company Halozyme. And first specific open this then I'd Elaine it's from of Al. those topics delight a pandemic. call recent firstly one the to to today, by the you, utilizing investors addressing call technology one FASPRO to our greatest and Halozyme Chief companies our affecting business her are impact our on DARZALEX ENHANZE the two interest to approval welcome at like all Thank FDA as of COVID-XX and to really Janssen's Officer the Financial and
the the company. many in remaining. history This drug growing May very name represents approval of our FDA of form This call first since a Xst receiving fast brand DARZALEX our in that for ENHANZE the received approval utilizing DARZALEX IV FASPRO. with be Janssen news is of with utilizing and on will the the of commercialized events of its for ENHANZE a the both exclusivity our formulation that U.S. exciting subcutaneous is which one technology significant most is This years product blockbuster
arriving receipt ENHANZE also generally in the approval. the heels potentially event approval of in This recommended the utilizing opinion Medicines means CHMP follows recent on U.S. for clearance Europe that European from is Agency mid-XXXX. The also subcutaneous DARZALEX a which Janssen’s horizon of positive on marketing
As DARZALEX the was broad FASPRO Slide approved. IV X, five granted ENHANZE indications of on which seven currently a the utilizing covering is you’ll note for technology label form
DARZALEX We multiple estimate today. address myeloma IV analyst is label of estimates ENHANZE that our to how this for the FASPRO on majority used utilizing patients allows DARZALEX assessment based of
the Importantly, the for arm the in a and it has for the studies approved this rituximab not was as it We first comparative during meeting that the indications large, be stated to complex for time alluded utilizing an was FDA first FDA ODAC every each of drug. view an on ENHANZE in demonstration which product this when studies. single actually based approach, might indication evaluating to do XXXX already necessary ENHANZE approved with at combination
for submitted approval Janssen case, studies. based on this In two
compared daratumumab treatments. ENHANZE to single The study examined with III daratumumab a the patients. study about is treatment called which Phase is subcutaneous examined different with which XXX first IV combination in earlier SC lines in Phase And arm II daratumumab three PLEIADES study multiple in myeloma second COLUMBA a
view for importantly, multiple all who a and this our are myeloma ENHANZE receiving for for the Most IV of huge partners. is very development plans from currently We believe suffering this with encouraging advance other win patients we a treatment collaboration clinical terrific DARZALEX. as
this strained offer the with value the to valuable three reduce from to ongoing system. often and five to system patients convenience more is down ability pandemic COVID-XX from four to is day every obviously time. even the today believe tremendous to hours the This and We the healthcare impact applies will six perhaps administration time at healthcare to but what it's minutes
Top the so of the those well investors lines many pandemic. This of enormous COVID-XX on great globe. the everyone has created X as mind Slide and This that for brings for at by second as impacted the Halozyme obviously to directly front are those the and topic treating is disease of challenges to interest people at around us patients.
community could I have how effort. be employees of The Halozyme our to not to is this our team committed joined part in prouder helping and doing the
COVID-XX, Now despite our our I'm pleased see and of can the in patients to challenges disruptive maintaining mission better progress patient solutions experiences that posed outcomes. overall by we’re providing to with lead
an where now to operationally update stands the me Let financially provide you and during today company as the pandemic. with
now our nine Halozyme in and position financial in strong remains products approved programs multiple partnerships, a with today four development.
a model to poised solid earnings. robust business have diverse We generate growth and
growth of and our long-term outlook. we in We've workforce. remain We the confident measures sheet health have many protect strong taken our to a balance wellbeing and
communities During and families, their is the our and of health this local our priority. highest employees, safety pandemic, our
essential onsite shelter-in-place anticipation the maintain staff employees to to high our to California. rotation we working limited COVID-XX from home began able from emerging continuity, to were that successfully and pleased pandemic we we've small State worsen. the implemented the a maintaining we mandates February, majority of number in a our quickly we home from been In see to working team of develop the staff for of and report majority able plan As should to of of a level in and to I'm transitioned situation a of mid-March, preparedness assembled productivity. business transition the the the successfully for
work collaboration by planning hard able of and our driven the proactive our this our were the nature the do of business to because model. continuity commitment of and we team to addition business In employees,
of to I'll from we the works plan To-date now between delays we national, with continue starts don't ahead two original yet our we what describe will regard the plan global that think XXXX occur returns program, in expected our business today, to to will when date. local to developed we of to And we to one what workforce know on majority continue quarters as clinical know the as we our team and community guidelines. preparedness With partner a on latest feedback, state the time project based based our a office, already COVID-XX. still in XXXX refine to that that fight study the has
clinical delayed has non-milestone COVID-XX trial date Phase that completion. study yet start where result as have bearing one know We been longer do information and I we start trials where not target resulting impacted been enrollment also has to new time have a an two of the on of in expected
usual did Moving pharma March broadest biotech to slowing quarter. of feedback, had. new the will expect second have some and we've the the with on pace discussions the see of ever conversations in revert enhanced companies discussions one we company of this of both deals, we in slates We Based and in April. ongoing pace that to
updates supply. currently and to our or we to our Let in ability with supply do our move the contract in update our as this to ensure Hylenex safety API reliability COVID-XX. working to feedback, an expect ensure our We're me on CMOs an integrity our to of chain. hear a of interruption of supply. contact now our Based not closely API on and manufacturers supply frequent We're with the result
or Our identified on contract that they substantial essential an have have COVID-XX manufacturers and communicated risk, continue to effect significant pandemic operate not the may a any resulting delay from concern have business delivery of product. any as that during
to manufacturers our the operations products. provide to of ability We'll obviously monitor their and contract to continue us continue our with
agencies to have initiatives pandemic, pace. we're appear to the regulatory at some proceeding report that a normal the while activities regulatory, regulators Turning curtailed major our with now pleased globe around be to during
a utilizing utilizing for in April also As ahead in FDA late with of we're after received examples and BLA April their July was its the and U.S. month, action the subcutaneous also XXXX for XXXX. SC assigned. the SC date demonstrating after July fixed-dose Janssen October XXXX FDA track of are pleased this utilizing their and that earlier received following ENHANZE submitted DARZALEX ENHANZE combination FASPRO DARZALEX late Janssen in submission DARZALEX utilizing XX, ENHANZE opinion to positive Europe things in note in of for in submitting of Janssen approval of December XXXX ENHANZE for BLA NDA on submission Japan CHMP Perjeta/Herceptin looking
the and highly with We're remain EMA our engaged certainly partners the the during encouraged that pandemic. FDA
as guidance at confident in we summary, the all based and from XXXX latest expenditures, on this as time. our planned feel our suppliers well partners So maintaining for of updates our
position to growth pandemic we monitor It's new to to the by information In emerges. unfold despite coming execute continually future our in quarters. posed situation continued COVID-XX will how difficult will a Therefore, in recovery summary, updates challenges on very if drive strategy obviously the remain strong predict provide Halozyme. for the the and we've well pandemic, and
quarter of project and partner quarter XX% move DARZALEX sales the update DARZALEX. stated that and franchise generated compared to IV formulation in of the deeper sales globally to addition on all a XXXX the has in programs its in Analysts approximately in frontline billion billion $X setting. treatment $X.X currently the growth beginning Slide I'll in is part, of of Janssen future a setting approximately our community strategy first utilizing subcutaneous form, of for current supporting core XXXX. with of ENHANZE DARZALEX $X.X this goals the their now expansion in grew X In DARZALEX key into first XXXX XXXX XXXX. billion to in on
ENHANZE The potential daratumumab value is proposition with strong. SC of
of commercial be period in an the established, during will ENHANZE and provide EU U.S. uptake resulting and for and and approvals, launch which the what franchise. the in reimbursement with ENHANZE all about robust ENHANZE of approval we for of mid-XXXX, DARZALEX post-launch DARZALEX in utilizing Halozyme. delivery With the strongest will formulary believe potential excited initial drug means strong validation approval DARZALEX date revenues the over extremely FASPRO are growth ENHANZE We granted potentially our orders FASPRO we're royalty just FASPRO after to technology expect this EMR
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in As announced filing year. BLA expects U.S. the in assigned October Roche an XXXX. this action drug U.S. the of February, XX in the this is we launch accepted of by Roche's the and date FDA
advance it pricing in occur most Herceptin product sees the CHMP that opinion On positive healthcare been technology offer the a that breast submissions completed would recent an an in for EU also Regulatory has that offering, also its Roche the the quarterly as and approval the the flexibility call, may an segments. some enhanced alluded interesting combined following advantage XXXX. we Perjeta, expect past strained fact system. utilizing SC, have indicated combination and the cancer in very competitive to And in
demonstrating Illustrated product very PK to have non-inferiority approved. successful date, products. non-inferiority currently now selected Phase study Phase have to to is turn are and approval approved development that ENHANZE. a risk I’ll a a support X approved, with then identify with a X been on usually carry or ENHANZE successful approved products These to and development pathway are endpoints. in the moved had the When X. We PK on To commercialized of a now the examples all this eight Phase products dose, with have efficacy that study that X of multiple and the ENHANZE. that slide has focuses already to these low Slide are been
labeled certainly FDA on provides each full indication. feedback, of granted SC was programs FASPRO discussing time label faster control this DARZALEX breadth need more potentially. just trial a to based without This development do formulation encouraging for designed development an our the that for of partners strategy. of the to current IV utilizing evidence And clinical for development separate indications of the excitingly, Now patients leaner to a gain are to allows many access ENHANZE earlier set
products. Herceptin and RITUXAN commercialized ENHANZE. products I’ll its move our commercialization global technology, subcutaneous our continues ENHANZE of now Slide to MabThera, with currently X and with HYCELA, to utilizing Roche
commented that modestly Although a royalty impact biosimilars, of subcutaneous seen decline result interest an the from anticipated this to from are from physicians Herceptin. year recently has revenues in level of products ongoing as Roche these it increased
of the the early for reducing others of amount worth the is While to trend, it’s call too time is and a this desired. it presence noting certainly current environment in
has we utilizing Moving from products of are see developed now can is target The On current information X our XXXX ENHANZE. to we our X and in Slide starts trial Phase this trial the X, Phase that pipeline most Based continue our X being on development summary starts Phase new you unchanged. been a for detail trial moment, new products. the and partners, to XXXX. project in we a accomplished nine I’ll have and projected in starts three five
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evaluating myasthenia is a argenx for strategy ENHANZE bridging efgartigimod gravis. with in addition, In
Alexion, evaluate ALXNXXXX year. in plan January associated no the basket no There recently had down was as to that us to renal this they Moving longer study. of informed milestone in study they they announced this with
now $X ENHANZE latest portfolio revenues growth the partners, information new Slide revenues in to to associated based of projected now on revenues we by end cumulative development. continue and the larger is in later-stage millstone in in non-risk strong million. projected Moving the of and $XXX XXXX. revenue and strong approximately next near-term indicator milestones. milestone royalty of many which planning milestone on revenue we between approvals advancing our XX. target in to this has billion of payments revenues with of potential, the driven have currently Based future is in or project number programs are be important million from milestone milestone to to with products been larger royalty years a to the which progress The development, growth This the increase three of in $XXX XXXX revenue associated project projections also we And adjusted to be drive for the and proceeds an
turn Let our now the of an me to overview capital Slide approach, return. XX,
capital expansion our share addition sign our repurchase in our accelerating recent drive growth strong this, value just to cash our reminder, growth first the flow, of investors at high are where similar our next collaboration to business. is priority partners. an to of will current goal in acquisitions activities moment. maximizing the details potential business With is the to return, with Elaine for to to and a free revenue by will a ENHANZE As a new we share commitment approach seeking is margin collaborations via repurchases. of our working returning our the priority discuss and capital And there evaluating growth. evaluate through ENHANZE new high technology long-term In our the platform we of
quarter to now the to very financial of Now update, first discussion results. the over I’m with a for pleased Elaine that turn call
