scPharmaceuticals (SCPH) 14 May 242024 Q1 Earnings call transcript

Good afternoon, ladies and gentlemen, and welcome to the scPharmaceuticals First Quarter 2024 Earnings Conference Call. [Operator Instructions] Also note that the call is being recorded today, May 14, 2024. And I would like to turn the conference over to P.J. Kelleher, Investor Relations. Please go ahead.

Thank you, operator.

over remarks I concerning call make like the following the forward-looking turning to would management, to Before statements. FUROSCIX regulatory federal the All other statements regarding other commercialization and expansion of scPharmaceuticals' within management's financial to, the ongoing plans than call label FUROSCIX. including, of the meaning of and expectations historical facts expected and not on are and forward-looking statements this limited potential securities approval laws, conference for the results business, but future statements marketing the The and believe, statements. estimate, identify used target, words expect, anticipate, forward-looking intend, other typically confidence, guidance, such are project similar expressions to affect These forward-looking condition and Pharmaceuticals operating involve risks may to business, results. statements and other certain not may are and uncertainties future important SC performance are other subject of financial and and guarantees that factors

by your what include, are expectations scPharmaceuticals' expressed and differ from reports These contained Form other qualifications law. the to update are materially XX-K to, expressively attention these results SEC except required quarterly made to statements, in on as implied is Form forward-looking based this disclaims filed by is conference by Actual limited company but intent and as and outcomes on may responses including directed. risk other factors of and forward-looking to which not the annual or obligation Any current XX-Q call, with statements. or today, your any on the statements report in scPharmaceuticals questions, these forward-looking reports

John? Tucker, to call John to of the over scPharmaceuticals. turn Executive It my Chief pleasure is now Mr. Officer

our results. afternoon's to call thanks and and first webcast listening PJ, Thanks, review to everyone XXXX quarter this to

the detailed Financial review update to will an update operational Chief call financials. Parsons, more on of Senior a and of Commercial Officer, our begin practice, our Nokes, commercial for I Rachael our our before As President has Vice over FUROSCIX then been for Steve with turning a

questions. the for open We will call your then

saw a we that growing care quarter, positive as During a of reflect the continuation and continuum. and the failure we new part trends first believe FUROSCIX the awareness innovative of of utilization heart

Steve prescribing patients written, unique As comfortable are the suggest including detail prescribers heart FUROSCIX more that indicators, post and critical completed are to prehospital leading providers intervention increasingly windows, discharge. failure our will in-services or during initiatives which doses shortly,

million filled We due doses during reported of to previously approximately cyber net widely in on care revenue reported experiencing negative $X.X the XX% quarter impact change the health attack. disclosed despite

some during patient quarter also seasonal reset impact first the as new the deductibles We year. experienced with

increase service rate. to our transitioned think In as our in which fill we and patient result it, we physician we experience. the steps take improve and to hub, prescription will continue improved March, patient We provider an or call

that pleased these through solid temporary another very are headwinds. quarter, We notwithstanding

from first net XXXX. slightly XX%, discount gross during up was Our quarter the

levels We our at the increase guidance year, this continue that to consistent to the of now pharmacy with quarterly for specialty our Inventory will first payers. expect contracting the as GTN. levels we time And the was quarter end with with approach over the at to the of at consistent GTN to end a long-term partners prior the end XXXX. Shifting inventory discount XX% expect in XX% on of by the basis evolves. payers discount marketplace GTN generally

over tier XX% FUROSCIX patients or our $XXX to less expanded make the to to previously favorable the have and FUROSCIX payers moving commercial we co-base in possible. continue fix at With ongoing who market dynamics of most available stated population to of time. and with have XX% an access We productive Medicaid patients have to heart Medicare, us more of or D Part terms to Medicare discussions favorable broadly failure closer to effort goal

come. to hope quarter that with to health provide last initiatives the progressing At this previewed like an we critical growth other update we would are we as growth several and plans, on that updates I long-term many point, view We months to have strategy. to long-term in our

discussed Association from treatment allow failure to III FUROSCIX currently and for patients potential indicated for heart is FUROSCIX expansion FDA the New feedback patients. Recall received the As that New fluid X York we Class of Heart the last positive congestion adult with failure. heart overload chronic the regarding we due use previously, York Class year, to of indication in II Heart Class in Association

have as prescribe October and we as to FUROSCIX. received opportunity of We many a IV indication as be occur XX% feedback date Class August, from would ACT and early XX% the assigned most possibility that still market providers the patients last of heart we would IV could severe as Based If in PDUFA we of are Class estimate are we benefit able successful, believe upon does all the the heart filed although FUROSCIX for year, the may of the we date meaningful many expansion as that represent failure that a a exist been these meaningful our failure this to patients. sooner. PDUFA percent from Class IV

to as now milligrams/X we the XX developing mL on-body Turning that an additional auto-injector to infuser. option low-volume the are

allow year. new plan pivotal this a announced us this we ago, a year will weeks few of submit we that the a we FDA drug by if PK successful, report to that end to supplemental to later study Just application results initiated the

treating their stated improved, believe with the an providers in reduced convert auto-injector, As advantages and to if more on-body infuser costs manufacturing and to well patients flexibility. current we compared as environmental treatment we previously, addition giving

listed XX bridge expansion that or the which FDA it's CKD of mL. fluid the kidney and include that the drug, of provided expand the edema furosemide no we an potential to for are the studies Finally, FDA injection treatment clinical the demonstrate needed from PK feedback we feedback can confirmed adequate overload due in that previously FUROSCIX is received additional of with indication to patients that pharmacodynamic megs/X to to CKD. chronic indication pertaining Recall discussed in we disease

CKD have of we oral a to and CKD diagnosis worsening fluid that with not loop by one are be that overload XX heart time, episodes over million they failure. is that which are The beneficial disease, with of aware diuretics. Americans common of FUROSCIX overload worsening most not fluid with CKD, being characterized estimated have progression, responding patients fluid disease in of a CKD could have with loop overload It renal and patients XX do is treated complications to who kidney symptoms simple million resulting progressive frequent function diuretics. XX% the disease are to in of worsens believe

month, new supplemental CKD with application earlier FDA this that see we the indication. To a that end, drug the for

Steve At I'll Senior Parsons this call Vice of launch for President our deeper our Steve? to into dive the turn Commercial, metrics. point, over

Thank you.

John February launch XX% we continue prescribers, XXXX, from had we've be As prescribers pleased indicated, from through December X,XXX up our XX. had in March XXXX, XX, X,XXX to launch. the with launch since through and From progress unique we unique

by broader are we it as strategy encouraged the prescriber of establishing quarter in prescriber this a growth We believe base. our reflects

multiple of have Importantly, written prescribers these more than half prescriptions.

we and first had filled. the X,XXX been have quarter, written doses doses XX,XXX During

attack. impacted negatively Healthcare earlier, our quarter filled cyber during the were doses indicated John reported widely by first the As Change

currently are to the as continue patient that our year. steps calendar pleased forward. we also the are and going the fill faced to of on trajectory at deductibles headwinds, normal with Despite explore rate reset We we seasonality we increase start those

as in One steps of or prescriptions month of not Increasing in written. future reported writing that up And and hub a in filled change on. we we our are the March. they doses significant filled are on actually in prescriber the the to directs. anticipation those as make in ship filled providers completed spread doses services Preapproved that patients when prescriptions doses for written number is of written portion our report a These them in patient report may between needs. which prescriptions they are doses the and quarter we of be statistics patients

that of for doses canceled by a do patients of or get proportion prescribers variety reasons. The

high be on stabilize prescription position was time, very XX% XXXX. Over Cancellation quarter anticipate in for costs the of been quarter or normalize. some payers needed. to decisions as rates cancellation The canceled. are lead are to quicker with will FUROSCIX. improve Other because and filling during when we or get not did patients X coverage before to Better Some reasons increase in rates formularies, by are will processed that situation the percent patient difficult of the or could fill the resolved prescriptions out-of-pocket care Change lower hospitalized have cancellation and standard reach cancellations patient co-pay an deceased. Healthcare

of quarter and prescription During the than the filled number sequentially our from in fourth X.X% quarter, X.X%, doses of the was higher remains which expectations per first slightly up long-term average XXXX.

from has force completed important services X,XXX the XX, ensures of offices from X,XXX FUROSCIX in training services prescribing through provide on last sales services of as December March this of readiness. process XX Our in to year. launch office and conducted In up

open and each meeting the conducted success, important remains in quarter we more regard of we the peruse an new of As to execution in fundamental accounts, indicator. services services number as

additional a Regarding but awareness, our and some and and presence, demand engagement plan sales long-term program the a and This provider adoption marketing brand campaign collateral force, marketing electronic Class and perspective, of in of activities, advance of development critical warrants. territories we on additional other to among CKD print that We key ongoing growth engaged ready opinion previously commitment. patient tasks. we of multichannel both as From development adding and include initiatives. different websites potential encompasses key many leaders, to in stand territories conference IV activities said drive the add we have are broad

FUROSCIX. to caregivers education reach we continued pleased That on. progress with the continue path that patients failure are Overall, concludes patient my their update. out and we heart materials to are our and with for We

to to turn call a over I CFO, financials. the now our Rachael? would review for like Nokes, of Rachael our

you, Thank Steve.

cash XXXX. XX, as of cash million March in in and investments compared we XX, and equivalents December XXXX, $XX cash $XX.X to equivalents million of cash, As held

quarter were million of income quarter first the items. for the a net XXXX. quarter $X.X of the XXXX. for $X.X compared first quarter million $XX.X will of first XXXX, to quarter Cost XXXX. a million Product XXXX for for quarter first cover I to few of million first Now to loss reported for a compared million and revenues statement of net We've for first XXXX the million $X.X of of revenues compared $XX.X loss the were the of product $X.X of

was an XXXX to costs into Presenting compared further and in The the increase research the of XXXX were the first development for in a of million cost quarter the of XXXX, costs. increase due quarter to expenses and launch the million in full in revenues expenses was comparable development March $X.X XX, for to for sales due FUROSCIX XX, and quarter XXXX. The of XXXX, and device both the March costs, increase of in employee-related ended manufacturing an commercial product ended and in study $X.X increase demand product related development clinical costs. quarter first period primarily for quarter revenues

million costs selling, general for and XXXX Selling, administrative and expenses quarter period employee-related from general the in support. was primarily March to for million ended The increase and costs, comparable $XX.X administrative for an expenses commercial compared of quarter the in in XXXX. the $XX.X XX, first patient XXXX, due were increase

we March As had concludes XX, shares XXXX, update. the John? That XX,XX,XXX financial total outstanding. of

call This remarks. for concludes our the open Rachael. point, At we prepared Thanks, SP-X questions. this will

will question at [Operator from first Instructions] And Glen your be Jefferies. Santangelo

my I'm question on not who Rachael, revenues. I guess to first wants John, answer. But is sure

that Just And you sequentially. that XQ. up the in build the just sequentially was million versus XX% where $X.X doses trying I'm the is fact from flat of sort looking of reconcile were at to sort

So how I sure recognition make the and just that all want I math works. revenue understand to

This Sure, John. Glen. Yes. is

had the million we last knocked impact Healthcare, Change the which of the the that to down. So $X.X similar was again, quarter,

talked resetting. why versus You revenue always about go It and higher into doesn't a the we was net bill order of just have Direct the the patients that last But very we same. of is but QX call, of the QX the difference stays in amount had out doses our headwinds quarter build Kaiser from doses, revenue. in in the on QX, as our pockets -- large in

in the So revenue there's the -- what difference would the you that's filled. net think doses from be difference a why would between

A compelling companies. can I the that. And are you maybe at hope a I value for lot the one care from either right. look or more, John, focused how follow-up. All to of proposition the us prescribing Obviously, But then, are just the can people maybe take And Steve the any of doctors. pushback this with sense quick just prescribe managed point going terms more. all sort wanting conversations in to some what the of are of at are give feedback barriers getting you at on

to do Steve, want you Sure, handle that?

pushed Yes. We're doctors. not back the getting from

can getting covered month over You our at is going our and are getting our demand conversations month, prescriptions covered payers. affordable co-pay. Most see with up continuing of they're

As They're do John our all or going XX% are in them. less. XXXX. heard with say, they're co-pays We're to engaging you of calculating what $XXX

So meeting we're positive and for them with been regularly, it's us. pretty

the aren't they the issue having So want. getting an docs that at all really product

Ku at Cowen. TD Next question will from be Stacy

Congratulations Change the Healthcare progress, navigating on especially attack. the cyber

had just few we So a questions.

and seeing prescriber First, it we're patient sounds demand. like good

to have get you if you plan high-demand need of on think FUROSCIX, comment for seasonality unfortunately. place there just you might have to lot summer, is could you instance, you can capture patient So that crucial regarding seasonality, if And allow year? where during do so, going trying be expectations or infrastructure a what of higher a just the in share to a quarters, ahead for this

then be around additions. second is to going And formulary the question

to will And how access. kind IDNs opportunity, So the process thinking talk then and when do kind you you how term? of about kind hospital long of you long are it expect FUROSCIX it and formulary of systems comes about take with that

you account are about that So as in where we target. progress think

it's Thanks, as well. Stacy. I'll This is step comment John. Seasonality, interesting.

seasonality. So there's

You they're get impact pockets doctor QX, in [indiscernible] to of reset out-of-pockets mainly because and reset. an out patients

in a there's So headwind QX. little always

we to same much Holiday Heart seasonality half are doctors are that QX, don't second QX, ] Steve the something salt. QX, If have grab see patients going into you at of QX, look end calls you too of [ worried -- they're where

in tend using a for kind of up a lot you just to lot a the scripts end case the writing them. patients more and So see of lot doctors patients of --

like some So or to see Thanksgiving. it I quite do something and X think much there's We on don't opposed the holidays as as based seasonality in QX. July around Christmas.

-- in question the I guess and all so So IDNs on sizes. IDNs, the shapes and come

the VA. obviously, is one So biggest

again, to get national goal national to VAs. a Our is the this we're go VA, But we every to separate formulary. formulary, VA month on year won't selling up

QX there they VA We've being the The ship protocols. second big end at there a formulated it their about unit put and biggest is Kaiser. did talked X,XXX of order almost and in

they're So using it patients. now on

to then all you can them you That's is now. your we're Steve, And anticipate of number again, with different. a we ones IDN. to So some second hospital order. have talk system. IDNs, sometimes of continue look biggest the IDNs Maybe, about That working are

Yes.

whole information easy their across into integrated. got and For UCLA San patient integration, that's fully working loaded really UC with having fast, FUROSCIX, into so for being them sites We're system. of Diego, when system example, to their all put you the it California Davis of the who having see EMRs, they're really -- It's Francisco, direct Irvine. able that to to University San see, the purchase them

think, interest that's ones have QX, think or the the of their that, we patients through in in there's over systems giving country that directly academic university other that's access and all are IDNs that. they bringing like So big one FUROSCIX same

Next Ruiz question Partners. at Roanna will be Leerink from

impact that services you streamline network. So help pharmacy boost you the transition to I I was at of all? provider FUROSCIX curious to it stocking mentioned inventory completed a patient could new and even patients? process does And specialty getting noticed a or or

well. to and product better it we getting fast we're patients impact inventory But data experience, physician improve as really and as really doesn't yes, patient as actually to all. the get can our looking So at streamline

reason any was didn't we but have that impact inventory. the the on made change, it So

Got it.

plan follow-up, awareness help curious label Okay. sex boost I And knowing that date for expansion? physicians the different IV you heart PDUFA to failure. as coming of a for that strategy, do field the and Class cetera, to was with et in August force at anything education the is educating time, ahead up Do

Yes.

and have physicians sales we'll the the So, But -- mind, we obviously, as mailings the in soon notification really same of in have would can't pre-promote that. that. that we're calling same force it's all the advance to be providers you Keep on. and as trained been doing approval, it's

same educating Class for But through the that, the IV -- it's in promotion So again, routes meet eligible that non-direct this the same are have docs, the FUROSCIX these use." and direct them it is nondirect we'll now will a same now be, "hey, and patients awareness to So we indication. offices. direct physicians

at be Next Knickerbocker Capital. question will Chase from Craig-Hallum

that thus confirm, and might seen kind your start, to missed it's along of usual script April, of to lines. this, you've but same normalize where in just to fill I Maybe those kind have rate back far just expectations

to have reason as March partially potential the less impacted were Any potentially physicians maybe heat change well when we as been we're in the around little situation. could written that believe of a doses in approval confident script

as looking getting There trends Chase, Don't going at what's anywhere were what through lull, the weren't might think wasn't little we paid weren't knew it paid we so fill Doctors getting were we but a cyberattack. forget we at all. their the claims because prescription coming side. been were near on. on going seeing in the doctors don't the have

was a the worried, saw we so end we But slowdown. there we quarter this have we especially. quarter, momentum out through really underneath the into that could of little been because really So think might cut Nothing see scripts I don't us. from growing some

really QX shipped. the think impact doses really we it impact, any on So in contained was was and

- yes. Got to is and expectations that QX, normalized normal just it. - certainly far so dose to shift secondary And in

level were correct. Yes, the That's Yes. before to get change. we similar where back

And on does that kind that our Are of going little that's question, relevant help long-term it that kind kind on of time to of script. is bit just Maybe same force expectations then a script? also per cap Medicare doses become a of Medicare thinking contracted. per Advantage our the well of doses larger how of with doses us some when script contract kind the when to side us adjust average we as with Advantage they more plans? per And X around Great. for does

through, to might I X, to bring So plans impact it's they it than change plans back with it had because was were anticipated. or were higher going we think do it little on X think going they if if do a script down. that still we have make that sure get will

with on of the contract will United as But more to be We and Our patient. help those moderate docket our it's a preadmission are formulary XX% their we're X. just still the a doses script X. and it. commercial And important note, to is about of know business X be that seeing we more think plans pre-acute, going

things, but to of I going anymore. to So I that X. way come it don't do all come think We so back think think down. combination it the Is down will back

in we're think areas. thinking X the it moderates I

readmissions, post-acute end, -- -- on after the they experience mentioned Kaiser's they're Got you've largely FUROSCIX kind to like far FUROSCIX. thus of really could give is talk that it leaning there their Can product? where about us front into using it. protocols how of of Kaiser And be like you are heard? pre-acute, how on kind IDN you around your kind it look and on utilizing Is a an prevent into just

they're Their staff readmission. prescribing first to regularly they're Steve. preventing seen post is experience, in that care, discharge their prevent they're different what pretty than is That's doing FUROSCIX their little admission, but always animal, preadmission home than what a this So it. see, hospitalists, an the to on own little expand are we use their different everybody unnecessary We what just they they're case a than else. differently and hospitalization, think of a they little save will that know we've

be that cases a long used So nuanced expect to haul. over difference, both is but it we the in

at [Operator Group. Maxim Cap be Rahman Instructions] Next will Nazibur

on progress. the Congrats

on on couple for and indications? you IV what of might Just number comment upcoming could Class those doses the think potential launches, also you a CKD the be

to? do you want Steve,

more severe. often fluid excess Class more bit. more lose for They bit times tend are where say a have sicker. control they IV, a little they to would They I year a are and little

maybe the patients than in moderate think So script size specifically. patient. they'll X% will more don't IV often ] I [ for It that or range down Class could get stand be the refills ful

have as our same us For more X tells the failure. they're in will with X market It CKD, that to range sticker kidney chronic about it's be research and unless fluid. heart disease

IV might then similar it failure. heart Class a be And to in

Got writing who of of was you are helpful. providers anticipation last writing future of my are -- what the And increasing on it. idea are by have that is future for providers mentioned scripts of in percentage scripts question you needs, an That potential needs? that

it's So hard tell. to

because expedited are lay the ones put definitely think at kind I away. of or look needed. XX% that it's can You those on they so But

Wainright. Next is Douglas Tsao a at

as how maybe between terms just I guess advance understand of it? script, of in I follow-up. is I or us writing what's then of adjudicated a prescribing in John, they pre sort to process you of of maybe the tell the is? help ship and it them guess, were maybe when sort it you the value And Can shifts that just mean, far advance. physicians the in sort

week to saw one away soon send the We Steve, check, doc a what on the fill sure Yes. Doug, as was is cleared and everything it's it from understood want to? ready as last And co-pay into January, you was. patient. lay doctor make I trouble, September, to the that the John. do put patient

Yes.

have that FUROSCIX. normal think call They little maybe it. the progresses. down The doctor that order patient, If have Every standard I some most these lost. gone. But the we think immediately week, prescriptions example canceled. see FUROSCIX need early, that's care do sees they patient is aren't scripts not from common they fluid, of filled it's they getting a they because the might certainly months utilization bit. They're symptoms work, excess doesn't They're ago. not they a an they

layaway times, group know scripts you of a we other have only So are what? know matter I flyers. of a days, these frequent sometimes

prescriptions improvements just it go. Let's known if get in they're down. trouble, set get co-pay, when them the a we And few just in ready call those to to all to we'll get see it let's

housekeeping some under patient to see think cases of the want of And I resolves them more cases, in should good filled variable. it's terms was for some in Or if remotely cases, is So prescribed. standard management. just fluid care. when in Other then from it say I they it

-- And the mean, lost? then and that sounds Healthcare scripts if filled then maybe follow-up. in most Change curious it sense first and a how I you matter of were have QX. fell just ultimately like you ultimately disruption was a you the just navigated quarter them of of sort of a just I'm it many Or out just well.

think don't QX, they were filled -- I I Doug. No, think in

we going When about ship XX% think we units about going said about looked you filling look out March. it's that. did -- was it should recovered units and some we them coming was XX%. wasn't what We've and that looked if what think out, of at than been were we I at of later in in, you that have higher was that if at -- it

down. It was because going of XX% worried them. be we it XX% was So shut just to -- it recovered closer was I some to was or

I think we this. most recovered of

we we lost in there. or about $XXX,XXX So think $XXX,XXX

Mr. to this Tucker. At back John I you. call to Thank turn time, like over would the

our Okay. call this afternoon. That concludes

generated out-of-pocket Healthcare of very which deductibles. annual cyberattack first Change the We quarter patient pleased the results, and we headwinds are resetting notwithstanding our of with an

more this their expect payer continue formularies. physicians We treating to to as gain incremental failure prescribing FUROSCIX and momentum heart progress comfort with we patients make as

discussions life in and are Thank to initiatives progress evening. with requiring through about we time, our At having cycle good as more look forward the excited quarterly you providing FDA August. updates same year and again, next a had have successful our for the by update projected a we XXXX

we ask sir. and attending. Ladies does this for And lines. do your conclude call Once you, you at indeed that conference again, you gentlemen, time, please for your thank today. Thank this disconnect