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Xeris Pharmaceuticals (XERS)

Participants
Allison Wey Senior Vice President-Investor Relations and Corporate Communication
Paul Edick Chairman and Chief Executive Officer
Barry Deutsch Chief Financial Officer
Randall Stanicky RBC Capital Markets
Dan Clark Mizuho Securities
David Amsellem Piper Sandler
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Xeris Pharmaceuticals First Quarter 2020 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Ms. Allison Wey, Senior Vice President of Investor Relations and Corporate Communication. Ma’am, you may begin.

Allison Wey

to Call. Quarter welcome Corporate Financial and Conference Update morning, Xeris’ XXXX First Results Good that is hope I everyone staying safe. doing well and is Safety priority. top our

different distancing conducting [indiscernible] with are this virtually speakers We call us. to so guidelines, in social please bear with locations,

release this and A found [indiscernible] can was website. our results be issued press morning on

line will Deutsch, will provide the opening are by Edick, questions. Paul we’ll Paul We for financial Chairman and then and CFO. Barry review joined today CEO; the results, and Barry remarks, open

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

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

to call the over turn I’ll now. Paul

Paul Edick

to the we and first for provide on update today date. Allison, us everyone, as you, thank you, Thank quarter and XXXX an joining

matter, industry, March, with we’re challenging were unprecedented that thrust and waters. the that uncharted the times. in the In and we, early It’s country of for rest clear into world to everyone along the living

decisively. the and team recognizing First, me and say of acting the to COVID-XX seriousness how has I’m of crisis, proud responded early that Xeris let incredibly the

we’ve had ongoing companies, address many dynamics so of adjustments to the to Like make pandemic. the

and health to focus community Our primary our quickly has of continuity employees, agile and been very to disruption. to health patient service care Thanks our service of adapted we of minimize structure, to continuity the safety ensure professional customers. our to our

the implement ensure important and implemented continue erratic safeguard health to actions our ways times swiftly We to and immediately a for by we customer and implemented stress to home. – employees mid-March, is from our hypoglycemia that of virtual at during sheltering ultimate convenient diabetes schedules. In our customer, we with increased people to in in the Pre-Filled access community and fact severe have risk programs of and the Syringe. engagement high plan to safety beginning will several model working place easy that are Especially moved our Gvoke diabetes,

touch of we co-pay May. the to late upon for Let relieve the recently, In that help through started And some the those initiatives. offer end burden insured me patients. March, we commercially co-pay of briefly a $X extended $X financial

delivery you that is and Xeris authorization Program, health offers pharmacy managemen, prior – the and HUB patients with, free non support providers the initiated providers also which all everything be may dispensing to We or Support verification benefits Gvoke. for familiar way from a which home care of

process. clarified of simplicity the Additionally, and we partnership PillPack community the reminded the diabetes with delivery of our home

virtual XX webinars, through pivot maintaining and Gvoke rapid conducting customer in gaining critical programs of with professional almost to speaker our been momentum converted prescriptions. We engagement to XXX has programs traditional dinner virtual recently Our attendees. April to health PFS all care

the stay and patients. and also help assist using physicians needed the meetings, with virtual virtual as figuring telemedicine. and text serve themselves representatives moved of to their fax were to as them sales they, including world customers Our and engaged FaceTime, e-mail to out their digital Especially Zoom, important

first launch, building formulary a XXXX, of like securing on retail quarter, our field the our up to ensuring about bit of say foundation FDA access the the Gvoke, our was and was for focus mid-September training which a I’d contracts product and hiring first securing time importantly, – from to through end back approval reimbursements Gvoke securing successful talk quarter in distribution, that wholesale PFS our of force, because real to the Now, through payer approvals. launch. I

distributed also was all physician our we And time, physicians to that use. that units of our customers. in confirming sample record electronic systems over Gvoke During the X,XXX health

continued the setting us throughout in the coverage approximately in of in in through the coverage we true was start high Getting to of to demand-based of drive and January prescription XXXX growth. place lives XX% we very XXXX. this the all of achieving year have of payer XX% Also, key was up end improvement quarter and lives fourth quarter first Medicare approximately in the levels experiencing of to – good By covered Medicaid this recovered of critical without And February, are quarter. restrictions. commercial sales

good weeks units COVID-XX And prescription we’re to this prior four market even XX%. and the in to in XX% PFS overall In at quarter, prior outpacing momentum disruption. received Gvoke range disruption. we five the We, to of per was to to market the X.X addition, X.X the fact, had weeks in growing the very

and and the March dipped slightly. April, of disruption, the slowed growth late COVID-XX glucagon market as into Gvoke result market prescriptions During a

work to week and XXX per a prescriptions programs momentum, the compared share. prescription past the the to we market more Unit commercial most and Gvoke to also two traditional to the in units and professionals average during prescription. pandemic. the continue allow our health weeks have However, that Gvoke with still fast in took mix of We the gain the this weeks, maintained continued care believe sales momentum, tireless additional recent to go patients gifts gain actions we Gvoke seen due some at most X.X We’ve is launch implement around to of the high recent than units per to four week. at solid over access teams immediately virtual

are launch we the been record contracts. as all listing for of payer HypoPen in the prepared Gvoke HypoPen systems, drug health electronic included all Gvoke physician has formulary compendia, all well. Importantly,

a track HypoPen So on the July for launch. remains

of growing result we the the per on Gvoke a established much with rise. will As with foundation the HypoPen hospitable a launch a of prescription units into launch environment, the PFS, more market

and are we may taking be launch be addition, HypoPen In solution ultimate country in of component severe to for a received on blood country and commercial form emergencies. customer and in significant Gvoke first teams what degree offices preparing of the the parts which has very for July treatment Gvoke business, we the successful treating low that by engagement is for will our a some prepared Gvoke and a person physicians’ community. for place. Regardless diabetes face-to-face to the with to open HypoPen, will of well in we only which be both will simple virtual depending and are sugar virtually new be returned degree July. [indiscernible] believe normal, HypoPen the of the auto-injector launch hypoglycemia, the the

to Now pipeline. our let turn briefly me

is Authorization First, our currently EMA. our ready-to-use with rescue Marketing under glucagon Application for review

a opinion we could Assuming this frame, early have year. or year review late next time a CHMP typical EMA

that So remains on track.

our We our properties epilepsy reported of diazepam by dosing believe our the that population. it study number occur diazepam. weight-based formulation seizures We of the patient pharmacokinetic this effective recently follow-on particularly displayed from be suggest IM IM that so in results positive often reducing of could in

with the a meeting next is to step forward path a FDA request to program. Our agree on to this

and line results results top Hypoglycemia, for Hypoglycemia, reported portions study. each we of portion This study with of for similar see FDA. the we a PBH have each, Phase Recall, outpatient those we outpatient III the will propose in-clinic Post-Bariatric have the study positive each the quarter, the of path the we approval EIH to in also also results Exercise-Induced already the portion If of of studies. and designs the

with get indication use patients glucagon As market. mini to is the of advance non will rescue dose programs these to our goal you a the ultimately ready-to-use glucagon for that know,

XeriSol assess regulatory and discuss our FDA later forward in path the next and insulin If results pramlintide again, quarter. see if will we study also clinical the we – XXXX. the clinical with positive steps will we addition, In have this results,

clinical We’re studies current this quarter. wrapping up

the spend will glucagon the quarters path forward meantime, applications We on its of each well next of indication. outside best few approved for we program. liquid discussions In the FDA our as with of current as having pursue our the those other other uses specialty technology, to continue

million market convenient, for are liquid inhibit example, movement aid required for another indication tract. to glucagon For The new at for approximately presentations. significant in radiologic reconstitution provide current $XXX current alternative annual the GI a of as Gvoke And no evaluating is market U.S. could temporarily examinations diagnostic sales. we opportunity during this Xeris a use to

now uncertainty, and this strategic always, at especially both of also to about capital and our As allocation. prudent be we time need

organization looked entire ensure We viable across have to maintain tighten yet enterprise. we our the a belts,

XXXX significantly we by potential and participating portion compensation to plan approximately a cash and in two-year XXXX reduce Directors compensation whole in my of implemented April, Board personal XXXX of of XX% until deferred compensation. of the For burn, my example, team that including their cash executive significant deferring are deferral a

Act, payroll, and accordance utilities, to terms with employees, and a We the maintain CARES cover loan the in specifics. more which Barry with will received also of PPP help retain pay all rent

results report in, prescription our So approximately critical additional We to HypoPen COVID-XX this let to funds for ourselves we support in Gvoke find the provide me where impact as line XX, On facing and the operations, were PPP launch we PFS studies. prepare that X April a $X.XX received Gvoke July believe top of these work on million drive comments we particularly we clinical PPP. funding. are necessary stage given growth, few from ongoing of

PPP consideration to of interest the and in has on funding May and days funding continued almost to determined in that due X, other public was available of and after SBA additional we change since make that businesses. return to and small in evolve guidance government it to the weeks the funded, approximately PPP Nevertheless, advisable approved light $XXX,XXX

of retain We will with maintain funds to payroll remaining Act. in and and accordance employees, CARES the the use rent utilities, terms all for

over our now provide end. the presentation is – like Barry to financial the then and results, to I’ll to turn me go a of at I’d summarize remainder and the Let return over do what

Barry Deutsch

for of XXXX. Net co-pay rebates prompt product gross product our PFS pay were service chargebacks, Paul. quarter Gvoke estimated assistance for allowances sales distributor less payer first represent sales, sales returns. and $X.X Thanks, of discounts, million Net the fees and program,

reason $X.X million had negative we of is the Gross first for for sold that the negative quarter XXXX quarter, in the profit for was reserve for Manufacturing costs and $X,XXX. and of which gross included to cost a profit initial of $X.X approval The development and establishment related excess obsolete were million incurred prior research to previously the commercialization expenses. for Gvoke goods inventory. as expensed

As our have fully-loaded goods will unit not cost reflect standard been of of cost materials goods consumed. those sold sold until such, per

million million $XX.X quarter XXXX. quarter Total operating of XXXX the for $XX.X to expenses the compared first were first for of

As $XX.X operating a reminder, total QX for XXXX million. were expenses our

for decrease time with for the same supplies million incurred expenses preclinical was XXXX. of Both as associated months commercialization. as ended for in R&D XX, year of well clinical was needed these $XX.X were mentioned by decrease to the Gvoke were the A the prior compared expenses March $X.X increases costs. preclinical and trials offset XXXX, reduction the for batches costs by prior due The the trials. of period impacts manufacturing partially and contributor second decreased personnel to lower clinical expenses to CMC in in to driven previously and X manufacturing million

by marketing administrative expenses The of fourth million months of compared XX, primarily and were expenses the salesforce quarter driven ended $XX.X was for for the period in three general increase in addition and Selling, the to XXXX. Xeris’ March commercial same million the $XX.X XXXX in XXXX. increases

loss the million for $X.XX per period three or Net same $XX.X was share share months for per or $X.XX in compared XXXX, to $XX.X the million ended XX, XXXX. March

in million investments. $XXX approximately held cash equivalents we and XXXX, cash, XX, March of As

$XX.X the shares shares XXXX, million were common were XX.X per and $X.XX expenses. the Total shares. During deducting share. offering as discounts equity at stock million other approximately commissions sold of a offering offering quarter, underwriting XX, of current company after XX,XXX,XXX proceeds follow-on Net outstanding public March in from a and of price the

Protection our of plans Coronavirus Aid, Program, as X, Valley the into entered of April, Paul and Small We April, deferred we the full XXXX, PPP Bank April. on XXXX May known of compensation the Xeris and burn. our Economic as as Paul in In terms of million, the Administration of enabled Business executive company $XXX,XXX members make by $X.X otherwise of the as relevant a known plan Silicon as are amount use has accordance company maintain a Directors remaining Security loan payments loan to repaid otherwise payroll the cash mentioned, Act. Also retain Act loan. to And implemented significant of compensation mentioned, Act. Relief conditions with a in portion amount proceeds Paul deferring The which in and mentioned, their Board team utility the and in the lease and management the Paycheck CARES employees, CARES cash with to the received U.S. under of PPP minimize until

to the of X% We least the on loan capital next operations annum. PPP that believe expenditures matures The have years fund X months. sufficient payments in cash our due bears significant their regard we portion to and at implement and for XX to rate of two the will significant deferring team first for are when board per No Revenue we no at will loan the interest compensation. be have the With clinical cash breakeven. and a we are cash and and determine reductions, expenses, months. Gvoke there from executive planned expenses spending flow controllable continue trial are

call Paul. now will the to turn back I

Paul Edick

in of In have we we’re for Barry. generating recently pipeline. have we the development believe weather storms Gvoke continuing Thanks, revenue, an track seeing and prescriptions improved July upcoming, we virtual to HypoPen, new momentum with opportunities engagement we important prudent we customer strategic data pivoted PFS, our several and we being aptly model, for a launch spend, readouts to will on effectively add have COVID-XX we to we’re are our Gvoke are because summary, product

open the With please for questions. you could that, operator, if line

Operator

RBC is Capital first Your Randall Instructions] Markets. question from from [Operator Stanicky

Randall Stanicky

got the few HypoPen a just around I’ve questions launch. July

left gating First, into your most do sampling work look level you physicians at to have that more the launch or how could you just what there? you What’s launch? items call Second, Gvoke does And around lastly, walk before factor characterize If awareness is those physician the final that would degree through universe, are coming do? of to do launch to this you generally aware plans? HypoPen?

Paul Edick

Thanks, Randall.

be are we’ll distribute expect fully we’re I manufacturing really in terms So in early of there and done One, final commercial and critical be to two July. items, supply, gating think currently we ones. able that will

will second and we’re is prepared effective virtual The need as be face-to-face environment still. of component in with significant continuing or well to good PFS the terms there’s a one get through extremely that currently of where to all extremely with implementing virtual that our selling. we as an We organization working programs for be Gvoke commercial

all virtually a the people of the and lot a with that And meetings, our programs, the cetera. ongoing of of with getting lot currently e-mail, fax, through physicians et skilled really offices, Zoom activities interacting media, at syringe much the are are more prefilled various

going important, be that’s and prepared. right of doing critically that’s part what be a think now to big we’re to I So,

samples a number we from will the if Then marketplace to on early formularies. being perspective, the the and managed the process sampling recall, a provided into you avoid prefilled because considerable rejected care prescriptions we pharmacy to syringe going weren’t for in of

PFS for HypoPen. and we’re – formularies, already for be on the both will all We the

component samples case physicians providing if that. anticipate and the at do of numbers some HypoPen. office use we we all be for they that require there of are some that in some be So physicians there And could may of have for in potentially consider emergencies. a in-office We with don’t asked will modest will pockets situations, have significant sampling some

– of kits. the modest And general, broader we’re physicians Physicians not They’re awareness, of engaging in terms the in people population. is Gvoke are old use the now. high awareness why patient In that it’s the more more of coming traditional HypoPen and PFS of instead to expanding of Gvoke have of yet. say it’s discussions I’d – level modest, right I’d to say need Gvoke of their audience focusing on a and

Randall Stanicky

helpful. for That’s And any the Gvoke trended that’s how you I Okay. follow-up. prescription just if on you launch? ask PFS? since Do one data rate can share could And have fill

Paul Edick

was was there retail. causative few early We question. written The rates injection we traditional some factors. prescription – relatively kits filled Gvoke One seeing we the Great were substitution confusion losing the where PFS. a for that was that, were fill prescriptions were on that And if Yes. not – being injection, low. We’ve a the retail. trend saw for at identified some and Gvoke they caused were at of

also We gone through prior XX% third piece going – What the from managed the less we’ve of and format care then done the it then physicians. since HUB early on is with coverage. and we a prescriptions – What to was some we’ve was the HUB authorizations. of are

So and to health pick whatever reimbursement, they’ll local a the of going the it will their means with prefer. a The the they they will it to a there. instead want deal just patients with records drop-down it product to send by HUB. deal in authorizations, If pharmacy, and to pharmacy, they send pick up they doing into electronic they’ll HUB prior send

high as We’re through home seeing well. delivery the rate a of HUB

the that So fill gives much and us rate increased. has greater control, dramatically

Randall Stanicky

Okay, great. you. Thank

Operator

Your Securities. next Mizuho from question from comes Difei Yang

Dan Clark

on guess, expect don’t that IQVIA aware reopen weeks then quick that the up distancing that that, and be you follow-up for mail-based show should of? to thanks. relax? This COVID. sources I Rx to is a mail-based as there of been we to And pharmacies once data any Do couple Hi, measures continue your are social in past has you up mentioned, and over start, Clark Difei. Dan just to due

Paul Edick

think, mail-based I – to don’t on question. thanks have it lot prescriptions, Dan, my do the – The percentage, I for So fingertips. a are have the

I the delivered now going and comfortable would will however, that population. expect are decrease very are overnight and in being think going the Keep XX% that, it’s right will people for at-risk HUB the back from pharmacy. feel is open prescriptions – into close of to a delivery. once we this more would up people One back pharmacies mind, that to pharmacies, home go picking to traditional expect

will diabetes their that diabetes – you’re going what their think I I return to whatever So in to is, to you’re see with more new normal is. think the people cautious going see be

of or IQVIA, delivery may up issue. still in So remain overnight Those the delivery mail rate that’s high. are prescriptions an showing not so

a few. are There

have We through go that PillPack. a few it’s not It’s tens. hundreds,

So average basis, PillPack what – if through the to an as X%-ish you’ll you you – IQVIA, covered you see in well. have if going on add what’s

Dan Clark

just gross like margin then to expect And sort quickly you cost on many how higher roughly of quarters do front, of goods? have the a

Paul Edick

– Barry. don’t I Yes. go ahead,

Barry Deutsch

Yes.

Sorry, Paul.

mentioned, I quarter impacted the year, as So was the by reserve. this E&O

as the our reasons. we’ve seeing this next R&D mentioned mentioned going Over inventory flow forward our here, uncertainties, so last in so as that COGS. our through commercialization erratic to and comment COGS XX-K I But product that’s prior moving near-term my expenses, in quarter. you’re as and for manufacturing and – September, involved One just already a were reserve time approval here, also, expensed period of is number products the launch not were costs with to

get until different of to to going we down steady state. up sort factors and you’re have a So

Dan Clark

Okay, the line. thanks. I’ll pass

Operator

is David Our next on open. David line is line your are your Amsellem you David Piper open, Sandler. question from mute. comes from

David Amsellem

me, Can I mute. sorry on that, hear you was Yes. about

thoughts, impacted on That’s practices COVID then they know be glucagon to of the of then extent they And that And is more and push the the I there? one. quick diligent I a the think terms going guess, is forward I endures? maybe that but path seeing diligent to is about that Paul, market just extent you constrained, mean, conscientious So or patients to on have sure priority of number sure forward? to you available? question how you’re would Can making overall rescue wanted available. the how therapy diligent much in terms rescue talk landscape couple diazepam the a I making you just is have I of your guess, in talk get resource you’re ones. rescue absolutely to do are you which what to creating patients more, or second going product. I behavior patients, think try about call that

Paul Edick

really out comments, XX%. week what the very that like all in of to to total – accelerating, you thank more much. COVID-XX my population, the are us market the to the glucagon terms bit concerned products market, overall and is situation patient David, But from glucagon. The most patients crisis. up for was pandemic, to steam in perspective, is of make reaching growth. has their sure of during market little a have a out taken The the physicians high growing in, of all-time And our we’re rescue data an the I seeing they said recent during XX%

more of and that’s Now to of increased risk be that the actually now reaching we’re sure probably with customers a patients than Gvoke at and that considerably about us out others fact I them got traction. they think little engaged bit due really making talking that really their And to is PFS. that our the are to physicians and fact have some they should right

that time, will I think Over endure.

physicians about patients becoming are to talking making they’re that more glucagon, I sure Gvoke. especially think attuned to

significant. I think going with be the advent it’s more to even the HypoPen, of

this remember talked decades. where that a to is have category being glucagon physicians about were You for to

the to beginning the self reengaging a it ability been hasn’t they’re administer. uses. administration. new, to and Historically, stage next patients be So talking self actually to going to think is their they’re with the recognize I their physicians And more about understanding convenient patients,

have patients a that have combined something in Hopefully, for place. think of that more at-risk that I So, they belief enduring the all just will answers should help to question.

What’s adequate original of in a have and second which the the we When our I we’ve weight-based study, adequate getting a it a look at that products, a is Phase great that got more while. drug blunting terms III we do was the question The the going really to dosing, And Phase for beautiful into the onset FDA is critically to to of going diazepam, quite is be we is than follow-on pharmacokinetics program. important think in seizures. product. time study system. In going require more hangs to what and than both forward you around

we’re So to this FDA go going the to year. later

to going where We’re is the we appropriate forward what and put go. see we approach believe

of kind that and ask is constraints, says we’ll required. it the population. we our more In terms forward we’re on of us see usually resource would be reasonable. to with We’ll an in propose orphan study meeting. would FDA mind, – decide resource Keep what constrained, be this is in that going And they investigating consistent do path after drug if would designated then what than the

David Amsellem

a based III with given that So that III, that a to feel confident path if is you I may this rapid of Phase Phase a move to just sneak your or determined can a sort to is dialogue follow-up, that FDA? on there’s reasonably in be the Or directly do a XXX(b)(X)? you

Paul Edick

Yes.

We where forward. that’s will examples been plenty propose III marketplace the Phase There’s the in path of a program.

the weeks have diazepam, to products very be We our going data. studied. we a that think a very very and we’ll it’s think have based argument, solid argument, cogent is that’s other on So proposed similar especially well XXX(b)(X), it’s There’s approach.

David Amsellem

taking question. Okay, for great. Thanks my

Paul Edick

David. Thanks,

Operator

showing no this at further am I questions time.

Paul Edick

and We much. joining safe Be very you healthy. us everybody today. appreciate Thank Okay.

Operator

have today’s this gentlemen, Thank for participation, concludes and wonderful conference. day. you a and your Ladies

may You disconnect. all