BeOne Medicines AG (ONC) Earnings Call Transcript & Summary
December 5, 2024
Earnings Call Speaker Segments
Yigal Nochomovitz
analystSo welcome back, everyone, to the third and final day of our Citi Conference first year in Miami. I'm Yigal Nochomovitz. I'm one of the biotech analysts here. [Operator Instructions]. So with that, it's great to have with me the senior leadership of BeiGene. Not going to be BeiGene for much longer. So I talk about that. So we have the new incoming CFO, Aaron Rosenberg; and Mark Lanasa, CMO of the solid tumors, although she will speak about hematology a little bit, too. So all right.
Yigal Nochomovitz
analystSo I guess, speaking of corporate identity and domiciling and so on, let's start with that in terms of your announced -- well, you announced in the summer that you're going to redomicile to Basel and be neighbors with Roche and Novartis. And then you also announced more recently the change of the name to B1 Medicines. So do you want to just explain the high-level strategic thinking around that?
Aaron Rosenberg
executiveAbsolutely. Sure. And thanks so much for having us. So we're really excited about both those announcements and as we continue our globalization of the company. We've had such great receptivity to our planned name change to B1 medicines. I think it really harkens the mission and purpose of the company. as we are united with cancer patients in the community to bring innovative medicines to really patients around the world. I think secondarily, as you see in our logo, there's a really interesting thing that happens at the end of the 1 where we really affirm our commitment to oncology. So there's a power button or signaling our focus that we're always on against the fight against cancer. And we also, as part of that announcement, said that we will be changing our ticker to on. And I think in this environment where many biotechs and pharmaceuticals are spreading their focus from oncology and maybe some other therapeutic areas. It was really important for us to affirm our commitment to oncology. It doesn't mean that there aren't adjacent areas where our science couldn't be relevant. But we were really committed to serving unmet medical need for oncology patients around the world. And reception has really been incredible. As you said, that followed our announcement at the end with our second quarter earnings to redomicile to Switzerland, I think, again, this just shows our continued growth as a company. We have a strong presence already in Switzerland. It's been an important hub for us in Basel hundreds of employees. An important part of our global infrastructure runs through Switzerland. And really, it's an incredible environment that supports the growth and the -- it's really the continued hot bed for science, which partners well with our other hubs, whether it be in the Bay Area, in Cambridge and certainly our new facility in Princeton that we broke ground on earlier this year for biologics and manufacturing and clinical -- global clinical development. So overall, really exciting and tremendous reception from all of our stakeholders.
Yigal Nochomovitz
analystAnd if I read the description correctly about the design of that rebranding the word is embedded within the word one?
Aaron Rosenberg
executiveYes. Exactly. Yes.
Yigal Nochomovitz
analystOkay. So let's talk about -- well, let's start with just the big ticket items. So BRUKINSA launch -- obviously going very well. So can we talk about the launch in the United States? How you see it evolving? What are the levers that you need for additional growth as well as talk about some of the new trials that could extend the franchise with novel mechanisms, which they are at least 2 that I can count, but maybe even more.
Aaron Rosenberg
executiveSure. Let me start with just our overall performance. We're really pleased with our performance this year. It's really been a remarkable year so far, and we're not -- we're still driving hard as we conclude the year into next year. Obviously, a big part of that is the foundation of BRUKINSA the leading BTKi. We've talked about it this quarter being the leader in the United States in first-line and relapsed/refractory setting for BTKis obviously medicine that's proven superiority against IMBRUVICA, the only one. And that's really paying for itself and showing itself in the marketplace with its use. We're still continue in growth mode in the United States. There's plenty of opportunity to continue on that journey. And around the world, we're really in early days as we continue to globalize the footprint in both earlier days in Europe and certainly in other markets around the world, we continue that expansion. So we really feel confident about our position for growth. And this is really the foundation for our leadership in CLL. And I'm sure we'll talk about it, but when you think about having the most the leader in the BTKi space and what we intend to partner that to fulfill the remainder of the patient journey with our potential therapeutics with Sonrotoclax next-generation BCL2 as well as our BTK degrader. We really feel confident that we will be a sustained leader in CLL. This is a market that will be $12 billion by 2030 and really, certainly, BRUKINSA plays an important foundation in that regard. And Mark, maybe you can.
Yigal Nochomovitz
analystIt would be great if you could kind of outline the key late-stage studies.
Mark Lanasa
executiveYes. The -- my role is in solid tumors. So here speaking on behalf of Mehrdad Mobasher, who is in transit to ASH, where we have a lot of exciting. Yes. So I think the key study that's ongoing is our CELESTIAL 301 study, which is the combination of zanubrutinib and Sonrotoclax. We believe that monotherapy BRUKINSA is a great option for a lot of patients, but there is a desire within the marketplace among specific patient segments time to limited therapy. As you heard from Aaron, we believe that our BCL-2 as a next-generation molecule is also favorably differentiated and has the potential to be a best-in-class molecule. We are testing that in combination with zanubrutinib in the frontline setting and a time to limited treatment. -- that is being compared to the combination of venetoclax and obinutuzumab. The feedback that we've received from investigators that they are very excited about this concept and this study is enrolling very, very quickly. because it's a frontline CLL study, it will take a reasonable amount of time for us to ultimately read out the time to event endpoints, but we're excited about the enthusiasm and the quick enrollment in that study. again to help to build this franchise that Aaron was alluding to in hematology across these 3 what we believe are best-in-class molecules of BTK inhibitor, degrader and BCL2.
Yigal Nochomovitz
analystOkay. And what types of patients are those that would be more interested in that limited duration of therapy? Who would you be targeting in the market?
Mark Lanasa
executiveSome of it comes down to patient preference and prescriber preference -- there are some patients who prefer the reassurance of continuous therapy. We think BTK monotherapy is a great option for those patients. there are perhaps younger patients who would like to have combination treatment that would enable them to take a period of treatment and then have a treatment break. There's a different group of patients who just like the idea of being off treatment for a while, so they can sort of retire their leukemia from their mindset. Our view of the future state is that it is likely to continue to be continuous therapy for the majority of patients. But -- again, we think for younger patients, perhaps fitter patients that time-limited therapy is -- presents an important option. And really, we want to have options available to patients so that they can choose the therapy both the patient and the provider can choose the therapy that's most appropriate in their case.
Yigal Nochomovitz
analystAnd I know you said it's time to event so it could take a little while, but do you have any rough estimation of when that could we could see that on the pharmacy shelf.
Mark Lanasa
executiveSo I'm not exactly sure. I will say something like 28%, but certainly on clinicaltrials.gov, we would have posted what we believe is our best estimate at the time of the primary readout of the study.
Yigal Nochomovitz
analystAnd then you mentioned, Aaron, as well that degrader. So that's a really important asset, too. There's a lot of activity in the in the protein to greater space, not only with you guys, and we'll talk about you have some solid in assets in that respect as well. So just give us a quick pitch on the degrader. What can you achieve with the BTK targeted to greater than maybe you can't achieve as well with BRUKINSA? Or you achieve something different?
Mark Lanasa
executiveWe think that the grader is a very important emerging mechanism for targeting BTK. When thinking about BTK inhibitors and the differences between covalent and noncovalent way back at the beginning of the time of the design and discovery of zanubrutinib, we made a conscious choice that because we want continuous coverage on BTK as a target that we wanted a covalence rather than a noncovalent inhibitor. So we believe that covalent to is the right way to go. We understand that they are noncovalent molecules that are now in the market. If you think about it broadly, ultimately, whether you're using a covalent or a noncovalent inhibitor, fundamentally, what you're doing is you're blocking the enzymatic activity of the protein. Degrader is it's highly different mechanism, where your medication itself leads to the protein being ubiquitinated and subsequently degraded. So it is actually removed from the cell. So it's a fundamentally different mechanism. That has the potential to address many more mutations within the protein. So we are sharing a lot of data for our degrader at the upcoming ASH in relapsed/refractory CLL and Waldenstrom's macular globulinemia and non-Hodgkin's lymphoma where we had previously talked about high response rates, which we're happy to share those data. We're also now able to talk a bit more about the durability of responses that we're very happy with how that molecule is shaping up in terms of both efficacy, durability and also the safety profile with extended exposure. So we do think that degrader presents a really exciting emerging technology in the space in BTK inhibition. Very happy to talk more about cell tumors as well.
Yigal Nochomovitz
analystOkay. I'll get there. But I just want to ask one. You have a second gen BCL2 as well. And what's the thinking there? I mean do you have an even better molecule or just to back up or IP issues or...
Mark Lanasa
executiveNo. What I would say is we're reviewing that as an additional novel BCL2 inhibitors, Sonrotoclax was designed with attributes in mind. It was actually designed to have a shorter half-life because we didn't want drug accumulation. This novel BCL2 has a bit longer half-life that has greater potency against BCL-2. It also covers specific BCL2 mutations. We are about to initiate a study of the novel BCL-2 inhibitor in combination with fulvestrant actually in breast cancer. So we think those characteristics are favorable to reexploring questions around BCL-2 inhibition in solid tumors. -- is an ongoing Phase I study in hematologic indications as well that's currently in dose escalation. So we're thinking about the novel second BCL-2 inhibitor broadly in terms of application beyond hematologic malignancies.
Yigal Nochomovitz
analystOkay. So let's move over to solid tumors for your wheelhouse. Okay. But we do want to make sure people understand that you have a very significant product in CLL. So all right. So there's a lot going on in solid tumors. You're -- you've got development programs not only sort of 2 dimensionally, you have modality. You have ADCs, you mentioned the creators. -- there may be others that you haven't even talked about yet. And then you have quite a lot of very interesting targets, CDK4 and others, which you can elaborate on. But before we get to that, can we just do like a state of play for Tisle and where you see the growth there in China and then in Europe? And I mean, you're collecting a very nice list of indications or I guess you're slowly catching up to KEYTRUDA. But so just -- and anything you want to mention as far as how Tisle may be differentiated versus the other PD-1s?
Mark Lanasa
executiveSo we're very happy with the data that we have generated with Tisle across a range of solid tumors. This has led to a lot of time and constructive work in terms of global submissions, aligned to our mission related to global accessibility to drugs. We're very pleased that we have recently received approvals in the European Union for frontline gastric cancer, front-line esophageal cancer. That brings our total number of approvals in Europe to 6. Those 2 indications are under review here in the United States where we had an oncology advisory committee to discuss a couple of months ago. But importantly, we're also having approvals across the same broad range of indications in many additional markets around the world. So the approvals that we're receiving in Europe are enabling approvals in other emerging markets that enable us to bring PD-1 inhibitors to countries and patients where there's not yet effective market access. And that's a very important part of what we're trying to do. This is not purely about market access. We do think that we have very, very strong data sets that compare well to the already on-market molecules. Perhaps one validation of that is that FDA felt comfortable to pool our data with other sponsors data for their approved products for the purposes of class labeling discussions. So overall, we think that tislelizumab is doing really, really well in terms of the review of global regulatory authorities. I'll let Aaron comment on how it's doing globally. Certainly, China continues to have very strong performance, where we have the broadest label of any PD-1 inhibitor -- and importantly, on the development side, it also becomes the foundation for novel combinations with our relatively broad pipeline that we think could bring best-in-class novel combinations to patients.
Aaron Rosenberg
executiveAnd we certainly see opportunities for continued growth for TEVIMBRA globally. In China, this is a market-leading PD-1 with continued opportunities to grow in the marketplace behind new indications, new NRDL listings. And if we look at our most recent performance, still growing on a volume basis in double digits. And as we mentioned with these launches, in areas where we have differentiated data, obviously, there's entrenched competitors. But we do feel that in the indications in which we're launching both in Europe and the United States and then certainly globally, where there's a bit less entrenchment opportunities to smartly invest and get this important medicine to patients.
Yigal Nochomovitz
analystI'm just looking at your solid pipeline chart an impressive list of targets. So I'm not sure where to start here, but where would you like to start as far as which ones would you like to highlight as ones that investors should start paying attention to? Obviously, you have a lot in early in Phase I, but it's sort of maturing.
Mark Lanasa
executiveSo maybe I'll speak to the high level, and then I'll start by talking about our CDK4 molecule for a little bit. So to understand our strategy, the way that our research and discovery organizations are thinking about target selection in solid tumors is that, first, we have prioritized certain common tumor types that we want to focus on. And those common tumor types are thoracic malignancies, specifically non-small cell lung cancer. GI malignancies in breast cancer. So the team is very much focused on target selection with the intent of bringing those molecules forward in those indications. Once they choose a target of interest, they then ask a question of what's the best modality that's going to be able to impact that biology in a way that we think will be favorable to patients. And then the third component is we're also thinking in a very intentional way about the opportunity for in-portfolio combinations. So the intent of bringing a lot of things forward, for example, in lung cancer, is to have cooperativity that leads the novel and potentially best-in-class combinations. Within the breast cancer space, this has been a very exciting year for us and that this is the first year where we've really had a big development effort in breast cancer. We are approaching our 1-year anniversary of the first patient dosed with our CDK4 selective molecule, which we think has the opportunity to be a next-gen or better-in-class than CDK4/6 based upon greater potency against CDK4 and selectivity over CDK6. So in just under one year, as of earlier this week, we had enrolled approximately 110 patients on that Phase I program globally. So we've made tremendous progress in advancing that early phase program. We will be sharing data at San Antonio a week from today on the initial experience with that molecule. We're very pleased with how the data are beginning to evolve. We don't have a lot of maturity yet, but we have enrolled a large number of patients. We're happy with the safety and PK profile that will ultimately mature and give us proof of concept to proceed. We also have made great progress with our B7-H4 targeting ADC that we licensed from Duality that is approaching the end of dose escalation and should be entering into dose expansion relatively soon. Happy with the activity that we're seeing with that molecule. We're also progressing a highly selective CDK2 molecule that's again, going through dose escalation. And then as I mentioned before, we're about to start a combination study with our novel BCL-2 plus fulvestrant in breast cancer with intent that we will combine both the BCL2 and the CDK 2 independent of each other with our novel CDK 4 in 2025.
Yigal Nochomovitz
analystSo how -- so tell us a little bit more about the CDK4. I mean you have some notable competitors there. Some heavy hitters, so to speak, Pfizer if I'm not mistaken. So what are you -- how do you -- what are you doing differently? Or do you believe it has a better molecule? Or -- or is it the way you're prosecuting the studies or the types of patients? I mean, for example, are those patients that had seen a prior CDK4/6.
Mark Lanasa
executiveSo we certainly are cognizant of the strengthen experience that Pfizer has in breast cancer, both development and commercialization. Nevertheless, we are -- we like the preclinical characteristics of our CDK4 selective inhibitor in preclinical cellular assays. It's 4.2x more potent against CDK4 than the Pfizer molecule Abemaciclib. And that potency leads to greater selectivity for 4 over that leads us to develop certain hypotheses and what we would like to see in the clinical data as it emerges that could be consistent with that greater selectivity for 4/6, greater potency 4 over 6. And again, we're sharing just the initial data next week at San Antonio that's going to be largely focused on our monotherapy experience in terms of PK and safety. I do think that the in-house operational model that we have built over time is showing its value now and how quickly we've been able to move. And we're hopeful that potentially in just 2 years from first patient dose, we could initiate our first Phase III study in later line if the emerging data continues to support that.
Yigal Nochomovitz
analystVery good. That's a big Phase I over 100 patients. You typically don't see that.
Mark Lanasa
executiveWell, part of the reason for the large size is that we're testing both monotherapy and combinations -- so we have monotherapy CDK4. We have a combination with fulvestrant to enable development in later lines. And we also have a combination with letrozole to enable development in a frontline setting. Those are all progressing in parallel, well on schedule. And again, we think that the body of evidence -- we're also doing our food effect studies and the requirements for PK and those sorts of things will be present to address the project optimist requirements around dose selection to enable Phase III starts as soon as we have confidence in the likelihood of technical success of those studies.
Yigal Nochomovitz
analystWhich other ones would you care to highlight right now in terms of the early-stage compounds just a very long list here. So there's something that I'm quite familiar with, obviously, like Zani.
Mark Lanasa
executiveYes. So it's a really exciting time for us because our stated ambition was to bring at least 10 new molecular entities in the clinic this year. Just in the past week, we have met that goal. We met our first patient dosed with our PNK RAS inhibitor last week. So we are now at 10% with a potential of up to 3 more prior to the end of the year. Certainly, we're very excited about the potential of our PNK RAS inhibitor there's terrible unmet need in KRAS mutant malignancies, most notably pancreatic cancer, where revolution medicine is disclosed intend to start a Phase III study in later lines. We're excited about the EGFR degrader, which should start dosing patients imminently. We're very excited about our MTA cooperative PRMT5 molecule, which also is set to start dosing patients imminently where we again believe that we have best-in-class preclinical profile for that molecule.
Yigal Nochomovitz
analystOkay. Interesting because that's also a very interesting area as far as Amgen has a molecule like that. They're working with another company I got over called IDEA. I think IDEA actually just announced that they have their own MT 52. So would you consider a strategy to combine with the MAT2A or that's looking at that pathway as well?
Mark Lanasa
executiveYes, is the simple answer. So it all ultimately links back to an understanding of the biology and the work that's being done by the research organization. So we have looked carefully at that specific combination and it does appear interesting. But again, we haven't started our Phase I experience with our PRMT5. So that would be a question that we could potentially ask and do course based upon what we see with our molecule. The reason why we're excited about the profile is of the disclosed molecules that are currently in clinical investigation. We do believe that our molecule has preclinically the best combination of potency, selectivity and importantly, CNS penetration, which is, we think, very, very important, particularly in lung cancer, where up to 30% of patients will ultimately unfortunately develop brain metastasis.
Yigal Nochomovitz
analystAnd then sort of just more of a conceptual question in terms of how you think about pipeline construction and relative prioritization of different modalities. I mean you have a lot of sort of straightforward small molecule inhibitors here, but you also have -- you also have ADCs, you also have some T cell engagers, bispecifics. I don't think I've seen radiopharma yet, but maybe you're working on that. Anyway, -- so how are you thinking about which modality to use and where you want to relatively invest in R&D on a different.
Mark Lanasa
executiveAgain, I would welcome Aaron's comments on this as well. But to speak to the development strategy piece. Our view is that -- over time, what we have done is we have built this almost entirely in-house research and development organization with a large team of 1,100 preclinical scientists, in-house manufacturing, in-house clinical development and clinical operations and biostatistics and that our clinical operations now has a global footprint in not just Asia, but here in the United States, in Oceania and Latin America and Europe that enables us to deliver a large number of early phase molecules at a relatively low cost. When you look at the total cost of bringing a drug to market, that entire life cycle, the majority of the cost still sits in Phase III. So what's your -- the question that you're asking is totally logical and appropriate. We do have a bit of an agnostic view of if it's a good target, let's bring it in the clinic. We can ask a titrated question for a fairly small amount of money. And then once we get to a milestone that would give us confidence, then we can appropriately value what that opportunity looks like weighed against other molecules within the portfolio.
Aaron Rosenberg
executiveYes. No, I think I said really well. As I think about it, we're focusing in the most important therapeutic areas. 80% of the cancer prevalence is where we're spending our time. We're building expertise and capabilities in the most important modalities. But ultimately, the biology will dictate the right tools. We are building those capabilities where we could deploy some of the most important modalities, whether it's targeted therapeutics, ADCs, as you said, or to greater platform, which we believe is leading and buy and trispecifics, and ultimately, that's supported by the foundation of best-in-class chemistry, global capabilities on the clinical development front. Ultimately, that will create value. And that puts our company in a position where we could optimize those assets advance the ones that certainly are right and worthy of investing behind. And it also creates optionality from a business development perspective.
Yigal Nochomovitz
analystSo can you expand on that a little bit more in terms of the globalization of the company? I mean we talked about the redomiciling, which is a part of the organization of the company and the name. But then in terms of sort of the percent of R&D effort that's happening ex China, the percent of clinical trial enrollment that's ex China? Like what's the progression there in terms of how that's evolving? As you become more global, so people can get a sense as to trend.
Aaron Rosenberg
executiveDo you want to start on the research front and then I'll follow with commercial.
Mark Lanasa
executiveSure. What I would say is that across the research and development organization that a substantial portion of our research organization, research and discovery organization, is in Greater China. However, our development organization is unambiguously a global organization. I mentioned a number of the regions where we have offices and employees and indeed are enrolling our studies. Our Phase I studies that we are initiating this year. Essentially all of our first patients dosed were either in Australia or the United States. We are a globally enrolling country -- company. My understanding or at least I was told a few months ago that over the last quarter or 2 quarters that the #1 enrolling country of the world was here in the United States. So our global footprint of patient enrollment is, in our view, largely reflective of other major global pharma sponsors. And certainly, when you get to registrational intent studies, it's actually quite formulaic insofar as there's a certain allocation of patients that the FDA expects is certain that EMA expect there's a certain that China's CDA expects in Japan expects and now Germany expects. So the allocation of patients in the registrational intent studies is again, fairly formulaic. And within early phase, the 2 countries that are, should we say, most regulatory friendly from our point of view or Australia and the United States, we're doing a lot of work there.
Aaron Rosenberg
executiveAnd we continue the globalization of the business. We're truly global in nature as you think about our presence all around the world. You look at our manufacturing footprint. We just -- we talked -- I talked earlier about our investment in Opel, New Jersey, which will be a foundational biologics facility. And certainly, our supply chains are global in nature. If you look at our commercial profile, more than 50% of the business, if we look at our Q3 results in the United States, approximately 10% in Europe. And rest of world, we're in very early days in the launches of our products, so very important markets like Brazil, Japan, Korea. Those are markets that will continue to drive contribution over time. And even today, you look at the globalization of our revenue, it compares quite favorably actually to even the most mature pharmaceutical companies, and we'd expect that trend will continue over time.
Yigal Nochomovitz
analystBecause I mean we track that, if you read some of our reports, the mix shift, as you shift away from China and it's continuing to move away from China. Is it -- are you getting to a point where it's kind of plateauing, and I think it's around 60x China, 40 China currently. Is that continuing to move away? Or are you -- or is it going to settle in at some kind of a predictable ratio?
Aaron Rosenberg
executiveWell, we're in a great position. The business has incredible momentum in every market in which we operate, and they are all important markets. But I would say, as you look at the -- where we are on the growth trajectory, whether it be our current state in the United States, whether you think about Europe, which obviously, the launches of BRUKINSA in the nature of reimbursement and timing in Europe is a little bit behind and some of the markets that I indicated, those will contribute outside growth relative to some of our more stable presence. So I would expect that, that would, by nature, would continue to evolve over time. And like I said, if you look at if you look at any of the relevant peer set, it's already quite global in nature, and I expect that will continue.
Yigal Nochomovitz
analystYes. I wanted to touch on 2 other sort of macro themes. You mentioned one manufacturing. So obviously, with the change of the administration and the potential for more protectionist foreign policy, there are questions around the ability to import products in the United States. So what -- based on that, what percent of your current supply chain is it in China versus in the United States? Obviously, you have Hopewell, you have a facility in Kansas City. So talk about that a little bit.
Aaron Rosenberg
executiveSure. And obviously, we follow what's happening with the discussion around things like tariffs. I'd say from an industry perspective, I don't see us as any differentiated from this is a sort of industry issue large. You think about our global -- our footprint and our United States supply chain as an example, as you mentioned, our drug product is manufactured in Kansas City. Our packaging and logistics is out of Chicago. So we already have a supply chain that is sourced to support the United States. And obviously, we made the big investment in Hopewell with respect to our biologics capabilities. So obviously, this is something we're tracking, but we don't see this as particularly differentiated from the industry dynamics in general.
Yigal Nochomovitz
analystAnd what about -- just in terms of sort of intellectual property and the sourcing of IP? Is it important that some of the core inventions that those are actually generated in labs outside of China in terms of questions around taking that technology back to the Western markets? Or does that not really matter you're filing patents globally.
Aaron Rosenberg
executiveNo. Our IP is for our global commercial sits outside of China. And of course, we've announced our redomiciliation, so ultimately, as subject to shareholder approval, we will be a Swiss company come early.
Yigal Nochomovitz
analystWell, when is that? Just so everyone knows?
Aaron Rosenberg
executiveSo we expect to schedule the shareholder vote likely early in 2025 and then the close will happen very shortly thereafter.
Yigal Nochomovitz
analystAnd by the way, was there a particular reason that the redomicile announcement and the name change announcement were staggered? Or that's just the way...
Aaron Rosenberg
executiveThese are things that we've been working on for quite some time. They have different regulatory and legal dynamics, and it's just the nature of when we were in a position to it.
Yigal Nochomovitz
analystTo change a lot of stationary. And then the other kind of big picture question is, obviously, IRA, you saw IMBRUVICA. So I mean, to what extent is that going to impact your ability to price in the United States? Obviously, you have very differentiated molecule and the market is moving there and recognizing that both the clinical value proposition and the value proposition for patients. So -- how does that factor in to your thinking?
Aaron Rosenberg
executiveSo the disclosed negotiated price that was announced earlier this year was completely in line with our expectations. Given our superiority versus IMBRUVICA, we -- certainly, we don't see this as a substitutable product in any regard. We don't expect any direct impacts associated with the announced negotiated price. -- potentially some indirect impacts, but it's certainly with in our planning continuum.
Yigal Nochomovitz
analystOkay. And then as far as capital allocation and cash management, anything you want to comment there as far as just in the financial stability of the company.
Aaron Rosenberg
executiveSure. I'd start with -- as you think about the recent performance, we continue type significant poses on driving the business forward. Obviously, we're still in very significant growth mode. But doing so with discipline, which has led to significant operating leverage, and it's translating to the non-GAAP operating profit that we have disclosed and improving and ultimately will translate to sustained cash generation and GAAP profitability. That puts us in a good position as we think about running the business moving forward. We're in a very healthy position from a balance sheet perspective with $2.6 billion in cash as of last quarter. And that provides flexibility for us to support business priorities and strategies as we see it moving forward.
Yigal Nochomovitz
analystAnd then sort of last just more of like a market stock question. I mean the stock has done nicely. It's was back over 200 for a period of time then kind of retraced a little bit and it's kind of hovering around there. So -- but nonetheless, in the last few minutes here, what do you think -- what is the market still not appreciating? Or what are they missing about innovation engine at BeiGene and the ability to deliver medicines and the strength of this pipeline, which admittedly it's a little bit under the radar relative to some of the other pharma competitors, but you do have -- I mean you're in the hunt with the same very interesting novel target. So maybe I already sort of answered it. Tell us what you think.
Aaron Rosenberg
executiveI think that's well said. -- we're really excited about the business performance and really kudos to the entire teams that have driven the business forward this year. I think, continued appreciation for the opportunity that sits in front of us with CLL, both not just with BRUKINSA but with our with our innovative potential medicines that will come to support and support patients in this important therapeutic area. So I think that's 1 that sort of as the external world sort of continues to appreciate the opportunity that's in front of us to deliver a sustained and growing franchise with these 3 important potential best-in-class medicines. I think that will -- it has resonated and I think it will continue to resonate. And certainly, as you said, the scale and potential impact of our solid medicines portfolio in early science, -- that will only continue to gain in its appreciation over time as we release data. Certainly, we have a lot of reason to believe in the quality of these potential innovations based on their potency, their selectivity, our belief in the biology ultimately, in this business data talks and we're very confident that over time, that data will show itself and we'll have continued appreciation from the market in terms of the quality. And that's on the individual asset front. And then I think further, as we show progress, it will validate the platforms that we had talked about, whether it's around our degraders, our ADC platform, and certainly, our capabilities in biologics, both with buy and trispecifics I think at the individual asset level, that also supports the platform capabilities. And I think when you combine all 3 of those items, I have no doubt that the market will continue to appreciate the value of our company.
Mark Lanasa
executiveIf I may, I'll just quickly echo the point around -- we're certainly cognizant of the fact that clinical data is ultimately what's most important and therefore, within the development organization, we want to get the data out in the public domain and begin to have conversations about why we're excited about our molecules. -- that what we -- when I'm claiming that we believe we have a best-in-class preclinical profile that we will ultimately back that up with clinical data. That's why we're sharing early data from our CDK4 program, again, please invite people to -- if you were at ASH, look at our degrader data, we're really excited about those data. And I think that there's a certain amount of inertia that once you start to back up the preclinical science with clinical data that we're confident that that's going to shine through.
Yigal Nochomovitz
analystWell, it's fortunate that you have 2 CMOs because you can't be at ASH and SBS at the same time.
Mark Lanasa
executiveSo I'll be in San Antonio.
Yigal Nochomovitz
analystBut I will see in Mehrdad I suppose. I could ask a lot more questions, but we'll have to -- I'm being told to wrap it up. So okay. Well, thank you both so much.
Mark Lanasa
executivePleasure. Thank you.
Aaron Rosenberg
executiveThank you so much. We appreciate it.
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