ITRM - Earnings call transcript Q4 2023

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Operator

Hello, everyone, and welcome to the Iterum Therapeutics Fourth Quarter and Full Year 2023 Financial Results and Business Update. My name is Emily, and I'll be coordinating your call today. [Operator Instructions] I will now turn the call over to our host, Louise Barrett, Senior Vice President of Legal Affairs. Louise, please go ahead.

Louise Barrett

Thank you, Emily. to Results Fourth Call. and welcome Year and and Financial XXXX Business morning, Iterum Quarter Therapeutics Full Good Update Conference press and fourth issued our our release full The was results website. quarter earlier be can and morning found on this of

joined opening Chief Officer, to We financial provide on remarks. and Judy this Corey Corey Matthews. results, by Officer, we'll our line Financial will Q&A. Chief Judy morning open and will Fishman; our are Executive our provide the then some details

of we on will XXXX; you plans, information statements the of Before received our like response some that ability sulopenem; remind letter our our efficiencies for the the the begin, development, potential to in to this I'd FDA expected complete business, therapeutic of the including from strategies concerning contain presented by and timing July to and NDA; prospects oral coverage call the fund by expenses set the intellectual otherwise process resources review off market term to XXXX; conference expected our of address the resubmission out or property forward-looking of to sell, provided cash sufficiency the the by value. of company's the into and and strategic resubmission patents our rights; to our right timing of operating -- the its dispose maximize license our shareholder sulopenem and other FDA; in

approved; uncertainties outcome, on a or the public accuracy will regulatory statements of terms, and results regulatory including one of listing our fund ability effects Capital changes expectations the concerning costs filings results and hand timing regulatory to of on those timing, report with on cash uncertainties our Actual and and forward-looking oral and NDA the how initiation morning. Risk ongoing commercialization lines pursuit sulopenem maintain and and the resubmission alternatives, under annual value our regarding by our factors the as potential in time policy benefits or the structure, plans sulopenem; design, the decisions is into oral our our changes if whether to filed clinical likelihood or and terms far attractive conduct and nonclinical other NASDAQ result impact, approvals including the for the risks of including complete from outside on future process; strategic in legislation, Factors all; all, or the in may differ authorities; our at inherent materially various this strategic factors requirements our these XX-K of of at development; operations; control, ability of on of discussed of Market; any SEC caption Form our indicated

views represent as be should In any our as our upon as of call obligation update of views addition, any relied only forward-looking such to this specifically not and statements. of date. subsequent We date the any statements representing disclaim

We will also non-GAAP during measures the referencing call. be financial

your this opening non-GAAP said, have reconciliations it reported over for now, you I'll We of to to adjusted turn With remarks. their in provided that issued press release information Corey, morning. GAAP

Corey Fishman

adult tract REASSURE Phase Iterum a trial. called Thanks, XXXX Overall, for for infections urinary of a Louise. trial to like thanks confirmatory and with good Good was XXXX our us clinical the morning, very our III milestones XXXX. activities women provide enrollment brief and year I'd and uncomplicated today. we key joining outline for completed in in recap as clinical

oral the trial Special reminder, oral a sulopenem and Agreement Augmentin. under to Assessment compared this FDA Protocol As was conducted with

the eradication trial's which with is at noninferior to response, cure were plus combined in you oral respect the intent-to-treat, of know, microbiological, many As susceptible was the that endpoint, primary clinical pleased which population. visit to trial was modified, to announce recently very that microbiologic we demonstrated REASSURE the Augmentin the sulopenem test-of-cure overall

also for patient efficacy endpoints. same key showed population. Additionally, Oral consistent sulopenem secondary statistically superiority oral also the sulopenem significant all in Augmentin to demonstrated

sulopenem a Lastly, solid demonstrated very safety profile.

sulopenem. obtained With We Pfizer, XXXX. regards now addition earlier to expire of granted in opportunities have original these to tablet Korea, we the to our oral the the in-license we to long-term of to issued continue bilayer of patents composition with license sulopenem patent patents patents estate, will agreement directed sulopenem in and seek Japan, U.S., no protection in enhance the the the Australia, than

earlier the no in due of multiple is patent expire treating of to use XXXX. to We sulopenem including infections, the U.S. also diseases, uncomplicated have in which oral method an than tract issued directed urinary

in-licensed applications believe patent Europe long We that a In our plus we allow and the addition exclusivity runway oral patents patents, a have in value. and the other U.S. and China. data these pending issued sulopenem to including potential capture number would of to jurisdictions,

tract XX estimated about target. market elevated with I'll prescriptions bit estimated large The the is patients, a quite which sulopenem sulopenem the are spend those which moment just see an a that market approximately annually million in and U.S. the It's for potentially entering. are talk now risk that dynamics urinary of we would uncomplicated prescriptions X/X into patients

in in urinary profiles. approved, first of resistance increasing urinary would impact since for are well the experiencing sulopenem the new exhibiting or and safety diabetes, first be infections If a significant new, rates infections approved the Elevated their for recurrent efficacious U.S. and oral one immune products penem century. risk of patients of treatments elderly the oral patients oral existing turn safe with with high uncomplicated infections patients treat as the United tract that patients as States oral products comorbidities uncomplicated subpar tract that need the as older approved system. to have history the a and negatively There's are branded

the received take first half letter in Provided quarter resubmit resubmitted the we the milestones, upcoming resubmitted year. the first we FDA the response the of complete complete our this review our the addresses expect in and the quarter NDA the NDA. half fourth in would Regarding of be we identified the of the which deficiencies in received from FDA the second all the its plan of this year, FDA that July to from XXXX, NDA of action months date will X FDA to

look operate have the we on cash our on company quarter current of through the we and fourth the in XXXX. to position, hand based PDUFA cash early plan, our at into operating As expected XXXX date

with or dispose value have the of Lastly, sell, as strategic engaged previously for goal to Board adviser otherwise a maximizing assist alternatives. a and evaluating in our the to stakeholders stated, we to our financial process have initiated management of sulopenem rights license and strategic

we of further disclose process, until or further timetable intend and determined a unless to this that evaluation disclosure do completion not set not has necessary. Board Our developments and appropriate is for is it

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

Judith Matthews

the Thanks, and to million $XX.X in Corey. $XX.X and expenses development million full million $X.X Operating and operating quarter full and and year in $XX.X XXXX expenses compared Total quarter expenses. research expenses XXXX. administrative million the and were fourth year fourth general and include

to for were XXXX. $X.X support the fourth October enrollment was October completed year enrolling the quarter $XX year driver the XXXX, in XXXX increase in and for and million expense XXXX costs in in cost for enrollment which and our quarter period and began X,XXX R&D REASSURE trial, full $X.X patients. same the fourth for compared The million primary R&D million of million to $XX.X the full

$X.X in of were $X.X XXXX, costs. back primarily $X.X with is Full in and in costs to million in G&A quarter legal costs dismissed due legal XXXX, means the lower G&A expense $XX.X of lawsuit filed rent costs XXXX, XXXX, lower million directors, August $XXX,XXX prejudice January insurance year to which court. which lower fees than share-based million quarter case associated of is be was fourth primarily and costs compensation expense cannot million costs, G&A and for the due lower lower with the in the G&A fees million lower were fourth $X.X XXXX, which decrease in which of in than XXXX, to brought a insurance employees

a year. net full and a loss Impacting basis U.S. for of on GAAP net of the fourth million XXXX year million the noncash the was Our included million $XX.X $XX.X full quarter of $XX.X loss adjustment with runway, for was was I adjustment value in There cash expense which a and in assessment notes. linked other or royalty in moment. impact cash to on turn this income connection will of our no the fair

were noncash loss and in the net of enrolled trial non-GAAP bulk On The result million and of our XXXX. million a loss $XX.X primarily related and $X.X certain excludes to quarter of increase REASSURE million net adjustments, year $XX.X higher full our our year million and non-GAAP and expenses $XX.X which R&D loss the million XXXX. for XXXX compared quarter full the in patients basis, million a of was $X.X quarter fourth non-GAAP $XX.X X,XXX the and the as fourth fourth year full to our in net for

quarter had December, including PDUFA amounts under half cash XXXX. cash the XXXX, cash, equivalents fourth and of of short-term into will of current the our At including of end and on million, through agreement of based February provide plan first ATM $XX.X the date which raised the operating our end through runway we XXXX, investments in expected the

FDA, of or the the resubmit the X to uUTI the X second XXXX half in NDA treatment weeks. sulopenem quarter of over expect the We of oral for next to to for the first

of February shares approximately be February of X.X million exchanged as we the had XXXX. exchanged $XX.X XXXX, of million we had exchangeable will approximately prior million XX.X the shares. As are obligated to accrued ordinary outstanding. XX, at interest of for which notes the approximately to XXXX, pay notes Also in end maturity, million $XX.X option January not the can noteholders be the of outstanding, plus noteholder we If

to will Corey. back it I turn Now over

Corey Fishman

open now. the go for Judy. questions Thanks, and We'll ahead line

Operator

[Operator Instructions]

Our Ed go Arce H.C. Please first Wainwright. Ed. from with question comes ahead, today

Wing Yip

Yip, everyone. This Thomas a for of Hi, is Ed. asking questions couple

as into cash like just any wondering, question fourth have to you that PDUFA do dates you strategic XXXX. considering seems first your options have, It events decide the have you expected we early in So triggering quarter is on runway some or and specified specific [indiscernible]?

Corey Fishman

how events question. take don't long whether these something is out any options to is counterparty Thomas. know on or Thanks, the the primarily interest and just process figure have dates triggering and that as of there's folks a We to side takes. them that Appreciate processes because, know, required regard strategic to don't time with we most specific whatever

disclose, we have time talk the because course, said So there's don't something appropriate to on any we're and until not our we of dates or then, do remarks, that. if about specific when in of time, as But each to it going on lines will, calls that. we at our

Wing Yip

carving consider it's the resubmission for while in areas still indication-specific option Will whether an consider understand as out you single for sulopenem as and for should indications up Perhaps Will the other that Understood. uncomplicated well? consider also geographic timing UTI. air. we you as NDA it's understand details, the package? we Or we sulopenem

Corey Fishman

and It's of conversations Yes. those flexibility depending good fronts, all how on those on question, we another go. have

You bring well. as and good There up a potential on potential different very carving for areas indications up there's depending also on other transaction is point.

have all yes, company looking flexibility conversations of potential for. again, all with of parties they're what we matter any options opportunities. those the answer is So consider on to But the as just a And we'd side. certainly as or it's other short the

Wing Yip

to NDA the We look resubmission. forward

Operator

The Maxim McCarthy next Jason question from Group. comes with

Jason Mccarthy

the the still guess, ahead the of divest is practices, to divestiture of or line sell about any seeking and type license. I an or Iterum sulopenem engage partnering? to getting educational getting planning talk focus to or their and finish actively done, is physicians Or NDA to level just Cory, on

Corey Fishman

is the for I Jason, parameters commercial side course, could, ongoing Thanks, a There to the manuscripts, be strategic continue we us present work opportunities. the awful the with a lot potential point, Yes. put is we which help an primary on physician commercialization, be to which time. refine will do ongoing at of counterparty continue see by to don't you'll like at a of to focus still the at world. together cetera, down going get et that ongoing the as this is think That time spending question. in little out. be the The and conferences, used bit things of around of out also sulo. appropriate message will, of But course, continue road

Jason Mccarthy

antimicrobial But for there's Got it there it Obviously, in Act, qualify in Congress And bipartisan drugs?" couldn't "critical get pure of days. in the by sulo And a the done be out heard should qualify PASTEUR Congress. under is getting it. getting closer of or ultimately cleared challenges need things wonder kind one bills if that that if always discussion the and does Senate, that is in and it's sulo I've could I closer. these

Corey Fishman

on like as have anything that of Act. critical well. qualified the for sulo I through applicable that product the infectious much I the coverage designation would GAIN pathogens, through would because those come FDA Act disease believe it's from Yes. that PASTEUR got under would believe be sulo the we

Operator

We call for the have so back no further to turn questions, closing I'll remarks. Corey

Corey Fishman

Iterum Thank will which during and FDA treatment appreciate market XXXX Thanks infections. in we a today. toward tract to include to eye you NDA physicians forward day. will an for strong looking and you. and bringing review year We XXXX, joining important was us the -- working urinary the the period with patients of again, underserved good for oral this potentially have uncomplicated sulopenem a with we're resubmitting our which

Operator

call. you, joining our us Thank for concludes This today. everyone,

disconnect now your lines. may You

Iterum Therapeutics (ITRM) 28 Mar 242023 Q4 Earnings call transcript