you, great. Thank and Jim, morning, everyone. That’s good
achievements a $X built portfolio. medicines. important billion XXXX we the developing line by highlighted important business across operational So top was through
of XXXX efficacy of ALPINE and for program, study. VUMERITY important clinical and the from submission Phase multiple our the the sclerosis, the safety With the NDA, VUMERITY the EVOLVE-MS-X XXXX positive data of study and X ALKS approval from ARISTADA presentation data ALKS initial
took actively reduce our steps company focused sustained doing position cost of in XXXX, accelerate business future and our also important for implemented a our pipeline and to shaping to of the our restructuring products, assessment We and in strategic long-term structure a and the structure, profitability. drive In rigorous we order the so on growth. through non-GAAP
thought We experience our creation formal leader, a an One and Board public Therapeutics, development oncology wide of building efforts expanding through value on strengthened acquired neurodegenerative Independent CFO, we in company disorders diseases into Directors. the range expert. CNS our and a on new Rodin our other two and in focused
enter So ALKS and XXXX, disorder; HDAC-inhibitor clear: through advance priorities we as in X development the of for of out execution; the are launch XXXX VIVITROL of and ARISTADA ALKS the growth commercial our platform. drive schizophrenia our key build and prepare oncology in XXXX bipolar
So turn. I in these will take briefly
the in of Our this many with work core exemplifies in and values of schizophrenia addiction ARISTADA company.
through our out there are medicines for We centered patient working these advance care day our advocacy and science, conditions. people to with our every serious
impact we real-world of a it. very making and are proud are We
reliant Alkermes is elements infrastructure growth, unlike force crisis for to address VIVITROL and state its other required dependence. health From products. large medicines policy is opioid important and a foster driven business. are our funding. to adoption geographically these Its on of positive which to represented the the part by is pharmaceutical any public in incredibly helping change
years In continue this is of medicine. trajectory predict. growth and to understanding XXXX, the increase landscape. awareness growth and in paradigm extending challenging treatment impact VIVITROL. the and will order this to for into And invested to dynamic drive focus driving We've on and we Its many access profitability
And differentiated strong are in XXXX compelling we and continues opportunity a grow this two growing execution. an solid access percentage a and our comprise of pair of These have ARISTADA a -- demonstrated in about ARISTADA products evolve. profile year-over-year revenue is XXXX. to growth to clear a XXXX. value to revenue. With drive engine proposition, increasing growth family, product the
was stream VUMERITY, we developed next a market from of discovered for revenues MS. XXXX, which and oral IPR dynamic was approval decision and and last FDA l new novel the royalty treatment this which generation TECFIDERA's relapsing into And Alkermes is a fumarate development quarter. of forms by MS, expect In for market. received a positive VUMERITY a launching U.S Biogen for week, last large of
a XX% unit royalty profitable has We VUMERITY. for sales on This net received from us the been of sold. product first
this acceptance of tracking X in to important was running, an of Biogen's launch. looking schizophrenia forward ALKS XXXX So we're bipolar last off for the milestone and we and the are and The program. progress month disorder NDA
are which of would at grow the the end and contribute XXXX of planning for to psychiatry approval We potential franchise. our year,
in provide payers made organization psychiatry we and well-positioned of ARISTADA launch thought leaders, for commercial to The platform are established investments and our XXXX leverage policymakers physicians, space. we've our a the in strong presence the with
schizophrenia X disorder, key Across successful efficacy and to bipolar is outcomes.
efficacy of to has important the be NDA treatment profile, XXXX and you to working look differentiated option. and the an preparations tolerability forward for with agency updating With new of the through review its the launch. olanzapine a on the We potential
Our in education state two payers. focused is prelaunch a of and disease work range with areas: engagement
the IL-X the protein Harnessing most exciting activation immuno-oncology. the to pathway be the So is activity selectively development designed killing IL-X the expand immunosuppressive I'll to turn of continues opportunities XXXX to cells, IL-X in engineered cells. antitumor investigational one avoiding fusion tumor immune of pipeline. induced while of our
clinical intravenous initial SITC our last XXXX elements, we In core ARTISTRY-X, and study; safety ARTISTRY-X The made efficacy from both and program dosing XXXX, dosing November. data in subcutaneous has two study. development and important presented at our progress ARTISTRY-X,
ARTISTRY-X presentation. since emerge data The continued to our have
tumor had of consistent SITC. new approved profile what pembro As responses at unapproved partial both presented safety we in observed cut, data and XX we with a and December types
and both on with will responses therapy meetings. the more had future reported year. we medical of patients on a And in more been detail than February at discuss XX, that for at As we’ve partial SITC others results
program only development dosing. for the active subcutaneous with IL-X clinical variant in is potential XXXX the Notably,
emerging We data are overview ARTISTRY-X. grief And from particularly initial give you some the encouraged the today from findings initial by study. I'll of that
every activity and examining the three weeks The In also every The of regimen compared for a administration both as that the consistent was doses expansion weekly escalation by may profile demonstrated the profile subcutaneous XXXX predictions. of cells. initial weekly once dosing, effector suggest regimen. IV initial observed measured our dosing of that ARTISTRY-X potential thus the as with biological far escalation have pharmacokinetic and tolerability data cohorts emerging in ARTISTRY-X weeks three to once improved showed subcutaneous
As drug December with In regimen serious 'XX in data escalation study no of treatment of adverse related cut, the XX February adverse of reports due were subcu discontinuations a the study. events the there events dose or of to to continue months patients that of more. XX XX received of ARTISTRY-X, were phase of dosed treatment having or X five subjects on XXXX those as ongoing with
data ARTISTRY-X progressing efficacy, interesting to number Patients designed of lead-in rapidly to terms single is the In provide potential agent a of has demonstrate the and help have of monotherapy activity XXXX. period disease enrolled sets. X-week
second continue of X data stable first patients December the stable with scan had upon these X the of and cut, As XX of a majority disease to patients have their disease scan.
of expanding new As accelerate opening process the we the and clinical enrollment. in program, the are development significantly we network we expand clinical U.S outside of are trial to our sites
this We sites first these to later of enrollment quarter. the for open expect
perspective, of into for are dosing profile, visibility evaluate potential subcutaneous collaboration increased now in opportunities ALKS we strategic regimen efficacy and XXXXs XXXX. with strategic a emerging the positioned From to
complementary With a a and the of cancer key potential to approaches, the XXXX variety collaboration potential will treatment option. as to be with exploring of treatment be maximizing
broad builds Alzheimer's other neurodegenerative and of well platform. experience by array us characterized Huntington's to that going developmental inhibitor as and explore diseases I’m allows a to wide our such synaptic in schizophrenia dysfunction, as turn diseases and our Rodin HDAC loss transaction The and like are on Next, depression as disorders. and to psychiatry neuropsychiatric
by that HDAC brain. that new synapses powerful potential have the And have of drive approved some are agents. the to diseases. clinical of address so, oncology neurodegenerative epigenetic formation disruptive as most regulators accompany the in symptoms doing inhibitors HDAC been inhibitors
and However, whether it these effects. their never could these separated agents are limited toxicities from be by hematologic clear prosynaptic was toxicities
HDAC's specific function multi with in protein complexes. association
CoREST, IND in CoREST This inhibitors HDAC for which of involved is focus and with genes which neurons. primary a Our with repression subsets, enabling advancing directly and activities preclinical program of is synaptopathies. one on chemistry these specific called prosynaptic targets is research
Anticipating our us insight clinic, move translational biomarkers into development. to developing tools and early in clinical we're the give
chemistry living This excited and commitment platform. options very chronic bring the medical about CNS diseases this therapeutic to of the investment are to around with our is the high. unmet We long-standing new biology innovative is reflective and patients where need
in products, oncology. the and growing for we updating you there, progress. billion while sustained top in an proprietary commitment across to on portfolio an So to forward is profitability our neuroscience exciting look strategy important non-GAAP path our $X with creation pipeline and XXXX clear. year We’ve to commercial driving a a will value line and be and shareholders
I that, run to Sandy turn Q&A. it will with So the to back