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Redhill Biopharma (RDHL)

Participants
Alexandra Okmian Senior Business Development and IR Manager
Dror Ben-Asher CEO
Guy Goldberg Chief Business Officer
Gilead Raday COO
Rob Jackson SVP, Sales and Marketing
Micha Ben-Chorin CFO
Bob Gilkin SVP, Market Access and Trade Relations
Brandon Folkes Cantor Fitzgerald
Boobalan Pachaiyappan H.C. Wainwright
David Hoang SMBC
Robert Hazlett BTIG
Scott Henry ROTH Capital
Call transcript
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Operator

Good day and thank you for standing by. Welcome to the RedHill Biopharma's Third Quarter 2021 Results Financial Conference Call. [Operator Instructions] At this time, I would like to introduce to the conference call RedHill's CEO, Dror Ben-Asher; Micha Ben-Chorin, Chief Financial Officer; Gilead Raday, Chief Operating Officer; Guy Goldberg, Chief Business Officer; Adi Frish, Chief Corporate and Business Development Officer; Rob Jackson, Senior Vice President, Sales and Marketing; Bob Gilkin, Senior VP, Market Access and Trade Relations; and Dr. June Almenoff, Chief Medical Officer.

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

Alexandra Okmian

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

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

Dror Ben-Asher

the the RedHill's mechanisms and and irrelevant emerging risk future of our thank Alexandra. financial and of highlights. on RHB-XXX quarter and you, we'll Thank Good against strategy action our variant Omicron detailed and elaborate day the R&D, commercial, In emergence by you variants. potential of third we opaganib variants be concern, presented recent with joining for the everyone earnings of presenting will increasingly call. Today, light

another further continues quarter revenue quarter Movantik drive with commercial and to both growth strides generated second perform, a new of million to products in challenging in are increase XX% continuing Both Talicia pandemic in commercial to out business government Rob Marketing continues is shortly. Jackson, a $XX.X growth, while prescriptions. reiterating Our who continuously despite prescriptions, formulary Sales also make heading X.X% U.S. record net elaborate environments. will record adding to coverage. gaining consecutive new and

R&D, RHB-XXX independently as variant, of COVID-XX. more spike emergence of the recent emergence heavily action other South well increasingly concern of the candidates expected as growing. the effects viral mechanism is to of of makes host importance mutated battle the Omicron likely of African and over opaganib This in both maintenance that targeted variants new protein or drug against Turning against given are and variants, of time, the relevant

completing third saw X/X patients. significant The hospitalized on quarter focus COVID-XX study opaganib's global Phase in

reduction Specifically effect This study high well what Pfizer XX% in and in patient mortality, us with across currently a more discharge. not study than Phase address. XX% severe population. opaganib's seen population, to consistent in sub-population air use endpoints provides total as we opaganib have hospital degree the is area hospitalized with consistency The which demonstrated this underserved improved the results and our compassionate multiple return territories group, A comprising do our patient moderately a confidence experience. Merck of as room of the showing in and and in X

parallel status States. discussions review EMA, Operating We topline COVID-XX first Officer other candidate in by to Gilead, novel our of regulators the once-daily provided with of to data additional drug quarter COVID-XX data and we provide various already in In of program with we'll granted regulators been programs robust the packages results steps RHB-XXX. Expedited regulatory progress Union's equivalent a European to has passed XXXX. facilitate X/X now the have shortly. the about Phase data United the in the We continue and to opaganib our in countries non-hospitalized to lance, South Africa, next patients FDA Chief States our in continue United in oral will body our elaborate on countries. expected

Our to in patients in Phase United States. study NTM pulmonary enroll the X disease of continues RHB-XXX

potential Phase a a stage company. breakeven disease quarterly year, along and of With Crohn's the EBITDA long-term subspecies quarterly excited medium, speed profit short, reduction success to end paratuberculosis short, an a gross before of RHB-XXX pipeline, is gross advanced, loss, for that. net We're awaited research. progress avium margin Importantly, much we operating revenues progress million are thanks with up, exciting, recent or emerging Mycobacterium detection $XX.X net expected with from record commercial for timely MAP well-positioned X improved and with about as in R&D steep and in the potential pharma to non-GAAP in and specialty very

a Before link turning presentation, to be and order Business Chief rest Guy remember our press the the in Officer, Goldberg Q&A view for to session. by our of the please our to detailed team followed slides to

Guy Goldberg

Dror. you, Thank

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several get submissions presentation a a for biomarker timelines in countries from demonstrating as months will submissions later hospitalized correct regulatory regulatory the provide is of milestone-rich post-hoc the feedback data world. next up have of feedback that these We and clinical more important conducted as studies, will Phase provide the both potentially in Gilead study far and around detail These the X the of PhaseX/X we and focus two identified in updates a COVID that patients, potential opaganib as support Phase also Gilead population target the of study our Xb new well agencies new as steps. for are analysis upcoming as opaganib. few as the open

patients. developed model Second, in we a non-hospitalized demonstrated SARS-CoV-X trypsin-like orally-administered serine has or result an studies, inhibition of indications patients. of from development a number of have in critical upamostat for protease, of viral tissue. prior inhibitor, have a a safety one treatment also RHB-XXX profile as replication upamostat, XXX there's as -- a preclinical several of COVID clinical best protein approximately family human bronchial we being And in

non-hospitalized topline in QX the study have and South and results COVID-XX completed We XXXX. are a conducting study we U.S. recruitment for Part in Africa the Phase expect patients and A X/X of

oral importantly also is to highlights strain. as and study host RHB-XXX mediated, the which of in patients are work should once-daily our slide a various it mutations, Importantly, part tested pill Omicron. also such that down financial the QX. Returning in means for potentially viral from the top Also is against also specific

of believe generated record quarterly next challenges into we we the end year. side, revenues throughout year we commercial the the will that and industry-wide see growth On despite

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large satisfaction. by launches, and reimbursement, of all to and a physicians both class. best maintain PAMORA RedHill we continue well-liked to great patient and in is and unrestricted these Movantik great status still and our especially almost during improve recognition population brand that it payers that exhibitions. continues great underserved With coverage also to times, we takes and OIC market acceptance leader continue it's to Movantik's of advise the with As There's build challenging time safety, very Movantik, efficacy awareness position. with

on Marketing a is a specialty and on fully commercial as into diarrhea may of VP gastrointestinal diseases, approved infection; position a non-invasive U.S. we by support detail and Sales cash biopharmaceutical focused drugs we've Senior Jackson, Aemcolo caused commercial the those Finally, of our new integrated I the the right and robust to September to slide, FDA story Movantik out headquarters, see to pylori for At constipation; for provide this RedHill million pipeline Carolina. Rob and with H. R&D overview E. of our of you be headquarters RedHill coli. commercial travelers' $XX.X Talicia XXth to of brief a operation efforts. efforts. would in for be opioid-induced going like call maintained world-class our three will the today. who for drugs of infectious promote, company our a Raleigh, and North of top strains of

The our to mentioned. review update for programs will unmet Gilead. will for of an multiple two programs two I shows COVID turn disease Raday, Officer addressing NTM will RHB-XXX needs. slide second Crohn's disease. provide I and part important late-stage medical the over I development Chief in our the on Operating that it just Gilead then now RHB-XXX

Gilead Raday

meaningful will emergence provide the for moderately which of I Thank an variant COVID-XX which previous slides, severe specifically apparent Guy. addressing been growing the the programs, I further an study, survival Phase also antibodies. COVID-XX promise with reporting will shared overview some X/X of of respect has the following bolster resistance analyses to due opaganib our from advanced Omicron not current data you, to global to and our before, of of concerns benefit and In provide and hospitalized patient. potential of the to vaccines the

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territories are delivery Africa. Colombia, to for on U.K., Scale, Health targeted feedback, Ordinal the the utilizes plans moderately our Russia, using in the we confirmatory of India, from making Organization device the severe regulatory study We're World the standards based with declassifications of shifting as and Additional opaganib also key Israel, FIOX severity will which Brazil, patients. define in South oxygen parameter. the Subject pursued consider type current a Switzerland, to hospitalized pneumonia COVID-XX

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and SARS viral South evaluated RHB-XXX expected RHB-XXX U.S. is insensitive the inhibition action. COVID-XX has human CoV-X A of mutations protein, host Goldberg variants been such topline plan of demonstrated we'll analysis to for that study programs We Guy replication outpatients I Recruitment and spike mediated XXXX. has going in reviewing currently completed with additional to concern of not variants Africa. and turn being analyze to of also part preclinical now is given in are in study the to include R&D it readout bronchial forward. in the COVID of back mechanism in its Omicron symptomatic plan expected will related. tissue As in be the is in model to for QX

Guy Goldberg

Gilead. Thanks

is standard-of-cure with or against non-tuberculous start drugs disease. therapy. NTM value-driving RHB-XXX currently antibiotic combination study This active first-line therapy approved mycobacteria are of is we'll treat treatment. So, and a three with is that novel as first-line a NTM infection study RHB-XXX. We're a difficult because X important a in to its Phase infection no FDA

pulmonary in drug designation, orphan RHB-XXX NTM the granted States. an designation. is Fast-Track this with disease disease product infectious designation XXX,XXX United qualified estimated patients has an addition, been orphan In and

slide of design. XX With shows is NDA the years these priority it eligible of market and This designations, review for the exclusivity. study

will be study controlled Phase XXX term X first-line estimate outcomes subjects. we is The but study patient including enroll longer we reported testing as at are randomized recent benefits standalone The added An of follow a evaluated size key placebo culture post change six to with of sample planned conversion. XX% is approximately interim critical endpoints and an conversion therapy. We oral up the RHB-XXX enrollment. potential that important sputum treatment

Crohn's to treatment the planning for additional our outside accelerate I United the recruitment, States, study RHB-XXX, territories U.K. updated and disease. to to In expand addition including will Japan. the we're innovative now an provide

MAP, program mentioned, Dror subject, towards regulatory avium based input. to severe paratuberculosis Mycobacterium on patients positive, diagnostic Mathcad to the Crohn's course, us study progress and enable or a published confirmatory in required As of recent potential technology moderate research, may advance

endpoints, that a about is we reminder mycobacteria specifically theory, Testing conducted this secondary a including others. that disease. disease. RHB-XXX disease Crohn's and the and and response durability, XX, at week meaningful, of demonstrated cause Phase early intracellular growing successfully remission in X of As putative program, role activity. in at play clinical consistent, evidence study Overall, Crohn's XX, crucial week have a maintenance this as MAP weeks, XX significant met there primary key the Investigators remission statistically our identified

to Phase In a that lot is addition, safely use study, be used potentially and easy RHB-XXX medications. anti-TNF completed we concomitant identify should an the diagnostic with Since adjunct not do. standard-of-care on in been by as benefit a there apparent us to patients an and It thing treatment has others the to companion effectively work of MAP other indicates X infection.

based believe research, confirmatory as method. because soon progress the status an with additional including for envision being an recent a study successful a entry conducting there have will can validate investors criteria endpoint, we we on is mapped public positive at primary clinical as there we update that we may be If of diagnostic, and However, healing.

through over monoclonal other to issues benefit limited feedback the course turn medical XXX of antibody immune-suppressive with our we I disease steady related now FDA drugs therapy large that treatments. such XXX small, a a Rob patients. market relatively to of to dollar those to to and progress. will walk due unmet need multi-billion could envision perhaps be safety however, commercial it need We a and will Crohn's large is

Rob Jackson

Thank and you, good Guy morning.

and going the focus constipation relief and is segment. in why so third our selling quarter. XXX% clear record disciplined you XX% to improvement added during and rate developed tactics quarter to I'm X.X% during the few objective class marketing, improving understand leader. our our quarterly for continues pandemic over fourth market a digital OIC. focusing the ability quarter, XX%, X% market Talicia achieve about of we confident the of the and growth of raise tandem, of to Movantik excellent heavily can Simultaneously, quarter Movantik Talicia from In made prescribers second to growth additional third the customers XXXX. how the progress next quarter quarter, the by to secondly, the volume quarter grew educate environment. prescription XXXX as feel also minutes, by a provide patients We've taking five-point the and we these help awareness second market. sales, that the Movantik we volume Over we This growing that capitalize challenging confident PAMORA prescription access business second on added achieved increasingly volume the on are XXXX pain over and In the with over on first executing a We in by despite activities, growth we're can summarize XXXX. key quarter. this Movantik approach strategies to of an the we've continuously about marketing RedHill by in we and established opioid-induced quarter leadership In RedHill third over QX market in grew maintain symptoms how first an RedHill environment PAMORA of marketing fourth of potential and invested

health of key third of predictor the and the payers will prescribing. growth significant or we market during of rate fourth OIC further opioid successes the quarter A decline achieve believe we During is quarter, the the growth XXXX. that in key also yield access market with Movantik the

continues stable opioid you the and PAMORA clearly between On volume Movantik over XXXX, a trend things a stabilize can a for this Movantik the improvement other trend during major next strong opioid and declining is As two XXXX. see in back way you support provides very entire are happening. here, to correlation the opioid that in class. prescribing began can prescribing slide, prescribing There see

and sign the a we're First, to PAMORA class for class is seeing this prescribing opioid good stabilizing, what volume similar the in is in Movantik.

to we and bottomed in a for this remained significant In in improved to a return Movantik market is annual total for since the has out volume Over basis, and is across in well see ever PAMORA enabled terms in very prescriptions total prescriptions return then. the steady as Again, continue XX% also Movantik continues XXXX. launch. its leader customer a to of Simultaneously, slightly coverage Talicia class the payer achieved prescribing to the Second, and or new to summary, reflects turn beginning has brand. new prescription both performance good and new Talicia X.X Talicia sign commercial in new PAMORA usage all dispensed our prescribing payers milestones third efforts since million achieve growth. during PAMORA and as moving and achieved quarter Talicia volume in Overall, access, This investments been and PAMORA a about improvements class shift achieved change achieve greater coverage growth. on writers to June increased have Movantik milestones. a class of with high which can trends trial in growth. of further quarter, third and and best business the achieved year-on-year

in expect second, the payer we the community and In accelerate this quarterly for fourth continue prescriber line, chance effect, as an fruition optimistic realizations and third, seen wins to in microbial and Given growth far Talicia to issue field come need trend the to used and is our among Any have growth will continues XX% quarter important they our into quarter, what stewardship new the achieved weekly, so will monthly, quarter. are fourth volume. most treatments. the antibiotics execution to enabling best inspect effective quarter, heading cure, on are and Talicia These lines provide focus recent we we growth further XXXX. performance when that in improve. record of eliminating and for for take fourth achieve And the wins third we'll this payer the third this while first Talicia increase growing accelerate accelerate to quarter, even are

has with the continued team payers. position commercial our our market front, competitive payer improve to On access very

will persist plans Medi-Cal with are Again, XXXX, managed treatments. second program. this all continues had Additionally, this by line Talicia Talicia using were reiterate; prescription outlined XX milestones. the to that a state we drug in a the of preferred secondly, million continuing accelerate State contract increasingly list, was clearly challenges new recognize for clarithromycin is by resistance California This And When the want country with Effective pylori awarded will H. what available will state be Medicaid very Talicia Medicaid uptake to we follow the confident restrictions. contract largest no January beneficiaries in individual Xst, recently the brand achieve Medi-Cal, significant to a infections first guidelines. Gastroenterology's quarterly as of that monthly, volume. choice. of pitfalls first, XXXX record is the sign and clear weekly, prescribers another the agent to therapy clarithromycin-based and brand I American of College as

the We had lastly, into over and going of in the expect commercial to with we And continue had XXX% when Talicia. achieved well. next and as unrestricted and our growth of recently prescription quarter Medi-Cal coverage, that's year highest levels we we fourth third quarter, government that certainly volume XXXX

continental where a We has promote COVID-XX Aemcolo pandemic non-essential also travel continue impact travel, especially gastroenterologist. international to obviously States, diarrhea greatest. to PCPs, of risk is on very The had negative and United consumers, travelers' outside

for to growing midterm in expectations We the to tempered our for class, the forward Micha summary, this I'll quarter are further strong third prescription and volume Talicia. milestones demonstrated Movantik class, In improving XXXX. in we finished in CFO, further prescriptions, to coverage. Our commercial looking consistent and Aemcolo performance to by And continue fourth Thank grow quarter PAMORA We're our with we numerous reality. PAMORA the Talicia of in in you your turn back market for achieved our the trend the on time stabilized growth. our already Movantik a new call as the Ben-Chorin. leader improve payer ability

Micha Ben-Chorin

provide strategy, and the quarterly year. Good short Revenue EBITDA by executing afternoon. is commercial of morning. non-GAAP us a value the summary will Good creation end near Rob. growth to be quarter. breakeven enabling a you, this Thank on of I consistent financial

net We a have profits, by reduction operating gross achieved revenues in quarterly and and of loss. another record accompanied net

more from increase $XX.X from equity this and for revenues previous than margin million XXXX second net consecutive attributable revenues Net were as quarterly million, revenues the record in November. $XX.X shown also previous represents compared in cash which XX% million with a gross quarter profit quarter gross Talicia contributed XX% during both net in of XXth, by Our quarter, Movantik, balance net revenues has from of financing record of of September of as XXXX, record to an $XX month $XX.X million quarter. a third of increase been revenues supplemented by an XX% the The of Rob.

mainly completion with commercial XXXX. global to I On quarter non-GAAP million in $XX.X reduction the of million ended increase XXXX, was profit, study second $XX in mainly of substantially year. in the share-based compared expenses $XX.X -- quarter, third lower and of in to by quarter of the our our quarter, end We've operating with used a with of Net Dror similar potential it great activities expenses. million quarter cash opaganib. attributable the revenues, breakeven side, third COVID-XX $XX.X Operating was loss completion expenses the the we second our million the was $XX.X of of which the attributable decrease programs, Q&A. the for compared COVID-XX over turn EBITDA approximately approximately compensation well-positioned will previous quarterly gross quarter now Phase majority had this to in for X/X to during million, in XX%, increase for

Operator

line comes Thank question Brandon from Fitzgerald. first of [Operator Cantor your you. Folkes the And from Instructions]

open, now question. you is line your may asked Your

Brandon Folkes

obviously, the potentially, EMA and congratulations thanks in progress that the know all opaganib, front. and being for going first, the there. the I commercial on firstly about speed on said expect feedback just X, you Maybe the else Hi, of XXX, that just great is the we in secondly, as to front, I of taking is congratulations, the all potential my up staying enrollments is on going there. three Should talked U.S.? additional data and you the the up most the the all about that think on to coverage, pipeline lead expanding from on the in And versus think there? the appreciate questions Maybe we're of and pace the slip just the pipeline opaganib if receptive indicative be just here we them Phase in program to may both something expansion probably Talicia or territories I in EMA coverage should lastly, driving the then

strong just very in those expect you. a in do additional steady now you here you're really Or Thank believe executing state and going Just we coverage? it's on or should points? wins improvements coverage forward,

Dror Ben-Asher

about EMA short-term. you. the be to is with likely Thank Starting in and the here. response Dror whether most question Its the this important

first very to this about, right be is an Gilead we which you're expedited fastest So, that but where happy the expect year. mean is as end before saying progress. this does we're the review, not said responder about likely necessarily of territory it the the that It's

of country population with point a We for we Israel, the degree are South know promising Africa, be need this most Latin and towards for not market. at the and treatment them many in patient applying or some more an an will countries America, which this India, very countries, for others advance in Europe, increasing high do in Switzerland,

Your the of the question about to RHB-XXX for we expanding NTM speed is study the are reason infections, yes, additional territories. that enrollment main

other for The infections for in the RHB-XXX Japan, other reason as NTM strong need countries, we than such that actually see patients where in is more U.S. there's

like Right Talicia team. we elaborate and the Access can we now coverage whether to expecting but is further moving be forward? on last refer Bob about additional Market Gilkin it coverage Your should improved. Bob, would is and expect to our improvement. what can excellent, question heading be who Talicia this coverage coverage I you

Bob Gilkin

Sure. Dror. you, that. Appreciate Thank

XX have commercially access So, first, I insured that with through Talicia. for the Talicia, pulling committed great of access are of patients Rob those restrictions. have with no out patients and Most coverage have eight we

to coverage. We that are expanding committed

working account hard national executive team diligently. Our is

indication what works the done, to definitely we take to at now. have and it there's of to more in AstraZeneca. at expect acquired once our look done into We're elaborate things we a ability able of this we If not do but as from it We many yet. right see any get Movantik I were cannot wins XXXX. time, go

are pulling there our to current I I continued you. has coverage Talicia. -- and same with Rob out improve expect TCs with our that do coverage is the the team Our with and committed to we in at thing Thank through gritty said field. Like

Brandon Folkes

Great. all you detail. Appreciate Thank the much. very

Operator

you. Thank

the next now that of question Wainwright. from will be line taking H.C. Selvaraju our comes from We Ram

is your line you now ask open, question. may Your

Boobalan Pachaiyappan

okay? hear you This is Selvaraju. Ram for Boobalan Can dialing me in

Dror Ben-Asher

Yes, we can.

Boobalan Pachaiyappan

right. All progress. Awesome, your great. Great on congrats presentation,

few questions end. a from our Just

Xb Phase your convincing. post-hoc So, solid looks analysis and

that you a thoughts parameter, as its any curious, with irrelevant in and aware to parameter So, KOL there FIOX in as just are practice? feasibility limitations of in current received COVID treating have you're medical Also, a patients? spoken regarding preliminary using any respect relevant to so medical FIOX using

Dror Ben-Asher

KOLs treating forward, by once a parameter is utilize the used going have and severity, as we you. Organization be explained. from but but with will we Health further we as being more Ordinal we interacted Certainly Thank information indicated have inputs well-known feasible with physicians that World parameter to a get have This Scale regulators a and standard that feedback is we is and certainly certainly characterizes have regulatory we the and interaction and very KOLs further a will FIOX change the feedback what measure is

Boobalan Pachaiyappan

Okay, thanks clarity. the for

X/X study, RHB-XXX expected data respect Phase So, the to first the readout with XXXX. quarter in is

us So, addition in efficacy any you report whether can data remind the to preliminary expect safety? to you

Dror Ben-Asher

Sure.

evaluating topline we the the in study, two study. A doses a primarily aspects that part expect evaluating part and the we're the patients study of that is for of RHB-XXX Part will XX currently the that So, enrollment be was is completed QX. readouts safety two the This main outcome. are stage and

of expect don't efficacy. indications main B endpoints also of course, to of the study, into and follow and be will capture dose the efficacy, that certainly, the productivity but given get efficacy optimal the select clear part signals get, for size parameters, which and we part we but going small forward will a with We the relatively may we on cohort, have

Boobalan Pachaiyappan

for Okay, the clarity. thanks

So, benefits RHB-XXX, space? any efficacy any treatment? in serine in yes, proteases perspective to you aware are of limitations targeting working are there a in respect this with competitors Also, from COVID safety

Dror Ben-Asher

adequate early COVID-XX. XXX has altogether outpatients RHB-XXX very and the been of terms over COVID think and prior the studied of patients are in safety So, stage patients the well-established XXX to I safety treating extensively aspects other aspect, indications, even and -- for clinically, -- already

other In in on was indications. fact, longer basis term provided RHB-XXX

So, we're not concerned about safety aspects.

can second remind the me else question, asked? what In of terms of the you part you

Boobalan Pachaiyappan

are there aware whether this any -- you of in space? just any Yes, competitors working curious are

Dror Ben-Asher

inhibitors, The targets. the targeting proteases in drug are or different of terms there inhibitors serine are other different In a like viral that and are protease protease similar class. our targeted, Pfizer compounds the competitors class that

Boobalan Pachaiyappan

questions. for Thanks again. taking right. All Congrats my

Dror Ben-Asher

Thank you.

Operator

Thank you.

taking from We our question that will SMBC. now of comes David line the be next Hoang from

is may now line your you question. ask Your open,

David Hoang

Thank Hey. you the taking for questions.

a had few I here. So,

trial terms I to factors regarding scenario with a another Or regulators is Is that guess, subject for your decision the you pursue patients. to feedback? expectations using running guess, to talked that one, definitely regulatory First post-hoc select Or discussions on, occurring? FIOX opaganib -- confirmatory just analysis, is the that of in I any your about in trial? other

Gilead Raday

feasible will selected that that subject prior contemplate. is regulatory the of regulatory The respect for Sure. makes sense. course, be likely Certainly, FIOX in -- in to parameter is further and Thank think of it's will of uses that of target study will we to everything terms parallel study illustrated to or question feedback to is timelines feedback. target in population feedback the the that we David. of Certainly, in lot other of full be of we the receive according whether is that a you, have with quite parallel the potential we But expected may timing, to a we And it the additional population. feedback, in very approval that emergency we that Again, get use clear discussed the required. it's initial processes, that also. any

David Hoang

Talicia, in had Talicia understand of you quarter. reported got for you're on me squaring growth seeing And can helped revenues the just Thanks the little a I with terms that. script a it. maybe then in the Okay, question for bit excellent

of you to sense And Talicia for product? what of just net over is material a for can maybe gross rebating the into change is any give recent there been -- on going type there So, has quarters?

Dror Ben-Asher

numbers here. for is Dror disclose. company It's would something rebaiting Specific David. you, Thank any not that

we Bob. However, can comments I'll general refer make and to this

Bob Gilkin

that. Dror. thank Appreciate Yes, you

relates to payer our rebate standards a than customers. doing bit We are industry well with industry it better within contracting as probably standards, little

advantage net, take gross discounting, we fortunate of We really to approach it with attributes product. really us a the does and product been the we've -- for like much base very value clinical and than provides payers therapies are are watch how where a an clarity to our very do conservative better see the Talicia, products we in the the really the fares

been fortunate very front. maintain on been But to hold we've on able to So, we've that rebate line. and that

see challenges the do continue we that payers of we're and is seeing that more to One the that increase rebates across board. deductibles

products manage are affordable So, Thank and you. that obviously, we're patients. that to sure trying for kind our our make of

David Hoang

Great, able on level confidence color Crohn's development then you question RHB-XXX provide there any the the And I disease. for tests? you to last expected and more maybe sharing appreciate timelines being guess just really on do and your of diagnostic that. in secure companion further

Dror Ben-Asher

David. as glad Crohn's you, as RHB-XXX I'm Dror. Its disease. are Thank for to because asked committed you ever we

it opposed to disclosed of the forward chance decent related patient robust was, types are directly of without the on very the And of us to very peer-reviewed that for basis daily a gives in which all And into study from comes and But in over on time to We study last have a asked that that always sure all-comers. How potential this patient paratuberculosis basis. on And Crohn's first for X confirmatory we numerous compassionate population. the product or this we a successful recently, is by of right were the this Numerous use? three Guy making very the in a happening right MAP mechanism though we the move dreamed is we X avium very, a patients were publication reluctant are that. suggested years, infected been patients, detecting Phase when understand as treatment what that Even We're investors can the world we we of. running population do target questions briefly, very a there progress results Phase a important daily four mentioned breakthrough is access Mycobacterium paradigm. with all-comers. program? and to in our And we aware the believe that access promising. all

timelines, validating Now, kind have the about test are we this weeks expect within highly some to and we to the of idea program. committed to

treatment data, very and with So, shown I'll we of Grail healing, healing intend there. completely mucosal quickly from study despite is take very, the promising. significance in our mucosal imaging number mucosal to design Phase from go healing remind you to relatively it Holy a is proposed the which that X the patients. is Crohn's regulators in and small objective We've

again, are excited we forward about program last, committed that it this we moving seems and for are waiting patients are So, as and because very forward. at now, as the we it fully have way possible to a quickly it

David Hoang

thanks Dror for it That's me. it. for really additional Okay, the color appreciate

Operator

Thank you.

question of Hazlett our comes We will from BTIG. next now line that the taking be from Bert

open. may now you question. is ask your line Your

Robert Hazlett

-- anecdotal Talicia any thank impressed lines, the sales especially condition improving with circumstances you the present or efforts of regard have engagement? itself? not any market little and have Thank with those you improving making or describe Do -- field it evidence Congratulations you bit, to the anecdotal on could your can Yes, force a is you're do progress, traction How's you. with And there. you the diagnosis regard you. to the effort? growing along actually is the

Dror Ben-Asher

Rob. I'll them Bert. Wonderful refer Thank much, to questions. you very

Rob Jackson

seeing I executing not Thank team definitely you consistency. a improvement the only lot in volume, in but is Dror. growth but we're of what's also our Great seeing in field. also mean lot better, of We're question. in happening week-after-week, a

is definitely traction the say would improving I Talicia. the in So, for field

conditions I the peak obvious performing in of think the as if biopsies back the breath or as component, certainly changed testing, prescribers of last were that go not a COVID significantly. hospital the to earlier has for diagnostic lot improved terms of well year year, this In endoscopic have you reasons,

bit So, the is out the of certainly at although of than better a issue year. was it's it an beginning us -- for there, COVID still the

Robert Hazlett

a it, you maybe I apologies. percentage and you Movantik Talicia Okay, in be apologies then missed for versus you of that. us there And missed that. thank I've may could you my terms Is if it. quarter? breakdown for of mentioned maybe chance the in Thank revenue And any it, give

Micha Ben-Chorin

is this Micha. Bert, Thank Sure. you,

million about Talicia. coming and So, over $XX from a almost little Movantik million coming $X.XX from

Micha Ben-Chorin

Terrific.

forward of Talicia Thanks. Looking going the of hearing growth to forward.

Operator

you. Thank

our now be taking from question from comes will next line We Scott that Capital. the ROTH Henry of

open, may ask your line you is Your now question.

Scott Henry

on I because commercial have operations XQ, Sequentially, possibly I be that's may the morning over a going critical, from good or want $XXX,XXX. couple little a more and and questions there. revenues I to you to went there. understand XQ Thank up afternoon, but exactly on about only only what's

was And or to sequentially, I about is the So, Movantik down is how seasonal assumption? that have thinking that that? should assume be we correct

Dror Ben-Asher

not No, and Its at here. Dror related very all. referrals scripts are Doctor Thank sometimes. it's different you. things

Scott Henry

can you revenue see down-- going as Dror is But Okay.

Micha Ben-Chorin

Aemcolo. But I there from that can revenues up we negative and add and from went Scott Movantik both Talicia took impact a

Talicia are Movantik both and So, up.

Scott Henry

on give was? negative of large Can how Aemcolo the idea you impact any me

Micha Ben-Chorin

neighborhood $XXX,XXX. big. very towards not of It's the It's

Scott Henry

Is are marketing thoughts which the -- what is know virtually taking from and there? keep how a I revenues that? lot understandable question lot given with COVID, there's long resources of it, And is it it don't coming it cash doing is but regards can Aemcolo, -- no Okay. to you your but burning product, a what of means the

Dror Ben-Asher

the Thank you a big are gradually right impact on doing a with had said investment, Thank of before in own you, nice Rob? to terms hopefully pandemic to what Aemcolo, eases. let before as explain halt product Rob, Rob believers high in we the which I'll have halt. has the I -- has come negative the was right I'll in beginning very trend territories. answer. now what risk we to turn Scott Therefore, very we're pandemic about. our Obviously, the travel let pandemic complete Rob

Rob Jackson

Thank few in you, Talicia, It's arises. Dror. to resources very typically relative right taking detail To Movantik a opportunity answer is the Aemcolo the second or question when third position and now.

at to deliver or during what Aemcolo we're we're able right our this the would I now be overweighting the concerned pandemic. looking our to outside on from that not effort relative So, spend

Scott Henry

the this I sound QX. mean, guess largely look because it is I But from went But you when and a at because very question went Rob to QX up it, of about QX. you, way division. direction QX know yes, Okay, in for loss I I the that's commercial enthusiastic down the from way

So, I story mean, if I isn't compare QX to the QX, as attractive.

So, my see quarter, going down a get question inflection declining to up in versus Thank and improvement? we quarter? one a that point When start is, one see sustainable can loss when to mode you. an are we really

Dror Ben-Asher

Rob, would you like to take this?

Rob Jackson

are we a Talicia, of terms in Certainly, Sure. sustainable seeing improvement.

prescription month, there end since quarter. volume second by at for we sustainable slide If a the of break has deck you out that Talicia, the improvement you will our the look see in been

seeing We what on year going I on an we're have seeing Talicia know, focus have as confident more and based the uptake a I'm to we're I'm well. already, second and strong definitely of put very half fourth quarter

combine take win it's kick of January the effect And that in if have, So, we're in right to going and year. Medi-Cal we the heading that next into with you direction.

we'll business continue plus some trend the performance get I seeing between XXXX able we'll be our right potentially continue on core for expect accelerate. and think in Medicaid commercial to through there that the side, sustained spillover I to plus what we're

Scott Henry

Okay.

But I breakeven. they obviously, it shifting margin just ask speak that number. to the did great, because I to want And going should gears, see every week, loss Talicia seeing in forward see How still that look the is start decline, want when I forward? that looking to gross we scripts to a Just of looked commercial significant but trends, about good. quarter pretty think the the

Micha Ben-Chorin

had to we also expiration after the quarter years two mainly this and much compared flexibility inventory two of contribute which exploration smaller to -- have the of to substantial margin margin. we extension us FDA from better increase increase this years, we is a is the part of this got of the in the comprise allows shorter the in So, channel. And you're now operations due three and right to the the the Talicia and the that quarters previous which to

that increase compared So, with example. you is margin we mentioned forward for of see going an QX will

Scott Henry

do can gross think I number? guess, So, QX QX I'm forward that saying maintain you level what you from is margin, going

Micha Ben-Chorin

margins. a than but QX, QX and be may lower QX gross QX above little

Scott Henry

trial, question then you Okay, helpful. confirmatory take if would you opaganib, that's -- to how long be do to it'll Thank finish? from a have final. the I And do On your think start that final think do you.

Gilead Raday

potential completed to severe population a here. XXX over from XXX that to was We better other think that targeted positive year. study think of the patients and moderately given data sites from sources, a also, last the than Thanks we we support given Scott. in the do get -- done under the year external even the close can in or Gilead study probably sources public that. patients, right actually and platforms the year. in terms the number hospitalized could enrolled of of broader And -- study these go a We resources

our be target. would that So,

Scott Henry

the you questions. Okay, for And great. thank for taking that Thank color. you

Dror Ben-Asher

Thank you.

Operator

Thank you.

no So, further question Sir, please continue. came through.

Dror Ben-Asher

the Thank to you out for and all feel if safe Keep Brian. reach questions. Thank pleasant us you to have have you, free joining day. Please call. a additional any

Operator

That participating. does all today. Thank you for conference the for Thank conclude you.

all You disconnect. may