PRTK - Earnings call transcript Q4 2019 | Paratek Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Paratek Pharmaceuticals Fourth Quarter and Fiscal Year 2019 Earnings Call. [Operator Instructions].

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

begin. may You

Ben Strain

earlier welcome referred XXXX and press Fourth and can website at was Quarter with posted found have Good on be on slides and to this Corporate Year our issued results quarter Earnings company's will A and Update Full we the also be afternoon, that fourth Paratek's today, to Conference www.paratekpharma.com. release Both Call. call.

Brenner, of Chief Chief are call Loh, Adam Commercial Evan for Michael Officer; and Executive Officer Higgins, Randy and questions. and Participants and on today's available Accounting Bigham, Development Woodrow, CEO; also Officer; Finance, Regulatory Sarah President be Principal will Chairman; Vice Controller President

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

Evan Loh

thank a Ben. achievements we and all a was sustained for afternoon, believe have Paratek transformative in XXXX and set corporate established and Paratek earnings quarter you year as key leader you, Thank fourth update. for joining anti-infective call for year the stage a number and full of Good with our XXXX have space. that long-term growth the

offering infections. alternatives serious life-saving These the therapies for launched therapeutic effective, and and of NUZYRA in for In and much launches. SEYSARA both the antibiotic community-acquired of the States, case need providing in needed are pleased innovative early progress NUZYRA, in we XXXX, United an both patients product now new are with

predominantly the are the significant NUZYRA's by throughout performance oral driven XXXX, increases in We with formulation. demand seen quarter-over-quarter by launch pleased of

from highlight in was access successes in by targeted access payers will detail. Adam This greater continued these success securing quarter-over-quarter increase hospitals. accompanied and the in demand within

million, over in revenues million driven the the of to sales net the sales in Net million $X previous NUZYRA. fourth by earned XX% primarily $X.X fourth generated other We the quarter, quarter increased We omadacycline NUZYRA quarter. in regulatory of from of million the China sales $X revenues and Zai for of SEYSARA the filing submission earned Lab which of the $X.X a in of development in from consisted principally approximately U.S. milestone royalties

Looking at and decade. is the setting be future last sustained foundation and XXXX, NUZYRA one believe antibiotic on growth the successful the trajectory the seen growth that most observed in sales for are believe track XXXX to that in of in achievements launches XXXX in trajectory we the We beyond.

we entering Late Advanced Health NUZYRA in is We part to this for would their significant against last antibiotics the public-private like broad-based and order to and development long-term sector. in for save the innovative, particular, of viability BARDA Services a resistance a their fight Authority, Biomedical Secretary Research appreciate long-term partnership of of States Preparedness and of and milestone, thank we confidence also Development with Department investment protect and the their In in Project or year, BARDA, and announced office Human the BioShield the United contract Assistant of which significant the into Response. Americans. Paratek in commitment for to lives antimicrobial the

the to And Paratek to is over if million is is This this awarded there partnership in unique initial designed XX for pulmonary years. NUZYRA potential we to which of the BARDA and support X-year $XXX that anthrax. a contract up scope at expand believe valued development contract, to successful, term. X-year

funding commence FDA fund for post-marketing in pediatric pneumonia full including required anthrax which and with all cost all X-year newly studies, the approved the is for Importantly, reimbursement post-marketing and beyond which this antibiotics. the award pulmonary of bacterial approval, months surveillance NUZYRA's provides studies, the support for program, associated will development requirements to initial the a coming also

expense included this cash As was runway. previously clinical in a our reminder,

these $XX million. now BioShield is procured However, activities the that This antibiotic the first the for BARDA an time be an of National will value be will through collaboration aggregate Stockpile. via to funded Project Strategic entirely

the contract XX,XXX up provides National for will on procurement to provide anthrax an procurement progress Randy for for million. use to $XXX collaboration Our against the valued Stockpile provides an courses of of update details -- overview NUZYRA at potential the of to up treatment Strategic date. of and attacks,

with [indiscernible] this disease. devastating further 'XX the treat novel to news coronavirus recent the The therapeutics near-pandemic and highlights need for

of associated the importance the treatment many need once-daily, bacterial virus this pneumonia novel the preparedness the IV influenza, in well-tolerated paradigm for for global antibiotic novel of unfortunately pandemic infections, with The preparedness. fatalities the and with of of spread new including a highlighting secondary rapid pandemic are importance highlights further coronavirus As further therapeutics. oral

up opportunities partnerships believe positioned for strategic for further opportunities. other we with announced profile and contracts actively BARDA to spectrum is with its patients our Accordingly, We partnership believe pandemic via these need. uniquely that Paratek open in broad-based, recently NUZYRA to support will national pursue broad preparedness public-private government help once-daily

I with also global slide and SEYSARA will next. detail into and recent expanding achieved NUZYRA pleased for China, We're the the progress the in footprint in both which this

following development partner, program. of omadacycline has made the Lab progress significant completion Phase Zai III Our

announced for bacterial omadacycline the recently Products for Zai omadacycline skin infections. the Lab of NDA accepted and the Medical drug application skin submission has new and in acute community-acquired successful its of late month that this National bacterial XXXX, structure Administration pneumonia the treatment Following China

receive percentages approval, we is half of Under the are first China. in on low double-digit of to to the anticipated which milestone royalties XXXX million at and tiered $X a mid-teen sales payment net regulatory upon terms in Zai of the agreement, omadacycline collaboration entitled

XXXX To launch XXXX. further in Now believe generated turning trajectory clinical granting Almirall to the we in SEYSARA, XXXX, are an to with yesterday in time with see in to develop global a we SEYSARA Almirall, pleased the its license SEYSARA anticipating augurs for commercialize SEYSARA. and successfully continued frame. and which the Almirall region. China has that the Almirall's opportunity demand, Greater announced regulatory agreement U.S. for for we of growth well a have we signed submission growth is

As entitled are agreement, single-digit we on to of sales. high receive the royalties net part

net finish $X.X sales net the to of I XXXX the attributable I to the sales alone. strong full highlights XXXX, would call like States, $XX.X driven a of in generated million by in million we our million, were to Before year In fourth Adam, over cover as to revenues year NUZYRA guidance. provide hand quarter XXXX which generated financial the total NUZYRA and United in $XX.X

earned the XXXX, as primarily from consisting $X just a $X States. million in from of royalties milestone payment We million and of SEYSARA collaboration received in United highlighted, revenues earned sales also Zai Lab,

R&D XXXX to of costs, NUZYRA million as commercial classified expenses an were capitalization of compared supply The in million were XXXX. was decrease expense $XX.X the approval of until for which primarily FDA R&D result $XX.X the NUZYRA.

SG&A to $XX.X expenses The of the compared primarily in $XX.X in was million were launch support investments result million in the XXXX of increase of NUZYRA. commercial XXXX. U.S.

procurement with more approximately expected $XX elements. of of half coming anthrax be million million be XXXX NUZYRA's million, of in total This $XX million net than our revenues financial to between courses. in sales to turning Paratek to X,XXX guidance slightly XXXX initial estimates revenues from to these XXXX. the compared is $XX.X consists $XX revenue guidance. and XXXX treatment BARDA following the Now

As reminder, half secured initial anticipated the is a BARDA first be in of to procurement the XXXX.

requirement consists revenue revenue million. combined to cost U.S. onshoring of and Of grant with spend the is activities, be program collaboration associated of revenue million and Royalty development grant note, with on XXXX and NUZYRA BARDA FDA manufacturing. $XX anthrax BARDA post-marketing expected between the $X the reimbursement

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

disciplined OpEx perspective potential create balanced areas We continue shareholder we strategic investments will long-term against in to believe an remain value. from

$X For NTM R&D for earmarked preparation expense registrational in for potential example, activities includes study. approximately the start-up million a

such the reimbursement, the from SG&A pursuing investment highlighting in expenses R&D and OpEx drivers value remain as and indication including flat perspective, infrastructure an and commercial disciplined relatively onshoring combined are Excluding remain commitment to to additional XXXX, potential in when expected to BARDA compared continued our NTM. our R&D

As many XXXX aware, you ATM a we are $XX program. million of in established

$XX yesterday, this X/X raised under XXXX. of close the approximately proceeds net the in in of of raised was approximately As market which million program, we have

advance it sheet, appropriate time feel matter we policy, not corporate of the a additional we financing some do no sell to to our at this future strength balance this in our plans the activities, activity, circumstance as on comment in equity, through provide current While recent we ATM. have specifically ATM of our including given guidance, given general

pathway end be and of the under $XXX.X runway Paratek operating our anticipated XXXX, cash security contract, NUZYRA capital pathway includes with on as which the related will December a fund existing we cash, XXXX, of Based to assumes Hercules and plan, loan service This our anticipated providing expense that activities full cash current the marketable of debt that we operating expenditures breakeven. BARDA agreement cash includes expenses, sales equivalents through and company will securities product able U.S. extend existing all in repayment and of to our the its BioShield Project returns. reimbursement anticipate XX, to flow million estimated

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

Adam Woodrow

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

particularly exceeded successes many our and indicators demand XXXX the believe fourth as fact, the in well In leading the strong demand the future. seen the quarter for such seen of December bode in expectations. of We

failures for is admissions convenient, with first unmet broad needs is clinical in in XX pathogens once-daily addressing combating years, cases, allowing serious NUZYRA's skin reductions outcomes IV hospital stays, to and oral and in that generic infections, antibiotic-resistant altogether. older oral believe patients spectrum, we IV in in hospital to approved flexibility and both avoid this in believe antibiotics. from once-daily arise antibiotic dosing that its NUZYRA nearly poor As community-acquired some important resulting while We providing prescribing, and well way on and the pneumonia

modifications we or many addition, with dosing along that needed and renal lack safety to a believe In much its alternative of tolerability provides antibiotics. impairment hepatic NUZYRA's for existing profile

adverse and their to serious example, the recently black their vascular, For neurologic warning. with were box quinolones added that events QTc

As companion be like establish community which in new education IV adoption it a in after a accelerated. the sustained setting, the does can and discussed in prior NUZYRA effort, hospital antibiotic for to take for oral once-daily setting momentum calls, patience a

quarter in an the in inventory of quarter channel to increase the quarter. approximately of XXXX, was net from fourth Accounting the As in quarter. million demand Evan in $X.X increased the for million seen million mentioned, quarter generated sales third the U.S. gross of Simply demand essentially in inventory, $X.X the remained stated, in quarter XX% $X.X as compared prior fourth fourth growth NUZYRA the versus to approximately NUZYRA $X.X third in by XXXX in million the driven flat.

For NUZYRA year, the $XX.X million right of our million, the by driven at which sales of of achieved landed in midpoint $XX full guidance the net $XX million, demand. to growth

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

taken value approach We on sales creation. hiring in ensure to return our drive a the with representatives right have measured investment objective balance place have we our process to we as

focused In NUZYRA, our awareness. raising making key while on and been in we've integrated networks, for progress access gaining targeted institutional steady hospitals delivery

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

path look and long-term right We're in the and the extremely believe and pleased we're forward initial ahead. launch to on are success, our positioned with quarters with we well reporting the on for NUZYRA progress commercial

over like call now Randy. to to With that, I'd turn the

Randall Brenner

Adam. Thanks,

We important to which shareholders. drivers, we the value and believe for potential add have have value patients significant several

bioterrorism unique a shared to public-private for to to for be our National for commitment We first-ever is biothreat Strategic recipient sole antimicrobial addition studying treatment anthrax. fight the treatment the BARDA from against NUZYRA and partnership award recognition of of resistance with Stockpile. are the antibiotic a BARDA including and the the and BioShield -- excited pathogens, in This of the

the activated of Let studies with million, approximately will an me NUZYRA of are planning treatment for plans anthrax. funding The these year. pulmonary studies to the for $XX is with this The approximately BARDA preparation work of for and provides The be of start as is million $XX for cost underway, these well reimbursed complete. initiate activities program base overview program. the program including and development the

of be balance National the purchase procurement treatment for is the XX-day procurement million million NUZYRA, treatment the acceptance FDA's The pre-emergency of quarter the year Stockpile. of program is initial the of purchased of of The quarter to of which upon $XX $XX Strategic FDA X,XXX, with courses year. will second earmarked NUZYRA courses for occur this this occurring authorization the in acceptance for projected targeted the use first submission in to for the

In provides $XXX for independent the are of post-approval reimbursement base support addition with There million, total NUZYRA the provisions commitments the X for $XX contract approximately the which first, approximately agreed to cost for include: full reimbursement cost approval million. the for initial also program, the FDA that following:

our was this previously in reminder, included expense a clinical runway. As cash

the these BARDA collaboration. entirely However, activities funded now will through be

provide for chain to adding secure This for cost approximately secondary suppliers of and BARDA investment chain, supply onshoring million. helps BARDA and $XX supply manufacturing reimbursement our security requirements further Second, by U.S. our collaboration chain. anthrax approximately the finally, prophylaxis the United of valued States-based And supply at time over a projected million. the frame NUZYRA manufacturing of for development secure $XX for will pulmonary

be BARDA, the BARDA year the upon and million Under June the on we the onshoring Based and $XX scheduled. scheduled with with requirements contract, million these be track in security with this activities is associated discussions begin will anticipate to on to track is post-marketing of activated commitment of April in ongoing and as the this year. associated $XX activated

the the the of procurements the is for activity of spread the success a remain against including are a of anthrax probability upon program. This published confident In NUZYRA program in factors, and number continued on throughout treatment in in the procurements total anthrax mouse high model; vitro course progress based of anthrax efficacy $XXX level highly courses, published in are lung conviction the approximately efficacy X in NUZYRA, vivo development Paratek contingent the in anthrax. are and data concentrations historically high the demonstrates durable contract, program. anticipated through the additional high annually of million. and We demonstrating addition, in of of PK tetracyclines clinical which that These projects on efficacy the XXXX and under profile which and demonstrated X,XXX of procurement of pulmonary macrophages; BARDA a pneumonia; pulmonary the have anthrax

ability As pathway. approved label anthrax highly treatment to confident show obtaining such, ongoing FDA the throughout ability additional X,XXX we and in the secure and progress to procurements our treat are via program rule in an this our animal to

order partnership is animal start. BARDA discussions terrific the contracts anthrax activities pre-EUA off review FDA. the place end filing include These such important to moving completion several preparation Since for the signing of activities The at have with and a program the procurement get with contract in of as last document vendor forward. and first and year, to taken

BARDA. look to and with also And kickoff meeting forward. we at together, program working BARDA our important Importantly, held team We highly are face-to-face our excited we partners. skilled forward experienced a this move with to

of the for XXXX, reimbursement have XX, BARDA the base January. for cost of base activation program month the the we activities first our invoice submitted the for to With December award on

an opportunities NUZYRA, We of an a pursue bacterial for will also PK community-acquired sNDA continue compelling to cycle oral-only number an study for oral-only life dosing. that pneumonia pneumonia support including

have will approximately dosing that is continue to in in oral OPTIC upon patients show established with the study. to profile to CABP an oral-only was the XX-patient IV pharmacokinetic regimen to a regimen We patients which approved agreed designed in with the pharmacokinetic FDA, that enroll dosing study comparable

later for by supplemental track NDA We remain this potential regimen for followed time pneumonia approval this year. the dosing a season for in on the XXXX submission

feedback the our in received team in through last to listen noted we continue to field. medical the we the call, As

annual abscessus of inbound result including address unmet XX,XXX the accounts interest, NUZYRA promising X,XXX infection type NTM, disease of a the to are disease to infection approximately we to with continuing cases abscessus. to lung for nontuberculous caused mycobacterium explore mycobacterium several opportunity species, a on cycle X,XXX occurring in mycobacterial, Mycobacterium or an orphan also an NTM significant As naturally basis. XX,XXX is an another need. rare U.S. for seen NTM clinical by life potential estimated and is of important significant

mycobacterium often There X-drug NTM complex patients challenges years patients X- by when significantly infusions are return to which caused regimens no tolerability are FDA-approved treat combination abscessus. require with daily to IV that quality have life. to to therapies months of treated These and of treatment, impact for for can

would choices therapeutic demonstrated vitro an mycobacterium have we very oral has community and clinically KOL of in that the published, activity noted important as and achieves option today. high abscessus, levels humans. IV-only suboptimal from a feedback welcome pulmonary limited in Omadacycline being effective to Inbound has addition potent the used be against list clearly penetration

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

We NTM that on initial disease the medical chronic and We've reach to new NUZYRA address opportunity life broaden remain coming the discussions constructive been significant for into to further for potential our believe the patient have excited and date that in the a this forward will oral-only NTM clarity begun NUZYRA need FDA to unmet rare populations. opportunities this with about indication. clinically looking regarding providing to months. and We plans in and CABP important cycle

point, questions. the line to this for we would At open like

Operator

Instructions]. [Operator

question H.C. Ed from of the Wainwright. comes Arce first line Our with

Antonio Arce

on Congrats a finish year. strong to the

on is the either is Evan. NUZYRA or that you discussed, Adam have and I question First for question on demand this

seasonality of you still strengthen demand? throughout trajectory or XXXX little where Given continues to is year? related driving And the you kind around was that you underlying what think expand in you -- in strength that the and do detail and you saw think that could room more there expect December, XXXX, to perhaps us a that, the give what drive in to would

Adam Woodrow

Adam. Thanks, Ed. It's

a us drive little things X there What about is is Obviously, X seen the there's to it. into the a also slight J-code recall, skin as more IV go that with we've towards in the decline indication. going an we continue we've to an addition during from will We've gaining and season seen in progress we back increase the continued committed in NUZYRA into make moved we and as bit your about [indiscernible] XXXX. corresponding expect that institutions see And demand look, that CABP uptick indication assist perspective to if hospital how to getting have accept some continue end seen to and or seasonality. we we've our the year. question XXXX, we're to in of to utilization. through answer growth continue So you granted the were winter to But the in a

Evan Loh

just throughout that J-code and I relates seen IV as team in to big -- the see build think they that continue that as physician to us front the having the educational I use another the Adam continue well, all that told of hospital on commitment will has awareness to on think effects and it to his interest the the different is have product. build populations actually to have utility

Operator

comes Gabelli question with of & Company. Kedra Kevin from line next Our the

Kevin Kedra

get the you sense know if early give be range that's Can maybe that that use you I IV. you earlier. -- what launch? we in you And secondly, then First, the -- the mentioned that gave us why you're gives a to looking nature mentioned the in Wondering seeing wouldn't at very of down something should Evan, for this don't target? revenue And specific. an NUZYRA, more guidance target you confidence given bound increased the

oral did, a I'm IV as I we kind use? If missed of are seeing of in what percentage versus you But it. sorry

Evan Loh

question to do take first? want you Adam, that

Adam Woodrow

Yes.

oral the you beginning, IV. oral. I the about we utilization XX% our the what discharge. And in and -- What utilization -- of only So in that the even than research said we that is question the tell IV. we continue before with About do oral if the of XX% I'll back tells launched, oral right we is in what is to And have us in an go see strength answer sorry, the IV to of IV the about at fact the in the consequence, us, NUZYRA is the more as physicians strength the is a oral.

Evan Loh

More first -- million the your it's the we organic And the We patient that royalty but what actually and feel that NUZYRA provided $XX somewhere and have prominent stories. for as total range in half be Kevin, this based going is have us, in component million. implies that and approximately are $XX sales to those XXXX the time, revenue $XX getting have expected XXXX well, revenues consisting positive we million I over the total secured confidence $XX we've will product be back ahead do the $XX.X million. award. doctors and BARDA really confidence we're that, demand about as to between upon think with from will of the estimates -- this comfortable of revenue I of that that to most we growth. the inbound of think still in because in I think seeing think of of that at stories guidance, look XXXX. we net the that terms And base initial collaboration some be growth as part million sales component is And significant the overall we said, was point come that have you told it procurement. we at said, think moving When than from And Randy high of

to you be place coming we'll be, and So good this is quarters. the a on updating

Operator

Our next the Robert line Hazlett of from question comes with BTIG.

Robert Hazlett

you a any And as at And about plans or well. to medium Obviously, have it couple. you're with you it. the plans in Adam, -- to sales about mentioned had questions and any force in to the least do that in of term? sounds just on expand how XX contemplated that do the the term? comfortable long call, how like there that I think of And people you a couple are near expand? XX other think have I

Adam Woodrow

in we've of use day mean, be been end -- think to our look, the I and the judicious clear, we of I sheet. pretty So balance the want at

more measured And do so number. of based so, approach we've over learn Obviously, it's on sort got, inconceivable that XX we the a we're of actually representatives. learnings originally we've we view hitting the now, truth, got may achieve we Right during course had But that for will field XX recall, in achieve add that you is time, of number force our expansion our that in is now, we've right a year. we think not we're what smaller we right taken And the trying this very more. And planned. if to to field the the force. our number with to as than

Robert Hazlett

partner the to talk positive in approval progress And is also With about a potential progress. as they're material strides like for other Zai Can then Lab, as Good Yes. timing possibility such you your well, there making in geographies China Japan? there. looks for it regard there? licensing

Randall Brenner

Yes.

a to approval Zai I what is anticipating regards gets review Randy. with is think XX- in China, in mean, of the to anywhere this approval the them which is XX-month from part early So XXXX. approval I frame, time

Evan Loh

other and for Bert, pursuing as is right be With the and well we what's opportunities not explored spent that regards for antibiotic authorities, we resistance and regions, in the given continue from will that Evan. to a feedback we've best will partners as what's That this said, being need, always to pathway as that, from in we one NUZYRA we see have global the we've that Paratek. is is both do, that best for said, regulatory Japan. we've actually And near term. potential received time explore

Robert Hazlett

And bit of more just predict, of any terms -- national opportunities press helpful. in to scale Okay. is definitely little government clarity what pursuing about magnitude, the then the would last there preparedness. opportunities release timing? other Could I additional a be you to pandemic talk but within you support about a exist know aggressively elaborate challenge types out the and that potential in

Evan Loh

have thought started conversations contemplate. really about we we've -- to these think I and are that initial

-- it's Defense, pandemic think specifically. think well Department early on as only preparedness of as opportunities of who HHS actually be but on there materials the I really for well as them containment are facets said, national continuum to That basis, of too that prophylaxis the that given terms to us of therapeutic as antibodies, commenting think being to is lives for also antibiotics, and think as as also an to important going potentially serve but that in we committed only serve the therapeutic well. view, significant to Americans, a BARDA opportunity in not ASPR And addition by this saving about other vaccine an the commitment be important forward. which our about a looking for armamentarium, protecting not and are

Robert Hazlett

consideration Okay. first on the road. And other award. I congratulations Well, hope the there's down

Evan Loh

Bert. you, Thank

Operator

of Our Ami the line from Leerink. next question SVB comes Fadia from

Xiaozhou Fan

This for is Sheldon on Ami.

what reimbursement that be the on onshoring of commercial So this studies sales? -- in those reimbursements about first, look BARDA and the those of about you to following following remaining will the you mentioned like? year. will sections for cadence some R&D do the you start in activated And more NUZYRA Could activities activities, elaborate years also, secondly, have an updated the outlook the long-term trials, of of potential

Randall Brenner

Randy. Sure. from BARDA can This question you. take I is the

December the procurement as The of year. of as signing treatment was courses. the X,XXX last development first we've in the including which activated program, we So are there award: anthrax about, December came the award as call the base was and announced the on again, contract, upon program right to today, out multiple which the of after talked the components program; BARDA well base

NUZYRA. milestones, the approval with milestones consist of the some which with time-based $XX receive other initial Paratek include of FDA million the The associated that post-approval commitments

cost this that will that early expect part -- occur activated. the of those is will those be option We once of will And reimbursement begin activation year. the

And on time we that that The in said procure target And and BARDA again, as be June security activated be activities prepared -- remarks, and year. in we of on scheduled second those $XX that are or the to activities -- are frames one our the outlined. X around we the onshoring activated progressing this is requirements is million. is pure approximately of the to the think

one about potentially actually is in place that work associated third with monies additional to of million of additional the of the put anthrax. development support prophylaxis $XX animal The is

the which the are support regards would be years throughout that treatment spread those efficacy animal the the This the recall have be the sense anthrax initial a progress component course would are showing program anthrax. You'll procurements, program contract once programs treatment we some need to program. the done for be to of first would the in actually noted we really is treatment to program. initiated actually last the in later of of that program. out three prophylaxis the of additional And the there's And that ongoing Paratek, additional to that development then had with linked are several pulmonary

Evan Loh

So commitment invoiced cadence build contemplated grant. the specifically that to over what during that majority actually you of XXXX the To trial on on said, of letter approval of the the time X-year into give asked specific frame. the actually fact for in that that time we in data FDA because and these of Randy dollars R&D a be the to it's CABP actually over this for is point of period through FDA vast our just case about would have our period reimbursement, you the our accounted have XXXX,

So it well. a and programs microbiologic surveillance program as those to was X-year specifically support designed

Adam Woodrow

of XXXX, committed long-term we're and updating NUZYRA. the opportunity at see we for guidance the guidance XXXX whether initial about Right for our to long-term what tremendous our guidance. not do a really dots your $XXX I this updating long-term we've we've given to our connect seen question momentum that million. time. we for continue And we're mean, can also But now,

Xiaozhou Fan

Maybe may have runway. a cash follow-up regarding question -- your and if just I I

XXXX. million have have options extended by think loan. Or loan pay through financing you $XXX will you XXXX, your from was due you runway that payoff off? other noticed QX that another have fully to pay Hercules plan that's convertible to of you I that? Do a of also, in flow your half potentially able you to the that cash breakeven? I can cash year And will that to lead update last end be another -- is

Evan Loh

due our and for day, you maintaining end the and strong alluded as it's first first the the have half, convertible of the Yes. balance sheet of to I of and strength think see to, Look, the Based in of our all And the end we debt of it's the end, May in of a that the current balance -- of this But our period the -- believe of closer that of time date. company a half at today, the for converted management at focus interest been over as we Directors a or performance our our principal strength Board core benefit upon we for sheet us, shareholders. always the will -- before shareholders. been expected on all our XXXX. this team remains for best Paratek convert maturity that have do of

Operator

with Our Wainwright. follow-up next of a Arce question is from Ed question the line H.C.

Antonio Arce

could cash this? risk, flip of are any flow So that pathway even side, along quite a a lines your And which a than longer low, if on of opportunities clear the risks now that seems was for to could that perhaps the there any wondering XXXX change potential runway? just and of your breakeven, over other period as I cash through the provide BARDA there potential runway are guidance end

Evan Loh

that said, that what upon within our initial much think, today is for Well, this the expectations. saw at thank momentum we that fit the based very with I we NUZYRA pathway you we upon based looked which in as and see and we performance XXXX, question,

is I oral majority that be from looks oral. IV actually think setting strength we'll tremendous do launch And of couple the are community product we And as is what as exploring scripts oral there the years coming typical know, of and is first that this that there there's as you of upside like. the what that well. opportunity and after the we've think learned also expansion our in

regards is see a to and will with boost the prior about already with indication as terms government the adding launch current we've the I full And And those a label by forward NUZYRA's in well seen as the cetera, stockpiling, growth having as to we contracts think, other upside question to talked of season, momentum what think only forecast. mycobacteria. as et not of came with I other our oral-only pneumonia Randy pneumonia piece that to opportunities or be pathway as for the to nontuberculous another well, regards

for end day, think we execution, always our is and that every and right deliverables. on we that operational us, the day about of the keep down heads center At it's a risk front and as each

have to development them, forward. our date. to commercial doing And milestone against commitments on going which each every we hard live that we to continue and We by either -- and have or plan deliver worked

Antonio Arce

perhaps obviously, now in of direct growth just over more IV sort then delta the that I diminish Around yet metrics community, time. earlier, mentioned would last that question. marketing. you you that, lot hasn't the awareness of assume quite XX%, that high And seen XX% in -- markets see time which that at Great. one a in gets as more will over whole both right

Adam Woodrow

couple we're look consider mean, the around I starting ID we through community that the later obviously, as years the community as space then said of But with associated business. we'll our time, go address and we've side target. our communication base and There's we will. definitely setting on before, focused is then specialties it the a first And the to the year. community and that hospital approach at of Yes. no initial the are this in focus direct to

Operator

Mr. in like the further back no closing Loh it hand I'd to questions are over There for to queue. remarks.

Evan Loh

we'll attention questions, more your closing, today. today's like for no time thank I all call. are conclude And you and there As in to would

unique specifically us. The journey commercial broad-based in of profile are to well-tolerated and interest well growth positioned NUZYRA, important oral for is continued NUZYRA well and of long-term Paratek The NUZYRA once-daily, our is success a underway. Your success. making commercial

the armamentarium to resistance to particularly omadacycline the of As save data is lives, physicians through development the to of continues cycle. addition be available omadacycline concern. antibiotics life are its and when to much-needed confident of increasingly NUZYRA wealth to effective an of in to the potential of continued committed on we expand, We remain

innovation that to public-private to collaboration provide with This We working positions unique potential for to Paratek option pathogens, not bioterrorism to this also deliver anthrax a is a the as but NUZYRA leader pulmonary an the potential and as that look the broader a closely for expect with transformative in collaboratively save only BARDA for sector. partnership. forward has Americans. important in fully lives treatment leader ID We and protect

These our at and have studies have who you need. We for apprised We to to who support much Goodbye our progress. opportunities clinical would of and for motivate continued employees tirelessly the worked keeping all NUZYRA appreciate patients provide now. thank our to very patients participated Paratek, and like interest. we forward in us in your look

Operator

this does for conclude Thank today's you and participation. gentlemen, your Ladies teleconference.

your time, day. disconnect and You may lines this wonderful a have at

Paratek Pharmaceuticals (PRTK) 25 Feb 202019 Q4 Earnings call transcript