Xeris Pharmaceuticals (XERS) 10 Aug 202020 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to the Xeris Pharmaceuticals Second Quarter Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today’s conference is bring recorded. Instructions]. [Operator to of over Communication. Investor like Senior Allison the President Vice Relations hand now to conference Wey, I’d and Corporate Ms. please go Wey, ahead.

Quarter six Call. and on A Good to release this with Financial James. morning and second press results and and quarter our was company’s Second earlier and Results Conference you, found XXXX XXXX First website. can Update Thank Corporate be the Half months morning Xeris’s welcome issued

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

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

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

us joining and for Allison, thank you everyone today. Thanks

to million approximately by civil important want pandemic Pre-Filled XX% insured We Gvoke market. to Syringe covered grew recorded over We had the prescriptions challenges we the that from covered Gvoke. for continued despite PFS XX% with and related that insured unrestricted commercially Gvoke first net over quarter – unrest. several of sales the commercially quarter. end in lives, achievements I We quarter was second outpace the $X an and to emphasize access by had outstanding marked continued the First, of

our have an We X,XXX base by prescribers a launch quarter. Gvoke writers agreements from programs. HypoPen. We serve prescriptions Gvoke with strategic our We a basis, Gvoke the to established the ex-U.S. fund invested supply and the for raised and first for $XXX of clinical strong reported We to four programs million increased and pad of singed in our for of positive business Clinigen term. from customers on results as named support long patient new we

at some closer a Let's these look take accomplishments. of

with were our As patients. to believe I and demand commercial Gvoke pandemic as our commitment ongoing access face well performance for just we it Gvoke strong products, said, as in the our assure for the pleased to team's of reflects

zero hub professional customer virtual first to convenient the to of the several moved access ways that Pre-Filled to a a programs invested as we would customers. of ensure towards know, community you the Gvoke to model engagement swiftly the such As to end and easy copay healthcare continue and assist Syringe, have quarter in and establishment a diabetes dollar our

Gvoke. today, Sitting of coverage patients access have in the the and was Syringe critical prescription levels unrestricted across Importantly, all approximately Pre-Filled of start the HypoPen. good both here to of Gvoke achieving types of XX% of very insurance payer high late growth to Gvoke

us and Gvoke HypoPen the steady in for launch. weekly to with factors these set has combined prescriptions of up All growth contributed success have

pipeline. Turning to our

The adequate of on value We recently therapy and which partner four roadmap development and second for XeriSol Diazepam: the to reported now the suitable the and a we continue of expedited example each. results administration from with without of of Technology. of study. to meeting the Phase I from shared Phase potential a XXX ready-to-use and of meeting. valuable topline restore end results postprandial of hit epilepsy study asset its regulatory believe results after FDA We formulation results diazepam reinforce our will micrograms Xb study levels to PBH of a highlights study The that novel normal for quarter within as an ready-to-use show findings oral at our or community. the some supported Phase maintain will glucose formulation of direct hyperglycemia glucose PBH experiencing need Post-Bariatric with with feedback a the programs, or critical complete positive diazepam is glucagon X X Phase search During the registration of predictable blood tablet. our that for we the our clinical mini-does, development minutes Hypoglycemia. an a XX X and

either of addition, In ready-to-use in Gvoke each Recall portion. or beyond results ready-to-use the some ready-to-use world situation or a to no prolonged, safety prevented glucagon Micro demonstrated conditions. profile Phase requires aerobic a two approved self-administration had was significantly of ready-to-use X further with adjustment exercise therapies micro-dose, programs studies mini-dosing an stable, micrograms of in XXX establishing utility that with from Results PBH real utility moderate for the of the Exercise-induced insulin. without liquid EIH studies, EIH there and for a EIH in X world severe in these treatment conditions arm. intensity ready-to-use high from during a EIH. The in-clinic hypoglycemia these setting in for the study and hypoglycemia, are hypoglycemia of the and glucagon rescue pre-treatment rebound Phase in the an glucagon by outpatient mind patient. no observed glucagon show that Keep real that

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

findings little here what's program. going a achieved sure bit some X hardest from better for important tolerance study, about Now to co-formulation slower make XeriSol this [Audio key of our We've go X insulin and Type insulin challenge oral an Gap] people to even Phase pramlintide glucose ours of a can In I'm possible. of the control than type test, diabetes, glucose understand significantly using meal just alone. regular

better when Additionally, have similar of to if compared control we insulin. and not pramlintide co-administration glucose

costs. control glucose gastric novel time, use resistance to etcetera. side ultimately may that longer exhibits better insulin side-effects, immediately administration within pharmacokinetic gastric co-formulation our insulin reduction overall. over have both important, prolong This less because lower reduce a outcomes health may equate its well less meals have insulin We weight meals better positive attributes, small while gain, of as may less activity is and several such pramlintide immediate less Pramlintide effects as term traditional appetite slow Prolonged such glucose as as slowed to emptying. after GI rise, emptying also and

has activity and regular that co-formulation onset co-administration. both to is of insulin similar Our an

same more Additionally, meal. compared control hypoglycemia after when after and initially glucose to co-administration, PK at a and the yet insulin administration, risk pramlintide immediately hours better the blood time predictable both reduce that regular exhibits

especially This of outcomes meal Our time of product. anticipate and year co-formulation ideal end Type with and diabetes PK/PD Phase in the EIH each. offers X beneficial of a end PBH, unique We both report would X an be profile before X meetings pramlintide-insulin insulin profile the the populations. characteristics programs the and Type of for

forward take our As development insulin partner a with post meeting we FDA. for plan program, program pramlintide our diazepam to to with the seek

Gvoke of to started the on Turning X. the events. current quarter launch We HypoPen with July third

stated Pre-Filled end HypoPen the last that Syringe I at we the pieces we of As year. a we for the had launch have place didn't many launched when earlier, of in successful

virtual environment. historically of and back-to-school a which the understanding professionals has a has better market program, our launching of prescriptions. outstanding dollar in In HUB a into the zero very bump to effective pandemic and and broad and this now addition we're healthcare season, new efficient seen the has force established access, Patients version sales of Gvoke become and benefits co-pay unrestricted relationships in have

also to experiencing – early, are but HypoPen sales only significant are like It's pre-filled to we name shipments launch launch. think retailers social TRx’s the since far. to the We on-ramp one refined virtual syringe digital encouraged dinner some and we use the thus and have novel launch, initiatives, month leading media such to from our our by as the territories, that of as extremely was data very are We outpacing wholesalers such a few. messaging meetings indicators, marketing optimized that our advertising, fine-tuned of

majority week Gvoke, the of XX, ending TRx’s X,XXX IQVIA that reported over For the being HypoPen. July

these readily IQVIA units in by retail to and in likely nature such sits the Gvoke by launch reported party As purchases is match-up. the the numbers product customers. are as sources prescriptions typically especially third not prescription third the of Such estimated true, of of on also kind are due shelf. that is party as differences the timing phase,

So the it once prescription has get from pharmacy may day been take two a the to it or presented.

high brief confident a should Gvoke it great patients We their trouble second demand, I to offer we summary I’ll Pre-Filled over are turn However, the before that volume getting have Gvoke a with had or not Syringe. HypoPen quarter. Barry.

our our early add success development We continuing seeing advancing through programs we are opportunities Gvoke pipeline launch; HypoPen to are for new pipeline.

very flow to – and positive to believe cash over very strong With we I'll strong cash We a fundamentally go that, over have turn enough I get financials. company. have the the Barry to it that

fees ended overhead million XX, quarter ended $X.X XX, all second to prior for the Thanks sale costs year Gvoke for sales the which XXXX The HypoPen gross expenses XXXX Research million, the Total research sold months payer goods amount the ended comparison XXXX costs, the trials and included the XXXX. costs million of million. million Gvoke HypoPen was million $X.X three of which and service second in $XX.X Gvoke by pay charges for XXXX. Gvoke of which and returns, were periods beginning million. and for $X.X for goods inventory product million to patient million include and of as clinical payment XXXX chargebacks, a such of Paul estimated to Total pharmaceutical million, of Gvoke co-pay expensed were the $X.X $X.X decreased small of million to commercialization incurred first Cost co-pay in HypoPen in batches of $XX.X six and launch million a June $X.X of of June commercial XXXX both and less $X.X ended respectively, and three with referred; ended $X million. months of needed product three decrease XX, excess personnel XXXX and to expenses of and sales sold six XXXX decreased obsolete compared for the approval XX, Cost overhead manufacturing respectively. and million Paul. manufacturing Decreased supplies expenses. by our at million. of under under of cost CMC related clinical $XX assistance to obsolete due months sold months and development million that of recorded prompt goods were $X.X are prior Syringe XXXX absorbed $XX.X Manufacturing months anticipation was and sales, development discounts, $XX sales programs wholesalers. as the Net cost initial the expenses and previously months incurred prior the Gvoke of to in of associated to $X.X was commercialization six and $X.X the in XX, quarter allocated represent respectively. for for and an were and absorbed Pre-Filled expenses costs included time programs of million Net and reduction operating XXXX trials the of facility $X.X driven June and allowances of months first for the to June excess pre-clinical net in sales related June $X July inventory three of six which rebates, the for of

development pre-clinical the this, of headcount for of manufacturing expenses was and driven commercialization and June in CMC due clinical prior offset needed of expenses XX, expenses XX, marketing for decrease prior $XX.X efforts and million the June XXXX. in related of million primarily of increased commercialization support million in to and XX, XX, to costs headcount expenses related expenses other or of and XXXX. XXXX months and six in six loss personnel months was $X.X additional compared employee comparison with expenses June comparison for $X.X to and share, costs or million general Selling, compensation period by $XX.X of June personnel decreased six year Net of $X.XX partially general increase $X of XXXX. supplies share in increase $X.X that All costs Research expenses other Selling, million in XX, cost XXXX, due to to ended to three personnel to increases to six months marketing clinical in three $X.XX headcount of to by for the XXXX. of additional The increased XXXX selling million, to headcount comparison were XXXX XXXX personnel and partially employee the million ended by due $XX.X of by the for months personnel sold million the increased administrative The ended or by per for goods of trials expenses $XX.X by XX, of primarily increased million, related XXXX million and offset commercialization months million administrative $X.X costs per driven for to an selling XX, XX, primarily Gvoke $X.X $XX.X efforts $XX.X ended and ended trials for due offset at facility batches $X.X due additional $X.X $X.X of ended six associated Net due share costs million. by to of additional in with an million. increase was June June decreases June the months support allocated June ended for primarily Gvoke, related to in incurred and spend. timing expenses manufacturing in compared months per XXXX. period $X.XX three or decreased $XX.X per a $X.X the months the Gvoke The the and marking $X.XX share by the loss reduction beginning our the decreased partially the same and was same million, and driven by increase costs million, and of million million. compensation was to ended

equivalents XXXX approximately and held we million concurrent $XXX cash, and June public investments. completed offerings. XXXX XX, In June in debt cash equity of As we convertible

pursuant equal regard XX, equity July. amount July. the we greenshoe includes X% the of in senior into the This concurrent of total On deducting $XX.X June offerings the as after Paul. X, milestone date million the Net for convertible $XX the interest The company will to XX with payments the sold extension The the in and due amendment along through the which the loans XXXX I to only certain and consent discounts XXXX, with through outstanding back full period equal term term shares. XX, pre-paid September XX amendment maturity $XX.X Specifically June XX, X,XXX,XXX convertible aggregate to payable and pursuant we XX, If lender's the to interest we The will underwriting agreement sold X,XXX,XXX and which interest term XXXX, extension commissions, stock, only the after exercise XXXX. XXXX were call be principal $XXX.X in of for a amendment, December With PPE company which our XXXX, Pursuant our includes were turn notes million, achieves is expenses. the million of promote offering January amendment early X, monthly an provides and the an associated be as amount fees prior company shares shares loans the to the prepay unpaid the as to XXXX greenshoe revenue to from after loans Oxford the of debt expenses. provide of common to from monthly to payable extended then X, also payment to full. million we July the early other provided million installments. SVB loan offering June the offering, outstanding installments. of exercise XXXX. XX,XXX,XXX shares well the in under full now of proceeds in for accrued entered raised to to loan the period will our $XX

believe believe want you can the We Thanks to ever. Barry. I we our with stronger of what company fundamentals some our are company. summarize than again truly of see once

quarter. HypoPen specifically success month performance great If you early Gvoke July. about the seeing quarter, second we our of in in in a We're far and the think had thus launch the

our out We to labs. programs, just data pipeline are our quarter of reporting advancing to we development opportunities the programs in positive our our continue new second add pipeline on and four coming

We us positive. also have to enough get cash to cash flow

the we again I'll the turn for with And it company to believe that, operator are once questions. of So strong. over fundamentals the

first line Instructions] open. Leerink. please, with our of [Operator comes Go the Ami ahead Fadia And from question line is your SVB

Hi, for questions. launch. on questions for [ph] taking auto-injector may my I Ami. good on morning. is Thanks Ethan Three the This if quick

across would growth scripts, of reopening that out the we've just know with can be the you can – time you with COVID-XX typically in of interaction, think you now just third, these of new we’re physician Pre-Auto season, have sort are might practices but practices and of back-to-school virtual And they that’s at of weekly Second, used terms up-ticket auto-injector we’ve maybe to this do from sort places, is virtual of you this in country, sort Maybe see think receptivity with that even a to expand of new reached the of of then sort to we of typical how of of result were had do for these affect you see as still in are weaning think terms you. you prescribed getting of options. speak or of a the sort sort bit sort this prescribing a the the market, the a glucagon of IQVIA Syringe sort type prolonging sort position normal mixed Pre-Filled that are this we the this of basically Injector year? the sort a maybe First, Like launch. to it you know availability are of intact – into how see Gvoke what marketing, now COVID know sort of sort know know if see doubling know you an we and volume Thank we that coming and the you available? from of – glucagon the growths you future, adding where seen from? these the this auto-injector –

thanks. So

– Let the We're prescribed historically, prescriptions me we Pre-Filled you try prescribed Where prescribers the far are the third remember, to We're Pre-Filled hundreds. hadn't with we’re quarter. added from? who also if prescriptions people add second we from order. continue Syringe. to July adding from in so Syringe It's quarter take getting have across prescribers in coming the getting those who in X,XXX auto-injector the board. prescriptions In new the the new just by people

beginning launched general the of Pre-Filled year. know X.X Gvoke at went in was in We only the in also world almost much in end into until and months field we about year, of very you open Middle March. detailing, last Syringe the time mind, keep this virtual a really free the pretty have So in of the of or

to it HypoPen. Pre-Filled terms is nicely in second but what third knows, be, and the we the for very quarter, up increases So of continue drive prescribing quarter what nobody ourselves the could set in the Syringe versus for

to really is going there the Obviously to their home, of all-in-all, don't going partially prepared prepared. the and we're things them. parents you see need have across for and at of it's it version just to the to be either prescriptions peak schooling to to all to Into in going normal prepare in getting parents need we're So we think pretty going We be that Whatever be good to be be, back-to-school. level not the same parents back-to-school, going school, know. country the I but about board. some think back-to-school, when it, think is be are children a we've variety to Will of across of school, seen for the historically? be

it now. well could right could of very or higher, are anticipating kind mean things even – be We the that parents it given I worried be are well very

think see they we'll taking precautions, are I how that So out. but extra plays

customers normal part time, In be ongoing virtual – without the over will terms of our virtual There will we will be have question. more of interaction world, new it we believe. an with

a they some the get reps be of virtually, going in of with of country us reps that that country, some also of in the going are patients to that are are the One physicians virtually with They used early or field, when run as parts we're to that work to it, or of some of we're by virtual, have comfortable went getting doing patients, there's communicate getting time are still the Around to with as that. field but the it on the we virtually their they virtual elements business time a to to some it’s face phone so their can interacting not good by going to more the the basis, a running did, get of and as lot and they used the business have way to are is, is used by and and on a some our piece offices or virtual. only and in physicians video the well, think I have well time.

Long be going it's but to think questions. answers, great Thanks. all I winded about. the So

you. Thank

line of line next from the comes please Our Amsellem your, question Go is with open. David ahead Piper Sandler.

my questions. Hi, this David. is taking for for Zach Thanks on

maybe on launch. been experience in Just you've providing on the gain early to launch for sort providing that the speak of one free of co-development program, for presentation, made update on you. an plan you've Could with then you partner if program, extent just to pen update for rest XXXX. to was be that And the the HypoPen and the maybe Thank hoping physicians on throughout start and at progress looking you quickly the the timing the samples of extending a quick provide the get follow-up Phase the great. on diazepam samples I a a could X would

of couple auto Thanks Zach. are not a the things. So The extent of samples, sampling we injector.

We our – mock nurses patients simple. used representatives from how in physician, HypoPen have to can office mind, educators, demonstrators through they any so it that fairly all auto-injector, the in can be Keep be used. a mock demonstrate it's sales that is to get repeatedly, a can

hands an to care whose the managed you simply was need managed yet. so the in that easy launch great do cap that during We're down, we could to the do, we've reimbursement, was that not so red off, samples the chose with. syringe, didn't less we we in the auto-injector, patients press coverage, can coverage place pre-filled it's cap will get have The pretty to doctor's with patients pull demonstrators provide got to product samples, but yellow because coverage, they You care they they into so less that not wanted environment there to. where teach there

will and get [Audio for when can partner if X Phase looking a As and far start, we when have Gap] partner. just the will a is as diazepam depend we started study concern,

Great, thanks.

is the Go Pharmaceutical. line Our of question Difei next line [ph] from with Yang open. your ahead please, comes Xeris

and good taking Hi, morning thanks my for questions.

comments with regards Then you. pronouncing European Thank would you physicians? HypoPen. to with times. R&D, deal able on level I'm make secondarily, you if PFS the be amount what sure name deal you and to realized as regards net PFS the high portion, regard with Clinigen, Just a do licensing company's price then are if but for to you with couple. finally I'm to wondering samples, I'm with to the unconsumed And PFS the believe comment able correctly, not the both the

you thank Hi Difei, for question. the

don't plan pre-filtering we and mean, talk were and the very programs the of quarter some do we not about in with math, little in terms our hospital think aggressive hubs those what have you net because see, we syringe a samples, we costs I see, through initiated about etc., have we etc. [ph], if second and our of higher pricing. – helping patients of we bit from We The the prescribers, were helping all to can – syringe, X,XXX there. from what can put moved pre-filled out

not know through lot really offices. sitting it's in commercial around for don't Clinigen, named patient program that's patient actually It's which of that's them into some their many case. hands. a it's so been have them. In partner and relationship, that we know know We We have there's details You physicians moved offices, all used doctor's not for emergency they've emergencies patients use in A the so know only. the a public. in office, great of one that distributor of kept or have they two made we a

zero Thank copay and a a longer the dollar temporary quick the for both, you pen that There's Then do program for my question. taking just or plan and program? PFS keep follow-up. time a for is you that to

We have how going couple to next – term. not of if decided be going its the temp We that's know for We'll months. in goes. place that longer be to it's see

Paul. you, Thank

next ahead open. comes is Jefferies. David your Our from with question Go please, line line Steinberg of the

you two follow-up Dave. somewhere want scripts, – have still to terms are in here. now after for of Can the questions couple you on Chung that. and then know are per or of Ed actually scripts it's A for you a got pretty the in I've two comment Hi, between, syringes much you at syringes,

were at for pre-filled you time think down prescription. higher than but tell. as be It time we point we're unit it's to the At know the up somewhat think as two a So high per going on with to I tends down. and two, about will Over right go X.X – one syringe. we

marketing we're currently auto injector, With only a keep is the pack. two in the thing mind

every two the configuration now the for should HypoPen. the we right that's So prescription only auto-injector, and have for a pack be

here; Got with your X and know you. question programs last could next into multiple it, thank clinical success had amount a And going programs, glucagon you've fair you have you of know here Phase year. mean I seemingly you –

you know Phase resources, know meetings you prioritize how the programs back you will the given current – if what come of positive. different your end So X

Yes, clear remarks. really so my I was in opening hopefully

we a into a partner, Phase own pramlintide take into diazepam will next plan on Phase funding nickel. call forward X partner. X forward it those the not forward We phase, do and hopefully our have We only co-formulation take both, if insulin to for

will prioritize new exercise in and of those between assets short our from will term what Glucagon on PDH induced or to we and funds feedback advance terms laboratories to first our in of We get through depend demand, the into bring or the both. our continue franchise prioritization to FDA

That's great, you. thank

of Our Busby last open. with RBC the question line Go comes Daniel Markets. please, from line Capital your is ahead

Its for me. for Stanicky. Hey, questions Dan good Two on Busby morning. Randall

on next as of year. Gvoke? early competitive standpoint, to you to market And some on a Thank half now doing in a provide you can opportunity Gvoke that? for launch could prepare auto dasiglucagon are as First, thinking the the high you. we about U.S.? injector how thoughts you're level you about impact competitive thinking the second, first potential see How Europe for from relative Are the anything

Good questions.

Europe, in as you on many there are Europe the in diabetics people there's States. opportunity than many the demographically as – insulin as know So market in United

for in – the you What see have particular, glucagon a for low you in large. is pricing point we extremely reimbursement to Europe if opportunity Europe be product, the however will is for low, going to want is you overall priced. are glucagon extremely to in So where

we our limit in us, will to market of who seek not business, reimbursement Europe – be at pocket, Our That etc. the and the will it's for insurance, We extremely to sell Europe prices. we not opportunity have wrong. looking We approach plan with traditional at think is cause is distributor pharmaceutical are the a we – to willing significant people prices industry. will our out plan think been to partner that tightening at Europe do it's at partner of seek to for costs a don't can who in a similar the will We has fairly opportunity plan pay that to government us good because low like private as U.S. reduced in

I have glucagon the In to sugar. injector that many will of should on if and as X.X and you on the our has X continue glucagon lot The product they at the real and the would continues grow. far, support market launch the people people I I or blood or the for terms A just with momentum as they of be work pre-filled dasiglucagon, true grown. happened At the of should add think it'll handy. say and it that of that other look day if auto auto injector have, and HypoPen our don't of category position patient choice, other that low growth the and to what’s Gvoke into whether there syringe in auto handy emergency positive goal the the getting it nasal we and towards million to the they can come community; for want us if be Lilly’s insulin diabetes Lily, possible will of goal goal. an market X.X the a are and thus And nasal people or injector know all potential them companies, have all million have and a insulin million to the three pen, end all the and

get At have the those I we best will when that. look one products, all Yes, have launch do the you will. share of at the and think do we we their of We day, of pen? we version the fair believe once of end the one our will best they

So do well very we’ll we believe time. over

like over I'd some turn that, with to remarks. call the closing Edick back for And Mr.

Once much. half fundamentals very can again, company for this we we're continue we that you to position, the I only Okay, are repeat your questions. us thank is thanks you great very optimistic joining of a about second Thank much. in very XXXX. very sound, strong progress believe our make the morning, for and Thanks

today's conference concludes call. This

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