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Philina Lee

Thanks, Kate.
In the third quarter, AYVAKIT achieved $128.2 million in net product revenue, with $113.1 million in the US and $15.1 million ex-US. This represents a 137% increase year over year, and our conviction in this blockbuster brand has never been stronger. Our team's efforts are coming to fruition as we build this market, and AYVAKIT's strong launch trajectory proves our success.
Growth this quarter was driven by strengths in our key business fundamentals. First, we continue to see strong and steady growth in patients on AYVAKIT, driven by new patient starts and low discontinuations. Growth in patients on therapy is driving AYVAKIT's successful launch. At our last call, we anticipated seasonal dynamics around summer holidays might impact patient starts and compliance, but this turned out to be less of an issue than expected.
Our team did a great job managing through these dynamics, resulting in strong demand towards the end of Q3. We have a large base of patients on therapy, and we expect this to continue growing. Compliance remained high, consistent with what we've seen, and trends in duration therapy remained strong, demonstrating the real-world benefit patients see on AYVAKIT.
Second, our mix of free and commercial goods remains stable. Our average free goods rate since ISM approval is in the mid-teens and has stabilized over the past two quarters. We expect this to remain consistent for the remainder of the year.
Finally, our international team delivered strong results this quarter, driving growth in advanced SM across several geographies and in ISM with the launch underway in Germany. Germany comprises the majority of international sales, and the ISM launch dynamics we're seeing there mirror what we've seen in the US. In the third quarter, strong growth and volume offset a lower price accrual from our planned German price reassessment process, which will be complete by early next year. We anticipate geographic expansion across both advanced SM and ISM to continue to drive growth in 2025 and beyond as we launch ISM in additional markets.
Breadth and depth of prescribing are strong lead indicators of continued growth. This chart shows how first positive experience with AYVAKIT leads to repeat prescribing among the top 400 providers by SM patient volume. But this is just part of the story. We're engaging with several thousand providers beyond the top 400, and adoption is growing across this broader range.
As AYVAKIT experience grows, we see new hemogs and allergists prescribing, with adoption evenly split across academic and community settings. These dynamics are exactly what you'd want to see in a strong launch, and they plant the seeds for continued growth.
We've also seen the first examples of prescribing by additional specialties, such as dermatologists. For example, we're seeing cases where dermatologists can become the local SM champion, motivated to diagnose and move more patients to treatment. This dynamic bodes well, proving yet another opportunity to further grow the market and our ability to capture it with AYVAKIT. Awareness of SM continues to grow across a broadening spectrum of specialists who touch the constellation of disease symptoms.
We understand the SM market better than anyone else. What activates patients to start a therapy that targets the root cause of ISM? What drives urgency to treat among providers? And how to streamline access to therapy?
Now, let's dive into some of our latest provider and patient initiatives. Our team recently launched a new branded campaign for providers, designed to challenge the notion of well controlled, along with resources that highlight the two-year safety and efficacy data we presented at the European Academy of Allergy and Clinical Immunology Conference. These data are valuable to providers considering AYVAKIT, and Christy will share more on this.
Having made progress educating the provider base and growing AYVAKIT experience among hemogs and allergists, we can now further expand on our direct-to-patient initiatives. We recently launched a patient campaign to raise awareness and spotlight how AYVAKIT targets the source of the disease. We also launched a new patient mentor program, increased support for face-to-face patient events, and expanded our patient ambassador programs. We know that patients find it helpful to hear from other patients as they consider starting AYVAKIT, and an educated patient is a catalyst for treatment.
Our efforts with the SM community are working. AYVAKIT is helping more patients every quarter, and we are continually enhancing and expanding our initiatives as we drive this launch towards its peak potential.
I'll now turn it over to Christy to share more about our data generation efforts and near-term catalysts as we head into 2025.

Christina Rossi

Thanks, Philina.
We've been treating SM patients with AYVAKIT in clinical trials since 2016 and have spent the last eight-plus years amassing a significant body of evidence on its long-term impact across the spectrum of this disease. In advanced SM, we've been able to demonstrate significantly improved overall survival versus prior standard-of-care therapies. And in ISM, we know that HCPs and patients find longer-term data on the safety and clinical impact of AYVAKIT meaningful and motivating in the setting of a chronic, lifelong disease.
We've continued to publish long-term follow-up data from the open-label extension of the PIONEER study. Most recently, we presented updated data demonstrating that with median follow-up of more than two years, and with some patients treated as long as four years, AYVAKIT showed durable efficacy and a favorable safety profile. Safety data were consistent for a subset of patients who dose escalated to 50 milligrams once daily, reinforcing the flexibility that HCPs have to customize treatment based on the individual needs of their patients.
What sets Blueprint apart, however, is not just the mountain of evidence we continue to amass with AYVAKIT. Our team has developed a tremendous command of the SM market by being at the table with a broad group of healthcare providers diagnosing and treating patients every day. We have an unparalleled depth of knowledge and expertise across the continuum, from research, through development, to commercialization, which affords us an evolved understanding of patient and provider needs over the long term. This creates a virtuous cycle where insight fuels innovation, enabling us to drive progress with AYVAKIT and guiding us on how to deliver an evolved value proposition with elenestinib, our next-generation KIT D816V inhibitor.
And we're establishing this same virtuous cycle in mast cell disorders more broadly. It was insight and feedback from allergists that inspired us to pursue a potent, selective, and tunable oral wild-type KIT inhibitor, resulting in BLU-808. And just last weekend at the American College of Allergy, Asthma and Immunology Meeting in Boston, I saw firsthand evidence of scientific exchange, sparking new ideas and driving strategy and impact across our mast cell portfolio.
As we approach the end of what has truly been an exceptional year and look ahead to 2025, I'd like to touch on some of the near-term milestones and catalysts our team is focused on, starting with our primary strategic priority of advancing this mast cell portfolio. This includes the successful global commercial launch of AYVAKIT, which Philina discussed today.
It also includes the advancement of elenestinib, where we remain on track to initiate the registration-enabling Part 2 of the HARBOR study by year-end, and BLU-808, which has been moving through a Phase 1 study in healthy volunteers. We anticipate sharing this data early next year, including initial data on BLU-808's safety profile, drug-like properties, and early biomarker responses that will help to inform how we think about the potential for broad disease impact. I hope you have a chance to dial in for the second in our series of science-focused seminars on November 14, where we plan to talk more about the strategic development plans for our mast cell therapy franchise.
Regarding our cell cycle portfolio, we have been closely tracking the emerging data sets, including those shared at ESMO, that continue to validate the promise of targeting CDK2. We are nearing the end of the combination dose escalation portion of the Phase 1 VELA study, and in parallel, we have also advanced our next-generation programs, particularly our CDK2 degrader, more quickly than we originally expected.
Given the significant investment and capabilities required to move into later stage breast cancer trials, we've been clear that we will not move BLU-222 forward beyond this phase of development on our own and have been engaging in strategic partnership discussions. Through these conversations, we are evaluating the emerging data from CDK2 inhibitors, as well as the profiles of our next-generation assets, to determine what may be the best-in-class approach and, therefore, what the optimal structure and timing of a potential partnership would look like. We anticipate sharing more about our plans and priorities early next year.
In 2024, our team has executed to both drive exceptional top-line revenue growth and prioritize our investments in our highest-value programs, laying a strong financial foundation for sustainable corporate growth. I will now turn it over to Mike to discuss our financial results.

Michael Landsittel

Thanks, Christy. Earlier this morning, we reported detailed financial results in our press release, and for today's call, I'll touch on a few highlights from the quarter.
In the third quarter, total revenues were $128.2 million from net product sales of AYVAKIT. And as mentioned earlier, we are raising our AYVAKIT product revenue guidance and now expect to achieve $475 million to $480 million in net product revenue in 2024. This updated guidance is based on continued growth in total patients on therapy, continued favorability and compliance and other factors, and stronger-than-expected performance outside of the US.
Our gross-to-net margin remains stable in the mid-80s, and our international business is on track to break even by the end of this year.
Our total costs and operating expenses remain relatively flat at $177.2 million for the third quarter. We anticipate that both our R&D and SG&A expenses will remain relatively consistent as we close out the remainder of this year.
As we look ahead to 2025, our capital allocation priorities remain squarely focused on investment in our mast cell portfolio. This is to ensure that we're capturing the clear opportunity that the SM market represents with the commercialization of AYVAKIT and advancing our pipeline of other mast cell therapies to drive long-term growth in areas where our conviction around disease biology is clear. We plan to share more perspective on our 2025 capital allocation strategy early next year.
We continue to strengthen our financial position with $882.4 million in cash on hand at the end of the quarter. And importantly, we've seen our cash burn drop significantly in 2024. And we expect this trend to continue in 2025, reinforcing our clear path to financial sustainability.
With the ongoing success of the AYVAKIT launch and our commitment to disciplined investment to drive growth, we are in a great position to continue to create long-term shareholder value.
With that, I'll now turn the call back over to the operator for questions. Operator?

Question and Answer Session

Operator

(Operator Instructions) Marc Frahm, TD Cowen.

Marc Frahm

Hi. Thanks for taking my questions, and congrats on another strong quarter.
Maybe just on the ISM side to start, you're getting a meaningful number of patients out at 6, 12 months now. Any type of reauthorization criteria you're seeing or any type of maybe headlines we should expect in terms of discontinuation starting to kind of factor into the launch trajectory?
And then as we get to the wild-type KIT inhibition data next year, just curious kind of where you think the thresholds are of kind of target engagement to kind of induce a response? And do you really need to kind of hit those levels clinically, or do you think more of a pulsatile or induction maintenance might be the best approach?

Kathryn Haviland

Thanks, Marc. So Philina, maybe you can talk about what we're seeing in terms of reauthorizations for patients. And then, Fouad, I'll hand it over to you for more on BLU-808 and what we're expecting there.

Philina Lee

Yeah. Hi, Marc. As you mentioned, we are seeing a significant and growing patient base of patients on therapy, and we expect this to continue to grow.
In terms of reauthorizations, I think, overall, we are incredibly pleased with the strength of access that continues. We have secured and maintained strong payer coverage. We have not seen problems with reauthorization.
In terms of the discontinuation rates, that remains very low. And as you know, I think the two things that continue to drive this launch is growing that strong patient base, as well as our ability to retain patients on therapy. So we're really pleased to see the trends in duration of therapy, which really connect to the potential for long-term chronic treatment.

Fouad Namouni

And Marc, thank you for the question, on wild-type KIT, as we all know now, wild-type KIT is a very well-validated target and we have seen a lot of good work from biologics there. I think developing a small oral molecule like 808 give us the flexibility to really tune and titrate the development and the schedule of this molecule in a variety of diseases and allow us really to navigate between the inhibition of the activity and the degranulation of mast cell all the way to the depletion of mast cell. And I think having such a molecule like 808 give us that flexibility, we are happy to work with this type of small molecules.

Marc Frahm

Okay. Thank you.

Operator

Brad Canino, Stifel.

Brad Canino

Morning. Great quarter. I would actually consider this to be the most aggressive guide you've provided in terms of implied growth in forward quarters. I think feedback I've gotten from investors, and I imagine what you've heard as well, is that some of the previous guides appeared a bit too conservative. Can you help us understand how your forecasting views and abilities have changed, particularly as you think about how to incorporate variables for the 2025 guidance coming up next year? Thank you.

Kathryn Haviland

Yeah. Brad, thank you. I mean, we're incredibly pleased to be at a point, at this point in the year, where we can now say that we're going to be nearing $500 million in revenue this year, which is a really tremendous place to be. And as you said, we've raised the guide. We've also tightened the range to $475 million to $480 million.
But Christy, do you want to talk more about philosophy on guidance, which I know we've talked about before, and how we think about this for this year, as well as next year?

Christina Rossi

Yeah. Thanks for the question, Brad. So our philosophy throughout the year has been to try and look at the range of variables that influence revenue, provide our best estimates on how we think what the range of outcomes on those variables may look like, and then what do we think that could imply for revenue.
In the context of a launch into a category that did not exist before, a market that we are building for the first time, and the first disease-modifying therapy in that market, which is an incredible privilege and such an opportunity. So many markets -- you're fighting for market share and trying to have patients switch off of therapies, and we are really building an entirely new market opportunity, which is compelling but has its challenges, and certainly, I think, forecasting the first year of sales in that context can be a little bit difficult.
We've definitely done our best, and we are thrilled that we have exceeded our own view, frankly, of how these variables might fall through the year. We're now in a place where we're 10 months into the year, and so we are providing a guide essentially on Q4. Our ability to forecast how we will land one quarter is obviously much tighter than when we're looking at a whole year. And so this guidance really represents our best thinking on how we will end the year, and it's really as simple as that.
As we go into guidance for next year, clearly, we will now be more than a year -- well more than a year into the launch, so we know this market quite well. We're still, of course, forecasting new therapy at a new market, but I think have a good sense of some of the key variables that will impact. We typically set guidance, as you know, on our Q4 call, having some early experience next year with aspects like, for example, free drug in the context of the IRA changes will be really informative and helpful to us as we think about setting that guide. But philosophy will stay the same.

Brad Canino

Great. Thank you.

Operator

Reni Benjamin, Citizens JMP.

Reni Benjamin

Thanks very much guys for taking the questions and congratulations on a great quarter. Can you talk a little bit about the direct to patient ad campaign and the new patient mentor program? How does it, you know, potentially impact SG and A and how do you evaluate whether this is working or not? And if it isn't working, what are the other options that you have at your fingertips to grow market share?

Kathryn Haviland

Thanks. Thanks Ben for the question. I think first and foremost, I think we're at such a wonderful place in this launch where we have critical mass where now, you know, makes a lot of sense for us to be kind of doubling down and pushing forward on some of these direct to two patient campaigns and, and initiatives that Selina talked about. But Lena, do you want to talk a little bit about how you think about that relative to G&A spend and the impact of these types of efforts. As we look to kind of activate and educate patients.

Philina Lee

Yeah, I think maybe just first off starting at the enterprise level, we've talked about how our, our top priorities for investment and blueprints growth are really across our mass sell portfolio including the Aviki launch Inest and A eight. And we will certainly look to continue to find opportunities to invest where we see the most impactful benefit in terms of return on investment. And so in terms of how that translates into the advocate launch, you know, you've just seen with our updated guidance that we are well on the course to deliver nearly half a billion in revenue. Firmly on the path to achieve that peak conviction has never been this strong. Now is the time for us to be leaning in further into these direct patient initiatives. Now that we have secured an activated and growing prescriber base that continues to grow. We have the opportunity to lean in and further engage and activate patients. Why that's important is, you know, we continue to see that challenging that notion of well controlled is critically important to open patients aperture to what may be possible in terms of starting on a disease, modifying therapy. While patients may have become acclimated to the sense of a new normal or sort of coping with the disease and like restricting their behaviors and their activities, there's nothing more compelling than just hearing from another patient, their experience on Avod and what it can feel like how transformative that can be to reclaim what that new normal is like. And so going into those direct to patient initiatives, both in terms of raising awareness, talking about the importance of targeting the source of the disease and creating more of these opportunities for patients to hear from other patients will be a critically important component of continuing to drive in this launch.

Reni Benjamin

Thanks guys and. Congrats.

Operator

Michael Schmidt, Guggenheim.

Michael Schmidt

Hi, this is Paul. I'm from Michael. Thanks for taking our question. And congrats on the quarter, just a quick one on advocate performance in third quarter was the sort of anticipated summer seasonality, actively counterbalanced by efforts on your end or did it simply play out less than expected? It would be great to hear your thinking on seasonality and I in general over the balance of the full 12 months now that you've had a year and a half on the market.
And then my second one is just on blue 808 and early signals of activity that we might see. How do you think about some of the classic markers like mass cell depletion, trip a reduction for the oral agent compared to what's been shown by the K antibodies? And what's the right way to think about correlation between those biomarkers and clinically relevant endpoints like the activity score. Thank you.

Kathryn Haviland

Yeah, thanks. Thanks Paul. There's a lot in that. So maybe, you know, if you could take the first piece and then we'll hand it to, to, to Fuad. You know, one thing I would just say is that, you know, the commentary that we have been making around as we think about new patient starts since before we even launched is this is a rare disease and we expect there to be very building and lumpiness on a week by week type type of basis. But over the long, you know, the longer perspective, we can we continue to believe there'll be strong and steady growth in patients on therapy. And you know, the commentary we made in the last quarter was that this is not about if patients start, it's about when. And I think what has been really clear is both of those things have played out exactly as we have described. So would you like to talk about?

Philina Lee

Yes. So I think Kate it up really well. We've alluded to some of the short term quarterly dynamics that can impact a particular quarter. We know that holidays have the potential to impact the timing of patient starts to go to the next visit. What we saw in the third quarter is that our team has done an incredible job managing through these dynamics with a strong increase of demand through the back half of the year. But I think most importantly, sort of lasering out from the quarter to quarter is really that year over year trajectory. And we can see from the updated guidance, we are on a path to deliver over 100% growth year over year. And again, I think that places us firmly on the path of marching towards that greater than $2 billion peak.

Kathryn Haviland

And then Paul, do you want to talk a little bit about wild type kit? And what we're thinking about from a biomarker and correlation perspective?

Fouad Namouni

Thank you. Thank you, Paul for the question. We are developing a small molecule, as I said earlier, answering Mark's question with the idea that with a small R molecule, we can really do in the schedule to really navigate the wide range of the activity of the mass cell. A number of type two inflammatory diseases. As Christy mentioned, we anticipate to report the data early from the Sad Mad study early in 2025. And we look at overall subject safety. We look at our pharmacology.
We expect the pharmacology to be a very good one and really allowing us to do the tunability and the titration that I talked about earlier. And we will report a number of biomarkers including the level ofse more specifically to your question. Tryptase is a supportive pharmacodynamic marker for the activity of the Asians and varies from disease to another. So would we would like to see, you know, tryptase decrease in these healthy volunteers. We also know that in some more complex diseases where there is already AP C like chronic atic Caria tryptase is much a part of the story, but a much more in a much more complex environment. As an example, when you, when you go to type two asthma diseases are more complex than just, you know, looking at other try but you can look at other markers. So we have the opportunity to share data with tryptase and beyond.

Kathryn Haviland

And this is where I maybe I'll just put a plug in again for our, our seminar coming up on November 14th where we'll talk more about how we're thinking about 808 in our overall kind of development strategy in mass. So please do tune in if you can.

Operator

Salveen Richter, Goldman Sachs.

Salveen Richter

Thanks for taking our question. This is Tommy Irial and congrats on the quarter. So to follow up from some of the previous questions on 808 overall, how derisking do you think that the healthy volunteer data will be with regard to navigating the therapeutic window? And what's your view on the differentiation here from strategies such as MRG Pr X two? And then just one on Ism as we look to 2025 maybe way out some of the moving parts that we should be aware of here. Especially as the X US starts to play a larger role. Thank you.

Kathryn Haviland

Yes, thank you very much for the question. And Fuan, we'll, we'll talk about 808 and of course, we'll be talking more about 2025 you know, on the Q4 call, but maybe you can just give a high level on that. But yeah.

Fouad Namouni

So from an English perspective, our development strategy is really to target Wild type K to fine tune the mast cell and go to a variety of diseases in in terms of the risk to your question.
If we look today at wild type KPUC, I think biologics did a very good job showing a strong proof of concept in chronic artics continuous and also called induced. Therefore, the data that we anticipate to share early in 2025 will be a major inflection point for us and for patients to really benefit from what we hope and expect to be a good drug profile for Adoa.
Now, there is a lot of room to improve on the overall therap index for these therapies. And we believe having a small molecule that we can fine tune with completely different type of pharmacology. From biologics will help us achieve such a goal, not only in chronic artic area but in a variety of diseases. And as Kate mentioned earlier, we will talk about these diseases at our seminar in a few weeks. Regarding your question on different mast cell targets. And you specifically AR PX two, there are a number of targets on the math cell we we believe and as the scientific community does too, that such a target is probably organ restricted, you know, potentially to, to the skin and could when we need to see more clinical data. Because I mean, it's, it's, it's, it's, it's a really data and it's a data free zone. If I can use this analogy on the, our strategy by going to wild type kit, we know that we will target the manle where it is either in the lung or in the gut or in the skin. And, and so we believe going after the inhibition of wild type kit is a much broader strategy than other targets.

Kathryn Haviland

Yeah. And then Christy, do you want to talk a little bit about just at a high level? What we think about 2025? Obviously, we'll spend a lot more time with you all on this going.

Christina Rossi

Yeah.
So we'll, we'll provide guidance again on the Q4 call. I think, you know, the variables that we'll be thinking about are going to be, you know, in broadly, very similar to sort of what we've been, what we've been talking about this year. You know, at a macro level, what's driving this launch is new patients starting on therapy and you know, keeping those patients on therapy over time. And you know what of course, is becoming more and more important as we progress through the launch is, you know, we now have a very substantial number of patients being treated with AVA kit that we will be carrying into next year. And then of course, growing from, from that base, you know, we'll have new markets coming on internationally, as you mentioned, as we negotiate pricing and reimbursement and move through additional launches. You know, every year has its own factors. I'm sure we'll talk a bit about free drug, Ira impact et cetera as we get into next year and sort of see how the first couple of months of the year play out. But you know, the big picture again is that we are in the early innings of a launch with a substantial amount of room for continued growth and, you know, look forward to providing more on that view as we get into next year.

Operator

Derek Archila, Wells Fargo.

Derek Archila

Hey, good morning and congrats on the updates here and on the quarter. Just 21 clarifying and then just one question. So just on three Q relative to the second quarter, just in terms of the net patient ads, I guess. What does that look like Q over Q? And then I guess in terms of the seasonal, you know, factor here, can you kind of just kind of, I don't know with some qualitative information on the magnitude and how it might impact four Q and then just on 808, you guys have been talking a lot about on the call. Very exciting, I guess is your expectation trip taste reductions in line with antibodies and you know, safety better than the antibody or how do you think the overall profile will look? And all said and done. Thanks.

Kathryn Haviland

Yeah, thanks Derek for the question. So, you know, we as we, we moved away from talking about kind of that projected estimated number on the on therapy at the end of the quarter last year, Derek. But we can certainly provide kind of qualitative commentary around how we're thinking about seasonality and, and what we've seen there and I know we've touched on that. But before I do, you want to kind of reiterate there, how you're thinking about seasonality?

Philina Lee

Yeah, I think I would just reiterate by starting with the expectation that we continue to expect strong and steady growth in the number of patients on therapy. This is what we have always said. There might be variations month to month based on factors like holidays. We know that in Q4, for example, there are fewer business days. But I think maybe going back to what Christie just articulated, you know, the most, the most important piece that's driving this launch is that continued growth in in patients on therapy, strong and steady, you know, quarters are going to be more steady than months in a rare disease launch such as this one. And most importantly, the arc of that overall trajectory is that we're showing significant growth on a year to year basis, significant headroom to continue to grow. And we're, we're, you know, really focused on marching towards that peak potential.

Kathryn Haviland

And I think, you know, Derek, we now that we're kind of coming into our like the end of our first full year of launch, we have a lot of confidence around the dynamics that we see in any given quarter. And those are, as I said in my prepared remarks, like dynamics that everyone faces dynamics that are specific to rare diseases and those that are unique to M&I think we now have shown and demonstrated that our team is able to understand those and work through those in a very constructive way. You know, the goal here is to move towards a $2 billion plus product and we're going to do that year by year, right? So that is our focus and we'll continue to be our focus and you want to talk a little bit about blue +808 and and how you're thinking about that relative to what we've seen from some of the, the data that's come out from the antibody approach.

Fouad Namouni

Yeah, I think the clearly the data from the antibody approach is very big, the target in specifically in two subsets of ARCTIC area, which is chronic spontaneous Arctic area and called induced ar area, which is a really good thing. And I mentioned earlier, this makes our set and map data important. We anticipate early next year, extremely important and a major a major inflection point for for patients and for blueprint medicine, developing a small monitor in this area, gives us the opportunity to really navigate the targeting of mast cells all the way from depleting the mast cell. When we need to do that to inhibiting the activation and the degranulation without getting full depression will allow us also to have a very good therapeutic index by on one hand, having activity on the disease. And on the other hand, not reaching that far and that deep to my myeloid progenitor to generate, you know, adverse event or toxicity that we don't need to. It is very difficult to do with biologists. We believe our strategy with a small molecule is very differentiated and will allow us to fine tune entire trade and achieve these goals.

Operator

Mike Ulz, Morgan Stanley.

Mike Ulz

Good morning. Thanks for taking the question and congrats on the quarter as well. Maybe just on the AVA kit, you highlighted sort of strength o us and being better than expected. Maybe you could provide some more color there and how you expect those trends to sort of evolve as we get into next year. Thanks.

Kathryn Haviland

Yeah, thanks Mike. We're, we're incredibly pleased with how the international launch has been going and the team has done just a tremendous job in terms of kind of delivering, delivering well beyond expectations. And Chris, you know, if you want to talk a little bit more about that international launch.

Christina Rossi

Yes, we were really, really pleased with the strength of the quarter. Of course, we talk a lot about Germany, which is, you know, the the first out of the gate on on IM and where we've seen as Selina said, dynamics that look very similar to the US in terms of uptake, which has been really, you know, gratifying to see including prescribing coming from both academic centers and in the community. So very, you know, very similar dynamics. And in the quarter, what we saw was the strength of that uptake really overcoming, you know, some of the price headwinds that we had referred to. Of course, we're still working through the process with negotiations in Germany. And we'll have, you know, a sense of where that lands early next year. But you know, the demand growth is really more than offsetting that which has been great to see. And then of course, we continue to see growth in other markets which are still launching in advance of them as we get into next year, we expect to see more of the major markets in Europe start to come online as we work through IM pricing negotiations So, you know, we talked about international being an important driver of top line revenue growth. I expect that to continue. Of course, the US will represent the lion's share of the opportunity in the short term. But, you know, we would expect international to continue to become you know, more and more important part of the opportunity. And certainly when we think about the peak, you know, we're, we're excited about the potential we see both in the US as well as outside the US.

Kathryn Haviland

And then 11 thing to add to that in, in Mike's commentary, he mentioned that actually at the end of this year, our international organization is going to break even. And so this team is really driving kind of tremendous, tremendous top line growth in a very financially efficient and disciplined way. So that is, I think that's a great place for us to be.

Mike Ulz

Great. Thank you.

Operator

Ami Fadia, Needham & Company.

Ami Fadia

Hi, good morning. Congrats on the nice quarter. Two quick questions. Firstly, on an an estimate, an estimate with the part two of the Hubble study initiating by the end of the year. Can you talk about how your development strategy differs from that of AVOD? And how do you see it being differentiated from AVOD? And with regards to blue 808, the tunability of a small molecule strategy. I think you've sort of talked about quite a bit in the Q&A as we see the data from the healthy volunteer study, a dose escalation study. How would you take that information? And then think about the different diseases where you could apply it and maybe sort of what are some of the indications that you're thinking about taking it into some initial thoughts that would be helpful. Thank you.

Kathryn Haviland

Yeah, thank you. Thank you, Amy. And I think maybe we'll start, I'll hand Chris, you can talk a little bit more about that and, and Flo will take the, the question about blue 808, I think just stepping back for one moment is that the position we're in at blueprint, medicines with advocate be, you know, becoming the standard of care and a durable leader across advanced M and ISM. And then the opportunity we now have to bring and forward to really maximize the longer term performance and, and innovation across the SM franchise is really a unique and an incredible position. Do you want to talk a little bit Chris about how we're thinking about bringing Ellie forward to, to.

Christina Rossi

Do just that? Yeah. So, you know, as, as KTA said, our strategy with L&S and I is really to extend you know, a franchise that we think is incredibly important, both for patients and for blueprint as we get into, you know, really the next decade and beyond. This is an opportunity that we are growing into and we, we think we have a, a significant amount of he and m to continue to grow. Our expectation is that advocate will be, you know, the durable market leader for quite some time and will be growing, you know, for years to come. And the value of ib is really to be able to bring a therapy that delivers additional differentiated clinical impact over the long term so that we can continue to drive growth in the franchise into, you know, the latter part of the next decade. And so, you know, we will be initiating part two of Harbor. We'll obviously share more about what the design of that study looks like. But we know that the only way that you get to extend the value of a franchise like this is by delivering clinical differentiation. You know, we understand more about, you know, the full manifestations of the disease now. And much more about that than we did, you know, five or 10 years ago. And so I think our ability to measure clinical impact and really demonstrate what a targeted therapy can do in this space is, is different now than it was when we started the pioneer study. So, you know, in terms of what the actual design of Harbor will look like, we'll obviously have more to say about that as we open the study. And again, I would point everybody to our mass cell webinar that we have scheduled on November 14th where we're planning on sharing more about our development strategy across our mas cell portfolio.

Fouad Namouni

Thank you Christie and thank you Andy for the question. So your first question is the, how with the data from the sad study help us understand the tunability profile of A I would say, as we all know sad study, we are exploring a number of doses, a variety of cohorts of patients over time. And we are also looking at pharmacodynamic markers. So when we look at the totality of the pharmacology and the data in healthy volunteers at a variety of doses of a different level of inhibition and their impact on the pharmacodynamic marker will give us really a good understanding of how can we, we can develop tunable and t schedules for a variety of diseases. For the second part of your question on what is the breadth in terms of number of diseases and what other diseases will go to? I think we're targeting type two inflammation in a broad way. We'll have the opportunity in a few weeks from now about our sem to talk really about these diseases and how we think about them. But you can think about a a really a targeting a broad variety of type two inflammation, how we will do it. And as we mentioned in the past is through some or a number of POC and cohorts or studies to really early on see the activity across a wide range of diseases and start step by step derisking a way towards the selection of a major indication for registrational development.

Operator

Mars Schreider, Oppenheimer.

I just mark this on Forma. Thank you for taking your questions.
You've you've showed already some nice frequential data on asthma. Is it fair to say that you know, this is, this will be one of your focus there?

Fouad Namouni

Great question. Obviously, asthma type two, asthma more precisely is one of the key type two disease will be looking at the range of the diseases. Obviously, I think in a matter of a few weeks, we'll be able to get in in a little bit more specific about the diseases. But I mean, it is safe to say that many diseases in the type of inflammation range or area will be part of our thinking.

Operator

Peter Lawson, Barclays.

Peter Lawson

Great. Thank you. Thanks for the update. Really appreciate it on slide sets for your data around breadth and depth. Just I thought it was an interesting dynamic, the number of physicians with greater than 10 patients. Just wondering if you could kind of talk through that if there's room to grow there. If this is how it, if that's how it kind of plateaus out or if there's an ability to grow beyond greater than 10 patients.
And if these are centers of excellence, thank you.

Kathryn Haviland

Yeah, thank. Thank you for the question, Peter and, and as Selena has, as we've, as we've been saying, this kind of across the launch, the breath and depth dynamics that, that we're seeing here have just been a tremendous strength in in the launch and, and that, that graph is a snapshot of some of the, some of the providers. If you just want to talk about our opportunity, as I know that we continue to believe will drive quite a bit of depth as well. So.

Philina Lee

Yeah, Peter to your question, I think the bottom line is significant headroom to grow across all metrics and measures that we see across this market in both providers and patients. So if we look at our provider base, so we're really excited to see the uptick in the number of providers who are treating 10 or more patients. Again, that, that even within those TOP400 providers, substantial headroom to continue to grow and treat more patients on therapy within those TOP400 as I said on the call, that's just a tiny part of the picture. There are additional, many additional providers across that TOP400 as well where we continue to see growing growth as well as depth. And we haven't even really yet explored the potential of additional specialties such as dermatology and others who are treating the broader constellation of, of, of patients based on their, on their symptomology. So, bottom line significant headroom to grow. And you know, we're, we're confident that places us on a, on a path to achieve really more than $2 billion peaks.

Operator

Laura Prendergast, Raymond James.

Laura Prendergast

Hey guys, congrats on the great quarter.

Kathryn Haviland

You know, I know you said you expect free drug.

Operator

Dynamics to generally remain.

Salveen Richter

Steady below 2020.

Christina Rossi

Percent for the, as you said, on.

Salveen Richter

Average. But.

Kathryn Haviland

Are you seeing or do.

Salveen Richter

You expect any month.

Christina Rossi

To month or quarter to quarter variability in these dynamics? And.

Operator

Then just a quick second.

Christina Rossi

Question for me, any.

Kathryn Haviland

Guidance on how to think about gross margin moving.

Salveen Richter

Forward?

Kathryn Haviland

Yes. So, so thank you, Laura for those questions. I do want to talk about how we're thinking about free drug for as we close out this year. Like of course, we know this is all reset in 2025. And as Christy mentioned, we're going to be, you know, paying close attention to that in January as we look at the impact of the rest of the IRA. But how do you want to think about it for the rest of this?

Christina Rossi

Yeah, Laura.

Philina Lee

So we've talked about how launch to date the proportion of patients on free drug has reached the mid 10s, that has been relatively consistent over the past couple of quarters. And we expect that to remain consistent through the end of this year as Kate alluded to, I think one thing we'll want to keep our eye on is this resets next year due to the changes in sort of part D from the IRA. And really, at this point, we have such a substantial patient base on therapy that, you know, small, small changes in these factors like free drug can have impacts on revenues. So another piece to look at along with all the other variables that Christie alluded to, that will influence how we think about 2025.

Kathryn Haviland

And like, do you want to talk a little bit about the gross margin question that Laura had?

Michael Landsittel

Yeah, thanks Laura just with respect to gross margin. Like first of all, like we think we are in a solid position with avod, we have relatively low cost of goods sold. And so we expect our gross margins to be high and remain really relatively stable at this point in the launch that we have enough volume coming through. You know, we do see some variation due to sales of product to partners like Cstone. So a month or quarter to quarter, sorry, you might see some variability but fundamentally, we've struck margins to be stable and strong.

Laura Prendergast

Great. Thank you very much.

Operator

David Lebowitz, Citi.

David Lebowitz

Thank you very much for taking my questions. I have two for you first on physician mix. And in the past you've broken down the academic versus community doctors. If you could just update us on that update on that in case I missed it. And then number two I just wanted to ask about and the Harvard two trial, it's been studied in Ism. I know it's getting under way suit a competitive therapy out there and studying it, but also in, in IM and smoldering mastocytosis. And I'm just curious as to why it would be im only as opposed to including em patients. Thanks for taking my questions.

Kathryn Haviland

Yeah. Yeah. Thanks David. And maybe, maybe you could just talk about the, the mix of physicians and then I'll hand it to Toa to talk a little bit more about LNS Nib.
And, and how we're thinking about the kind of inclusion criteria there.

Philina Lee

Yes. So, one of the most important leading indicators is, is the prescriber base which continues to grow for Ava Kit. We see that across all specialties and settings. So in terms of the mix continues to be pretty evenly split between the academic and community setting, we continue to see additional he hemos as well as allergists, immunologists. Try it for the first time and as they have that first positive experience going on to repeat, prescribe and really broadening the lens on the patients that they see as addressable, but for, for treatment. And importantly, you know, we're really encouraged to see the growing interest and receptivity from a broader range of specialties as well. We alluded to an example in in dermatology and we see potential there for you know, continued growth and and interactions to really grow this market and move more patients towards treatment.

Fouad Namouni

And David to your question on the design of Harbor part two or People's Registrational study. I think as Christie mentioned earlier over the last many years, we have been really working with the overall community on this disease all the way from indolent to advance and exploring all the spectrum of the subtypes of this disease. And we have a good understanding of m as a disease, not only from subtypes of patients, but what really patients and physicians will be looking for in the next many years. And I think all these data and this knowledge is, is, is is factored in our development. We're able be able to share more in the next week and months on on these data. Smalling to your specific question as we all know is a very, very small group of patients, about 2% or 2.5% of the of the sm and clearly dedicated studies for these patients are very difficult to execute. But it is a group of patients that are very interested that we know very well, including, you know, the way we work it and our, our data are influencing the change, the changes of definitions of, of this disease with the expert community.

Operator

Sudan Loganathan, Stephens.

Sudan Loganathan

I thank you for squeezing me in and congrats on the great quarter and and take my question with the strong launch trajectory for AVO kit and the market knowhow that you have established. Do you have any interest in M&A or other business development activities to bolt on any late stage assets that can benefit from the synergies that you have with the advocates market that you've established? Or you know, is the focus kind of looking towards a capital allocation into the inhouse pipeline that you're that you're developing with L MS N and New 808 and maybe some other areas that you're interested in.

Kathryn Haviland

Yeah, thank you so much for the question. And I think, you know, we we have just a tremendous kind of benefit of blueprint medicine to be able to drive our growth growth organically. And our research team has been over the, since our founding, you know, 13 ish years ago. It has had a tremendous productivity in bringing forth innovative new molecules against targets of it. And so our focus and our capital allocation is really on internal programs between Advocate L&S and Blue 808 you know, has this potential to go very broad. Those are really where we're, where we're prioritizing, how we think about capital. There's a lot going on in our own labs that we don't talk about with all of you. And so as those progress, we look forward to be able to discuss those, we're always out talking to everybody from a BD perspective and that is to optimize our own portfolio and how we allocate our own dollars and, and thinking about how we can partner on our, our programs. And also if there is anything externally that that would make sense, but really our focus is, is internally and really driving that operating leverage, both based on and financial efficiency to continue to bring innovation forward for patients who have significant medical needs.

Operator

Thank you. That concludes today's Q&A with Kate Haviland. I turn the call back over to you.

Kathryn Haviland

Thank you everyone for joining us today. You know, as we, as we come into, you know, closing out 2024 really advocate strong revenue ramp coupled with our disciplined investment and most compelling product opportunities. As we just talked about with the last question has put us on a path to drive sustainable growth while we enhance long term shareholder value. And we're setting up for a very, very exciting 2025 at blueprint medicines. And we look forward to in a few short weeks here, talking more about that when we kick off the year. So thank you all and thank you for your continued support of blueprint.

Operator

Thank you. This includes today's conference call. You may now disconnect.