Thank you, Kevin.
spin-off a As remind quarters, the I'll stand-alone our in if you a of as on are presented basis done results to carve-out Organon previous I've present It's were not to which is GAAP convention. intended that company. results accounting, prior
financial XXXX we to of June that financials it X, a our that comparability date where year true periods, clear where won't can Organon. time, and line we'll that's as comparisons discuss be P&L we'll revenue draw have I prior was that where stand-alone want prior to represent for discussion. spin be items best is post-spin our we to the until third the results, year because quarter apples-to-apples So results, the start all Until
impact not we primarily and brands the portfolio only LOE facing washed LOEs quarter up X, to currency new billion, The constant turning quarter. impact was of out We the was exclusivity more related out In in during happen we modest a loss first in it's new drivers, U.S. DULERA. LOE United Barings of graphic, up entrant LOE quarter to and XXXX, generic according in established revenue far of has impacts. significant in in XXXX, December any the have of of exposure Since for exchange most rates some XXXX. third and as highlight the X% So approximately when I'll been have expect reported to States. for this The this year. did XXXX $XX compared LOE happened in Slide the didn't thus we quarter the the million, break last revenue forward. or the the and change X% first significant expecting That to going in not at $X.X key
will should year happen currently results, that is our this limited incorporated read Continuing LOE that significant Our have guidance. due and potential current first quarter to the into implementation expectation chart. In year, to it was December impact is year XXXX a in for on any waterfall view the of DULERA, third China XXXX from of VBP. the volume-based round across of impact the last procurement the full
year then, products. X to of point on that largest first PROSCAR, Arcoxia. round compares new included was there from was the back Singular PROPECIA no impact when quarter Now Organon's that products. with and and Organon's of this pediatrics, That LOE the VBP
from this U.S. volume also China for and as grew products from business brands, in the volume well growth our to came fertility, base our LAMIRA growth retail significantly now, which China and non-VBP Moving established NEXPLANON increase region. for as brands, The but volume quarter. particularly Europe the in pillars, biosimilars, in and in in quarter outside the demand first
volume growth some the mentioned, If brands, And pressure. by business. this about onetime FX XX% we Kevin XX% evenly that the in XX% think onetime in base pricing of revenue quarter about X% and ex in the that favorability As was volume growth Established growth, growth to in the was items offset for was split of items. due established quarter underlying it brands between
of moving. Japan the compares currently under to Japan kind geographic and The of was them of when none sales competitors the was just of this contract was you action quarter of of onetime which third supply give franchise, products that the to to government the the the outperformance preparing to product among items be year bucket and Merck taken in arrangements. take would expectation an lower drove the in lower to due sales issue example consists several last parties, which we're a about, that quarter, weaker in demand represents manufacturing in supply needle performance other Given things market. talking margin the to alone, brands That established supply temporary largest the diversity other primarily prices. in But impacting Japanese lower pharmaceutical first
supply quarter, to about our were $XX year-over-year, consistent with expect the these arrangements that decline. For view under that's down million we and sales volume
fluctuations on is currency this derived that XXX of global understanding surprising basis markets the revenues of revenue. not headwind and during Finally, distribution X. we first translation show Foreign about This exchange represented approximately of points XX% also, for outside States quarter, our is quarter. which the given where Slide in geographic Briefly were the United
established on in the ex-U.S. both earlier showing in in All following in year you had in in brands solid Japan, established were brands prior and our here, can in the NEXPLANON growth nicely constant see ahead Latin the at regions China favorability up and the of up my performance APJ of in America, good region, and currency, fertility. we comment,
women's take on let's a by X. look at with Slide franchise. We'll start performance health now, So
reported X% business as Health in currency year, Those in decline led XX% quarter offset quarter. in Follistim, FX down continued constant and Women's was currency which declines NEXPLANON strength by partially fertility decline X% the driven and grew Our constant first in ex were X% in by a at prior versus the by NuvaRing. a X%
explained buying vary we've quarter, performance trends start. we patterns in solid as quarter prior can As good first and based But exiting a Kevin is saw on quarter-to-quarter to the customer mentioned, off NEXPLANON's second tenders. quarters, and
on the to for NEXPLANON currency growth double-digit constant We continue to year full a expect deliver XXXX. revenue basis
grew Slide FX. reported on XX% XX% as and XX. biosimilars ex Biosimilars to Turning
offset X in and XXXX products in RENFLEXIS in quarter driven our and its pressures and up are by immunology July the by X oncology. by X%, in both -- offerings performance partially strong U.S. have portfolio, continued X in was U.S. the uptake And largest launch X ONTRUZANT FX in competitive U.S. the in in XXXX ONTRUZANT driven in ex the offered XX% and are Globally, continued Europe. grew since We the RENFLEXIS
brands XX% brands have to first, base context growth no ex we impact VBP reported this there Revenue up XX. FX the quarter. first the while on and now quarter. volume as did Established business, Turning the in for should taken of, be And was Slide this Established in XX% was in
dip, no brands first LOE a final, XXXX shows there established comparison quarter in in point. our Slide Kevin QX which was Second, a brands showed third made quarter. favorable this revenue at and And you the of look of last year X if that earlier, established
was to related the related of was of consumers. to year COVID patterns Some some Japan, buying and some was dynamic prior
So performance is what is comparison of do well this more in currency, the point, as versus expectations. good there this flat trajectory brands of the our nicely close constant the February. the important we to the longer-term out guidance and single-digit believe in And the provided for really, answer gate of franchise growth embedded ahead established get which double-digit Established well low how quarter expectations erosion. quite year-on-year getting XXXX first as in underpins than the can looks, comment that now our our in revenue we better brands Kevin's is estimated is at
turning statement XX. to Slide income Now, on our
that release, quarter encourage statement the available Our important investors earnings information. our first is in for look and GAAP income I at to
statement Slide on Here at looking our for we'll the be XX, non-GAAP quarter. first income
operating these that draw purchase gross the first margin adjustments profit pre-spin you at XX.X% adjusted items there with GAAP cost amortization quarter again, XXXX, Making meaningful as not the we of the supply year-over-year EBITDA in from XXXX, margins moment reduce excluding point lowest to margin. straightforward speak Adjusted benefited to about gross were expenses the in we're lens non-GAAP outlook because the the the discuss $X this to full costs were year. a related onetime timing, was in their our sales we higher year. this gross due sales, point as improvement driver which from XXXX. were profit, the XX.X% and a which of to as expected can gross goods of to gross adjusted incurred when more well with were in first hard quarter product are the Due an For in in history, of representing I'll point year. margins though, sold. in margin accounting billion, compared spin-off of of operating company's that XX.X% this it's at the comparisons allocated remind for and compared first in margin, lower And first I'll quarter quarter
XX. we look Slide at on leverage debt As capitalization and
As was Using debt of for billion EBITDA have not an our leverage in-process million. that guidance, XX, of ratio of number and March against of adjust the approximately acquired net equivalents cash X.Xx expense $X.X does recent R&D $XXX we bank cash netted LTM March XX. SEC's for as
past consistent priorities Our capital allocation remain communications. with
priority, first which flow reinvesting delivering near-term onetime is course, for targeting free value between before servicing we're and which and strikes Our of we items growth cash appropriate balance at an the XX% believe dividend, of for shareholders.
priority deployed opportunities our supported include plants. manufacturing second portfolio, existing Our by would in capital management products cycle within organic for growth, which is life our
to of in we revenue latter, On expenditures on the expect capital separation annual range basis, costs. the excluding X% of an ongoing to see X%
say last BB Once quarter reduction, sustained our flow tie continue product capital we third growth new self-generated between priority, discretionary X.Xx. adjusted I progress that to of We're is not these reduction execution and a new to would external debt balancing we'll debt the committed of a capital, with initiatives. rating, against Now, cash significant ratio deployed sourced absorbers plans that below towards externally priorities for of did leaves will pipeline growth net opportunities, are in fourth BAX a Parent to develop balance allocation first X our debt maintaining big really again, EBITDA make capital because just for like of to we which year.
to guidance Slide now Turning on XX.
original an FX on spot basis this to No or better basis mostly biggest business, year-on-year. XXX difference Here, currency, version million or $XXX the of February the of approximate constant $XXX and impact today. $XXX has changes slide XXX we or which XXXX translation impact, net page from even million gone point significant to the showed our based at expected million bridge unfolding most the aligned $XXX to on million The headwind are on approximate headwind we is drivers slightly the revenue Operationally a expectations. rates you to are is that an change XXX guidance. our to this in with year identical where XXX to our from points than
the data within we see range. to With that guidance have at we the original revenue present, continue XXXX
billion we exchange rates where are $X.X our if don't Although the be they end billion from to today, improve lower at would likely $X.X revenue of range.
expect $XXX competitor still we NuvaRing the in of last communicated and approximate coming we LOE, [indiscernible] quarter, for from generic impact as an a million For possible U.S.
As for both Kevin which have last XXXX reiterated our significant and expected we impact was product today, the year LOE I portfolio. within revenue
And based continue rounds VBP this million and be we X also last that think be implemented in China. $XXX message X later we to year, that approximate VBP is communicated the an will VBP impact manage on same our quarter. will We assumption
supported COVID And that XX% the first recovery. with for well, And business been million actual volume, tracking to activity. do the by recent as remains our The is our expected in brands important and is the global million for to a that business selling in lesser base growth China less for way, quarter in development estimate our of $XXX volume We than growth of markets about and of trends come XXXX, This increase and many volume performance. first established the growth line erosion biosimilars, volume once and multiple full we the again, that's expect quarter years. pillars, supported million by results. pricing into $XXX unchanged, $XXX growth guidance attributed it retail fertility, expect our Organon year. to projecting we're NEXPLANON, actual be historical to that to of has for of majority we're component We from price extent, by can that
Turning other over are in saw XX, to which first absorbed of the will we and the forward looking margins, margin in guidance EBITDA we Slide metrics today. to be regard quarter With of execution expenses expected well will quarters business as initiatives as related in remaining increases energy well as with costs to drive by of growth, operating driven XXXX, the as downward inflation. XXXX, affirming development supply all favorability adjusted that revenue increased balanced higher on costs, chain future
be impact and We operating for chain expense increased of impact mainly all although that. marketing on Forendo R&D, expect And Mercilon volume. the COGS example in Asian the and around the promotional launch supply of item, will as up rights costs cost line an completed would Marvelon in inflation deals examples spending SG&A, operating certain expense where reacquisition development will [indiscernible] the show Incremental primarily business for countries. of
beginning expenses for exclude XX% XX%, be in if at forward of revenue, last other our guidance year being low that point As with to the views expenses they align or There quarter EBITDA for range are, to Important remain the discussed be lowest as expenses practices with our expected for where from the the is Organon and is while no to sector, results. being need for well And longer looking build the range the will are the year, at this our adjusted throughout we margins. no maintained full year such were full to first by our in-process exchange year R&D currently year. to XXXX, companies XXXX. SEC. rates end along in quarter expressed non-GAAP just the fourth of as operating for in changes I made These going
of fourth The be have Tables in found been in XXXX of quarters business the last transactions for year, along, with as of to full detail year slides guidance can our reflect that to full X of recasting of these development release, the third and incorporating and course, our an into R&D not changes press We're not X as future yet appendix in executed. presentation. this earnings any in-process well estimate recast
and based to stabilization details back Our the quarters established in solely discussion, Wrapping that I'll criteria strong to strategic contract. our to those growth start and/or double-digit solid associated for on year. might tailwinds point, not of have non-GAAP fertility, in plan be payments we're with is alone. the financial up demand any business that this would we NEXPLANON, structural to results well, inclusion a the those trends we'll the Operationally, the performing off for biosimilars between in for provide. have and business signed payments on the some payments the questions. operator transaction, involves we business turn call brands future we At time. development while as signaling a been for our the guidance we provide milestone upfront us, activity to announce priority update impact And will when also impact is guidance would work relevant Business development do a to