- Earnings call transcript Q3 2022

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Operator

Good evening or good afternoon. And welcome to the Xeris Biopharma Third Quarter 2022 Financial Results Call. My name is Adam, and I will be your operator today. [Operator Instructions] I will now hand the floor over to Allison Wey, Senior Vice President of Investor Relations and Corporate Communications to begin.

So, Allison, please go ahead when you are ready.

Allison Wey

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

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

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

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

Paul Edick

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

regarding we things most to quarter, Number we are, clarity. into with the results knowing Xeris. one, what second how want there we call has executing are aspect strategy important the quarter multiple team over a years to the few get we a building Before the I where to trying absolute at about on we of plan as where been our build talked and getting to want that of successful companies reiterate against be,

on We Phase technology be one and last unique full-fledged I the asset partnerships. growing two company what products of you technologies development over three journey. and that meaningful commercially end is focus what enterprise, of the has focused, we therapeutic quarter pipeline patient-centric, second evolved very continuing progress where pipeline few promise with that commercial to value-added from technology a will that long-term we and today Reiterating on II highly with to hear growing very partnerships. areas, development we targeted with have are considerably and What biopharma products, targeted want at building day, the beginning development is to a business each on successfully significant self-sustaining said increasingly substantial, multiple potentially call, end in a years, and multiple a

We vision. are on executing our

part the quarter Our and continued the the third XXXX of through fourth into quarter. early momentum

three all growth record demand products patient delivering and for our revenues the of quarter. continued We in marketed net through

levothyroxine the advancement pipeline our We also continued of program.

With and the cash, expenses of the the three products following. performance confident are solid we can and disciplined management we year-to-date all of achieve

our guidance net product to an of thus revenue I At point calls, narrowing product end good from we and to where net year said to At have point a the the As $XXX line million million. million $XXX to the XXXX. guidance of this commercial of believe our result we $XXX $XXX may are million sight revenue I $XXX million and have on in exceptional by same guidance, of the any the cash range year, end previous currently in which be our our to million a happen expected at cash performance that to to would operations. $XX equity operations flow And our million was markets are cash. balance funding is $XXX XXXX breakeven, without ongoing to year for end in adequate million to need XXXX we time, purpose raising fund are we expectation to now the year cash reiterating previous is position that tap $XXX the

and low XX% third same approximately glucagon glucagon are severe year, In quarter the Now total with versus people increase share total million, go and growth to year. revenues prescriptions a such I to third glucagon to than great Gvoke last from additional the prior this the XX% therefore, was the and were X% for at QX Gvoke compared a the compared into Gvoke and the growing last market. will market approximately record period performance. more compared are The the were prescriptions. and had see quarterly XX% event year. to Gvoke. Gvoke revenue strong highlights in XX% net Gvoke’s behind products by ready-to-use of record quarter. XX% XX,XXX, increased a XX% at fueled prescription after period quarter, the $XX.X outpace of diabetes of drive an market last Gvoke are over getting to blood serious performance. ready-to-use more XXXX. specific who It’s XXX,XXX to more sugar a in XX% to the revenues some as on each grew product quarter with and increase year another considerably that risk over quarter in end compared same same prescriptions approximately continues Year-to-date, last Gvoke’s glucagon Year-to-date, market third total now period a quarter. grew net Gvoke growing insulin, performance October

all in to until who high on Gvoke go all patients insulin available we However, at long have a ready-to-use are case. risk a have way just

Keveyis to over quarter approximately revenue and increase, Moving Year-to-date, an third increased XX% XXXX. basis. of XXXX compared we compared a quarter. forma net quarter X% million basis, on $XX.X In grown me, increase XXXX, with of saw from to to last has Keveyis. XX% an in demand record to the XXXX, year-to-date a net third patient a quarter in period Keveyis period same another same in excuse had XX% X% has on patient revenue, in XXXX quarter increase demand. XXXX the Comparing third pro

at Looking Recorlev.

a number therapy. quarter, to we an referrals of of patient on the increase continued meaningful generate starting and During in number patients

of potential. revenue for grow to from It’s long-term $X.X quarter. We but launch, quarter, very have the the patients up show the great third resulted dose, in growth started titrate which continues This still that XXX% in average performance early are good second revenue is therapy launch also seeing daily begin Recorlev Recorlev to in growth on net a very their and million sign.

I’d from few like levothyroxine. comparison turn Now Phase reported we to encouraging Synthroid results to -- oral A of versus turn pharmacokinetic XP-XXXX. X very the ago, subcutaneous over XeriSol weeks

longer The maximum provided initial XXX Our once-weekly relative we exposure Tmax to therapy. crossover has phase single normal the XeriSol of proof-of-concept Subcutaneous bypassing novel not to gastrointestinal that design oral Cmax, results with as a with XP-XXXX maximum microgram well potential lower study, a concentration or small the dosing, of crossover of profile treatment oral volume the a the Excuse or levothyroxine offer and time of adherence, mitigating potentially tract utilizing in concentration Synthroid. levothyroxine first are subcutaneous in to me, ready-to-use more doses technology. study our volunteers. the a improving as formulation -- compared of sustained formulation limitations patients provide and

the of comparable NDA. combined develop similar course FDA the Phase steady of us review at continued study Type a registration doses identified. micrograms. All data on Phase state, and a XXX of simulations our for and that to to granted conversion to to the implying proposal chronic model X,XXX enable from scenarios. daily an XP-XXXX XXX, dosing. to Xx once-daily ascending then with X model. dosing our safety provide Phase Throughout other a could this data were estimated present, a factor dose X,XXX oral X,XXX has the between and study weekly for This of meeting confirmed Based pharmacokinetic Synthroid, model population We once-weekly C At were exposure once X study micrograms additional single requirements linear X/X request and various to perform we exposure two concerns allowed major study, and XP-XXXX of between proportionality no micrograms

end We the -- feedback the of expect at by the end their year. of this

of products longer administration. Our findings regulatory previous FDA based for for in safety on oral effectiveness weekly FDA levothyroxine and guidance approvals versus strategy assessment pharmacokinetic products and of FDA’s or comparing daily published Synthroid. is vivo precedent for

-- hypothyroidism several for Our excuse treatment standard-of-care levothyroxine has been for the standard the me, been levothyroxine has decades. oral

At current prescriptions those have this condition or XX% mouthful the as at our on I for think effectively. treatment the the improved one patients in which detail us dispensed this that’s on Yet, take Levothyroxine most of due safe branded patients to remain gastrointestinal our hypothyroid with concomitant we details generally managing I pricing, every could of could once-weekly oral as and if $X either approximately medications, once $X million financial XXX United Conservatively, States a to again. challenges will market for very options. levothyroxine a tract, billion terms prescriptions believe over mean with levothyroxine to X levothyroxine market absorption important concomitant need their over presents billion it this potential several or performance. does this remains compliance a point, turn in a of year. GI to of of issues. I to levothyroxine subcutaneous that prescribed compete be While in patients we condition, What including opportunity? I inadequate market described million segment well as interfering effective in in in know medicines of levothyroxine, multiple issues, it’s but Steve

Steve Pieper

increase morning, $XX.X results, issued remarks our patient for morning. my a compared release Total Gvoke which press on the key a third Gvoke the growth product. demand, To has details year. continued be on in a prescriptions, demand for This by decrease clear, the quarter XX% call. revenue first Good This more a Breaking was quarter, the million, financial on XX% we starts driven believe period for over of which in a pricing a representing it therapy quarter. revenue same and the net period forma XX% representing again a the than products, by was net revenue by same This growth period of on XXXX. in driven increase last growth $XX.X in pricing. was will to demand our few XX% increase million a in last both were of This was growth pro are detail underlying compared key the the in compared XX% revenue that same year driven Keveyis, three drivers was in in net net the prescriptions, new for last in net was revenue product our the period to same by I everyone. and for representing net down all $XX.X this explained offset Year-to-date, basis. increase topping record stabilized. in quarter the product pricing, offset the decrease increase for of by I focus strong approximately increase a million, compared XXXX, Recorlev $XX,XXX time, increase patient a year. partially by the was increase partially growth Gvoke was to same in to which last total

same XX% period basis, revenue increase to increase revenue million, representing the $XX.X Keveyis. pro a Keveyis last forma last representing $XX.X Keveyis year basis. a net on pro On period to same on a basis. compared the net Moving the year-to-date quarter for compared a was year XX% to was forma a million,

the was direct to second million. of the steady a quarter and increases therapy. the Recorlev of pricing of net revenue Year-to-date, with increases, $X.X for to We the These net Recorlev revenue increase million, see more XXXX contributed this than quarter continue double Keveyis. net revenue in patients on result a patient to patients number on growth coupled of growth. compared $X.X was

also are We pleased new performance continue we therapy. patient growth of of Recorlev financial new be outlook our initial and by weekly the of Recorlev the coming encouraged on the given patients to with and referrals

of revenue our As are million. $XXX to net million still range million, Paul within mentioned, tightening $XXX guidance to $XXX million product we our of total previous of $XXX

$XXX.X Selling, was P&L. sold the goods ended period Consistent attributable with or the on not product compared basis. increased expenses compared launch $XX.X increased cash had expenses September higher short-term also perspective, to company for increased September XXth costs. $X.X forma as increase and million Recorlev by same cash XX, $XX.X equivalents a to XXth of incurred XXXX. product to by X% costs incurred the in mix investments lower for this We driven same and and period our in a field and million development of same year Keveyis primarily months costs. the in of increased QX nine September nine the quarters, administrative $XX.X months spend the compared at the million ended for by as Cost XXth, an marketing personnel-related in compared costs, XXXX. and due Moving increase Recorlev. nine The was XXth pro well prior in Research primarily development is in months ended the as From sales, and September total or million change inclusion driven to $X.X to roughly commercial last the XXXX. roughly of the period Gvoke of The XX% as increased June general infrastructure XXXX. the offset Xeris increase by down by to million, personnel-related of cash, increase of expansion million

spend previous this facility maintain we current Hayfin have by position, our Strongbridge the with and from end continue and healthy sheet inflationary than headwinds. the our to to additional on cash as the previously under $XX guidance acquisition a synergies a faced strong of while more guided. million forecasted balance Based even We delivering end debt year, the have to draw on cash expect we position, XXXX available our cash

cash end commercial three ultimately we believe with range million to that turn breakeven to Xeris of end year XXXX. of range $XXX from a back call the Paul. $XXX million of our position We cash is a now million. in reaching a to XXXX guidance new increasing $XXX a million Xeris are growing will the will sheet $XX and I balance We by healthy that assets flow to feel unique give

Paul Edick

Thanks, Steve.

growth, and head we expect we build this value open please to revenue creating the As allocation at resources line questions continue upon of expense careful momentum Operator, you point. shareholder year finish XXXX our into the prudent management. continued XXXX, for and and would through

Operator

from our question Jefferies. line first comes your go Of Please And course. [Operator Instructions] Glen, Santangelo ahead. is today from Glen open.

Glen Santangelo

glucagon market question. into Oh! a Thanks I my taking Yeah. for little Paul, bit more. wanted dive to the

will maybe deceleration stem about here sunset enough products. but the am that seem we products it’s It fact the XQ quarter, also be generic if kits generic very ready-to-use where towards and this legacy the were a could ready-to-use somewhat be one enough it’s are where they to big market -- in that competitors and legacy speaking from products their two But legacy that said beyond tide grew in a about the total of and You of we differential are your your a who with from wondering decelerated kit, XQ between the going to X%. seems these encouraging, excited that that high talk slight XQ view the soon. manufacturers a their manufactures level. And that from that, price were to I so you

So I moving you of your this given market, was for shapes sort think all you just XXXX wondering assessment Thanks. the it give could if us how parts? up of

Paul Edick

of could to when you to have your the impossible There -- ready-to-use issue the in products. day the study has the when order, And factor three comments in the pertinent this from marketplace. dynamic could deliver use the has I in they severe the nature those not of other price of market you that Glen. price. human are marketplace and this is at easy the are -- reverse look can’t It’s the best they speed with products of is the ready-to-use The out the kind self-administration Thanks, us kit. most impossible caregiver, And option, the end at dose medical of because by of out best say the by professional to get that been that the factor. manufacturers, describe the which to could execute the are legacy a usable would products what And a of form execute They to made will and products gone self-administration. I legacy has can function, proper to almost of I in every of marketplace. think done cognitive use of been the because use XX use XX% tell products. as in losing you studies user the use, end are Yeah. nature nature any to kits. relative new seven no I take never probably for they for products. been using three need hypo the people the complicated of a and And really a outcome the approximately actually ready-to-use was the are for has kit easy also and new easy you people critical an difference -- to

think people important view I to critically market. how this that’s So

far is, have and the had growth think double The and where double-digit. it’s grow. doesn’t As digits the majority Gvoke that as of down Xeris been gone the up it shouldering of and throughout quarters growth of has in and fact growth to that’s was scare us to matter a going couple at as below That growth, XX% high the have marketplace. we the to are XX% have in happening reverse all. continue but we and We period, COVID the that’s we as consistent had pre-pandemic had

in, comes Novo and gets nasal their with active more more gets Lilly As active.

for is have one of million people insulin on should in these severe And low more are that have risk louder products voice the Gvoke. there will X ready-to-use bottomline at high such as who marketplace. a the are We

later, or that Sooner get will message clinicians. to through

Glen Santangelo

the I Paul, mean, reduction, prepared your million just suggest the I just range million. encouraging generally that right, midpoint guess the And you Okay. of I of if at ask remarks, agree. guidance seem I on in maybe the by anything range $XX lowered follow-up quick end very guidance looking the guidance, $X original be But was -- and top and sort you within can some to the by

to kind Steven, in I number so or relative to the you ago? am you cash, on what And be great? been lastly, changed days have your would then but just us And update that debt curious today, maybe thanks for the might the mind give thinking of as XX could as of Thanks. what

Paul Edick

Yeah.

I think we -- the continue saw was single-digit is, answer to first growth your to market expected your The in growth. double-digit Glen question. we and market question, high

end -- original growth substantial guidance was market the in. built So top more of had the

Glen Santangelo

Okay.

Steve Pieper

XX%. And currently we then as mentioned But Hayfin plan have $XXX my and that roughly we has to draw the to with on a outstanding I us facility. debt, have Hayfin the the then $XX under additional remarks, we in convert million available

we $XXX million. have will So

Paul Edick

relative especially have products, just three guidance all that as that double beginning some anticipating performance well digits that bottomline But variability. all I the versus would at Gvoke Recorlev, company. anywhere beginning, range for from to be us there have two in reiterate had They products launch from be excellent would And that, with a would a the in we wide And said is, fairly I grow. very growing said to that launch prior year. are mode incredibly the continue guidance, still being we range,

Glen Santangelo

for the Great. Thanks responses.

Operator

Please from Sandler. line David, question from Amsellem your ahead. Next Piper is comes go open. David

David Amsellem

Thanks. Hey.

few. a just So

And with lost about how patient-specific be there’s are be there also going by field if of to see the me, Novo capacity, And the that are market, are of share think talk you what regarding will what XXXX? it then do patient hearing lion’s be the surrounding going we the kits Thanks. First, just their your talk or -- you the generally to continue on glucagon you discontinued helpful? that products. capture sort you could that about glucagon And noted do doubling through Amphastar product. do going not you to the will but to as just metrics or ready-to-use you the payer and receptivity move to is that underlying prescriber grow kits what your being that and the overall mix -- generic are that view ready-to-use Recorlev, I the share can mean, to you metrics products any in can they that I comments so of a business about would hit usage? back ultimately, dynamics seeing shaking and it how out Lilly and

Paul Edick

Lilly the like the continue market. for kit an discontinuation the Gvoke going entry, course has the Okay. the is products first type of the that, patients. nasal appropriate in cetera, their of form does or glucagon Well, we kit let we not seen couple et of a whether marketplace of that signal last that business are greater prescribers evidence me we And And the is years the seeing the clear have percentage in you are start of to believe delivery factor the decline. of and a to over Amphastar What with to company biggest continued and believe is again. regardless legacy Lilly that kit it to ready-to-use take the generic believe of like

And rubber to are So the not the legacy prescribing the they generic meets if prescriber. old going converted road with kits. be the they ready-to-use products, are where is the to

in a the have such and lion’s of don’t to of linger, the share. continue bit always but anticipated period think market I take to short the little So we be said that a it portion that ready-to-use anyone it expect might expect time. XX% in we we to of would decline ready-to-use And

are good are stepwise we would approach at taking faster. usage, people we -- strong. That’s had initiations titrate dose patient up Recorlev The to strong, an that are titration. bit medicine. of about patient to usage optimal on their is referrals not that terms payer But is seeing that Recorlev difference Physicians are appropriate patient concerned all. anticipated In are patient little dose we a

and the insurance busy, are has Recorlev effectively are being visits through busy starting We patients There a physicians clearing patient insurance. There’s patient the payers, They very testing. a Nobody -- the working EKG are is initial to to with they Recorlev. cleared. until is gets on to get -- then and and time. some referral take repeat an need go are to those process

we has it the said weeks patient a beginning to months an been have Receptivity patient on that So can outstanding. drug. from to be actual from referral

got getting pushback from have of We have utilize than a Korlym, no Isturisa, cortisol. to when physicians. lot have It’s how normalize good think We can product of doesn’t think best a that. they which about matter in side and goal it, better effects. practice. got them it sense their of we Recorlev Cushing’s has Korlym better than We is we the think a product do a in you androgenic which a

think very product. we we So have competitive got a

been so far. have know the a results In by negotiation are and payer do, time. at expected. It’s And we dynamics we encouraged fact, as one we a

David Amsellem

Okay. Helpful. Thank you.

Operator

question comes your Oren from next The ahead. H.C. Oren, is open. line go Wainwright. Livnat Please from

Oren Livnat

If could I to XXXX think your talk upside breakeven, you cash probably Thanks. expectations. current year-end a flow for picture, I big few questions. just a breakeven or is have have guidance year-end which street reiterated major we

main on of couple in current -- that quickly maybe titration a product the drivers have I safe backlog year-over-year that about largely conversion a in your of that seeing, others. component just is that So that can drivers of just growth major they main accelerates is insurance versus mind? the And and now that’s a that? or trends up of to patients of I through there? are main we talk assume it the get guess, the as Recorlev is And Should of you growth

Paul Edick

Yeah. dose, plays big about patients to they The patients Oren, a we better better the we well be get driver, Recorlev titration at to the drug. on to et -- be optimal role it efficient time we an is from cetera. important to the more And getting get a rate over more payers, is as referral where of with time -- more that, the to the as… importantly, going that, that lot the it pretty and at in need negotiate is

Oren Livnat

Okay. And…

Paul Edick

in growth as a Gvoke yeah. …continued --

in growth as well, Continued Gvoke Oren.

Oren Livnat

up something vest following should up drug you or on the any And the Can be point, talked off-label about patients you -- Recorlev issue maintain expensive we phase Is you to a going on drug that close even that adjudication forward? a referred patients titration, and/or any out comment in you going And the and numbers conversion expect is at on just we superior to to Okay. having get to on is are it insurance process? or and a adjudication on the with face ketoconazole that’s very normal just to regards an phase there? pushback trying put a patient drug.

Paul Edick

expensive It’s drug It’s what trying patient process. a and a a very the it’s you put on end. said at just to

in at pushed getting and back having being an are level, something label has not on as we in actual that’s there’s the because, are actually been We -- studied, keto, fact, physician embraced it’s are in is a off-label. to physicians keto the good require They Recorlev. order to really not being detailed on using label, just not payer get aren’t. position And to comfortable keto

Oren Livnat

on Okay. Gvoke. just last one And one

be it growth, it you has should your strong. in think were prescription net there from going looks surprisingly was is that Aside revenue above you just Can play or than dynamics if said like forward? quarter-over-quarter the I recognized any confirm was maybe inventory and higher It it that XQ stabilized growth stable at our was where estimates. price

Steve Pieper

inventory stabilized bit is But I that we kind think of could remain We yeah, where mix. in QX. assuming it price, the of Yes. a It you build what be of inventory it quarter. in to relative payer from Oren, in leveled demand. bit QX, see consistent we would off expect a quarter alternate net and saw I a little we going think, did in the time-to-time. to build did third channels. But, that the little see It see

particularly… So

Oren Livnat

right. All

Steve Pieper

season. … flu to back

Oren Livnat

help. thanks Perfect. Well, the for

Operator

SVB Roanna go next question from Ruiz from The Securities. comes ahead. Roanna, please

open. is line Your

Roanna Ruiz

everyone. morning, Good Thanks. Great.

did BAQSIMI? holiday seeing a could the little going there couple have that end into I some between you questions anything months for of Gvoke. you talk bit expect Gvoke dynamics of and the So about should Maybe a we competitive is on are of XQ? this year And

Paul Edick

to dynamics, franchises Lilly BAQSIMI. biggest competitive are and think, active are much we season during pretty The real the most in endocrinologists. expected. pediatric their They I continues promote back-to-school as

are voice active, little we a and grow to continue they about, when they we more them a I active. of our share usually have And product and bit big because I’d you that’s So more ready-to-use. have and Like said drive they even market to can like growth. previously, I even the got talked a great and are see

think outset, a I bigger early than they is we Like piece of dynamic said the take out. So pie on. are we are competitive going to playing the the at

as much companies they up just want. I manufacturing in products patients product do to to We They And previously, and at can’t as are a ramp we pretty generic continue somewhat. the well. both are that gap to the said But extremely that going their point. much they grow Lilly and us market, like are to the close both can it’s have use. if continue grow this going way And

Roanna Ruiz

Recorlev. to about wanted bit Fair Yeah. And I ask point. little a

like into curious sort you up? ramp average super helpful? know if I very talked about more of maintenance what to color any would had the be Any a insights going the So was as going be that XXXX dose I overall well. titration little on on patients you you expect

Paul Edick

commonly studies XXX. the was saw titrated up we most what were patients Well, in clinical to

neighborhood the except risk the We will during holiday increased I playing way also expect in question, previous you normal. your -- something are But in XXX than it’s any holidays XXX and about Nothing at the that they -- asked you on in dynamics. we special, way. -- that the in different asked utilization and people about manner it holiday eat that somewhere the et think out And end practical in attack up the based drink, don’t cetera. to

Roanna Ruiz

Thanks. it. Got

Operator

will questions. the to further for no remarks. back have Edick We Paul turn concluding I call

Paul Edick

last support all the to personally I want of years. shareholders for you. their long and Thank loyal thank investors over our few

are building. we what in belief continued your appreciate absolutely have We

to continue every to hard on work We deliver value your day investment.

discussed from just see is business in everything shape. our great can You that we

represents affirm to year-over-year. our guidance, continued growth continue and We which meet excellent

and therapeutic areas, day. aggressively. much. substantial development growth unique pipeline in strategy morning products joining and very your the multiple caregivers continued Thanks patients on that a build we biopharma and With multiple have needs based focused, significant support patient-centric, this call expenses managing cash of profitable highly on commercially we value-added to increasing plenty execute technologies and meeting targeted for We we enterprise. partnerships -- every a and Thank and long-term has are our of the as you promise

Operator

This your call. concludes very attendance. Thank for you much today’s

disconnect may You now your lines.

Xeris Biopharma (XERS) 9 Nov 222022 Q3 Earnings call transcript