PRTK - Earnings call transcript Q4 2020 | Paratek Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Paratek Pharmaceuticals Fourth Quarter and Full Year 2020 Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a remainder this conference is being recorded. I'd now like to turn the conference over to your host Ben Strain, Vice President of Investor Relations. sir. ahead, go Please

Ben Strain

Randy results Evan Brenner, welcome will and www.paratekpharma.com. Vice Loh, fourth found and Development A corporate and company's can call. at on Participants full for and we've Chief also today, on will year posted referred Commercial call also press and Chairman; to XXXX and be the slides year available and Accounting Principal quarter earnings update Officer; Officer; website fourth Adam issued to afternoon, earlier quarter and that CEO; President Paratek's Regulatory our for are Chief Woodrow, and Controller Executive Michael full release questions. President Both was today's be Officer, be of Bigham, Good conference Finance, Higgins, this call. on Sarah

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

Evan Loh

joining afternoon thank Good call. update Ben. XXXX you, Thank earnings corporate quarter you our all and and for fourth and year full

pandemic the medicines also of and challenging of in ensure need. Paratek at NUZYRA the who the dedicated putting to provide The who to fourth as and first have mission strong employees Before every generated in I growth and being for quarter, environment. increase through revenue the commercial provide acknowledge like to of revenue in throughout lives million, I the healthcare quarter. advancement to an patients continued need overview NUZYRA three of and XXXX over bedside a our our the Paratek's like at selfless thank worked corporate $XX.X XX% risk and highlights, seen XXXX success for lifesaving would I are each this all of net patients would third quarters courageously into save of tirelessly those quarter-over-quarter thank professionals day to themselves continued

at the generated of $XX provided range, For last NUZYRA original of recently in core end which had most our well was NUZYRA XXXX, commercial commercial high sales communicated of exceeding $XX.X we the million, million full our year February year. business that guidance

primary significant care Our through targeting achievement unique ensure for belief a continued with skin setting, significant is of our in to upon believe support a formulation offers the have in treating combined combined against reflection commercial attractive option evolving that The NUZYRAs expansion the commercial launch a time setting, been into further specialists the NUZYRAs believed In a with place, in NUZYRA much-needed NUZYRAs NUZYRA disease trajectory especially providing community by outcomes we in educational the healthcare approximately deliver launch to and it post now our expanding potentially the Adam in only is approved objectives, with scientific spectrum priority will profile. and of antibiotic years. positive our the importance larger environment development relevant the $X.X but clinical setting. new formulation has which in success strengthen one with estimation, with a to benefit XXXX product NUZYRA very the promotion is established for indications, and launched stays market as oral and saving use, ability infections. acquired today's on minimize always oral of for details exciting successful our life hospital for most to is that many serious opportunity. meaningful initially infectious patients now, for prescribers COVID NUZYRAs patients. an volatile successfully growth the and not addressable once-daily confidence hands formulation. continue and infections, metrics Throughout patient quarter-over-quarter appreciate rapidly access understand execute settings. of physicians community from profile and to who patients based last profile hospital the NUZYRAs oral tolerated and demand We've we to makes profile well The serious hospitals hospital focus broad years of two billion provide clinicians. date in broad-spectrum long-term five once-daily this in on care XXXX continued while NUZYRA. NUZYRA of intravenous NUZYRA specifically unabated NUZYRAs antibiotics the that performance success right XXXX, firmly launch its With strong two the the commercial continues in community the more exchange will

year on As noted this exciting in a rich we'll of slide, number a on XXXX, for and be Paratek be both transformative next priorities NUZYRA. catalyst in focused what should potentially and

Strategic which prepared community of care to pneumonia, NUZYRA expansion the China Zai infections milestone his into million to Xb skin NUZYRA setting, in the trigger of for for FDA provide the of NUZYRA NTM the in and on Lab BARDA BARDA a In the we include primary additional $X remarks. The Stockpile. and study NUZYRA will oral loading for in dose in Randy on of decision abscessus catalysts will initiation sNDA programs these National NUZYRA NPM that for a anticipate and addition details from procurements launch Phase CABP, two the both approval Paratek. payment the the both

US government the of prior the quarter, contributed an quarter, of in of prior of increase and quarter increase Paratek's like XXXX XX% the highlights financial the fourth guidance. XX% $XX.X Adam, our year over XX% sales revenue and XXXX review to increase the quarter, an and Before financial Fourth total I I XXXX quarter net $XX was full million, now NUZYRA hand provide call and was quarter BARDA would over the $X.X the contract XXXX. versus million revenue in XXX% over an of fourth XXXX. were of XXXX quarter and XXXX. to fourth over in over no revenue grant was service million note third $X.X in the Of fourth from quarter generated quarter of million contracts Fourth of that increase it $XX.X million the XXX% end $XX.X total generating XXXX, revenue Full year. executed as in NUZYRA in year XXXX US net million, XXXX, year. near of a with prior was over the sales December

were contract $XX.X grant million in manufacturing $X.X compared compared government compared primarily decrease process the BARDA demand service expected an revenue to million period million collaboration contributed million million million, R&D and for increase to partially in the incurred expenses $X prior future year. scale NUZYRA. Fourth quarter when revenue to of meet increased Full an under to third-party up SG&A for $X.X the clinical $XX.X prior $X.X in compared XXXX the and in year incurred the in to SG&A in same and While to Fourth contracts $XX.X and $XX.X to the to expenses study hospital our royalty were in period result in prior XXXX. expenses costs by due quarter territories The expansion. Full same million expenses were realign year. year cost million year our community lower expenses $XX.X periods million, is offset XXXX. XXXX the additional R&D both

XXXX slide comprised left Now side be this expected two turning the million R&D I SG&A financial between R&D $XXX to $XXX on begin our to XXXX is and is and on focused which and Full million of guidance, SG&A expense will of year expense. components.

of XX% XXXX and expense will component a of core The histogram of be million, of in XXXX represents a represented is in business estimation MTM. increase business the over and Both as This expected in all an stack primary in Phase significant of the the R&D bar, study core of efforts care drive dark business histogram Xb by $XXX level that capital R&D expansion The to levels. for and driven SG&A and in value both is XXXX for XXXX compared increase pre-pandemic with is blue the will XXXX dark shareholders. expense and R&D SG&A our the poor allocation but expense noted first the Paratek the bar. modest consistent which to leftmost initiation SG&A blue by the XXXX,

other are $XX both BARDA onshoring driven is The $XX of BARDA which between reimbursements year be full manufacturing by will which full and million. range cost R&D million to component to and to expense SG&A subject anticipated of XXXX R&D

each revenue the Turning range are now two to the core represented of in the range like $XX I'd between by right NUZYRA orange product between range total of to million. an million full consists US revenue range. million estimate to net $XXX estimate XXXX side includes additional by expected estimated of expected between green which stack revenue BARDA to revenue the majority million the $XXX in $XXX from sales year procurements from of XXXX This and a XXXX bars, XXXX this $XX million The represented for breakdown estimates histogram SNS, histogram. of the revenue this slide business, range for sales, $XX commercial revenue provide the and million. NUZYRA the year stack Paratek million to $XXX to

for the procurements of this the previously. service and procurement $XX of BARDA revenue collaboration revenue half occur the year and grant of of noted as occurring year. of contract second service $X revenue XXX% and and reimbursement to first the year expected first expenses $XX in grant to part R&D The the BARDA of BARDA these XXXX estimated government XXXX full and million balance full million is the half second provides revenue the contract consists approximately Again, two with in The between of million. royalty year, BARDA SG&A

core ongoing guidance, larger flu shortly. interactions Adam impacted physicians, of be contracted While hospital-based we hospital our pandemic, XXXX quarterly with sales and anticipate which face-to-face limiting in force, not early NUZYRA on will more provide to details the to the due we normal provide do than season commercial typically a business reorganization COVID the modestly

quarter, vaccination acceleration second the just Healthcare cap royalty with our collaboration of team including revenue The that from of per driven assumes agreement Our license This will access coverage the an not payments, initial month. only hospital-based latter $XX annual the plus will XXX% Lab repaid community will herd an immunity, net XXXX milestone US cash approval the sales full in sales revenue related year. also Lab expansion, into Hercules both pay non-recourse million Capital. of this the amended which interest NUZYRA all and in near-term XXX% an of fourth agreement proceeds together guidance an be kicked carry agreement entered using our with which R-Bridge loan to and affiliate million The expectation as of loan also and a half us Zai excluded off company's company's Paratek. maturation loan by in Advisory. we X.X% but with of from hospital Late Investment with improve proceeds initial on closer of the by brings the outstanding $XX to sales loan obligations hand All with the the pre milestone of NUZYRA. Zai used remain and net are and restated was security under the

and runway provide our would just our amortization our Hercules years facility. like plan and emphasize overall Adam? marketable nine call XXXX, I like flow a non-recourse cash beyond million as cash XXXX, that to securities for that the to operating strategic cash, now a $XXX.X as to breakeven. to to believe We balance equivalents upon up provides further described, as over is loan Adam. cash is current R-Bridge XXXX that structured as of to December our the flexibility late Importantly, this the as of to turn maturity would period the existing to I pathway cash anticipate the strengthens end and Paratek materially which XX, of with sheet financing extends position. we through and Based of

Adam Woodrow

Evan. Thanks

Paratek I'd new past months. welcome sales the the that I representatives like have Before couple to of begin, over joined our family

in have pandemic. need. to US us well continues growth COVID-XX opportunity ahead progress even seen the NUZYRA tremendous face patients to look journey The NUZYRA launch, quarter-over-quarter a forward launch provide And and ongoing each strong since with We challenging of of of the the you. in I to of to with

this can revenue net from As see you the fourth quarter. quarter when slide, compared grew XX% in NUZYRA to the third

broad We of both face-to-face Reduced and into wavered dynamics consists scientific continues and with the We to fourth hospitals COVID generic strategic historical the and progresses. for focus are and to this XXXX. personal of does access, and serious efficiently status. saving to further the well Regardless to physical associated we representative spectrum the to gaining physicians restrictions utilization COVID-XX access these a community effectively related patient normally who access education antibiotic We physicians the ability from will virus challenges. reduced engage shift XXXX. physicians' second environment reduction more made environment decline XXXX are early and our continue lives has trust interactions, when levels in a into productivity. within hospitals impact the year it increasingly acquired awareness affected these and antibiotic. in challenging at see face-to-face of through and to hybrid In the to not flows of March and of due introduction virtual the compared model interactions, credibility a have our Nevertheless, with of to new were represent interactions. quarter offices headwinds, particularly steady and future, in interact of to results our our infections an not that increased present the half with accompanied despite institutional institutions, formulary These building flows quarter-over-quarter on every balance also a with the These continue obtain to from fourth encouraged existing business have operate quarter spiking with number to And grow and XXXX. least by face-to-face considerable model saw impactful throughout day. sales patient and treating XXXX by as to for establishing foreseeable a

of that XX.X XXXX, setting. tools. of we and we're marketing supplemented challenging Medicare. safety made XXX prior do XX.X sales translate in And to we efforts focused demand. million NUZYRAs antibiotic acknowledge of to net that XXXX launch convenient commercial approximately from product a quarter, three one care past We XXXX able progress approximately Accordingly, these growth covered materially the fourth the third lives the two of perspective, in still NUZYRA of million million profile with of have and access the and approximately fourth factors the include common launches and NUZYRA NUZYRA and by launch. utility five with by demand some January. into the indications; We continuing gross one, product the that was a achieve to XX.X the sites sites operational and other sales quarter years broad NUZYRA hospitals very heritage; success in We IV representing versus pathogens attributes with to in from many work of spectrum market that NUZYRAs formulations continue hospitals is great commercial our resistant in strong backdrop. the fourth with as enable two, US quarter million commercial quarter care. future efficacy, tetracycline continued the have and across including past strong three XX% over such, best force establishing as consistent will launch The multiple sales a and of that of in care the increased in favorable five demand years settings in the differentiate years, once-daily adjacent first Paratek's primary build increase these against believe of supports driven as launches quarter to even success driven a From on strategy, antibiotic of for virtual execution, care which in adjacent our is oral end itself

NUZYRA off reimbursement into denial support coverage than our utilization care. With planned into setting for established, beneficiaries specialists who we support current our decided However, adequate successfully are we disease is solidly launch XXXX, Medicare plan. more been since care have to extremely rates, our primary commercial our low. using Therefore, early primary from infectious expand to with believe expansion the in our efforts overall significant including and combined label now original that per

it skin that NUZYRA targeted physicians. to primary will provided off into pilot and to The challenged pilot for Current with small and can the on expand these clinicians of of antibiotic is months, care care upon that XXXX pilot, market bacterial limiting trial the launch trial the a addition data the billion access with the infections. care This utilization physicians. $X.X current meaningful is concerns, primary conversations pilot and past the kicked clinically need safety skin serious there In Like once-daily of or our a This a MRSA focus clinical has in physicians' universally by options to occurs support, coverage year. builds needs first our with clear NUZYRA program care primary middle infections. opportunity program utility. by physician resistance in is through generic data verified ran broad-spectrum tremendous end plan fewer in an are primary their several from to pilot skin awareness for the primary well-tolerated for our suggests the against primary unmet adoption. lead building either that by and significant hospital-based includes In than oral address the significant setting quicker our among suggests over the by in calls physicians infections unmet initial care the care antibiotic opportunity at

to our approval anticipated include only loading bacterial also, of after the have later efforts acquired pneumonia a oral We sales regimen dose the community this to year. plan broaden

of sales focus sales across of hospital a opportunity the Paratek force. our to sales then the force, and representatives. most vacancies XXXX, converted and overall new sales targets, created most training hospital the January Subsequently, the realigned In time This we have hospital quarter force full into this footprint. size at we and care productive detailing primary this refine now our sales States the productive reduced to in have most launch hospital their These most the territories started of new doctors highly realignment, representatives efforts select completed recruited to productive the and the United now in our employees. Turning to fourth sales us having our contract allowed filled month. talented hospital and representatives the

by that is will and have specialized sales expectation XX These XX hospital-based Our organizations. payer the in field. approximately supported will sales by be and representatives second we teams quarter, the representatives inside care approximately primary

full changes. during see realignment quarter, the it the expect sales a before recruitment of and impact of these Given we last months the personnel the new will take and few this we

So far, community positioned with right are are And over and long-term to believe continued early encouraging. the one we're path We quarters month and reporting signs to now ahead. in on to our Randy. the call turn I'll And with look on in the the NUZYRA success. expansion forward commercial for that, well we progress

Randy Brenner

medical and successes to Adam. the have thanking CABP the manufacturing dose early loading research, under first number the We physicians, the shareholders. for potential work and activities startup work you, medical the half significant regimen our these begin of believe enrollment value for through XXXX. for and a submission pipeline of a to Phase making affairs and oral progress significant as our begin sharing at of all the data such build as and conferences, NTM by Xb advancing XXXX new Thank team will patients year study advancing progressing included with standout efforts manufacturing of anthrax for our with as I'd publications Paratek BARDA many the and clinical preclinical, in like that development, to the their hard activities. was program,

this for with to in well. the potential against of bioterrorism of NUZYRA continue develop that to commitment partnership currently has jointly important recognition the manufacturing and resistance planned progress This of 'XX the will production for have to knowledge partners a an order in the List, of made process will additional XXXX. BARDA in process in and the development the our to the Strategic only be NUZYRA Stockpile. designated. US. but against and we as partnership, fight The process Paratek advancing our US recently development equipment for The our are codified validation published the flow, the stage public partnership onshore modifications completed BARDA executive API to having FDAs best of begin Omadacycline fulfils White House's to process will of onshore private States facility progress BARDA initiative. efforts pathogens treatment in in enable National and of our NUZYRA Together manufacturing procurement XXXX. our be important to is of with antimicrobial completed early advancing produced in us the selection the unique shared first NUZYRA be API and in we chain starting and commercial the the US within to with the onshoring To expected continues engineering secure goal along for Medicines This anthrax earlier, knowledge noted medicines an NUZYRA As Essential the production. to supply make including antibiotic our including transfer NUZYRA so also the been United the Paratek was are supply deliverable is

in the to PK A will on recently study program. the in completed, also progress rabbits which into significant lead pilot species. We this studies efficacy make anthrax animal was continue roll

the half either that These activity We're second of in be an was pleased are expecting shared resistant bacteria collection Congress. two XXXX. a those with upon strains, Omadacycline of against to the strain-resistant of potent many the to addition, currently and aligned report XXX Omadacycline MICs recent the effective note anthrax dialogue antibiotics In to BARDA, ago. Scientific and very will isolates a due not evaluated upcoming the in we first against demonstrate impacted all the strain-resistant anthrax in which second their procurement was had Of at data Ciprofloxacin Doxycycline approval Based MICs and near-term continued tested. the SNS to procurement additional Paratek in to considered and against strains. years

of delay expected the upon is the first our feedback future in procurements. not from based BARDA, the timing procurement on to have Importantly, impact any

for progress lifecycle opportunities with NUZYRA. some Beyond we BARDA, also the of our continue other to work

July community for pursuing last oral these NTM. submitted acquired in abscessus We're pulmonary sNDA loading XXXX. of for caused disease rare was May set with non-tuberculous or by The for of regimen dose Mycobacterium our in pneumonia. This program year a first mycobacteria action bacterial disease a of our the application date is also

with Mycobacterium pulmonary clinical highlight KOL community reminder, need to the an an the is treat Inbound and orphan to As no abscessus. a well FDA with continues infections tolerated antibiotic fever, duration. non-tuberculous analytics, our Patients of unmet approved from abscessus Mycobacterium abscessus many for by in disease the therapies. efficacious symptoms caused Mycobacterium pulmonary severe have market feedback Mycobacterium oral alone. can cough therapy upon and addressable durations $X include Antibiotic abscessus shortness breath. that a market fatigue, in potential often be Based billion has US lifelong internal

needs. for will advanced This in for study be plan treatments. are the NTM size the about startup disease about We'll the XX details subjects include for more to to point. X.X study time this as study two weeks who controlled the the year at will disease Paratek. an endpoint expect was study take and for opportunity in is a approximately randomized ratio. and of enrollment. we other randomized generation great with to for with as study patients potential Phase efficacy initiation placebo half first which of to Therapy abscessus are assessment numbers early activities of this symptoms XX We unmet not exciting study NUZYRA in pulmonary receiving with assessments XXXX. our endpoints, patients of microbiology for The a Xb this data the be X disease medical monotherapy with important safety a affairs an and that overall address that efficacy provide meeting. medical at small Due This significant activities will rare both years XXXX complete future for lifecycle a is

therapeutic studies clinical challenging In The addition XX will accepted manuscripts and from continue real clinical in with investigator-initiated in NUZYRA disease special progress world osteomyelitis. evidence additional the were features journals, including outcomes Omadacycline, foot unique the from that published studies story parallel, and investigator-initiated publication in there states Mycobacterium scientific evidence that non-tuberculous our patients were theories throughout in Omadacycline reviewed independent XXXX to In difficile for ongoing our of addressed and its C. the research peer XX initiation use receiving case infections of program, populations, with expand program of and define areas will with research be or to our continue abscessus that further to observational diabetic two infections. profile. like pathogens, non-clinical describing and

clinical medical the team work field pneumonia to two skin will optimize also the take continue algorithms In protocols addition, the growing launch to NUZYRA. considering Omadacycline years in research on a MAC in non-clinical model, complex the first build will implement of studying NUZYRA. alone data and Mycobacterium of to osteomyelitis the avium to rat in activity Mycobacterium learnings treatment over institutions studies with combination and and abscessus or and from when The treatment scientific with

access and launch for Importantly, provides expansion request and funding investigator-initiated on care website related as this resources a also It request for use access the to our healthcare the resource setting, affairs resistance. website professionals. launched new resources tools also the product we've for providers NUZYRA Healthcare antimicrobial time medical bibliography, educational can research. into information, completed to primary in a medical

state community disease resources infections, Additional pneumonia skin acquired as be on as well bacterial available will soon.

for engagements primary China, care and mechanisms Additionally, access allow the community data broaden the field regard generation is to to this Operator? ensure Last, for opportunities scientific community the patient to good make and this approval year, milestone and deepen educate and in in to affairs the We line providers More now triggering open NUZYRA. regulatory expansion from resources fully deployed to to thought NUZYRA the additional with medical a clinical like will review face-to-face $X and physicians clinically Lab institutions. care payment being team focused continues to that reach will potential medical process important in new with expected with believe the Paratek. provide the NDA engagement At the primary into order questions. would of and we to specifically, first research progress China community medical Zai support with further the to populations. a half to extend point, in the million leaders, approval

Operator

our the is At time, [Operator And we'll Instructions] Fadia question-and-answer question with this first session. be conducting SVB from Leerink. Ami

Eason Lee

of what two terms of on getting Eason question. first, have Hi, I of assume this BARDA on just just I'm award? the this I Ami. Thanks the status taking for procurement, our million recently is in you the maybe is sort may, the to pre-EUA, first Lee had curious $XX if Maybe remaining for which dialogue step

Randy Brenner

Sure.

I'll that Based the Randy, recent discussion data completed BARDA, data, first which been triggered the on PK procurement the we're that of be by based take the we most scientific believe is with near And was aligned on recent submitted to and that. very this review mouse expecting has our FDA. will the communications in pre-EUA So term. the recent then

Eason Lee

Great, thank you.

the the the trajectory how in is of in just this., commercial you Okay, relative the about you a guess it are to to then sort slightly you. core growth force I realignment? launch the business, maybe million number for the how I thinking maybe strong maybe for guidance $XX impact terms you COVID, guess XXXX guess estimating community above sort I the was and maybe performance just in $XX question do the on million from relative then my of I second XXXX, like like did of Thank - sales guess, consensus seemed

Evan Loh

that? take you want do to Adam,

Adam Woodrow

interactions into with our got our is year have which large is of the check hospital-based we contracted we're is foremost to definitely quarters, modest half be kick in perspective, of is COVID gear of early really we see we ongoing. mainly expansion first to we essentially is the of predict that. and which we season impact impact difficult business. provided limited the expect this physician. because very, very saying year. one and and the it's get guidance our a why our that a of to got the the we forces going cognizant into as sales obviously part from community Look I'll COVID-XX face-to-face on, we the that on Yeah, reorganized year, to to very pandemic new had We've But flu to We've mentioned feeling into continue the that how see still into earlier going the as second impact went a things

Evan Loh

in We that hospital Yeah. COVID. grow that are of that incrementally. do year That being primary think, when strong will continue you uncertainties expand the expansion - got half of care provided, each regards to to give see the of that quarter-over-quarter you we've coming confidence you you then to fidelity with the add come I sales vis-à-vis And to of was said, numbers able with we upon second those some of of this and And to curve. our the quarter that very see I what I force, guidance we'll acceleration what terms terms you back more sales saw foundationally in growth think that what in we're forward. And think we today, as I do. would referenced, team growth, terms based that'll as we is on comfortable build is range the once

Eason Lee

Great, thank very you much.

Operator

question And question. state Arce from H.C. our your Wainwright. Ed next Please with is

Thomas Yip

asking this quarter couple Hello very Yip, for questions a NUZYRA. of Ed. strong on Thomas everyone, a is Congratulations for

formulation oral be question for there Or updates first far? from so perhaps remaining that needs completed? the are only there is that sNDA, the work related FDA any all for So any to to

Randy Brenner

as mean, work in I answer submitted no. study as July last of filing was far is the the year. sNDA the within remaining So

no on PDUFA to upcoming year how data the now with this in to progressing. and further review of right report May our So is of updates as regard

Thomas Yip

Okay, was said the be near-term and is the expected the one in guys update. second Randy one two in half. one And thanks - you procurements who BARDA I believe should then clarified the XXXX, for

there - expect for different curious, is in going spacing we forward Just should any any procurements? and timing tranches

Randy Brenner

Yeah. Sure.

So the the mean, Because contract thank the of general, about contract. of other years the BARDA four the the over is years into reviews the procurements This to courses is originally has future is priorities little of three again. you bit initial generally the was and that our now remain pre-EUA due the focused annually X,XXX next I shifted of FDA. first the way treatment the Randy of is for were FDA XXXX. anticipation first question. in delays timing annually the the from out over one four spaced and will contract. from That But one COVID-XX were procurement structured a that

Evan Loh

that compression there year, to which delighted be at this we're this anticipate to a will but Yeah, two being said having in be able point.

Thomas Yip

Okay, NTM that switching to gears sounds the study. good. Thanks for then clarification. new And

that regarding preliminary United details the any you thoughts chances expand specific And You guys focus to tend geographical the to on? areas on there to are are of sites? States? Phase study gave outside What Any some some Xb.

Randy Brenner

time US. the to conduct is so in the Yeah, current current entirely a at plan study the

the people NTM, referred As far have get of general, Centers Excellence NTM where where sites go. to Mycobacterium people think the as abscessus. all NTM, but of are specific ultimately diagnosis of I final to, generally In know study species specifically and

around as sites the some the centers across the centers, will major the well of specialty So NTM academic generally other that US. align as exist

Thomas Yip

for back for much for Thanks now. queue. XXXX. the to busy forward in elegant very for look We'll the very it be the you thank us a Okay, questions show. That's and

Operator

our Kedra Kevin question with from is Research. And G. next

Kevin Kedra

taking Hi, you I through details follow the study. NTM. that of went of that thanks on for Randy, the want up some questions. to

thought therapy. missed in have one or be any of two had trying said But So on patients them keep that will I study I to the track. basically you may not

patients It's to therapy of cocktail they antibiotic purely of sort use. So and be antibiotic or these off able of out to or be sort any going on? to label background kind be basically going what on placebo won't be washed are patients background

Randy Brenner

diagnosed patients patients. These I'll will question. them the generally call newer for thanks NTM so be Yeah,

been some a So NUZYRA symptom for of on relief period had time. versus you're monotherapy likely on come is they a the therapies period placebo for of right symptom, and will of previous the time. three-month the primarily monotherapy most study or this therapies into not that at other stopped And looking study placebo-controlled

Evan Loh

diagnosed a move specialty when that these referred lot more newly get color. to Kevin, of In try of three-to-four-month And time. a a they to recommend period to like therapy toilet pulmonary do they generally just to secretions. almost for to patients, these bit little add centers, generally physicians the

that this the care of of their with is another algorithms arm it of standard the in over to addition placebo-controlled consistent antibiotic into time, is period So addition care. another completely actually

very excited patients. about the ability intervention at improve - monotherapy So to it's a these look chronically to we're the ill symptoms of

Kevin Kedra

out be there the part and of patient have symptom going Great to you for score? termed I'll would diagnostic sorry, and going tool as to be Is that from stop up be the and it what endpoint guys - some follow - is primary endpoints, with there.

Randy Brenner

the trial pushing rather FDA - I FDA of NTM think we've know, as endpoint the and endpoint. We've NTM or may about for you as endpoints talk XX microbiological before. abscessus had months meetings over So the more of and about clinical that Mycobacterium shared a last generally couple symptom than for is a relief so with really

significant it efficacy to the endpoint But be first. as harder that at changes microbiological well. to pure may microbiological, XX-week So symptom be show look abscessus study, won't say will in at we look the And not we a endpoints. in

be will the ones endpoint at symptom the primarily. we look So

Evan Loh

endpoint they primary NTM a antibiotics. individuals respond because a of FDA these advisory where to away from how combination vagaries as about ago had an Kevin, couple panel the the microbiologic cocktails years the of walked endpoint of specifically

for create different a what team like And planning pneumonia I think Randy we're looks forward dialogue It's aligned And meeting FDA. improvement with we conduct to And symptom had that too in scale. of the that an that share driver the, used to upcoming near think in symptoms being have I looking and we generally, here. there's an his the scale than And lots the to we're are able pivotal future. that was to really are trial. so symptom here. think for the us opportunity here our not

Kevin Kedra

those something them primary two Great and if sort able you're old run efficacy to and do would - to data you Would or you filed be get X? possibly to on show any run generate on with the the then this, to one would data a Phase feel secondaries. have just would this symptom would you ones see be last powering hit this you expect of in I'll anticipate to to And and assumptions you reduction? that endpoints

Randy Brenner

through I off meeting review the we're much an power Yeah, to more assumptions soon hold Evan of NTM study some upcoming at we'll working time the that. the schedule design detailed too think around we're so we'll that mentioned, a specifics and have statistics this as of planning giving in and around the still

deflect don't question So future if until a that I'll mind, you discussion.

Phase not what is abscessus a approved based need clear Phase been we the the we've Omadacycline as the there's the X in for - hear published what far a very study. high. an therapies I no and mean, case KLO Mycobacterium itself a As this from community believe super from on reason. the for oral study therapy that it do FDA are We're series treatment place that where a there is and we've study for of goes, calling Xb have seen We

the back about to have Xb and to information on on there in by little the it an have a for that best out. fact this got enough is comes go stand to will if continue goal with go indication. we how so discussions ways designed should us this to label see And be to the changes. to FDA I with think how But potential that study study from and robust and discussions we the data support data we'll the FDA a this that opportunity label study ultimate future the But Phase supports as is a how data include

Kevin Kedra

thanks. Great,

Evan Loh

And actively and Randy might still safety aspect to are FDA, which determined discussing how will that is that think I to with component right? they're long-term around look be extension this like. is focused another yet that evolve, There you the that component

Randy Brenner

that's correct. Yeah,

you listening to heard carefully, study. that a XX-week if you words my were So is

through future. safety into an which the to patients in roll considered collect to opportunity is more the come use the also some complete that so study of setting. on of would data with this to of on extension, Omadacycline the logistics other allow working to in on longer label enable And that study team open us Our us allow combinations a clinical term are controlled as standard to care, they Omadacycline the

Operator

from Hazlett [Operator and our next with Bert Instructions] is And BTIG. question final

Bert Hazlett

Congratulations Thanks. folks. Thanks the question. on taking the progress for

purchases, me. Just excuse BARDA the first to specific or BARDA the come and - back for reimbursement

probe a given the you some XXXX? actually little of that just payment, second within So the bit issues what more, gives payment occur the confidence will with to first the

Evan Loh

phone our discussions have BARDA a on we Bert, comfortable basis calls team very with guidance. and at through ongoing them, recent are and but regular development to contact we've allowed had feel in with very continue joint confident with current BARDA. align senior we that Very leadership have the in not to only us

Bert Hazlett

during just some coming things more little of you. bit in and Adam the wood mentioned to put coverage of in that accomplish were in you a on not-too-distant Medicare. And to could regard question terms you'd then the kind reimbursement to left terms that there his Thank comments like subject future coverage, Medicare? chop Okay. in with to of Adam,

Adam Woodrow

benefit - focus which on do. And has perspective Medicaid been we're to that's commercial, the the they important the is remember, Medicare into pneumonia purposes Medicare of years. actually Look, players regimen, population a care the for of that's in of billion get remarkable skin point a achievement most been we've which that's would which negotiations, before, actually only within from low allude is cautiously is huge because about always with We're very the got that's It's and patient label have work holding single through a number. rate. that's rest of a into in Medicare us the the we optimistic And still thing left digits, market of to new coverage. the first to. on covered, fact that that are extremely in quarters branded the little the still said out I now, I dosing will is community approval couple should Right primary more from also commercial what more or skin. high setting Yeah, not that But label. a Medicare The a on of and for million enables approach would you it out in the we that sort that ahead. bit population. of addressable And on the happy a agent oral XXX for couple amount lives is is our a But off refusal a small $X.X the only community an or gets rejection other the just market. as our year come later

the we making trouble, the sure setting. community benefits either in hospital with issue a big the So have we really or investigations through get don't big prescribing approval and the for

Evan Loh

think that Bert that Yeah, to - and I and just that. add to

day we've a ideal, continue within that longer contract not or those as and have the well, with where fully CVS defined a population in the commit process a the ensuring could has we've specialty take forward, a day at I that have team have to support a And go who potential his to to through see had move committed Medicare to And population, it think we've very eligibility had it support, that internal settings, everyone great vendor in coverage. the strong not we to half CVS success in we pharmacy having the comes does even to but a but do as particular as continued need model. relationship to forward. they is team continues Medicare Adam least that get created well

Adam Woodrow

that the It's sampling ensure can for that of They Adam, it's patients. every that obviously, program including support that bridging. we for type affordable add imagine have ensuring we patients you have provide we should a

that there just is side. in the well product likely to actually changed. hold But move the care move perspective we because our where and from The nothing's specialty so will we sites side care primary next may of we geography actually as change as as expect into thing continue time number a expanding everything's well. that's into we over primary over the year So only we're

Bert Hazlett

question regard just sales structure. - have then actually with did to one That's force great. And I

do and that care, with a take months regard that - you months, the primary force patient traction lot COVID post do a XX point XX the loading right is at sales approval to force? you in XX-person XX you XX hopefully variables of access look whether mentioned as care you is to but here primary what of reps in get hospital, you reassess is sales at do six oral Again, that get, primary at think in dose, care primary the might that care, You that what point assess the I at look the there's to sized? start

Adam Woodrow

the a two, sheer We learned to side we in and number based But But we targets. know of hospitals. by X.X based add. more because quarter we find just actually primary determined primary pilot ongoing away actually plan whether lot unlikely we could Well, would it'll versus this lot additional the definitely that similar in one this rich a representatives on to everything find We that are And tracking a the size actually the on side quite considerably be and with where because that we more after - we'll what virtue indication, that there's we will to going be did will the of there indication that that the first, the need the care as look the assist to we if environment. how tracking far upon field to for, billion be projections to - with largest skin It's an or add pilot be the is force. put in X.X community, is need see to that target physicians highly help we be nothing for there's plan, in targets, somewhat of there, - first shrink we're institutional we're care because potentially and could will assessment, use targets. targets we're billion. if

Evan Loh

thoughtful et cetera, the in I of that which the and the and before sales force I in we at done we And that discipline in that of understanding with Adam institutional things one - Bert their a has think did before think, and walk in last Yeah, to of way really, expanding really, run. year. is territories, performance the metrics he end changing our getting terms did

months a to I think modest we're six data because think to sized focused see I able than from preliminary of that - able the data and very of and community pilot. more generate we're that

data for plus think the a the think, to now from by gauging that of a XXXX. standard give in talented we very the as And in talent characterized that to, phenotype the we had it looking know most we that force relationship. think the portends we're and as what recruited from sales been upcoming being contract institutional the we've and productive that has auspicious on sales individuals good most effective I of a think base of that start to we this we us, foundation I think see expansion what the XX want before because be I reps. we're metrics data productivity we will set excited expansion of very With about terms actually the that, the adding

Bert Hazlett

Great, progress. Thank look you. forward to more

Evan Loh

Thank you.

Adam Woodrow

Thank you, Bert.

Operator

And now the Evan call and ladies reached I to remarks. the for session. end to like gentlemen, have And we over would of the closing turn question-and-answer back Loh

Evan Loh

all attention for you, In operator. your thank I'd you to thank like today. Yeah, time and closing,

are to a in is interest The important continued making success NUZYRA NUZYRA underway. Paratek Your and of us. journey well commercial

in physicians The lives, the against a to antibiotics in to pathogens, NUZYRA to the particularly bioterrorism increasingly collaboration to as NUZYRA microbiological provide when effective of of NUZYRA available clinical be is but not IV in of Paratek only potential for potential resistance and leader, BARDA leader concern. studies a we much-needed continues broader addition sector positions data the an to battle save to are for and also innovation the resistance. antimicrobial a confident of as outcome with As the armamentarium on wealth the expand,

us We and the have all a be building motivates Paratek. patients commitments, as physicians at lifesaving will of to continue to well to our be novel capital patients our We'd ahead The to our focused long-term employees of on allocation, now. every need, Good very executing opportunities antibiotic and participated keeping in able for look patients apprised delivering forward selfless the provide to patients, and our like for our and being clinical for who value in passionately on support studies day. thank disciplined shareholders. and as in at your appreciate tirelessly NUZYRA continued and to dedicated hard, have healthcare the progress interest. ahead. and to our in provide bye quarters are you worked bedside and much each those who professionals continued We who We us

Operator

you. tonight's web concludes This Thank conference.

have lines at your participation time. this great you may a You evening. disconnect and for Thanks. Thank your

Paratek Pharmaceuticals (PRTK) 25 Feb 212020 Q4 Earnings call transcript