Earnings call transcript Q1 2023

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Operator

Hello all and warm welcome to the Xeris Biopharma Holding First Quarter 2023 Financial Results Call. My name is Elisa, and I'll be the operator for today. [Operator Instructions]

And now have the pleasure of handing over to your host today, Allison Wey, Senior Vice President of Investor Relations and Corporate Communications to begin. Allison, please go ahead when you are ready.

Allison Wey

Elisa. you, Thank welcome results and Biopharma quarter first Good call to and financial conference webcast. XXXX morning Xeris A press our release earlier with the company’s financial and be this results can found on website. morning was issued

morning by CFO. open remarks details by few Pieper, provide on We are financial will call joined Paul Chairman for and and Paul will and Steve remarks, will closing results, Paul the Edick, Q&A. opening our we Steve CEO; provide a this after

remind you are we this I Reform Litigation statements of begin, commercialization, like to and which which XXXX. expectations, but of Before contain Act corporate will include concerning future performance meaning statements the approvals, constitute not that Private forward-looking prospects, practices, would call to clinical forward-looking Securities plans, strategy, the our statements may business limited within

materially including made statements of Actual our efforts. or commercialization those results during various financial a financing development may programs to our important for position as this differ these indicated need including result by forward-looking factors, product from call, fund and

macroeconomic our set factors ability the our property to risk existing and intellectual our maintain new to our conditions and clinical clinical as -- protect to party as drugs, and the activities in business on third third product other our Securities of on source market effects operations commission. filings collaborate proprietary our ability and including with reliance conduct our and Exchange products collaborate end forth well single will with technology reliance suppliers, parties suppliers, trials, acceptance, complete our Whether successfully candidates of achieve on adverse and

applicable this relied any we of call as disclaim obligations representing views upon in update and Subject under statements should to any law, of represent call looking only date be statements. our this date. obligations as of such as our to not subsequent the forward views Any

call turn over to now Paul. the I'll

Paul Edick

Allison. you, Thank

us You today. everyone, can joining for thank and morning, take Good you a breath.

quarter, first that achievements we're for build reiterate Before what to highlight I the trying I important think I our it's Xeris. at

intensely is products on value with patient-centric, multiple technology promise multiple enterprise. self-sustaining Every that commercially-focused, biopharma commercial development therapeutic significant -- focused partnership areas, targeted business, increasingly substantial, and a building long-term significant a in has day, Xeris added a literally everyone enterprise a highly pipeline at products three-dimensional

hear you'll progress continuing that that successfully is What today we to are journey. very on

vision, on few are We as reported short said, we our when a executing weeks just I outstanding XXXX ago results.

has XXXX. XXXX Our from set a momentum for up great us

and another First of quarterly Keveyis strong quarter Gvoke revenue, delivered demand XXXX, Recorlevlev. Recorlevd for underlying

a valuable potentially continued and position. partnership healthy Another cash very XeriJect

headlines. the are Here

revenue of with We We have XXXX first quarter first achieved cash cash, quarter $XX.X equivalence and short 'XX. first in compared growth term quarter XX% investments. total million ended $XX.X representing of million, to

reaffirming total million cash, and utilization from activities are We $XX collaboration and XeriJect million. agreement with our year-end $XX and announced revenues cash-equivalent million a research of formulations and million Regeneron investments operating $XXX $XXX of and million XXXX to we guidance of of $XX and for option between short-term $XX million cash between

progress. Steve will we greater detail in go those as into

our increase of $XX the a million year representing quarter, portion over business, commercial the which XX% first with the start Let's in generated quarter. last in

XX% just Recorlevd and First prescriptions to revenue net and of 'XX. million increase of had in over Gvoke. $XX quarter net quarter Gvoke revenue first a another compared

to is market is flat were prior the a which 'XX, quarter growth fourth quarter XX% for the year. first XX,XXX, and year, from period shy of very first good increase just compared the the prescriptions Total fourth quarter historically of to quarter, last sign, the same growing a XX% since of

in products outpace of growth. digits April, At with the end approximately is driving XX% growth total grew respectively. continuing Gvoke market glucagon of beginning XX% other share all market of the Gvoke the prescriptions back and market Since market and double to the to that year, new to and

also XX% a weeks. products for per over now new of second week and prescription is two Gvoke first glucagon. glucagon market X,XXX recently time for represent for good total to the quarter, start consecutive prescriptions having off the topped Ready-to-use in the

I mentioned in I due our weeks this call an it significance, on repeating, a fourth since believe few period. the we're entering to quarter but ago, bears conference especially important

ready and a people just insulin more in to While more such case. on patients use ready at X Gvoke million still insulin and risk Gvoke, as glucagon who on over don't getting are have to are there remain available use high

Society, Clinical incorporation To address of their Endocrine American to this professionals and clinical Diabetes and focus ready-to-use of The guidelines situation have critical and Association, Association important the The updated into algorithms others, glucagon include motivate Endocrinology practice. to The on more, American an do healthcare recently

daily been Endo we've example, risk expanded confirming use who those along. sulfonylureas, recommends glucagon of For the should and severe definition blood Society be at the what insulin for low saying high or on that for strongly to ready patients diabetes all with are all sugar prescribed

Recorlevlev generated for in quarter, $X.X from of of fourth XX% an quarter the Recorlevlev, Onto first net the 'XX. billion approximately revenue increase

to steady prescribers in of drug referrals, first Recorlev see in a unique the continue increase quarter. and We on new patients

nearly For from quarter. referrals example, in increase of the we quarter saw to the Recorlev an the of in XX% first number prior

lab that XX% as This valuing syndrome means developing is Cushing more patients their healthcare the are Recorlev first-line were a than expected. of Recorlev exactly first as first lab in drug treatment Interestingly, as Recorlev post-surgery. professionals for therapy. Overall, prescribed quarter,

Moving to Keveyis.

in it which on was for a XX% to material revenue in date had late million, impact was first represents 'XX. of not first $XX quarter to kavas an First compared XXXX. increase the approximately has generic of the December, quarter Keveyis approved Since

drug there our to steady. won't patients That fact, be impact. rates remain referral In an isn't say very on and

that to on therapy. However, this requires marketplace initiate, a is challenging maintain and patients identify, work significant

of of the historically, over have year. far the generics and a and generic dynamics we plays seen maintain monitor course a patient invest on the the how hard PPP considerable that continue We business said, it to the of can how market to believe the only we see given we've as and whole. impact so of of how we so to continuing a the community behalf worked process may portion glimpses landscape. entrance That the Keveyis, We'll the, out market build, are despite

who to to Xeris everyone Keveyis Recorlev ensuring needs will and is access committed receive it.

Our effort. care reimbursement, that healthcare mentors, and dedicated Xeris connections we product advocates titration the will patient support and initiation, patients process, and team, through continue providers and

Let's programs. turn to pipeline and our partnered

X focused the dose XeriSol on you the As quarter. first recently second and hope to Xeris we program recruiting Phase of are commercialization. the began our Levothyroxine development the eventual advancing patients study to in before end patient We know,

this our one determine study to Le of stimulating The will dose and safety thyroxine liquid levothyroxine course target subject's the with factor injection, each of to or XeriSol objectives the assess after Phase X study. hormone levothyroxine the thyroid subcutaneous primary levothyroxine, -- gather hypothyroidism. conversion oral are study and our tolerability and weekly of ready-to-use insight or over week The from on to a oral TSH once injections, in also subcutaneous subjects TX levels for

more of is program. pivotal and FDA prescriptions X the proposal the of the a been Data most to from of one the for Phase United study years, year. help XXX than for inform per it levothyroxine standard hypothyroidism in Oral has million prescribed treatment X care will Phase States our many generating medicines for this

be condition impacting medications regimen, same patients and absorption. of taking patient. report the of combined that some have XX% admit GI may issue interfere or with oral XX% XX% of the GI whom patients compliance issues many oral with However, with concomitant absorption to daily

a As a result, our levothyroxine, we $X $X compete market to once in that weekly subcutaneous believe billion potential will approved, segment. billion if

on enable our to monoclonal subcutaneous XeriJect one partnership, antibodies. delivery March, -- to Now business; the with platform Regeneron, of potentially Xeris we growing growers this in partnership announced several

Under volume develop of XeriJect use option monoclonal this Xeris agreement, injections subcutaneous ready-to-use undisclosed two the collaboration terms antibodies ultra-highly developed of Regeneron. to will small concentrated our by formulation and

in Horizon, and the value technology has progress readiness. recently option highlights which as for been and commercialization. additional proposition and license GMP nominate making rights Regeneron unique formulation third these XeriJect investment and XeriJect is development to clinical partnership for of our with the to Xeris advancing has development disclosed clinical potential as Xeris This molecules XeriJect, following molecules collaborations well Merck and an commercial to into

have point Merck this we Horizon and For are Merck with where at formulation further programs? product evaluating XeriJect Horizon we the stability and the with completed Merck is for the So, the and molecule, partnership. of commercialization development assessment clinical

as would they category, licensing If be Horizon. the the in milestones, sales. well we future them regulatory royalties million from giving formulation entitled exclusive the meet and on rights agreement, previously profile, Xeris to as the currently Once We're receive agreed our of XeriJect delivery initial product upon we TEPEZZA the $X in disclosed system. will stages in future of development, sign sales-based

total stand great to today, from With first guidance million, $XX reiterate we a $XX the our behind and utilization affirming breakeven quarter I to we want cash our fund of quarter, fourth $XXX without range additional revenue that achieving million of million, in million $XX a capital $XX to $XXX need cash us where operations. the the in year-end to to of position cash flow and for are

turn details the call now first on quarter to Steve additional for over performance. I will our

Steve Pieper

Total last quarter products issued I Strong results record press a total the in partnerships XX% which patient this a focus financial three of the Thanks my year. details in all growth quarter will with demand was Paul. over same drove underlying from the remarks everyone. release key coupled Good first morning $XX.X are XXXX, million, on revenue for the morning. across revenue our collaboration representing increase revenue. this

record the same a for revenue $XX compared period net XX% quarter Gvoke to year. last million a compared was the representing increase

prescriptions increase for drove Gvoke in the XX,XXX XXXX. share time, increase. this first topped a the to Gvoke in growth XX% Continued market period prescriptions compared same and

The quarter prescription Gvoke grew market outpacing to compared compared the significantly of quarter total Gvoke period Notably XX. promising. glucagon XX% approximately total with same the XX% grew X% share XX% market XXXX. of once the more the of fourth to total in prescriptions in again retail ended March approximately market

prescriptions seeing second in Gvoke, consecutive as into momentum continue this weeks. the X,XXX We prescriptions mentioned quarter, with are Paul weekly exceeding

by have impact any Keveyis. the Keveyis. number quarter to net Keveyis launch of increase million, was patients the we to compared XX% in period on driven negative to same was the representing from the material for generic. increase an of date, a $XX.X year. revenue experienced revenue not Keveyis Moving To last growth This a

to monitor restore continue patents generic against while Keveyis rights. our and exclusive proactively competition seeking to We defend

million, revenue patients quarter Recorlev, to which for quarter. This increases the primarily growth on Moving $X.X of by over in represents Recorlev. driven net was increase XX% an the fourth was the number

we a with increase a to As Paul steady the XX% quarter. mentioned, in fourth over referrals continue see increase

Recorlev valuing patients prescribed the are quarter post-surgery. treatment our therapy. drug believe syndrome is in first first of XX% line first a healthcare Cushing their over that were Additionally, for as Recorlev We professionals

total In addition of partnerships. and product from collaborations million, recognized $XX.X revenue to revenue we XXX,XXX of

we another Regeneron were announce in Additionally, with pleased partnership March. to

the year revenue for total ahead our $XXX guidance of to XXXX, we affirm Looking $XXX full million. between

Moving The decrease was year. sold decrease increase the $X.X product the product same of favorable was credit attributable offset one-time compared $X in to P&L, sales. contract last by and down million cost a mix million, an quarter goods a to

compared Research decrease the expenses million and development year. period was $X.X same last a $X.X million, to

driven decrease This period. development the lower costs was product by in

are We practice and prioritization focusing continue to our discipline XXXX.

the R&D study of work optics science. program. development theoral proprietary on our of of continued formulation completion Levothyroxine funding The and

compared million, We a R&D This driven XXXX, by was restructuring expenses. general and year in increases the $X.X XXXX. primarily modest expect when drive to last to decrease $XX.X expenses over administrative initiatives Selling compared same no million period in expense year. decrease year were to these

$XX our capital. XXst, first in XXXX approximately changes was March From reflected expect to total experience in XXXX. discussed in and equivalents the and years compared cash in with commentary, at to As continue compared as December prior we $XXX SG&A of flat XX, hired we a cash working utilization to total quarter short-term when of we had be million March March, in investments Consistent our to cash million to in XXXX. XXXX, perspective, cash, relatively due

to March, when expect quarter we the investments middle short-term of moderate and year breakeven. equivalents until activities and that from utilized utilizations position $XX expect are the we from be fourth of XXXX in said, million million cash With cash Reiterating achieve cash operating our million. through our $XX to range to between cash cash, total the utilization the affirming flow to $XX and of end to $XX we guidance

Assuming from we be reach we quarter our break on, in the fourth guidance, enterprise. cash-flow performing to even that XXXX. a are self-sustaining to project we point And will

we as plan to we we our a become fund As to do raise not discussed, capital self-sustaining have operations enterprise.

Operator, please for questions. line open the

Operator

for Oren Instructions] of question [Operator Wainwright. from H.C. first Our today comes Livnat

Oren Livnat

It's just On good through year-over-year. a get quarter. And the it have growth on third one I quite the some that. year. a reiterated the wide to solid few. a help I'm narrowed on haven't you of range still guidance, you Congrats trying of and way

pulls include So follow-up. Horizon could end, mentioned the And I the who'd revenue major recognition pushes you at there? can't the just remind And past, have remember also, and does that us the formulation? but top a this I for potentially in

Paul Edick

Oren, this the is of revenue. is. Paul. Yes, question The does include second your answer it to part that

can we lot the In when unknowns tighten a how year of we range, generic back said progresses terms and out March we'll and plays the range, established we that now. see plays and breadth as we there's right But the of in of know the out how range. Keveyis if the the

Oren Livnat

the into gains the seasonally do impact whether been have wondering, space, there strong on the a sale highlighted that dynamics stay you've or with recently. And you in quarter-over-quarter toughest pretty maybe your was any And they'll to competitive Gvoke, you think one. that's better, just impressive, highlighted, of vaccine, the like On share the same? I'm accelerating firstly, Okay. going get even you worse

expect normally first comment, the of can the seen. first should quarter? So actually, net you than that better in year to we were all, we've And as through improve to gross expected

Paul Edick

Steve?

Steven Pieper

of year, off. can answer as kind and kind we moderated, gross leveled question, Yes, of through midway to it of kind second last I net, said The Oren. the they've

not it. to We over that's of that expect no, XXXX. improve the So driving course don't

Oren Livnat

on... lastly And Okay.

Paul Edick

marketplace first the want market get part we order we and of on in we more your need, To question this to along growth. all voices said Gvoke, that have in our

somebody I I to only think and endocrinology category, that extracted the value to dedicated and their the who the product think, potential having is the really for help. speaks to category can for

will increase So in we're market the voice that benefit and the anticipating another long growth, in marketplace the run. will us

Oren Livnat

despite, I OpEx, both were of going across And surprised board? about, Great. know quarter actually force to year on trim think was how expansion. quite is was some you core the just it forward? I that I did sort down you Can full lumpy talk you SG&A they guess, I light. actually the characterization. fourth But sales see costs gave

Steven Pieper

some to relatively there mean, at quarter-to-quarter. for year not spend to the of perspective, we and all. lumpiness marketing year We're relatively XXXX. Oren, at terms SG&A flat in No, But expecting by promotional full it full be large, compared it's I flat. could to be be going look from a

Oren Livnat

here R&D, And good R&D? on X that the it current kicks levothyroxine. you in on you're sounds Is rate said Phase run until pretty go really focusing to like

Steven Pieper

in. in it QX Yes. the On primarily the second of a in kicks Phase when R&D, II perspective, would of for balance really levo expect see I the slight to half uptick year looking you're program at a and that quarter-over-quarter from

Operator

from Jefferies. of comes question from next today Our Santangelo Glen

Glen Santangelo

XQ. Gvoke want in Because Paul, little flesh look and we flat price reimbursement sequentially versus if they out reimbursement right, at But with maybe have have the the than dynamics right? on these were, for versus was XX%, your increase, XQ, there the bit as scripts think little a would also they a strong to more. revenues were can dynamics better been here follow-up up scripts, so I bit I -- being would thought as I I a

So be could little that great. that you a flesh if bit, out would

Steven Pieper

is this take that I'll Glen, question. Steve.

and two If makes really. unusual tighten inventory from it with will quarter, -- we're just in saw that that. they and shift first time-to-time. bit. a swing about saw the what little pretty bit that that's The we difference, there one their up a or within But we in And a happens channel of the yes, nothing concerning happens our think proactively and wholesalers. was quarter, inventory wholesalers our the weeks in quarter, from I working That So first time-to-time. nothing what

Glen Santangelo

to prepared Paul, kind said, with competition. you this then any generic with respect in you're revs of million. evidence really I your four And think seeing in quarters $XX about not And is Okay. a any roughly right, remarks, of row Keveyis,

right marketing of So thinking kind we for of think do should the absent incremental of that here? absent see you growth roughly Or that sort this generic this about? run plans, that bigger we generic opportunity based going on sort is be competition? competition, should forward, product any rate your about the product a How of

Paul Edick

would good see we're The without or generating of a -- Keveyis significantly that potential without as as a add And think, said, resources we is and threat now, Keveyis a can hard The harder. we need taking quarter-over-quarter with and for and even quarter, kind Right have wait that's every you -- -- that. higher. resources generic, solid drive the a good Yes, single million-ish. we're we Keveyis, current the driving of we on like question. generic we $XX we're

market. we to generic plays to also that on and If not in -- if and the And have to and we out the whole patent in then application or they successful middle discounting thing whether how appeal a we the our going payers year. what rebating, the enters this and do see of generic relative need are we and have second and see

substantially over not time. could effort more we now. But upsize drive a right lot out, cards the play just things that's as in So our and Keveyis

Operator

Ruiz of SVB Our next Securities. question Roanna today comes from

Roanna Ruiz

shorter if quickly? could the titration more drug around more if get you and been question has was could physicians patients quick as us on long patients update get on, titration a for get comfortable, process curious So period anything you how I on Recorlev. seeing possibly that can you're

Paul Edick

Good Yes. Roanna. question,

and very titration, dose good see that's up, We a the sign. more to start we're seeing are to creep average starting

drug the and getting working seeing higher that is for use doses starting are that is patients. to think good thought, The which also drug-naive we we're physicians dose, other we're maximum the to thing a I not sign the even it is

So slower that or over time, to starting all Whether and good going we have see not signs, it's enough to we versus the titration. yet. happen faster understand don't are to

Roanna Ruiz

Got it.

might could I more what clarity really this to or us Regeneron. the rundown with your for you then new And programs? collaboration a we steps more give ask these program and milestones multiple Basically, of excited opportunity products? And about a bit when makes get Okay. around wanted about future on possibly you

Paul Edick

love talk we lot what a products So it's about we want started. I of getting But there's our with to we're is, -- or platform The talk starting a that would out status us deal. system. they about -- put Regeneron is excites just Regeneron identification that to molecules two can't just about. the which deal of mean, into

first mean, -- just I and development. the molecule road having on to kickoff formulation molecule things for formulation the the that of soon. The real they just think start and then can down and they we're molecules I additional like part nominate interesting to follow continued second the meetings is

degree of platform of and molecules, comes and become them if products of forward well is very eventual clinical depending development, own with into commercial set those regulatory commercialization, and a exciting. in milestones, as you and our as formulation each take milestones they both it, its So royalties. one development to think about the one it could which when each And on approval

very value significant. eventual the So be could

Operator

go today ahead. David Piper question David, Sandler. Amsellem next comes Our please from of

Unidentified Analyst

David. on Skylar is for This

speak of if challenge received you your was wondering, exposure the all? then to were a modulator Recorlev as cortisol you that the on also view can you talk posing about Recorlev? they see I who Are is kind to with relacorilant, potential what prior of And patient just First, that those at patients and Can overall ketoconazole? mainly on Recorlev impact Corcept's the next-generation mix? commercial getting

Paul Edick

that just Corcept take We're would additional Good the the one an it will the morning, product cannibalize expect don't big soon. We half have. would as marketplace. Skylar, they first. I in seeing not competitor that second next-generation expect and anytime probably that the product

that hit not at the just terms We're we products patient first specifically two do cortisol, normalizing Korlym, your we mix, our keto. To to it's other from coming excited about that. predominantly that If doesn't patient from mix, prepared in question, because patients very effective Korlym have is very tried in a remarks. areas. because product in patients of very One, coming

patients That and the about of is not patients got The we're using sets into from this, more drug, we're the that exciting piece we've surgery. therapy a physicians and others. with more been year have Isturisa And on very we're getting -- Recorlev post we're first-line are exciting. experience only XX% getting therapy. any drug Recorlev, into that very really year quickly, That's are first one physicians and

surprisingly the the anticipate have the several we uncontrolled for been positive. the good, really mix more through patients getting future is patient think getting very drug. mix So bodes who We products. we're well of did the or of is But

Operator

further questions, team no back so closing remarks. have We management I any to would to hand like for the

Paul Edick

have can that Thanks once by be being very the through you much. flow that Thank achieving to company. again quarter. on we of durable fourth a prove and prudent today to expect us. for milestone heard resources cash careful biopharmaceutical revenue continued growth, management, we breakeven self-sustaining, in way you we allocation self-sustaining all expense its And joining What business confirms

every to like you the imagine. and excited also team Xeris their future they've caregivers our and headwind for tireless about our of take several the could this patients years thank business through our I'd work and for We're just support excited time the over about prospects. very about done to that last also all very

great So thank day. have a and you very much,

Operator

day, your concludes Thank disconnect. joining. you for Have first That you great call. results Xeris financial rest today's a now Biopharma and may quarter all Holdings' of XXXX

Xeris Biopharma (XERS) 9 May 232023 Q1 Earnings call transcript