Earnings call transcript Q1 2023

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Operator

Good afternoon and welcome to the Eton Pharmaceuticals' First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode.

Following the formal remarks, we will open the call up for your questions. 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. proceed. Please

David Krempa

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

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

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

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

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

Sean Brynjelsen

afternoon I'm for first for as Good of over you our as everyone, quarter thank talk David. and year the you rest go of outlook our to you, all well excited Thank to and today. the results, us beyond. joining with

we communicated, major point to was profitability. ETON’s going knew to inflection new seek product be more products history. a We sales, double reach and XXXX in than launch previously disease As rare

quarter for quarter sales to and quarter. revenue sales both say and product announced we fourth over up royalty reported results today. revenue SPRINKLE first the our record start good from million, XX% the Carglumic of the growth. It XXXX. sequential exceptional record ALKINDI product product pleased increase I'm of another was the we're an $X.X off very of ninth Acid, to sales with XXXX of Total in XXX% quarter and was quarter straight a ETON,

believe patients the of so. which interactions strong increases quarter saw treatment we in in-depth I to allowed pediatric SPRINKLE focused discussions, during visits endocrinologists prescribing with growth of habits changing a ALKINDI having number for reduce required physician reps more they believe our during their solely the the likelihood has on ALKINDI and do

launched insufficiency ETON and the with strong ALKINDI patient throughout unconverted. a adrenal to have engagement the patient direct-to-consumer large QX, campaign ALKINDI during also sales the marketing Even of further of community front opportunity a remains percentage increase implemented with our huge XXXX. remains in quarter new our population initiatives us, SPRINKLE in

product, the increase adoption We that are provides track ET-XXX adoption, our product, is optimistic and runway further of us throughout We a sold an expanded patented the for patent-pending pace product ALKINDI of with help alternative, the can at year. this accelerate force long our XXXX. end as of believe this growth which sales ET-XXX for submission will remains treatment new on alongside which SPRINKLE NDA will a be

XXXX. launch This for could in a provide commercial potential

We continue SPRINKLE than ALKINDI more have $XX potential million and peak to of the believe ET-XXX sales for annually. combined

sales force. in we Carglumic Moving over of Acid a our quarter, believe also aided Carglumic conversions significant were direct to expanded the in a strong by part quarter, a very which had few result Acid.

for of leveraging successfully have launch which will Acid base. Betaine be We commercializing relationships same Carglumic the we developed shares Anhydrous prescriber the

insurance patient Cares financial will week We're educational assistance other as our ETON available. prescription support, access program. services benefits services to With well offering Betaine, designed this Cares and commercially and Betaine ETON will pleased now is as treatment. investigation our be help that to announce eligible through full patients provide we fulfillment, and provider

received from had strong we providers to the launch, interest the patients to gain and trying product from prior Even us.

generate our annual I've has several in minimal, So pleased of been thus the the million dollars potential are for in we SG&A. with We very far. incremental launch. performance Betaine we well-positioned with believe revenue to believe sales investment force

in first expanded of year our expanded of be new record relationships members the sales final fully the the help half quarter the believe field force pronounced to We in team XX-person of the to and second this reminder, expect were and both products deeper in contribute the sales a in February. trained as we larger members the develop benefit the with more even of prescribers. team As

the is regional of and benefit conferences. conferences additional An us that at expanded many our allowed it has increase smaller medical presence attendance team to including

Our than year. XX medical this commercial will conferences be attending more team

Our second potential our this product injection. is dehydrated launch year alcohol

aware are by FDA. PDUFA a you of of assigned many been date the June has the XXth, As product

fully been all We communication will information address addressed agencies with requests. the have in shortly regular and have of or we believe FDA the

a we quickly As as if of as date our allow implemented approved. PDUFA the possible for is will that partner a it commercial launch result the after product with have launch plan execution the

the innovative quarter, a would that address we pediatric acquired During ET-XXX, need. candidate a product development for also an condition endocrinology under rare unmet significant

perfect a XXXX. plan, repeatedly ET-XXX Physicians address goes to file this and prescriber the have believe expect as all has for SPRINKLE, NDA we need the unmet strategic which we we ALKINDI can the same to expressed according this makes product If fit. it need. base in

for short-term more this product than year. goal was double sales to Our XXXX

that. on XXXX. And term, is of results rare Betaine the is to commercial as of market launch now XX the our with commercial products The quarter by impressive disease end you to can were our product. well see our achieving have third on Longer way first goal

commercial a three can am and more close We the confident current pipeline are at development will I transactions products deliver business find to continue XXXX. attractive can our by and of very in believe I that position. four we least that more end solid provide

have have or commercial environment, capital we facing markets favorable raise companies challenges. attractive products number assets struggling of are able are financial not capital by and that be increasing to to to Due will pharmaceutical less an advance seen late-stage commercialize they ultimately themselves. months, recent needed In

opportunities are we forward. move an everyone position I I cash our expectation of on to the spending pleased in we as today with to position, near ideal is in we be believe strong hope our as results the capitalize am. Given prudent our as and these type profitable future,

the work in are and groundwork to a behind Our to of team starting that quarters has the scenes put results materialize. lay for in hard recent lot years

internal have We to the to have dedicated year a The company be terrific we're growing better. will of development external now of to further execute business for and to dehydrated behind vision which potential a commercial sales of that, Carglumic activities the were could our at we add coming diverse force start. top all critical development was off advance be our and a in profitable, not disease of of SPRINKLE continue outlook knew a the with the already in-house impressive them, going and rates which Betaine creating on alcohol XXXX months we the and rare launched growth, power Acid portfolioof ALKINDI launch on products.

In summary, started. just we are getting

we traction sharing the news more getting forward as and move are ahead. look great some quarters good forward to We in

Financial Thank discuss you. financials. that, I'll And James? our turn with Officer it to James, to the Chief over

James Gruber

Sean. you, Thank

first and of driven and was to XXXX by or in $X.X $X.X growth ALKINDI compared entirely SPRINKLE, million, Carglumic both and the first increase. sales revenues revenue quarter million comprised royalties increase a periods, In product was Our the XXX% in Acid. quarter of

fourth of compared grew to Sequentially, percent the product XXXX. and sales XX% quarter royalty revenue

beyond. to year expect product throughout the sales We quarter-over-quarter rest growing continue of and this

decreased the year prior $X.X costs $X.X million product the period, for to for were in compared candidates. quarter with million, development primarily expenses due R&D new

We slight in quarters, and in in due expect increase R&D ET-XXX. ET-XXX to to activities related see a spend development to future payments

salesforce expansion. year the the were sales related associated of co-promotion with General quarter were prior supporting are force elimination in and legal $X.X expenses of million employee-related expenses marketing offset the our incremental with compared products administrative million, the commission that cost expenses period associated increased costs, and partially the to in by The paid $X.X for our primarily partner to to expansion the due divested being XXXX. lower elimination with

highest is and million. we still expense G&A expense quarter seasonally anticipate our full year approximately $XX to our QX be of

loss share prior Total during the was compared to a quarter, loss period. in share net for $X.X a of diluted quarter, $X.XX Net and per $X.X prior period. $X.XX million year the basic per the compared company net loss basic of diluted and loss was net million year to the in

with remain developments. to execute us on operating was the and first quarter million. and hand cash during new to our finished plan confident $XX.X cash that product We our bolt-on quarter pursuing allow million sufficient and of ETON our cash $X.X burn the continue is position transactions

Q&A. concludes This with the turn remarks results. that, And it our over on we'll back for operator first to quarter

Operator

[Operator Instructions]

with a have Raghuram question Co. we Selvaraju H.C. Wainwright from And &

line now Your open. is

Raghuram Selvaraju

questions. very for thanks Hi, taking much my

on and on if timeline? sales potentially that updated the light of you so, expanding or your in us So field robust whether you're give and seeing, force thoughts what not in you cadence anticipate can the revenue what

Sean Brynjelsen

the Sure. as it's bring Yeah, at will products, expanding Hi, next two, that. quarter in our be we sales we but or and have we keep for ultimately Ram. salesforce where ramp new to decided up I next don't in right to we is future for size where SG&A Obviously believe at quarters. for least significant at the will see we're the few for plan the increase a the salesforce We need accordingly. today. at

with you so very can far And results. pleased it's so with we're their But the see, as good performance.

come think to necessary accelerate. you'll though additional that I a headcount. There point will see that be add may

Raghuram Selvaraju

Dr. front at the And be update expect you in steps there be on can the what collaboration time? this on in with particular, to give with to expect Reddy’s? you point And to what, in the legal an your us respect next you the front, legal outlook

Sean Brynjelsen

would filed winning you're million Cysteine $XX court some to expect The that think tough timing We it’s and when confident will talking in remain obviously ultimately, Sure. payment or exact XXXX. that and be payment it appeal has I into we in likely always commercialization process. cases. would translate a that commercial about milestone ETON. of to been time But is the predict

track case I far. done and the think good a have good read with I They winning. Reddy's Dr. of very job documents their a briefing record have of very so several has

Raghuram Selvaraju

lastly, the the R&D, less of quarters, trend you the is first of expect And you these to do where of upcoming it's respect or to quarter more meaningfully to be filing remainder to XXXX? preparation over of coming activities given the for this number course ET-XXX? the that anticipate including some Or in do up stay for the likely with going say

Sean Brynjelsen

is and year rest the our R&D little of was to both going timing ET-XXX Yeah, the bit activities than a first to is up the quarter, with quarter higher just the first in tick the for development ET-XXX. spending due of it -

So, be it assume, representative not full of reasonable spend. year to would not is QX

it but do slight tick to increases up bit, a QX. over we little expect not So multiples,

Raghuram Selvaraju

most the the you pipe to And of potential Betaine product to for newer the me, significant of margin? anhydrous in ET-XXX contributors evolution question which down positive if last are gross look likely margin, for be the example, and at gross ET-XXX improvement

Sean Brynjelsen

James.

James Gruber

Yes. and biggest be margin gross would Hey, The Ram. benefiters ET-XXX ET-XXX.

On the the profit comes a that licensing of have our Betaine split line. COGS we to XX% do original partner out

bit the lower royalty but will high profit is be of So, obligation. because that a ET-XXX, margin gross ET-XXX little with low relatively very payment,

should boost overall company the margin. gross So they

Sean Brynjelsen

Thank you.

Operator

Instructions] [Operator

time. call questions now Krempa. no more to see back turn I at And David over this I the will

David Krempa

We on an update yet you. you Thank emailed do that color was any haven't today. question covered we for is the going provide one ET-XXX. indication It for? it Can on have asking

Sean Brynjelsen

Sure.

ET-XXX, products. is exciting most this So one our with of pipeline

we The also adrenocortical ALKINDI in alongside SPRINKLE. for stated release, our As as you be sold press would insufficiency. indication know,

XXX after to XX,XXX it envision, about up it from XX. going And be zero roughly way all as patients benefit used the would primarily could we in that patient on population indicated may really mainly the range. to be six there's think that but We this, X,XXX those would we're

the about need at we It's as area in that So, couple we've are very and think that's this spoken a more an this about it's point the can about say product. to today. our to share say, it. gets doctors, what fulfill excited year information patent and of dozen Suffice we I it unmet specialized issued, progresses but Physicians one will will

David Krempa

That's the end the that for today. we've questions you received. us Thank email everyone of joining

Operator

participation. conference concludes you call. today's Thank your This for

disconnect. now may You

Eton Pharmaceuticals (ETON) 12 May 232023 Q1 Earnings call transcript