RDHL - Earnings call transcript Q1 2022

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Operator

Good day, and welcome to RedHill Biopharma's First Quarter 2022 Financial Results and Operational Highlights Conference Call. [Operator Instructions] At this time, I would like to introduce to the conference call RedHill's CEO, Dror Ben-Asher; Rick Scruggs, President of RedHill Biopharma, Inc. and Chief Commercial Officer; Guy Goldberg, Chief Business Officer; Gilead Raday, Chief Operating Officer; Micha Ben-Chorin, Chief Financial Officer; Adi Frish, Chief Corporate and Business Development Officer; and Rob Jackson, Senior Vice President of Marketing.

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

Debbie Bechor

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

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

Dror Ben-Asher

Debbie. address is you, current call. our earnings first reality, Good To for and its day, quarter you Thank thank RedHill own controlling decisive joining about market destiny. the everyone,

focused are We half highly from start positive XXXX. cash of operations profitability, to targeting on achieving earlier second during the

expected operational XX savings cost is generate of million to reduction months. next plan over $XX Our the comprehensive cost approximately

an The U.S. reduction XX% our X/X approach, the activities cash reduction commercial seeing operating majority a already used positive We are quarter. results of team the over the savings, cost cost of a significant in of first workforce. from plan, in with disciplined approximately impact reduction of our control in

generated who on expenditure, the operational of data Chief funding gratitude Raday, be also SG&A the external date, to and behalf Officer. streamlined to express sources my have like mostly rely refined our RedHill. the also promising shortly and now. clinical profound Operating by for Company's On to on Company, will excellent R&D strategy discussed the I Gilead Based departed progress have respectful expenses We colleagues our would R&D to including

acquisitions While results to current necessary, diligently agreement growth, further in rest to and would business the made will our presentation to Officer, and have continue by we commercial a against I of R&D also plan, improved the now thank for is, discussion. we coverage as Q&A be expedite and RedHill decisively additional summary, potential products robust Guy the and the given the and pipeline both therefore, to with of stakeholders savings, as highly our cost reality. commercial and recently term. continued where our of detailed prescription cost own Business FDA-approved non-organically well like reduction longer financial followed team team as the difficult, well Royalty. the changes for expanded their drugs, with through as In various portfolio our driven patience to the be support managed resilient Goldberg, stability care various organically proprietary grow from short generation, synergistic and significantly credit revenue-generating growth, improved RedHill increase Chief headwinds. major I financial and term positioned three part cash our from Healthcare for both turning

Operator

technical slightly problem. a have we that appears it Unfortunately,

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Guy Goldberg

and Slide beginning presentation. then the listeners Guy, overview with had we Dror, to continue who start at on and to I'll challenges. X. we'll through us and my the some our of technical you, I walk is This apologies will an while had Thank bear section,

his now Slide remarks, made I'll on So be Dror just and X.

biotech measures the the important going an longest is end financial of been the sector will independence. the one at to So ever achieve this This tunnel. Only resilient downturns In RedHill transformational of able process slide, the investing is control new through and and bottom point important reality, at breakeven. has implemented stronger to emerge words, of companies as the be that illustration we're RedHill through. can by where to deepest achieve cost the conserve less, up weather storm. the other cash we speed seen the in In

to operational we second million with reduction over implementing improving savings program have that a the including on half opportunities fit of expect during revenue focusing from stage approximately in of covenants We're the commercial Royalty. Healthcare In key is strategy, the initiatives our XX the of of and also we terms other and this call complementary We us that return that achieving goal various match strategic have are points current BD agreement cash completed terms been partner, discussions XXXX. support comprehensive to our make investment. accretive conjunction, operations profitability our cost credit products in earlier, that positive flow By $XX next months. aims on continuing on

We talent and of team product company-wise experience have excellent of scale. would organization and additional drive, and from commercial commercial see a also in place our economies benefit top-tier any benefit would the

while currently programs funding. including external on R&D, other progress our continues RHB-XXX to as we Next programs our those expecting two for drug are COVID to candidates, through before, advance

reasons. continue two for and infection-induced sub-variance continues is move the activities. this for therapeutics in our will programs U.S. COVID-XX capital, for neutralizing discussions oral drug we and promising believe important core development. of upamostat, justifies committed opaganib largely to have still this want substantial is generated grants, our the partnerships. sources we field the in and activity. and to other forward. are environment, resistance to data Europe, including platform for COVID-XX highly vaccine-induced to indicates to public and our and be Research programs are shows of space need of and non-dilutive emphasize private are We that The funding and serum RedHill, slide Omicron COVID industry In continued programs, acute. an I that studies COVID R&D new we shows development in This

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

are turn in be unique in believers firm post-directed other their to and general puts the very at of progress. action development provide fact, will our over interest will field, programs COVID of later. us growing updates I the we development commercial Rob this programs, programs mechanism of pandemic important with COVID to on preparedness. our think Gilead discuss now broad-acting in forefront We our the in nature are our to and more it programs antiviral

Rob Jackson

good and Thank you, Guy, morning.

going summarize the we feel sales, our so about heading you made minutes, the and activities I'm business we Over first quarter to confident during progress that marketing the understand few continue to the is why this next access with where year. market can

the we the Our expenses towards contributions. begin efforts team, in clear we your corporate priorities for to operational our especially and growth as to RedHill growth. deliver profitability as continue profitable colleagues, half to XXXX. all are to everybody progress by to I'd Thank manage drive you of like of our sales second revenue recognizing consistent presentation my strive

best and RedHill the Movantik deductible market quarterly first market our start the clear maintained nearly XX% achieved During always challenging In a record second share. to RedHill volume. strong prescription our portfolio. leadership to class delivered quarter, trend the of Movantik we a season, quarterly continues during very We new add prescribing performance with maintain first Movantik, with since the quarter, PAMORA

Talicia close patients overcome prescribers strong health During Talicia. that Talicia H. achievement ability record every patients the and resources pylori the effective XX-day to therapy a while is Talicia's XXXX, for of tolerability and the therapy following the recognize first endure grew has antibiotic the a regimen rounds increasingly as fourth very challenges diminished branded prescribers establishing resistance, significant in over are efficacy. day, RedHill quarter, that the prescribed rapidly consuming This our Talicia valuable is evidence frustrate by volume year. H. United XX.X% to searching multiple of States. volume forcing issues regimen prescription prescription quarter And such strong an combined Pylera, care to most of surpassed payers and and pylori last these clarithromycin and

trends positioned with a new trend the prescription of the both are of brands lead weekly Movantik are quarter volume half performance second the two In we've and with June, of achieved for month records Our already and second well the volume into quarter year. the to third Talicia, continue growing the positive closing we're momentum. entering

on can and focused specialty customers the we Movantik for PAMORA disciplined we quarter raise we also and achieved During a the quarter leader, in segment. take of volume these improvement quarter the in key approach Movantik delivered positive invested RedHill the This XXXX. our first be next tandem, and X% an patients about potential provide And was to prescription market continuing achieved can In constipation. market. awareness to these fourth the to results. growing prescribers of record marketing and prescribers first our volume this relief by market investments executed in symptoms strategies also impact opioid-induced opioid-induced from how within The X.X% seen what with the constipation educate quarter, the over development in We first pain a focusing is objective on target slide. of represented established of that as Movantik

three of annual PAMORA building moving believe in the has a tandem market at the trend constipation over reflecting developed change in total the a provider conversations. encouraging decline past XX-month awareness opioid-induced with prescriptions, patient This quarters. for is the of would PAMORA Looking PAMORA investment RedHill's of class, opioid class and market. significant the Many growth clear

guideline, is even the providing and opposite the the for the new Movantik opioid flatten benefit is disproportionately provide announced in to market. near prescribing fact, may being agents. PAMORA treated in patients In clear Movantik for support Recently, use will or this experiencing expect patients PAMORA pain. market expected further to from future, we CDC is happening, opioid opioid prescribing and further support draft and that their chronic leader with more XXXX increase revisions guideline

quarter advantage view as having focus of insurance year. be for continued final guideline resulting prescription Talicia XXXX, Movantik XX% a to launch, competitive delivered of its Movantik And monthly of alternative milestones. increase Movantik to quarter March quarter our and the and increase last reported by X.X% prescription end in to with developed continues guidance a new trend share, is more summarize, remains providing XXXX responsible launch achieve expect nearly in potential XX.X% the Talicia XX% revised original of XXXX. agents. previously may Talicia on of guideline dispensed. represented new also quarter. in first To prescriptions this versus and intents the publish robust misapplication An of growth the of achieved seen, have record volume in CDC its prescribing represented we to an challenge In for volume the access the market fact, address achieved best-in-class volume, additionally, portions into of milestones. demand And payer data, this It In total guideline Talicia XX-week prescribing coverage in results relax the to annual allocation guideline the pandemic Movantik And a but been shows quarter, we PAMORA quarter finish compare year. growth their in XXXX one since the the to the the of of In performance expects first maintains of first trend some from corporate quarter, move COVID-XX volume the achieved fourth you and see Simultaneously, continue. on to of volume Movantik prescription subsequent record prescription increase opioid the moving and of consistently. X first trend achieve we to building growth million growth strong volume that and facing the terms improve. graph, first and quarter Movantik. in than growth new we second quarter-on-quarter to continues plans XXXX. best first when Movantik After Talicia's the to positive ever XXXX, successfully a continues of as the of can first this XXXX in quarter

pylori already our of On our million payers. beneficiaries to as to position January preferred year, Effective the X payer Medi-Cal market gained RedHill accelerate became team with brand Talicia This uptake second XX April what helped available a improve for with similar no front, access on in H. individual has has continued this to treatments. the coverage restrictions. Talicia Effective is competitive largest and easy Florida state infections Medicaid. X,

X, July preferred coverage became D another And national access another to commercial quarter. Additionally, not formulary, this Talicia's on plan from effective improving restricted, per to preferred. Part earlier position Talicia PBM large effective improve will its

XXXX level to last of growth with and this of continues we the XX.X% the outlined toward quarter prescribing other are our and two to by independence that prescription we choice highest recognizing; the and to as expenses revenue second the and and year. for generated Gastroenterology's XXXX resistance. in a benefits payer what carrying lift operations We of the second XXXX, fourth clarithromycin improvements half and coverage continuing new the clearly clarithromycin Talicia. secondly, half we guidelines; of To from quarter achieve over first win lead to treatment from expect the of to payer therapy summarize, growth currently clinical brands: a of a continue branded cash of consistent are wins XXXX. driven pylori We coverage We've as significant record increasingly volume further challenge quarter therapies. positive had providers progress summary, achieved signs the this the managing consistent in first-line of see XX% of using first payers of Movantik Talicia. These growth College persist, of volume driving over remain increase pitfalls H. Talicia third, the and In compared priorities are milestones. American by on corporate trend have prescription volume our These growth first, based year. of focused into We any during challenges in we finished the healthcare

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

build the look the pull we growing shortcomings Raday of based for forward We of remainder care And primary with turn continue to during thank ways benefits Talicia to the We back our clarithromycin to and our advance to of emphasizing Talicia. call segment. case in you the and payers, Gilead volume the and clinical the continue the up prescribing to year. COO, And therapies business known new I'll grow further

Gilead Raday

viral antiviral as the Opaganib indications highly antiviral with X to will provide brief replication also is infection. administered, response, and in activity a in oncology on advanced multiple activity orally kinase inhibits therapeutic body's opaganib you, development Opaganib sphingosine data will development. With influenza, action is Phase line in providing Thank a continued viruses, response broad XXXX. confirming against being hospitalized the including opaganib's patients Phase I study I new from data candidate cholangiocarcinoma X/X is the inhibitor discuss top in Rob. COVID our dual has activities. immune X viral and promising which capacity by could spotlight coming opaganib types with public expected slides, with is field RedHill clinical first-in-class of in a by study towards is also update also infection, QX treat to potential prevent data in hosted promising and two reduces progressing our where in they RHB-XXX, R&D to to clinical Opaganib proteases, patients selective outpatient excess safety that to inflammatory SARS-CoV-X Opaganib that replication. a second of COVID-XX. benefit with severe to tolerability or important excellent Part tools and events. X/X pandemic variants announced preparedness, serve COVID-XX other health targeting oral COVID-XX With and well are upamostat in results candidate. A symptomatic responding holds [indiscernible] caused stage positive We viruses. promising viral promising novel COVID-XX moderate study. is participation our of mild patients and for non-hospitalized current RHB-XXX waves, show in Phase the products which platform future serine through RHB-XXX positioned viral deterioration human pandemic potential the COVID-XX of from are which early-stage

viruses might therapeutics, and are in in rediscover Phase targeting sources, focus the our could novel and in rapidly towards data highlight programs of and constitutes in in approach. for mechanisms positive government suitable to and waves. of regulatory which support R&D ongoing preclinical Overall, obsolete action public industry operational for development platform to I address variants regulatory regarding of of been antiviral first-line and shift package to approval few The fact, a approach are In of program clinically this the profitability other of half external pandemic in participation quickly several seeing meet slides. second mycobacteria. to opaganib's combat long-term broad the some than clinical we viruses. more The through each date, territories. promising mechanisms confirmatory and likely partnerships clinical opaganib view reinvent having pulmonary create U.S., in the study has generated X in sustainable Based SARS-CoV-X host funding antiviral very highly specific to experts, progressing. demand and EU the data preparedness treatment of a in our next This institutions with and strategy the of submissions further other Opaganib funding new non-tubriculous details stand-alone study. a anticipate input, is will on that emerging RedHill's line highly therapy face study health grants, is to pathway also become for XXXX submitted looking much mutating multiple future the pandemic promising oral potential agencies. antiviral for of of RHB-XXX RHB-XXX is advanced we the that long-term most industry

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

presentation the moderately COVID-XX peer-reviewed Phase severe been with journal. was in on to diseases, of of opaganib XXXX, moderate four late-breaker Data patent in X.XX, of late Adding a this nominal and with viral Additionally, subject treatment collaboration patients. time force in days in a days, X/X patent, Atlanta. oral by which using unique recently the market The the post-hospitalized improved XX, p-value which held scientific a June the has infection a symptoms processes clinical X.XXX. of setting is will global XX% clearance least subpopulation additional analysis antiviral clearance RNA and reduction of XX RedHill suite International of a viral for a be the granted stage such submission U.S. COVID-XX in Medarex advanced by Seeing also from is infection. on infectious median the in of opaganib's viral with most at emerging of to task be showed hazard is in ratio indicated patients at on over for viral median finding, mortality, consisted with of of clinical the onset which an at opaganib. opaganib's benefit to study in reducing severe half improvement challenging hosted of Further to ID a is cost Conference August from patients large of global study the the participants, an published effects to CDC also results a health the severe expanding method covering

those additional part Institute utilizing indicated including infectious capacity The be is Previous demonstrates for assay obtained the inhibit toxicity the viral human data of Given of levels. opaganib's strain. its virus Institute the Recent the no of antiviral infection. concentrations services the test potent potent at realistic of preclinical continuing human activity has Ebola replication diseases, influenza. infections, cells, RSV, new is against of the from a virus, National with are Health, influenza activity, results target and and low which National opaganib treating of Ebola allergy which bronchial at model to evidence in of inhibition application. A data opaganib's HXNX to Opaganib achieved broad were viral developed making epithelial natural

antiviral XX%. broad-spectrum be which in target of lower can viral of threshold for inhibited the at As viability opaganib's This and than reduces over concentration seen provides times was from activity evidence replication XX% this by cell that the activity. concentration indicating markedly antiviral assay potential the XX further results, exceeds opaganib potent

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

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

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

submit MAC, complex, is moving rare RHB-XXX is to therapy. Given oral to FDA-approved first-line and the X with first-line we complete in with the stand-alone studies. for a pulmonary agencies participation regulatory is a promising preparations treatment clinical work no by late-stage mycobacterium study, only disease regulatory which in outcomes, development NTM caused condition FDA. avium potential platform Phase data anticipate advanced analysis Further, into in underway for

advance mycobacteria this potential We non-tuberculous for in X NDA first-line ongoing the submission study pulmonary continue to Phase indication. towards

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

RHB-XXX this study over a sputum additional study benefit As endpoint clinical been a with these for a months, in from to of designations from clinical the review status. XX Of practice. U.S. patient-reported outcomes. years NDA potential in open-label lot first treatment in market active of and exclusivity the provide culture conversion of for We from an expedited co-primary industry and total development, priority a approval the six a conversion interest now note, has see Drug QIDP accelerate. the are potential XXXX with Orphan months randomized support partners turn to subjects Designation placebo-controlled six-month will Micha has XX program and in several I and discussions over is industry to it After cross further RHB-XXX QX using granted financial and and reminder, for accordance results. with reviewing the Together, study

Micha Ben-Chorin

savings flow for you, operations in segment cost This RedHill targeting half cash flow the of $XX implemented last year. now commercial which approximately plan, this the for million year. to facilitated positive now achievement the and XX follows independence. whole on contribution operational of first from during Thank And from next cost comprehensive is This financial we of operations months. are Gilead. before recently focusing company cash start the time interest two our of QX reduction expected payment positive over

in signaling activities compared QX a $XX year, last QX, week reduced used to continue cash R&D to last million on for of more which of elements $X.X QX, year in remains revenues Movantik of trends quarter the to $X.X million by of million of QX which in measured track the in to Research stated to compared Importantly, implementation attributed measures, optimization approximately the programs. cyclical This in XXXX. $XX.X was financial our achieving as $XX.X to are ongoing the costs and of as clear to last and in Net revenues RHB-XXX continue expenses improve of XX%, to in sales, path looking scripts than development reduced of million towards earlier was cash independence. of decrease and XX% QX Gross of both Movantik. grow. quarter at gross continuous goal to QX expected opaganib completion typical $X operating million approximately margin, due million with million development were $XX.X the representing this profit fourth optimization month, in showing scripts Talicia is compared Talicia and record

with compared to position proceeds had this of the March gross lower in operating quarter, activities. in offering $XX To cash $XX million our previous Prior led lower loss, lower of from operating million organic back loss net projected of XX approximately of registered As and This to sales summarize, used direct year. we cash May. as our growth potential products flow licensing to FDA well of approved and I'll vigorous position our revenue-generating turn second with positive operations half interest target of activities Q&A. our plan, synergies achieve together discussion from in during year. reduction before cost now strategy payments start cash to Dror, the out-licensing to the and to expected this

Dror Ben-Asher

Thank you, Micha.

questions. take are to happy We

Operator

from go Folkes today Brandon. Instructions] from please Cantor ahead. Fitzgerald. line the Brandon Brandon, Our [Operator comes question of first

line Your is open.

Brandon Folkes

remain you just on in today. questions all team? of impact for taking any firstly, the remaining Maybe about can be covered XXXX? net some to color overall though and Maybe the on reduction terms maybe for updates or secondly, how And those about Thanks of the uncovered? portfolio, just talk they staying commercial And just commercial reps XXXX do the the you will think then in territories gross thank compared by to we sales.

Dror Ben-Asher

Brandon. you, Thank

I second starting And Officer. please. question, As be to question Micha. far refer Micha, the your net our thereafter to Commercial from Chief by Rick, will first taken as gross the

Micha Ben-Chorin

less net, are we more and continue or will in gross We now. to believe on stabilized we where we

Brandon Folkes

how last does sorry. compare I'm year? to And that

Micha Ben-Chorin

coverage The is comparison last increase. of year a of because little to bit gross net the more

Dror Ben-Asher

net, on to okay gross are Brandon, we should continue? you

Brandon Folkes

please. Yes,

Dror Ben-Asher

please. Rick, with Thank coverage. you. to Well, it has increased gross to net,

Rick Scruggs

Yes, sure.

answer mention So had have that do territories answer could questions Customer group commercial and territories. opportunities this our in going territories territories, a organization, of did space. from out the We employ be territories of merge a a We also space. white to territories physicians for is operation. or with profitable, merged. the We white reach were We did line the all to the physicians Rick. analysis comprehensive I called that They Engagement commercial your will the did We do just growth, a Specialists. analysis up did briefly comprehensive few our question.

consolidated. have we So

We as sales leadership consolidated well. have

a XXXX. but poised did we completed for eye and lot do, and our And to consolidation. we successfully this we operation, we So have year now. with of tough there's something forward we It a and right targets need reorganization, to did hit feel revenue this go to that into was the

Brandon Folkes

$XX terms months, more, color think I XX at we in And should achieved? the you that modeling about of million may. be on any to And just next the if how savings Or that least how XX months? expect the over one maybe quickly OpEx over

Micha Ben-Chorin

Yes.

we prepared or less the $XX will we same save next which plan, very a more detailed coming on million. So, the those pace, that quarters, six in shows

Operator

Boobalan from Thank ahead. from of you. today comes next the The go Wainwright. question line Pachaiyappan H.C. Please

now is open. line Your

Boobalan Pachaiyappan

Boobalan. This me hear you is okay? Can

Dror Ben-Asher

Very you. well. Thank

Boobalan Pachaiyappan

All right. questions from Great. our end. A few

off to on acid discussion wanted So I our focusing start blockers. first by potassium competitive

received your one obviously, So competitors recently FDA approval. of

blocker treatment thoughts evolution Talicia in kind of the the agents these to see also, And sales? can of H. how on you on just pylori this kind hear pressure on of So potassium of channel the approval? upward your wake put do

Dror Ben-Asher

discuss first answer Thank with will Gilead. will Jackson, of landscape. start evolving Sales, you, about our aspect. Marketing Head the and Boobalan. And the Rob Gilead We'll

Gilead Raday

Thank you.

the population, first-line So best-in-class efficacy, on-label H. in issue Talicia, the infection. of the addressing is for treatment as it pylori which to especially clari-resistant major succinctly, empirical put

brand to going H. treatment So, the Talicia we're forward. leading continuing pylori for highly confident in be

Dror Ben-Asher

we see you evolving? Rob, like you, speak landscape Thank to the Gilead. about would how

Rob Jackson

Absolutely. you, Dror. Thank

need pylori I certainly new the think H. welcome a we increased focus the infections treatments. as company, for and on

will a any from positive. new entrant additional comes a into we be category So, the that think noise

In disproportionate the point, I how against into really to competitive in And key XX% term. we'll the that stand the think status. long landscape, new this studies is for favor share true competition, Talicia going resistance to of we'll really resistant with we our impacts And regardless brand really market issue strong it's think Gilead a patient's continue stand play terms a the to here. we've that's of going Talicia, how of up differentiator in think grows, for I identified business. is have clinical that's the to I efficacy, as the our capture what And the

Boobalan Pachaiyappan

then next And the Okay. one.

two and So profitability. doing you're reduction things once, it which cost at are achieving appears

Talicia rising interesting a backdrop what's comes is the that in So reduction Movantik in sales. of the and momentum cost

an So are graph, Guy communicating I slopes and some presented the believe value. interesting

whether the grow fast, Just than at early curious profitability, later grow stage. to ambition priority achieve but a slow at profitability here rather is a pace but

Dror Ben-Asher

excellent and Boobalan, question. you, Thank

cash as operations. We during to This to time the P&L have cash and are Longer much a profitability, that. comes when possible to whole preserve is cash clear it clear want goal. the we achieve generate having we breakeven priority half term, second from very and and company as

outlined, As can lot that analysis, given grow we done the we optimization sacrificing resources a Rick to have continue we as far the cost of growth, as shifting inside confident are and Company and together.

Boobalan Pachaiyappan

Okay. Great.

more, two if I may. Just

mentioned you a release engaged to non-binding are press drug. today's a in GI So that discussion acquire

how the And complete? the transaction? order for Just curious to has to in process fund expect do to you what happen

Dror Ben-Asher

you. color beyond Thank this we provide what we additional stated. cannot already on Unfortunately, one

Boobalan Pachaiyappan

Understood.

for therapeutics one thoughts the are pandemic? of COVID-XX outlook question. severely nature the given more the your targeting commercial patients Just ill What evolving on last

Gilead Raday

We mutations continuously. with see arising COVID-XX and problem -- variants very evolving problem dynamic remain a

SARS-CoV-X So is waves for SARS-CoV-X comes is COVID-XX sources health in on family and public to spotlight hard focus infection preparedness in all very from terms the the Certainly, of landscape the pandemics exactly predict of other variants, what outside of it's next from of pandemic line. the waves shifting, of infection.

and wake. long late-stage for and interest, potential very antiviral lying other the and future health for also in both infections stage early in the both our for focus we much COVID-XX the programs are viruses term, public that potential in waves So term is in of the see short

Operator

Thank you. ahead. line next The the Henry question from today from comes Scott please go Capital. Scott, ROTH of

now is open. line Your

Scott Henry

Thank you starters, later seemed morning. a in the the for year guess for Was that? was I like calendar year. it and good call there this reason

Dror Ben-Asher

Scott. reasons are that. you, There Thank several for

improved just agreement. important. was we announced That that an example, saw credit For you

ago We was also in had already a that delay, but month for in results so over extreme there filing, doing the a public are reasons nothing was other so. announced particularly

Scott Henry

profit I guess out. from wanted ask. pulling enough. Gross to you're then other just those million. to probably how to And about hard but numbers the I that. flow match, is you see SG&A things operations cash I Fair the define will million. wanted how just It's Okay. $XX understand and positive I thing, $XX is some think

a just wanted better get cash define flow to you I So, understanding the of way from positive operations?

Micha Ben-Chorin

Scott. Yes. Thank question, the for you

our expenses And going do whether mainly whether substantially of go and expense operations the to be on is half shall we the doing this very are cash going down and will and action second faster. revenues to and or R&D. QX, and -- even is we in side, And to see sales grow that see. it So, to allow G&A before a starting year, to all terms, marketing, interest it's we the us we obviously, QX from will -- on payment need also continue achieve from vigorous

Scott Henry

Okay.

including are selling expenses in all you G&A and that So calculation?

Micha Ben-Chorin

Correct.

Scott Henry

you just out I are, stock comp, clarity. assume maybe maybe for backing but you're you're not,

Micha Ben-Chorin

Sorry.

you question? Sorry, can repeat the

Scott Henry

you cash by operations, are flow from and guess expenses I including So G&A that? in selling

Micha Ben-Chorin

we do. Yes,

Scott Henry

Okay.

are and -- including So compensation? stock you

Micha Ben-Chorin

are because equity to be flows. in the P&L, flow, compensation talking cash we so cash are we and No, will referring about the

Scott Henry

Okay.

that, a how trying on quarterly need to you sense a approximately to levers to that what And can million that I'm just $XX Okay. mean, close basis? of happen is close I get basically, much gap.

Micha Ben-Chorin

the the give we call the the even will since we levels completed also like. lower this positive cash are R&D, to is interest support programs we that that of expenses you go you percentage operations how continue of payments. look using. going and can presented of the We This the in COVID, than will on third our before will the conference And are -- that assume the from R&D to workforce to achieving answer

Operator

today comes ahead. question Thalmann. next The you. Kaplan go Thank from Ladenburg from of line the Please Matt

now is open. line Your

Matt Kaplan

kind guess, XX cost-cutting runway the your the your end at I on I direct. what's to levels I runway? of, the question. given cash implementation plus guess, up plan, given What's cash Scott's your, wanted your current current cash of of Just registered guess, follow quarter of the

Dror Ben-Asher

is Thank Dror. you, Matt. This

We but well have covered XX that. and months, are concern beyond concern probably the next not noticed, we confident by going as which remark, going in you remark, the only no no feel

Micha Ben-Chorin

be And current we and able to that we just the to cash that to said, together, have, we later our with of cash to will debt reach flows on support plan the as terms to service. overall to -- add also operational that, according put we profitability in

enough hand the coming we So quarters. for cash in next have

Matt Kaplan

Movantik out Talicia performance for first That's quarter? contribution break revenue the And the can for Okay. helpful. and you

Micha Ben-Chorin

of quarter, over main Movantik little had So in We sales $X Talicia had for this components, for we rest three million an with commercial a Talicia. XX. the deal out-licensing and

Matt Kaplan

terms then some Okay. it regarding can in the view, the clinical from a a Thank will And for question now? point do regulatory us more COVID-XX? pathway the your in you plan you that use for thoughts off include opaganib authorization? to that have pathway detail of is, give table, you. I is of full Or guess right development

Gilead Raday

of the seen, for at the or and the answer. on month upamostat, use for opaganib time outcome also the either I study potentially that be that depending on applications pandemic on hope support a submission. the is but that positive the of depending confirmatory situation approvals, also expectation also pandemic of COVID-XX, So current state full remains to confirmatory, the depending a study, the of

Matt Kaplan

NTM. then terms yes. And question Yes, last in of and RHB-XXX

plot what's in there I some of X? look if the Where ongoing funding you to the if timing And program in you that you bring yourself? have guess, what out you for You're external that getting talking you the if funding, are it Phase external both that. about fund on fund scenarios? And does two potentially pathways yourself, it like then there? enrollment secondly, can some

Gilead Raday

high sources on lines, provided course, the out territories timeframe for the exact and the of for additional that but very of haven't to of resources, provided could guidance be with the Japan, NTM. which of capital and possibly expanding market U.S. partners patients, the sites, U.K. of are number enrolling with the instance, could potential study accelerate interested We which by need increasing interesting also time and unmet

enroll completion the six towards six-month years. lot respect NDA could would review So, and we endpoint to in study, that the able finding of in. filing. say, study pretty interest the of ongoing of And an and a We think we X.X to primary of discussions. allow accelerating put a rapid and months that accelerated within I proceeding see lot for NDA can be to benefit co-development study That's and there's in where come hope a benefit partners, the

Operator

concludes That you. today's Thank question-and-answer session.

remarks. to like Dror I'd back over the closing So Ben-Asher pass for to conference

Dror Ben-Asher

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

Operator

you That concludes Thank your participation. all today's conference for call.

now lines. You may your disconnect

RedHill Biopharma (RDHL) 23 Jun 222022 Q1 Earnings call transcript