Earnings Transcript for IPN.PA - Q1 Fiscal Year 2022

Operator: Hello, and welcome to Epizyme's First Quarter 2022 Financial Results Conference Call. At this time, all participants on a listen-only mode. Following the prepared remarks, there will be a question-and-answer session. Please be advised that this call is being recorded. I would now like to turn the call over to Kristen Hilton [ph] Investor Relations. You may begin.

Unidentified Company Representative: Thank you, operator. This morning, Epizyme issued a press release providing a business update in addition to first quarter 2022 financial results. The press release can be found in the Investors section of the company's website at epizyme.com. On the call today are Grant Bogle, President and CEO; Dr. Shefali Agarwal, Senior Medical Adviser and Interim Chief Medical and Development Officer; and Joe Beaulieu, Senior Vice President and Head of Finance. Jerald Korn, our recently appointed Chief Operating Officer, will join us for the Q&A session. As a reminder, today's discussion will include forward-looking statements related to Epizyme's current plans and expectations, which are subject to certain risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the Risk Factors section of our most recent Forms 10-Q, 10-K and other SEC filings. These forward-looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date. We undertake no obligation to publicly update these statements. At this time, I would like to turn the call over to Grant Bogle. Grant?

Grant Bogle: Thank you, Kristin, and good morning, everyone. It's great to be here with you today and to provide an update on our first quarter 2022 results. On today's call, I will provide our commercial overview and performance at TAZVERIK, Shefali will speak to our clinical development progress for Tazemetostat and EZM0414, our investigational SETD2 inhibitor, and Joe will cover our financials for the quarter. Following our remarks, we'll open the line for questions. During the first quarter, TAZVERIK generated net product revenue of $8.7 million, including $0.5 million related to the sale of TAZVERIK commercial product for a third-party pharmaceutical company use in clinical trials. TAZVERIK commercial net sales in the first quarter were of 2022 were $8.1 million, representing an increase of approximately 10% when compared to the fourth quarter of 2021. Figures [ph] from our patient assistance program represented approximately 15% of total demand for the first quarter of 2022, a rate consistent with Q1 of 2021. Commercial demand increased 16% in Q1 2022 versus Q4 2021. While total demand, which, as a reminder, is commercial demand plus free goods provided through our patient assistance program was similar to the fourth quarter 2021 levels. These fluctuations in total demand and commercial demand are directionally consistent with prescription dynamics we saw at the end of 2020 and into 2021. We believe these fluctuations are a result in part of the Medicare Part D drug benefit design and year-end prescription patterns that impact Q1 demand. As in the prior year, TAZVERIK demand rebounded in March and reached its highest monthly level since launch. While more time will be needed to understand the impact of seasonality on the relapsed/refractory FL market and TAZVERIK demand in particular, I'm encouraged by this demand growth. We continue to be optimistic about prescription growth for TAZVERIK based upon physician feedback Wave [ph] from our ATU survey and recent changes in the FL treatment landscape and subsequent updates to treatment guidelines. Recent market research suggests that TAZVERIK market share continues to grow in the third-line relapse refractory FL study for both wild-type and EZH2 mutation-positive populations, consistent with the company’s commercial focus, messaging and our prescribing information. Following the recent changes in the FL marketplace, TAZVERIK is now the only oral treatment alternative approved in the third line plus setting for relapsed/refractory FL patients. And based on physician reported prescribing behavior from our tracking [ph] studies, physicians we sampled reported the intent to increase prescribing of TAZVERIK in patients in both wild type and EZH2 mutations in the third line plus setting. NCCN recently updated its guidelines on B-cell lymphomas. The updated guidelines for grade 1-2 follicular lymphoma now include tazemetostat as a suggested second line treatment regimen in FL for elderly or infirm patients with EZH2 wild type or unknown relapsed/refractory disease with no satisfactory alternative treatment option. Tazemetostat remains a suggested treatment in the third-line FL and systemic therapy consistent with our label. The inclusion of tazemetostat in the second-line setting is an exciting update that reinforces our confidence in TAZVERIK's potential to reach many more patients. In addition to the NCCN guidelines update, we're also witnessing the FL treatment landscape changing in real time with a voluntary withdrawal of PI3K [ph] inhibitors from the relapsed/refractory FL marketplace in recent months. In December, SecuraBio announced it was withdrawing Copiktra the most approved FL indication. This was followed by Gilead's decision in January of this year to withdraw Zydelig’s from its improved Zydelig indication and TG Therapeutics decision in April to stop selling Ukoniq in all of its approved indications. The FDA is also looking closely at the risk benefit profile of PI3K inhibitors in FL. As seen with the recent ODAC meeting on the topic in which the FDA will ask advisers to specifically discuss the absorbed toxicity of the PI3 class and whether [indiscernible] data in this class of therapies are limited to support the evaluation of benefit risk in patients with hematologic malignancies. Our internal market research has consistently shown that the PI3K class accounts for approximately one third of the FL market share. For physicians seeking an alternative to PI3Ks AZVERIK is now the only other oral therapy approved in third line plus setting. Combined with the NCCN guidelines update, we believe this presents a significant opportunity for future prescription growth and corresponding commercial sales. At this time, I'd now like to turn the call over to Shefali. Shefali?

Shefali Agarwal: Thank you, Grant, and good morning, everyone. I'll begin our clinical update with tazemetostat. As shared on March 15, we dosed our first patient in the Phase III portion of the SYMPHONY 1 study, a confirmatory study assessing tazemetostat in combination with rituximab plus lenalidomide compared with R-square plus placebo in patients with relapsed/refractory follicular lymphoma previously treated with at least one systemic therapy, including those who are rituximab refractory and/or have experienced progression of disease within 2 years of receiving their last treatment. We are proud to share that the randomized Phase III portion of the study is open globally, and we are actively screening and enrolling patients in both Europe and the U.S. We are happy to share the data from the SYMPHONY-1 study has been accepted for a poster presentation at the upcoming American Society of Clinical Oncology Annual Meeting in Chicago in June. The poster will include updated safety and activity data from the Phase Ib portion of the study, specifically updated overall and complete response rate and a subgroup analysis of rituximab refractory and POD24 patients, which, as you know, to present about 30% to 40% of the relapsed/refractory FL population in the real world and in which new more effective treatments are needed. As a reminder, recent safety and activity data from the Phase Ib portion of SYMPHONY-1 were presented at ASH in December 2021. We continue to follow this cohort of 40 patients and report additional updated data from the Phase Ib safety run-in portion of the study later this year. We have finalized plans to begin a natural history study CAVALLI, evaluating R-square in second-line relapsed/refractory FL patients. Given the lack of the real-world data evaluating R-square outcomes in the second-line relapsed/refractory population, which includes rituximab refractory and POD24 patients. Our goal is to design a prospective natural history study to better understand the outcomes of R-square usage in this patient population. The study is designed to create a synthetic control arm with R-square to compare the outcomes to the SYMPHONY-1 Phase Ib activity data in a MASH [ph] patient population, which may allow us to mimic a randomized study. Our goal is to submit data from this study for publication in a peer-reviewed journal in 2023. Turning to the LYSA study. Progress is being made towards complete enrollment. LYSA has fully enrolled the FL arm and is near complete in the DLBCL arm. As a reminder, this is a large Phase II study evaluating R-CHOP and tazemetostat in 62 high-risk frontline FL patients and 122 high-risk frontline DLBCL patients. LYSA, in collaboration with Epizyme anticipate presenting top line results from the Phase II portion of the study in the second half of 2022. Moving to our solid tumor program, CELLO-1, an open label randomized Phase Ib/II study evaluating tazemetostat plus enzalutamide compared to enzulitamide monotherapy in metastatic castration-resistant prostate cancer patients continues to progress nicely. The study is approximately 85% enrolled in the randomized portion toward a target of 80 patients. In 2022, we expect to complete enrollment in the randomized Phase II portion of the study and present updated data from the safety run-in portion as well as interim data from the Phase 2 portion of the study, including radiological PSS and PS50 [ph] in the second half of 2022. We continue to screen patients in ARIA, otherwise known as EZH-1501, the Phase 1b/2 tazemetostat hematological basket study, as well as SET-101, which is first in human Phase 1/1b study of EZM0414. Epizyme novel first in class oral SETD2 inhibitor in adult patients with relapsed/refractory multiple myeloma and relapsed/refractory DLBCL. For ARIA, the visit of the Phase Ib/II hematological study will combine tezmeostat with mosunetuzumab, Roche's investigational CD20 CD3 T cell engaging bispecific antibody for patients with relapsed/refractory follic who have received two or more prior lines of therapy. For SET-101, the company expects to enroll between 30 to 36 patients in the Phase I dose escalation portion of the study. We plan to provide updates on both of these programs in the second half of 2022. As you can see, we continue to advance our development program for tazemetostat and EZM0414 and anticipate a steady cadence of data in the second half of this year and through the coming years. Our post-marketing FDA commitments are also on track. We plan to leverage the SYMPHONY-1 confirmatory trial and the ongoing post-marketing commitments to fully expand the TAZVERIK label. We have several post-marketing studies underway intended to inform aspects of the label. These include clinical pharmacology evaluations to assess the effect of tazemetostat on liver function and the effect of CYP3A inhibitors and inducers on tazemetostat for patients with solid or heme malignancies. We have also expanded enrollment in a cohort of our Phase II study in adults with INI1-negative tumor to enroll a total of at least 60 ES patients. The cohort is a paired biopsy design to assess potential immune biomarkers. Finally, I would be remiss if I didn't share my excitement as a clinician in terms of the recent update to the NCCN guidelines that Grant referenced previously. These changes, which are more closely aligned with our current label in relapsed/refractory FL, which support physicians making informed decisions as they consider appropriate treatment options for the patients regardless of mutation status and relapsed/refractory FL. At this time, I'd like to pass the call to Joe, Senior Vice President and Head of Finance.

Joe Beaulieu: Thank you, Shefali. We ended the first quarter with approximately $200 million in cash, cash equivalents and marketable securities. We continue to guide our cash runway into the third quarter of 2023. Total GAAP operating expenses were approximately $60 million for the first quarter of 2022. Total non-GAAP adjusted operating expenses were approximately $53 million for the first quarter of 2022. As you may recall, last quarter, we revised our full year 2022 operating expense guidance based on expense reduction measures and operational efficiencies. We continue to expect 2022 total non-GAAP adjusted operating expenses of between $160 million to $180 million. I would now like to turn the call back to Grant for closing remarks. Grant?

Grant Bogle: Thank you, Joe, and thank you, Shefali. This was a very good update and I look forward to questions. In the Q&A session, we'll be joined obviously by Joe and Shefali, but also Jerald Korn, our new Chief Operating Officer. So I'll serve as kind of the MC and as we open the line to questions to them, I'll first one to be appropriate person, okay. So why don't we open the line right now.

Operator: Thank you, sir. [Operator Instructions] Our first question comes from the line of Peter Lawson from Barclays.

Peter Lawson: Great. Thank you so much. Thanks for taking the questions. I guess the first question is the confidence you have around essentially a rebound in revenues for Q2, that would be - any details around that would be great? Thank you.

Grant Bogle: Peter, we're one month in, and we haven't reported on that. We did see a very strong rebound in the Feb and March. That continued into April, but the quarter is not done. But I think that the broader scope of changes, this is - there's been more change in this market in the last quarter, I think, than they probably have been in many, many years. And I think physicians are just processing that information. And in terms of what the future holds, that's obviously something that's difficult to predict, what I can tell you is from what our market research has shown and what we hear from physicians is this is a significant opportunity for TAZVERIK, but the patients that are put on other therapies as well. But for many patients, especially in the third-line plus setting, which is where the PI3K is we used the most. We're the only oral agent that is now approved in that setting. And because of our profile, not just being oral because of the safety profile, because of the tolerability because of the efficacy, quite frankly, where I'm most excited is the growth that they're projecting is not in the mutant population. It's actually in the wild type of unknown population. And so for those reasons, all the NCCN guidelines, I'm quite encouraged. I would say this is more of a back half and into 2023 when it starts because you've got to build patients and then the lines of therapy component if that would with kick-in. Does that make sense, Peter?

Peter Lawson: Yes. That was actually my follow-up question. So you think that's more of a backup because of the - you're waiting for patients to come off the PI3Ks, that's where you get that...

Grant Bogle: Yeah. Remember, most of - so if you take - with the exception in chronic, all of these drugs remain available in the market. And I'd like to ask your colleagues [ph] but I can tell you my experience from working with physicians for many years at US Oncology, if you got a patient that is doing well, it's generally you know, there is not an immediate change, especially if the drugs are still available. But I think each clinician is probably weighing the changes and as things like NCCN guidelines get pulled through, pathways get updated, all those various types of things, it pulls through the system. Shefali?

Shefali Agarwal: Yeah, absolutely right, Grant. I think the - as you know, follicular lymphoma is an indolent tumor, and patients actually do well. So - and if the patient is not symptomatic, physicians tend not to change the therapy if they're continuing, for example, on PI3K or any other therapy, I think important to see, Peter, is that you know, that point that Grant made, that we will be the only oral approved therapy in third line and beyond. And now with the NCCN update, availability in second line as well, although it was our label, but now aligned with the label. We believe there's a great potential for TAZVERIK. And additionally, as we'll talk about all the great trials that we are doing and additional data that we will be generating, not only in FL, but also in other hem malignancy and solid tumors, we really substantially add to the value of TAZVERIK in terms of potential of TAZVERIK combination as well.

Peter Lawson: Okay, fine. Thank you. And just a final question on the weakness at the beginning of the year. Is there any way of breaking out any COVID, Omicron effect that you may have seen in first few months of the year?

Grant Bogle: Like all of the things, Peter, short answer is I can't really quantify that. There were portions of the company or country that were enrolling lockdowns and so forth. But I would say that my experience in other drug classes, as well as what we saw last year, I really think this relates to two factors. One is the design of the Medicare drug benefit, which, as you know, as you get to the end of the year and the re-upping and the donut-hole and all these things that affect how prescriptions are dispensed towards the end of the year. And the second aspect is, given that the semi tumor, a lot of patients, to be honest with you decide to - they drive us out or they do different things that impacts the refills and so forth. So I can't tease out everything, but those are the - and since we've seen it - similarly last year, I've seen it in other classes, not all of orals. That's what I think it was predominantly. I can't read out if there was a COVID effect growth.

Peter Lawson: Got you. Okay. Thank you so much.

Grant Bogle: Thanks, Peter.

Operator: Thank you. I show our next question comes from the line of Peyton Bohnsack from Cowen. Please go ahead.

Peyton Bohnsack: Hey, good morning, guys. This is Payton on for Joe. Thanks for taking our questions. I guess just the first one, could you elaborate or provide any additional details on the prescriber base for TAZVERIK and how that's evolved since launch? Specifically, what are the number of new prescribers versus pre-prescribers and how that's changed over time? And then also, any additional information on the number of hospitals integrating TAZVERIK to be moderate [ph] all you can give? And I have a follow-up. Thank you.

Grant Bogle: Okay. So let me just talk a little bit about how it was introduced, and maybe Shefali you can comment on that, since you were here, and I was on the board. But predominantly at the start, given our patient population, which was in ES to begin with, that’s a epithelioid sarcoma, plus the fact that you know, [indiscernible] with TAZVERIK was not broadly distributed in the United States when it launched, it was predominantly taken up in the academic setting. And what we see is a migration and greater uptake in the community over time. And today, roughly the split of volume between the community and the academic setting is roughly 45% to 50% community in the balance in the academic environment. And it goes up and down in that environment. There's probably more patients in the community than is in the academic environment, but you have greater concentration of physicians that all they do is treat follicular lymphoma in the academic environment than in the community. So you get some different dynamics on in that environment. In terms of growth of prescribers, that's something that we have a really difficult time assessing because, as you know, 60% of our volume goes through the specialty distributor channel. This is - if they are through the specialty pharmacy at which we've got one, we understand it's Dr. Smith [ph] and it's a patient that's either ES or FL, we can track that. But that's only 40% of our prescriptions on. When a drug is set from the distributor to Memorial Sloan Kettering are sent to Minnesota Oncology. We can't tell from when that drug is dispensed from a pharmacy, whether it's a new patient or a refill, which doctors so forth. So we don't have visibility with that. What I will tell you is we are continuing to see growth in more accounts coming on board. Many times, these are satellite accounts of a parent account that is already ordered in the past. However, recently, we did see some accounts that have never ordered and we can't be for sure because I don't have direct access into those accounts. But this timing was coincident with a lot of the issues around the PI3Ks and some of the challenges they have. So one could speculate, but it might be related to that, but I view that as a positive sign. So I think physicians are rethinking how to position TAZVERIK, especially in light of the NCCN guideline changes, our change commercial strategy in terms of simplifying the message and really focusing on the broad population and expanding our use in the wild-type setting. So I think those changes are having an impact. Did that answer your question?

Peyton Bohnsack: Yeah. Thank you. That was really helpful. Thanks for all the color on that. And then I guess kind of secondly, due to the recent CRL issued to Hutchmed, due to the FDA rejecting clinical trial data generated in China and the U.S. routine [ph] studies. Does this have any read-through to enrollment in the Phase III portion SYMPHONY study or any planned combination studies with tazemetostat effort? Thank you.

Shefali Agarwal: I think - I really think it is a big thing that PI3K and really, although there's a discussion about China, but I don't think that specifically to China, I think there's still a question about PI3Ks overall. Overall, for simply one design, as you know, we have 180 sites globally, right? Our focus is to really get patients in U.S. and many other sites in Europe. China, as you know, with our partner, we have 20% in terms of sharing of completion, but that's not just that 20%. We - our goal is to enroll the study as quickly as possible globally. And currently, we are working to open the sites. We are going to be screening enrolling patients globally as well. So although I do see - I kind of understand your question about CRL, but I don't see an impact on SYMPHONY-1 because we do have many sites that can be able to enroll this trial.

Peyton Bohnsack: All right, perfect. Thank you very much.

Grant Bogle: Thank you.

Operator: I show our next question comes from the line of Michael Yee from Jefferies. Please go ahead.

Grant Bogle: Hey, Mike.

Unidentified Analyst: This is Sid on for Michael Yee. Congrats on getting into the NCCN guidelines and Q1 revenue. I just have a few questions on this time a lot. My first question revolves on SETD2 inhibitor. You said that we can expect data sometime second half. Could you give us any more guidelines as to can we expect at ASH? And what kind of data we're expecting to see? And what do you expect to see as a good result?

Shefali Agarwal: Yeah. So as you know, the SETD2 EZM-0414 is the first clinical SETD2 inhibitor, and we are very excited about that. As such, in terms of the Phase I trial, it's first in human trial, we are doing dose escalation for six dose levels. And the goal is to escalate and really get into a maximum efficacious dose or an MTD. We are screening patients. We are - we have sites open. And in terms of the data, because it's open label, it's dose escalation, we'll be presenting data, not just at certain time, but at any time as we can. Eventually, I think the important thing is that specifically SETD2 inhibitor is very important for the T414 translocation multiple myeloma. And that's a big unmet need. So our goal is to enrich for that patient in first-in-human. And as a result, we are not only doing that but also non-T14 and DLBCL. That's our first-in-human design of the trial. But once we have a dose that we would expand add additional patients on that dose and eventually have cohorts that are specifically for T414 about 20 patients, non-T414 and then DLBCL. In terms of what is considered like I would say, a win, I would really think there's an opportunity in T414 multiple myeloma because there's a big unmet need. And we know that, as we've heard, the therapies don't work well in that particular subset of patients and the prognosis is poor. So there's an opportunity to study monotherapy in that population and possibly a registration part. Now we do have to discuss with the agency about the path as well. But we are - our goal is to enroll that trial as quickly as possible to get that data you know, possibly second half of this year. And as we progress, we will provide more guidance on when we'll be able to present that data. But eventually, first-in-human open-label as we get data, biomarker data activity, safety, we'll be presenting forward.

Unidentified Analyst: Thank you for that. And the second question I had revolves kind of just overall commercial strategy. We've seen kind of modest quarter-on-quarter growth for taz. What's kind of your commercial strategy moving forward? Is it dependent on EZH2 screening status with physicians? Is it a market access strategy? What are you trying to focus on to just generate increases in year - quarter-on-quarter revenue?

Grant Bogle: So great question, and I'm glad you asked that. It's really pretty straightforward. We don't have access issues, and I mean, from a payer standpoint. There continue to be challenges just in terms of nature of how oncology has evolved in terms of access to providers and they're busy and quite frankly, in some it is - they kind of like the fact that they lock down in a COVID environment, and they're not opening up. But I would say in the vast majority of the cases, offices are opening up, we're getting access, but we're meeting physicians and engaging with other caregivers on their own terms and if they prefer to do that electronically, we can do that. But in terms of the strategy, it's really pretty straightforward. We're simplifying our message. We're focusing on the broad patient population. We are appropriately leveraging the changes in the marketplace, as well as the NCCN guidelines to continue to educate on the label, which as you know from launch was not exactly the most intuitive in terms of understanding the full potential. And it's really then putting that through from a systems of care standpoint into the over sets, into the pathways, driving it through education, driving it through physician interactions. So I wish I could - there was some secret sauce here. This is just about education. I think that resounding feedback we get from physicians one, we just had an advisory board here in last in a couple of weekends ago, Shefali, was out of with me on with many other colleagues here. Physicians have really just - even at this point in time, we physicians TAZVERIK are fair amount [ph] just appreciating the data, the depth of the data, how the drug performs, the fact that patients can tolerate this, the data behind the wild type, not just the mutant population. So there's a lot of factors that have taken time. We should have been faster, but that's really the focus. Shefali?

Shefali Agarwal: Yeah, I think there's an important thing as you think about TAZVERIK, one of the things that was a challenge initially is understanding of the label and then, of course, COVID just reaching to the physician. Now as Grant mentioned, that's not the challenge. It's just educating physicians of the importance of wild-type data. And as we saw when we discussed with the agency and talked about that, it works in both. It is - the durability is the same. The PFS is the same. There's a difference in absolute response rate, however, that may be due to the patient population demographics as well. So the goal is to really educate physicians about that data, understand that data. So it could be used overall in broad population. But the important thing is also bring as big [ph] data as we can and combination. And that is what our focus is. So we started with monotherapy, but we are moving towards combination. We have this great lead that with SYMPHONY-1 that is 40 patient data that, as I mentioned in the script, we actually are going to do a real-world study to create a synthetic control, then we will have CELLO-1 solid tumor data. We have LYSA data in frontline high-risk patients and other combination as well. So cost and cadence of data to realize the value of TAZVERIK, not only as monotherapy but also as combination, although we understand we cannot promote that, but we can talk clinically and medically about that data, and I think that would be our goal.

Grant Bogle: And I'll just ask Jerald to comment on this, and I'm sorry this is a long answer. One change we have made, as you know, we restructured the commercial organization, we brought in new leadership. We've worked on simplifying the message. There's been a lot of changes. The new skill sets that understand systems of care. We've also increased the size of our medical affairs group. And I'd like Jerald to just touch on that, briefly talk a little bit about how that group is changing in light of the additional data that Shefali mentioned too, we think that there's a real opportunity we need to educate in an appropriate way based on all this data. Jerald?

Jerald Korn: Thanks, Grant. Yes, we think this education is critical. As we talked about this morning, a lot of the treatment occurred in the community setting. But while that treatment is occurring broadly in the community setting, many individual community oncologists see only a small number of ocular lymphoma patients per year. And when you combine that with the indolent nature of the disease and the overall quantity of oncology development that come out annually, keeping up with development can be challenging for some physicians. So it's incumbent on us to identify and reach those physicians, so we can ensure they're aware of all the changes in the marketplace and appropriately educate on updates to the NCCN guidelines, as well as our TAZVERIK data. So we've put a lot more resources into this and making sure that we can go out and identify those community physicians across the country. And that's really the focus of our medical affairs team at this time.

Grant Bogle: Thank you, Jerald.

Unidentified Analyst: Thanks for that. As somebody that works in market access, I can understand those challenges. If we have time, just one last quick question. It seems for the Phase III portion of SYMPHONY-1, much of the enrollment will be in China. Due to the lockdowns, are you seeing any slowing down of enrollment? And lastly, do you expect any milestone payments from Hutchmed for clinical developments in that Phase III portion? Thank you.

Shefali Agarwal: Yes. Let me just clarify. Actually, its on the contrary, we don't have our patient expecting from China. We have 180 sites globally and only a very handful of them would be in China. Majority of them are actually in Europe and US, about 75 to 80 sites are in U.S. So the goal was to really enroll the study across globally. It's not specifically in China. As you know, there are about 500 patients. So we would use US sites, all ex-US sites and China as well to enroll. You're absolutely right, there is challenges in terms of lockdown in China, and we are working with our partner, Hutchmed to make sure that we can start those activities in China. But overall, we are not dependent on just that. We have all these sites that we'll continue enrolling across the world.

Grant Bogle: And yes, related to the milestone payments, our milestone payments, I don't believe we disclosed what they are and the amounts, but there are some clinical milestone payments, but there's also some important expense offsets, as you know, simply SYMPHONY-1s and for us. It's a large randomized global trial. So there's a fair amount of expense there. And as part of our agreement, Hutchmed has agreed to pick up both portion of that for the patients that are enrolled in China. So - and that's not an insignificant amount, although that's not the majority of patients as Shefali said.

Shefali Agarwal: And I just want to add to that is, the SYMPHONY-1 Phase III is open. It's open now in many sites in US, ex-US, we are screening patients and globally enrolling. We are really working very hard to get this trial enrolled as quickly as possible.

Unidentified Analyst: Wonderful. Thank you for your time. I appreciate it.

Grant Bogle: Thank you.

Operator: Thank you. [Operator Instructions] I'm showing no further questions in the queue at this time. I'd like to turn the call back to Mr. Grant Bogle, CEO, for closing remarks.

Grant Bogle: Thank you, Ben. This is very helpful. And I want to thank everybody for joining us today. We're available for follow-up calls as needed. I would also like to point out that we have revised and updated our corporate debt, which is now on the website, I encourage you to download it. And of course, this meeting will be recorded as well and posted shortly. So with that, I thank you, and I hope everybody has a great rest of the day.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.