Q4 2023 Mirum Pharmaceuticals Inc Earnings Call
Good afternoon, ladies and gentlemen, thank you for joining today's mirror pharmaceuticals with reports Q4 year end 2023 financial results and provides a business update.
Operator: Good afternoon, ladies. Thank you for joining today's Mirum Pharmaceuticals Reports Q4 Year-In-2023 Financial Results and Providers. My name is Tia, and I will be your moderator for today. All lines will be muted, with an opportunity for questions. If you would like to ask a question, please press star 1.
Tia: My name is Tia and I'll be your moderator for today's call.
Tia: All lines will be muted during the presentation portion of the call with an opportunity for questions and answers that began.
Tia: If you would like to ask a question. Please press star one on your telephone keypad.
Andrew Mckibben: It is my pleasure to welcome you to another edition of The Real Housewives of New York, vice president of investor relations. Thank you, and good afternoon, everyone. I'd like to welcome you to Mirum Pharmaceuticals' fourth quarter 2023 conference call. I'm joined today by our CEO, Chris Peetz, our President and Chief Operating Officer, Peter Radovich, our Chief Scientific Officer and Head of Research, Pam Vig, our Chief Medical Officer, Joanne Kwan, and Eric Bjerkholt, our Chief Financial Officer. Earlier today, Mirum issued a news release announcing the company's results for the fourth quarter and full year 2020. Copies of this news release and SEC filings can be found in the investor section of our website. Before we begin, I'd like to remind you that during the course of this call, you will be making certain forward-looking statements about Mirum and our programs based on management's current expectations, including statements regarding current and future business plans, development programs, regulatory expectations, strategies, prospects, market opportunities, and financial expectations.
Tia: It is my pleasure to pass the call over to Andrew Mckibben, Vice President of Investor Relations and Finance. Please proceed.
Andrew Mckibben: Thank you and good afternoon, everyone I'd like to welcome you to Mirror Pharmaceuticals fourth quarter 2023 conference call I'm joined today by our CEO Christie for President and Chief operating Officer, Peter Rabbit.
Andrew Mckibben: Our Chief Scientific officer, and head of research and our Chief Medical Officer, Joanne Quan, Eric vehicle, our Chief Financial Officer.
Andrew Mckibben: Earlier today <unk> issued a news release announcing the Companys results for the fourth quarter and full year 2023 copies of this news releases SEC filings can be found in the investors section of our website.
Andrew Mckibben: Before we begin I'd like to remind you that during the course of this call we will be making certain forward looking statements about miramar programs based on management's current expectations, including statements regarding current and future business plans development programs and regulatory expectation strategies prospects market opportunities and financial expectations <unk> is under no duty to update these statements.
Andrew Mckibben: Mirum is under no duty to update these statements, and they are subject to numerous risks and uncertainties, and actual results could differ materially from those results anticipated by these statements. Investors should read the risk factors set forth in Mirum's 10-Q for the quarter ended September 30, 2023 and the subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris.
Andrew Mckibben: And they are subject to numerous risks and uncertainties and actual results could differ materially from those results anticipated by these statements.
Andrew Mckibben: Investors should read the risk factors set forth 10-Q for the quarter ended September 32023, and the subsequent reports filed with the SEC, but that said I would like to turn the call over to Chris Chris.
Christopher Peetz: Thanks, Andrew. And good afternoon, everyone. I'm excited to kick off an update on the many achievements for Mirum in 2023, another year of significant growth for us, and cover highlights for what lies ahead for the company. Our continued progress in 2023 and opportunity ahead reflect the dedication of the Mirum team to making a difference in the lives of patients and their families around the world. Over the year, we transformed our business with a broadened reach to patients in the U.S. and internationally, achieving This was driven by continued strong growth for Livmarly and the expansion of our commercial portfolio with the acquisition and integration of Kienadal and Colvon.
Chris: Thanks, Andrew and good afternoon, everyone.
Chris: Excited to kick off an update on the many achievements for Maryland 2023, another year of significant growth for us and cover highlights for what lies ahead for the company.
Chris: Our continued progress in 2023 and opportunity ahead reflects the dedication of the Marin team to making a difference in the lives of patients and their families around the world.
Chris: Over the year, we transformed our business with a broadens our reach to patients in the U S and internationally, achieving a $179 million and net product sales.
Chris: And 142% year over year growth in total revenue.
Chris: This was driven by continued strong growth for <unk> barley, and the expansion of our commercial portfolio with the acquisition and integration of came at all and cobalt.
Chris: We have now built a growing self sustaining leading rare disease business that is positioned for a great 2024 and beyond.
Christopher Peetz: We have now built a growing, self-sustaining, leading rare disease business that is positioned for a great 2024 and beyond. The last year has shown the value creation potential of our strategy, driving growth in our commercial medicines, unlocking the potential of upcoming label expansion opportunities, leverage our expertise in cholestasis in adult settings, and continue to grow the pipeline. Looking at the year ahead for execution on our strategy overall from the current commercial business, we expect to achieve $310 to $320 million of net product revenue in 2024.
Chris: The last year has shown the value creation potential of our strategy to drive growth in our commercial medicines unlock the potential of upcoming label expansion opportunities leverage our expertise in cholestasis and adult settings and continue to grow the pipeline.
Chris: Looking at the year ahead for execution on our strategy overall from the current commercial business, we expect to achieve $310 million to $320 million of net product revenue in 2024.
Christopher Peetz: This is expected to be driven by growth across all three commercially available medicines. We also have multiple regulatory and clinical catalysts this year to advance our pipeline. For LeMarley and Pfeffig, we are on track for our PDUFA date on March 13th.
Chris: This is expected to be driven by growth across all three commercially available medicines.
Chris: We also have multiple regulatory and clinical catalysts this year to advance our pipeline.
Chris: For <unk>, we are on track for our producer date on March 13th.
Christopher Peetz: We're excited for the opportunity to bring the strong results of the March PFIC Phase 3 study to patients with potential label exposure. We're also preparing for the submission of the Positive Restore Phase 3 results of Kynadol and PTX in the first half of the year, an important label-enabling opportunity. And we've also made great progress with the VISTAs and Vantage studies for Velixibat and PSV and PD. Patients for the interim analyses have been enrolled, and we expect to conduct a dose selection interim analysis of these adaptive studies in the first half of the year.
Chris: We're excited for the opportunity to bring the strong results of the March perfect Phase III study to patients with the potential label expansion.
Chris: We're also preparing for the submission of the positive restore phase III results are keen at all in CTX in the first half of the year and important label, enabling opportunity and.
Chris: And we've also made great progress with the Vista and vantage studies for <unk> and PSC in PBC.
Chris: Patients for the interim analysis had been enrolled and we expect to conduct a dose selection interims of these adaptive studies in the first half of the year.
Christopher Peetz: We see the PSE program as an opportunity to bring the first ever therapy to market for this progressive, burdensome disease. I'm proud of all of our progress in 2023 and the potential ahead. We look forward to continuing to grow the impact of our programs, providing life-changing medicines to patients with rare diseases. Now, before I turn the call over to Peter to discuss our commercial business, I wanted to welcome our new chief medical officer, Dr. Joanne Kwan, who joined Mirum in January. We are thrilled to have Joanne and her extensive leadership and scientific expertise helping to drive the value creation we see ahead for Mirum. We'll hear from her later on in this call. And for now, I'll turn the call over to Peter to discuss our commercial business. Peter?
We see the PSC program as an opportunity to bring the first ever therapy to market for this progressive burdensome disease.
Chris: I am proud of all of our progress in 2023 and the potential ahead from here.
Chris: We look forward to continuing to grow the impact of our programs, providing life changing medicines to patients with rare disease.
Speaker Change: Before I turn the call over to Peter to discuss our commercial business I wanted to welcome our new Chief Medical Officer, Dr. Joanne Quan, who joined <unk> in January we are thrilled to have Joanna and her extensive leadership and scientific expertise helping to drive the value creation, we see ahead for Miriam.
Peter Radovich: We will hear from her later on this call.
Peter Radovich: And for now I'll turn the call over to Peter to discuss our commercial business here. Thanks.
Peter: Thanks, Chris.
Peter Radovich: We are excited about the tremendous progress that we have made across our U.S. and international business. Coming off of 2023, where we saw 138% growth in total net product sales compared to 2020. We are already seeing the benefits of our newly expanded pediatric hepatology franchise and enhanced offering amongst the patient and prescriber. I'm proud of the Marin team's focus on..., while simultaneously driving the seamless integration of Colvon and Pinochet. And this is evident in the $69.6 million of total net product sales we achieved in the fourth quarter of 2023, which reflected growth across all three commercial networks. For Liv Marley, total global net product sales grew to $41.4 million in the fourth quarter.
Peter: We are excited about the tremendous progress we've made across our U S and international businesses coming off of 2023, where we saw 138% growth in total net product sales compared to 2022.
We are already seeing the benefits of our newly expanded pediatric herpetology franchise and enhanced offering amongst the patients and prescriber community.
Peter: I am proud of the team's focus on patients while simultaneously driving the seamless integration of cobalt we've seen it all.
Peter: And this is evidenced in the $69 6 million of total net product sales, we achieved in the fourth quarter of 2023, which reflected growth across all three commercial medicines.
Peter: So although modestly total global net product sales grew to $41 4 million in the fourth quarter.
Peter: Our U S business saw $31 4 million and $111 million for the quarter and year, respectively, representing approximately 63% year over year growth.
Peter: And internationally, we are seeing consistent strong uptake as well, but we continue to anticipate over quarter variability in international weapons.
Peter Radovich: Our U.S. business saw $31.4 million and $111 million for the quarter and year, representing approximately 63% year over year. And internationally, we are seeing consistent, strong uptake as well. So we continue to anticipate order of quarter variability in international weather.
Peter: Moving on to <unk>, the fourth quarter was the first full quarter with these two medicines under <unk> leadership.
Peter: I'm very happy with how quickly we have been able to transition these medicines into our business.
Peter: In the fourth quarter, we recognized net product sales of 28, $28 1 million the highest quarter to date for the biologic products and looking ahead, we expect steady growth for these two medicines in line with historical trends.
Peter Radovich: Moving on to Kingdall and Colbaugh, the fourth quarter was the first full quarter with these two medicines under Mirum's leadership, and I'm very happy with how quickly we have been able to transition these medicines into our business. In the fourth quarter, we recognized net product sales of $28.1 million, the highest order to date for the bioassay product. And looking ahead, we expect steady growth for these two medicines and lines based on historical trends. Taking all the strong dynamics in the business together, we expect net product sales to be 310 to 320 million in 2024.
Peter: Taking all of the strong dynamics in the business together, we expect net product sales to be $310 million to $320 million for 2024.
Peter: Represents over 70% growth from 2023 with increased contribution from all commercially available medicines.
Peter: In summary, 2023 was a fantastic year for our team as we expanded our portfolio we commercial.
Peter: Products and grow our presence both in the U S and worldwide.
Peter: We continue to see the tremendous impact of all three products across their patient communities and we look forward to further expansion in 2024, as we stay committed to our mission of delivering life changing medicines to patients worldwide.
Peter: With that I'll turn it over to Joanne.
Peter Radovich: This represents over 70% growth from 2023, with increased contribution from all commercially available products. In summary, 2023 was a fantastic year for us, as we expanded our portfolio to three commercial products and grew our presence both in the U.S. and worldwide. We continue to see the tremendous impact of all three products across their patient communities, and we look forward to further expansion in 2024 as we stay committed to our mission of delivering life-changing medicines to patients worldwide. Joanne?
Joanne Quan: Thanks, Peter just wanted to again I'd love to sit down throughout the join Europe. This experienced team has accomplished so much in such a short period of time and I'm excited to continue the momentum and progress in the treatment of rare diseases.
Joanne Quan: 2024, looking forward to multiple regulatory and development milestones.
Joanne Quan: From a regulatory perspective, we are tracking well towards our if a date of March 15.
Joanne Quan: A decision from the EMA in the first half of the year.
Joanne Quan: Okay.
Joanne Quan: Cts, we're making good progress here as well we've.
Joanne Quan: We've had positive interactions with the FDA and no additional clinical studies are required to support our NDA submission, which is planned in the first half of 2024.
Joanne Quan: Turning to the list that we are also looking forward to our upcoming interim analysis and our visitors PSC study.
Joanne Kwan: Thanks, Peter. Before I begin, I'd like to say that I'm thrilled to join Miro. This experienced team has accomplished so much in such a short period of time, and I'm excited to continue the momentum and progress in the treatment of herpes. In 2024, we are looking forward to multiple regulatory and development models. From a regulatory perspective, we are tracking well towards our PFIC PDUFA date of March 13th and expect a decision from the EMA in the first half of the year regarding Ketadol and CKX. We're making good progress here as well.
Joanne Quan: Vantage study in PBC patients.
Joanne Quan: For the interim analysis to we got in the first half.
Joanne Quan: This year.
Joanne Quan: Now that the studies are now continuing to enroll patients with the goal of supporting registration.
Joanne Quan: As a reminder, this does PSC study will have a blinded interim analysis to support dose selection.
Joanne Quan: On the data this will allow patients from the selected dose and placebo arms to be included in the pivotal dataset.
Joanne Quan: So the larger indication of PBC study is designed so that we unwind and show the topline results from the interim analysis, which will include data on pruritus improvement change in serum bile acids and safety.
Joanne Kwan: We've had positive interactions with the FDA, and no additional clinical studies are required to support our NDA submission, which is planned in the first half of 2024. Turning to the look of that, we're also looking forward to our upcoming intramenology studies in our VISTA PSC study and our VANTAGE study in PBC patients. We are on track for the interim analysis to be adopted in the first half of this year. Note that the studies are now continuing to enroll patients with the goal of supporting registration. As a reminder, the VISTA PSC study will have a blinded interim analysis to support their selection.
Joanne Quan: Both of these studies represent an important step towards addressing the accumulation of bile acids and broader patient lives with adult cholestasis, where a significant portion of patients without adequate treatment options clinical status and severe symptomatic.
Speaker Change: I'm excited to be part of this team and look forward to sharing our progress with you this year.
Speaker Change: I'll now turn the call over to Eric to discuss our financial results.
Speaker Change: Yeah.
Thanks, John earlier today, we issued a press release that included financial results for the quarter and full year, which I'll briefly summarize.
Eric: Note. Our 10-K filing is planned for next week as our auditors to finalize the first 404, b and other audit procedures for mirrors.
Joanne Kwan: Based on the data, this will allow patients from the selected dose and placebo arms to be included in the physical data set. For the larger indication of PBC, the study is designed so that we will unblind and show the top-line results from the interim analysis, which will include data on caritas improvement, change in serum bioassays, and safety. Both of these studies represent an important step towards addressing the accumulation of bile acids in broader patient groups with adult cholestases, where a significant portion of patients are without adequate treatment options for their cholestases and its severe symptomatic burden.
Eric: Total revenue in the fourth quarter 2023 was $69 6 million and for the year ended December 31, total revenue was $186 4 million, including total net product sales of 178 9 million. This is compared to total revenues of $27 9 million.
Eric: And $77 1 million for the fourth quarter and full year 2022, respectively.
Eric: Our operating expenses for the year ended December 31 were $293 million, which includes research and development expenses of $102 6 million SG&A expenses of $145 9 million and cost of sales of $44 5 million.
Eric H. Bjerkholt: I'm excited to be part of this team and look forward to sharing our progress with you this year. With that, I will now turn the call over to Eric to discuss our financial results. Earlier today, we issued a press release that included financial results for the quarter and full year, which I'll briefly summarize. Note, a 10K filing is planned for next week as our auditors finalize the first 404B and other audit procedures for MIRA. Total revenue in the fourth quarter of 2023 was $69.6 million, and for the year ended December 31st, total revenue was $186.4 million, including total net product sales of $178.9 million. This is compared to total revenues of $27.9 million and $77.1 million for the fourth quarter and full year 2022, respectively. Operating expenses for the year ended December 31st were $293 million, which included research and development expenses of $102.6 million, For the year ended December 31st, 2023, the net loss was $160.9 million, or $3.94 per share. The net loss for the year included non-cash, stock-based compensation expense of $35 million and intangible amortization of $10.4 million.
Eric: For the year ended December 31, 2023, net loss was $160 9 million or $3 94 per share net loss for the year included noncash stock based compensation expense of $35 million and intangible amortization of $10.
$4 million.
Eric: This intangible amortization is largely reflected in our cost of goods sold.
Eric: In the fourth quarter Cogs also reflected a reserve in excess of $5 million for inventory primarily related to the bile acid acquisition.
Eric: For the year ended December 31, 23, our cash used in operating activities was $79 million down from $128 1 million in the year before we had cash cash equivalents and investments of $286 3 million as of December 31.
Eric: 2023.
Eric: We remain well funded with a strong and self sustaining business are increasing revenue base places us in an exceptional position to grow the business through clinical development and continued expansion of our global commercial presence over the coming years now.
Eric: Now I'll turn the call back over to Chris for final comments.
Chris: Thanks, Eric.
It has been a strong year for merit, finishing with the biggest ever revenue quarter for <unk> and the biologic portfolio.
Chris: We are poised for another great year in 2024, with three growing commercial products and with several clinical and regulatory catalysts as we strive to make continued advances for rare disease patients around the world.
Eric H. Bjerkholt: This intangible amortization is largely reflected in our cost of goods sold. In the fourth quarter, COGS also reflected a reserve in excess of $5 million for inventory primarily related to the bile acid acquisition. Therefore, for the year ended December 31st, 23, our cash used in operating activities was $70.9 million, down from $120.1 million the year before.
Speaker Change: Forward to keeping you updated on our exciting progress throughout the year and with that operator. Please open the call for questions.
Speaker Change: We will now begin the Q&A session.
Speaker Change: If you would like to ask a question. Please press star followed by one or you touched on key pad.
Speaker Change: For any reason you would like to address that question. Please press star followed by two.
Eric H. Bjerkholt: We had cash, cash equivalents, and investments of $286.3 million as of December 31st, 2023. We remain well funded with a strong and self-sustaining business. Our increasing revenue base places us in an exceptional position to grow the business through clinical development and continued expansion of our global commercial presence over the coming year. Now I'll turn the call back over to Chris for final comments.
Again to ask a question press star one.
Speaker Change: As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking your question.
Speaker Change: We will pause here briefly to allow questions to generate in Q.
Speaker Change: The first question comes from the line of Jessica Fye with Jpmorgan. Please proceed.
Speaker Change: Hey, this is Nick on for Jeff Congrats on the quarter and thanks for taking our questions maybe looking at the 2024 net product sales guidance of $310 million to $20 million can you maybe discuss a bit more about how much with marley growth is baked in there versus contributions from can't Oncall mom and also comment a little.
Christopher Peetz: Thanks, Eric. It has been a strong year for Mirum, finishing with the biggest ever revenue quarter for Live Moderately and the bioasset portfolio. We are poised for another great year in 2024 with three growing commercial products and several clinical and regulatory catalysts as we strive to make continued advances for rare disease patients around the world. We look forward to keeping you updated on our exciting progress throughout the year. And with that, Operator, please open the call for questions. We will now begin the Q&A, if you would like. Press Start, followed by one.
Speaker Change: On the <unk> and maybe provide an update on what youre seeing on the competitive dynamics with bill It may if any.
Yeah. Thanks for the question first just from a starting point, we're not giving product level guidance at this point, but really great dynamics across the products all at Peter.
Speaker Change: Kind of give a little color on what we're seeing across the business and I think as you think about all that.
Peter: Some of the color commentary there.
Peter: Biologic product portfolio, we expect to grow in line with historical trends.
Operator: If for any reason you would like to remove that question, please press star follow. As a reminder, if you are... We will pause here briefly to allow questions to generate. Hey, this is Nick on for Jess. Congratulations on the quarter.
Speaker Change: On the order of that.
Speaker Change: Growth.
Speaker Change: Growth rates.
Speaker Change: So tomorrow cases in the U S, which has been strong over the last.
Speaker Change: For all the quarters.
Nick: And thanks for taking our questions. Maybe looking at the 2024 net product sales guidance of $310 to $320 million, can you maybe discuss a bit more about how much Livmarly growth is baked in there versus contributions from Canadian Coal Mom?
Speaker Change: Thanks.
Speaker Change: Continue to move forward with that change and then on the international side, we do expect quarter to quarter variability.
Speaker Change: Sales.
Speaker Change: Good question.
Speaker Change: Diana.
Diana: Sure I think as you can see from the numbers here, it's really.
Diana: Measurable impacts from those at all of the.
Christopher Peetz: And also comment a little bit on Livmarly and Eligeal and maybe provide an update on what you're seeing in the competitive dynamics with Bill LeMay, if any. Yeah, thanks for the question. And first, just from a starting point, you know, we're not giving product-level guidance at this point, but really great dynamics across the product. And I'll let Peter kind of give a little color on what we're seeing across the business. Yeah, I think as you think about the components and the color commentary there, you know, the biological product portfolio, we expect to grow in line with historical trends, which have been kind of on the order of bits and digits year on year growth rates. I mean, looking at the Little Marley growth case in the US, which has been strong over all the quarters of its marketing, expect to see it continue to move forward at that cadence.
Diana: Borrowings growth trajectory has been attractive.
Diana: Yeah.
Diana: Great and maybe just one more thinking about the vantage studied and how it allows for patients with first line setting second line setting post ptca beyond the rate of pruritus observed across these two settings can you maybe talk a little bit more about the differences in how each presents indoor maybe severity, which that is observed in these two patient populations.
Diana: Joanne will not occur.
Diana: In terms of line of therapy.
Diana: No.
Speaker Change: No correct.
Speaker Change: And both of these diseases.
Speaker Change: We have a broad patient population that we're accessing in terms of the books that studies.
Speaker Change: Actually there is.
Speaker Change: This is broader than for instance, some of the other entrants in this space who are looking at biochemical abnormalities.
Peter Radovich: And then on the international side, we do expect quarter-to-quarter variability there for Little Marley international sales. And then your other question about competitive dynamics and knowledge yield, and I think, as you can see from the numbers here, we haven't seen a measurable impact from those at all. Really, the Little Marley growth trajectory hasn't been impacted by that.
Speaker Change: And as you that we have agreement from FDA that pruritus is the Registrational endpoint.
Speaker Change: And both of these studies are actually positioned to be registration after the interim analysis.
Speaker Change: So we feel pretty confident.
In terms of both the study design the drug itself does selection to moving forward at this point.
Joanne Kwan: And maybe just one more, thinking about the Vantage study and how it allows for patients about the first-line setting, and the second-line setting post-EDCA, beyond the rate of pruritus observed across these two settings, can you maybe talk a little bit more about the differences in how itch presents and or maybe the severity of itch that is observed in these two patient populations? Joanne and I can speak to the differences between the lines of therapy. Yeah, so, as you know, pruritus is a big issue in both of these diseases. You know, we have a broad patient population that we're accessing in terms of the BLIXBAP studies. And actually, this is broader than, for instance, some of the other entrants in this space who are looking at biochemical abnormalities.
Speaker Change: Great. Thanks.
Speaker Change: Thanks, Josh.
Speaker Change: The next question comes from the line of Kevin Clark Gardner with Evercore ISI. Please proceed.
Speaker Change: Hi, This is Sean Entre Gavin just two questions for us for the first one sorry, barley, especially with the start of the year. Just wondering if you have seen patients being be weighted in time higher dose you can figure out.
Speaker Change: Hi.
Speaker Change: The next question we have published.
Speaker Change: And last year.
Speaker Change: Not surprisingly the rate based product.
Speaker Change: The growth.
Speaker Change: We've seen partnership with Harley.
Speaker Change: Adjustments.
Speaker Change: Awesome and then one for the EU business do you have any commentary on potential implications of Epsilon re filing go to Victor.
Joanne Kwan: I'll remind you that we have agreed from FDA that pruritus is a registration endpoint, and both of these studies are actually positioned to be registered after the end of this now. So we feel pretty confident in terms of both the study design, the drug itself, our dose selection, and moving forward at this point. Thanks for watching. The next question comes from the line of Gavin Clark Gardner with EpiCorp. Hi, this is Yesha. I'm here, Gavin.
Victor: Under a different brand name not like orphan status and then also I want to confirm that there would be no reimbursement access impact on <unk> in the EU.
Victor: Yes. Thanks for the question at this point, we're focused on getting access.
Victor: Broadly across all international markets for with Marley analogy I'll.
Speaker Change: And having great progress as we see demand continuing to grow across across Europe.
Gavin Clark: Just two questions for us. For the first one, about Lib Marley, especially with the start of the year, just wondering if you have seen patients being reweighted and put on higher doses as they grow? I'd be happy to take a look at the questions we have, and we published some of that information last year. Not surprisingly, it's a weight-based product, and the growth data that we've seen published so far, we have major weight-based adjustments. And then there is one more for the EU business.
Speaker Change: Other international markets.
Speaker Change: Can't really speak too much too.
Speaker Change: The bill the procedure.
Other than that.
Making great progress getting with Marley.
Speaker Change: It really rolled out a standard of care analogy all across all markets.
Speaker Change: Great. Thank you.
Speaker Change: Thanks for the question.
Leerink partners: The next question comes from the line of money with Leerink Partners. Please proceed.
Money: Hi, Good afternoon. This is <unk>.
Money: Sorry, I couldn't hear.
Money: And apologies if it was asked.
Money: Earlier I heard the question, but we Couldnt hear the answer regarding the growth expected in terms of weight base increases.
Peter Radovich: Do you have any commentary on the potential implications of Ipsen refiling Odevexipa in the EU under a different brand name, not with orphan status? And then also want to confirm that there'd be no reimbursement or access impact with Marley in the EU? It's a question.
Speaker Change: And get all that too.
Speaker Change: If you could comment.
Speaker Change: Kind of how should we or.
Speaker Change: How should we think about the way and then the time it takes for a new patient adds versus existing ones.
Peter Radovich: At this point, we're focused on getting access broadly across all international markets with Marley and Algiers. And having made great progress, we see demands continuing to grow across Europe and other international markets. Can't really speak too much to the Bill Bay procedure, other than that we're making great progress with Marley. It really rolled out a standard of care analogy across all markets. Great, thank you. Thanks for the questions. Hi, good afternoon. This is Lillian Songo on Harmony.
Speaker Change: Yes.
Speaker Change: So the question.
Speaker Change: To make sure of that.
Speaker Change: Recap it here and ask for any color from Peter basically across the original question was around do we see.
Peter: Adjustments to dose as patients are on therapy over time.
Peter: Per the label.
Speaker Change: We do see that over time I think we're it's mentioned that there's been a recent poster presentation on it.
Lillian Songo: I'm sorry, I couldn't hear. And apologies, it was asked earlier. I heard the question, but we couldn't hear the answer.
Speaker Change: So that is a dynamic that we see out.
Speaker Change: The treating physicians.
Speaker Change: Or were you able to.
Speaker Change: The microphone pick us up this time.
Speaker Change: So we are seeing.
Peter Radovich: This was regarding the growth expected for lymphoma in terms of weight-based increases as the patient gets older. And to add to that, if you could comment in terms of how should we look at or think about the weight and then the dosage for a new patient versus the condition. Yeah, so the question, and just to make sure that I recap it here and ask for any color from Peter. Basically, the question was around, do we see adjustments to dose as patients are on therapy over time, per the label? And we do see that over time.
Speaker Change: Yes, yes.
Speaker Change: And as a follow up regarding.
Speaker Change: No.
Speaker Change: Could you maybe comment in terms of what the international growth opportunities are for those assets.
Speaker Change: Yes, so a question about Kinder I'll call bond growth opportunities and I'll, let I'll, let Peter speak a little bit to the dynamic of what we have today and then also a little bit about the keynote all label expectations expanse.
Speaker Change: Expansion opportunity for CTX.
Operator: I think it was mentioned that there's been a recent poster presentation on it. So that is a dynamic that we see out with the treating physicians. And so were you able to, did the microphone pick us up this time? Thank you, Eddie, so much. Yeah, yeah, we could hear you really clearly.
Peter: With both products, we continue to see growth in line with historical trends.
Peter: Certainly.
Peter: All of them.
Peter: They announced phase III data for Cts.
Peter: Central approval next year for Cts I think of it as an opportunity.
Peter Radovich: Thank you. And as a follow-up regarding the Kinabalu Shodan assets, could you please comment in terms of what the international growth opportunities are for those assets? Yeah, so question about Kenadol coal bomb growth opportunities. And I'll let Peter speak a little bit to the dynamic of what we have today, and then also a little bit about the Kenadol label expectations expansion opportunity for CTX. Yeah, I think, you know, with both products, we continue to see growth in line with historical trends, certainly with Kenadol and the recently announced phase three data for CTX and potential approval next year for CTX. I think there's an opportunity. Kenadol's never been promoted to CTX before.
Peter: Also our best promoted for Ccs before.
Peter: So I think there is an opportunity to find more patients through disease awareness.
Peter: The increase in the diagnosis rate.
Peter: Ccs, maybe only about 10% of the patients are diagnosed and under management.
Peter: So the opportunity there.
Peter: To try to identify more patients.
Peter: Eric.
Eric: Thank you.
Eric: Thank you thanks for the questions.
Eric: The next question comes from the line line of Michael <unk>.
Speaker Change: Stanley. Please proceed.
Speaker Change: Hi, This is Robert on for Mike. Thanks for taking our questions can you just talk about your expectations for the upcoming <unk>.
Robert: Any launch prep that's associated and do you think that any patients who are currently using it off label. Thank you.
Peter Radovich: So I think there's an opportunity to find more patients through disease-safe awareness, and we're increasing the diagnosis rate. One thing we know about CTX is that maybe only about 10% of the patients are diagnosed and under management.
Speaker Change: Yes. Thanks for the question Rohit on the regulatory front, we're kind of where we.
Speaker Change: We expect to be so excited about the <unk> date coming up and I'll, let Peter speak a little bit to how we're preparing for that and some of the.
Rohit: So, you know, the opportunity there is to try to identify more patients and get them on therapy. Thank you. Thanks for the questions. Hi, this is Rohit on behalf of Mike.
Peter: The first opportunities we see there, yes, we're really excited about the potential approvals rather than earlier.
Rohit: Thanks for taking our questions. Can you just talk about your... for the upcoming Liv Marley PDUFA in PFIC and any launch preparation that's associated with it? And do you think that any patients are currently using it off-label?
Peter: These data reinforce the strong value proposition the moly offers.
Peter: Various stakeholder groups.
Peter: They help us.
Peter: The physician prescribing universe.
Peter: Actually I'd ask Paul to Dallas Shell.
Peter Radovich: Thanks for the question, Rohit. On the regulatory front, we're where we expect to be, so excited about the PDUFA date coming up. And I'll let Peter speak a little bit about how we're preparing for that and some of the first opportunities we see there. Yeah, we're really excited about the potential approval for LIMARLI and PPIC. I think the MARS data reinforces the strong value proposition that LIMARLI offers to our various stakeholder groups.
So.
No need for <unk>.
Operating expenses decreased access that we do.
Peter: The number of patients in the middle East we're receiving.
Clinical rollover or extended access robotics.
Peter: Eligible.
Peter: Commercial upon approval.
Peter: Okay.
Speaker Change: Thank you.
Speaker Change: Thanks for the questions.
Speaker Change: The next question comes from the line of Cte House with Raymond James. Please proceed.
Cte House: Yes, Hi, this is some more volume on for Steve Steve House. So our first question is related to the gross margin I think you mentioned.
Peter Radovich: I think that will certainly help us. The physician prescribing universe is essentially identical to the allergy audience, so there's really no need for meaningful operating stress increases to access it. And we do have a number of patients in the mid-20s who are receiving clinical rollover or expanded access LIMARLI who would be eligible to roll over to commercial upon approval. Thank you. Thank you. Thanks for watching. Yes, hi, this is Timur Vanikov on behalf of Steve Seedhouse.
Cte House: There was an inventory charge related to the acquisition and <unk> just what are your expectations for gross margin in 2024, and perhaps also the opex trajectory in 2024.
Cte House: Gross margin.
Cte House: We do expect that the intangible amortization will continue I mean.
Timur Vanikov: So our first question is related to gross margin. I think you mentioned there was an inventory charge related to the acquisition in 4Q. Just what are your expectations for gross margin in 2024 and, perhaps also, the OPEX trajectory in 2024? At the last gross margin, we do expect that the intangible amortization will continue. I mean, it's largely related to the bile acid acquisition intangibles, which were amortized over 50 quarters. As far as sort of traditional cost of goods, it consists of the actual cost of the product and royalties.
Cte House: Largely related to the bile acid acquisition intangibles, which were amortizing over 50 quarters.
As far as sort of a traditional cost of goods. It consist of the actual cost of product and royalty. So that will continue at approximately the same sort of percentage of sales.
Cte House: And then we did have a larger than we expect going forward.
Cte House: Foundation of our reserve for the inventory that came with the acquisitions, though.
Eric H. Bjerkholt: So that will continue at approximately the same sort of percentage of sales. And then we did have a larger than we expected going forward amortization or reserve for the inventory that came with the acquisition. So we might have some reserves in some quarters, but not to the extent we had in the fourth quarter, terms of overall operating expenses. R&D and FP&A in the fourth quarter are probably pretty representative of what we expect the next few quarters. Okay, thank you very much. And then just a question on your overall enrollment dynamics in VISTAs and Vantage. I think in VISTAs, your interim is only on 45 patients. So can you comment on the overall enrollment target dates, and do you see any differences between the studies in terms of the enrollment dynamics?
Cte House: We might have some reserve in some quarters, but not to the extent we had in the fourth quarter.
Cte House: In terms of our overall operating expenses.
Cte House: R&D and SG&A fourth quarter is probably pretty representative of what you expect for the next few quarters.
Okay. Okay. Thank you very much and then just a question on on your overall enrollment dynamics in this disadvantage I think I think investors. Your interim is only on 45 patients.
Cte House: So can you comment.
Cte House: The overall enrollment target dates and do you see any differences between the studies in terms of the enrollment dynamics.
Speaker Change: Thanks for the question.
Eric H. Bjerkholt: Thanks for the question. I mean, the simple answer here is we have patients in for the interim. We're continuing to enroll for part two now, and we'll be able to give better guidance for the full study enrollment when it comes up. Okay, appreciate it. Thank you very much. Yes, thank you. Hi, this is Debanjana on behalf of David.
Speaker Change: Simple.
Speaker Change: The answer here is we have patients in for the interim we are continuing to enroll for part two now and we will be able to give better guidance for the full study enrollment at that interim.
Speaker Change: When it comes up.
Speaker Change: Okay I appreciate it thank you very much.
Speaker Change: Yep. Thank you.
Speaker Change: The next question comes from the line of David Lebowitz with Citi. Please proceed.
David Neil Lebowitz: Hi, This is <unk>, thanks for taking our call.
Joanne Kwan: Thanks for taking our call. We wanted to ask about the blinded PSE interim analysis. So besides the dose selection, would you share any other data points on a blinded basis? So, we will be blinded in this interim, and, you know, this is designed so that if it passes the threshold, it is designed to be predictive of a clinically meaningful and statistically significant positive pivotal analysis at the end. So that's all I can really share with you at this point.
David Neil Lebowitz: We wanted to ask about the blinded plc interim analysis until beside dilutes, the nextgen, we're going to share any other data points.
David Neil Lebowitz: On a blinded basis.
Speaker Change: So we will be behind us in this interim.
David Neil Lebowitz: And.
David Neil Lebowitz: This design so that if it passes the threshold.
David Neil Lebowitz: It is designed to be predictive of a clinically meaningful and statistically significant.
David Neil Lebowitz: Positive pivotal analysis in the end.
Speaker Change: So that's all I can really share with you at this point and it's really.
Joanne Kwan: And it's really, you know, this threshold was developed based on what we know about the drug, this class of drugs, PSE in general, and pruritus. So we feel pretty confident in terms of the design being robust and this being kind of well set up to produce a registration study for us. In terms of communication at the point of the interim for the VISTA study, assuming a positive interim, we would communicate that the interim has occurred, and the study continues as planned, which would be the extent of the information that we received here on the team as well. Okay, and so as a follow-up to that, could you tell us a bit more about, while unlikely, is there any other scenario like that would play out if somehow, like, So the study design, in the event that that threshold is not met, basically converts to an open interim analysis, where we'd be able to look at the data, share top-line findings about it, and what the next steps are for the study in that scenario.
Speaker Change: Specialty was developed based on drug this class of drugs PSC in general in pruritus. So we feel pretty confident in terms of the design being robust.
Speaker Change: And thats been kind of well setup to produce the registration study for us.
Speaker Change: And in terms of communication at the point of interim analysis study.
Speaker Change: Assuming a positive interim we would communicate that the interim has occurred instead of containers as plants, which would be the extent of the information that we received here on the team as well.
Speaker Change: Okay.
Speaker Change: A follow up to that could you tell us a bit more.
Speaker Change: While unlikely.
Speaker Change: Any other scenario that would play out.
Speaker Change: Thank you.
Speaker Change: You see that market.
Speaker Change: Because he is not crossing that threshold on a blinded basis that will be simplified.
Speaker Change: So the study design and the event where that threshold was not met basically converts to an open interim analysis, we'd be able to look at the.
Speaker Change: Look at the data share topline findings of it and what the next steps are for the study in that scenario.
Speaker Change: Okay. Thank you for the insight.
Joanne Kwan: Okay, thank you for the insight. Yep, thanks for the question. Brian, on PBC, beyond pruritus, how are you thinking about the impact on outcomes and other markers in Vantage, and how can this help you make the case to physicians and patients?
Speaker Change: Yes, thanks for the questions.
Speaker Change: Thank you.
Speaker Change: The next question comes from the line.
Brian <unk> with Baird. Please proceed.
And on PVC beyond Pruritus, how are you thinking about the impact on outcomes and other markers in vantage.
Brian: And how can this help you make the case to physicians and patients.
Brian: Yes.
Brian: Yes. Thanks for the question I'll, let joanne to speak a little bit to kind of the Registrational plan for PBC.
Joanne Kwan: I'll let Joanne speak a little bit about the registrational plan for PBC. So in terms of the interim, we're just going to be looking at top line, so pruritus, serum violence, and safety as top line. And as you know, it's just a big issue in this particular patient population for which there's really no particular therapy.
Joanne Quan: Yes, so in terms of the interim we're just going to be looking at topline, so pruritus serum bile acid safety.
Speaker Change: As top line.
Joanne Quan: And as you know <unk> is a big issue in this particular patient population for which there is really no particularly services.
Joanne Kwan: So, you know, we're pretty confident that this study, the way it's designed, actually addresses an important medical need. Yeah, and just to recap, one of the points made earlier, the eligibility criteria for the Vantage study does not have an alkaline foster case criteria, so it includes patients that are traditionally thought of as first-line, that have really only UDCA as on-label and are still experiencing the same rates and severity of pruritus as later lines of treatment. So there is a lot of unmet need across the PVC patient population. Great, thanks.
So so.
Joanne Quan: We're pretty confident that this <unk>.
Joanne Quan: Study the way, it's designed <unk> addresses an important unmet medical need.
Speaker Change: Yes, just to recap what are the points made earlier.
The eligibility criteria for the vantage study does not have.
Speaker Change: In alkaline phosphatase criteria.
Speaker Change: So it includes patients that are traditionally thought of as first line.
Speaker Change: Uh huh.
Speaker Change: Only <unk> has.
Speaker Change: As on label and still experience.
Speaker Change: The same rates and severity of Triton.
Speaker Change: Later lines of treatment, so a lot of unmet need across the PBC patient population.
Speaker Change: Great. Thanks.
Thanks for the question. Thank you.
Brian Peter Skorney: Thanks for the questions. Hi everyone, thanks for taking my questions and congrats on another strong quarter. I have three, if I may.
Speaker Change: The next question comes from the line of Ed Arce with H C. Wainwright. Please proceed.
Ed Arce: Hi, everyone. Thanks for taking my questions and congrats on another strong quarter.
Ed Arce: I have three if I may firstly on the vantage study in PBC as you said, it's a blinded data readout.
Unnamed Questioner: Firstly, on the VANTAGE study in PBC, as you said, it's a blinded data readout. Obviously, this is, as you mentioned, versus placebo and whether it's BAT-seq. But I'm also wondering if there are specific thresholds for, but also as you think about the competitive landscape and where you'd like to see that.
Ed Arce: Obviously this is as you mentioned.
Ed Arce: Basically pruritus.
Ed Arce: Versus placebo and whether it's that seek but I'm also wondering.
Ed Arce: If there are specific thresholds.
Ed Arce: Activity on pruritus that Youre looking at not just so much to proceed but also as you think about the competitive landscape.
And where you'd like to see that come in.
Christopher Peetz: Secondly, if you could speak a bit about the PFIC opportunity in terms of... for watching, trajectory. And then, lastly, I'm sorry, I didn't hear... When Peter was reviewing, I think it was Peter, the numbers for Liv Marley, both U.S. and international, as well as Biolast.
Ed Arce: Secondly.
Ed Arce: If you could speak a bit about the <unk> opportunity in terms of 2024 sort of the sales.
Ed Arce: The speed of the sales ramp kind of what youre expecting.
The trajectory to be through the <unk>.
Ed Arce: Meaning quarters of this year, and then lastly, I am sorry, I Didnt hear.
Ed Arce: Peter was reviewing I think it was Peter the the numbers for live Marvin both U S and international as well as the bile acid products for the fourth quarter. Thanks, So much.
Peter Radovich: Products for the Fourth of July. Thank you. Great, thanks for the question. Maybe I'll just hit on a recap of one of the points on Vantage and then pass it over to Peter to talk about PFIC and recap some of those sales numbers. And, you know, the way we think about Vantage and Valixivat and PDC, it really comes down to this, you know, the highlight here on lines of therapy and where various agents are labeled and expected to be labeled. The majority of patients are first-line patients, and the majority of them have pruritus. So that's, that's really the primary unmet need that we're going after.
Speaker Change: Great. Thanks for the question, but maybe I'll just hit on.
Speaker Change: Recap one of the points on vantage and then pass it over to Peter to talk about.
P thick and recap some of those sales numbers.
Speaker Change: And the way, we think about vantage and <unk> and PVC.
Speaker Change: It comes down to.
Peter: The highlight here on lines of therapy, and where are the various agents are labeled and expect it to be labeled.
The majority of patients are first line patients and the majority of them have tried us. So that's really the primary unmet need that we're going after so showing a significant impact on that pruritus, we think will be very clinically meaningful.
Christopher Peetz: So showing a significant impact on that pruritus, we think will be very clinically meaningful. And that's the lens that we're going to be taking toward that interim data when we look at it and make a decision on next steps and continue to roll into the pivotal portion of the study. With that, I'll pass it over to Peter on the next two points. Sorry, I'll try to speak up a little bit here.
Peter: The lines that we're going to be taking towards that interim data when we look at it and make a decision on next steps.
Peter: Continuing to roll into the pivotal portion of the study.
Peter: With that I'll pass over to Peter on the next two points, yes, sorry, I'll try to speak up a little bit here.
Peter: So on the 2024 revenue expectation piece.
Peter Radovich: So on the PFIC 2024 revenue expectation piece, I think we'll be, upon a potential approval here in March, spending a fair bit of time working closely with payers to get Libmarly positioned in their new-to-market policies. So I think, if you think about 2024, we'd expect a lot of free drugs or PAP, with PFIC really coming in more in 2025, somewhat similar to what we saw in the initial launch of Alajil, where the early quarters were high PAP drug prices. And then in terms of the numbers from Q4, Libmarly totaled $41.4 million worldwide, $31.4 US, $10 international, and then bio-acid products were $28.1 million for Q4.
Peter: I think we'll be upon upon potential approval here in March we'll be spending a fair bit of time working closely with payers to.
Peter: Again, good Lamar repositioning dinner new to market policies.
Peter: Do you think about 2024, we would expect a lot of free drug or pop.
Peter: With <unk> really coming in more in 2025.
Peter: Somewhat similar to what we saw on the algae oil initial launch where the early quarters for Hi, Hi pop.
Peter: And then in terms of the numbers from.
Peter: From Q4, <unk> total of $41 4 million worldwide 31 for U S 10 International and then bile acid products were $28 1 million for Q4.
Peter: Great.
Peter Radovich: Great. And then just further clarification on PFIC, appreciate the comments. Just wondering, given that you mentioned earlier there are about 20 patients right now on expanded access. How soon would you expect those to be able to roll over?
Peter: And then.
Speaker Change: Just a further clarification on Patrick I appreciate the comments.
Speaker Change: Wondering given that you mentioned earlier.
Speaker Change: About twentyish patents patients right now on expanded access.
Speaker Change: How soon would you expect those to be able to roll over onto commercial growth.
Peter Radovich: on, Boyle. Yeah, what we saw in the AlgaeO launch is that occurred in a quarter or two, generally what we saw. And so yeah, I think that's probably consistent with our expectation for those 25 or so. Thanks so much. Thanks for the questions. The next question comes from Delon. Citizen.
Speaker Change: Yes, what we saw in the allergy launches that occurred in a quarter or two generally is what we saw.
Speaker Change: And so I think that's probably consistent with our expectation for those 25% or so.
Thanks, so much.
Speaker Change: Thanks for the questions. Thank you.
Speaker Change: The next question comes from the line of Jonathan <unk> with citizens of JMP. Please proceed.
Catherine: Hi, this is Catherine, on behalf of John. I just had two quick questions. One is kind of to follow up on Valexibat and just kind of how you guys see it fitting into the PBC paradigm in the setting of other approved agents that might potentially be effective also on pruritus, whether you see it as kind of a combo therapy, sort of a monotherapy for earlier patients. And then also, just as far as preparing for the PFAC launch, I know you said that there's not going to be too much of Thanks for the questions. And just to kind of recap the PBC positioning one more time.
Speaker Change: Hi, Katherine on for John.
Jonathan: Two kind of quick questions, one kind of follow up on <unk> and just kind of how you guys see it fitting into the PBC paradigm in the setting of other approved other approved agents that might potentially be effective.
Jonathan: Also on pruritus, but everything is kind of a combo therapy or a mono therapy for earlier patients and then also just as far as preparing for the Pizza launch I know you said that there's not going to be too much of an investment aren't S. Jacob right like what what else is kind of being done to sort of get the word out there about.
Jonathan: Most of the systems already know that it's coming.
Speaker Change: Yes, thanks for the questions.
Speaker Change: And just to kind of recap the PVC positioning one more time here.
Christopher Peetz: The Vantage study includes first-line patients that really are, when you look at the eligibility criteria for the PPAR programs, for example, and how vasofibrate gets used outside the U.S., we are upstream of that setting where when a patient is biochemically controlled, they can still have substantial pruritus. That's the area where IVAC can play a very unique role in being ahead of the other second-line therapies So this is pretty unique positioning that we see for PBC.
Speaker Change: The vantage study includes first line patients that really are when you look at the eligibility criteria for the P. Par programs for example on how base of fiber gets used.
Speaker Change: Outside the U S. We are upstream of that setting where.
Speaker Change: When a patient is biochemically controlled they can still have substantial pruritus right. That's the area, where <unk> can play a very unique role and.
Speaker Change: Being in front of.
Speaker Change: The other second line therapies <unk> CA for example.
Speaker Change: So pretty unique positioning that we see for for PVC I'd add on PSC.
Christopher Peetz: I'd add, in PSC, really exciting opportunity here where Valixavet is positioned to be the first and only therapy for PSC by using pruritus as an endpoint. Really gives an outcome to use for bringing a new therapy to these patients. So quite excited about the positioning there, and I'll pass it over to Peter for part two here.
Speaker Change: Really exciting.
Speaker Change: Exciting opportunity here, where <unk> is positioned to be the first and only therapy for for PSC by using pruritus as an endpoint really gives an outcome to use for bringing a new therapy to these patients.
Speaker Change: So quite excited about the positioning there and pass over to Peter for two here, yes, yes.
Peter Radovich: Yeah, yeah, in regards to PFIC, obviously, there's been, you know, there's no promotion until approval, but I mean, I just kind of emphasize that there is a really small number of physicians that take care of these patients in the U.S. You're probably talking about on the order of a hundred physicians in the entire country that take care of PFIC patients. There have been presentations at the major medical conferences on the data, phase three data as well as phase two data going back for years. So I think there's a kind of relatively high awareness of the data and certainly from allogeal approval and commercialization, a lot of comfort with Marley's clinical profile, my familiarity with using it, prescribing it, working with our patient support hub, the Mirum Access Plus program, you know, co-pay So I think that's probably a fair summary of where things stand today.
Peter: In regards to be picked obviously, there's been there's no promotion until approval.
Peter: But I just kind of emphasize that it's a really small number of physicians that take care of these patients in the U S. I mean, you're probably talking about on the order of 100 physicians in the entire country.
Peter: Take care of patients that have been.
Peter: Presentation that the major medical conferences on the data phase III data as well as the phase II data going back for years.
Peter: So I think there is a kind of a relatively high awareness of the data and certainly for <unk> approval and commercialization a lot of comfort with the <unk> clinical profile kind of familiarity with using that prescribing it working with our patient support hub to Miramax's plus program.
Peter: Co pay support et cetera, So I think thats, probably a fair summary of where things stand today.
Peter Radovich: Thanks so much. Thanks for the questions. They're in order.
Speaker Change: Thanks, so much.
Speaker Change: Okay. Thanks for the questions.
Speaker Change: Thank you.
Operator: I will pass. Great, thanks. Thanks again to everyone for joining us for today. Before I end the call, I do want to put a plug in for Rare Disease Day tomorrow. It's a day to build awareness for the more than 7000 rare diseases impacting patients around the world and celebrate some of the meaningful advances in research that we've seen in recent years. Tomorrow, as part of Rare Disease Day, we're excited to be able to share a manuscript published in Hepatology featuring long-term data and patients with Alice Jill syndrome treated with Livmarly. So please join us in supporting the many advocacy groups that passionately lead efforts to support patients and research in rare diseases tomorrow, and have a great evening. Thank you.
Speaker Change: There are no additional questions at this time.
Speaker Change: I will pass it back to Chris <unk> for any closing remarks.
Chris: Great. Thanks, Thanks, again for everyone for joining us per day for running the call I did want to put a plug in for rare disease day Tomorrow.
Chris: Hey to build awareness for the more than 7000 rare diseases impacting patients around the world and celebrate some of the meaningful advances in research that we've seen in recent years.
Chris: Tomorrow as part of rare disease day, we're excited to be able to share a manuscript published in herpetology featuring long term data in patients with <unk> syndrome treated with Marley.
Chris: So please join us in supporting the many advocacy groups that passionately lead efforts to support patients in research in rare disease Tomorrow.
Speaker Change: And have a great evening goodbye.
Speaker Change: That concludes today's conference call. Thank you you may now disconnect your line.