Earnings call transcript Q4 2022

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Operator

Good afternoon. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Halozyme Fourth Quarter and Full Year 2022 Financial and Operating Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. Instructions] [Operator

Communications. this over recorded. Vice to Investor and that turn will President is Relations call ahead. the Tram Corporate event note I being now of Please go Please Bui, Halozyme’s

Tram Bui

you, full XXXX and Good fourth conference operating year And to financial welcome Thank our Operator. quarter results and call. afternoon.

Investor find our during our presentation that slide press to after today’s addition supplementary in issued today of the be a referenced Relations market In release close, website. call the you section could will

call update the Helen LaBrosse, for XXXX. Halozyme’s business; as Leading the who be will Torley, for quarter who Nicole results Officer, fourth President Dr. XXXX, Officer, well Executive and will as will and financial year review our and on guidance Chief Chief Financial provide our an our full

we will list a for making be SEC I uncertainties. forward-looking full our to refer today’s On call, you filings of and risk statements.

and Certain the financial measures and During financial will both call, slide GAAP presentation. financial discussed. comparable are GAAP measures earnings measures in be press the our adjusted release non-GAAP reconciled or non-GAAP with

call turn I over the to Helen will now Torley.

Dr. Helen Torley

results, across Tram, continues financial positive everyone. and good XXXX very reflect Halozyme XXXX. am with to momentum fourth the for performance entire you, positioning quarter company, full and and year I operational our strong and exciting Thank pleased afternoon, which creating an

auto-injector of subcutaneous to with our and platform company in auto-injector addition delivery Pharma software diversification our expansion of volume The products as through drug of progress specialty and the ENHANZE the businesses. portfolio also In platforms. a and XXXX, through leadership revenues resulted small of extended we continued and the a and the our acquisition Antares the acquisition

driven three, our of product of includes the businesses. in from slide portfolio revenues by achieved an primarily continued acquired strong This $XXX to specialty auto-injector increase million performance of growth ENHANZE revenue was we our Moving XX% year-over-year. XXXX, record and

sales same the replacement and XX% royalty resulting and from prior product. million, sales volume period revenue of royalties year, an was testosterone product over quarter our increase from $XXX XXXX small continued incremental commercial therapy in our Fourth ENHANZE of XYOSTED, growth the of revenues, auto-injectors

ahead, look entered Year opportunities. we we with the growth compelling As New

the support utilizing new and our ENHANZE, auto-injectors goal our volume Our current volume to and plus our expand ENHANZE number high of capabilities partners auto-injectors. small ENHANZE

reflected As over million, is million $XXX XXXX. million, $XXX growth to growth. a project for result, of Halozyme of guidance positioned revenues growth. in we to XX% for is growth XXXX continued $XXX of of EBITDA This record our million well XX% XX% $XXX year-over-year project and We to growth

goal In XXXX, for we launches have new multiple atezolizumab. include Current two efgartigimod potential commercial and ENHANZE opportunity and contributing near- These growth. subcutaneous subcutaneous new drivers partners advancing of to long-term for it our to volume new agreement. programs. advancing in the plus and their ENHANZE agreement development and into And is agreements targets science a ENHANZE auto-injector small auto-injector new high-volume clinic and

projections. slide Moving now will provide revenue I to overview the royalty of an four,

revenue fourth growth XX% from which million, auto-injector of For in XXXX, to ENHANZE of XXXX. million royalty royalty XX% over total growth reflects devices the guidance record $XXX of our quarter of a to $XXX quarter our revenue, continued and projected was we which $XXX strong growth revenue royalty project represented in This including fourth million, from XX% total $XXX performance, million XXXX.

real growth. Phesgo subcutaneous and barriers and Wave either Our adoption revenue of X and Europe robust the the adoption continue in faces strong The royalty demonstrate no subcutaneous in that rapid products, drive to geography. DARZALEX DARZALEX U.S.

our patients of Wave our worldwide X by ENHANZE product X in utilizing and X, upcoming growth demonstrates strong growing As fifth for rapidly and products physicians the the acceptance ENHANZE. excitement The supports launches. of launch Europe our product subcutaneous adoption

remarkable on FASPRO, achieving XX% growth focuses which DARZALEX sales, grow five, slide the total version to in of sales the the share on subset move quarter total fourth of of to States its now XXXX. trajectory. share United which DARZALEX continued continuing of will I of the DARZALEX, end of by is DARZALEX

total DARZALEX continued strong in XXXX to also growth. sales demonstrate Importantly,

of reported Janssen’s subcutaneous Johnson billion, parent IV full $X on year an of Johnson XXXX & worldwide both including basis. DARZALEX, XX% year-over-year increase sales almost of forms operational the and an

more basis. of quarter, For the an worldwide an operational year-over-year fourth of increase billion, sales on were DARZALEX than XX% almost $X

DARZALEX by Johnson strong market gains & year-end that share all results sales and highlighted Johnson in driven in growth continued call regions, the on continued of FASPRO. their increase was uptake

DARZALEX annual use sales will for total of where for frontline result continue revenue subcutaneous. grow a We for will strong come as by to the continue in analyst this DARZALEX DARZALEX than to and the $XX projections of to FASPRO estimated more years growth predict majority XXXX. With in are use more achieve is therapy, to opportunity in billion vast be DARZALEX

for a injection second subcutaneous with and combination of Perjeta HERX-positive Herceptin Our X for is Wave and metastatic breast which cancer. Roche’s is product early patients commercial Phesgo,

time the sales In good a With intravenous million continued XXXX, administration. to brand. conversion the in Phesgo XX% a saw to to Phesgo launch standard in CHFXXX XXXX, with $X year X-minute well with countries, for billion early full reporting subcutaneous Roche underway compared offers to X-minute uptake becoming ours administration a

conversion stated and to significant On fourth to that call, expect their they continue. Roche continued recent growth Phesgo quarter

overview of six an our slide Waves On of potential launches. is

represent subcutaneous Focusing Wave projected with mixed and ocrelizumab. launches on The XXXX set royalty XXXX. opportunities atezolizumab, potential nivolumab are Wave X, products between these and revenue X efgartigimod, of a products

potential XXXX which are remaining eight of comprised launches long-term growth is timeframe. start testing. X Phase products, XXXX the by ongoing and trajectory testing or in X completed our X Wave partner Phase two Our Phase further of the XX products in supported to or about is have X are clinical to X Wave in with

X by now to say I is seven Wave launches. about I few that a about our why excited am move and potential words will slide so the represented

at important derisker development administration. an is of products the terms an of in Wave least in all intravenous indication risk. Firstly, are This approved as X one

all of year the along and between Secondly, this potential XXXX. soon

represented Roche’s argenx and review and decision atezolizumab approval our our are terms key for the opportunity the projections of higher Thirdly, point here for products revenue of analyst subcu positive than launch fourth opportunity sales the with X in that strong potential regulatory significantly from growth in studies completed subcu billion for XXXX, further is in total are products, derisking under $XX that the currently product opportunity and X the is XXXX. royalty efgartigimod to-date. driving Wave have two Phase And these

provided European generalized to January argenx subcutaneous myasthenia and X the for utilizing XX, on of announced of the Agency. has argenx, of sufficient right. of the to summary License FDA provide is now of detail update product. review for the with allow the has A gravis June PDUFA on submitted. slide efgartigimod with products November also XXXX, provided that the of a time acceptance of the some treatment the the Wave each XXXX, Medical authorization for XXXX, Application me more to in been Beginning Let Biologics date ENHANZE marketing adults indication-seeking ongoing studies In that submission their application an for been argenx a extended data

the our with of partner has efgartigimod launch Wave subcutaneous in and commercial to the second approval launches first U.S. XXXX. potential X that projected excited are be We the of half

indications, autoimmune for being development treatment of are indications which six disease efgartigimod indications product, pipeline for flagship argenx’s delivery. the with subcutaneous of developed multiple four subcu of is As only

in inflammatory Multiple second of purpura revenue for predict XXXX, efgartigimod half thrombocytopenic data readouts in quarter chronic idiopathic including in total of annual the in $X data and the Pemphigus and projected are in the demyelinating second Analysts of billion year. XXXX. approximately polyneuropathy XXXX potential

$XXX The the the launch physician fourth early its countries. and quarter, XXXX strong revenue of version for demand net and year million revenues full Vyvgart of product reported to the preliminary million. launch total results argenx noted certainly start is patient intravenous for In a $XXX quarterly and off in strong of

Moving atezolizumab now our our delighted and with are Roche of with subcutaneous is to them X Roche. we collaborate opportunities, partners two and and on subcutaneous Wave to ENHANZE, of ocrelizumab. longest-standing experienced one

the the of be License November Beginning with minutes physicians time for subcutaneous an ENHANZE. and for convenient with submission X-minute XX Subcutaneous approximate a IV the to Biologics of treatment. to with atezolizumab to announced to more the for atezolizumab FDA administration Roche a Application XXXX, minutes patients EMA has atezolizumab. and Marketing potential Authorization compared In XX Application subcutaneous to

the XXXX, date September PDUFA Roche on only full With a anti-PDLX subcutaneous XX, of expects for to the be atezolizumab year. market

call, year XXXX. revenues earnings to In growth for billion recent IV year-over-year Tecentriq to full increased the of Roche CHFX.X its excited are reported We see continued Tecentriq. XX%

Roche. at billion to than for now in Transitioning OCREVUS more of for regimens Currently, approved IV OCREVUS of are sclerosis. XXXX, OCREVUS achieved both fastest of XX% X and during for sales the longest. multiple time at CHFX representing X.X is there an consider the hours the increase receiving patients We Roche’s year-over-year for use. X schedule, the observation IV the hours range treatment to

Phase target for ocrelizumab time. and the each and the for administration dose second is a is the observation ongoing administration goal or X hour, the subsequent The X first total subcutaneous, data that XX-minute observation subcutaneous trial time approving for and dose, supports with regulators

expected out study As this mid-XXXX. is read in from you

recent its call, nivolumab X recently in Moving second patients BMS year-over-year to carcinoma. XXXX, ENHANZE sales of increase fourth study progress its with quarter nivolumab, in of Wave study XX% with cell of with patients BMS nivolumab, fourth XX% OPDIVO our an with for excluding renal utilizing also to X BMS melanoma. FX. ENHANZE continues $X.X IV X a product On subcutaneous of subcutaneous full year Phase billion noted Phase And initiated or

within derisked driven timing summary, Halozyme, royalty opportunity the drugs that more approval the also the and the speed X of of revenue of In Wave time projected and peak versions window opportunity for the XXXX with subcutaneous to represents subcutaneous. substantial new XXXX conversion of by to near-term

and meeting study to make the a supporting XX comment I on studies. Let pipeline to that expand brief just our pleased goal least report me continue XXXX we am advance initiation partner support XXXX. ENHANZE pipeline, now in XX very progress starts, of new to new our ENHANZE at

new supporting two into three and advancing regulatory final with the X development products of to prior submission. clinic These programs, ENHANZE Phase partners step supporting starts initiation new the included in

subcutaneous an explore the further we studies potentially supported profile new addition, designed seven to of additional and partner initiation In of ongoing programs. expand

the nivolumab+relatlimab of revenue contributed collaboration pipeline approximately recognition subcu. notable Phase X to $XXX XXXX, amivantamab subcu In progress total for initiations for with this in milestones study million recognized strongly and

of In is streams. to and new adding advance number and multiple expand to development beyond, royalty revenue continue in development to through approval goal to regulatory launch, and XXXX the our products products

X will slide move nine. is I candidate shown our on which to pipeline, now product Wave

if Wave potential which XXXX. XX revenue to proceed have in launch between and X We development represent they product in and pipeline, XXXX drivers candidates our approval and

combination fixed-dose derisk. Phase these which BMS’ nivolumab+relatlimab and amivantamab an important or X soon Both IV is development. with in again approved to ENHANZE, as products already development of are subcutaneous start advanced most two The are treatment, of products

the is with In Janssen being RELATIVITY-XXX, studied cell combination with Phase drug administration ENHANZE goal also not has study of advanced Phase of in lazertinib+amivantamab or initiated that ENHANZE intravenous of lung Bristol-Myers a combination. metastatic levels of called X the patients study in initiated nivolumab+relatlimab to patients of non-small untreated fixed-dose with XXXX, this cancer. the In metastatic exposure X inferior EGFR previously same unresectable or demonstrating Squibb melanoma. XXXX, mutated is which And

patient expecting We to in the in first early study be XXXX. dosed this are

slide an now XX. on auto-injector Let to update our and on transition beginning product specialty me businesses

strengthened opportunity combining ENHANZE our Our auto-injector a further acquisition the auto-injector know-how. by high-volume drug our of last Antares develop with in delivery, leadership to year, creating

quarter, with and auto-injectors volume and for our high new current partners. the discussions the our opportunity continued In we small fourth on potential

enabled small and that drugs of patient-friendly, rapid up ml for for XX opportunity biologics. treatment both of areas differentiated can for delivery be across multi-injector subcutaneous disease the a high-volume delivery ENHANZE utilized to truly Our offers high-volume spectrum molecule

feasibility In XXXX, working the by clinical and and progress XXXX. development we significant made complete for of is on prototype. midyear team studies expect the human testing prototype ready initiate The the to

auto-injector. development gain an to with or a a on of current is high-volume to custom XXXX partner a in goal new elaborate agreement the Our

which I commercial and is treatment, includes shown as TLANDO on delivered XYOSTED auto-injector. turn now XX. is which will with XYOSTED, weekly replacement slide by to patients painless our virtually Beginning subcutaneous business, this our testosterone

in stone accelerate Our beyond. a is goal as in in and million growth to grow XXXX $XXX over stepping XYOSTED to XXXX to revenue

gross-to-net the deductions in we focused identifying and have acquisition, seven developing points-of-prescription since leakage reduce opportunities demand, XXXX, the that identified. XYOSTED increasing identifying we In address to to on months and plans

a slightly QX continued came in and mix than lower month driven of While lower to high we achieve have price our levels expectations, weekly new lower prescription net by projected. in each XYOSTED revenue XXXX, than demand

am over exit is our revenues XYOSTED with million to see $XXX to As to that on growth in plan we excellent demand pleased in the I start, with an off start deliver year-to-date, XXXX, track XXXX. QX

focuses strategy injections. from common which on the growth treatment Our most approach, patients is converting intravascular

healthcare testosterone that virtual injection physician associated approach may pain or be a XYOSTED delivered painless subcutaneous a offers practitioner can injection weekly IM challenges. these auto-injector administration. can require with with its address new by and patient-administered

We gaining on for treatment. our also access focused TLANDO, testosterone oral remain

We have for pharmacy not on we rebate TLANDO yet rate. revenue appropriate reached access is XXXX. are benefit an in agreement Until with managers projecting established, low

the slightly million, projected acquisition. of Antares, came on which the acquisition was $XXX million have at our total below to in we provided our which of Closing the $XXX revenue since million, time range $XXX

allocation our commitment our shown slide on strategic capital the XX. reiterate hand and to to Before over I growth Nicole, let priorities me call

revenue goal durability. to and Our continues be maximize growth to

continuing plan. our to shareholders with buyback share to are return our capital We

have program by Board million million was We of now the of the $XXX of that $XXX XXXX. completed in three-year December approved Directors

up factors part as goal $XXX of Our this XXXX million repurchase to is in additional and pending conditions an market other plan. to

we evaluate are revenue companies or seeking where and platforms M&A we additional see durability. continuing derisk platforms revenue or with significant also And for assets, growth the to opportunity opportunities, technologies

call Nicole, Nicole? discuss who I will the to XXXX results outfit turn and for our over the financial now for XXXX. will

Nicole LaBrosse

the of non-GAAP in We Thank the was Antares and marked record to a financial by completed of of a royalties revenue growing business. accretive recorded as revenue that expectations ENHANZE the and performance. being you, our Helen. year addition Antares acquisition XXXX result strong met Halozyme EPS.

We with at strengthened debt-to-EBITDA that X.X% strategic of puts sheet interest balance refinancing a net combined our rate cash position our a in capital also a through walking generation, into a with us lower year-end. ratio strong

have repurchase our our share repurchase our the million XXXX. share as committed share contributed full shares to through of XX.X which to we With the per non-GAAP Helen resulted earnings to remain program buyback mentioned, growth. And deploying complement EPS capital programs repurchases, year XXXX our XXXX, since in $X.XX for

XX I our will slide now quarter to financial XXXX fourth for turn highlights.

on million, $XXX was which to as a the revenue, royalty focus increase to DARZALEX fourth $XXX.X primarily the increase will for total I addition in of of result quarter, The for driven increase was acquisition. XX% of attributable and fourth subcutaneous revenue million a an XXXX. Here, sales quarter compared Antares by the product

quarter the an million for royalties, XX%, $XX.X included period. million Revenue year of increase $XXX to in compared in the prior

and quarter, Lastly, $X.XX share for GAAP per non-GAAP earnings was the share diluted diluted per $X.XX. earnings was

more to I available release press some results. with year of a here will will I with the today. review SEC now touch the XXXX turn on XX-K full slide XX details our and highlights briefly filed in for

product up $XXX.X million from contributor XX% in royalties in Total revenue an revenues main $XXX.X to revenue grew XXXX, base The XX% to substantial sales of decrease million million, million, from increase $XXX from of milestone million. from of of year higher from revenues up sharply Product $XXX.X $XXX.X $XXX.X was of from due partner saw to XXXX off acquisition. already the $XXX.X million contribution of this from XXXX events. XXXX. a resulting Collaborative driving prior the Antares in million fewer were XX%

that the assets the useful result and acquired for products. as auto-injector Antares a related in expense $XX.X the life acquisition, year are intangible which we of platform a Now over of is proprietary amortization million to amortized technology

primarily to ongoing in development XXXX. combined expenses in related larger acquisition XXXX. were million, to These an general million administrative compensation to $XX.X increases Selling, and million $XX.X workforce. expense $XXX.X increase to and the compared the were Research $XX.X were due and million, expenses compared in

was to $X.XX $X.XX, XXXX. in EPS compared GAAP

tax included from our valuation XXXX reminder, GAAP share. onetime $X.XX a the As approximately per representing reversal EPS of a benefit tax allowance,

XXXX by increase Non-GAAP prior for $X.XX, our XXXX EPS expense, an year achievement in tax recognizing an share. non-GAAP the per year year impacting as impressive the EPS income $X $X.XX was reflects first approximately from and

and $XX.X compared million December million $XXX.X on equivalents were XX, December securities cash XX, XXXX. Cash, XXXX, to marketable on

are Now was XX, provided XXth our and guidance year. let of this to on XXXX we first me which slide reiterating on turn January

of the representing million, total we XX% year revenues over For to to between million XX% XXXX, $XXX full expect of XXXX total $XXX growth revenue.

increase $XXX over expect in to to XX% revenue of from royalties a million to XXXX from XX% between million. royalties We range revenue to $XXX

We related acquisition. Antares expect to EBITDA of excludes amortization of million representing $XXX costs XX% of to over more XXXX and growth impact $XXX million, the than the EBITDA

per earnings to $X.XX non-GAAP share We of $X.XX. expect diluted

repurchases. Our share does potential earnings share per consider the of guidance not impact future

the back With call that, turn I over to Helen. will now

Dr. Helen Torley

great year supported company culture you, combined for made team our enhanced drug transformational in We one as Halozyme. that Thank XXXX a our delivery was continued growth. a leadership our strides with Nicole. and

XXXX for the will approvals of with Wave our our collaboration commercial subcutaneous be year resulting the potential with growth subcutaneous our two ENHANZE, agreements goal of revenue include in atezolizumab, opportunities. and X development of new the and products. across growth start high-volume product launches potential Highlights XXXX auto-injector progress continued another from with platform signing significant our in efgartigimod continued

I regarding by growth that made thanking and is the our in I will XXXX progress Halozyme excited for our revenue EBITDA guidance. in strong strong and our team end resulting and plan collaborators our XXXX. am partners

for be joining take call delighted And us with for would you questions. open you, your we would that, now today. to Thank everyone, questions. the please Operator,

Operator

Please question first the Fargo. go [Operator Bansal Instructions] line come Our Mohit of ahead. from will with Wells

Mohit Bansal

products on co-formulation the we have the you. to lot treat question patent have which on for clarity and products Act Inflation you Reduction Maybe patterns? taking do protection progress. the one this Thank Thank how will ENHANZE some congrats Great. point, a all is, question due my get especially at longer we

Dr. Helen Torley

and this provide as as update are provide still an be is details will going it’s to We watching it Thanks, to implemented closely we obviously and and CMS exactly awaiting a still regulations time, are clearer. how there so At to the clarity. not Mohit. we that becomes

is, the clock. difference obviously, it’s a that really restart And a and would a launch different different whether subcutaneous, filing have question a BLA which date

And interest that’s so, of partners. no give answer our definitely but that can and them to us we yet, Mohit,

Mohit Bansal

Thank Got helpful. Super it. you.

Operator

line will Evercore ahead. with of question go from the come DiFiore next ISI. Your Mike Please

Mike DiFiore

second cancer X question a Hi, on Two Number is quarter. me. is to subcutaneous big Vyvgart for noticed concerning and opportunity. from thoughts cell a Obviously, be pretty ENHANZE? my non-small the taking XXXX lung this the And for congrats in question may guys. Phase to you on pembrolizumab+hyaluronidase. Merck Vyvgart. project of on one, I be Any Thanks how the that different bullish the subcu size of expected conducting trial be seem and

didn’t that, a PDUFA your not in guidance? So Vyvgart delay having said why change the lead to

Dr. Helen Torley

Thanks Yeah. questions. those for

begin as Let on on we Merck. me We how question the is exactly noted study details Mike, they are proceeding. to what have that with the don’t data any using and Merck start. that

So on be we can’t question, to really would them. obviously, comment better a that. address That

position the than who position with number we patients deals we proven great is negotiation subcutaneous supporting we regard with ENHANZE our puts ENHANZE, five of delivery have. a in do have leader great with and well-tested versus record to to in we drug really track proven say more continue success received drugs obviously and established expand can What the for XXX,XXX us of find of approvals, treatment a that have

that I will on all one. that’s So say

data to PDUFA as PDUFA of and so time be additional FDA three date the some was during They that more the did June now review. Vyvgart, they that extended that needed submitted by that aware, to due months people date On XXXX. feel is review process may the

to pushing today. make associated out with XXXX still that have all so, change information we milestones months based within expect guidance fall approval products, do of our just the any and have to three this doesn’t on We obviously, we

Mike DiFiore

it. much. Got Thanks so

Operator

next Securities. question with the line comes JMP Your ahead. Jason from of go Butler Please

Jason Butler

question. for me. taking Thanks for Hi. the Two

doing, auto-injector give about that the that, your collaboration or can us this expectation that how then, for that to you are partnership some testing, occur? work an ENHANZE you secondly, success First the of that you Thanks. feasibility assessing And year. parameters all, or the potential Is with could XXXX? clinical maybe are previously progress work you in pointed still

Dr. Helen Torley

Yes. Jason. Yeah. Thanks for that,

are actively a development We both high-volume and are potential discussing planning and -- we program partners, auto-injector. current indeed beginning with new of still the ENHANZE with

discussions. So very the happy those with progress of

some other the we The models mentioned, in human which feasibility we studies remarks take created to that prototype. our year, data last we is have of midyear -- just study. a which and But a patients, goal. feasibility by in and tested We end prepared my for volunteers clinical now reliability basically to it We it. expect want of of show into was the it

on That’s to the So, designed in as appropriately to amount and doing a the endpoint primary of that types the required the devices way for was focus the will and an confirm pretty do. of tests drug example, of standard prototype it’s in just it number nice deliver these fired what effective time. is

Jason Butler

the taking for Thanks Great. questions.

Dr. Helen Torley

you. Thank

Operator

Your JPMorgan. next Jessica question Fye the of will come line from with

Jessica Fye

questions. Thanks Good the taking Great. for afternoon.

elaborate you enhancing studies slide studies little can the deck device. and profile the First, on last of regarding mentioned -- on-body preference patient the the bit on a

like well. through second, Can earlier not products hyaluronidase own a whether and/or approach, any similar a be you Merck would there. Just curious ENHANZE-ish as pembro hyaluronidase you. to you about little that an sounds then, following Merck’s to walk using you worried question to why about pursue up creating it’s on trying expect And learn subcu more Thank IP? partners infringe with their

Dr. Helen Torley

the And device. those about on patient for begin profile on-body we showed. for think, enhancing of slide you particularly to and hear Jess. Jess, with Thanks XX that’s study preference deck I I the will studies questions, the on the wanted everybody that

are can And provide enhance used. to partners all patients development types drugs. it’s late-stage or or already be for profile regard with are physicians done information and/or the -- these drug doing additional are commercialized inform the to how studies These that studies of to

partners think here, but from about routine profile and the our These to more we and you them partners are drugs actually list can are I are but expand listed that didn’t actually pretty exciting that in have continuing development. explore them all on to that are find permission and clinicaltrials.gov, trials on

With start Merck, develop and think, incorporating really are partners worried focuses factors. a about the to that number reason their of to hyaluronidase current own move regard wanting not I we our and on

is track we immunogenicity been bring worry very one has a first you strong that, The a a record. safety that they biologics profile. is with combine treated, and well-characterized when The very XXX,XXX about two safety issue know that together patients

First negotiations comes that question up is in all that of deal our new worry.

the that’s think I first one, Jess.

also reason why think, fix a another low-cost reliability with very phrase our all strong and supplier broken, of relationship We to in reliable consider expertise And a development conscious being our it, regulatory like if our of supply. partners, established very would aims have and doing demonstrating the you of that. that obviously are is partners. and I We that about the not

So no sense. about then would that thinking make

molecular strategic to large more and I And the royalty speeds new for deliver partners, example, many as new bit at little is it’s on are, on they resources reduction in to more of time rate. partners, and entities developing focus we the in a a take third are to think, one, then rather for our them the look than costing, revenue what focused modest

that think to and those rUpHXX indication our highly And so all unlikely we partners own develop there. of their want factors, with would it’s for no

Jessica Fye

Thank you.

Operator

Jenkins of Please line go Corinne ahead. Goldman Our Sachs. come from will with the next question

Corinne Jenkins

Yeah. Good everyone. afternoon,

just for me. I think for clarification So maybe

you the about a X a that enter ml, some mL talking as are we and but now XX I development lot where of you the talked XX ml clinic? gating previously version before you Can stand about about in the well. just talk have the can think of steps what that are

Dr. Helen Torley

Thanks flexibility for X XX that, it ml to been wants, Corinne. can And on prototype actually designed with partner from deliver ml. has what anything actually Yeah. our depending that a

And we cartridge in just depending development. actually the same able so wants. fill the basic have partner what volume on be it’s to It’s be the will varied prototype that

plan evaluate to that of testing we to will year do options volume clinical several XX this So this ml. up some

Corinne Jenkins

you versus Thanks. portion your of of something mL provide that? less helpful. under than you clarity what fall partnered that portfolio on? X ml XX then as kind That’s And about them think of products, versus can current Is

Dr. Helen Torley

Yeah.

XX small We acquisition, volumes, today We tended have volume are when did a handful for that current work ml but in Boeing, are there common mentioned those on our certainly the mls in a XX range. of are that being quite number to partner have to partners that we X we programs our of ranges. larger ml who

and information the They when said haven’t this in deals to ENHANZE also provided that. get what that do we position we are the But to auto-injector we a as so not to and part acquisition, did strategy publicly, the moving collaboration new is new high-volume a partners. is of

in to the out the ml be used as alone ml may us that allow us I be future to well. And can opportunities there say XX that of number from us evaluating for landscape, we see X that delivering a

of open as a So this the was opportunity here opportunity with think market whole of some current for up really partners, to that. it but ENHANZE for new

Corinne Jenkins

just me. one one Thanks. for Maybe last

launches product those year. this we for in we patents can a some should coming about We near-term? the the path think Is of have co-formulation get to something that visibility couple on How got products?

Dr. Helen Torley

Yeah. have applications marketed to partners for ones that advanced- for development Corinne, patents. co-formulation filed pending already I actively say all who our can of of have currently number in all that or got say, received products co-formulation have also I very can late-stage our are the engaged patents. a of patents development

by and point domain, will at come about find patents something to them Specific talk public is and and about we not time, able think you that as to are partner because the issued, will be can able that’s be visibility those will partner I we talk confidential information them. become in

the support our can obviously, of protecting we we time for benefits are which general, partners and to time of the about out support, unanimous and inventions duration get pleased very But their or in patents, down. spec co-form filing royalties also their terms have in been us they the in push have and because, those

are on we new So our co-form submissions. aligned very -- and active focus are very we

Corinne Jenkins

you. Thank Yeah.

Operator

with from your next go ahead. Your line Purohit will of come Vikram, the mute. question maybe Please on line Vikram Morgan Stanley.

Vikram Purohit

hear Can now? you Hi. me

Operator

can. We

Dr. Helen Torley

Vikram. We can,

Vikram Purohit

Great. my taking question about Thanks Okay. for and that. sorry

we So subcutaneous one ocrelizumab. had question on

the foresee So positive, for do market, subcu here recent should how here developments Thanks. data this multiple ramping X competitive sclerosis particularly some assuming oc in the a Phase given space? in you uptake is

Dr. Helen Torley

Yeah.

treatment And observation, of supports taking latest of comments is with are the an injection data on therapy X initial to goal being which Roche, based so hours the subcu a the we minimum and midyear, hour the X.X ultimately, to from minutes from the the and XX for goal hours if and with for down observation that. data expecting, doses time

that So MS a receiving who see to lifelong an go for patients you will therapy, what having are and be infusion to suite. can transformation

competitive that specific I do has that but be And for that commented to uptake, and so XX-minute injection, this market delivery. to that not other Roche they able an subcu think a option will based on market. very they the exciting have the simple with on get commented be and available profile on products see are the

Operator

go the from [Operator Securities. SVB will Your ahead. David of question come Please Risinger Instructions] with line next

Dan Tarjan

Two for us, This Dave. is Dan questions please. Tarjan on for

decision X X advancing So, a more the candidates time Phase color after typical to candidate you of X. X X your in and portfolio also for provide enters including the Phase on go/no-go Phase actually Phase Phase can one, line on and some historical candidate

Second and provide the first on quarters? Thank question, you of following the quarter color can XXXX any you. modeling

Dr. Helen Torley

All right.

our that simply, regard Phase as with to candidates, be So right? So today that our are would what that And calling on individual as products page listed just plans depend really Dan, those and Wave to is. programs to we really you that exactly be the X does line all can it nine. on X page, turn partners -- imagine, the will what time

In pretty atezolizumab the The at such into studies in end nivolumab Phase that the ongoing, cases, two have moved of as we their the that top and are products from list decision. are that Phase [ph]. repilvary rapidly of X ARGX-XXX other and case X

you forward. wouldn’t So those studies and still are so move active

teplizumab. there, study one is There

where with heard the and going final on there. in before, for we Horizon XX we comments without and plan so still that are I options to forward think a they from we have say talked waiting Page were about evaluating decision

on the being X But in that’s still majority I with here completed. examples, are the the say based teplizumab of just would ongoing listed Phase those one studies

And Phase once a X those and decision studies a of with finished and design are study. conversation the made is so the FDA often the about there’s

sorry, to is into quickly X for plus It partner development. for of usually X to think, a and us. time a is out see you is between just I bit little measured wanting question, a the If in time, move I can cut forward a a six or reasonable who for transition, am we months second you frame Phase months might Phase Phase X move repeat a minus,

Dan Tarjan

problem. No Yeah.

So question for any of the the perspective following second was, the modeling first XXXX quarters? and quarter

Dr. Helen Torley

Yeah. I will ask address that. Nicole to

Nicole LaBrosse

share. Happy to Yeah.

we we total a are from look provide a guidance while revenue is collaboration to quarterly able we perspective, can QX, that So basis. forward I to revenue. on don’t share What say

to flat of the second year. year beginning be the into in are half in and of of have second weighted milestones we XXXX We the sight quarter and really do versus line more being to XXXX forecasting relatively the

a of So little that of expectations. bit give sight to you line can

when then at I royalty. maybe looking talk And about

to full just our $XXX for So $XXX guidance to is million. reiterate, the year royalty million

EpiPen. and is see of seasonality after quarter growth be flattening to in then and do driver the in QX our we really what sequential first that’s there throughout the sequentially grow a with While year

reset start year FX expecting first and the quarter. have QX, of in the we true-up are the into looking We minimal at also

Dr. Helen Torley

And bit that of will color. to provide wanted add that we so just I

to a in of We growth that going milestones also the quarters terms in are our in royalties Nicole subsequent excited the both but QX, see continued are are as little will about we said. that that very -- begin

Dan Tarjan

That’s you. very Thank helpful.

Operator

further Thank no Ladies questions will have for this We gentlemen, conclude that you today’s all joining. and time. meeting. at

may You now disconnect.

Halozyme Therapeutics (HALO) 21 Feb 232022 Q4 Earnings call transcript