Thanks, today third pleased progress to speak I'm you in Dan. the Good quarter. with steady the made about morning, everyone. Mallinckrodt
have discussed last quarter, right on making remained the our portfolio Our sheet, strategic and keenly executing the teams focused strengthening pipeline. balance our stabilizing investments the priorities in we
reflected sharing solid we are These results efforts today. the in are
we Importantly, are reaffirming guidance. accordingly as progressing year expected our as we full XXXX
When have joined we last our have just call, Mallinckrodt. I
So I'd like CEO with a level focused in lives full reinforced Mallinckrodt build as business great high the to and to my confidence start of ability My observation. on a the talented improving patients. quarter employees a of our first
have of was more a do pivotal and clear quarter, opportunities developing While to I work this we in understanding know the challenges ahead.
an will plan we Mallinckrodt important XXXX move right in believe the to and forward be place have I successfully. for year
of steps products to the we'll and and With perspective, including results. a we Officer. into experience existing that, leadership Chief and more third the Lisa new of I'll From and we our the and new in highlight than of roles, dive strengthen took XX StrataGraft Lisa geographies, instrumental her decades appointment continue Organon branded pipeline, during products advancing commercial then as quarter at Merck French organization have we will Terlivaz years Commercial commercial deep the be spent some with bringing to as financial expertise launching
already human as and retaining key Mallinckrodt great great Henriette addition, ESG created functions, enhancing further related and and In role talent, do and started with she we newly joined Officer. is resources to focuses Mallinckrodt acquiring here. has Nielsen communications, on Hikma some Chief program. Henriette, worked It on building Transformation as at to employee together previously This reunited our work Pharmaceuticals, be
Stephen ensure Kassie our talent and at Mark continuity Harrold, Corporate Secretary; Welch, of and to executive and internal Specialty Jason Head of have Head number Tyndall, We Chief of also Development, These of leaders Mallinckrodt bench Officer promotions Goodson, a deep leadership underscore the Officer business. key to parts Legal we the across Corporate including committee, Chief Generics. Compliance appointed of
board Karen all efforts decades And human promote at reflecting organizational XX-year enhance in Susan's experience we addition inclusion that Silbermann. organization. at leaders and and follows in these bringing our career appointment relevant brings our the levels directors Karen to I'm and resources Susan Ling of diversity level At to her new transformation. welcomed pleased experience significantly of diversity Pfizer. and our
third in we'll achieved with the begin Turning brands. the business to the specialty quarter, progress we during
to expectations. demand quarter our was We see for the and in early signs of are encouraged performance with consistent stabilization Acthar Gel
Looking affordability Acthar Acthar optimizing new intend access patient investments, through support to innovation our lifecycle affordability resources, market We entrants. and after access services. are addressing dedicated ahead, and this stabilization objectives demand, and increasing and and our our patients through the team provide for and differentiating do
unit approved, our if be patient Gel single device, to Turning next delivery Acthar dose friendly and Acthar indication. would generation for an version of easier more
completed quarter, been we proceed As with has and to last said ready development we submission. device are
a one launch remains XXXX. anticipate matter partners of However, our in as do result, a regulatory not the we involving ongoing,
to updates resolution. partner continue our provide will as We a works towards
in approved Terlivaz approval Terlivaz of hepatorenal launched This syndrome and PDUFA We treatments HRS schedule our for was of received its September December now ahead product date. Terlivaz function. for the formally and milestone a ahead kidney shipping rapid first FDA only is or adults is Mallinckrodt. reduction significant in FDA with out.
to have interventions excited very Terlivaz for U.S. who and incredibly historically bring limited physicians are We treatment had to HRS. patients
challenging of when and Diagnosing patients be it. and managing essence HRS the who have treating time can is
reflects our option. underserved U.S. caregivers, and on and delivering their very goals. are working with for to have important This physicians which the focus we intensity with in We achieve patients pleased to wide the approval our organization provide this
holds for Terlivaz received designation an orphan the period exclusivity FDA, Mallinckrodt drug from this therapy. a seven-year
raise launched, to awareness officially continue formulary committees the the with as decision the product, with doctors. while our therapeutic to focus With hospitals pharmacy they and now the shifts working in product we make for
have to remain and INOmax, customer and brand to a it's technology this the pressures. product in leader continued despite market, recognition, nitric Turning oxide strong service enhanced enabled our superior competitive
we this in pleased the quarter, led in this a lower While sales see U.S. are a to market. Japanese net the to sale strong net
towards also EVOLVE of XXXX generation strive launch plan the We next of system INOmax. delivery might our INOmax
In for submitted summary September, certain of the submitting information look with review FDA asked EVOVLE. we Consistent tables provide later to premarket data process, we application and notification that to this its XXX(k) the forward to the FDA us month. submitted
in trends. cell and early the that transplant in be use disease Next the line a we the year-over-year from We versus quarter in recovery was occurred StrataGraft. and will believe that Therakos, host volume solved during suggest sequential in from in decline volume non-promoted stem will graft recent expectation COVID-XX recover Feedback case Performance surge clinicians this the brand. XXXX in hospitals. for as for XXXX this growth enter procedures
deep new For have options with StrataGraft, we make innovative for and surgeons on adults this and sickness inroads treatment physicians informing burns. ambient turn
we is As last shift a it we to autographed. accustomed be burn paradigm discussed to ethic that for quarter, this surgeons expect product slow given
in We community treatment there the real approximately from the is XX% option. have surgeons medical this in to that in presented now excitement additional a of U.S. conversations know burn the those about We centers
has will increased adoption progress U.S. see, confident We and availability we focused to follow. although we we across raise have to are continue ramping with slower and like been that adoptions on than awareness to the
U.S. volatility to due the yen. was this Performance competition and quarter in down authorized from Amitiza in generic Japanese of the
under move extends see we royalty will As with market. exclusivity continued where Accordingly, the we utilization is focus to U.S. our to to the lose strong shifting we the associated Amitiza XXXX, market, for XXXX. Japanese
continue strong year-over-year protect we Switching gears benefited the the improve levels, to bottom position and bottom favorable to Specialty continue and advancing our evaluate will we near lines. on We achieved pricing growth the top products. and supply line as segment, This primarily I'm by to a was pipeline growth ADHD term pleased and inventory of competitive Generics from here report opportunities. driven business and a APAC that
to I of Lastly, we business want to quarter. optimize during the the continue that cost the emphasize structure
priorities. move costs remains and wisely forward, As reducing we spending important
company's sheet We are manage core balance working invest to drivers. in our while to the continuing proactively
remains goal growth Our sustainable profitability. and long-term achieving
I clear to and StrataGraft INOmax Amitiza, bring seeking the spend includes on to competition opportunities also in continued XXXX challenges have These about want promotion and and Terlivaz ahead to be generate we EVOLVE with our term to have into visibility in challenges our confident remain long good business meeting , we markets. and the so the we said outlook performance far. for these over That's expectations for the
aggressive We in be on are going to priorities. strategic executing our
With to turn I'll our quarter to over results. financial discuss that, third Bryan it
