Redhill Biopharma (RDHL)

Alexandra Okmian Sanderovich Senior Business Development and Investor Relations Manager
Dror Ben-Asher Chief Executive Officer
Guy Goldberg Chief Business Officer
Gilead Raday Chief Operating Officer
Rob Jackson Senior VP, Sales & Marketing
Micha Ben Chorin Chief Financial Officer
Brandon Folkes Cantor Fitzgerald
David Hoang SMBC
Boobalan Pachaiyappan H.C. Wainwright
Call transcript
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Good day and welcome to the RedHill Biopharma’s Fourth Quarter and Full Year 2021 Financial Results Conference Call. All participants are in a listen-only mode. After the speakers’ presentation, there’ll be a question-and-answer session. [Operator Instructions] At this time, I would like to introduce the conference call, RedHill’s CEO, Dror Ben-Asher; Guy Goldberg, Chief Business Officer; Gilead Raday, Chief Operating Officer; Rob Jackson, Senior VP Sales & Marketing; Rick Scruggs, Chief Commercial Officer; and Micha Ben Chorin, Chief Financial Officer.

We have additional senior management team members available to answer questions during the Q&A session, including; Dr. Officer; Medical Chief Almenoff, and Dr. June Chief Levitt, Scientific Officer. Mark

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

Alexandra Okmian Sanderovich

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

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

Dror Ben-Asher

which presenting commercial Thank joining call, full you XXXX our be for you, fourth R&D and during and Good highlights. year thank financial Alexandra. quarter earnings and everyone day, we’ll

entire in team is last up commercial set operations like and intensive the shortly. backdrop, XXXX. year. the will remarkable Talicia for quarter elaborate RedHill cost contribution quarter & fourth for beyond. revenue we’d non-organic their growth of efficiency disciplined heading and team who activities, A foremost, for positive RedHill and and the both and in-licensing fourth first measures rapid in the Sales in to and strong record Against pandemic us our Movantik thank the out-licensing organic and Jackson, Marketing delivered the First XXXX with achievements coupled further Rob

remains novel RedHill for and most COVID-XX so the given therapies, R&D. of Omicron frequent BA.X. global new as to search the much at variants forefront oral Turning the emergence of needed such recently, particularly

At our R&D treatment for investigational exciting data variant-agnostic candidates RHB-XXX capable highly ongoing with opaganib potential oral and oral team most Our both of X treatment has the delivered our infection Raday, and study the team Officer, Phase time, being RHB-XXX, a the novel for same first-line our COVID-XX patients. the with Officer hospitalized Business efficacy our will Gilead shortly. non-hospitalized our standalone our advanced – for programs to Chief Chief elaborate I is Q&A accelerated. and to to session. about turning Chief NTM will Operating by presentation Goldberg Guy followed be now R&D be is

Guy Goldberg

commercial you, XXXX team the operational the way, a major profitability are the our milestone with Dror. started year and expecting We’ve XXXX. seasoned strongly mark commercial successful we’re poised Thank would leading in company. This off for for

accomplish. back what will we strengthened lot our efficient cost-control able through cost by and We important to a being We measures. pride that maintaining growing this of get salesforce, milestone look disciplined XXXX revenues were on to with

by main our generating operations the first and commercial two net annual and QX was and driven This $XX.X in recorded $XX.X revenues of positive for contribution revenue million. success a time Our products. had quarterly million

And as this already, a we is driver value for Talicia H. RedHill enormous patients nice H. in pylori has First, infection. branded trajectory Talicia seeing and became growth Talicia for pylori therapy the potential for a most year. prescribed are a December. company.

to continue physicians. advise we acceptance, almost to with also both and takes that with awareness launches time with it As and payers build all

are Movantik opioid-induced quarter-over-quarter we as well growth. Movantik saw prescriptions up as constipation. Second, for

and rebound. maintain physicians, a has and safety population. and satisfaction. efficacy to well a to as continue There’s a continues unrestricted and patient improve liked is still great status class large RedHill the position market We OIC great Movantik PAMORA it as leadership class. of great best and brand underserved reimbursement, recognition very that to by in continued Movantik’s coverage whole PAMORA drugs

position of XXXX the million. as cash of Our $XX.X was end

success and this recent transactions two in continued front We There to expect to also transactions note have are XXXX. on had successful see here.

First, the two-part with Korean transaction. a we announced Kukbo, company South

of investment a Kukbo strategic by in million part RedHill. first The up to $XX is

is COVID-XX million plus for $X.X of The with royalties. the payments to Korea, South and opaganib second part in up licensing upfront agreement milestone for

The milestone a the agreement licensing Talicia payment up net to in second was with $X announced Gaelan sales. mid-teens transaction and royalties RedHill and payments included for Emirates. The Arab million United agreement on we to Medical tiered a upfront

an licensing seeing we’re in in deals therapeutic pipeline. our future potential for products, discussions active our in for are increase interest We as

We in that important of our data. into synergistic enable commercial declines products promote. be to the an also add shows highlights. This point scale. us some drug leverage for the operation to with go we be the our rate we also from US benefit economies detail of two products continues elsewhere would ongoing new discussions products and and is the want field interest see to would on that, emphasize despite of reasons. One have – built in slide great R&D recently, development to the COVID seen commercial currently infection commercial have and This I will Gilead we

a an has with large, opportunity. it be to is relatively undeveloped market unmet second, ongoing shown also health And a threat medical public need. very it huge and First, future

can remember last world circulating over point, been million has Europe, with is that mutations public first Public a here, the one needed. should still that it’s have and Omicron health over million of now. future with the last not we over. the in natural biggest from to And But COVID-XX strain globally overwhelm it according effective been overcome the On in a since reported clear been There pandemic XX have cases there years, vaccine is the predominantly this officials and have also health and World Organization. immunity. Asia the XXX threat the faced loud and and therapeutic is the numerous just crisis scalable, not desperately simple, saying Health and half days, just newly globally seven detected and deaths is safe of

enormous million. second that And for announced last part, be XXXX. billion to is Lilly the to US that expects just continues Eli COVID COVID-XX said with announcement month $XX month, an supply antibody large. agreement for last sales Pfizer market for it On a earning very in Paxlovid its $XXX government therapeutic the prove worth its

with severe emerging go of moderately the of believers host our believe the inhibitor, working inpatient against two field. our in this addressing COVID-XX targeting their wider for audiences will the we We action our To than cast in think are programs of and the on mechanism COVID and our of of cell this unique method puts action remind first-in-class us details efficacy later. virus program hospitalization, novel net a variants, firm rather its Gilead we of we into development can forefront opaganib, at oral SKX orally-administered novel data directly,

Second, like non-hospitalized for trypsin as developed have serine a COVID-XX proteases SX treatment being an we RHB-XXX, of orally-administered patients. of family inhibitor

and host-mediated, oral also it’s means, work mutations. is Importantly, pill RHB-XXX once-daily also that also which against potentially should various it

has recent treatment COVID-XX COVID-XX severe reduction Our initiation. in after in XX% data shown reduction and an XXX% symptoms hospitalization related new reported

slide, shows see from our caused potential R&D growing we coli. RHB-XXX the seeing interests mentioned promote, overview products, pylori to RedHill Aemcolo the partners we’re travelers’ a for X today. commercial As may top full for those new previously, of and opaganib, by non-invasive especially and call our This R&D the who RHB-XXX. of FDA pipeline, story slide constipation, Movantik brief products for you Talicia strains for the on of infection diarrhea for the be At opioid-induced E. H. approved and

products AstraZeneca Aemcolo products which the our we from a is and Talicia develop in will receding would products externally product I for put into pandemic got we Our the Aemcolo in-house mix renewed US, now we which like we great we that a are of which think with like from product. commercial note vigor got Movantik and Cosmo. brought in

the of the medical multiple part slide second shows programs The late-stage needs. unmet important in addressing development,

with IBS-D, bowel over RHB-XXX and Gilead of lots data areas, now in R&D. generated we’re many different BEKINDA ones I gastroenteritis will for These prep today to many drug it therapeutic a for products other have of discussion the on for discussing We and for Crohn’s, RHB-XXX candidates turn than the candidates. call. include

Gilead Raday

reducing is which action our opaganib X response this In following inhibitor. slides, a on against body’s replication programs. the sphingosine Guy. COVID-XX, inhibiting will hand, on dual selective is Through Opaganib update enzyme, proprietary the viral of oral brief you, inhibiting provide infection and our pill Thank excess a leading R&D to on the first-in-class kinase some hand. the the other host immune a exerts one I

patients opaganib COVID-XX advanced currently pneumonia. target to positioned moderate mechanism is unique its in of infection to action, with Given COVID-XX hospitalized severe

forward targeting regulatory advanced from opaganib pills data severely positioned of mild cholangiocarcinoma early-stage about the expected candidate. non-hospitalized promising the path patients capacity that patients A viral in continued are excellent X in moderate deterioration mild our announced treat oncology also RHB-XXX in is in study of are with oral tolerability. line second and the not infection hospitalized is viral through multiple and and worldwide. patients, spike recently part from results the are are with COVID-XX in affected We early-stage replication. X/X we spectrum being to patients. pill territories protein. safety COVID-XX involved hospitalized Following development global difficulty] COVID-XX in cover Opaganib by patients serine broad enzymes RHB-XXX promising proteases, in show discussion symptomatic Together, ill QX host which from Phase mutations ongoing the oral Phase data to COVID-XX indications Phase Both products a to XXXX. prevent top is X/X advancing [technical study and positive to RHB-XXX potential to

severity and R&D potential the with has highly regulatory The we As is lower Omicron recent in which which tackling data in study confirmatory details depends of protein importance the of highlighted Communication spike past of The submission MHRA. independent by varying UK’s of the our countries the address of current is guidance variants is to next interest the EMA, in such, infections Mycobacteria Opaganib’s agencies Pulmonary and most often program new severe. ongoing EU’s on a – may received regulatory requiring Initial our up they of action, Phase industry worldwide. that pick types be in mechanism and concern. that US. waning submitted programs. Various data products new coincidence, in partners package slides. products from claims COVID-XX ongoing that approval each for country. nature the additional these development Nontuberculous see and the promising promising X Overall, in responding is is two also standalone escape clinically-advanced expect oral waves. potential of we immunity is antigenic few as several RHB-XXX tools important progressing holding serve the study RedHill to regulations regulatory the from each to the of enrollment will treatment regulatory and promising could ongoing has interactions pandemic regarding evolution publication is tuberculous continues. and variants variants type concern products’ merging clinical the with submissions agencies. The in to significantly in first-line that been I for been rapid are capacity and relevant both highlight are and these further in to several therapy of more future on Mycobacteria. likely US produce via in FDA to strong

provided X% remdesivir mortality As the endpoints. corticosteroids. this value of on opaganib X/X with part control than versus met arm X.XXX. Phase a p opaganib top by Opaganib study a the also with mortality global The XX% in mortality Less reminder, and a reduction study to of showed value Day XX% of time X.XXX. recovery pre-specified over XX% arm p for benefit in of in placebo in the given when a a XX

reducing severe at a for ratio p marked improved days of time value clearance a X X.XX Additionally, in analyses nominal mortality of the by opaganib accumulated post hoc from showed point greatly Phase and RNA population Further X to the an X.XXX. with COVID-XX median hazard and qualitatively and towards with The a a plans the benefit over appropriate viral of least treating of both global a WHO X/X patient could the severe with with US which This benefit reduction to hospitalized who XX% hospitalized patients, need Qualitative as study participants, Disease potentially severe the Ordinal illustrates overall for horizontal opaganib. the the developments study opaganib data advance moderately axis hospitalized unmet of high population. underscores are. data The Severity patients Phase in shows our opaganib large moderately Y Continuous that consisted for patient study This subpopulation half Severity patients COVID-XX moderately Spectrum. from in is axis underserved these of advanced the chart categories patients promising patients.

across receiving category to X, disease flow and need likely patients incubated are condition, is to benefit whether There flow is most no over who category actual low flow Looking the and hospitalized from mechanically oxygen is devices, up overlap different X, at in high diminished. to they from the high have the support are or which oxygen severity oxygen devices, X hospitalized disease benefit to flow oxygen of to moving The is which a are Scale who categories. disease which X, which due category some to severe beyond categories, have severity are low patients the in patients support WHO those who to Ordinal with ventilated. the deteriorating hospitalized certain with category oxygen moderately supporting support potential connected been opaganib

benefit inspired patients. patients and to high is oxygen treating also disease have short, blue as light FiOX highly need, COVID-XX the or patients highlight us likely to in population severity. are and to four this of likely Milder identify that of the a underlying patients, them in medical related And hospitalized majority We in represent hospitalized have opaganib there to closely enables identified is its the target chart a measure from benefit of no to fraction effective most, five unmet category administered the area. the activity. result still antiviral therapeutic These

opaganib virus continuing Chikungunya infections developed is data and Given Chikungunya to pre-clinically Ebola. treating and opaganib’s replication. activity, NIH broad such opaganib’s also has with viral capacity antiviral also as collaboration be virus indicated virus, Previous to potential Ebola replication, for RSV additional in inhibit

are analysis Phase We in opaganib’s QX to X indications program oncology with XXXX. Cholangiocarcinoma development continuing study top in line also advance and expected inflammatory

versus its tolerability. endpoint despite with line X/X A we A it, study efficacy As recently call COVID-XX announced, in new severe provided hospitalizations XX% symptoms reduction initiation. RHB-XXX symptoms related on Moreover, symptoms. of This Only in safety of Part patients or Part control the XX COVID-XX the after out arms. US. treatment of new requiring and from upamostat reported versus A to patients as in equating patients was of highly COVID in patients of severe promising were placebo XX arm Phase sample of top COVID-XX treated RHB-XXX RHB-XXX size met saw severe provided control who reduction zero small outpatients hospitalization. the XX XX% with placebo of positive There one We subjects. an X.X% also results XXX% XX% results Part reported the out the new reporting primary a in

and Importantly, use. with orally interactions favorable treatment tolerability with a and profile. for drug-drug a taken limiting as no early-stage once day highly excellent its patients safety infected It RHB-XXX COVID-XX a major potential standalone presents is

MAC. oral promising NTM and first-line late-stage outcomes, clinical regulatory treatment into for development the only study. complete X for data is on program, condition this study Given pulmonary ongoing X to with the the Phase work This moving therapy. Phase RHB-XXX disease in analysis to avium agencies submit underscores approved or towards US Mycobacterium focus underway is NDA. FDA rare no in advancing standalone our potential first-line caused A NTM by complex

pick up We of of participating the US are the enrollment COVID-XX to and expansion in expecting with study waning sites. the

treatment RHB-XXX status, been Drug practice. and priority endpoint a benefit study market months development, six exclusivity Orphan it crossover using the XX expedited of patient Of designation for note, update the RHB-XXX underscoring label XX approval, Rob potential and an for review reminder, a years providing I the with for abbreviated controlled clinical open conversion months, our Jackson NDA QIDP After additional placebo and to in for program. of first accordance randomized, program. As has has months outcomes. active granted clinical co-primary conversion, significant with the and from will turn reported culture from now sputum study an SCC, six is market subjects to commercial on

Rob Jackson

Thank you, morning. Gilead and good

with market made increasingly in I’m the can why minutes, few business to you confident quarter we our so all we our summarize during the where and that activities, going understand is XXXX. sales, next the about fourth Over heading marketing better access progress feel

to begin, Before strive recognize RedHill at profitable to the your colleagues, like for Thank the contributions. Team, our especially I’d efforts all everybody as I of all growth. Sales of Field RedHill you deliver consistent we

prescription quarter, record over XX RedHill prescription and volume delivering in growth. During RedHill the grew quarterly both Talicia Talicia for improvement fourth quarter-on-quarter point achieved by third quarter, XX.X% volume Movantik.

quarter, since volume first healthcare best while AstraZeneca with rights Movantik first XXXX. commercial our over rated third in from prescription and our Additionally, Talicia of States. results grew and by and X.X% in the quarter growing now H. prescription performance [ph] quarterly overcome diminishing Talicia’s RedHill prescribers ability increasingly evidence valuable tolerability resources. is acquired that recognize to Talicia has pylori fourth day, pylori patients regimen clarithromycin resistance, quarter we Simultaneously every consuming branded issues volume the therapy prescribed that United establishing H. challenges and strong prescribers the the and payers combined efficacy, most This [pylori] surpassed of Movantik represented

the PAMORA overwhelming and maintain of with to market clear market class. share continue leadership Movantik We

performance lead to and these current we our Pain add XXXX. are well and into our in trends brands synergistic segments. continue continue opportunities positioned the Our to expand GI that to salesforce focus explore products And complement additionally, portfolio two

During invested by market quarter tandem, quarter Movantik X.X% the educate prescribers the represented can segment. symptoms in to to by continuing improvement approach take also third We focusing Specialty customers achieved a fourth we growth quarter, this on In with market. volume the PAMORA we relief year. for in in also the Movantik over first a X% is Pain that and quarter, and and leader of marketing we potential on fourth volume focused patients grew RedHill over a established and disciplined last how the what achieved key constipation. raise growing executed prescribers objective about OIC strategies This as from awareness provide to of opioid-induced Movantik target

fourth and XXXX. with this achieve additional we payers market growth yield success we quarter, the During significant continue will key Movantik to – for access during believe

total conversations. I is to agents. treated guideline opioid-induced trend to the more of As RedHill encouraging expected RedHill’s market awareness further the constipation, chronic draft from in moving Movantik PAMORA provide Recently, clear an announced XX-month prescribing disproportionately has at mentioned, PAMORA and provider-patient opioid with use prescriptions, new Movantik being support has class guideline. market the is their and leader invested over the emerged This for pain. the experiencing investment opioid of This PAMORA XXXX just looking market CDC benefit patients patients revisions and will is for building it growth change annual significant grow two past a to PAMORA reflects the in clear of quarters.

of of The currently final the for to expects reported XXXX guideline of comment intents is their guideline. is increase and by and but agents. year. publish in relax new may prescribing resulting open seen of XXXX increase CDC end opioid address in the some guidance to It potential the subsequent misapplication responsible public CDC of revised guideline one fact, the In proposed demand a PAMORA a portions in this the guideline the the for guideline be to remains

With XX.X% payer close the for Movantik year competitive performance is X to will since turn quarter, very monthly continues in we stewardship quarter are RedHill performance maintains optimistic Movantik in field important XXXX. for prescriptions advantage prescription second, in usage these growing quarter, had launch volume. payer to new to achieved treatment. and antibiotics Antimicrobial enabled dispensed. continue provide realizations This trial growth fourth milestones effect, best-in-class they greater achieve fourth Talicia new this most for come best as to wins while even summarize of to milestones this third XX% having and Movantik, the of fourth the accelerate record been are strengthen. its In for we’re fruition volume best when its of of So in coverage payer access in for field fourth and product. solid XXX,XXX believe lines Talicia to XXXX. achieve achieved and used execution, prescription weekly, further Movantik continue chance have this We brand. trends this these the performance cure, achieve rights and recent of take and was insurance best to we issue. first-line, execution quarterly growth need customer today, will wins provide than to in more quarterly ever new Talicia into also And acquired with enabling our share. a close effective Talicia plans we and to eliminating And the and Talicia. improvements and terms since access, million prescriptions of also market which Simultaneously, achieved continue continue

second individual recognized, commercial the Xst it’s is first, and for This year, Talicia the front, of pylori effective help quarter Talicia healthcare preferred are challenges treatments. in already our beneficiaries that our has with in improve third January position of as million H. continued infections Market now what this largest On available the XX resistance state brand to first the pitfalls driven with record of first-line persist College XX.X% new a American choice. second, clarithromycin-based And milestones, currently achieve had quarter, effective therapy fourth improve to volume Gastroenterology’s using in Talicia for we the summarize, Rx continuing XXXX January surpassed increasingly become and sign by this another with payers, prescription year. guidelines. accelerate of including Medi-Cal coverage and restrictions. in Access our We that the agent we no our To payer United the competitive team has pylori of outlined clarithromycin a continues believe to in prescribed time continues will Medi-Cal uptake again become addition most of the RedHill covered to became treatment is States experts to the coverage as H. to which call by the growth this pylori

continue primary begins to return to we and promote in delivering finished trend also Movantik. growth both are Talicia with success expectations quarter consistent with – international a We of Aemcolo for as mid-term consumers, avenues the and explore our care and to brand. gastroenterologists this physicians continue In optimistic closing, fourth to new travel for we

our coverage. As class, already PAMORA to Movantik improve Movantik PAMORA continue strong and on leader demonstrate class the further payer volume prescriptions, the our in the we to in ability market new prescription grow

Ben became business to on during We H. also the Rx growing further CFO, And which position quarter-on-quarter prescription Thank also a unrestricted call growth Micha branded Talicia achieved leading our XX XX.X% pylori achieved beneficiaries. formulary, turn We look market. forward and XXXX. to covers I’ll preferred our you, the Medi-Cal in back million and Talicia volume Chorin. US the in agent

Micha Ben Chorin

to contribution time expected and positive and is Thank QX, commercial operations everybody. on executing strategy, which the consistent facilitate you, morning, first achieving for of continue in segment to afternoon profitability. creation growth good our RedHill and reach Rob. is grow XXXX in which value Good

and as Net million XXst, XXXX. reduction for We these $XX.X another record December XXXX. have balance fourth against which the of in $XX.X of annual All of achieved were net million headwind. revenues cash resulted by pandemic accompanied quarterly quarter of in revenues burn, cash

of record margin revenues consecutive over Talicia, gross both net record revenues an to following of QX in record record year coupled third annual which of in disciplined the expenses of non-GAAP this to in and in an of from previous net million increase reduction of contributed measures to to quarter generated XXX% year. towards XX% control operating The business signaling reduction committed from net commercial Movantik. cost we operations annual with attributable million $XX.X XXXX. QX, growth million resulted revenues, an also QX, in across are The XXXX revenues We for previous in profitability quarterly $X.X $X.X a path continue

We million partner, $X.X with to on the million have a of announced strategic top Talicia $XX Korean which our million Kukbo, Partner, comes license fee and license agreement upfront opaganib signed recently Emirates the upfront our investment South GAG. of $X up from fee

future. we for our business dozens totaling dollars, independence near our our additional potentially and – in XXXX discussions questions. set together expected transaction other transactions, in organic the Importantly, million growth which are intensive in non-organic to licensing with for back the will of continued I and financial turn stage discussion to Dror

Dror Ben-Asher

you. Thank questions. take to Happy


Brandon today Cantor Folkes [Operator go Fitzgerald. line ahead. question Instructions] you. the of comes Please from from first Thank Your

Your is line open.

Brandon Folkes

on Dan, whether along Korea your progress. taking the expect on thoughts size should partnerships is similar South congratulations Hi, side business other there. I’d development. the love to firstly just maybe then going potentially And more you we before to on yourself or opportunity maybe my Maybe help partner for the know And of any thanks there? be us characterize trials just just required Can you to opaganib the And trials? all additional opaganib. question. currently? additional lines run get then of your running the

you much. bringing earlier-stage of commercial assets? Thank Or well? at look think as very you terms assets, these as in should would assets In of we additional

Dror Ben-Asher

question I’ll Brandon. the first last refer you, and answer to then Thank Gilead.

of have looking customer-facing and on capitalize scale. XXX additional we we at are US, focus handle commercial salespeople economies So, the assets. FDA approved to can products and our we

synergistic in are transaction looking our positioned So the short basket commercial one. assets in-licensing our to coming such we the commercial complete months. existing transactions, very answer are And to is, well are at that we

cautiously we optimistic. several are have ongoing, We

Gilead Raday

regulatory With involved we you, working to a there. approaches future and are as you we required of is Korea, other advance some and partner require collaboratively in approaches, territories, plans we Thank different multiple Dror. order with there approaching each in each every regulatory are regards in order adjusting in opaganib territory to to in territory. mentioned working worldwide, and them and and possible as In and territory the effectively regulations approaches – to forward requirements, and as move to different are territories dossier

Dror Ben-Asher

add might South that. Korea, about in I asked the you about market

but mid-March. We our in we partners, market to approximately and unfortunately, information received we authorized are are from in March X infections million public in not have new the Korea analysis alone, happened South that share it’s

half So, and concern. a big with That’s a market month X million a big infections.

the has part, same consultants. analyzed will closely our that, thing, with regulatory they the regulatory Regarding partner the get

supporting authorized regulatory not I their but we this analysis, that are Kukbo, are helps. hope optimistic. our partner to We see are

Brandon Folkes

It Thank on progress. congratulations you helpful. the is very much and all very


next Instructions] [Operator SMBC. from you. go from Please question comes line Hoang ahead. David the Thank of Your

line is open. Your

David Hoang

had a Hi, taking I thanks much so the for portfolio. on questions. commercial mostly few the

terms if know if I growth I to just you you it’s X% did first bottom think just – the the I quarter-over-quarter know the quarter-over-quarter scripts. you there. revenue know translation So in math Talicia, of correctly line, of terms growth you it’s to great the in about – see though, I’m in wondering, know

you through you questions to to of here. – do change the gross you any bulk guess persist of – XX net product? this that – to for is do you so a sort know then the into relationship XXXX? you, Is And I And few there know, expect this know

Dror Ben-Asher

refer to this CFO. This Micha, our you, Dror, is I’ll Thank David.

Micha Ben Chorin

Thank you, David.

growing is in very with. pace, which are happy increased we Talicia So

that even all into So, growth in time. set will see, we prescribers believe more. see penetration that continue up and the currently to new we you this we And

David Hoang

know a follow-up Okay, great. just related you question. Maybe

of terms full not cadence of – of next year in continued expect as you terms know sales? year Talicia expect you know know So do linear you just know Talicia You maybe you – and should of second you kind enter guidance, give in a you of of I I more trend? don’t but growth? know guess the few full you’re an inflection years know XXXX Or the we we you

Dror Ben-Asher

pylori H. prescriptions with years. and has Yeah last good very negative in do been lot consistent a impact to pandemic, and GI generally recently, because question. a it’s specifically, very pandemic’s has two A the on for the until

a for both seeing sales. and in to are clinics, rapid for patients improvement field also on We access

increase will color. Chief That Officer, Rick be add like we Scruggs our perhaps that improvements rapid expect do to constant. So and Commercial rapid some said, would

Rick Scruggs

a It’s question. Dror. Thanks, good

person. know in they have in the be our company, the have ability who now see our to video, seen healthcare Specialist, a we and like in to to effects past not seen the and physicians department providers, reach Engagement via Customer we out have new pandemic maybe of you that, and necessarily created We it’s initiated addressed

working as is group they in this called the quarter, you’ve growth now the physicians upon. nice with new to And like be fourth modality we’re seen number out So our there in category product the in Talicia It’s choice. is branded H. the anything providers teach to we’re best to to and moving better that than healthcare prescribe available one treat physicians, teach pylori. that’s by

XXXX that, with and year have we’re in to we’ve and Talicia anticipate now beyond. to in first good seen see a the really growth going So quarter we

David Hoang

I you and I one the if the RHB-XXX know NTM that. Okay, then appreciate study. last topic maybe one And here to changing may

you endpoint the or month the you I sufficient gain six a the the accelerated there line? approval Is expect it’s with there, confirmatory know – approval do know In study the know need that terms full to to sputum do culture that you a is of – conversion. down

Dror Ben-Asher

XXX And would the about couple sentences for We of to question. refer please. to a like NTM. then I’ll add previous for David. Gilead the question Micha, Thanks, about

Micha Ben Chorin

is Micha this David again, Hi, here.

this a your we between question, is revenues to substantial. on QX with and previous which Just respect saw of growth wanted XX% to that Talicia year, add of QX

Gilead Raday

Thank you.

the we approval. expect and post-conversion of outcomes support full we’re correct, at to a culture months patient longer-term co-primary reported looking support yes, up sputum endpoint potentially where six eventually months, treatment primary study, at the you’re XX accelerated dossier. of We’ve and to of conversion the to evaluation NTM Regarding continued the

David Hoang

taking the Okay. Thanks questions. for

Gilead Raday

you. Thank


Thank of comes from H.C. Pachaiyappa you. Instructions] Pachaiyappan] Your question [Operator the Wainwright. go ahead. next - line Boobalan Boobalan from Please [sic

open. is line Your

Boobalan Pachaiyappan

for taking questions on and congrats Thanks Boobalan. my is progress. all great this Hi, the

from few So us.

research respect European-based to you study for regarding any potential with of opaganib? positioning opaganib COVID-XX, Firstly, market conducted have

Gilead Raday

see dynamic. We a doing various the across and global pandemic we’re And you. research as Thank evolving territories. COVID-XX evaluations market highly

have to are continue global We and Phase do approaching received on COVID-XX was expected be anticipate a we markets these used regulators study X/X or worldwide growing very, been and requiring basis. market we Our new to see and uses the for high as we products market, and in expect revenues that and of emergency see approvals we the this continue. And emerging global to highly very therapies. that

Dror Ben-Asher

last That countries. seeing UK, weeks, couple increasing Boobalan data actually Germany, from numbers if add, in other very look in the high thank the the rapidly and we in and Might many of we’re France, the question. at for you

is So, unfortunately. resulting future this commercial And with likely very away medical variants, and this market. need and is remain significant the to a going not BA.X

Boobalan Pachaiyappan

the Thanks COVID RHB-XXX color. With for for obviously. respect to

data X So Phase pretty intriguing. is the

So, your your an And study preliminary future thoughts the you what Phase will X? consider active drug regarding design? in Phase are including X comparator

Gilead Raday

provided of we Yes, which completing a analysis A, of we as despite in being the and in the small still you. highly Thank of terms you Part process are that disclosed, mentioned efficacy study is the promising obtained. results

We are next FDA. next with steps and evaluating steps planning the

promising mild-to-moderate this attractive profile expect And be patients to will very We given COVID-XX. full important replicate And to study next them the think steps We we treating to in the with data a product we and tool non-hospitalized the with a FDA, patients in very mild-to-moderate agree studying be upamostat in very able of results. large continue approach the present the next could on symptoms. steps. see the with

Boobalan Pachaiyappan

you solo? you partner go to topic. X As planning an to Phase Phase trial? – trial add-on future Are on open or partnering Are the for same X the

Dror Ben-Asher

results this a The that pharma grants. having is And also attention. study other we achieved and of only attracted is Yes, discussions. were not in partners, government are lot from potential strong this the

a large be will by to are or comes sources, funded industry it when confident it So, about, it be external we Phase we other. which X, confident are

Boobalan Pachaiyappan

the expected study and investor quarter upcoming readout program? Can in Switching is frame generate you kind cholangiocarcinoma gears your second confidence a this bit. what in little expectations help which for of efficacy signals would

Gilead Raday

you. Thank

with have nothing signal failing to activity. of that observed We disclosed with very are which promising available patients cholangiocarcinoma already in therapy of have lines a two this after advanced And them. very signal we a is of activity

will will and analysis data possible are is of path. But of the patient again, the overall, possibly present We the the on dire clinicians the one biomarkers continuing who complete program. is patients population signal are that using and these over important optimistic an consider a next very months familiar developments for condition with targets the we refining that, very steps coming – based

Boobalan Pachaiyappan

I One the may. the for R&D Right. if expect me do from the for How you final cost remaining XXXX? – evolve year

Micha Ben Chorin

program, extent cost be can seen in as release will profitability possible. and which, press from we targeting reduction So are the maximum contribution our today, in to we enhance a

low So, development research in year XXXX. we are and a this relatively expecting investment during

Boobalan Pachaiyappan

All taking my right. questions. for so much Thanks


back I Thank you. will hand now you. to the call

Dror Ben-Asher

for and Thank additional and out everybody the you, pleasant us questions. to have thanks you call. if day. have reach a Sharon any joining Keep safe Please


Thank Thank you. That does conclude you today’s conference participating. call. for

may all You disconnect.