ITRM - Earnings call transcript Q1 2021

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Operator

Ladies and gentlemen, welcome to the Iterum Therapeutics First Quarter 2021 Financial Results Conference Call. My name is Katie and I'll be coordinating your call today. [Operator Instructions] I will now hand you over to your host, Louise Barrett, Senior Vice President of Legal Affairs to begin. Louise, please go ahead.

Louise Barrett

Good morning and welcome to Iterum Therapeutics first quarter 2021 financial results conference call. the and quarter our can with earlier was website. release morning, this be press company's results first issued A found on

Judy the provide details We Fishman, our financial provide morning this then on Q&A. opening Matthews, we'll and and open some will are will for CFO. Judy by remarks. results, Corey lines joined CEO Corey

for including the ability with concerning sulopenem, activities to fund and of sulopenem COVID-XX related out the on ability and to risk meeting launch most the of our filed into any report to call Committee condition potential will Form the this expectations expectations approval, to to our we Before discuss if filings enter the our NDA oral sulopenem strategies response to of the you actions commercialization our indication, plans, measures remind SEC, or XX-Q. regarding review filings operations, successfully begin, impact including, cash the a recently regulatory resources the financial these sulopenem Advisory and I sufficiency forward-looking NDA for including the Actual by adding approved, in set FDA result agreement would factors, that potential date, services of differ results related including of and commercialization far statements our and timing plans and clinical market suppliers timing likelihood with on of may and the the approval organizations, of holding of oral additional prospects of from cash research operations, timelines, approved, the forward-looking accuracy PDUFA our a factors PDUFA execute our approved sulopenem business, is into on our FDA date, respect for the as definitive the those strategy. to just respect statements business label and will for or materially like indicated hand expand ongoing the with quarterly future by thereto by an contain commercialization and various in third-party for other to oral our manufacturers, if our on how important

over In obligations our addition, his statements that, as forward-looking only as opening representing date be I’ll We represent for on remarks. and of this to the any should statement. as such call of the Corey views update With date. call disclaim now to any relied any views specifically our subsequent of not turn

Corey Fishman

for joining with Thank share you, highlights of interim, Welcome Louise. the you I'll for busy a and was thanks now. some us QX and today. quarter

tract in New July with urinary First, of oral Drug January, non-susceptible in of XX organism patients quinolone late Application our a sulopenem date with was infections for accepted PDUFA a XXXX. uncomplicated for

Additionally, cash And pre-launch first EVERSANA, the we work with with to on of raised successfully over a quarter. in activities. end-to-end we $XX enterprise, world-class million variety us commercialization a of partnered

had FDA review meeting. the the we in informed the Committee data our June and but As an on of it they X, application, our that drug had and package more planned to was as FDA new communicated, postponing review to needed holding this therefore, time relates Advisory us

We continue to meeting, on the prepare clarity timing. for FDA and await this from

and detail some a this our approval. progressed be to further where are we'd well review I'll interactions FDA typical to to new months from data as and the drug you however, now. on of share with Importantly, a our continues application few potential expect

that sites, regarding inquiries to Over a and audits and performed audits and of addressed. report clinical of date. all have number routine those no the us been last on of number months, these data, few of noted to in has The observations any the has a sent been our requests have FDA FDA I'm manufacturing happy information

the has identified. data, have and manufacturing no been to issues date, reviewed detailed FDA Additionally,

understand a prepare work I'd far platform have with oral launch The we highlight quarter, for been recently build pre items. can As reimbursement could lives helping better third these discussions we a for in market unrestricted has a the sulopenem. access in potential The very US, of that year about commercial collaboration few XX% sulopenem we to and valuable of the XXX believe, research access done of in in US, we payers, sulopenem launch. the in within launch payer us We've million which the coverage useful about EVERSANA one in approved. us with achieve in oral to sulopenem oral landscape. Based like conducted oral understand thus was on incredibly the solid on fourth research helping launch potential plans represent if tier

research understand physician uncomplicated commenced also in the current urinary to have space. We market tract infection dynamics the

real of that purpose of sole the the of that be tract urinary refine based infection physicians with shortly, and will resistance as the commercialization in in our out provide the campaign US, physicians level in well. the our data general, will can developing the with are these with payer in are And zip to uncomplicated of codes, various unbranded targets US, territory, be classes antibiotic value use availability coverage a optimize territory we where We rolled rates currently segmentation awareness in practicing. highlighting and targeting territory and resistance finally, in world market physician of to in resistance high challenges in particular which particular the an the to on drugs, that strategy, continue work

launch on commercialization are the working on services for to include definitive and with and we EVERSANA negotiations and a coming these agreement full weeks. relationship expect with agreement the to EVERSANA the expanding activities ongoing, in currently are finalize We

in tract approval the treatment development a the next to Iterum sulopenem the discuss meeting On complicated path be requesting in for front, to urinary the few B clinical potential FDA with type will of weeks, the regulatory infections.

around in complicated but the filing missed of a important trial infections, the sulopenem to completed as discussion FDA basis three measures, focus we plan for variety tract well very upcoming, a tract infections. of where next With expect We over that work, urinary quarters. endpoint there outcomes, may the clinical our due in of and the any, what to have complicated as across we key points you microbiologic provide if additional As are asymptomatic see are to to impact few endpoints, could performed number with time including well catalysts urinary events a that regard some recall, large bacteriuria. phase already

next have so. quarter potential We committee advisory a over will meeting the or

FDA under PDUFA expect of to tract position in a infections urinary with sulopenem third NDA with year. we in And in launch sheet. our about have we’re the of quarter very quarter we and the potential third discussion balance this that $XXX fourth planned of a the the on this oral also that the have the we our million cash date. In complicated have quarter, have We solid believe having In year. we review, closing, on of

will are XXXX, our additional to assuming this able We being allow year, to later indications additional development begin into of desperately sulopenem oral further the and operate launching oral where sulopenem in strategy this expect agents approval, new business execute We without of the needed. funding. on anticipate us

Now on details Judy our financial I'll results. turn the some call over for to

Judy Matthews

in to our million costs, $X.X Operating in the million the functions, of higher quarter include headcount. general in to operating higher were which total the $XX.X first quarter period costs million Phase $X.X XXXX. X million first $X.X and The costs offset million XXXX, includes support with XXXX of the lower for costs expenses development driver the quarter million higher first CMC Corey, in in dollar category is regulatory of research $XXX,XXX the expenses. of spend by first were of partially completion G&A same administrative development our expenses our compared million expenses than program $X.X our administrative R&D expense. of in program, costs due to quarter quarter activities and $X.X for The Thanks for expenses XXXX, were on and and XXXX, R&D decrease costs and primary compared for to of the XXXX. pre-commercialization the G&A and XXXX. consulting G&A first $X.X R&D of clinical

quarter loan, fair of primary of write-off our of reason cash compared linked being amortization monthly to the our was term The reduction our moment. will we quarter on is previously The Moving was non-cash million the quarter principal a $XXX,XXX $X paid interest first the capitalized derivative as in XXXX. On approximately $X.X of for recorded the are expense following associated interest began a to accounting, SBB compared now of first basis, million value March cash due of $XXX,XXX and in financing with $XXX,XXX items. a with expense until first to term lower in in XXXX, loan related XXXX. of will which interest non-operating in the for discuss final with the at interest continue to strictly fourth XXXX interest to XXXX quarter notes in first increase the largely payment associated in expense fees which XXXX. quarter in on balance I royalty our

price for million capitalization, cash million have these reiterate, in and and recorded XXXX. was derivatives million equity driven exchangeable on on February as loss changes GAAP To absolutely investments first non-operating, large derivatives losses. $XX future, for significant market cash our the to stock adjustment which our runway, royalty million $XX of resulting cash raised end by the on to was changes of fair March, primary I Based US we the this derivatives following of and explanation, record of At a a net in is turn complex, derivatives, in had of value half into capitalization, this the price assumptions, may is financings or note. during our to in and quarter non-cash first increase on The result net a value our no $XX and it adjustment $XXX.X just, application gains XXXX. share adjustments link of misunderstood. the Our the XXXX note financial the plan, accounting short result often basis there non-cash will the surrounding there that In of in now. basis. and statements market was the is two term their we changes current on cash reason impact or in The of management's in over at

the with and funding. ability operate As tract such, if in trial for have FDA sulopenem U.S. the the urinary review, infections complicated registration approved, oral our in we a pre-launch incremental activities potentially without we initiate to believe continue complete XXXX launch EVERSANA,

warrants million we shares XXst holder. approximately X.X XXXX, share, price which of the XXX outstanding, per of ordinary an which XX.X million interest, as a notes, million at March average also at $X.XX $XX.X we for approximately of outstanding, be March, includes and outstanding, crude of can As had of million of the option exchangeable the note shares still end exchanged had

Now I Corey. the will turn back it over

Corey Fishman

Question-and-Answer like now. Thank questions open-up you, Session some Judy. would to We for

Operator

comes [Operator Instructions] Capital Our go question please Gregory, Markets. Renza ahead. first from from Gregory RBC

Gregory Renza

and of like date clarity bit you will with just you, PDUFA when or standard light just in I'm Corey, think the a as get reschedule, of currently Corey thanks pine playout. course kind and good to maybe the in morning, scheduled, a would with questions. it's little that you Thank sort color I for but could curious do this today we've Judy. just characterize sense have regulatory you Ad you focus, status Thank appreciate I any pushback expect there. with on, review, respect actions all of and timing in Com know changing, the of and sounds you. if the the It taking of my how

Corey Fishman

we can. I as mind answer whether ours. Great, now, question, definitive share, share may not on you appreciate the and I wish change of more FDA had changing we're and PDUFA I the but believe that, we everyone's our right is what times, it. changing, it. what's Greg I thanks a is on of number with will I have the information asked I know, to it, for certainly it's

a types us. know, during that along review, set a So to some is I we schedule the out reasonably number of what as to planning little a internal have they're internal process And are of get on of you it's as sense think holding of people trying not schedule, where will for the terribly those still with can definitive. meetings is you bit well I they meetings that tell of as a are, I meetings meetings stick their of But FDA original other think planned. help

to or confirmed Having whether So, timing on change correspondence to PDUFA not. it's And no or that on not terribly PDUFA of regard as for has clear to with a certainly the been or Ad we to a yet, timing there not. date said the, [Technical that, Com us, date there's Difficulty]. being

Operator

you is to able speak back us? Corey, your open. Are line to

Gregory Renza

Can you Cory? hear,

Corey Fishman

guys you me? hear Can Yes.

Gregory Renza

Yes, I can hear you.

Corey Fishman

– a you stick what and – little meetings the so other that you review I on had and explanation said internal the know, no We with so is here, did tried or meetings so FDA continuing. basically no? Okay, was schedule has us. that in background noise is to far to their hear

FDA. that weeks, PDUFA to we any we clarity would as yet, and at that least change the that have from coming be so have don't there'll to to And whether hope clarity, the a over

Gregory Renza

I'll occurring maybe anti space, I'm there infective the of have been gathering bit strategic on sector zoom perspective see curious your have anti general. your the again. thoughts great, thanks And latest how Cory. last for a in evolving? out Iterum, in deals interest thinking sector my just across unique Thanks been little That's that You're position question, worth just just in latest just with certainly I'm and of some that but a you on infective, do

Corey Fishman

about antibiotic bit activity side. I think side, on been little of Sure, talk the a a bit certainly the yeah. been when little on sector, the of there's And antifungal we there's activity

do allows little happened, the Pfizer the work. flexibility, opportunity potential now APX question think companies only of they a doing said more who's did Having not commercial Iterum both are development need the them, best they that companies reengage. commercial? at for of for in worlds antifungal of to I development interested development. both have commercial. have I acquired in offer both acquired people partnership doing to becomes, pharma whose last or can think to near couple is company, a are It but of those an And bit that, someone stage Arixa they larger the there's and with this because interested or And of they some company having deals the you name like you of

clearly not So Pfizer to anti is doing development infectives. adverse on an

have and these that have on severe there of driven by I think needs and coming has think there's particularly back able pneumonia not part of that some in of to in know little shift where products folks of way, to been it and secondary to there be marketplace. think side think the of bit of out we serve lot can you new I needs COVID for sulopenem companies with infections medical like highlighted to some regard the, as a therapies So the the And met, but been the a space, drugs and infections, provide the a of the applications the helpful on basically of not be that's still getting. today also that a of is terms community, the are also kind that of others – larger that are I know the ideal. recognizing really are And for other follow I suite to

Operator

you. Thank

Arce Our your next open. Wainwright. question comes Ed, from line now is Ed H.C. from

Ed Arce

questions. Corey, Judy taking Thanks for my Great.

Pfizer the by company. -- as acquired Corey, the way, to Amplyx, the that First, a company recently just I referring you're anti-fungal that think, is

Corey Fishman

That Thanks, correct. Ed. is

Ed Arce

Yes.

meeting you really not few And But can in to of have believe that beyond Com applications. that about in know sort to point I'm a I the confuse beyond that's was and careful stated think of about much you on that, I with to tending request, what at of another and that -- sort that, thoughts say cUTI. you've more top just of mind, obviously --not to the wanted because I application on be weeks don't get one the have just potential one I intend while that. So wondering FDA overlap past the said. the couple I to I'm timing PDUFA sort next your discuss we an NDA of not wanted and to active one Ad there's discussion future this follow-ups. you curious there

Corey Fishman

that I UTI, idea a uncomplicated was The on meeting for is if think while we challenging have we be uncomplicated Sure. for -- review UTI would it agency. asked the ongoing, more the

not we the a their so way of get And in of that review meeting we've -- uncomplicated should uncomplicated. said the

won't there we not there exact very it's is course, crossovers having But of Now, are same the are intertwined. that expectation because indication, same be elements the conversation. and certain that our are

just think we to end hasn't in weeks where request sit the us, for doesn't that's nothing meeting that the presumably of then, close on next there we this I be We day clarify, their so, XX should work FDA pencils a Again, time as that to reasonably get that time And review. and the like grant by frame. here the today, down, few said, that. been hold doesn't, gosh, anything they'll

belief our you right other doesn't it than come That's doesn't going fruition to and some send point know is reasonably at now any certainly is that. So, signal this our -- hope, that to soon.

meeting, the spot PDUFA ways sign in a review, have and needs be I the a good to review, everyone so the you we when know complication should to have quite advance we their pretty off. get And of think agree because an to in not finish FDA cUTI as of over

that review. in cUTI to time hopefully have they'll a that FDA All without impacting uncomplicated coming challenge be really our for we believe is And the by we don't months. of the entertain happening the over meeting, the

the that'll So, comfortable we're case. pretty be

Ed Arce

with covering said you payer question the the clarity as number of for payers, next recent that you The approximately is around research Thanks million completed Thanks. XXX lives. a Okay. there.

If the goal year. you lives in a and bit discussed covered that that could first third -- lives of number expand of tier having coverage on commercial the the commercial the by you tier

I helpful? what that think there. on some the from I you're sort missed seeing Any expansion be of of survey would detail

Corey Fishman

Sure.

this research which is did we standard. So pretty

go payers, what they fitting profile, are you and tier where status. looking product talk this we payer for What drug would You'll you'll and see the talk large on out any. and what based if to into is, restrictions, the about

$XX third means It's unrestricted and it. at that mentioned, about And we what authorization, co-payers for patient. And that and our so puts no unrestricted the usually we and with strategy commercialization prior there's do basically, stool. as there's somewhere in step XX% expect would the tier that no again, is, is, range $XX an to leg we the of what important our would that's

We the three is value coverage one is is legs high one of that number in the have payer and resistance territory. third rates, targets

an to to get the and pharmacy for Because important that's we be so the is us to prescription, want last have do be into thing not get And walk drug. element where the understand we placed. would someone a able

And in reassure pretty and years, resources other to pretty of regard a antibiotics result, to months spec but couple as to oral well be it's And elements other five payers. also good that products. last a are pretty our that with did, the well, probability with value And commercial with at so the we'll have have that the we three as launched research pharma last success as can set that's provide. consistent just -- look it's in clear just branded higher a the of what those that we they of

they happening is like -- not think want what is hear. the you research to want it's This that been where marketplace. tell in what you you has they that -- really So of kind this

us puts putting highest the data so position, places an and from And of in scripts we access reimbursement and lever we're sure good spot that in to commercial resources will a be really I those where that think probability getting filled. have

Ed Arce

with definitive with Final helpful. forward. with is If on around commercialization move them Corey, your question enterprise. this to ongoing That's Great. agreement approved a very for me, EVERSANA and for end-to-end when negotiations

to the wondering, get to are in the expectations need so remained think are be for resolved what's you wondering, steps agreement left? into if barriers that, I weeks, said some coming that what there just Just any that

Corey Fishman

the wanted it's on commercialization. and our No, we've that work with can question been Yeah. that to original services, since working a signed this good full literally imagine we knowing pre-launch agreement for them partner EVERSANA we and with you on

in typical process. sort So of the pre-work negotiating there to is just just this to has being partner the a a in down the months next we details this way last This getting done in that. all isn't been few and we is standing signed And believe few no up of barriers. and just is started anyway. nothing handful the agreement weeks leading of for of really getting this that with there's This and kind with

in So, get be prepared efficiently we quarter as still importantly, as we we will If the for PDUFA we agreement to does be our that And for fourth assuming PDUFA. launch. will can. signed prepared be then we'll the launch to as said, prepared stick a we've change,

we bit to little have caught time, then six don't want preparation. little gosh, we’ll go, launch and another are it's from the more What is outcome to be because a then FDA it, prepared. it so a FDA need we be ready -- months not do positive to be want don't so if bit We have flat-footed. So needed of later we

for books, approved. prepare is good the cost to going on that And you be news get that is basically going much we're after So to is the of launch. put

reps reps, offers that to like allow we're not are get contingent continue switch the to going will we ready of and add and an going that up and for be in are us a as on approval offers but we have go. soon we're So ready launched sales that reps preparing as trained approval, to will products and expense so And not market approval. to get to being put the prior launch. hire everyone to contingent looking sales we're until to It ton most nowadays the turn

Ed Arce

detail, Corey. extra the for Thanks Fantastic.

Corey Fishman

the for Thanks Ed questions,

Operator

comes line now from is Research. your Kedra Our Kevin open. G from Kevin, question final

Kevin Kedra

script I comfortable want to of part Great. about that note a of are the you're doctor did coverage likelihood the for that sulopenem indication going a Are PPAs. other how factor tier it's if that go resistance. for to things that determine that? understand Corey, the not there's a they want Will the or they specifically survey high script indication is appropriate quinolone quinolone for, whether to idea into to to really a I questions. resistant run of appropriate edits payers that third or Thanks this through back step that that maybe there this differentiate for thinking third of you tier of kind having not any -- no appropriate real between a scripts? taking barriers writes seemingly or will -- they or be guys on appropriate will restricted

Corey Fishman

won't be predominantly reason the that There any UTI will differentiation market Kevin is of the written Yes. really empirically. and much uncomplicated be

So of you and went what that got know bug culture. answer won't kind a you unless of you had

they're who've sulopenem of use outcome; putting folks, infections. category many hasn't looking at that's resistant a quinolone patients much to on diabetic bad for know And think in kind So as of, higher That history pathogen sulopenem else of, in there's causing had you time. patients failure those a that's the physicians sulopenem, payers, recommending where payers patients. gosh, the patient sure resistance in there the plan is are the giving And why long folks, it. well with side that elderly story we're that way a activity who a are a and terms brand payer with resources of highly immune when those I Remember part conversation as compromised that use wasn't. Those have that the the a resistant profiles others everyone -- why the, recurrent that's is we're had we've or to of understand know, real the it's I areas, folks, they be high. unlike comfortable no rates in been specific think this it for risk places folks we're or and commercial

gotten right be we're that. a inappropriate So not we'll trying be no patient and understand talk priority strategy doing think to that doing segregate it's this high was them thing to I has been sure they the turnout. them commercial for very comfortable helping and about our there's And want them

Kevin Kedra

appreciate the Good color.

As should far we with holding from should FDA is date expecting decision to be of as possible it of, be moving a the note, make the conversation factor without drug an AdCom AdCom uncertainty kind seems expect or it's seems be aside AdCom so. rate will expected, FDA on a Certainly, -- an the the of they're might the we that, kind AdCom along the, but that on they've, the AdCom still the an positive like as approval? actually the limiting on timing on

Corey Fishman

clear, reason They We've do AdCom FDA ability Z. oh haven't we're from one it's and not upfront don't PDUFA really don't the original good. a opinion. Y has for the have there's That is stay to $XXX,XXX line this on to to the timeline, go is us. a through we say, possibility. decision. super Yeah. concrete It's that an and they my my the to but Obviously, don't of you everyone lots question the AdCom give that need is drugs and this they say, you an have FDA, certainly or to give everything could say said This Having X, have and I hit that told the any decide been just we're that said, to be the any that, going gosh, yep, coming to reason, be FDA. about I will my from opinion on and

sign stick that that it's their I good think months think planned point, a three again, it's of a to kind ago. -- four of had trying they a planned to I your number or to they're meetings

June, schedule the AdCom and now we of to possibility. schedule That's the to end whether okay the AdCom. have we'll don't end that's to stick of an for Now ability But We're know. that. they going they certainly great, that's original an say, whenever say don't need a

Kevin Kedra

Okay.

B for don't Type that really NDA. the there with complicated, overlap as any As meeting the you far you mentioned see

NDA So the of might that where expect issues endpoints. be for had we wouldn't an with the we Ad of take part of Should of the uncomplicated? Com, that some you complicated other issues in to should that indications, set into to that you UTI the case be specifically expect tie bacteria the off you not it kind there had discussion

Corey Fishman

an I we an be that some population. quinolone up. Look, Ad in the comes there's always to is I for if UTI reality, remember, I imagine this have But in that. discuss NDA the going to resistant mean And Yeah. think opportunity there's to FDA for uncomplicated Com, would

well someone symptomatic in you say yeah, had complicated. bacteria Now to but face

think that you have XX%, make it's but of sort at endpoint derailed a which argument, bolsters is that just and heads sort our little one. this XX% you Even sense? the I have micro you, FDA in that outcomes yeah clinical that unusual scratch their of bit and rate. is Does

barrier to as So I XX the if a going well be saying their I the conversation sort done get finish having August, PDUFA. about figure up the want it with days of its the review, don't let's this they their of this cUTI. I we to to I'm because it'll May, of -- have we conversation what the a timing, not on August, in later, out us sort as they're going as okay done but that July, don't June, of come hopeful well see that review to think of a, tomorrow, that They're part advance do as They're minute a last think in end basically, in Kevin, request in be advance. And given few do. to weeks, at then get doing it's I next said, we're this could again,

there's any think don't I So going factors the putting with for in of be regard the to complicating request UTI to NDA. complicated

see of uncomplicated, I in think we conversation there barrier study that there's crosses did the have a as some big and a and I did in uncomplicated. to same in be over, we but the having conversation that complicated the way the issue of don't the review getting that -- because could

Kevin Kedra

Great. Maybe, last question.

a would three a be say in that month there's if You mentioned even still delay preparing that for QX. launch you

QX to a pushback to later. launch is comes were three kind if we in of of should the there pass, bit to be timing that months the a or or a time in cards approval launch from comes should still we months if think delay three the on of about whether that understand So QX FDA. three-month

Corey Fishman

Yes.

any So, a be, we is I people. to of the delay three that that number there FDA don't could know if months know potential has done don't where what

a only we is third the to the put to the the middle be practical with really the delay got approval I if answer you've of to think want the quarter, when this end to that there of possible. of try quarter, as early If the So push the in an short will launching be year. to the at holiday probably And is that's the is, as have reason you launch approval first holidays, don't fourth comes. season, going

the quarter would to us in reality a prepared I could the even be delay I be the the I the today, slight a quarter, as of we is and even XXXX. launch, and the about but first into pushed still, three fourth to given said, have we'll on fourth into certainly, launch hope why, if that something of know to PDUFA put think think then that's months, order what So it's

Kevin Kedra

you. Thank Great.

Operator

have further And no we questions.

it will back I you. Corey, So, hand to

Corey Fishman

Thank Great. you.

good working feel the strategy in So, and Iterum. cash today. on to feel for product execute about sulopenem We our appreciate in questions. and hand develops solved for like I and transformational our thank oral like approved concerns do capital. progress I it, get into no our to is that year everyone further appreciate towards the the have cash first closing, and for indications, a we for first getting We're time for just on your this launch have sulopenem really need being, indication, with time really XXXX importantly additional really other

look we sharing as forward very you with So more updates are. we to progress we about and our good them. And we have soon as feel where

So, time everyone. for thanks again the

Operator

today's for joining. concludes call. gentlemen, and Thank Ladies this you

lines. now your You may disconnect

Iterum Therapeutics (ITRM) 14 May 212021 Q1 Earnings call transcript