NBRV - Earnings call transcript Q2 2022 | Nabriva Therapeutics plc

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Operator

Good morning, and welcome to the Nabriva Therapeutics Second Quarter 2022 Financial Results Conference Call. [Operator Instructions] Please note that this event is being recorded today. I would now like to turn the conference over to Dan Dolan. Please go ahead, sir.

Dan Dolan

Thank you, and good afternoon, everyone. call XXXX where business earnings conference the be update. Nabriva’s quarter second and to and we’ll webcast, discussing Welcome providing a website, the Events The on Presentations section. found presentation today’s and the www.nabriva.com, company’s under in slides be and tab are Investors can for the posted We you the refer presentation be we will recommend those slides that using for to as today’s discussion.

company. conference forward-looking begin, like to uncertainties to that that differ. our the date this as reflect would statements subject Slide contain remind opinions Please statements will I call of statements the X, on this webcast risks Before that of we actual and are could note These about results only forward-looking everyone and these cause to call.

expressed detail forward-looking from XX-K revise other those by any results Forms discussed periodic to outcomes in results release We on filed the to reports events. our forward-looking XX-Q and or SEC. statements actual materially recent in in Form no or revisions of these our with that will on of new such filings information Factors are or differ statements X-K most light future and obligation the to in or cause implied publicly could undertake greater

Turning to Slide X.

to quarter. I back Ted Officer, Schroeder, our the leads would will run through before present Chief the final today’s commercial then session. CEO, over Let’s review and briefly with some to provide financial comes agenda. Nabriva’s I now business the turn commentary start from Ted Q&A Executive highlights update Ted a call a will an with of Schroeder. like and Nabriva’s overview

Ted Schroeder

our you, afternoon. thank this and Dan, call you, for everyone, joining Thank

quarter. demand prior of well. the in performance the to business position SIVEXTRO’s accelerated performance in quarters continued Our continues quarter theme strong the growth from second

I presentation. top growth driven parallel, areas business each continue We resulted burn, with the our we in three the to versus prior This improve more and in creating get and improvements growth XX% SG&A clinical commercial, in versus development in prescription XXXX. the position. move the key this is In We business expenses Dan all by later to about line of we double-digit the all forward. across XX% these significant move areas: further the quarter work same will our will in highlight efforts financial forward hard very development. SIVEXTRO’s operating into demand continue growth. to declining It which We presentation. detail encouraging focused also saw momentum as later see efficiently achieved year,

to have to I Slide the on it’s the X. positive and we’ve believe this had impact important Turning changes they business. remind made the everyone of year

provides April distribute As for XXXX. we to stream to will with extension you serve continue as extended SIVEXTRO least at at promote our us Merck and agreement This revenue foundation through least U.S. the recall, more established an X.X mind, in on focus of with commercial X, SIVEXTRO runway efforts over the years. our bringing beginning additional X,XXX to our extend commercial nearly and realigned X,XXX. date. we total from our to adding have in With this SIVEXTRO, built universe targets our target the we execution

experienced the I that benefits in and will have here from expand quarter, realignment We second later. immediate upon this

more streamlined of expanded the program. sales the role dynamics program its an the managers line sales the a ago, have further And we representatives targets. brought we A piloted success, to in-house, inside help evolving we expanded sales inside uptake and based with accelerate in to in We and sight so upon believe extended SIVEXTRO’s representative communication also nimble our district year enhanced field. be we provides of responding which can

prescribing the inside from is focused both keep the generate increased approach, simple: more frequency new use representatives our high a with and with strategy expand current targets. of Our and targets SIVEXTRO sales

our we As as impact year-over-year is realignment in an XX% quarters. surpassing had This historically infections our demand more of our this commercial SIVEXTRO immediate you been The strategy, impact what are posted very we the on that QX demand promotional through ‘XX beginning. since for put place over over to growth, efforts. on on promotion. the the even see acute skin take and we to retail performance. has X Slide significant year the X, prior by has and bacterial to another ABSSSI, This skin the prescription outlined were real season since demonstrated has or I reaffirms continue with consistent poised of confidence from brand The sensitivity high and year-on-year refocused -- growth strategy Nabriva can brand. in continue earlier took growth efforts peak X,XXX of the work structure momentum with execution the the promotional had for brand we reengaged in SIVEXTRO prescriptions the advantage in encouraging

Turning to X. Slide

let the we alignment implemented SIVEXTRO. First, discuss me for briefly new

more we Specifically, on demonstrated prescribers, early XX% SIVEXTRO QX in target of including second ‘XX. dermatologists, nurse primary we doubled podiatrists, the demand key by writing with the PAs our in of impressive two reach ‘XX, prescriptions prescribers by new seeing In our or QX, quarter. target, and our the target practitioners, to are growth In QX reach versus writers, sold driven physicians. than care those over already quarter, more SIVEXTRO returns XXX refocus our for with increased

and the and time. early result encouraged frequency are drive We reach expect to over growth increased the by

further program we prescribers. additional which promotion X, are initially on focused sales We that On continued space well representatives, has a targeting initiated a geographies growth white our we positioned of potential for SIVEXTRO the pilot X,XXX confident inside are Slide work been by year ago, approximately supported SIVEXTRO. with potential

representatives with reps, space the utility of now effectively you we SIVEXTRO plan been field-based and white of their a of are inside X,XXX We to sales on, expand inside nearly potential covering sales have potential prescribers XX,XXX of combined consider were by number close to ways. encouraged reach activity representatives to prescribers. the in calling date When the the

reps geographies, assigned driving representatives. to made now addition additional by to in our by the writers support making calls districts help field-based calls In will will provide sales high-volume They for demand white between in in coverage. insight with also increase frequency vacancy the space

As so the for increase reps continue of field-based to calls their mind ISRs the remains in the keep additional reach high provide top prescribers. will universe, frequency expanded to SIVEXTRO

of XENLETA into X Slide financial hand large intravenous a team oral tough biotech an part pleased of to We’ve business for formulations environment. just I’m we income to of for had companies XENLETA XXXX and to will one This Er-Kim XX. Er-Kim, double-digit and presence of a also distribution with a yet geographic generate in for Moving execution it especially asset, countries. the terms to now countries to over announced XENLETA. in a highlights Under patient leading exclusive partner executing transaction for the another distribute weeks in a and to our taken additional we of Nabriva for with This agreement agreement this goals through update. macro be Dan international X significant passive Nabriva markets exclusive named opportunity may expands gained unlock such our for rights program. entered in the Er-Kim XENLETA. distribute with Er-Kim. ago, to supplier royalty XENLETA usage for I our X development exclusive territories. will the the an agreement, these sales provides steps value for on a

Dan Dolan

Thank you, Ted.

by reduction, operating in second X% current sales expenses and in driven increase did XXXX. net in growth reduction XXXX of Phase our expenses metrics a key sales of quarter in in of Slide decrease net reflects a current payments positive year-on-year of switch consisting the XXXX enrollment of onetime in operating moment. the I’ll XXXX grew versus million versus a a the double collaboration a financial the you cystic Other for milestone on $X.X quarter, million the XX% of revenue I the our this Total the of continue versus early of our quarter expenses sales. XXXX. XXXX. the some of decreased digits SIVEXTRO second Net summary will same $X.X slightly notably, more and improve in a XX% in a touch primarily XENLETA. quarter same $XX Turning The recognition fibrosis percentage NDA. ended of due to Within in our period quarter R&D our June impact most prior SIVEXTRO small to quarter the April XX, to cash the SG&A for Nabriva and to second period revenue SG&A the of revenue see trial XX, have burn, year XXXX which on versus in leverage ago. the to decrease X is months to operating the grew million, versus

also Hercules second with began April this $XX debt us exited prior million, quarter. down X We cash runway year, paying the We maintain the enabling of guidance. to to down cash approximately our on and in cash $XXX,XXX of quarter over with debt pay equivalents our of

Moving second to continue XXXX. ahead of to through focus quarter to our Slide XX. of I’d on like cash the burn operating the progression

was year-over-year trend burn sequentially continuing Our and million current operating $XX the positive a in cash quarter-on-quarter. quarter,

ended came months to ending June For XX% X burn months by operating cash X XX, XXXX. down our XXXX, compared the June the XX,

on compared to The SG&A XXXX, XX, months remarks. quarter I’d some back by our the our the burn in a of trend as period turn Sequentially in of operating and down call continue X came our XX% burn versus through came enhanced operating positive the same additional XXXX, continued the leverage move For tight to the for growth quarter SIVEXTRO our operating by June Ted like and operating to benefit over first down ended our second of XXXX. controls burn spend XX%. XXXX. we

Ted Schroeder

operationally Thank quarter, macro Nabriva tough you, in solid another to a execute Dan. continuing environment. had

turn remain XXXX priorities for we to XX, As unchanged. our growth commercial Slide

recently uptick the prescriptions by continue business sales SIVEXTRO development the the off to strong of date agreement and XENLETA for agreement opportunities with SIVEXTRO’s execution the distribution reflects Er-Kim. organization marketing The will focus to our build demonstrated extension and progress on We efforts. commercial to capability announced in with

XXXX. Phase I in And trial this for half in forward underserved with generating PK how our fibrosis of population. communicated has lines for expected date, with progressed tracking we safety to with line first to patient are data the this important and look cystic we our enrollment Regarding XENLETA, time data previously pleased

an with that its action. novel of Lastly, opportunity approvable we represents drug remain mechanism and an confident CONTEPO is

a We when and as we know FDA continue the us the CONTEPO. move and how overseas potential the NDA for we consider eye we to on package. are development keeping evaluate has a CONTEPO our of forward inspections, We situation close resubmission some inform initiated to timing with

NDA, the XXXX. of reminder, provides to a resubmission time which As were on granted through an extension any June at Nabriva we flexibility the submit

As asset ahead as Slide our we can an with XX, have potential the SIVEXTRO look to for asset value core story. serve with we growth that foundational excellent

take multipronged to approach We with continue a XENLETA.

the a pulmonologists to we U.S., have opportunity the indication patient for continue focus population, to We on proposition million-plus X CAP which presents the an in a brand. and create value for

to that more patient population the to provides fibrosis are in opportunity We trial, XENLETA. medical finalizing cystic address and I create which for another with close the value enrollment Phase need

goal progressing patients and NDA the recent adds in is for asset China CONTEPO, drive we The streams with value royalty add multidrug-resistant late in deals an with our Sunovion outside an being anticipated Sumitomo unlock more have catalyst a submission infections. finally, tract China continue as with with And help future with deal urinary XXXX. potential to our and to to with to million in in Our growth is a existing for Er-Kim opportunity Dainippon commercial Nabriva. near-term a to portfolio treated expected XENLETA in to to Canada U.S. approximately X approval still third complicated mid- and

the with the to the we for in moving turn first line would like operator of Q&A made progress and I call forward progress over the you upcoming that back to we during excited have the that XXXX, the very continuing so forward and look we are our the open to now can quarters. momentum with We session. half sharing

Operator

[Operator Byrnes with Our question from Markets. Instructions] Northland will Capital first come Carl

Carl Byrnes

bit the to couple Merck which a you Congratulations $XX million your the us And timing in of think back SIVEXTRO guidance when I progress. a if give get I on were million, on follow-ups. have I’m wondering levels, can kind of then the range? $XX you think will of of

Ted Schroeder

Yes.

expect get discussed as So this year. there we’ve previously, Carl, to we

the get range think year. before trend that $XX we on end So sales we’re million $XX in gross the line million to us the will of the to

Carl Byrnes

Er-Kim the give and little in other Can respect with to you maybe and this unique licensing that us to what detail more to next? I Excellent. of year it’s respect And then agreement. contribution turning on a with know recognition be a agreements. bit revenue types would economics

Ted Schroeder

to Yes. -- Dan, questions do rev you rec and about take all revenue want the that? the

Dan Dolan

Carl. Yes, distribution a the more of agreement Thanks, of for Er-Kim traditional Sure. agreement. is kind

So territories in will us they’re we’ll a significant sales revenue over net those short recognize become in those a territories the in royalty supplying those pretty we’ll recognized sales stream on also when start but making made. We expect don’t the And do product much, could for to be they time, term. it all too territories. be when

Ted Schroeder

Yes.

emphasize Carl. Just to that,

agreement. distribution a it’s So

royalties to So can from expect distributor-like you them us.

Carl Byrnes

of trial With clinical respect And -- just again, Perfect. the one Exactly. I’ll was you back Phase Is involved queue. as into involved assume progress, expect they the hop half CFS and XENLETA well? there’s and it this? be question, And year. study the to Phase data what would be I the in to that’s first safe would then I imagining. if next II And in

Ted Schroeder

Yes.

have at the potential microbiologic we on situation with involved, opportunity further think of I And in based the looking we’re CF studies at at just using engage models on But be sputa, data have like FDA, then effects they the what their cetera. grouping and centers look for been for of and a in looking as for the strength would So some I focused the at some study study. at and to and them of now, nonclinical the the the this Phase mouse would certainly we et area. research we’re DDIs, absolutely looking

we complete relatively CF So expect performs when year, we have how to bring of a XENLETA in the package next data population. forward a

Operator

Arce question come from Ed next with will Our HCW.

Thomas Yip

the Perhaps for questions your perhaps of question, are the strong [indiscernible]. here rest the happy for preparations what year? Thomas XENLETA to your for U.S. remainder asking is Very regarding XXXX quarter are and a first This Ed. [indiscernible] sales, expectations the of what

Ted Schroeder

Yes.

season the And efforts -- certainly, the SIVEXTRO. expect the respiratory we’re And given of at SIVEXTRO, So this heavily level switched year. that we’re of to we’ve uptake our of to promotional we of remain through out rest the support kind point. the high

have appropriate this often, in have where for patient However, allows specifically, are focusing to to more patients XENLETA, on been antibiotic they exposed you bit get XENLETA, that for are prior us group pulmonology, that more a tend and have really therapy there. that patients compromised patients to

out opportunity The other thing the the that treat of in of pulmonologists pulmonologists actually find quite the attractive era about lot And the in to the enter product to or a is reluctance there’s treat many COVID, imagine part you hospital. of the an of that hospital. on the of patients can patient a

outpatient flexibility to attractive the them setting, in having is where the clinicians. So to treat appropriate,

and are the move first year -- quarter the that So as will our the rest as resources we behind for give focus And -- is need SIVEXTRO we’ll future of current evaluate to pulmonology. possible to that how high on -- efforts the us we strategy as pulmonology. to that, going effort revenues expect the drive that be into But we our and our for will XENLETA. a it’s investments and with

Thomas Yip

major to Got And the launched distribution it. for take net [indiscernible] be to sales How in contribute Perhaps sense. another Er-Kim top we discuss countries? agreement. should from royalty makes steps before to me you there regarding also, XENLETA question That expect Er-Kim those can the just can the line? are

Ted Schroeder

Yes.

pieces of about talk you maybe can the that. Dan, So financial

Dan Dolan

Thanks, Sure. Thomas.

we guidance don’t have expect. what give really enough So mean on I to data we

as significant expect sales. agreement. on a royalty touched we’ve net just on, we it’s But the can as still signed double-digit we -- early the We’re

agreement like this other the time. we Europe maybe it of model the all kind guidance But distributor those can specific pharma You in we regions. supports companies of in expect at a with data, to have really level give wouldn’t that Er-Kim on sales and don’t

Ted Schroeder

as we’re far as of already Yes. these And in approved. countries, some

countries require broadly will submission. And Turkey the recognized Some EU. some approval be because limit separate in kind like a in approved will and be of they’ll -- the countries it it’s will

And kind the online different so of on they’ll times depending come situation. at what

have some like bit countries, others that to that quarters you be might few some Turkey their through longer than lagged and immediate that a will So a regulatory take by work process.

Operator

Carl question with is from Our a Northland follow-up Byrnes next Markets. Capital

Carl Byrnes

the complete, It $XX,XXX obsolescence line inventory looks in like and see you that believe about had respect XENLETA adjustment Do kind is to won’t you of with the obsolescence. forward anymore? going COGS that we

Dan Dolan

I take Yes, can that. yes.

the So and be dating we X-year that’s can which retested. that the got of more majority We’ve adjustment before have an the hits product then inventory channel.

seeing So COGS it to line forward, the as I I wouldn’t quarter. material should are just flow It’s But minor through you’re think was expect quarter ones. inventory. adjustments adjustments forward bit cleanup moving moving of be some a more on in immaterial either. the little this the it insignificant

Operator

our question-and-answer any the I’d This turn for closing Schroeder to session. like Ted back over conference remarks. to concludes

Ted Schroeder

Thanks Thanks for future evening. some forward you we your in upcoming throughout the you. Have to Thank Great. updating questions. attendance, fall. the and conferences the good for of only in but Thanks, quarters, a everyone. not look

Operator

now has conference for Thank attending presentation. you The today’s concluded.

may You disconnect your lines. now

Nabriva Therapeutics (NBRVF) 4 Aug 222022 Q2 Earnings call transcript