SCPH - Earnings call transcript Q4 2023

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Operator

Greetings, and welcome to scPharmaceuticals Fourth Quarter and Full Year 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce PJ Kelleher with LifeSci Advisors. Thank you.

You may begin.

Peter Kelleher

operator. you, Thank

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

These Mr. XX-K, SEC include, statements. my expectations Chief turn today, in conference is on company statements, law. It this call of filed the the obligation the in Report Executive risk your John? pleasure now are responses scPharmaceuticals' current by which of and Form Annual forward-looking are update from or qualifications to forward-looking on Form to, Tucker, including and these to by any other the is scPharmaceuticals. these directed. required made except call, Officer statements forward-looking materially factors Any expressed to by over reports and scPharmaceuticals as other to Actual expressly what contained intent on is John with XX-Q questions, based reports may as not and attention disclaims your outcomes results to quarterly but limited differ or implied

John Tucker

listening our year fourth results. afternoon's webcast quarter to Thank thanks, call XXXX you, this and full and PJ, everyone and to review

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

open questions. for your then will the We call

the continue The fourth of quarter We our the including of in prescription. failure the comfort we believe FUROSCIX third patients total in XXXX of availability, reflected these continued demonstrates positive indicators, of that KPIs specialists has doses and doses, represents grow our meeting late of number of needs prescribers quarter and full filled continued the suffering number heart launched commercial prescribing February of XXXX. Demand product per is trend fluid to it. overload FUROSCIX gain key from to as

XX% third the sequential representing of to predominantly XXXX, the shift end the was fourth through network. This range on specialty of quarter that we X. of reported $X.X million increase For $X.X net for at provided patients by a and pre-announcement quarter driven press million January in of our dosage of release revenue XXXX, our from upper pharmacy we the

to FUROSCIX of integrated sales direct delivery had also We networks.

one fourth of order the fact, QX. the towards of sizable In revenue quarter country end closed a included the largest in by IDNs net the

cover this to QX we size quarter, this in have We'll can to year, IDNs orders including sales vary. more expect these in Going while every of of shortly. forward, the detail

per our like is prescriptions reflective we internal the adjusted the fourth as to KPIs of use would that projections across metric business, is doses vary. I prescriptions number from quarter, further, in to more the number note we our our the diving current especially of Before doses, in as of doses

end running XX% through QX. from of launch of the discount net at approximately to for gross end down from the XX%, was QX Our

the and payers to discount GTN contracting to discount with We anticipate due marketplace fourth paying. QX the at levels levels the of to the with third We the we continue anticipate the Inventory discounts consistent at relative inventory will the quarter end end to quarter. Shifting pharmacy XXXX XXXX expect over at to of the now levels increase of partners payers. evolves. our increase GTN were that as time specialty

to We discussions favorable Part have the to productive to Medicare FUROSCIX and with Medicaid broadly most in effort make an possible. terms continue commercial, payers, D ongoing at available patients

in in the Also, access has As fixed copay FUROSCIX, of one with authorization, an $XX. over $XX retired on agreement to providing of unrestricted formulary ranging closed lives largest with we the payer of October, reached mentioned to preferred number United without million at additional late from earlier, access November FUROSCIX as prior as by X, one FUROSCIX lives. XXXX, increasing the a the largest States government brand, X lives added an to million been X.X to of IDNs preferred formularies,

to FUROSCIX, less With XX% or these moving copays to population have with time. previously goal favorable to stated payer closer heart $XXX decisions, expanded who of of failure over more our access we've of us XX%, fixed or patients the

plans, to with come. the We have other announcements like hope to many health and months are we in more progressing these

heart critical Heart regarding Class XX% congestion point, for this is use provide strategy. indicated In adult to announced from FUROSCIX estimate currently III of patients are quarter, We meaningful for we percentage our Class all heart favorable expansion meeting feedback many Association we of IV due potential last initiatives Heart like benefit indication XX%, the with patients. the growth as patients as fluid several C that Association failure of previewed for of these, FDA failure to York chronic as IV an view Class the II I would to update At New York a August, in FUROSCIX and overload many long-term from we New in may on that treatment long-term failure. Type the heart as that growth FUROSCIX. Class and allow

we assigned PDUFA We've for FUROSCIX date market for to to agency, from If failure we August. severe successful, opportunity Class IV most Based this the be believe a patients. the meaningful we the our expansion Class we represent October XXXX. early enable of heart received indication filed prescribed upon a the been are would IV to feedback of that

year of of the XXXX. That, a remain application in pivotal successful, to we year. that the XXmg/XmL supplemental that infusor. We an on track auto-injector, approved, this on-body auto-injector infusor study option this on-body are confer submit current costs now advantages. the to believe as drug report later PK will developing an the to if results initiate us end additional FDA a allow to if by in environmental Turning new QX manufacturing compared and the We reduce to and

with Finally, pertaining of kidney the CKD. include edema announced FDA to feedback the overload potential from treatment fluid of we This expansion or in indication patients to the to disease chronic due bridge confirmed adequate feedback, can no pharmacodynamic PK we and clinical drug, demonstrate Furosemide that the FDA the which studies additional are that provided is injection. an to listed indication needed the to expand FUROSCIX

in fluid CKD a patients worsening by one Americans have time, episodes with treated could are being is a frequent aware most that not symptoms worsening CKD of a CKD diuretics. worsens and end, function second to in that have XX% who FDA to to diagnosis common characterized the they kidney of CKD drug XXXX. new of for indication the plan which that FUROSCIX through disease XX the It that CKD, with are are responding complications have fluid overload application The renal disease we be overload progressive and XX with fluid resulting is oral heart We beneficial diuretics. to failure. submit of To over with with overload not patients in of the do estimated loop disease's progression. loop the believe supplemental quarter

demand patient headwinds deductibles highest normal resetting, for XXXX. dose we Now of saw in the Despite the by quarter. March. first growth turning quarter to out-of-pocket This brought further has first the in demand of accelerated half shipment the QX in our

impact However, resulting cyberattack patients of Change claims processed, delays on a Healthcare disruption of beginning third February the of in ongoing. has being week shipments FUROSCIX. in in is receiving the caused This and in the

patients, as with treatment specialty as position With partners heart unit of we're see actively these failure concerned our of to the that ship has the all possible. will ultimately many if shipped. a report the We're intend first our how impact quarter. to results. will we this when working unique We FUROSCIX know do not quarter not much pharmacy in point, provide units and this these of we we more At detailed update

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

Steve Parsons

Thank you, John.

we fourth up we X,XXX pleased remain John our September FUROSCIX's December XX% availability from quarter progress. launch through unique unique our the was and had commercial prescribers of quarter launch through the XX. X,XXX indicated, full From third with prescribers, from XX, As

base. it as growth a this by in encouraged of prescriber our extremely establishing broad XXXX are We reflects strategy

have the Importantly, end written multiple more by year. prescribers than half the prescriptions of these of

doses doses pending QX X,XXX and During the were of filled. X,XXX been ended. had still fourth XX,XXX quarter, written those that have were as There doses another already we

We of write how continue for overload. of fluid physicians our prescribe because the of nature to written prescriptions FUROSCIX. doses to anticipation doses due report unique in worsening filled of and physicians Many future patients needs

not the they patient the we in report treatment or patient month they needs new them. doses are the do might receives quarter be filled when when While get the these filled prescriptions and written,

not our of the prescriptions XXXX. that to process important during XX% prescriptions is are are the It Recall quarter canceled, rather they approximately of payers. pending note in still with that were fourth canceled

few continue We queue, written pending every the Some in first fill are we still category while authorization. filled of to weeks into day. waiting significant more filled the approved are prior and XXXX, pending QX of and prescriptions prescriptions others these in in portion in the

have more coverage that providing a hard various anticipate main rate patients' Of We decrease that the been reason is are that it's have to health copay for unreachable that given. decisions. as are deceased. are canceled for expected to reached contact, will better become with including on a to patients cancel, and to formularies, lowering high -- who the prescriptions reasons, continue out-of-pocket FUROSCIX, cancel are quicker positioned those costs plan number the hospitalized are small Now

quarter, fourth doses which filled the expectations. the than long-term number doses, prescription our of higher per was During remains X.X average

this Our X,XXX training and of September ensures sales force XX. as for as from in-services is FUROSCIX has prescribing XX, office the in-services provide of conducted X,XXX process readiness. on up which December to offices In-services conducted important

the each leading open more and we important execution quarter FUROSCIX's number indicator. regard in-services of in-services success, as fundamental remains the of accounts, we new to As an conducted

ready warrants. engaged campaign to in to We've we said IV a From drive a include stand adding advance and Class activities out collateral our encompasses both on perspective, additional are opinion and ongoing heart marketing different initiatives. key program tasks. and in This We've territories of presence, and previously print development other brand development the of conference disease engagement for websites as and marketing and commitment. demand key among FUROSCIX. their awareness, chronic multichannel we kidney add to many that patient additional plan broad territories failure We reaching some patients and begun electronic with but activities education caregivers patient materials of the leaders, critical of provider adoption

with call Financial over to our and my path pleased are progress for Rachael? update. concludes we're continued Nokes, to update. -- I'd our That Chief the Rachael our the Overall, on. Officer, like our progress financial we turn

Rachael Nokes

Thank you, Steve.

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

loss XXXX cover compared loss quarter of XXXX. income for million statement items. $X.X We to reported a Now of the net fourth net a the $XX.X I million for a fourth of few quarter of will

year the XXXX, reported XXXX. Product year for full million. to we fourth loss a a $XX.X revenues loss million $XX.X $X.X of for were of compared and million XXXX, net the million revenues of cost product For of were quarter the full net $X.X

the product cost generate commercially $XX.X or FUROSCIX product $X.X the not full million. quarter launched were year approved was in For and year XXXX during XXXX. XXXX, We revenues October fourth of full in revenues did million, XXXX and as were February revenue

development development and to by due quarter million to by period in XXXX fourth for decrease compared XXXX $X.X $XX.X development partially development expenses increase for The is for for to for costs. of the The in year ended the primarily XXXX. the were in for costs. and the quarter regulatory medical offset expenses due to Research costs, costs. Research quality the XXXX clinical pharmaceutical primarily were $XX.X decrease development in a employee-related was comparable expenses pharmaceutical increase and full development full million XXXX, the decrease in expenses compared offset in increase affairs and December device XXXX. The increase XX, million million study and year research an consulting in partially research $X.X and year an employee-related and costs. was costs decrease a The was and full

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

year our full costs The we The increase expenses $XX.X of the commercial and the current compared employee-related the operating full offset for and administrative we the FUROSCIX we was million launch as February XXmg/XmL increase year was costs in selling, a partially the year the to as to XXXX our to costs general in on XXXX. XXXX, plan, an in increase general commercial XXXX For million for further development selling, and expenses operating administrative in support insurance-related following the decrease and increase auto-injector. XXXX, reported primarily of due FUROSCIX full of as well launch costs. Based increase by legal in expect in an of $XX.X costs.

As we XX,XXX,XXX total XXXX, of XX, shares had outstanding. December

concludes John? financial That the update.

John Tucker

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

Operator

the [Operator from Partners. Leerink of first Ruiz with Our comes line Roanna question Instructions]

Rosa Chen

at Rosa Chen Leerink Roanna Ruiz on for Partners.

individual first by agreements your that that the additional on and guys us. securing Can IDN details efforts some trends of FUROSCIX expect could the seeing more of So share some you current one you're impact how from in uptake the additional prescribers? you

John Tucker

in. I'll ask to Rosa. jump This Steve and John, is Sure,

the IDNs largest be Kaiser the to VA is already with in this we closed are a into and we've working selling year, national the We key being a of contract, have Kaiser, drive struck And VA. initiative individual the country -- where in sales I We've then X and VA. we're the with the the VA, mean been for a So uptake. IDN will us for think for And formulary the more largest. system VAs there. the that

So that and kind integrated closed think who's of really, little in you those X those well. the we are as of unique a the -- have Geisinger, one system,

opportunity IDNs continue systems, pharmacy expansion So not see a those sell we big hard into into really call closed but of you might involved. the we'll really have closed that part what to the would

pharmacy. also about benefit. we can be So track is They the docs have might the in but us pharmacy message, be good don't not employees, able value for but the FUROSCIX because the This to talk the they're still prescription.

business, regular go so for as thought So of us defined. that this be those growing would through anticipate world our the it. lot the of distribution network. But percentage a in there we've are would more that outside But as we well still than IDN value a is always there's patients a proposition market good the

if Steve, anything add know, that? want don't I you to to

Steve Parsons

product see readmissions, some having campus as penalties an right the available they integrated delivery as stay unnecessary systems by We and they of which shorten on the length preventing pay Yes. in well by get approached for. regularly, opportunity network, cases quite hospital to there

be in doctors to right their order involved directly and FUROSCIX EMR hospital. through it their the like in they'd distribution So systems the have

be more that and So more this there'll year. of happening

Rosa Chen

And That's from us, one efforts. label your helpful. expansion CKD on second

you thinking you potential from would you may there? would prescriber the So there and call specifically for And current of anything population learnings differently your nephrologists what apply it's on, patient the approved if that launch FUROSCIX launch base? and do

John Tucker

we actually they loop So way in diuretics -- they more around at than look a the how cardiologists when prescribe productive they're nephrologists, many use.

starts and a totally patient that is as the we've that to critical. -- better, oral that treating this learning being Critical apply get response as keep to is when patient really think early diuretic soon showing again, think, as reduced that to that to on, nephrologists patient I overloaded. had fluid I patient well, will critical So feeling from

with cardiologists. they we the prop, the So to and nephrologists, the it market earlier I they're message research of and in even that would plays embrace at understand think research we our think really than think value when to perhaps any well look going fact, I market nephrologist, in

don't Steve, know... I I mean,

Steve Parsons

a that with them, patients overload. to of already some We've calling heart fluid overload we deal them seeing number cardiology been with been referred have the of due having failure -- patients them to that to small are nephrologists fluid

a them anxious and on have indication to calling we're So already, to broader very include they're CKD.

John Tucker

response But cover sales can And been We've you I'm enthused, the most them we've enthused of less anything. with if want nephrologist, to the He's profile, and with very of the the not value on John our incredibly prop. sure, them kidney. to so to Mohr, work we more force. the there's product add done of been

anticipating in in than nephrology we've uptake really quicker even we're a cardiology. So seen

not that John, to like you'd do since to you've sure, I'm you add anything multiple... done have

John Mohr

with description Yes, the that and and didn't you'd kidney their they're talking that you when problem. I'll disease, of they think add describing patients you research same that problem know and were nephrologist, that exact cardiologists. story doing if hear you chronic just with the nephrologists the hear were a describing they in the They're

out to when and so treat of and They don't their are well, cardiologist for nephrologist a say, And them. to your reaches do vice and fluid nephrologist worsening overload, inclined cardiologist patient it your versa. let signs the go symptoms to

nephrologists like the the exact problem, points. touch individual additional just it So different same the that so use it's will being opportunity, they'll cardiologists, just And presented. have now just

Rosa Chen

the perspective. appreciate Really

now range? mentioned doses Can average? you're So going in you the that seeing X.X I'm last one share What's one, just right You for the the to in. range squeeze FUROSCIX?

John Tucker

So see a while we unit. once a the every for script -- in you'll range, one

the is at looking think typically, but fairly a X, it's a But and X patient's preadmission I for overloaded you'll something think you're X who in I that's range. X I on. or to think is is the that's volume usually, see going maximum weird X,

Operator

Cowen. question next comes with Our line the from Ku Stacy of TD

Stacy Ku

We had few. a

So the prescribers, driving questions. on on especially expanding uptake continues but And for first, you're Steve, and just infrastructure we to progress. focused more patient I currently understand your as activation few for views a reimbursement establishing have curious, DTC,

let's So them out kind of first. leave

As curious then if needed. details. Is may. to other are the contribution? helping delay of will prescribing kind understood also follow-up, good any appropriate base, about a can When But the to Do reasonable your patients of as additional clinicians think improvements QX think the of you you you which break anticipate the could just provide to IDN a cyberattack broaden QX any if just as prescriber implement sense just think out adjudication as help might point. what questions issue will get this this kind at for is that for lost? And they thoughts a well you the workarounds? have you ease these clinicians copays, last that about copays are the then temporary we in of around prescriptions you we be question, if pretty disclosures? patients long-term Healthcare. and about comments Clearly, your fulfillment. And Change What types you I do repeat from out

John Tucker

probably writing We're Okay. wasn't to -- I going fast.

me the Let first. do

them about -- take me Change I'll first. talk from I think Let end. I'll the

coming to XX, them, the down ship happened system what's since adjudicate is the able said, I them. prescriptions As went and when February copays in, being really

dramatically written prescriptions than delays higher have, number quarter-to-date filled it's of this of my we last the prepared is I units higher seeing. think being it our Obviously, different. our units the is I the remarks, and at we're So prescriptions way demand, quarter, because lagging but said in time,

ongoing delay? back? think them? And a the They've question, workaround the partners. but pharmacy weird Again, delayed, is, our the for do they're it's specialty you for is just unless next We now. We can is and and that Change that now. a right started have I issue, So said back now. get about happens, we your ship right It's XX. just you is, long-term we think, it a them lose we're fully here. us we big of February We're yes, consensus have a this everything question of question don't making with that's should hoping online some remain up comes is, year, optimistic sure Do something shipped, it but not week. disruption

the of shipping talk the talk work a a not report. reporting a be as been about depend because our around. little contract what the first It break slowness the We metrics the as can We've units IDNs. bit with little of just IDN will should out. we sales have to system. I'm that's on and the of we them question, the of bit, going We many so could

are crazy. to of want Steve, IDNs the I end large we QX, you it do range for think what with be will in to into said they you able you Kaiser. XX% the visibility metrics then, hospital-based very doctor -- other what for purchase wrote, the doesn't had Kaiser, metrics on somewhat that let was have don't is have some think -- the more the Again, don't the ones, detail you we've the to the doctors, want year be questions? purchases. do we to That a But at XX% scarce. And which think to Steve -- vary. have share. will Kaiser But IDN see from mentioned, that going We I of unfortunately,

Steve Parsons

a patients going asked for patients who going is are they yes, less, able confident copay you about at those them The have have to patients like the much think helping copay $XXX for can of less patients can that. identify doctors XX% $XX our $XXX what do or is of to copay so range. with of we access average in to FUROSCIX success. less. some I pretty And the be the are -- We're or

lot they They submitting when a to And they a who's the [Technical get now imagine need very it, very, product. towards, cost -- the know does of get doctors for the are and when get good. prescriptions you FUROSCIX it a They just that it's get copay's they're need and the patient and they're that's needing then and go advance an specific feedback. in So anticipating time, going an the going does of they approval Difficulty]. and of can ready A product, sick answer it's call down patient on to and coverage quickly. matter

the may about patients copays, So they at product the higher them talk copay, for have who there's support have hesitation not good foundational they'll those. really and funding the and people tell all to some until no who charitable

So I don't know answers who they question, copays. are know patients lot the they to on that get if a and these but of preclearance able has the really good

Stacy Ku

question That's know around the really what focused thoughts the are then your as reimbursement, helpful. there long I curious, term? activating And first was by progress your as really patients prescribers But get we you on now. the DTC, auto-injector, thoughts you're you asked, your right

Steve Parsons

have a plan. We

have giving caregivers. patients strategy out reach of to them, market them. they -- to begun so an that research in website and what We with brochures the them to their we to patients. We reach direct awful office, and to doctors like directly where patient communicated a out to for just what be ready reach be a We've -- did things, how lot and know to how to, building we're

year their [indiscernible]. focus more is this one. us groups, connecting with The us signed of big networks and patients year We Hearts are that opted-in in have than who it have people for was HeartBrothers, advocacy Mended and through patient a

John Tucker

patients. educated the spent before XX first cardiologists plan months, was We our we as educating

We're giant Survivor lot doing there'll on a the be to to year, outreach campaign DTC going patients targeted this or be something, and a more probably So caregivers. not.

think including patients I but you'll that, see see well. targeted won't things some as potentially media You to

Operator

the from Douglas comes with of line question H.C. next Our Tsao Wainwright.

Douglas Tsao

the it really Congrats affected just your of because that has was United just been -- of payer? what mean, Health, terms for in percent this the in curious I'm John, I progress. really Change by it one business

John Tucker

the -- so the Doug, of But United, it's or United use our most owns No. Change. of owns think specialty pharmacies often specialty, payers United of of Healthcare. owns really Change and you -- all

through of So the go scripts adjudication Change. the

our time impacted. period all of could scripts say and that of are for you ongoing So

Now for had called slow and that doing be happened thing. manually, days everyone couple said, it really because a of everything was same was was what to the in

slow. So was incredibly it

that called have our utilizes. pharmacies We in another place system managed of one Relay, workarounds. other There's specialty

ship were focused move That's we to we has started well. But it need do totally down, that to the on up there. didn't in have not through we specialty the working system. here heard caught slow It's now. workaround. It's the working coming a getting saying when scripts think back be the it And to I'm we with not next were was obviously pharmacies better. So all able And is as online of at those I better think workaround -- working are making work. smoothly we're workaround really, the and business and I We've it's that will what what sure limitations week.

to the We've man work. we're to put ship drug. to the asked on people phones, to to more pharmacies continue going So specialty

business ship to give impossible of shipped. So final us business prescribed question that to what percentage that going the if right percentage is the be that got answer relevant. have question you -- ask aren't for what what would our of now. percentage impacted, It's should units That's you the of

just portion written. so the able than those are good We it of coming in sitting to up, far? docs writing be and need that they're ever then very in ship writing a with The recovered they've still now deal No. of is system. have recovered all and it. what's keep kind We still in more The of the to we we're are good Have demand still thing robustly. seeing come

Douglas Tsao

challenging you I'm getting And to just any or know curious, I in starting written? some Okay. loopholes. off-label then somewhat That's nephrology, but in for, being also see it's helpful. paid of just are you terms scripts I mean, terms -- of plans are

John Tucker

it. some go to We that We mentioned have we'd nephrologists.

cardiologist say, even a those see So will heart a failure for is of CKD, I'll they nephrologist take us. lot you'll "Boy, if patients for nephrologist. they're our of and care heart just That's failure cared times, part let the So TAM, even the of have it." that's on-label by

on-label. be would that So

it's get we all IV, II have it's CKD, they it Class it be first if and label and be. wrote wouldn't all. promoting if then III a was and failure, they will off, Now nephrologist it it's and and heart If But that's wouldn't that at filled.

Second off, it filled. not will probably be

Operator

comes question the Craig-Hallum. Chase next Knickerbocker of from Our line with

Chase Knickerbocker

those perspective? where my share time adjudication at and Change the disruption. been we Maybe completely have is again, paused I -- to start, everybody of talking average then, this the me, that's just And as for you're we well. a almost that from guess, of before as adjudications of average the it that think Healthcare about, disruption experiencing? PAs what's are just the underlying should And then give since causing congrats lot on an time, I'll those progress

John Tucker

couldn't We Change since we've time down. went workarounds. And got what you I it's variable. the Yes. average mean, is tell

have Now pharmacy they then triaged there's we goes to Relay, through is get specialty adjudicating that our still and an if for Change issue. that primary claims Change

that other involves us clearly. -- know your out, out, So we've workaround answer that and again, the coming due the seem on. We what's couple of hard going to in. question is That specialty get pharmacies. went for itself a again, is an to to scripts now data thing can impossible Chase, -- It's see got we a hands when they here, is the very

is data the some so it And -- report kind of differently.

Change if there's before to talk know, we that, can after prior that Steve, what -- tell impact. soon this way is. I want Change, the about don't So you just no

Steve Parsons

not trying what really be how prescriptions it's the ever but on doctor depends on It fast filled. get wants. to Yes, question multifactor a evasive,

of want can as ways And doctor for X order that expediting determination. and coverage more it's that with We cost that's can meaning to check could call the XX-hour approved very, very the the copay, they the possible could quickly it for review, they down. sit a And They until one, there product. quickly after to sit known layaway. that as doctor check or there weeks it have wants

something the say, next very just it possible." focus where pharmacies Now they Our the brand as will "I as want them fast let's day. on ones get

us day they free the quick and get delivery. out answer it one get the have the and from the don't day. then answer we next from able ship following we overnight answers the reached then we that hours it it payer, payer. ship them me a through we'll something get to for payer, to a Let quick for still so the very for patient, next-day And XX ship get dose If the another buys to are

well well for So they're wrote in October all prescribers, add purposely we're filling of that's even our be ordering people them finally it to down. happy as rate like working calling November, them. to impact not discourage prescriptions fill in there We and our ones see been do but very advance quarter months, and have They to weeks these or doing can very this it average, the where do them or doctors in to that, that. We that to speed do as from the you We're an both our satisfaction like preapproved. to when getting does them but dispensing.

Chase Knickerbocker

to with color expect it, around some that Maybe this the the year, net there complexities given contract point, Medicare you large in sense. expect of of Yes, that these appreciate it XXXX. to you answer. Advantage payers I some some year with it that call midyear certainly and on just where end some to based gross you've color makes the at earlier indicates

Just the to you some those activity to kind happening of background of conversations done. that contracts get are that give kind that speak in the of assume the to and kind confidence are of going that

John Tucker

Yes.

And it in didn't that. talked iterations aren't Medicare. couple These of there's they they here We've that with agree done of we had us. with with them. iterations. we offered So negotiations what a what we've agree We quick first offered to went about ongoing -- big out, payers didn't we've X when

up phone takes the Tuesday and think we're but don't some pick it's give call and up -- You pick phone the you progress. We Wednesday. It call an making answer on key. on they time,

to on get at to for done is look this of that going you these year the especially next year If we how have we're because here reset. too. Part formulary But D

for confident messaging to these going to GTN and discount not going to up we we're we're happen be that going So go. lower to to is to unless and The them that the keep makes we're rebates. copays this brand the $XXX patients, it's sense why for also we being the where to do But we pretty able And of paying think again, or is them speed that's that it because adjudication is less to get think going. brand. important XX% time it's go the year, to paying to going go

we the plan And doing We've So on still yes, we'll once sign that's them. that. them, said plan. we it, they're progressing. And announce

Operator

line comes Maxim question next Rahman from Naz Group. of with Our the

Nazibur Rahman

Congrats progress. on the

from couple a me questions indication. CKD your of just on So

see do 'XX? Do how we the this So benefit expect? kind have label or one evolve with already you discussions a you are might review progress? sometime review the approval? reimbursement about is, for two, paradigm have the back might the indication? Or this benefit discussions indication review you cycle see what to conversations think go the you do regarding X-year how X-month payers in that first Like, and expect discussions and of in later for think you or Like, potential you reimbursement so those expansion And for having label? and kind do of upon do you of reimbursement additional product,

John Tucker

There's would Will chance will anticipate the could way. wouldn't that filing Steve, and chance, date, I'll one. month that months, months? a the way receive next months. be but be one. not We a XX-month XX a PDUFA entity, anticipate, we'd Yes, but always said we're our There's but be that can But be again, not a say, April. you XX we and I first months. Is conservative, could think, there in will really which file a it's take a [indiscernible] be we we it XX review, XX next take path be a there it X to months. anticipate we've

expect the We the or the the label IV. that straightforward of did study review. matching IV. CKD PK IV The their the -- PK in matches the pretty We of label label a matches of that a has IV

it's a before, talk think we're we do So pretty straightforward you about... want review. And said I to as excited. Steve,

Steve Parsons

Well, auth we're way it pretty with authorization we assurance failure acute generic not for that. oral prior this not a do the be is have for to good Yes. we label. that just want know, CKD. do HIT at diuretics, covered CKD that's intervention. Payers prior will approved same means be heart don't working an they will that FUROSCIX stage. and be Yes. simple It for trying have before to negotiating be to But And FUROSCIX would really

have the label won't any CKD, label, it it to PA same, and complicated more than So essentially our be be will will that.

John Tucker

a it really There's exceptions approval. plans rare. Again, the It's prior to start indication to reviewing that will they pretty where though, a the an approval. or do prior to spend product with... time review rare, start It's pretty they

Steve Parsons

review are you to at things have to under file likely they're When -- priority more FDA, the a review.

John Tucker

exactly. Yes,

Nazibur Rahman

And helpful. question. just one was That last

decision think there? -- you said plan for Change magnitude I your comment the impact does you prepared FUROSCIX. making timing Could that impact And So be? you you force what of the in expanding the expansion on your commercial on remarks, of would

John Tucker

here, for impact no right, don't which anticipate. Change unless months be There'll went we

anticipates at no how at force anyone There's expanding all. on the sales that. I think looking we're impact

to XX that. the been it here the impact has approval our That's that Change front right Healthcare front then the IV midyear thinking be XXX expand early So is CKD no year but from thinking of to very in to and will Class now, on of in expansion. think what I next there

Nazibur Rahman

Once congrats again, the on progress.

John Tucker

it. Thanks, Naz. Appreciate

Operator

no management queue. to like remarks. in I'd for are it further to hand questions closing the back There

John Tucker

Thank very much. Great. you

concludes with trajectory afternoon. pleased of We our our this FUROSCIX That the remain launch. call

expect We as patients will the affordable access payers that to with gain momentum we're to that making FUROSCIX. failure our heart meaningful progress add

to we are and XXXX. Overall, updates providing our FDA forward year. initiatives pleased a and through and and as with look discussions about have the on can great with I'm progress momentum excited we We progress having believe cycle a some that Thank our again, our life build evening. productive after towards successful look current forward you

Operator

gentlemen, your Thank this conclude you and does teleconference. participation. for today's Ladies

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

scPharmaceuticals (SCPH) 13 Mar 242023 Q4 Earnings call transcript