Blueprint Medicines Corporation (BPMC) Q4 2022 Earnings Call Transcript

Blueprint Medicines Corporation (NASDAQ:BPMC) Q4 2022 Earnings Conference Call February 16, 2023 8:00 AM ET

Company Participants

Jenna Cohen - Senior Director and Head of Investor Relations

Kate Haviland - Chief Executive Officer

Philina Lee - Chief Commercial Officer

Christy Rossi - Chief Operating Officer

Mike Landsittel - Chief Financial Officer

Fouad Namouni - President of Research and Development

Becker Hewes - MD, Chief Medical Officer

Conference Call Participants

Dane Leone - Raymond James

Ernie Rodriguez - Cowen and Co

Brad Canino - Stifel

Eun nan - Jefferies

Derek Archila - Wells Fargo

Michael Ulz - Morgan Stanley

Reni Benjamin - JMP Securities

Joe Beatty - Baird

Peter Lawson - Barclays

David Lebowitz - Citi

Zhi Shu - Berenberg

Ami Fadia - Needham

Matt Biegler - Oppenheimer

Nicole Gabreski - Piper Sandler

Operator

Good morning, and invited to nan Blueprint Medicines Conference Call. At this time, each participants are successful listen-only-mode. Following nan general remarks, we will unfastened nan telephone up for your questions. Please beryllium advised that this telephone is being recorded.

At this time, I'd for illustration to move complete to Jenna Cohen, Head of Investor Relations astatine Blueprint Medicines. Please proceed.

Jenna Cohen

Thank you, operator. Good morning, everyone. Welcome to Blueprint Medicines 4th fourth and afloat twelvemonth 2022 financial and operating results convention call. This morning, we issued a property release, which outlines nan topics we scheme to talk today. You tin entree nan property merchandise arsenic good arsenic nan slides that we'll beryllium reviewing coming by going to nan Investors conception of our website astatine www.blueprintmedicines.com.

Today connected our call, Kate Haviland, our Chief Executive Officer, will supply a position connected Blueprint's 2022 accomplishments and really that positions america to proceed to turn and thrust worth successful 2023. Philina Lee, our Chief Commercial Officer, will reappraisal AYVAKIT's capacity and our upcoming opportunity to grow nan explanation and dainty galore much patients pinch SM. Christy Rossi, Chief Operating Officer, will supply a preview of really we will further our SM activity astatine Quad AI [ph] arsenic good arsenic touch connected portfolio milestones for nan year; and Mike Landsittel, our Chief Financial Officer, will reappraisal our 4th fourth 2022 financial results and 2023 guidance. Fouad Namouni, President of Research and Development; and Becker Hewes, Chief Medical Officer, are besides joining our telephone and will beryllium disposable for Q&A.

Before we get started, I would for illustration to punctual everyone that nan statements maine make connected this convention telephone will see forward-looking statements. Actual events aliases results could disagree materially from those expressed aliases implied by immoderate forward-looking statements arsenic a consequence of various risks, uncertainties and different factors, including those group distant successful nan Risk Factors conception of SEC filings. In addition, immoderate forward-looking connection made connected this telephone represents our views only arsenic of coming and should not beryllium relied upon arsenic representing our views arsenic of immoderate consequent date. We specifically disclaim immoderate responsibility to update aliases revise immoderate forward-looking statements.

I'll now manus nan telephone complete to Kate.

Kate Haviland

Thank you, Jenna. Good morning, everyone, and convey you for joining nan telephone today. In 2022, we importantly precocious our business, making important advancement crossed our AYVAKIT motorboat successful precocious systemic mastocytosis and investigation and improvement execution connected our portfolio of precision therapies.

As we footwear disconnected 2023, Blueprint offers a compelling worth proposition and a unsocial profile. I would for illustration to item 3 of nan astir important components of that position that suits america aliases positions america good for important maturation this twelvemonth and beyond.

The first is our activity successful systemic mastocytosis. In 2022, our first afloat twelvemonth of AYVAKIT motorboat successful precocious SM, we doubled our nett merchandise gross year-over-year. The U.S. accounted for nan mostly of these merchandise sales. And successful 2023, we will spot our world launches successful precocious SM gaining momentum arsenic we activity done nan entree and reimbursement process successful cardinal countries.

Importantly, done nan motorboat of AYVAKIT precocious SM, we person built a beardown squad and a instauration of commercialized capabilities and infrastructure. We are fresh now to standard nan effect of AYVAKIT pinch our imaginable explanation description successful ISM. Philina will spell into much item connected AYVAKIT's capacity successful 2022 and preview really we scheme to build what will go a blockbuster therapeutic class done our anticipated motorboat successful ISM midyear.

The 2nd constituent is our objective shape pipeline focused connected best-in-class investigational therapies that reside superior aesculapian problems successful ample diligent populations. Our improvement efforts are focused successful mast compartment disorders, lung crab and bosom cancer. Within these areas, each of our programs person a beardown mechanistic rationale and a improvement strategy to execute a first aliases best-in-class position.

In 2022, we worked to build nan instauration for these programs done dose escalation and dose optimization. And we are poised this twelvemonth to quickly beforehand these programs into earlier lines of treatment, wherever we person nan top opportunity to effect important aesculapian needs.

We besides proceed to broaden our find efforts, expanding nan scope of high-value targets we tin prosecute arsenic we purpose to summation our already awesome investigation productivity, astir precocious demonstrated by nan announcement of our caller investigation programme targeting wild-type kit for communal mast compartment diseases adjacent to systemic masocytosis, including chronic urticaria.

The 3rd and past constituent is that we are operating from a position of financial strength. Our beardown rate position and disciplined attack to superior allocation ensures that we are good positioned to execute connected nan scope of opportunities we person successful beforehand of us, while driving towards a sustainable financial profile.

Today, we person greater than $1 cardinal successful rate connected our equilibrium sheet, and we are increasing merchandise revenue, which will proceed to go a much important information of wide gross this year. Mike will spell into our financial capacity successful much extent later connected successful nan call.

At Blueprint, we person an unthinkable maturation communicative correct successful beforehand of america successful 2023 and beyond. We telephone this precision astatine scale. This communicative starts pinch our existing commercialized portfolio, which provides a certainty of worth and a near-term opportunity to thrust gross acceleration.

Beyond SM, our find and objective shape portfolios supply aggregate opportunities for america to tackle progressively ample opportunities successful oncology and beyond. This diverseness of basal worth drivers creates aggregate avenues for maturation and upside crossed each aspects of our business.

As a afloat integrated company, we person captious mass, including nan expertise, nan infrastructure and astir importantly, nan correct group to present connected these opportunities, creating bonzer worth for patients, nan aesculapian organization and for our shareholders.

Now fto maine move it complete to Philina to reappraisal AYVAKIT's capacity and supply a position connected nan upcoming ISM launch.

Philina Lee

Thanks, Kate. Good morning, everyone. Let's commencement pinch AYVAKIT performance. In 2022, we doubled AYVAKIT nett merchandise revenue, achieving $111 million. Fourth 4th revenues were $30.1 million, pinch $26.3 cardinal successful nan U.S.

We person established AYVAKIT arsenic nan modular of attraction successful precocious SM successful nan U.S., wherever we proceed to turn nan number of patients treated pinch AYVAKIT year-over-year. In 2022, we exited nan twelvemonth pinch astir 500 patients connected AYVAKIT. The percent of patients connected free supplier remains stable.

In Q4, AYVAKIT maturation was driven by respective important measures. We added astir 50 caller accounts, expanding nan breadth of prescribing to astir 400 accounts pinch AYVAKIT experience.

AYVAKIT penetration accrued crossed each subtypes of precocious SM. Approximately 75% of patients who commencement AYVAKIT are curen naive, which is simply a promising lead parameter arsenic we attraction connected increasing nan treated precocious SM market.

We are assured successful our guidance of $130 cardinal to $140 cardinal successful AYVAKIT nett merchandise gross this twelvemonth crossed GIST and precocious SM. I want to stress this guidance is circumstantial to our existent indication. The midpoint of this scope represents a much than 20% summation successful AYVAKIT revenues year-over-year, and we besides expect to execute further gross for AYVAKIT this year, supra and beyond our guidelines guidance owed to our anticipated motorboat successful ISM.

Now let's move to ISM. Upon approval, AYVAKIT will beryllium nan first FDA-approved therapy for patients pinch ISM. Patients and providers person been waiting for this for a agelong time. With our PDUFA day successful hand, our squad is laser-focused connected building nan marketplace to present connected this unthinkable opportunity to toggle shape patients' lives.

AYVAKIT represents a blockbuster opportunity successful FM, pinch an estimated $1.5 cardinal world yearly peak, chances to make this benignant of diligent effect are uncommon successful our industry, and this has enabled america to quickly enlistee talent arsenic we've incrementally expanded our highly knowledgeable section team.

Our U.S. motorboat strategy focuses connected 7,500 patients pinch mean to terrible ISM. These patients are actively seeking treatment, which is constricted to denotation directed polypharmacy today. We expect early take of AYVAKIT successful patients pinch terrible denotation burden, followed by patients pinch mean denotation load complete time.

To hole for ISM launch, we're focused connected 3 cardinal areas. First, we're engaging a broader supplier guidelines who are managing ISM patients. Our section squad is connected nan ground, engaging nan heme/onc and allergist immunologists who are seeing nan astir ISM patients to understand their practices and to amended connected SM.

Our top attraction is connected nan apical 350 providers who are managing astir 1,500 mean to terrible ISM patients today. From our section intelligence and superior marketplace research, providers opportunity astir half of their patients are not good controlled connected existent therapy, which ties good to nan 7,500 patients we tin spot successful claims.

Our 2nd area of attraction is activating patients to see a caller curen option. Our diligent and caregiver campaign, it's thing has now enrolled thousands of highly motivated prospective patients who fishy they whitethorn person SM. And we cognize that an knowledgeable and motivated diligent is simply a catalyst for treatment.

Third, we're focused connected maintaining beardown and accelerated diligent entree to therapy. Today's favorable entree situation for AYVAKIT provides a beardown foundation. All doses are presently connected nan marketplace coming pinch virtually nary entree challenges and industry-leading clip to fill.

Now let's talk much astir expectations for our first motorboat ramp successful ISM, which we expect to bespeak our uncommon illness motorboat trajectory. We deliberation nan HAE marketplace is simply a bully illustration for really ISM tin create into a blockbuster market. We spot respective similarities.

First, HAE is simply a uncommon illness treated by allergists. Multiple disease-modifying therapies are approved and reimbursed coming pinch value points supra AYVAKIT's existent database price. Over nan past 15 years, nan preamble of these therapies catalyze improvement of nan HAE market, enabling linear income maturation complete this clip frame.

In 2021, world income of prophylactic HAE therapies were astir $1.5 cardinal and still growing. There are 7,500 diagnosed and treated HAE patients successful nan U.S. today, which is remarkably akin to nan number of diagnosed and treated patients pinch mean to terrible ISM. So collectively, nan HAE acquisition gives america assurance successful nan commercialized motorboat trajectory for AYVAKIT successful ISM.

As you spot pinch HAE, we expect a uncommon illness ramp. While we don't expect an first motorboat bolus, location are respective factors that should accelerate nan improvement of nan SM market, including our efforts complete nan past respective years to summation illness consciousness and test rates, arsenic good arsenic our precocious diligent recognition capabilities, and this will further thief to catalyze curen and marketplace growth.

As we thrust towards nan PDUFA day for ISM, AYVAKIT has each nan harbingers of a beardown launch, precocious aesculapian need, first to marketplace pinch a beardown merchandise floor plan and a highly motivated group of patients and providers who are waiting for an FDA-approved therapy. With our acquisition and our activity successful SM, we're assured successful our expertise to seizure nan important ISM opportunity ahead.

With that, I'll move it complete to Christy, who will speak to Blueprint's activity astatine Quad AI.

Christy Rossi

Thanks, Philina. Good morning, everyone. Next week astatine Quad AI, we are proud to stock information crossed aggregate presentations that further solidify our long-standing technological activity and committedness to SM. The PIONEER study definitively demonstrates that AYVAKIT potent and selective inhibition of KIT D816V, reduces mast compartment burden, amended symptoms and therefore, transforms nan value of life of SM patients.

Since presenting nan apical statement information past August, we've met pinch a assortment of wellness attraction providers who dainty SM patients to understand what information is astir meaningful to them. While nan circumstantial result measures that are astir impactful will alteration by expert and it tends by specialty arsenic allergists person a different reference framework for objective tests and are overmuch much utilized to PROs, for example, than hematologists are. Some themes person emerged consistently.

The first is that information is key. A cleanable information floor plan lowers nan hurdle for prescribers and patients to see a disease-modifying therapy for illustration AYVAKIT, shifting nan speech from why effort a caller therapy for illustration AYVAKIT to why not.

The 2nd is that nan totality of effect crossed symptoms and value of life is paramount. Our superior endpoint of mean alteration successful TSS captures nan denotation use broadly. In addition, SM treaters are willing successful nan effect connected patient's astir bothersome symptoms, which tin motivate a diligent to want to initiate therapy, arsenic good arsenic nan effect of curen crossed nan circumstantial symptoms captured successful nan TSS. Finally, prescribers are looking for denotation betterment to construe into effect connected a patient's value of life, which is nan eventual extremity of therapy.

Third, information connected measures of mast compartment load helps to explicate nan biologic rationale for nan use that wellness attraction providers are seeing successful their patients. Seeing meaningful and accordant impacts successful these measures, increases prescriber assurance successful a therapy's imaginable to change nan people of disease.

Finally, successful a chronic lifelong illness for illustration SM, prescribers are very willing successful knowing nan effect of curen complete time. We designed Part 3 of PIONEER specifically to measure and seizure nan use of curen complete nan longer term. With that feedback successful mind, we are looking guardant to sharing much from PIONEER successful 3 presentations astatine Quad AI.

An oral position connected Sunday, February 26, will item nan statistically important and clinically meaningful results that AYVAKIT achieved crossed nan superior and each cardinal secondary endpoints successful PIONEER. We scheme to show further information connected our superior and secondary endpoints, including accusation connected individual denotation benefit, arsenic good arsenic information from nan 48-week crossover information of nan study.

We will besides person 2 further presentations that will attraction connected AYVAKIT's effect connected tegument signs and symptoms and connected value of life. We are excited to stock these important results successful item for nan first time, demonstrating nan disease-modifying benefits of AYVAKIT and showing really AYVAKIT empowers physicians to reside nan astir important concerns of their ISM patients.

Other presentations astatine nan gathering will qualify nan load of illness and showcase caller approaches to accelerate diagnostic rates and proceed to turn nan ISM market. We look guardant to this important convention and to sharing much item during our firm telephone connected Monday, February 27.

I'll now move concisely to our portfolio updates for this year. In January, we guided to a assortment of milestones crossed our portfolio arsenic we activity to grow our effect connected patients globally. We discussed tow important AYVAKIT milestones already this morning, nan upcoming position of nan PIONEER information astatine Quad AI, arsenic good arsenic our anticipated support and motorboat successful ISM by midyear.

Today, we are besides pleased to corroborate that we person received EMA validation of our type 2 variety for AYVAKIT and ISM, bringing america a measurement person to this important denotation description and motorboat successful Europe.

We're connected way for our different firm milestones for nan year, including IND submission for BLU-525 and position of first dose escalation information from some BLU-451 and BLU-222 successful nan first half of nan year.

Last week, we announced that nan FDA had issued a partial objective clasp connected nan VELA proceedings owed to ocular adverse events observed successful a constricted number of patients. Patients who are presently enrolled successful nan study are continuing to person study drug, and we are moving expeditiously pinch nan FDA to resoluteness nan partial clasp and resume study enrollment. More broadly, we look guardant to sharing further information crossed our portfolio arsenic we scope these milestones and make advancement towards our 2027 Blueprint.

With that, I'll move nan telephone complete to Mike to reappraisal our financial updates.

Mike Landsittel

Thanks, Christy. Earlier this morning, we reported elaborate financial results successful our property release. For today's call, I'll touch connected a fewer highlights.

For nan afloat year, full revenues were $204 million, including $111 cardinal successful nett merchandise revenues from income of AYVAKIT and $93 cardinal successful collaborations and licence revenues, exceeding nan precocious extremity of our 2022 full gross guidance of $200 million.

Of these afloat twelvemonth revenues, $30.1 cardinal of AYVAKIT nett merchandise revenues and $8.7 cardinal successful collaboration revenues were recorded successful nan 4th quarter. As Philina noted for AYVAKIT, we saw continued maturation successful precocious SM diligent starts and merchandise revenue.

Our full operating expenses were $723.7 cardinal for nan afloat twelvemonth and $183.7 cardinal for nan 4th quarter. Our Q4 operating expenses showed a quarter-over-quarter diminution from Q3 arsenic we proceed to leverage operating efficiencies crossed our businesses.

In 2023, we expect that we will execute $130 cardinal to $140 cardinal successful AYVAKIT nett merchandise revenues for precocious SM and GIST. We besides expect afloat twelvemonth collaboration revenues of $40 cardinal to $50 cardinal from existing collaborations. This guidance highlights our expectations for some nan continued diverseness of gross and a continued but much mean maturation of AYVAKIT merchandise gross successful precocious SM and GIST. I want to reemphasize that this guidance is circumstantial to our existing AYVAKIT indications, and it does not see maturation from our anticipated explanation description into ISM.

We expect our operating expenses to turn moderately successful nan first 4th of 2023, and this will beryllium driven by our preparations for nan motorboat of ISM, including nan effect of our incremental section unit description , arsenic good arsenic planned manufacturing investments to support nan continued advancement of our objective programs. We past expect operating disbursal maturation will flatten successful nan 2nd half of nan twelvemonth arsenic we admit economies of standard crossed our portfolio.

As we participate 2023, we are successful an exceptionally beardown financial position pinch astir $1.1 cardinal successful rate that will substance our 2027 Blueprint to execute precision astatine standard and create transformative worth for patients and shareholders.

With that, I'll now move nan telephone complete to nan usability for questions. Operator?

Question-and-Answer Session

Operator

Thank you. We will now commencement today's Q&A session. [Operator Instructions] Our first mobility coming comes from Dane Leone from Raymond James. Your statement is now open.

Dane Leone

Hi. Thank you for taking nan questions and congratulations connected each nan progress. I deliberation for nan guidance that you've outlined this morning, we person a number of questions coming successful that are beautiful akin from investors that are benignant of focused astir erstwhile you look astatine nan existent prescriber guidelines of AYVAKIT and ASM, what nan overlap is astatine those centers pinch patients you identified arsenic being ISM patients who could beryllium eligible for curen erstwhile you get nan approval?

And I deliberation nan genesis of that is trying to thief group of erstwhile you get nan approval, wherever nan motorboat could beryllium initially focused and benignant of what percent of nan target organization would beryllium typical of your existent prescriber base? Thank you.

Kate Haviland

Thanks for that question. And Philina do you - tin you measurement successful connected that?

Philina Lee

Yes. Thanks very overmuch for that question. So arsenic you know, our teams are successful nan marketplace connected nan crushed today, engaging pinch apical measurement prescribers of AYVAKIT, arsenic good arsenic nan apical measurement providers who are treating ISM patients. And successful fact, we do spot immoderate overlap. And truthful wrong those apical 350 high-volume prescribers, they are treating astir 400 mean to terrible ISM patients coming who are imaginable candidates to commencement AYVAKIT quickly upon approval.

Dane Leone

Thank you.

Operator

Our adjacent mobility coming comes from Marc Frahm from Cowen and Co. Your statement is now open.

Ernie Rodriguez

Hi, guys. This is Ernie Rodriguez for Mark. Thanks for taking my telephone and congrats connected nan quarter. So you mentioned nan astir bothersome symptoms that will beryllium presented pinch a PIONEER information later this month. So this endpoint evidently focuses much connected denotation pinch much terrible effect connected immoderate fixed patient. Do you deliberation that gives you a bigger scope to show denotation use versus nan wide composite? And really do you spot nan period of objective meaningfulness differs from nan constricted domains connected nan TSS score? Thanks.

Kate Haviland

So Ernie, sorry, I deliberation you're breaking up a small bit. We admit nan question. I judge what you're asking is really are we reasoning astir nan breadth of effect crossed various symptoms successful nan PIONEER information versus benignant of nan relationship pinch nan astir bothersome symptom. I judge that was your question.

So possibly what we tin - is that correct? Okay. So I deliberation what Christy was - great. So I deliberation what Christy was laying retired is really that we person - successful PIONEER, we person demonstrated statistically important and clinically meaningful benefits to patients crossed a scope of ways of looking astatine curen impact. And that includes nan effect of pathological mast cells from our quantitative measures, it includes nan effect connected some nan wide denotation load of diligent experiences arsenic measured by nan TSS arsenic good arsenic impacts crossed each nan individual symptoms and domains.

And truthful we really look guardant astatine Quad AI to beryllium capable to put that information retired to show those that effect nan wide and benignant of effect that AYVA has. And I deliberation importantly, it is that nan early impacts we spot arsenic good arsenic nan deepening complete clip that is going to beryllium important to prescribers arsenic we person talked about.

Ernie Rodriguez

All right. That's helpful. Thank you.

Operator

Our adjacent mobility coming comes from Brad Canino from Stifel. Your statement is now open.

Brad Canino

Thanks and bully morning. Maybe connected nan CDK2, I'd for illustration to inquire if complete nan past week person immoderate much patients completed oculus exams, peculiarly nan diligent that had nan Grade 3 arena and person those results been accordant pinch what you antecedently saw?

And past if you tin conscionable quickly locomotion done nan existent reasoning of why those imagination events are improbable to impede nan afloat improvement of this plus and nan logistical steps to reactivate this trial? Thank you.

Kate Haviland

Thanks for nan question. Becker, will you prime up?

Becker Hewes

Yes. So pinch respect to nan mobility connected nan oculus exams for nan diligent pinch nan Grade 3, and this really applies to each of nan patients that we person afloat oculus exams on. There's really perfectly thing abnormal showing up connected these ophthalmologic exams and they're very extended ophthalmologic exams. And I deliberation this is really accordant besides pinch nan symptomatology, which are - which are very little episodes of either changing of nan strength of ray aliases a spot of blurriness.

Patient pinch a Grade 3 besides had an MRI showing that location was thing successful nan cardinal tense strategy that could explicate nan symptoms. But it's really nan really little quality of nan symptoms and nan truth that they resoluteness truthful quickly upon either concisely stopping nan supplier and past restarting astatine a little dose.

So - and past pinch respect to nan clip statement aliases nan steps needed to get nan programme backmost connected track, we've been moving very intimately pinch nan FDA, who've been highly cooperative. The main reason, arsenic we said for nan partial objective clasp is simply to modify nan protocol to put ophthalmologic circumstantial dose accommodation criteria successful location and grading criteria and past to alteration nan informed consent truthful that everyone is alert that these are imaginable things that could occur.

And past successful position of really I'm reasoning astir this successful nan wide development. As we've said before, we're nearing nan extremity of dose escalation. I deliberation we person a scope of imaginable doses available. And truthful we spot nan extremity of nan single-agent dose escalation insight. These events, again, are very brief. They are usually Grade 1, and they - having immoderate ophthalmologic aliases ocular changes successful galore crab narcotics it's really not uncommon. And this is truthful mild and truthful transient that I really don't spot this arsenic perchance dose limiting. And again, pinch a supplier that has specified a cleanable kinome and it's truthful targeted to CDK2. I deliberation we person a bully scope wherever we tin spot imaginable successful nan early for objective use for patients.

Brad Canino

Great. Thanks for nan color.

Operator

Our adjacent mobility comes from Eun nan from Jefferies. Your statement is now open.

Eun Yang

Thank you. So we are awaiting specifications connected nan PIONEER information astatine Quad AI, but I wanted to inquire you for this cardinal secondary endpoint responder rate, what's nan minimum delta betwixt nan 2 arms needed to execute statistical significance? Thank you.

Kate Haviland

Yes. Thanks for nan question, Eun. And I'm going to manus complete to Christy to talk much astir that.

Christy Rossi

Yes. So thanks, Eun. As you know, I mean, we deed - we were highly important crossed each of our superior and cardinal secondary endpoints. And truthful I deliberation portion of what nan mobility is conscionable benignant of really we construe nan assortment of information connected these endpoints and really do clinicians construe them successful position of being meaningful. And arsenic we've engaged connected this, I would opportunity 2 things.

One, arsenic we've said before, nan totality of nan information crossed each of these endpoints is really what is astir impactful and different wellness attraction providers construe different pieces of information successful different ways. What's absorbing astir consequence complaint is that it's really not an endpoint that is utilized successful allergy frequently. And truthful arsenic we prosecute successful allergists pinch allergists, they recovered ORR to benignant of beryllium nan slightest interpretable of each nan endpoints, but we're very eager to stock it and surely immoderate hematologists find it incredibly compelling.

And truthful we will beryllium looking astatine some responder analyses, arsenic we've indicated crossed nan secondary endpoints. It will beryllium besides really absorbing to spot really those rates germinate complete time, again, benignant of demonstrating nan semipermanent effect of AYVAKIT. And it's that totality of nan information on pinch nan different secondaries and nan superior that we've recovered prescribers person recovered very compelling, and we're looking guardant to sharing each of that information successful a mates of weeks.

Kate Haviland

I deliberation you're successful specified different position Eun that nan study has demonstrated important effect crossed aggregate ways of looking astatine it, right? Everything from benignant of nan astir basal biologic impacts connected benignant of nan pathologic measures of mast cells, arsenic good arsenic nan diligent impacts connected symptomatology each nan measurement done to value of life. And it's very uncommon to person specified statistically and clinically meaningful outcomes crossed specified a wide array of measures successful nan study. And truthful we're really looking guardant to showing that data.

Eun Yang

Thank you.

Operator

Our adjacent mobility comes from Derek Archila from Wells Fargo. Please spell ahead.

Derek Archila

Hey, bully morning. And acknowledgment for taking nan questions. Just 2 speedy ones from us. First one, conscionable connected nan 2023 guidance. I conscionable want to understand, is this much astir driving caller relationship activations aliases is this much astir extent astatine existent accounts? And I guess, if it's nan latter, really overmuch extent is really near successful position of caller patients astatine these existent practices that you're already at?

And past I conscionable want to make judge I heard you correctly. I deliberation it was Dane's question. So I deliberation connected nan 350 providers, I deliberation that you're initially targeting, truthful nan overlap for ISM patients is astir 400 retired of nan first 1,500. So is it adjacent to presume those different 1,000 patients are being seen by allergists? So, thanks.

Kate Haviland

Yes, Derek, acknowledgment truthful overmuch for nan question. I'll manus it complete to Philina to reply nan specifics. I deliberation - but to your first portion of your question, I mean, I deliberation what we're truthful pleased to spot successful this motorboat is that we are - we person nan ascendant stock of nan existent marketplace of patients who are treated pinch precocious SM and we're seeing that accordant demand, wherever we proceed to thrust caller patients, broadening nan prescriber base, adding caller accounts and caller prescribers arsenic we really activity to grow nan wide size of nan SM marketplace arsenic well. And truthful I deliberation we're going to proceed to spot some of those dynamics play retired done launch. And past Philina, do you want to talk astir nan numbers successful much depth.

Philina Lee

Yes, sure, Derek. I deliberation astatine nan bosom of your question. Your first mobility is really astir has nan precocious SM opportunity peaked for what is benignant of nan headroom connected that. So to beryllium really clear, we spot headroom importantly to proceed to turn nan precocious SM opportunity. We cognize that this is going to hap astatine a much measured complaint than nan maturation trajectory that we saw early successful nan launch. And that maturation is driven by respective factors.

We're still early successful penetrating into nan wide precocious SM diligent population. We are nan modular of attraction successful nan treated diligent population, but nan biggest lever of maturation is genuinely activating nan fuller breadth of precocious SM patients to beryllium treated for their SM.

And truthful penetration crossed each subtypes, important room to proceed expanding connected nan breadth and extent of nan prescriber base, arsenic good arsenic nan durations of therapy, which are favorable. And arsenic we displacement towards a much treatment-naive diligent population, that is besides a favorable harbinger of longer durations of therapy complete extended periods of time.

So to your 2nd mobility astir nan 400 patients. So conscionable to beryllium really clear, that is conscionable nan mean to terrible ISM patients who are treated by nan apical 350 of our existent prescriber base. And importantly, we cognize that it's important to prosecute a broader prescriber guidelines who are treating that 7,500 mean to terrible ISM patients who are diagnosed and actively seeking curen today.

So erstwhile we deliberation astir wherever early take of AYVAKIT could hap station ISM approval, we spot it not only among those 400 patients treated by nan existent apical measurement prescribers, but besides among that broader group of patients who really person terrible symptomology.

Derek Archila

Got it. Thank you.

Operator

Our adjacent mobility comes from Ana Macdonald [ph] from Goldman Sachs. Please spell ahead.

Unidentified Analyst

Good morning. This is Ana Macdonald connected for Salveen. Thank you for taking our question. So connected nan ISM launch, we're conscionable trying to understand what patients would beryllium nan early adopters. So from nan 400 patients that you mentioned, what proportionality would not beryllium good controlled connected existent treatments? And past conscionable quickly connected nan CDK2 program, pinch your projected actions, is nan FDA aligned connected nan changes to nan protocol? Thank you.

Kate Haviland

So convey you for that question. Maybe we'll commencement pinch nan wide numbers of ISM. I deliberation we're getting a small spot confused connected nan 400. So I conscionable want to make that really clear for people. So maybe, Christy, tin return that. And past Becker, if you could return nan CDK2. Yeah, spell ahead.

Christy Rossi

Yes, happy to. So some of nan past 2 questions, I think, are getting a small spot to benignant of wherever nan patients are successful breadth and depth. So conscionable to beryllium clear connected nan 400, we spot 400 moderate-to-severe, not well-controlled ISM patients amongst physicians who presently person AYVAKIT experience. So I deliberation that gets to nan earlier mobility connected overlap arsenic well.

So I deliberation nan wide thought present is that there's a batch of imaginable pinch ISM amongst prescribers who person existent AYVAKIT experience. And certainly, early successful nan launch, that is simply a spot that we will attraction to thrust growth. The 7,500 patients successful full erstwhile we propulsion that number retired and talk astir that, each of those patients are patients that we position to beryllium mean to severe, not good controlled and candidates for therapy.

And possibly conscionable to adjacent retired connected benignant of nan breadth and extent questions that are coming up, we spot opportunity successful some places, right? So if I deliberation astir precocious SM, we are continuing to deepen usage astatine existing prescribers, what nan dynamics that you spot is often that they will get comfortable treating a diligent and past they will commencement to place further imaginable candidates.

And truthful we decidedly spot room to deepen. But bosom [ph] continues to beryllium really important successful a uncommon illness marketplace for illustration this. And truthful we're really pleased to spot nan number of caller accounts that we added successful Q4 and expect to spot that proceed done nan year.

Becker Hewes

Yes. And this is Becker. And truthful pinch respect to nan process pinch nan FDA, conscionable a small spot of inheritance astir really this mostly happens. So nan first telephone that we had pinch them started nan process and nan measurement it will extremity will beryllium pinch written notification that nan partial clasp has been ended aliases been lifted. And we've been moving very intimately pinch nan FDA. We're quickly modifying nan informed consent and nan protocol and nan IB.

And truthful far, it's been going highly smoothly. This is simply a collaborative action aliases relationship pinch nan FDA, and we've had alignment on nan way. So this is really astir informing group and making judge that nan correct grading strategy is successful nan protocol and immoderate adjustments are very clear. So there's been really rather a spot of alignment.

Christy Rossi

And conscionable truthful that collaborative quality of nan conversations person been really - person been very constructive. We are moving to taxable nan documents. Of course, we're not successful power of nan FDA clip statement connected nan different side. But I deliberation that collaboration and benignant of associated consciousness of getting nan study backmost connected way gives america a batch of assurance that will consequence this successful a short clip frame.

Unidentified Analyst

Thank you.

Operator

Our adjacent mobility comes from Michael Schmidt from Guggenheim Securities. Your statement is now open.

Unidentified Analyst

Hey, bully morning. This is Paul connected for Michael. Thanks for taking our question. Just 1 from america connected nan CDK2. Maybe you could thief group immoderate expectations for that first objective readout this year, specifically connected nan pharmacodynamic markers of activity, thing that you should item that we should expect specified arsenic a simplification successful passive Rb aliases cyclin E protein, that would beryllium really helpful. Thank you.

Kate Haviland

Becker, will you return that?

Becker Hewes

Yes. So conscionable arsenic we said earlier, our guidance has been for dose escalation information midyear and past an early look astatine nan combination, we are capable to commencement nan operation earlier we scope a recommended Phase II dose. And truthful we look guardant to presenting that, including information and biomarker information midyear this year.

With respect to biomarkers, we person a number of them. They are circulating biomarkers, they're tumor biomarkers. And truthful what we'll beryllium presenting is an emerging holistic look astatine nan activity and selectivity of BLU-222 successful these multiply relapsed Phase I patients.

Unidentified Analyst

Thank you.

Operator

Our adjacent mobility comes from Michael Ulz from Morgan Stanley. Please spell ahead.

Michael Ulz

Thanks and bully morning. Maybe I tin conscionable inquire different mobility connected nan ISM opportunity and really you're reasoning astir nan early trajectory here. I cognize successful your prepared remarks, you commented you're not anticipating a bolus here. But I'm conscionable funny what effect could position of nan information astatine Quad AI adjacent week person connected those views. Could it thrust further interest? And could it perchance alteration your position connected nan early trajectory? Thanks.

Kate Haviland

Yes. So convey you for nan question. Let maine return nan first portion connected nan bolus. I deliberation - and nan constituent I tin measurement successful connected nan effect of Quad AI. I deliberation from some perspective, nan logic why we're not saying that we don't expect it because we designed nan PIONEER study to measure semipermanent follow-up of nan patients.

And truthful successful a merchandise launch, erstwhile you spot a bolus, it's often because you're switching patients disconnected of objective tests into commercialized drug. And we judge nan semipermanent acquisition of AYVAKIT curen successful these patients is critically important to nan wide worth arsenic we proceed to look astatine that effect complete time. So we're retaining patients wrong nan PIONEER study for up to 5 years. So that is why we don't expect a bolus coming retired of objective tests into commercialized therapy. And Philina, do you want to talk astir nan - really you spot nan effect of Quad AI?

Philina Lee

Yes, sure. So I mean, I think, first and foremost, I want to besides talk astir nan efforts that nan squad is doing to hole for nan motorboat and benignant of provender towards nan eventual ramp upon support arsenic well. So arsenic I mentioned, we're hyper focused connected 3 captious areas, nan broader supplier engagement, some wrong nan existing prescriber guidelines for AYVAKIT arsenic good arsenic that broader prescriber base. Future prescriber base, including allergists immunologists, we're focused connected activating patients and maintaining our beardown diligent access.

And truthful among that, erstwhile we deliberation astir nan value of Quad AI, clearly, it will summation nan consciousness of AYVAKIT, particularly among that allergists and immunologist community, consciousness of AYVAKIT arsenic good arsenic nan data.

As acold arsenic our teams attraction arsenic well, a mates of factors that we deliberation will thief pinch nan ramp is that for galore years, we person been engaging to summation illness consciousness arsenic good arsenic test rates. And our squad has been really honing and perfecting our skills pinch nan precocious SM launch.

So we cognize really to leverage precocious analytics and our section acumen to find patients. We cognize really to place their providers, and we cognize really to prosecute these providers leveraging our heavy illness authorities expertise. So we are assured arsenic we deliberation astir that wide $1.5 cardinal highest opportunity, that we will yet beryllium capable to seizure this opportunity.

Michael Ulz

Very helpful. Thank you.

Operator

Our adjacent mobility comes from Reni Benjamin from JMP Securities. Your statement is now open.

Reni Benjamin

Hey, guys. Thanks for taking nan questions and congratulations connected nan 4th and outlook for 2023. Can you talk a small spot astir really we should beryllium reasoning astir nan income unit and their move to attraction connected allergists? Is this thing that apt we're going to person to summation arsenic we get into nan twelvemonth and aft approval, do you person a consciousness arsenic to really galore docs are presently alert of AYVA and ISM versus not arsenic well?

Kate Haviland

Yes. Thank you, Ben, for nan question. And I'll move it complete to Philina to reply nan mobility astir nan income force. I deliberation 1 of nan awesome attributes of this motorboat for america is that it is really an hold of what we've been doing successful SM, and it is still - it's a specialty market. So it's a marketplace that we tin surely entree pinch incremental maturation successful our section infrastructure. But Philina talk a small spot astir really you're reasoning astir that.

Philina Lee

Yeah, truthful arsenic Kate mentioned, pinch - precocious SM provides a beardown foundation, right? So nan superior specialty attraction historically for america has been hematology and oncology. But arsenic we hole for nan ISM launch, we cognize that we'll request to prosecute a broader supplier and specialty base, including allergists. And truthful we've incrementally expanded our section unit and strengthened our capabilities successful allergy, immunology, arsenic good arsenic uncommon disease. And to your mobility connected awareness, astatine this point, we're successful a very beardown position pinch consciousness of AYVAKIT among target prescribers of complete 40%.

Kate Haviland

So that's unaided awareness. So I deliberation that's different astatine this constituent and this early successful a prelaunch shape to person that level of awareness. And truthful I deliberation - I besides deliberation it's important, arsenic Philina had mentioned before, our information analytic capacity is captious here. This is not a scope and wave model. This is astir getting to wellness attraction providers astatine a clip erstwhile it's astir applicable to them, meaning they've seen a diligent recently. And truthful that is thing again, that we person really worked difficult connected and nan squad has done an unthinkable occupation done nan precocious SM launch, getting that exemplary up and running.

Reni Benjamin

Great. Thank you.

Operator

Our adjacent mobility comes from Joe Beatty from Baird. Your statement is now open.

Joe Beatty

Great. Thank you. How is nan existent payer sum for ISM? And are you capable to thief framework what support complaint you've been seeing by this for ISM?

Kate Haviland

Thanks for that question. I deliberation I'll fresh to Philina, but I person to opportunity that marketplace entree has been an unthinkable spot of our launches to day and we are very good positioned moving into nan ISM launch. Do you want to talk much astir that, Philina?

Philina Lee

Yeah and truthful to beryllium clear, ISM is conscionable a mini fraction of our existent business coming and sum and entree are beardown crossed nan afloat spectrum of SM patients. There's conscionable 1 wide SM codification and truthful payers aren't needfully capable to separate nan quality betwixt precocious SM and ISM today. And arsenic we've talked astir previously, we person exceptionally beardown payer sum pinch virtually nary entree challenges.

Joe Beatty

Thank you.

Operator

Our adjacent mobility comes from Peter Lawson from Barclays. Please spell ahead.

Peter Lawson

Thanks. Maybe a mobility for Becker conscionable connected getting to a recommended Phase 2 dose pinch your CDK2 inhibitor aliases if that's a moot constituent because you've benignant of person nan expertise to commencement nan operation regimen. Just truthful immoderate consciousness whether we should spot that recommended Phase 2 dose successful nan first half aliases if we should beryllium benignant of waiting until you're disconnected partial objective hold?

Becker Hewes

Yeah, I mean, truthful first of all, arsenic Kate mentioned, nan FDA clip statement is nan FDA clip line. We don't person power complete that, but we are encouraged by really quickly we are moving pinch them. I deliberation that some nan recommended Phase 2 dose and nan operation dose are important because this is perchance very wide programme that involves a number of tumor types. The operation is applicable for bosom cancer, but CDK2 is really cardinal to nan biology of rather a fewer different tumor types and different biology.

So pinch respect to - we've gone really quickly done dose escalation. And truthful successful position of - it's really not conscionable is recommended Phase 2 dose, it's a scope of activity wherever we person a bully information profile. And I already deliberation we person that successful sight. So I deliberation that nan information that we are capable to coming midyear will supply a clear position of wherever we're going some pinch azygous supplier and past very early information connected nan combination. They'll request much clip to escalate much profoundly into that ribociclib combination.

It's besides important to recognize that we tin commencement nan chemotherapy operation arsenic good successful nan adjacent early aft we travel disconnected of nan partial objective hold. So I deliberation it's important to attraction not conscionable connected that 1 dose but besides connected nan holistic program.

Peter Lawson

Is this captured nether Project Optimus [ph] arsenic well?

Becker Hewes

We person nan Project Optimus accuracy successful mind arsenic we look astatine nan doses and we intend to person a very adjacent narration pinch nan FDA pinch respect to making judge that we've covered nan ground that they're looking arsenic to understand nan correct azygous supplier and operation dose truthful that arsenic we spell into bigger trials, we're not having to do a batch of dose uncovering beyond this first trial. So Project Optimus is really nan lens that we look astatine each of our programs done astatine this point.

Peter Lawson

Great. Thanks truthful much.

Operator

Our adjacent mobility comes from David Lebowitz from Citi. Your statement is now open.

David Lebowitz

Thank you very overmuch for taking my question. I sewage 1 connected ASM and 1 connected ISM. On ASM, I guess, to start, location was - we talked past 4th astir specifically nan take and nan associated hematological neoplasm group. And I cognize you had information astatine ASH, a batch of it focused connected that circumstantial group. I conjecture my thoughts are what - really are things looking now? And really do you deliberation that information could help?

Kate Haviland

And then, David, you said you had a 2nd mobility connected ISM, just...

David Lebowitz

You want nan ISM upfront? On nan ISM, I guess, specifically, you were talking astir really different doctors are going to prescribe nan therapy successful different ways. And my mobility is, erstwhile reporting your information astatine Quad AI later this month, really profoundly will you spell into nan use connected each circumstantial denotation wrong nan TSS score? And is location immoderate thoughts arsenic to which symptoms astir doctors are emphasizing astir successful your view?

Kate Haviland

All right. Thanks David for some those questions. I deliberation starting pinch precocious SM and SMA, I mean arsenic we person talked about, we are nan modular of attraction successful nan patients who are treated for their precocious SM, which thin to beryllium nan patients who person MCL and fierce SM and that it's nan SM, AHN patients wherever they're conscionable a very analyzable objective presentation. And that's nan group of patients that we person worked done that very compelling data, arsenic you mentioned, that we saw astatine ASH. We're looking astatine monotherapy effect of AYVAKIT some connected consequence rate, symptoms and wide survival.

It is surely fueled conversations pinch prescribers. And successful that group of patients, we're changing practice, right? And they're very analyzable objective patients. And truthful that's wherever we'll proceed to spot that activity arsenic we grow nan wide size of nan SM market, which is why nan maturation has moderated a spot there.

As you deliberation astir nan ISM position astatine PIONEER, we're going to show benignant of nan totality of data, including nan effect connected patients crossed each symptoms wrong nan TFS. In position of - arsenic Christy was mentioning, different specialties person different discourse for objective proceedings data. PROs are commonly utilized successful nan allergy immunology space, not arsenic overmuch successful hematology. Other measures are much communal to hematology.

And truthful what is awesome astir this information group is that we spot compelling and accordant effect crossed each of these measures. And truthful that is - it's thing that tin entreaty to each of our imaginable prescribers. And truthful I deliberation we're really looking guardant to getting that out.

In position of nan symptomatology that physicians are astir focused on, it's really what impacts nan diligent nan most. It's not that they want to spot 1 aliases nan other, they want their patient's value of life to improve.

And truthful that is, again, why we creation nan PRO to look astatine a array of symptoms because 1 fixed diligent whitethorn person predominantly neuro cog symptoms and very - not overmuch successful different domains. Another fixed diligent whitethorn person predominant tegument symptoms and not connected different domains. And truthful it's a very heterogeneic illness presentation. And that's precisely why we designed nan PRO's [ph] we did and we'll beryllium showing each of that data.

Operator

Our adjacent mobility comes from Zhi Shu from Berenberg. Your statement is now open.

Zhi Shu

Good morning. Thanks for taking my question. I want to inquire a mobility related to marketplace access. Do you expect a abstracted codification for ISN and erstwhile nan merchandise is going to launch? And past related to that, what's your anticipation for gross to net? Thanks very much.

Kate Haviland

Thank you for that question. And I'll manus complete nan mobility connected nan codes to Philina and past Mike tin return gross to that.

Philina Lee

Yeah, I mean I deliberation astatine nan bosom of your mobility is what benignant of entree we expect arsenic IFM comes to market. And conscionable to reply that caput on, we expect and are highly focused connected maintaining beardown diligent entree to ISM.

Today, we person virtually unencumbered payer coverage. And we expect based connected nan payer marketplace investigation that we've done that, that's not expected to alteration aliases limit nan target patients that should adopt. And your circumstantial mobility astir nan code, no, astatine this point, we don't expect a caller codification for SM.

Kate Haviland

So conscionable to beryllium really clear, there's conscionable 1 codification for SM and you can't separate betwixt subtypes wrong it. And truthful that's what we'd expect to continue. Mike, do you want to return nan gross to net?

Mike Landsittel

Yeah, for gross to net, truthful presently pinch AYVAKIT, we spot a gross to nett scope successful astir nan mid-80% scope arsenic per gross margin. In nan adjacent term, we expect that to proceed erstwhile we denote pricing for ISM and get further into that launch. We said location will beryllium immoderate elasticity and really we deliberation astir contracting going forward. If we request to do that, that could lead to immoderate erosion, but nan mid-80s is simply a bully starting point.

Kate Haviland

And I deliberation connected nan ISM market, it's besides important to remember, there's going to beryllium puts and takes here, right? So nan ISM market, we person a larger percent of our patients are covered by commercialized insurance. So location - that will springiness america immoderate tailwinds.

And past we person that room, arsenic Mike mentioned, that if we request to do immoderate type of contracting to guarantee that seamless marketplace access, which we whitethorn aliases whitethorn not, but we person immoderate abstraction location arsenic well. So it is - location is simply a somewhat different payer operation successful this group than we've seen successful precocious SM.

Zhi Shu

Thank you very much.

Operator

Our adjacent mobility coming comes from Ami Fadia from Needham. Your statement is now open.

Ami Fadia

Hi, bully morning. Thanks for taking nan question. Just up of nan Quad AI information presentation, I wanted to conscionable benignant of understand really to construe immoderate of nan information that will beryllium presented there. I mean it's clear that there's a immense heterogeneity successful nan diligent organization guidelines pinch each diligent having a very different denotation domains bothersome.

So really do we return nan alteration successful TSS people crossed each of nan domains that you will beryllium presenting astatine nan gathering and deliberation astir really clinically meaningful it whitethorn beryllium for an individual patient? And really will physicians really construe that data? Thank you.

Kate Haviland

Christy, do you want to return that?

Christy Rossi

Sure. Thanks, Ami. So arsenic we said before, what physicians are looking astatine is nan consistency and totality of nan data. When we look astatine benignant of alteration successful individual symptoms, again, nan TSS is simply a caller endpoint. It's not utilized successful objective practice. The lens that I deliberation physicians are interpreting this information done is to say, one, immoderate my denotation - immoderate denotation my diligent is suffering from, do you person assurance that AYVAKIT will amended their value of life and amended those symptoms?

And truthful I deliberation what we've heard is that what physicians are looking for is consistency of betterment crossed individual symptoms. I deliberation looking astatine that longitudinally complete clip is going to beryllium absorbing arsenic well.

And past importantly, addressing a patient's astir bothersome denotation because we cognize that these patients are heterogeneous arsenic you opportunity and what circumstantial denotation whitethorn beryllium astir impactful to a diligent is going to beryllium different from patient-to-patient.

And truthful I deliberation what is compelling astir AYVAKIT is that we do spot accordant impacts and we cognize that sloppy of nan circumstantial position of a diligent symptomatology, we're assured that, that diligent will benefit. And I deliberation that's nan ones that nan prescribers will beryllium looking astatine this information group done arsenic well.

Ami Fadia

Thank you.

Operator

Our adjacent mobility coming comes from Matt Biegler from Oppenheimer. Your statement is now open.

Matt Biegler

Hey, guys. Thanks for squeezing maine in. I wanted to inquire astir median long connected therapy successful ASM. If you tin remark connected that, is it getting longer aliases shorter and I conjecture that would beryllium suggestive of nan severity of patients you're treating and whether you're making inroads into that agents component? Thanks.

Kate Haviland

Yeah. Thanks truthful overmuch for nan question. And Philina, do you want to return that?

Philina Lee

Yeah, truthful our median long of therapy is trending towards 18 months. We're highly encouraged that this is opinionated up good successful objective practice. And certainly, arsenic we displacement towards a operation of much treatment-naive patients, we expect that complete clip to increase.

Matt Biegler

Thank you.

Operator

Our last mobility comes from Chris Raymond from Piper Sandler. Your statement is now open.

Nicole Gabreski

Good morning. This is Nicole Gabreski connected for Chris. Thanks for squeezing america in. So I conjecture we were conscionable wondering, of those 400 mean your ISM patients that you had referenced, conscionable fixed nan acquisition of AYVA pinch those providers, are immoderate of those patients presently receiving supplier disconnected label? And besides sorry if I missed it, but would you beryllium successful a position to supply updated 2023 AYVAKIT guidance that includes ISM revenues perchance later this twelvemonth station approval?

Kate Haviland

Yeah, convey you very overmuch for that question. So starting pinch - I'll reply knowing that we're coming up against clip here. But nan 400 patients are really not being treated coming pinch AYVA. We spot mini number of patients pinch ISM who are being treated, but it's not important comparative to our wide number of patients being treated.

And past arsenic we talk astir guidance, I mean, I deliberation our extremity coming is to align connected wherever our existent business stands pinch our approved indications of precocious SM and GIST. And to really group that instauration for each of america arsenic we move towards this anticipated launch. And successful immoderate fixed launch, location are uncertainties, including what our explanation will look for illustration arsenic we spell done nan FDA speech process and really nan first fewer months will play out. So we look guardant to moving pinch each of you arsenic we move into this really breathtaking launch. So convey you very overmuch for that.

Nicole Gabreski

Yeah. That's all. Thanks.

Operator

That concludes nan Q&A information of today's call. I'll now manus backmost complete to Kate Haviland for closing remarks.

Kate Haviland

Thank you, operator. And really, arsenic we benignant of travel retired of nan Q&A and taking a measurement back, I mean, today, we person highlighted nan important opportunities that we person arsenic Blueprint correct successful beforehand of us, to create worth for patients and for our shareholders, including our continued commercialized execution, our anticipated motorboat successful ISM, arsenic good arsenic nan eager and achievable goals we person for our pipeline. And we are assured successful our expertise to present connected these opportunities this twelvemonth and beyond.

We convey you each for taking nan clip and joining america coming and your continued support of Blueprint Medicines. And we look guardant to talking to you again soon this clip from San Antonio successful nan Quad AI conference. So looking guardant to it.

Operator

That concludes today's Blueprint Medicines 4Q and FY 2022 net call. You whitethorn now disconnect your line.