Eton Pharmaceuticals (ETON) 9 May 242024 Q1 Earnings call transcript

Good afternoon, and welcome to the Eton Pharmaceuticals First Quarter 2024 Financial Results Conference Call. [Operator Instructions] Please be advised that this call is being recorded at the company's request. At this time, I would like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.

Thank you, operator. welcome First and Call. XXXX everyone, afternoon, to Quarter Eton's Conference Good afternoon, release discuss plan press issued on outlines call. This a we that we the topics today's to on etonpharma.com. is our release available The website,

call today, Gruber, James Joining me CFO. on we Sean CEO; our Brynjelsen, have and our our

answering can to addition send to be their questions are e-mailed call, we on questions In that today's to live will taking questions us. Investors investorrelations@etonpharma.com.

forward-looking this statements like to involve remind that the call begin, may that we earnings during filings contain from those uncertainties results I the would and forward-looking contained Before actual in in forward-looking company's with the release in to and statements see materially remarks risks our everyone the cause and these SEC. factors made could Please disclaimer statements. differ risk

turn will Sean over to call the our Brynjelsen. I CEO, Now

momentum you, productive today. for Good we to I you XXXX has am Thank pleased exciting strong very revenue have been XXth growth. sequential of joining for It product discuss to us this XXXX, items everyone, thank a say finish afternoon, and After a straight we quarter company, XXXX, into number a David. to to the of start delivering our and today. carry

SG&A grew declined cost to more revenue X% year-over-year our in deliver growth spending Revenues than drug In of GOLIKE. to growth submitted strong acquired asset do more application to our sales while We by and pleased QX, in million, for our were launched record addition another new to by revenue a posting Eton sales importantly, while actually $X.X PKU year-over-year. structure. also quarter so ET-XXX. We we new commercial Nitisinone capsules maintaining from product and disciplined XX%

in We current as we we multiples us should coming that we our can place, over in our towards many the scale business. $XXX modest goal operating support run significant earnings see, infrastructure you years. leverage rate, could deliver SG&A our believe a a As level spending. company in our there of to in substantial revenue our only our revenue have is now This being revenue increase allow a plus million with

population, product ALKINDI we Carglumic portfolio remain part and to quarter GOLIKE. ones by our and patient in the Nitisinone more the I have primarily very acquired in captured and the our quarter that in as believe Acid added of we metabolic the record exceed QX launched were in we Carglumic additional by strong but now additional the capsules SPRINKLE. from both trajectory and of grow, it also our X expanded encouraged a as growth PKU product first Our sales expectations. continues to to Acid XX% than is QX. Carglumic product patients products We products continues of driven have in X

Nitisinone launched a to number already but patients we know, quarter. the may the end estimated and around before annually, to is competitors capsules The in market. February, of in there the of for you Nitisinone were able market million number are As add $XX be a of

it the Acid frequency of opportunity expanded the metabolic break view down very prescribers. patients our patients to asset with expense to incremental the found as PKU this also is with needed compelling phenylketonuria, already amino increase a and recent view more opportunities our opportunity commercialize help was can which little for neither GOLIKE like since offers Betaine has own, We to we I us product. Carglumic PKU. our in acquisition March, infrastructure betaine, excited formula similar cross-sell its growth one with will have another this medical require for And a place. Perhaps revenue they way strengthen GOLIKE, phenylalanine, and now the importantly, acquisition, drive which expectations known to spend helps modest on an believe have but to Nitisinone is I relationship a GOLIKE the very we about. I in few close minutes the additional and talking So we metabolic acid to portfolio. interactions in protein. portfolio large high-value enzyme

For neurological these patients, including [ which protein in and seizures leading the buildup phenylalanine, brain of ] could results cause problems, damage.

As of medical take or such patients PKU PKU many as no a result, GOLIKE. must these formulas, protein specialized low

patient Just support. covered products, is a insurance, about is I'm distributed it by a and by prescribed is distributor typically compelling dispensing handles a GOLIKE like is metabolic by number The and professionals. believe other opportunity, our it specialty that excited for GOLIKE product healthcare reasons. I and of

strategic metabolic actively very and geneticists an engaged serves with States. corporate in of support healthcare same patients and patients rely medical an a on estimated the professionals PKU metabolic the by X,XXX other ultra-orphan with that infrastructure. is GOLIKE on products. are product population and condition United our formulas commercial their strategy First, is the our fit The we managed staff, These

launched revenue Bars product come. the in Secondly, tasting, day significant expect a patients It patented finally, number paid and we growth of is a GOLIKE PKU has believe we replacements. has Historically, must end annual to to launched designed for as medical comes meal see or than for powders less is benefits. a granules full financial a for delayed-release format. revenue of GOLIKE offered ready-to-eat advantages better amino have GOLIKE on competitor over believe medical competition. it years product keep the be opportunity, acid is were is smelling to attractive Xx and in periods it GOLIKE significant each providers technology times that and significantly We the XXXX longer mixed an mid-XXXX. at and relied multiple compelling were that bar patients of and drink time. And than convenient GOLIKE better products,

benefits $XXX at attractive years. goal market our launch. capture formula With for to in U.S. infrastructure, is PKU commercial adoption. The metabolic product is in annually existing be approximately commercial to community $XX or share estimated in XX% GOLIKE our accelerate the the million market with our the believe product medical relationships least infancy still is and of its So GOLIKE's help footprint larger stages We product's the annually. coming can million

to in Our product quarter. from ownership see and our and side patient and dietitian sales significant awareness posted GOLIKE that conference an launched the in interest feedback This Eton's come business. endocrinology community. Switching to of strong dieticians metabolic and growth and International as ALKINDI the raise record under SPRINKLE should improved positive the our in experience the received years growth mid-April, at education now significant the the also we sales we in belief at community team the reinforced the very further conference. provides

year, exhibiting in recently and a at very we active Pediatric As call, Endocrine conferences previous last week. far sampling including been team discussed meeting we has our so medical program introduced our this Society the commercial at

We try have continue who ALKINDI does, on seen discontinue remain most and see of growth texture due in granules. to to to however, a patients the patient the treatment positive therapy. choose experience patients new so far, have prescriptions and Eton that

materials, As rate, to grow, we also have number including this administrative issue. will continues believe this to ET-XXX address educational ALKINDI a and most adequately discontinuation our underway we of revamping but initiatives lessen

week. patients that our liquid that NDA. now once with or because which the home ET-XXX been important a application allowing ALKINDI is to study, submission mixing will to we at they by product We that stay not of ET-XXX FDA the say call, an that own of had and use passed the addition will make from thrilled the form. We be patients In Either am clinical submitted the form which crushing version or anticipate a the provide assign thousand liquid the with liquid with a approved. pleased want mentioned a during ET-XXX the of approved review, was dosing their in we our that today. FDA they XXXX. discontinuation, for it potential is alternative hurdle water, first accurate have On of formulation will quarter last I last large a include treatment final that resistant will several I dosage them this approval in XX-month could population, that a to that of tablets portion reducing NDA to to provide suspension contingent SPRINKLE believe the compounder

sales Our million approved, ALKINDI and the once of to effectively a product in be to ET-XXX the efficiently launch confident $XX position achieve of remain we preparing begun and commercialize and combined significantly order that has growth I commercialization that activities over accelerate trajectory, in SPRINKLE will peak ET-XXX shortly annually. team company's will after approval. the believe

study, and the ET-XXX. endocrinology We run ET-XXX, new for launch the soon are development a a track also of passed of on another ET-XXX The to study with product product this was make in insipidus. candidate to is second after we bioequivalency hope that pivotal pilot treatment product as under pediatric diabetes half to continue we progress year.

NDA approval XXXX end of early team XXXX. Our for submit the expects in potential near to the

I to continue further. propel think can us our look business our clear us pipeline long-term plus we for products it position for X opportunities attractive said, well is late-stage That development commercial growth. that being that sustained even

team is business products. revenue-generating Our development focused currently on commercial

given growth, available valuation for and such debt for we large positions value-creating acquisition. And Our current use intend our any expected primarily a capital would us acquisition. to

product. bidder of for our example bankruptcy an runner-up Zokinvy the were the BioPharmaceuticals in in we April, auction As capacity Eiger

of days quickly we did we capital support a to bid. auction, $XX were While to arrange not win committed matter able million a within the

the we a While not the are interested competitive we in offer any for overpaying asset, at end day, submitted asset. the of for

our we able have expectation on extremely potential our next current tailwind position, Given to disciplined ET-XXX financial the M&A. of and strong significant the deliver growth year, to attractive remain luxury organic for being

do While to. am a not that cautiously the I we asset so larger do optimistic portfolio, would -- add need product we we to to can like certainly

the reach existing positions the and James? that, to years. And it us to with turn to goals our pipeline Officer, Financial over our Our Chief profitability I'll financials. coming discuss portfolio in James,

Thank you, Sean.

quarter entirely increased was due million the periods, volume of SPRINKLE first of product $X.X to to compared $X.X in products. revenue and both revenue and was comprised sales In was Acid ALKINDI XXXX, XX%. first an and sales our Our of the of quarter increase million increase primarily Carglumic royalties

year quarter with ET-XXX. continue We the $X.X sales due to primarily and development million related expect with the to to activities million the prior were the prior R&D for the beyond. Gross to the in in expenses product million profit was for quarter year $X.X and period, quarter-over-quarter increase throughout of year compared rest $X.X million grow $X.X period. was compared this

and excluding While second expect R&D we increase expenses ET-XXX, at to million total filing for quarter R&D expenses with and one-time due approximately compared expect employee-related $X million, an $X.X year spend to million $X a expenses in remain logistics we the in filing the slight with million fee $X.X the costs. decrease fees. General XXXX for with Administrative quarter prior reduction for a were the period, in

to and and PKU expect We was the the General Administrative a $X.X even share prior diluted company of compared the net loss basic million per GOLIKE to net loss loss remainder expenses Nitisinone $X.X for was launch. Total prior diluted Net constant a quarter throughout period. acquisition the million and loss recent the $X.XX of compared remain $X.XX year with net XXXX, the per during in in and share basic period. of year to quarter relatively

was to quarter our quarter Given net and cash of cash the R&D activities, expect our of first operating timing burn finished million income surrounding this report hand end year. Eton $XX.X by $X.X expectations the of positive current on quarterly during the the million. with we

associated turn operating and positive PKU quarter of sales payment new half confident our a of continued GOLIKE in quarter XXXX XXXX, SPRINKLE in the concludes on sales cash achievement. A million by by of ALKINDI Q&A. and of it XXXX spend half in and will product cost And acquisition structure and that, growth the result with While the disciplined first We related This achieved allow the the milestone throughout remainder $X.X we positive with was is to operating for the over weighted the actively opportunities. million remain operator first of first results. payment $X.X year. impacted one-time I'll flow that to pursue that XXXX to of flow inventory marketing remarks the heavily of cash for us product promotion second calendarization our

from Instructions] Chase question First of [Operator comes line Craig-Hallum. of Knickerbocker the

through think Sean. Or a couple this of by here. cycle? maintaining go at to kind year? handfuls we still? year in of of product on going the volumes have, say, in about we that Maybe think should as you patients that of product just I'm Carglumic, just we product's add line start of line kind patient it to Where you are life can this Do XQ you kind

still Chase. some Well, There's apparently. runway

add is up in more to I patients. added our just estimate XXX to patients We -- past the patients. X And continue week. We there's

it lot a more half to period to actually of have which We continues of use extended We little tend about time. product patients that, same new and that grow. than of on, over get a an

terms the the due product provide In patients. wraparound robust for it's we of all a us, product for services detailing to the been life, think the and that we patient services primarily

And it. on on Got quite GOLIKE, growth a maybe one bit new there. then you're of the expecting

the get that You How us level or I Is already it that X you or kind know all XX% quickly XXX odd you think kind already just considering of you penetration know expect benchmark Is X-years? to from kind those how of would of positions. growth, physicians. help you of it quickly do mean, so here? can X-years?

market. I XX% of could $XX that -- XX% we that positioned want more We as the terms promote to about but say, a little as difficult that's which have PKU in current able in would peak depending few of the actually being that Yes. be hit to is. There to very predict, on are a -- well uptick companies let's how approximately of sales, are we there product. out exceed us fast million

hit said, higher year million I $X us that's with to that, very sales may cards. So achievable. be in the for but It GOLIKE that believe is than significantly in next

of Obviously, if another we're seeing before hydrocortisone in you ALKINDI nice think think there's waiting add there on XXX And helpful. you're growth Or us kind and portfolio ET-XXX. launch? to growth from launch. before That's it. ET-XXX ALKINDI of ET-XXX for Do kind the of runway kind help kind of still. kind patients Got here bench just of as we about --

we getting it's challenge The not scripts. is that new of ALKINDI with -- challenge the a

to of get that not stay we on scripts. we've issue So due a patients happens do before. is some mentioned product What lot of the texture the

products. those a have mitigated planning all physicians' we and I've could things. It out mitigated additional can So to seen fairly which by doing rate than all of the offices. with of pharmaceutical the are other to are working And we some discontinuation go doctors of caregivers, higher be education. It educational in materials be by the we

going issues largely but think an can initially. child we have the first patients prescribed of most they main we look product, those off of to did not reasons patients we ET-XXX the driver why challenge quarter-over-quarter. the reducing the with that It's have discontinuation -- goal, and really be texture us go for are it in growth it's for hinge really -- at when a of place. We add ALKINDI the of the patients? So product is it's to the on rate, right handles ET-XXX out understand gate. drug which achievable why And I certainly Can another XXX

product. we're why that's -- is really that think excited I So about the

product it's ahead XX-month We're to PDUFA already a filed. have of Now produce looking and date. even that been

continue patients, reduce will we add a going robust the and going. challenging. to going week. If it's week same another discontinuations to little the a But more product, are can discontinuations, keep can if numbers to bit get it's at ALKINDI level after So XXX be we're scripts we

of gotten guys. more us bridge. Maybe ET-XXX, on PK side I us recent -- Got manufacturer talk that of approvals kind confidence the kind of a lines you've to recently and mean, manufacturing just a Just your you on they us manufacturing? there. submission. the successfully established obviously, about the have along CMC talk has of kind who speak FDA of kind some to just it. that couple of the around working gears some confidence through are of are audits Maybe to kind -- I are shifting you to of Maybe with partner your

Sure.

oral So and to solutions. the zonisamide what similar files are we topiramate did with very

the products, are -- won't one. say which of of same One one manufacturers as the the I the

that And they have confident passed so quality already FDA their readiness, gone inspections. process in our we're and through

around has a today. commercial really actually and zonisamide, level topiramate good of than put don't together. risk products So the for higher any what we did are put We facility it. has been way It's NDA about at which feel approved the both I been submission the feel together in

and process deliverables files the as had the So that in we those what with are same we the have exactly ET-XXX.

So we'll inquiries smoothly as get And timely significant I very process be really see to possible. any is in the time. product on launching that, don't make the from FDA we'll going barriers sure that and obviously

line This really last And a of with Sean. kind then is just me, ET-XXX. extension from

these physicians all know You already.

You'll obviously with a confidence patients quick targeting investors kind that with, ET-XXX fit of of drive those launch? of post scripts of that discontinued that thinking be speak you ET-XXX should some kind great quickly kind how your can can Just launch be is how be? to on

absolutely. Yes,

pleasure. Our

So revenue launch today, of a press getting in plus we'll feel the goal think, way. I the XX-month to timeframe, XX-months stated, achievable. -- it that well that in on to $XX I products. release X is we And is our with to within terms between I think million earlier was these that $XX and our comments of be in what in ramp-up million our get our

how that gives you we're thinking So some on -- of idea what things.

doctors product. They did, be doctors adrenocortical believe course, they of treating was you I once nation. specialize top in the get there, it -- panel a in it for was about Of prescribers this of example, not some XX out more excited and are maybe insufficiency, we of just X, who could the

to believe needs patient will sort product the designed really by just to of important. like serve a that want and their and us meet well we we've And to prescribed and in conversations marketing be advance is received and We patients, doctors. so needs for understand have studies

time. Thank participation I'm for and right. program. questions in your further at question-and-answer conclude All today's showing you does no session This this the the conference.

You may now disconnect.