XERS - Earnings call transcript Q4 2021 | Xeris Biopharma Holdings, Inc.

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Operator

Hello everyone. And welcome to the Xeris Biopharma Fourth Quarter 2021 Financial Results Conference Call and Webcast. My name is Seth and I will be the operator for your call today. [Operator Instructions]. I will now hand the floor over to, Allison Wey, to begin. ahead. go Please

Allison Wey

and morning. found XXXX Good and to Biopharma's morning fourth Xeris A was financial Thank earlier our issued results And website. and quarter this quarter company's the financial release can call year corporate fourth XXXX press results be you. and with welcome full on update webcast. conference

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

we remind Safe statements call Act practices, which Before Securities COVID-XX Harbor begin, Xeris' clinical that the I statements business performance, forward-looking Private Litigation Xeris' Reform contain corporate to would future forward-looking of the you and contain commercialization, Xeris' plans, purposes impact of prospects, like provision approvals, on will business practices, of for the expectations, this under concerning strategy, the forward-looking indicated including and results may discussed effect related Actual XXXX. pandemic trials in factors, to business, SEC. including and markets, and financial the clinical with various and on of manufacturers Xeris' these differ filings a operations, condition, the uncertainties global COVID-XX suppliers from risk those result the of U.S. important the third-party by other statements, materially our as those

over as to Edick. the forward-looking to In call update upon views views this our I'll of date now of disclaim and of represent any call We addition, turn not any as such specifically obligations statements relied representing any only subsequent Paul as should be our the statements. date.

Paul Edick

a notable to then plans my commercialized our of the and integration today. for XXXX us a and over remarks fourth respectively, step grow with remarkable key mass achievements. XXXX and joining highlights Other necessary include XXX% to in Biopharma our pharmaceutical throughout profitable increase on prescriptions for grew and take pro creating impressive accomplishments morning, last on forward Strongbridge XXXX. capable expand in of XX% million This Thanks a Keveyis, net critical product continued Most XXXX products, and primary significant everyone. an benefiting $XX sales I'll to fully basis many to and morning, $XX acquisition company. Keveyis portfolio Xeris was was year compared Gvoke is increased outlook. to by Gvoke our our which to year. become enabled total review of that focus and Xeris of important patients the and reaching the number full XXXX a guidance. The year the year-over-year forma end for and from of million quarter $XX top XX% paralysis XXXX million sales Good

the to We significant in UK in also yet partnerships a future important commercialize value trade technology create and could is with with which undisclosed two and Tetris Pharma an as XeriJect to for for access our Gvoke the Merck our Europe, international monoclonal Ogluo, antibody. that formed name

in FDA multiple XXXX. approvals received also We

kit treatment importantly Gvoke product syringe the ready shelf-life option single Syringe very is First of our An use And patients to Cushing months sale presentation, and syndrome. which HypoPen to Gvoke one from Gvoke available new And from The and vial our XX stability. of suffering giving the a temperature for use milligram room temperature for week. patients another option. months be for presentation XX for next for Kit, extension Prefilled Recorlev. will room important

morning position has More we the strong having added then $XXX $XXX assuming specifically, since and company's debt the we as been pipeline go will flow the When million million submitted with outlook. development ever start we programs, Hayfin inception. with financial believe financial million with in cash of and our the our will announced recently as additional Xeris' our placement end Exercise-induced in INDs at reach advancements and it private the supported XXXX. made strong sheet, to for Steve most that year with various XXXX financial XXXX is $XX this that detail ended very Hypoglycemia. year XXXX. And that also by end We more product revenue into an of balance achievement performance, we XXXX, guidance, strength will a on and financial we on breakeven coupled million to restructuring $XX with position

a Now I'd more bit into three starting detail like to our Gvoke. little go products with on commercial

is severe and low physicians and community. is of continues healthcare glucagon message event product have strongly rescue. That blood ready-to-use a insulin on resonate medical at to Everyone other increased to should clear risk available in and sugar message the our simple. Gvoke, a for providers For experiencing therefore

prescribers practices HypoPen ready-to-use their prescriptions fact, of over from considering board, plus just quarter impressive have add ready-to-use prescribers patients particularly X% Gvoke the strong the market insulin market in the glucagon the hand, declined which Every same In two new the total are Gvoke products grew performance. fourth all glucagon quarter. to week, that contributing third at Gvokes grown In performance period. accelerating to come on X% of XX is in over have additional percent the week should every years. and This

glucagon reviews, of previous part third You a in quarter quarter phenomenon. surge back-to-school the which a will as normally recall prescriptions that from is our

And declined so comparison. fourth in historically quarter has

our at performance Gvokes strong We continue market due future. continuing our to such currently to Gvoke with into for the market standing for the grew retail share headwind so product strongly XX%. in outpace The demand strong glucagon approximately overall reinforces enthusiasm a

achieving Keveyis. of million Keveyis the $XX million strong end proforma us sales enjoy at top to XXXX joined our of a $XX also has product guidance. to on Moving

paralysis hard we As previously, patients identify. have periodic peripheral discussed to extremely are

helped XX now approval We to relationship an continued on transition for and So also team Recorlev. community. working the ensure Xeris early commercial this a performance. close is Keveyis FDA within December able operations after year, to pharmacy specialty a the And end XXXX. team during the and collective the of Recorlev to healthcare of of The with we sales testament weeks launch received expertise strong hold our and the amount were performance the of the at teams meeting with virtual strong our of to product integration partner. shipped few the Because smooth - the the incredible for work by sale and the approval,

who existing addressable billion in the XX% controlled. is are XXXX key By therapy $X and Recorlev market targeted remain infrastructure. treatment, the discussed for pharmacologic of requiring prospects poorly in was leveraging we've very Strongbridge are commercial with acquisition endocrinology approximately there this of We We legacy excited Gvoke patients the whom of opportunity about organizations As approximately managers. value for that the the Strongbridge professionals driver and to on more supporting have our been estimate fit the a market journey commercial US. the syndrome experience infrastructure estimated Xeris's The total the at pharmacists, And Recorlev. Recorlev our have people great since a entire reimbursement help and launch, to few placed provides access patients, only several achieve with direct Xeris in a diseases. to access services rare and believe inadequately normal already lifestyle. we and weeks we're patients position CareConnection Cushing are controlled patients able treatment CareConnection. We healthcare while with support support it's to through Xeris been specialists, throughout them

some updates on of a of our Just pipeline programs. couple

dose evaluate continue injection. we single of a initiated formulation study to once of previously we Phase and our subcutaneous As in potential for X announced to a participants novel ascending levothyroxine the weekly

an the proportionality range results We clearance March. dosage a from of from for IND and quarter third in the dosage recently Hypoglycemia of expect submitted received Phase We've and Exercise-induced study in complete X FDA XXXX.

Phase to quarter outlook providing XXXX. call work this total we committed our product guidance third XXXX. later On We And expect to moving start additional on company revenue for X for our year. to

reemphasize entire Our I obviously company portfolio. outlook we be is product providing total only to the for on the revenue. that will focus product Therefore, driving want

product all million XXXX. between total branded expect in to sales million We $XXX of three and $XXX products

outlook. XXXX internal with company performance and is consistent guidance our Assuming our XXXX

expect to breakeven We expect with to million by to cash end flow end cash year achieve and $XX $XXX XXXX. in we million XXXX

cash addition commercial also given exceptionally that refinance, placement, markets position the private would capital anticipate recent order needing in not result fund from strong We capital hand, our believe the from of raise on a to cash as purposes with generated for three products, of and most return would to our cash our additional likely the to A be M&A we our debt ongoing operations. revenue only.

our pleased with ahead Steve to in Our at what couldn't year financial be our employees, our to XXXX With stakeholders, of a serve, we and look details and our for I'll beyond. that, partners. more the the to strategic we a it very professional history, point future important has communities holds and the company performance. I inflection our turn over patient healthcare arrived of execution. review our is shareholders, XXXX

Steve Pieper

everyone. my will fourth Good Strongbridge and key morning, be Thanks October, Because I this include focus the year XX-K quarter filed the Strongbridge in financial from we a acquisition. few today. release full acquisition morning financial that The our later the covering the are quarter including impact results of details Paul. press today, only which closed results. of the XXXX the remarks will early issued in I'm fourth and on

be net However, year full results. on the commenting also proforma I revenue will product

fourth net in product forma and XXXX. Gvoke the year of On for the November. we say, was revenue million, reflecting at $XX GAAP in basis, $XX.X $XX.X net reported XX% Paul the pro heard year, million the total high for total contribution. was XXXX end finishing a you pro full quarter of one As strong revenue revenues, representing Keveyis only On basis, over product provided increase full demand million Keveyis a for forma back guidance continued and was a quarter

that year of net are achieve topping range from X% of more end guidance I of XX% not the reporting its quarter-over-quarter continued Gvoke prescriptions, previous the than say strong $XX driving quarter, will growing in to revenue million for the of prescription XXXX. XX,XXX and we our $XX did Keveyis momentum product, QX growth fourth full by high XXXX. While million

generated representing year XXXX. over prescriptions XX,XXX full full the XXX% over For year increase XXXX, Gvoke

down an we to three offset compared XXXX, increase P&L $X.X the cost the year $X.X approximately to of As obsolete $XX.X million million and increase XX move by year same primarily was product for December of December in the million product sales, ended full lower expenses. was sold the compared Cost of included for XXXX. ended increased full the sold million XXXX, costs period $X which access XXXX, goods XX goods of for an months partially

administrative in million attention in programs. XXXX. On year million XXXX. process in development XXXX a full basis, to pharmaceutical higher development, compared our Research million XXXX. and approximately costs million and the expenses. and approximately driven full in clinical of the compared On increased to approximately XXXX the $XX.X year XXXX same to were period multiple expenses by by year million full by Selling expenses and approximately million, approximately million to by $X to in same $XX fourth $XX XXXX. a research These $XXX million $XX period the expenses increased quarter fourth increased XXXX compared approximately the increased the by development to across Turning year $X.X SG&A in quarter $XX.X compared to general to expenses primarily increases to full basis,

relative these Let to some to context important increases me XXXX. provide

the important financial of the would fourth related quarter Strongbridge are the and full on recur Xeris's million quarter incur acquisition related quarter in SG&A, SG&A I full did we at also results. closed end to respective in do that fourth infrastructure would quarter material the Furthermore, October, prior of this With XXXX. year acquisition cost and by early not earnings relative call, costs the given quarter. these a million fourth XXXX of that the any realize As in both is we to synergies, include which increases we $XX results. employee costs. the in of communicated insurance Strongbridge our expenses context I to of fourth in absorb savings which commercial I XXXX increases associated Keveyis Strongbridge, mentioned to from acquisition with in of Strongbridge, expect related including majority with year terms transaction of the third costs restructuring that year the This the exist $XX the one-time mentioned materially mind, the not costs, XXXX. impact will the results not These bulk in and looking acquisition transaction XXXX and context approximately to increases,

and Gvoke include related Keveyis XXXX and full the QX of commercial launch for expenses expenses, of including Additional fourth drivers preparation salesforce of and communicated of the 'XX, the XXXX. fourth our increase expansion XXXX. are year split These by believe in other track million of clear, XXXX, QX SG&A of in commercial Recorlev deal the quarter in $XX for inclusion year related team in expenses in related previously and cost the be reductions $XX end accounted To full the equally $XX million increase. million on approximately quarter that the XXXX to we and and we synergies, cost between avoidance approximately realize

operating public our and running include Additionally, future continued the Keveyis other and going operating launch Gvoke a for expenses Recorlev, supporting R&D associated with growth in costs and administrative forward of will and the costs of the company. both

attention our Turning to cash.

$XXX.X million cash, equivalents total December and of investments XX $XXX.X XXXX. to million, of XX term short Xeris As compared at XXXX, cash December had

acquisition accrued XXXX, related end year in pay at XXXX. We costs and will Strongbridge liabilities severance to other including continue

attention our Turning to debt.

remaining earlier million proceeds into facility available working date. this with upon to closing $XXX our term of XX-months. agreement a plan. end debt of and managed the a the fund entered The the we by loan with million operating we to An capital. $XX is of Silicon current plan, expect election previous secured to And during $XXX draw our us announced senior of at the provide repaid with year. to we $XX.X net Oxford drew million we Xeris by finance provide facility, debt we morning, the on total business million funds Under will Valley this Bank. million up As terms of we our our will next additional capital Based $XX the additional Hayfin

business pleased added encumbering of Together approximately increases financing, without $XXX sheet company of investments sheet. increasing to XXXX. thereafter be drive our with the operating from and flow balance at equity by provides constructed and very year which recent short strength debt January resources with year greater operating term Xeris the provides debt cash, are to balance end securing XXXX in by Hayfin, growing flow. non-dilutive terms equivalents cash facility with financial $XX attractive over our to and our to flexibility additional on currently significant $XX us million facility on cash now to capital than We breakeven produce end capital base million partnering with access closed already cash the our his rapidly the commercial substantial has million as This and the cash

As improve we we rate look the Strongbridge costs. course ahead, base project the with acquisition revenue obligations we and our the XXXX over of to to see in as cash of associated related grow, continues decline burn a

and flow Keveyis great breakeven in sales. quarter year million net we debt and Gvoke growth $XX current received With Hayfin, a from cash achieve cash summarize, with we end marketed recent XXXX. three the To the approximately with restructuring combined revenue and financing with our the XXXX our to $XXX position, products finish and of can the product from by had equity believe further million will that year cash terms

We and a R&D are million the in have Xeris synergies we'll growth Gvoke, to solid our cash perspective and integrated from And end by and a quickly of into achieve $XX drive we position XXXX. of pipeline. in Keveyis Recorlev fund Strongbridge

Let back me to Paul. the call turn

Paul Edick

Thanks, Steve.

the the a by that of heard, great our believe it entire a of just our expect Kit breakeven you of and levothyroxine from $XXX also the XXXX. The Phase cash to now and to continued X mentioned. in we're we launch in Tetris initiation the year. we Gvoke products because Exercise-induced as you and in over later the can In availability week, in several end I'll we've net million. end the for XXXX. X of questions. study third from $XXX team times capital Phase We Ogluo position Steve additional the off Keveyis three work at see sales Gvoke, to of to next start generating of we flow XXXX European expect XXXX great million commercial as cash to countries. several in growth the result lines to a data full products, range As And Recorlev, done with year and hand on hyperglycemia said as the XXXX cash quarter, with year Operator, Hayfin, an program turn open And healthy cash XXXX, of very

Operator

ahead. Instructions] first Roanna Please Leerink. from go The SVB from [Operator question today comes Ruiz

Roanna Ruiz

morning, everyone. good Hi,

So two questions for me.

XXXX. to about driving Recorlev. million guidance I wanted financial your And $XXX Curious your for net what's about wanted revenue asked product ask I range? First,

about Have have you like switched the help they could Recorlev? what products from or that prescribed drugs first previously? been early little like, talk patients about, as think more us they through they Recorlev? and patients just of Are So Cushing's a adopters look other bit the to cycled

Paul Edick

second have Hey - yet few on we've you. of patient Roanna. morning. on so far, Thank that coming level have don't We handle Good the they're where don't from. don't per one got I information specific yet patients we basis. pay take a first. a We

more will get begin on the a specialty in we coming from aggregate pharmacy patients general, to where percentage patients, are As the basis.

in strong, what When we're you fourth script are if data but positive. Recorlev, more. incredibly XX example, to of And confidence. great and few we're and more those beginning it far, normally really we're the - We'll terms market year, had does, feeling if at get weeks to I holding we your encouraging. start. you very know think of off a so we did so Keveyis compare XX the look that's into coming in quarter. then what is from remarks, good prepared products for as a And that patients, driving we So our through. cycled had other of We, first our percentage what's question a

Roanna Ruiz

makes Great, a Thanks sense. lot.

Operator

question next from from Vamil ahead. comes Securities. Mizuho go Our Divan Please

Vamil Divan

taking Thanks my great. Yes, question. for

maybe it Thanks commentary more provided. you for made. what Recorlev? So guidance, all for couple else A on info you on that

through just expecting on having in Can just to product? what there terms Recorlev. and going adopting through one environment side, out [ph] on requirements just guidance And from what of talk gone you're about little bit understand payer questions or So you had any as then come of would people I the a patient over this just said. other what a there make you sure couple the therapies,

So the that your want includes end. to I'm you're down being million of color year. just sounds clear to to And year from triangulate of million million sure $XX like at Hayfin, next to I end expecting cash cash draw that. the That $XXX the already of $XX from to breakeven, it that on then am I flow trying make by

similar Aside soft just between get am at your flow 'XX where Thanks. sort you're the more get overall would beginning point stay steady to talked cause to your breakeven. that trying cash of to of burn follow be 'XX. to which of the about I declined from that you and going somewhat to year, sense expect you a what this And a basis. a how rate expenses in

Paul Edick

Vamil, you only Recorlev, a have very far. Appreciate much. Hey so patients the we question. On thank few

going The price patients levels products at the established. authorization. them getting category all all and getting reimbursed So, branded require most process. - that of we've are We're reimbursed, the of this are these in through they're and that prior

And it out we referred they're the going over are pre-approved. products with it, you support so go be the patient get and it foresee bit know, out therapy, They're process. think the it's process. can process, referred going go our they that them getting we about the buying up takes other at Pharmacy to help to them worried through Walgreens, patient, the and don't not to them roadblocks that a works We we're them XX is to there. care through there patient, a adjudicated process, to referred every get they're connections seconds reimbursed. Each in the a any and we're Specialty prescription and that little reimbursement like shows get But everything. of through and time, history we're Pharmacy, And individual the is with Specialty So we all not computer.

that never We won't an So we XXX%, you is But there should do. not think a have pathway. issue. be

a year. the Yes, expenses, In other $XX have terms in one pretty good 'XX flow in get to are state $XX expect quarter And Rest timers terms we 'XX of end to cash quarter. and be past 'XX, the pretty the million and breakeven should in that that guidance. 'XX then it million $XXX-million-year first the of cash drawdown does consistent. to first we steady of include of late once the some

Vamil Divan

you thank Okay, very much.

Operator

Please David comes Amsellem Sandler. next from Our go ahead. from question Piper

David Amsellem

Thanks.

So just few. a

potentially First, that you made comment a about additional the capital Paul, you accessing to M&A. equity do extent

M&A more get to kind be clarity forward? you'd how of just first And some from a the So want you going I question. in interested in. as of the assets is much So to priority general, that's

The on Gvoke. second question is

which extent In or the on on are see get Recorlev. last pandemic, to a sales extent product overall piece ready the the as of are days? from know, the more sense, you your of related moving a the terms question these to thinking on radar could person on portion you will endocrinologist, that? the regarding And pandemic, which, what's then hopefully is in your of, adoption, And of what about calls how moving from question, expansion we

to Just your have you follow-up exposure Or the promise you time, your payer it patients have question, product? wider over as is keep even to see access? to expectation on might order all had a the will that in Recorlev think access

Paul Edick

joining Okay, you much let them order the to this me you very in And for morning. us that David, same them gave me. take thank

going continued activity. the the important and most markets, M&A growth business get that our more likely that we and flow with hand cash we was capital on breakeven in The can than cash have markets. do we're capital my statement access to to we that before believe point is we access it of cash terms In generate. to organic If

to on our the plays level business are we our to getting continued company kind growing with without potential and focused requires product and advance critical overlap are to in a we're we move question, previous organic get profitability critical and and and would role of that. mass we and to for, a the We mass, on it that exquisite M&A focused at Strongbridge And business and our look business, our current profitability it's significantly. look in acquisition, us its assets we of allows or acquisition

there, So part if consider. something there's that's strong But a our another know, of that's result you just then would there's we plan.

In the terms growth. of Gvoke. quarter The ready-to-use to third beginning the back in double market expansion. see We're of getting already late to and quarter starting fourth digit

they So of of if have more going we're end lack go, don't that day, you've behavior, ready-to-use at patients It's of the decades that it's to confident insulin, mean generating disagree available. glucagon handy products very a I just because are on the physicians behavior. of got should

churn physicians and And day mean fingers we are day. there, doesn't XXXX all to be we're And every the there. quite single products, there's whole of more getting thing. treatment, the an of there's And XXX%, equals to more virtual. focused of we're Gvoke ready-to-use case, degree patients pretty physicians out more crossed, uncontrolled, on inside have will our far on we on and we're we of giving every normalization as actually of get group, as achieving good coming remain all that reps interactions out now of and looking in a [indiscernible], are they're because not So hopefully, we're access. focus field, It's to in do still which the But this the patients patients is XXXX insulin And get that nearing products. is control totally patients, face cortisol. step which from these Face which expect different the expect are one then begin plenty their normalization market. onboard to pandemic of out those pharmacological not cortisol, growing with to through, give

David Amsellem

Paul. Thanks That's helpful.

Operator

remarks. for back further it to I closing no have waiting call, will the Paul hand questions We on

Paul Edick

and Thank XXXX. for very year a to successful the questions. you Thank forward Congratulations you for team fourth everybody, another great guys we're and Thanks, your in to great listening. a quarter year looking much. on

Operator

This for very concludes much joining. Thank conference you call. today's

now disconnect may You your lines.

Xeris Biopharma (XERS) 10 Mar 222021 Q4 Earnings call transcript