, Micha consistent we As given last this is quarter. have a

moving opaganib R&D the quickly. On with studies our side COVID-XX

moving nearing of of of U.S. that X patients QX global is study. on the our pace completion in few for last of end in the depending recruitment we the expected our are are We month, great rates we the That study. next recruitment X Phase Phase XXXX. study, And X, expect a at at

ramping use, anticipation we come up in as emergency authorization could have begun soon QX XXXX. timelines, these as And this. manufacturing applications, of Given

in products. for This Phase trial initiating study be currently first our part is for could cleared patient shows expect X stand-alone study and FDA shows first by to bottom part soon. chart. NTM are RHB-XXX the will the R&D. we the treatment top RHB-XXX line market. The July. commercial activities first The was pipeline any orally the and disease clinical And administered be Our one

on R&D are discuss COVID and NTM will products that we not call, briefly discussed this I other For several important since today. mention being will

So to development appreciate activities. can investors diverse story knew our the

our we Crohn's, next X an in results begin X which for First, prep into finally, move in Specialty now X we our where us Phase Phase before commercial have where integrated of fully in puts are gastroenteritis a from ongoing Pharma Company slide IBS-D, successful positive a have X going. This study. to we infection we in results And had study. specialty and working X center. Phase product, and small-scale a We've company oncology to company, and now on grown had a Phase RHB-XXX U.S. opaganib studies being plan with -- diagnostic an in from RHB-XXX, to an and we in U.S. ongoing Phase diseases Phase leaders came we GI bowel positive X R&D RHB-XXX X infectious important leading MAP a with study, Phase perspective we for a for operation, we one oncology, specifically. the we're

We field a headquarters sales built Rick the ever. North our team with from in Scruggs, coming a team commercial and companies world-class one have most successful line by Carolina of Raleigh, the GI who's led Salix, on leadership

We have a motivated reps. XXX sales with very highly team

with to Aemcolo. progress developed at them rapid as the of hope as, it wonders, U.S. to what a excited have acquisition the will approved and the working good And they to leader in consistent very are R&D. over continued organically specialty through and we reps now non-organically, the coming field we're Talicia, such be we products do. I with walk We growth and turn our years in such in have ourselves, both, with Gilead which in back made pharma our Movantik to already in Our

Gilead Raday

highlights. provide to progress pleased I'm Guy. you, Thank R&D some

in therapeutics therapeutic cell of the front, urgent currently know, QX at highly upamostat Opaganib an are emergency as orally readouts the data safe use a authorization as clearly effective received pill highly urgent our potentially a unmet X. are mild factor, have therapy. need have novel anti-inflammatory or the of our Each we potentially outpatients lead targets Both global as readouts. mechanism shots distinct to COVID-XX multi-billion and have COVID-XX compounds the both dollar have only small an demonstrated which each medical This cover the Opaganib potent action. promising advantage to potent an have Both of assessed compounds might of for which therapeutic remains safety They effective our action. The global despite against of X a activity. being X, term opportunity. market have molecules few the anti is compounds also addressing far for established have incremental with of use and COVID-XX antiviral Phase program, patient to advancing SARS-CoV-X potential acting date that data benefit. mutations, a viral our emergency unique X, ineffective. combined these on potent we application hospitalized term specific host an COVID-XX X represents hundreds as administered, promising, antiviral of database render dual such patients, with with of near and direct supporting activity from XXXX. an near It action. with forefront to remain importance of novel early the them mechanism likely There already candidates. spectrum patients. company full On efforts two COVID-XX stage human goal, unmet RedHill advantageous Opaganib antiviral as the to positions our leading with With orally supportive administered is the severe activity needs, populations highly Phase candidate compounds Slide and It

a antiviral blocked potent SARS-CoV-X which favorably a in viral in study. tissue, fact, model compared completely the of human bronchial control replication it the in was As with positive Opaganib remdesivir,

properties preclinical responses COVID-XX. extensive the is indicates data with are of broad activity, that associated damaging hyper and also addition, anti-inflammatory highly In to applicable Opaganib which immune

treated being a vulnerable Furthermore, compared signals in were the patients benefit Importantly, the as patients patients who tolerability. been were and from far obtained match clinical who a case severe indicating to use obtained published in advantage case the treated the Encouraging reducing cases Opaganib of which same matched to to viral medRxiv, zero resistance by involved emergence has to in possible with for demonstrated hospital its human Opaganib the a with Opaganib of less standard XXX safety treated in as substantial factor, compared replication, of of were host through mutation. key as mechanical with ventilation over on those COVID-XX Opaganib need targeting data cell controls with compassionate care. such good is has Opaganib controls. safety viral patients one-third in

has dual spectrum of from marked improvements addition, its and markers to of to action in the the in to potential outpatients In time With mechanism recovery address populations unique mild inflammatory were inpatients. full Opaganib observed. severe COVID-XX

hospitalized up the highly we XXXX. profile of early also Opaganib, patients, rapidly promising clinical as application basis to distribution and studies have wrapping anticipation been potential as the use rigorous On of support advancing of COVID-XX manufacturing emergency in commercial Opaganib are QX and of

slide. Next

full to update Committees studies. un-blinded study Opaganib is it indication and For know the over to study signals, Opaganib The Safety efficacy no establish independent study of enrolled regards progress XX% a already positive to and safety. get ongoing quick Monitoring to safety three studies COVID-XX X this the Phase continue our providing the the with of subjects without remaining statistical changes, for on with XX object twice was another has subjects. to The any significance. that powered We recommended is

been It Russia, U.K., has XX% study we is XXX Phase We with three have readout patients about of Italy, to this global approved target nearing COVID-XX. careful the ongoing and and the Mexico been of line very in ensure Israel, completing top are severe patients into and data The hospitalized with randomizing year. enrollment anticipate quality by the Brazil. X/X in coming swiftly appropriate and screening days reliability. high the end enrolling We study

outcome includes X/X Independent are an ventilation potentially either viral The of study outcomes, or additional territories. committee's the detect progressing the the with of recovery, XXXX. could in continuing enrollment We a designed times requiring to and are array in will inflammatory application is Committee. outcomes QX pleased to of power study as as study the facility to standard load use and pace to these The to we will and mechanical by weeks. also A X/X expand recommendations Phase comprehensive The reported including markers. analysis reducing and safety emergency be Phase global The Opaganib benefit Monitoring the studies proportion patients positive of study support the as coming receive early assess unfortunately dying. of

optimistic We this, prospects the about highly signals given of obtained are the product Opaganib's cautiously and to-date. profile and efficacy promising safety

bronchial is COVID-XX stars Next XXX slide. novel also safety clinical X/X over is the it to a multiple final targeting It Phase patients studies. profile program, outpatient inhibitor clinical demonstrated a patients from and activity, has model with setting. potent stuff The anti is as human of our administered second orally serine go tissue. demonstrated protease COVID-XX in a across Upamostat in

NTM RHB-XXX. infection FDA safely treat Given the and initiating therapy. its with manifestations. the rare COVID-XX have in which line applications, other promising a we line in potential mycobacterial be Nontuberculous a coming infection X initiated first nontuberculous therapy chronic or Phase study is debilitating are a pipeline short, line Phase On is is NTM. with promising the first of to RHB-XXX in study mycobacterial with planned to upamostat X/X in for approved effectively first we standalone fronts, no profile, intended oral And treating designed U.S. weeks. disease

NTM received we sites have XX up expect both granted patients qualified the been randomized orphan clearance disease. screening designation. disease controlled infectious enrolling FDA XXX The and drug initiate We has start the and to product enroll to Phase is RHB-XXX the in to to coming and study subjects study across and pulmonary placebo X in U.S. weeks. planned

and the NDA of So exclusivity. full it review is development, eligible priority track XX for market the of years fast

to first approved, and need line of Guy a of reflecting patients, the progress. growing of the is U.S. the address back to numbers in RHB-XXX I'll commercial for turn X therapy safe unmet the on to study excess update effective opportunity now Phase $XXX for medical initiation million. well market positioned With it NTM an our

Guy Goldberg

Gilead. you, Thank

turning back our our efforts attention FDA So to products. three commercialization approved for

new, infection E. the common problems is to given more and indicated which is resistance and reminder, indicated need as Movantik, of side therapy, for caused of we in treatments bacterial standard of opioid eradication, constipation, which most by commercialize for serious very diarrhea of travelers pylori So induced current which widespread effective is care. a H And Aemcolo, indicated growing coli. for effect opioid Talicia,

a the pandemic the before, So have industry. our as been I to want said in there news on about impact bit of disruptions talk good little is, to we've the The no our chain. supply past

Our down in been has field else's everyone shut like field returning promotion, which the early through steadily to since March was May, June.

We reimposed, the are face specific that is is restrictions that to parts and see want be of a rates mind restrictions. where pandemic Keep where on effect affect in country, at get some to strong approaching, re offices RedHill. doctors regional not this shown and calling the without Talicia. now we that there here data. mostly here we do we in industry-wide emphasize situations The activities. slide I our challenges slide commercial It's are can and on affect would

treatment. time Talicia chart Lab lab that because H of top be down. necessary testing positive to last pylori for at the same compared shows to of continue the So year critical is facilitate patients are tests identification rates to the

since with chart physicians, that primary H. by will true happy be physician shows we is two know of year-over-year, now scripts lower. We which continues diagnostic are doctors. new coming metric, This The down caveats, on Industry-wide and new-to-brand gastros to major the prospects bottom which are as groups doctors. all pylori an we significantly Notwithstanding, types especially us. care across with are brand scripts for and are of significantly for also for levels those tool is progress making in writing colonoscopies important our the an launches new-to-brand important depend gastrointestinal see. quarters doctors target is the you

we March Talicia the with gradually correlating been you Talicia only discuss June which two in field returning So the the to return a our have nice performance. due here. we I'll very and our monthly related in since to see now restrictions to we and To to recap, increase field launch the script launched see pandemic, volume,

quarter-over-quarter COVID-XX very continued and momentum the the in significant in we and field, prescription engage and are about with QX the to our promotion Launches new we was was growth. product. XXX% terms month by Similar and continued September As healthcare this ability both in the best of volume, mentioned, influenced yet, cases. also presence trend, to professionals expect sensitive, growth in rate script of

been Our the medical Thought and educating in team healthcare professionals whether have throughout team, actively pandemic, Liaison our science virtually Leader or sales person.

type versus changing at status, have. considering prescribers are of of in important future prescription prescriptions volume detailing what number -- Talicia. of the the for way continue at we mix why the seeing the we is per the many million standard both to of new potential prescriber the just There growth It slide increasing, as there, as metrics reason and slide person firstline important prescribers every is script we treated Talicia And the on unique course but happy its become here. initial pylori million expect scratching This possibly in are resulting X are H. and coverage coverage only the believe and to We the the shows depending is of another to also trend pandemic. on H. the is course care treatment. Americans possible number both out we in for We the growth. pylori year, the are are we prescribing least for of all also that have scripts We're in X of not number getting. numbers are the immense of looks with optimistic. very surface we This habits of

very have lot includes Right coverage have hard the right, at on see the that a million national lives. then was dedicated coverage to This good to increase the team time. been fully company in Prime biggest for can around working payers country and sure effort priority is wins make more all there to we we for importantly, you PDMS a terms the on now, since commercial of number. spread lives. of and a put XXX with high launch. And we focused As have we This us as Scripts a have Express getting markets managed

a awareness We launch And underway slide lot patients. organization. initiatives them. practitioners to entire drive we're healthcare here with few across of to have keep a activity is and very This working highly This a hard of our commercial shows coordinated the momentum going.

to opioid-induced So leader our Movantik, switching gears brand for constipation.

April Our in key years, has The this in decline transition this initial that AstraZeneca important, acquired product all it we in have focus drive reversing many Movantik and to since from Xst fully completely activities want. have transitioned in of been and hands after and This to RedHill for growth because our slide it us to way aspects product done getting our the to recent to the the we from related scripts goal get to be are AstraZeneca. the product critical was just need we things a of control hands. shows few

to take did conditions it. challenging Movantik, which light And We in considering can in that were especially are able over the we pandemic of pleased transitions be. we how seamlessly

is one This We that targets and to the also around of has that targeting take the have base the the time. over things What we're success. product growth. the but AstraZeneca, product of the are differently turning taken now all we completely level ready critical are slide done shows to brand been doing successful and and continue next not physician into have we only to stopping decline, increased add the we seen it

opportunities more because XX% important AstraZeneca. have is So generate than targets right we scripts. now more more targets, quality comes That with about to

grow more This from continue Despite seeing This healthcare provides to and this growth the We more our As pandemic, the slide for shows turned took with great shows time, trend also Movantik, as NRx coverage promoter footprint. preferred shows leadership script volume. coverage. sales slide this existed over XX,XXX the of and in than And Movantik. granular team from we're coverage eventually class terms our reach also quarterly did the covered slide commercial to promoter both healthcare TRx position we AstraZeneca script excellent consistent stayed job brand We're has practitioners data a And on I terms around lives plan basis. The monthly in -- very a that percent proud which Movantik percent product. getting over class. has before within pretty we have accomplishment. of we lives Movantiks overall mentioned the of Movantik. with

excellent that important this very maintained is the transition. during And have We accomplishment. a coverage

to of with great to in begin initiatives are are marketing We to the some efforts extensive that of on and even shape in aim ongoing we we tireless undertaking And success the our sales build further. support finally, field. here are team the

programs, digital we As also examples, such we're PK active in doing media. are broad patient outreach professional programs very education programs an such are as also as online engagement, and

year. could when believe highlights the quarter. a now prepared Aemcolo, be product excited because happen for does know that this we come Turning And will with We Cosmo, diarrhea halt that indication. course, of our great over travel of it become discussion which to We product, has at from this international about return. significantly enormous has we will this our Micha important Aemcolo I third and next market. for will commercial is acquired of are for potential to indicated Aemcolo, turn with affected neglected travel we this travelers' to international a and largely an it that partners will standard-of-care financial

Micha Chorin

with Strong we million and QX, September profit $XX gross discussed, modest reaching ATM next XX. as approximately revenues script is operational are well which cash profitability gross in of inflow. approximately with for million previously $X growth only together of year of positioned a a approximately net $XX As plant discipline million substantially supporting improved cash burn of balance

Dror Ben-Asher

Micha. you, Thank

you, Please question Ladies of take the [Operator Kaplan of Ladenburg. now sir. gentlemen, first line from comes go now begin and ahead. will question any Thank audience that We have. will session. we Matt your And the the question-and-answer Instructions]

Matt Kaplan

focus to your Thanks Hi. Good on taking in program guys. of question. want in a morning second there. I for opaganib COVID-XX terms for the

you year that of in have You us U.S. X/X have phase terms could the phase with potentially emergency where X later as first the the you year? study study of in you I are mentioned as data preparation, guess you the first give quarter request a this quarter. early the can authorization in could manufacturing for next use that given and sense

Dror Ben-Asher

Good you, Thank Matt. morning.

such larger expect going agreements and with and agreements initiated Starting weeks, have manufacturing have inventory scale and several a the days to larger we there will into UI several suppliers, We be the initiatives. Canadian more with European the application. in coming

we two -- the things larger government Canada, highly different the do parallel likely the centralized other We receive orders. two studies, U.S. several support As as places, other given towards all-in government in meaningful manufacture and are a at government our well to including Europe success and that expect U.S., progress, we as expect inventory.

funding we a points large studies positive manufacturing show are Gilead could continue of exciting, successful. challenge, data likely As So, our we results the near be scale mentioned, in are for less become to to less that and is assuming more we

compiled could are that we assume and you So, chain several been secured, speak. parallel supply as

secured. been have already them of Some

Matt Kaplan

from for Can you for are the saw That’s quarter. and both growth terms of script translating a in revenue Thank guess, Talicia how your growth I Movantik And shifting Okay. to commercial us quarter-over-quarter to each those products. the you. some helpful. during products, strong just give sense of

Dror Ben-Asher

a the course, especially available, people which scripts, know, product. just that's you The speaking, pricing random, pretty script. when key factor in ex-factory at is would we urge launch have publicly look really detail. for sales, indicator Therefore, And best what we most as do effectively is here of be to can presented growth. The available. The important the is you

in discussed, Movantik XXX% the years. quarter as as growth second As consecutive growth in the there well we for prescription Talicia for time for was for literally first

be So, this coming for at continue script the would look script, the Again, to sales is reflecting quarters, very in and exciting we us. disclosed the in the totality growth. will ex-factory

Matt Kaplan

question. And enough. then Okay, fair last

able being your that give out terms In you Can terms RHB-XXX in a read programs, X X potential program timeline for to in data? NTM. terms the of of for program us initiation Phase Phase of sense of

Dror Ben-Asher

Sure. Thanks, Matt.

of to from start at analysis enrollment six we Phase months pro the have have a and hope is XX points reported which end will developed. of are across time we importance And point complete specific sites XXX month patients, We the we outcomes, clinical of outcomes initiating within conversion have highest X and the the been to that enroll where will to plan where questionnaires eight, the variety the year. up U.S. a the study,

be will for. look So timeline that main to out the

Matt Kaplan

the a detail added lot congrats for Thanks and on project.

Dror Ben-Asher

Thank you.

Operator

you. Thank

David Please of ahead. SMBC. line question comes from Next go Hoang of the

David Hoang

Hey guys. and on my for this taking congratulations progress Thanks the quarter. questions

approval. in And was MTD, full with then, one to expected or to to commitments you that product? the relation just first a ARIKAYCE into do which my is be an lastly, product, accelerated So if And looking there NTM study, first expect that from is post-marketing line to wanted know advance any competitor you setting. Insmed

their product? to your how hear just thoughts might compare your positioning curious So guys' to on

Gilead Raday

Thank you, question. David. Excellent

actually So when do not know. we post-marketing, it to comes

fact. be administered three a as going is factual It It the until is few drug. not We the administered brand kind when very know comes an name of to In standalone priced well know inhaled. standalone not administered over top the And and is We of a of will The gives on orally It a Insmed top differentiating separately submit more price patient, also feel It's that is it's else. week. will you device year. us indicated ARIKAYCE for no a that last that the $XXX,XXX is Insmed product. NDA. we fact intentions, elasticity is involved drug. per several not anything can we relation two somewhat a factors, there's probably to moment, that I times on to a It's a its refractory statement. antibiotics AADXXX know being drug.

orally will administered therapy, hope the by the if and option We when first-line this seeing study, value forward which treatment be are we be standalone that for fast approved I three and this a agency. question. results of patients for may times to generated -- the attractive the our of relatively a week eventual looking well believe I believe proposition answered

the you think also about asked acceleration? I

David Hoang

a approval? accelerated whether That's would it be Right? right. full It, versus an

Gilead Raday

honest, to dynamic and unique the of market, high KOL, and part and and until Insmed of a It's reviewing life. the regulatory course of and to process FDA of Right? infections. The Academia implies degree NTM end. very and clear be has the that at with not life. interacting like ourselves agency is companies the It's may things the part way uncertainty, there it's be infection looks to all the NTM inherently nature of it, of the way not

We that. are for ready

that whatever value as would there We will we will that account study if generate results. at And our believe be will into such remain be and point. payers that patients uncertainty regulatory -- confident are take successful for the will proposition conduct great the agency those we

David Hoang

the appreciate COVID. color And maybe on Really just that on one. opaganib then in Great.

of spectrum in So, you you fits with where therapeutics, for being more close know, more the know, cases? that being EUAs likely and of severe several change you -- vaccine best whether you about the along the the know, hospitalized of does how think several, sort paradigm, in, outpatient issued versus opaganib that's treatment

Dror Ben-Asher

you. Thank

So, the and adequately future. continued to vaccines to be therapeutics pandemic are the consensus both the in foreseeable control is in that order be to required COVID-XX going

Authorizations based therapeutics, at Convalescent that improvements the relatively failed terms have has plasma we studies And that -- has have studies. is on incremental to secondary territories. has as minor various in the the approval minor been some latest of Use conducted only. improvements any these from also it that In benefit in endpoints various The are little if observed. best Emergency [indiscernible] mentioned, that benefits WHO been stated granted

to a helping a unmet really sick have So potential We in believe changer will upamostat there's anti-inflammatory uniquely profile the supports activity which very anti-viral unmet response. address for combines hyper opaganib, anti-viral that this that has dual immune which the and given prevents activity a and game the and be and need need activity of find -- benefiting therapeutic with opaganib the lot potential patients that potent a the COVID-XX. that to a

think could the of the this that together, from which So studies course, game changing provide conducting. a pending we're outcome, we outcome

David Hoang

Okay. Got in. flip I one will more it.

the of front, consider that needs sales view the the present? would that? you and Just could of at know, appropriate force, on the you what I And, that as of you the trigger in would any, the, sales what be commercial know, your would sizing for guess, events expansion you future force terms be the

Dror Ben-Asher

Thank out yours. Rick Carolina. you, refer I'll question all Scruggs, David. Chief Commercial Raleigh, Rick, North our to this Officer,

Rick Scruggs

question. Hey. the for Sure. Thanks

needs. sales address sufficient we is current size force feel that to So currently our our

we currently considering hospital right might We're in things need process going sales, may at how in like better. are relief, use systems that We and are as may some for optimize that. group looking through particular to we emergency get authorization, hospitals merge now. opaganib additional at people We a looking integrated or authorization, health help

So, we're looking at all those things.

come Thank we'll with now our salesforce size. right current you. So

David Hoang

Got questions. it. Thanks for my taking

Operator

your Thank next Hazlett you. line of the Please And Bert go comes BTIG. from of question ahead.

Unidentified Analyst

could Talicia, resistance to talk growth going thanks you're if on context taking of any for XXXX? This with plans rifabutin could for on into Talicia, commercial is about a based Bert you Thanks. And call. coming in said then physicians two second the antibiotic progress. for the like the kind questions detail on you the new give approach, of that sales space? the the Hi, H. on the for Congrats size, approached of pylori on size I've in the to any treatment getting your Salesforce feedback especially [ph] new you any and from willingness this bit for Perry Hazlett. related the into months and line

Micha Chorin

Thank Perry. you,

guidelines. which this We high the issue how is is in and far of and know is reflected underlying this and how raise the resistance space. indeed whole You critical distance growing ACG the

feedback at our plans. force Rick about sales And the also size your to it. way field, the prescribers from and referring the about Regarding questions I'm look again.

Rick Scruggs

for Physicians With physicians acceptance It or in patients, are new adopted been phenomenal. regards the board, the the immediately. it product, positions, question. works thanks product. patients to the product we of factory patients is Hey, seeing love across

one out. also there remember, there you new therapies us been to there's out selling are this And As new in else speak against space and years. no numerous no

the wonderful with So product. doing we're

of really is product with the its access COVID. because challenge Our

Our representatives are there out diligently. working

message Our the marketing still teams delivering country. of And great to restrictions seeing to June. middle did across back then have off close physicians, more start up now, but until the a to the we're we job

regards to size are And our are have so I there. great But to Physicians the feel sizing, With we comfortable stated with the guys we're we work for now. restrictions. abide love right by doing those as out previously, product.

size? in some is quarter We right to now need getting you the are that things, fourth looking doing health other size we can We that comfortable or integrated are, analysis we do in things that, know, with we we're the for but hospitals the results systems or we're right envision at determine, Do don't deliver are to size this bigger? we're achieving. this the

Salesforce to of looking the the the year. we're you. beginning not So, in Thank expand

Unidentified Analyst

for Thanks Thanks. Okay. detail. the

Operator

Please your go ROTH ahead. next Scott And the Capital. of question you. of Henry Thank from comes line

Scott Henry

Thank for I've specific multiple that you calls. did product already. you in Talicia, and first, good give this been revenue any said, if morning. of that juggling And apologize, quarter? any But you've covered I the

Dror Ben-Asher

being for Scott, on call. the you, Thank

the urge detailed which is numbers, everybody at We do investors, have to and send our in happy script have to earlier it analysts, not. presentation to What you. look we over we to

because the is know x oftentimes really best you are scripts As factory sales indication, as random.

The numbers very logically So in is growth scripts presentation. XXX% The available. and very and are is available. the the there. quarter-over-quarter, good clear That with price are our trend is

the figured we I'm So can where are heading provided. out given it information sure, be we

Scott Henry

despite both. going Revenue anything Okay. asking factor back changes flat we for way. quarter out in from in revenues? up or of inventory the kind guess And maybe any that to somewhat another second when quarter was Were scripts there just I we should third

Dror Ben-Asher

Yes.

us. the legacy back. them voluntarily products, the quarter. previous the earlier meaningful impact longer mentioned had We with still I in So products are gave legacy They no a

you So control Everything our and products that that Talicia three we Movantik, of completely question. answers your is see Aemcolo. part approved now

over, our terms is. quarter of and script, in about that Secondly, seeing of second a product be and mid consecutive X growing. Movantik telling given for it into but scripts, with what thinking oriented the growth launch moment highly, factory we end COVID the years was a After how urge beginning Therefore, we went March, looking the from sales trend is is May, somewhat you is reversed detail very which of random. the salesforce the and force. Talicia from motivated would what fresh have of both moment sales in what into are is of that we growing highly the could do field at matters. With in can June, again decline Talicia, Movantik the the very indicating took strong field product initial the

a the in see products you the see mixture products growing. quarter. the will will very coming of And total healthy You revenues in

Scott Henry

Okay. Great.

to Now I shifting from sort expense and is expenses. kind PPP XQ loan, gears, XQ items which of went you reduction that to know notably a contra sequentially of up have

as So should being going I guess we indicative when those look at the QX, question is, we levels of expense think forward?

Micha Chorin

have can quarter this quarter. you second as in we said, P as Yes, in had This you. of Thank QX Micha. program, and did impact is current rightly expenses the triple indicative, at look the the positive we not

Scott Henry

the But just talk potential kind and obviously, expanded what that for, final is? the don't It's expanded you has indications thoughts about by a Can question, And you. lot Thank I of product indications of diarrhea. molecule? beyond potential know on travelers' you other talk Okay. can leveraging the obviously that agreement. Aemcolo, how about And, -- impacted Cosmo there? that about just

Micha Chorin

you, a, under working and when will If by we great This the development is Cosmo dear step. Cosmo. outside on to potential and available the diarrhea decide indeed managed that's be Scott. with Yes. is sufficiently, significant. next Thank a the very It's question the data our is partners, travelers' currently

associated will come big of only that, right very infection, but back we all the given far time, back experiencing focus comfortably it away would risk awareness because of and the Not pandemic. will infections with travelers' are particular, melts travel as confident, loss diarrhea, we now, of that a now, For higher come are with in COVID time. on travel we pandemic international over the

aspirations, quarter high a very it. So we laying to and ground we're have the time for Guy come for that mentioned big back

for that for business we do, as takeoff. the back, prepare a everything or we need to the travel leisure soon So the else. as In anything are international Aemcolo demand or and to scripts is ground rapid doing

Scott Henry

you Thank taking my Great. Okay. question. for

Operator

you. are Thank time. no There at this further questions

Dror Ben-Asher

all Valerie additional you, have safe. you Please the wish We for questions. [ph]. pleasant Thank you if call. us Thank reach any joining you out Keep a to day. all

Operator

for participating. Thank And webcast for you that your conclude does and Ladies you, sir. today. disconnect. gentlemen, may Thank you now

RedHill Biopharma (RDHL) 12 Nov 202020 Q3 Earnings call transcript