Q4 2024 PTC Therapeutics Inc Earnings Call
Speaker Change: Ladies and gentlemen, thank you for standing by. Welcome to the PTC Therapeutics fourth quarter and full year 2024 earnings conference call.
Speaker Change: All participants are in listen-only mode. After the presentation, there will be a question and answer session. Today's conference is being recorded. I would now like to turn the conference over to Ellen Cavallari, Head of Investor Relations. Please go ahead.
Thank you.
Speaker Change: Good afternoon and thank you for joining us to discuss PTC Therapeutics fourth quarter and year end 2024 corporate update and financial results. I am joined today by our Chief Executive Officer, Dr. Matthew Klein, our Chief Business Officer, Eric Pauwels, and our Chief Financial Officer, Pierre Gravier.
Speaker Change: Today's call will include forward-looking statements based on our current expectations.
Speaker Change: These statements are subject to certain risks and uncertainties, and actual results may differ materially.
Speaker Change: Please review the slide posted on our Investor Relations website in conjunction with the call, which contains information about our forward-looking statements and our most recent annual report on Form 10-K, filed with the SEC, as well as our other SEC filings, for a detailed description of applicable risks and uncertainties that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.
Speaker Change: Additionally, we will disclose certain non-GAAP information during this call. Information regarding our use of GAAP-to-non-GAAP financial measures and a reconciliation of GAAP-to-non-GAAP are available in today's earnings release.
Speaker Change: I will now pass the call over to our CEO, Dr. Matthew Klein. Matt.
Matthew Klein: Thank you all for joining the call today. 2024 was a year of outstanding execution across every part of the company.
Speaker Change: With our many 2024 accomplishments, we are well positioned for success in 2025 and beyond. I will now review some of our 2024 highlights and discuss some of our plans for 2025.
Speaker Change: In 2024, our customer-facing teams delivered another year of strong commercial performance. Fourth quarter revenue totaled $213 million and full year 2024 revenue was $807 million, exceeding guidance.
Speaker Change: These results are a testament to our commercial team's ability to effectively execute around the globe, even in genericized and competitive markets.
Speaker Change: With this strong commercial performance, effective OPEX management, and the rapid modernization for $150 million of the PRV received with the ability approval, we ended 2024 with over $1.1 billion in cash.
Speaker Change: And following the closing of the Novartis PTC 518 transaction, we received an additional $1 billion in January.
This strong financial position enables several important things.
Speaker Change: It allows us to support our planned 2025 commercial launches, continue to invest in our innovative R&D platforms, and engage in business development activities to complement our existing commercial and R&D portfolios.
Speaker Change: In addition, in this time of uncertainty on a macro level, our cash position provides the potential to reach cash flow breakeven without the need to raise additional capital.
In 2024, we've also achieved all clinical and regulatory milestones.
Thank you for joining us on schedule.
Speaker Change: We submitted four approval applications to the FDA, all of which were accepted for review.
Speaker Change: Kability for AADC deficiency which was approved in November, Cepheid Karen for PKU which has a regulatory action date of July 29, 2025.
Speaker Change: TransLarnap and Nonsense Mutation DMD, and Vitiquinone for Phragic Zytaxia, which was accepted with priority review and has a regulatory action date of August 19, 2025.
Speaker Change: These submissions create the potential to have four commercial launches in the U.S. within 12 months.
Speaker Change: In addition, outside the U.S., we submitted a number of marketing authorization applications for Sepia Tarin to support the planned global launch.
Speaker Change: In December, we announced a global development and commercialization collaboration with Novartis for the PTC 518 Huntington's disease program. As part of the agreement, which closed in January, PTC received $1 billion up front and is eligible to receive up to $1.9 billion in development and sales milestones.
Speaker Change: In addition, PTC will receive a 40% profit share in the U.S. and double-digit tiered royalties for ex-U.S. sales.
Speaker Change: Novartis will assume all development, manufacturing, and commercialization costs of PTC 518 following the completion of the placebo-controlled portion of the PIVOT-HD trial.
Speaker Change: Strong economics of this deal are commensurate with the promise of PTC 518 as potentially being the first disease-modifying therapy for HD.
Speaker Change: As we look forward to 2025, we anticipate several value-creating milestones, including the global launch of sepia tarin, 12-month results from the Pivot HD study of PPC518, and a number of regulatory decisions in the U.S. and around the globe.
Speaker Change: Starting with the global launch of sepiaterran, there's a great deal of excitement for patient and physician communities for sepiaterran, given the significant unmet need and the strong data package generated to date.
Speaker Change: We continue to collect data that support the potential for sepia-tearing to address all key patient segments, including therapy-naive patients, patients not well served by existing therapies, and patients who have failed existing therapies. Eric will provide more details on our global launch planning shortly.
Eric Pauwels: Also in 2025, we look forward to the potential launch of the Tiquinone in the United States. If approved, the Tiquinone would be the first therapy for pediatric Friedrich ataxia patients and could provide an effective and well-tolerated treatment option for adults with FA.
Eric Pauwels: Turning to our PTC 518 Huntington's Disease Program, in the second quarter we plan to share 12-month results from all patients in the PIVOT-HD trial, approximately 140 in total, which includes stage 2 and stage 3 patients.
Eric Pauwels: These results will include safety and tolerability data, biomarker data including Huntington protein levels, as well as data on clinical scales including the total motor score and CUHDRS.
Eric Pauwels: Based on our discussions with FDA in December, the results of this study could support Huntington lowering as a surrogate endpoint for accelerated approval of PTC 518.
Eric Pauwels: In summary, with our strong performance in 2024 and demonstrated ability to effectively execute across every part of the business, we look forward to an exciting and successful 2025.
Eric Pauwels: I will now turn the call over to Eric to discuss our commercial performance.
Eric
Speaker Change: Thanks, Matt. Our commercial team continued its strong performance in the fourth quarter with revenue results driven by our inline products, including our DMD franchise, despite significant challenges for both TransLarna and Implaza.
Speaker Change: I want to note that TransLarder remains on the market in the EU, and we continue to generate revenue in the first quarter consistent with 2024 levels, and have even had new patient starts.
Speaker Change: and we will continue to provide the only therapy to treat the underlying disease for nonsense mutation DMD patients as long as it remains authorized.
Speaker Change: As Matt mentioned, TransLorna is currently under review by FDA and our experienced U.S. team is well positioned to bring TransLorna rapidly to patients pending potential approval.
Speaker Change: Our IMPLAZA performance was solid as we see continued brand loyalty from physicians, patients, and caregivers.
Speaker Change: While there may be brand erosion for future generic entries, we continue to successfully defend Implaza as we prepare to expand our neurology portfolio in the U.S. this year with two potential new product launches.
Speaker Change: Moving to Septia Terran for PKU, we are actively preparing for the potential upcoming global launches in the U.S., Germany, Japan, and other key countries.
Speaker Change: We are focusing on key markets with approximately 58,000 addressable PKU patients where reimbursement of medical therapies is available.
Speaker Change: We will coordinate a specific strategic launch sequence targeting septiateran access for a majority of these patients in the first 12 months of launch.
Speaker Change: The U.S. represents the largest opportunity for septioteran with approximately 17,000 PKU patients, of whom a vast majority are not on medical treatments.
Speaker Change: Of those, most patients have already tried existing therapies, and were poorly controlled or failed, and are currently without any treatment options other than a highly restrictive diet.
Speaker Change: The clinical efficacy of septioterin supports its potential to address all PKU patient segments, including patients who have failed current therapies,
Speaker Change: patients who are not well controlled or tolerating current therapies and therapy naive patients including those with classical PKU.
Speaker Change: Our customer-facing teams are actively profiling main centers of excellence and meeting with key stakeholders in preparation of the upcoming launch this summer.
Speaker Change: These stakeholders include health care professionals, nurse practitioners, and metabolic dieticians who are instrumental to medical treatment decisions and are often the first line of contact with children and parents when diagnosed early.
Speaker Change: In addition, they also provide long-term continuity of care well into their adulthood.
Speaker Change: Our key pillars of successful commercial launch are in place for sepiateran. First, along with the newborn screening, there is a well-diagnosed prevalent patient population, and these patients are closely tied to centers of excellence to manage their disease, even if many are not currently on medical treatment.
Speaker Change: Second, with the vast majority of PKU patients who have poorly controlled fee levels in need of effective therapy,
Speaker Change: Septia Terran's well-differentiated dual mechanism of action and clinically meaningful efficacy across a broad population of PKU patients positions its potential to become the future standard of care.
Speaker Change: Septuaterine rapidly improves feed lowering, allowing many more patients to overcome the challenges of dietary restrictions and neurocognitive consequences of the disease.
Speaker Change: Third, the clinical profile of septioteran has been presented to many payers who clearly understand the value proposition of more effective feet control that can be measured rapidly via lab testing potentially reducing the time for patients to receive therapy.
Speaker Change: With these pillars in place, and leveraging PTC's experienced global commercial infrastructure for rare disease, we believe septioterin has the potential to exceed $1 billion in revenue opportunity.
Speaker Change: Now, turning to the Vidiquinone program for FA, where there is a significant unmet need for all patients.
Speaker Change: Our U.S. commercial team is preparing to expand our neurology portfolio with an upcoming launch following a potential FDA approval this summer.
S.O.S. S.O.S. S.O.S.
Speaker Change: The current approved therapy for FA is only indicated for patients 16 and older. In the United States, there is an estimated prevalence of 6,000 patients. About one-third of them are pediatric and for whom there is no approved therapy.
Speaker Change: PTC has many years of experience in neurology, especially in raising disease awareness, which can increase earlier diagnosis, benefiting all FA patients.
Speaker Change: We believe disease awareness and education will move diagnosis to occur sooner.
Speaker Change: and at an earlier age, providing an opportunity to slow disease progression in more FA patients.
Speaker Change: There are also many adults with FA who are currently not on or cannot tolerate current therapy.
Speaker Change: And we believe viticinone's well-differentiated mechanism of action, with long-term safety and efficacy, can provide an important treatment option for these patients suffering from this devastating, rare neurological disease.
Speaker Change: This is a very exciting time for our global commercial team as we prepare for multiple new product launches throughout the year.
Speaker Change: With that, I will now turn the call over to Pierre for a financial update. Pierre? Thanks, Eric. I will now share the financial highlights of our fourth quarter and full year 2024.
Pierre Gravier: Beginning with top-line results, total revenue for the fourth quarter was $213 million, including $144 million from the DMD franchise.
Pierre Gravier: From Flana, net product revenue in the quarter was $94 million, while in Flasa, a net product revenue of $50 million.
Pierre Gravier: For RISD, fourth quarter global net revenue of approximately 415 million US dollars was achieved by Roche, resulting in royalty revenue of 58 million for PTC.
Pierre Gravier: A full year 2024 total revenue was $807 million exceeding guidance.
Pierre Gravier: This included DMD franchise revenue of $547 million and Everyday Royalty revenue of $204 million.
Pierre Gravier: For the fourth quarter of 2024, non-GAAP R&D expense was $116 million excluding $9 million in non-cash stock-based compensation expense.
Pierre Gravier: compared to $113 million for the fourth quarter of 2023 excluding $8 million in non-cash stock-based compensation expense.
Pierre Gravier: Non-GAAP SG&A expense was 76 million for the fourth quarter of 2024, excluding 8 million in non-cash stock-based compensation expense.
Pierre Gravier: compared to $68 million for the fourth quarter of 2023, excluding $8 million in non-cash stock-based compensation expense.
Pierre Gravier: We have provided a wide initial total revenue guidance for 2025 of $600 million to $800 million, including in-line products, potential new product launches, and royalty revenue from MVP.
Pierre Gravier: We plan to update our guidance as we gain greater clarity on several factors that could impact revenues.
including regulatory decisions.
Pierre Gravier: We anticipate non-GAAP R&D and SG&A expense for the full year 2025 to be between $730 million and $760 million, excluding estimated non-cash stock-based compensation expense of $75 million.
Pierre Gravier: Cash, cash equivalents and marketable securities total approximately $1.1 billion as of December 31st, 2024 compared to $877 million as of December 31st, 2023.
Pierre Gravier: In addition, in January 2025, we received the $1 billion of prompt payment as part of the PTC 518 Novartis collaboration.
Pierre Gravier: This strong financial position provides us with the resources to execute on our strategy and to achieve all our anticipated milestones, as well as advance and expand our R&D efforts and explore business development opportunities to augment our commercial portfolio and pipeline.
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Pierre Gravier: And I will now turn the call over to the operator for Q&A.
operator
Pierre Gravier: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced.
To withdraw your question please press star 1 1 again.
Stand by for our first question.
Thank you. Thank you.
Thank you for watching!
Speaker Change: Our first question comes from Kristen with Cantor Fitzgerald. Go ahead, Kristen.
Kristen: Hi everyone, thank you for taking the questions. I have two. The first one is on PKU. So ultimately the understanding out there is that diet liberalization is something that could impact
Kristen: patient treatment both for naive patients as well as those on current other therapies. Do you have a sense of what the bar or the minimum that these patients would want to see in terms of liberalizing their diet to at least try sepiatarin?
Speaker Change: Thanks for the question, Kristen. You highlighted one of the most important factors for individuals with PKU and that is the ability to have a therapy that enables them to liberalize their diet, quite simply take in more protein.
Speaker Change: As we've talked about, one of the compelling parts of the
Speaker Change: is the evidence that the vast majority of patients are able to liberalize their diet. We're going to be giving an update on the feed tolerance protocol at the upcoming ACMG meeting next month in March.
Speaker Change: I'll give you a sneak preview and say that we're going to be able to show that over 97% of patients
Speaker Change: in the Feed Protocol are able to liberalize their diet, and about two-thirds of patients are able to get to the RDA, the Recommended Daily Allowance of Protein, and beyond, including a number of patients who were able to get to two times the RDA.
Speaker Change: What that means is not only are we enabling virtually all the patients in the protocol to take more protein,
Speaker Change: which is incredibly important for patients. Any amount of diet liberalization is incredibly meaningful, but we're able, with sepia tarot treatment, to enable many, or the majority of the individuals, to get beyond the recommended level of protein for you or me.
on social media.
in social media. I'm Sandy Pawwels,..
Speaker Change: our conviction of our ability to deliver a meaningful therapy for the full spectrum of patients, including those not well served by current therapies and those with classical BKU that are therapy naive. So again, we continue to collect these data and the story keeps getting stronger and stronger.
Speaker Change: Thanks. Appreciate that. We'll definitely be interested in that presentation next month. And then on Friedrichs ataxia, I think a lot of people aren't necessarily giving this credit yet, so I'm hoping, can you give us a sense of how you're thinking about the market opportunity? You laid out specifically the patient populations that you could target, but how should we be thinking about peak sales, anything around a cadence of launch,
about modeling that. Thank you again.
Speaker Change: Thanks, Kristin. I'll make a general statement and let Eric comment on how we're thinking about preparations for the launch.
Speaker Change: Look, we're excited about this opportunity to be able to bring a therapy that's demonstrated to be safe and effective.
Speaker Change: for the full spectrum of freeger cataxia patients, including pediatric patients for whom there's no available therapies. The data package from MOVE-FA, the long-term data from MOVE-FA study, and the earlier placebo-controlled study demonstrate that treatment's been associated with both short- and long-term modification of disease progression.
Eric Pauwels: We also have demonstrated strong safety in the full-age spectrum of patients and really look forward to the potential of being able to provide therapy for all FA patients. Eric, do you want to talk a little bit how we're thinking about launch preparation and market dynamics?
Yes, thanks, Matt, and thanks, Kristen, for the question.
Eric Pauwels: First of all, to Matt's point, we're really thrilled that the FDA has accepted the file and given it priority review.
Eric Pauwels: for us, it means that there is a high unmet need for all SA patients.
Eric Pauwels: In particular, I think we're looking at three areas in terms of our immediate focus. The first is obviously the pediatric population. We have a significant amount of experience, well over eight, nine years of experience right now with pediatric neurologists. We know the key hospitals.
Eric Pauwels: at Children's Hospitals, where over one-third of these patients exist. We know that this is an incredibly important segment that has nothing. The dynamics in the pediatric sector are incredibly important and quite different sometimes than the adult.
Healthcare providers and centers are really organized around these kids.
and his children.
Eric Pauwels: The parents and the caregivers are very engaged in treatment, and they really want to ensure that these patients get diagnosed early. They look at the upright stability as being an incredibly valuable endpoint.
Eric Pauwels: that is meaningful for their children and ensuring that they can maintain ambulation long-term. Additionally, these parents are really focused on high compliance. So they're really working very closely with these children to ensure high compliance and treatment follow-up and are really advocates for access to treatment.
Eric Pauwels: What we know about this whole segment that's very different is they're really seeking for safe and effective treatment that has limited or no monitoring requirements. The next segment really for us is in the adult population, and I would say that
Eric Pauwels: we, as a neurology experts as well, understand that there is high unmet need in the adult population. It's been two years since OMAB has been actually launched and there's still 80% of the patients who are diagnosed that have not had any treatment or have therapy.
Eric Pauwels: In addition to that, there are adults who are poorly controlled and can't tolerate those. About a third of those patients actually drop out after one or two years. So there's a tremendous amount of anxiety.
Eric Pauwels: in this population, and we work closely with health and healthcare providers to have emergency groups that we can engage in with our health as well. And we typically have very strong relationships. And I think our real focus is on those issues. We're talking about endometriosis and endometriosis, and we're trying to make sure that we get MGM patients treated sooner and at an earlier age.
Thank you.
Thank you. Thank you.
Speaker Change: Our next question will come from Eric Joseph with J.P. Morgan. Go ahead, Eric.
Eric Joseph: Thanks, and thanks for taking the questions. Congrats on that quarter progress. Three questions. I'll try to work it quickly. First, what kind of visibility do you have on the trans-learner review process in the U.S.?
Eric Joseph: Do you anticipate a formal PDUFA date in place ahead of a decision?
second
Eric Joseph: where it was in January, I guess, how does that accommodate or factor in TransLerna?
Eric Joseph: maintaining authorization in the EU. To some extent, do you think you should be thinking...
Eric Joseph: are trending kind of off the lower end of guidance. And then thirdly, as it relates to Volta plan and the Pivot HD update coming next quarter, I guess.
Eric Joseph: How should investors be kind of framing their expectations when looking at measures of functional benefit given the slightly different mix in patients including stage 3 disease versus the initial 12-month readout last year? Thanks for taking the questions.
Speaker Change: Thanks for the questions, Eric. I'll take one and three, and then I'll pass number two to Pierre.
Eric Joseph: So, on number one, we know the review of transluoride is ongoing at FDA. We know that clinical site inspections are moving along, and so it's clear that there is an active...
a review process occurring.
Eric Joseph: We don't expect there will be an official PDUFA date, given the circumstances of the resubmission, and why we can't guide to an official date, given the fact that the review is ongoing and clinical inspections are well underway. We remain of the belief that we should have more information and outcome in the first half of this year.
Eric Joseph: Regarding VOTA plan, we were planning in the second quarter to provide that update on the complete 12-month data from all subjects enrolled. As you point out, that'll include both Stage 2 and Stage 3 subjects.
Eric Joseph: The key we'll look at here again is the biomarker data and then as you asked on the clinical outcome scales
Eric Joseph: We know that different outcome scales have different relevances at different stages of disease. So, for example, the total motor score is something particularly relevant for stage 2 patients.
Eric Joseph: in stage 3 patients, the CUHDRS remains important, as does the TFC. So I think what we'll be doing there is looking for the whole population at each of those measures, at TMS, at CUHDRS, at TFC, much as we did in the interim readout last June. And then, of course, we'll be looking on a stage basis.
Eric Joseph: Stage 2 and early Stage 3 to see if we see a different clinical signature. But the important point is we have the endpoints in place to capture.
Eric Joseph: differential impact of treatment if one in fact exists. If it doesn't exist, then we could very much see the same pattern we observed with the interim readout last June. On top-line guidance, I'll let Pierre talk about the inputs to that and the potential for continued
Transmarine Sales in Europe.
Pierre Gravier: Yes, as it relates to our guidance for 2025, there's very limited
Pierre Gravier: transfer European sales in there. So as you pointed out, Eric, there's definitely room for upside there and we will update our guidance as we gain greater clarity on several factors that could impact revenues.
Great. Thanks. One quick follow-up, if I could, on PivotHD.
Pierre Gravier: I wonder whether there's the potential for a longer follow-up from...
The set of interim
Pierre Gravier: Some set of patients reported in the interim last June. That is to say, you know, upwards of 24 months follow-up, particularly when it comes to Huntington decline in the CSF in those patients.
Pierre Gravier: The short answer is yes, it's possible, but the timing of that readout will be driven by having all of the data available for the 12-month time point, so it's just going to be a question of how much longer-term data we have available, but clearly we understand that there's a strong interest in understanding the effects on the biomarkers over time.
Thank you for your time.
Excellent. Thanks for taking the questions.
Thank you.
Speaker Change: Our next question comes from Kelly with Jeffrey. Go ahead, Kelly.
Kelly: Thank you, congrats on the quarter, and thank you for taking my questions. I also have a couple for the PIVOT-HD trial. Firstly, from the 12 months to 24 months,
Kelly: What kind of improvement do you expect on total motor score and UHDRS and maybe also the TFC, the total functional capacity?
Kelly: And also, can you help us on the info regarding the stage 2 and the stage 3 splits for this pivotal trial? Is this relatively similar to the last interim update?
made it for the last year. Thank you.
Thanks for the questions, Kelly. On your first question,
Kelly: As we move from 12 to 24 months, what we would expect to see is continued benefit and continued slowing of progression on the TMS, as well as the CUHU-DRS and TFC as
Kelly: with time. Of course we have the placebo group out to 12 months, but what we fully expect to see is a continued slowing of progression relative to the placebo and relative to what would be understood of the natural history of progression.
Kelly: regarding the split of patients overall in the study with about half stage two and stage three. Now, keep in mind the data readout last June included only stage two patients since the initial inclusion criteria of the study was for stage two, and then we added the stage three patients later. So what you should expect in the readout.
Kelly: in the second quarter of this year, is there'll be more patients from stage three that have new data, but the overall 12-month data set that includes the initial subjects from last June and this new readout will be a balance of two and three.
Thank you for the clarification.
Thank you.
Speaker Change: Our next question will come from Tiago with Wells Fargo. Go ahead.
Speaker Change: I just have a follow-up on PKU. Kind of one of the pushbacks we generally get from investors is that the low treatment rate for those patients.
Speaker Change: So I'm curious, if you were to break down the $1 billion potential that you see in the U.S., part of that is an assumption on premium pricing, which we've kind of made clear, but how much of that is also the assumption on potential conversion of existing patients on therapy versus bringing
Speaker Change: patients quote-unquote back to medical treatment. I'm curious how much is conversion, how much is expansion, and how to think about that 1 billion dollar opportunity. Thank you.
Speaker Change: goes back to one of the earlier questions about what's important for patients with PKU and the desire to be on therapy is often related.
Speaker Change: to the ability to have a therapy that allows for diet liberalization. In the absence of therapy, individuals with PKU rely on a highly restricted, highly unpleasant diet. And so if a therapy is not able to provide the ability to liberalize that diet,
There's really no motivation to initiate a therapy.
Speaker Change: That's why we've talked about being able to access all of the segments that you mentioned, right? We know from patients who are currently on therapy and maybe having some benefit, we've demonstrated in our clinical studies and also just based simply on mechanism,
Speaker Change: We fully expect if you have a response to BH4, whether branded or generic, you're going to have a much greater benefit from sepiatarin, not only in terms of phenylalanine lowering, but also in terms of diliberalization. And again, that's something our data substantiate.
Speaker Change: Our data also show that we're able to provide benefit to patients with classical PKU as well as mutations thought to be quote-unquote non-BH4 responsive. We previously shared some very nice in vitro data showing that we can have a significant effect on
Speaker Change: on mutations of the enzyme considered to be non-VH4 responsive. And then again, we see those mutations in patients in the affinity trial. We see that those are patients, again, who we can provide significant benefit in terms of phenylalanine lowering.
Speaker Change: So when you take that as a whole, we have a data package that clearly supports the ability to access all of those patients. Patients who may be on therapies, we know we can actually...
Speaker Change: give a more significant effect if you're currently having some benefit of the BH4. If you fail BH4, you're therapy naive, or have classical PKU and not currently at the clinic, we've shown that we can address those patients as well and motivate them to come back to the clinic because we can offer the benefit of being able to potentially liberalize the diet, which is what an individual with PKU really would want to have.
Understood. All right. Thank you.
Thank you.
Speaker Change: Our next question comes from Brian with RBC. Go ahead, Brian.
Speaker Change: Hi, this is Johan from Bryan. Thank you for taking our question. On PKU, what is your sense on how the payers will potentially think about utilization management?
Speaker Change: for those who are currently taking treatments and are looking to switch and what about for those who are not on any treatments but prior experience and other therapies. Thank you.
Speaker Change: Thanks for the questions, Joe. I'll let Eric talk about the work we've done with payers as well.
are.
Yeah.
Speaker Change: So we have had extensive discussions with payers, we've also done...
Speaker Change: significant research with both U.S. and international payers. They absolutely see the profile of diet liberalization. They see the benefits of additional feed control. They also see important aspects in terms of quality of life.
Speaker Change: and neurocognitive protection. So, these are many of the things that we see with payers. So, essentially, what we're seeing right now is a willingness to pay the premium to Palanzig, but more importantly,
Speaker Change: with a large segment of the population right now, the segment that is actually uncontrolled, payers do not see any issue with going first line in those patients who are poorly controlled, failed therapies, or even those who may be on the cusp.
of
Speaker Change: reaching potentially the goal, but ultimately physicians would like to have normalization and diet liberalization.
Speaker Change: So we have not had any pushback at this point in time with regards to our Profile and and the and the payers actually see very similar things physicians do and indicate a willingness to pay a premium to Palansky
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It makes sense. Thank you.
Thank you
Our next question is from Ellie with UBS. Go ahead.
Speaker Change: Hey guys, thanks so much for taking the question. Another couple on the PKU launch. I guess, how should we think about the size of the target prescriber base and is a centralized or dispersed?
Speaker Change: And in terms of the population, and you mentioned this a little bit in terms of Tiago's question, like the longer term, but
Speaker Change: In the near term, as you approach a commercial launch, who's the population that you think could be the most rapid adopters? And I guess, how often do these patients see their physicians?
Speaker Change: And then just last one quickly, just on the pricing, did I hear correctly, you're talking about a potential premium pricing to Palanze? Just want to clarify if I heard that correctly in your latest commentary on pricing potentially in PKU. Thanks.
Thank you. Thank you. Thank you.
Eric Joseph: Thanks for the questions Ellie. Let me, I think I'll tackle the second one then I'll pass the other two to Eric.
Speaker Change: Eric, I'll explain a little bit. We've clearly mapped these centers of excellence and one of the that exists and one of the important things to bear in mind with PKU is that we're coming into an established
Speaker Change: commercial infrastructure, right? There's centers of excellence, there's a well-coordinated patient community and such, which makes the mapping exercise quite easy. The other thing we've done is not only make contact with physicians, but also importantly, as Eric mentioned in his prepared remarks,
Speaker Change: nurse practitioners and dieticians who are incredibly important members of the care team and often make care and prescribing decisions and so in
Speaker Change: We talk about contact with centers, there's physician contact, yes, but there's also, more importantly, longer-term connection with the dieticians who manage patients' diets who are not on a current therapy.
Speaker Change: Now when we think about those different segments in terms of what are the quote low-hanging fruit or where would we go first
Speaker Change: given that we have the ability to address each of these segments, and these are each large segments,
Speaker Change: We've heard, not surprisingly, that the initial segments vary from center to center. So the important message is we are able to access all of them. There's enthusiasm at the centers to treat patients in each segment, and who will get treated first may vary center to center. But we do know that there's...
Speaker Change: centers where there's already lists of very long lists of patients that they want to put on the drug that can come from any number of these segments.
Eric Joseph: So I'll let Eric provide a little more color on that as well as talking about the pricing.
Eric: Yeah, and we actually have a tremendous feedback from these centers. We have profiled all 100, actually about 103, of these centers that account for 90%. So it's very centralized at the time of when they're diagnosed.
you know, at birth.
Matthew Klein: and then as the continuity, as they get into adulthood, so that, to Matt's point, it's very, very centralized.
Speaker Change: Our medical affairs teams, our patient advocacy teams have been engaged.
Speaker Change: at a number of different levels. And what we're hearing is that physicians.
the dieticians, the metabolic geneticists.
Speaker Change: They immediately want to use this as first line for all the patients who are poorly controlled who have failed. And what has been a really big game changer is actually showing the data in non-BH4. They believe that these patients who are responding can get really key benefits.
Speaker Change: including getting more patients to goal and the diet liberalization component that that in turn leads to quality of life. So we've had a number of different things that we've done to prepare. We believe that many of these centers will will have a number of patients in operating next week.
Switch patients.
Speaker Change: And in addition to that, there'll be patients that are at the highest unmet needs, the ones that haven't responded to therapy. In addition to that, what we're doing is we have a disease awareness center and program right now where physicians and healthcare providers
Thank you. Thank you.
Speaker Change: can actually opt-in. So it's called PTC Reimagines PKU, and we are seeing increased enrollment every single week and month for people who opt-in into these programs, and what we're doing is aligning staff and everything else to handle what is potentially a very strong bolus of patients at the time of launch following FDA approval.
Speaker Change: So, there is a high degree of awareness, but also a high degree of interest in utilizing this across a broad population.
Thank you.
Great, thanks.
Thank you.
Speaker Change: Our next question comes from Gina with Barclays. Go ahead, Gina.
Thank you. I have two questions.
Speaker Change: One is regarding ventricular fractures ataxia. Did the FDA confirm that there would be no atacom?
Speaker Change: And then my second question is regarding the PIVOT HD data.
Speaker Change: in second quarter. Since, you know, this is based on your FDA feedback, this will be an important data set to show the correlation between the Huntington
a lowering and a clinical measurement.
Speaker Change: So how would you define there is a correlation? I think, for example, you have three cohorts, placebo, 5 mg, 10 mg. Do you need to see the dose response?
among all these.
three cohorts in terms of a protein knockdown.
and also the correlation to the functional measurement.
Speaker Change: And I think that you did mention two different important measurements based on the stage 2 and the stage 3.
Stage 3 and how would you
look across different measurements, which would be the most important.
Thank you for your attention. Thank you.
measurements for the FDA based on your feedback.
Gina: Thank you for the questions, Gina. For your first question, the FDA
Gina: in the acceptance of priority review, I said they had not yet reached a decision on whether they'll convene an adcom or not.
We expect we'll learn more as the...
Gina: Review continues either at the Day 74 letter or mid-cycle meeting, so we'll of course update as needed. Regarding the PIVOT-HD data readout, as you mentioned, FDA has supported scientifically the concept of HDC lowering being likely to predict clinical benefit, and then asked for us
to show in the PIVOT data set associations.
Gina: between changes in HTT protein levels and clinical measures. They were not prescriptive in terms of
Speaker Change: one correlation, an r-squared value, which endpoints, but simply said they wanted to understand from the data whether we can see some associations between changes in the HTT protein and changes in the clinical measures that can support that over the longer term.
Speaker Change: The observed HCT lowering would in fact lead to clinical benefit, which is the essence of accelerated approval.
Speaker Change: And, of course, I think it's going to depend a little bit on the data, what we're able to show. I think one of the important take-home points, as you mentioned from the interim readout last June, was the fact that we were seeing dose-dependent changes on the clinical measures.
Speaker Change: on TMS and on C-HDRS. That's really important because what that says is that if you're having twice as much lowering of Huntington protein,
Speaker Change: you're having a greater clinical effect. So even something as simple as that certainly supports the idea that the extent of Huntington lowering can influence your clinical course. So we believe if we can have similar type of data, that would be very supportive. Certainly if we have...
Speaker Change: outliers or those that have significantly more lowering and have significantly greater clinical changes.
Speaker Change: data points like that could also be helpful. So it's going to be a little bit of what the data look like, but I think there's a lot of different sources of association between the HCD changes and clinical effect.
Speaker Change: Thank you. If I can may just ask a quick question regarding the protein lowering. Did the FDA care more about the CSF Huntington protein lowering or blood Huntington protein lowering?
Speaker Change: So we discussed Huntington-Lowering as a general concept. Clearly looking at both the blood and the brain is important. Of course it's with the understanding that the CSF
Speaker Change: changes are not a direct reflection of what's going on in the cells. And we've talked a lot about how the CSF is not a cellular compartment, but but in fact, the blood cells.
Speaker Change: are a better reflection of what's going on within the brain cells because the drug activity is occurring on the neurons.
Speaker Change: Nonetheless, it is important to see what's going on the CSF because it does give us a read on what's going on in the central nervous system with regard to Huntington protein. So I would say it's the whole package gene that's looking both at the blood, the brain, and what that's telling us about Huntington lowering, and then of course looking at the associations with the clinical scores.
Thank you for watching!
Thank you.
For more information, visit www.fema.gov
Speaker Change: Our next question comes from Joel with Baird. Go ahead, Joel.
Joel Baird: Hi, thanks for taking the question. This is a follow-up to a question a couple of questions ago. For PKU, you mentioned there's a long list of patients at centers with a
Joel Baird: all of the patients waiting, could you help us think through the cadence of when those patients could start on therapy of sepia tarin and maybe what the rate limiting factors are for that?
Joel Baird: Thanks for the question, Joel. Yeah, what we were alluding to is the fact that
Joel Baird: In general, we're seeing a significant amount of market pull now, a lot of enthusiastic patients, a lot of enthusiastic physicians, as well as other members of the care team, and a desire to get on the therapy as soon as possible. Eric, do you want to speak a little bit of how we're thinking about cadence and RAMP?
Eric: Yeah, cadence is really going to be based on how our teams are going to be prepared to handle the physician start forms.
Eric: We know that the centers we're going to be preparing for already have a significant amount of experience
with PKU Medical Treatments.
Eric: So this is not going to be something new. We will be working with them very closely before and then after the launch to ensure that all the proper documentation will be assigned for those who actually have failed on previous therapies.
Eric: who are poorly controlled. That way we can minimize step edits and move directly into therapy. Our goal will be obviously to ensure that the time from the start form to the time to prescription is very, very short.
Eric: And obviously, part of our goal is to align our staffing and ensure that our case management will be able to handle that bolus. And we're very confident with our previous experience in handling that with Implaza and others, that we'll be able to pull a number of these patients through and triage, if you will, the demand at the time of launch.
Thank you.
Eric: Thank you. Our next question comes from Sammy Corwin with William Blair. Go ahead, Sammy.
Sammy Corwin: Good afternoon. Thanks for taking my questions. I was pleasantly surprised to hear that you still have new patient starts on TransLarna in Europe. And I guess I was curious if you expect that trend to continue into Q2 or how you're kind of expecting, like, what the current status of TransLarna is in Europe.
Sammy Corwin: And then, how are you thinking about the timing of additional meetings with FDA regarding Huntington's, and when do you expect to have alignment on a registrational path going forward there?
Thanks for the question, Sammy.
Sammy Corwin: In Trans-Ireland and Europe, look, we are in a bit of a unique situation, right, we talked about it expecting a European Commission action within, typically within 67 days of the CHMP opinion, I think on last count we're at day 133.
Sammy Corwin: What we do know is that the European Commission has voiced a desire to find a way to ensure that current patients remain on therapy.
Sammy Corwin: until there's any action from the European Commission the drug remains fully authorized in Europe and so not surprisingly there's interest in continuing to put patients on therapy and keep patients on therapy.
Sammy Corwin: We've talked a lot about the fact that during this long procedure with translator, what was very clear was a strong physician conviction and patient conviction of the benefit of the therapy, the safety of the therapy, and there's a clear lack of
Sammy Corwin: alternative genetically targeted therapies for non-sense mutation patients. So we fully expect there to be interest in starting new patients while authorization remains intact and continuing patients on. And again that's what we've heard is the desire of the physicians, that's the desire of the patients.
Sammy Corwin: may also be the desire of the Commission as they're trying to find a way to keep patients on therapy.
In terms of cadence of meetings regarding PTC 518,
Sammy Corwin: After the data readout, I think it'll take time for us to absorb the package. We'll obviously work with our partner Novartis.
And the partnership is underway, and we're quite excited
Sammy Corwin: in selecting a partner for PTC 518 is to have a team that can bring a lot of muscle to the effort and also have this as a priority program and that's certainly what the partnership is demonstrating.
Sammy Corwin: There will clearly be a desire to understand the PIVOT-HD data readout, and of course then move as quickly as possible to understand from FDA the potential for accelerated approval. In parallel,
Sammy Corwin: All heads are decked and all efforts are moving forward with that efficacy trial planning as we speak.
Sammy Corwin: Based on the data we've seen already from PivotHD, there's clear evidence that the drug is working the way it needs to work.
Sammy Corwin: in terms of target engagement, dose-dependent Huntington-lowering in the blood, what we're seeing in the CSF, and the early signals of clinical effect. We have the data in terms of exposure confirming that we have the necessary biodistribution to have the efficacy effect over the long term that we fully expect to have.
Sammy Corwin: So, regardless of the outcome of the PIVOT-HD interim data readout in the second quarter, it's full speed ahead now in planning for that efficacy trial, whether that's going to be a Phase III trial under a standard pathway or the confirmatory trial under the accelerated approval scenario.
Speaker Change: Great. And will Novartis be taking the lead on those regulatory interactions now, or will it be a joint effort?
Speaker Change: Yeah, I think, as we said, the partnership is about a joint development committee that's going to work together on these key elements.
Great, thank you.
Thank you for watching!
Speaker Change: Thank you. Our next question comes from Peyton with TD Cowan. Go ahead, Peyton.
Peyton Hunter-Jo: Hey, good afternoon. This is Peyton Hunter-Jo, and congratulations on all the progress in 2024.
Peyton Hunter-Jo: I guess you mentioned looking into exploring business development opportunities and prepared marks. How likely is this to occur in 2025? And is this contingent on all three therapies being approved this year? And then kind of building off that view, how do you plan to balance that with the internal pipeline? And do you plan to bring anything else from the internal pipeline into the clinic this year?
Speaker Change: Thanks for the questions, Peyton. I'll make a few comments and then I'll pass it over to Pierre. Look, we're incredibly excited to be in a position where we're in an incredibly strong position where we built a strong balance sheet with over $2 billion in cash now.
Speaker Change: steady stream of ongoing revenue and a number of very promising prospects for future revenue on the horizon, including the PKU program, which we've talked about as really being a foundation for significant future revenue.
Speaker Change: We also have two valuable platforms, highly differentiated scientific platforms, that we have, again, focused our efforts on so we can leverage the full promise of that science. I think the PTC 518 Novartis deal demonstrates once again the potential promise of splicing, small molecule splicing, as being a transformative therapy.
Speaker Change: I'm sure everyone has seen the recent New England Journal of Medicine article that just came out on a RISD showing that.
Speaker Change: a pregnant mother was given a RISD and the child was born without – the child was prenatally diagnosed with SMA. The child was born without any signs of SMA and at two years, there's no clinical signs of SMA. And so all of these factors really continue to confirm the promise and the potential for oral small molecule splicing for genetic disorders. We clearly want to continue to put our efforts and leverage the experience we have and the important learnings we've made.
Speaker Change: So, as PTC has always done, we'll continue to populate our pipeline and commercial portfolio in a combination of our innovative products, as well as things that we in-license. And, of course, as we said, as far as business development goes, we also are going to look to leverage splicing as a source of additional early-stage innovation.
Speaker Change: strategic partnerships, because while there's certainly a number of indications where splicing is relevant that PPC could develop and commercialize, there's also a number of potential indications that are non-core, such as larger congenital disease and oncology, where there's a number of splicing targets, and that could be a very valuable source of strategic partnerships. I'll let Pierre talk about how we're thinking about business development priorities in terms of the commercial portfolio and the
Thank you.
Speaker Change: Yes, and as Matt mentioned, so BD has always been part of PTC's growth strategy.
and we'll continue to do so.
Speaker Change: I think we still have a few cards to turn, obviously. You mentioned it, Peter, based on your question, is it dependent on those three products' approval? You know, we will utilize BD. The question is, are we going to go in near-term commercial opportunities, or is it going to be intermediate term? And obviously, if...
Speaker Change: You know, we are success across the board. I think our team will be extremely busy launching three products. And we welcome that challenge. But obviously, we look at more intermediate term. I think that's the way we think about BD's multi-pronged approach. And let's turn a few cars to really see in which direction we go.
Great, thank you guys.
© Pauwels, Ron Aldridge, Pierre Gravier, Matthew Klein, Jane Hanlon
Thank you.
Speaker Change: Our next question comes from Paul with Goldman Sachs. Go ahead, Paul.
Thank you for watching!
Speaker Change: Hi everyone, this is Khalil Khalil for Pauwels. Thank you so much for taking our question. I guess I'll ask about your capital position. So I see that you guys have a very strong cash position right now. And if you take out the asset impairment, it looks like you guys are close to breakeven. I guess the trends are not where he's not withstanding. I'm curious to hear what your capital deployment plans are for the remainder of the year.
Thank you.
Speaker Change: Cleo, thank you for the question. I think one of the important aspects of our strong cash position is that it was built with an understanding that we wouldn't have any TransLarna revenue contributions from Europe in 2024 nor 2025.
Speaker Change: So, in fact, what we've been able to continue to generate revenue for TransLarn in Europe in 2024, and continue to see in 2025, is all upside from the very strong base capital position that we've established.
So I think it's important as we sit here.
Speaker Change: where we are today with the strong cash position, the solid foundation of revenue we have today, and the very important prospects of near-term revenue in terms of the PKU program, which we've talked a lot about, the potential for Friedrichitaxia, the potential for TransLauren in the U.S. is all
Speaker Change: Since mutation patients here in the U S. And then lastly on Translarna. How are you thinking about the competitive landscape with the introduction of gene therapy, which does seem to be having a good initial uptake.
Speaker Change: Thanks for the questions <unk>, so starting with the question around the splicing modulation and competition look I think we've talked a lot about the essential element is to have a successful splicing molecule.
Speaker Change: One having a high degree of selectivity and specificity for the target having full brain bio distribution, which is incredibly important while huntington's disease at certain stages is thought to be.
Speaker Change: A disease of the striatum, it's it's not it's a full brain disease, and if youre going to effectively.
Speaker Change: Leverage the benefits of Huntington lowering youre going to want to have full brain bio distribution. So when we think about some of the more advanced therapies now Pete.
Speaker Change: <unk> is the only therapy, that's oral highly selective and specific for the Huntington target.
Speaker Change: As well as achieve full bring by a distribution now there are of course other therapies in much earlier stages with a long way to go but I think right now.
Speaker Change: We're quite confident in our leading position in the field in terms of EQT lowering and the significant.
Differentiating factors that makes <unk> unique and hold so much promise and is the reason why to date, we're seeing such important evidence of Huntington lowering effect as well as safety and Tolerability.
Speaker Change: On the Trans warrant a launch question.
Speaker Change: Hi.
Speaker Change: PTC is.
Speaker Change: Commercializing DMD therapy for a long time, and we were the first in the space of a developing DMD therapies. So that our roots are deep and we're incredibly well connected.
Speaker Change: The patient communities and the physician communities in terms of specifically cap.
Speaker Change: Capturing the market I'll, let Eric talk about I'll, just make one important concept.
Speaker Change: Trans Lauren if a proven yes would be the only genetically directed therapy, specifically for nonsense mutation DMD patients and there are a number of limitations with nonsense mutation DMD that fall into exxon's that may be relatively contraindicated are contraindicated for the gene therapy. So we believe that there is a definite.
Speaker Change: The room for a nonsense mutation specific therapy.
Speaker Change: So when you talk about how our resources, we have and how we would go about.
Speaker Change: Launch.
Speaker Change: Yes, <unk>. Thanks for the question good to hear from you.
Speaker Change: Excited with the opportunity and I can only say, it's really plug and play to Matt's point, we believe that already we have a very strong connection with the DMD community. We have treated thousands of patients over the last eight years and we have a database right now.
Speaker Change: All of these patients who have been treated with an plaza that we can go back into and obviously provide geno typing and and.
Speaker Change: Allow them to have access to it if they test for nonsense mutation. We also have close to 150 patients that are in our clinical studies and many of them have been on for almost 10 years. So they've been getting benefit from that we would expect to convert them as well so between the context of Av.
Going into the existing database that we have our experienced within DMD and understanding that there's approximately 10% to 15% of that of the prevalent population that could have nonsense mutation.
Speaker Change: Were already set.
Speaker Change: To be able to provide the therapy to these patients at a very rapid manner. So having that experience over the last eight years is really for us a plug and play situation.
Speaker Change: Thank you.
Speaker Change: Our next question will come from David with Citi Go ahead David.
David: Thank you very much for taking my question.
In terms of your meeting with the FDA on Huntington's in December.
David: So they provide a framework for which clinical endpoints they want to see and what they want to see from them and in an analysis.
Thanks for the question David They were not per script to the FDA was not prescriptive. What they said is they certainly appreciate the scientific rationale supporting Ht lowering.
David: As potentially or likely to provide clinical benefit given the fact that it's a monogenetic disease. The disease is caused by the mutant Huntington protein and the wealth of preclinical and some clinical evidence showing that lowering Huntington has in fact been associated with clinical benefit so with all of that as background. There asked us pause to look at the data.
David: And that we're collecting and be able to show some associations between changes in HGT levels and clinical effect and so they were not prescriptive in terms of specific P value specific endpoint specific correlations are analytical methods, but simply said as we look at the data can we provide some evidence that theres associations.
David: So we've talked about the dose dependent effects, we observed at the interim cut out and of course. That's one example that supports that the more Huntington long when you get the more differentiated clinical effect you could have so those are the kinds of things, we're thinking about heading into the full data readout in Q2.
David: Got it thanks for that and then towards that end.
David: They want to see some of that data with respect to the prior update or are they just want to wait until after <unk>.
David: So to be clear, what we went into the meeting in December of course, we provided them all of the data that we had to date and to provide them confidence that we were in fact, achieving the magnitude of Huntington lowering between 2050% that in fact hasnt been associated with clinical benefit. So that was an important part of the story as well as the dose dependent changes.
David: Of course, they were aware.
Having data on additional 100 patients in a few months and not surprisingly they're interested to see if these trends continue as we turn the card over on the next 100 patients.
Speaker Change: Yes. Thank you very much for taking the question.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Joseph with Leerink Partners go ahead Joseph.
Good.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: No. That's based on published natural history, particularly early on total total motor score is that I think how youre thinking about the larger cohort of patients who your ability of show associations with Huntington lowering that the FDA is looking for.
Speaker Change: Also other competitors in the space have switched to natural history comparisons. After one year placebo control is that something Youre also doing another way should we expect to see two year data and that's my set of patients versus the placebo or our external natural history control. Thank you.
Speaker Change: I apologize if we missed the first part of your first question you didn't come through or do you mind repeating that.
Speaker Change: Oh, just the smaller cohort the 12 month data the placebo arm looked slightly worse than what we would expect our natural history, especially on total motor score does that affect how youre thinking about the larger cohort to cohort of patients in your ability to show the association's at the FDA is looking for.
Speaker Change: Okay. Thank you for the question so.
Speaker Change: The reason, we do placebo controlled studies is because they provide the best benchmark for the patients who enrolled in the trial and are exposed to therapy, that's the whole.
Speaker Change: The concept behind the gold standard of a clinical trial of the patients would be identical except for the receipt of the our except for receiving the intervention in this case PTC 518, so while it might be that the placebo group look a bit different than natural history. I think it speaks to the fact that HD is a heterogeneous disease and even.
Speaker Change: If you have patients who are specifically quote unquote stage to the specific factors that could be driving their progression again highlights the importance of having a placebo group one of the thing one of the things. We did do in pivot HD was to stratify patients by what's known as the pin score, which is a prognostic score.
Speaker Change: So that is predictive of how rapidly patients would be grasp. The reason we did that is because even within stage. Two there is a number of other factors that could impact one of patients' baseline status in terms of baseline Tms or other scores and to how quickly. They would progressed. So I think we're not.
Speaker Change: All concerned regarding what the placebo group group look like but in fact, we hold onto that as being very important because it is a very good benchmark of how similar patients would have done if they did not receive PTC five eight.
Speaker Change: I think we're currently.
Speaker Change: The only group in development right now that has 12 months of placebo controlled data, which again, we think is very important as we get out to longer terms, we could certainly think about the use of.
Speaker Change: Natural history to augment what we've observed over the first 12 months and that's something we can we can certainly do overtime.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: This concludes the question and answer session I would now like to turn it back to CEO, Dr. Matthew Klein for closing remarks.
Speaker Change: Thank you all again for joining the call today, we are incredibly excited about the successes of 2024 and the incredible strong position the company as in.
Speaker Change: Two for continued success in 2025 and beyond we look forward to a number of catalysts coming this year and sharing them with you and continuing our growth and success. So again. Thank you all for joining the call and have a good evening.
Speaker Change: Thank you for your participation today's conference. This does conclude the program you may now disconnect.
Speaker Change: Okay.
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Speaker Change: Okay.