Rani Therapeutics (RANI) 20 Mar 242023 Q4 Earnings call transcript

Welcome to the Rani Therapeutics Fourth Quarter and Full Year 2023 Financial Results and Corporate Update Conference Call. [Operator Instructions].

As a reminder, this call is being recorded today, Wednesday, March 20, 2024.

I would now like to turn the conference call over to Kiki Patel at Gilmartin Group. Please go ahead.

operator. you, Thank

the Executive on Arvinder from Therapeutics Rani and Joining Talat call Imran; Chief Sanford. Svai Officer, Financial Development, VP are Chief us Officer, today of Dhalla; Clinical

potential, XX-K Exchange uncertainties that report make conference this that results quarterly statements. to identify the sizes, as, potential, platform business differ and These of discussed materially to, statements results call, with platform to strategies, not or will include, in on certain financing differ plans Factors timing in and the capital may and During the forward-looking Actual specific the company's those such events the assumptions, product such Form filings without may from Commission, performance. Risk limitation, management on events are annual could and actual described or XX-Q, materially statements market subject limited forward-looking Form cause including forward-looking statements those its projected but statements. risks, reports and section development operating Securities regarding progress, of in which factors these product resources, from trials, those clinical

I of to Executive over With Rani the Talat Chief Therapeutics, Imran, turn that, call Talat? Officer

oral strong share device. highlights to high-capacity delighted company I'm you. Thank XXXX of performance Rani during numerous in delivery the pipeline the and its programs Therapeutics' milestones in achieved the which development of

used. technology for to subcutaneous where administration is Therapeutics are oral injection. that designed platform a has Rani the RaniPill therapeutic address is clinical-stage platform biotech biologics area a comparable The with developed biologics of any bioavailability to company

and modalities. and with discovery other and focus current therapeutic underway efforts endocrinology Our in on immunology obesity drug areas is

recent Rani throughout we I shared important month the milestones call, RT-XXX. past Then provide on last on her has reviewing the year. today's will by will Arvinder During data achieved perspective the start that

year will data, Phase RaniPill provide I And then is third trial and Svai encouraged We now the finally, technology. our position fourth on this this financial our our and using are for highly XXXX. full an by update successfully completed quarter

now achievements over the for by I begin X orally positive I that of Phase the highlighting results will call biosimilar. ustekinumab past administered and our is RT-XXX, year, our an biggest

the in supplied a reminder, company. into is the a partnership used by and biosimilar studies. adalimumab supply the XXXX. to commercial program of to in right acquire Celltrion, the In Celltrion of a Rani cases, was to after first include biosimilar middle each XXXX. rights global beginning ustekinumab This our both Celltrion I has RT-XXX respective long-term negotiation Phase expanded biopharmaceutical agreement completion of at program of an the As entered the

Last for month, RT-XXX. completed announced as very humans. RT-XXX excited achieved the those in trial results I positive Phase by results were bioavailability of We high we

which arthritis, oral have We large Crohn's adverse no subcutaneous and medical addition, events. tolerated was the serious potential treatment for to In only well moderate is with as to this the it of ulcerative colitis, in a disease to currently States of plaque severe opportunity by and as as large moderate ustekinumab psoriatic an injection STELARA active psoriasis, United marketed for Janssen a severe treatment. all severe moderate unmet is needs is believe available

billion XXXX. in As in approximately worldwide for approximately for commercial were States potential sales the STELARA and billion opportunity, $X United $XX.X the

of involving deal middle bioavailability. liquid high the HC, adalimumab the with high-capacity the first biosimilar with our Celltrion XXX RT-XXX a announced RaniPill program partnership our to in of payload for was Rani up for program an that announced is to additional the to last device for This year. designed on Moving deliver programs. second a microliters

the delivered adalimumab successful The HC X in via preclinical tracked study. enteric-coated administration successfully serum a The capsule preclinical concentrations RaniPill models. RaniPill oral announced of of HC of XX to the RaniPill the adalimumab milligrams Last of or adalimumab study Humira the in subjects. Humira fall, canine all Rani delivery HC containing oral following

in high-capacity of HC. RaniPill we with as date the we progress pleased believe Further, we programs the and Overall, clinical studies completed to additional have preclinical forward. have antibody pill will at made are peptide with the with this be development molecules our we our forefront moving

delivery make incretin GLP-X, data our weight And loss finally, and we the multiple our the RaniPill in believe platform demonstrating glucagon billion obesity GIP announced delivery preclinical are Preclinical elicited XXXX, enable animal that another obesity the RaniPill impact an XXXX, the to market market. is Considering this treatments. by area the potential to data to Rani is about triagonist for expected $XXX an we can RaniPill area. make of of therapeutic an December In highly supported for in transenteric obesity rapid an potential potential enthusiastic study. oral the impact exceed of

vision Overall, a have we biologics variety commitment of our believe making wide in indications. across a the that oral progress our XXXX reality of to made reflects we

let me to the to now more clinical in discuss Arvinder that, With Dhalla call detail. turn updates over our

afternoon, at time delivery delighted of Arvinder a a provide high-level to showing you, Therapeutics. of via Dhalla. overview of Rani I study monoclonal with antibody oral everyone. RT-XXX, My for from RaniPill. the VP name Phase exciting the I'm Talat. is Good our the I'm Thank first Clinical data Development

study I of XX X.X enrolled Phase RT-XXX, RT-XXX in XX STELARA injection milligram X.XX study each participants the participants evaluated healthy and a in milligram subcutaneous The and in conducted open-label RT-XXX group. The study milligram and Australia. single-center, in tolerability groups was a safety, dose volunteers. This pharmacokinetics X.X of

administration quite for in in X.X AUCs a delivered XX%, a milligram The of were RT-XXX the study, to of comparable, this ustekinumab via Rani compared bioavailability route group. groups X resulting the dose biosimilar proportional subcu manner. In

ustekinumab Cmax oral RT-XXX injection. deliver In and Tmax to a by addition, demonstrated subcu compared a higher shorter

There the route antidrug of in via compared no and Moving tolerated X were of was study. was subcu no the tolerability. injection. all difference events safety in to Rani by the the in and delivery RT-XXX on well adverse antibodies participants to STELARA RT-XXX meaningful groups, serious observed incidence

Additionally, the passed remnants no RaniPill swallowing difficulties participants and from reported participants. capsule all

antibody data any with other differentiated or our serious a to bioavailability. delivered as compared RaniPill aim in have highly the and to in injectable are product high and biosimilar without we ustekinumab that we development. very is currently that commercialized With events adverse oral RT-XXX volunteers pleased Overall, being healthy options with

STELARA therapy launched, recent the address intend Whilst RT-XXX. XX PASI early for we differentiated the scores more high with was loading something as are dose not disruptive to This when as is its treatment entrants. regimen in patients justifies The transition most reason loading dose of biologic. start typically in middle of a Ultimately, though, will use is maintenance that dosing. new a flare-up, psoriasis which to patients the is the critical serious

We therapies, review, plan explore potential is begins believe we of month SOTYKTU, after a as XX a here approved the injectable Furthermore, the biologics. more Otezla a And compared oral like pills with STELARA X regimen XX-day shown maintenance. on beginning that have just loading lower PASI improve recent for to each there currently daily dose at by and to scores dosing followed well. as to

oral to Newer improve outcomes. the potential therapies have

of being by has that Therefore, to those patients twice studied the potential with oral a achieved that daily efficacy monoclonal has not believe schedule RT-XXX or or for dosing However, provide antibody a the been daily other we with dosing. therapies. require are

Now Sanford, Thank financials. Officer, to Svai call review you. our Chief I our Financial would like to to pass over the

Thank you, Arvinder.

summarized call. that press in issued In will financial financial this highlights addition the our to share release briefly earlier I some results was key today, on

You XXXX. can also find for Form additional ended December XX-K our XX, in information the year

million and cash marketable Cash, turning XXXX. equivalents our $XX.X of totaled as XX, XXXX, securities to balance to $XX.X sheet. compared Now XX, of December December as million

We raise potential support fund partners. expect financing offerings, and operations operations to additional additional to capital capital to the debt and licensing non-dilutive cash, through our from for be into sufficient XXXX to the our We fees We equivalents equity marketable XXXX. recognize need current beyond. cash and plan pharma securities raise to

million same operating million, results $X.X the our XXXX, XXXX, for year were $XX.X and fourth for quarter in December and XX, quarter $XX.X For $XX.X research full expenses the and XXXX and million million year periods development to ended compared fourth respectively, for and respectively. the

during RT-XXX advanced clinical have Phase expected is sufficiently of And operating ready this managed limited clinical the significantly even RaniPill be the our development we of year. which the for completed I to challenge studies in second capital XXXX, of for HC, We half study and costs. with successfully the

$X.X due million The $XX.X expenses by million it compared million administrative to for XXXX, $X.X year were and the and fourth $X.X of to for decreased XXXX the primarily our million XXXX respectively. expenses full stock-based is noncash full for compensation. General compared the the respectively, $XX.X G&A full year for containment to compared XXXX periods which million, prior to XXXX, approximately quarter expenses and $X.X and in and year includes in measures, cost $XX.X the same year million million

$XX.X includes and fourth same respectively. noncash full year loss the $XX.X million for quarter XXXX, $XX.X for $XX.X of million million same and The $XX.X periods Net and to for and the loss in for quarter the million million the stock-based for respectively, compared million was full respectively. XXXX XXXX, and fourth expense $X.X million, net the compared year $XX.X compensation to periods XXXX $X.X million in

will concludes I the comments. over financial call Talat? closing Talat to for That and turn section, the back

delivery our provide injectable is Arvinder into Overall, reviewed the clinical study pleased results these oral this can I'm exceptionally of large validation molecules platform that by convenient our antibody believe oral the first pills. of high such a that of monoclonal with bioavailability. Thank you, results evidence Svai. our To RT-XXX earlier. knowledge, We transform

over potential with in the any convenience the a human events pill. half-life announce to a related the RaniPill monoclonal of of X proud adverse are The to platform RaniPill platform. we without dosed we addition, studies and times flexibility have to subjects XXX combine serious specificity has dosing efficacy, long the now antibody In in that the and observing clinical

intends impossible X terms of safety combination are, originator. oral the of Rani to to other of there as is with efficacy, we potential in to create the and/or that replicate where products any as additional better formulation. believe compared a products now, The opportunities could schedule to identify dosing create

of team proud everyone far built to in and are the past to oral stakeholders a a to world-class our at your their leadership all we vision of this making for efforts year move biologics would Rani, so XXXX. and at and closing, reality. company us thank helping Rani closer our like support also to thank of In like for I I'd continued have for

the now With that, call I Operator? up questions. open for will

Olivia [Operator And from comes from first our Cantor Instructions] Fitzgerald. question Brayer

Celltrion? with And Where cost I are the the with got terms guys the development then are RT-XXX path forward forward how moving a And you with you quick respect of a obesity. alone? follow-up with partner versus thinking sharing to about negotiating program on

Great questions, Olivia. Yes.

say which we if the a -- going can do, excited the this were I terms the show provided, the by of we this to forward. that. that we do Celltrion, PASI I capital would were the support of And about are first ongoing. partner the in dose think bring There's much would alone through repeat if ourselves, borne color additional So weeks. I Arvinder with they be a by would score And in case we program to look Phase apologize. it. I II a XX it in to in study given doing partnership, to higher think we of to the We're negotiations, the to expect cost be partner go in not like middle the versus to

that? question you So follow-up to have a

I'm a follow-up I the at question opted can they've quick got -- obesity. question, officially think right? I've that That Because comment A was was you in? or not window there of passed, and end has Yes. not on whether then if mistaken? on February, But

comment cannot on I that, correct. That's unfortunately.

where this Okay. recent some then your how considering that think obesity, commercial pill realistically market? developments a program priority strategic do just big that of that fit of space, in into point? at could And And on you is the

Yes. Absolutely.

a looking So it opportunities. on now, us priorities and at of for company, highest the is we've for this years one potential working as been

of very other schedule dosing and publicly, kind doing any would oral like to what would discontinuation we're said be injectables. to is and safety technology I've like while profile replicate of rates with difficult getting with think RT-XXX, I do that -- a the efficacy the we same create,

than month showing to maybe GIP at generation every weeks. dosing so be drugs. incretin it looking first looking are once that end, And GLP, the better ahead couple that we're strictly And generation, tolerability a at could once schedules, in technologies even one of or

the around it priority a plan that's for strategy and So it, the us. top and is

This it's from And I about combinations proof, think is is swallowable perspective, drugs auto-injector. technology thereof. whether or future exciting that oral an what's muscle -- Rani's it's, preservation our auto-injector

really doesn't matter. it So

and really over with to I RaniPill. preclinically Phase think what a an we've demonstrated should It to We put this able injection. Is. in bioavailability similar deliver drugs you be it matter doesn't X that's now XX

next Nash our And from question Edward comes Genuity. Canaccord from

now about the to Phase entering going -- and is year, bit size a that XXX II could XXX trial little maybe design? just you be that this talk of

I'll over to Ed, question? Absolutely. there -- turn was that sorry, another

that's No, it.

jump Okay. the provide in Great. you and Arvinder, on maybe can RT-XXX? color

sure. Yes,

]. to X they And Forteo And we're just the of groups plan look we're be per going of XX for X have arm. MD the well one as enroll subjects planning study, correlate quite we'll RT-XXX to and comparator. So a biomarkers duration, with in at we is study weeks for the as and to [ using the one

do II trial? into the Would only before to Okay. be moving need that you bigger would a that Phase

need a before This of we wanted bigger would trial. that a just dose-finding do study. do type a No. to do is We proof-of-concept of study to bigger sort we

question Julian next from BTIG. our comes from Harrison And

front, On of incretin-based could And as the wondering efficacy, both I'm inhibitors obesity about context tolerability if such the PK axon how maybe benefits then an maybe therapies, incretin-based curious classes the enabled I'm by obesity, thought as of could potential advantage or some CDX in RaniPill analogues, if to any on traps, talk receptor-ligand given translate you've is more in beyond therapies? example, Amylin you to emerging

Julian. Absolutely,

COGS would of I in -- So PK, also efficacy can. terms and in if there, safety, add I

well. really terms of work drugs the efficacy, In

the the is there. So changing into there you based I a benchmark, make on modality. But think the change safety material a you into pill injectable, put are unless the going or to and potential incretins the tolerability, don't difference

in it Lilly a of Eli right getting course with when up data, it was think when patients, were AEs I their new popped the and a they Mounjaro out time-based they was dose. put

was showed beginning the at spike a cycle, AEs it new in So a of that like seemed there up.

you those you So We to patient, that peaks literature, the those can and go have induction escalation potential the RaniPill, we're in an on data early of to curves troughs that out if with thinking away similar the so what the a doing in you a for and dosing don't to daily move drugs goings run about of one smooth the phase, the RT-XXX like, And find incretin-based dose. based therapy. the linear while progression improve in the a of to we'll yet, out. we have have to feel study a with the tolerability of there's more

second Amylin-based But maybe your on horizon that are better question, kind brings right look here things other to showing is GLP-Xs, which right the us now GLP-X, you therapies, are much that tolerability. of at or there

will the get in we're be and in trials mind today something top to for by RaniPill use obviously, of we is RaniPill. number selecting us for The when to think to program tomorrow to a on competitive bring when commercial. find a and And of we partner and, tremendous a partners. works to the us potential There's interest that so about obesity thing when that's space the

And just think what finally, then it with I I dovetails maybe said.

this, and And at finally, category. all looking en who sleeve. And can to think competing the absolutely I requirements, have I see billion one the morbidly approach entire should Y I think into you'll as are next with maybe a people there's address a do over We're this a going time, obesity. take generation. you'll We obese, or will portfolio gastric adverse will to bifurcate And $XXX There's that mentioned where you other don't there's to to maybe say, drug analysts be I the going of COGS. you're with they patients then maybe Roux weight lower of subcategories events. loss finally, then self-pay. the but start

a want injectable. get some a COGS what therapies, on oral have increase companies to dose generate think patients that, data, compared by to And that many doing great when at drug to an they there's production. while of it's XXXx there's that make with to waste that so I And to therapies. maybe are issue the just these COGS they

So or term, I'm X in the over the issues near production be will years. the those X skeptical maybe solved of next

feeling to a of an these who them. obesity industry we have drugs, patients produce that much I as take there'll be But as as can want

that there's I a injectable RaniPill really So with you molecule do a approach an market and take as think dosing small in with for get with good injectable schedules, said, fit I this that oral. can an dose efficacy can't

And Vandermosten our from Zacks. comes next question from John

funds the Celltrion your pipeline, and question that Starting will that for on how you assuming just with of if a out focus a XXX, with your deal happens? signs -- rest shift

It's question. assets. we've I talking mean been a good obesity about

we making to And But we in we place that would of hard be there. it's that to now. are would putting a -- right pipeline capital. something a don't think So describe lot invest I have the a on selection focus

then biosimilars very drug And there's there. amongst not clinicians differentiation the coming RT-XXX. And of popular just despite Humira the into patients. lot and remains there's a market, a

So bringing exciting a in space. a that perhaps really about thinking is in product, think. we're Would once-a-week something oral be a pill I TNF-alpha that

along? Yes. guys How on to RaniPill were we processes some stages, And for be stage of automated using know product? that about you working clinical getting later stages, And think kind and for I will is as manufacturing that you coming manufacturing.

automate, We year. we've strides question. incredible Yes, made last need the great do and to over

of pieces require every fully of of turning something then a a doesn't end-to-end fully for in-house And ultimately, fully manufacturing make step into all together we'll the automated process to automation line. have that that's string equipment that's those automated. and dedicated team it taking operator, We an RaniPill the

can the demonstration good studies. low for And this Phase the pills per deliver that and We Phase We're Phase day. the need in III shooting it goal thousands Is As IIs. have a for progress. I or pilot is to of we've line ready our made said, for don't

that We a we place CMO partner have studies. would production commercialize then, be the capacity these XX,XXX day and in with need already that those is work line, able of scale it which that per course, can scale we per do of order what pills to But to in and products. does up like to we'll support any have mass to or XXX,XXX to make so

some if out of doing at more, I there. just research are biosimilars that new the biosimilars. was I was one And looking Okay. may. I rate on

I think U.S. think were about What X thoughts months. about to of started last of biosimilars come? off environment about the there decade approved the It the What your are more environment and biosimilars? do maybe accelerated growth ago, in in legislative especially you this for XX about pretty a slowly for the kind

Right.

I points here. a of that there's think couple

The patents allows that should first -- clinicians, everyone you want good Congress biosimilars innovation, from don't to want an because is is to in old forever. but artificially from because high prices keep drug exclusivity payers patients, it for for

a the which I example and uptake -- they if gave X one we just PBM market for their how But work, healthcare the of for -- can that. also I how Amgen prices to at the industry says look Humira doesn't biosimilar think industry, Humira we needs our in paid the need say but think to are things and biosimilars. or And payer large, I lot works about as need So had not for. at rebates,

biosimilars Humira well in, they really only you and price. could making also the more It's or I like coming there's see say. but hard AbbVie clinicians. with to can That going thing on patients think play to unbranded. is compete Humira that And be

our even -- novel a that of though Rani biosimilars bio final or in be playing making as products I our may going betters, company. a will, making drug biosimilar. not a substance about out to not drug if is What novel biosimilar we're of we're we product, use We're -- love products out you

think example, elevating for, even then, near-term better there. efficacy, potentially, efficacy, phase, RT-XXX shooting are we getting potential the the as an as So Arvinder dosing scores and some maintenance faster schedules there's with PASI in referenced, We're different. and

not opportunities, of profound, So just think, just it's a doing pill, we're itself. really one-for-one replacement is looking a though where that in and for we those

So look to kind that's I how Whether think impact whether doesn't this. we strategy. more, as at Rani, there's really there's it of our fewer, it relates

And back to now would over no Instructions] remarks. am Talat I questions. I for [Operator like showing turn call further closing to the

quarter concludes corporate year Justin. and Thank This financial again, and you, XXXX our afternoon. Thank update you full joining for results conference everyone, this fourth call. us

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

You now may disconnect.