RDHL - Earnings call transcript Q2 2021

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Operator

Good day, and welcome to the RedHill Biopharma Second Quarter 2021 Financial Results 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; Rick Scruggs, Chief Commercial 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; and Bob Gilkin, Senior VP, Market Access and Trade Relations.

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

Alexandra Okmian

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

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

Dror Ben-Asher

as announced Delta morning, that need many but we viruses we and Starting probably To candidate of with demonstrates you, there's medical patients. oral effective strong the potential the cases to dual clear such remain kind there. and the call line year trial concern last was your ago. announced everyone, models things a RedHill's U.S. of COVID-XX. experts, COVID-XX for resilient COVID-XX highlights. out by relevant pandemics, proud epidemics and it This that including RedHill nearly therapeutic unfortunately, COVID-XX devastating Quantum spread for from COVID-XX Interleukin-X, the Good even University to this activity, Delta, the is promising patient challenge Today, anti-inflammatory team immediate action, relentlessly agile such need This to in well thank as Along explored study announced hope front. clinical RedHill and, for you this to target to world, showing way and R&D. U.S. the note of and devastating across perspective, variants at currently advanced broader and on beyond perspective, a the government, executed strong inhibition. more with the finish pill was is Alexandra. Phase being be an commercial finds severe joining and rising speed second the patient disease. the and diseases small by lead Director well NIH. oral safe rose COVID-XX, COVID-XX quarter continue presenting call. in is pharma by rapidly month, R&D health at COVID-XX as A of We loved with times. Ebola and hospitalizations is opaganib to goes Opaganib Thank in therefore our potential disease. globalized important inflammatory novel Opaganib's all antiviral an as patients. it and pill that you of and other. arm global an our study opaganib. execution-focused. most are a form, of the in highly about recently interconnected new for including recently cytokine Louisville important here variant with Delta by other In COVID-XX. that Also in outlined in possible BARDA, ones despite strong death, the around. It With stop planned candidate its commenced and public globe. the and everything and be is including in or of will it to its and only havoc an Remarkably, we a and additional of does key with lot COVID-XX X/X we I'm From the urgent R&D, financial and earnings opaganib's doing development data as team our partners for support XXX get data important included of inhibition mode day, not as for light, an variants this I-SPY challenging very detailed severe and terms, activity, drug happening partners parallel, the by hospitalized IL-X driven infectious last about a in opaganib humanly Leap morning, fighting and put of concerns is are

For example, we of review. the study on Phase X prostate primary opaganib based endpoint the morning, ongoing met this our preliminary reported that was in cancer in

X/X and Phase its in COVID-XX oral disease. or early RHB-XXX the antiviral the once-daily of Our upamostat, second the patients COVID-XX drug drug study course in non-hospitalized candidate, continues

is For NTM the U.S. also RHB-XXX, infection X in the study ongoing. for Phase

Officer, add shortly. about Our will color Gilead, more Chief Operating programs select R&D

prescription launches quarter the Moving today, prescription the of volume even the Movantik such to strong, we as record been on grow front. announced levels. has beating achievement pandemic from the particularly during for despite quarterly Earlier growth and so to new pre-pandemic continues Talicia. environment, challenging new revenues commercial drug Talicia

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Guy Goldberg

Dror. you, Thank

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of virus announced data First, elsewhere. important in as contagious and Delta the in variants. than United Delta States is we the is of the the because Xx positive previous the currently preclinical variant highly more as opaganib This Delta is The predominant strain contagious, variant variant.

Delta variant cause against suggests be illness than that drug previous persons. data a may unvaccinated variant Some major work might the severe breakthrough. would specifically strains in a Delta more that Having

even mortality designed to therapeutics a time and are novel most validation acute this very trial there on treatment, infrastructure. oral the candidates final I-SPY Quantum There optimistic vaccination scenarios, X reasons: test with this to failures concerns and have The given we platform. against need on by our utilizing confirm COVID high-impact been all ventilators. for is to breakthroughs Second, reduce for no for trial accept Collaborative existing science. important front in effective First, treatments There and around COVID out been There and especially have mutations. for the any, leading inclusion treatment global I-SPY the an as COVID-XX the stages are And few, Opaganib's opaganib be which rapidly growing an BARDA screen is likely to endemic developed great problem, date. if very to is for we will many great to time. selection and clinical Leap beginning in around is second, inclusion is of health long a And other is platform a aggressive be Healthcare successfully.

world-class Carolina. infectious robust commercial focused diseases U.S. the RedHill is COVID, the combination COVID we fully pipeline top androgen preliminary headquarters it of RedHill who related, be agent At before on we drugs specialty that developed opaganib the an Movantik to strains Sales, Marketing, run in of of to based continue the that will it go and Raleigh, was a oncology a we the gastrointestinal North today. of E. and new Third be and efforts. FDA-approved prostate and on primary met promote: for we briefly by in out the endpoint is the biopharmaceutical indications, X these the a on in for of most cancer President with X and story to detail travelers' for our the originally continues finally, constipation, an to will results may call operation coli. on in develop see would our review our holds opaganib show Vice as an multiple like noninvasive promising company the with slide, you well to opioid-induced Aemcolo H. and caused announced, Rob those pylori Opaganib commercial infection, of Jackson, this diarrhea data. Senior ongoing overview of I Phase agent for drugs study where Talicia inhibitors targeting into promise. not integrated provide

multiple late-stage Gilead development, RHB-XXX. second review programs COVID The needs. slide medical in our programs of the addressing our in Operating Raday, part shows unmet Chief Officer, will this important

are Crohn's notably So I will briefly update where programs, disease. our RHB-XXX other with for we

the successfully Phase RHB-XXX Testing primary in we crucial reminder, conducted that for As theory, intracellular study key met Crohn's various in X Crohn's microbacteria a builds that on a from a growing our the disease this and studies evidence Crohn's play endpoints. disease. secondary role

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

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the presentation turn I R&D our will with to now into more the in to continue future. discuss over detail. Gilead will We strategy that

Gilead Raday

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study, The activity the which second is of X is also evaluating Phase opaganib cholangiocarcinoma, ongoing. advanced in

cholangiocarcinoma. As first patients preliminary advanced ongoing Enrollment subjects of cohort a opaganib for number hydroxychloroquine the with currently anti-autophagy agent. activity indicated cohort, data and in is second with a previously is signal XX which evaluating combination in a reported, of of from

a which Phase mycobacterial rare Another FDA-approved been Orphan It potential designation, Drug standalone and first-line with Nontuberculous is therapy. Qualified Disease and a of non-COVID has nontuberculous X disease designation. programs mycobacterial manifestations infection in evaluated a is therapy chronic no is with debilitating Product first-line a first-line novel oral as RHB-XXX our study promising Track being infection. for RHB-XXX, Infectious Fast is designation granted therapy.

and these exclusivity. years priority the is ongoing With planned NDA placebo-controlled The enroll XXX XX eligible to review it randomized market X is designations, Phase for and is of subjects. of study

on and continue our site progress. we ensuing I it The to enrollment outcomes evaluated Senior X endpoints with on at the to Marketing, imposed commercial Sales by patient-reported will and and to study of clinical conversion study culture additional are We low of outside experience now conversion. key month sputum physicians including U.S. post-treatment the expand follow-up, Rob, will territories maintenance pandemic our planning to and update to the be VP and of longer-term due patients to constraints screening turn the the

Rob Jackson

and good Thank you, morning.

raise achieved this few quarter by I'm with PAMORA focusing market challenging capitalize the as strategies sales, to marketing environment the taking for and going segment. This pandemic marketing of how are second executing heavily achieved focus an customers provide to record growing quarterly objective achieved is selling about a second in leader. X.X% during first, summarize this disciplined Movantik both the established and pain symptoms market also marketing potential key Movantik that the and XXXX approach Talicia, the patients second, on minutes, Over improving We we prescribers; opioid-induced to despite achievements. RedHill we're a awareness quarter access to: to from market. In can environment. We've on Movantik tandem, of quarter, we educate digital Movantik RedHill with next constipation opioid-induced and revenue our second growth very constipation. ability half year. invested the this tactics the and on In confident the of a help by in second In the quarter, volume over these first year. relief our grew

mentioned On The also volume During growth non-PAMORA growth I treatments. for the patients. for as in is very prescribing and February quarter, in well reflects hope for The out annual RedHill. of And is trend overwhelming for second shows the off. to has XX meet downward investments provide beginning these constipation represents U.S. for efforts that layer rate majority is will an a underserved prescribing market of years. major the This million opioid to we needs also during our And since. decline from therapeutic that to the of and a remained the it and also users successes and X opioid half large market stabilizing. the to access year. Movantik it our moving Movantik. in positioned Movantik second a PAMORA growth. with PAMORA significant a is opportunity trend This no for Opioid-induced is report who see earlier, constipation to steady basis, taper occurring return to very that has of benefit continues class. business the we yield opioid million been change achieved Movantik from and we significant the total sign class prescribing Simultaneously, may the if signs stabilize, the suffer bottomed market many PAMORA support of additional to payors OIC PAMORA little the will good

major In the ensuring chance Movantik access continue to to the On second, differentiation eliminating to take routinely our the the provide Movantik to with of payor Movantik no very more the improve. antibiotics growth, confident that key of payor Movantik our Medicare And in are and this Part can for the included drug new members, position field which third again, wins prescribe write even a of improve Talicia RedHill best reason coverage. with XX payor our commercial will and to committed in restrictions. and XX than half Prescribers execution insurance more team class. Prime further today and Movantik issue. for and the with continues is front, come the the added with million And coverage. payors. best Nine formularies, D point continue important out need are serve they effective are XX% most are from in second covered was market refer this and this the market position on improve as accelerate we consistent that for April, recent continued prescribers insurance of PAMORA our hopeful as and A Therapeutics than why a competitive will Movantik quarter, to government as we In lines future. used also Antimicrobial In D the commercial no is overall Net lives wins treatment. year and effect, to strengthening Part Cigna first the growth our second leader the formulary and an both fruition has when restrictions. we to coverage July, fourth brand cost-effective achieved stewardship cure line, while Series Results is was

volume. As and continue continue reach traditional we focus further in milestones this quarter, we the commercial of Talicia coverage. and new second volume into tactics on Talicia Delta to payor heading growth plan to prescription and high the variant its to took year, in in print Talicia to the XXXX. prescription new our to terms employed in also our of Talicia best quarter, hold continues half accelerate live, achieve prescribers. second And ever a digital second in achieved will increase the quarterly performance our also key and weekly achieved

clear and educate H. As need with of even for Talicia abilities Talicia patients' is pylori in of now clarithromycin instead, how and reverse them and understand prescribers, cancer and fact with for eradicate therapies, treat are they XX also formulary College improve And the resistance this the restrictions, to OptumRx commercial the The significant gastric guidelines another proven and with million expanding XX a growing of they clarithromycin steer containing issue Talicia. is of leading of more negative H. the payors to was and clarithromycin continues X to and prescribers to coverage important even and covers to has as access and And infections. risk July, challenge benefits becoming factor pylori commercial for the out In commercial added of of more this H. clinical no realize the realize payors real embrace infection clinicians, H. based on rapidly infections, clarithromycin to growing to more very development therapy. Americans. Talicia to therapies pylori we recognizes resistance lives. more Movantik, the their patients. impact American payors pylori Gastroenterology favorable as

trend expect of support We continue accelerated the for providing improving to XXXX into and throughout coverage even growth. XXXX, stronger

travel States We pandemic essential PCPs is gastroenterologists. the international especially Aemcolo also United risk promote to travel, impacted continue greatest. has negatively outside The where travelers' consumers, COVID-XX and not to continental diarrhea

Our midterm by tempered reality. this expectations are

the highest We commercial summary, In highest patients commercial in note milestones well Micha in our we returns, already coverage. the now to as ability numerous our Movantik travel Ben-Chorin. coverage. finished in you we new the we the strong to this demonstrated in year. Talicia, XX prepared in to the strong improve a coverage. of our volume, looking prescription to quarter access quarterly class performance second the have highest when June. your of and on excellent half stabilize month However, our grow prescription And and to Movantik including time, our turn for on our Aemcolo. volume PAMORA are continue payor Thank weekly on the commercial I'll leader We're and back X further level prescriptions, call market of commercial with building CFO, class, prescription payor for volume PAMORA achieved second forward

Micha Ben-Chorin

an quarterly in quarter revenues profit RedHill also of also million growth Net June margin in gross XXXX. and attributable revenues quarter year. enabled is Good the of $XX.X enable end Rob. record a XXXX, by this for the $XX.X of we increase record increase of more this an strategy net $X.X record first revenues gross and environment. compared increase a delivering net from planned challenging Talicia Movantik the you, than million pandemic of year. the morning. cash represents Thank clear which achieve million, XX% operational of The of second was XX, a to to breakeven The despite quarter. on $XX.X us were net to million revenues. of We revenues balance potential as this of maintained designed quarterly to commercial, And achieved

of mainly year We attributable expense had On second The the net first financing operating expenses first ended was forward. share-based respectively, by X core development programs, COVID-XX and and was and $XX.X in in year. drive study and compensation, relating related million RHB-XXX approximately cash increase cash quarter the anticipation discussion $X.X the to of Through respectively, the quarter NTM to mostly quarter in to respect to million second the second this in first used Cash Net the quarter XXXX. compared of option our was than $X.X will Net increased development expenses financial million of quarter million, the attributable million, to just actually mainly the $XX.X us which position to expenses in side. in the loss Movantik expense related of progression with back as of discipline, share-based The Dror. the second discussed. million, allows disease, programs continue now progress our marketing in compared prior first for quarter the cash our of comprised to I $XX.X to in for lower loss to activities programs, used quarter. compensation, quarter we turn collection approximately the year. $XX.X pulmonary with were million, a higher of the to increase with in Phase to than primarily quarter payments COVID-XX were have for related business this $XX.X first Operating and revenues of the quarter. acquisition exchange. activities deferred to expenses one-off

Dror Ben-Asher

Micha. you, Thank

are take to We questions. happy

Operator

of now question We're from Instructions]. Selvaraju H.C. Ram our Wainwright. first line [Operator at the taking

Boobalan Pachaiyappan

This is Ram for Selvaraju. Boobalan dialing in

The quarter, Cosmo's about you Phase the from one, rifamycin evaluating study first in involving data clinical mentioned IBS-D patients. X last

I'm curious the and just the next would has been be analysis whether possible steps. done So what

Dror Ben-Asher

with you Boobalan. Thank to We're glad us. you, have

evaluating We are with partners friends our Cosmo. still together and data at the

Boobalan Pachaiyappan

hospitalized understood. patients and in Phase inclusion trial, with steps assuming next study XX COVID are ongoing to respect X/X And to the months? That's what XX expectations? positive, involving thoughts so Okay. what opaganib I-SPY the upcoming your the and for COVID are your are And your

Dror Ben-Asher

It's hope any BARDA start I-SPY just soon. other and funded study. We parallel obviously it expect that study. clearance, FDA The will study subject a to like remains

data And we'll announcing we them everything I-SPY on data BARDA we see next Everything depends key, Because data, depends do we regulators, soon. say As ongoing, plan in not them with data Phase what the well, steps data. All the industry, them will of The A what on. pursuing then hear the on we are. and is and and out evaluate mentioned, the go next. data. show goes regardless. some to discussions be lot the the on funded X/X on our will depends study

Boobalan Pachaiyappan

to plan in the do future? the infected study patients Delta you specifically in opaganib variant Along lines,

Dror Ben-Asher

work variant. in opaganib tested the news is data with discussions strong approval The has to very and RedHill inhibition been U.S. consistent encouraging today's subject of or assumption elsewhere. regulatory that the eventually variants right about and at and from now, here All all assumption the Delta including and goes well

will knows treated Lambda. the months we And Delta from that could I In on. When started there is subsets we months the of community a we closely. who there We study, dictated no X now. which mostly a that in study, no X our closely. little things. We But now, be planned it's the It is it it's AY.X. where It follow imagine following the U.S., from everybody. be Delta. Delta U.S., were or by spreading regulators. but medical label was could be the It the or now course, across all is that are following of lot Right could

the by dictated be will regulators. label the So

label when any for narrowing not a a the down planned of variant if for and We is have granted. label specific

Boobalan Pachaiyappan

question final Great. from One me.

to will and Crohn's involve X will be you you on that So it patients do partnership? do trial comment Phase the could confirmatory And RHB-XXX, great. in plan of current disease a if a status

Dror Ben-Asher

be X really that. asked planned about was Yes. I'm happy Great all along question. confirmation study A you Phase done. and will

study we our minds next that steps, look As are up should like. as making far how

manner, holy it and I that healing What regulatory will based able a prospect if should and, and we of significant RHB-XXX you input subject able And endpoint primary show now, to because providers care health in discussion. a We to endpoint it can about course, on investigational make is have right be imaging shows patients drug seems is are should be of how the met where to remains be the of families that, this it mucosal Again, conducted first is primary lot that drug. happy significant tell we their the grail. should manner, that look. regulatory everything some statistically

Operator

now from of We line Hazlett our question next BTIG. Bert at the are taking

Robert Hazlett

Phase the an manufacturing actually in order short clarifying Is a on Yes. others. I've And results or there opaganib X got to EUA? X that of on couple could a just X/X comment opaganib. Then here could got lead are upcoming that context? status just I've more where study in scenario you

Dror Ben-Asher

Bert. I'll Gilead. refer Thank this you, to

Gilead Raday

Thank Dror. you,

the of authorizations emergency next safety As the process, the study. terms the results the The across and data endpoints are evaluated in steps regulatory determine use terms the territories. efficacy from in that the and of key of U.S. being is mentioned, other in various the in study, will

in the can we're from in what say are for. already manufacturing, support severe to broad deep support has be And will I population opaganib that because we mild patients, in for out scaled-up of So patients that eventually use. manufacturing will currently but that the looking mild and potential utilization to in in terms the preparation broad

Robert Hazlett

of one of I-SPY Do in to regard And with other sense data timing trial? terms any the just on have you opaganib.

Dror Ben-Asher

It's say. too to early

Leap and be at the will our first looking Quantum FDA clearance intended partners We with I-SPY together for platform.

and approached a company, the a it only to health is at a who to it. care a study arm is BARDA, of strong it and Assuming the all Leap This I-SPY is a quickly study the platform not providers, organization, reputable in study of with this on platform, that as being to happens such because backing clinics that funded It's comes small that -- is enroll are important commence the different by will quickly, soon, look likely very RedHill, very government, supported we by prescribers, study and U.S. be study. will conducted very that is believe and when scale a the conjunction are Quantum conducting the a favorably.

it, but the cannot study time [finalized] enrollment we starts. is belief on will So be that our the once put lines

Robert Hazlett

that I'm how If largely there Okay. elements to quarter. you study. was materially And R&D should second... describe them X additional NTM spend there, picked on And then just up assuming, this -- NTM are the a R&D question of just R&D. spend? the comments, or The due and think about on your we could initiation based

Micha Ben-Chorin

And R&D had program, most we as progress press the also so this the the release, of NTM quarter a our COVID-XX which in for investment. we also obviously Bert, of investment took mentioned was a a in study. we had the significant on lot RHB-XXX that

Robert Hazlett

brief That's prostate on well. as a just for question data helpful. the opaganib And cancer

indication? your setting? expect with in additional does development So we opaganib that regard more to prostate Should that create for in cancer there enthusiasm investment

Dror Ben-Asher

to this refer I Gilead.

Gilead Raday

development about pleased indications we and its quite we we is Yes, supportive encouraging, now in are now, Dror. while saw signals and and what gathering. the the oncology very activity the for information cancer you, been have cholangiocarcinoma. study. that are The in subject a in further previously Opaganib both all data given with activity prostate of of in course, in data where to has Thank we preliminary,

continue develop So in follow data, taken on conferences. to oncology up existing in And data, will scientific presentations to to full opaganib we ongoing we are And aim and arena and the the next final we the continuing announce based decisions on together, we have on studies. once will take steps. those

Robert Hazlett

upcoming. look to the We detail forward seeing

Gilead Raday

you. Thank

Operator

at Hoang our SMBC. from of question the next taking are We line David

David Hoang

Yes.

Talicia. So just my first on is one

more pandemic half on comment out driver as the trends continued the is continuing here? growth, seeing of As it major with interaction we access year, think to head on the we force if between payor is your into positive with and prescribers sales more of wondering the the back you as get could you or whether just that --

Dror Ben-Asher

launches. growth, also, you, and I state has depends before Rick, refer the seeing this the pandemic. patients, David. affecting I'll to team. labs, forget, the It to diagnostic affects extent, Pandemic Thank to with Rick Talicia. clinics, Yet healthy affects do of a that drug is on that it are refer to this Not we the the the regardless. to everything large

Rick Scruggs

It's Yes. good Thanks, question. Dror. a

had lockdowns effect Physician the our on dampening see to put, We the past. offices are has sell Talicia. I COVID in closed. ability think simply if a

sales capacity. at full are We force now

quarter be quarters for COVID. good really fourth have quarter really We fourth great coverage. And this all do quarter, on anticipate and third will us. -- hinges payor We the this quarter of

So change as good physicians worse but updates now or very that could we is impact or whatever. have And access good, right our payor COVID coverage. gets to

me, that's of end So for commentary Dror. the

Dror Ben-Asher

Thank you, Rick.

David Hoang

Okay. Great.

more know COVID. the So being -- question just had for on of a recall outpatient I a, focused that's I think, XXX, correctly you I molecule. If also molecule, there, investigated I that's have another

the was opaganib the and overlap So I the is the be strictly molecule here wondering, for outpatient? the between eligible development Or is hospitalized is will going inpatient to more other both sort side on that it just plan there's population of be products?

Dror Ben-Asher

regulators because of the have patients. was COVID different non-hospitalized It's hit question. small do XXXX, to was you, Because late type is patients patients at little. who with things. an a winter decision discussions carefully. again, very the are us for mean for towards deteriorating. setting, monitoring non-hospitalized spring risk need When study the a severe hospitalized, clinical to a is, made are complicated David. wonderful The to of costs and of or RedHill and our patients, non-hospitalized we Thank knew very and of company, where complicates And opaganib resources all The which not And study. clear endpoints the go outside to for serious rational -- the require patients allocate define. patients very very very relatively different, entirely hospitalized are

is once with at where non-hospitalized hospital the RHB-XXX in is or we patients both opaganib SARS-CoV-X, inhibition tested is it against not both population we already for because which are and we time. are very or I We opaganib opaganib. exciting them at this We who do results. commenced went outpatient in non-hospitalized, study, the symptomatic to XXX, trying was announced ideal of So have few a for because headed very to and yielded was because Very few managed complicated. in companies first very of And patient February. managed how And took monitor RHB-XXX successfully believe to actually figure the It's this at it. to home. them study out the and do so. home properly daily,

to host both having variants, It's the other are of oral both are ago. as be that long opposed both said, emerging The discussions and goal, molecules, they're expanding having So studies, us places. And novel with effective molecules of right but are directly U.S. speak, so virus. is whole expected beauty study, Gilead the spectrum X that now the to shots that opaganib act oral to cover novel company to and existing RHB-XXX, of it as because allows assuming cell a disease. of small successful them with and subject on on to regulators, existing it on beauty not the the to we a against with

that not of patients, what vast antibodies the course, far we require are the there have expensive. clinical So biggest That's majority that is by setting, market. now, hospitalized. Right are of

changing them even market. very out have shown showed of Novel we probably with the of or non-hospitalized be that's emerging or have situation sensitive the small This RHB-XXX. to of If tell. the are molecule once oral daily which is are variants, for more time different. paradigm against a Some successful, weakness And pulled symptomatic patients, been patients. highly we will something XX%

answered what to very to So exciting according what a direct the the chronologically questions. it's situation according was a It's more for simply resources. the to able more programs and we status your turn the available community according our answer. were we I us. for, looking of was, hope medical I long the events to And of learn, the our was disease

David Hoang

color. forward the looking Yes, soon. Super all the and seeing to certainly. Thanks and the much really for so the helpful. taking questions detailed response And data

Operator

at Kaplan next Matt Thalmann. our taking Ladenburg of now line are the from We question

Matthew Kaplan

it's Phase Just trial the to everyone take of we complete are -- crunch a X/X now Can soon major get of that parts wanted going to to the should data give zero is in in you how opaganib how the the the terms trial. on us long sense and data?

Dror Ben-Asher

important It's you, Thank Matt. an question.

our have and upcoming, will filings today, in stated that is We we repeatedly data at it the keep that. also and

Matthew Kaplan

you reaching assumptions day -- severe data XX. that Okay. these the to in patients proportion the secondary in with room of trial, think patients? give respect the by X/X then of upcoming? the air we about endpoint and Phase terms us Fair a and endpoints in terms How of sense Your powering the enough. patients of primary And as can some should is

Dror Ben-Asher

to refer I'll this Matt. Thank you, Gilead.

Gilead Raday

Dror. Thanks,

Phase a difference powered we global we the the XX% what from day XX and delta we looked in the study -- Phase of approach We on And room we for versus study. where how in XX% that globally. primary based air study study study X by U.S. a X/X the XXX X the X/X endpoint we that the saw for that's Phase Matt, at patients. in conservative powering already of reaching a for the XX% size in Phase So completed arrived U.S. saw took

and covers looking that also other being the captured intubation of additional outcomes study. So include primary are clinical the clinically and endpoint. we in those are X/X and And that important, endpoints, are meaningful global course, which for and mortality Phase secondary

Matthew Kaplan

I in And its us That's the the the of program, cancer -- of very you Gilead. can X for now the you've thinking sense primary continued terms endpoint. helpful, in that steps met are you next Okay. opaganib? give then there a prostate guess, terms for What development Phase

Dror Ben-Asher

asked. you Glad Matt. you, Thank

indications. the in at are that study. about. very prostate this looking something South And about of excited of about and are oncology, know the cancer lot the the review, with other it completed. to be cholangiocarcinoma, needs everything data to novel plan cancer be a lot It's that conducted excited company prostate University a American opaganib a complete Carolina. We as very is analysis, is are X in We people a molecule We at. Phase

it's We about there us. we promise regulatory oncology Either opaganib partnerships supplying in or get continue numerous with prospect I way, patients it conference will present several patients. from basis have the we the it been about remind described, way there. oncology, I on to learn opaganib's specifically possibilities here, subject a helping we say more and are pharma to looking and elsewhere. major the have including at cancer, also that a is take excited to various exemption oncology Gilead prostate including fine indications, it in alone. more of including use to we the U.S. compassionate The

experience as in with to outside not and study it's studies with the if exemption. are the use when the subject both from to actual our compassionate starting regulatory use, it comes we scratch So

Matthew Kaplan

X Phase in then pipeline NTM. X on one And the RHB-XXX Okay. and questions, progress on commercial. more for one

hopefully of forward You has mentioned sense a line that picks to terms give the as that are continued you Can for what your time in thoughts up? program kind going be enrollment for enrollment us some slow. of

Dror Ben-Asher

and you. enrollment, been And respiratory Yes, indications Thank in on COVID slow. been especially enrollment has in studies indications. our harsh has respiratory yes,

activated we have sites. many However, already

live clears We gradually continue are and confident our the over as with up regardless. Time next for year and that study ourselves say. and the better line, conduct the it's right pick stays, will out. now, call. discuss ability COVID, COVID it too to both patients situation sites early And during especially to Initially, if the estimated even changes to it it enrollment earnings about park maybe best X it's so time. we learn to enrollment to last to so But fast, given the it of

Matthew Kaplan

us Talicia and question. the on last quarter? Movantik you for then the Can revenues of revenues record And a the give the enough. Fair Congratulations Okay. quarter. for breakdown

Micha Ben-Chorin

sure. Yes,

And But additional is Movantik. the of obviously. well with majority for have, with some Talicia we great Movantik, revenues great as Aemcolo. the majority the are So revenues with obviously,

Dror Ben-Asher

XX%. about is Movantik And

Operator

Henry taking next from question are at Scott of now We the line our Capital. ROTH

Scott Henry

couple a questions. Just

the high think do spend. but of QX? the about think and about like When why year, in will more $XX.X QX First, QX. on was I it second million half in QX was $X.X like the it in or million R&D it you understand it looks XQ, look we

Dror Ben-Asher

We Micha. refer to this

Micha Ben-Chorin

And believe be This and good between QX it is I will question. QX. a somewhere

little expenses So level I would QX, it than in the expect bit a than higher be or could but lower QX.

Scott Henry

so $X.X XQ in -- there events high any Or the also to million why jumped onetime in just there? Okay. from then get sense million. G&A $XX.X to XQ? number Fair trying a enough. Were was And of

Micha Ben-Chorin

Yes.

expenses, can in was an the as to a future. expected which increase the stock not from which did we option expenses. onetime see, onetime the you expenses This exchange, are of pricing. option We So -- in substantial created repeat option have there majority significant

Scott Henry

Okay.

of kind that that to expect that revert should we back So fair? Is to QX level?

Micha Ben-Chorin

is fair say. Yes. This to

Scott Henry

to that Okay. the you then be you breakeven XXXX. end operations And just by Great. the comment of -- expect made commercial

G&A Now one are it I how gross R&D equation. than also operations. and always profit out like of of think would that greater allocating I mean, pulling that commercial expenses maybe and your you're some defines meaning Typically, that just wanted I selling sounds just out depends expenses But than operations? G&A and G&A And maybe out of expenses as of some can selling commercial pulling if higher gross the do Or think combined? clarity, selling I you be could. that well. profit you

Micha Ben-Chorin

Yes.

We includes are marketing taking into and commercial on of we -- including the basing which also are a all expenses, and not account it commercial the relevant the the obviously, R&D. some expenses including basis. the sales G&A, non-GAAP And

share-based elements, taking which are non-GAAP. other and also So compensation not into account

and talking about are latest portion -- obviously, the the So we of year.

plan. our So this is

Scott Henry

Okay.

and upcoming of I expect end presentation. the thought you but like answer a data you of a give in program I'd -- I'm to -- typically you confirm commercial by the to to you just want defined basically, September, mean, end words your QX third not, comments? the Okay. not exit Dror, be that. by So want the if a mean used data that that quarter? safe opaganib this I pin don't prior the operations you've questions but by shortly know I would down, of as with assumption, positive, couple quick your going I on for but That to then helpful. clarification chance is you would And or

Dror Ben-Asher

with here. There's announce than the wants to team absolutely. more data us Yes, the nobody that right here

mentioned. upcoming as that that to answer yes, date question, before as sure possible. you make soon certainly, reach And the your will we market the the So results

Scott Henry

wanted angles. market, which if couple of question, on file kind get of up says different the your this indicated that My the the studies just you've depend a I press said just studies. the is to the that we on from is in one firm? Or the been question then additional you've release, FDA Is And take but is, final the significant do data, in need to of U.S. data With the Okay. will significant. will on then always to statistically asked But is U.S.? it to it that that know to hand I regards ability and additional of strongly the interpretation language need press the release, you is has specifically set? complete the definitely to will in final data kind

Dror Ben-Asher

are important everything. you letter. stated where carefully consultants very our and are This who very are worded clear other And FDA. is to we a point It's raised. is up Everything the data with that that exactly the dictate experts will is ex-FDA

vast of the Now outside well. other remind this not but the for ex as is majority I many U.S. the hitting FDA pretty everywhere. correct the Europe much to countries. disease that including as as market the it's the once U.S. with and we outside you data is only U.S. plan the is U.S. evaluate And right the available. well regulators now The

Operator

it for There closing line. are no more hand questions remarks. I to over will Dror back on the

Dror Ben-Asher

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

Operator

you participating. That concludes the call today. for Thank for

may disconnect. all You

RedHill Biopharma (RDHL) 26 Aug 212021 Q2 Earnings call transcript