Q3 2024 Amicus Therapeutics Inc Earnings Call

Bradley L. Campbell

Great. Thank you, Andrew and welcome everybody to our third quarter, 2024 conference call. I’m pleased today to highlight what has been a very successful nine months of the year across our global business and in particular, another very strong quarter in Q3.
In this time, we’ve continued to build on our top line revenue growth momentum, putting us well on our way to our first full year of nongaap profitability while also advancing our mission of bringing hope to individuals and families affected by rare diseases as we did in this morning’s press release. Let me just highlight several key points here.
First, we continued our excellent commercial execution and delivered total revenue of $142 million in the quarter, representing 37% growth year over year or 36% on a constant currency basis. This strong performance has led us to increase our total revenue guidance for the full year to 30 to 32% from 26 to 31% previously at the product level. Gal fold continues its outstanding performance with $120 million in global revenue in the quarter which represents 19% growth from last year on a constant currency basis on a year-to-date basis, gald revenue growth was 18% year over year at constant exchange rates coming in. At the high end of our guidance for this year, we continue to observe strong trends across our key performance indicators for Gallup and all key geographies in the quarter including continued demand through new patient starts from both switch and naive populations in all of our leading markets and sustain compliance and adherence rates of over 90%.
All of this of course is against the backdrop of significant growth in people diagnosed with and treated for Febri disease.
We are extremely pleased by the significant difference. This medicine continues to make for people living with febre disease with amenable variants in countries around the world. And we see it serving as the foundation of our business for the next decade and beyond.
Based on garold sustained performance, we’re also increasing our full year 2024 revenue growth guidance range for a third time. This year, we started the year with a growth range of 11 to 16%. And now we’re rejecting gald growth of 16 to 18%.
An important update we announced during the quarter as well with the license agreement with Teva, one of the lead parties in our ongoing litigation.
This agreement allows Teva to market a generic version of GALD in the United States beginning on January 30th 2037.
The settlement reinforces our high confidence in the strength of our case against the remaining litigants as well as the overall strength breadth and depth of our it estate. And this is a huge milestone for Amicus. It represents a major step forward in ensuring Amicus can continue to support the fabric community with Gald for many years to come.
Second, let me highlight the continued strong global commercial launch of Pomel AODA our novel therapy for laid off at Pompe Disease, myability upfold, of course is continued to be a huge driver of growth for us this year. And as we’ve mentioned, our number one focus continues to be maximizing the number of patients on therapy by year end. Therefore, it’s great to report that the rate of new commercial patients coming on to po ability on foled in 2024 continues to progress exceptionally well.
As of the end of October, there were 203 people living with late onset pompe disease treated or scheduled for treatment. And we continue to see the breadth and depth of prescribers increasing across our markets.
We’re very pleased with the demand globally for this new therapy and consistently hear inspiring anecdotes from health care professionals around the world and how their patients are responding to Pomel on Folda, which will help keep fueling the launch throughout the remainder of this year and beyond.
We’re continuing to build momentum in our launch countries with strong switch dynamics in the US Europe and the UK as well as seeing great uptake in the naive patients in markets outside the United States. And we’re also making significant progress on the reimbursement front globally. This includes moving patients more quickly through the insurance process in the United States as we’ve anticipated.
And for the remainder of the year and into 2025 we will focus on increasing patient access as we gain reimbursement and launch in additional countries throughout Europe.
On the regulatory front, we’re continuing to make great progress on expanding commercial access to pond bill. Now folda through our multiple regulatory submissions as well.
Given the strong global launch for the full year 2024 we are now raising our full year global sales guidance to 69 to $71 million in Pomel in upfold, which would be a significant contributor to our growth that sets us on a great course to achieve our ambition for pom off to become the new standard of care for this devastating disease. We’re incredibly pleased to be providing a real choice for people living with pompe disease and challenging therapeutic expectations for both physicians and their patients.
Finally, as we continue our excellent commercial execution across both therapies, we’re pleased to share that we are reducing our Non-GAAP operating expenses guidance. As we continue to judicially manage our expenses throughout the first nine months of the year, we’ve exceeded our financial expectations, which as I mentioned in this morning’s press release has resulted in achieving our full our goal of full year nongaap profitability as we close the third quarter.
And finally, let me touch on slide 4, our key strategic priorities for the year again, sustaining double digit gallop fold, revenue growth.
And as I mentioned, we’ve raised the expected annual growth rate of gal fold to 16 to 18%. Continuing to successfully execute multiple commercial launches of potability folda. And again, we’ve raised our guidance there as well, advancing ongoing studies to support medical and scientific leadership and fabry disease and Pompe disease and finally maintaining a strong financial position as we carefully manage our expenses and investments to achieve non-GAAP profitability for the full year with that. Let me now hand the call over to Sebastian who can further highlight our commercial performance. Sebastien.

Sébastien Martel

Thank you, Bradley. Good morning to everyone on the call. I will start by providing you with more details on our Galafold performance for the quarter on slide 6 for the third quarter. 2024 gallaf reported revenue reached $120 million driven by strong patient demand particularly from our leading markets.
We ended the third quarter with more than 60% of the global market share of treated fabry patients with amenable mutations.
We’re very pleased to see that prescribers continue to position GAAP as the treatment of choice for family patients with a minimal violence.
The great news is that there are still many more potential patients eligible for our therapy.
Turning to slide 7, our results in the third quarter highlight the strength of our global commercial efforts. The demand for Gaap food globally continued to be strong with patients added in all major markets, delivering operational growth of 19% over the same period in 2023 at constant exchange rates.
Our leading markets such as the US, the UK top EU countries and Japan remain the biggest drivers of patient demand and gives great confidence in the growth. This product has over the long term within the global mix, which is about 40% switch and 60% naive. We’re seeing stronger uptake in naive populations. So we continue to achieve high market shares in the country where we’ve been approved the longest. There’s still plenty of opportunity to continue to switch patients over to GAAP and to keep growing the market as we penetrate the diagnosed untreated and newly diagnosed segments.
All of that is underpinned by sustained compliance and adherence rates that continue to exceed 90%. Reiterating our belief that those patients who go on Garold predominantly stay on Garold on slide 8, we know that there’s a significant patient demand for Kold and that the segment of the global fabric market made of patients with aidable volumes has the potential to reach up to $1 billion in annual revenue. By the end of the decade, we anticipate system growth in 2024 and beyond to be driven by several key drivers. First, the fab market is growing robustly with a significant portion of growth coming from finding new patients and reaching the diagnosed and treated population.
We’ve seen many new patients going through treatment through family screening and we continue to see increased patient identification through ongoing medical education and support of noble screening initiatives.
Febri remains one of the most underdiagnosed rare diseases. So the more people that can be identified, the more people may benefit from catapult.
We’re also seeing many diagnosed untreated patients transition to treatment as the need for earlier treatment especially in females becomes better appreciated.
The other piece is continuing to drive gpos market share of treated aidable patients through continued commercial execution.
As noted, Gallup will currently has more than 60% of the global amenable market. We’re seeing in our most mature market that we can reach up to about 85 90% of market share. So we know that there’s the potential to reach those levels in the global market here as well.
And again, all these efforts are supported by solid compliance and endurance rates through physician and patient education and support programs.
Additionally, we’ll continue to make progress on expanding GAAP for new markets and extending the labels.
Importantly, on the IT front, as Bradley mentioned, we recently announced in October that we reached a settlement agreement with Teva Pharmaceuticals in the ongoing protection of our US intellectual property for Gafford Amicus entered into a license agreement with Teva granting them a license to market its generic version of Galafold in the US beginning on January 30th 2037.
We’re very pleased by this outcome as it reinforces our confidence in the strength of our case against the remaining litigants as well as the overall strength breadth depth of our IP estate.
We now have often drug, sorry, we now have often drug exclusivity in the US and Europe. In addition to our 62 orange book listed patents, 46 of which provide protection into 2038 and beyond including 15, this gives us the opportunity to provide access to g globally for a long time to come and we intend to continue to protect and enforce our broad intellectual property rights.
Looking ahead, we expect steady double digit growth for Galafold throughout 2024 and we remain confident that with our strong IP protection, Galafold is a long runway well into the next decade.
Turning now to competes on slide. 10, we outline our global launch progress with poil and up for the third quarter. 2024 poil pull their reported revenue reached $21 million. This represents an increase of 33% compared to the second quarter, 2024 and provides a strong condition for the remainder of the year in the US. We continue to see a majority of patients switching from Nexi Zyme about 68% and the remaining from lumizyme.
This means we’re switching patients proportionately from both products. We’re also seeing a broadening and deepening of prescriptions with more sites coming online and multiple new prescriptions from physicians coming in over Q3 outside of the US. We’re seeing patients from all three segments, some switching from myozyme and from nectarine at a proportional rate to the respective market shares and some from the native population.
Exactly what you want to see at the stage in the launch.
Given our solid commercial execution in the first nine months of 2024. We’re pleased to increase our full year revenue guidance from $62 million to $67 million to $69 million to $71 million for probity and folder moving to slide 11. We’re very pleased with launch momentum through the first nine months of the year. As Bradley mentioned, there are about 203 patients that have been treated or are scheduled for treatment as of late October. That’s about 196 patients who have been treated. We remain very satisfied with the ongoing demand for this therapy.
Our launch has leveraged our highly experienced cross functional teams and we’ve had great outreach with key opinion leaders. We’re seeing an increase in the depth and breadth of prescribers across all markets indicated to us that physicians are having positive experiences with the therapy and are gaining greater confidence to use it again in patients, all core treating centers are engaged and we continue to receive very positive feedback from HCPS and other stakeholders as to our business approach, our support and our patient focus.
Finally, an important metric to track is our progress with access and reimbursement. We have a highly experienced team interacting in positive conversations with payers to demonstrate the value of mobility and folder in the US. The largest payers put mobility and a fall down to their respective formularies. And we’ve also seen strong acceptance by Medicare and Medicaid.
The overall time from prescription to effusion is now down to around 60 days with pay approvals happening on the 30 days, we believe this will continue to improve.
Today. We’re launching in Germany in the UK, the US, Austria and Spain. And we’re pleased to announce that we now have pricing and reimbursement in the Czech Republic, our sixth launch country.
We remain in active pricing and reimbursement discussions with additional major European markets.
We continue to be focused on securing broad patient access throughout Europe and we anticipate further reimbursement agreements over the next 6 to 9 months. This will be a key part in driving the commercial uptake in new countries next year.
Great.
We’re very pleased thus far with the launch of community and a folder across the first wave of countries in 2024 our focus is on maximizing the number of patients on therapy. By year end, the strength of our clinical data, the depth of experience and talent we have at AMICUS gives us great confidence in our ability to make a very real difference for people living with Pompe disease. With that. Let me now hand the call over to Jeffrey P. Castelli to highlight our clinical and regulatory progress.

Jeffrey P. Castelli

Thank you Sebastian and good morning on slide 12, we outline how we continue to grow the body of evidence for building a FDA through our ongoing clinical studies and registry as we continue to execute on expanding commercial access through regulatory submissions.
In addition to the regulatory dossier is already under review in Canada and Australia, we’re pleased to announce that we recently submitted a Japan new drug application or JND A for P building up f to the Ministry of Health Labor and Welfare in Japan.
For the younger Pompe community, we continue to enroll the ongoing open label zip study for Children, Children living with late onset pompe disease. In the open label rosella study for Children living with infantile onset pompe disease. We see this as an important opportunity to support label expansions into these patient segments in the years ahead and importantly to address the significant unmet needs in these Children through ongoing clinical studies and the Amicus Pompe Registry, we continue to generate evidence on the differentiated mechanism of action and long term impact of pomel and upfold across endpoints and patient populations.
Our medical conference presence and scientific publications continue to be an important part of our education efforts.
Finally, as highlighted in the pipeline slide in the appendix for our earlier stage pipeline, we continue to focus on novel approaches to next generation therapies and Fabre and pompe diseases. And with that, I would like to now turn the call over to Simon Harford, our Chief Financial Officer to review our financial results, guidance and outlook Simon.

Simon Harford

Thank you, Jeff. Our financial overview begins on slide 14 with our income statement for the third quarter ending September the 30th 2024 for Q3, we achieved total revenue of $142 million which is a 37% increase over the same period in 2023 at constant exchange rates. Revenue also grew 36%.
The global geographic breakdown of total revenue during the quarter consisted of $85 million or 60% of revenue generated outside the US. And the remaining $56 million or 40% coming from within the US.
Cost of goods sold as a percentage of net sales was 9.4% in Q3 2024 as compared to 9.6% for the prior year period. Staying relatively flat total. GAAP operating expenses decreased to $107 million for the third quarter, 2024 as compared to $111 million in the third quarter of last year. A decrease of 4% on a nongaap basis, total operating expenses decreased to $83 million for the third quarter as compared to $90 million in the third quarter of last year. A decrease of 8%. We define non-GAAP operating expenses, research and development and SG and a expenses excluding stock based compensation, expense loss on impairment of assets, changes in fair value of contingent consideration, restructuring charges and depreciation and amortization on a GAAP basis. Net loss for the third quarter, 2024 reduced to $7 million or 2¢ per share compared to a net loss of $22 million or 7¢ per share for the third quarter of 2023 in Q3, 2024 non-GAAP net income with $31 million or a profit of 10¢ per share compared to non-GAAP net loss of $4 million or a loss of 1¢ per share. For the third quarter of last year, cash cash equivalents and marketable securities were 250 million at September, the 30th 2024 compared to $286 million at December 31st 2023 turning now to slide 15, we are raising our full year 2024 total revenue guidance range to 30 to 32% from 26 to 31%. Previously, this is driven by the increase of our full year 2024 galafold revenue growth guidance from 11 to 16% at the beginning of 2024 to most recently, 14 to 18% and now narrowed to 16 to 18% at constant exchange rates. In addition, we are raising the guidance for Poil and folder sales to 69 to $71 million for the year.
Our full year 2024 non-GAAP operating expense guidance has been lowered from 345 to $360 million down to 340 to $350 million. With our commitment to full year non-GAAP profitability during the first full year of launch of Poil in our folder, we are keeping operating expense growth in low single digits year over year at the midpoint of guidance. As a reminder we continue to have R&D commitments including registry studies in both Fabri and Pompeii.
The ongoing Pompeii phase three study in countries not yet reimbursed as well as next generation manufacturing for Pomel.
With our total revenue guidance of 30 to 32% growth, we remain comfortably on track for 2024 for our first full year of nongaap profitability.
As a heads up as we begin to think about 2025 we anticipate next year to be a hybrid year for pom ability folder COGS. As we expect to work through the previously expensed inventory during the first part of 2025 total gross margins for the first nine months of the year, 2024 were approximately it it the 90% we expect gross margins in the mid 80s for the 2025 full year as we begin to recognize poil and folded COGS through the P&L next year. And with that, let me turn the call back over to Bradley for our closing remarks.

Bradley L. Campbell

Great thanks Simon Sebastian Jeff. As you can all see, we have been relentlessly focused on commercial execution and performance across the business driven by our passionate team of global employees who continue to lead us on our patient focused mission. As we near the end of 2024 I am confident we’ve laid a solid foundation for Amicus and continue to deliver transformative therapies in 2025 and the years beyond with that operator we can now open the call to questions.

Operator

Thank you.
Ladies and gentlemen. If you have a question, please press star 11 on your touchtone telephone. At this time, we request that you only ask one question. If you have any additional questions, please enter back into the queue. Thank you.
Our first question comes from Ritu Baral of TV, Cohen. Your line is now open.

Ritu Baral

Hi guys. Thanks for taking the question this morning. I wanted to ask about, sorry, your poil, prescribing trends that you mentioned. You mentioned that you had improving trends on both sites and prescribers. Could you go into that a little bit and describe a little more what you’re seeing now about us per like the, the point at which us prescribers and patients elect to switch specifically, you know what the patients are experiencing. And then could you help us just quantify the Japanese market opportunity in Pompeii since that’s coming up? Thanks.

Bradley L. Campbell

Sure. So it’s a very well articulated one question with three parts. So I heard, I heard breadth and depth a little bit more color on breadth and depth and then kind of what we’re seeing and hearing around decision to switch and then the Japan opportunity. I’ll start maybe framing the first ones we’ll ask Jeff to comment a little bit and then Sebastian can provide color on Japan. So in terms of breadth and depth, it’s kind of exactly what it says, right So in some markets like the UK where it’s a very concentrated market, we had all the key centers prescribing through the Eams program and continue to prescribe on a commercial basis. But most other markets, Spain Germany, United States have more prescribers.
And so what you want to see is you want to see, you know, both breadth, meaning continuing to have new prescribers prescribed the medicine and depth, meaning they’re repeating prescriptions and we’re seeing both of those things. So more new prescribers, you know, using pom bill, hold it for the first time and then more prescribers prescribing multiple prescriptions. So I think that’s a great tracker to see how we’ll continue to spread the, the use of this product in terms of when they, you know, when the decision is made. I think this is an important part of the ongoing discussion with the community broadly speaking. I think what we’ve heard and seen is that physicians are, you know, want to see some evidence of decline in their patients. And we talked a lot about that over the course of the year.
You know, once a patient switches, I think physicians are looking for t of for 12 to 24 months before they’re ready to switch. And so I think that set us up well for next year, but maybe just talk about specifically what are, what are kind of the signs and symptoms that would be typical for people to follow and then Sebastian just give a quick update on the Japan opportunity.

Jeffrey P. Castelli

Yeah, thanks Brian and thanks for the question for two. So, so I think Brian covered it very well there in terms of that kind of 12 to 24 month period. After starting treatment or switching treatments that physicians follow their patients, they typically see them every six months or so. A lot of what they’re measuring are sort of quality of life measures. You know, how is the patient been doing, in their day to day activities? They, they do still measure a lot of the things we see in trials, different measures of respiratory function, different ways to assess mobility. Certainly not quite the work up, you see in the trial, but it’s really that sort of holistic assessment, you know, at each visit how the patient is doing. But, you know, it’s certainly even some of the guidance we’re seeing has recommended that, you know, physicians at least wait 12 to 18 months before, you know, initiating a second switch after that first switch.
And, and currently it is sort of, you know, if a patient was, you know, declining and they start new treatment, they want sort of wait to see. Are they declining on the new treatment again? You know, if they were stable, they wait to see if they remain stable or show any improvement. So it’s sort of somewhat patient by patient. But, we’re definitely seeing that the majority of switches are coming in that 12 to 24 month period.

Bradley L. Campbell

Thanks.
Actually just real quick on the Japan opportunity.

Sébastien Martel

Yeah, thanks Ritu for the question. So, you know, we’re in the fabric world. We’re used to being a a very sizable market. This is actually the second largest market for F disease. It’s not the case for pompe disease. It is speaking a smaller opportunity, Pompe disease is less prevalent in Japan. The market is also very fragmented. We estimate that there are about 100 patients currently treated for Pompe disease in Japan.
Thanks.

Operator

Thank you. Thank you.
Our next question comes from Anupam Rama of JP Morgan. Your line is now open.

Anupama Raman

Hey guys, thanks so much for taking the question. I just wanted to dig in a little bit on the previously sort of untreated patients that are now on Garold. I think slides that around 60%. Can you speak to like what you’re seeing about these previously untreated patients in some of your core regions or more legacy regions versus some of the emerging market regions? That’s my. One question.

Bradley L. Campbell

Yeah, thanks a lot. Not a problem. So I’ll just take, take that one. So I think in our key markets. So us Europe, Japan as an example, we’re still finding significant numbers of new patients and, and remember also there’s a significant pool of diagnosed untreated patients. So we came into the year. With updated figures, estimating about 18,000 diagnosed patients, about 11,000, sorry, 17,000 diagnosed patients, 11,000 treated and 6,000 diagnosed untreated.
So part of the phenomenon is is penetrating into that diagnosed untreated market. But with, you know, advances in low cost genetic testing with I think significant adoption of family screening, where you find, you know, typically four or five family members when you find an index Febri patient that’s led to diagnosing a whole host of new patients as well. And as we come to JP Morgan, we get some update numbers there. But I think overall what you’re seeing in, in, I think the more developed countries is significant level levels of of diagnosis.
The other thing is we are still switching patients. You know, we’re at very high market share is 80 plus percent. But in our newer launch regions, which tend to be sort of Latin America, Southeast Asia, some Middle East, North Africa regions, there is still a significant switch opportunity as well. So I think, you know, two growth drivers there. But, but again, I think that solid underpinning of diagnosis and market growth.

Anupama Raman

Thanks so much for taking our. Question.

Bradley L. Campbell

Thanks.

Operator

Thank you. Our next question comes from Tazeen Ahmad of Bank of America Securities. Your line is now open.

Tazeen Ahmad

Hi guys. Good morning. Thanks for taking my question on GALFA as it relates to IP. Are there any filers still left on that front. Is there a chance? I’m wondering if you could get any kind of better outcome than the one that you’ve just announced the settlement with? And then just a point of clarification as it relates to dropout rates for gasol. Can you tell us if those rates have remained the same or changed much at all recently? Thanks.

Bradley L. Campbell

Thanks very much to the Yes. So on both of those. So, you know, as we said on the call, we’re very pleased with the seven, with Teva. It really reinforces our confidence in the strength of the case against the remaining litigants. And to your question, there are two or Bindo and loop them.
However, you know, we will continue, of course, to vigorously prosecute and force the IP and remain very confident long term potential based on this outcome. I will say that because we’re still in litigation with or Bindo in particular, we can’t comment on the litigation strategy. But of course, we’ve pointed people to the statistics which say that in the majority of these types of cases. Ultimately, there’s a settlement with the parties I would not expect earlier or excuse me a later date to your, your question. And again, I won’t comment more than that other than we’re very confident in where we are. And I think we’re, you know, everybody’s very pleased that that this gives us an opportunity to continue to support Gald for many years to come. On your second point on compliance and adherence for GALD. Actually, we, we review these numbers quite regularly. What’s interesting is the rate of, you know, discontinuation has actually gotten smaller and smaller on a broader base. And I think that’s what’s given us, you know, this continued, sustained patient growth effectively. When patients come on Gald, they tend to stand GFD, which is a fantastic place to be.

Operator

Thank you.
Our next question comes from Ellie Merle of U BS. Your line is now open.

Ellie Merle

Hey guys, thanks for taking the question. In terms of thinking about your pipeline, I guess what’s your focus? As you think about building out your clinical pipeline from here, are you more focused on internal development work or are you looking externally with business development? And then I guess, you know, as you think about business development, you know, are there specific modalities or stages of development where you’re most focused and just how you’re thinking about that strategy overall? Thanks.

Bradley L. Campbell

Sure, I’ll start with framing the overall strategy and maybe just talk a little bit about our internal program. So overall, of course, we continue to focus on growing the business and I think we delivered another strong quarter here, which is great and that will continue to be a focus for amicus. We do believe because of the great infrastructure we’ve built to support Gallup M&P UP there is an opportunity to bring assets in. And I think we’ve said over the next kind of 12 to 24 months, we we would be looking to bring in first de risk later stage or commercial assets into the portfolio and then call it 24 months and beyond. When we’re really generating strong positive free cash flows, I think we’ll have an opportunity to also begin investing in the pipeline again. Jeff, do you want to talk a little bit about our hope for what might come out of our internal pipeline?

Jeffrey P. Castelli

Yeah, thanks Brad and thanks for the question. You know, in terms of our internal research efforts, you know, we developed some really exciting trans genes for fabry and Pompe disease with proteins that are much more active, potent, stable than the wild type proteins. And as you know, we’ve been looking to deliver those through various approaches. Our original focus was a AV with DNA constructs. So that still is our lead area that we’re looking, but we’re also looking at other ways to deliver those proteins or trans genes, whether that be through lino particles or other approaches. So focus there is absolutely Fabre is the main focus as well as continuing to look at Pompei secondarily. But we think there’s a real opportunity for next generation Febre treatment, especially for people that are not amenable to Febre currently are on and some replacement therapy.
In terms of the future. I think maybe I’ll turn it over to Sebastian to talk about, you know, BD and how that might influence what we’re doing on the internal pipeline. I will say we pay close attention to every single product medicine approach out there for Fabre and Pompey.
So that is something that we’re, we’re obviously very keen on. But we also have a broader approach of disease areas of interest. So Sebastian, they’ll turn over you mute off.

Sébastien Martel

I think we’ve, you know, we’ve developed a framework looking at specific therapeutic areas and, and indications of interest. You know, we’re looking at adjacencies, we’re looking at you know, rare renal rare cardio, rare metabolic, but also rare neuromuscular rare neurology, broad therapeutic areas.
Great, thanks.

Operator

Thank you.
Our next question comes from Joe Schwartz of Leerink Partners. Your line is now open.

Joseph Schwartz

I thanks. It looks like around 17 patients were added from the end of July to the end of October versus around 30 prior quarters. So I’m wondering what is driving this and how things are trending in the fourth quarter? And how should we be thinking about the cadence of new patient ads as we get into 25? Have you started to think about expectations for 25? It looks like the street assumes sales of around $145 million and that’s about a doubling of sales year over year. So, what do you make of the activity in terms of patient demand this quarter and going forward? Thank you.

Bradley L. Campbell

Yeah, thanks Joe. So a few things. So we did a very strong Q3 which is great. And from a, from a revenue perspective, I think that, you know, if you look at the top line number of new prescriptions, I think your numbers, you quoted that right? I would also call you to the to the number of patients who’ve been treated, which is up to 100 and 96. So I think part of that is we’re kind of closing the GAAP on the insurance process which Sebastian talked to earlier. You know, as we think about what happened in Q3, a few things, Q2, you had both the Spanish launch and you’re still switching a number of clinical trial patients. And so Q3 was really just kind of the, the ongoing launch in the various countries that are out there. We’ll have more of that in Q4, we don’t have any new launch countries expected, although we do expect to get some reimbursement outcomes which would lead to launches going into next year in terms of next year.
You know, of course, it depends on, on the rate of patients that we finished this year with. It also depends on the launch sequence that Sebastian talked to. You know, we have a number of countries that are coming out of the back half of next year, we also have ongoing reimbursement discussions. And while you know, those are kind of playing out over a 6 to 9 month period, of course, the goal is speed to, to launch, but you also want to make sure that you have a sustainable price. So we’ll know a lot more about that as we get to the end of the year and then we get more clarity on on what next year looks like. But you know, super pleased with the launch so far and very excited to be raising guidance for this year.

Joseph Schwartz

Helpful. Thank.

Sébastien Martel

Thank You.

Bradley L. Campbell

Thanks, Jose.

Operator

Thank you.
Our next question comes from Digon Ha of Steel.
Your line is now open.

Great. Good morning. Thanks for taking our question as well. And congrats on the progress I wanted to circle back on the BD side of the story. Now that we’re done with the election, there’s a lot of chatter around TC and who might come up next. So on the BD front, when you think about these late stage pre commercial assets, I guess what’s the driver here ultimately? Are you more focused on getting to GAAP profitability and a significant cash flow before pulling the trigger? Or is there something that’s all your on your radar already that you might think about pulling the trigger once you get over the hurdle of the nongaap profitability and just a clarification for Jeff on the pipeline. These genetic approaches are these the same ones that you guys had for Katas that you guys are retaining or are these evolved versions that are separate from what we had seen from Katas? Thanks so much.

Bradley L. Campbell

Yes, Dan, thanks a lot for the question and, and you know, from a, from an objective perspective, and I think the point is that we’ve built an infrastructure at, at Amicus that now is self sustainable based on our current business, which was part of the goal. And, and therefore we think we can add to that by bringing in products that are de risked and or, you know, already launched. So we really focus on top line growth while maintaining our financial discipline around the bottom line. So, I think that’s the way we think about the focusing on later stage products first.
And then, as I mentioned, as we go along over the next few years and you know, you can, you can think of the sequence of non-GAAP profitability to GAAP, profitability to deposit free cash flow is playing out over that period of time. I think then we’ll be able to have our own resources to really start funding a pipeline as well. So that’s kind of generally how we think about the financial component to it. And Jeff maybe just clarify what specifically we’re focused on with our current technologies.

Jeffrey P. Castelli

Yes. So in terms of the internal work we’re doing. It is similar to the constructs we’ve worked on previously as part of Amicus and then what was going to go into Caritas. We’ve, even as we’ve been focusing R&D resources and efforts on our core businesses and gifo and pop up, we, we have refined those constructs, made them even incrementally better with some new A I technologies. And we’ve also been looking at alternative ways to deliver them. You know, I’d say the lead approach is still in A V with one of those constructs in fre but still early and most resources still focused on early stage programs.
So.

Bradley L. Campbell

Yeah, we’re, you know, we took the decision of course, when we moved away from gene therapy to really, really slim down those efforts and focus on the core commercial business, which we’re delivering on. Again, our goal would be kind of in the next year or two to generate some important proof of concept data that might allow us then to move closer to the clinic. And again, as, as Jeff said, focus primarily on Fabre Pompeii and, and Fabre in particular because of course, we can’t treat about two thirds to a half of the population who don’t have the mental mutations with GD. So that could be an exciting approach going forward. But, but again, that is all, you know, low priority right now and we’re, we’re just moving things along kind of behind the scene until we can fund them in a more significant way.

Makes sense. Thanks. Thanks very much.

Bradley L. Campbell

Guys. Thanks.

Operator

Thank you. Our next call comes from Dennis Ding of Jeffrey’s. Your line is now open.

Dennis Ding

Hi, good morning. Thanks for taking our questions and congrats on the strong Q3. I had a question around Pompeii and you know, your new 2024 guidance assumes Q4 would be generally flattish for Pomel.
I was just wondering how much conservatism is baked into this guidance. And you know, if there’s anything normal worth calling out in terms of inventory or timing of drug shipments that may have benefited Q3. Thank you.

Bradley L. Campbell

Yeah, thanks for the question, Dennis. You know, again, there is some increment, incremental growth baked in there. The question is kind of how much new patients do we add over the course of the quarter? There aren’t any new launches this quarter. Again, we think there’s going to be some reimbursement breakthroughs. We did see a check as an example, get to reimbursement recently, although that those patients won’t come on until next year. So it really just kind of depends on the rate of new patient adds as we go through the course of the quarter and that’ll tell us kind of where we are within that range, but there is some incremental growth baked into that guidance.

Dennis Ding

Got to think then maybe as a follow up, you know, as you think about the trajectory of the Pompe launch. Is this kind of is the messaging more around steady steady and the new growth or do you see any point of acceleration in terms of new patient ads? Thanks.

Bradley L. Campbell

Yeah, thanks for the question again. You know, we don’t, we don’t give guidance yet, but I do think, you know, a couple of factors will determine how that plays out. So first of all, you’ve got the rate of new patient, new patient starts in the existing markets. And we do think in the US as an example, you’re going to have a fairly sizable number of patients who are now moving into that kind of 1 to 2 year zone next year. So it could be a great opportunity to start to switch those patients.
And I mean, patients who’ve been on Nevi Zy for a year or two and then you also have the rate of new countries launching and that’s in part dictated by the reimbursement process, which we already talked about and then part dictated by the regulatory process. As an example, you know, some of the submissions we’ve made Australia, Canada, Japan, we think will come online in the back half of next year. So still some moving pieces. I do think over time, you will see you’ll start to see momentum build as you have more markets and the ability to draw from more patients. But again, we’ll, we’ll kind of see how this, the rest of this year plays out and more color on on the rate of those new launches as we go into the next year.

Dennis Ding

Perfect. Thanks so much.

Bradley L. Campbell

Thank you.

Operator

Thank you. Our next question comes from Kristen Kluska of Cantor Fitzgerald. Your line is now open.

Kristen Kluska

Hi, everyone. Congrats on a great quarter, not just from the revenue side but from all the operational updates as well. I was hoping you can comment more on some of these main drivers that have led to some of the tightening of the operating expense guidance you’re providing today. Thank you.

Bradley L. Campbell

Thanks, Kristen Simon. Do you want to take that?

Simon Harford

Yeah, I really, I think it’s fair to say that we continue to manage our operating expense. As we said, we wanted to do extremely tightly year on year. So we have really limited, I would say head count editions because we have the infrastructure that we’ve talked about in place that was built to support Fabri and we didn’t need to add significant additional numbers as we launched probability folder. I would say we are, we continue however, to deliver importantly on all the things in the OpEx that we need to do from a activities perspective such as some of the registry studies.
Yeah, the adolescent lopdiopd and some of the sort of remaining expenses related to open label extension. So all of that is I is taking place from an activity perspective. But we look at all opportunities really to, to work with the, the overall management team and employees to ensure that we’re managing OPECS tightly. And that’s what you’re seeing as a result, is alluring of that. Non-GAAP Operating Expense guidance, which obviously is also helping the bottom line because as you know, we’ve talked about full year non gaap profitability in reality, as of the first nine months of this year, we’d already achieved $45 million of non gaap profitability. So that’s what’s going on currently.

Operator

Thank you.
Our next question comes from Jeffrey Hung of Morgan Stanley. Your line is now open.

Jeff Hung

Hi, this is Michael. We add on for Jeff. Thank you for taking our questions and congrats on the strong quarter. How far into 2025 for like the pli in the fold of previously expensed inventory? How far would that like that inventory be able to carry for next year? And like, can you provide any commentary on the potential for next gen manufacturing? When would you expect that could start to, you know, impact gross margins?

Bradley L. Campbell

I’ll take the second first and then Simon, I’ll have you talk to the first one. So next gen manufacturing is something we’re investing in and, and we’ve talked about that before. We think we can reduce cost of goods by, you know, maybe 20 to 30%. Although we’re still working through that process, that’s probably a kind of, you know, back half of the decade kind of impact. So we haven’t given formal guidance there, but that’s still a few years out before that starts to hit the commercial supply chain and it has a real impact, but maybe it’s time to talk to the near term drivers next year.

Simon Harford

Yeah. II, I mean, in, in terms of the, the heads up on COGS in the sort of the mid or should I say gross margin in the mid 80s percent range next year? That’s really driven by the fact that that expensed inventory will run out in the earlier part of next year. And therefore, that’s why we call it a hybrid year. We will see as we’ve said previously, full year impact of Pommel folder. It sorts of gross margin rolling through in 2026, but we wanted to at least make you aware of what we see at this point in time as a difference compared to 2024 in 2025. And, and hence that statement.

Jeff Hung

Thank you.

Operator

Thank you
Our next question comes from Gil Blum of Needham and company, your line is now open.
Hi, everyone. And.

Jeffrey P. Castelli

Thanks for taking our question.
So. To genetic medicine in February, kind of recent feedback from the FDA regarding potential for accelerated approval.
Was it was pretty interesting. I just wonder what you guys think and whether you know, our current dynamics could. Push a Program for genetic medicine in February a little faster than expected. Thank you.

Bradley L. Campbell

Yeah, it’s a good question. I think, you know, it relates to the other therapies that are out there in, in development. You know, we really see those as impacting patients with non amenable mutations just based on the data that we’ve seen. And so we’re really excited about Galp to continue to grow for amenable patients. But we would love to have something, you know, for that other part of the population. From a regulatory perspective. I think broadly, you’re seeing some flexibility in the part of the agency, which we think is exciting, hard to know what’s going to happen with, with the other other therapies. You know, we just read the same things you do. But again, I think if any of those are able to get across the finish line, they’re almost certainly for non amendable patients. And so, you know, eager to see if we can do something on our own in the coming years to address that population as well.

Jeffrey P. Castelli

That makes sense and then congrats on the quarter.
Thanks Bradley.

Operator

Thank you.
Our next question comes from Salveen Richter of Goldman Sachs. Your line is now open.

Salveen Richter

Thank you. Good morning. Just would it be possible to give us some further commentary on the competitive dynamics versus XFI as I’m in the US and X US just given the appreciable growth in the X US share for, for that asset percent of his last earnings. Thank you.

Bradley L. Campbell

Yeah. Sebastian maybe talk a little bit to kind of the proportionality in terms of how we’re getting patients to switch to to ability a folda and you know, sort of what we’re seeing is as things evolve in those two markets.

Sébastien Martel

Yes, thanks Brad then.
So for the question. So, you know, as I mentioned earlier, what we’re seeing in the US is in terms of, you know, switch dynamics is pretty much a reflection of, you know, the current respective shares of, of Luis I&N I in the US. So, you know, at, at this point, at least based on 23 reporting numbers nature on accounts for about 60% of some of his sales in in the US and they’re still 40% from li design, I, I did say that we’ve got, you know, slightly more than two thirds of our switches coming from from next year I which, you know, which is a great indication that as we said, all along that, you know, there’s there’s potential for us to switch a large proportion of negative on patients over time. We are we’re seeing also that, you know, X US, it’s actually the reverse situation. So there is still more mizy than Nexi Zy So, roughly 60% Myozyme X US and 40% Nexa sign.
And so here we tend to see a greater proportion of switches coming from Myozyme. You wouldn’t be surprised. We also have the benefit of seeing some naive patients moving straight on to onto your folder.

Operator

Thank you. That was our last question. I would now like to pass it to Bradley for closing remarks.

Bradley L. Campbell

Great. Thanks everybody. Have a great day and thanks for listening to the conference call.

Operator

Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect.