ITRM - Earnings call transcript Q4 2021

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Operator

Hello and welcome to the Iterum Therapeutic Fourth Quarter and Full Year 2021 Financial Results Call. My name is Alex and I will be coordinating the call today [Operator Instructions]. I'll now hand over to your host, Louise Barrett, Senior Vice President of Legal Affairs. Over to you, Louise.

Louise Barrett

Thanks Alex. to results fourth call. and welcome year and and financial XXXX business morning, Iterum quarter Therapeutic's full Good update conference press morning fourth was our on release full site. A results year our quarter Web issued can and and this be found earlier with CFO. this our by Judy morning joined Fishman, our We're and CEO; Corey Matthews, Corey will remarks. provide some opening will some details then the open will Q&A. provide on and Judy lines we our financial for results,

concerning with and in resource matter of I'd complete begin, of the reach strategy. respect agreement of including; for the indicated set timing sulopenem, will response like forth FDA ability to plans, with that for measures with our third-party design research trials, our into you our regarding or manufacturers, suppliers of changes legislation, operations, clinical prospects our call the organization, likelihood such filings a impact statements our or Actual those expectations regulatory thereto, our proposed and COVID-XX and differ to including from on communications on statements with the sulopenem, letter hand the approvals, carrying materially just SEC, sulopenem, forward-looking development in in far sulopenem the XXXX clinical remind these on received of response to risk approval and public our the capital recently the other the potential by of ability most including additional our execute related post oral and cash in contain and our regulatory this on to regard our and forward-looking the accuracy Before oral the clinical the of listing our maintain with markets in clinical our of interactions the including future resolve actions initiation to of trials, mission report future and how out the inherent our of including NDA various clinical strategies policy development and of SEC conduct important ongoing NASDAQ of clinical result obtain oral will development, out and our July we timing to potential of sufficiency or availability on uncertainties annual lease and the FDA results for factors may to conduct Form to business, fund timing as ability planned from of and filings the XX-K. data factors the expectations cash and requirements, set filed clinical

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

also be believe with financial measures non-GAAP We the during GAAP referencing in We of the these will the morning. GAAP and press our reported to when measures adjusted under issued this call non-GAAP release facilitates of and results remarks. said, Corey, reconciliations viewed have additional presentation by that provided over it turn our and results I'll management to accessing and our analysis you, in period provide your information that and With reconciliation investors, accompanying from supplementary for period. to our opening the information useful analysts performance

Corey Fishman

proposed XXXX planned allowed proactive cash extend an amount us you steps continued conduct by of extremely substantial a streamlined our and subject to have final to thank XXXX, we runway highlighting in the with XXXX, to the Louise. XXXX conference We our of about determination support, additional events These the oral XXXX operate non-clinical cash Since sheet. balance today and begin to the FDA. later resubmission on fashion. out the into in share. I'd like joining discuss cash and more ended of organization there and to to and in detail million development sulopenem, of that of design that I if are I'd of for end year-end Welcome NDA $XX development Thanks our to Great. us like call. to the will two clinical which on successful, significant carry of additional our raised call,

have repaid debt bank balance with sheet. Bank, term the First, loan fully Valley we outstanding all no on our Silicon at and now

March, early XXX-day this requirement. relates to a reverse affecting as share regain if by extension NASDAQ's compliance to now it price meet requirements, minimum to this We have necessary. Additionally, bid compliance we including with requirement, September a split Xth in with received until

On the FDA discussions package. and have front, talk work a clinical potential with the meetings resubmission support additional our substantive the to three held over agency to of we the last of about few required the months, number

our resubmission those the based they clinical successful, has X NDA. existing infection, should package, additional Phase uncomplicated Specifically, study tract on require discussions an the with of date, which, if FDA support to data stated will urinary our along in

been year. the potential is of proposed enrollment a this working be study to diligently NDA. for design second timing top-line the on with of second and successful of our to plan high hope level we'll Once for this its successful, we finalized, likely timing availability are this clinical the finalizing parameters, details in the in Phase details if resubmission finalize and additional the outline in and of that this study the conduct the If for are study We quarter, with has study specifics in study we including and completion the of sulopenem an timeline X to half the of expect would in of a provide align in the study study, FDA begin oral position additional relevant to the second of quarter. data, the

sulopenem urinary we Also, elevated to their As with we'd work path the in uncomplicated the infections those before, can we of patience thank and to believe patients our with infections. stakeholders the as resistant our oral define play and risk diligently in important FDA have community like for very that said forward. treatment we tract role for patients investors

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

Judy Matthews

lower in Total and Corey. were quarter the year prior based include CRL increase the costs compared costs higher to Phase million in quarter $XX.X $XX.X in XXXX. of year primary R&D $X.X million noncash million expenses costs XXXX XXXX fourth The $X.X the asset employees due same headcount. development million were to expenses quarter and of amortization in R&D million full in Full million $X.X X the were compared operating R&D in Full expenses. $X.X fourth in our fourth higher July were G&A and in was the million as share of compensation of G&A XXXX receiving for result compensation a primarily completion directors. through costs G&A versus the in XXXX. year fourth of period the noncash consulting XXXX, to in a to XXXX. million an in quarter Operating the of than pre-commercialization $XX.X were million XXXX $XX.X activities and compared XXXX of by million $X.X $X.X for G&A quarter and research on and higher to trials half to $X.X costs or $XX.X expenses increase driver of spend partially XXXX costs million million year $XXX,XXX $X.X for the fourth full intangible million which first for in administrative and million offset of and XXXX general Thanks higher expense, and is based a XXXX. due XXXX $XX.X share

interest interest with the of exchangeable quarter in December quarter December Moving the On the on lower compared strictly million of interest we $XX.X interest principal in on $XX,XXX expense basis, month. payment, continued our our fourth to XXXX million our loan items. $X.X the the the is XXXX. amortization paid XXXX Interest loan notes was balance a of lower until of with million $XX.X reduction made decrease XXXX XX, outstanding primary in of to expense million cash non-operating fourth in a began was this $XXX,XXX fourth XX, The in monthly reason due largely XXXX. XXXX and term cash quarter in which term balance fourth approximately of quarter for to of earlier versus was as as to of XXXX. SBB as quarter associated for $XXX,XXX The fourth noncash versus of the expense $X.X related approximately final

a impact year on had on $X.X in and a full million clinical SBB discussed. spent on year. of value in cash total operating made of loss non month of as And non-GAAP repayments we the At On fourth our exchangeable I exclude we XXXX. Our and million a final quarter $XX.X as $XX.X the end we XXXX, And of approximately XXXX basis, million full for non-GAAP year the The expenses adjustments basis million $X.X subject will on and XXXX million. in full year to which $X.X $XX decrease adjustments, our also December, average the approximately net per net or compared have of fourth or Based noncash a turn full XXXX. US design in by earlier million basis. primarily the no operating cash at million lower term recorded certain loss notes into spent year The we for net payment the which was year the and loan for nonclinical totaling business fair to loss was of driven quarter $XX.X and of of of cash sulopenem, fourth current was runway, $XX determination mentioned, loss March. final and our the the SBB to planned and net made for to conversion net cash a efficient on investments moment. $X.X additional XXXX. million was $XX.X $XX $X.X quarter million. approximately short $XX.X in result and our loss potential and and million previously and and $X.X these as in million of of conduct plan million time million million the GAAP previously quarter an development operating Full our XXXX full adjustments There fourth of noncash for of GAAP $XX.X was million cash

allow successful that proposed expect NDA to the our FDA uUTI. cash a oral sulopenem the carry will for to support sufficient resubmission additional of we development be existing of to to such, the treatment us As out the of if

accrued includes an Also As and option exchangeable we for warrants of had at outstanding of shares, million notes, million have of exchanged outstanding. interest end as share X.X price of we million XXX approximately at $XX.X the December the shares be note million which ordinary $X.XX which approximately XX, XX holder. average of the XXXX, of December, per can

will some turn Corey back to it I Now over for closing comments.

Corey Fishman

you, We'd line to questions. the for like open now Thank Judy. any

Operator

Thank you [Operator Instructions].

for question of open. Ed now first your today Ed, is Arce Wainwright. H.C. line Our comes from

Thomas Yip

This couple Ed. is Thomas Yip asking of for Perhaps first Corey. for question a questions

Phase this yet? year. of As size obviously endpoint the in the Can you idea drug primary a important finalized most starting have rough FDA and half comparator year on X a the this and us second perhaps been study with give

Corey Fishman

soon today We continue except the previous have we finalized and of the to be we other that The that, I that to course, to that micro. study, agency that, endpoint we has the it all mentioned, information And that of we'll we be as a have happy you yet. next But here in what hope as been as of as on. the have clinical same aligned details combined endpoint far in know would with as discussions of yet. endpoint the been sit is is to as and part uncomplicated you. the quarter. as not with agency finalize finalized not UTI provide we love will And give which was to And

Thomas Yip

tell study on estimated Phase perhaps that. perhaps you relative new perhaps X and completed the to study? uncomplicated And the this UTI timeframe Can Phase follow-up us X of costs

Corey Fishman

the for parameters to, the you those well really investors fully agency. the don't It's course, defined I'd it only that down give course of with veracity that of answer. as like a we wouldn't know And that do And therefore to for projection us nail to a yet we it's because have we have little and that any tried I'd as FDA. hard with little frustrating, don't

give cash change balance the as could as months. want So on up, cetera. at a next cash the of of sufficient will well believe a something to to how course we But size I wouldn't to tell get that cover should the pretty that outcome is the XXXX. current agency suffice We that that regarding our Judy et we And have you say, derived chance that's to into important study, have think that the mentioned, I in finish study with one depending comparator, the elements good I the and least. that thinking couple of us

Thomas Yip

Judy. that And repaying tell one payment, the notes. the there's Perhaps outline Valley release, and repaid was confirm primary Bank for In that the final is you rationale question you loan amount to rough can us just want XXXX Silicon what the for press the loan? the

Judy Matthews

we off loan. term the said it SBB So the pay you

the we well do as So exchangeable notes, the call. during which have I mentioned

to only out shares. started million So now we other $XX.X million converted we people $XX have outstanding, and $XX.X had with the had the year million

interest will due in one with no XXXX. that be So convert if January $XX.X million along else

Corey Fishman

Corey, add some Important are be impression that the redeem. this to that. redemptions conversions the has sounds anything just that note are or like Those Thomas, those notes holders. Iterum may to paid we paid Those is to not to cash you by it under And off. because of note

early as distinction. them. we during that's said, any cash are and folks of did 'XX, the a And convert those redeem number to those of Judy But pay part So important notes. an not did convertible

Thomas Yip

repaid So million so XXXX, plus it the March was approximately to loan, clarify would year, amount this interest? the that be XXX.X for

Judy Matthews

of about paid talking million year, December. SBB year. only that term that as first This a We one We this had and off half we if about the outstanding quarter. this you're had loan repaid

the So gone. million have if would has do $XX.X it, back that we that pay holders the in January not note Again, exchange to XXXX.

Thomas Yip

month March, about I So in $X.X the earlier would guess amount this that repaid was million? be

Judy Matthews

Yes.

Thomas Yip

look Thank again appreciate our much X. later you Corey, also with clarifying starting trial this you Thank forward all so for the We to for that. details questions. we year. Phase taking And

Operator

We have questions no further for today.

Corey for closing any So remarks. Fishman I'll hand to back

Corey Fishman

you. Thank

by close community oral our for resubmission. the additional the you of confident joining patients today. Just physicians the we call want remain We to needed collaboratively work and FDA will for clinical to NDA conference in with value to continue saying provide we a in the data both appreciate sulopenem and potential

We study, expect And more we a of to existing resources to you additional such as the subject details great to and they in us become the cash Thanks, final determination out our allow available company sharing design to proposed into the operate day. forward clinical carry of with coming study. to XXXX months. the have look and

Operator

Thank you call. for today's joining

You disconnect. may now

Iterum Therapeutics (ITRM) 28 Mar 222021 Q4 Earnings call transcript