Horizon Therapeutics Public Limited Company

Q3 2021 Earnings Conference Call

11/3/2021

spk_0: good morning thank you for standing by walk onto the horizon therapeutics third quarter two thousand and twenty one earnings conference call as a reminder to this conference call is being recorded on i like to introduce miss teen of interim senior vice investor relations please go ahead
spk_1: anthony the morning everyone and thank you for joining us and the with me today or tim walberg chairman president and chief executive up her powerful sure that could have a president chief financial officer the camp and executive vice president research and development
spk_2: and and the pats lack executive vice president chief strategy officer
spk_1: can will provide a review of the business including our third quarter performing level them provide a review of our aren't a program alibi paul will discuss their financial performance and guide and in more detail after closing remarks from tim will take your question and the reminder day day call we will be making certain forward looking statements including statements about financial projection development activities their business strategy and expected timing and impact the future events are actual topic could differ materially due to a number of factors including the rep factors and other information outlined in our latest form ten k ten you and any a case filed with the securities and exchange commission and and if preferably which we issued this morning you are caution that place undue reliance on a forward looking statements and horizon this claim that the application to update that statement in addition and the conference call non get financial measures will be used did not get financial measures are reconciled with the comparable gap financial measures and our earnings press release and other filings from today that are available on our investor website at www dot horizon therapeutics dot com
spk_2: i will now turn the pall over to him
spk_3: mean a good morning everyone with delivered strong results again this quarter cross or business and continue to generate record performance for t great drivers the purple and christopher the to preserve relaunch continue to a performer expectations driven by rapid pace and starts stronger patients the man than increasing prescriber base as a result were increase your full year two thousand twenty one to peasant net sales guidance to more than one point six two five billion dollars think the generated another shrunk quarter with new patient growth cross rheumatology in the project is was confused acceleration in the use of perfect the pussy when your modulation which is now more than forty five percent of new patient starts we're arabia or full year two thousand and twenty one percent the net sales guidance more than five hundred fifty million dollars we also generates strong growth for both rubik the emphasis be in toting or net sales increase sixty three percent year over year and adjusted able to increase fifty four percent year over year underscoring our positions where is the fastest growing biotech companies girl performance we're in creepier full your net sales gun and to three point one six to three point two one billion dollars and able to guidance to one point three one five to one point three four five billion dollars the midpoint points represent forty five percent and thirty three percent year over year growth respectively a strong performances accompanied by several key achievements we initiated arts a peddler randomized clinical trial and chronic labrador disease patients in september when else results from work or sex a mere randomized clinical trial that demonstrated that respect the plus the iming a modulator methotrexate result in a complete response rate of seventy one percent at month six a more than thirty percentage point improvement compared to respect the to thiebaud in love with their thirty to expand our pipeline for future growth we announced five new are programs dornan our girl or indeed day in september we've written in new a plate the data and multiple metal to meetings adding to the compelling evidence supporting the use of a platelet in neural my letters up because spectrum disorder or animal as the record the new biologic drug product manufacturing facility in waterford ireland to support the continued growth of the pepper corsets and replacement as well as our development stage biologics from a tell and workplace perspective we've demonstrated gender and ethnicity pay equity for the second consecutive time based on a pay equity study conducted by a on a leading compensation consult consulting firm we continue to be recognized as a better workplace receiving eleven workplace recognition this year including being the highest rank company in the biotechnology and pharmaceutical category a newsweek inaugural most loved the workplace list which recognises employ happiness and satisfaction at work the form of on for for core performance i also wanted to highlight the announcement we made this morning regarding the retirement of our see a photo paul whole sir paul planning to retire may have two thousand twenty two was the on an advisory role to may have two thousand and twenty three to ensure a smooth transition l cox who has been named mvp finance and it's been much cheaper stamp and had a corporate development for the last four years will be picking on the ceo overall have been a tremendous partner to me of the last seven years and i'm very grateful for his leadership and dedication to horizon i'm equally please name air into the role of cfl enter the deep knowledge of the business even been a leader in many of our major strategic efforts his letter capital market activities and there's a strong financial background and comfort that aaron along with our spray financial leadership team will continue driver long term strategy horizon moving on for third quarter results beginning with the peasant third quarter to prison net sales were six hundred sixteen million dollars with your we're growth of one hundred fifteen percent with the or did they pump isn't that sales of a billion seventy two depends it became our first minutes into dinner at a billion dollars in annual net sales we continued our strong execution on the launch the paul the government mandated first quarter supply disruption since then we have help patients his treatment was disrupted resume their treatment we successfully converting new patients added during that structure and and we continue to see strong new patient the man for to peasant we attribute this strong growth the fact that we have continued to a new prescribers and further penetrate our existing prescriber base keeping the penetration among up the margie phelps wrestlers prescribing the peasant such a psychopathic surgeons are all tomic surgeons and strabismus specialists we also could send to continue to expand our reach ophthalmologist and an endocrinologist refer to a tv specials on diagnosis we also continue to significantly in bath and direct to consumer marketing initiatives including are branded and unbranded television campaigns which had been effectively increasing awareness about the peasant and he be our goal for the national campaigns is to increase awareness of the peasant and accelerate the speed the diagnosis and treatment p pd were also thanks for who actively engage positions on the use of the present and chronic patients as we noted last quarter we now have six publication setting the successful experience with the pets a treatment for total more than fifty chronic tb patients surpassing the number to pivot to patients that it in the face three clinical trial the commercial team is leveraging these new publications escape the decisions about the efficacy of the peasant and chronic patients with the goal to expand the is to peasant beyond the chewed patient population were made very enthusiastic about the prospects for depends pets helped more patience address the serious debilitating and site threatening aspects of td given third quarters better than expected results and continue strong new patients the man we increase or for your to present that fails guidance to more than one point six two five billion dollars which has the near doubling him net sales in her second year of launch despite that the fuck supply disruption and other limitations from covered
spk_4: nineteen
spk_3: our kind of contest assume that the the third quarter the highs and that feels quarter for to peasant and two thousand and twenty one this is a function of three factors first disrupt patients who resume treatment beginning the second quarter second patients with pick roman forms or perhaps there were generated the fourth quarter of two thousand and twenty and the first quarter of two thousand and twenty one who started treatment after supply resumed in april and third new patients he started treatment in the second and third course or increase for your guidance positions as first year we're growth of more than sixty percent in the fourth quarter we made that the vast majority of fourth quarter growth will be driven by have generated after reinitiate and of supply and april we continue to see significant opportunity head for it's a peasant open the to patient population as well than the and have chronic population where mean well on track trapper to pet the p global net sales estimate of more than three point five billion dollars christopher delivered another quarter of strong performance generating net sales one hundred fifty eight million dollars as a result we've been increase or two thousand twenty one net filled guidance to more than five hundred fifty million dollars representing your rear growth of more than thirty five percent we're very pleased to announce complaint data from a mirror randomized controlled trial last week gonna the same seventy one percent of patients randomized this to receive respect the both methotrexate achieved the complete response compared to forty percent response rate for patients randomized receive prospective plus placebo our clinical team is working to complete the analysis of the result the summit supplemental biologics license application or the ole in the first quarter of next year we anticipate a standard ten month review and approval but allow or commercial team to proactively promote respect the put methotrexate to positions and the meantime or medical pairs in clinical teams are working to present the mirror travel results and additional now feet from the trial and medical congress's next year will be engaging with t opinion leaders on the data is well the marathon or combination of significant a better we have made and mean the modulation for the last several years they are long held belief and it's potential to increase the complete response rate of sir which we're has now substantiated even the modulations core element of our product strategy to maximize the ballad chris thaksin because allows more patience with uncontrolled go the benefit from the medicine the only biologic approved for treatment of this debilitating disease we've been seeing increase adoption of the approach and estimate that respect the put him in your modulation is now being used more than forty five percent of new patients because sex the team is continuing to drive strong pep growth and adapter but we're both rheumatologist and the project we're seeing results in the growth of our prescriber base by october more rheumatologists of prescribe perfect the this year compared to the total number prescribers and all of two thousand and twenty in a prodigy we significant grew up prescriber pace compared to two thousand and twenty to date exceeding the total of full year two thousand twenty prescribers by thirty percent with a plasma our team that monoclonal antibody be felt the player with generated strong third quarter net sales of eighteen point seven million dollars given the timing of a prisoner approval last year almost the height of the pandemic we're actually doing a full relaunch of the medicine leveraging the patient centric approach we use for both to peasant and for prospective we've made significant progress on that front be completed expansion of our commercial team in the third quarter our new theme with deep neural immunology experience relationships and market knowledge is now fully on board and started meeting with key position targets early in the fourth quarter in less than six months we developed and launch new brand campaign based on t opinion leader feedback and market research our goal here to drive awareness about a pleasant and and a most the reduce the time to diagnosis and highlight the urgent need for treatment we put a robust commercial structure in place device sport the complex aspects of the uploads the patient journey both have bolstered our side of care and reimbursement support and when have been receiving positive feedback from both positions and flights of care a critical part of our stretches dry position of pace of preference for a place that they found it the french make making of a mechanism of action from clinical data and clear patient benefits which are going to our investment medical and scientific engagement to develop our scientific leadership position the animosity which lives will discuss and morty
spk_5: for shortly
spk_3: take time to affect we launched and pews rare disease medicine and educate stakeholders about the new medicine we're up a good start with the played them and expect to see the benefits of her new commercial organization and investments as we head into the new year oh now turn the call over to live
spk_6: and he ten and good morning everyone the third quarter twenty twenty one march another quarter of great progress in already in addition to advancing our existing headline programs were significantly expanded our pipeline announcing the addition of five new program during our inaugural aren't a day in september
spk_7: all told a pipeline today has the potential for ten new medicine or new indication approvals and the second half of the decade
spk_1: yeah only they also gave us the opportunity to showcase our talented and experienced team it was a pleasure to be able to talk more about our aren't indeed strategy
spk_6: in particular how are expanding our pipeline with early to late stage program for sustainable growth in three ways first by acquiring and developing medicine for indications that address unmet needs in rare auto immune and severe inflammatory diseases particularly those in our therapeutic areas of focus
spk_7: second by leveraging our internal research as well as research faith partnerships and collaboration to drive earlier stage innovation and third by maximizing the range of potential diseases or pipeline molecules can impact i look forward to continuing opportunities to discuss our progress in each of these areas
spk_6: today i'm going to recap some of our key programs similar to return cause of that with that still a mad or a cn seven seven three four
spk_1: extra amount is the first and only plasma site or dendritic cells or pdc deplete or in clinical development
spk_6: ptc their found in high concentrations into these issues of individuals with certain auto immune and inflammatory diseases and this results in a significant information and tissue damage which are the hallmarks of auto immune disease in addition to our ongoing phase two trial evaluating deck fill a man for the treatment of systemic lupus erythematosus we announced in september for new indications we are exploring to are lupus related discord lupus erythematosus and lopez a fight us the other two are l a p c area and him outta my aside us this good lupus is a scar find disease that can be significantly disfiguring and can also result in hair loss on the most important manifestations and lupus through the involvement of the kidney ptc can promote kidney damage and are associated with more advanced disease which is why we're pursuing us know fight us next develop you said area
spk_1: patients with this disease for which there are no ft a proof therapies experience baldness to varying degrees l a p shariati can involve the entire scalp or even the entire body and finally will be studying that's still an effort in out of my sight is a rare condition that manifests as severe skin rash and disabling muscle weakness
spk_6: we expect to begin phase two trial for the for new indications and twenty twenty two moving to death of allah that or a cn forty nine twenty cd forty like an antagonist designed to block a central pathway involved in many autoimmune and inflammatory diseases that's valid that is currently in phase two trial for three indication chevron syndrome rheumatoid arthritis and kidney transplant rejection during aren't a day we announced a new indication for desert alabama and focal segment mental cool marry loeffler of or fscs a progressive kidney disease with high unmet need and know at the a approved treatments
spk_7: expect to begin a phase two trial for ssds and twenty twenty two as well
spk_6: it's the and eighty five or oral selective l parwan antagonist has shown early signs of clinical impact in five arctic disease we expect to initiate to pivotal faith to be trials for a fee and eighty five by the end of this year one and diffuse cutaneous systemic sclerosis and the other and idiopathic pulmonary fibrosis for both of these disease said we work closely with leading experts to incorporate learning from prior trials to optimize trial outcomes moving to a place now are anti cd nineteen humanized monoclonal antibody we're currently enrolling patience and to save three randomized controlled trial one and by a senior gravest or mg and the other and ninety four related disease and he is a chronic rare auto immune neuro muscular disorder that affects the voluntary muscles for the body especially those that control the eyes mouth throat and limbs
spk_1: i see for related disease refers to a group of disorders marked by to were like swelling and fibrosis has affected organs such of the pancreas salivary gland and kidneys
spk_7: we expect a to for both trials and twenty twenty three however because the i g for related disease trial as event driven three that timing may extend beyond twenty twenty three
spk_6: a prisoners indicated for neuro my life as optic a spectrum disorder or animal sd a rare and devastating euro inflammatory auto immune disease that hacks the optic nerve spinal cord and brain stem and i'm a lefty a severe and relaxing and because it has can result in blindness paralysis us and other disabilities often permanent it is critical to prevent relaxing we're rapidly building a base of compelling data to support the efficacy and safety profile of a prisoner this growing body of evidence is a key component of our clinical strategy to establish scientific leadership in an emo sd we share data this quarter a key neurology congress's including a presentation of a new date
spk_2: analysis from our faith three animal as lsd clinical trial
spk_6: the results demonstrated the correlation of be sell depletion and improve outcomes and patients receiving up listener showing that the greater the be sell depletion the better the patient outcome writing additional evidence of the central role the self play and and ammo sd at another neurology conference we presented data showing that a prisoner may provide durable efficacy and a favorable safety profile for blocks with animal as the who often have earlier onset of the disease with more severe relapses finally a new analysis of data from the open label portion of the phase three trial way
spk_7: published in the multiple sclerosis journal that highlighted a positive sustained effect on attack risk in people with animal as the treated with a prisoner for four or more years
spk_1: for to has a we began and rolling patients during the third quarter and the faithful or placebo controlled trial evaluating to preserve for use in patients with chronic third eye disease
spk_6: td a serious progressive and potentially vision threatening rare auto immune disease begins with an acute phase during which inflammatory signs and symptoms such as i'd hang swelling hothouses or i bulging and upload the our double vision progress over time the kids stage of followed by chronic says in which information is no longer present or is markedly diminished however significant signs and symptoms may remain and continue to negatively impact patients quality of life as a reminder to pass the broad indication for all to eighty patients and physicians can prescribe deposit for chronic patients today i objected for the chronic to eat a trial is to generate clinical data to better informed pairs and physicians about the efficacy and safety of to together and people with chronic to edi weeks or topline result in the second half of twenty twenty two we also continue to advance our to puzzles subcutaneous administration program as well as our clinical program for to peasant japan
spk_7: we submitted are trial designed the japanese pharmaceuticals and medical devices agency and anticipate a trial start in the first half of twenty twenty two in addition long term data from our to puzzle optic x open level extension trial recently published in ophthalmology that should high rates of maintained response for proposes cause and diplo via with no new safety signals
spk_6: and as a reminder the arctic x patients had longer to the duration than those and the optic faith three clinical trial we also shared longer term followup results from optic at the annual meeting of the american thyroid association in october
spk_1: that reinforce previously reported data showing a sustained response in the majority of people treated with the pepper
spk_6: we plan to continue to share to has a data at are coming medical meetings over the coming months and finally for chris deck that we were very pleased to recently announced the positive result of our mirror randomized controlled trial evaluating immuno modulation with methotrexate the trial which men it's primary endpoint it months six demonstrated that seventy one percent of patients who were randomized to receive christian
spk_1: plus methotrexate achieved a complete response compared with forty percent of patients randomized to receive sex up with placebo
spk_6: the results of the chris decks of plus placebo arm was very similar to the forty two percent response rate previously demonstrated with chris sex amano monotherapy in the face three program a consistency that helps support the robustness of the trial results the addition of methotrexate resulted in the thirty one percentage point improvement in the complete response rate over mana therapy
spk_7: seen such in a substantial improvement to a response rate is rare and it reinforces the positive results of christopher plus i'm you know modulation be seen from multiple publish case series as well have our own open label trial evaluating for sex with methotrexate
spk_6: this important milestone is the culmination of significant investment over the last several years with the goal of enabling more people living with uncontrolled got to benefit from chris sacca and we continue to explore ways to improve outcomes and identify new path for treatment with professor as exemplified by are shorter infusion duration monthly dosing and retreat and trials beyond these substantial efforts we also continue to invest in developing new approaches the target the underlying cause gout such as our arrowhead and he monsieur preclinical programs as mentioned we expect to summit and as the ole application and the first quarter of twenty twenty two to incorporate the mirror trial data into the prescribing information and week set the standard ten months for view finally we'll be announcing the result of the chris of protect trial at this week's american society of nephrology kidney week this trial evaluated christopher in the management of patients with uncontrolled gout who have undergone kidney transplants
spk_1: we look forward to providing additional details on t pipeline program as well as updating you on our continued progress in the coming months
spk_8: i will now turn the call over to paul
spk_9: there was a comments as forty will primarily focused or gap results unless otherwise noted
spk_3: third quarter sales for one point zero three seven billion dollars representing your rear growth of sixty three percent isn't that the record performances of our key great drivers the plaza and texas as well as a strong performance of our other rare disease medicines
spk_9: or orphan segment generate net sales of nine hundred and fifty one million dollars a year be are increase of seventy eight percent and represent a ninety two percent of total company third quarter that sales orphan black that operating income was four hundred and seventy six million dollars
spk_3: that fell for the information segment radio six million dollars with second operating income of thirty four million dollars we can see you to focus on maximizing the catholic generated from this segment to reinvest in our growth drivers and are expanding pipeline and i get third quarter gross profit ratio was eighty five percent of that fails
spk_9: not yet operate expenses with return seventy five million dollars this included nine gap or in the expense of seventy four million dollars or seven percent of sales versus four percent of sales and the third quarter of twenty twenty not gap as few expense was three hundred one million dollars third quarter adjusted ebitda was five hundred and nine million dollars represent a nearby your growth of fifty four percent nine gap that incur naga income tax expense for the third quarter was seventy four million dollars as we've seen in prior years there can be variability in our tax rate across course can see the back of the tax rate in the fourth quarter to be in the mid teens the bring our for your tax rates in line with are projected low double digit rate non gaap net income for the quarter was for and forty million dollars and i get diluted earnings per share for one dollar and seventy five cents the way it average shares outstanding used to calculate third quarter twenty twenty one nine get the little dps were two hundred and thirty six million shares third quarter nine gap operating cash flow was four hundred and thirty two million dollars as in september thirtieth catholic catholic problems were one point one billion dollars given up for the forget what's ability to invest in are grown operations and the further expand our pipeline including additional strategic transactions the total profile lot of our god is two point six billion dollars but the early of maturity and twenty twenty secs as of september thirtieth or gross that the last twelve months adjusted ebitda leverage ratio was two point zero times represented achievement of are gross leveraged target of two times well ahead of our year and twenty twenty one goal thirty now to our guidance this morning we announced that we are in the and our full year twenty twenty one that failed guidance range the three point one six the three point two one billion dollars from three point zero two five to three point one two five billion dollars
spk_3: this reports are strong performance across all of our business units of the third quarter as well as our increase or your twenty twenty one that sells guidance for the plaza and respectful
spk_9: for it's about other are updated twenty twenty one that failed guidance is for more than one point six two five billion dollars represent a year over year growth of more than ninety eight process as ascended noted we can you expect a third quarter to be the high if that fails quarter of twenty twenty one or to bother for perfect for are updated twenty twenty one for your net sales guidance is for more than five hundred and fifty million dollars represent a year for your growth of more than thirty five percent
spk_3: in our information does this year that we expect less than five million dollars of do access for quarry that sales and are twenty twenty one guidance given the at risk in eric laws that occurred in the third quarter
spk_9: we're also increase in our just leave a dog guidance range from one point two one point three one five to one point three four five billion dollars from one point two six the one point three billion dollars we expect are not get gross profit ratio for the full year to be approximately eighty seven percent or just or up updated the just leave a dog guidance assumes that increase in that gap operating expenses in the fourth quarter driven by this little as three an expansive support the up was the relaunch and continued investment into plaza we expect for your twenty twenty one or in the expanse to approach double digits as a percentage of that sales we can expect not get better to expand for the full year to be a proxy seventy five million dollars we continue to expect a full year nine gap tax rate in the low double digits we estimate that are cast tax rate will be in the mid the hype and will digits and twenty twenty one as always our tax rates could change significantly as result of any acquisitions or divestitures we they make or any changes in tax laws we accept our four year twenty twenty one weighted average delivered check out to be approximately two hundred and thirty six million shares with that of her number to temper as concluding remarks thank you paul the third quarter with another actually quarter marks by strong commercial execution continued progress on our strategy and multiple achievements
spk_3: we generate a record financial results you're like the peasant them as well or bus performance for or other rare disease medicines or if he continued strong underlying demand we read got it for for your to pass the increase second it fails total company it fails and adjusted ebitda we continue to expand our pipeline with the addition of five new phase two programs we announce positive topline results for sex and mirror image i'm i'm relation trial will be submitting an appeal a to the of the in the first quarter to update the chris the label the completed the commercial expensive a plasma and read launched an early this quarter we continue to demonstrate the value we place and tell them sitting gender and ethnicity pay equity once again receiving multiple additional workplace awards right or means one of the fastest growth and transformation stories and biotech and we continue to generate significant value not only for shareholders but also for the thousands of patients living with rare item units severe inflammatory diseases we're excited about her eyes as future remain focus on realizing the tremendous opportunity we see for the company had but that will now open up the call for questions and of cam anthony ap please open up the call
spk_0: and does a reminder to ask a question you need to press or wanting a telephone company during the question press the pound key and the first question come from line of chris scott from tp morgan your lungs know
spk_10: hey guys are present the questions are a disservice to on to pester me first talk about i think it's implied but a but and fifty million dollar fourth quarter number for the drug is that a decent run rate to build off of as we think out twenty twenty two or are there still some sales in the fourth quarter from warehouse pay asians the came in during the supply disruption and he just as my second point here is also want to pegasus chronic use what percent of has a sales and allen a setting and are you seeing more uptake in in chronic with some of the recent data publications or do you think the face for study is really what's going to be needed here to get the attraction in that setting like them
spk_3: sir chris the it as we look at the disrupted patients and help of sequence they continue to come down the vast majority of patients in the fourth quarter week six weeks back and it will have been generate post supply and as we look at two thousand and twenty two get the will look at it is and we've had four quarters of revenue and three quarters in two thousand twenty one a a a rare dynamic given the supply disruption and in the best way that we think the look at growth and twenty two with on a full year basis so look at it year over year and as we look at consensus estimate of mid thirty percent growth and we think that's a pretty reasonable view in context of that dynamic looking at the chronic population we see that now increasing to los double digits as a percent of overall patients so it as a mentor my remarks wave fifty patients of data across a number of published and investigator initiate studies and in our self forces as begun at what case studies and and presenting that data throughout the last several weeks so what we expected continue to drive up taken the chronic patient population right
spk_1: thanks crack anthony next patch and place
spk_0: and your next question from from i have decent censor very from l a airlines now open
spk_11: oh i'm a guy thanked her think i can have to teach to for me i'm him in the past the guy to talk about and doctor who are low prescribers for as my purse hide something like one or two at the scripps curious yeah your commentary earlier where the low prescribers where you've gotten here have he that he had success for hang up or skybridge becoming more may die higher death out had been prescriber and then based on the mere ah how come i realized that will get more detail data to feature medical meeting the get can you comment you actually what we saw a the in fusion reaction profile at that looks similar to what was seen in an investigator thousand and was an improvement had here monotherapy thanks
spk_3: so first on on the mirror we expect the publisher so result of those results and and everything it with that we've seen to date is fully in line with expectations in and every publisher data will will share more more specific details so i'm looking then towards the passer it we continue to make progress the across the prescriber base the first phase of launches always getting to those prescribers who are regular seeing those patients interacting with those patients i gotcha plastic surgeons narrow down like surges and your business specialists and and as he moved to the launch it's expanding that to of the mileage earth and and endocrinologists and and overlaying that with are direct to consumer campaigns saw that continue to progress and that evidence in the results we found the quarter
spk_1: and take them anthony next question plate
spk_0: and your next question got on the line is david hansel i'm from piper center airline is now open
spk_12: thanks so one castex a one on uploads non constructor so is it your application that you will be returning a significant audience of position physicians who are new to the product or who are on on the fence about using it now that you have the mirror dad and his talk about how you think about the expansion of the position audience and on a pleasant you talk about what's driving new starters it's switching from atop the man was switching away from older immunosuppressant or de novo patience or some combination thereof in in your conversations with kilos and practices in general up where you ultimately think the bulk of your business is gonna be coming from at least in the near term on a prisoner thanks
spk_3: sure with with for sector with a really good point when we when we look at the approach with aiming of modulation that is provided to real opportunities wanted to go back to those positions you didn't have a great experience with chris sexes mana therapy and and when away from the medicine many years ago so that certainly has been an opportunity to go back and give those positions a reason to believe that they may feet different results with critics of puff methotrexate as evidence in the mirror trial on but also if it's evidence when you when you have result that there are thirty plus points better or so seventy plus per cent response rates like we've seen a mirror and replicated caught the recipe trial with make a final eight and the other studies that that have been represented similar response rates and getting those de nova patients to physicians you haven't had a lot of experience it's much different approach especially as as you see if use your reaction the number of the other issues that were faith early in the the launch eleven years ago of art issues today so i think what we expect to see growth in those new positions the patients but also contain to go back those physicians who didn't ever great initial experience and and combination that's what drove that forty six percent year over year growth we saw in the third quarter and and that's right the or guidance for the rest of the air relative to a prisoner we we see about half those patients currently on reflects the map that the base of patience with animals the as we look at our new salesforce that felt there were continuing to see and we've generated data that we talked about last quarter being presented on a have switched from or attack the map we i would say with you the majority patient switching from the touch map but also to novo patients coming out for the medicine so i still think familiar with how reflection abuse and the market it's it's a little over half the market and and were saying that be the similar conversion rate to a plasma and as we ramp up or commercial effort to this quarter which back to be able to really start making a difference that we got for your data published outlive also talked about impressive data in the black population so we think all of that together with our expand a commercial effort positions as really well
spk_13: david anthony next question play
spk_0: and it's the some constable on this animal some meaning from stifle your lens now open
spk_14: hi thanks for taking my questions like a fun together on going around got the that summer that camps a they can talk about where he'll have the market i'm not a true close now are meaningfully different than in your other franchises and i guess what can you comfortable they eating repeat on the same success as the you have think that the have i given that it's a market that does have other therapy nuggets were that mean for on other in his and into that does have a number of compare the program and then and christopher again on the same boat forty five percent on
spk_7: ah patients on a new modulation other physicians that aren't using mean you might lose an arm is there some other rate limiting factor for those the for that patients because it seems like there is a pretty decent amount of debt already not just with that the track paper with other me to modulators i'm that could have gotten them oh
spk_14: over that hump so maybe you can just talk about i'm what other rate limiting factors there might be on and getting pieces to comb are prescribed thanks
spk_3: sure annabel and big really come from for the whole premise of doing the mirrors a placebo controlled trial and that is for submitting that getting that included within our label and giving us the ability to actively promote growth factor put him in a modulation of right now we we are getting the word out via congress's medical education and publication of the birth of studies that have been out there in the mirror data hopefully we'll the public the as we get into next year so it's really about ability to drive that up eight vs it naturally being learned in scientific communication and as we get that data out and and hope hopefully approved towards the end of next year that have put us in a position to actively drive patients onto the winter modulation strategy that is support now by the mirror results i'm looking at a place that we are going to look at in it in a very similar way that with the pair them with perspective we are competing with damned of care and and center panic a of have to pass his surgery that was seen as the best option that the time until a new advances brought forward and we see a pleasant a very similar way for tacoma was the best agent available at the time with would not much else available in the in a population were flair than and patients that can get like threatening complications just don't have the option so with the a my as competing with better care and in this case it's retook the map and will approach of just as we have with her other medicines of them understand the long term day that the differentiated benefit sober humanize monoclonal antibodies city nineteen benefits vs city twenty and how we see mechanistically that works better with them anymore state so we think we've got the data and and improvement from state of there it just happened to be a medicine in this case vs surgery or really not treating patients and the case of cross section and and about anthony that question please
spk_0: in your next question cause from a lot of can can touch apart from palin company for is now open
spk_15: hi good morning team or congratulations on another the progress that just wondering at tim now you've had to pizza of in the market for as sufficient on a time to understand any kind of changing patient dynamic so just wondering as you continue to push d t c are you moving at all into more mild patients and know mild is still very bad to this piece and popular a symptom of anything generally surprises you obviously know performed incredibly well on into were driving and chronic a bit more the maybe any context around our differences of from launched her to what you're seeing now and then paul congratulations i'll ask you a question maybe ten will chime in as well obviously there's gonna be potentially lot of bottom line leverage as we go
spk_9: and to next year as we start analyzing off of these not really nice to pizza increased tax and of listener trans can you speak to how we should be thinking about the potential leverage as we get below the top line until next year thanks so much
spk_3: or think that ten at when we look at that to pervert dynamics and how they bothered the the the biggest evolution has been the is and chronic patient that we're not seeing them and go back to mild patient so we see the fifteen to twenty thousand moderate to severe patients coming into the market and that seventy thousand population of chronic patience to be the appropriate use of the plaza we we don't have data nor do we think the path of the good choice in mild patient says that once they get to and progressing getting pain and and to plebeian double vision battle with a to becomes the the the right treatment for those patients that were were solely focused on the moderate to severe population of acute patience and driving that up and in the chronic population to that the of lucia we've seen and all the on earth do you want to speak to leverage yet so
spk_9: you know we're not going against guess is of the guidance and twenty two until after the fourth quarter on our call in march but as is sad and the path over the coming years we do expect margin expansion and we do think that you know the either that margin will expand as we get leverage on the us a bad that should more that off that a significant increase that we had our that were making in our investment in our indeed the as well as our investment in are irrational expansion ahead of really generate significant revenue there and paul that question please anthony
spk_0: mean your next question from a line of yeah teens and young from guggenheim your lungs know
spk_16: had i thank you for digging might question and glad some very good education question on a cortex i could you give that a bit cleaner on in on the contribution you're seeing from the prodigy losses in the polity segment and then any thoughts in obviously you on in the forty percent range now that the combo use what the peak my ah an hour what time period thank you
spk_3: i think the theme so when we look at the the chris deck that it as a match and they're looking at through three quarters we we had thirty percent more than all the prescribers than two thousand and twenty and the froggy vs exceeding the total number for rheumatology three quarters vs to twenty so and the prodigy or i'll be off a small bases growing even faster than rheumatology
spk_17: as an overall contribution then again we we can get the that data because a lot of these patients from the projects infused and similar places is rheumatology patients but we're we're think strong growth and both of those segments but up a smaller base prescribers increasing more rapidly on that prologis side with emily
spk_3: modulation it as we said it is greater than forty five percent which we don't see a hundred percent as as a result but into that seventy to eighty percent ranges with a pretty reasonable and in the building get there will be accelerated with getting approval of inclusion of this data in the label for christie like that which we expect expected be around next year
spk_1: right thing it in next question please anthony
spk_0: and your next question line of a tough to worry from jeffries salons now
spk_15: think the much are given the amount of keep any reports you seen and your pattern assumptions for your to pad the chronic study the year before that the quantity the data will look very similar to the queue population on top of his response and additionally what was the dollar amount of supply distracted patiently fact that contributed to keep retail and moment the quarter over quarter on demand growth for the plaza at the patient is that thank you
spk_3: so on on specific we're not getting into specific dollar contribution and in the third quarter that disrupted patients continued to sequence through when we expect the vast majority of patients in the fourth quarter to be those generated posted the supply disruption of with the chronic read out and and expectations around it we we look at it is a summer design and and population that has has been years since reagan would expect results and in a similar age
spk_13: thanks the cash at that question please anthony
spk_0: and your next customer fossil i have carry not math from b m b m l capital markets or line is now open
spk_18: a guys the morning and first i'm supposed to talk a bit more about your btc efforts and what sort of been packed you seen from that finding these patients and improving diagnosis and how much he might step that up going into next year especially as you want to spend more it's a crime nick the and then in terms of your ex us efforts ah i think paul discuss presented before til principles that outside of japan
spk_3: where else where you look outside the us navy also just talk about that fine line up from doing the study in japan when it could reach the market and and then for who plays know just talk about what you doing in the you to prepare after the launch their but the statuses thank you sure thanks carry that with the plunger up we've we've hired our leadership team
spk_17: one crop of on a pan european basis is was key reimbursement
spk_3: and also several the the commercial leader said no we we expect to be in places to launch beginning and germany post approval which is still expected in the first quarter of of next year so we are contained to ramp up our efforts they're also looking to
spk_17: prepare wrap up efforts and and certain countries and and latin america with the that we continue to prepare our study and working with the japanese authorities and and look to finalize that and and get a critical program beginning enrollment over the next few
spk_3: orders which will then and said and timeline in that a few years out to get those results and and get to the record for process when when it looks to dtc wait we have ramped up those efforts substantially over the second half of two thousand and twenty one and into the real goal there has been too get patients whether that is in the one of our three at the one is is target grace patients educate them that you may get there i disease and that's more just to educate patients if you look at our third eye disease that ran a campaign and that the pedal that com or to pad that btc campaign both of those are geared toward helping patients get to our website and and look to find
spk_1: specialists who treat their with i disease so education and the symptoms and and we've seen a significant increase and the number of patients going to the website looking for specials finder and and we're stories from our field and other areas of of significant increase in in questions being asked as a result of these comers
spk_0: full so the ri and all the different metrics that we look at our performance exceedingly well and and we continue to expect to use that as a resource living in for next year
spk_19: and gary anthony next question plate as the next concerned council line of my who's from morgan stanley your lungs now hey guys are thanks for taking the collections to for me
spk_3: maybe follow up on for stacks up and until maybe could just talk about some of the trend that you're seeing more recently and peace in rome at forms of compared to we saw earlier in the year and then just on priests decks and time to the mirror data and what impact that could have on utilization is the way to think about it that presentation of the data early next year to derive some of that increased utilization or is it really more the the label expansion in that allows you to to promote correctly thanks sure relative to pep growth that we've been really impressed with the groceries on the third quarter especially in context of
spk_1: the the delta by it and and the impact of had on the market than the fact that we're still grow through that and and we continue to expect to see strong pembroke of throughout the fourth quarter earnings and next year
spk_0: i'm with with the mirror data is that that is greater than forty five percent ah we we plan on spending that date of birth congress's which would would probably be presented made year based on our early estimates and and i think that will continue to raise awareness and will have an impact but optimal ability for us to proactively promo
spk_20: okay will be once it's included in the label which is expected by year and mixture and make and anthony get him for one more question place
spk_3: i think and are less question cause milena navan t from seeping airlines no cost
spk_9: how the money on have to question on the some small move on seemingly have on public has been awesome
spk_17: the chronic ted child can you be defensive citation around here at upton don't mean and complain to the droid on my second one i may ask on to comment on your retirement all wasn't and driven by has no reason not to pursue another person
spk_3: thank you paul you want to come at first sir up it's strictly for a full ravens us as we noted i'm going to found a cfl for of the six months with then stay involved as an advisor for the cabana you're up to that and utterly to support my life forever read a step back got from it i dated a full time employment
spk_1: baseball
spk_0: of the question around chronic data and when we expect to get that data in the second half of the year or think the key benefit there will be certainly to help from a reimbursement standpoint and
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