Earnings call transcript Q3 2022

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Jessica Breu

Good morning, everyone, and welcome to Immunic's Third Quarter 2022 Earnings Call. My name is Jessica Breu, Head of Investor Relations and Communications at Immunic. I will also be the moderator on today's call.

Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer and President; as well as Glenn Whaley, our Chief Financial Officer.

we'll Dr. session, Q&A the also have For Hella Chief Scientific Dr. Officer, and Kohlhof; our Chief the Officer Muehler; Medical Andreas our on line.

[Operator Instructions] [Operator recorded. This event is being Instructions]

results this cause words by a note and words differ I remind those as forward-looking statements may, to reflect these statements. in begin, involve statements like anticipate, obligation such more statements. Immunic's may similar this to statements presentation Immunic's as risk estimate of future uncertainties or discussed light meaning, expect, to that such result refer or the no Such presentation identified publicly we the risks factors or forward-looking the that date from revision may release the new that Immunic's a information Immunic's number Please be of Before can forward-looking actual of will, could for only contain Please with SEC would materially you opinions filings here. to revise these of and and detailed events. undertakes statements and to affect of that forward-looking it description any of these results

I would to Daniel CEO Daniel, over to the now turn Dr. presentation. President, please to open the ahead. call Vitt, go and our like

Daniel Vitt

you, Jessica. Yes. Thank

quarter also upcoming the pipeline. development as Earlier ended quarter welcome to well September this highlighted I would XXXX, activities financial everybody related call. as for to XX, third XXXX our morning, our earnings like on Immunic's results we recent milestones announced clinical and

anticipated our During well and XXXX results and today's quarter subsequent third as financial through operating walk will highlights, as call, we milestones.

opportunity the call, to before, we ask will you Jessica close have noted the questions. As

commercial from operational Jan experience review more a announced of XX to appointment clinical - in including recent of years step global valuable our Bossche decided the in States Van quarter, executive years Board to of down after in our an Earlier Tornsen, with Directors industry we the United of At time, industry ex-U.S. same move me updates. Maria quarter, of service. the den six detailed Let the our the and

markets thankful available become intestinal and molecule for has Maria of systemically to to orally restoration regulator bowel our acting key regeneration we guidance are and targeting support. small barrier function our Board contributing With IMU-XXX, of and member respect Directors. her a and epithelium. of

Allowance were compositions. matter have and of We Office IP to key pleased U.S. our a by from related and Patent of Notice position IMU-XXX receiving for the covering strengthened pharmaceutical patent Trademark composition of

for patent to subjects. clinical results X This single IMU-XXX XXXX, potential is into we of part September protection in healthy expected of reported trial In term ascending least positive extension. provide and Phase accounting without unblinded our XXXX at the dose multiple human from

revealed and therapy. IMU-XXX maximum multiple required of therapeutic a dose ultimate investigated our reached favorable No results establishing IMU-XXX a were and doses as support profile oral data was safety, dosing. first-in-class and dosing The IMU-XXX. XX-day vision in single pharmacokinetic potential to tolerability for of expected celiac tolerated disease exceed the The

could of believe associated serious many a entirely of widely current with gastrointestinal therapies. to without treating we and present And action new significant number consequences immunosuppressive IMU-XXX mechanism serious potentially approach benefit prevalent an the it could diseases. a clinical offer

extends $XX creation bolstered our the multiple inflection Going in the million on our fourth having a into sound forward, through financial XXXX. we points footing; with financing. value closing runway private are of significantly of October quarter balance financing sheet This

with IMU-XXX an in analysis patients Finally, our moderate-to-severe clinical last of Xb month, trial we conducted of interim psoriasis. Phase

data doses group not to level the Unfortunately, the mean show a tested compared benefit active did of two placebo.

than experienced expected greater arm. in prior expectations, decrease the with a trial line in the performed arms active PASI the in Although the placebo

remains for been us steps this look which these best blinded. observed. safe should IMU-XXX a observations key have full allow ongoing and - no safety were better would early placebo trial signals And and tolerated and forward the analysis, pharmacokinetics to program. Administration including determine next to we which understand biomarkers and and well to is of The and

further in XXXX. the time. us steps today's disappointed in results the We release provide quarter guidance surprised results like these on in plan would reiterate, potential updates I that noted that to - next of and as at these to first same both

we generated on other totality of and that high degree of volume inflammatory with far important patients available treatment efficacy the evidence However, chronic option of efficacious data a the the to potential thus diseases. has and and conviction psoriasis and the for IMU-XXX IMU-XXX, based retained potential for be safe, of a autoimmune

were on higher the only in patients we the based profile two safety pharmacokinetic levels IMU-XXX also to of to these the psoriasis drug's explore including dosing dose date, and have first parameters tolerability in testing, future Given favorable periods. flexibility longer and different treatment clinical very tested and

subsequent That quarter third highlights. concludes our of recent summary XXXX and the

Glenn?

Glenn Whaley

you, Thank Daniel.

for and third XX, ended results now will financial the the XXXX. quarter review I September operating

start equivalents. with with and cash We overview. in ended cash me the quarter Let cash million third the $XX.X

these our October with be should sufficient 'XX $XX.X financing cash million to fund PIPE XXXX. earlier, the fourth net Daniel of into in As funds, stated quarter operations of combined raised the in

were September XXXX, months expenses the million for XX, ended Regarding XXXX. research ended compared XX, results; million operating $XX.X months as and for $XX.X September three to three the development the

vidofludimus development were trials costs increases personnel IMU-XXX development The in UC related by in offset driven RRMS. in external expense increase the calcium decreases clinical calcium, ongoing vidofludimus by external mainly and the in X partially to were IMU-XXX, R&D. costs costs related These an and clinical to and of trials, Phase

as ended to months the XXXX. XX, period compared expenses million September for same million XXXX, September ended R&D XX, $XX.X were $XX.X nine the For

UC, by partially R&D. also The external in calcium in were costs X programs driven development clinical and trials of Phase related chiefly our in increase three RRMS. in COVID-XX an These were development by costs expenses external personnel decreases also offset clinical increases vidofludimus to expense of and

a XX, million period ended and million $X.X across same General lesser three the by to by increases compared to categories. and XXXX, driven were $X.X expenses extent, increase The XXXX. administrative September for XX, as personnel September ended for months the numerous expense was

months For September expenses same the XXXX, XX, ended for $XX.X to XX, compared the period million $XX G&A XXXX. as ended September were million nine

expense XXXX. XXXX, same to million the was by driven increases extent three Other a lesser ended $X.X months increase across chiefly the and million personnel September XX, for was $X.X by The numerous to ended categories. XX, September for as period compared expense

partially The to interest million exchange income currency on due increase gains, primarily by currency transaction for in of result the Immunic AG Australia. a tax and favorable loan attributable in rates to and trials as between a increase $X Immunic intercompany Inc. changes and loss interest clinical was incentives offset rates in

other relatively expense to unchanged For months at XXXX. $X.X as for same the XX, compared nine XX, million ended $X.X the September XXXX, period million remained September ended

loan grants. the a interest and result increase the However, by million rates, an which gains and was favorable Immunic rate intercompany between increase in in increased AG $X.X loss Immunic gains, income currency as due a to Australia in in for clinical offset on trials incentives interest had the company Inc. of currency fluctuations, tax transaction

period XX.X per XX, common XX, loss or approximately common Net and to share basic diluted approximately shares a million September September shares million million compared was per approximately based weighted the ended the million on average same XXXX, for three and based loss average outstanding $X.XX for of diluted weighted share on outstanding ended net months $XX.X $X.XX basic XXXX. XX.X or $XX.X

based $XX.X million approximately approximately outstanding XXXX. Net per approximately loss diluted shares ended for $X.XX XX.X the weighted on basic net based share was diluted or outstanding and XX, September nine million of for and basic average XX.X a or loss XXXX, share, period average per same September shares million weighted $X.XX ended common months common XX, approximately to $XX compared the million on

With milestones. call over outlook to on that, I'll our clinical turn the Daniel an for back upcoming

Daniel?

Daniel Vitt

you, Thank Glenn.

trials MS update would sclerosis, readouts. relapsing trials on enroll like provide an our ENSURE X leading in asset, to X continue specifically and Phase upcoming the MS we to data in to I development the to our Phase multiple continue in important vidofludimus respect progress calcium, clinical With patients. progressive now

vidofludimus ENSURE vidofludimus that As other along profile tolerability you the is CALLIPER us drug recall, potential draw corroborate and designed strong allow data, the calcium If already versus and proven the oral this with may the a clear differentiation of calcium. neuroprotective to safety will for of program, trial medications. to successful, clinical

data current data XXXX at CALLIPER XXXX. goal half in RMS. line to of X potentially a end the from read regulatory first is ENSURE the of the the of Our trial straightforward report is the potential targeted ENSURE that We analysis the Phase of second currently the readout towards XXXX. vidofludimus the end believe interim approval The of trial calcium top of and our to Phase the - design of has of provided trial in for path X

open-label part open-label learning status the and XX XX X to about Furthermore, we nine with years. forward up look patients perform extension trial in for during has RMS milligram of these the either plan readout to our in how an more in Phase vidofludimus are developed. continue patients extension EMPhASIS to trial offered of placebo disease many were interim to Patients We over or this treated soon. calcium how continue trial of the

our in profile patient remain demonstrated preventing vidofludimus this population, formation tolerability and about therapeutic calcium RMS shown has far. highly thus of trial safety in we enthusiastic become and RMS Phase demonstrated X its in its EMPhASIS best-in-class potential to the Overall, for as lesion activity given exceptional

Phase assess celiac with Part treatment ongoing placebo tolerability gluten-free IMU-XXX clinical during X designed with in is and and The and XXX safety challenge. IMU-XXX C of once days gluten daily trial milligrams periods diet of of during XX of patients XX of to disease or our

acute as gastrointestinal and Secondary objectives and as inflammation. markers, pharmacokinetics disease evaluating architecture comprised those chronic well including

XXXX. of initial We presentation. us This to expect in our the data the readout formal brings end

session. call Q&A the open please for the Jessica,

Jessica Breu

Wedbush. Instructions] Great. for is third Thank through Our today Andreas, quarter. you, go ahead. first Daniel Andreas walking and the of guest unmute [Operator and Argyrides yourself us please Glenn

Andreas Argyrides

for A taking Okay, around and the couple questions. here our XXX. good and update thanks morning,

RORgamma RORgamma are would number a the you are what psoriasis? you in class t implications thinking around the of you - discontinue think decision t around a run So therapies. about XXX to study like Do GA thoughts you one, and see the development your think psoriatic for class inflammatory lastly, How in inflammation? of the a And disease indications more AbbVie's markers, future change different mild time endpoints XX arthritis? of then to to Thanks. you too be like do short explore you find and days period patients? secondary autoimmune architecture would moderate might do their Or

Daniel Vitt

you, question. Thank that AbbVie for for Maybe Andreas, starting with the the Yes. question.

this, time of we as And Of lot spoke tons has to a or communicating shown IMU-XXX important molecule we issue, with we - have been we our of agonist. for observed XXX, we in inverse because a think that selectivity the sure and so course, have you on t believe spent has it's the solved was other that lot selectivity data. in make inhibitors models know, which RORgamma about preclinical

At don't that difficult end, big side Therefore, know was we does decision. AbbVie And the before is the that available, therefore, details a their it's on, we for we AbbVie exactly decision. have and to decision. And I don't for data think looking this the were not surprise not IMU-XXX. what lot talked on going believe of know this we about what the about that reasons further. And I on just maybe to was the apply - we think comment see a

on mild Maybe, Andreas, or you potential on psoriasis. arthritis to if question the moderate over go take to the forward

Andreas Muehler

is from vivo to on of psoriasis the entirety have the of strongly here this a in The believe right concept. clinical of drug proof to our of test believe the think I it that - severe based to that and we is experiments. IMU-XXX Andreas side. Andreas, we the population activity And also Yes. we data vitro on this get in more

a This this sometimes through a always are been is trial. hard relationship. trial predict a Phase where Phase And in response dose dose very - works you to has escalation. X X it's And

don't I And we're to so But to something change. going how think is assessing exactly the like continue that population think would we I currently forward.

announce had was right concept in a is it. about test next to studied. the will this first question show quarter forward XX - gastrointestinal. be we will be the - days and And year. change think said think details don't third proof I of in I in going I as But you whether more think it release we said, hope to enough then because populations that you I about to population is of I we're And the we will to here how think, - the today,

this is IMU-XXX... So about

Jessica Breu

IMU-XXX.

Andreas Muehler

IMU-XXX sorry, Andreas, - just to reiterate what I'm

Andreas Argyrides

Yes, XXX.

Andreas Muehler

okay. XXX, Yes.

regeneration restoration question barrier we enough. use is our the function you drug of a last So that epithelium IMU-XXX, candidate and for this the asked is basically about days bowel third XX of

Phase chance we this So days. - another XX is now of trial, where dose is to course, X this for have the

- Based we change would histology assessment for including, good in agree you that be example, include trials for endpoints a of I decided in would and we the would on show shown I within able to the endpoints currently trial it have in gluten that that trial you with dose previous longer. this XX because are challenge, that But say, some - histology. some this we of had all of has this to days

this And like endpoint. histology, understand where to we the that and that of have think dose action this to exploratory first certain data that its an - us chronic gives endpoint, here hope effect it's gluten whether marker an trial also relationship is to I But exploratory Phase endpoint included some I acute drug the are response mechanism and which acute the extent, the release show say of we a would our absolute day usually of also marker. X an on challenge, this trial. first we is in an in have like of the But on nice immune IMU-XXX IL-X there's markers

timing I the that So I on that think timing - is the do. give right the think this you could sure, we basically one for But day. - us is

we in would trials, find we it opportunity. so we the designed longer when like So say future that can would certainly in general, But dose think something. have we to I I it

go So again, path the development step IMU-XXX. with a about and we're learning where this forward Phase information right each one piece is, another the to learn new for trial with a X little bit drug time at about

Daniel Vitt

All questions. taking my right. Thanks for

Daniel Vitt

Andreas. you, Thank

Jessica Breu

Andreas. you, Thank

Piper ahead. Yasmeen, guest next unmute Our of go Yasmeen Rahimi Sandler. and is yourself

Yasmeen Rahimi

Two team. the Thank for you. you Good morning. for update. questions

first you - comment going of reductions mean you the the PASI, when lots sort And and can then exceeding seeing placebo of The you're comment effects helpful. at are us, one, maybe just on but could that, secondly, one, to and half can have to that like data? a asking that XX% is understand XQ you I why - it look times And be the this being a of on maybe earlier of like, follow-up whether CALLIPER. you're saying XQ in and you it it. why take question Are I could in quite analyze to is just analyze treatment come towards time time bit of then conservative the

Daniel Vitt

you, Sure. everything can't Thank But questions. unfortunately, now. my answer. try I for best very to think Yasmeen, answer I the right I do to

two basically, think, placebo. there we observed now that is of I First - all, benefit the over for disappointment the over no tested doses is

has And for trial initial something patients We which takes now. for that's this and the is analyzed yet not have values further our knowledge and it - right we mean time. groups. is, only on and is And going unblinded the happened

on update give want make we first the currently a I which understood that, is for full forth, and something blinded measuring still, includes that's which set. and on work guidance need really digest for is conclusions on the based and to go next biomarkers we therefore, can hope where based to to data them fashion. be quarter on example, done info so have an And data, also

Yasmeen Rahimi

CALLIPER what for Like understand readout, should of then - success? be team considered a And interim into in of like population on that have based we as weeks on this treatment, XX help is bar head we the is the us half finished expecting? population, Okay. which what

Andreas Muehler

the Andreas. question. So hope a little I can answer bit this of I is

assessment population, interim progressive some for MS in we planned the there's CALLIPER initial understanding the had of trial whether get trial. the activity to this So in

The primary is trial atrophy. of this brain endpoint

atrophy where reliable atrophy. not So have it's weeks a long enough an MRI-based of to measure brain of really is measure XX brain

can early. that some So more that's through biomarkers why measured go surrogate or some had we to endpoints be

Both decided and related serum to biomarkers at activity to disease. are also blood blood chain that's for suppression called assessment look basically GFAP interim or So neurofilament of neurodegenerative and light why we in or plasma. neuroprotective an G-F-A-P, for

MS. active sure that lot measured in relapsing of there less you see the But light as inhibition course, than chain. progressive of activity neurofilament indications some also progressive an in is is and light also think MS. Make therapy MS. evidence, MS - a a evidence This more of MS. most for is an in a by neurodegenerative neurofilament There's I in there's evidence relapsing chain

good as that's experts. another But probably emerging MS could some discussions GFAP under there progressive is although that for initial by biomarker. this well, a be still data is biomarker

there's probably And population, some the in progressive we But IMU-XXX. see in it that's, is a that. for inflammatory think, major also I activity. for there MS biomarker our where wanted is as much difference placebo evidence the of discussed no less basically and GFAP very get that So population, where patient a much XX-milligram really for we to understanding

So done and biomarkers are been these underserved. there's MS two more the progressive surrogate think are emerging this population the MS trials is they endpoints understand, relapsing population. progressive the in in in population MS than that less Yasmeen, useful evidence I are that have And There population. where please

relapsing maybe is for entirety evidence in be MS used of also yet can as not that that we the they good these chance so progressive MS. believe the X. a there's And biomarkers these But there a

relatively at functional readouts little patients. for MS early exploratory, of for early provide also have we think in trial, population, these also more then the these which is look the whether which some that may a MS XX And outcomes bit progressive functional we'll probably weeks is treatment I

readouts. a these see a to there's functional that difference in begin already You trend

exploratory there's indication trial. that the side, activity indication interim give was on really would us in an there was is us early analysis. purpose analysis that I think an activity the the trial. in to this is interim early this give And that's which also of more that this initial this designed And

Yasmeen Rahimi

Great, thanks.

Jessica Breu

please yourself will next from Yas. and you, Kaplan Matt, Matt unmute Thank ahead. come The at Ladenburg. question go

Matt Kaplan

Thanks Jessica. Good morning.

I term What open-label in would the there? kind interim be on RMS are what Just a and X wanted looking we readout EMPhASIS of portion. nearest that to, guess, sign for with your positive Phase zeroing

Andreas Muehler

relapsing-remitting long-term Thanks the Phase in is for Andreas. think designed this this of to so at this really portion question, look Hi, treatment yes, to allows with the trial safety. patients approval, when long-term several and relapsing I X patients was the And safety the NDA data open-label MS it with have MS for available us relapsing years file of in we for MS.

major of is And open-label driver the portion. so this this

And majority trial, on patients continues is vast enrolled on and EMPhASIS that fortunate very we're that of treatment the the the treatment. in still

that have see And so we we luxury patients. long-term the the from data these really safety

analysis. is this major the of the interim So the purpose -

think, look other, The to certain these possibility I outcomes is at patients. of

in be readout report. develops how time that an analysis for So we additional maybe because of, and interim example, is this which over and can disability this would also captured

you placebo a no control, longer of course. But have here, understand, there's to

that's outputs is all a But you treatment. in think trials basically have this population. that from the So other disability But this expect I to we development very the interim you two in similar analysis. major can that of compare maybe seen

Matt Kaplan

celiac Okay, cohort And the patients. back Part just great. then, in XXX going C Thanks. here, to

some the histology, to of what terms there, for there? for In you're you in terms you're endpoints anticipating of and gluten can looking see challenge the and challenge gluten us help the beyond understand what of

Andreas Muehler

that to that's are or either yes, principle, in acute related celiac So these disease. chronic so are markers -

of So immunology of to can within challenge. that be starting acute have like is IL-X and done an a challenge gluten known activation certain hours gluten markets

the of settings that gluten challenge of in immunology actually that more, gluten And that's markers that I is So been first gluten where then used a challenge. chronic lining reliable bowel market of damages is And has the there's settings. disease in something epithelial the to this think, on over the again, these the many time. day nature more relate

some this in the we patients disease a - think see an disease. think the look of I explained the what a markers at at the And biopsy. of difference they're can readout this at that issue markers little And XX-day bit immunohistochemical study. from. a of celiac it to basically is I as biopsy in the and suffering for that harder established And maybe That's I trial looking between that capture the But the we before, where and we're maybe in histology trial, us probably for IMU-XXX the histology the hope markers end also is placebo. is major also that beginning initial something gives these at

too bit for was are proof possible. based acute Phase a But the I in of XX we both to be treatment a And data, at short. also think, And understand Xb on a historical where my But think to look days I and celiac choice of I for here a the - disease, good little treatment combination trial and true to designed concepts of chronic that a is may are think mind. really think of I think the I this that, markers, response relationship. dose probably

Matt Kaplan

Thanks. very It's Okay. helpful.

Andreas Muehler

Matt. you, Thank

Jessica Breu

you, Instructions] SVB Matt. Securities in questions Tom writing. Smith submitted with Thank around team The their [Operator

than happy So to them. more I'm read

is again. AbbVie one first around The

RORgamma the agonist in for compound? signal specific preclinical are hypothesis do and inverse a chronic IMU-XXX discontinuation findings And Regarding differentiations for the between the AbbVie's may IMU-XXX what that and retro synthesized Have have ABBV-XXX you to due study, of any ABBV-XXX. have recent what been. any tox you

Daniel Vitt

No, I the question. SVB team thank you think for

know that, they I don't to it. reiterate what didn't think found it's disclose they because exactly important first, we

a guessing here. So little bit we're

an on companies MS. that on guessing of is in of we in seen the in with So some maturation more are looking line drugs impact those this maybe other detail have

already I didn't see think that I our test. we earlier, mentioned as And in

is on that XXX with really the have we superior respect. selectivity So shown

and and and the we we in is by not the just of course, is unexpected. how decision that speculate to here our can't therefore, something conclusion So AbbVie. guesses made compare which And molecule. that data the public basically is related the that that's base reemphasized here But

can interested learning what all have studies. that's think now. getting I for I about they would So we their in say more in be seen

Jessica Breu

is, you SVB's you response update the driving what the be rate to you could going with suspect outsized suspect in IMU-XXX XQ? IMU-XXX? What again, readout do what the are of second question could additional observed have - do in The be data placebo interim

Daniel Vitt

Of over going course, a I'm guessing. to Andreas. to hand It's still

couple still I I a times quickly we really it's, course, have address We work group as level as think of and only possible. said of as something to data.

So we can't really there that. from look into detail on how individual patients to data the on conclude and sites, for is example, specifically

level just we far our So group data, to only so limits the full access have unblinded the which dataset.

Andreas Muehler

what I And we I have And course, an and extremely contribute we this. can to also Yes. discussions only psoriasis for say, had think think that to medical against they with, really course, hypotheses. well-experienced could recognized these unblinded of until board I of And test have have advisory data we data. now. gave we of the hypotheses have them, And also to wait their unfortunately, us the some of some hypotheses we for

of bit activity really unfortunately. we And against may in our we hypothesis of course, actual we a we have but to of kind of believe and data, because this drug. in factors can this that forward, would that's like little that these think mode make - I contributed we that we're the test and wait believe unblinded full, think response I exploration show this understand this have to And drug to in we the activity dig full in to placebo eliminate because some sure that going to in

Jessica Breu

what's and third on final from And and the SVB team the latest Okay. IMU-XXX is, question mCRPC?

Andreas Muehler

What what sorry. is the I'm - greatest and latest

Jessica Breu

mCRPC. In

Andreas Muehler

Okay.

or for we last ongoing this think is the I nine trial months So - now have probably so.

dose And increase basically, phase, done. we is escalation without where dose-limiting far are in this have We toxicity. now we dose cohorts the a dose reaching several how test can

really we what and dose-limiting can seen at - why dose terms about what moment. running way we in at say have think the the dose this this a without toxicity And targeting the trial it's so bit think more is moment limited at or part into little it's we point. without escalation can in because that I major increase a running I the that's less of And

Daniel Vitt

Yes. already XXX-milligram And we the have dose we announced completed escalation. that

XXX - we next level So the milligram. is

that's that right may we the stage So now. are be

Jessica Breu

Yes. Great.

any we the to for given our more closing Q&A remarks. have think I webcast no over session. like I turn would questions, open concludes back this to Daniel

Daniel Vitt

today's Yes. and you your to Thank you, for insightful attendees questions. thank Jessica,

a to I mention unmet that medical MS scientific like on forward multiple with discussing would the key As look November XXXX. final our Thursday, sclerosis findings and we leaders program, upcoming to XX, remark, renowned webcast R&D our at recent opinion needs

the received not event, possible. date have invitation you to also further to If the detailed will provide that, as and I us information as Jessica closer saved soon call. for this please event. with With contact a like would today's close

additional any much on are happy answer questions one very we for one. to very joining. thank you And Again,

Jessica Breu

The thank my from now side, for webcast concluded. call our you Also joining today. has

disconnect. You may now

Immunic (IMUX) 3 Nov 222022 Q3 Earnings call transcript