Rani Therapeutics (RANI) 30 Mar 222021 Q4 Earnings call transcript

Welcome to Rani Therapeutics Fourth Quarter and Full Year 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are a in a listen-only mode.

Following management's prepared remarks, we'll hold a question-and-answer session. To ensure that we have ample time to adjust everyone's questions during the Q&A session, we'll ask for a limit of one question and one follow-up question per person. [Operator instructions] As a reminder, this call is being recorded today Tuesday, March 29, 2022. turn Gilmartin over Group. to Managing Laurence like at Director now the to conference Watts, I'd Please ahead. go

Thank you, operator.

Sanford Officer, Joining us Imran; Svai Talat Chief Executive Chief on the call Chief today Financial Hashim. Mir are Officer, and Scientific Officer,

resources risk cause development report events factor to, risks, include statements product statements with During to factors clinical These materially factors reports statements. limited Rani. to forward-looking in are a capital product results from are such those Executive Talat of Actual future XX-K identify and/or subject in risks the which make may potential, the company's of of to subject financial Chief related to timing described Exchange regulatory discussed that the turn projected that not those performance differ certain and or regarding differ the and and XX-Q, forward-looking of but events filings section in Imran, this uncertainties the these Commissions as uncertainties the company. including on results quarterly and will such could Securities statements that, Form call call, of may business events management over specific and its materially I'll those from strategies, environment, statements. the Officer the to trials, forward-looking breaking assumptions and without on Talat? annual These number limitation With forward-looking Form or actual performance.

results period Therapeutics. XXXX to and all XXXX quarter thank full for call. you joining you, proved financial fourth Thank and transformative Good for afternoon, our year be a Rani everyone Laurence. conference

executive platform. NASDAQ, its an offering on leadership, pipeline delivery made oral optimizing the the initial company and completed expanded During progress the further progressed year, RaniPill development public its

to the going Before achieved start recent call milestones like to key would XXXX. events, over today's turn I we I by in

$XX approximately IPO the achievement raised August, proceeds. the in completion which million notable was in of most successful gross Our

result, was a lead Rani through appointment process. Eric in In exited Counsel. by IPO was public prior a altered Groen note, position. Rani year to I strong appointed honored going the CEO the Rani's financial team personal further of executive to the us As be and to Therapeutics On General a XXXX to

expanded Lisa Butel Lyn team, Rometty, also our We our welcoming Laureen in Baranowski, and non-executive Board January. our Directors of DeBuono, with joining Jean-Luc Board to

Turning year. the operations, our made over we to our plans progress furthering have in past and significant development refining drug

biologics. RaniPill of which Phase delivery our not proof refined Following near for for platform and capsule, our results which platform, delivery XXXX, study term itself, oral but plans positive the serve only in were to Octreotide as announced I the our further original our a development we using for concept oral clinical injectable also of

doses and administered up PTH and quickly As development to injections or enables a treatment and pursue led became drug a reminder, daily the osteoporosis hormone capacity growth osteoporosis host can Parathyroid capsule key deficiency, tumors the deliver acromegaly, for RT-XXX. us a or neuroendocrine three of our to original is hypoparathyroidism. for to us milligrams per candidate a focus hormone of by the of of of drug RaniPill indications, including arthritis, This disease psoriatic NETs, whole pill.

published successful a We data capsule As payload of program our intend RT-XXX second RaniPill in the PTH our study once such year. and safety in a Phase study growth November, the to evaluated for of that for half the demonstrated second X-day significant injection. subcutaneous PTH, as study tolerability week study we The initiate RT-XXX, oral initiation a program announce delivery I pharmacokinetic with the Phase canine completed that enter profile a I'm model. for last The of daily a repeat represents Rani human in to second the happy dose GLP oral the comparable administration milestone another hormone of with our the RT-XXX clinical to program I osteoporosis. study of our clinic. with via of began initiation this to

potentially expansive pursue a for significant the to our that Now we potential capsule. delivery for let high payloads our such HC, dosing major additional me development with through is drug for oral development internal XXX% designed turn this delivery plus company, initiative, current believe to capable over biologics option capacity other opportunities XX of a administering newly provide a RaniPill the biologic device breakthrough than RaniPill in daily higher or We partnership. the could

could us development potentially current capsule now intercept, development milligrams. we market with with target daily RaniPill our the this original pipeline. pembrolizumab, From include XX this Importantly, forms idea, significant. be of of and RaniPill drugs our the is with capsule, for potential is believe higher to mgs. making up can you potential deliver the To you will current etanercept, drugs the from us a give with we tell some for an opportunity secukinumab. three these that core optimized alone, HC HC The not device RaniPill should The to of dose trastuzumab, progress to able RaniPill which detract capacity up

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regimens the discuss survey independent medications for research their third genders, oral over for there survey infrequent party over ingesting treated We was injectable to Mir an severity consistently involves Across US receiving older, or preference an condition of conditions The presently released injection presently to XXX for an patients. want and injection of we mostly Lastly, patient years switching an investigate even commissioned to patient versus biologic before I to six rheumatologists, patient on injectable strong up treat our condition, biologics a more therapeutic groups, preference physicians, a market and XX injections. preclinical injection. to in using months. turn and cover and that to pills, aged to and preference data XXX I patients from physician call the all endocrinologists prescribing detail, to ages, oral for

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the XX%. for patients of injectable Together with there presents For dosed blockbuster demonstrates groups drugs. drugs This was who the number future. a an among expansion latent Humira, prefer pills is HC, of this at demand RaniPill preference is many daily biweekly, oral for which pipeline that tremendous alternative percentage opportunities exceeding indicated Rani's a All surveyed a for oral XX%. the potential or by in patients to biologic over of

me In in mock involving pill OOO the RaniPill a the surveys, again, no that, which RaniPill individuals to call a favor is patients Remember the evaluate conducted own Of able addition that what in size the pill Hashim to more capsule containing needles and Thus, we all detail. similar market and Once be overwhelmingly the preclinical RaniPill to a commission turn were found Mir an research over of pill. XXX now injection. true. prefer discuss we to a mock official pills. potato sized to starch ease to in and swallow tolerability let difficulty. confirmed could reported we People that our participated, to capsule study believe taking preference With with with RaniPill the swallowed. be the that place clinical updates of old our hate people capsule

joining for thank Thank everyone you, Talat and us. you

provide which pipeline HC. major capacity we the developments. call RaniPill on some program, and me on Let device, One development on focused the updates two RT-XXX RaniPill other a higher of our

which Rani me Hormone project. formulation oral therapy an is the RT-XXX an RT-XXX update containing osteoporosis. on with Let a PTH capsule RaniPill analog being developed by osteoanabolic is Parathyroid begin as of for human the a X-XX,

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the week able as This evaluating to were were there abnormalities and administration a safety of significant subjects. for study be successfully of feed or RT-XXX to on volunteers. over pharmacokinetic, XX and the center women XX we label to dosed have in Phase report planned we no gastrointestinal designed Each trial, this administered range first with micrograms. dozing open RT-XXX. that Phase associated oral the happy I'm initiating and study clinical of human a Specifically, dose healthy of initiated is subject third micrograms of the single RT-XXX a findings, requirements the adult in RT-XXX. was these tolerability of Based a will already I March I single

expect I We line the results second of in the the Phase announce year. study RT-XXX top to half of the

XX high the Rani HC drug on major to with over to milligrams. update, RaniPill the payloads has second working up of development turning been capacity Now the of a deliver potential RaniPill to

to of the RaniPill laparotomy. over We canines. the deliver PK systemic via device the which HC adalimumab the of to successful serum were PK and the coating preclinical chemical unit the duodenum study of X monitoring PK inserted approximately XX three actuated reactance by PK generated levels dose by with pleased without the a to deliver curve. model of doses. The with to a the lower data X.X enter was five-day directly subject, test and milligrams achieved milligrams study delivered for source RaniPill a approximately then XX proportional using PK first the and the the RaniPill the milligrams HC. normalized of of delivery external followed The of completion an are the get RaniPill HC drug which by period We of our canine was weight adalimumab to compared pressure curves announce when utilized curve, milligrams levels preclinical concentrations an This successful into in each that We adalimumab capsules. historical to device or in original was previously of was

doses. While And we expand to parentally additional at our with in the reach of by capsule. similarities RaniPill the the existing delivered stages we many RaniPill are currently higher are RaniPill excited of early HC HC, that candidates way, drug shares are its development to the

to fourth it quarter XXXX. and end Now the go I results the will year Svai? financial for turn over Svai

results Thank good you, The financial issued we today earlier afternoon, our detail. provide in everyone. Hashim and release press

will fourth million $X.X to period year and call. Operating the $XX.X in only provide same I respectively. So were million quarter million on $XX for and XXXX the compared $XX.X full million expenses highlights this XXXX and for

were expenses year $XX.X for operating Excluding the XXXX. non-GAAP quarter depreciation million stock-based compensation, for million $XX.X full fourth the and amortization, and

to is call cash, which for Turning to turn balance operation, XX, and were equivalent With at $XXX.X back we our of our I XXXX. comments. the Talat that, sheet; to sufficient until cash XXXX, end believe least the term plan Talat? million as of over closing fund December will investments short

Thank to to results sharing the you, with progress initiating far Svai. momentum the the very I third of RT-XXX of maintaining to so We Phase half program forward our clinical year, our top pleased are second and line we our In forward in look from XXXX. clinical closing, our trial in and RT-XXX. look

system. to exploring a progress opportunities of with the RaniPill HC and We payload this are make involving number also further higher plan

and a subsequently. I past thank efforts built Rani, us to like With our Operator? world-class this reality. I'd helping oral at thank and at and stakeholders continued have of like closer now everyone year support for making all also call biologics leadership of We that. their move would Rani our open for your questions. company team the of the a vision I to up to will for

comes from Bank America. Geoff the Meacham with [Operator of question instructions] line Our first of

open. Your line Please. Go is ahead.

Hey guys. question. much the for Thanks so

within very ability was thinking the any look I modifications at I if up few. just Just at capacity sure to Just is, maybe that, health -- HC product. agents is those? back whether just question any are product going have to second beyond had a to forward? prior fair you you pill safety likely lot the the the go and or to to the approved accommodate. the say be was that preferred pill, a studies. When of would all additional changed repeat tolerability there wasn't scale could higher it be strategically given you are a Thank guys dose device the high And the much.

of Ultimately, RaniPill try the our increase modifications I'll RaniPill should it'll the same platform. and size by And of given order. to that, would current capsule Jeff. different your what said good perspective least HC commonalities the Having The expect be and There be is be balloon them you, hear with say The doesn't use device, into Thank tolerability biocompatibility XXX%. is will or doing the the like the in questions. shares a all. mechanism we work, to a capsule. it's the in the in areas and I done similar voice. of generation there packaged some some at from to same, safety dose take some may already patient, this ability Appreciate that itself obviously are change number some we in --at we've the space be there that. where that

opens RaniPill opportunities number you're a space. -- of lot to this relative the up the In where correct absolutely is and biopharma terms a in pharmaceutical this goes of the new that current of where platform, growth

at oncology that, suited are for looking immunology to their the space current the our RaniPill dose pipeline really currently that like So go the is HC. osteoporosis. like, for monoclonal in the dosing are a because in lower generation RaniPill likely antibodies in of therapeutic Having drugs, into said ones PTA ideally or a those

So there's and cases. commercial the fully that committed turning forward we're into moving and move clinical get that product through over no to we to the a once to plan it HC

Okay, great. much. you very Thank

it. Appreciate you. Thank

with of our Stiefel. from Thank next Annabel comes And the you. question Samimy line

Your open. Please go line ahead. is

question. my taking for thanks Hi,

have but size before, hormone, for would example you they better to like be call, pill So something of And you human where high any you had this have HC, maybe have could you or current there a current capacity? listed you for high to I a that you're which touched the of master suited guess to priority going any this, think growth programs with for that therapies RaniPill? then also on file smaller you master what the for you like RaniPill, do curious obviously take would that start was capacity? the the that with programs guess touched formulation there I are there's, mechanism, on whole to And as follow-up but with to like file that. the of or deal access that administered would of a now, you maybe kids kind it and I kind new do Thanks. over some initially to programs are your be the the

Yeah, sure. Thank you, Annabel.

an or important get think size let smaller years of I on pediatric to HC patients to a under getting any So who would age. touched are RaniPill point here for XX you of application around you the

size the HC is further the same an the as but to require you the potentially RaniPill. version So application that would move that where the current development RaniPill could because of HC current is RaniPill

new are, would sense applications fit programs, applications, certain at that HT. our the move but RaniPill, In to there programs. on current terms could that of primarily adalimumab dose higher well, be we're our makes in continuing on new where put programs it I just before into new to looking But biosimilar

be because your So you're good that yes, that's We announce any as of to right programs what segue HC, changes intimating There's clinical later if a I that'll the RaniPill want to it's making we now, RaniPill we this but have any adding yet, and not us question. can going guidance for as to validation the additional our think of clinic, second can, don't is and year, we're I put pipeline right? year, to in go perhaps we're to the as how HC, we the of into on everybody. give development we'll good do think those. good we'll but on move prioritize and We the strategically some show soon for some

far as you're I concerned, file the this. speak master of is to As kind right. did

dose identical the things commonality that other are safety to with have of are of they some share many and able go and platforms realistically, biocompatibility RaniPill do and these share. many they'll validation be tolerability will of so the is into HC, it's going I the will we verification think repeat where that and to to components

to But a is be new going file great. it whole Okay, though?

No.

there'll file. be master one So

to also chapters have it embodiments those be can for for to will different there in specific as cover drugs You well. and have potentially

Okay, great. you. Thank

just So one file. Yeah.

Thank comes you. from Canaccord Michelle And Genuity. next question the of our line Gilson with

Your Go line open. ahead. is Please.

the maybe that for what is, in more difficult some study trial within and can one question. pill it's other subq guess, other too. us my pill. the RT-XXX the they to Hi, on I dosing the I you profile? very program of have there to the different I or other And, on we design understand doses bit result planning Phase PK than use thanks that for PTH alternative capacity in you What I Yes, guess, recently PK programs. been the learn I a experimental healthy you're and RT-XXX, in results. evaluate Can walk then for then, through data biomarker BMD study. And taking from through read that for you a translating anything volunteers. high initiated help us that the good are study? is that detail, parameters in terms maybe else can aren't routes guess one

why, So, show can you should maybe you RT-XXX? the you we comfortable be that get profile, guess, PK guys -- with can why address I for

the then answer I HC and to that we'll go Sure. should question.

Yeah, that sounds good.

Fair enough. Okay.

healthy volunteers. for go Thank single Happy I. is question. details to It Phase RT-XXX our dose in the by you Michelle, the hi into on some So a study way.

clinically which We're commercial well. microgram, an do intermediate where XX mentioned, also an you is is to microgram as we're And As which we're dose forteo XX doing a dose. going [indiscernible] doing dosed. the dose, is a

You look It's a Rani is you attempted the most this correct ultimately is an what has need area patch injection. to it's and recently. are what an at doing oral in and formulations that number biomarkers has of jejunum ultimately, is but else an to with injection. everyone had be in both failures difference this The to injection sure,

the is you'd as see to expect shown very we've the similar peak preclinically subcutaneously. to and So trough what

when share some though, we'll of part correct story that part to but that an details additional this give the to this is that on you'd are the produce read of what to that going important we results subcutaneous will some out yet, from have the PD Phase this of and comfort expect year I nothing Teriparatide. You share report is similar to hopefully later delivery

you. RaniPill And guess, I in did original HC, you this what into to comfortable for of, the via next next HC done the jejunum. know you're what, the do RaniPill to, at thank people. the what be And, RaniPill I expect, the I we for of the guess the placement terms proof forward I Should initial into of pill? concept first for steps looking very was are to steps guess Okay, with similar what to clinic? bringing the point evaluating or get bring the the you laparotomy

me getting company. announcing important Well, into glad that I'm And an we that months thank clinic? it month a asking is are when after development the excited two are enough it for it, that for or think the question. I everyone's you folks

did and results it with and as that with the a step and in this this was soon plan. laparotomy did and first unfold, into get oral to watch deliver, talking getting placement candidate those canines. good pipeline it terms the that in the to is then from We'll knock hopefully of have delivery. selection And step vial product our the as it reasonably packaged next doing We wood, we're in administration again, We platform get on hopefully was externally watch in final both, the the goal year, is that's clinic, as take the put parallel, RaniPill via potential well. laparotomy, some fully reliable correct. PK of possible. to through there, partners order and in -- You're, and in for powered it visualize And a then

I been a day, perhaps which we've lifting was to think able down development hard that of is has or comfortable part deliver Getting the to predict really to is more. a even and XXX% the lot that mechanism the completed, always already. announcing it. heavy were been That plus hard month, could the why we right, or show but

a Right. your Well, question thank you first for my and congrats on taking public as your, company. call earnings

much, you so Michelle. Thank

comes with next you. from Thank of Folkes And Brandon the Cantor line Fitzgerald. our question

open, please. line Go Your ahead. is

Hi, and all success. taking questions my the on for congratulations thanks

about RaniPill resources new I'll in think a about because ask just second the relocating RaniPill? to understanding indications still today maybe So we I you then following RaniPill something the answered as good… is along question, and the what similar RaniPill in the maybe the expect mean HC, I to probably study just we have When the that, pursue through at there from going the look term, with market. original the it we second that forward, those parallel line, is getting potential aspect a my in just And longer to you same. committed contemplate I think you multi RaniPill should HC. Phase RT-XXX of have given to And HC, communicated both coming or

have good memory. I a

You can go for it for sure.

especially the pull Thank the runway the solid progressing just sort runway, that's HC of a know, end the there in development, you. you cash XXXX? is in that's Sure. about factor statement programs pretty programs where contemplated cash. study Can limiting versus of forward given cash the you there, potential really or through Just talk to of the any still

Sure.

get in considerable that generation use see the both in parallel. from generation RaniPill within for want So think really I applications space. inbound next current our some still to will short, interesting companies biotech developments pharma with platforms you We

go speak there that are we now to that won't places could I are really right suited. So ideally

PTH interesting RaniPill oncology and and used certain immediate be the market over days of peptides several the with are platform that them opens release. areas like instead well. current I'll a all sustained would There generation up our that can other opens an virtually That make release rare virtually for disease. we're The RT-XXX that version the of that doing RaniPill for are deliver thing indications space hyperparathyroidism inflammatory other as take HC monoclonal many, or on said in the applications of course say and that, in very antibodies the there. all currently many up is Having

opportunities clearly there number of So are pickup. a for

where terms contemplated our does in Now, that Phase I budget? Our Phase budget two two a I, of running in fit repeat dose and IDE XXXX.

So to two obviously If to resources we add report study this at year. dose into repeat year, going in next doing right that we're need the partnership. additional will look But that, bringing now. nothing to or to on

think platform say definitely over you this HC figure when where we're is RaniPill should know. things is -- or And out I course let some up, to ready of move we'll we'll to program additions that going going year. alterations I or the the make

Thank much. you very Great.

comes question of the next line was Our instructions] [ph] [Operator BTIG. from Bret

ahead. open, is please. Your line Go

it's strategic Yeah, taking progress for past, the and and just you in Thank [indiscernible]. the Congrats on one. months years the question.

specifics, You've lot it. and RaniPill, of let's call the but RaniPill, a let's both regard regular with touched the HC to the with strategic their with portfolio, it on one call

for RaniPill a as with well potential the you partnerships yourself as is internally? regular? partnerships thinking contemplated and as you about again, for you're how can there both how are HC being how take of versus any are the sense strategics Just programs Can contemplate actually you give sense us much

Sure.

then far current there additional as generation our programs add two the on far expansion we're So the HC call current about platform, we is it oral the small our testing. I be will the of RaniPill as additions, through platform, realistically concerned, the it, as with pipeline absolutely preclinical as and what may OG, but that as an the I think regular, or -- one thinking RaniPill we program doing get some

potential be think case this for -- either programs. I that partnered those is there's in to

the both and management before, are lifecycle interest compounds. using platform mentioned deliver kinds I in products to getting of we As novel

just this think We to I remains seen. everything. can't be do

the have when the they're given expansion, what we after. very to think we, be we of But the in large perfectly, you as talk about for I we opportunities platforms. potential RaniPill capabilities said, go very strategic

the the expansion is, those as trial and of the into comes we'll an oral for potential of the access opportunity of the that currently burden, those revenue burden with So cost for take products trials, injectable and regimen the particular account potentially clinical a formulation. running of patients

those are our So like I said, things that have the thinking. in into we'll are think later year. going color I more the And

great. other the timing it, from in call you any, indicated there? quick you've the missed particular up, file, maybe there mentioned timing maybe I Okay, file, one master just of a And follow result with any that terms progress master a or let's is

track we haven't, No, we're on with our plan.

for than of say ready then update a it's have go study happens. study And that. and when get two we'll from running IDE to to So we go. itself and the share lot a into the That work that into IDE there, submit study actually and later, rather or may that gearing up sooner should takes enabling file. GLP a have we're run a we'll pretty I significant month GLP master data We and an get that having to

again. Congrats Thanks. Terrific.

much. you Thank so

remarks. Thank you. any to And I'm for the showing no turn to would like at questions over this conference further back and I further Talat time,

operator. you Thank quarter you joining our and us again, This year thank concludes afternoon. this conference XXXX fourth call. Well, everyone for full

conference today's concludes Thank call. participating. for you This

Have everyone. now day. a great disconnect You may