- Earnings call transcript Q3 2022

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Operator

Ladies and gentlemen, good afternoon. I would like to welcome everyone to the Theravance Biopharma Third Quarter 2022 Conference Call.

During the presentation all participants will be in a listen-only mode. A question-and-answer session will follow the Company's formal remarks. [Operator Instructions] Also today's conference call is being recorded. like Executive the Officer. would Rick over I Chief Winningham, now, to call turn to And Please ahead. go

Rick Winningham

materially Good afternoon our of and forward-looking statements clinical results. Biopharma you cause third about thank this statements you for SEC. of XXXX attention that timing filings trials, our differ Information results factors pipeline, and anticipated and our call financial joining Slide regulatory to is that conference products, expected our involve to I uncertainties, statements will development our could concerning discuss call business. that risks to in remind your described from quarter forward-looking filings I X. would further contain the direct including Theravance benefits the expected with

Rhonda Rick Research Officer; today me Graham, Hindman, Financial Business Chief Development; and Officer. Farnum, of Chief Andrew and Head Joining

Theravance Slide make purpose Now a X. to that difference. turning Biopharma’s create medicines unwavering to is

a We we X where with are hypotension patients Rick on today the Symposium neurogenic TRELEGY of ampreloxetine of in closed MSA ELLIPTA the International another meaningful quarter third net major program, sale program. cash, GSK’s interest the up a we return offer review record ampreloxetine were outer will Rhonda share included demonstrating We milestones the in at in the in on Royalty to a inflection marked the royalties financial will profitability details. Theravance the effectiveness details. We Pharma ended Pharma, Pharma further Study and where intellectual recognized in our initiate point orthostatic tender $XXX auction Biopharma $X.XX the third the to Phase $XX invested Royalty holdings XXXX a and as which $XXX property Dutch build XXrd for Andrew ordinary open. continue session with share year upfront of ampreloxetine our opinion for clinically field of in $XXX with portfolio. System. at in cents a The presented currently headed. to we're opening million durable the potential approximately our result Autonomic deal a debt. quarter shares, will and Royalty billion review data able to million tender capital $X.X leaders royalty company's zero and quarter and and launching million in And of in YUPELRI entire Three million that's and and sales cash transformation. purchasing offer Nervous

value. goal towards now YUPELRI. drive turn of I'll over Rhonda the to shareholder maximizing actions All these call of review our to

Rhonda Farnum

Thanks Rick.

is the maintenance the as nebulized are LAMA that for We patients update and hours YUPELRI, long-acting very of provides to with XX treatment once-daily control pleased which on for muscarinic is patients of antagonist first performance full share or latest a the COPD. only indicated

to Turning quarterly reached YUPELRI of Slide sales another X, date. to high net in QX launch

with the treat XX% Overall, by for going $XX.X XX% certain YUPELRI YUPELRI. increased XXXX implied expenses Slide YUPELRI’s Theravance As I highlight to of the year-over-year net am combined hospital profits increased co-promote for the and XX% to X% increased commercial demand a From pleased Theravance segment cover medical and infrastructure Viatris share our and XXXX in year-over-year. XXXX of and Biopharma’s XX%. has reminder, quarter Biopharma. a the from Theravance outpatient-based that of Biopharma patients sales XX% shows million. third U.S. QX QX community X by targeting to also in Viatris during share with sales of suitable net for we Biopharma’s the who healthcare healthcare professionals Theravance U.S. financial responsible on teams and is perspective, and professionals. Viatris YUPELRI COPD sales

slight a total versus overall growth cetera. quarter-over-quarter patient prior see we fewer et third exacerbations, of We within saw to same last prescriptions year. QX typically and the XXXX encouraged QX of anticipate to time very also maintenance the dips the are quarter seasonality census, the decrease COPD net given due in decline We lower And over slightly in year. market in sales also

Looking launch specifically right year-over-year represented and of in at the efforts side sold demonstrating previous from of hospital Slide Hospital an the quarter, of Theravance the deployment X, X.X% hospital on segment XX% of to setting, QX in date. dosage [indiscernible] increase XXXX volume a the exclusively increase

hospital of led wins and remainder now which weekly. growing continues second have growth stated, acceptance to YUPELRI's have significant in over of and we and pandemic respiratory impacted previously in see phase XXXX setting. progress the launch each YUPELRI’s believe XXXX, XXXX systems continue the We clinical of and to continued business the these growth will hospital the team's with half the to be the yield the will placements recognition to many achieve have due as been XXX we placements has once-daily formulary key growth continued system the YUPELRI’s for beyond, that growth XXXX new additional of to LAMA hospital through launched benefits. As of forthcoming in to Contributing in and quarter to-date, first hospital system Since particularly XXXX. total the successes YUPELRI to increase proposition formulary throughout account choice ability purchasing the value accounts number

our up can which XX.X% to see Turning in in the YUPELRI's increased point Slide quarter. in also from market that community quarterly in latest XXXX share of you previous XX.X% YUPELRI’s QX. X, setting through data share of XX.X% of the from setting increased XX.X% to the up XXXX, QX to is hospital August

experience of growth treatment have been in key retail prescriptions to by or convert work the noted highs appropriate that maintained their COPD therefore provide and the their seen and collaboratively Biopharma script new also switch require of and in opportunity to patients be support therapy continue serious outpatient trip XX.X% QX many where hospital Viatris the the patients their The to both XXXX, or reaching patients a in launched current and from encouraged prescriptions continue assess and we YUPELRI home. to hospital receive setting acute community, over who enough quarterly with a in and continuity visit, of have the medicine convert through them hospital maintenance Data to YUPELRI with the to year-over-year trends YUPELRI post-hospitalization. are an to after discharge in have we respiratory allowing Understanding the becomes prescription hospital YUPELRI. during shows to-date. on teams metrics a for their XX% to As with total enable Theravance patients them approximately to community YUPELRI discharged effectively XX% once YUPELRI previously, episode return the new-to-brand increased setting again have increased QX data point

total do fulfillment As channel, useful DME channel, sales the a reminder, while as proxy YUPELRI of the include volume. script the for they serve majority use, includes these a medical the retail retail data which plus which represents community community only equipment durable or

throughout we education to continue improved a our leverages and the effectively the as and that strategy, benefits impact digital patterns and communicate of on team We to is growth which mix promotional the which continues year continue in-person, core the of see will efforts hybrid our against execute virtual YUPELRI. demand of remainder believe of the acceleration pandemic business to leading the proceed,

XXXX. for within actually upside Slide addressable those population, patient sizable Turning represent there well a X, YUPELRI to beyond beyond patients an recognizing YUPELRI the there the COPD brand receiving niche do for significant we is believe opportunity which today, is

another term, potential, longer Book. in in treating YUPELRI's and enhanced that is by to listed to Looking the covers has commercial it are patent patent we XXXX now share issued COPD. in new of a of method recently that U.S. been This use Orange further pleased expires revefenacin

severe Lastly, turning the COPD XX, with lung following jet to tiotropium inspiratory severe in PIFR-X delivered either XX% to delivered nebulizer rates, results and a half top responsible actively improvements flow to the Phase once inhaler to I'll X to XXXX. Rick over revefenacin and daily second study with cost suboptimal line function adults call powder Theravance or of standard Graham. the enroll continues Slide turn via treatment is comparing patients. study via the dry in guiding are now a this for very of of

Rick Graham

of orthostatic development system from as MSA. disease MSA. of falls norepinephrine, hope atrophy, multiple Thanks has with symptoms In a going on patient's a norepinephrine life. mitigating potential MSA. inhibitor debilitating in to and the blood patients release rare ampreloxetine States. thereby which demonstrated impact with of affecting to owing reuptake referred treatment durable profound the focus treatment treat hypertension MSA other the is have the that a for offering approved Neither approximately options, a therapies markedly symptomatic leads effectiveness people patients in United the to Rhonda. on quality of nOH, XX,XXX MSA, impaired for debilitating when the to symptoms have to upright Today also I'm unmet two can with patients in with need exists differentiate hypotension significant ampreloxetine in There to orthostatic pressure neurogenic to patients

treatment orthostatic NOH. study, effective Moving the include OHSA length OHSA a fatigue, meaningful Study magnitude XXXX, trouble clinically mechanism demonstrated concentrating, and as including change supine symptom day, the by the to cardinal tablet a constellation This options. XXXX no was ampreloxetine score, neck ampreloxetine hypertension in X endpoints treating to symptom also placebo. composite Phase other Phase associated from favoring six study. over a score. The meaningful of relative for significant durability effect the X patients score hypertension, patients multiple assessment the administered impairment, with to on has a OHSA of clinically and effect was was a maintained composite was with of head action, durable all once driven MSA benefit The scores XX-week with observed to to a unique treatment on These Study and in the effect Slide discomfort. of symptom potential dizziness, symptoms composite XX, nominally, differentiate and statistically referred MSA effectiveness the was and of the in the In single items vision on ampreloxetine signal a the at weakness, in

based Although on demonstrating constellation a droxidopa these approval short over these the symptoms like a dizziness importance only change duration. for I'd we've was one benefit basis was the on underscore previously, symptom, of comparison, By in patients. which described of to for data

ampreloxetine. ampreloxetine items on a daily the composite scores In addition on favorable short-time. standing impact treatment, favored for patients a symptom activity was score to with for impact also The largest the MSA

that walking was MSA that not Ampreloxetine with long-time, which of quality therapies each on the differentiating day. nOH for from to transferring short-time current nOH, increase debilitating a is treatment; considering has single bed while and MSA therapies. a the with been can two per that favor symptomatic patients healthy It item day, potential risk yet database are several XX even a is to have warnings may ampreloxetine of supine at for disease is nOH supine with multiple milligram the risk a consequences. in for Patients severely their The each relative require therapies with enormous from difficulty another The a isn't This feature approved life. difference of tablets boxed a an suffering approved the highlighting This to as once surprising someone disease the the for dangerous signal did supine of in only MSA have for label, administered differentiating XXX not have that swallowing is more patients of offering impact hypertension. result ampreloxetine with times the observed another known hypertension. In can For blood a subjects position. beneficial as pressure than standing which on a hypertension administered mean is FDA factor wheelchair. for safety the their progression. tablet supine

burden applies to and Rare stated the to and investigators and time Moving significant burden. on meeting non-medical diseases cost meeting. were economic and nOH Autonomic there's due repeatedly just urgency American extreme medical Slide and well as indirect The a of Society patients attended the as costs. within to XX, pose direct opinion leaders, patient Having with burden. to conditions these MSA the throughout organizations quality advocacy treat life an spending caregiver clinical impact suffering the messages

and was three durable symptomatic opinion were For medical and so patients oral effectiveness Horacio In the the meaningful data conference clinically and Kaufmann, Dr. was X presented Phase of first nOH. through evidence at the Roy program the by Dr. Freeman. time, presentations Biaggioni the in X Italo done highlighted, supporting the a from with presentations totality ampreloxetine Phase leaders: Dr. MSA

starting patients open primary in double-blind XX, CYPRESS or registrational new symptomatic a to study to withdrawal Study the of in Study study XXXX randomized MSA controlled we're quarter Moving in label; with XXXX change score. XXXX. with first is nOH: eight-week XX-week Slide endpoint OHSA of forward a a looking composite placebo

endpoint the primary during a Type or year. a reminder, agreed was earlier with As upon C this meeting FDA

majority fund costs. now expect call Andrew We the from study I'll investment Royalty of to million the X Phase turn financials. Pharma the $XX over review to to the the

Andrew Hindman

Thanks Rick.

to represented Pharma Biopharma. XX% rights deal delivers worldwide the The which for units Slide an was value, transaction TRELEGY, exchange payment XX, closed or three all billion of as carefully in of royalty approximately royalty the components Theravance in previously ELLIPTA. Turning that Company of Respiratory the sales LLC, Royalty interest of TRELEGY GSKs structured economic on transformational upfront Theravance our discussed, TRC third for $X.X during our with in cash quarter

in payments XXXX. years exceed XXXX potential medium net term eligible through be throughout of receive milestones specifically, a form milestone XXXX billion. payment $X.X the Secondly, value paid the million In $XX to calendar aggregate achievement TRELEGY sales up equal $XXX to various the trilogy million. if are an we global thresholds will revenue of is to upon of milestone These

in XXXX. global recent form sales our of within these sales United increase metrology OYR in the the in the point Biopharma TRC XXXX of third approximately [indiscernible] of TRELEGY the OYR, royalties. of net begins sales for long-term or XX% the reference, for begins the of over the is value finally, States. the $X.X outer XX% XXXX Theravance interest ownership nine We to and component billion, a the United States first return retained [indiscernible] of the call XXXX outside of in royalties year and As reached have sales months an period And of in

as in monetizes well time. and long-time outer benefit to TRELEGY dilution royalties, both interest program regarding the In the goal program. with removed directly and Theravance as will the as of This attractive In deal also we off benefit Royalty mentioned medium year allows before removes programs. the it relatively was with of we deals Biopharma execution retired $XXX will deal, input of and announcement during uncertainty be [indiscernible] because July, with sufficient we These we this royalties directly strong the XX. September, the global Theravance structure convertible in made As financial to paid creative outlined indebtedness capital the of company's of end, down successfully approximately value August components deal the an Pharma TRELEGY $XXX significant we time board that cash royalties return at Directors debt from of royalties from transaction which of LLC. Theravance and design paid our board In term the key benefit having notes over by cash, the to receipt notes the peach by manager shares closing the Furthermore, TRELEGY to in to making program quantum the speak shareholders Board TRELEGY our non-recourse capital two million source on performance us retaining the $XXX took our many TRELEGY TBPH advisement allowed the the for At TRC and free did continued economic and the million, important continue also it early expect Biopharma One XXX% Slide authorized and prices. GSKs Biopharma this excess of transaction was from decision was and to from commercial of TRELEGY third and our outward lead to the repurchasing monetization as return our pay quarter, million of with of equity costs. while minimal low and Vivo near-term

million approximately with $X.XX in share. Biopharma stake X.X approximately Theravance million $XX at GSKs purchase deployed equity Firstly shares to per

will XXth. offer component today's September the offer are extending is ongoing initiated stated we is auction and as the an please press tender New and the $XX regarding And midnight The of of [indiscernible]. more such offer at close second Dutch for release, November offer York This length the expire contact million XX, City the XXXX. details that in implementation the time, of open the deal,

the the the repurchases program Biopharma share, repurchase end of repurchase pay open creation Finally, on This its market would have to by for initiating, of transaction share base in immediately share of [indiscernible] third focus royalty count the share million after At significant XXXX. YUPELRI in $XX I execution positions [indiscernible]. of to as equity materially. sheet strengthened complete This program, element and balance Dutch future and think we authorization completion the offer, by has program. TRELEGY the equity the to tender ampreloxetine debt with Theravance the Board the the the company the of subsequent up value close goal by reduced the we an commercialization Theravance

third with expenses. one-time that please and compensation, the XXXX, the $XXX in and company transaction quarter estimated a million approximately period TRELEGY SG&A We to of one-time Slide our $XX.X XX; million million million the mind the same financial compared of make will associated in cash in for ended highlights for in to payment million were fourth in quarterly period keep in $X.X XXXX expenses expenses on of XXXX the $XX.X XXXX. of equivalent. the $XXX restructuring R&D taxes cash And compared third quarter to of million were related quarter the quarter figures third third transaction. These XXXX Moving based XXXX. share quarter due with same exclude the $XX.X during or

additional ongoing could an QX. of Dutch tender million $XX the utilize offer addition, cash in In

Moving financial we Slide XXXX. are of full to guidance XX, for the reiterating year

programs. expect actuals For million team support $XXX the our pipeline. invest measure in down approximately was $XX million the R&D investments XXXX. XXXX expenses, to reflects wind in and between in Of ampreloxetine QX $XX beyond of clinical of we R&D the million recurring million to and that non-recurring previous relative expense strategic QX and normalized to spending incurred range, is to in izencitinib $XX has this spending

in flow between $XX financial onetime we XXXX First, XXXX. and YUPELRI's the we of operating XXXX. take the been and our to expenses highest to I'll compensation, basis YUPELRI, quarter spending as to on turn actuals has onetime during again, and quarter $XX moment a based increased on $XX In million that even XXXX, flow realized transaction closing cash and profitability related to in Hence remarks. the the expenses. reduced launch. now call restructuring result back brand the expect a cash quarter sales approach its corporate stronger, from current section, since closing of invest in million I'll And QX years million are SG&A relative during generation Rick of a for to XXXX expense, to properly of share breakeven the and third in reflect of the business since two expect With Winningham

Rick Winningham

quarter a Andrew. has midst is Thanks in Biopharma and Theravance pivotal. strategic been of the this transformation

intellectual the partner growth has property YUPELRI, for continue Breztri, and our to As continued with strengthened exclusivity around YUPELRI. until progress pipeline on key front delivered and patent the product focus team extending demonstrate Recently our a on we our sales we XXXX. strategy the noted

leaders dated top registrational trial. finalized we design with and way delved the MSA a the the Phase in for quarter, a into ampreloxetine – patients opinion the This world's X further in

Royalty the of like on with debt total and begun the potential capital On forward our we of value $X.X to for the deliver billion sale return of resilience drive future to the your our moving that with In medicines closing it to royalty determination. the progress financial we're team positioned hand their make momentum Pharma shareholder needs over announced program. difference communities thank make we TRELEGY drive the closing, as and in well you the in to Biopharma for I'd early that to patient quarter, side interest eliminated focus, to operator strong value. questions. everyone the efforts for participation. and well we back for as serve as their the Theravance a and time in tireless we I'll meet Thank forward, now We're

Operator

our Eva of from first question from Thank Cowen. you, for sir. [Operator the comes line today Instructions] Privitera And

please. question Your

Eva Privitera

Hi. to quarter, accounts Congrats it our less do for and just the taking IQVIA or previously incorrectly expect discrepancy the IQVIA think What you vary? accurate thanks going fairly predictive. you even been for on and noticed do great that questions. though had trends be have the scripts to down is quarter forward, We a going indicated

Rick Winningham

Rhonda, want that? take to do you

Rhonda Farnum

that's, to visible so certainly comment script to and XX% that smaller Absolutely. to business. retail, One It percentage, is have total of inclusive mindful of roughly is try thing keep I you that's mind only be in this publicly. to data the a our

So in or of entire retail is expect a depicting business that to scripts view. not it's the decrease reflective that whole the downturn

Eva Privitera

if And question; reaching positivity timeline helpful. estimate I what the the Thanks. second that? on can what's and your latest have underlying assumptions of flow some really for a cash That's

Rick Winningham

Yes.

Andrew the in an our said positivity as We're are XXXX. XXXX. approach moving to it cash towards plans basis, well flow So in operating on

and on our Andrew, for that? information XXXX outlook anything give details provide more year. else that when we in will We on the early

Andrew Hindman

it. about No. That's

Eva Privitera

Thank you, and congrats again.

Rick Winningham

you. Thank

Operator

Instructions] H.C. from Our [Operator comes Douglas in of line next Wainwright. you. the Thank question Tsao

Your Douglas, mute. you question, please. on might phone – your your have

Douglas Tsao

mute, sort different in the of where go is the you a moving fourth Congrats good implied I sort think, two in on we Should it. the see question, we've what with terms sort Sorry normalization I deal into parts we revenue. recognize just realize didn't as some a myself seen the row about recognized a I especially YUPELRI. lets that. below had this there as sales, progress revenue quarter? Maybe are and of of know of on quarters so

Rick Winningham

you want – that? want you take do to Andrew,

Andrew Hindman

Breztri. is nets about spoken the we the Yes. of P&L which the book Doug, due, collaboration the our collaboration out past, what receivable behind in with Well, synthetic expenses as certainly we've

that So to we increase accounting try fluctuations bit going line us the GAAP. your transparent of YUPELRI treatment hampered the we collaboration by continue some under that revenues forward but to are also to provide to commensurately. GAAP on, as for Hope a accounting that There question. disclosures expect on revenue grow, booked a continue based that we're also that should answers

Douglas Tsao

Yes.

Rick Winningham

Just reduction point. cause add one other, one of and one us a Douglas of let as associated was other of level cause lower from aspects our the which to our the – which of yes, changed a I the reimbursement of restructuring restructuring, costs recording Breztri level was removal here of which therefore lower mean, recording me with sort the the costs revenue. us a –

it actually their to the Breztri somewhat quarter-by-quarter site that on depend the P&L. incurs of calculation of does on a basis prior synthetic So cost the

Douglas Tsao

third the quarter? product. not calls, been really And for maybe was jumping I how a in hospital remarks. products? was That's it between I I've of a know a should which And pre-COVID much there covered was often quarter, fourth the think we Rhonda, couple sort in Okay. the guess that see the seasonality helpful. seasonal And strongest strength in question period YUPELRI and apologize hospital if is opening typically only based you historically for but some I

Rhonda Farnum

any impact in do pandemic obviously continue that reflected seasonality that's forward. was And That's We every over going hopefully that we QX. without question to and understand time to fair, with that somewhat try great Doug. year anticipate each a

in the QX in did this commentary. still little bit sales. We the in missed view, QX. have COPD that encouraged which dip We may growth you in a quarter-over-quarter maintenance decreased overall However versus see an see were to market

relative in that point that an was to you have impact season COPD going that's anticipate propensity other commented where seasonality around to do that's and volume, flu to patients increased that census, think So the have is I virus increase correctly respiratory and seasonality, we higher all obviously anticipate typically there the but relative on on due we the to is patient that importantly QX more high what that and exacerbations. on of whether

Douglas Tsao

so Okay, much. great. you Thank

Operator

next Thank you. from the [Operator question our Instructions] from of Stringer Needham. And Joseph line comes

please. Your question

Joseph Stringer

thanks our taking questions. for Hi,

on is one breakeven. flow First the cash operating

potential you secondly cash the the cash what place, much understand additional, Thank label potential factored breakeven of given sort trial balance capital that a preclinical then you on PIFR-X program a are the of affects the in guidance guidance or previous BD but cash delay your get of curious Just updated or into flow on expansion how and how that? return early from if plans operating on YUPELRI activity? can the say results And have you. balance into current for programs any your thoughts clinic in bringing stage any the

Rick Winningham

Yes.

any both So PIFR that previous comments outlook XXXX from – on we effect that the yes, include we'd and didn't made really significant XXXX the study.

no – the previous So – the end estimates. until increased the other our of on our fact data pushed has and on study XXXX effect that we've the size of out that the

the outpatient success both question? the YUPELRI cash with the growth and the the we outpatient but the the the continued quarter greater is do think in expect, company. recedes in and YUPELRI fourth have the that driver of also obviously on growth your and positioning fact setting. as of second in the also And flow profile – pandemic in Joe, the we is of greater we're I XXXX I'm fact as highlighted into in institutions, sorry, the

Joseph Stringer

Yes.

the updated any terms in of I provide terms of your have you rest of the In curious clinic. pipeline a return but just advancing capital BD in current you given program internal could the that activity or place, potential if thoughts understand the into programs

Rick Graham

the focus But you'd program of do to accrual that profile on our right the make take and any the and our on some study Rick programs PIFR of adding our is of XXXX is. here like. if to can execution think don't circuit going on we really extraordinarily a other ampreloxetine, ampreloxetine majority rapid when of to and we we're turn of into consumption the cash completion vast really comments and I now Well, what all be the clinically resources, focused rapid the see going launch that's

Rick Winningham

in right by remarks, where Yes, through focus of prepared program. we're the KOLs with that's where of Autonomic said the created bit the I now. the headed think, coming team presentations energy we, just around Like I Society meeting this off the the quite a of American

lot in going of quarter the effort into XXXX. a energy and rest So and that the of first

Joseph Stringer

you. Thank Great.

Operator

our Thank Risinger moment from you. for our David line the of And SVB question. One comes from question next Securities. next

please? question, Your

David Risinger

as me Yes, much. very on the congrats progress. well And thanks all let my add

when could CYPRESS help obviously first So, you guess that for launching XXXX, you're first XXXX, essentially ampreloxetine guessing the patient, a trial? just thinking I about would five top Side So know, it's I expect the it XX on readout? I'm months be that comment timeline in but quarter for that. is the should how potential each quite line we don't in you're of but

then first are $X.X expectations target of for TRELEGY So, question. the that GSK is And billion year, for the with below that consensus second, next billion I respect believe to XXXX. $X.X

color you. on just milestone. $XX any So to Thank to wanted potential million from the you that realize get additional

Rick Winningham

we discussions a got for finishing of then the on bit size into once of roll provide I size the to XX%, just MDA. with thanks ampreloxetine, the then the of got we'll of of the outlook Yes, and we've XXXX, to to finished into study be them. study think the the XX% think, we the And study the on timing and ampreloxetine. trying the done, and We've – that Well do get a translated I FDA little filing as able better ticking design questions. for with once probably XX%

other So I you comments any Rick want to that? don't, make on

Rick Graham

that's exactly it, that's right. No,

Rick Winningham

TRELEGY TRELEGY, tailwinds forecast pandemic. TRELEGY. come There of on of think, we obviously some Then as out behind variety are the TRELEGY, I people

gets to drive X.X getting the to I I we'll think have the can in to sort execute kind their biologics particular more say of to potential that whether back the of way progress. TRELEGY we business the TRELEGY think biologic. promotional I for continued on TRELEGY track. they the COPD $XX that's million, to market are the certainly that those related patients strategy, of to they see. something that would continue then and it the the medicines as through as get just top affect factors controller And for built are on the watch fact is But on in asthma in

I also us number in is think us and is that importantly XXXX million that us number gets the XXXX. $XX XXXX gets the for that

to were XXXX of we up lower I in Andrew, come anything that then don’t TRELEGY of the the else were probably increases if that? So, know, probability milestone. the of I short, on XXXX – short to come think, it up end dramatically

Andrew Hindman

quarterly comment the seen basis, The after is only reports that the a versus outperformance I consensus make would GSK we've quarterly on consensus their earnings. increase given continually other

have right, you're expect to is revisions next David, think continue the GSK over producing. is I that based So, billion. that to $X.X current upward we And the for that year consensus just performance on

David Risinger

you. Thank

Operator

Thank you.

Rick Winningham

you. Yes, thank

Operator

we our while our from question. next moment Purohit have One And Vikram next Stanley. question line from the comes Morgan

question please. Your

Unidentified Analyst

Will Vikram. the on congrats quarter. progress And this is on Hi, for this

We have two questions ampreloxetine. on

estate the the profile on to of would guys color what be remind that duration IP that you you might intend Thank the helpful. secondly, very first study, patients pace us just about you, provide The around and provided currently molecule you protection could be any terrific. that what the of that be enrolment MSA could And is on expected by the enroll would and is is additional CYPRESS what if of

Rick Winningham

Rick.

Rick Graham

Rick part second the the first if part IP. take take want I'll you around to so Yes,

we And reminder, the just possible. to as be close study a profile in the prior what we're regard will with endpoint be are study as making to we're with for CYPRESS relatively but the minor, data-driven. significant designing purposely was they the doing which that the The are the a saw is on XX statistically study. primary XXX as to XXX So new patients OHSA composite, study Will nominally to the effect there study changes that

So weeks. period and for example, what of and period we our at randomized you eight the withdrawal XX Slide six. presented was is XX that our open today, study label XX In prior when weeks, weeks look is

With process sorts of but most same relatively early comment point, feasibility. study for we're in enrolment the those At with this and made adjustments, rate, to just of too on similar detailed the patients the doing regard part, targeting we've So design. that. to we're a

that and we've tier us had here. relatively established allowed really and and top us we and advantage significant sites, a one think those previously, X experience to for some built is program top relationships Phase sites. have I large Now, identify with We performing

So We've we get we we seem have feasibility. that those enrolment interesting, the so data established, and compelling sites. rate the to back will relationships be come going those got to be more as to on

Rick Winningham

with of is with patients, then at patent it, a in for then probably And term the think, extension looking MSA ampreloxetine that's think, XXXX used associated composition ampreloxetine, of and I matter for treatment XXXX. on and patent IP I

Unidentified Analyst

very Okay, Thanks. helpful. that's

Rick Winningham

pick also we're likely, And it designation. MSA is because to orphan an drug obviously, up

Operator

Thank next the next Skorney And Baird. Brian you. from moment our question One in line question. comes of for our

please? question, Your

Brian Skorney

Yes, guys. thank the taking for you question

on latest issued updated one extension it's just one for patent Just IP the XXXX. expires after Orange in YUPELRI, the opportunity, think, pretty that's question been the Book new big a I

basis patent So COPD this for could you patents of that's you hoping have and method [indiscernible] I about of the was one. other XXX talk the versus other that over use the extension

Rick Winningham

Yes, absolutely.

a question, the that observations information that Brian. that indication PIFR-X were program the of from the basis PIFR study just form which in in such patients. patients that's the of X of and section an into PIFR-X integral patent are covers fact really the details use And that we group fact and novel for they resident those the obviously is Phase label. our FVC in addresses number COPD patent. Sorry, for And are the did, FEVX sort in the obviously made the that we comes patent The without that getting in study great

Brian Skorney

just size then you the the assumptions? read ask of And if sample we study, one Great. could can second changes sort increase, just PIFR-X those on

Rick Winningham

want review Yes, sample Rick just the you size? to

Rick Graham

sure. Yes,

are assumptions sample So from on increase size to sample we size Slide what the XXX. XXXX potential XX is the say and to

re-estimation. in do Now of The pre-specified, is the terms PIFR information was protocol, is And we information. which the to it relatively had sample based way very we limited re-estimation. because by reason on from did common prior that we the was blinded size study, the that, that did a but relevant size reason blinded sample

second study and the For endpoint primary FEVX primary the day baseline that day study of from PIFR-X was endpoint is FEVX example, for XX XX. change the at

to day have on that have gap was day higher was the was, a in variability XX we the a estimate could XX, sample XX then turns blinded we at the bit used the we variability, to size the predicted translate day from So, does based which for data day fashion, out PIFR-X. little where XX. it Well,

determine So was is for the the on basis that study the outcome read just Again, here. is that into the based there factors increase. sample size. This no of simply

Brian Skorney

you. Thank Great.

Operator

to There appears Mr. further further for you. at like no remarks I'd to Thank back turn questions program time. Winningham this be to any the

Rick Winningham

we participating. We're very this with time an for busy for quarterly aware everybody everyone So thank calls. is incredibly

So update. for we questions, appreciate if the us, answer you that you please us contact have reach out, our joining that can. And we'll and any questions we

So thank day. good your and a have you much time for very

Operator

program. conclude conference. Thank This you ladies today's and gentlemen, does the for participation in your

Good You may day. now disconnect.

Theravance Biopharma (TBPH) 8 Nov 222022 Q3 Earnings call transcript