Q1 2025 Blueprint Medicines Corp Earnings Call
Good morning, My name is Angela and I'll be your conference operator today at this time I would like to welcome everyone to the appropriate medicines first Q 'twenty 25 earnings release and conference call.
All lines have been placed on mute to prevent any background noise. After the speakers' remarks that would be a question and answer section. If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question press. The star followed by the number of Chi Please plan to limit yourself.
Speaker Change: Two one question. Thank you Gena Cohen you may begin your conference.
Speaker Change: Thank you Angela good morning, everyone and welcome to Blueprint medicines first quarter 2025 financial and operating results Conference call. This morning, we issued a press release, which outlines the topics. We plan to discuss today you can access the press release as well as the slides that we'll be reviewing today by going to the investors section of our website at double.
Speaker Change: W. W Dot blueprint medicines dotcom.
Speaker Change: Joining me today are Kate Haviland, Chief Executive Officer, Lina, Li Chief Commercial Officer, Becker Hughes, Chief Medical Officer, and Mike lands at all Chief Financial Officer.
Mooney: Mooney President of research and development and Christy Rossi Chief operating officer are also on the line and available for Q&A.
Mooney: Before we begin I'd like to remind you that some of the statements made during the call. Today are forward looking statements is outlined on slide three and are subject to a number of risks and uncertainties. These may cause our actual results to differ materially including those described in our reports filed with the SEC you are cautioned not to place any undue reliance on these forward looking statements and blueprint disclaims any.
Mooney: To update such statements.
Kate: I'll now hand, the call over to Kate.
Kate: And good morning, everyone.
Kate: We have blueprint medicine strive to be a standout top tier biotech company with a core focus on innovation commercial excellence and maintaining a durable financial profile that enabled disciplined global investment across our portfolio.
Kate: Following strong performance in 'twenty 'twenty four we've continued our execution momentum and 2025.
Kate: This quarter, we achieved 61% year over year, Eva kit revenue growth.
Kate: As we continue to capture the substantial and growing multibillion dollar commercial opportunity in systemic mastocytosis.
Kate: Which we expect will drive our global revenue growth well into the next decade.
Kate: With every additional quarter performance EBIT progresses on the path to our goal of $2 billion in revenue by 2030.
Kate: The underlying fundamental demand driven by growth in patients on therapy.
Kate: Is the critical determinant of long term revenue potential and we are pleased that our results in Q1 reflect continued strength in this metric as we expected.
Kate: This strong fundamental growth coupled with significant favorability in our free versus paid good mix is leading us to raise our revenue guidance for the year.
Kate: Well, we know will go into this more specifically in a moment.
Kate: We also advanced our industry, leading pipeline of muscle directed investigational medicines.
Kate: Our two prioritized pipeline programs.
Kate: Sudan and Blue 808.
Kate: Have the potential to drive significant upside value for blueprint as they progress in the clinic this year and beyond.
Kate: With Blue 808 are wild type kit inhibitor. Our goal is to raise the bar on what a treatment for a wide range of allergic and inflammatory diseases can offer by considering the full patient experience.
Kate: Because he tolerability and the burden associated with administration.
Kate: Blue 808 early clinical profile supports our differentiated approach to development, allowing us to explore a range of doses as well as dose regimens.
Kate: As we announced this morning blew it away. It has achieved key milestones with the initiation of two proof of concept studies, one in allergic Rhino conjunctivitis, and one in chronic or to carry out.
Kate: We hope to be able to share. Some early data. This year from these studies, which Becker will talk more about later on the call.
Kate: Oh, that's the Lib, our next generation Kit D 816 V inhibitor.
Kate: Has the potential best in disease profile that builds on our years of experience in S. M.
Kate: Given the strong receptivity of advocate by both physicians and patients. We know it is not enough to incrementally innovate with a follow on medicine that will enter the market years after advocate.
Kate: With the pivotal Harbor study up and running we have a plan to deliver substantially differentiated and meaningful innovation with Elena snip that goes beyond the symptomatic control to measures of Oregon healing and disease modification.
Kate: Blueprints durable commercial growth profit profile strong cash position and disciplined capital allocation strategy afford us the ability to focus on executing our business to plan despite the broader market volatility.
Kate: With our intellectual property being domiciled in the U S and our low cost of goods, we are insulated from potential biopharmaceutical tariffs and do not anticipate any material impact on our business.
Kate: In terms of the staffing changes at the F. T E. We do not have any major regulatory filings planned over the next 12 months and we have not experienced an impact in our routine engagement with the agency to date.
Kate: We will of course continue to monitor the rapidly evolving external environment and work to mitigate any changes that do impact our business.
Kate: Our results today are possible. Thanks to the impressive team of people, we have a blueprint medicines.
Kate: And I, thank them for their thoughtful and urgent commitment the people whose lives we set out to improve every day.
Galena: With that I will turn it to galena to discuss the quarter's commercial performance in more depth. Thanks.
Speaker Change: Thanks, Kate and the first quarter, we achieved $149.4 million in Ava kit Global net product revenue was $129 4 million in the U S and 20 million ex U S.
Speaker Change: Our strong commercial execution drove revenue growth and what we expected to be a challenging quarter due to the typical Q1 financial headwinds inherent in our industry.
Speaker Change: Let's walk through the headwinds and tailwind.
Speaker Change: The short term financial headwinds we've discussed previously played out as we expected, including typical first quarter insurance dynamics impacting gross to net and the impact of fewer ordering days.
Speaker Change: With our growing base of business. These factors can have a meaningful impact on our quarter.
Speaker Change: As Keith mentioned fundamental demand growth driven by a growing number of patients on therapy is a critical determinant of long term revenue potential.
Speaker Change: This is a function of more patients starting and staying on therapy.
Speaker Change: We were pleased that Q1 met our expectations as we saw growth in new patient starts both in the U S and in our international business.
Speaker Change: Discontinuation rates remained low and we continue to see encouraging trends towards multiyear duration of therapy in both advanced SM and I S. M.
Speaker Change: A key variable we were watching this quarter was our mix of free versus commercial goods as we managed through the Q1 reauthorization process and monitor the impact of the part D redesign and foundation funding availability.
Speaker Change: This played out more favorably than we expected with our free goods right now well below 10%.
Speaker Change: As a result of these favorable dynamics today, we are raising our guidance range to $700 million to $720 million for the year.
Speaker Change: We are exactly where we want to be at this point in the year and we are well positioned to drive growth through the rest of 2025 and beyond.
Speaker Change: We have a clear view of the S M opportunity in front of US as we move further down the path towards $2 billion in Eva chip revenue by 2030, and a 4 billion dollar peak S M franchise opportunity.
Speaker Change: S M diagnoses are increasing globally and with approximately 25000 diagnosed patients in the U S. We know we're in the early innings of market penetration.
Speaker Change: Roughly 20% penetration of currently diagnosed patients in the U S alone gets you to $2 billion in annual revenue.
Speaker Change: We expect to grow new patient starts through the end of the year and beyond.
Speaker Change: Of course, it all starts with the right medicine, Ava kit and effective therapy with a broad label that addresses the root cause of disease and is also very well tolerated, enabling patients to start and stay on therapy over the long term.
Speaker Change: Baca will discuss the growing body of evidence supporting Ava kits long term benefit in S. M.
Speaker Change: In addition to Ava kits compelling clinical profile, we know that what drives prescribing in this market is the powerful combination of and aware and ever expanding educated prescriber base and an activated patient base.
Speaker Change: Both recognizing the benefit and urgency to treat the root cause of disease with Eva kit now.
Speaker Change: Let's start with prescribers.
Speaker Change: Since launch we've been focused on increasing the breadth of our prescriber base through education and awareness.
Speaker Change: Driving awareness among allergy has been a key focus and is critical to long term growth as the providers managing the highest volume of S. M patients are predominantly allergists.
Speaker Change: Our first experience with Eva Cat predictably leads to broader use in more patients.
Speaker Change: Growing foundation of experienced providers prescribers directly drives growth in the number of patients starting Ava kit overtime, increasing market penetration.
Speaker Change: Since I am approval, our prescriber base in the U S has tripled with adoption split across academic and community sites of care.
Against the backdrop of a growing number of diagnosed patients. This creates an engine to drive growth in the number of patients prescribed Ava kit.
Speaker Change: What really catalyze a steepening of use overtime are positive perceptions and experiences with Eva kit.
Speaker Change: <unk> launch we have conducted market research with over 700 providers.
Speaker Change: Initial favorable perceptions of Eva kit from the pioneer study results have grown even more positive with firsthand clinical experience and now with longer term data.
Speaker Change: Across all specialties, even dermatology and gastroenterology, where we haven't yet started to deploy promotional effort.
Speaker Change: Majority of providers you Eva kits profile is favorable.
Speaker Change: Since launch we've been targeting he marks an allergist.
Speaker Change: Amongst St less than a third of all lives M patients.
Speaker Change: You've talked about the importance of allergy for the long term opportunity and by expanding our call point to include Germs and G is we will meaningfully increase the addressable patient pool.
Speaker Change: Across the specialties, roughly 70% of the providers managing the highest volume of S. M patients are allergists Durham N G eyes.
Speaker Change: This is why we're investing in expanding our field team to increase our reach and frequency where it matters. Most our field force expansion is designed to capitalize on where the majority of S. M patients are treated.
Speaker Change: We have just hired a new team members, who are onboarding and training.
Speaker Change: They bring a diverse set of experiences with an emphasis on allergy dermatology and rare disease.
Speaker Change: In the field by second half of this year and I look forward to the growth with bill catalyzed in 2026 and beyond.
Speaker Change: Ava gets positive reception among providers is matched by growing enthusiasm in the patient community.
Speaker Change: Also on patients are highly engaged and active in their care decisions and we're starting to see the clear impact of marketing efforts launched last year, including new direct to consumer and peer to peer programs.
Providers report that significantly more of their eyes in patients are asking about advocate compared to last year.
Speaker Change: And once patients are on treatment they have a very positive experience with over 95% of patients, saying, they're highly satisfied with Eva kit as a treatment for their S. M.
Speaker Change: The SM market is highly promotional sensitive with the top two drivers being the efforts of our experienced sales team, who are outperforming industry comps and promotional effectiveness scores.
Speaker Change: Our direct to patient marketing efforts.
Speaker Change: Our growing base of experienced prescribers and increasingly engaged in activated patient base and the compelling profile of Eva kit put us in a great place to drive growth in 2025.
Speaker Change: But we're not just focused on this year.
Speaker Change: We are on the path to driving continued growth towards $2 billion in revenue by 2030 and are committed to continue to grow this market well into the next decade.
Speaker Change: We plan to drive that growth by taking the same powerful combination of aware and educated prescribers with activated patients and amplifying it with a strategic investment in our field.
Speaker Change: We are confident in our multifaceted approach to develop and capture this market.
Speaker Change: I'll now hand, the call over to Becker to share clinical updates across our portfolio.
Becker: Thanks Paulina.
Becker: First I want to talk about <unk> long term data in systemic mastocytosis.
Becker: We prevented that we presented at quarter and.
Speaker Change: Buena just referenced.
Speaker Change: What was remarkable and pioneer is that the safety profile of either kit was superior to best supportive care, that's six months a rare occurrence for an efficacious treatment.
Speaker Change: Now after three full years of treatment, we see the same safety profile.
Speaker Change: This is extraordinary in my experience.
Speaker Change: Generally the safety profile becomes more complex over time.
Speaker Change: The frequency and severity of treatment related adverse events.
Speaker Change: Been consistent and remained low throughout three years.
Speaker Change: And importantly, only 3% of patients discontinued due to treatment related adverse events over this extended time frame.
Speaker Change: The 25 milligram dose of every kit provides an exceptional benefit risk profile for the vast majority of patients.
Speaker Change: In our real World post marketing experience more than 90% of patients who start at 25 milligrams stay at doctors.
Speaker Change: Patients are compliant.
Speaker Change: Compliance satisfied and our discontinuation rates are very low.
Speaker Change: However, we know that there is a spectrum of disease severity and systemic mastocytosis and a one dose fits all approach is not appropriate in this disease.
Speaker Change: The pioneer study included patients with very high disease burden.
Speaker Change: We've enabled more severe patients to dose escalate to 50 milligrams.
Speaker Change: Part three of the study.
Speaker Change: We recently presented data showing that these patients have had a safety profile consistent with that we've seen a 25 milligrams.
Speaker Change: Efficacy continues to improve for partner patients as indicated by durable responses measured by TSS and quality of life measurements through three years.
Speaker Change: Among the patient subsets in pioneer who titrated, they're dosed to 50 milligrams, 93% of patients saw improved or stable psf benefit at 50 milligrams without any trade off in safety.
Speaker Change: We're expanding our commercial and medical reach to even larger target physician audience Allergist dermatologists industrial neurologists with multiple years of consistent data demonstrating that <unk> is a safe and effective treatments can head.
Speaker Change: This helps drive comfort and trying a new therapy in prescribing a neighborhood.
Speaker Change: Finally, we continue to advance the science of systemic mastocytosis in the Harbor study of <unk>.
Speaker Change: Study designed explorer is disease modifying measures of clinical benefit, notably the impact on bone health and recurrent anaphylaxis.
Speaker Change: These have been enthusiastically received by investigators and they report also from patients interested in studying.
Speaker Change: Turning now to our wild type kit inhibitor Blu 808.
Speaker Change: A quarry or this year, we presented data from the healthy volunteer study and with this promising data in hand, we're moving into four proof of concept studies this year.
Speaker Change: We know that a strong safety profile is critical in the field of allergic disease.
Speaker Change: And with Blue right away, we have a wide therapeutic index to work with us.
Speaker Change: We're building them arrange a flexible dose strange strategies across these studies, including consistent dosing induce and maintain and titrate to effect, which we know is in line with how allergists treat.
Speaker Change: We've initiated our first two proof of concept studies, one in allergic conjunctivitis and one in chronic urticaria.
Speaker Change: We will be initially testing doses between one and six milligrams.
Speaker Change: This covers the IC 90, well and will allow us to examine a spectrum of biologic impact that ranges from calming or stopping myself into granulated, killing them entirely.
Speaker Change: This will allow us to determine the impact on symptoms. So that we can achieve the right balance of safety and efficacy for chronic treatment.
Speaker Change: I'll start with chronic urticaria, where the role of myself as the key driver of disease is already well established.
Speaker Change: And our proof of concept study, we're using this indication to explore various dosing regimens for blue right away.
Speaker Change: Our initial 12 week Phase Iia study will include two key parts, an open label study of patients with chronic inducible urticaria or Cindy and a randomized double blind placebo controlled study of patients with chronic spontaneous urticaria.
Speaker Change: Both parts will include multiple doses and dosing regimen.
Speaker Change: Our goal is for blue right away to become an attractive oral option that achieves that balance of tolerability and efficacy and differentiate us from the rest of the field.
Speaker Change: Now, let me turn to the Phase Iia study in allergic Brian of Conjunctivitis.
Speaker Change: We see this as a way to demonstrate the activity of blew it away in the respiratory tract.
Speaker Change: This is a 28 day placebo controlled challenge study where patients are exposed to Allergan, then treated with Blu right away or placebo and then re exposed to compare there before and after treatment reaction.
Speaker Change: Similar to chronic or a carrier in this study we will assess multiple doses for safety PK and clinical efficacy.
Speaker Change: We expect to have some early data by the end of this year in the <unk> cohort.
Speaker Change: In the second half of the year, we plan to initiate studies in allergic asthma and Ymcas with.
Speaker Change: We discussed the role of the myself in allergic asthma at our webinar last year and similarly, clamshell blueprints approach to MKS at our webinar on June 4th with Doctor about G&A.
Speaker Change: Leading expert in muscle diseases at the Brigham and women's hospital here in Boston.
Speaker Change: Results from these proof of concept studies will help guide Blu ray to wake development plan as we work towards improving the lives of patients with Marcel driven disease.
Mike: Now I'll turn the call over to Mike.
Mike: Thanks Becker.
Speaker Change: Earlier. This morning, we reported detailed financial results in our press release for today's call I'll touch on a few highlights.
Speaker Change: In the first quarter, we achieved total revenues of $149 4 million from net product sales of <unk>.
Based on the positive fundamentals that philina discussed as well as the additional insight we gained around free goods. In Q1, we are raising our <unk> net product revenue guidance to $700 million to $720 million for the year.
Speaker Change: Consistently strong fundamentals and continued growth in new patient starts in all markets will continue to drive performance through the remainder of the year.
Speaker Change: For our international business, the timing and outcome of ongoing pricing and reimbursement negotiations are another consideration.
Speaker Change: Turning to operating expenses, we observed an incremental quarter over quarter increase in R&D expenses related to <unk> and Blu ray to Wade clinical studies.
Speaker Change: SG&A expenses were flat in the first quarter relative to the prior quarter.
Speaker Change: And we anticipate that we will see continued modest increases in both R&D and SG&A expenses as we invest in our priority pipeline programs as well as increased investment in our sales and marketing efforts for advocate Scalenus.
Speaker Change: Scalenus spoke to in detail earlier on the call.
Speaker Change: We continue to expect that our operating cash burn will decline significantly on an annual basis.
Speaker Change: To reinforce what Kate said earlier in the call. We are in an incredible position of strength today, particularly when you consider the macroeconomic environment.
Speaker Change: We have strong and consistent top line revenue growth driven by global sales of advocate.
Speaker Change: The ability to continue to invest in innovation to drive future growth.
Speaker Change: And a strong and durable cash position of $900 million.
Speaker Change: Our commercial and financial profile stands out among biotech is a positive differentiator and now more than ever before we are in a position of incredible strength to drive sustained growth for the long term.
Speaker Change: With that I'll turn the call back over to the operator for questions operator.
Speaker Change: Thank you.
Speaker Change: At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
Speaker Change: Your first question comes from Mark from with T. D. Cohen Your line is open.
Mark: Hey, Thanks for taking my questions.
Speaker Change: First on the commercial side.
Speaker Change: Frame the type of rebound in Peru.
Speaker Change: Peru or acceleration of growth you might see in Q2, given the fact that the free grip. The free goods is already so low which was you know maybe limit some of the kind of typical Q1 to Q2 rebound. So we see that we see across the industry and then on the R&D side for either we just talk to the strategy on the dose selections.
Speaker Change: That you put into those are.
Speaker Change: Sure.
Speaker Change: Joseph.
Speaker Change: Posed to really kind of test that intermediate range with the titration or are you trying to maybe with the doctors really showed the full power of either read an inability to get close close to if not matching the antibodies.
Speaker Change: Yeah. Thanks, Mike for that question, maybe Christine you want to talk a little bit about how we've considered kind of the fundamental growth in and drivers of demand and as we think through the year and then maybe play please add color of Becker or do you want to you can add into that the question on the yeah.
Speaker Change: Yeah, Hey, Mike. So you know if we think about the year, we obviously updated guidance and so if I think about the remaining three quarters am I would certainly think about the guide in that guide does imply you know growth, which is really what we expected when we when we set guidance at the beginning of the year as well, we always knew that Q1 was going to be challenging for all of their.
Speaker Change: Reason is definitely in a sad, but you know what we expected to see was you know strong underlying growth in terms of the drivers of the longer term potential for Ava cat, which includes patients starting persistence duration etcetera, and so and that's exactly what we've seen and that's played out in line with our expectation and so if you kind of play that forward through the year, we would expect to see browse and the remaining.
Speaker Change: Orders are you know the one wrinkle we saw in Q1 around sort of a shorter quarter from an ordering perspective I believe if I'm not mistaken is made up actually in Q3 interestingly enough, but you know we we definitely expect to see a nice steady growth as we go through the remainder of their let's.
Speaker Change: And our results this year really our big cars left in Q1 was around how we're going to see pretty good to play through and I noticed when did you want to talk a little bit more about that.
Speaker Change: As we entered the year I think one of the biggest variables that we had that informed our guidance range was that we had a large book of business I E. A really large number of patients and we didn't know to what extent these patients would be able to transition and access paid versus free goods.
Speaker Change: Over the course of Q1 like this is a big variable that has been tremendously derisked and that has been one of the key drivers for our guidance update together with the expected growth in the underlying fundamentals I E growth in patients on therapy is as Christy just said.
Speaker Change: So I think at this point thinking about the free goods trends I'm looking for the rest of the year certainly you know the the range has narrowed we have a better sense of the range to expect were below 10%. We don't expect this to be able to really be able to go appreciably.
Speaker Change: Down further and really over the rest of the year will need to be watching as new Medicare patients come on therapy their ability to access commercial versus re drug, but I would just take it back to the trajectory that we're seeing in Q1, we firmly believes puts us on pace for our guidance as well as marching towards that $2 billion by 2030.
Speaker Change: Like I do want to talk about the motorcycle question sure. Let me talk about the dose range of Blue later aid and and how we selected this on what our strategy is here. Just a reminder, that we do have all three regimens, one which is consistent dosing gather which is an inducer maintain which will look at speed to symptom resolution.
Speaker Change: And then our ability with a lower dose to maintain those that symptom resolution and then one where we are will allow titration to the effect and I think it's important to remember that in many diseases, including chronic or to carry their multitude of symptoms and really driving the relief of the patient at the <unk>.
Speaker Change: Doses, what we're exploring and we're doing it in a way that the antibodies really can't do so we're going to better understand the myeloid biology. The D E and the response with respect to symptomatology as we use these different dosing strategies and then 10 of this study is to really set things up for the next phase of studies and clinical to the carrier and the no.
Speaker Change: Other indications, where we get the optimized dosing for each of these indications and as we said earlier the 1% to six milligrams given some range that covers the ICU 90, well and we all myself don't die at once and so we'll look at different levels of killing in different patients.
Speaker Change: Better understand killing dose and a dose.
Speaker Change: It's designed to calm down and myself.
Speaker Change: With respect to comparisons again these.
Speaker Change: Studies are designed to help us understand how to use the drug and then to understand the full efficacy and the next wave of studies, we will bring that optimize dosing into a more definitive study.
Speaker Change: Thank you.
Speaker Change: Next question comes from Laura Prendergast with Raymond James Your line is open.
Laura Prendergast: Hey, guys congrats on the progress this quarter.
Speaker Change: Just let me reiterate that question what exactly have you guys baked into the guidance you know any expected seasonality EU contribution any specific <unk> or headwinds on new starts that you expect.
Speaker Change: And then just if you guys could comment on part two harbor data no. One should we expect that and is any I don't have enough data priced into the 2 billion by 2030.
Speaker Change: The 2 billion by 2030 is that pricing in on us and it being on the market. Thank you.
Speaker Change: Okay. Thanks, Laura just to remind everybody, let's try to keep it to one question just given the number of people we have in the queue, but we will try to handle some other things offline. If we can maybe Christian you Christy excuse me, where you take the guidance question and then back or we can talk about part two harbor I can just clarify right away, there's nothing from and Alan That's net perspective no.
Speaker Change: 2 billion by 'twenty 30, that's completely driven by Eva Cat and we expect it to grow beyond that.
Speaker Change: So so just so I can take that one because you don't talk about guidance.
Speaker Change: So you know the factors that we think about what guidance are very much consistent with how we framed it up at the beginning of the year actually but how we talked about it last year right. So you know that the two biggest determinants in my mind of either cat I'm getting to 2 billion by 2030, and a $4 billion opportunity we see across the us.
Speaker Change: That franchise over time, Israeli treating more patients right. So having patients started on therapy and having them continue to stay on therapy. So those are those are the two big drivers and we expect to see him you know it was growth in new patient starts as they go through the year based on our expanding breadth and depth of prescribing that we're seeing in the U S.
Speaker Change: And they activate the patient base et cetera. This is obviously still in the context of our end use market youre going to see fluctuations there, but the overall trend line is is you know clear and positive and we expect to see a strengthened and duration of therapy as patients are staying on therapy for you know, we think three plus years potentially multiple years here.
Speaker Change: And so you know those are two of the most important variables as we go overtime, then theres a number of other things that you know actually may have more impact in the short term and so you know we we think about gross to net I'm free goods rates are you know et cetera, and then of course, our international business coming off. So those are it does continue to be the most important.
Speaker Change: Variables.
Speaker Change: You know as Helena said, we had a a major I would say car flip in the first quarter mm by understanding how a very large base of patients who are now on therapy as they went through the re verification process I'm understanding how that commercial mix is going to play out we knew was going to be important and we knew that was going to be a big.
Speaker Change: You know swing as we thought about topline revenue and so we're really pleased to see how that played out in the first quarter and also pleased to see continued strength along the other variables that we mentioned that really again part time that longer term term potential. So those are still going to be the things that we'll continue to watch those ranges of outcomes on all of those and all of those areas.
Speaker Change: But as you know plain to see that we were able to raise the guidance off of off of Q1 performance and terms of quarter to quarter performance. We know our business you talked about things like seasonality et cetera. We've you know we're now far enough into this launch, but I think we have a good sense of how these factors will play out in terms of impacting quarter to quarter revenue.
Speaker Change: We've baked that into the guide them and in fact, I think that and you know when we started the year and unexpected Q1 to kind of play out after that.
Speaker Change: But can you just talk a little bit about harbor, obviously, we're just getting this up and up and running now so yeah. So we're just starting the study we have a highly motivated group of investigators and and I'm hearing patients as well who are very interested in the study.
Speaker Change: As we see the evolution of the systemic mastocytosis in the world and we see how this study unfolds, we'll be able to keep you all more well informed about when we might see top line data, but I think it's premature to speculate at this point.
Speaker Change: Thank you. Your next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.
Speaker Change: Hi, This is Paul on for Michael Thanks for taking my question.
Speaker Change: Just on <unk>, so for the ex U S. It looks.
Speaker Change: It was sort of flat quarter on quarter can you just comment on what your overall expectations are for the international market drivers this year.
Speaker Change: <unk> when I assume reimbursement beyond Germany could start to kick in and then maybe a quick follow up.
Speaker Change: Dose Escalations that you mentioned and ICU patients Quad AI data suggested around a quarter escalate to 50 milligrams whats your current visibility into what percentage of commercial patients on <unk> 50 frosty. Thank you.
Speaker Change: Yeah. Thanks for the question I will start with Chris even take international and then I know you talk a little bit about what we're seeing in dosing one thing I should say the international team has just done a tremendous job in there year over year performance more than doubled from Q1 last year. So we're really excited about where we are we do want to talk about Q4 to Q1 dynamic you're absolutely right and keep that you know the international team has been doing very well.
Speaker Change: We've talked about the fact that you know we think about the contribution to the top line last year are we expecting it to be sort of in that 10% to 15% range. This year in a much bigger base. We expect it to also be within the 10% to 15% range right. So you know the international team continues to perform and were seeing nice growth there and it's important to remember that a jerk.
Speaker Change: Many is the only ex U S market with ISR reimbursement at this point and we do expect some others to come online through the year, but you know well really start to see I S. M E growth across a number of markets as he had even into next year and beyond you know.
Speaker Change: That that business in Germany is doing quite well, we're continuing to see trends that look very similar to the U S, which has been really encouraging to see some nice growth in patients being treated at very similar trends in terms of uptake are you now.
Speaker Change: Fluctuations can happen quarter to quarter. There were some you know things between Q4 and Q1 for example, like timing of distributor orders, which can be lumpy a little bit of FX at the beginning of the year, we're still talking about a relatively small revenue base relative to the U S rights. So these these little factors can obviously you know have a role when we look at Q on Q and we've seen that before I show you.
Speaker Change: Go back and look at our international performance over the last year or so but you know the bigger picture is that business is doing well German launch is doing really well and we're looking ahead and looking forward to having some other I S. I might just come online.
Speaker Change: So the question on dosing the 25 Meg benefit risk profile.
Speaker Change: <unk> to serve the vast majority of patients very well, it's under 10% of patients that we're seeing who may dose escalate to 50, Megs overtime and this is occurring against the backdrop of the profile of the 25, Meg holding strong and improving with continued long term efficacy and safety outcomes.
Speaker Change: We also see this reflected in just the really positive sentiment were able to get reflected in both our provider and patient satisfaction and add just one thing to add to that is that even what Becker showed you from the both the safety and efficacy of the 50 Megs is that what we see is that you know with Eva cat, but at 25 milligrams or 50 milligrams patients don't have to weigh a trade.
Speaker Change: Off between efficacy and safety and they can experience a very low treatment burden that really allows them to just get back to their lives and kind of where the medicine that really empowers them to to live in and do the things they want to do so both the 25 to 50, you have have really come through in a very nice way.
Speaker Change: Patients and the other thing to remember is that the.
Speaker Change: The pioneer population, whereas the highly advanced patient population.
Speaker Change: Enrolled in the middle of a pandemic first study out there with a really effective therapy and so it's probably not indicative of what will be seen in the real world.
Speaker Change: Okay.
Speaker Change: Thank you your.
Speaker Change: Your next question comes from the line of Michael <unk> with Jefferies. Your line is open.
Speaker Change: So.
Michael <unk>: Thanks, Good morning, Congrats on the continued growth thinking about growth for the rest of the year I know you've gotten a bunch of questions about it.
Michael <unk>: Winston tailwind some different dynamics.
Michael <unk>: Can you help give some color as to perhaps the trajectory or shape of the curve in Q2, three four is it sort of consistent year over year growth each quarter are there different things that oh.
Michael <unk>: Impact those quarters and as part of that perhaps even O U S. Given that it appeared to be more flattish and I'm. Just wondering if that's a factor as well to any of these quarters for the rest of the year. Thank you.
Michael <unk>: Thanks, Michael So I think what Youre asking is as how to think about kind of the remainder of the year. You know obviously, we're really focused here and how we're exiting the year because that is what really drives us to that that laser focus on that 2 billion by 2030, but understand that you guys wanted to kind of get a sense of how we're thinking about the quarters I don't know, Mike if you want to provide a little bit color on.
Speaker Change: And how do you think about that yeah, I'll start I mean, I think what's most important is to put this in the frame of what our updated overall annual guidance is and using that like that's the benchmark that we're guiding to and as we've talked about before like each quarter can have unique variables and U S and international I think the one thing that Christie mentioned that we.
Speaker Change: I did want to point to as you think about like the growth, especially over like Q2 Q3 is like we've talked about weakness in order day in Q1, right that actually gets made up in Q3, and the calendars and just for context like our biggest customers tend to order on the same day. Each week, we had one less of those in Q1. It gets made up in Q3, so right there.
Speaker Change: Youre going to see a differential dynamic between Q2, and Q3, where you would say there is probably a little bit more shifted into the Q3 period, but.
Speaker Change: But fundamentally I, just I'd point to consistent underlying patient growth and that's been as expected and we continue to drive towards that as we as we go over our updated guidance range.
Speaker Change: Thank you. Your next question comes from the line of calling Cousy was bad.
Speaker Change: Your line is open.
Speaker Change: Great. Good morning, Thanks for taking our questions and congrats on all the progress one quick one from us for the growth. This year can you talk to how much of that is driven by the newer specialties, they're going after and germs and G is versus the allergist and him answer to your first target prescribers.
Speaker Change: Yeah. Thanks, calling completed you want to talk about how youre thinking about the prescriber mix this year versus next year I guess, yeah yeah.
Speaker Change: Yeah. Thanks for the question. So I think it's Christy started alluding to we expect growth, we expect to drive increased treatment rates and growth in the number of patients on therapy. We have a strong engine in place to do this already with what we've established across our target specialties and an increasingly activated patient base.
Speaker Change: And so I would say our primary driver for growth over the course of this year is really that activated prescriber base and our ability to both grow and expand that as well as deepen it overtime.
Speaker Change: Our chart shows we understand very well the dynamics of how our first patient starts and then a positive experience leads to growth and deepening over time.
Speaker Change: Secondly, we.
Speaker Change: We see more and more patients coming in and asking about Eva cat showing that our direct to patient efforts are really working and we expect this to also catalyze our growth over the course of this year.
Speaker Change: As we shift into the newer specialties. We think this will enable us to further amplify. These efforts, there's really an untapped opportunity of additional S. M patients.
Speaker Change: Who are being seen by germs and gastro is I think what we've learned from this market is you know he marks alone are only about a third of the opportunity. So we know it's important to expand them.
Speaker Change: Our objectives with terms and gastro is or really the ability to move these patients towards treatment, whether or not they're literally the prescribers at the outset, but they can also refer to our very strong and growing prescriber base.
Speaker Change: And we expect this to further catalyze growth you know really in in 2026 and <unk> and beyond.
Speaker Change: For clarity, but we really do expect our primary prescriber base to be not growing base of allergists are stable base kind of a behemoth group, which sees is the minority or the smaller group of patients and then the growth into <unk> in terms of really be 2026.
Derek: Thank you. Your next question comes from the line of Derek <unk> Chiller with Wells Fargo. Your line is open.
Speaker Change: Hey, good morning, and thanks for taking the questions I just want to understand how durable are 10% free drug rate is and I wonder if you could characterize how the patient adds have trended in April relative to <unk>.
Speaker Change: So that we don't really talk about kind of the ongoing quarter, but we can certainly talk about how our view of of the durability of the pre patient goods right in and just to note, it's actually well below 10% at this point. So I'm. Just wondering do you want to talk a little bit about how you're thinking about that for the rest of the year, They pretty Detroit, Yeah, I think what we.
Speaker Change: Hmm.
Speaker Change: What we're really emphasizing is we've derisked freak, but we've made really derisked.
Speaker Change: The variable of free goods by just moving this big base of patients. This large number of patients have been able to access commercial therapy in Q1, and that's been due to the availability of foundation funding the ability of patients navigate the new smoothing process.
Speaker Change: And so we also feel like you know with with this type of floor.
Speaker Change: Well.
Speaker Change: There's probably not room for this to further improve but we expect that rate to remain relatively durable over the course of the year now of course, what we'll be watching is as new Medicare patients come on.
Speaker Change: How able will they be to access commercial therapy and that depends on factors like you know how long will foundation funding continue to be available as well but.
Speaker Change: But I would say that it's the it's the derisking of the patients who have already moved which has led to a favorable more favorable than expected upside. That's one of the key factors in our updated guidance range, but really it's the underlying fundamentals that we expect continued growth in patient starts and patients on therapy.
Speaker Change: B.
Speaker Change: And that we expect to grow throughout the course of the year.
Speaker Change: Thank you. Your next question comes from the line of Southeast enriched sub with Goldman Sachs. Your line is open.
Speaker Change: Hey, Good morning. This is mark on for Sylvia and thanks, So much for taking my question.
Speaker Change: You guys mentioned you May show AIA data from the POC studies.
Speaker Change: Was this year.
Speaker Change: In your view what is the bar for <unk> and also in allergic conjunctivitis and how do you think this all compared to the antibodies here.
Speaker Change: Yeah.
Speaker Change: In terms of the cadence of the data, we're going to need to see how the enrollment goes can do is a relatively rare form of the disease and we will update you all as we know more about how the enrollment is going and as I stated earlier in terms of the bar I think they're gonna have to stay tuned to over time to really understand.
Speaker Change: Full efficacy of eight or even these diseases because what we're really trying to do is learn the optimization of the regimen and which symptoms matter most of the patients and how quickly we can resolve these with various dosing regimens of eight okay.
Speaker Change: I think for the the allergic they are C. Study again, you know we're we're watching in your enrolment there the studies up and running them and again, we hope to have some data by the end of the year and we'll we'll kind of keep you guys posted on both of those as we continue to execute those those programs.
Thank you. Your next question comes from the line of Brian Chen with JP Morgan.
Speaker Change: Your line is open.
Brian Chen: Hey, guys. Thanks for taking my question.
Brian Chen: Can you elaborate a little bit more on the drivers behind the flat growth ex U S. This quarter, it's a flat growth there driven partly by the negotiated price. Thank you.
Brian Chen: Thanks, Brian I think as Chris he was mentioning them.
Brian Chen: Your line fundamental growth in terms of you know growing patients out there growing patient starts and keeping patients on therapy.
Brian Chen: When we expected it internationally as Chris had mentioned yeah, we do get some lumpiness in terms of our dispute distributor markets in particular and there was some pull forward ordering in those markets in Q4 that that really just kind of influence the dynamics between Q4 and Q1 I think what's most important is that the international growth year over year nearly doubled.
Speaker Change: And as Christie mentioned, you know we were just in one where just in Germany, right now and I guess and then we're gonna have other of the more of the larger markets coming online this year and so it's it's flat from a revenue perspective, but certainly not flat growth from an underlying fundamental demand perspective.
Brian Chen: Yeah.
Speaker Change: Thank you. The next question comes from the line of friend Benjamin with citizens. Your line is open.
Benjamin: Hey, Thanks, guys for taking the questions and congratulations on the quarter in the range of guidance.
Speaker Change: Just want a little bit more about the metrics you guys use to gauge the success or failure of the DTC advertising strategy those those tend to be quite costly in them.
Speaker Change: Curious as to how you evaluate and you mentioned that there'll be promotional efforts that you're going to employ to dermatologists and gastroenterologists wanted to see how big the physician, who was and whether this would increase the total pool of diagnosed patients or about 25000 that you mentioned already.
Speaker Change: Me into account, the dermatologists and restaurants.
Speaker Change: Yeah. Thanks, Brian.
Speaker Change: I'll I'll D C. It's not the same.
Speaker Change: We certainly are having more targeted approach here, but did you want to talk a little bit about what we do from a DTC perspective, and then also just kind of the the universe of of additional or specialties were looking to target yeah, absolutely I would say that our direct to patient efforts are really focused on two things.
Speaker Change: The first is increasing the awareness of Eva kit is a new treatment option and the second is really creating opportunities for patients to hear from the very positive experiences with other patients who have benefited from either cat.
Speaker Change: And so we use a lot of metrics I think it really comes down to the growth in awareness in Ava kit non users. Obviously, we've seen the number of users increase but continued to drive the awareness of of Eva kit using our direct to consumer ads.
Speaker Change: We are I think importantly, executing on these initiatives in a highly highly targeted way for this rare disease market.
And some of that I think.
Speaker Change: Most most resounding method metrics, we've seen is more patients going into offices, asking about Eva kit as well as the growth that we're seeing in the patients who are starting.
Speaker Change: To your question about dermatology and Gastroenterology I would say, it's a bit of both things that you mentioned the first is there's already an untapped opportunity of already diagnosed SMA patients.
Speaker Change: Being treated by these additional specialties.
Speaker Change: And secondly, we would actually expect us to to grow that the treatment rates overtime, which can lead to some of that longer term sustained growth.
Speaker Change: Thank you. Your next question comes from the line of Amit <unk> with Ehow.
Speaker Change: Your line is open.
Yeah.
Speaker Change: Hi, good morning, Thanks for taking my question.
Speaker Change: If you think about the different buckets of physicians, the German gastro the outages haemonchus.
Speaker Change: Can you give us a sense of what's the mix of.
Speaker Change: The patients that are being treated by each specialty and maybe give us a sense of your penetration in terms of reach and frequency.
Speaker Change: Where you are today and then how you see that evolve with this expansion into the Johnson gastro data this year.
Speaker Change: Thank you.
Speaker Change: I'm going to talk a little bit more about doing.
Speaker Change: Specialties, yeah. So I'd say there are a number of S N patients being treated across all of these specialties today its our conviction in the market opportunity, that's really triggering us I think to invest in the field and expanding the field force, which enables us to increase reach and frequency.
Speaker Change: Across the Allergists and heme office, where we've we've targeted primarily to date as well as expand into the the germs and G eyes.
Speaker Change: I would say there's incredible headroom across all of these specialties to continue the growth most of the prescribing to date has of course been in allergists and he box.
Speaker Change: One of the things we've been really pleased to see is that the growth of breadth of prescribing has actually been faster into allergy and we know this is really important to capture that long term opportunity and again for for germs in Gis. We are just getting started and you know.
Speaker Change: We know that the they are both treating and already diagnosed.
Speaker Change: A number of SM patients, but there are also patients coming in who can who can increase that diagnosis rate. They are presenting with cutaneous mastocytosis in the dermatology offices.
Speaker Change: Or things like Ibs with some other signal of a systemic involvement in the Gi offices.
Eva Cat: Maybe one thing I'll just add is that you know as we think about you know Eva can.
Eva Cat: It really is the opportunity the long term safety data that really lowers the bar and people think about the patients who are most who could really benefit from the treatment and so we all use these kind of measures of TFS score and we try to classify patients with moderate mild severe all these things and that's really a regulatory tool and what we see out in clinical care, it's about Ah patient.
Eva Cat: And whether or not they are well controlled and whether or not they can do the things. They wanted to go to work participate and family events and what we know is that there's a lot of patients who cannot across all of these specialties and that's really the clinical context in a commercial setting that is very different than a context that we need for regulatory approval and.
Eva Cat: And so I think the fact that Eva can is so well tolerated. We are three years now plus data really makes US believe this is the right moment to be continue to expand in allergy and moving into Gi and derm, who we know will have will be very.
Eva Cat: Positively received that that clinical long term profile.
Speaker Change: Thank you. Your next question comes from the line of Pizza Lawson with Barclays. Your line is open.
Speaker Change: Hey, good morning, it's Alex on for Peter Thanks for taking the question just a quick one on the new field force required could you quantify that relative to the most recent or I guess existing salesforce. Thank you.
Speaker Change: But anyway to talk about the sizing Chris Yeah. So this is an incremental field force expansion that will enable us to both increase our reach and frequency on the current prescriber base.
Speaker Change: As well as to expand to these other targets. Other there are other specialties, but importantly, we're able to do this in an incredibly targeted way leveraging the strength of our analytics to know where patients are engaging them. Most frequently across the specialties. You know I think they keep the key piece sort of underlying all of this is like most of them.
Speaker Change: This market, we can see resides outside of hematology and so this is an important lever for us to continue to drive growth in in allergy as well as moving into other specialties.
Speaker Change: Thank you.
Speaker Change: Your next question comes from the line of David Type of Cvs. Your line is open.
David Type: Okay, great Yeah. Thanks for taking my questions I, just wanted to drill down on the <unk>.
Speaker Change: Our prescribers, but also you mentioned that you know as soon as the claim to the dermatology and Gi for scrubbers, how should we think about the compliance rate of these patients given that these patients are continuing on motor symptoms.
Speaker Change: Yeah, David that was a little bit to what I was mentioning is that it's the idea of kind of milder or sometimes its not really the pull through here right and in the clinical care setting. It patients who are just not do not have enough control over whatever there's sometimes may be to be able to do the things that they wanted to do in life and so really in the commercial contacts that is that is the context.
Speaker Change: It's around is a patient well controlled or not and so you know.
Speaker Change: The rubric of patients being kind of more severe versus less severe across specialties is really not its really not relevant for the commercial setting like it is for a clinical like a clinical development study so.
Speaker Change: The only thing I would add to that is that you know our commercial compliance across the board has been exceptionally high which I think just speaks to the profile of any of the cat. Once the patients you know it makes a decision to start on therapy, we see patients doing really well, they're staying on therapy, they're highly compliant and.
Speaker Change: They're they're sticky.
Speaker Change: Thank you. Your next question comes from the line of Judah Frommer with Morgan Stanley. Your line is open.
Speaker Change: Yeah.
Judah Frommer: Hi, Thanks for taking the question just a follow up on the order carry indication for either way I'd be curious, how you're viewing unmet need.
Judah Frommer: <unk>, whether it would be would you pick sooner approval in CSU effects that and whether risk benefit profile could be viewed differently by gums versus allergists. Thanks.
Judah Frommer: Hi, Yeah. So just first of all I think that in most of these are these disease, having a small molecule daily oral solution.
Judah Frommer: What patients are looking for and so we were pleased to see the depiction of how the activity, but a good really helping everyone understand that this is a chronic inflammatory disease, but we still believe that are addressing the mast cell directly which is the driver of the disease is the right way to approach. It and then a small molecule will be the preferred.
Judah Frommer: <unk>.
Speaker Change: Thank you. Your next question comes from the line was Saddam Logan Knutsen with Stephens. Your line is open.
Hi, Good morning, Thank you for taking my questions and congrats again on the sales results they became.
Speaker Change: My question is regarding the progress with.
Speaker Change: Great or even goes to nominate your first push integrator programs How's your opex spend breakdown between the commercial and development programs prioritized.
Speaker Change: The ability and free cash flow in the cards potentially this year or could we expect any of those things for me to get to be reinvested into the pipeline.
Speaker Change: Yeah. So it's like you want to take that.
Mike: Yeah. This is Mike.
Speaker Change: Yeah. So I mean, as we've talked to previously like capital allocation and prioritization has been one of our key priorities really over the last couple of years to make sure that we are investing in what we see are the greatest opportunities to drive.
Speaker Change: Top line growth book now with advocate and in the future with pipeline and so we've been really disciplined on.
Speaker Change: Both being able to make sure that we're investing appropriately in Africa, but also targeting within our pipeline, where we think we have the greatest potential to drive growth. So it's not so much like we're expecting to see modest increases as I mentioned in both SG&A spend and R&D spend because we'll be investing in both areas to drive to drive again, both near term and long.
Speaker Change: <unk> growth and I think specifically, we don't typically break down like within the pipeline where that program is spend is growing but clearly <unk> been 808 are going to be the top priorities in the near term to drive that and one thing I would just add is that I think we have a really good track record here at blueprint AD as I don't in terms of our business develop.
Speaker Change: The strategy and I think we are very committed to maintaining a durable financial profile, making sure were sustainable and able to kind of invest in the highest prior.
Speaker Change: Prioritize drivers of growth and if there is if there are programs that either we we believe we would benefit from a partnership in terms of execution and or maybe not.
Speaker Change: Not our highest strategic priority, we have a track record of having out license those and you know for instance, just recently, we put a program in the hands of <unk> and we just received $80 million at the beginning of this year due to that transaction and that was a program that we chose not to move forward ourselves, but certainly need was beneficial to move forward in someone else's hands. So we will.
Speaker Change: To look at using business development to enable us to be first and foremost meet our corporate strategic interests and then secondly to make sure we're maintaining that really sustainable financial profile.
Speaker Change: Thank you that's all the questions we have time for today.
Speaker Change: Jake happening.
Speaker Change: I'll turn the call back over to you.
Speaker Change: So thank everybody, where we are off to a very strong start here in 2025, I would advocate firmly on the path to realizing its multibillion dollar peak opportunity. We're advancing our pipeline we have the assets in place we have the strategy in place to really achieve our goal of fundamentally shifting the way allergic inflammatory diseases are.
Speaker Change: Treated by targeting the myself. So we thank you all for your continued support of blueprint medicines and we invite you to continue to follow our progress throughout this year.
Speaker Change: Thank you.
Speaker Change: This concludes today's conference call you may now disconnect.
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