PRTK - Earnings call transcript Q2 2022 | Paratek Pharmaceuticals, Inc.

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Operator

Good day, and welcome to Paratek Pharmaceuticals Second Quarter 2020 Earnings Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to Sarah Higgins, Vice President, Finance and Principal Accounting Officer. Please go ahead.

Sarah Higgins

to Call. Quarter welcome Corporate Earnings and Conference Update afternoon, Paratek's XXXX Second and Good release the slides press this and to A with we call. we earlier was which have today, issued also refer posted will on website company's our on financial results Both at found be can www.paratekpharma.com. Officer; and Participants Chief Randy call Executive Development Loh, and President and M.D., Evan today's Woodrow, Chief Officer. Brenner, on Chief Regulatory are Adam Commercial Officer; and Chairman I will available be questions. Executive also for Bigham, Michael

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

Evan Loh

our call. attributes. second unwavering pathogens by oral growth joining earnings the you, and you all business driven commercial of Thank for second update strength and thank indications, in include a quarter Good XXXX disciplined quarter commitment XXXX Sarah. IV Paratek's with against and These core efficacy proven favorable formulations, clinical once-daily and The in clinically important X was execution tolerability our profile. NUZYRA's and resistant combined afternoon, many corporate of to approved safety product and operational continued

NUZYRA sales year-over-year one reviews growth to commercial last Strong to being quarter, in core successful disciplined in Net access $XX.X the million core a of prescription business. utility NUZYRA quarter NUZYRA expansion represents approximately Our from U.S. coupled decade. $XX.X of have past of by our formulary access. enables and growth. most commercial formulations in business a year-over-year resulted continues the successful setting growing This in care. launch in both million NUZYRA's to second the improved performance both the every this setting, as oral community NUZYRA XXXX is from a hospital XX% significant of and driven execution, significant with Having community, second antibiotics in ongoing a differentiate IV physicians our number in in commercial to increased momentum launched demand, the which increase quarter clinical

As you'll in hear net continues for growth by from be strong sales Adam, driven this NUZYRA. to demand

a on can slide, as Importantly, that growth the revenue NUZYRA's side significant trajectory upward of balance continue commercial see year. the expect core this we demonstrate you trailing through consistent of right performance this continues XX-month and to to

to prioritize We principal pathways continue to revenue NUZYRA X generation.

This current business. commercial the main core NUZYRA's First, driver continues performance. growth our to be revenue of

therapies. NTM abscessus provide represents changes. from ongoing that support the and/or to data nontuberculous We approved future a generation the potential will mycobacteria of a study the inclusion results future no or $X potential billion the Phase believe the rare IIb addressable M. orphan growth disease U.S. In NTM space. alone, Paratek a with disease, the promising represents estimates that currently disease the abscessus NTM, NTM treatment label opportunity. NUZYRA is in and subtype guideline opportunity Second, market

other deliverables and both to stockpiling the that life-saving important under the tactics BioShield NUZYRA's it make government formulated strategy component antimicrobial of opportunities. under Department U.S. These pathogens Defense. bioterrorism government HHS and broad believe and with initiatives include address U.S. emerging should threats. preparedness against procurement Third, infections for today's wound an We within NUZYRA the pandemic opportunities of BARDA resistance, utility being and contract

ended of in quarter the in $X.XX million the period $X.X equivalents expenses contract for period our compared royalty expenses for of from for due million in compared Research quarter cash This NUZYRA operational NUZYRA confident period $X.X a NUZYRA increase year. procurement $X.X and the year cash, XXXX million BARDA XX% prior for million contract, the administrative or the second the the call first year. XXXX, and $XX.X $XX.X per incurred like were costs XXXX Adam. for turn the would and net reiterating net primarily securities. for reported U.S. remain XXXX $XX.X million second on I XXXX like in revenue quarter business, for costs incurred same of compared of over share under or for Paratek highlights. of excluding revenue the we comprised of and million same $X.XX same XXXX Selling, second million the of prior was BARDA to $XX.X was earned in development of from community Based second for in and revenue. guidance. core Total $XX.X under result expansion. and to $X income the period to $X.X million and and to same Revenue the prior financial million. million sales now with a was general $XX.X This were to XXXX net Paratek's the XXXX to commercial primarily Now increase financial per performance would quarter drug the quarter share full in the for year million marketable expenditures, review Paratek quarter second manufacturing revenue the the the the second in $XX.X the studies. increase million million respectively. quarter prior Adam? in other loss million of was $XX.X to I nonclinical when the of $XX.X of year, in

Adam Woodrow

community in continues commercial to the settings NUZYRA progress according plan. and The of launch hospital to both Evan. Thanks,

in and in expectation business confidence our through of in XX% during the growth demand, period, also year-over-year noted demand a disciplined can has leading net in increase core growth impressive Environmentally, accelerated half factors. for to increase and settings quarter and cases, primary of Gross turn in by led sales, outpatient earlier, strong NUZYRA's physical both indicator second prior Evan execution resulted the face-to-face be same access compared sales. year. to care in the the As both evidenced severity when several office-based to and saw attributed commercial in increased the an XX% this year-over-year which net quarter. number we growth promotion commercial continued second NUZYRA's reduction in a the Omicron as the furthering in by of

physical leading seeing in of reviews resulting hospitals. in In sales addition, their in we and resumption business we as largely These access Notably, terms to XXXX with starting additional formulary through year. availability on see important open as that certain hospitals are we are were meetings we usual activities the stewardship as a access hold resume these in to NUZYRA to more to throughout committee have and combined seen stewardship field the and through go access. NUZYRA doors forces expect put several improvement hospitals hospitals, in physical reviews increased availability and and are access Further, continued formulary XXXX. representatives indicator meetings, another

in and know discharge of to care or is suspected be the physicians valued both for We who patients have for oral continues NUZYRA who complicating the hospitals Our on resistant comorbidity. enabling formulation patients a also that early IV focus pathogens by physicians. with known

up a have length bacterial health realized pathogen. the another care setting, which In momentum a stay prescription risk infection community the formulary system, agreements also NUZYRA also addition of resistant has the access salesforce. yet to by community provided the hospital-acquired shortened Recent cost to the for reduces improved savings with pick in additional patients for

most nationwide number to formularies, of is payer patient with or example, with and which fill For along almost a oral covered IV Medicare branded assistance programs, and accessible co-pay of increased with on significantly indications, national X daily in This limited NUZYRA payer of access, X XX% of written and the across as antibiotics to care. is was both insured the enables prescriptions. excellent our XX%. the NUZYRA no every and one nearly once restrictions formulation oral recently NUZYRA populations. patient such, Medicare commercially used beneficiaries to excellent added Medicare all access, setting market is us now

to flu second physicians strategic due itself traditional skin in growth set This branded continued contributing driven first setting. has the shift market approach the in the community other to apart select the targeting focus high-decile launches. oral of competitive detail our lack from care In decision the dermatologists. on on For season. recent the year-over-year number of prescription we was community a podiatrists, strategic refining concentrate in NUZYRA strong these in quarter and a late quarter primary IV a community, reasons, to combination in seen with first growth the has prescribing Further the

such a drug-resistant as in known the Our patients of pathogen by a value impairment significant and comorbidity in patients hospital diabetes. keeping those or is suspected or with using oral renal NUZYRA out

data efforts As field and toward these from force slide, primary generated we that the based this community care the from generated upon marketing ever-improving access, field exceed payer you of those prescription end hospital by therapy force anticipate the XXXX. will see can targeted the

an historical our as year In this remain Most by believe based brand-new the year. date, additional to our combined the in representative community a number, of market of last access Looking of I In an XX to on begun geography. salesforce year. the trends, the is growth we noted will with total XX significant to half we we at to favorable small with community, expand a are the performance adding second added potential. commercial This productivity this territories. representatives strong our of throughout existing and quarter, have balance these

to remainder these to the schedule pleased the approximately have onboard be field are on representatives say of half We QX. already by we with now expansion in

establishing serious new And remains every building focus infections each are that, by and lives and I'll with turn usage repeat now the credibility saving and and who gaining day. with trust and call treating to Randy. Our physicians over trialists on community-acquired awareness

Randall Brenner

its our the strategic community. to just ensure Thanks, of the Affairs scientific priority with Adam, Medical Adam. continues Team described expand expansion into the Consistent community by the to reach success

XXXX with with and or science skin geographically as are field on MSLs, resistance patients, of July engage First, placed limitations we options. early with pneumonia focusing successfully The community-based and including to liaisons, new this the MSLs, treatment current today's community in community commercial care exchange on complement entered health have map, in planned and the expansion. who the will onboarded seen providers and medical all challenges patterns hired the scientific

also found to on execute providers. family all program, in and electronically our supplement link together contract. published expanding the and practices a education. delivered are and Family Practice supplement was we Journal primary community and journals care to Second, the through of exchange and to release. to XXX,XXX we under to is deliverables meetings, scientific With press the community-focused continue available education BARDA scientific The regard can BARDA, June medical medicine over in Notably, be reach with the

preparatory efficacy We of in initiation study of the rabbits, with year. expected study in the of the topline are the final this stages pilot for activities end by from the data

the tablets tablet are anticipated important. of year. turmoil of available topline progress commercially with key valued second in the process global complete As purchase Amid Notably, second a the NUZYRA million. previously validation onshoring and particularly BARDA's in study U.S.-based continues commercially manufacturing NUZYRA a is onshoring chain will $XX approximately trigger data for to and receipt from of this this mentioned, available program U.S.-based procurement with U.S. for supply a rising of our pandemic, XXXX. The international the positive the some milestones antibiotic at half

beginning study, caused continue we indication studies. NTM FDA advance program for the in progress to pediatric continue this nonclinical first by development BARDA-funded quarter. including and initiatives to abscessus, both clinical during to the disease With for of pulmonary cycle post-marketing study, NUZYRA, Finally, with commitments Pediatric regards the mycobacterium orphan PK enrollment life the NUZYRA's

avium infections. addition Track disease NTM both caused an designation, June Enrollment all XXXX. and manage granted in In pulmonary and NTM The by end topline opens to abscessus orphan abscessus health NUZYRA dialogue as help complex, door the infections the of IIb providers MAC. pulmonary of began FDA the data with to the for Track well subspecies of Phase devastating who mycobacterium as NTM, designation study with of patients struggle lung Fast expedite more randomized frequent as mycobacterium these development of mycobacterium the or in Fast expected with to for at treatment care FDA in XXXX for to NTM designation option NUZYRA including opportunity the

group, quarter, as second trial through IR, a this Paratek poster Colorado awareness Mycobacteria advocacy a NTM the of Conference. with partnership as During the at patient our raised well presentation

commonly of Following from both omadacycline model to additional alone in system the in encouraging These used activity and investigator-initiated mouse Paratek against fiber with vivo data include in MAC, an model combination model. and our antibiotics has hollow nonclinical the of studies evaluate studies an vitro MAC. initiated

pulmonary are the which NUZYRA potential XXX,XXX As body by There of than prevalent mycobacterium these of evidence to use cases estimated an the XXx a patients. reminder, abscessus. NTM at and a conferences. of with infections. U.S., caused patients part growing the shows antibiotic MAC posters more summarizing of agent generally supporting X with continues utility there new real-world is be the NTM, treated treating In NUZYRA in second is of In in NTM concluding quarter, disease in combination also with were potential real-world were experience as a NUZYRA XX months, to promise authors tolerated well these, treatment up XX NTM of for regimens presented in as NUZYRA in

Japan. future series and of NTM formalize we would agency, with event licensing around already have additional meetings this At the excited the we'll at further to NTM of to the discussions been of development open second and conducted regulatory generation point, in a questions. being A for meetings for updates investor provide in the Japanese basis for of These the program like data ongoing half Japan. the efforts in Operator? scheduled efforts the partnership this year. Finally, agreements efforts ongoing planned form XXXX will fall. line remain PMDA, We with about remain the

Operator

[Operator Instructions].

question with from comes Our Jeong first Suji Jefferies.

Suji Jeong

questions. two have I

use first the sales you. for look receive when $XX The million quarter over timeline how NUZYRA in is, of And receipt of first second is expect second to of like BARDA, expectations wanted Thank next I question spill to especially year? year. hospital-based will for procurement, current the about you the to and remaining that the the you ask think by you my is demand from the BARDA do the one contributed might this of your

Evan Loh

Evan. the Thank very much you Suji, Hi, for it's questions.

like the Randy. this first regards question For to to with hand procurement, to I'd over the

Randall Brenner

Great. Thanks, Evan. Hi, Suji.

I As in second the positive and BARDA for process we'll delivery as you is data know to the trigger remarks, procurement. the upon prepared my said that the topline execute

which in have process to provided will year, believe the continue and BARDA We that acceptance we will and from at point of BARDA's latter this of around to the part data that the that the study procurement acceptance start payment.

can't their that a of As process. it yearend take but we to control what around towards time may is year said, be the event, anticipate end the we we to BARDA the execute

part that While there the it occur we will in think slip XXXX the towards the may end of year, XXXX. is early it a into of chance

Evan Loh

of For in growth, the hospital the our to Adam? contribute continue prescriptions question to will second terms how and business

Adam Woodrow

thanks. Yes,

I community hospital you business that which actually part can sales the is bar think blue that our as slide, see that of chart. grow the community, to which the was That's on saw in the a represented in continue the the by in the you contributed are doctors.

also growing. represented hospital nicely the moment. we there that's at a And wasn't is growing business quite course, that also that Of have actually

and expect continue. see now starting was reviews than is committee and more I mentioned, it to more meetings in stewardship being that offered hospitals NUZYRA formal we're and before, As we to

hospital continue will throughout as this as probably and Our we for investing contribution in year it. continue keep long

Operator

The Arce next Wainwright. with Ed question comes H.C. from

Antonio Arce

for A few me. questions

I Phase to study. the IIb First, NTM wanted about ask

inclusion of label study as you that this mentioned expansion. results well believe guideline be from supportive would both You positive as

gives that the get to that. detail a Looking what kind of more you little around around stage set and confidence

Evan Loh

it's Randy. for question. hand you over I'll Hi, Evan. Ed. Thanks, the this Thank to

Randall Brenner

study to done It's of the really randomized It's Hey, the before, these Ed, in you from kind. experiences certainly diseases. guidelines. placebo-controlled anti-infection inclusion in of its the We are heard so lung many done of trials gatekeeper generally randomized say mycobacterium question. the first you've as first this ever Evan. one, randomized in abscessus. any first feel study devastating study guidelines. absolute that disease across this parts again, Number see historical that Thanks controlled is the me And to X

trial guidelines of study the the inclusion. into lend a part it guideline on Committee Guideline randomized the If your get before itself guidelines of having as completes in updated. depending are itself even review to when doesn't So will a

many many on, are guideline and that that closely only many, you mostly often updates focus As X as indications years. every years really for know, watch take of done be we We the well. to to updated XX

As far as noting and such. as expansion been label is the part a that Phase study consistently designed goes, we've is this II

Track to the continues we of now nonclinical whether ultra-rare our FDA good data that received the from the even we'll be have data nature and to side because from that Fast for just that through on or a the setting, we think orphan on totality Phase NUZYRA, real-world be IIb FDA. robust However, of of disease, top the generated study, designation discussions assuming it's will, of position with we in this

at to product you to expansions components where an that be X stand there potential this of opportunity regards for That's asked. may Looking the the we the totality of with what think label for. evidence about question

Antonio Arce

Great. Thanks. prepared point at share future towards this that? further, of And a details staying you your bit mentioned the around a with could end remarks, investor this fall. NTM you Any event

Evan Loh

Ed, Thanks, the question. for

allow and we we stages based on both interest but now Medical to actually planning timely in Affairs to the for abscessus a event more vitro We MAC accruing. Group. currently animal the the us regards are vivo NUZYRA think review are data side, our robustly is that that in are upon We that the on will NTM, in receiving this with side inbound that through the currently

to with along a us, date when we that, this NTM addition believe you But whether and to can do we that see we we it's trying pull actually event. are certain we a to off. date have fall In forward can look a participate investigators giving to we particular find

Antonio Arce

Fantastic. I for last me, Adam. One may, one probably for if

was I XX I'm XX And as now just that think of curious you added expect I would where by that it there by were kind reps progresses, year, or it yearend? right yearend? to is heard and numbers where this the around

Adam Woodrow

all year. plan, XX to to And again, about to the us the in following a opportunity And add maintained. of should XX are based that to middle in get by is hospital our is I clear and is return going another of XX I these will We're of probably Yes. want the add after year is us the by that XX hospital more but see representatives few to our community. in on be year. XX, normality to add the to representatives. That for XX an then -- to see the to sort we're starting end year, There that analysis, the next this what obviously,

Operator

The from question Hazlett Bert BTIG. next comes

Robert Hazlett

solid the for performance a A of on me. quarter. Great Congratulations in see. to questions couple

give and this actually general the revenue First as breakdown oral the between quarter? a -- you of in you is, terms could IV

Adam Woodrow

That's of in about so XX/XX, is XX% oral. our business

Robert Hazlett

then and additional growth And -- the reps. operations you for business, the the the of just with the clarity at thanks as looking

of remainder about SG&A terms grew increased million to the about in we from should think roughly growth. of the SG&A of the expect $XX.X year? for throughout trajectory that I million we in $XX $X that Is million, spend

Randall Brenner

in expansion of community salesforce you and delta of our at Bert, into quarter, when currently. I a think this resources past today the that's commitment think a terms reflection I the really of take that look

very expenditures We in terms much in year. with what full were line guided that terms in continue our we've operating to of of remain confident

Robert Hazlett

might tough a your fall any Or then impact has seasons there. material in just that and to is and flu, of to XXXX? know of sense there at more And season patterns, obviously regard I to it's the but normal. thinking flu COVID with predict, return normal had sense just flu looking kind

Evan Loh

Yes.

a us, Hemisphere, to take regards think have countries, I very southern said, we their really if presentation, I And thing its detail know Southern other fairly they think robust with in second would that if being skin a large like saw of first at are Australia is countries having upon assiduous of current pneumonia vaccines. skin call, surveillance predict. emphasize last in advantage what all again, those we that the more year skin population end though, second be of when One both to with variance season seeing look of unlike That coverage rates noted very pneumonia, to terms mean by in very the hemisphere first and infection hard it's seasonality terms traditional flu quarter. line in of robust to what fact round. driven to a pivot primarily in to season. And that early based of you which actually we Australia to COVID ready an date is the terms in our and growth a actually I were been had the was in I as we well like it quarter our to will strategic flu/pneumonia that in for our regards has Which terms at indication. we augured the quarter, materializes. for year-over-year as of

in our are of through So and for strong it year terms balance the which to that this projections is us do year. of kind will to absolutely Which allows our believe us of see demand, reiterate we and that and continue not critical pneumonia the growth I confidence the round of nor minimize with something to the season to financial is have continuing would continues in guidance. that that's remain XXXX I all itself

Robert Hazlett

That's terrific.

to Just One I'm X for me. these goods. is more of X cost ask going together,

actually, -- next just should As of come one think operations for any beyond online, to the cost gross about with this goods I'll get differently we And U.S. regard margins? then deliverable the so back one been year, the us the this rabbit deliverable Thanks following the is? for that what but you study could that, what next you've Again, clear deliverable? remind BARDA, much. very is

Evan Loh

BARDA the question? want do to Randy, take you

Randall Brenner

the a to milestone you the next of were the Paratek milestone. sure. and PEP The studies probably With referring next Sure, providing some studies include Bert. PEP treatment Yes, procurement around when you're the would rabbits contract combination and The the both be the trigger and both program. I a is BARDA and for then treatment the At on for -- was where we extended where the more procurement what think same some it about around deliverable, will to next time monkey triggers of program. to for also procurement time clarity be, BARDA work say regards PEP. pilot combination speaking the

program that timing areas is that XX around expect in of of somewhere the We to the XX the months from procurement. second

through. As multiple into but I'll now be the PEP like, able program, we what on lot that study. that that, the which year, this second, assume of included, come to But looks XX pieces provide procurement of to think specificity because as a provide more next fact we we'll like and specificity early get tight able a is will procurement, XX get you the deeper the be third there's timing not more could through on of studies just moving there's right exactly Hold to the when single part months. on we

Robert Hazlett

shifting all? Thank then of you. goods cost And at

Randall Brenner

question you Yes. your can just Bert, for repeat again me?

Robert Hazlett

Yes.

operations manufacturing think online there of NUZYRA? for in manufacturing, goods U.S. we material of changes should cost is any in the As come -- domestic

Randall Brenner

chains have commercial for one fact think with of is partnership we're the NUZYRA. of manufacturing of very ability Yes. we through that public our Look, I that X private the supply the that BARDA proud actually to now have things

for also going the utilized BARDA to being chain forward. being U.S. procurements addition In the supply actually

functions FDA-inspected chain supply approved. intact, efficiently, again, and remains is extremely Our to and European emphasize,

the for think the think But I going we but will biggest see reduction As reduced, a the it's as in for goes be going of goods, not I and those about to may up, margins slightly costs cost we our term, down. volume, demand think be near drivers materially.

Operator

This for the our Please to to question-and-answer back ahead. over turn session. closing Loh any conference Evan go I remarks. concludes like would

Evan Loh

need positioned be that product attributes long-term growth. right Thank Paratek with you, the today. begins always patients Operator. continues with for well A launch successful to the right

team creation life-saving, in broad-spectrum every product has a once-daily, a NUZYRA, IV have clinical progress. committed that, We to and oral care. for for of focus our attention has been now. forward to and look resonance future that Thank that time setting through to Further value always Goodbye our antibiotic disciplined management. your on delivering apprised of keeping and cycle on you in execution today. continued life you We

Operator

for conference presentation. now The concluded. Thank has you today's attending

disconnect. now You may

Paratek Pharmaceuticals (PRTK) 4 Aug 222022 Q2 Earnings call transcript