Q4 2024 Amicus Therapeutics Inc Earnings Call
Bradley Campbell: Thank you for joining our conference call to discuss amicus therapeutics full year 2024 financial results and corporate highlights leading today's call. We are proudly Campbell, President and Chief Executive Officer, Sebastien Martel, Chief Business Officer, Dr. Jeff Castelli, Chief Development Officer, Simon Harford, Chief Financial Officer, joining for Q&A.
Rosenberg: Rosenberg Chief legal officer.
Rosenberg: As referenced on slide two we might make forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 relating to our business as well as our plans and prospects are forward looking statements should not be regarded as representation by us that any of our plans will be achieved any or all of the forward looking statements made on this call may turn out to be wrong and can be.
Rosenberg: <unk> by inaccurate assumptions, we might make or by known or unknown risks and uncertainties.
Rosenberg: You should not place undue reliance on any forward looking statements, which speak only to the date hereof. All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update this presentation and conference call to reflect results or circumstances. After the date hereof.
We'll disclose discussion of such forward looking statements and the restaurant uncertainties that may impact them. We refer you to the forward looking statements and risk factors section of our annual report on Form 10-K for the year ended December 31, 2024 to be filed with the Securities and Exchange Commission today.
Speaker Change: At this time, it's my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer Bradley.
Bradley Campbell: Great. Thank you Andrew and welcome everyone to our full year 2024 conference call I'm very pleased to highlight what was a remarkable year for amicus exceeding expectations across our global business in 2024.
Bradley Campbell: And this time, we delivered significant top line revenue from our global commercial business to provide us with a solid platform for sustainable growth in the years ahead.
Bradley Campbell: With our portfolio and global rare disease capabilities, we have a clear path to deliver continued revenue growth and accelerating profitability in 2025 and in the years ahead.
Bradley Campbell: We have firmly established amicus as a unique biotechnology company with two growing medicines with long commercial runways are leverages <unk> global infrastructure and the financial strength to continue to build the business. We are confident amicus is in a great position to achieve our vision of becoming one of the leading rare disease biotechnology companies delivering gray.
Bradley Campbell: Medicines for patients and creating great value for shareholders.
Bradley Campbell: As we did in this morning's press release, let me highlight several key points about our about 2024 on slide four.
Bradley Campbell: First we continued our excellent commercial execution and delivered total revenue of $528 million for the full year, representing 32% growth year over year or 33% on a constant currency basis.
Bradley Campbell: At the product level <unk> continued its outstanding performance and we're very pleased with the robust commercial growth of this precision medicine globally at the end of 2024, they were more than 2700 people living with Fabry disease, taking California for.
Bradley Campbell: For the full year <unk> revenue was 458 million, which represents 18% growth year on year or 19% at constant exchange rates.
Bradley Campbell: <unk> continues to be one of the fastest growing products within the fabry treatment space and in 2024, the number of new patients actually grew with the largest rate since the first years of launch.
Bradley Campbell: This growth was driven primarily by net new patient starts in both the naive and switch populations in our leading markets, including continued penetration into the diagnosed untreated population, which we expect to be a major driver of growth in 2025 and beyond as the fabry market continues to grow through improved diagnosis and medical education.
Bradley Campbell: To put these numbers into perspective, when we first launched <unk> in 2016 market research suggested that there were about 10000 people worldwide living with Fabry disease, who had been diagnosed.
Bradley Campbell: About 5000 of them were treated at the time and about 5000 were untreated.
Bradley Campbell: Fast forward to 2024, and there are now 18000 patients globally diagnosed with fabry disease.
Bradley Campbell: The treated market alone has more than doubled to 12000 people globally and some form of treatment for fabry, while the untreated market has also grown now to 6000 patients. So there's been significant growth from diagnosing and treating more patients.
Bradley Campbell: Regarding Gallup holds long term outlook, we announced last year settlement with Teva and our ongoing IP litigation with the agreement, allowing Teva to enter the market with the generic in January 2037. This is a huge milestone that represents a major step forward in ensuring amicus can continue to support the fabry community with <unk> for many years to come.
Bradley Campbell: These underlying market dynamics combined with some additional market expansion are strong IP protection and be over 90% compliance adherence rates that we continue to see will provide <unk> with the opportunity to grow for many many years to come including next year of excuse me. This year in 2025 with projected revenue growth of 10% to <unk>.
Bradley Campbell: 15% at constant exchange rates, we are extremely pleased by the meaningful impact. This medicine continues to make for people living with fabry disease with amenable mutations in countries around the world and we believe that we have a very clear path to surpassing $1 billion in product sales from <unk> before the end of its lifecycle.
Bradley Campbell: Second let me highlight the continued strong global commercial launch of possibility in a folder our novel therapy for late onset Pompe disease.
Speaker Change: Tom off as we like to call. It was a huge driver of growth for us in 2020 for having had multiple successful launches around the world for.
Bradley Campbell: For the full year possibility and uphold our revenue was over $70 million globally.
As we've mentioned our number one focus for the year was to maximize the number of patients on therapy by year end and as we shared earlier in January at the JP Morgan Conference. There were 220 people living with late onset Pompe disease, who had been treated or scheduled for treatment with commercial product at the end of 2024.
Bradley Campbell: With 25, new prescriptions in Q4 alone.
Bradley Campbell: We are pleased with the global demand for this new therapy and consistently hear an inspiring feedback from health care professionals around the world on how their patients are responding to possibility not pulled out most recently at the World Lvn Conference, which we think will help to further fuel the uptake in 2025 in the years to come.
Bradley Campbell: We're continuing to build momentum in our current launch countries with strong switch dynamics in the U S Europe and the U K as well as seeing great uptake right now you have patients in markets outside the United States.
Bradley Campbell: We're also making significant progress on the reimbursement front globally. This includes moving patients through the insurance process in the United States in under 30 days as we anticipated.
Bradley Campbell: Additionally, we're still highly focused on increasing patient access and expect geographic expansion to be a big part of the launch story in 2025, we're.
Bradley Campbell: We're seeking to new approvals in Canada, and Japan, and we're very pleased to announce the most recent approval of <unk> in Australia.
Bradley Campbell: And there are now 10 markets, we hope to get reimbursement and launch in over the course of the year, including the four countries that had already received reimbursement agreements by the end of 2020 for early 'twenty five and now most recently, the Netherlands and extremely.
Bradley Campbell: Really important market for Pompe disease, Sebastian will provide more details on all of these activities later in the call.
Bradley Campbell: Given the strong global launch to date and expected geographic expansion for the full year 2025, we projected 65% to 85% probability of that sold to revenue growth at constant exchange rates, which will be of course, a significant contributor to our overall revenue growth.
Bradley Campbell: This sets us on a great course to achieve our ambition for possibility of ethanol that become the new standard of care for this devastating disease. We are incredibly pleased to be providing a real choice for people people living with pompe disease, and challenging therapeutic expectations for both physicians and their patients.
Bradley Campbell: Finally, as we continue our excellent commercial execution across both therapies. We are focused on delivering significant long term revenue growth and anticipate surpassing $1 billion in total sales in 2028.
Bradley Campbell: Amicus achieved well over half of $1 billion in global revenue from our two commercial products in 2024, we judiciously managed our opex within our guidance range and we achieved our goal of full year non-GAAP profitability.
Bradley Campbell: We continue to believe that our highly leverages <unk> global rare disease organization can allow us to continue delivering strong revenue growth in the years to come as the commercial business grows and we expand our portfolio over time.
Bradley Campbell: Finally on slide five let me highlight our key strategic priorities for this year.
Bradley Campbell: First and foremost continued delivering total revenue growth of 17% to 24% at constant exchange rates.
Bradley Campbell: That includes a double digit gallon fold revenue growth of 10% to 15% at constant exchange rates as I mentioned previously possibility in a folder revenue growth of $65 to 85% at constant exchange rates. We will continue advancing our ongoing studies to broaden labels and strengthened our scientific leadership in fabry disease Pompe disease and finally, we.
Bradley Campbell: Look deliver positive GAAP net income during the second half of 2025.
Speaker Change: With that preview now let me hand, it over to Sebastien Martel to further highlight our commercial performance Sebastian.
Sebastien Martel: Thank you Bradley and good morning to everyone on the call.
Speaker Change: By providing you with more details on the organic performance for the year on slide seven for the full year 2024, <unk> reported revenue reached $458 $1 million driven by strong patient demand, particularly from our leading market.
Speaker Change: In 2024, we delivered <unk> sales growth of 19% at CER, which was above our latest guidance range of 16% to 18% at CER.
Speaker Change: We ended the year with more than 60 scarp side of the global market share of treated fabry patients with amenable mutations.
Speaker Change: We're very pleased to see the prescribers continue to position <unk> as the treatment of choice for a couple of patients with amenable volumes great.
Speaker Change: Great News.
Speaker Change: Still many more perpetual patients eligible for our therapy.
Speaker Change: Turning to slide eight.
Speaker Change: Our results in the full year highlight the strength of our commercial efforts the demand for gasoline globally continues to be strong with patients added in all major markets.
Speaker Change: We are pleased to share that in 2024, despite being on the market for eight years <unk> grew at the largest rate of new patient demand since the first years of launch.
Speaker Change: Our leading markets outside of the U S. The U K, so new countries and Japan.
The biggest driver, but based on demand in fact in 2024.
Speaker Change: With the highest year for U S growth patient stopped since launch.
Speaker Change: Growing demand gives us great competing therapies outlook over the long term.
Speaker Change: Within the global mix, which is about 60%, 40% switch, we're seeing stronger uptake in naive populations.
Speaker Change: So we continue to achieve high market shares in countries, where unit growth the longest.
Speaker Change: Still plenty of opportunity to continue to switch patients over to <unk>.
Speaker Change: To keep growing the market penetrate the diagnosed untreated.
Speaker Change: <unk> segment.
Speaker Change: So we know that there is significant patient demand for <unk> in.
Speaker Change: It is the fastest growing treatment in the probably the space to date, we also foresee the segment of the global recovery market Nadir patients with medical volumes.
Speaker Change: Should you reach up to $1 billion annual revenue by the end of the decade.
Speaker Change: For the full year 2025, the company currently forecast revenue growth got it.
Speaker Change: 10% to 15% growth on a constant currency basis.
Speaker Change: We anticipate sustained growth in 2025, MBR could be driven by several key drivers.
Speaker Change: First the fabry market is growing robustly with a significant portion of growth coming from finding new patients and reaching the diagnosed untreated population.
Speaker Change: Second we continue to make progress on expanding that according to new markets and expanding the labels.
Speaker Change: Third we're also seeing many diagnosed untreated patients transition for treatment.
Need for earlier treatment, especially females becomes better appreciated.
Speaker Change: The other piece of confusion.
Speaker Change: The other piece is continuing to drive <unk> market share of treated amenable patients through continued commercial execution.
Speaker Change: As I said earlier identical currently has more than 65% of the global <unk> market.
Speaker Change: We're seeing most of the dual market can reach up to 80, 590% of market share.
Speaker Change: So we know that theres the potential to reach those levels in the global market share as well.
Speaker Change: And last all of that is underpinned by sustained compliance and adherence rates that continue to exceed 90% reiterating our belief that those patients who go and get a full credit please stay on nonaccrual.
Speaker Change: Finally, as I mentioned in past calls due to a variety of factors, including uneven ordering patterns and ethics durations the rate of growth within that you're typically non year.
Speaker Change: You have historically seen Q1 revenues coming below the prior Q4 due to the timing of orders on the reauthorization process in the U S.
Speaker Change: And we expect that to continue into 2025.
Speaker Change: Looking ahead, we expect double digit growth will get approved in 2025, and we remain confident that with our strong IP protection that afford us a long runway well into the next decade and clear path to surpassing $1 billion in revenue in the next 12 years.
Speaker Change: Let me briefly turn the call over to Jeff to provide you with an update on some of the initiatives. We're currently supporting to improve diagnosis.
Speaker Change: Jeff.
Jeff Castelli: Thank you Sebastian and good morning, everyone.
Speaker Change: Moving to slide nine.
Speaker Change: We know there is still a significant diagnostic unmet need in fabry and have done a lot of work recently to further understand the size of the undiagnosed population and importantly, what we can do to help them have a proper diagnosis and the opportunity for treatment.
Speaker Change: Currently we have seen many new patients coming onto treatment through newborn at risk and family screening initiatives.
Speaker Change: And continue to see increased patient identification through ongoing medical education, and the support of novel screening initiatives.
Speaker Change: We're making great progress on one of our own initiatives with a machine learning AI Diagnostics company AUM, one where we're piloting that technology at Penn against over 500000 Medical records and through that process. We've identified the top 100 people in the system with a significantly increase suspicion of having diagnosed fabry.
Speaker Change: Those individuals identified are in the process of being offered a diagnostic workup and genetic testing to determine if they have fabry and then to further characterize and validate this AI algorithm.
Speaker Change: We've also been collaborating with the NHS on a pilot program in the UK to assess diagnostic disparities in rare disease, which has revealed that 85% of the people diagnosed with Andre and the UK are within the highest associated economic decile.
Speaker Change: Means theres a lot of work that can be done within and outside of the system to help identify people with undiagnosed fabry disease, who otherwise would not have been diagnosed and focused outreach efforts are underway.
Speaker Change: So Greg remains one of the most underdiagnosed rare genetic diseases. So the more people that can be identified to more people and they benefit from treatment, including California for patients with amenable mutations.
Speaker Change: And now I will turn the call back to Sebastian to continue reviewing the 2024 performance of possibility and a pull that Sebastian.
Speaker Change: Okay.
Speaker Change: Sebastian I believe you're muted.
Speaker Change: Thank you Jeff.
Speaker Change: Now, let's turn to slide 11, and we outlined here our global launch progress we've completed yet Palmpilot general pull down.
Speaker Change: We had a very successful first year of launch in the U S, Germany, Austria, Spain and the UK.
Speaker Change: And we're getting great early feedback from physicians and patients as they continue to build the body of evidence using this therapy.
Speaker Change: For the full year of 2024 completed yet or Bulgari reported revenue reached $70 $2 million in line with our latest guidance range. This is really strong growth coming up debate of roughly $12 million in 2023.
Speaker Change: We're looking at the geographic mix of revenue over the course of the year, we observed 57% of sales coming from ex U S and 43% within the U S. That's the global average for all company sales to date, we expect that number to move closer to a 50 50 split over the course of this year with the U S being the <unk>.
Speaker Change: Largest market in terms of.
Speaker Change: Patients in the highest price points.
Speaker Change: But also at the same time launching up to 10 countries. This year.
Speaker Change: Moving onto slide 12 overall, we're very pleased with the launch of the product and the first wave of countries over the course of 2024, and we remain very satisfied with the ongoing demand for this therapy as.
Speaker Change: As Brian mentioned earlier I'll focus for the year was to maximize the number of patients on therapy by year end and we ended 2024 with about 220 patients treated or scheduled for treatment and five countries. That's about 209 patients have been treated.
Speaker Change: And also about 25, new prescriptions added in Q4.
Speaker Change: And as we've stated before digital clinical trial patients and a launch market have been converted to commercial therapy by the end of the first half of 2024.
Speaker Change: Our launch of leveraged our highly experienced cross functional teams and we've had great outreach with Kols, we're seeing an increase in the depth and breadth of prescribers across all five markets, indicating to us that physicians are having positive experiences with the therapy and are gaining greater confidence in using again if patients.
Speaker Change: All core treating center the R&D.
Speaker Change: The feedback from HCP all the stakeholders.
Speaker Change: Our business approach supports and patient focus.
Speaker Change: As it relates to our progress with access and reimbursement our highly experienced and continue to attract quality conversations with payers to demonstrate the value of community get a pull down.
Speaker Change: Very pleased to say that the overall time group the U S insurance process have dropped to less than 30 days. This was exactly where we had hope to get it.
Speaker Change: In the U S. We continue to see the majority of patients switching from next year by.
Speaker Change: About 68%.
Speaker Change: And the remaining from Lumina one.
Speaker Change: This means we're switching patients proportionately from both products, we continued to see a broadening and deepening of prescriptions with more sites coming online and multiple new prescriptions from physicians.
Speaker Change: Outside of the U S. We're seeing patients from all three segments.
Speaker Change: Switching from Iowa and from Nate design.
Speaker Change: Right to the respective market shares and some from the naive population.
Speaker Change: On slide 13, we are expecting commodity kind of pulled out to be a huge driver of overall growth. This year, and we anticipate around 65% to 85% revenue growth at constant exchange rates.
Speaker Change: We see the following key drivers of growth, allowing for this to happen in 2025 and beyond.
Speaker Change: First continuing to increase the number of net new patients.
Speaker Change: <unk> talked about in the U S.
Speaker Change: 40% of mixture of foundations will be coming up to the two year Mark on therapy versus 10% last year.
Speaker Change: I mean, a larger pool of patients are more likely looking to switch to a different therapy.
Speaker Change: Secretly given our data and improvement and experienced patients demonstrated in our phase III study.
Speaker Change: Second we're also going to keep increasing the depth and breadth of prescribers.
Speaker Change: Third as I said, we'll be launching up to 10 countries new countries throughout 2025.
Speaker Change: Next we're continuing to drive differentiation of our therapy.
Speaker Change: Those generation and real world evidence.
Speaker Change: In addition to continuing to look more closely at our phase II extension studies, which continues to be an important part of the conversation with physicians, but also starting to see a number of case studies presented to conditions at congresses overtime as well.
Speaker Change: Large enough cohorts of patients where physicians can actually compare their experiences over time on the three therapy.
Speaker Change: All of these publications, we hope to be able to see coming out overtime as well.
Speaker Change: And finally, we are anticipating a 90% plus compliance and adherence rates.
Speaker Change: All of these growth drivers will help us get to that 62, 8% growth guidance range.
Speaker Change: Moving to slide 14, and looking more closely at the geographic expansion growth driver. We have emphasized a few times now that this is going to be a major driver of growth for you to kind of pull down over the course of this year.
Speaker Change: Today, we'll launch in the U S, Germany, Austria, Spain, and the UK.
Speaker Change: And I've mentioned in January we received pricing and reimbursement Italy.
Speaker Change: And now in the Czech Republic in Switzerland, and in Sweden.
Speaker Change: We're very pleased to announce today that we have also received pricing and reimbursement in the Netherlands, and that's an incredibly important pumping market. This is the country in which the Bds was actually discovered and.
Speaker Change: And one.
Speaker Change: That has a very high <unk>.
Speaker Change: You can go.
Speaker Change: As a result, the new demands of the highly regarded research hub the globally.
Speaker Change: <unk> center of excellence and respected previewed fiduciary.
Speaker Change: In Sweden pumps, you kind of pull does receive first line positioning and have had their first patient treated with commercial therapy.
Speaker Change: In Italy, the regional process approval is.
Speaker Change: Now progressing nicely with the first patient.
Speaker Change: Anticipated to occur in the first quarter of this year.
Speaker Change: We expect the first commercial patients from all of these respective countries to begin treatment in the first half of 2025.
Speaker Change: In addition, we have the regulatory dossier under review with approval in Canada and Japan.
Speaker Change: Broadly highlighted Omnichannel Borgata was recently approved in Australia.
Speaker Change: Okay.
Speaker Change: We continue to be focused on securing broad patient access.
Speaker Change: The EU.
Speaker Change: <unk> launching in up to 10, new countries in 2025.
Speaker Change: Including the five that I mentioned.
Speaker Change: That represents around 650 patients age 18 and older. This.
Speaker Change: This will be key to driving commercial uptake country. This year.
Speaker Change: Overall, we're very pleased with the ongoing launch the strength of our clinical data that the depth of experience and talent.
Gives us great confidence in our ability to make a very real difference for people living with diabetes.
Speaker Change: And with that let me hand, the call over back to Jeff to highlight our ongoing clinical studies.
Jeff Castelli: Thank you Sebastian.
Jeff Castelli: On slide 15, we outlined how we are continuing to grow the body of evidence for possibility in op soda to our ongoing clinical studies and our registry.
Jeff Castelli: Importantly for the younger pump a community we continue to enroll the ongoing open label study for children living with late onset Pompe disease and the open label Rosella study for children living with infantile onset pompe disease.
Jeff Castelli: We see this as an important opportunity to address the significant unmet needs and opportunities in these children and to support label expansion into these patient segments.
Jeff Castelli: Through ongoing clinical studies in amicus pump a registry, we continue to generate evidence on the differentiated mechanism of action and on the long term impact of palm up across endpoints and across patient populations.
Jeff Castelli: Our medical conference presence in scientific publications continue to be an important part of our education efforts, including an exceptionally strong presence at the world Symposium earlier this month.
Jeff Castelli: Moving on to slide 16.
Jeff Castelli: We once again had a very significant presence at the World Conference.
Jeff Castelli: 20, posters and two oral platform presentations, highlighting our ongoing work across both fabry and Pompe <unk>.
Jeff Castelli: This year symposium focused on a number of key themes relevant to our ongoing work in fabry and Pompe <unk>.
Jeff Castelli: One important theme as the accelerating number of patients continuing to be diagnosed across rare diseases in particular for fabry and pompe driven.
Jeff Castelli: Driven by advances in screening and access to lower cost genetic testing.
Jeff Castelli: A lot of work is also coming on to determine the best time to treat these newly diagnosed patients and we see evidence that symptoms occurred much earlier than historically believed and therefore, we're seeing a lot of.
Jeff Castelli: <unk> is moving us towards earlier treatment and these newly diagnosed patients.
Jeff Castelli: Another important theme was on the impact of the various new treatment options and amicus presented a range of data, including an analysis on the number of pump patients experiencing clinically important improvements in clinical trials.
Jeff Castelli: For Fabry disease, we also highlighted our ongoing studies to expand the real world evidence of <unk> and on the machine learning initiatives I spoke to earlier.
Jeff Castelli: And for Pompe day, we also highlighted a number of important case studies and additional data generated from real world evidence supporting the use of building up Florida. So are all of those patients living with late onset pompe disease.
Jeff Castelli: Our team had a number of discussions with key stakeholders to further drive awareness of <unk> and Tom building out, Florida and overall, we were highly encouraged by the engagement, we received and look forward to presenting additional data for both of our therapy that future medical Congresses. This year.
Jeff Castelli: And finally, we continue to focus on novel approaches to next generation therapies, and those fabry and Pompe.
Jeff Castelli: With that I would like now to turn the call over to Simon Harford, Our Chief Financial Officer to review, our financial results guidance and outlook Simon.
Jeff Castelli: Thank you, Jeff our financial overview begins on slide 18, with our income statement for the full year ending December 31st 2024.
For the full year, we achieved total revenue of $528 million, which is a 32% increase over the same period in 2023 at constant exchange rates revenue grew 33%, which was above our latest guidance of 30% to 32% growth at constant exchange rate.
Jeff Castelli: The global geographic breakdown of total revenue in 2024 consisted of $322 million or 61% of revenue generated outside the United States and the remaining $206 million or 39% coming from within the U S.
Jeff Castelli: Yes.
Jeff Castelli: Cost of goods sold as a percentage of net sales was 10% for the full year 2024, as compared to nine 3% for the prior year period.
Jeff Castelli: Total GAAP operating expenses increased to $450 million in 2024 as compared to $439 million in 2023.
Jeff Castelli: The increase of 3%.
Jeff Castelli: non-GAAP basis total operating expenses increased to $348 million in 2024 as compared to $342 million in the prior year.
Jeff Castelli: An increase of 2%, we define non-GAAP operating expense as research and development and SG&A expenses, excluding stock based compensation loss on impairment of assets changes in fair value of contingent consideration restructuring charges and depreciates been amortized.
Jeff Castelli: On a GAAP basis net loss in 2024 reduce to 56 million or 18 cents per share compared to a net loss of $152 million or <unk> 51 per share in 2023 and.
Jeff Castelli: In 2024, non-GAAP net income was $74 million or a profit of 24 cents per share compared to a non-GAAP net loss of 39 million or a loss of 13 cents per share in 2023.
Jeff Castelli: Cash cash equivalents and marketable securities with $250 million at December 31st 2024, compared to $286 million at December 31, 2023.
Jeff Castelli: As highlighted on slides 19, and 20, we are reiterating our full year financial guidance for 2025 as follows total revenue growth guidance of 17% to 24% <unk> revenue guidance of 10% to 15% and profitability.
Jeff Castelli: Not fold, our revenue guidance of 65% to 85% all growth rates are at constant exchange rates.
Jeff Castelli: As in prior years, we anticipate non linear quarterly growth of <unk> to continue in.
Jeff Castelli: In Q1, we anticipate <unk> to represent approximately 22% of its full year sales as we have seen historically in the last five ipos as.
Jeff Castelli: As we announced at our Q3 call gross margin is expected to be in the mid <unk> percent range. Today, we are introducing our 2025 non-GAAP operating expense guidance of 350 million to $370 million and GAAP.
Jeff Castelli: Net income to be positive during the second half of the.
Jeff Castelli: With our commitment to full year non-GAAP profitability during the first full year of launch the possibility of not folder.
Jeff Castelli: <unk> operating expense growth in low single digits year over year.
Jeff Castelli: Point of guidance as a reminder, we continue to have R&D commitments, including registry studies in both Fabry and Pompe pay the ongoing Pompeii phase III study in countries not yet reimbursed as well as next generation manufacturing process development for comparability.
Jeff Castelli: As previously noted we anticipate 2025 to be a hybrid tier for profitability and not felt at Cogs as we expect to work through the previously expensed inventory during the first half of 2025.
Jeff Castelli: Total gross margins for the full year 2004, where approximately 90% again, we expect gross margins in the mid 80% range for this year as we begin to recognize probability outsold our cogs through the P&L given.
Jeff Castelli: Given the proportion of amicus sales generated outside the U S. A 60% approximately we see significant FX exposure to our reported revenue numbers, the euro British pound and Japanese yen of the currencies. We are most exposed to we note that the change in the <unk>.
Jeff Castelli: <unk> dollar exchange rates of plus or minus 1% compared to year end 2024 rates could lead to a $4 million approximately.
Jeff Castelli: Move in total reported revenues in 2025.
Bradley Campbell: With that let me turn the call back over to Bradley for our closing remarks.
Bradley Campbell: Great. Thank you Simon Jasmine Sebastian as we've highlighted today, we have been highly focused on commercial execution and the performance of our two approved therapies across the global business as well as sustained financial discipline. We believe <unk> is a unique company in the biotech industry today with several key drivers of growth along.
Bradley Campbell: With significant operating leverage that over time will lead us to become one of the leading rare disease biotechnology companies. We have laid a solid foundation for amicus to continue delivering life changing therapies for people in 2025 and for many years to come with.
Bradley Campbell: With that operator, we can now open the call to questions.
Bradley Campbell: Ladies and gentlemen, if you have a question. Please press star one on you touched on the telephone.
Bradley Campbell: At this time, we request that you only ask one question. If you have any additional questions. Please re enter back into the queue.
Bradley Campbell: Thank you.
Bradley Campbell: One moment for your first question.
Bradley Campbell: Okay.
Speaker Change: First question comes from the line of testing with Banc of America Securities. Your line is now open.
Speaker Change: Hi, guys. Good morning, Thanks for taking my question.
Speaker Change: I wanted to ask about <unk>.
Speaker Change: You go through the launch and as we look at let's say the switch patient population.
Speaker Change: On average how long our doctors keeping their patients on let's say the first or second Gen <unk>.
Speaker Change: <unk> before moving.
Speaker Change: Patients over to <unk>.
Speaker Change: We've done checks, which indicate there was excitement about.
Speaker Change: The third option being available for patients who have <unk> needs, but there's also been talk about keeping patients on their first gen. John as long as possible. So I wanted to get a sense of what you're hearing from your sales force on that thanks.
Speaker Change: Sure. Thanks, Tom.
Speaker Change: I appreciate the question totally agree we continue to hear great excitement for the prospects of possibility out fold and I think Sebastian highlighted the great uptake that we've seen and Jeff two highlighted all the data that we're seeing and continuing to see it come out.
Speaker Change: Your world, but another publication that we hope to continue to support that but as you said I think there's clearly a portion of.
Speaker Change: Physicians, who suggested that they want to see a year or two of experience once they switch to patient.
Speaker Change: And I think Thats why were so excited about the U S situation, where we estimate now up to 40% of patients who have switched to <unk> will be entering into that kind of two years of experience. We have seen instances where that switch happens much sooner I think anytime where a physician sees their patient.
Speaker Change: Declining they're going to look for new answers and as we came into this market. We did share some market research that suggested that about 25% of all patients are in some sort of decline phage phase on a previous medicine and I think those are the sort of clear target opportunities but.
Speaker Change: But about 50% may be in some stable.
Speaker Change: A portion of their disease, and I think thats, where we are waiting for that kind of one to two years of experience. So really excited to see the trend so far and we think this year is going to be an important year.
Speaker Change: Get to that kind of especially the United States that large bolus of patients getting to that two year Mark.
Speaker Change: Thank you.
Speaker Change: The next question coming from the line of Ali <unk> with UBS. Your line is now open.
Ali <unk>: Hey, guys. Thanks, so much for taking my question you mentioned that there is a high prevalence of Pompeii and the Netherlands can you elaborate a little bit more on the number of patients there and specifically at that more on the timing for when you expect to start dosing in.
Ali <unk>: Recognizing revenues from that region and then just generally I know you mentioned.
Ali <unk>: But there are a lot of.
Ali <unk>: Countries, where you expect the first commercial <unk>.
Ali <unk>: To begin in the first half of the year can you maybe give us just a little bit more detail on the country by country timing for the revenues per pop.
Ali <unk>: And your expectations, particularly as we think about.
Ali <unk>: The quarterly cadence of revenues throughout the year.
Speaker Change: Sure I'll have Sebastian comment on most of that I will say just as a reminder, pompeii disease.
Speaker Change: He was first described by via Dutch position, Dr Pompeii and.
Speaker Change: The key opinion leader in the Netherlands is at World renowned key opinion leader she is an incredibly well respected in important.
Speaker Change: Researcher and clinician treater in the comp base space.
Speaker Change: And either because of.
Speaker Change: That's.
Speaker Change: Yes.
Speaker Change: The long term sort of evolution of the disease or because of the higher awareness or because of potentially both there is a much higher diagnosed population in the Netherlands versus what has been historically described in some other markets from a population perspective.
Speaker Change: And so for all those reasons, we think it's incredibly important now to be able to provide possibility up sold.
To that community.
Speaker Change: And to your question on timing in the Netherlands.
Speaker Change: We do think that we could start to see first patients coming onto to probability of default.
Speaker Change: It's sort of towards the end of Q1 or into early Q2, but it will be an important driver for us this year with that further detail Sebastian do you want to talk a little bit more around some of the other dynamics that Ali asked about.
Speaker Change: Yes.
Speaker Change: Thanks, Brian.
To do so.
Speaker Change: I mentioned that we're targeting up to 10 new countries.
Speaker Change: Countries in 2025.
Speaker Change: All in all these 10 markets could represents north of 650, <unk> PD patients in total and we highlighted also separately of those 10 five we are.
Speaker Change: <unk> had some great success from a pricing and reimbursement standpoint, and those are.
Speaker Change: Italy, the Netherlands.
Speaker Change: Switzerland, Sweden, and the Czech Republic.
Speaker Change: We also shared that those countries represent 350 plus of the 650 that I just mentioned earlier.
Speaker Change: This gives you a little bit of the.
Speaker Change: We'll achieve.
Speaker Change: The importance of those markets.
Speaker Change: Five clearly based on the comments, Brad just made about the Netherlands. This is one of the largest markets in.
Speaker Change: In Europe.
Speaker Change: We estimate that there's about 125 patients.
Speaker Change: With a low PD.
Speaker Change: Yes.
Speaker Change: In the Netherlands, Italy is also a sizable one now while the.
The Dutch market is very concentrated.
Speaker Change: The market is on the concrete pigmented and while we have already.
Speaker Change: Reimbursement at a national level, we are in the midst of regional negotiations and those are going very well, we have now I think more than five that I've already provided.
Speaker Change: The Greenlight re.
Speaker Change: <unk> reimbursement in each city, so progressing fast we indicated that.
Speaker Change: We would expect the launch in these five new markets will be.
Speaker Change: Obtained access to gradually increase over the course of the first half of 2025.
Speaker Change: Also means we've got another five markets to be launching.
Speaker Change: And.
Speaker Change: Probably more towards the second half of this year.
Speaker Change: Of those.
Speaker Change: We will win includes.
Speaker Change: Hopefully Japan with.
Speaker Change: That approval anticipated in the second half.
Speaker Change: Yes.
Speaker Change: <unk>.
Speaker Change: Closer to around the fourth quarter of this year, so that might be one of the last.
Speaker Change: You launched countries Japan.
Speaker Change: We did highlight that we.
Speaker Change: Recently got approval in Australia mentioned that we're expecting approval this year in Canada, both Australia and Canada.
Due to the.
Speaker Change: Reimbursement process would likely be launching in 2026.
Speaker Change: So again, although the regulatory approvals will be five launches in Canada, and Australia will take place in 2006.
Speaker Change: Great. Thanks.
Speaker Change: Thank you.
Speaker Change: Next question coming from the line of Dennis Yang with Jefferies. Your line is now open.
Speaker Change: Hi, good morning, and thanks for taking our questions I just had one specifically on FX can you elaborate a little bit more on FX, and where do you see that going this year, especially with this all macro narrative around interest rates being higher for longer does amicus have any hedging programs designed to mitigate.
Speaker Change: Volatility and maybe also comment how impactful those are historically thank you.
Speaker Change: Thanks, Dennis I will say, we would hesitate to speculate.
Speaker Change: Looking at Beck's given as you said all the interesting macroeconomic factors going on but.
Speaker Change: Simon maybe talk a little bit more remind dennis in the audience.
Speaker Change: What's happened with FX, So far and then answer your specific question around are there opportunities to mitigate against FX.
Speaker Change: Yes.
Thanks for the question Dennis in terms of FX.
Speaker Change: For a company of our size, we have not traditionally had.
Speaker Change: Our FX exposure, primarily because frankly, we're not.
Speaker Change: But predicting.
Speaker Change: Where FX will go as broadly as sort of said it can be a positive it can be.
Speaker Change: A negative at.
Speaker Change: Obviously with 60% of our revenues.
Speaker Change: Based outside of the U S.
Speaker Change: Some exposure to that.
Speaker Change: In both directions.
Speaker Change:
Speaker Change: I would say in terms of thinking about rate currently.
Speaker Change: As I said in my call text.
Speaker Change: Basically a one percentage point move in the dollar up or down.
Speaker Change: Essentially it is.
Speaker Change: We're roughly a $4 million.
Speaker Change: Revenue impact.
Speaker Change: Sure.
Speaker Change: But that can be positive or negative we highlighted <unk> purely.
Speaker Change: At this point in time, given where we are.
Speaker Change: With some of the discussions that are going on geopolitically as well as I think you referenced sort of more sticky inflation.
Speaker Change: It's possible that some of those actions could impact.
Speaker Change: Exchange rates, one way or the other.
Speaker Change: I would say, we're not really predicting at this point in time, but that we just wanted to understand what the impact is up or down.
Speaker Change: Perfect. Thank you.
Speaker Change: Thank you.
Speaker Change: Next question coming from the line of Joe Schwartz with Leerink Partners. Your line is now open.
Speaker Change: Great. Thanks, very much for taking my question I was wondering if you could update us on your progress towards establishing second source manufacturing for palm up and is there any.
Speaker Change: Risk or exposure regarding tariffs and the importation of palm up from China currently.
Speaker Change: Yes, Thanks, Joe really appreciate it yeah, so making great progress on the second side of manufacturing in Dundalk, Ireland with Wuxi have had successful PDQ batches of success successful European inspection, there and we're on track for commercial product to come into the supply chain in Europe.
Speaker Change: Probably in the back half of <unk>.
Speaker Change: This year in the U S. The following year so right in line with what our plan was from a global supply perspective.
Speaker Change: In terms of tariff exposure very little exposure this year.
Speaker Change: From from any potential tariffs and likewise very little exposure next year, we've done a great job from a supply chain perspective, ensuring that we are sort of optimizing.
Speaker Change: Where the drug.
Speaker Change: Drug product in finished goods sat in anticipation of potential changes so.
Speaker Change: You should expect very little impact and all of our guidance includes an anticipation of those tariffs staying in place of course, we are doing everything we can to see if there are ways, we can mitigate against that but for now you Shouldnt expect any.
Speaker Change: Material impact on our financials.
Speaker Change: Excellent. Thank you.
Speaker Change: Yes.
Speaker Change: Thanks, Joe.
Speaker Change: Thank you.
Speaker Change: And next question coming from the line of.
Speaker Change: Kristen <unk> with Cantor Fitzgerald. Your line is now open.
Speaker Change: Hi, Good morning, everybody you talked about the proportion of patients that may be considering switching to Palma from next redesign based on being on therapy for up to two years and some of the effects starting to wear off but I wanted to ask on the flip side of that for those patients that were treated with <unk>.
Speaker Change: Perhaps before the other option are you seeing something similar or are you seeing that physicians want to keep their patients on <unk> for longer as the effects are still persistent.
Speaker Change: Sure. Thanks, Kristen for the question I'll, just say at a top line, we're seeing well over 90% complete on compliance and adherence with possibility of folder, which again it has been a great strength of <unk> and Thats kind of levels that we would anticipate for palm up going forward, but maybe Jeff just talk about you remind kristen.
Speaker Change: The audience around sort of how long some $1 billion for the patients have been on therapy.
Speaker Change: From our clinical studies and also just some of the opportunities to publish on those data as we go forward.
Speaker Change: Yeah, Thanks, Brian and thanks, Kristen for the question so.
Speaker Change: We have seen now it gets published out there four years, we've shown data from our trials.
Speaker Change: And really that.
Speaker Change: <unk> improvement that we've seen on many parameters is sustained over that time so far.
Speaker Change: I think one thing that is really an important dynamic that.
Speaker Change: Is out there for many years.
Speaker Change: Stability or a slow decline was viewed as sort of the goal in pompe treatment.
Speaker Change: Through our propel study and other studies a lot of what we highlight a world we have shown that when patients switch to palm up there are substantial number that actually can regain some function after switching and thats an important sort of education I think for the Palm Bay community and the treaters that thinking.
Speaker Change: Thinking about that stability and only waiting to switch after patients decline might not be what's best for patients that might be better to switch earlier and how that person regain some function, possibly or the opportunity to regain some function. So that's important for us to remind folks of that dynamic early on on the switching but as Brad mentioned, what we've seen both from trials and so.
Speaker Change: Far from a commercial perspective.
Speaker Change: Really good durability in compliance and adherence once patients go on tomo.
Doug: Thanks, Doug.
Kristen: Thanks Kristen.
Doug: Thank you.
Speaker Change: Next question coming from the line of Malcolm Maclennan with Jpmorgan. Your line is now open.
Malcolm Maclennan: Alright. Thank you for taking my question for the EU countries coming online during the first half of 2025.
Speaker Change: With regard to the.
Speaker Change: Specifically the EAP patients how many should we be expecting to transitioned to commercial therapy.
Jeff Castelli: Yes, Great question Sebastian can you remind us on kind of the room.
Speaker Change: <unk> clinical trial in expanded access patients in those markets.
Jeff Castelli: Yes happy to do so so.
Jeff Castelli: The 10 countries, where we intend to launch this year, we're talking about roughly 30 patients.
Jeff Castelli: On the clinical studies that would then be switched to commercial treatments for the course of the year.
Jeff Castelli: Zero.
Jeff Castelli: And that's in the late onset population, we do of course have a fairly large number of pediatric patients who are involved in our clinical studies. Some are also on expanded access and as we get closer to.
Jeff Castelli: Finalizing those studies in pursuit of label expansion will also provide similar color into how many patients.
Jeff Castelli: Yes.
Jeff Castelli: Cohort, we could expect to switch over to commercial but for now we're focused of course on the late onset population.
Speaker Change: Great. Thank you.
Jeff Castelli: Thank you.
Jeff Castelli: Next question coming from the line of Saul.
Saul Richter: <unk> Richter with Goldman Sachs. Your line is now open.
Speaker Change: Hello. Thank you for taking my question does this show much Laurence I'm sorry.
Saul Richter: While we are executing commercially.
Speaker Change: Stability could you HTS childhood cancer.
Saul Richter: Future R&D.
Saul Richter: Yes.
Saul Richter: Yes, thanks for the question.
Saul Richter: Really oriented to opportunities there. The first is as we've said we think we have a global commercial infrastructure that is highly leverage able and late stage development infrastructure and so we are looking for ways to build upon that portfolio.
Step wise fashion and bring in additional assets over time, we think that's a real opportunity, but we do have both our internal very very early stage discovery efforts and I think over the next kind of 12 months to 24 months I'd like to see an opportunity as we have more room in the P&L to potentially move some of those technologies.
Saul Richter: Forward and Thats, primarily in the Fabry and Pompe <unk> space and then likewise I think we continue to look at all of the early technologies in Fabry and Pompe and again kind of over the next 12 months to 24 months as we continue to build a strong financial profile I'd like to see us build out our early discovery and development programs and maintain.
Saul Richter: Our leadership position in Fabry and Pompe base. So I think those two are.
Saul Richter: Areas of focus will help us over the next three years to five years evolve into a fully integrated biotechnology company and again, one one of we hope the leading rare disease focused biotech companies.
Saul Richter: Yeah.
Saul Richter: Thank you.
Speaker Change: The next question coming from the line of Gil Blum with Needham <unk> Company. Your line is now open.
Speaker Change: Good morning, everyone and thanks for the update maybe a question on the AI aspect here, so what regulatory our logistical burden if any do you anticipate.
Speaker Change: To be required to rollout something like one one thanks.
Speaker Change: Yes, it's a great question right. Now this is very much driven by I think two factors maybe three factors of course, the first is proving to the technology and that's part of why we're so excited to go through this this.
Speaker Change: Project with University of Pennsylvania, and with one if we can prove that in fact this leads to a better diagnosis of fabry patients.
Speaker Change: We think it could be very beneficial for the medical community and the patient community out there I think the second two factors frankly are right. Now this is relying on electronic health records and so within the United States. As an example, there are a fair number.
Speaker Change: Maybe a dozen to two dozen really large systems that have end to end electronic health Records and Thats an important part of.
Speaker Change: The opportunity here.
Speaker Change: If youre in a distal node of the health care system and you don't have EHR it'll be very difficult to apply this kind of algorithm in a sustainable way and then the third piece frankly is this is very much a partnership with physicians.
And so the idea here is not that amicus theres going to commercialize some new AI diagnostic product, but rather help provide this tool to fabry physicians, who are interested in proving the diagnosis within their population. So I think those three things are really what will help us deploy this within the United States and then us.
Speaker Change: Jeff mentioned, we are doing some similar work maybe coming at it from a slightly different perspective in the U K and we hope to bring that that process into other markets as well. So I think youll see us kind of come at it from two different angles Gil.
Jeff Castelli: Thanks, Jeff.
Speaker Change: One of the great things as a reminder, for Sabra is it's an X linked dominant disease. So as you.
Speaker Change: Find a patient and a health system through this type of approach you can make sure that there's good family.
Speaker Change: Selling and kind of screening to family members and typically you find three to five additional family members that might live anywhere in the United States not just in the health care system being screened so it's really highly leverages <unk> theoretically could roll this out to a collaboration to five to 10 different large healthcare systems, you could really make a big impact on signing people press.
Speaker Change: Our country and their systems and their family members living elsewhere.
Speaker Change: Thank you and our next question coming from the line of Jeff Hung with Morgan Stanley. Your line is now open.
Jeff Hung: Thanks for taking my question, maybe a follow up on the AI collaborations one in Penn have any of the high potential patients began to be seen by physicians and formally diagnosed with fabry and I think you said that it will take about six months to do the testing phase I was just curious if you'll provide a formal update when this phase is completed.
Jeff Hung: The outcomes of that whether in terms of like families that additional patients that you guys identify thanks, yes, yes, we would love to publish on and share the outcome of the research here and so look for opportunities for us to do that over the kind of the back half of the year. What we've said so far is that.
Jeff Hung: We have <unk>.
Jeff Hung: <unk> the process of identifying the most high risk patients who are having on diagnosed fabry within that system and the position is now starting to reach out to those individuals to offer them a chance to come in for confirmatory testing. So that's kind of the phase we're at right now.
Jeff Hung: And we're very eager to see the outcome and then share the results as they come up.
Jeff Hung: Thanks.
Jeff Hung: Thank you.
Jeff Hung: Next question coming from the line of Duval.
Jeff Hung: Duval with TD Cowen Your line is now open.
Joshua Fleishman: Hi, This is Joshua fleishman on the line for it to thanks for taking the question.
Joshua Fleishman: How is the commercial competitive dynamic evolved for Palmer, our team attended World and we noticed that Sanofi and Genzyme are doing less with <unk> is this something you guys have noticed in the field also can you. Please give us an update on the <unk> PD label expansion and enrollment and timing for the <unk> study and lastly, what technologies or features or Youre looking at.
Speaker Change: Business development candidates.
Speaker Change: So Josh you are taking up the mantle of your colleague Ritu and asking one question with multiple parts I. Appreciate that so I think we had the sort of competitive dynamic out there. We had the last one was BD and then the middle one was kind of a label expansion opportunities.
Speaker Change: So I'll take.
Sebastien Martel: Maybe the first one I'll, let Sebastian again kind of reiterate what I shared on the BD side of things what were at.
Speaker Change: We're focused on anything technologically or from a disease perspective, and then I'll let <unk>.
Speaker Change: Jeff talk a little bit about the regulatory piece, so from a competitive dynamic perspective.
Speaker Change: Yes, we also noticed.
Speaker Change: Perhaps a slightly lesser presence.
Speaker Change: Sanofi at the World Congress I don't want to speak for them, what I will say as we were as Jeff said, we were just super excited about.
Speaker Change: Really having a chance to across both of our products <unk> Pandey would have sold a share new data have conversations with physicians focus on diagnosing new patients focus on the dynamics and the opportunities and drivers of of switching to possibility of fold.
Speaker Change: Some real world evidence starting to come out and I hope more and more of that will come so I'll, let <unk>.
Speaker Change: Santa Fe speak for themselves, but from our perspective, we thought that the reception for our team for the questions. We were asking for the data we are providing the interaction with physicians was just super Super High energy and we were pleased to see the note that you guys put out reflecting some of that.
Speaker Change: Maybe interested in order, Jeff talk a little bit about the label expansion opportunities.
Speaker Change: Okay.
Speaker Change: For <unk> and then <unk> just hit the highlights and kind of strategically what are we focused on from a business development perspective.
Thanks, Brian and thanks, Josh for the question.
Speaker Change: So first starting with the late onset pompe disease and the pediatrics. So it's really broken into two cohorts of 12 to 17 year old kind of adolescent patients and then the sort of 1% to 12 year old earlier.
Speaker Change: Aged <unk> patient so for the adolescent group, we've completed enrolling that group they are finishing up their sort of year or follow up will.
Speaker Change: We will be submitting that to FDA. This year and we would look to have as early as next year kind of official labeling into that group.
Speaker Change: For the one to 12 year old <unk>, we're making great progress on enrolling that and are looking to have our last patient enrolled this year and then obviously you have a follow up so you'd probably be looking at the year. After next door that it'll be officially added until labels and then.
Speaker Change: On Iot.
Speaker Change: One cohort of <unk> to 17 year olds either experienced their names.
Speaker Change: And that group.
Speaker Change: Making good progress in enrollment that those patients are much more rare so it's taken a little bit longer to enroll so we're probably looking to finish enrolling that by the end of next year.
Speaker Change: And then obviously the amount of time to treatment and labeling.
Speaker Change: The nice thing with the late onset group. The first two I talked about is we do have alignment with our agencies for extrapolation of efficacy in those patients. So really it's just sort of safety in PK and.
Speaker Change: In that group, so making good progress looking for the first labeling in the adolescent LPT. Then then that kind of younger LLP and that Iot to follow.
Speaker Change: Last thing I'd quickly add we did note at world, what we're seeing especially in the U S. With newborn screening is a lot of these kids with.
Speaker Change: What I really late onset pompe disease mutations are now being followed and theyre seeing symptoms much earlier. It was kind of thought before that you wouldn't see symptoms till 2030, and we're actually seeing a substantial number of those kids being treated so for us getting labeling down into that group is kind of be a really important opportunity.
Speaker Change: Offer what we think is a great treatment to those kids and also even though more and more from a market opportunity that that group is going to be really important.
Speaker Change: So over to you for the rest of the question.
Speaker Change: Yes. Thank you Jeff Thanks, Josh for the question.
Speaker Change: I think we've clearly.
Speaker Change: Highlighted today that overall the business is in great shape, we've got two growing medicines with Gaslog continues to deliver in <unk>.
Speaker Change: Which continues to be rolled out with another 10 markets today, so that will drive sales of the existing business.
Speaker Change: And the double digit range for the foreseeable future you also heard from.
Speaker Change: Simon.
Speaker Change: Our growth in Opex is.
Speaker Change: Measure, though limited and so that also gives us.
Speaker Change: A lot of confidence in our operating leverage and the goals that we will see in our net income and cash flows over the next years to come. So we're now at a stage, where we feel we could even potentially accelerate the stock.
Speaker Change: And bottom line growth.
Speaker Change: By leveraging the infrastructure that infrastructure that we have.
Speaker Change: So we were.
Speaker Change: We're carefully looking at opportunities within adjacent spaces. We are more focused on late stage assets and near commercial or recently launched opportunities.
Speaker Change: And a lot of those have to do with <unk>.
Speaker Change: Licensing.
Speaker Change: Do you happen to be in.
Speaker Change: Global biotech market, where you've got a fair number of.
Speaker Change: Small U S biotech companies who don't.
Speaker Change: Has the ability to commercialize.
Speaker Change: <unk> products outside of West So there was licensing opportunities.
Speaker Change: At times May come up from regional rights and again I think we've built a very solid.
Speaker Change: Global <unk> infrastructure that.
Speaker Change: It can be put to good use to further.
Speaker Change: Similar.
Speaker Change: Top and bottom line.
Speaker Change: Great. Thanks Sebastian.
Speaker Change: Okay.
Speaker Change: Thanks, all for the questions.
Speaker Change: Andrew anything left in the queue.
Speaker Change: Nope operator, we can end the call. Thanks al.
Speaker Change: Great. Thanks, everybody for listening and have a great day.
Speaker Change: Thank you your last question, ladies and gentlemen. This concludes today's conference call. You may now disconnect and have a great day.
Speaker Change: Okay.
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Thank you.
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Speaker Change: Sure.