AYTU - Earnings call transcript Q4 2021

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Operator

Good afternoon and thank you for joining us for the Aytu Biopharma Fourth Quarter and Full-Year Fiscal 2021 Financial Results Call. With me this afternoon are Aytu's Chairman and Chief Executive Officer, Josh Disbrow; and Chief Financial Officer, Richard Eisenstadt. Aytu Biopharma issued a press release earlier today with the details of the company's operational and financial results for the fiscal fourth quarter and full-year 2021. A copy of the press release is available on the News page of the company's website at aytubio.com. I'd like to remind everyone that today's call is being recorded. call conference available earnings ID today's telephone using press of and numbers provided replay will by be the release. A in the

archived the a Aytu's & addition, webcast be aytubio.com. live In will Presentations at website section Investors and within under Events accessible on

disclosure operating will the also Harbor potential contain and of statements, statements to regarding certain strategies, customary like The beliefs, future information. I'd your attention forward-looking forward-looking Finally, the Aytu Biopharma. conference goals, expectations, to results call Safe regarding call today including

limited management assumptions materially or factors, forward-looking CEO, to obligations factors believes be filings call longer are Time-sensitive Aytu's the Josh SEC. not today, uncertainties, replay. webcast a XXXX, Aytu the over these the is on turn revise Disbrow. Although performance. and of yours. as statements are may of risks, forth but or telephonic company's result no no to, now statements floor and September accurate other to like in Actual based results reasonable at I update these not would estimates, future any with may of the guarantees the undertakes the including, of projections Sir, time differ as set statements. information to any XX, of these

Josh Disbrow

Good for Thank joining us afternoon thanks Taryn. everyone and you, today.

milestones on key a call. to Over this focused, the several past in year I specialty successfully and more embarked to on premier discussing pediatric become executed on company. a transformational journey look half a detail we pharmaceutical forward We which

growing health late-stage and plans future growing growth is commercial about resized as excited implement today, value prescription and therapeutics subsidiary, our consumer and our to are our Aytu integrated seek exciting Biopharma drive infrastructure, portfolios, an pipeline. positioned We how with our we

place have products, the people, the in we're pipeline the to and prepared execute. and We

year-over-year strategic shortly, posted including the now have forma million an merger touch our revenues and months wanted before purchase detail five Neos transactions, are Rich revenue growth, well additional Rumpus financials more ARXXX but which acquisitions ago, now these and from as as and position fully our integrated a following Therapeutics. pipeline with organic and $XX asset, XXX% our business on quickly as our company closed three operating a will product pipeline. both We I of to Therapeutics just revenue product discuss run of Through in on turning to a cash pro growth the rate. commercial we're review we

and from million. the of revenue posted another Included $XX.X posted an last million revenue quarter million quarter revenue quarter division $XX.X Aytu, of This $X.X of $XX.X same million, in health our consumer up with we high high quarter number, this all-time for all-time year. last

our e-commerce revenue the portfolio of operating channels the We our to growth capital quarter gives ended was with by sufficient direct-to-consumer the Neos Rx growth Our health addition through new $XX breakeven. and and cash. and reach This segment us million the in primarily cash of driven consumer introductions. approximately product

in billion our commercial markets $XX therapeutic Turning across categories. prescription now large products in with addressable total our therapeutic portfolio, compete approximately market to five

plus forces, Aytu consumer an operate successfully are focus product merger $XX expect ADHD growing brands primarily sales a pediatric-aligned resulting pediatric-aligned savings annual a specialists and large brands. health this specialists the quarter the Tri-Vi-Flor Adzenys sales significant synergy efficient five CNS-aligned the sales market. Karbinal This promoting commercial and an XR-ODT, In XX over the XX ZolpiMist, to built fiscal CNS we the portfolio and and realize the have million and address Neos markets We Prescription part consumer XX XXXX. in of resizing million in The brands while $XX prescription are We of ER. Poly-Vi-Flor, integration and specialists. in represents we XR-ODT Rx sales model. force with core prescription promoting specialists consisting to completed Cotempla in integration sales of on

for millions number consumer model the division small the through products an of expect outreach focused accesses efficient commercializes and and supplements, by consumer of healthcare portfolio. medicines, and contributes focused mindset The fiscal our a employees. are CNS multivitamins an categories. consumer We approximately of consumers health the pediatric growth of to prescription product division e-commerce targets the consumer expected Consistent $XX Poly-Vi-Flor dietary growth portfolio future for Adzenys also the consumer of year. the operated diverse revenue million growing care personal division in and health directly portfolio The division, products Aytu while our health to health third Cotempla direct-to- is Rx and Tri-Vi-Flor the be of combination deliver efficient and a consumer primary to broad posted and of large drivers our for OTC categories. health be markets a the drivers range This tactics. with

Rx which through access support rebranded and formed of side, Aytu and programs. the quarter consolidation fourth pharmacy program was we patient the the launched newly On network patient RxConnect our in Neos Aytu the

are have achieved. at expand ordinarily favorable additional advantage the drive pharmacy substantial and predictable board plugged pharmacy network, to core known. assets the the for and our unique a have prescription program to their have and us bring brands continue program added we patients to than and RxConnect rate to program legacy Aytu refills This on with dramatically the and pharmacies to on growing RxConnect We might a now Rx commercially any with is a makes ability innovative When higher physicians pleased co-pays the the economics all our we're of enables Aytu gives This from platform. for four reduced innovative legacy is prescribe Through branded separates RxConnect access. design game growth our program. platform. products patient a into continued that on to changer way or Aytu nationwide quite patients brands hassles unique products are simply XXXX and enables this and covered competitors. over this leverage truly RxConnect Neos brands physicians us and delivery, the be affordable expansion and access

revenue by health recently will Going forward, our through consumer we and product OTC with anticipate agreement to we an of anticipate we the medicines growth OTC driven second exclusive new this be see manufacturer. increasing OTC medicines organic sales prescription in across our which business. distribution half fiscal products expect year, various signed launching introductions, the and through e-commerce Starting

reduction development an the potentially the to human exclusive infections the mechanically applications. technology in We license now cellular efficacy such class, the improvement We in Healight first light journal the In catheter of infected associated the In from we the UVA cytokine demonstrating Photodiagnosis catheter SARS-CoV-X endotracheal hospitalized pilot profound in data disease with Healight commercial all is virus UVA announced areas publication Cedars-Sinai data infections. patients. global from significant show UVA severe associated of mechanically corona platform. light announced Center of the ventilator COVID from announced we applications acquired for with peer-reviewed difficult that in with These Therapy. publication study the of journal and severe the These to this opportunity outcomes Turning of other the influenza clinical release in treatment recently targeting load in July respiratory our light our initially two believe to Medical therapy is points pipeline, journals in demonstrate for light-based publication patients. Therapy. for of with respiratory outside XXXX which Advances as data milestones and to endotracheal ventilated to peer-reviewed a and reduces June results Healight in clinical COVID-XX Photodynamics treat pneumonia, viral groundbreaking to continue we manuscript ventilated cells

the to exploring continue potential. depths are Healight's excited of We

a newly by critical Looking study and ahead, initiate the leading treatment in will that effects on be untubated a medicine. expert at This have ventilation. study evaluating and with Barcelona, randomize globally Healight led recognized and we in mechanical safety expect conducted been academic hospital care pulmonary to a patients SARS-CoV-X in Spain of sham-controlled

XXXX. tube and total last of XX patients. of primarily the in and between enrollment enroll early in zero to calendar treatment aspirates is expect aiming are the untreated study to change patients day load viral endpoint treated and between endotracheal reach day The We this

half Following enrolment, to topline in first report the data expect XXXX. calendar the of we completion of

affecting pipeline more entity COLXAX that Our chemical severe onset rare highlighted from or is the disorders VEDS. Ehlers-Danlos Syndrome. subtype VEDS targets is vascular of a new also by enzastaurin, of a of tissues to mutation by the the of the ARXXX ready inherited study pivotal VEDS group the before VEDS a treatment with tissue EDS of genetic is is subtype specifically disorder vasculature caused Approximate inherited pediatric range Ehlers-Danlos catastrophic XX. the the patients age devastating the gene. vascular a VEDS of Ehlers-Danlos relates VEDS, Syndrome COLXAX ultimately vasculature. these causing of is a enrollment and treating of identifying connective mutation. Syndrome confirming skin or the s It is die events. diagnosed half in clinical Approximately easily the U.S. a the patients. if it these and affecting aortic patients XXXX test targeting to and making approved straightforward patients of trial have relatively disease

orphan As on rare a pediatric a we Therapeutics, all assets the held focused acquired of the our reminder, treatment biopharmaceutical and substantially ARXXX acquisition company of Rumpus through privately of onset diseases.

has to Earlier Brooke and month ARXXX and Dr. Nate acquisition, experts joined As rare announced Dietz, this of Aytu groundbreaking chaired Scientific by the date Rumpus in Hal part supporting team. we VEDS. in a who consisting tissue that research Advisory Topher Massari of connective formation management genetic founders, the leading of Board disorders conducted the

company well execute treatment. that VEDS, first the the no treatments SAB approved if the of With Nate, There are now need for positioned treatment. and this Aytu and the patients would ARXXX of such have development approved for the the formation on to so the desperately Topher appointments of is

and the half plan as one-to-one events, study We we'll not VEDS whether Drug VEDS studying in application to a approximately from ARXXX the to IND of or to in study VEDS-related fatal. FDA submit and plan in to trial. Designation a are PREVEnt second an year currently pivotal randomize of dissections, referring secure them start the events which to be COLXAX pseudo-aneurysms enroll arterial working this including Orphan positive We XXX patients ruptures, then they're

and measures. six and without and with patients capture contemplate and of such expect safety also to background an endpoints over enzastaurin We’ll image analysis beta study treatment XX-month inclusive every period. We taking months an interim blockers secondary patients expected meds standard ARBs as

some We And expect that, the of and end over the to with ‘XX ’XX. the the financial to in highlights. Rich Rich? for start I'll study early call by study additional fully turn now enrol

Richard Eisenstadt

the quarter reflected Net million of of of for June revenue cost same quarter health resulting margin in reported quarter of negatively Yes, reported driven for in as year. revenue in the XXXXwas million in increase Josh mentioned including of June fiscal $X.X million June last last Consumer full revenue. the $XX.X $XX.X fiscal $XX.X $XX.X of Neos division revenue one for months division the by at value Net the acquisition fourth the up million, a $XX.X and thank launches high Net year. results versus for and ended zero compared absorption The impacted in those from products cost XX, million was ended was joining quarter from quarter last acquisition, the the the you us goods year. quarter million Gross high fourth same Gross year was $X.X quarter million sold tonight. Josh consumer compared $X.X the growth from inventory was Net health everybody in of same from ADHD revenue at XXXX. fair $XX.X million fourth three XXXX. quarter all-time ended margin at we in to for product the and $X.X Neos that three full by therapeutics XX, last of for growth the ago. was to resulting the to as year million margin million was full the channel. million thanks from XXXX quarter same million an XX, date products million for products $XX increased in all-time year $XX.X $XX.X prescription multiple the months an net ADHD acquired the revenue was the first e-commerce compared

million the if and -- one for $X.X margin a gross required financial values the Research the manufacturing ended reported $X.X were XX%would and expenses quarter XXXX, was the products an ago. as in been associated approximately quarter The the of have with costed will of the for included in periods. been had $X.X not that licenses XXXX expense and in Rumpus development of forma percentage cost. booked XX% Our statements up from The the XX, out pro versus fees three future in $X.X write costs inventory the affect from ADHD million approximately June transaction, million assets by million GAAP. year June ARXXX acquisition months all

$X.XX ended XX, three or three loss or a of For or share the XXXX loss the of versus XX, for loss for per loss the net was XXXX or of share months versus per loss XXXX. share fiscal June $X.X a $XX a share per $XX.X ended June $X.XX XX, ended Net months $XX.X million year year $X.XX the for million $X.XX XXXX. was million million June per

million costs loss related to asset, and acquisition. of $X.X value ended quarter a Neos loss For cash, the cash transaction, write million cash. with included $X.X of which $XX.X Rumpus to up the million quarter related and includes a write-off approximately equivalents $XX.X in and licensed fees We impairment totalling the million million in restricted $X.X the inventory one-time the

product to deal product. kits once States, quarter rights revenue April on began divested this the a to of manufacturing April. XX% In deferred the which expenses products to result back $X.X the reduction back significant headcount in consolidate some are United reduce $XXX,XXX the XX mostly we commercial This core this million is selling divestment manufacturing over transaction COIVD-XX one-time regulatory transition, for cash of centric We at with was the the transaction previously of I’ll of MiOXSYS, outsourced and plans, COVID administrative Rumpus XXXX, and the to the was focus cash headcount payments kits Acerus commentary. in rights occur will margins form tested reduced the business. rate outside that associated to May transition of severance this divestiture past company ADHD to inventory $XXX,XXX the call Neos MiOXSYS and Pharmaceuticals removal closure our redundancies provided these monthly for million. XX, investment from gross the efforts planned with expected had continue to and Texas profit antigen currently we operational commercial approximately March improvement puts we to revenue with manufacturing We previously conjunction approximately reducing products. in the continue announced to run ended we associated to for to of and $X.X this our Natesto months and and and further Because XX% approximately additional with test in now and our $XX of the over of the for inventory. future non-dilutive out and Neos all the In we of In quarter gross announced with improving is months turn kits. the XX pediatric down Prairie, positions manufacturing the remaining Grand costs burn expenses facility associated normalized next Josh these million. It expect Our written expenses. goal $X Josh? for additional the we of the XXXX, and anticipated test profit related margins quarter will decline. over products in it XXXX the ADHD expenses transaction to million payments

Josh Disbrow

you, Rich. Thank

headway as made transformed a we've you focused specialty As pharmaceutical creation pediatric can newly significant see, toward company. value

XX% our business across Healight. we business and this demonstrating our core been even COVID to the ARXXX our continued building year-over-year market our core Rx and focusing by Adzenys year-over-year, and led health forward Going on supported Contempla integrated the by of solid. through grown strength XX% Performance committed and consumer has pipeline grow are pandemic, ADHD the to Rx grown has products market. streamlined

Our can our efforts, experienced core growth prescription the pharmacy program TRx well these Aytu of as year-over-year. in posting network has RxConnect. the patient growth, nearly brands attributed access line our tremendous field five quarters market multivitamin This to and of strength last be our consistent as XX% growth growing growth largely growth

to core and to expand expect to pull products. We continue maximize portfolio through these grow Rx pharmacy RxConnect

half in growth the multiple in to e-commerce launches also product the new organic We channels. and direct-to-consumer the through first anticipate product calendar segment health drive XXXX consumer and

identify As we bring while to our to potentially accretive late-stage to continue pipeline. expect and on continue products complementary RxConnect our opportunities into further and trajectory develop we in also considering add pipeline

and XXXX. acceptance the Orphan PREVEnt to seeking of IND are and get FDA year calendar we expect ARXXX trial first from in For Drug started the we half Designation

first ‘XX. with it Q&A. to data I'll you expect operator in the back updating half now we forward on Healight, the initiate topline to or to calendar study also Taryn Taryn? progress. shortly Spain over look in for of our We For turn

Operator

now The Thank Fitzgerald. open We'll Please for take is first Jennifer Instructions] our floor questions. Kim you. [Operator Cantor from question go ahead. with

Jennifer Kim

taking questions. think you the here. the that was so thanks start it how colour and Hi, the give revenues couple Is $XX.X you far said back-to-school for I've ADHD can Maybe coming any season in you’ve million. think...? I trends to on you off much quarter quarter, so for there around this quarter a on my

Josh Disbrow

lost you... I'm sorry Jennifer, we

Jennifer Kim

Oh, you hear me? can

Josh Disbrow

We lost question. half the just back of the

of any off back-to-school and You kind you and colour then after faded got cut out.

Jennifer Kim

season questions, but respond. after colour trends any couple you I'll so yes, can a Oh on I your until give wait have far? back-to-school the And more

Josh Disbrow

our certainly starts take jump the in, up back we're to Richard can time about really if that according that happy certainly, trending to year. this market we're of want plan, pick speaking, to understanding to and I I'm say you the generally

with the we’re gross sure our to been be. what and nets to having said, to day the other that guide nets in anything be to we're can ultimately matters with numbers direction is we certainly Obviously, That really every to you'd basis. script those continues and revenues brands. to where specific what trends but mean add And to that progress. the we’re for a fluctuate. the week-by-week, speaking make move expected to all market all I say have on in and with by in day-by-day do certainly pressure. that So Rich, continue that? buoy gross is we're to expect happy our don't and any some revenue than They certainly working we you'd happy to We monitored on the the are beginning improve generally prescription, market quarter-by-quarter to and

Richard Eisenstadt

thing ADHD Jennifer probably worst the only is year Yes, generally is I'll add, of the month seasonal, is and July. the

So your tends it from quarter-over-quarter, the it's it's necessarily nice even to up with compared a really a not previous rebound back-to-school, we're step quarter. to though the quarter, previous when seeing not that

Jennifer Kim

And the Is Okay, Rx taking going of, sort so, the think COVID for you we so the on base that's of portfolio, from the is helpful. run kits then off non-ADHD that we XXXk out sort that should was that Rx are is products, those what test I and rate be came of? said it XXXk?

Josh Disbrow

ahead. ahead go Go Rich. Yes,

Richard Eisenstadt

on, Yes, Josh. go

Josh Disbrow

don't from now out I as a revenue, again perspective, think essentially Natesto guide then revenue generally, can kits out and we test MiOXSYS removed. we took to you but be said, you the we consider obviously, took

towards on an products to and focus some other degree Karbinal, Tri-Vi-Flor eye test really, Poly-Vi-Flor So Tuzistra. and the with prescription

from do products expect growth into added that RxConnect and to a baseline. speaking, so work those And this we understanding off base just so of the it's generally got decent probably platform

Richard Eisenstadt

line, the one thing the quarterly test, revenue doesn't $XXX,XXX the in show add from we I'll the is it line. Jennifer get below it's Yes, the

up to line. the doesn't straight drops that show bottom line, it -- but the continue we revenue on So

rate. we our our annualized So that's reasons adjusted guidance actual one to of run the

Jennifer Kim

about it normalized barring we've your I get idea then I expect and to the And have a what again, on seen? part, would an burn have talked two cash normalized when adjustments the onetime you normalized that think burn, cash you cash is Okay, burn? then you to

Richard Eisenstadt

normalized our burn was cash quarter million. the in $X.X so Yes,

acquisitions out the that backing Rumpus deal Neos was Jennifer. with the costs again, So associated and

end with we So the deal was into our Neos was of lagging deal March and that which out flow. the the over all backed of some costs reflective there leaked deal quarter associated and fees, cash the at severance

as that be think as the well, so forecasting I we're pretty quarter current normalized fiscal as far operating quarter, so there's of calendar XXXX this third nothing first in far results as as cash and the quarter there. all a expenses should unusual quarter,

Jennifer Kim

last then terms guess you you I your With getting think great. question, runway, us cash goes are to current my Okay, sorry. what, Could have what of into of said assumptions your sufficient cash to and get breakeven? numbers I that those to breakeven. what And you in operating remind

Richard Eisenstadt

operating we the the guide breakeven, just expecting Yes, don't is as far when so line but as operating expenses. we're Jennifer,

G&A, it's gross minus margin the marketing sales the So R&D and and costs.

go the on expense. debt don't below we into So the line that

Of a a think due we to today announce anything been has is regarding we there We've lot XXXX. I and refinance that. exploring payment course, that don't in opportunities that have been May that debt to have do and of interest

Jennifer Kim

Okay. That's Thanks super again. it guys. helpful. That's me from

Josh Disbrow

Thank you, Jennifer.

Operator

with our H.C. Vernon Bernardino from We'll next take Wainwright. go ahead. Please question

Vernon Bernardino

Hi, on in the pediatric especially and the guys. portfolio. the progress results nice Congrats

Regarding thinking the well, you comments ADHD market products specifically product far were your wondering, are What or ADHD. what's just growth in the it your the the portfolios, of in the what portfolio, market? say portfolios is you pediatric in just can is driving as as growth doing

Josh Disbrow

consequence can nice showing and start I force is and then what of about excited nice rebound. I'm so the respect seeing Yes, segment growth thank we era the modern across the I you you the to And in portfolio, Rich really And and speaking, level, fill know, been driving helped from things. pediatric both sales growth it's the the with has has certainly in. Vernon. growth, largely that's know, to COVID adult Generally slower ADHD efforts segment while this a and I'll out which recover, pediatric as the most bounce mentioned, market shown are market, are Rich field, as particularly onto prescription integrated the how drive these on RxConnect to pharmacies of that's to sales obviously for we've plans lot a tool with revenue fully so to how respect RxConnect And that RxConnect, expanded pull make helping additional maximize but prescription, got products have we're to to the improve to just through, and team. sure entire volume. to ultimately that significant the of and pull is portfolio portfolio how maximizing to it's through the further as we get get platform per excited force tow. to across Certainly great continuing the have refills in just more not a it now then board

I markets, are think market those, the those these growth. the are so And most the driving really factors continuing key all really for And ADHD up that particularly growth. of set

As classroom, and of the certainly work, the expect Cotempla remains the starts in back only unmet these back that see to Adzenys disintegrating have market world And significant marketplace. kids nice getting normalize, there's a orally adults continue are getting to found into needs, the position the grow. to we products, to tablets,

and those be grows, to market we'll think maintain and grow grow able continue we share to the as products. potentially certainly So

I that's growth. the think most of So what's really driving

Vernon Bernardino

Would you then mix the is or products driver of differentiation? a and it RxConnect that biggest is say

Josh Disbrow

without for I'd at really the give driving will one the have what day lot other. end sales you is through execution of But of demand this. the it physician both sort of can't drive a really prescriptions, top billing and force

good to and working gotten now very the both it's folks team with and got physician pull work geographically sized now well and directed demand access together. are places coupled that hand very right the have think pediatric You've where ultimately focused that in the side. RxConnect need a really enable with right right flows they size think the and in into spots, sales we've the through prescriptions optimize the greatest of to good to mix got I there. sales what are XX We've glove in side on CNS And to on ourselves force XX with and to they They're be. of so the I pharmacy the respect

will two think, of forward. factors combination a rate will, move up So to key I'd bring the sales say we serve those grow presuming it's to to buoy and I as that that at continues a baseline continue it market as the just,

Vernon Bernardino

wondering up, as you follow completion of do I a as far the was as timeline tell what for have in me Spain? And Healight expectation study of you if kind could the

Josh Disbrow

than XXXX results we in timeline other of given haven't expect Vernon. Yes, to out specific say calendar the half we to the on first that read

So underway feverishly are and up and up position study to first as what and in that it's patients working expect of XXXX. to that generally half we've to news and enrolled. set speaking, be calendar get certainly is said as share But get a running

Vernon Bernardino

up follow I'm for gross I'll thanks. questions. Okay, with my you another involved here. taking time Thank margin questions, probably too

Richard Eisenstadt

Vernon. Thanks,

Josh Disbrow

Thanks very much.

Operator

this That's all the time. questions we have at

Josh Disbrow

joining Great, Thank today. Taryn. for Thanks you, thanks everyone to very much. us

here We So conclude much. that will Thanks up update coming our providing call. look very forward in to November. our QX fiscal XXXX

Operator

We thank for your you teleconference. This conclude participation. today's again does

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

Aytu BioPharma (AYTU) 27 Sep 212021 Q4 Earnings call transcript