NBRV - Earnings call transcript Q3 2021 | Nabriva Therapeutics plc

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Operator

Good day and thank you for standing by. Welcome to the Nabriva Therapeutics Third Quarter 2021 Business Update and Financial Results Call. At this time, all participants are in a listen-only mode. After the speaker presentation there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mr. Financial Chief Nabriva’s, Dolan, Officer. Dan

Dan Dolan

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

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

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

quarter. Lefamulin’s through on President and briefly the then start Slide management. of will update prospects afternoon's the to from an with and cycle Turning Nabriva’s, update, and give run for Ted the highlights this business present Schroeder, commercial Gelone, will I to like the Lefamulin CEO, an the a life would agenda. COO Nabriva's will X, Steve overview

the some and summary I Lastly, to turn Chief Ted with now a review session. I comes provide Ted leads would over Executive comments Officer, call to Schroeder. Q&A a financial back before Nabriva’s like will

Theodore Schroeder

call this afternoon. everyone joining Dan, thanks and our you, Thank to

Before Chirstine Officer like Nabriva every small first to extensive bio-pharmaceutical leadership over large would Dr. Chief I and Medical including October. and get Pfizer in research Guico-Pabia global and She welcome outcomes, multinational including at joined McKesson, held brings who experience our again, positions in of has expertise affairs. and Guico-Pabia drug of Dr. previously started, I as startups Merck, Christine. stage companies, and Welcome development, Metagenics. pharmacoeconomics XX-years Wyatt, medical

Let's on start X. Slide

are we was TRx. are sales net very and our double-digit SIVEXTRO’s both increased progress efforts promising figures on impact. an confidence with in give performance are growth We multiple These having in this strong, are pleased and quarter, our results fronts. the and recording making quarter-over-quarter commercial that us

which XENLETA. white expand team field-based in our through awareness SIVEXTRO historical As top XXXX personal additional promotional reach in this XXXX. to mentioned recently both expand SIVEXTRO, to our the increasing sales updates, trends of we by back an our has prescribers mid of geographies program will We estimated sales efforts space peak help supplemented targeting believe promotion. in expect additional get reach sales and SIVEXTRO’s XENLETA an launched previous inside we program, to To by representatives and

the to the Moving in access U.S. company to agreement announced performance healthcare with XENLETA improvement to We Vizient, the XENLETA. largest recently in expand setting. an hospital

setting. CABP a XENLETA approval we the Taiwan. of treatment CABP option in in setting Community Acquired that the For volume annual each well XENLETA hospital Pneumonia In represents as provides approximately costs. improve those in patient million three a for and lower purchasing than advisory partnership Vizient this believe as that treated year, or step the are toward establishing hospital we is also great in services, billion not With and people analytic to XXX for expertise, aware, September, Bacterial outcomes a announced more portfolio as contract

As many which regulatory know filed have regulatory XENLETA application. every in of received approval in we you, a country has

through driving additional entering with direct recently can flexibility for of cash see investments CABP anti-inflammatory such published we as the growth to through geographic expansion. now for gained towards this first the non-promotion our data We the strategic Earlier partnership demonstrating season. properties Hovione opportunity growth We initiatives, as initiatives advertising, renegotiated lefamulin. in continue we Hovione patient XXXX, deploy allocation. our increased additional we near-term to We XENLETA are by agreement potent extending and the with month,

color data patients. by additional and We the anti-bacterial the potential encouraged and will these clinicians an these anti-inflammatory combining Steve in data important later agent offer that and are on provide may properties presentation.

celebrating As a our deployment, be quarter and through extended XXXX. substantially we to cash to runway have with growth result resource now second revenue continuing the prudent the of our of

to TRx Slide X. United graph Moving shows their in for antibiotic market This the States. oral the

while the current is growth see, pre-pandemic is As consistent and the return trending positively antibiotic seeing This incidence into infections. a not XENLETA fall promising trajectory are to we of pre-pandemic to we upward see especially and when you winter back greater season, expect trend as can levels, typically encouraging towards is prescribing. The prescription head overall. a to for respiratory we

XXXX Slide Looking specifically at to announce prescription I’m that mark SIVEXTRO this on SIVEXTRO excited the X. hit quarter.

second since this has of the XXXX. been quarter first The quarter achieved

that peak a to XX% SIVEXTRO, with report remain increase. quarter-over-quarter by can a sales levels Additionally, sales we confident demonstrated mid-XXXX. We reach excited by SIVEXTRO are sequential growth historical

factor responsible was in We awareness, for infections Some the outstanding the covered U.S. for of in million the include SIVEXTRO. approximately driving our currently rate strength XXX lives factors the productivity increased MRSA the for adoption. The community product and of salesforce. have the SIVEXTRO the another of coverage

XENLETA we are a visits them keeping ahead of have of to season growth laying level of top see current is Our the Not as office progressed the representatives but field-based mind. interactions, in-office high also for good sales CABP at believe increased continued we the only SIVEXTRO, throughout year. this the by these groundwork

performance agreement me spend X, which largest to represents few includes US. discussing September improvement Moving Vizient in XXX networks outcomes. in Vizient, the healthcare improving on customer we which to to focus program. signed our Vizient’s company an opportunity Pharmacy and systems, early to XENLETA minutes available health XX Slide base patient is let make approximately next with the Vizient’s the Network

XX XENLETA. us expand this this partnership of access expertise, in to will Vizient’s Our out CABP treated to the XENLETA and opportunity With efficiently a the key analytics overtime. hospital afford advisory benefits services. annually, significant adults bring to relationship some million three setting with approximately will use that Slide lays the represents

access to and expand to through we in presence the a Vizient the channel of due hospital created Given getting COVID XENLETA believe that challenges awareness the to hospitals recent restrictions, have setting. we

therapeutic have treatment scenario, usage for profile. in with the that that is were resume and is action, mentioned, patient previously also we its a favorable course transition winter. experienced Vizient expand setting. as reasonable fall the goes the the resistance a to a the anticipate What of rise the in respiratory important continue optimistic opportunity As from normal short drastically But people recognized outpatient to agreement hospital and mechanism Last we season seeking activities, this to of reduced infections. as be CABP of bacterial it low about is of safety will care when patients CABP the we of number expect winter, we therapy, propensity develop XENLETA novel XENLETA to promising to

X increased efforts start drive the patient promote point additional therapy discharge. for to identifying and and We the hospital rates prescriptions XX are through messaging additional demand they employing convenience. QX representatives with capitalize sales are prescriber Generating the then envisioning medical congresses take CABP season. focused are and of upon brand while These leads the of and XENLETA for sales highlights highly representatives XX-Count get to patient the some beyond Pack on prescribers at office expanding to we diagnosis. Oral improved will in to Pack respiratory non-personal regional home an from the Slide the introduction on the and efforts, efforts in local access engage or qualified

leave a Doctor on with discussion CABP guides, patients website likely content key We most are the developing also destination repository. focused to by messages patient leveraging reach patients. activating XENLETA drivers targeted and behind and

excited As distribution a networks. X Oral for an we The of XX-Count efficient Pack across announce XENLETA. for we availability are Pack option their Oral our for XX-Count allows turn to XENLETA or Pack Slide to watching carry for XX, to pharmacies

As we XENLETA experience of will overall result, patient across the the a this and believe access enhance, by availability market. retail improving

provides Our availability as actively will another positive Oral activity. Steve. which a and the now Steve CABP the we XENLETA, lefamulin’s With can lefamulin I that call believe promising upcoming with data we for enter discuss anti-inflammatory the update, progress step the as XX-Count salesforce and the commercial in pass who will to showing season. fibrosis Pack, over of the recent communicate Gelone, cystic the

Steve Gelone

of you, life is Ted, some to my pleasure activities. it the on Thank and ongoing update a XENLETA cycle provide management brief

As is exacerbations we disclosed, and of (Ph) potential by have previously of bacterial XENLETA cystic the caused fibrosis. evaluating patients management the in with Nabriva [Staphaureus]

Staphaureus respiratory and fibrosis even the the remains report common unmet of the the after most cystic pathogen data Slide help to from reminder, most CF, a modulator introduction CFTR the showing recent frame need, As therapy. with in depicts medical patients XXXX, identified XX foundation from registry the patient

time tract with or on culture patients CF in patients the culture of a the as with impacts observed in of is negative MRSA. resistant survival shown Methicillin Staphaureus respiratory as for right reduction the slide, Importantly, a X.X of CF median to side compared respiratory the that years, negatively an presence MRSA

antibiotics to utility. to reliably in or MRSA that agents tolerability While limiting upon not the issues their had of of clinicians in to be they rely order treatment have demonstrated armamentarium, for anti administration number have intravenous effective effective staphylococcal their significant require and has a that clinical have either safety treatment be been

been Given in treatment antibacterial most we believe often that potential risk in for that oral unique the treating and this That in has pose is a potential both to clinical existing to utility to formulation lungs, many this experts the at multifaceted and take available population. patients Slide with field, that well drug, challenge increased XX We we concomitant XENLETA be tolerated. to placing XENLETA taking including environment classes. antibiotics, resistance In may of potent provide is these CF, population have is patients identified them with option attractive that presence collaboration CF. agent difficult an with the and shown the drug important inflammatory exacerbations treat their of heavily MRSA they pretreated patient approach have present interactions. patients it present the in may are for it with as an provides overview intravenous in an of a demonstrate patient medications is

the constructed we to key our approach XENLETA. As of optimize attributes

CF from modeling isolated have potent against the prescribed activity drug, with for most interactions example, For potential demonstrated Aureus And drug we if the of patients. completed anti-staphylococcal modulators. XENLETA Staphylococcus commonly CFTR the

mouse the quarter Additional describe the on in XXXX. of are we And in the ongoing to patients safety the in study patient first will work, in first our CF in efficacy Phase infection evaluating XENLETA pharmacokinetics lefamulin CF I and track models. with dose the of

We the coming scientific community world's be to on are program very to anxious many our with continue to over of are the experts the with working and months. share excited this progress

advancing well to is of XENLETA's number been HXNX Austrian support and potential elucidate in survival specific our the potent providing animals. Research recruited In XENLETA's neutrophils, and of virus LDL in pandemic recently anti-inflammatory to simulating One. alpha is that associated shown be It action fibrotic to lung in also tract influenza cytokines, infections, from to exacerbations XENLETA's consolidation. animal and immunomodulatory caused including used reduced to different SARS-CoV-X look and rate applications, respiratory was activity clinical One and published of kind the commonly Promotion as with also the models the cystic and of patients further that two cell in IV In to of was team it to anti-inflammatory auto-immune It notably get properties, next antibacterial It my acute updates of these infected will inflammation. Agency, anti-inflammatory antibacterial over the possess that demonstrates Dan. inhibited as poor Plus pneumonia. colleague, production our swine strain acute outcomes have similar are immunomodulatory validate guide journal addition diseases. is of effects and shown work effects, pleasure the potent HXNX the results activity. designed to important for distress, models specific lung with disease respiratory steps to of white presentation ongoing anti-inflammatory has that superior our influenza Dan to interleukin to XXXX. that by virus that in-vivo macro to its was the grant a TNF inflammation future that known dexamethazone, XENLETA the With my known the mechanism flu as effects, the with these of will caused that similar help acting to another virus. progress. work direct corticosteroid, to the bacterial caused lung which blood by agents a And of azithromycin We financial reduce forward conditions as on shown the potential pro-inflammatory increased importantly level. into who turn corporate fibrosis, Dolan, describe XENLETA projects tend we and is to animals such provide now treatment Nabriva's with observed

Dan Dolan

Thank you.

Revenue would If highlights grew versus on of the revenues of primarily X% includes touch for was of the funding XX, key sequentially growth revenue quarter to $X XX% Austrian some collaboration you second product million SIVEXTRO of third second and XXXX. driven also turn XXXX. the $X.X I of from This quarter like Government. by versus grant over XXXX. Total sales sequential the Slide the million quarter in net

adjustment results, bottles of quarter to of for a year return serve launch third dating. three which shelf had the expiration we life Within the XENLETA, special recorded initial of the

to we be four available this replenish anticipate product which Pack. With of expiring XX-Count soon new XX-Count year Pack, Oral some with newly the will the will wholesalers Oral dating, have

work allowing agreement for more on the focus towards put third supply balance for near-term cash our sheet we amended disciplined During to allocate provides the we renegotiated with initiatives Hovione easing we continue management, manufacturer API and to growth quarter, XENLETA. cash XENLETA need SIVEXTRO. amount behind to as flexibility, of both agreement inventory for to the cash us The and

equity the next Lincoln which access years. an to into over entered of efficient line provides with credit agreement discretion of also our option at We an course Park Capital, capital two the

execution exited run We will are the driving driving to cash cash expense our continue our quarter quarter cash our mix substantially while equivalents of operating million, with to commercial of us maintain and investment, was approximately maximizing on strategy, and in a through revenue second ensure We allocation the laser-focus cash we $XX efficiencies providing growth. XXXX.

look ended the on the as of partner. we months driven from SIVEXTRO, collaboration versus sales September of same milestones experienced XX, at XX, as Chinese Slide of to XXXX. for the period on We XXXX by year-on-year Moving achievement upon net our revenues for P&L the three our well recognition significant growth product revenue our top-line

reflects our was evolve year sales own how prior that with SIVEXTRO $X.X our a will of commercial run million increase approximately community-based of compared of representatives increased XXXX. in SG&A see QX line initial in in back driven efforts resulting to in our sales versus the supply XXXX, quarter by NDC the a full the of from You cost rate rate $X.X of launch our the of second quarter SIVEXTRO. our impact This COVID-XX. million would P&L for scale The approximately of expectations purchases the during around of run following

operating leverage. Our to our highlighting year-on-year, SIVEXTRO on of net of our commercial impact the scalability highlighting drive improvement operating loss and the the P&L infrastructure of shape showed

September a XX, Slide to Turning our as balance XXXX. XX. at sheet look We take of

XX, accounts primarily in As $XX mentioned quarter the at earlier, our our due is million XXXX, increase December by included of in cash purchases cash sale the and the operating equivalents the to an end attributed approximately SIVEXTRO. This supply ATM The quarter wholesale SIVEXTRO cash can of of by were increase driven be activity our million, in burn, of quarter. timing from was cash second offset receipts $XX receivable during which from the approximately XXXX. of on

of on discipline a our to liability focus will we carry attention sheet continue our notice maintaining continued towards pivot minimal balance As you the amount we management. commitment to that section, debt,

burn. Nabriva’s to well have the to net from launch time highlight our we revenues. on our sales SIVEXTRO model reported can recently impact would of of you as as had our April cash to royalty our from P&L turn take NDC own the has of a sales pivoting Slide XX, benefit If of now like of operating XXXX, realizing In done NDCs a we on launching of full own of percentage SIVEXTRO, some the of NDCs Nabriva to moved receiving cash maximize Mertz, of the the that in SIVEXTRO to I some flow shape has work

cash the third step our XXXX burn, to from improving the Nabriva of double showing second quarter, the XXXX. this growth of in quarter how net operating You burn. down to chart, SIVEXTRO first sells to impact product second In on the quarter, we saw operating quarter compared will of digit the see cash provided the the further

the operating on on This QX decrease operating back see cash expenses revenues XENLETA composition chart, the XXXX, evolution leverage QX and consistent of increased the burn with coupled I drive leverage. versus our the for remained increased you with steady margins XXXX. improved provides agreements profit revision Nabriva turn operating in Ted. As and of presentation over with for X% total P&L help Hovione now our will our This quarter-over-quarter. recent operating to supply in to a in revenue

make of Ted. next Q&A part Ted then some call, remarks closing a will we into For session. will and the the head

Theodore Schroeder

you, Thank Dan.

me for the the Slide Before and XXXX, of stands can found summarize be achievements we where Q&A, our quarter which XX. on remainder let the to in Company move touch a

quarter. SIVEXTRO performance were we First, the thrilled the with of in

it where major pandemic, the a milestone for the of onset is the X,XXX since company. drug truly quarter prescriptions, first the The saw

the fourth gain our infections of in as efforts to to market for share we continue field expect quarter, force, the XENLETA. increase respiratory Given

in new top quarter, enhance important work getting sales program. anti-inflammatory and Vizient another approval the this our our of we we hospital, for to During representatives has the We in the like all We and on for time highlighted the field. Hovione, of launched with lefamulin. effects the commercial on Taiwan agreement we our done that hard team layered inside several other achievements, data first agreement partnerships with an of programs sharing XENLETA XENLETA renegotiated in and completed

our I appropriately year, past are the you the and open changing we broadening are quarters. progress adapted updating line look to forward to our Over for now opportunities. further we on maximize to our we pipeline up we conditions performance have market to well positioned think Operator, questions. coming commercial the now in ready

Operator

[Operator Instructions] Our question Capitals. Byrnes the Northland Carl line first of comes from with

now is line Your open.

Carl Byrnes

for congratulations the as progress. And out a third Thanks. lefamulin I question, thanks on then for sales and Great, follow-up well. you the SIVEXTRO have break the and Can the quarter?

Dan Dolan

Yes.

So, we specialist were quarter, SIVEXTRO think the roughly a and a X lefamulin reserve were little a over net took sales million I of X. one-time dollars. million sales current in the returns

XXX,XXX So that had us for lefamulin. record a the in quarter negative

Carl Byrnes

also, Thanks. filing in provide update China? with anticipated to can a of NDA respect lefamulin an Thanks That then helpful. you is the And

Theodore Schroeder

Thanks, Yes. Carl.

expects Sumitomo end file Our the still that to partner year. NDA before the of

Carl Byrnes

Perfect, thanks.

Operator

Our [Operator comes Suji of Instructions] Jeong line with the next from question Jefferies.

Your open. is now line

Suji Jeong

is the could be salesforce taking with in the hospital also, you comment Is questions Is formulary I care good my to reestablish salesforce Thanks available on with ongoing XENLETA on afternoon. to have XENLETA, a and SIVEXTRO. network. how and that it the Hi, few primary hospital for question. the XENLETA plan your going XENLETA.

Theodore Schroeder

Sure. Suji. the Thanks for question.

a hospitals, COVID at in current We be salesforce, aware very traditional no plans because have salesforce, sales is in may and you the non-existent. restrictions not as difficult a for fact almost across lockdown broadly access traditional of reps hospital's to hospitals least reestablish

insights help leveraging to optimize contract So for our Vizient, the to including we opportunities leveraging other present with us and are opportunity lefamulin in the analytics Vizient’s hospital.

need the question an be is So salesforce. community-based focus still most And not will formularies, of through on vision for to effort of driven the of overnight occurrence second on it outpatient type our It system. get regarding, the then part the but our XENLETA. will

And that in U.S. will effort year, high quarters into do position and be we an expect we great move moving season stronger the the as and in year, see so summer see children school salesforce have top colder obviously in mind to were We some freely. and previously, the first during year, we are as infections. we So months down as as gain position a mentioned we into the that in share, like XX% the are kept CDC we are this come of of our think as And last increase promotional the weather people with we restrictions XENLETA, the that in influenza of move off respiratory months. infections back reported to fourth and the market mentioned respiratory a we where to around the more XENLETA traditionally

we and In outbound responding full the at have sales geographies time people then sales into salesforce, product. the of to decision promoting have addition - support inside efforts we pilot a suite calls are non-personal direct white to inbound started inquiries. just then reps prescribing. we of XX digital that And program the treatment making space and the product And to with a

Suji Jeong

That is you. Thank helpful.

Theodore Schroeder

you. Thank Suji. bet You

Operator

Our next H.C. Ed is question Arce Wainwright. with from

line open. is Your

Unidentified Analyst

related the questions Eric. is Perhaps to a a XENLETA This everyone. study for (Ph) in question cystic I couple asking Hello Phase [Thomas] of fibrosis.

slide As quarter. it dosing the in first patient you aligned first expected in

on? and in mind PK focus of So, you points efficiency I that discuss Phase end that study. keeping is any we can there Can safety a key data, the

Theodore Schroeder

main CS sometimes fibrosis question. It dosing be aware, of are Thanks patients The and with drug the for points safety patients XENLETA with first cystic have pharmacokinetics you in as PK. our in end altered time handling is products. with may

efficacy not is really a that is readout. primary single an is study. There our dose It So, objective.

at is do we and how oral read PK on in it might those patients, a intravenous sense what looking the are make and form hopefully and get well both We tolerated. will and

Unidentified Analyst

or plan fibrosis into the non-profit Got your I foundation? it. And partner own develop cystic Phase II then perhaps to on a is the with Phase after

Theodore Schroeder

That No. question. a great is

data some will the the of I to I with alluded out the broader obviously development read nonclinical that Phase work inform help from plan. along think, to I

little think speak to we optionality like And until as see it like have see are a data. and ahead here. we that bit we that what move but the so, what premature we looks excited looks I to see is about what

Unidentified Analyst

Understood. we talents Perhaps, XXXX? you upcoming can data discuss Can XENLETA. one highlight final and SIVEXTRO for question

Steve Gelone

upcoming will filing announce So, when files catalyst the Sumitomo NDA China in NDA. the

course, rest be sales with quarters. for working the additional we out-licensing of there other feverishly territories. Europe Of will at world and progress And the opportunities are on

So partnerships have fibrosis anticipate do dosing we in and announcements commencing addition the the the X coming safety around quarters will to of that we Phase in PK well, those as cystic study.

few think are look those coming main forward we I the the quarters. to catalyst as next

Unidentified Analyst

the forward we you Thank SIVEXTRO and your mix tracking for and questions the update. traction continue taking to look

Steve Gelone

Alright. Thank you.

Operator

Carl line Capital. comes Byrnes the with question from Northland Next of

Your line open. now is

Carl Byrnes

for Thanks Great. a follow-up.

back going to cash. Just

that expect of cash but you XXXX agreement Is operations assumed the XXXX. to inclusive front was the be references into Park balances years. that You in Lincoln rather two sufficient is quarter our of that through over second

at look you do how So that?

Dan Dolan

Carl. thanks Yes,

substantially through of is doesn't of XXXX account into we do otherwise the take So QX It credit. on operations. the line anything would just based

an access it, but have if cash our anything we to into we to don't that factor We like efficient it. to runway. way need It is capital get

Carl Byrnes

have one revenue, correct? been then million was SIVEXTRO that is the like then Effectively, X.X XX prior back in more Great, being question XENLETA terms to going is XXX,XXX. thanks. was basically sale basis negative adjusted would to And of quarter plus with on a sales, normalized my

Dan Dolan

fair. is that think I

X.X the sure make number was reported SIVEXTRO about XXX,XXX. XENLETA we then total, Just X.X was to about and

one product. about was we there yes, time on So million. It was reserve for short took $X dated the the

entered window. returns We have a

reserve that XENLETA. took we So on

$X we on quarter negative sales, total for you was that XXX,XXX XENLETA in to you around X.X, SIVEXTRO the in higher net have could X.X sales. say but was out, If would ship been million million XXX,XXX

Carl Byrnes

Got it. Thanks.

Operator

remarks. I are back Mr. closing Dolan call now questions. will turn no there And to further over for the

Dan Dolan

again, have Thanks Thank continue your you call. progress. to and we we joining to as make for a I and updating good everyone. evening, Thanks look forward you appreciate questions the

Operator

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

You may disconnect. now

Nabriva Therapeutics (NBRVF) 10 Nov 212021 Q3 Earnings call transcript