Earnings call transcript Q2 2023

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Operator

Good afternoon, my name is Chris and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Halozyme Second Quarter 2023 Financial and Operating Results Conference Call. After the speaker's remarks, there will be a question-and-answer session. [Operator Instructions] Please note this event is being recorded.

I'll now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications. ahead. go Please

Tram Bui

Good XXXX operator. welcome our to Thank and afternoon operating quarter financial results second you, and conference call.

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

Chief review our Leading will Helen Dr. Executive financial be the Nicole business the XXXX. Chief an and will second will who provide Torley, Officer Financial LaBrosse, results for our call our update Halozyme's on Officer President quarter and

call, On risks filings of as also for two. will refer today's on would list full and we statements uncertainties. be making I SEC a outlined forward-looking you our to slide

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

I will call the to Torley. Helen over Dr. now turn

Helen Torley

that making of this will coformulated the sixth Good notably very our year-over-year June, increasing Tram. we and the you, annex delivered subcutaneous for meaningful afternoon, product strong royalty received deliver line FDA ENHANZE. on revenues top will our ENHANZE begin with bearing milestone multiple results next of VYVGART Hytrulo wave we Myasthenia we generalized Wave in Gravis events XXXX products most products, is With X growth. project argenx's that approval with Thank quarter bottom pleased utilizing three. where I We're for approved partners line everyone. Valley Slide second

D active are the was includes the the CMS combination distinct inflation monitored the the or notable benefits final more XX June drugs, Halozyme’s for substantial guidance healthcare The to XXXX the for for program, Price publication to and of ENHANZE under guidance and ingredients applying Medicare Medicare final that technology two quarter using on created in Negotiation continue fixed products, provision. potential We're The another for Act. which excited system. event Negotiation applies the drugs. In purposes Reduction guidance Part Drug deliver co-formulated final was patients products of which treats as the to

will combination one of the versions D products, ingredients. administered IV with our capped that assessment product product negotiation, to under subject ingredient ENHANZE separate a active treated drugs. will product from products combination drugs, We contains the our if healthcare separate eligibility of Part practitioner negotiation Today covered and combination B. become be drugs our to a continues will combination which the as are negotiation as only subject product a that fixed approach our subcutaneous believe this partner product price, A final remains Part single different fixed that guidance, be its Medicare own if becomes timeline. from the when for light of CMS treated eligible combination In Part D be the co-formulated regarding these at

product. would then that be is added [ph] timeline. the We outcome ENHANZE believe on product. the And patient IV its product the ENHANZE eligibility the ENHANZE negotiation appropriate combination believe of would then combination apply subject of because We kept price drugs the to imposed benefit a represented version combination is not to own by maybe this

our I'm of rapid a milliliters volume and a high was auto-injector injection ENHANZE announce combination products. Our enzyme listed out that in active Closing rHuPHXX to as our of confirming both clinical various also is delighted a tolerability auto-injector. of biologic XX with ingredient tests of the highlights. the high FDA by an success, these feasibility volume

total where year increase we range financial our the end for the in guidance, confidence our full and XXXX this achieving of and lower for non-GAAP range of All our raised progress EBITDA. have strengthens updated EPS revenue

events the on details revenue some provide me XXXX quarter beyond. during let that are in driving the summary, and that With

leading includes products. royalty specialty Turning and four. delivery company with is business a portfolio, robust and platform ENHANZE diversified our a business, our commercial drug our to Halozyme which Slide auto-injector technology

leader their the partner rapid ENHANZE differentiated subcutaneous established with the we drug remain technology, and As delivery auto-injector across industry. and of an choice

now to strong the quarter, for comprised X Halozyme. our that progress and commercialization Moving X our launch significant milestone to Myasthenia Halozyme and Wave and between in development are with The received partners first are In XXXX, four approval generalized also make XXXX product to their to will and launch product. Slide five. the durable products with to result Wave and revenue launched and Wave in related receive X which projected activities expected for is second our royalties FDA shortly VYVGART growth thereafter. sales. on in Halozyme On the of long-term Gravis ENHANZE approval net June product quarter. XX, Hytrulo resulted of

inflammatory argenx positive XX, VYVGART patients July chronic on which data update Hytrulo, demyelinating it's CIDP. or thereafter, polyneuropathy, in Shortly with ADHERE with ENHANZE study, evaluated

relapse risk reduction marks second positive for With six of are that the of being placebo, in currently versus XX% evaluated. readout Hytrulo this indications the the VYVGART

minutes, OCREVUS forms progressive evaluated in subcutaneous patients of multiple in July primary multiple products reported Roche with or treatment that time of compares XX, will second quarter. clinical and that their multiple of Phase primary the sclerosis, treatment subcutaneous in sclerosis. time co-formulated with the total ENHANZE secondary our met study the positive XX hours which Wave OCREVUS, This OCARINA CID. On to with X with endpoints now of III study with had Moving study II results relapsing

summarized co-formulated with for you We all with delivery subcutaneous rapid can on will this volume patients, independent Slide our In partner actions, is patients. time for ENHANZE drugs. by a which patient reactions, experience. also multiple large it six. benefit active publish in potentially of saw decreases be what of threatening infusion the are subcutaneous clinical and excited DARZALEX is when And progress clear ingredient resulting with of for than and an studies, subcutaneous treatment mean which product an allows see delivery for in improved as patients burden life rate related we treatment we as

to delivery have healthcare throughput the with been wastage. decreased also drugs healthcare Subcutaneous including time and and patient drug of decreased into resource savings system, to greater co-formulated translate and advantages meaningful ENHANZE utilization, demonstrated practitioner cost

infusion be constraints patients capacity clinic in allowing to become time. more access therapy treatment delivery able to role play acute to more their vital can subcutaneous on global a As planned and receive

now of I'll performance. financial provide an overview our

The quarter we revenues Slide our revenue For growth increase. seven. revenues which driver representing million royalty of are revenue a shown year-over-year the is reported of $XXX total XX% and key on

We record revenues quarter Second XXXX revenue years. million. $XXX.X project quarter on quarter the royalty year-over-year to of a royalty continued XX% throughout increased growth

year, of growth million XX% $XXX million over $XXX projection in maintaining royalty revenue, For we're to our representing XXXX. the full to XX%

drivers. EpiPen. Phesgo DARZALEX will the note remains confident revenue. royalty stable are and of is And that timeline Generic largely And for Tecentriq the included this Hytrulo approvals, subcutaneous regarding our Teva’s the royalty products assuming revenues royalty and XXXX, physicians based VYVGART is revenues revenue also XXXX the are timing FASPRO from royalty by and reimbursement. growth nominal for on it we in to be business for contribution and driven no takes our small I the Wave volume which X auto-injector

growth on approximately was DARZALEX and penetration growth continued XXXX subcutaneous approximately Moving eight. second driven revenue treatment on operational reported Cancers increase year-over-year combined quarter This result basis of to shared increasing an DARZALEX, to impressive the IV remains was which with regions XX% in of Slide the on with front setting. gains all in billion. and previously market, line by into the $X.X the increased of

the DARZALEX the subcutaneous in DARZALEX XXXX. the share annual billion who of an of treatment physicians patients for in choice is outside DARZALEX myeloma and $XX.X States. for sales with United project using States United share multiple XX% Analysts established globally a estimated XX% are

DARZALEX driven key formulation, brand subcutaneous total overall now of brand by the also DARZALEX use which to subcutaneous is was growth performance and performance. metric the XX% the With growth, year-over-year the measure

Phesgo, schedule. five shown metastatic is patients allows lengthier Roche’s Slide on for to combination the positive formulation Of early a preferred minutes’ cancer. injections is breast a HER-X and to much of subcutaneous over subcutaneous Herceptin. for now Turning patients of and nine. XX% Phesgo’s of which Perjeta with with note, Herceptin IV for This Phesgo and compared single treatment Perjeta administration the IV subcutaneous treatment eight

grow. XX% first of million. share, CHFXXX An increase of Roche expecting time. Roche represents commented countries eight Roche that of the reasonably XXXX, year-over-year. also is longer to to sales XX% half they're XX% recently [indiscernible] share XX% no U.S. which is continues reported than and of grow of share recent over Phesgo that Phesgo’s and the increase highlighted For countries, XX to

path the second anticipating Pivotal Phase study expected of We're year. with on-body with patient injector the Phesgo self-administration also Roche’s data of half from X an in a potential for

shown is which Wave I'll turn XX. products to now our Slide X on

four As year for these revenue noted potential between launches of and this projected represent products group with earlier, royalty opportunities XXXX. next the Halozyme

the formulation quarter-over-quarter $XXX is with Generalized with of launch organics growth Myasthenia million progressing XX% Let well, is lifeguard the this me of year. start in with quarter to intravenous in Efgartigimod, of second Gravis patients

second injection Efgartigimod Hytrulo for recent of healthcare the subcutaneous annual Myasthenia multi-billion-dollar XX patients administered VYVGART option on in be will new that FDA time predict Generalized Gravis. practitioner to approval a brand Analysts monitoring a The revenue shorter XX with XXXX. with launch provides with ENHANZE

the subcutaneous these disease line is was these immense a argenx’s July with ENHANZE indications being developed autoimmune demyelinating for the only top Efgartigimod six and first pipeline as recently VYVGART reported study, inflammatory four XX, Hytrulo and in a Argenx. is are with only data delivery. indications On argenx from Data polyneuropathy. of on developed being of positive product flagship chronic total subcutaneous evaluating of to-date, indications by ADHERE ENHANZE

profile significant VYVGART its to X.XXXXXX a a tolerability for compared the at from statistically upcoming and to safety meeting XX% with data of of profile demonstrated met submissions. detailed regulatory risk And of the medical endpoint we were and safety study global relapse The argenx for in primary reduction study with value preparing with look This the consistent placebo. confirm presenting VYVGART. and Hytrulo forward P an

underway is that the study the data. CIDP commented population ADHERE Argenx addressable and informed the by which I now the to size positive evaluate of is work opportunity

We study pemphigus Hytrulo VYVGART continue additional this purpura, and two expected with year, the for ENHANZE idiopathic readouts beta thrombocytopenic, to quarter. fourth with in project

atezolizumab has for patients We the subcutaneous ENHANZE a that with XX represents minutes the with XXXX. treatment. minutes in Moving looking to which of the for offer believe within potential advancement prepares. to September administration we're Tecentriq greater time, patients, became and of providers for compares and Subcutaneous to approval physicians date third significant the convenience XX forward XX PDUFA seven Roche's to U.S. now potential IV its to quarter this Roche, approximately healthcare

hepatocellular frontline Roche driven XX% year-over-year, accident, first in cancer of increase billion, Tecentriq cancer. cell the half lung is IV reported the XXXX, which For growth an and of CHFX.X of revenues by non-small

for third findings have Moving the treatment globally. to to forward Wave proceeding demonstrating no X primary positive look Phase We and data ENHANZE, upcoming OCARINA for The regulatory events study XX the potential OCREVUS. an endpoints Roche sharing trial III now meeting of compares for in opportunities for supporting This minutes, approvals the with ENHANZE. the the is to and at regulatory intravenous formulation. that which the of secondary management met results co-formulated submitting authorities to II injection, just hours detailed with with subcutaneous OCREVUS help four data

a than XXX,XXX OCREVUS X. its half globally and and market reported XX% $X represents annualizes which Roche EU patients greater first share CHFX.X than as the more remains With year, leader In now to the revenues continues OCREVUS trajectory. of OCREVUS with the the of in and billion. year-over-year, growth U.S. ID of increase patients an treated, an billion, XX% impressive of

of administration opportunity don't further IV III infrastructure for the possibility of gains market over renal additional The reported ID treatment is their subcutaneous also Nivolumab. FX. registration brand. of quarter IV BMS for of billion expects constraints, an product, sales the utilizing fourth with cell capacity of Opdivo second sclerosis new ENHANZE receive adding have of in with patients excluding OCREVUS, year-over-year X Myers share the Squibb in Nivolumab X% increase infusion patients study the doses progressing XXXX, is carcinoma. Bristol subcutaneous that multiple in growth with potentially Phase Roche approval their $X.X Wave subcutaneous centers, to creating

IV Wave the term projections growth this We Analyst royalty $XX note substantial products approximately and I royalty today. advancements XXXX, is regulatory are Halozyme. higher formulation. is products billion revenue including significantly will in for are than for X these sales near opportunity our opportunity with X total pipeline. product for which driving the in total, the pending approval for delighted In represent subcu products, strong for our that our the new these revenue Wave

Wave pipeline some Moving our partner to ENHANZE. Slide XX, development I'll touch product from with and X on highlights

Wave to for is Our with to XXXX XXXX by supported through get in longer term timeframe. these potential products its the growth continues launches development X

is have completed products, are are X Phase the Wave in two comprised X Phase partner III, ongoing of testing which or and of remaining in Phase XX clinical study. X eight

continuously and new streams. to through is sustainable advanced launch, products number to development approval advance goal expand Our subcutaneous Janssen most and and ENHANZE. revenue of products in tuff And clinical Squibb IV Myers are amivantamab regulatory designing with Phase royalty formulation products Both excellent testing. development The plus to multiple III in approved two treatments. adding nivolumab with the of are Bristol the of already formulations combination subcutaneous relatlimab are

PALOMA Phase their Notably, at Janssen study. presented data from year this ASCO X

reported, designed related reduction all to data data the grade amivantamab opportunity XX% This with Phase from Also for reactions drive amivantamab clinical For dose. to our was identify just technology. regimen XX% malignancies. showed that benefit with in with study patients ENHANZE a II point infusion to the ENHANZE. IV subcutaneous with the the reinforces The solid subcutaneous in

to deal. and high for volume comment volume discussions. recent for on new to expand this year. results partnerships and goal We believe study our serve auto-injector auto-injector technology. small enhance that clinical will our the deal deal, HVI engaged sign a clarity further ENHANZE deal auto-injector the a of these on new and and Let new remains We in now highly IRA new me It new ENHANZE a remain discussions our

Turning was the ENHANZE would biologic, administering were a XX, be a demonstrated study. injector XXml our representative results tolerated XX high XX of immune The willing We provide injection the now was and the seconds of was to HVI well volume the they have feasibility said auto-injector. which it globulin, level subcutaneous to I'll via using successfully of XX% such a Slide that clinical a in The review of is delighted with of subjects, approximately the results again. auto-injector they all injection high delivered that success.

No one a technologies, could inject that seconds. be approximately biologic in differentiated our unique knowledge had done. to technology, to proprietary of auto-injector of able our XXml and XX ENHANZE we're a combination subcutaneously been With this effectively position two in today a our demonstrate and to

garnered. for we across already that for auto-injector results, spectrum expect solution the a disease friendly With volume, advance truly strong can small for volume biologics. offer delivery molecule these positive subcutaneous interests high the patient differentiated have to will drugs areas we that The and both high for utilized be of

Let me subcutaneous virtually by weekly, replacement our treatment, delivered is is painless our to auto-injector. XYOSTED commercial turn which portfolio. now testosterone

of treatment to first their with first is strategy treatment. quarter, demand XXXX, second the of who growth not patients the goals compared replacement demand convert XXXX. intramuscular in the half strong with to growth, achieving we In Our are their half of sequential saw testosterone injections XX%

this a not yet we XYOSTED managers in remain million $XXX on approximately At run TLANDO benefit we TLANDO, And also keep the an this And rate. revenue established, appropriate access with agreement access XX% treatment. on to we're the in rate continuing from project is for testosterone rebate XXXX. time, following to oral gaining reached have our remains low acquisition. revenues in for until goal increase pharmacy Our focused XXXX, representing

which and focus and is strategy capital our growth to maximize our key now allocation growth and are with we in believe to durability, on We're move line M&A. evaluating clear term long and durability focus I’ll shown stakeholders. increasing on all to of our priorities of slide to revenues. XX platforms Investing a our our which revenue our the to continuing can expanding and through approach delivery leadership of that technologies create M&A drug sight extend on value for will our

We’re with broadly licensed, in focused partnering demonstrated on that technologies companies. leverage expertise be can biopharma our

results discuss of for Now who turn the with will quarter XXXX. the financial Nicole? to that, I'm call Nicole, over to the second going

Nicole LaBrosse

Thank you, Helen.

the million another line the our $XXX.X record of well We performance for sets in of quarter expectations year. strong in million achieved total year-to-date, in updated $XXX us financial our up performance plans financial record with second for supporting a for Our revenues year. full

securities cash compared $XXX.X million as $XXX.X to marketable are XX as XX March cash, of XXXX, equivalents Our million and XXXX. June of

projected Our EBITDA balance in sheet remains growth strong with generation in cash continued and XXXX beyond.

share We net-debt-to Our XXXX, X.X ratio in decrease completed $XXX to million XX which for buybacks quarter continue the is EBITDA planned first times quarter. EBITDA of full as growth. is the June with year in expected to each the

while and and to factors, evaluate capital We capital growth our preserving other of use and through to will fund market also continue M&A. conditions monitor future durability revenue

Slide second comparison the second closed Recall that XXXX. our of detailed quarter to quarter by for through May partway And full from on the is the the Antares we of versus the therefore acquisition business. the now XX, Antares year, quarter the for partial financial Turning XX contribution results year-over-year last impacted quarter XXXX.

$XXX.X product related $XXX of XX% in and Revenue well compared and as revenue to and result Hytrulo, addition sales second driven and approval million strength enhanced for a of Antares the the The increase Pharma the by for was of as largely second the to XXXX. the launch royalties of an acquisition. to quarter due growth milestones streams million, quarter as the was VYVGART increase year-over-year

uptake combined ongoing ENHANZE. as well support as and quality Royalty to revenue of due device workforce in as larger for in were period. increase investments planned regulatory by strong compared and in an for and to XXXX. to Roche’s Primarily related second compensation of quarter platform XX% quarter $XX.X million DARZALEX million, second well Janssen quarter the expense manufacturing, development compared year the $XX.X to $XX.X an in million was of to Phesgo. Research Driven $XXX.X the prior as million, the the expenses increase continued

$XX.X one-time of occurred commercial replacement primarily ongoing expenses costs resources including in million the quarter approximately expenses last the to $XX offset workforce, compared that sales marketing second increase combined million XXXX. by quarter products. $XX.X is larger for related to of of SG&A of transaction The in compensation year therapy the were addition testosterone in and million, year-over-year the to for due decrease second an our

transaction second million EBITDA $XX.X When was second diluted of earnings million, costs Reflecting quarter to was per second diluted in share GAAP adjusted the the EBITDA in in from was revenue $XXX.X the million XX%. or for quarter XXXX. increased the performance. year-over-year strong XXXX $XX.X second one-time the earnings compared quarter in quarter $X.XX. $X.XX and non-GAAP of adjusting per share

Turning are updating our strong our reflect to now XX, guidance to results Slide year where to-date. full we XXXX

We million million, revenues million, XXXX total growth from to $XXX and $XXX and increase revenue. total lower representing the increasing are revenues end an of to of expect million XX% between now $XXX over XX% total $XXX

be primarily SC to We DARZALEX and full expect driven auto-injector total royalty year well our strength Antares by Phesgo contribution. and continued of sales ENHANZE product revenue Wave growth product, as X a in as

a over maintaining are royalty increase million of year. to of XX% $XXX year $XXX to an XX% revenue We million, expectation

more XXXX are increasing an We the increased to of $XXX million impact to acquisition. million, expect to the $XXX EBITDA million representing now excludes EBITDA growth lower which related million than of end XX% and $XXX amortization Antares costs over $XXX EBITDA, of the guidance from of

guidance the occurred diluted earlier in increase the now share the an and our of share With of reflect expect range $X.XX. And are non-GAAP strong repurchases per both to that year. earnings $X.XX from $X.XX. lastly, to to guidance earnings increasing results impact our non-GAAP And prior of diluted share we $X.XX per our

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

Helen Torley

Nicole. you, Thank

for focused throughout our robust our of platform by trajectory conclude remain drug Halozyme and and that expanding the XXXX by and growth XXXX. half differentiated the for and on of strong leading and We strong This first a appreciation our and expressing ENHANZE for advancing progress are the my me products collaborators diverse establishing partners is Let sincere team beyond. our auto-injectors. portfolio enabled delivery

in additional positive another we half, the Phase several We're ENHANZE expanding also product CIDP. subcutaneous to subcutaneous with based enhancements predict in There's study our the related and approval progress stage auto-injector Hytrulo Tecentriq potential for our late date readout partner And on second the III breakups for VYVGART ENHANZE. recent with agreement. readouts September. from resubmission and OCREVUS data expecting additional two data and PDUFA a In

delighted your the for open Q&A. With operator, to the you please we question, take that, be would now call could

Operator

from Instructions] Mohit Our with [Operator question is Wells Bansal first Fargo.

Your open. line is

Mohit Bansal

here. Thank for Great. congrats question. And taking progress you my Easy on question. the all

parting patent come how technology talk protection when your of a you for much after about think how partners standalone Also, regarding partners to lack do ENHANZE So into IRA does discussions? potential XXXX? opportunities,

Helen Torley

issued. that for Thanks, with being clarity the Mohit. come focus conversations not isn't is I or into there's With can ENHANZE guidance really divide we it the regard up But focused potential up auto-injector What a that say following are differentiation on and it IRA conversation. D bring. the and will does clinical that I'll more of to really partners can partners, come benefit the or may Part now bring

still is that conversation say would I so and differentiation benefit. clinical very focused And on

of current this partners. with partners can will we are out Part in generally what we of issuance the say guidance, mean. have few aligned And a they us some terms and those our final we that been For conversations. I of believe the have D to reaching After

so Mohit. a conversation, And that a has of become bit

the turn patterns. let And me that to

potential there the are structured, focused they're which way to first granted, If years again, patent you granted, would period a recognizing as after a really And we patent of partners, contracts be royalties the higher on co-formulation there would was we talked be royalty received is XX that if recall for if sale. our rate. a commercial protection,

comfortable patent and be it'd play we composition we very and royalty rate that. matter co-formulation have event lower would be the our the with there would in patents not And expired, that of any think

invention. because to to you And the identify co-formulation patents know, as ahead partners in our of also full steam so they are their novelty that protect majority result far want can

see for back it in has our launch lot XXXX. after So are not not products till can a will you wait us really held of

bit the high So you opportunity that that of nice you that the that their inventions. patents focused are on a and way gives I gives really is them protection rapidly evidence co-formulation they volume only this for think can on deliver

Mohit Bansal

helpful. Super Thank you.

Operator

with Vikram is question from next Stanley. The Morgan Purohit

is line Your open.

Unidentified Analyst

some was for on Hi Thank [indiscernible] of have pipeline question. are of look new for? everyone. what which Vikram, color provide of potential backlog one you to your they we This like Could leverage you. looking products and partners types ENHANZE

Helen Torley

auto-injector, on not Yes, to-date working ENHANZE volume signing drugs focus as say or are either potential opportunity we've that be the go high that mentioned, drugs types own, the two new deal and for surprisingly, also really products for its these the subcutaneous the perhaps and volume subcu, with ENHANZE to for extending interval. of would on to small large we And the dosing high have I auto-injector, volume auto-injector. have IV ENHANZE volume

The majority as are focused around antibodies rather well. than small molecules

ml. there injector in So high be between anything volume really auto people volume where and is interested XX sticking where still would that are we've played obviously, is three before

obviously, For the out there, small for that auto injector for are by our we larger volume of would be volumes, push, in are reliability. choices a auto other and people that there injectors small seeing where a volume that interest who are is obviously lot a looking syringe

reliability. many what cases That tested it's in to differentiates been is XX.XXX% Antares auto-injector,

patient the it failure. looking of people are emergency you by be to that the drugs want that administer use, who've drug got because and don't want to people unable expensive have too, So for want because

area and companies expense drugs. then interest fluids. high who've finally, with And high reliability ability inject interest certainly remains I and said small them, as We drugs, auto-injector, off shelf well. the have an say also got where [indiscernible] with viscous to have So volume have as an I that viscous need some demonstrated we unmet there's the fluid pretty that's from the

Operator

is next with from Michael The ISI. DiFiore, Evercore question

line Your open. is

Michael DiFiore

final does potential it offer prepared any not prior for after and are documents any my and thanks boost Part for or sounds what June on CIDP One, Two out Argenx’s up? and you saying nice top Future fact get you are a future. D about dose line success, believe guys, And about CMS the considers XX. will the OCREVUS progress. be Part CMS to more partners a from like stock all congrats And fixed to trial Could follow on questions the subcu guidance your reason not that products the Hi, did this? came optimistic D? me. remarks, to perhaps Part resemble have I in on whether then Halo’s guidance combination your B color products Is further documents the there taking

Helen Torley

draft right, very reaffirmed Mike. was guidance did this more active one the these D purposes be product the see as That just we And Part B. interpreted came with in guidance And combination going two out. are ingredients is separate treated in we March differently of think when But I would Part that pleased guidance. were nicely drugs of found our say ingredients. a when All fixed with timeline, which that have of as that, the for we negotiation final you include distinct thanks I say that most from are drugs the or for products, earlier consistent of to what the what guidance noting D the is the Part that guidance really terms

And -- CMS drugs. reaffirmed coming and coming despite was comments questions questions D to in response Part for the it that in, in

by know, an you as ingredient. designated active ENHANZE the is Now, as FDA

we bringing clinical some that benefit infusion ingredients of we give that cases, are can reduce just or related two ENHANZE active combinations a it benefit, being also the feel those a reactions. was in obviously clinical injection. And great for and to the so In able recognition this rapid subcu

of with IRA. the So CMS clearly this fitting into intent

CMS have see an doesn't we from D feedback on specific hands the in. basing confidence ingredients any being Part is our two ingredient. received very are clear And on not have provided We a to treated to they the fact comment fit active We're as active separately. guidance whether

B Our see be there D believe between final Part probability was until experts and is Part we guidance in question given this B Part a say a there confidence the But we that can't specific a absolute with won't good that the that that obviously D. asked guidance. was Part change

Michael DiFiore

very low is, to I and of rest low That's in this be explain least it. conversion Got the the in anything is my physicians the terms geographies in compared seems uniquely conversion the, helpful. unique this question comments and follow-up at Germany Germany opening And but comparatively would actual may is how Phesgo to Phesgo question of relative have EU? missed my there? other That to in practice there the your on QX call back

Helen Torley

and like Phesgo, the Herceptin was administration. Yes, can't Mike, the other the the to of the back uptake because have a But specific is system countries And Herceptin administration an I physicians where with speak receive what that bit little -- U.S. wasn't if launch the German were healthcare dynamic. I lag don't we've reimbursement go seen for that to I saw we IV fee information.

where get So perhaps a a Herceptin. see lag the you U.S. of bit grow more terms little uptake. like did we time, Germany in Over the with

up. dynamic ever believe it certainly don't because has seen we've of I reimbursement. a saw it I But is it so catch And been the

see or and But to of similar similar answer I the ENHANZE found partners our whether a realized have our just partners, we to Michael, for Part a had pharma guidance you're potential we'll interpretation read didn't conversations. beginning any in another interpretation. large D through and I asking as date, question, And those to we're

Michael DiFiore

you. helpful. Very Thank

Operator

David is with from Leerink Risinger, open. next question your Partners, is The line

David Risinger

the please. much, two questions, congrats I have updates. very on thanks Yes, and

is track. heard in previously in on that side And Could you your like, deck? a question and response verbally Halozyme partnership to a more you color your So deals you isn't dialogue sounded since quarterly expected an hear little first, please a Helen, included provide just expectations? on wanted I out the to ‘XX. update comment in new slide

second, then remind in about And ’XX? LOE products U.S. will impacted EU and the much. Thanks enhances us be LOE ‘XX very you by could specific in that any

Helen Torley

and new be and include dialogue to the active And experience. In believe auto-injector of we companies the addition of in would would to course across deal, clinically in a remarks, and the types range the Thanks which it ENHANZE prepared the new a HCI, deal. we comment did in Yes. benefit hands as David. deal confident treatment that of small for continue that we assets the of well, from patient's improve ENHANZE new remain volume different you signing

is that So clear. hopefully,

continue just the royalties, just first the products to to for sure we I sale. after LOE, say of period this. regard commercial make everybody to to XX years With want understands receive European All our a

of And extend that the for Phesgo those it revenues on the and royalty at impact so DARZALEX beyond least often from that, we all to co-formulation And for XXXX. extend can launched patent. because all to the expect products

products, step for XXXX half of when be same our down for DARZALEX, patent revenues, expires. the And all a And in that patents terms could hard we're commented the of partners durability in down for the there all -- We we've of while the to our XXXX, valid U.S. with no there is revenues so step States. royalty at the continuing commented, And in as an previously does patents. LOE least our in some a on of XXXX over in just in rate to not that United and extent get the XXXX. current in general, impact Europe get previously XXXX -- all co-formulation is European highlighted and to There, royalty there that. to the have to we'll if we've work in seek

we the composition our extend expert of factor other have duration the of most the expected matter be royalties co-formulation patents of to going that is very clear the step continue an our pass to by any Many important products of unaffected is have down. to to time just are co-formulation to got patents, of But

David Risinger

you. thank Right,

Operator

question with The GSC. Corinne is Jenkins next from

Your is open. line

Unidentified Analyst

Corinne. is potential I describe afternoon. differentiating Good has or Craig This for to volume your high of your partnerships and seeing this one you positive helped foster as had partners on or data Can in what how regards are data auto-injector. partners about it? most exciting recent

Helen Torley

HCI is the just just the that say And Craig. study completed data I off would few price. a ago. weeks specifically Thanks, We

job to believe on file all found novel our don't this number in terms that intellectual done. approach filings is that so innovations one being with we regard And property of all was to we based the

that very actually at sharing has done. filing we're all this start partners just IP of now data that with of And so been the

had of the prior say and it will the once very I were study, we can strong to the that, more with learning was interest intent the that data. prototype sharing I about tell clinical partners, we in you we had

were the XX and more delighted everybody that we're XXml had indicating So which, position in that that, the better Craig, to by well to were see. to have with injection the looking all to partners we feasibility data, know be have the safely we this. about weeks show of beforehand, tolerated know in with couldn't reiterate, injection come over would they and what exactly willing seconds, is We start a the the to potential we're subjects just to months, next again. sharing approximately talking that of partners I and outcome And and a

more what the in So weeks months. next and

Unidentified Analyst

much. very you Thank it. Got

Operator

Jason is Butler with The JMP line next from open. question is Securities, your

Jason Butler

how had the just representative volume I of thanks that injector? to do taking have that? There's brought a data has molecules. success injector just high different here, XXml then as study. couple high And a the you Hi, this you act study thoughts support other value referred bridging in viscosities for biologic, a to questions. preclinical IGG Thanks. think in I auto value on would Helen, predictive

Helen Torley

of was as what is it such to or the we Jason. each themselves. I with partner Thanks, many this in say we immune expect biologics, many know do ways do other of our the value, bridging selected. [indiscernible] going viscosity Herceptin mirrors that viscosity, do regard able it and that to But and With be that's why to the globulin, will

understand a FDA But of great this model I And going do data so ultimate their that across be viscosity, there's in is the believe on able picky the products terms partners to and be similar going different lot based do some of from to being use to a value. with requirement of to we lots have own clinical studies.

right And why team select which so of in Jason. we viscosity, that, our spot the was technical it is sweet recommended

Jason Butler

about or renew mechanisms give Great. you versus powder buyback Helen, for of just capital a would and That's development other dry evaluate, current return looking capital thanks. can you keep how you at one wanting purposes? thinking returning to increase versus And helpful. your shareholder us more, business then whether just

Helen Torley

ask Nicole I'll That's address to Yes, that. alright.

Nicole LaBrosse

Yes, Thanks, Jason.

So we have not plans seen the allocation our year. for capital

to execute this when execute we the opportunity amount year the repurchases -- quarter we We a the in saw first fully the for $XXX share allocated opportunity. nice million and plan continued to took the we for did we on year, buying

in change time. no So at plans this

also via revenue the durability in continue We investments and to very platforms, on much M&A. our growing focused in also our

focus to So this we at on avenues time. continue all

Jason Butler

great. Okay, you. Thank

Operator

is with Your next Kapoor line open. Wainwright, Mitchell is H.C. question from your

Mitchell Kapoor

the question in for the Hi, Thanks everyone. quarter. congrats taking and

we're DARZALEX, FASPRO and with Phesgo. success As seeing

wondering us with launches how go uptaking products? in Just if of oncology you. space quicker of instance, for in the and understand quicker, other and approval can potential the you future kind will help of terms Thank oncology atezolizumab

Helen Torley

uptake, bar Yes, of of been COVID, and in like question. terms speed terms in high and launching think of having of challenges is do shortage sets the just that. the the during nursing thanks I sorts for all that pace DARZALEX in

what identify going it look that good of we is about do sales so more pace saw think uptake Herceptin as over is time, we products, the take that to of we what a uptake three a be. approximately just to different perhaps we a range of we we is around where is how we and about And years. look in example, XX% think share that and to pace at the And

What for oral we plenty an as settings its for certainly, is with we're or therapy. see either of look is at atezolizumab used are atezolizumab. going there on own So to

patients avoid for going to an In that able setting, to infusion, you wonderful. being be can imagine be to that's that

would uptake there. expect that strong a And we so

who patients being by you're very sequential to you've reduce infusion being almost still which value in proposition important. chemotherapy, by possibly and treatment is a hour, an For the for suite, time, an if hour therapy, overall able IV are strong been getting shorted an in

opportunity So well. see we in that a setting nice uptake for also as

the comment to is going we'll wait And earnings go see call. Roche where so they and for as I uptake that their the believe if on think to makes

health Just XX% to patients very important. burden, they really in to expect a of are thought couple because UK, see for countries possible that they their treatment strong ago, with system. conversion then the Phesgo, of as benefit bringing here. care reduction saying pleasure European they the weeks do and That for above for reduction in the Tecentriq attendant some time levels at well, specifically like and expressing comment we're the in seeing certainly what in uptake, of we're the And did the that, savings that

patients to as of come by this and the because expect that oncologist received are benefit. we to underway. launch more we be So do see the But healthcare clinical by well and system

Mitchell Kapoor

Helen. you, Thank Great.

Operator

The Mack from line is next is question Chandler your Jefferies, with open.

Matt Chandler

completed next? Phase Phase and you in quarter. X Congratulations or taking question color able was know, that noted ones eight to be for the you for Wave to X, progress One completed products have just X Mack This X. Wave is expect have for on questions. Phase are you products, do Thanks. which Could you into give Eun. which on any Thanks X the the on

Helen Torley

can because get partner data of analyzing a in their decisions, on us partners any certainly communicate we were be the information. Mack, little we And confidential like that of what in Yes, to and would are the making development they restricted them. so don't bit that ahead process

to wait we on plans. So steps their make until next announcements have they and

recall, disorders. reasons. that nice products HIV of other competitive for are are the wait until Obviously, we we're ready not eye in we're But And delighted relatlimab X to for and that development, often clinical thyroid and have a do very two our other have choose products they are to just partners their neurological disease, programs array going that nivolumab. for Wave development talk that including for in and products to amivantamab of that clinical about to

are so them can't specifics as as yet, as And soon all but giving we as we by in any announcements are we interested run when can. making front you

Operator

from Capital The Caroline Palomeque with Berenberg next question Markets. is

is line open. Your

Caroline Palomeque

the Thanks Great. taking for question.

an you runway Thanks. And XX-Q mentioned months. are what On cash on you your up the look about sheet. on cash wondering, or follow would you which And balance that raise? XX just strategy have like? M&A for prioritizing to I'm just So that a

Nicole LaBrosse

thanks, Yes, Caroline.

equivalents securities of and with on So cash cash marketable we ended million and quarter the sheet. balance $XXX.X the

at continue to in EBITDA nicely note and net we ended well EBITDA within that debt leverage ratio a Also growth and flows. very cash So feel in project this to we with capitalized very from Also a quarter times. time, perspective. growth X.X the

general, that find to our mentioned plan, platform, and our invest in in look in the M&A of remain be timing we an and in our From capital investing unchanged. and share four perspective our year also to M&A in three right cash when deploy repurchase meets capital our criteria. will continue growth allocation investments really the to per plans target I the that We'll perspective allocation our

Caroline Palomeque

thanks. Great,

Operator

We have for participating. conclude time no further at and you will this this today's questions call. conference Thank

now disconnect. may You

Halozyme Therapeutics (HALO) 8 Aug 232023 Q2 Earnings call transcript