Antares Pharma (ATRS) 3 Mar 222021 Q4 Earnings call transcript

Ladies and gentlemen welcome to the Antares Pharma Fourth Quarter and Full Year 2021 Financial and Operating Results Conference Call. Throughout today's recorded presentation all participants will be in a listen-only mode. After the presentation there will be an opportunity to ask questions. [Operator Instructions] I would now like to hand the conference over to Tram Bui, Antares' Vice President and Corporate Communications and Investor Relations. Please go ahead.

good and operator you, morning everyone. Thank we XXXX financial today, announced our year full and quarter results fourth Earlier and achievements. operating call of corporate Pharma copy for Investor the release section are conference Relations and the available the website. A of in slide press today's Antares presentation

I'd forward-looking include remind Provision impact results our meaning on the those of ongoing Reform Before our Examples Securities made Safe some financial Harbor and statements the listeners including business, of of US Litigation within we begin, this to forward-looking and conference statements pandemic XXXX. results, future expectations of Act that operating statements the at condition. our overall Private during COVID-XX call of related financial like to operating the will regarding the contain the

to achieve and guidance, filings efforts. presentation and for certain on looking are Slide on X Form actual for our regulatory for slide our These hereof, information presentation undue call or obligation future on the They information, otherwise. business is by the are updated update substitute growth, of ability in management in law by subject described periodic on measures any statements with future in statements. our date contained statements market and except company's launches to providing found result references future ongoing in clinical of actions reconciliation to for SEC and filings after or and Antares' identified partner not our the the XX-Q actions products reliance any is non-GAAP as our and product development not partners conference call forward-looking recent cautions future could time. of of differ isolation as the circumstances and over be product measures timing as in product, on release A risks accompanying and the This evaluate to these include Our X The development future and or operating uncertainties GAAP Form date our They revenue Form forward-looking in programs considered for to events and and does forward- results by as GAAP materially. today's FDA XX-K be not the will nearest press and a undertake our required trials place revenue potential financial and performance and Company products, new Antares company are XXXX partner volumes, of should prescription K. These our measures. in products, of the for used and share conference results investors this today's this non-GAAP to can also earnings products and approval our partnered our measures. measures release. to a

President the Powell, and Bob and Research are Officer; today Officer; Vice and Joining of President Richardson, President, Apple, President me Chief on call and Financial Chief Commercial. Joe Renda, Executive Executive Vice Peter Vice Development Office; and Medical Senior Executive Chief Fred

will our update Bob Please with Let's questions call Slide will detailed limited before will call to up a over to turn the then on then closing then for the I review to ask our to X. the a handing and and and R&D X lines for agenda to through will Apple, go before over to strategy business opening our comments portfolio. review pipeline Joe be Bob to of proprietary which then and Bob hand Dr hand with will in caller. per conclude achievements Bob. we the discuss for begin your provide financials call Bob overall back Fred business. two initiatives provide the XXXX questions, and Slide the our to accomplishments today's call an commercial and review on Richardson

you for operations morning in and and our fourth XXXX Good Tram. your Thanks, quarter interest thank year and update. full results

our another results. well operating highlight on financial excited across have on proprietary our outstanding In year built overall We believe and financial year results future to successfully record and we as potential the strength and company opportunities executed the operating a full for we Antares growth and continued spotlight report XXXX, partnered with business. strategic believe we foundation the growth. are the for put a our We of as very have initiatives

at For revenue the $XXX of us $XXX range which to full year, million. $XXX million, puts total year-over-year of to our XX% guidance midpoint increased the revenue our million

to also almost $XX physician relationships in across due with year proud build I'm our of at revenue team annual $XX XX% drive the ongoing over improved as year our almost proprietary sheet maintain and the million strong the flagship EBITDA $XX adjusted challenging million increase accomplishments despite helped another that substantially asset, year. balance extremely achieved end the to generated our organization We the cash to continue in of the million. we entire pandemic. XYOSTED, in and a Throughout commercial

relentlessly support Teva's strong in the We demand million to $XX generic annual revenue. for approximately contribute worked EpiPen also which

in partnered growth As to foundational our assets these balanced our we two business, forged and more XXXX. between proprietary were

XXXX. which objectives portfolio supports focus, also our expectations strong to executed our expand in strategic growth and proprietary We on our streamline

First, market and with of expertise leverage offering. of FDA. and with to testosterone, our to TLANDO the been the approved intend temporarily in gains opportunity an has XYOSTED success us which the complement the market broader oral the drive share our launch We by TLANDO of in-licensing gives testosterone formulation support to

for core in commercial the acceptance resubmission we we end organization. Xth year, approval, March with to date. which while allows our points final NDA our team Pending launch to of an commercial was at the quarter With sheet. Overall, FDA we focus same to This divestiture portfolio TLANDO, balance the submission, a PDUFA be XXXX. of we expect the the expanded the At XYOSTED, our excited growth. TLANDO with completed call their our second time, divestiture look strengthen are to endocrinologist, FDA's of OTREXUP non-core asset urologists forward future the we that in and our proprietary and introduced legacy to back NOCDURNA with

look range in such to where TLANDO ahead, Forteo. of $XXX our we we does be As as products to million the include million revenue unapproved expect and $XXX XXXX not any Teva's

our subsequently positive also XXXX Phase third in the year, made ATRS allow advancements of quarter filing X rescue. development the and to our of results. IND particularly the last we During report adrenal past in the significant for Completing initiate crisis year pipeline, company

was unmet from the pen rescue the for for need In for addition, suffering further Track those FDA's recent this crisis. designation adrenal validation Fast

our Our technology advances introduction research to with recent as well a and the and our XXXX. as ATRSXXXX highlights XXOX of commitment opportunity to ATRS our leverage the continue of to platform development

in of to Our We program advancement will Phase products, opportunities of initiation remain we led partner expect rescue with the the progress that anticipate achievements, a on business for X pipeline provide coupled partner these with our the we which the the selatogrel strong pipeline by foundation, our were pen. internal continue potential bolstered internal Idorsia's grow. to attack heart our

that expand is manage flourish, to drive VP to Claude are success. leadership that, ongoing I excited future and we look a will As I'm With that HR the and have leveraging to critical employees organization Richardson, team where performing our his as Antares cultivating Human joined for recently culture to and support growth. Resources. continues proven a ability develop of high forward built our strategy performance an Senior who help welcome

our Joe over run call me proprietary to and now strategy commercial achievements portfolio. commercial our to detail hand on the more Joe? Let overview our of for an provide

focus quarter split and effectively as quarter. of in-person virtual it region, join successfully remains XXXX, detailing OTREXUP reached we the fluctuated XYOSTED from to with commercial the commercial we call. bag, their The appreciate and our fourth challenges out to with until and Thanks, the the proprietary effectively especially balancing despite growth recent were the reach With in to and access good did compelling XX% the the as TLANDO able year. well efficiently and XYOSTED to opportunity Throughout due quarter, between Physician but the morning revenue enter year increase Omicron more variant physicians NOCDURNA today's we new overall while more team the in and complement the Bob, physician the then maintain as year with XX-XX the opportunity annual with throughout committed now with a with roughly carrying products NOCDURNA. its first closed supported also patients to for year pandemic, from divestiture. as region everyone. a team to Delta and in I a organization to managing the

prescriptions million supports nearly excitement opportunity second prescriptions replacement with million XYOSTED X, TOLANDO well Slide injectables on the see as approximately market with the can quarter between the of in you gels the The remains therapy grow X testosterone X to strong, really year. as to XXXX, in overall introduce prescriptions with split million and X and As annually.

our focus that from entire XX% drivers. XYOSTED which of remains can X. the XYOSTED, increased in you first year, leading XX% quarter Slide approximately one fourth prescriptions growth me the see year-over-year Let total on in and for

enable and consistent XX,XXX now XXXX. to expanded persisted as the in of prescribers remain new fairly penetrate in more highest we December. field representatives XX on in prescriber us year the new grow XX, to pandemic footing end to close switches pleased base the the even prescriptions happened or the to strong of and our year, geographic able markets patients throughout over that physicians. We month as to fourth to Although continue year our actually were quarter the they actually get more between well out we the also and with weekly throughout By to the split with than

currently we new efficiently As anticipation different covered patients XX% ensure hit With which which expect appropriate on of we fourth we year. replacement the is the hard In final count, we're potential market drive for testosterone also to anticipate will year. this metropolitan really more easy now or March believe reach the of for growth look larger prescriptions second working of areas enter to the XXXX. XYOSTED, be we that continue prescribers. XYOSTED, only order PDUFA its oral We're TRT, to an territory use to head to options, date, over year size TLANDO, continue physicians XX% approximately painless so XXth. on commercial and be for similar approximately ahead TOLANDO, and this expect to in upcoming quarter. venue subcutaneous time Throughout for weekly really me With we commercial in that we expect the and expect to new preparation, with launching second reduce in-licensed treatment and their we which the building TLANDO excited in access in prescription detail to to of a expertise expanding platform said, quarter approval which highs experts to the now Sales by for portfolio TRT that FDA TOLANDO brings and detailing to also launch With therapy we formulation the options. that in in of our use by Meeting commercial quarter, TRT a prefer all to can to as train lives. organization is injection themselves commercially space, that we we they demonstrate to as the potentially offering this continue, National organization as In the

or the a and and in XYOSTED we oral option. TLANDO for choose injection transference of is their particularly risk men gels who children, physicians TLANDO, the as the to compelling treatment X for XYOSTED. an those specifically expect almost are option given TLANDO prime alternative, that's to market other. with offers an to as profile. their And that We injection, daily an spouse, and to or application believe convenient a for not challenges their XXXX million first once-weekly patients with clinical target would the prescriptions significant complementary

bag in research have titration, doesn't for We starting your need strong expressed process testing our expertise We allows our them this need profile, as oral means and this with building in to will titrated, for of Physicians have focus in our commitment be positive it message their building physicians market growth place of our product maintenance are also the TRT in team, market. suits offer opportunity efficacy such simple both comprehensive that patients, force's are market the product support and you're believe in to launch TLANDO we to speak. a space options growing and TLANDO choose as and XYOSTED treatment which several attributes gives we is to The of gains share groups their to ability sales no to both as which we really strategy requirement in year revenue best needs. dose a such the and the and have the inclusive the believe dose. and

remain to We grow committed to NOCDURNA. also continue

NOCDURNA in cycle With so the the stable needed we physicians can consumer and remainder as the and polyurea. remain that and our during we pickup year we enhanced the to official sales prescriptions year as our March saw due patients commercial bigger relaunch of of campaigns educate marketing prescriptions XXXX, pandemic longer sales of NOCDURNA on the progressed. that the a made to see quarter, throughout tools In fourth impact a we is believe provider branded started digital in the

quarter the seen XXXX pickup NOCTURNA we year. in first of the at look As we prescriptions have

organization we proprietary will XYOSTED, portfolio believe growth of enhance we XXXX, NOCDURNA. will a forward, in commercial TLANDO, with stronger which Looking our bigger, the and have

leverage as growth contribute to with to continue identifying our a continue NOCDURNA, appropriate treatment educate physician patients. we to expect We alternatives. believe simple as to build TRT that, while a the the opportunity our TLANDO on physicians compelling also convenient will option and We relationships XYOSTED offers

a are going And hand patients. call more on Peter? excited to that with their yet with We now embark Richardson. I'm physicians our bag offer to year to to another and Peter Dr over competitive the

on Joe, and able clinical XXXX. the to initiatives pleased everyone. Thank significant we've progress to development morning made you be highlight very I'm good our

compared ATRS-XXXX, XX the without adults rescue to and the the us initiate pen of X Solu-Cortef, according and safety, hydrocortisone the designed of a to intramuscular crisis tolerability, stable to was FDA the the quarter, acceptance proprietary IND to evaluate the dosed with of The healthy on in fourth establish we by hydrocortisone on Let formulation XXXX of profile ATRS-XXXX this of start crossover adrenal Phase to formulation before subjects shown for product. in the that my study stable PK X. references discussion begin Slide need to a liquid reconstitute summer, me of the injection. the our allowed study plan. study of first pharmacokinetics and drug liquid Right given the

the the initiate completion if we ease shortly along we with study the quarter Now new device positive of to earlier with named another Vai, study our pivotal demonstrate under reported auto this year, stimulated stresses. successful the we study, of clinical in factor results seen use using human the just and to second expect this further of PK injector relative have the

We continue target by of the with XXX FDA the the year. to end filing NDA the bX

The to time these cumbersome underscores designation patient injection ongoing We the FDA with for this and our auto for core development as grant, collaboratively a is of believe of particularly to this VAI, multi-step Track continue And particularly offers patients. a potentially feedback both commitment for North to forward diseases, on platform from efforts. that reporting the the adrenal rescue which proprietary improved remains the designation the asset. American the caregivers, the development. With the and we're base received crisis. an situation in the encouraged FDA's essential to Track option device Fast new new an well agency treatment patient XXXX as our by positive the for administered Fast program's groups care, We This of can focus the the injector underserved life-threatening need development of working therapeutic urgent we an can easily for research is their look to which that population. and opportunity demonstrates convenient be simple therapies introduce a platform patients challenging current standard be provide versus

with emergency program I'll reactions. physicians X later for under Bob. us many of supports to look leveraging expertise we committed patients IND We the therapies. and our allow now formulation this programs to injector be ex-US developing the a forward new proof moving used the We which an pen ATRS pipeline believe a proprietary and internal concept grow back a designation our we conduct the the At development of rescue hand where with an open beneficial of ATRS-XXXX, Phase year As or our designed better review the success pipeline formulation IND, to once the with asset XXXX. injector available. studies of this treatment pipeline in select portfolio healthy the discovery advantages strategic what successful. the emphasis robust development provide in is study an trial authorization, call with of third we work to therapies to will forward. this expect this We auto be serious recently will of to to communication will continue life filed for order the prove file the exists, Authorization treatments announce by may this for doses and initiative over explore studies mediated year. currently to under rescue thereafter. and which a asset, and start patient FDA potential program able these the if remain We Track this reminder, advancing immunologic With We're US to more our on that, use to to in technology, to XXXX auto later of Fast weekly development over be is where second threatening and throughout to program also accelerate volunteers clinical in FDA the diseases no process shortly to treatment be we in completing pleased uro under year study to This trial acute the the in preclinical with clinical expect be the oncology, expansion next thereafter FDA an we believe anticipate of completed

Peter. Thanks,

While to we grow our continue expand and portfolio. proprietary

business We Slide Teva's EpiPen on strong I'll X. remains that a with also company. extremely generic to the start have partner valuable

Our year-over-year million by as required EpiPens centers roll heightened out, well partner almost in EpiPen. for total XX% increased royalty a vaccination you as to EpiPen Teva's the demand primarily prescriptions levels, mass that there Total $XX during was revenue driven XXXX. Teva's from when combine XXXX, the in which increased was pre-pandemic and generic vaccine

their staffing pleased strong were suppliers ability of millions our and worldwide, we support manufacture overall almost injectors issues every to the non-immune the with to demand. that Although organization affected Epi auto were

expect while year, the rebuild in the As share stock market will that also we fruit. generic Teva We opportunity Teva's to a start their we durable safety belief Forteo maintain new soon EpiPen is their leading our and generic also for that share we of product. believe the bear

potential we any Of order approval remain unapproved have Forteo, I to anticipate as our conservative. earlier, to products decided mentioned from we revenue course continue guidance exclude XXXX the in but to

I note rescue pen expect believe with there undisclosed be adjustments rather have As to priority the which we this with in was for targeted been market Pfizer, product continue that the that rescue year. work Pfizer's and an development continue to filed shifted last we for still this on submission but no NDA program for we XXXX. FDA XXXX and the to to develop would in opportunity this pen, to need

continue excited year which expect to XXXX I'll of year. rescue partners our financials. as support opportunity Phase platform heart to continue we We we and that to as and to over leader future hand attack our enroll Overall, a we wish as in a use rescue call this continued to programs. a products. about in review Fred? potential the selatogrel our throughout pen advancement now Fred position support continue and last X detailed for to trial, all combination development our During Antares will initiated well remain them pens believe technology their Idorsia's this of success

balance Bob, throughout financial statement both and the everyone. achieved sheet I'm good across year. income significant Thanks, we pleased the morning our very that and with improvements

year quarter full both XXXX, the and For record we achieved of revenues.

XXst, December our period in months million three XXXX. $XX XXXX, above same ended the XX% of revenues the was For almost

right revenues $XXX our year, to to of middle full year-over-year $XXX our putting For million. the range $XXX XX% increased us guidance of revised total million million

In income addition, our net million. over $XX was

gain the Excluding on sale the of OTREXUP.

net share, million more results double adjusted our was than $XX.X XXXX. $X.XX per income for which or was Our adjusted

debt termination million. Another significant achieved reduction from XXXX, to Capital our with and million -- $XX our accomplishment the XX from venture $XX was in Hercules of we of outstanding debt

us compared facility new operations with Fargo in of in Our strong footing with we Wells was beginning OTREXUP the from the debt on significantly almost year allowed new generating to to sale interest rate has XXXX, lower balance completed $XX a the remaining that XXXX. on million from After the that this almost million December. are excludes XX% credit $XX million the of almost starting cash on the due $XX sheet financial year by in remaining and that

to ended Let and revenues million XX% XXXX. review in financial December which NOCDURNA, In brings $XX the to compared XXst, principally XX and proprietary million The in net generic and XXXX, ended provide December from of total ended compared $XX.X the and royalty $XX.X XXXX, three generated period more and the revenue a $XXX me periods proprietary results million the December for XXXX products, and year, royalties $XX.X sales months Teva full ended a X. was $XXX.X for million XX million, December Total XYOSTED XXXX in on the for revenue XXst, Sales ended increase growth to OTREXUP, increase their EpiPen. the $X.X to the quarter to months compared of and XXXX. was our million the the million December December detailed revenue three three in in primarily an now XXXX. XXst, of million for increase revenue and product sales was XXXX, XX% XX XX XXXX XYOSTED, of in from same of were for comparable in in fourth was months same prescriptions million sales and a continued Royalty period XX million the the compared and Slide to $X.X XX% million $XX.X the XXst, million as and XXst, increase $XX.X three us to months months XXXX increase XXXX. attributable substantial same in XXst, attributable three $XX.X periods and in $XX.X for for The ended months X%

generated million XX periods and programs. relaunch expenses expenses months million $XX.X Selling, XXXX. and of The with basic and increase internal height quarter research which includes sales fourth $XX.X sale attributable periods quarter or expenses general XXXX XXXX, diluted development ended was or fourth associated profit was $X.XX and margin million gross Adjusted earnings an XXXX. as margin marketing royalty. $XX.X increases three XXXX income basic and XX expenses expenses in Our the full or gain and The had operations $XX.X December or for million XXst, during XX% and adjusted NOCDURNA and comparable million share the today, margins compared the and revenue profit per XXXX per compared XXst representing to gross XX% to our for as XXst, XXXX million net and million $X.XX and XX diluted net million, million the to well sale and primarily three and earlier year XXst, Net $XXX.X cash as increases Epi to attributable and in share in share in the in per and for $XX.X cash of I and $XXX XXXX increase Our per was the upon of XXXX. ended announced the income of $X.X $XX.X $XXX per pandemic December as were sales share, that December XXst, December compared of for Earlier diluted as as $XX.X we of XXXX $XX.X in primarily XYOSTED were months ended and year gross months million and in of $X.XX the three the compared ongoing gain administrative per December attributable XX adjusted guidance on million the $XX.X costs, development in earnings million million million $XX.X equivalents ended $X.XX million as and the the to XX to XX% of the ended million $XX.X for $X.XX was or and XXXX earnings from for XXXX was million. the per SG&A $XX.X $XX.X of $X.X XX% Company on excludes and were and $XX.X million of December for months OTREXUP, touched and to XXst, gross and XXXX were the million our which and diluted the December $XX.X Research per the $XX.X and comparable same million The XXXX of full OTREXUP. to declined XXXX the in periods for in cash $X.X development increase million earnings

Bob December. did approved, revenue remember not and yet been have complete mentioned, has our guidance excludes of in which the sale also OTREXUP As products we that

year-over-year rate XXXX, growth turn expect remarks. the I'll we growth. specifically these our growth, of In revenue, to represents call a the launch now continue the for Excluding our potential back closing Bob to We XX%. enhance investments XX% of TLANDO our invest and to future will believe XXXX OTREXUP our for internal Bob. guidance proprietary pipeline. development in of to

demonstrates rest our revenue and persisted our business growth, Fred. all EBITDA, cash organization. that the the year. of diversified with throughout of pandemic were believe by generation Thanks net our products, strong pleased performance proprietary We driven of another generic despite our partnered XXXX we and quite in EpiPen, and income, breadth Overall, of XYOSTED, Teva's

products organization new to As expansion and supporting pipeline our supporting enhance remain as of leading rescue capabilities, the we with the of proprietary well trajectory as our way. ATRS-XXXX, the portfolio our we our growth such continue as with the crisis development TLANDO, to grow committed pen, adrenal with our

with and growth multiple forward and also for corporate open appreciate employees on you you can we the expect performance potentially continue operator future strong to another to the year. to execute we and our our still thank record Finally, partner questions. work of now development interest opportunities our and look hard pipeline. We for your up have Again, to lines supplement

Instructions] Raymond Wilbur James. Elliot will with [Operator begin We with

things kind see the good that I interesting light question priorities, the to the the prescriptions, upward specialties the the your in Thanks, be just Joe, stand get trajectory in about you bigger wondering of mentioned ago in basically Encouraging call of maybe just last mean key you year, amongst to inflection could where year, sort of fourth in are Bob of XX-XX person versus have you're your for seems challenges anticipating? your terms currently detailing relative of I, over prescriber follow-up trending? here I think of, calls And -- kind versus in just sort couple quarter and picture of maybe then perspective in part things in the guess, stand in emerged. point of on virtual, XYOSTED is approaching first been that company And priorities sort evolution. the morning. trended how BD had just of an for on just what's where or I early December, mix, of also levels maybe visit a what terms continued relative of any And balance talk then that over its

had balance a certainly going of sheet an a is in Company's challenges the funding lot you've time. got probably than environment history extended of period here ever obviously You the present to you've for much and biopharma stronger

BD seeing little potential guys, like asset taking of Thanks. whether in here how it look on flow you evolve So seems trying more the in the opening may additional portfolio. gauge just you as you're development, bring regulatory and the it's consider environment to sort up a and actually risk, more to just lot for and assets opportunity in bit a you

to started kind volume. of happen Delta well Elliot, saw Yes, both became then see us for, question year, patient physicians' kind with bit I the a what guess of obviously obviously little hit as end with as for of And more offices during comeback, challenges much subsided we we challenging and XYOSTED, us obviously the and of last tail candidly, that because obviously a then created as certainly so of I'll time, the start little Omicron a Thanks bit year. first some that

to impact happen. more though, definitely that we're we we challenging relates became now year, begin good the it to beginning an for So, this is the opposite certainly physician news us very as in access that. The saw seeing saw of

subside. So, continues the news patient to standpoint just for to are obviously us with beginning continues as up, to patient see be pick news Omicron to access for good and we an good volume and from us That beginning that's standpoint. back

were primary starts urologists, that. should coming patient is be impacted from for group, about in brand. the asked the come offices the back think XX% We're of about You care by still business is as coming GPs. kind Obviously, of a coming we seeing the about from we XX-XX positively XX% the there split is healthy from endo the anticipating new more good that still split, see patients

So you bit to give happy then, saw your that of back of I'm it we but it. what that's didn't question. answered more, certainly a to and think if answer over And I'll we kind Bob. little kick

priorities. the on BD mean, I Joe Thanks

think I the the of for that year. balance

assets. a we even that commercial We look continue at to assets earlier look at bit continue to and ones little than are

We TLANDO, I for think some the that's bag that's relatively But on a and full to moving bit development us take a also ability X. already have completed, X we been X little urology, you have right that products maybe now to flexibility here and go that when -- or are is what's into that and news Phase interesting going Phase development into for earlier and and is at the NOCDURNA, our look good endo the the bag in in with now focus that future. is XYOSTED the Phase

on which have obviously urologists. is have uro be focused and an is adrenal the we asset, We which in focused rescue asset endocrinology going the pen, then to oncology

calls think make Uros, has a really complement bag move and And forward. team on as have we to a for the full strong of Endos we so the pipeline that continue commercial sure products to that I

we to area eventually Endo us which line. assets kind commercial we the or on Uro other development, add look they're of that looking across can gives and at XXXX, potential pen as XXXX development start have another I beyond get endocrinology therapeutic when whether or urology now that announced, of the goal some state of indication where new we be business will on building right good and in, focusing on anticipation when a our of bring focus assets of that So and team, in because small we current we're -- we development corporate rescue which sales

us that because the Elliot, niche opportunities financing amazing financing areas, we And an on tough we're think for that have product we where so detail XX what areas said, I for with are effectively you to earlier environment to focusing companies, can XX some specialty there right a presented of tough is reps, of amount really now environment think companies. single being but with stage niche I product,

more on this execute those, year. And of the so it's given us to balance year a or potentially opportunities lot on next

So it's seen TLANDO ever were were NOCDURNA. of far as history we our selective like opportunities, corporate it very the with and as development I've being in we like company, with busiest probably we're the

at to very continue ability just that have profitable, now doesn't continue to very we we so way, and and cash a think can that go I to be we look type again that a but be that beyond these urology continue generating, sure make to way disciplined endocrinology, organization the the opportunities. in it flow structured of stress in

the more up. side saw and to out. of now virtual of offices about seeing I clarify The kind in-person missed also on think beginning asked And I states didn't of message, Eliot, on was leaning between a the thing one definitely because are the heavy your and the time chance other we're some see you open play one how we obviously that have year side virtual, in-person back get which to thing I beginning Omicron, but on less

upwards that have our because this of to person, still will are some and of year to actually are we capabilities find the showed our We virtual our really -- some what I with say ways XX% I in customers in guiding is access person continue that virtual. team to versus engagement, last digital continuing preferred we're some year of but did and positive our have leverage method again that's are things impacts. to doing really we

push our we're well. this to on going So to digital hard year as campaigns continue

didn't that I chance get Sorry to part a question. your of answer

will our And that with move next now Piper Sandler. Amsellem I'll from to David come question.

Thanks.

So just few. a

more top down on guidance. the line wanted I drill So to deeply

reflected So guidance. to with I you're of guess safe that that's XYOSTED, well. on from then of can contribution the And that product OTREXUP degree are out portfolio, about NOCDURNA, about factoring maybe talk it your as how is How say the in but talk the some as to Thanks. in your for underlie about restrictive more specific thoughts but you it gross gears of you're not not, to you've that about volumes. assumptions know longer on precise just you evolve guide guidance, net I just some just XYOSTED providing talk maybe the extent thinking thinking And landscape the or then general to the to switching play become not about the and which seeing how can out, potentially talk XXXX, landscape you wanted the XYOSTED. of a just payer term. bit, get might grows, footprint you're on how payer but

guidance, to Thanks as David. what makes well. This at looking is Fred, a as as as lot of here our cover it up well items

look an products, You're approved as have our approved NOCDURNA we're focusing well this that right, the that partner as year. products guidance, certainly right? a our take we on our and well It's is at products as area we that when we it's have

growth said, we -- there. the I you When growth that's the significant break QX, we have expect we're assets to we're year-over-year. to because at I know, Joe the that with XXXX was to that that long-term see the you asset growth comes and value continue has but as XYOSTED we're we seeing don't in that We and there, amount the can't we great, looking as there. us it growth in range which as dollar significant for pleased is see, NOCDURNA scripts probably individual will we out for see greatest in mentioning, believe it's each item obviously give that a will

we we've now, with sales sales that reps are As that expanded In leaving we XX, to areas up metropolitan that was the well there sales from year, the focus we we reps, we've right we've major those were which and around we as focused on force, taken during it grew on mentioned, was well started were the split XXXX, as we successful XXX the business knew table. as the we more areas sales on territories we're

are the going So adding able reps there. get to those by doctors be to

there coverage in at reach XYOSTED looking providing will we're we in have though, remain we additional the So additional growth with increase with to the really The us the that constant. expecting the reps, revenue. the were

and as you constant we're the the think a We mentioned XYOSTED. that it's but mid-XX% have much as the as started challenge, or for increase for are challenge and suffer coverage product, rebates has in coverage satisfied were a with the we at not net, market I We with with only gotten about that, one to maintain major that's think gross continue we challenged consolidate, we we're that's companies pharmaceutical very unique. we by continue can to that the from PBMs all right. to PBMs the When the level

and have for that launch, up goes product. allows focus that If coverage a When it's but that seven the or is price limited look consolidated go gross the to to PBMs protection, to to that it's to we increase we our really I and always keep and that also slight have our out to in Yes, and pressure. But back that have XXXX, only to going you the when and our continue we we down we continue a so there. amount tried Really the rebates XYOSTED. is we cover pressure, maintain six now will have a to that's have have is big see we a our some XXXX that at the for different a you year, probably in the that numbers take is providers focus think that that can how decline direction we do up. every one growth in We net have, us that do we three prices as

down that, the units get take little expand in to of the need a it it may we to stay to dramatic bit similar revenue of at a growth not flat, as look level and that but had number change So at go may years. We're in a clearly selling, we looking we're in prior continue units we the there.

going was just I just to add.

did the year pay just You or nocturnal really really an make was we of did key good mentioned in which with, off last that to is three last happened really that about help an would know that and component, in word two we're important peer seeing marketing spread I middle results year, that polyuria, the launched things now to which we're see digital of we peer news labor impact, as beginning NOCDURNA, part second fruits mentioned about we that programs. then event the the with saw NOCDURNA, we campaign the

how help bit and that's that to to understand of provided kind identify so things team point in increase with diaries patients did these last to with All this then to better the their think to could to a you of patients also practice. of So we're back speakers educational Fred can get them that far. those I voiding about latter programs physicians seeing field give little why of and the these hit part year of help we our physicians kind identify nice in year ground part a

at XX% well a combined through to comes I of that price, the getting with to XYOSTED was continue NOCDURNA, the helps with it country, we then those also have only nationally, as mentioned that But we anticipate positive that access but direction patients pharmacies is So throughout coverage important, the specialty on that obviously our regionally thing is see with in that other it's. getting partnerships therapy. and as process go things the

so. net, gross also positive to because but the brand, in to it's it access So to a regards hit definitely get some the the

a Stacy to moving from Ku question Now with and Company. Cowen

the I and the questions. appreciate progress. details, on thanks taking all for Congratulations our

COVID-XX EpiPen, on XXXX guidance, around continue to follow-up So first, growth clarify, but Teva's prepared further related your least remarks demand year, to the continued be a it partners vaccines, strong less from just should like potentially sounds appreciate XXXX. to another product at specific

better thinking us question, do for TLANDO the timeframe please six kinds know the TLANDO, standard let way. expected about think about nine all to for can timeframe we payer kind access, second expect you coverage the about XYOSTED those as conversation support if leverage month right we're around given to of you So of And meaningfully think here, this contribute. as then XYOSTED, a Thank we you. for

first around Stacy. question Thanks your EpiPen. I'll take

the to So, beginning that we believe, depending the maintain over and share. market some year more we lot had XXXX, and so it depleted we of was the that to centers because than growth in devices. share stock sold maintain of of the we grew will saw the was or market XX% devices Teva expect when upside really vaccine expected, We're offset, COVID overall, to on the is devices we XXXX, from expected, a of, it-- we not provide And lot share, continue seeing duration sold we're have for XXXX more on that likely them the market expecting higher in expect we the that because a year a lower they continue XXXX obviously a share week growth than of our and to started additionally, the but reported. it we going XX%, safety to Teva they market in market their XXXX. our throughout And during their believe will leading we position believe And that -- that that

the in process that of we're replenish And so now. to trying really

who manufacturers EpiPen and stressed everyone like were imagine else and everyone XXXX, was as can concerned you was As the as so far -- forth. our with in labor pandemic, make

to see consistency overall we Teva. where starting where now see device open sell likely up so and we're revenue we'll in And product so the is labor the there that again the to an increase

last from back-to-school the and when we royalty school the probably key, how market to that on devices, side, how that will side in hopefully huge volume million see expect $XX normal, of So to in we number, to in is normal of that year little back with that you relatively with royalties between know growth of third just relatively on timing. more that overall was improvement impact the and and did mix business a we pandemic, of the saw quarter do be a XXXX we saw is at the look we heavier device be being and And - we don't the it- flat much that. bit -- the that, additionally, expect the and related to the

one. don't we expect last so anything that Renda, see you want different from regards. other And on to the year year from to this cover

share The was TLANDO, I to a going that are couple of then. things often

would couple with a coverage. question TLANDO So the I regards about say in of things to

get Our early of got anticipation hopefully that's least hopefully similar bit we've on one on. that. we're us that obviously partner is with have time to coverage we'll XYOSTED, develop to a Initially going thinking at board take potentially where point to a little to

things, relationships. though one say really is is would going I out regardless the thing of to us other two is help The of that, gates customer

customers these been these we've calling on know we So customers.

for help that a least get therapy. really to on And be team experts at have identify a offices So them with go we advise to secondly, would built through prioritization team TLANDO. of across patients to us then our going process appropriate for to help say, I that's patients how field to big the

that want a where our coverage, skill that's help you the real up will Fred, us to team to in So set any point field but answer we've have payer on? do got know broader add that we we

echo market with them already kit, the No, access are of coverage have communications to has you the I XYOSTED, already Having we're our that said. what we been with team the all at strong price. looking together just what we regular communications have in putting as

a getting in coverage full year of full year. took this in to second the and it expect With launching their XYOSTED place get We up us. initial quarter for to out to We're feedback. go

we the So payers, grow certainly coverage our results gives with soon that yes, come the will front hope as But a with year. add out step-up as seeing additional I think doctors, and TLANDO. launch the as during in it coverage being launch we then right us now of we

will our Thalmann. that Kaplan from to question, Ladenburg come Moving next and Matt with

your sense Hi, those I quarter focus wanted with represent internal just give little the good and Idorsia, with Teva. I congrats bit well. with and as terms what the at give of a respect those-- pipeline Pfizer, can to of timing for of each of a the you sense, internal timing, us of in launches each guess opportunities those guys, potential and and the fourth products us impact the business. XXXX partnered guess XXXX, to XXXX, by to With on a initially morning results. then pipeline, products on future I opportunities products growth and the driven the XXXX, respect for

review pen product try I'll them to cycle, is review, take There there was didn't a guarantee Matt, that. our the no that continue were And are question. for of obviously Hey look future crisis. most looking forward be-- quite in by of a this end for we're targeting XX-month year. for as but hydrocortisone But term If things right far a obviously so. of near now a quite rescue to there very we products, -- the that's we view, not number and is filing expect it's adrenal us we normal to and our we're get on accelerated to NDA

approvals. goes well. So everything XXXX I at potential we're a looking mean, extremely

pen, publicly benchmark of use assets. far we all at at the our is of believe XXXX. that I look as and we try for million internal at deal And or and $XXX so something that stated value with end of would internally. year about we is is our as we as Yes. opportunity rescue develop concerned launch is When looked least our hydrocortisone we kind that maintain at assets, a threshold when There a to that beginning be the of that

it's exceed so for point that going not that that. get we know could we're we to or don't And obviously to-- definitely

those to were like -- we that for ROI but and because only stage eventually really those and the it's order we but our internal assets, the early to through through going applies then that measure clinical think go develop of I and in we're program, of with to XXXX. timelines I'm to they're also XYOSTED, use assessment going not XXXX so to just forth. working still an and not commercial

I very add strong That's to our a goals to internally, So year pipeline and new of a we're development capabilities. technology as candidate one robust we add to forward. we going believe overall think that is our that. very continue always good, we have with that one have to move we try And more

As in we in where our even did corp internally. dev, weren't in our opportunities, opening success our things revenue, developed with well TLANDO, NOCTURNA, out generation with bag like like our really our as three we cash our through success of our up two did is current really that's

a relative us just we that's a difference ago. were huge So where for few to years

in those they either partners we successful, them the at assets of more a whole those, of continue but at because be therapy, goal our talk and you looking get about, it, number is that it when are When rescue we developing but that I another when they our are see orphan we we'll company. developing much too opportunity EpiPen, I in look for for future bigger those think of pretty for corp assets range looking so to And look growth type high significant we and commercial obviously and dev, in assets line, broad. opportunities, drivers will believe assets our think so because get we're are finished in really products for set look when internal bring in that pipeline value assets partner can just our with device across indications, are that to at you our we're continue up helping our with or already can and they side, for as launch the don't that's we're there

both to programs, the partners, increase the that mix development us development partners for were like continuing products as internal alliance us are partner those opportunity the to a we could we really our try partners. and the only not of rescue have new to of of a alliance with high opportunity different during paid and it's future us -- gives low-risk internal the more business, but that more very potential products, they talk partnered because Because we'll has for programs. the well the yield partners, so I'm EpiPen. to number mean, cash pens a continue Again, that as to I the alliance committed of get conjunction pipeline also these good in if it's sorry, combination lot partner with have And business potential a

year's, forward Fair maybe and you there that this year Okay, your visibility or that then a sense you back what's do on to just file enough. for moving Great. are have commitment Pfizer, last point? said you to And filing to at just more moving expected this to for a still little them bit color you--

like that as to that the contact program working far done, and so file, their we're in along. strategy and Pfizer to to are we is year along. It's to Pfizer move file, to and how mean but we're supporting move target going what this again we're on and with are constant with I obviously as-- Yes. filing working it's them get we trying

really again have that's ability talking They're it's product, about our when not don't products. And the programs, it's -- not I I can external them. to speak all partners our so, we're say about

There pen And like the remarks, I in rescue no doubt market can needed. for that's said so changed, now. it's a say still, about And hasn't not, it's gotten it it's best my if is the prepared is still bigger. if I anything,

move of we're of And try on the committed to to that forward with the hopefully next and guidance couple we the Pfizer, program, and in we'll months to going further so have more program. conversations to timing have we're once that continue to some

to with Now Truist Securities. Fraser Greg moving

better the sure and material XYOSTED relative support decline growth the not payer but I'm expense thanks think slight for excluding You any a to the missed we that I operating in then mentioned will Thank taking gross to incremental growth? coverage. changes net, morning if in questions. did about will that there you. with for Good spend XXXX tied coverage XXXX help this, XXXX, that should And the but was come how in be launch. for TLANDO

problem, Greg. no Sure,

when their their cost fees increase want their that most -- our charging, regional yearly net. rebate exactly payer, PBMs and and fees current -- consistent. about been them, although laughed call increase for Sorry fees they just the affects we if real rebate, you might payer they're increase that those obviously I'll payers. regional lose laughed to that right additional our relatively frustrating the an rebates, not increase in getting might a reason you -- And part quarter mean, is not it's levels data, you quick, to about we to coverage fees gain for environment cover we're why to our the gross every additional in want of is the that's that coverage. that a so have net, the anything for you're still you're lot whatever I the same, even but payer, the and is, call XX% it's every in just around payer the the They said and their that

And so coverage relatively is the stable. same, fees are have the up gone rebates and

On the that. OpEx I -- think we about have

We we Greg, launch you launch I have the on proper the TLANDO. at force two make and sales majority When year pieces it have there's of a right. the the right? hit sure looked of a coming to for board And We product. we additional want we think there, of the commercial side have

and SG&A targeting So as end admin well. the hydrocortisone, an Peter continuing year-over-year. are it those On development, done of his two items there are went XXXX, the through change have XXXX, forward that the side. are products year work When not much expecting earlier with as going to see NDA. to contribute this a XXXX, to we of we're comes in increase we on our I'm research the for moving for presentation, side,

So we internal XXXX expenses R&D that in based year-over-year our own upon announced. to increase our R&D will see from we've an XXXX, projects

we we mean se. that year overall TLANDO, launch It because didn't launched resources in during we pandemic. that have, two launch for I and would of committing the have Yes, our really you the was the the year year didn't do and same per loss with and pandemic, typically a and are invest to of want have We invest so level one, NOCDURNA a of a grow. that in XXXX is strategy brands

to new like for things if For-- challenging they was didn't get that. much for it product worked, it or products, Especially more was how the to and know doctors what access about,

And So we're NOCDURNA to in seeing that's accelerated want we because pipeline, obviously X, growth for XYOSTED still product, we're very cycle. is our investing of in in that in in continue and in important us invest to these in bring obviously that. to and early it's stage to really opportunities We're its life year forward. we're the so investment continue

put the some strong continue cash -- with in that generation in the of commercial can to business so a to that as profit, with we're portfolio as we we we move so the and to have back grow. into really revenue, continue able increase And increase

question-and-answer over this will ladies to And Tram closing call and gentlemen your session. the back for conclude I does turn Bui remarks.

have everyone Have you to Thank questions. free additional me great Please day. out us a today. for any to joining feel if reach you

you this participation Ladies and now gentlemen, conference conclude may for your do for your disconnect. you and thank today. We does