Q4 2022 BioCryst Pharmaceuticals Inc Earnings Call

Speaker 1: The.

Speaker 2: Good morning and welcome to the BioChrist Fourth Quarter 2022 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

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Speaker 2: I would now like to turn the conference over to John Bluth at BioCRISP. Please go ahead.

Speaker 3: Thanks Andrea, good morning and welcome to BioCris Fourth Quarter in your end 2022 corporate update and financial results conference call. Today's press release and accompanying slides are available on our website. Participating with me today are CEO John Stonehouse, CFO Anthony Doyle, Chief Commercial Officer Charlie Gyer, and Chief R&D Officer Dr. Helen Thackray. Following our remarks, we'll answer your questions.

Speaker 3: Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results on audited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance, or achievements.

Speaker 3: to be materially different from any future results or performance expressed or implied in this presentation. You should now place undue reliance on these forward-looking statements. For additional information including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I'd now like to turn the call over to John Stonehouse.

Speaker 4: Thanks, John . 2022 was another outstanding year for Ledeo as we doubled sales in our second full year of launch on top of the fantastic start we had in the first year.

Speaker 4: It shouldn't be surprising given the excellent safety, efficacy, and one's daily oral profile.

Speaker 4: we are consistently hearing from patients that Orla Deo is changing their lives.

Speaker 4: As you will hear from Charlie, in the US our prescriber base continues to grow both in breath and depth.

Speaker 4: In addition, Orla Deo is already commercially available to HAE patients in 15 countries around the world.

Speaker 4: The ability of Orla Deo to deliver meaningful results for patients is driving the steady patient growth we are seeing quarter after quarter. And in 2023, we expect this strong steady demand to continue.

Speaker 4: leading to the global sales of no less than $320 million.

Speaker 4: Our goal with this guidance is very simple, to be accurate.

Speaker 4: Accurate guidance has been our track record since launch because we're the only ones with access to the prescription data through our sole source specialty pharmacy.

Speaker 4: With our sales performance in 2021 and 2022 and our guidance in 2023, you now have three data points to get a sense of the slope of the Orlidaeo launch. We are on a trajectory to achieve peak global sales of $1 billion in our IP for Orlidaeo extends out to 2039, so we expect to be at peak sales for many...

Speaker 4: financial position moved us closer to profitability.

Speaker 4: You will hear more detail on this from Anthony shortly.

Speaker 4: Now I'll turn the call over to Charlie to review Orla Day of Performance in More Decorating.

Speaker 3: you to. Thanks John . The base of patients treated with Orlodale in the United States continue to grow as expected in the fourth quarter as new patient starts and patient retention remain consistent with the trends we have seen over the last two years.

Speaker 5: The prescriber base expanded strongly again, and existing prescribers continue to add new prescriptions.

Speaker 5: New starts on Orla Dayo were also distributed evenly, with just over 50% coming from the top tier of healthcare providers, who treat half of all HAE patients.

Speaker 5: As we begin 2023, we have confidence that we will achieve no less than $320 million in global revenue this year.

Speaker 5: Our US field team expansion is in place and patient growth trends are on track.

Speaker 5: Our European growth is also gaining momentum, and we continue to lay the foundation for Orlodeo Extension globally.

Speaker 5: And this weekend we will present more long-term clinical and real-world evidence at the QuadAI meeting. Adding to the growing body of evidence showing how Orlidaeo can improve the lives of patients living with HIE.

Speaker 5: We have noted before that typical US payer reauthorization dynamics for rare disease products like Orla Daya will soften Q1 revenue growth as many patients shift temporarily to free product.

Speaker 5: What we are seeing so far this year tells us that Orla Deo revenue is likely to be flat to slightly down compared to Q4, even as our patient base continues to grow.

Speaker 5: We ended 2022 with a total number of patients on Orlodale that we expected, and the patient growth trends we see in the U.S. and around the world give us confidence, not only in our 2023 trajectory, but also that Orlodale peak revenue will reach a billion dollars.

Speaker 5: I'll turn the call over to you.

Speaker 2: Thanks, Charlie.

Speaker 2: Today, I'd like to provide some additional updates on the next steps with BCX10-013, our potential once daily factor D inhibitor for complement mediated diseases.

Speaker 2: We shared last month the initial data from our phase one single ascending dose and multiple ascending dose trials in Healthy Volunteers showed rapid, sustained, and greater than 97% suppression of the alternative pathway of the complement system 24 hours following a single 110 milligram dose.

Speaker 2: And, BCX10-013 has been safe and generally well tolerated at all doses studied to date in the clinic.

Speaker 2: These data provide early support for the development of BCX10013 and we believe this product has the potential to be a differentiated, once daily oral, factory, and inhibitor for multiple complement mediated diseases.

Speaker 2: The next key staff and clinical development is dose ranging work in patients with the goal of confirming optimal dosing for pivotal studies.

Speaker 6: The non-clinical program helps us to assess the safe dosing range we can evaluate in humans.

Speaker 6: Recently, we have seen emerging dose-related observations early in an ongoing chronic nonclinical study.

Speaker 6: which were not seen at the same time period in a separate already completed study.

Speaker 6: We need to understand the full picture of these differences as we complete the currently ongoing study. We need to understand the full picture of these differences as we complete the currently

Speaker 6: In the meantime, as a result of these observations, the pace at which we can evaluate higher doses in humans to assess efficacy will be slower, and we expect a related delay in the timeline.

Speaker 6: So, in order to progress towards clinical selection, we'll continue working to understand what we're seeing in the ongoing nonclinical program, and we'll keep you posted on our progress.

Speaker 6: In addition to 10.013, we are making progress with our research programs to identify oral medicines directed at other targets across the classical, lectin, and terminal pathways of the complement system, including C2, which is a critical upstream serine protease enzyme for activation of the classical, lectin pathways.

Speaker 6: As reported in January , we have developed potent selective molecules targeting C2 and these are currently in the lead optimization stage.

Speaker 6: Our long-term goal is to bring multiple novel orally delivered products forward to treat many complement-mediated diseases.

Speaker 6: Now I'll pass it to Anthony.

Speaker 7: Thanks Alan.

Speaker 3: You can find a detailed fourth quarter and urine financials in today's earnings press release and I'd like to call your attention to a few items

Speaker 5: Total revenue for the year came in at $271 million, over $250 million of which came from Orladeo in just its second year since launch, more than doubling net revenue from the prior year.

Speaker 5: Revenue for the fourth quarter was 79.5 million of which 70.7 million came from net sales of Orla Dale with the remainder coming from sales of RapaVab including the fulfillment of the last of our contract government stockpile orders.

Speaker 5: Operating expenses, not including non-cash stock compensation for the quarter, were $110.6 million. This puts full year off-ex at $374.6 million. The increase compared to prior guidance was driven by almost $10 million of accelerated costs.

Speaker 5: related to closeout activities for the termination of 9930 and 9250 programs.

Speaker 5: cash at the end of the year was up 444 million dollars.

Speaker 5: Earlier in the year we provided guidance for 2023 or Lidar revenue of no less than $320 million. For OpEx we expect 2023 to be flat to prior year at around $375 million.

Speaker 5: We previously stated that 2023 R&D investment would be in line with prior year. We're now forecasting that R&D expenses will decrease year-over-year following the discontinuation of the 99.30 and 92.50 programs and the delay in the 10.0.13 clinical program that Helen described.

Speaker 5: This will be all set by additional commercial investment that we're making both here in the US.

Speaker 5: and as we continue our international expansion.

Speaker 5: As our Revenue and OpEx curves continue to converge, we expect net cash utilization in 2023 to decrease compared to 2022, even when factoring in debt and royalty servicing.

Speaker 5: The combination of our strong balance sheet, increasing revenue and our disciplined approach to capital allocation puts us in an outstanding financial position with an ever-decreasing reliance on the capital markets for funding.

Speaker 5: Now operator, we'll be happy to open up the Q&A.

Speaker 2: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad.

Speaker 2: If you are using a speakerphone, you will need to pick up your handset before pressing the key.

Speaker 2: To withdraw your question, please press store then 2.

Speaker 2: At this time we will pause momentarily to assemble our roster.

Speaker 2: And our first question comes from Jessica Fye of J.P. Morgan. Please..

Speaker 2: from Jessica Fai of J.P. Morgan. Please go ahead.

Speaker 8: Great. Good morning, guys. Thanks for taking my questions. Two for me. I guess first, what else can you share with us about the dose-dependent finding with 10.013? And second, what else can you share with us about the dose-dependent finding with 10.013?

Speaker 8: Maybe a new one's here, but if I recall, the healthcare conference, you indicated that one Q revenue would be roughly flat with 4Q, I think now you're saying flat to slightly down. Does that just mean we should think of 4Q revenue as being even higher than it would have been otherwise, or does that take a little bit of the buffer out of whatever?

Speaker 6: we did not see at a time point in our other completed study.

Speaker 6: The impact then is that we want to learn more about the safe range of exposure and we need to understand this difference.

Speaker 5: And just as far as the Q4 and Q1 revenue, so this is not a Q4 being bigger than it should be. It's really based on what we're seeing out there with Q1 reauthorizations. It's always a challenge every year. And what we're seeing is that this year it's just.

Speaker 5: this isn't an Orland-AO specific thing, just broadly, the reauthorization process is just more work than ever. And so that's why we think it could be a little bit down or flat to Q4, but patient growth trends are on track and no less than 320 million is very much on track. Yeah, and that part's really important to remember that.

Speaker 2: The next question comes from Tazeen, on the note of Bank of America.

Speaker 2: Hi guys, good morning and thank you for taking my question. On Orla Deo, John , I'm just wondering, what do you think could change in order for sales to be above the minimum that you have just guided to for this year? So outside of negotiating with payers, where else would you see sales to be going?

Speaker 4: you know if Charlie's team is more successful than we had planned around getting patients from free drug to paid drug, he's got this expansion, mini expansion that they went through late last year, maybe that has more of an uptick you know on revenue as well, those could be things that that could be a lift.

Speaker 2: Okay, great. And then maybe one question on 10013. I think you had previously highlighted that there was no crystallization toxin before in your pre-Klin models. Is that still the case? Okay, that didn't take long.

Speaker 4: Yeah, this is very different than the 99... Your question is around 9930 comparisons to 10013, is that... Yeah. Yeah. Yeah, that's very different from that.

Speaker 9: Okay, thank you. You're welcome. Welcome.

Speaker 2: The next question comes from Chris Raymond of Piper Sandler. Please go ahead.

Speaker 4: Thanks, and if you don't mind me beating the dead horse here.

Speaker 10: I don't want to answer a ton of questions on exactly what you saw, but I guess I'll just ask

Speaker 10: 10-013, when would you be in a position to tell us exactly what you found and what's the path forward and the next steps for when the issues will be resolved?

Speaker 10: And then on the C2 program, you know, I know you described this as a program that's in development, but can you maybe give a little bit more color, maybe on the timeline, pathway to be in the clinic on that program?

Speaker 10: You know, you describe this as a program that's in development, but can you maybe give a little bit more color maybe on the timeline pathway to be in the clinic on that program? Yeah, I'll take the second one.

Speaker 4: can take the first one. So what we said in January is the C2 programs and lead optimization and you know it's hard to predict when it'll get into tox and and you know phase one studies but it's its lead optimization now once we pick a lead we'll go into tox and move forward from there but we can't give timing on that right now.

Speaker 4: And the first question's around...

Speaker 6: On 10-13, what we're saying is that we're seeing something that is different. We're seeing it at the same time point where we didn't see it before. What that means is that we need to learn more. We need to learn more about that difference, and we need to learn more about the nature of what we're seeing.

Speaker 6: The goal here is to understand the safe range of exposures, and that's the point of the nonclinical work at this point. The goal in the clinic is then to understand the effective dose in patients. And so our next steps are to complete the nonclinical study and understand what we can from there, also to go on and wh transit to the clinic. We'll hear from terrorists next year,

Speaker 6: into the studies and patients that we've been planning and assess the dose in patients and get to an understanding both of what is the safe range and what's the effective range for this dose so that we can define the dose and take it forward into the physical programs.

Speaker 4: Yeah, Chris is an ongoing chronic talk study right now and so until we're complete that's hard to give you some sense of when we'll.

Speaker 4: non-going chronic talk study right now and so until we're complete that's hard to give you some sense of when we'll you know have a better picture.

Speaker 11: Thank you.

Speaker 2: The next question comes from Lisa Baker of Evercore ISI. We go ahead.

Speaker 12: Hi there. Thanks for taking the question. Can you give us a sense of the degree of free drug and sort of gross to nuts and where you're at for the beginning of 2023?

Speaker 5: Sure Lisa overall what we said is

Speaker 5: all what we said is...

Speaker 5: that based on our contract status, we expected at least 80% of patients to be on paid drug, 20% on free. In recent quarters, we've seen that tick up above 20%. And then in Q1, it's just a larger portion that will temporarily pretty much.

Speaker 5: all the patients are going through reauthorization in Q1 and so a lot of them step back very temporarily to free product. So overall that plus the fact that we also have the impact of commercial copay assistance is the greatest in Q1 Medicare donate hold payments. You're going to see the lowest, the worst growth growth to net in the first quarter. Yeah. And then it'll...

Speaker 5: What the emphasis was? Yeah, so the basic, the essence of that was we expanded the number of sales regions. It was not a major Salesforce expansion, but we made our region smaller, so added more regional managers so that they can work closely with their teams as well as some of the top KOLs.

Speaker 5: Then simultaneously we also added more to our market access team and our patient access specialist teams so that we can do more to work with customers and particularly patients to help them get to paid therapy.

Speaker 12: Okay, thanks. And then just follow up to Chris's question. there.

Speaker 12: Are you when will you get when are you going to complete this some chronic preclinical talk study?

Speaker 13: There will be some time this year.

Speaker 12: Okay, and in any sense, do you think this might be something specific to the species and like what species have you been looking at?

Speaker 12: Okay, and any sense, do you think this might be something specific to the species and like what species have you been looking at? That's a really good question that we don't have an answer to.

Speaker 12: Okay. Can you mention the species just for a... Yeah, not at this time.

Speaker 12: Okay, okay. And then just a final question for me. Are you able to get clinically into what you think is an efficacious dose range? Or as you described, going more slowly now and kind of your dose escalation?

Speaker 4: Are you are you going to be kind of capped below what you think is the target efficacious dose? Our hope is that we get to a effective dose in a safe range.

Speaker 4: I don't think we can answer that question today, given what we're seeing, but that's the hope.

Speaker 6: And I would add we already know from the data that we presented in January that we're seeing you know excellent suppression of the alternative pathway of compliment at 24 hours already with the dose that we've

Speaker 6: been evaluating healthy volunteers. So we have more to learn about the range, but we're encouraged with that information.

Speaker 6: and healthy volunteers. So we have more to learn about the range, but we're encouraged with that information. Okay, thank you.

Speaker 2: Welcome. The next question comes from John Wollin of JMP Securities. Please go ahead. The next question comes from

Speaker 10: Hey, thanks for taking the question. Just a couple on Orla Deo. I wonder if you could tell us what the quarter over quarter patient growth was in the fourth quarter and then with regards to the $320 million guidance, what's the breakdown between US and ex-US contribution there?

Speaker 5: Sure, John . We haven't specified the growth. What I can say is we are on the same trends, both in terms of new patient acquisition that we've seen over the last many quarters, and also our discontinuation rate has been very stable. So what that means is that every quarter we're going to have to be able to

Speaker 5: we're growing nicely and that's what gives us so much confidence in the $320 million this year and the long-term projections to a billion dollars. And yeah, I think in terms of contribution from from you, the way I think about it, Joan, is the US continues to be the majority of revenue.

Speaker 7: the US and from a global expansion perspective.

Speaker 11: That's very helpful. Thank you.

Speaker 2: The next question comes from Ken Cassiatore of Cowan & Company. Please go ahead.

Speaker 5: Hey team, good morning. Obviously it's been a fantastic launch of Orla Deo. You've set up a great US commercial infrastructure that would seemingly be attractive to many companies either don't have a US infrastructure or would want some further leverage. I'm guessing just looking at the P&L the product's now profitable which is a credit to the organization excluding R&D.

Speaker 5: unfortunately over time here, kind of an organization that's a little bit in two separate worlds. Can you just talk about that, how you think about maximizing that value and maybe kind of just strategically what you all are thinking? Thanks so much.

Speaker 4: Yeah, thanks Ken. You know, we agree with you that it's off to a fantastic launch and have a real high degree of confidence that we're getting to the billion dollars in peak sales and we're on that trajectory. So and that it's you know on a standalone basis. It's profitable today and I even said in

Speaker 4: prepared remarks that you know with the investment that we're making we're getting closer to profitability because revenue is growing faster than expense basically. So anyway I think...

Speaker 4: you know, we're always looking at the goal here is to have a second product that's as big or bigger than Orla Deo. That may take us longer, you know, with our pipeline and so we're also evaluating BD activities as well. We brought Clayton Fletcher on board recently, who's a very experienced biotech BD person and you know, we're probably getting

Speaker 2: The next question comes from Justin Kim of Oppenheimer. Please go ahead.

Speaker 14: Hi, good morning. Thanks for taking the question. Just with the upcoming QuadAI meeting and based on the recent commercial progress, is there anything that needs to be better clarified with the prescriber-based independence? Just wondering sort of what your goals are and any changes in the dynamic of where transcripts are coming from.

Speaker 14: either from a patient perspective or clinician. Hey Justin, so.

Speaker 5: You know, I think as far as clarified, we're just continuing the messages that we've been delivering about how well Orla Dayo is working in patients, particularly over the long term. You look at our long-term data, our 96-week data, where patients were getting down to 16 out of 17 months attack-free. What we'll see at Quad AI is more data of the same coming out from clinician...

Speaker 5: who do absolutely the best on Orlodale are those who switch from other prophylaxis products that were already stable on those other products, they switched to Orlodale and they continue to do really well with very good HAE control. So that, it's sort of a long-term building of that and there are lots of doctors who already get that and then there are others who just haven't absorbed that message yet and we're confident that we're gonna

Speaker 4: I think part of Charlie's expansion, where we're having the regional business directors focus on KOLs is to get those potential high prescribers to start to break through even further, get the ones that haven't prescribed and the ones that have to prescribe more.

Speaker 14: I guess I'm just sort of curious in terms of your views on the long-term growth trajectory, is that mix of where the script's coming from expected to change, whether, you know, between the 500 and non-500 base, I mean, just trying to

Speaker 14: understand if that split of 50-50 is expected to continue and sort of for how long.

Speaker 5: I think that's a good question. First of all, I'm really happy with that balance because what it shows is that we're reaching all parts of the market and we're growing in both segments. So we're constantly expanding the number of top 500 doctors who are new Orlodale prescribers and then we're seeing them.

Speaker 5: once they do go deeper into their list. And then that next thousand or so doctors, we're expanding into them as well. So there's, what it tells me is there is a lot of opportunity left in front of us, both amongst what HCPs can do, and then the number of patients that still haven't experienced the benefit of Orla Dayo.

Speaker 4: And our goal long term is to give every patient who needs to be on prophylaxis a chance to try Orlodio because most of them are going to do really well. Yeah, I think there's two really interesting pieces of evidence that we're going that direction to. One is quarter to quarter we're expanding the prescriber base and the second is the market research.

Speaker 4: quarter after quarter after quarter says that docs are going to prescribe more in 12 months than they're currently prescribing. And that's a combination of people who have not yet prescribed that will in the future or those that are prescribing that will prescribe more. So those we think are two really encouraging pieces of data that give us a lot of confidence it's going to keep growing.

Speaker 11: Thanks so much. Welcome. Welcome.

Speaker 2: The next question comes from Brian Abrams of RBC Capital Markets. Please go ahead.

Speaker 5: Hi, good morning. Thanks for taking my questions. You guys have talked about a recent slower conversion from free drug to paid commercial drug in fourth quarter and of late. And I just want to better understand this trend. Do you think this is reflecting

Speaker 5: just expanding to new physicians who are maybe less used to prescribing Rolodale, and are there ways to help educate those physicians about how to process the necessary paperwork? Or is there anything different about these patients? Either they have milder disease or are on prior prophylaxis or have different types of insurance plans that may be contributing to this greater lag time.

Speaker 11: proceed. Thanks.

Speaker 5: I'll take the first question, Brian . Yeah, so it's really much more the first thing you said. So as we're expanding to less experienced prescribers within the HAE space, it's work to get any drug, whether it's Orlodia or any other HAE therapy, approved by insurers.

Speaker 5: It's not a contracting issue. It's really about providing all the information, the lab tests, the clinical history, the complete information that payers want to see before approving any treatment for HAE. And so that's a big part of the team expansion that we've described. So we have more people out there to help.

Speaker 5: with this process to get patients to paid therapy. And it's really about having a very complete prior authorization and reauthorization to make sure that we help them give all the information that the payers need. So I'm actually with what I'm seeing, I'm confident that we are going to make great improvements in this ratio of paid to...

Speaker 5: It's not all going to be in Q1. This is going to be a year-long process, but I think we are very much on the right track.

Speaker 6: Helen, you want to take the 10-013? Yeah, so the question on 10-013. So this is the nonclinical information we're reporting today. This is an ongoing study, and so we still have more to learn here. We always are in close touch with regulators over what's coming and what data comes in programs with nonclinical and clinical.

Speaker 6: We have differed the higher dose levels in our healthy volunteer study until we learn more about this information, but we do still plan to go forward into patients and to take the drug, you know, at the therapeutic range into patients to understand their. What we're saying is that as a non-clinical data informs your understanding of the range

Speaker 5: It's all about the other things that I described, just giving the doctors, or sorry, giving the plans the information that they need. And remember, half of our patients since launch have been patients switching from other PROFII products. So it's really, it's not about the patient mix.

Speaker 14: That's really helpful. Thanks, Charlie. Thanks, Helen. Appreciate it.

Speaker 2: The next question comes from Marie Ray Croft of Jeffrey. Please go ahead.

Speaker 3: Hi, good morning, and thanks for taking my questions. I was wondering for Quad AI later this week if you can provide some preview around observed similarities or differences in treating pediatric HAE patients and remind what the SNDA timeline could look like and how does the pediatric opportunity fit into your $1 billion in peak sales estimate.

Speaker 5: Sure. So, where we are with our pediatric clinical trial is it's open, it's enrolling. It will take a little time to get that fully enrolled until we get to the SNDA.

Speaker 5: But what we're seeing and one thing that we'll present this week at Quad AI is just the overall burden of treatment and of HAE identified by both caregivers, parents and patients.

Speaker 5: And one thing we hear over and over again is

Speaker 5: when a kid has symptomatic HAE.

Speaker 5: Sometimes the treatment, if it's injectable, can be almost worse than the attacks themselves. It can be really traumatic for kids to have regular injections or infusions. And so there's just real demand for an oral therapy.

Speaker 5: to help these kids. And so we have, long term, we think that this is gonna be, it's not so much about the number of patients treated, it's about the fact that we're gonna be able to make the lives better for a lot of these kids. And then of course it's a genetic disease, so.

Speaker 5: we see typically families will often use the same types of products. And so it gives us an opportunity to kind of tell the Orlodale story to a complete family, which we're really looking forward to. I think the other thing, Maury, is the formulation that we have for this is, we used to call it mini-tabs, what do we call it, granules now.

Speaker 4: But it's like sprinkles that you put on a cake almost it's that size and so you know Asking a little kid to take a capsule is a difficult thing, too So we've come up with a formulation that you could put on applesauce on Yogurt and just make it way less traumatic

Speaker 4: you know, along the lines of what Charlie was describing, and that'll be huge. And then, this is a patient for life, right? And so, it's not a huge market, but we think it's an important one, and we think, you know, these are customers that we could have for a very long time. Got it, that's helpful and makes sense. Maybe one of the...

Speaker 7: Yeah, so it's factored in what the way to think about OPEX for the year, so flat year over year, but what we said is that commercial expenditure is going to increase based on

Speaker 7: The additions that Charlie has talked about predominantly here in the US as well as expansion from a global perspective, given that we're now in 15 countries and we'll be going to more.

Speaker 7: For R&D, the delay is factored in.

Speaker 7: depending on what we see on an ongoing basis, that may change when we get more information. And we'll update that later in the year, but yes, it is currently factored in. And what we said about R&D is it's going to decrease year over year anyway.

Speaker 7: When we were talking about this about a quarter ago, we said it was gonna be flat, but now we're saying it's gonna be down, but offset by the commercial investment that we've seen. And then most importantly, with revenues increasing.

Speaker 7: and then seeing that flattening of the OPEX line and the convergence of those two lines, the net cash utilization and what that means as we move towards profitability, I think has a lot of value for the company.

Speaker 7: that flattening of the OPEX line and the convergence of those two lines, the net cash utilization and what that means as we move towards profitability I think has a lot of value for the company. Got it. Thanks for taking my questions.

Speaker 2: The next question comes from Jenna Lang of Barclays. Please go ahead.

Speaker 2: Thank you for taking my questions. The first one is regarding 10013. So just want to confirm, is it fair to say that we should not expect the FDA clinical hold regarding this program? And then my second question is regarding the OLADAYU.

Speaker 2: In early January , you mentioned that the retention rate is about 60%. Can you clarify if that is one year or three months retention rate? And also, do you expect a similar retention rate maintaining in 2023?

Speaker 6: So the first question on 10.013, we're not on clinical hold with this program. It's also difficult to say what will happen in the future. So... you

Speaker 5: That's where we are today. As far as the patient retention, Gina, yeah, 60% was at one year. And we would expect, what we're seeing in the overall retention rate is it's really stabilizing out. And so that's part of our confidence to less than $320 million this year.

Speaker 5: And so we'd expect the same retention trends overall in 2023.

Speaker 5: we'd expect the same retention trends overall in 2023. Thank you.

Speaker 2: Our last question comes from Rohit Basian of Needham & Co. Please go ahead. Okay slash.

Speaker 5: Hi, this is Robert on for Serge. Thanks for taking our questions. Just in terms of peak sales estimates, do you still expect about 20 to 25% to come from XUS territories? And can you talk about your expectations for the long-term competitive landscape for a day? Sure, we do. Thanks. I'm going to be taking sure. Hey, Robert. So absolutely. So when we talk about...

Speaker 4: to the competitors, you know, it's a pretty crowded space, but with regard to oral specifically, it's been challenging for some to advance their programs. And so what that means for us is we have more time to get people to try our drug and see if it works for them. And what we've learned in the marketplace is to get people to switch. There's got to be some meaningful benefit.

Speaker 4: that they're not seen with the drug that they're on. And it can't be efficacy, because if you're on our drug, you're controlled. If you're not controlled, you're not staying on our drug.

Speaker 4: So that goes for injectables as well. And I think a tailwind that we're curious, Charlie has pointed this out multiple times, but we'll be curious to see is, as new products come to market, if a physician is saying, ''Hey, maybe I'll switch from one injectable to another.'' Why wouldn't they try an oral first? And then if it didn't work for that patient, they'll switch to the new injector.

today's presentation and you may now disconnect.