PRTK - Earnings call transcript Q1 2020 | Paratek Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Paratek Pharmaceuticals First Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Investor Corporate President, Vice Strain, Relations Communications. and Ben you. Thank

You may begin.

Ben Strain

Company's welcome Good be A quarter the posted was slides to will have XXXX can website referred and and earlier press quarter today issued Earnings with on call. first Both also conference to www.paratekpharma.com. Paratek's morning, on found we call. results at update and release that our first be corporate this

Brenner, and call today's CEO; Evan Development Chief Michael Commercial Officer; are, Randy President on Participants Adam Bigham, Officer; Loh, Chief Chairman. Regulatory and Woodrow, Executive

and would risk for I to making may results call Before factors filings based and additional to our the over I uncertainties, turn materially. which Evan? differ SEC risks statements statements, out to on you discussed be and Evan, we'll our These to I current our detail. consult expectations subject beliefs. like actual that our in encourage are point are forward-looking certain

Evan Loh

our all Good Ben. you, Thank update. and joining morning, quarter thank you earnings call corporate for XXXX and first

outcomes. at of ever patients of COVID-XX by the highlight where those challenges successful posed Paratek, needs For bacterial to clinical threat resistance is critical infections growing antimicrobial an with the us

our therapeutic We intravenous infections. our We providing much are care antibiotic alternative of for community-acquired providers serious to who that as these lifesaving with mission for the spectrum a serving well proud as them. offers need remain for as antibiotic once-daily needed to in broad new patients patients, and to ever healthcare be NUZYRA, oral as an committed effective

the remain beyond. cash for we a position strength We stated strategic and strong goals believe our this would committed pursuing from our mission and are of also to We enables us to to XXXX that position efforts heroic of lives the medical myriad save pandemic who the and working are U.S. and applaud clinical in come complexities to around COVID-XX the the world back, to professionals like of

for you transmission, containment patients or patients of its to the needs and those putting by safety measures the constraint are treating impacted Thank all virus, efforts. directly your you implementing selflessly Whether first.

these thank team times, ensure their community-acquired access commitment like approved would and and take intravenous During entire broad Paratek once-daily, unwavering dedication and opportunity to NUZYRA, oral and to for to have serious providers our to healthcare I for also that skin spectrum bacterial unprecedented this both antibiotic pneumonia. patients, the infections

have with the other Paratek interactions embraced guidance thought of virtual clinicians, and community researchers of utilizing payers. employees provider and leaders, health or all working During of with pandemic, we from each home the healthcare COVID the now our and at meetings diverse

at times, NUZYRA. While community this to building with can environment awareness medical engaging success have be to challenging and we continue the will in

NUZYRA launch be clinical still to While the our resulting of successful believe the in profile we early within phase, in in our value the of and institutions and targeted strong continued continue NUZYRA. demand awareness for augmenting commercial efforts uptake

with to-date. results pleased are We the

today’s can environment challenges for significant NUZYRA that address. potentially While COVID-XX believe also we opportunities future presents Paratek, current the the launch and has NUZYRA pandemic operational presented

patients COVID-XX therapeutic benefits many believe of can actively pneumonia NUZYRA we to be community community-acquired and We clinical that awareness candidate the build offers. continue an the for and effective developed that is that ideal throughout NUZYRA secondary care clinically bacterial educate

bit importance further serious patients treatment clinical of and once-daily for for as with the as COVID-XX addition, and In paradigm infections pneumonia. bacterial community-acquired the pandemic the large, IV oral in skin highlights preparedness antibiotic a well-tolerated well novel, pandemic

prescribers. proposition HOME concept and hospital the resonating make that a that is for every be for appears major possible As STAY flexibility HOME shared the as to bed from NUZYRA’s you to IV push discharge patients can hospitals imagine, dosing there once-daily COVID-XX to have patients. foundation compelling a available with oral to serves pneumonia we GO discharge value with patients the you, in

generated increased the NUZYRA previous by revenue over sales Paratek net NUZYRA. quarter of the of million the in Net driven in XX% primarily revenue quarter, to first $X.X $X.X million.

significant We by NUZYRA formulation. by increases demand, the in see are we the as oral over-quarter, pleased continue driven predominantly to performance of

access also Further, our we hospitals. in access had targeted in continued Adam provide this success quarter, in and payers from details later will securing more and prioritized call. institutional within this

significant Late announced year, a also last we milestone.

States with into approximately or the with BioShield and a BARDA, a million. Assistant Authority Specifically, which contract the the we Health entered to $XXX is Human Development value coming Office of of Services and total Secretary Advanced of Preparedness Paratek and and broad United Research Response Project Department Biomedical of part the based for

significant confidence BARDA’s development public-private appreciate fight partnership resistance antimicrobial lives of We NUZYRA to and long-term and Americans. bioterrorism innovative, the investment in in the order a this Paratek protect against in in save and for

to achievement final partnership only we the drug company be that future important from One BARDA API biopharmaceutical from is product. this chain a that will with Paratek fully U.S.-based supply believe antibiotic with

large recently antibiotic we to several for pursue the manufacturing an with partnership companies, proud shortages from BARDA. especially potential Given in such announced pathway important are NUZYRA

progress global bacterial COVID-XX provide further highlights not pandemic including an of on this this the only spread for need resistance. novel therapeutics, update antibiotics preparedness, on that collaboration of the call. the to-date later Randy but importance in will address The pandemic rapid

to recently BARDA via for government partnerships Paratek procurement announced our actively patients pandemic need. will that other that further public-private provide broad with and strategic based open for preparedness partnership national in support NUZYRA up pursue contracts opportunities believe We will

our beyond once-daily, collaboration. to NUZYRA of the spectrum its scope government believe BARDA strategic oral uniquely number are current broad with and We and IV profile we positioned the opportunities a pursuing relationships other is expand of

safety an NUZYRA address supply We stock to and to ability uninterrupted demand. of providing their including on focused building remain continue sufficient

to the levels, initial into current inventory a sufficient upon Based including demand forecasted we procurement. supply of NUZYRA have next BARDA year, meet our

to Our manufacturing our our needs. perform which continuing provide requirements, for inventory anticipated, contractual to will partners are longer-term

to incremental To expand address our making current beyond potential, strategic, BARDA, capacity. investments manufacturing also government supply we procurement and opportunities are

last region, of of importance granted our new Greater infections. was community-acquired role for Additionally, reinforces Regulatory resistance NUZYRA Zai in Labs, its anti-microbial Authority. antibiotics regulatory milestone globally, NUZYRA’s application further announced China important serious the in review a by rapidly and in time This partner the in highlights Chinese the priority developing week China

Before provide like financial I first quarter I hand would our Adam, call to and XXXX guidance. the over review highlights to XXXX

As the noted earlier, in of revenue we generated in total States. million, $X.X XXXX, of which net to the NUZYRA’s were first of quarter attributable revenue $X.X United million

revenue $X.X approximately We which other of contract of revenue government million collaboration consisted earned another $X.X from $X.X also revenue service million. and of principally of royalty and BARDA million,

for compared program The $X XXXX. $X.X decrease quarter with continue million to was of million of completed the was as the operational for expense first study of R&D quarter other the efficiencies to Phase clinical result UTI to and business. million we associated primarily strive optimize our X cost XXXX, $XX.X the lower

the compared the was to for $XX.X first XXXX. $XX.X quarter for quarter million expense million of of first XXXX, SG&A

our forecasting Now evaluating pandemic. strong related financial our Paratek’s challenges against to first we results In the turning to XXXX COVID-XX guidance, the guidance. quarter XXXX financial balanced

As a XXXX currently year result, we are maintaining full guidance. our

the estimate $XX guidance to approximately $XX million courses. $XX.X expected This total last in anthrax to the initial slightly in As of procurement the revenue is compared be more following with consists earnings we and treatment NUZYRA XXXX revenue million, highlighted in call elements. XXXX in XXXX. million XXXX to BARDA $XX net million be between coming half February, this than revenue of of from our revenue we

with in reminder, and million. BARDA $XX earned revenue be a million collaboration the NUZYRA As procurement of secured under is $X initial to royalty to anticipated the Government combined contract, quarter BARDA XXXX. be is second the to revenue expected contract service between

Of onshoring manufacturing. note, service revenue of consists activities, U.S. NUZYRA program government requirement XXXX BARDA post-marketing our the of cost for on reimbursement FDA development and spend anthrax the contract by

year to be and expected SG&A expense R&D Full $XXX million. approximately XXXX is

to SG&A and Excluding BARDA, to are of an XXXX, the when remain OpEx our disciplined combined to commitment and compared R&D reimbursed highlighting expenses relatively perspective. our R&D flat, by remain from expense onshoring expected manufacturing

continued commercial value long-term that includes mycobacteria areas while will in non-tuberculous or as potential NTM This investments strategic pursuing lifecycle in investment program. create infrastructure, shareholder such our

NUZYRA cash, product as Contract, equivalents, marketable for cash provide end includes through a operating XXXX flow securities which reimbursement runway to revenue cash March breakeven. current pathway of million Project the $XXX.X existing of plan, the anticipate to related cash the and Based BioShield upon a XX, and activities cost BARDA estimating our we of their with of U.S. XXXX

agreement anticipated This and fund expenditures will be we terms. under able service debt in security all full to pathway repayment anticipated expenses, Hercules assumes existing its and company loan capital includes of the that operating

You may morning. this statement we also have filed on registration Form a S-X noticed that

our and in six had on have XXXX. We left we that governance is good consistent amount prior and with the filings. and current This only standard the shelf the filed approach, housekeeping we believe months corporate

We foreseeable shelf. utilize have this to the plans no in future

over will to call Adam? Adam. now With that, I turn the

Adam Woodrow

are by the continues in Thanks, quarter. Evan. of launch continued encouraged U.S. first we to in growth demand the The well seen NUZYRA progress and

This of increase XX% along IV in pneumonia-related saw our driven a business, primarily oral up over by of the in increases strength quarter, prescribing continued prescriptions which we formulation, in makes with modest our volume.

that season to that a were setting It’s seen these limited in all first results representative and that else. relatively patients this, our above the environment quarter light hospital Despite a access demand COVID-XX important and expectations. prioritized exceeded in included flu overall achieved challenging a

balance demand, of and continued we trends year. the all these believe the remain growth cautiously that We for for go optimistic in well

we normalized the as and adjacencies to anticipate of progresses. environment As the more hospital associated care evolve will setting year a slowly

maybe on and arise addressing combating its community-acquired broad clinical first antibiotic poor needs and in the serious while IV in these unmet is infections, we skin and resistant way with years, generic As that failure NUZYRA outcomes antibiotics. of spectrum, pathogens antibiotic that once-daily proof believe a to well older from both important oral pneumonia XX

convenient resulting some allowing in altogether. in patients flexibility and admissions NUZYRA’s IV and avoid cases, in oral believe We hospital prescribing dosing in hospital provides stays to once-daily reductions

patients. some potentially ability been stays an significance. hospital meaningful feature taken always environment, today’s COVID-XX has NUZYRA for this minimize in message The is of our benefit to of on prescribers our for and a more But even important

with that QTC tolerability for along adverse profile, In dosing renal to neurologic needed hepatical NUZYRA’s and addition, drugs, we quinolone other as alternative events Box serious provides quinolones, in their believe of black impairment and modifications with the much lack codified cardiovascular class the its label. a such safety

with risks a is events associated aortic increasingly COVID-XX is antibiotic note even life-threatening any secondary a only unwise as or with carry and mortality. not bacterial these dissection important our known patients. cardiovascular belief, It’s that to such that other also QTC mobility as it is associated in potential or to but severe Accordingly, such quinolone pneumonia, cardiovascular use is it macrolide

adoption which thorough in IV setting by after effort establish antibiotic accelerate. and calls, companion unwavering NUZYRA in a As oral the for community for like accompanied education patients the new discussed once-daily prior a a to hospital it can in sustained takes momentum setting,

sounds While one, that building a of a laser-focused minds physicians. in healthcare NUZYRA marketing awareness all hospital we’ve to remained ER, shifted pulmonary the prescribers ID, including of and virtual and model profile the on

continue the model, profile months. we it’s building continue monitoring believe traction While in be coming of process, as we'll see and closely there the targeted pleased NUZYRA still risks we in for virtual institutions weeks to while our results, to we the and early NUZYRA, our in be are in so with the our far, successful uptake are efforts to within

inventory, increased As Evan the XXXX. seen first by fourth approximately $X.X million the quarter fourth compared of demand. in in gross revenue to the Accounting quarter $X.X first $X.X in in of in the from quarter XXXX, quarter million to in of million XXXX, $X.X million for net the demand driven increased approximately mentioned, generated NUZYRA’s NUZYRA U.S.

believe appropriate hospital key including outreach Our currently to market specialists XX adopting hospitalists XX experience nearly level our and by are in given approximately to-date. within supported XXX initial to the pulmonologists, which accounts, doctors, representatives, we ER be towards which continues ID physicians early being the directed U.S. is

and we place right integrated approach for have delivery in on to while raising creation. focused to access the institutional process objective networks, our making targeted awareness. our sales key been we We we balance a in In gaining have drive taken our measured return hiring ensure have with hospitals steady value progress NUZYRA, representatives investment as on

consider targeted physician the XX% We This awareness base have hospitals. in is XXX serves prescription achieved institutional of and broader important gatekeeper expectations. ID writing NUZYRA community for Awareness in now exceeds over access as to XX% over of meeting target for a in a the our because the NUZYRA. physicians XX%

access lives perspective, of access and now or to Medicare commercial XX% lives a From NUZYRA have in no lives, continue success. XX% than we reimbursement, payer one-third over and with greater of restrictions. U.S. of to have the Medicare Over limited

first both and a this a with to a Humana Humana and earlier Humana number value oral placed business patients quite the fact, a secured Part on new with NUZYRA lines of In the is spectrum This month, in that branded on years formulary broad out Medicare for of no agreement hospital. their restrictions. commercial the has B keeping the of we multi-year shows

Securing the thus prescription to due this access with greatest enabling restrictions. we help with Humana the step for population to continue to access rejections is first able will patient believe, in agreement most vulnerable and great potential be the to will space, Medicare the to need believe have to we We a minimize formulary NUZYRA expand NUZYRA. a

are positioned we forward and to-date. are our in ahead. performance We path We are believe commercial with pleased and success the on continued commercial progress right to NUZYRA long-term reporting on the for look we with extremely well quarters our

turn I now Randy. to With the call over that, will

Randall Brenner

Thanks, Adam.

clinical several we the continue add potential we to value Within significant and drivers and important to have patients believe medical areas, the development shareholders. value have for which

off for pathogen antibiotic strategic excited added be to The the terrific BARDA the sole the BARDA’s NUZYRA treatment biothreat to great contract start momentum. partnership the stockpile. We being of for honored with first-ever of were BioShield to is national and recipient a which includes a

with the is bioterrorism recognition fight including NUZYRA shared the of unique BARDA commitment and treatment antimicrobial in resistance public-private to pathogens partnership of against This our a study anthrax.

the contract early activities. which initiated quarter, initial for requirements as the manufacturing approval now post-marketing close all of provide in communicated options, first BARDA will time-based had onshoring as we associated two reimbursement at the FDA our NUZYRA, cost with As April the of security well and of

The surveillance FDA funding includes the total newly as the for commitments, the bacterial to post-marketing all for well commitments approved study year these million. and this approximately post-marketing five studies, reimbursement required regard is $XX cost the antibiotics. With as pediatric pneumonia to post-marketing for projected clinical

onshoring initiation the believe setting an U.S.-based the with pull-forward articulated ahead In NUZYRA The for of initiation supply consistent support contract is of months three by stated was activities this funding the current importance the Paratek’s fully schedule. Administration. this we White antibiotic manufacturing initiated approximately of to chain of pandemic, option as publicly of the and of COVID-XX a House

comprehensive to $XX onshoring overall based total and onshoring important million. requirements by activities The a to our cost already all-European is chain additional reimbursement security to is for the NUZYRA’s projected supply supply The approximately initiative well-established chain securing adding manufacturing infrastructure.

States-based collaboration United were projected United will a chain. worksheet this the we actively Over antibiotic the biopharmaceutical timeframe, provide and supply for into currently States. its committed only bringing believe, secure in chain the world the We supply company

for courses million We national $XX XXXX also remain on designated procurement track earmarked for approximately treatment anthrax to the of of NUZYRA the receive strategic stockpile.

this The by submitted is quarter of the of CDC following of year, the mandated million application XX was BARDA. guidelines. second to a occur each at $XX review per in that end As purchase pre-EUA reminder, course treatment February to procurement is expected days the be FDA’s

the oral and and T our national NUZYRA spectrum stockpile doxycycline ago. two will decades added first added since IV nearly be to antibiotic the knowledge, were broad ciprofloxacin strategic

Beyond the of also opportunities pursue continued we to a work, for BARDA NUZYRA. compelling number lifecycle

that The dosing an oral-only is community-acquired first regimen in will CABP. bacterial these oral pneumonia study PK support an of –only

pneumonia this regimen is comparable the dosing FDA a upcoming patients an remain supplemental oral on approved pharmacokinetic optic track oral-only designed submission with this CABP by during in to oral-only followed approval in This the to in upon season. middle dosing will the dosing a study that XXXX, of study. for IV have regimen NDA year, established regimen We XXXX a agreed for was that with to potential our show profile

lifecycle medical noted listen address with another result we As interest, NUZYRA are opportunity clinical important to promising the last NTM, or we to explore as to mycobacteria inbound in feedback the unmet to call, also field-based receive for continue we our of needs. a non-tuberculous significant through significant potential team continuing

reminder, approved orphan no FDA as therapies. a disease non-tuberculous As mycobacterium an obsesses with

clearly the to secondary long-term used line sub-optimal regimens are These effective antibiotic infections IV-only therapeutic option list noted Inbound KOL tolerability, drug today. important welcome to complicated three four a by limited be that would a adverse IV-only an of oral being clinically lack addition often feedback the has and community and multiple from choices of events.

published, NUZYRA and mycobacterium achieves against not in tolerability humans. it Further, have only potent have vitro in as also a safety high profile we clinicians demonstrated penetration pulmonary activity has that very appreciated, but NUZYRA obsesses. levels

is additional indication clinical this these in reasons, For warranted. investigation

and clarity constructive address years. We to therapy orphan to the look need with been NUZYRA can providing forward for plans chronic to-date NTM unmet that We indication that significant this continue an coming remain in to have about medical and regarding last months. excited discussions have antibiotic our requires opportunity FDA on a to that months

generation of Data an important continues also the medical to team. component be

Just we researchers Investigator-Initiated for through our for to or present online funding last IIR interested new Research launched ideas month, a portal program.

was infections program, as of of has of more acinetobacter other need of and world important part and identified C. IIR interest and for As important such which patient opportunities difficile unmet high such this interest risk as the pathogens strains, use real Paratek at health to registry studies generating include vitro experiences, against address approval, clinical acute in FDA the research areas programs enterococcus groups. initiated time trials and or chronic which

seven are and additional in clinical conducting with researchers these the by contracting The non-clinical active programs ultimately in phase. them. published IIR studies seven the are there program from Today, data

pathogens special profile. further its plan, Regarding therapeutic populations or process unique these currently define our in in over NUZYRA to XX there address publications are publications that or

published or supported Clinical abstracts. Infectious the Annual of XXth four and recently Disease accepted Microbiology Paratek Congress and ECCMID, In addition, European

patients a and quality CABP moxifloxacin. vitro on describes NUZYRA’s in C. This occurrences and of omadacycline for with of treated epidemiology infections patients difficile bacterial outcomes activity patients or of key pneumonia risks in number of research community-acquired hospitalized C. Oasis life from with pathogens, in X, infections difficile with

adding of highlight continue utility evidence patients and profile to NUZYRA’s NUZYRA, to life-threatening These against safety body the efficacy infections. of growing the of

medical discussions medical the KOLs, dissemination adjusting challenges increase for adapt of are plan current and media teams virtual This an to social includes We’ve in field environmental been utilizing facing. to our also between and information. our XXXX we appropriate strategy

planning to upcoming have addition, at to since been In a is canceled due COVID-XX. being congress, we which support medical an symposium

now are a symposium materials which conduct and clinicians to We this symposium planning virtually enduring develop can from utilize.

We believe generation potential additional NTM oral-only new of populations. lifecycle and NUZYRA and the data at will into CABP to further broaden that patient reach clinically important opportunities the

At to this now point, we for like Operator? call would the questions. open

Operator

[Operator Instructions]

from the Bert with Please Hazlett comes proceed question question. your first Our BTIG. line with of

Bert Hazlett

Yes. couple. a Thanks. I just have

First timing interactions. regard are with is within BARDA that to our pursuing. regard and of Give terms timing know, of perspective, can timing particular do any with with the the additional the in you of agencies government? the from sense collaborations to a difficult. be have sense you collaborations interactions those I But,

Randall Brenner

It’s Hey, Randy. Bert.

procurement in additional think, specific provide I the are activities comments within active at the your going able government But additional to timing for U.S. stockpiling difficult yes, of project we So, the remain mean, opportunities. this within Not to look U.S. our to very pursuit some government. for and and try for accurate. discussions fully a opportunities I time. it’s on

Bert Hazlett

ones. have of are sales on novel that in may sales finding quick employed Okay. that Adam, Then, model you actually spend? two side, efficiencies just the you Thank terms some finding are you’ve you. this other

and an what in And quickly development in quarter. just results And of length the you. like, clinical again, numbers on on study then terms the congratulations of of the therapy? side, look just, very first might patients Thank MPM

Adam Woodrow

the to from not it were Bert. and virtual obviously we hospitals process. right Thanks, is a March, spend as remote. And is pivoted the Right. before. still sales through model. side, a early fact it Everything spending are now, detail going in now in look, we became quite to the Look, could be as much possible it’s But that,

there I the within successful, you target that certainly thing can that because institutions. is with I really efforts a awareness, already think It good And get reasonably are news see to tell good utilization. awareness that being risks that started you are obviously actually this without And can’t one model. was some the, the we’ve

is one our But I why given tell we spending you There in can the are are obviously are some the that, as perhaps recent sector, much. not efficiencies thing is bit a announcements more certainly efforts which XXX% they because a have skin have the been voice the broad perhaps spectrum than pneumonia in we oral, oral, a markets. share and about past, skin in of effective in actual

Randall Brenner

one, question I can the about take Bert’s NTM. the second

say, X,XXX microbacterium X,XXX dialogues ongoing a got little being specifics that it’s FDA. the we to with the NTM very is subset a we’ve That than population said, to for looking comment early small far, of So estimated are U.S. obsesses on too is group, the other to in

typical very disease orphan type rare studies. So, type,

provide So right numbers ongoing more hopefully. months coming to still of reasonably be small the patients. we discussions anticipating able But, in and now, we’ll are those are

Bert Hazlett

the Thank on again you. Congrats results.

Operator

Thank you.

comes next Please SVB of line question. Ami Leerink. with with question from your proceed Fadia Our the

Unidentified Analyst

Hi, for this Ami. taking for on our question. is [Indiscernible] Thanks

the good a quarter First, questions. on we have couple and just congrats

patients? secondary on you among the the have do CABPs color COVID rate on First, any of

chain. much you that with that results. second – to contributed how that, about on any Does And much used on could have visibility population pretty mean done? onshoring Paratek sticking the do full activity And that being manufacturer NUZYRA is your U.S. being, Thanks. your your you supply antibiotic comments patient QX company in only

Adam Woodrow

about talk CABP the part first. I’ll So,

uptake of But so really development year. seen definitely from COVID-XX. seen it to in this far to are CABP gauge relation NUZYRA this pleased quite is actually We the with is difficult an whether we’ve

major STAY our once-daily with oral IV imagine, and dosing resonating is HOME to the GO to discharge a trying As is message can from pneumonia, prescribers. in there and patients the push HOME you hospital

and bacterial the effect. ideal educating building we to and that well As the awareness product environment have that secondary will patients pneumonia that normalizes, are work we develop for believe COVID-XX we actively can

of obviously don’t how regards question? publications, definitive COVID-XX, few is as a CABP onshoring a to did that I As result much secondary is a juries out question. on there Randy, you is take to to the been think think that answer there but want the I

Randall Brenner

Sure.

make a manufacturing fully. now, we But chain right just EU-based API me have onshoring as finished the I understand BARDA. full product. sure the are The Let around supply – reminder, question from beginning the just through just with a efforts

So early product take a and in that. we the bring couple tech to of API on it will are phases takes both years time the on fully fully transfer The drug implement. and our steps to two a

a lot So, what to for work are of done a bit is those initiating really that. excited on still be planned. ahead schedule we of little But we activities initially about

Unidentified Analyst

it. you Thank so Got much.

Operator

you. Thank

Our proceed G. with with comes the Please of Kedra Research. question. next from line Kevin your question

Kevin Kedra

for questions. thanks Hi, taking the

should it see to about be for should ask NUZYRA? the thinking of - Should about sequentially? from revenue growth of skin? shift think some about First, in we should year. the this I kind be given we into wanted revenue consistent Or cadence pneumonia the we of How variability balance growth

reported on if demand how over has have couple channel? you say, It second, inventory could And wondering sales quarters. of been past in out seems just like then you the the inventories, much outstripping

Evan Loh

the It’s Evan. Kevin. Hi, question. Thanks for

initial – with for remain the more other of be track to I may they revenue the arrangements But, think we’d cadence just may we that when you on – procurement like be in can that at that like look lumpy still familiar use. potentially the quarter. second you procurement you where

said, about as is commonly and look being as pneumonic the of infections. bacterial of maybe go-forward with remainder as pneumonia, for seen all the we type that secondary That viral at these year, XXXX, also this you well, into think the

the year herd wonder a And as season well of sort whether general shifting will evolves near-term dialogue We a this lot to in just of into seasonal in immunity terms pandemic is upon as really from a that away what natural long. for the COVID vaccine, overall. pneumonia least depend the all also episodic at of pneumonia

next And right, is then around inventory, think of I what with the the question is that balance is course, Kevin?

Kevin Kedra

Yes.

ahead on the quarters demand like see net been you’ve sales? last have put we in of couple up gross the seems that Just what numbers of

Evan Loh

did you Adam, address Yes. want that? to

Adam Woodrow

of the there more to. excess mean, I at Yes, of the can am inventory time. is end the day, product build what inventory will I certainly in as there. But grows, not the is, happy tell I over you an

think fact there to seems were a a that of little working alluding in are than seen to sales last picking bit you down up. the be more actually We’ve of the quarter. I you a inventory

am come sort back to standard will of the levels. that I sure I up

that, were, would key call for in are the everybody the think and driven the thing inventory call. I the channel a on on highlight build-up is they of our sales actually not by that if we

Evan Loh

Yes.

closely aligned, think in I demand fair to very market saw Kevin. our you as the ordering in institutional it’s say that, were strong demand was the first quarter

Kevin Kedra

a me With have emergence as agent of about dominated large need and in change diseases. an currently awareness the the and throw for conversations with follow-up. the the COVID we all have about payers novel both seen as that that that infectious one well given being importance anti-infective by you the tone of are that, let having political just of And Great. the antibiotics, arena of

Evan Loh

as very time as I therapies therapies. anti-infective think prophylactic direction I are it’s a has interesting of spotlight right. the in you well type as shifted really think of The

I about you been they solutions. the are think clearly that’s HHS, think from when end-to-end in of search made commentary

anti-virals, thinking as commitment well as diagnostics. pandemic think the be I not their I also think the is bring end-to-end in and includes, technology possibly the is anti-bacterial in they as to a solutions, testament think that But there this to as interest BARDA only an strong that patients. BARDA in can it for at it to be armamentarium about best commitment when the question And asking vaccines, is our forward

be CMS think space. way believe and continued been at looking we’ve and and difficult and that be will I hospital heard will a very has there more And we also in terms moving that of evolution that time very in reform quickly for antibiotics the this in they reimbursement seen payment reimbursement

they And side specifically another in think the Medicare recent our this commitment no and most – a them the pandemic, the to with our Part with the over are available age the made on prescribers all who most to D lose are the fact patients restrictions. vulnerable, also finally, Humana this most contract success to post is patients co-morbidities that is to big for I with they’ve of ensuring XX at testament that potentially their if NUZYRA COVID in in want

Kevin Kedra

Good. Thanks.

Operator

Thank you.

with of Wainright. from [Ph] Our your Dennis question. proceed line next question comes Please with H.C. Arce the

UnidentifiedAnalyst

morning everyone. couple is this Congratulations all in questions This and good asking BARDA contracts for Ed. for a Hi, the NUZYRA [Indiscernible] progress the quarter. on of

So, a the BARDA bit first little about question, contracts.

approved steps that in Assuming first take need are the order? to the in what some EUA you order will SNS to quarter fulfill is this immediate

Randall Brenner

Tom, Hey, it’s Sure. Randy.

Evan Loh

Randy?

Randall Brenner

Yes, Randy Brenner.

BARDA. the the working those of I analysis, use most – closely been of we’ve So advance with which things. word that administrative those of are certificate quality procurements There in happen documentation, kinds agreements, activities occurring, around - of revolve have a to number of for

happen. documentation comments, are So, together, well putting teams the Paratek in BARDA said busy as t initial I all and both the in extremely his place to for my are working

and review once our is we’ll pre-EUA with FDA, So, forward to the is the by that completed complete expectation ready be documentation all will that, procurement. be the progress

Unidentified Analyst

Okay.

since order NUZYRA quarters is BARDA? spread lump Is be to few next wondering it's $XX becomes out the good. then, just contract? payment going for the sum as about Sounds a million. this to to it this recognition revenue And going a shift first Or

Evan Loh

set single have as We up payment. this a

Unidentified Analyst

Okay.

the sNDA to Can And other So, before preparations oral then, NUZYRA. Thank to formulation is some for outline the switch the final submitted? want single payment. you just of gears for you. developments

Randall Brenner

Yes. your missed of the question. beginning I

are understanding Just you the are say interested in going – that preparations of for the and sNDA? on

Unidentified Analyst

That’s Yes. right.

Randall Brenner

Yes.

in closedown clinical of we COVID our So, late at study ongoing are the of stages the outbreak. activities. only It’s the study time

working activity to all So, with we remotely are closeout. the sites study do our

and analyses, summary it’s for programming closeout So clinical the any then traditional of study FDA. – study creation very analyses, for data the report

study in out things at are very any as for typical So, this progressing time. close point

Unidentified Analyst

Okay.

quarter. on questions again and good. you a for first Sounds our Thank congratulations good taking

Operator

you. Thank

follow-up a Please with Hazlett is Bert question. question with next proceed from BTIG. Our your

Bert Hazlett

China. to would on why received Yes. like in could And you our partner’s just here? have We on the your priority as just some it us views potential give your they just it you review? China. gets thoughts opportunity get But frame see I we’d your opportunity you. the understand closest to reality Could in better obviously maybe as like that estimates. you activity to Thank

Evan Loh

see that So, problem, then, can’t a in in like think U.S.-based importance the a problem. to China China. I minimize a talk little the actually taking It’s not with environment I of resistance. about Adam, the and Bert, in bit the step back, we it’s you the a little way and – talk is maybe regards can I just about bit antimicrobials a we maybe terms maybe think, of issue can global

And terms tranches some of And China world. the has they’ve at in a antibacterials the the do bacteria of of for China. the – because outcomes, experience of there in of has sure, come And through out been adjuvant FDA. highest resistance data I of I and the rates am not use the China don’t first know lot COVID believe I and resistance bacteria

I end-to-end of the that for the that citizens that want have sure believe see solution And is But make and country. Chinese to they they – that I they best that NUZYRA technologies. in think see part

excited very are we that. So about

patients first to of Chinese we in product the the And of Chinese the process forward then getting into half and an forward to getting XXXX. physicians the this look moving hands approval and

Adam, to it what as omadacycline? about relates China

Adam Woodrow

know Thanks, ensure There upon novel there work still and antibodies the is is a a for potential clearly preparation doing Look, deal up in Evan. from mean, perspective are unmet approval. everything is teams great China. a medical need initial some to got that there significant that their push I of for we set they’ve

first entitled half XXXX sales percentages million low payment expect Just to of under collaboration that Bert agreement, obviously to a we royalties the $X approval. milestone mid-teen net and double-digit We we the terms that of sort received then that receive the at on the of a in actually upon reminder, tiered are that of regulatory follow.

and expand with will proven that work They’ve got how And they’ve and for got significantly of we’ve products a our great will commercial global we’ve endorsement good partner to China. things great Zai. footprint expectations in a be the the developed. This partner

fair of that will especially a in got think that say tell. NUZYRA, marketplace is But drug opportunity So, it’s to type that's there only significant like I for time the resistance. a

Randall Brenner

Bert, just as that to well. build on

mentioned, order in Pharmaceuticals any Zai opportunity with As get in what a partnership full understanding company to it has product this announced Adam year to of the will has earlier a launch space as Hisun approaches commercial order take the and launch, And there. U.S. be there in there the to

Evan Loh

In China.

Randall Brenner

And that committed the they and address they upon focused believe XXX around I – believe be where they’ve – be launch. initially cities I is to to China. will representatives you said verbally thank in Yes, tier-X able actually around, that their what have

see Zai can potential well – generates with that China early the similar of gets you that made seen momentum is very it have Labs in and to commitment has is need NUZYRA are off to terms And here in the the pleased and launch in denominator that in we that launch the U.S. massive we the unmet ensuring momentum the

Bert Hazlett

you. Thank for you color. you taking for Thank follow-up. the Thank the

Operator

you. Thank

like to the We of session. any I end Mr. turn answer to the back closing question have over our remarks. for and call reached Loh would

Evan Loh

NUZYRA interest we As journey In The attention success in you I commercial questions, and is continued well your making today, there of today’s conclude no more to call. for your to like closing, Paratek us. thank are underway. will important all NUZYRA are would and time

and in well The unique specifically community-acquired success broad for infections. patients oral commercial with growth long-term are well-tolerated profile is serious of based once-daily, positioned NUZYRA,

in increasingly NUZYRA to of continued of NUZYRA when As is addition to a armamentarium and opportunities. of save on to an the confident particularly wealth data NUZYRA to we the We to much expand, a oral-only committed be NTM lifecycle resistance effective concern. of physicians to the the potential pneumonia development are the to remain needed and continues available lives, antibiotics

to The off a the signed partnership taken last of initiation Several is place the NUZYRA of securing NUZYRA of in the BARDA activities for end We support activities the a of with terrific at start year. approval of have all associated addition funding with first the support manufacturing post-marketing including for contract and to momentum. important the the to progress our onshoring procurement. towards requirements great

not for a The antimicrobial the BARDA collaboration against innovation leader, bioterrorism Paratek as only the broader potential but with sector as resistance. the in positions battle the in ID leader to for provide pathogens, NUZYRA the

strategic that since NUZYRA antibiotic IV to to potential and stockpile deliver fully ciprofloxacin oral anthrax the Americans. lives first protect and important save we treatment were broad added expect the added spectrum addition the an has decades doxycycline In new for national two being and pulmonary nearly ago, to option to

motivate the would us in clinical have studies selfless to and tirelessly our have at participated providing are providers every all employees opportunities and in we bedside worked patients These who each at the in thank for like Paratek care and who NUZYRA who day. patients need health for and our their

of very success. support for continued Good-bye apprised our interest. look We appreciate you keeping your much now. and We forward to

Operator

concludes today’s teleconference. This Thank you.

wonderful Thank may You Have you day. disconnect this participation. lines for at a time. your your

Paratek Pharmaceuticals (PRTK) 11 May 202020 Q1 Earnings call transcript