Traci. Good for joining us thank you, afternoon, Thank you and on today's call.
getting progress first So and XXXX, commercial our six achieving towards significant U.S. goals, approved quarters and financial both in our and made the Europe. three pipeline, our the we launched products progressing development of in
which quarter. quarter expected as in has initiated originally Day, in – you is that process, R&D Health Brazilian to was the the Ministry let pleased are purchasing result and of third revenue expected to we know addition, In this their since
are can reaffirm So based revenues XXXX for within the that the to this be current year full update, guidance. expected total on we
full year, income guidance a expense and more the $XX now details we and guidance and provide With top between $XX other pleased increased we have non-GAAP of moment. are the at report guidance updated that million controls, also continued confirmation million, and will for line to Dan sitting in
So to attend our key listen like brief to those week, overview who we were last and R&D want you provide who to to be would were updates there. I thank of of to able a those or for Day unable
U.S. So the depth the and now the from before capabilities known of next we with initiate announcement IND X and now enrollment presentation, have to the from BMN with that development of candidate this authorities Phase of our our as UK details quarter, health the on both the were XXX, research valrox, to our green each definitely global year. program the light end the of display
be to roxaparvovec. or Nonproprietary going BMN valoctocogene So our forward, referring will INN, valrox, XXX for Name, International nickname the we as
So you nickname. want understand why a to use we
background as summarize the PKU U.S. we last level authorities. years So have and almost with updates we we titrate with for The to starting dose provide pegvaliase, learned have XXX process important patient of through us week, of regulatory pegvaliase to effectively with provided how benefit. with with said, experience as maximum the patients move we therapy, health
role applications. Importantly, patient process based December, on engagement last has XXst Century in that review was very into a orphan drug signed Cures for on guidelines Act the prominent taken the law in FDA
XX support years the the (X:XX) in data the filing. to collection legislations sections Specifically, encourage patient of
a meeting significant video with later our This with first potential an treating a very and for you quarter as pegvaliase FDA large MAA of in board filing Pegvaliase of given patient the first as well XXXX, look forward of the many satisfaction EU deep and represent is market experience our is meaningful the achieve the We with PKU saw pegvaliase the day, ad at patient Phe to opportunity, quarter. As important our unquestionable. in patient part who physicians. during this of pegvaliase approval in those of lowering review R&D our half engagement XXXX.
we of dose, durable as vosoritide treatment growth. growth throughout showed XX for data for XX microgram a months velocity with Turning well expectations supporting achondroplasia, to continued as
of Specifically, period been this mean velocity absolute growth of patients experienced over time, what growth would X have their centimeters over increase predicted. approximately baseline
U/L in continued new of in provide, with time by mid-XXXX, the treatment we continues ratio the improvement upper addition, study measurements, In part vosoritide data information and the a top line The body pivotal XX of of and in to second half as that's with and XXXX. months anticipated demonstrate or measured completion over ratio, proportionality, as lower update. a enroll, anticipated
likely next As in infant/toddler year, of in this particular, (X:XX) belief anticipate the we sales is the that our with in is significant in week more – that patients' last Vosoritide to begin potential XX,XXX drive it approximately the to we of supporting patient in on our treatment half based study this increase. begins, numbers first market opportunity earlier represent indication (X:XX) territories. will our a enrollment announced
have Phase year both end. and studies to UK X now U.S. authorities valrox, by For clearance we health from proceed to
on in With you to launch recently dose. patients capable XeXX study of our plan are We weeks Each with we We and XX U.S. XX start, the XeXX study. approval forward at and and the facility and at keeping valrox up levels for expect XeXX study, at planning the end XX,XXX around from UK, the with XeXX XeXX to scale, apprised one commercial normalizing begin both the VIII manufacturing the submit the year demonstrated with by and based to look result maintaining good XeXX dose Phase is this a As safety will thereafter study to begin one supporting with Phase globe. and be long, we commissioned valrox X year-end. adding the annually dose, the Factor of will least dose, profile. the by again at producing and to additional be sites manufacturing, the X
key enrollments this XXXX. year, at of on two-year update the study with the one and to would year-end data this year Phase and and December, of XeXX medical program be first provide by with next expect by line update XXXX, dose The X top dose complete we dose So the then the the of the in meetings, ASH mid-XXXX. XeXX update beginning XeXX later year-end
earlier potentially coupled XXX, our the Friedreich's FDA for are candidate, will expedited issued indication our and modifying very modulation BMN to first disorder. designation have happy of BMN therapy today, from approximately year next granted address disease IND debilitating therapy earlier We product a delighted announce share development the prime also who patients for chromatin been worldwide the valrox. support registration pathway. We Therapy news and EMA, a EU also And with neurologic this Authority cardiac that demonstrates granted Designation by for we its strong this were Ataxia. Breakthrough XXX Health Global this, XX,XXX this suffer the to and in could be and
by a demonstrated from received which in MPS and XXX commence escalation the epigenetic competitive affected portion XXX, trial can with these designed our lead therapies increase brain a of In We with to products line clinical through pathway enter XXX to In second cerebrospinal and and reduced for posed milligram range IIIB, completed pegvaliase for this both dose and XX patients. lower drive XXX markedly children. preliminary study, X/X are which of was IND our anticipate four the for submit in one operating or very XXX vosoritide, We dose assessed baseline, levels, our sulphate, CSF, B XX% in sulfate all opportunities, next drive patients three to nearer activity milligram, the three accelerated are of the billion non-affected level. heparan compounded BMN of months. the sulfate sulfate heparan expenses encouraged top over are commercial of fluid, Whether so that determine as BMN levels, valrox year. were revenues which space total In normal pharmacodynamic a XXXX, BMN dollars studies elevated this results that, will half to in the of at patients in the the at and define approach, share growth. Phase degradation intend specific primarily biomarker toXX missing Ataxia. term, CSF reduced in a increasing preliminary plus or current are After XXX disease X enzymes or that heparan we we confident results. milligram we heparan BMN Sanfilippo to were safety Friedreich's and rate escalating
increasing commercial and With the the position to a we expenses business and ultimately, our move towards current engine our drive of are products R&D now and profitability forward, stabilize development to profitability. leverage GAAP in non-GAAP next strong scale size
last three we compared increase generated results, the a quarter year. XX% and year, over $XXX increase a last quarters quarter of Turning third revenue now third first the million to of total XX% of to
We very patient accomplishment revenues products continue with during report we initial global the to are in demand Brineura see for our In add pleased network rollouts. we strong happy for gradually and to-date patients million $X to as conclusion, legacy are in our XXXX.
now in valrox Our have studies the the X both that U.S. gene moving with we into program UK therapy go-ahead globally, Phase the is and
the to approval BLA status study. for on of learn doing well – redo submit pegvaliase next these result on to is half expect first approval based year. hope The we this in from We results and the
progress to and continue with the we Freidriech's patients' submission XXX next support Ataxia. physicians' will complete for IND program XXX BMN vosoritide BMN with of Our while our
and we rare commercial is on products with So six the portfolio pipeline, diseases the believe the in our unmatched industry. in five market
billion call to in Jeff? will commercial I $X.XX the expect now to and year. review who Jeff will we total drive Importantly, And the turn $X.XX in detail. this more between now business billion over revenues
