NBRV - Earnings call transcript Q2 2020 | Nabriva Therapeutics plc

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Nabriva Therapeutics Second Quarter 2020 Financial Results Call. At this time, all participants are in a listen-only mode. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to Mr. Financial Chief Nabriva's Sender, Officer. Gary sir. Please go ahead,

Gary Sender

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

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

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

and Then, Officer, Schroeder, I today. will the Francesco highlights to discuss will come relaunch the of studies CEO, lead to the will Maria Chief Moving Schranz, for comments Officer, XENLETA. back session. financial on Chief following our and Jennifer a recent the Ted start Dr. and Ted Nabriva's XENLETA with summary and some with Commercial the transaction Q&A a exploration expanded with provide review, will overview Merck. SIVEXTRO for present the Nabriva's like with Slide X. of business Lavino, I'd will strategy agenda an a commercial update. share Medical

President Operating In addition turn the us Schroeder. Executive I Chief and would session on to and to call the Gelone, now Chief to is our call Francesco, joining the Officer. Ted, Jennifer Ted Officer, for our over Q&A Steve like

Ted Schroeder

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

in X. Let's the team strategic the Earlier has shift management sheet community-based planning, opportunities, thoughtful CONTEPO; products; launch pursuit Europe strategic of spent laid XENLETA and These Slide commercialization to to the licensing on Nabriva of executing obtaining the focus the for year, on out last and priorities approval with and on priorities. company's expenses. several the the balance plan our preparing active this Nabriva's the to XXXX optimally of position of recent have we for development XENLETA to business assets the and we maneuver start environment. months a development. Canada; capabilities business Even we conduct our a towards of our community; in and management included leverage shift the these and the you the manage which, year. and created working half attaining developments solid COVID-XX our through community first to focus our have has through pandemic, and the to amidst been revenue, our on diligently the as continue we as how announced can impacted have set business has ongoing way The challenging know, commercial preparing foundation goals limitations

of today. summarize me Let where as we stand

coverage, our what the is recall, to Nabriva's you market shift dynamics, excellent coupled payer dictated As with community.

that second exclusive well SIVEXTRO. community to into on underway. we as This of Our leading Merck, with and promote organization, and the an end entered announced focus Nabriva quarter, SIVEXTRO Amplity to the community-based the the And is distribute who with subsequent and Amplity, agreement Publicis, We and At uptake is we the engagement will Merck both common Merck the we also our Health, with differentiators, infection. why doctor is sales community. to arrangement ones commercial expected view represent contract product in and true strengthens agreement customer deal; our announced deal announced Amplity services accretive the from transaction pneumonia the Nabriva's ABSSSI time, bacterial commercialization XENLETA. and formerly provide same a organization most reasons drive X the known for of and patients X visit we Nabriva for pharmaceutical as peers. Community-acquired think an distinguish the

second the As for continued care expand XENLETA, managed to our coverage quarter. in

utilization of million have majority As to all or of XENLETA, of detail, safety of covered monotherapy favorable U.S. access but profile, speaks remains fluoroquinolones. into this XXX XENLETA management. no unrestricted, more versus think access adoption approximately XX% because cap. a will it short offers with go a especially June, greater value We lives with the for of to the the than Francesco course

Health We Canada Agency. subspecialties. have and and we Medicines meaningful physicians the European a look our fresh from Internationally, approvals the opportunity progress XENLETA also to at of prioritization by obtaining take have made

partners XENLETA to European considering patients. actively are bring We to

turn Now, CONTEPO. to let me

As resubmission will partners how to COVID-XX, implications formal our partners a restrictions, FDA forward. when their CONTEPO a concerns potential from receive proposals find data, The efficacy of NDA prepared unknown, path we their regarding Even meeting What's due inspections, host letter A we subsequent a important time, new at from manufacturing the were team how the collaboratively its the any for the FDA, to visiting FDA though Once sites. did clinical will and approval. they prevented feedback the manufacturing the our not complete can FDA to on raise inspection, Type complete an of agency CONTEPO. safety in did we required disclosed the for and the CONTEPO. request to request not for any this response execute inspections, or June, international and of has received travel the the timing is FDA's which

our remains predict partners. FDA, for a timing program for as you exact CONTEPO While contract our assure the priority can't manufacturing high with the the the team for can I interactions well as I that

in that. a us and prudent so. can manage for appropriate an structure agreement our scaled flexible resources, that healthcare to do reach is remaining The and gives are example how providers with XENLETA both It be continue we and as to and is efficient, Amplity we'll SIVEXTRO. We community-based of

we a With in we first into cash runway funds quarter raised have May, the the of XXXX.

to Slide Turning X.

SIVEXTRO, oral Let that this addresses transaction business course, me It's our staph better minutes spend an the SIVEXTRO antibacterial. as is aureus, oxazolidinone class a few most therapy, MRSA. known aligns and common highlighting one short that including cause how of once-a-day treatment a ABSSSI, methicillin-resistant part pathogens development with strategy.

complementary and XXXX, Nabriva XENLETA, including for there physicians care of will sales and see SIVEXTRO highly renewable the infectious procured customer base is for will with be December disease as X-year you care well As will later end responsible and for primary today's in in brave through and marketing, SIVEXTRO presentation, distribution the be Merck, prescribers. extensions. a urgent U.S. as

some On IV As new United oral X, Canada should exciting approval approves for Agency recognition Europe, scale class our July coupling first providers, of and with I additional pneumonia experience the XENLETA Health XX the about in on patients the for approved XENLETA efforts also formulations Medicines for including international from XX, and XENLETA. July representing for CABP CABP, community-acquired came the for The in nearly European antibiotic XX. Kingdom, on commercial with years. as we the for Nabriva's healthcare by Amplity On with synergies Slide of details has distribution SIVEXTRO, our SIVEXTRO already team. our will which that and prior and enhance the access. is, with Amplity believe touch promotion good brand product is engagement, allows there

and Chinese regulatory Our with has to National partner, Administration in Sinovant, resumed for development filings XENLETA. Sinovant safety Products study continues for recruitment efficacy Medical activities expedite engage activities their the China. to and

receiving on named program to WEP is that patient basis. or exclusive live oral is XENLETA agreement yet meeting Lastly, can in approval, IV on the of request to physicians, XENLETA necessary into contingent Nabriva countries designed a patients certain where not patient The supply entered criteria behalf an available. eligibility who on ensure it with Clinical named and

to made several efforts ever-evolving advancements over the for have current, environment. last position our substantial We the commercial months properly

management of the physicians. XENLETA Amplity SIVEXTRO for SIVEXTRO, the sales that the with resource with prepared community confident effort, care and Nabriva well are managed We thoughtful that relaunch the and access reengagement and addition outstanding is

now to over the call turn Francesco. Let me

Francesco Maria Lavino

Thanks, addition contract SIVEXTRO diagnosed the on going call. I'm the share SIVEXTRO settings, X, infection. Slide opening, abscess ABSSSI. and a of on a opportunity plan everyone cellulitis, variety acute I and and our skin like and of on Health with to the expanded and our infections lighting good to would Ted, Ted's to portfolio, with to as one most infection, Building the to with our commonly bacterial cutaneous afternoon more in sales wound partner. the XENLETA and Amplity frequently details infection of referred include and relaunch overview about structure is to brief treated ABSSSI are start skin

causing common is ABSSSI staph most methicillin-resistant including of One the aureus MRSA. also as strain, known pathogens the

for setting XX, course the expected Turning Similar XENLETA IV SIVEXTRO prudent for overlap pathogens, is a these interaction, of dosage. to patients, million than has healthcare infectious a Slide involved discontinuation of prescriber and we of trial dose, MRSA, is prescriber is a about of and outpatient formulation, in like total prescription in the with loading to dermatologist. professionals, analysis in a has drug once-daily for and activity given XX; primary formulation is antidepressant and for ABSSSI. outpatient tolerability range no interaction account against SIVEXTRO treated to XX% opportunity since synergies the the patient. shown an especially and are target agent. more SIVEXTRO of will to of as for business no management for There Please the adults an advance X% podiatrist SIVEXTRO profile no And need both with and SIVEXTRO. would had including to relaunch drive safety a the bioavailability. short total Slide ABSSSI, indicated to plan both oral the right a Approximately patients food are major X.X treatment for available low June, in antibiotic monotherapy key favorable our SSRI It disease once-daily rate. clinical ABSSSI; doctors, XX% to last is I and for Its ABSSSI. we optimize adolescent X-day broad and shared of the antibiotic review and care CABP, and physician, with oral very XENLETA.

target X/X the portfolio. potential more we high of patients and infectious both They and both SIVEXTRO treated to Given execute priority for they primary physicians, of providers ABSSSI, share of CABP these highest and urgent are and a than the going the XENLETA, as volume customers' our patients key care for account disease relaunch are physicians group. care very by for the be

prescriber for well as podiatrists like such key and include targeting as also final XENLETA, pulmonologists, Our for SIVEXTRO, list will dermatologists. key prescribers as

Moving gain older, of consistent generally reason more second age, in excelling patient And for strengths, to on XX a as than patients hypertension treated the X to appropriate that antibiotic look than familiar. generating we or that These quarter, such coverage but managed XX; growth XX plan in exposure on can in Annually, diabetes, is confidence latest Part care expand CABP XENLETA. setting, common outpatient Slide are strategic Medicare with for the should are with home. coverage without at shift, we one are the XENLETA. CABP these to patients comorbidities The About of key more to growing are continue suggesting antibiotic outpatient as patient ability adult still during to commercial setting therapy. previous our we care and with plans. or patients risk the managed Slide million covered our the prudently with either follow million be by in effort. D adoption days with and or and of XX% the score working restart our its treated

a market Our continues do access team job. tremendous to

XENLETA. or utilization such And of that U.S. XXXX, our no have of pleased management We access about lives our coverage about all as XXX prior care are authorization. step most managed million unrestricted, with access of expectation. to or is June the as covered XX% say is edits to And exceeding

in Part The good plan. formulary to place COVID have plan. with with of the had D Medicare both has increase Commercial large with on We made as payers, with in an we impact some expect as contract progress well for XENLETA pandemic XENLETA, reviews D But further coverage Medicare Part QX.

As reimbursed XENLETA granted previously views X, J plus that allows outpatient the a effective July Code, at to disclosed, was IV X%. ASP be

and coverage managed Turning detail to like to share formulary Slide date. XX; wins care I'd more the about to significant XENLETA's

Express pushing team, without like of we of plants major to Cross including to XX%. to also expand Scripts, managed the coverage. Corp., Services SIVEXTRO Oklahoma initial And the plants, to United Texas, coverage second therapeutics prime both Blue success of addition our Health care commercial demonstrative XENLETA excellent restriction and market access the added has Healthcare In and and given close Aetna in downstream formularies expect Based Group, as as quarter, for TRICARE, was XENLETA on coverage Illinois to continue OptimumRx, well our SIVEXTRO. assessment, Shields

Turning to share community. critical XENLETA's success me are to believe Slide XX; for going we the let what the relaunch factors in be

We to value clearly communicate patients. platform proposition for been refining our XENLETA have messaging community the

cure a data days. patients a antibiotics, local XENLETA's for key will We adoption to just we old efficacy, in resistance ability driver and the X leverage offer on its and focus for to will

any work the not in respiratory particularly important This who people of have millions will employees flexibility symptoms. home. they the to work business pandemic, back COVID if the be for have don't to from welcomed is Given

that a and emphasize X fluoroquinolone. days will XENLETA monotherapy, we has short versus continue safety differentiate the We on profile to will

our of will interaction target by on SIVEXTRO Medicare right the identify will customers, will XX, the generate prescription as we leverage coverage, frequency customers we target expanding will shown for we to Commercial Part ensure growth. and right criteria. Slide XENLETA the We prioritizing D and using multiple And do that, and

of geographic of XENLETA including of prescribers, SIVEXTRO areas we CAP highest on prioritization historic and patients ABSSSI will focus between and the will We prescribers. prescriber, with the concentration high the and consider level overlap and

for those We will restriction identify for managed access, the care we'll responsive XENLETA also assess are and COVID the HCP remote to who coverage and SIVEXTRO, physicians detailing.

patient of both We distribution will to access. products also ease hone our in

We health, will and deploy Amplity partner we staggered that will a fashion. with in

September. end number rep as in with or to reps, sales to COVID further by we expand planning field plan force perhaps not soon as physicians of And in eventually, have sales plan access a very in the XX- we the XXXX. and a expedited small to year, allow the early XX the scale effective improve, expand provides us flexibility are of considering all only up organization the scale to but to We XX-person to number to manner. it sales a to to XX, as the a contract down sales And Partnering efficient, do restrictions. of

very get with the provider the ready approach Health on Moving to two Amplity X Health, new delivering we And to sales healthcare industry XENLETA have and experience the healthcare both SIVEXTRO approximately healthcare channels, relaunch Amplity pharmaceutical years. been they launched launches. conducted in had support solutions over more to norm. They for has XX capabilities experience million than focused, excited in partner extensive Slide we are XXX% XX; past personal the engagement to also interaction. virtual as the XX products community. to and as and the we Nabriva execution in Amplity Health brings of years,

be therapeutic disease. help experienced areas, as organizational of services communication. with blend As the and of deployment. the that, Amplity Nabriva working been of companies, And forward, in manage pharmaceutical They the provided have infectious have total XX will flexibility moving face-to-face part remote SIVEXTRO. Publicis, multiple top sales and model they to a anticipate engagement customer we provides and most for agility resource generate including

a skill Health flexibility XX, the SIVEXTRO are substantial than with a community, and partnered addition for with Slide portfolio of more patients to combined Turning X We ABSSSI to since to set. in in CABP. million the community-based ensure and our conclusion, Amplity treated created opportunity

availability and believe retail delivery, digital the coverage in targeting, we HCP is Community-acquired segment we access outpatient common in XENLETA for element network we the potential two specialty a ABSSSI firmly high expanding in frequency and ensure will effective continue most with of home care represent the and work non-personal a marketing the on infections of bacterial expanding pharmacy will target, channel. continue will right revise while three in that Nabriva phase enhance the both Nabriva pneumonia community expand appropriate XENLETA SIVEXTRO and and sales the significant addition and near term. the managed scale SIVEXTRO, mix. issue will in our the focus success, also as on leverage already of to we the promotional in deploy like We'll will reestablished targets call to broad to and customer synergies allow creates Jennifer. footprint approach Critical and would and the to rep on We now the portfolio. the to for and turn I our the over we'll to to setting,

Jennifer Schranz

some Francesco. of some call I at new projects. upon topics last the you, will introduce earnings the and expand Thank discussed

continue community. Given unmet the that advance the XENLETA, need global we unique antimicrobial crisis within the address management projects to of of and the resistance properties life healthcare cycle medical

well have pandemic, the seen host to to Slide patients we insult respiratory as with lung Turning reaction, damage infections. a XX; from COVID-XX too in in immunologic causing significant learned an all inflammatory result acute can response the tract recent

part dexamethasone, neutrophilia, the the result, of corticosteroids total awarded become has in experiments dexamethasone reduction proprietary will COVID-XX modulating a fluid supplemental the inflammatory results to particularly inflammation, compounds our measured and antibiotics, potent a Research to result excited and COVID-XX and promising, proposals that patients and significantly inflammatory with As a call with demonstrated partner bronchiectasis a as is using evaluated drug. that and in Promotion This XENLETA known be agents counts model characterize to murine oxygen. library. ability has in further in their by as disease pulmonary management cell effects trial emergency to from anti-inflammatory neutrophil positive significant have XENLETA us will been as Austrian pleuromutilin possibility led comparable bronchoalveolar fund Nabriva or demonstrated If including reduce of local anti-inflammatory recovery to a immune other the chronic requiring or who following lavage obstructive lung utility patients of assess is immunomodulatory to conditions, cystic for mortality grant Agency, of in that XENLETA is such which macrolide fibrosis, XENLETA's lipopolysaccharide-induced validated, conditions. The commonplace response, of the anti-inflammatory properties in the possible. the the

fibrosis. in Turning address review like medical need to I potentially aligned the XENLETA's cystic would XX; properties to unmet Slide how with patients to

severely As a background, fibrosis lung over CF or to due cystic is CFTR dysfunction a infections regulator, that in chronic ability mutations breathe a patient's time, progressive that limits persistent disease causes genetic to transmembrane and gene. conductance

pulmonary with aureus So The be staphylococcus from is isolated infections. patients Cystic data how staphylococcus of organism wondering, with aureus Research tract MRSA, cystic respiratory potentially particular, of or lives to patients you methicillin-resistance from might infections those have the can Foundation [indiscernible] the with up with And fibrosis. at worse MRSA fibrosis? the of on persisted CF improve years with XENLETA associated survival X.X most in than Fibrosis Cystic the Based prevalent or CF the of median is time all associated Registry, in is been presence MRSA. colonization patients shorter aureus with and that staphylococcus has outcomes XX%

pseudomonas modifiable important long colonization duration emphasize and of potentially risk factor co-infection older approved are of patients. rates concerning are chronic Additionally to cohorts for infection is trends for increasing this no mortality with treatments, and are in CF there and MRSA that aeruginosa. often which It and

bios for potent potential or retains the is the XENLETA in a to MSSA, fluid U.K. are the mutation staph lining oral that organisms. and low possesses known EU, communicare patients macrophages is in recency presence penetration Moving MRSA susceptible a for antibacterial with it agent infections, against Canada, activity XX; a as aureus. and of anti-staphylococco intravenous in U.S., of XENLETA both pulmonary option lung, excellent the treatment epithelial for approved and pneumonia the has and XENLETA and Slide of

pulmonary with As infections. assess may XENLETA of are important funding in aligned opportunities Based exacerbations chronic XENLETA's for are patients that on a be of management we potential cystic characteristics discussed these exploring the caused properties by earlier, the infections MRSA. XENLETA's attribute to particularly further anti-inflammatory with in fibrosis, managing difficult-to-treat

our significant of attention and STIs. infections multidrug or need, turn XENLETA's medical to let's treatment the sexually Lastly, potential, another unmet resistant, transmitted

abdominal rates become Centers gonorrhoeae, to rates fifth their infertility have HIV, genitalium STI concerning surge XXXX can term long increase and pathogens, threats continued report. due increasing to straight Control left Slide been pregnancy health to STIs the a Neisseria one's Turning pain, increasingly difficult Mycoplasma urgent for public because, complications. for for treat pelvic XX; and as and officials antimicrobial of Disease have and Prevention risk and resistant untreated, have year, trip in as result, and the to emerging resistance by respectively, recognized at

it as for doses trachomatis. and failing and all see a would against can most Slide potent mycoplasma moxifloxacin important action, on bacterial chlamydia the of option, XENLETA Neisseria vitro noteworthy of unique mechanism multidrug-resistant because making of you and threats. against management XX, has as ideal of be in possesses patients these is in an activity gonorrhoeae against doxycycline. of is clinical treatment advantage XENLETA cervicitis, a its public causes As which treatment XENLETA's And and the activity maintained significant kit isolates erythromycin, most high genitalium of syndromic health well common with What urarthritis is, the

grant support collaborating to treatment the on urarthritis evaluate with with global design program actively for this development progress program a to to syndromic and experts a potential cervicitis. and as been have of continue XENLETA's We execute STI team and

study, in an work. And we series, investigator-initiated in We plan evaluating refractory to mycoplasma are additional infection. executing with through genitalium K patients an XENLETA open-label resistant vitro support

STIs, I which the particular, we as our with new live important pandemic, disease is the to economy. We we fourth to reminder closing, an in for stark school In this and of innovative development held In treatments the antibiotic health this mother physician administrators, of as frontline as with be anti-infective approach the year. expected steady the agents responders, it research the agencies, regulatory upcoming excited is of X school our workshop infectious of to in infection a program the coaches and about as of global COVID-XX flow the FDA, quarter are potential the year. in development my threats continue preparedness children, of for the and sincerely importance teachers and for disease on for express gratitude our discuss is and and summary,

committed resources We this presentation make the at outcomes this to in improve our turn scientific to to patients available today will Nabriva financial are review. public I global health for in Gary health fighting discussed the and now over we pandemic.

Gary Sender

Thanks, Jennifer. On Slide XX, I've listed the some key in financial $XXX,XXX highlights. Nabriva generated second total revenue of approximately quarter.

As from one-time future expected, pandemic with stocking to demand from minimal some promotional initial channel. year, Austrian primarily prescription and depending are the financial it There conservatively made against and given continue and the government. sales inventory to activity prior updates, XENLETA a I Like our evolve the actively of disclosed on XENLETA second of which all and to Other wholesalers in income scenarios predict or the promoting both SIVEXTRO. COVID-XX of could sales get for adjustments discuss fill representatives at on made our rest IV in the inventory. to our companies, is quarter, to collaboration revenue existing of grant pull-through strong And and the XENLETA there sales. has reserve ability will difficult comprised their variety the sales was orders, efforts launch. in lack products

forecast. deploy approved to utilizing XXXX ensure difficult our direct remote quarters returns. we expenses sales in products, We actively preserve subsequent are our our achieve when are reps expected our to tactics, both physicians resources. about commercial We We working and about we medical that excited to getting want and efforts, in education back educate but to managed community-based

the lower than half prior was and was the spending to second compared in SG&A year. in quarter, Our quarter cut first

expect community. we We sales the as reps increase both XENLETA going with to forward SIVEXTRO commercial and that investments will medical discuss our carefully deploy

balances We through supply our the to million the SIVEXTRO activity. million. approximately $XX second quarter our Merck with We approximately the in cash for our We fourth also equity ATM quarter purchase $XX raise ended will initial cash added in of and quarter.

XXXX. that first expect cash will balance We operations current fund of the into our quarter

our gross Let's than our Slide The sheet. in to which of our P&L, product the on gross at mentioned, on focus net of the look right and which to now made the lower the balance insurance the community, the XX. accrued gross was We ask the has significantly were - $XX,XXX our P&L of Slide look payments inventory the Prepaid previously XXXX. I predominantly due debt of IV provides balances to stated side. XX% for details SG&A first and to advance IV due sales expense you our generated Please a adjustment notes for that IV second carries in for quarter. quarter channel. to details of commercial returns higher at for the version first Interest sales. actual represents booked to and consistent the the XENLETA, R&D of occurred are second oral which against partially to the a Slide I reserve pay reduction net and we of active IV XENLETA. recorded lower We claims be of the in adjustment This due our sold, Overall, XX, tend and the to based sheet. noncash on XENLETA quarter $XXX,XXX negative gross a for uncertainty partners formulation. in reserve quarter product second to the the of prescriptions reduced resulted to balances. was of XX for what sales. as an offset was new And which goods We in turn to based underlying - expenses $XXX,XXX distributors. on contract return activity cash significantly Please adjustment reserve revenue Under by This balances. is a is resources. a expense $XXX,XXX Year-over-year increased past and recorded our our XENLETA on expected was decrease debt for favorable oral activity in sales, year-over-year assessment XENLETA net net discounts based activities. of expenses primarily management rebates. to product in with lower inventory the quarter to combination down adjustment our slow-moving balance at actual of product to given our IV significantly adjustment cost inventory. held debt, specialty due a discussed manufacturing June the This XX% XENLETA due XX inventory for

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

Ted Schroeder

have and to as new our providers adapted conclusion, about how we we patients. how help for think promoting laid out have access we products minimizing In Gary. Thanks, think we about

built have We the are care put to it is confident our right It's environment. place, that current but pieces early coverage programs favorable, are in leverage the strategy in the to managed and new access. time taking implementing we upon

goal both to relaunch as world. success under positioned engagement for Our community-based interactions sales be a will with well as of face-to-face On ever-evolving of our COVID a scenarios variety is virtual physicians. targeted utilize in effort, Amplity post-COVID channels and

important we stronger with our to complementary and and reviewed new We grant ability assets primarily in assets. capabilities. peers, coming pursuing, leverage Nabriva's funding. of the With SIVEXTRO position opportunities to we sharing be will SIVEXTRO us and progress that exciting apart our is that our look with with to bring you the core find to Jennifer community. evaluate development transaction a in in to programs realigned as infrastructure believe are forward our Adding some We and the effort in-licensing demonstration quarters. SIVEXTRO continue selling together, fit are business we in sets Merck from we opportunistic XENLETA and a

duration our the rare that of with is focusing this a for Operator? The our to believe these on expertise like infections. are the drive medical ask than mission. on of are our treat will We a value questions. therapy line resources, to high and would shareholder open pursuits. doctors is of look absolutely to unmet updating We acute diseases, these We you forward investment many how now in progress proven need. longer consistent there I infectious good operator where Nabriva's is important for development

Operator

of comes question line [Operator Alan from the Instructions] Your Carr. first

Alan Carr

on a has? comment what you that noticed of that? have able you comment volatile. bit on what might momentum And sort SIVEXTRO; be can you Wondering momentum I of over if time sort Can been added sales once setting? leverage Is around - I do you can what in have comment some brings? taking then over? also, they or you expertise space And start there the the guess, community knowledge Amplity to it on

Ted Schroeder

sure. Yes,

So does Amplity Alan, what bring question the thanks, for then that party, momentum to you SIVEXTRO, will. with as the and about

about don't go about trajectory responsiveness? and SIVEXTRO it's why Francesco, the what promotional and we So talk you know sales ahead

Francesco Maria Lavino

all. much Sure, you question, for Alan. Thank the first of so

when experiencing of SIVEXTRO, can actually, Amplity the in examples by mean, good guess, a prescription. how really represents I very, Merck, in promoted past, and promotional-centric. was itself, then I antibiotic very by SIVEXTRO very very was initially growth So And be steep

is has SIVEXTRO declining, lack in that, been promotional know of we So activities. prescription primarily and XXXX, the this given

been of we using So be bring we strongly patients. to believe Amplity, historical that promotion SIVEXTRO as prescriber have is with prescription, because reactivate that there we base many able on a will back especially

second to believe as we to be bring asked brings soon resurrect the back we Amplity it you the able was we as the activity question some So table. sales. about And and to that what might -

the space infectious SIVEXTRO. mentioned, very sales space. launching I have multiple with they a as They experience in disease brands, They of experience have contract a organization experienced have Amplity and specific organization. the in So been the is

that experience really be second sales that COVID establish out the we all guess really we give situation think, world So might one Nabriva goal. basis quickly I going agree for and is different is in XENLETA, what on need We also virtual a believe to anyway. to we the reactivate will hand bring, growing I SIVEXTRO They they as possible. be of or in hope engagement. as this quickly that we that remote all this But managing sales

especially so we their place. Amplity restriction expectation be customers engagement And with that helpful, consider some the well I channels that think that a in also a in as And of as as extremely face-to-face the phase remote. our experience relaunch, is COVID blend there are in engagement where will will remote still be offers

Alan Carr

have CONTEPO, you that Okay. FDA, weeks with you'll further And sense or around have that away the when discussion a is a away?

Ted Schroeder

Yes.

the question? why closest to with interactions. don't the Steve, respond about the that you're CONTEPO question FDA and to ahead Alan, that thanks, process, and go you So

Steve Gelone

question. the for Alan, Thanks, Sure.

remain communicated be have host manufacturers that may as with to So FDA, to restrictions. they the informed been we and how agency achieve have FDA's response the able previously, to contract travel in our and inspections, prepared they they're in dialogue awaiting inspections those completing of face the

timing come with in a us, be remains agency. meeting agency with possible. work as when that, our at and us may this as for But and bit on to very fast around happen to difficult solution very a to partners, for - it's continue to a the compromised diligent for we So the trying point, little specific to this comment

Alan Carr

and discussion clarify manufacturer? FDA? going you visit can to is going a that next you schedule it actually, interaction once they the can So the the be to get to between a Or be

Steve Gelone

So little just a and clarify - more. bit to

parallel trying happened. have going communications that of they're the I plan and and manufacturers NDA line. time ensure there's, sponsor One appropriate So to out two working the and to the inspections between the towards those to us in agency And is on. the a and between the the second guess, map agency is aligned

things those are together. So two synched basically

Operator

H.C. Wainwright. next Your Ed Arce comes of Instructions] the question from line [Operator from

Eduardo Arce

regulatory on recent Congrats on the all and BD progress fronts.

three questions So me. for

possibility for is virtual start a In you other possibility up to contract is - I'm got the on agreement around come get around an whenever Either inspection? a to sort waiting for the what with question. words, by I with or else. need any there way that inspection follow-ups. there or I documents think I'll until any is with to there perhaps to that around discussion a yourselves and what happens? and I've then Is of couple checked be previous agency physical - following some guess, asking of your And the of everything any organizations, getting

Ted Schroeder

Ed. Yes,

have And review, in-country there the to do having believe regulatory to some that we FDA. on that FDA. physical conduct utilizing a question authority about, the that's inspection like So remote for resolve on-site that the answer they is flexibility authority the inspection? representative the a of these qualified a the to or the alternative video parts an I regulatory is inspections think to the that that is of as desk methods as of even That within

available. a believe of So, the there FDA are number tools has do we that

Our and could contract making will believe be that that a the the host manufacturers meet proposal and of fulfill about requirements how inspection. they they

with that's our conversation quality earlier, about And that role, office manufacturers then, that. the only once between Steve the occurs line communicate the manufacturing So the work role, the indicated through FDA and will division, time the as within their and resubmission. them of and we'll

- to is. the has kind state it to where authority the the that's of reiterate, we this But tools their other in other means available, FDA of So believe do do just regulatory toolkit. the

Eduardo Arce

with Okay. was this. a when a you the discussion all wondering that that approach a otherwise to but And then, than value-based regarding service had your I Amplity; was of else it, be, qualitatively? if some describe bit and I equal, taken sort describe bit And announced know some could you - in-house, you recent more is to contracted pains expensive how this despite fact that around would there a agreement

Ted Schroeder

Yes.

the contract you bat, are start fee additional - what of qualitatively, And with you into Nabriva we think it? standpoint. of So right specialty what's a Well, that's sales a I thinking getting about that? the the now employees. that expense morphing kind force. a push recall, it's from when one having top things on community-based would management had organization. the If sales of I for a sales Because We're force the - the off say, Nabriva of hospital from

force just sales sales so for are specialty lower general than that would salaries And of a type force be.

in greater. tapping of historical the been. contract of force in change into investment So One, sales benefits, organization our sales there's have are much that course, manufacturers in has we're dozens what not forces, with dozens The an a real of big field.

from can we comes learn when what's to what's engagement. working remote so them particularly it And and not,

expertise. a Amplity through It we can enough up secondary so team. with trying leverage view. buy Nabriva, And a have comes hard wind for the sources And small wide company, to anyway. That like we with to that that, it be would

put that to we to and responsive ability their in have distribution think traditional quickly the what as as but nimbly sales also physician with experienced prescribing. where the and are, only in just well that managed support access in pandemic care I a not and levels geographies access, reps environment access are access

the going of educate feel we we looking sales offer view Nabriva how flexibility, in as the appropriately to think advantages in at that are coupled what's current marketplace, I So on nimbleness and their with broad can and environment. really team physicians significant a

Eduardo Arce

last may. if I then, question, And

this, together Regarding SIVEXTRO other each bring and there is by ABSSSI? how marketplace, in to and XENLETA, as Amplity forward that the you that would in address a look for with investors you some others work to concerns as cannibalize the they potential at here

Ted Schroeder

pneumonia skin Well, so relatively cannibalization skin to is think, bacterial for about - community-acquired in And bacterial structure the in that's and I think bacterial for answer of approved straightforward. that, and is treatment in two between - adults the I that's approved - And adolescents. yes, so products. the acute only question ABSSSI is adults. the XENLETA SIVEXTRO And infections it.

only promote will those products. two we So

role of the strongest area of a It's play, pneumonia particular I strong. in class got in and use not not class. that in it to think is for products been of Pneumonia antibiotic traditionally XENLETA that area, has the strong a their positioning been area. other new the has a

I two the antibiotics, their indications. appropriately So, two playing approved differentiated think the appropriately strengths positioned to and we're for of

Operator

Kedra question [Operator Your Research. from line of comes G. Kevin from Instructions] next the

Kevin Kedra

be in to of did considered to maybe out-licensing products company products of focused to do have with maybe you without past, guys community be your But hospital? able more on I the the transition cost the thinking take bringing that? having about SIVEXTRO, or discussed apologize on guys some divesting Might - idea you've late, about that thinking I a have success to there jumped been several the the more like some Are including IV a with you you might of IV have and setting I the up CONTEPO. so you towards do earlier this. I in the missed comments, you on SIVEXTRO, potentially picking little if so know products,

Ted Schroeder

can the we're toward for the the scenarios ill now seriously manage are hospital is Yes. IV think of I But those we're variety optimize is to flexible access believe portfolio focus? toward the the because while If best hospital have about the No, to in considering patients, question. hospitals realities our our how treat products. of effectively thinking open to it's community, right and pandemic we great looking products; the that to it's antibiotics not home we we of what one new future, important access minded. shifting And a best that resources the possible a we're about of restrictions.

much say the about that, can't more I open-minded how but we we business. remain So, than structure would

Kevin Kedra

funded do, then, that CF And of Can grants, that's Great. XENLETA that in opportunities on some - guys what of of the you kind proof-of-concept some programs you? to STIs, to proof-of-concept know financially a And you some of commercialization lot data, get much to of willing far you to products? can with and your can but how are putting grant into on get given data to showed data? funding resources you where I of how and spend these are gets

Ted Schroeder

Yes.

in that it, have And particularly trajectory a and with If a difficult, So understand to we get important. program CF, past the a if they forward understanding forward. patients looks the if And acute susceptibility doesn't look CF it's different can important. there's infectious company from encouragement different antibiotics, - PK the have think that PK we - we programs certainly, focus I at disease do that no funding, promising that can vitro and the hurdle, up, PK hold - of and then the the we particularly from an changes get I those there in rare to It, PK if diseases of grant is I to the value. and the as a the that program think decision economic then antibiotics rare we'll data be is And standpoint. we we CF be and gives think us because that case believe could point. move

Kevin Kedra

Thanks.

Ted Schroeder

Thanks.

Operator

participation. are there no today's Ladies conclude you And call. does conference time. this and gentlemen, for further your questions at this Thank

You disconnect. may now

Nabriva Therapeutics (NBRVF) 9 Aug 202020 Q2 Earnings call transcript