PRTK - Earnings call transcript Q4 2017 | Paratek Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Paratek Pharmaceuticals Fourth Quarter Full Year 2017 Earnings Conference. 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 reminder, this conference is being recorded. I would now like to turn the call over to your host today, Mr. for Director Managing Arndt, LifeSci Advisors. Paul sir. proceed, Please

Paul Arndt

quarter Officer, update as Paul Paratek and for Thank of Director recent opportunity Officer, morning be Financial for I’d conference to Paratek’s call. found CEO and Loh, is Woodrow, year. and and release then at XXXX coming Relations Company’s Company’s you, the progress product Good Chief morning. will and fourth Evan financial like of year fourth Michael to you the Tonya. can A Arndt, welcome full brief full for for full LifeSci Chairman commercial earnings Michael And is near-term year Chief review the the results the for Q&A. the call commercial for update quarter. the quarter was up activities, plans follows: for regulatory The and remarks Managing speak will and firm. This and overview closing with omadacycline will Advisors, agenda press Investor will today’s to Board, quarter Chief financials and Officer, make readiness review fourth and development issued call Operating Commercial Chief Adam as launch. and open Medical prepares earlier provide this the will of President, the www.paratekpharma.com. Bigham, an Officer Pagán, company’s Doug the and Paratek’s

risk today various factors may that’ll Safe and disclosed the the Litigation from Form our release statements of a for The in our about plan, of Before differ that words forward-looking XX-K, forward-looking press and Company’s of words plans we denoting indicated Actual will with forward-looking Act these as events today’s other the future be prospects expect, you as that discussion will those result and begin, would factors, the Reform materially statements Harbor include Private SEC. including important by statements identify filed remind results potential, I XXXX. section statements. like under to in of constitute the statements anticipate, future those Securities provisions purposes expectations,

In XXXX, addition, our be not of Thursday, should upon as our today, as date. views only represent of views X, and any March forward-looking as subsequent relied any statements representing

While we may specifically update we statements to in disclaim do future, forward-looking elect so any obligation to our if some at these even change. the views point

call over Now, Bigham. to I the will turn Michael

Michael Bigham

for all and Good fourth quarter. Thank you thank earnings the you, joining Paul. corporate our and for update morning call

know, completed With ABSSSI. skin U.S. earnest Food acute activities, in including on submission validation year was you we many payer manufacturing us and supplies, and with commercial development bacterial us. a X account the pneumonia, and importantly, community-acquired began CABP, Xnd now Phase management skin successful pivotal year, completed, and Most of a for our for X we initiation of or program We affairs the for structure to omadacycline Administration. expand completed and NDA readiness infections program anticipated of and launch. commercial medical this XXXX our build-out the teams omadacycline of prepare As the Drug to February for Phase in or of

now our as NDA before last submission authorization the with commercial our complete, application. With the expanded interaction meet finalizing EU, October a NDA a rapporteurs review our efforts European potential to to date officially would PDUFA of these prepare have we of we early mid-year Assuming and submissions marketing working as accepted by part the year. to schedule the for EMA regulatory date are this launch. are the in expect process, the we In

once-daily of safety oral treating characteristics truly market needs while urgent serious well-defined trust need, treatment the modernized antibiotic the a that a tetracycline, overcoming our multi-indication class, efficacious, retains omadacycline for for physicians. and IV, the bacterial and current of with a there community-acquired meeting of is of the infections. and view, bacteria novel is well-tolerated, antibiotic research In to continues Our omadacycline, demonstrate the resistance and that an

optimistic are to about are for opportunity available We life-threatening severe patients, this make for drug remain the who and omadacycline, possibly facing and determined infections.

Additionally, U.S. tetracycline a XXXX, moderate NDA to in for Allergan, FDA severe sarecycline, under the that antibiotic Seysara. rights. announced we treatment U.S. will for the of royalty the or payments which is the in and milestone December brand be the retain with narrow we for spectrum their known that name of acne which accepted Sarecycline

to in retain UTI FDA’s unique regulatory and significant our on progress. Evan We also Evan? perspectives the update unmet also some that an to FDA this will half opportunity omadacycline and over provide will provide development believe turn patients. we medical needs of why for represents a program call rights. I’ll Evan all on the anticipate Loh We sarecycline ex-U.S. approval year. who second now of address

Evan Loh

Thank you, Michael.

heard applications. last oral Since for you omadacycline, submission rolling in our supporting completed submission just As one we the the the for review applications from two to of of month, active and the FDA been for drug the Michael, our formulation one start new December, of FDA’s formulation. our we’ve intravenous

and final acceptance filing. XX-day our the review determine As That the a FDA of the review PDUFA acceptance you know, will the start evaluation to of action set date. application phase final for process application includes

Accordingly, and be in that expectation completed from Our April FDA months date translates which will is review With the on we early accepted priority applications eight the of QIDP this PDUFA our are year. date, early XXXX. submission these to anticipating be a Track set based October status, the will with Fast experience NDAs. our for

eagerly looking to can for forward waiting imagine, as date are all you are we As patients that omadacycline.

and the commercial manufacturing validation production with soon medical our ongoing account to payer including a of supply as readiness hear the commercial in XXXX. the you have Michael build-out quarter and by bring from As possible launch following to we’re from omadacycline planning patients we approval, as as and management to an call, enable and you’ll of for activities Doug teams. In heard later Adam begun bit affairs earnest our commercial a first also order us

We this on year. will our Phase like provide program urinary of now infection or on to later clarity X would tract I have in greater update launch an timing UTI.

As omadacycline utility confidence a reminder, possesses infections. that tract attributes in potential its provide unique urinary in

access attribute class, occur active is The tetracycline has urinary binding, first such where drug protein infections as tissue uncommon tract the in important that enables very low omadacycline which to more the in system.

conclusions renal the proof-of-principle results parent and high simple significant second where cystitis study Phase XX% The in that of urinary based excretion renal is patients to urine of we compound. in unchanged to are Xb up attribute upon our level These important levels omadacycline. clearance has the coupled omadacycline excreted the high as of is with confirm active

passages most microbiologically and Finally our in the to UTI UTI was of The with the the omadacycline have us key enabled E. observed in the combined these Phase patients, effective against pharmacokinetic results study microbiologic X program. totality Phase study, coli. of with the notably we progress that Xb proof-of-principle forward

urinary of omadacycline tolerability of in This Phase study UTI the in year. will tract of safety, We uncomplicated infections of and clinical efficacy, January first in X the patients first and examine this pharmacokinetics have omadacycline in with studies is initiated efficacy, study dosing Later similar pyelonephritis, of XXX patients safety, infections. also complicated examine patients. pharmacokinetics urinary the the of and approximately the size year, clinical that begin common in most tolerability this second we subset will acute tract of two will

XXXX. sharing of to studies, results top-line will keep program of and this look progress forward in half both We of you these the with you informed second with of the

know you has on Paratek commitment data through our to As all transparency. deliver continued

significant medical review team affairs enrich publications, data disease Spain both future which European omadacycline’s Congress of our peer exchange Paratek at upcoming Disease presence have the treating late Our will To publications microbiologic conferences and in that and April. will serve or in clinical effort scientific leads with infectious of Microbiology Infectious in end, physicians. ECCMID scientific in and to a

OASIS-X presentations ABSSSI. the presentation. data and oral with posters presentation oral-only That one include features oral and nine Our omadacycline e study

all working key success also our published prelaunch top-tiered building ensuring to diligently doctors will X studies our on accessible Having will Our that in prior our data team journals, medical approval. awareness. of Phase be affairs in FDA to to is be pivotal

well-tolerated infection largest omadacycline and bacterial and antibiotic pneumonia related mortality. a the been for is has infections often influenza in progress remains combat can now, It bacterial belief is market we well-defined increasing there to time the for omadacycline to value Influenza acquired thereby long-standing some attributes: Remember, approved, skin circumventing omadacycline proposition, associated is bacterial IV season. cost that with it for The during we’ve of and bring pneumonia. infection intend pneumonia Accordingly, our to strong new antibiotic compelling community IV unmatched deaths third, daily saying with and to CABP. such tetracycline next as infections, minimize three comfort firm to a often resistant, As of are treatments influenza other investigational an and overall safe whole. responsible is go-home staying infections; the proposition by has for potential If treatment the level both First, care. simplifying by our as and for hospitalizations, oral formulation second, the strategy core the monotherapy. once defined be reducing resistance; decisions home an oral Having and value class a to enables and late-stage and cause pneumonia community-acquired need that a candidates. fact generally single pneumonia

expand on me a these, time. at each Let of one

resistance patient infections. they known relevance to skin for antibiotics. higher of with antibiotic efficacy used rates spectrum that with that nor and resistance classes with mechanisms as will affected solution Omadacycline’s are know the progressively modernized these resistance classes. documenting and physicians’ First, data, known by elegant and mechanisms beta-lactams tetracycline circumvents Accordingly, rates do of pneumonia any safety is appropriate rising treat direct is cause clindamycin, of generic quinolones the and as vitro macrolides an skin prefer prescribe tetracycline have such reality is to cover resistant surveillance pathogens, efficacy infections concern This antibiotics or when tetracycline across for is offers CABP and commonly acknowledged CABP other any that an proven not pathogens. in a in profile. doctors omadacycline Of really from all the skin established sick cross-resistance efficacy and a the both antibiotic an not about indications once-daily in monotherapy, resistance their

many that the myriad, patients first, IV include, dosing physicians Secondly, treatment other choice attributes oral and day a with attributes important once These will simplify encounter when omadacycline [ph]. possesses opportunity.

Second, for no and for with concomitant for adjustments renal dose in third, patients insufficiency. no dose need medications patients need on adjustments

CABP these in treatment simplify All choice and of patients attributes skin with the infections.

potential believe that on Thirdly, been most for tetracycline have class, recent had the physicians the community has believe tetracycline XX over treat we setting. broad We clinical physicians in or will the omadacycline of wide of allow know safely, effectively omadacycline which to the the and infections, that and In market years. physicians a class. restored either efficacy conducted, the surveys array consistently, trust hospital

consistent quinolone, the X in our patient where cases eight diff important C clindamycin, beta-lactams lower safety of this arm. Another which clostridium diarrhea. a of a another is We associated is in antibiotics. quinolones, and yet associated saw versus trust the believe what especially broad in to difficile absence data clinical omadacycline complication diarrhea our with from tetracyclines the enterocolitis Phase base. other that difficile our use element Historically is elderly. spectrum C moxifloxacin and secondary omadacycline is spectrum the a we observed for in differentiator have antibiotics, excites arm that is we f in of with of difficile of data This rates particular, enterocolitis zero the cases study, OPTIC tend physicians Clostridium broad enterocolitis in

and just As through Adam. team boards. you excellent the the that, a omadacycline Adam from advisory value on the you’ll baton, on our is will to-date. commercial preposition Adam hear activities payer I to in feedback commercial moment, of now With receiving update commercial pass our will

Adam Woodrow

Evan. you, Thank

treating and community a this before November that with first, in physicians I XXX targeting disease has generate a go-home also with specialists, discharge an room our with as made credibility will to and among have to been about objective XX% approximately this commercial critical field we treating we Paratek, team, and force the between omadacycline progress talk In exposure, physicians. oral details, inside of including XX value the outlined of take the infectious we achieve value omadacycline representatives, on both conjunction others, XX with with since emergency significant have back the three inside receiving step can more of like primary for our very doctors, commercial where initially care hospital ability gain we efficacy, day. based important side our things, exposure proposition a We outside as believe we or for believe We and reach there the will and hospitalization Evan hospitalists the in that United This system. hospital hospitals. necessary It option generate oral feedback IV get But transition with even would from to the branded sales -- setting the entirely our is to of deliberate to stay-home gaining setting, approach from to will it allowing say our is spoke overall months market those into commercial I to or to the proposition we the safety emergency omadacycline hospital at the trust This to with avoid antibiotic our last you is strategy. hospital to say for of potential step States room experience an receiving tremendous we investor is as provide strategy. physicians. in to is early opportunity in and and omadacycline, at we first understand visit severe oral-only it a know On or strategy. this patients broader establish an once-daily opportunity a access

their to their the omadacycline’s in patients practices it severe well. doctors in community begin the in will As as in more they to experience prescribe efficacy the patients hospital,

with year in our the while in the on we we space community setting. Full years, in considered oral community So, either approach the to couple of however expect in not anticipate the some see of promoting partner. do of own as community a we first promotion will do end utilization or the be two, our

ready in by accomplishments of recent omadacycline as with mind, we Now with to you share that can quarter the first context year. get I our about more launch next

key positioning management We on brand trade, VABOD, key of team of the our promotional positions is prior within of markets recently fully our team now is finalizing directors hiring including all Our board and completed the our managed and accounts. messages. account

and You’ll in back drive recall help we the utilization. ultimately activities prepare core that our that two about November, will talked for launch market

second of awareness exchange, scientific our target The prescribers medical being through and access. formulary first being raising among omadacycline education and the

that continued terms unbranded our Up awareness medical oral Rise of need which formulations. for In we raises have the campaign education, around have new effective antibiotics

Up, If Rise you you more want antibioticriseup.com. learn go can to to about

prelaunch formulary data As Evan, you in also effectively a we’re will to now. we Madrid, be Based day acceptance our key has our what will for and and our begin our to regard Omadacycline earnest, conference that have formulary to favorably process. date, April. in be ability pivotal comes of in heard will Having in those the formularies preparing it the Spain research will late when adoption upcoming from heard ECCMID believe in on our to from payer we’ve at their least part formulary as that can of at to hospital omadacycline adoption. accessible success and all NDAs, access, doctors five consider omadacycline presence members building upon with features discussions awareness Paratek viewed promote With one. significant to committee right

a home very once confidence both which send First, and and omadacycline’s a compelling pharmacists and physicians the is spectrum to formulation, that antibiotic value new rarity earlier, it IV oral an a with provides patients proposition. broad daily, the

indications broader which antibiotics, for provides approved potential will recently have many launch, unlike at utilization. multiple omadacycline Second,

of tetracyclines have as options efficacy none similar the Third existing the IV both displace to need in profile a formulation. existing oral an and generic is

efficacy exists there adoption. this So, and and with that problem to is are simply hospitals diff formulations, quinolones telling pricing need beta-lactams our tetracycline to with are of two put, of with C Fourth, high And and a facilitate many the safe to us, benefit today. both be modernized well-tolerated, formulary do being have for hospitals looking clear the strategy for oral we flexible of alternatives IV generally light with formulations. in these in rates finally, able they

formulary and these we’re adopted recent some to to feedback launches. hospital in omadacycline, we Given our from approval the encouraged well progress of benefits, be extremely earlier the more research. forward And with this our omadacycline Overall, may looking year. the than date the potential later ongoing are of

the have could little than on launch a very And of much case As commercial that. Evan XXXX. by launching that scenario deliver quarter a in for sooner perhaps help we’re we’re mentioned, to fact, bit preparing us first best track

to Now, our Doug financial say words time will performance. about the a few take

Doug Pagán

you, Adam. Thank

as equivalents We included million and are which commercial million continue the and million of financial in omadacycline. and position additional principal from in the drawdown Company cash $XXX.X launch for the we during XXXX. investments, strong ended Hercules QX in $XX with of year a to in The an prepare cash $XX.X debt,

affairs XX, XXXX, with million year. compared by milestone decrease For for part for and Paratek $XX.X upfront was collaboration of million our a expenses payment for the sarecycline upon medical was million million and $XX of costs, The million were employee with NDA Phase fees resulting development activities. the General administrative program preparation costs, compensation FDA decrease $XX.X and ended NDA. driven $X.X offset million a higher full for expenses Zai from the $XXX.X employee from was as for net development lower were clinical the received earned and omadacycline. the of Research The year. commercial of December acceptance by study payment the Allergan associated prior of earned expand loss to of full-year user year. Revenue Lab primarily the increased prior efforts. and reported $X X increase its team and a compensation the business $XX.X as higher partially XXXX company year primarily million loss net costs XXXX pre-commercial by prior as during compared costs XXXX continued to as well $XX.X driven full-year with activities included The million completion compared to

As anticipate omadacycline. continue mentioned, a QX launch we XXXX Evan to for

of for launch. however investing an possibility We are the proactively earlier

including will the and medical commercialization support we throughout affairs efforts and the functions some marketing, XXXX, the organization. build During functions that out sales important

securing the expanding and our out chain in investing supply, robust beyond launch. years secondary omadacycline for commercial we’re Additionally, supply capacity, a ensure by suppliers commercial to building

Michael? continue omadacycline’s these Zai Lab, enhance through together collaborations Based extension anticipated resources UTI on interest-only to will Hercules regulatory we with expenses our fund to the Paratek sales with and with and the efforts Allergan will for back potential commercial Lastly, loan period anticipated Paratek’s turn development call estimated the XXXX. into capital of payments to to over enable in and capital from program. close. term late And the milestone commercial Michael expenditures current product I’ll activities, that, and omadacycline operating

Michael Bigham

us. question, Thank productive was year you, Doug. Without and for XXXX a gratifying

With for our that one omadacycline X path for us set positive the year Phase on the noteworthy program and a approvability. towards of up being most the completion accomplishment and clear

delighted date, three of We alone our be just reiterate and not expect program ago. few our We acceptance with Phase with review priority more just exciting our for of months by early X are to the promises we and which submissions if in FDA years under the in are FDA anticipate as of we so. to accomplishment a as the October. PDUFA confirmation particularly review, now industrious this the NDA just began preparation proud to be XXXX NDA to have and our next

a novel keeping the such questions. bringing now of to much that, to prepare potential energized activities no of goal by and you needed to with and to are open apprised efforts will We look is our progress. market. at launch. to the more time are daily the company we And commercial antibiotic clearly our for biopharmaceutical a floor we potential forward the we be exciting With line, established, expanding There and

Operator

your instructions] [Operator line live. Bert, is Thank you.

Unidentified Analyst

Hi for line this for Bert. Jay questions. [ph] Colby is the on Thanks

the the are timing factors So, driving of this, what to the variance in commercial in launch? launch, primary commercial start of

Michael Bigham

you the XXXX, approval way January confirmation issues, stated launch. like unless plan, launch activities we’d the two our month move is notably Well, January or of find goal in influenza to more on and PDUFA to according And XXXX that a know, our focused basically game try date clarity as timeline capture of up get that if around actual the to go early But other to to the to we’ll a XXXX. we and remain of until current season.

Unidentified Analyst

you’re Okay. important what’s in adoption? important now, across formulary need most for what’s get the faster you carrier most then, preparing message promotional message the think the you And to

Michael Bigham

of patients Well, tremendous if is try that push formulary faster clear quicker. the to is very the one for adoption, you’re out that’s a looking and of things there hospital today, get

to of are to is challenges with that happen. that enable the hospitals of effective lack One faced options oral

days earlier, number we value that is and one formularies as compelling discussing looking is of fact, IV very In And patient about a and an formularies actually, at just can be a thing the few with to talking the Wall obviously with Journal clearly we out was guidelines. positions hospital Saturday. on come we hospital it something oral will out get on that and proposition the Street option that

Operator

with Our next question. Chen proceed from Please Fitzgerald. Cantor question Louise comes with your

Brandon Folkes

on is quarter, Folkes on questions. Hi, the answered actually of Brandon Louise. color for for guys. the a lot our This Thanks

the at seeing you. your get to may consolidation that on there launch? are partners see just the you tailwind the next the How we’re create we around is trying a in your lastly, then, with love So, year? a are level. healthcare think update in may antibiotic on anything to there higher that amongst about think And companies you the the moment secondly, Where perhaps industry. to thoughts thinking outside U.S.? potential then, just in legislation And I’d you what Thank over

Michael Bigham

move we’ll for you and Thank first questions. there. the start on I’ll then from with one the

with Greater know, in place our Zai we region. the In partnering in ex-U.S. China strategy, terms have Lab a as collaboration you of

call are are greater, focusing our two conversations are along I going on the the Pacific Asia areas area, The would efforts what there Pan that the and the we other well.

to a to as EU, the meet We’re expect you introductory with not outcome, EU on EMEA in the as remarks, productive. discussions are those our of With active when that to an this authorities specific to year have to sometime thereafter. my heard application just the but going and by file putting respect middle say we’re timeline and

the antibiotics. So, question, the application we can from to the your or our partner, second that’s as get. also in. have consolidation is who will reason launch there with not such the perspective, and through consolidation as time, give And infrastructure European need for work time from around prepare I in them the space potential no than topic. absolutely popular a invest process, companies EU. the someone our right thereafter basically opportunity an a soon but for leverage ours a the us to time to basically of in I perspective, did Oh, to get think And that commercial the It’s for to go very over the a other

is thing first. First

antibiotics. over time, approved get to with in in the launched properly other with the is within and that that makers passage partially hospital important view establish the and relationship in goal even Our setting our and the deepening treatment the become of paradigms and community decision home we for more and ongoing natural ultimately omadacycline time and

Evan Loh

Evan. it’s Brandon, Hey,

hill. positive potential been your of we we’ve different feel couple about a third specifically that bills about continue question healthcare talking legislation, about to of terms on In very the

R&D first your and of provide and a look potential monetized, being a could one we seeing tailwind is tax that day a that deal of year. proposal expenses up specifically could act a R&D something some light The to think rolled potentially at of this ready a where is having that something that that [ph] has be that’s credit into called chance portion the there a is

specifically that’s a challenge specifically antibiotics active bill think, for current that Washington And payment opportunity just the have little particular an we Act Act. they could the hill that CDO that one the more longer and to something will a to DISARM schedule outside see DISARM established bit whether with also at a called bring being a as pay whether I is separate be health Obviously, well discussed tail for be in of system. the with and is there of other the with a committee life. looking there both bill the could agencies DRG is to is discussions for the in on

Operator

question next Leerink Partners. Matteis Please comes from your Paul with question. Our with proceed

Jeffrey Lin

is Jeffrey on questions. Thanks for taking Yes. This Paul our for Matteis. Lin

potential partnering end would you year color please also that of Can community. the and guess bit you of the I what the like you on Asian the have a I little area the sort -- guess more of I I two explore of bit along discussed into the around But, you and that So, clarity you’ve a perhaps as you partnering, year guess partnership, and expansion with more end partnership the and lines EU little mentioned that at the give two, more also discussions expansion Pan discussions after EMA and filings. the entails?

Michael Bigham

once first the during in out and of as based two such first upfront as establish And roughly that I years. over home years course, little take two, I daily our and that with patients once hospital of of a and in the indicated, as to oral time of that basically home frankly the with the the year experienced into move time have with start of the oral end course a basically upon daily that omadacycline And color, community give which reputation oral. patients has course experiment over will the sent setting, bit hospitalization will the think, are drug think to the setting which historical estimation the two will that Adam are stay is and its happen the strategy, and physicians time overall. comparators will when years avoid two reputation

as ways marketplace can to time alternatives There is evaluate are to different penetrate goal community several period, aggressively that those how During two might happen. as more the that years unfold. we our into

it’s with be And for or it at like what hard that to will may uncertainty couple us of predict hybrid time of a approaches. the look so, the

to ability one the call would learn because to areas certain where thing use to of and more hospital approach tell marketplace. with we approaches. there For of And There the example, where are organization. extended, that could the areas are with other over data two inform effective hospitals, or years more more that standpoint, from different combination to the have that community our aggressive partner, Other the perhaps be course in like the we use. to what ourselves first the are all we’ll gain or tell connectivity It it most us would happen. way the the expect decision make we sales avenues around a is is time could of to contract aspects will promotion the be areas, settings to will remote, with other as be that as it

Jeffrey Lin

provide the can on C talk you question, lower alluded opportunity perhaps difficile. C that is common about how Can to infection, the difficile or perhaps big Okay, on great. in and has then omadacycline space? of talk you And about rates -- the more the commentary separate potentially you how

Evan Loh

told that diff, have a And we had finally pneumonia. significant -- our board, and are And community-acquired It’s are broad I Jeff, when physicians C with systems feedback in to alternatives the as C us have spectrum really beta-lactams top antibiotics, of you And hospital quinolones. and systems patients. the history enterocolitis, of hospitalized and we’ve that as in who particularly patients all difficile of spectrum also there in the to at the specifically of continues of to ones in to hospital those know, at be are prior who are that already are seeking elderly problem antibiotics, have broad elderly. those you the exposure as it the these the bacterial advisory have adverse Evan, received as risk said, from that they’re portion actively these think, clindamycin, classes linked look hospital many it’s mind. as well terms antibiotics, systems believe significant we’ve a pharmacists

Jeffrey Lin

not also is, And hospital how expect alluded question hospital have while dynamics you Can perhaps that the I to community I physician may focusing -- many of community the guess great. you describe, also on of uptake. on Okay, as only practices? these some focusing launch, guess, you’re last

Michael Bigham

to we’ve they give I Yes. we’re about how on what you business our a an XX% spillover, our Based first of the out sort business the about first in idea community-based we’ve couple any years. take more of years, expecting a promotions And community. spillover of the as of without can of X% expecting we’re making it, looked is projections. couple at into the in direct been of

Operator

Please with question next Robert question. Baird. your comes with Our W. Ulz proceed Mike from

Mike Ulz

few a I launch talking we I could Maybe question for related if few approval to to think timing. a guess, weeks? just when of the or ask earlier when on how prepared actually be days an timeframe launch? we timeframe from should Are follow-up you’ll about you the get

Michael Bigham

Yes. Good question.

suggest if more -- perhaps bring actual and let’s upside just think, assume up or purposes, date as clarity would launch. we the simply the case I we that can next the do we for expectation. if best a cetera, January And capture that. we’ll et modeling the a two for think, let’s of consider I XXXX the it’s sake once an really if to That’s what or January year, flu of approval now we month just have our But season on it goal. the have the opportunity, we XXXX launch more keeping have is

Evan Loh

it’s Mike, Evan.

to a hands. approval, as of really there’s those materials. And promotional the we our overall prepared label are of that we I we things components that Just upfront. get of negotiations be did are best as also to provide color. of other well components can our some And as Once you out think date. clear of of couple review become that PDUFA actually will have But to approach just

Michael Bigham

extent, will some company to facilitate slightly control. if those, beyond call, to have we which be But, our issues I only The administrative goal of place as helpful. on is what that’s which in we elements would control, have earlier partial a launch, a

Mike Ulz

guys helpful. last to be current your Thank maybe comment Yeah. not, you And or That’s on an expectations that’d for potentially then, just here, question could you if helpful. having related that. AdCom a

Evan Loh

is Mike, more can’t benefit We to in have here much I very we’ve upside at favor see we for base dossier think of the that speak But, compound. clarity the as consistently case. we being think said, risk the we’ll and this our FDA. this and letter, day-XX notification that is

Operator

Please Our proceed question your from with with comes next Gabelli. question. Kedra Kevin

Kevin Kedra

question. taking you the Thank for

or is secondly, you Phase some pricing have First, with XXXX. And market on of you kind flexibility data timing around want proxy from Are coming X of out UTI, any omadacycline; at you in there to for then, look the there. market ask second the strategy pricing about you how mentioned to mentioned the half go that? a that products just as

as X it. timelines, kind I Phase X? Phase using you don’t months side on then First, are Did conservative if for studies you like far I know know enrolling timing what being seen to missed dosing with And want XX as data going we’ve I to mention and if secondly, of seems in Thanks. in anything there. complicated your just more you’re on there’s UTI. X It UTI. a

Evan Loh

Yes.

Phase not little So tetracyclines, your bit can look And allow we question every the about unique first, we talk that us plus Xb same, think have I that about unique. data here, molecule think do in populations you drug We deliberate, you driver now not to you rational X move into historical PK have go efficacy. have know committed PK plus to taking us presence you you probably nor have to think the -- the X. gives through of on and that animal where take It’s Kevin, I at earlier, Phase you attributes when do development. tetracycline why on all question. I historical guidance Adam then, Look, Phase microbiology, and that we don’t first I talked model is are the tetracyclines in take think us that a always an we and allow the the have

two Phase Phase in but well-designed have we design. size are such, they terms they are X adaptive studies; of also in robust As X

X. to dose don’t analytics data we comparator here are is think that the be what into posology knowing the acute what a CABP our is, without pyelonephritis, is to can and very, tolerability, The in trial. high be move what seen want I principally we had because take ultimately dosing, what start go best that the trial X want but approval enrolled as believe we that actually ultimately study, based delay longer, is going testing up very do exactly important will exactly take which to will Phase that on the XXX going some study an by we success. X. that chance to And we’ve as get Phase omadacycline the Phase X probability little regimen maximize failed to of And we to is be and for That exploring oral the approved as in is into successful the we us only way of the of to to Phase believe chance the of data first you’ve seen good milligrams as having similar second CTAs give it minimize Europe. in of the And our timing best us being therefore will to

always question is to So, crown franchise omadacycline. and called you. we to going believe especially with comes Adam, jewel it a development a such product to be drug rational deliberate we are this when this second

Adam Woodrow

because mentioned multi-indication drug broad a great launched actually been some oral, I spectrum once-daily calls, two prior decades. analog this, there Yes. in not is as in almost has really IV a Unfortunately, there think I’ve not for

will some a So, terms we’re closer new pricing, this have to will price be on a I of PDUFA I setting mean, going in to to bit this. date. going our clarity be And how give more suspect of is I to us precedent but it

Operator

comes Guggenheim Please Securities. question. from Adnan with Butt question with your next proceed Our

Adnan Butt

miss Hey, is being it thanks dose UTI? I tested folks. it, for Evan, one did

Evan Loh

multiple No, there are doses.

those arms. trial enrollment be we will comes the and multiple design, it showing early generate we have will dose see of We data then It’s efficacy. towards along that an and signs that optimizing adaptive as doses

to are clinical see. that outcomes we strong, a to are So have we hopefully see the we really our success of value hoping going kind the to predictive ability around if enhance

we So, multiple arms that share in the finally have XXXX will be chance you and doses. data-rich the story half to of multiple It a second data with when

Adnan Butt

or study? adaptive X/X ongoing enabled you it study, it so prototypical study to X The is is a design a the Phase expand Phase

Evan Loh

going really to And a determination. Phase study, -- Phase not X It dose it’s do are X/X is is it is a study. response adaptive, what we

depending is efficacy, take have based you upon on maximize probability, upon of will in typically dosing actually terms can doses determinations that flex for then, initially you pretest to order see start that other And efficacy. way you you with. of exposure needs to where that response arms, the what So, into you be your your in

to what cohorts largest dose, the arm early we we is and you’ll So, we enrich arms And what share be you to efficacy. and efficacy. dosing where dose want to do of in dose, optimal should to able should sail efficiently, believe the ultimately -- get signs sense? from where starting then see [ph] you final final Makes year, with is upon be want next then, we see have into the to based that the final optimal

Adnan Butt

and guideline omadacycline, Very helpful. happen do skin how is And they -- Yes. guideline do changes CABP, then specifically Thanks. And drug or specifically? inclusion? on important class

Evan Loh

I’ll at look little have bit. you guidelines, a about when So, Adam talk and this

hospital is is have we I once is care because guidelines. a had that these primary get terms to work think larger it’s call to talked ultimately on big how times and for And -- what several certain local guidelines a those upon us access. years. walk to priority a guidelines, as we of we hospitals, to guidelines, indications. hub linked about of groups diseases. formulary systems and talking But we we that earlier that of he’s level got local often do through you mean refreshed about will about on recommendation through as have are protocols should Michael be the networks And deliberate evidence the smaller sort our local other compound hospitals believe awareness we local based will getting you have what in such America and terms by levels cycle be guidelines. agent in it I of Adam to certain two there hospitals the think do and if IDSA, of Society, on specific for use Psoriasis guidelines. important these treat And to in Ultimately, those get of compound that of look hospital at treatment piece well

Operator

with Ed [Operator Arce proceed Instructions] questions. comes next HC from Wainwright. with Our question your Please

Ed Arce

Thanks guys. my for questions. Hi, taking

said know quite terms an don’t AdCom? wise, that’s to are the I what First you But, of for speak expectations that, couple prepare Thanks. are I of what the a for on? you you possibility I’m are And what doing for specifically you And sure. follow-ups. in for one Michael. and is your at all FDA, focused then, have

Michael Bigham

that done believe work Ed. I do Phase X benefit all drug we and that you, trials internally compelling. what we omadacycline submitted, for we said before, obviously of to have that mean, the the the the dossier believe FDA. three Thank robustness of not relate the very just from We the risk reiterate the speak course data of earlier is we on for

be guess the an margin, to obvious would But FDA that’s there need for decision not on make. AdCom. the an would, we that so, And

end of And so, going the hear to and determination be at wait have patient the to day-XX. we’re final around just and or their

So, the investment a to obviously, that we’ll timely basis. on community communicate

what two managing like it October. year. standpoint, We preparing out. all are next working So, the up But, from a more well, season see or launch. plays a being capture able we’re toward obviously PDUFA month prepared, for to we’re be sometime if early to things flu go to said move just how have of we’d XXXX before, that date again and against And our expectations from January we’ve in is as we

Evan Loh

with in And requirements. we it not are Yes. NCEs having -- think is that’s last on to said, year because And priority precedent overall short terms comp, review doing I caught that Ed, That there flat was themselves [indiscernible] preparatory work. is and that I we that to build be nice said, the what know was precedent time so of to think Michael AdCom are in setting. in not can’t driven footed, being there of

Ed Arce

are And oral. you’re then, mentioned you acne, what around significant preparing that. present great. Evan, you presence more to could Okay, a give nine there. Thanks little Perhaps one expecting and a posters detail you for for

Evan Loh

opportunity about put We’re excited that data very there. out to more

We and will analyses Phase also There us that we well. studies. there be be oral-only at skin study our of X be And be enhanced microbiology and looking presentation. looking the will at to most subgroup data as will is an Century what’s OASIS exciting oral will

transparency our consistency build of story think I terms in the in I good feel to think a clinical outcomes. very the microbiology in data fashion to to about So, but continues fashion a commitment all you’ll timely continue also of of observations the robust that spheres in

Ed Arce

Evan. Thanks, great. Okay,

for Just one last question perhaps Adam.

committee, are now any for hospitals they share perhaps wondering us are and work prepare from managed hearing or that your perspectives you as IDM. was with in upon just if You personnel and other approval. account early they mentioned markets engaged discussions the key could I and that fully

Adam Woodrow

acceptance we the out So, to actually getting are we’ve first final [indiscernible] actually that until file. got not there, we do preparing the in discussions are for yet the

is both of pleasant which with many in probably terms last It can doing share meeting months. prior of from because case here. today, a there are actually medicine payers is edits very and of and in step that perspective, of class don’t necessarily getting classes you’re surprise a authorizations drugs, this much aware they management anticipate the payer not you heavily involved the one scheduling fifth advisory the So, and we’re payers, of What next I the be will the in still and we’re those about hospital actually or week. payers what had is events all having in fact we’ve fourth meetings commercial got with with six too we’ve the --

the mortality best down prescriptions of So, an They community-acquired the they acute care especially oral the like meetings necessarily a annuity anticipate I there’s or see an broad we reasonably for payers to overall for in actually get antiinfective patient. quite positive. quite field logical The have And associated I They also setting oral a thing not multi-indication time. know this. and slowing of new a where haven’t most realize don’t that excited one pneumonia care. perception. a is you’ll in that we IV, seen am spectrum long a antiinfective need that good are

are the had sometime April, aware So, some after on this later players discussing time. I’m with that’s detail specifics of where May. the to you probably a gives the in that come we present opportunity start bit more we’ve

Operator

proceed with questions. next question James. Raymond comes Chico Our from your Please Laura with

Laura Chico

guys. morning, Thanks for taking question. the Hey, I appreciate good it.

Are and a follow-up using apologies trial? dose that one cystitis missed the loading this I Just quick you in earlier.

Evan Loh

terms It’s the dosing. in how looking one the are considerations of of at we

are I ambulatory coming a with urgent bacteremia is the sepsis. fever, have risk to less pyelonephritis and tenderness have perspective a think, cystitis don’t in acute costovertebral a clinical or dose elevated in of from because developing are it well near-term angle patients That’s or white generally CVAT. setting where as different as loading patients count

in very more And and studies that, be at dosing IV so, you’ve the to our before an quickly hours. looking think up treat And skin we regimen, similar what get I it’s first with to seen will in XX to urgent pneumonia and steady oral type of our state quickly. them combination

Laura Chico

IV an oral, But to be then that correct? starting be would on setting the acute pyelonephritis in transitioning would and that

Evan Loh

possibility always these we the of right. to that given a how option have exactly there patients therapy. continue some there But, IV the of That’s are, the through duration is ill

Laura Chico

guess one just know, you and But, targeting for be a you be utilization settings I community on little share bit will Okay. the you. wondering any might trends. that if you. I commentary Thank have for downstream follow-up this Adam. I then, And further could have

a [ph] from seem to antibiotics the spectrum been it that caught published actually greatest that was So, showed And XXXX rates outpatient decline fill broad and study declining period. Blue have since we antibiotics last over year. Cross see

changing curious couple you how to think of how should if you in omadacycline? And on next see the the ahead. perhaps comment can I’m impact years guess I So, these trends we coming about

Adam Woodrow

these steady look, a you’ve some other general is various and a what that of ever Z-pak you symptoms, when antibiotics. today they an And seeing in an primary come not you couple antibiotics. physician care here, are the in And a take of alleviate infection to that feel has do so a decline use of lot got fact better of of And says about. days, There viral and antiinfectives, inappropriate mostly got there where population stewardship I physician receiving hospital there where antibiotic ill inappropriate that’s realization truth clearly The think, a less else Yes. the the people efforts a is viral It’s many around all is the good lot anywhere what of have a patients these are actually in that inappropriate been focused than stewardship community Look, a in in is antibiotic and use is if there infections use. have acceptance acceptance actually. necessarily is don’t the is back. of that remedies that there than have of been. hospital in because says, use question more

so, seeing the And you in are use decline a antiinfectives. of slight certain

the of the media benefit outpatient the We’re in quinolones, and those where a ultimately decline utilization decline actually, recent other of around setting, in more in black do change uncomplicated also well, the which really at utilization type homeopathic FDA for overall point and a otitis the clearly the approaches sort withdrawal of remedies quinolones to as guidelines which look you the I included if an conditions There UTI, seeing data and would three types has patients the and overall quinolone warning of before of suspect be in indications antibiotic. steady the box manage risk the been in of a sinusitis. from label with require the more getting to

said than this the get probably it’s year antibiotics And going that. our we it to XXX not right over and some that quite of have size that, is a go significantly in down market physicians, when time into community, more all prescriptions where going option are really can Having there those to patients just the the terms for those the it’s eventually United to really Laura, before that in the are in patient [ph] remains dent. approach per sheer all of severe numbers are Because this are the I of the community lower will the patients somewhat we million something do to that Given facts needs and before getting for setting. our States one however take not that, in generics honestly, chance make hospitalized. and think as to big going you be more aware,

to oral medication the that we��ll their hospitalization most have, price Given those severe less we’re going will point using patients expensive option. and are and a omadacycline be the only that is be like where best alternative,

Operator

Our comes Securities. next with Wedbush question Driscoll Robert Please from with your questions. proceed

Robert Driscoll

Thanks guys. for the morning, question. Good Hey. taking

the to I that. So, dosing. in any design you’ve the if to IV failure -- was that elements X, you recent anything wanted of we know are there about gain comparator oral study the Phase such already just study. could any the insights regarding the that just second And from I And study share cUTI? as importance other talked adaptive there eravacycline and arm the if

Evan Loh

the question. thanks Robert, for

And view are any any move our to us actually other that setting. UTI I regardless all said and same the with of unique tetracyclines forward that prior unique. we as start first earlier today, from allow other is we we molecule think every think in observations attributes I the have setting, not

we’re So, confident we what very about feel good and doing. very

a we look earlier IV what I data. in overall, deliberations being and having the an will that has study via to and as data-rich I will to when I to design able be regulatory that of of said well I believe with robust, later design. be Second it you option comparator, fair think that has have comparator us up acute study, but in Those the And And pyelonephritis. important, very design that to only close, of that’s which pyelonephritis designs of setting looks want like-for-like dosing FDA, both we be an understanding comparator. are a our discussions in for part ensure to terms are the the of the oral I as and spring. that terms it the we just We with think completed. X have an that interpret outcome actually are this Phase be I But, will planned us extrapolatabel think, posology it think are to to into when at all, as complicated think, still uncomplicated [indiscernible] comparator

terms Phase sets that We and way in have not fail from Phase we a of can’t in I in will commitments X X of too much deviate X, that. having into Phase because those terms up think risk just

Operator

Please Bert with with Our comes your next question from proceed questions. BTIG. Hazlett

Bert Hazlett

regard Thanks. How could that are the you Hi. CABP, possibility interact And Thanks affect, with to appeal does as with a the there to considering? for is you there’s that safety then, FDA regard you FDA all thoughts omadacycline? also all, comment, Biaxin. taking regard approval of skin study for the a an if -- you have in if been your in all clearly. something follow-up. With oral Is recent warning at that to with oral

Evan Loh

Thanks, Bert, for the question.

before and it’s both predictive. consider posology with consistent say continue an set good Melinta’s have regimen their pharmacokinetics, only only oral that upon there’s pharmacokinetics dossier IV-oral, and only conducted only they We without trials because precedent and where for to study from an the and precedent two said oral with FDA of oral we to the based dosing that

is consistent be PK. would have of posologies is we that have study, We enhancement pneumonia, upon relevant other our for that believe we same the it based using bacterial exactly skin completed actually an dossier the and that community-required different oral-only

on clarity will with and during more we So, as discussions well. FDA, that’s when negotiations have those have we label will this

notation So, Biaxin. thank you the for about

you to I such that of in all and them, attendance, of look is at QTc. as macrolides antibiotics whenever it’s prolongation they note for important clarithromycin classes one think potential carry of risks

medications that I a are warning as running community think into consideration old think antibiotics look is of when really It’s classes this may carry at Biaxin new. is you you that thinking the all relatively at not they that been the that’s around that for Now, given particular be concomitant based typically of that in QTc community the that an liability, as about especially internists while. a a antibiotic them I setting kind get home. can prescribing about have one QTc then warning. It’s that exacerbate But, really liability, nervous elderly But dead has fact the risk lead outcome. to found and

Adam Woodrow

thing pneumonia heart the over the is that are Biaxin in would be that that in community-acquired with community-acquired and particular problems have obviously elderly. One I setting that tend to bacterial used And is the XX% add pneumonia people of the elderly. issues obviously get to patients

clearly. us, of seen that don’t that’s tetracycline decades know for opportunity been issue. that We an this over last not it’s either, have sort So the seven antibiotic something class utilization. with We of is

we’ve as pathogens going And provide issues like fundamentally, confident gives new not specifically or to anti-infectives, taking successfully. trust antibiotic, that an a can to that you feel for take why it’s come resistant other you’re it’s when to us opportunity branded a reason down And class. only very also we before, the reasons would tolerability said with reasons So, for this just drugs. commercialize with safety it’s

Operator

to to Bigham Michael turn like At comments. closing call I back over the you. Mr. for this Thank time, would

Michael Bigham

Thank you.

remain not no omadacycline and you. your call brief up to in very closing your appreciate you for your today all of us. to This continued for much a and time today’s are just questions, attention wrap we with there important be We your thank Paratek and interest without comment, As would questions, will journey more specifically possible support.

we So, to progress, few of months you for exciting apprised particularly Good keeping continued forward bye our look ahead. now. in the

Operator

concludes today’s teleconference. Thank you. This

your for disconnect participation. thank you at time. may this your And lines You

Paratek Pharmaceuticals (PRTK) 1 Mar 182017 Q4 Earnings call transcript