Q2 2024 Rhythm Pharmaceuticals Inc Earnings Call

Advising you your hand, just raised to withdraw your question. Please press star one again, please be advised to today's conference is being recorded I would now like to hand, the conference over to your speaker today, David Connolly Investor Relations and corporate Communications. Sir. Please go ahead.

Operator: You will then hear an automated message advising you that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David Connolly, investor relations and corporate communications. Sir, please go ahead.

David Connolly: Thank you, Michelle. I'm Dave Connolly here at Rhythm Pharmaceuticals. For those of you participating on the conference call, our slides can be accessed and controlled by going to the investor section on the investors page of our website, ir.rhythmtx.com. This morning, we issued a press release that provides our second quarter 2024 financial results and business update, and that is available on our website. Listed on slide two is our agenda. On the call are David Meeker, our Chairman, Chief Executive Officer, and President, Jennifer Lee, Executive Vice President, Head of North America, Hunter Smith, our Chief Financial Officer, and Yann Mazabraud, Executive Vice President, Head of International, is on the line joining us from Europe.

David Connolly: Thank you Michelle.

Speaker Change: On the economy here at rhythm Pharmaceuticals for those of you participating on the conference call. Our slides can be accessed in control by going to the investors section of the investors page of our website IR dot rhythm TX Dot com. This morning, we issued a press release that provides our second quarter 2024 financial results and business update and that is available.

Speaker Change: On our website.

Speaker Change: Listed on slide two is our agenda.

Speaker Change: On the call are David Meeker, our chairman and Chief Executive Officer, and President Jennifer Li Executive Vice President Head of North America Hunter Smith, our Chief Financial Officer.

Speaker Change: Don <unk> Executive Vice President and head of International is on the line joining us from Europe.

David Connolly: And on slide three, I'll remind you this call contains remarks concerning future expectations, plans, and prospects, which constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed on our most recent annual or quarterly reports on file with the SEC. In addition, any forward-looking statements represent our views as of only today and should not be relied upon as representing our views as of any subsequent dates. We specifically disclaim any obligation to update such statements. With that, I'll turn the call over to David Meeker. We'll begin on slide five.

Speaker Change: And on slide three I'll remind you. This call contains remarks concerning future expectations plans and prospects, which constitute forward looking statements actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed on our most recent annual or quarterly reports on file with the SEC.

Speaker Change: In addition, any forward looking statements represent our views as of only today should not be relied upon as representing our views as of any subsequent dates we specifically disclaim any obligation to update such statements with that I'll turn the call over to David Meeker will begin on slide five.

Dave: Thank you Dave.

David Meeker: We are pleased to report out another strong quarter with continued steady progress on our commercial opportunity both in North America and internationally another regulatory milestone with pediatric approval for <unk> in patients ages, two to younger than six in the EU.

Brian: And Brian progress across our development programs, we remain focused on our three main value drivers shown on slides five and six this quarter, we've made advancements in each <unk>.

David Meeker: First, as noted, the team continues to execute on our global commercial strategy. Second, we remain excited about the hypothalamic obesity and the likelihood of success in our ongoing global phase three trial. And third, we continue to make progress with two new MC4R agonists in phase one and phase two trials. We have completed the phase two daybreak trial and the phase three MNA trial remains on track to complete enrollment in the two leading cohorts by year end.

Brian: First as noted the team continues to execute on our global commercial strategy second we remain excited about the hypothalamic obesity and the likelihood of success in our ongoing global Phase III trial and third we continue to make progress with two new emcee for our agonist in phase one and phase two trials, we have completed the phase II DAYBREAK trial and the phase III.

Brian: M&A trial remains on track to complete enrollment in the two leading cohorts by year end.

Speaker Change: Revenues for the quarter were $29 $1 million driven predominantly by bvs two years post approval in the U S and with increasing market access and international what remains most striking to me is the extent to which Bbs is a classic rare disease challenge.

Speaker Change: The obesity and the hunger are there for all to see but the disease remains relatively invisible to those who are not expert two.

Speaker Change: Two weeks ago I attended the Bbs Foundation International Conference in Minneapolis, The first in person meeting at this level in more than four years more than 200 patients and family members attended along with a number of the expert physicians. One common refrain was aren't you tired of having to explain to each new doctor that you see what BARDA <unk> syndrome is.

Speaker Change: And the opening session. The head of the foundation charged the attendees with one goal meet someone they did not know from the community.

David Meeker: Of the many challenges facing the rare disease patients and families, which include getting to a diagnosis, finding an expert physician, managing their disease, one of the biggest is simply feeling alone. Rhythm, from the beginning, has not focused on selling a drug. Instead, our focus has been on supporting community development with the goal of having more experts, more integrated care centers, and most importantly, more opportunities for patients and their families to interact with other members of the community.

Speaker Change: The many challenges facing the rare disease patients and families which include getting to a diagnosis finding an expert physician managing their disease. One of the biggest is simply feeling alone.

Speaker Change: Rhythm from the beginning has not focused on selling a drug instead, our focus has been on supporting community development with the goal of having more experts more integrated care centers and most importantly, more opportunities for patients and their families to interact with other members of the community.

Speaker Change: That meeting was one big family and we as rhythm, we're privileged to be part of it.

Speaker Change: How does all of that relates to revenue growth and do the right thing for each patient and their family and the community and the revenues will follow.

Speaker Change: And hyperkalemia obesity, our ongoing phase III pivotal trial remains on track for a first half readout in 2025, and our enthusiasm remains high at this point. The first patients enrolled have completed their placebo controlled portion in our rolling over into the open label extension. A brief reminder, the pivotal cohort to this trial enrolled 120 patients randomized two to one.

Speaker Change: Drug to placebo with the protocol, calling for up to eight weeks for dose titration and 52 weeks in the therapeutic dose. The trial is over enrolled dropout rate remains exceedingly low and the trial is 99% powered to show a 10% placebo adjusted difference in BMI.

Speaker Change: Of note, we do not counsel these patients on diet or exercise as a formal part of the trial design patients received only what is standard of care for that institution recognizing almost all of these patients have tried diet and exercise previously without success.

Speaker Change: Of interest approximately 25% of patients enrolled in this trial had tried GOP ones and about 10% of enrolled patients entered the trial on active DLP. One therapy, we did not exclude patients on or with <unk> experience from the trial. They were allowed to enroll as long as their weight with stable over the preceding three months.

David Meeker: We did not exclude patients on or with GLP-1 experience from the trial. They were allowed to enroll as long as their weight was stable over the preceding three months. The Phase 1 study of RM718, our weekly injectable, built off set melanotype, is progressing through the SAD, the single ascending dose, and MAD, multiple ascending dose portions of the trial in normal, healthy volunteers with obesity.

Speaker Change: Our overall.

Speaker Change: Our overall position on GOP when used in this population informed partly by our engagement with the community, but also by the research. Many of you have done is that many patients with HR. It may have some initial response to GOP ones, but the percent of patients with sustained benefit will be less than 20% in the magnitude of that benefit maybe 10% or less.

Speaker Change: In Japan, where we estimate the number of patients with hyperkalemia obesity to be five to 8000, which is on par with European and United States total patient estimates despite Japan's overall population being much smaller we have dosed. The first patients in our 12 patient cohort and we are actively screening patients at four sites in Japan.

Speaker Change: This Japanese cohort will enable us to seek regulatory approval in Japan with data from these 12 placed patients plus the pivotal cohort and not affect timing for U S and European regulatory submissions.

Speaker Change: Our two next generation <unk> agonist designed to avoid the Hyperpigmentation that comes with MSC. One our agonism are advancing on schedule last month, we announced dosing of the first patient in our 20 patient phase II placebo controlled trial evaluating the oral <unk> agonists lb by 464, <unk> and hypothalamic obesity.

Speaker Change: The phase one study of RMB 71, eight our weekly injectable built offset monotype is progressing through the sad single ascending dose and mad multiple ascending dose portions of the trial in normal healthy volunteers with obesity, we made the decision to add two additional higher dosing cohorts and the sad portion with the goal of satisfying the regulatory.

Speaker Change: <unk> in this early phase study potentially avoiding the need for a dedicated <unk> study measure of heart rhythm, thereby simplifying the regulatory development path.

Speaker Change: Finally, we were pleased to receive an expanded marketing authorization for <unk> from the European Commission for patients two to less than six years old with BARDA beetle syndrome, where pumps <unk> deficiency in the U S. We completed submission of the supplemental new drug application to the FDA in the second quarter, which keeps us on track for a potential label expansion towards the end of this year.

Speaker Change: As we have previously highlighted this approval modestly expand the treatable population, but more importantly, it may offer patients fortunate enough to get a diagnosis at an early age potential for better outcomes. Two key takeaways from the phase III trial, where one patients as young as two can be severely affected and two as shown on slide <unk>.

Kevin: Kevin They responded uniformly and well to a treatment with an 18, 4% mean reduction in BMI at one year. These are genetic diseases and the defect is present at birth Jan will share modeling data, which was presented at the European Congress of obesity in May that model the impact of early intervention on long term comorbidities in patients with obesity.

Jan: Given the potential benefit why would you not want to start treatment as early as possible.

Jan: So I'll now turn the call over to Jennifer to provide the North American update Jennifer.

Jennifer Li: Thank you David.

Speaker Change: This quarter marks the eighth full quarter anthem every sales for Bbs since it was approved in June of 2022.

Jennifer Li: Looking back over the last two years and has been an amazing journey in many instances better than we'd tobacco.

Speaker Change: We have done our research and heard feedback regarding the need for Cowen therapy to address persistent hyperphagia early onset obesity and Bbs patients we have learned so much more sense our lives.

Speaker Change: Look around us and gives US conviction every day are the story, we acquired with a consistency relating to the benefits patients are receiving <unk> and symphony.

Speaker Change: And one story, there was a woman who with 210 pounds before initiating and Stephanie.

Geoffrey King: Now coming up on two years of Geoffrey King required redemption in our Honda and Hawaii is now stable and approximately 135 pounds.

Speaker Change: While there is patient by patient variability in the amount of weight loss experience.

Speaker Change: Dan outlets consistent theme is the positive impact of both hunger and weight reduction.

Speaker Change: This particular patient after several years of not working he recently started job as a customer service representative working from home as the first visually impaired employee for this company.

Speaker Change: He also told US about her first solar plant yet to see a friend and he is now looking forward to markets and this will occur.

Speaker Change: Stories like this motivate everyone at random Gen. Sir all eligible patients are able to have access to them for free and we continue to make progress with our sense of urgency as a collective team now.

Speaker Change: Now to the quarter beginning on slide nine.

Speaker Change: At a high level our results for the second quarter, our strong and consistent with our expectations well continue to see steady growth in prescriptions per prescriber breadth and depth quarter over quarter as well as ongoing positive reimbursement decisions or both and Mitchell as well as reauthorization approval.

Speaker Change: Onto slide 10.

Speaker Change: Here are the top level metrics, we've been sharing since launch.

Speaker Change: We received approximately 100, new prescription forms Geoffrey T treat patients with Bbs here in the United States. In addition to owning approximately 70 approval for reimbursement, which is representative of the steady growth quarter over quarter.

Speaker Change: While not detailed on the slide we had approximately 70 prescribers this quarter.

Speaker Change: To date more than 30% of prescribers have written two or more prescription.

Speaker Change: Lastly, the breakdown by physician specialty remains consistent with what we have reported in past quarters with endocrinologists being the lead prescribers Evans Jeffrey.

Speaker Change: With access the story is also consistent as we have seen positive reimbursement decisions by state Medicaid programs that represent more than 90% of Medicaid covered lives.

Hunter Smith: Our success in the reauthorization process continues to be strong. With reauthorizations, we are still seeing the vast majority approved right away. By the beginning of the second quarter, less than 10 had not yet been reauthorized, and we are working through the appeals process for these patients.

Speaker Change: Our success in the re optimization process continues to be strong with reauthorization. We are still seeing the vast majority approved right away.

Speaker Change: By the beginning of the second quarter Western Ken had not yet been reauthorized and we are working through the appeals process for these patients.

Speaker Change: With the consistency of these metrics over the last several quarters and knowing what we know now we look forward with confidence in the long term ABS opportunity.

Speaker Change: Onto slide 11.

Speaker Change: We are pleased with the progress we have made across our areas of focus and we are constantly evaluating to see if there are ways, we may refine moving more moving forward.

Speaker Change: One example, we identified was within our patient support program with rhythm in June we started with one group of patient education managers, when we launched.

Speaker Change: As we have grown we have evolved how our teams are organized and split out the responsibilities and the patient support services group by adding field access managers.

Speaker Change: This group focuses on gaining initial payer approval and ensuring ongoing reimbursement through the reauthorization processes or insurance changes throughout the year.

Speaker Change: This change has freed up our patient education managers. So they can focus on providing education and support directly to patients and their families to ensure they understand treatment expectations and help manage through the process of treatment initiation and long term maintenance.

Speaker Change: Also physician engagement, we continue finding and engaging with new potential prescribers and seen more physicians gain experience with <unk> and see their patients benefit from therapy.

Speaker Change: They are their experiences there have been healthcare providers, who have been inspired and motivated to optimize care of Bbs patients, including the recognition of the benefit in need of multi disciplinary involvement and the diagnosis and care of patients.

Speaker Change: Each rare disease is unique and comes with its own opportunity and challenges I am proud of the success and progress. Our teams have made to help increase awareness and build community. There are active education engagement and support we are thrilled to see hundreds of patients and families benefiting.

From mid century every day.

Speaker Change: Now I'll turn the call over to Jan.

Jan: Thank you Ginny soon.

Jan: On slide 13, with a great news from last week, the European Commission extended marketing authorization for ancillary to now include children with CBS on Sealy power efficiency.

Jan: Housing is two years old.

Speaker Change: His decision to allow for Pts, we choose our CMC renal patients Zheng.

Speaker Change: Decision, which came one months before which was expected until schools subsidiary impact of the disruption of the emcee for walnuts.

Speaker Change: There's a significant unmet medical need for young children.

Speaker Change: And Germany is the exemption process, which will allow us to get reimbursement has already started we are also already submitted the reimbursement to see to.

Unknown Executive: We have also already submitted the reimbursement dossier to the French and Italian authorities and we will do the same with several other key European countries in coming weeks and more. This is an important milestone for MCV. We know it is important to diagnose patients with these diseases early in life before the comorbidities of severe obesity take hold. Next slide. Patients who begin therapy before 18 years old can remain under inverse therapy if they continue to show benefits.

Speaker Change: To the French and Italian authorities, and we will do the same with civil it was a key European countries in the coming weeks and months.

Speaker Change: This is an important milestone for CBRE. We know it is important to diagnose patients with these diseases early nice before as a promoter entities of severe obesity take all.

Speaker Change: And now we look forward to working with decisions and caregivers to provide access to see beginning at a young age and making a positive difference for the patients.

Speaker Change: Next slide.

Speaker Change: And since we are talking about this topic.

Speaker Change: At the European Congress on obesity, we presented research is showing as a negative impact early onset obesity can have on Comorbidities nice expectancy and we also showed the positive impact of early intervention, which really shouldn't have in reducing the risk of comorbidities and increasing life expectancy.

Speaker Change: As you can see in the table.

Speaker Change: Early onset obesity model developed based on the detailed assessment of more than 200 published studies showed that the patient with the BMA Z score of 2.50 to <unk> <unk>, four which is typical of patients with rare and Chief officer disease has increased likelihood of soluble <unk>.

Speaker Change: <unk>.

Speaker Change: Type two diabetes cardiovascular disease asthma.

Speaker Change: And the life expectancy of such a patient is 37 years of age.

Speaker Change: With an intervention that reduces BMA you made two points life expectancy, almost doubles to 64 years old and as you can see in the table the risk of suitable comorbidities is greatly reduced.

Speaker Change: For example for cardiovascular islands or asthma.

Speaker Change: Sleep apnea.

Speaker Change: Next slide.

Speaker Change: <unk> <unk>.

Speaker Change: The European Congress of obesity selected these compelling results for inclusion in the concurrence official press release more than 30 media outlets reported on these results and as a prison until towards the British news allocated volume designed to the treatment has been put off until the development of type two diabetes.

Speaker Change: Appreciate it.

Speaker Change: It was a warning signs.

Speaker Change: Certainly.

Speaker Change: On the next slide slide 16.

Speaker Change: We're also pleased to share the news is up nice recommended that the National Health service reimburse <unk> for treatment of obesity, and hyperphagia and patients with Bbs between the ages of six and 17 years old.

Speaker Change: <unk> will begin to wrap up before <unk> can remain under industrial IPC continue to show benefit.

Speaker Change: We are very pleased with the successful negotiation and JV grateful for the support we received from a leading UK Bbs experience Enzo Bbs patient Association.

Unknown Executive: We now expect Incivory to be funded for BBS in England and Wales in the third quarter, and we anticipate Northern Ireland authorities to follow and adopt the NYE guidance in the next several months, and the Scottish Medicines Consortium to do the same in 2025.

Speaker Change: Without them for hypothalamic ability and just pay the early access program for Bbs. We also now are seeing increased commercial patient activity for Bbs in both Italy and Spain.

Speaker Change: And importantly, and this is recent news that is new today, we received an exceptional pre EMEA marketing authorization from the Italian Ministry of health for the inclusion of <unk> and there was a low 648 for the treatment of obesity and anger control associated with hypothalamic ability for patients.

Speaker Change: 6% and 24 years old.

Speaker Change: And similar to France will begin receiving reimbursement to treat these patients.

Speaker Change: This development speaks to the severity of the disease significance of unmet medical need.

Speaker Change: Interesting I put dynamic ability and just how compelling the data from our phase II trial.

Speaker Change: Label extension.

Hunter Smith: Now to Hunter.

Hunter Smith: Thank you.

Hunter Smith: Turning to slide 19.

Speaker Change: That revenue from global sales of <unk> in Q2 came in at $29 1 million, which represents almost 12% growth over the prior quarter.

Speaker Change: As we show here on this slide net revenue has continued to grow steadily during the two years since the launch of <unk> in February for Bvs in the United States.

Speaker Change: And so every revenue generated in the United States accounted for 74% of net sales this quarter consistent with the first quarter of the year.

Speaker Change: U S revenue of $21 6 million increased $2 2 million or nearly 11% versus Q1.

Hunter Smith: The primary driver of COGS was the 5% royalty to Ipsen under our licensing agreement, as well as minor fluctuations due to product costs, volumes, and inventory. Additionally, separate from the consideration related to the licensing agreement in the first quarter, we experienced a decrease in R&D expenses due to a reduction in cost for Daybreak, M&A, and Phase 3 HO studies, as well as lower costs related to our ongoing open-label extension trial. Second quarter operating expenses included total stock-based compensation of $10.4 million for the quarter compared to $7.8 million in the previous quarter. This reflects a one-time non-cash gain of $8.9 million resulting from a decrease in fair value of the issued convertible preferred stock between the deal execution date of April 1st and the closing date of April 15th.

Speaker Change: And for the second quarter compared to $33 5 million during the second quarter of last year sequentially.

Speaker Change: Sequentially Q1 R&D expenses.

Speaker Change: $128 7 million driven by $92 4 million in costs related to <unk> 540, 640 separate from the consideration related to the licensing agreement in the first quarter, we experienced a decrease in R&D expenses due to a reduction in costs of our DAYBREAK emanate and phase III studies as well as lower costs related to our ongoing.

Speaker Change: <unk> open label extension trial.

Speaker Change: SG&A expenses were $36 4 million for the second quarter compared to $30 million for the same quarter last year.

Speaker Change: Q2, SG&A represented a 6% decrease in sequential quarterly.

Speaker Change: On a sequential quarterly basis versus $34 4 million for the first quarter of 2020 for the quarter over quarter increase was due to increased levels of stock compensation.

Speaker Change: For the second quarter weighted common shares outstanding were $61 million, let's move to the next slide for a more fulsome discussion of EPS and cash on hand.

Speaker Change: On slide 2021.

Speaker Change: As of June 32024, we reported $319 million in cash and cash equivalents, which includes net proceeds from the convertible preferred financing that closed in April.

Hunter Smith: While no cash dividends are payable prior to the end of the second year post-closing, US GAAP classifies these pending payments as increasing rate dividends, i.e., 0% dividends in years one to two and 6% dividends thereafter, and requires that we accrue for a portion of those dividends payable in future years. With that, I'll turn the call back over to David.

David Meeker: Thank you, Hunter. So as I was reflecting and listening to our update here, it was almost two years ago to the day when we presented the first six weeks of data on the BBS launch.

Speaker Change: To aid here it was almost two years ago to date, when we presented the first six weeks of data on the DBS launch.

Speaker Change: In August of 2022 and at that point I mean, there are a ton of questions. You had questions. We had many questions and two years later.

Speaker Change: It's quite remarkable I think you've heard quarter on quarter as we've reported.

Speaker Change: How.

Speaker Change: And the way thrilled in some level a bit surprised by the extent of approval the extent of progress that we've made in the number of approvals we've had around the world.

Speaker Change: So.

Speaker Change: From Bbs standpoint, we're in a really good place we're incredibly excited about the progress to date and we're increasingly excited about what is ahead, so with that I will open it up for questions.

Speaker Change: Thank you as a reminder to ask a question at this time. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment, while we compile our Q&A roster.

Speaker Change: And our first question is going to come from the line of Jeff Hung with Morgan Stanley. Your line is open. Please go ahead. Thanks.

Speaker Change: Bbs.

Speaker Change: Testing done and genetic results and there are opportunities for us to understand who are the physicians with positive Bbs patients.

Speaker Change: So when new opportunities like that pop up those are opportunities that we explore and evaluate in terms of if it's worth being able to execute on.

Speaker Change: From a payer perspective, I would say that we're very happy in terms of our current status and the.

Speaker Change: Number across each of the different.

Speaker Change: [noise] payer types of folks who happens to very specific policies in place.

Speaker Change: I think the one lever that still remains and you know still ongoing.

Speaker Change: Ongoing dialogue is this space around Medicare, which has been a challenge for them.

Speaker Change: Many other drugs as well.

Speaker Change: Great and then second question is can you just remind us of what you hope to see in stage two of DAYBREAK later this year.

What kind of a placebo adjusted benefit would be considered clinically meaningful.

Speaker Change: Would there be sufficient numbers of patients to get a sense.

Speaker Change: And if not and like how do you decide which genotype students. Thanks so much.

Speaker Change: Yes, Jeff that is a challenge with DAYBREAK and again as we've said that was a very ambitious effort starting out with a very large number of genes and we knew.

Speaker Change: That is coming out of this we would likely have relatively small number of patients for GE and so with that qualification.

Operator: Thank you and one moment as we move on to our next question.

Speaker Change: Both trends.

Speaker Change: Which is important.

Speaker Change: We did not achieve these pre EMEA approval axis.

Speaker Change: Just on phase two data, which is extremely rare and to be more precise there are just too rare disease therapy with such status and trends in the last 10 years.

Speaker Change: So I will not give a precise number of patients, but yes, we are happy with the uptake.

Speaker Change: We are happy with.

Speaker Change: The willingness to treat coming forms of rare endocrine disease community and <unk> also to treat so what was that for France, and Italy. It will there's a first patient will be likely.

Speaker Change: At the end of the year. We also expect because we have already had conversations with many of the stakeholders in exports. We also expect a significant traction of course.

Speaker Change: A number of the population is a big difference as you've heard it.

Speaker Change: Between six and 24 years old, but is comparable to <unk>, we expect to patients to start of the year end.

Speaker Change: And then early next week Thanks Jos.

Speaker Change: That's helpful. Thanks, again for taking our questions.

Speaker Change: Thank you and one moment as we move on to our next question.

Speaker Change: And our next question is going to come from the line of Whitney <unk> with Canaccord Genuity. Your line is open. Please go ahead.

Whitney: Hey, guys I'll add my congrats on the quarter.

Whitney: Just to follow up on Phil's question on the HL patients in France, or there is there any data being collected on those patients.

Unknown Executive: six-month talk study to be able to treat patients for longer than four weeks, and so that will be a key aspect, and so that will finish up in you know mid to late fall here and will be a key trigger for moving on into Part C.

Whitney: Wow.

Speaker Change: Important university hospitals in currency for your information we have 15 of these university hospitals, who are already treated twitching of Bbs patients. There is a major center in the west of Germany with many many Bbs patients. So one of the key factor of our success for us is to.

Whitney: Continue Philadelphia decentralization and two to.

Whitney: To speak to them more hospitals and more more physicians.

Whitney: In terms of compliance or in terms of patient adherence, we have a very strong pace.

Whitney: <unk> program in place.

Speaker Change: As nurses and tailor our program so sometimes enough will be at home for each injection, sometimes once a week, sometimes once a month they are in touch with the patients that caused them to text them et cetera.

Whitney: And it's one of the country.

Speaker Change: The world.

Paul: The best at their own thanks to these patients to Paul Paul.

Speaker Change: So it was one of the answer I would say, it's a major factor.

Unknown Executive: facts about Germany that I can talk to you about.

Whitney: It's about Germany.

Speaker Change: I can talk.

Speaker Change: Talk to you about.

Speaker Change: Okay, great. Thanks, so much.

Speaker Change: Thank you one moment as we move onto our next question.

Speaker Change: And our next question is going to come from the line of Brian Johnson with Goldman Sachs. Your line is open. Please go ahead.

Unknown Executive: So maybe I'll take the first one and Jennifer take the second one.

Unknown Executive: Yeah, so, Jan, I'll let you take the pricing question and you...

Unknown Executive: between BBS and HO. There'll be some that'll be you know, sort of at the BBS end of the express https://www.youtube.com

Brian Johnson: Yeah. The question was just around pricing in Europe as we go to other countries should be should be seen in others think differently about pricing as we get into some of these smaller markets.

Brian Johnson: Sorry.

Speaker Change: Breaking again so your question is yes.

Speaker Change: It runs between price season is a key European countries in the smaller countries.

Unknown Executive: Yeah, so exactly. So the question is, as they develop their model,

Speaker Change: Yeah. So.

Speaker Change: So the question is as they develop their models should we think differently as we move from the Germany, and France as to some of the smaller markets in terms of what the pricing we might expect to get.

Unknown Executive: Okay, okay. So yes, no.

Speaker Change: Okay. So yes no.

Speaker Change: It's an interesting question because in fact, sometimes we.

Yann Mazabraud: So it's an interesting question because, in fact, sometimes we have higher prices where we don't expect them, and we end with lower prices when we were expecting maybe a medium type of price. So I would say first that there is not a rule, especially in recent years, where there have been a lot of prices that are a bit lower. Spain is one example. But I mean, yes, we've had good surprises with what I can say in general about pricing in Europe.

Speaker Change: We have higher price, where we don't expect zim.

Speaker Change: And with lower prices when we were expecting maybe medium type of prices. So I would say first is that there is not.

Speaker Change: Sure.

Speaker Change: Especially in the last years.

Speaker Change: We have not been a lot of.

Speaker Change: Changes in terms of negotiation dynamics et cetera. So.

Speaker Change: I would say is that.

Yann Mazabraud: So with our pricing in Europe, and I think it's really because PPL and BBS have been recognized as rare diseases, distinct from general obesity, and priced as such. So I cannot answer country by country, but for sure, we are in the same range as other more typical rare disease therapies and Christina.

Operator: And our next question is going to come from the line of Joseph Stringer with Needham and Company. Your line is open, please go ahead.

Unknown Executive: So I characterize it as modest. Jennifer's gonna provide some more color. In terms of

Operator: And our next question comes from the line of Michael Higgins with Landenburg-Solomon. Your line is open. Please go ahead. All right, guys.

Michael Higgins: All right guys, congrats on the strong results. Looking forward to seeing pivotal HO data in the first half of 2025. In regards to NCIVRI, earlier this year you had an issue with one of your Medicaid state programs and reimbursement. Any update for us on the progress and getting that business to return? Thanks.

Unknown Executive: So the guidance in the past has been that for us, we really didn't put in our forecast that we were going to regain all of those patients back, and that was also our guidance for others just in terms of consideration. We still do get prescriptions from that state, and like I said, it may be a slow process, but our teams are very actively working through to try to gain approvals for these patients.

Unknown Executive: Michael, I think that's the key. This state is working. It's just, you know, in the beginning, one of the more, perhaps more liberal policies. You know, clearly there were more patients going through, but it is working. And, you know, we're continuing to get patients through, so we're feeling good about that.

Unknown Executive: Michael, I think that's a

Speaker Change: Yeah.

Speaker Change: [music].

Speaker Change: Sure.