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Good morning ladies and gentlemen and welcome to the Amicus Therapeutics third quarter 2022 financial results conference call and webcast. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Executive Director of Investor Relations. You may begin.

Thank you Shannon. Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics third quarter 2022 financial results and corporate highlights. Leading today’s call we have Bradley Campbell, President and Chief Executive Officer; Daphne Quimi, Chief Financial Officer; Sébastien Martel, Chief Business Officer; and Dr. Jeff Castelli, Chief Development Officer. Joining for Q&A is Dr. Mitchell Goldman, Chief Medical Officer, and Ellen Rosenberg, Chief Legal Officer. As referenced on Slide 2, we may 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. Our 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 affected by inaccurate assumptions we might make, or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date hereof. All forward-looking statements are qualified in their entirety this cautionary statement and we undertake no obligation to revise or update this presentation and conference call to reflect or circumstances after the date hereof. For a full discussion of such forward-looking statements and the risks and uncertainties that may impact them, we refer you to the forward-looking statements and risk factors section of our quarterly report on Form 10-Q for the quarter ended September 30, 2022 filed this morning with the Securities and Exchange Commission. At this time, it’s my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer. Bradley?

Thank you Sébastien, and good morning everyone. On Slide 13, we’ll start with our AT-GAA program. Pompe is a severe and fatal neuromuscular disease and one of the most prevalent lysosomal disorders, and we recognize that Pompe poses a range of health challenges for people affected by the disease and having therapeutic choices is crucial. Multiple publications and natural history studies highlight the initial benefits of treatment generally being followed by continued long term decline for many individuals. On Slide 14, we present a summary of the primary and key secondary end points from our Phase III study. As a reminder, PROPEL was a double-blind randomized study assessing the efficacy and safety of AT-GAA in adult treatment naïve and ERT-experienced participants with late onset Pompe disease, or LOPD, against the approved therapy, avalglucosidase alfa. PROPEL is the only controlled clinical trial to date that included both ERT-experienced patients and ERT-naïve, with the experience patients representing one of the sets of patients with the greatest clinical unmet need. End points across motor function, muscle strength, pulmonary function, patient reported outcomes and biomarkers, including the two most recognized end points in Pompe - six-minute walk distance and FVC, shown here on the slide, favored AT-GAA over avalglucosidase alfa in the overall population. We believe this consistency of effect across the key disease manifestations of Pompe illustrates the potential impact of AT-GAA for patients. Additionally, in the ERT-experienced population, where 95 participants were on the standard of care for more than 7.5 years on average, generally associated with continued progression for most patients at this point in treatment, we actually saw an increase in six-minute walk distance and stabilization in FVC after switching to AT-GAA, which achieved nominal statistical superiority on both end points versus the current treatment and showed a clinically meaningful outcome never before seen in this population. Moving to Slide 15, as part of the growing body of evidence supporting AT-GAA, the Amicus team presented additional positive long-term data from the Phase I/II study of AT-GAA at the 2022 World Muscle Society Conference. As seen here on this slide, these latest data continue to represent very meaningful and durable improvements in functional outcomes as well as persistent reductions in key biomarkers of muscle damage and disease substrate. Compared with what is known about the natural history of both untreated and ERT-experienced Pompe patients, the observed durable improvements give great hope that AT-GAA has the potential to become the new global standard of care for people living with LOPD. On Slide 16, we show key results from an indirect treatment comparison of Pompe ERTs that was also recently presented at the World Muscle Society Conference. This analysis used published data from the Phase I/II and Phase III studies for the three ERTs currently available or under regulatory review for early onset Pompe. A multi-level of network meta regression accounting for effects of study-level covariance was performed using individual patient-level data from the PROPEL study and available aggregate data from the other studies. The four plots shown here on the slide estimated relative effects and 95% credible intervals of each treatment comparison and the base case analysis in which all covariance were set for the target population of the PROPEL trial. These results suggest cipaglucosidase plus miglustat may potentially have a differentiated clinical profile versus the other ERTs, particularly for individuals with some level of previous ERT treatment. On Slide 17, we have highlighted key updates on the AT-GAA program. First on the regulatory progress, as shared previously, last year the U.S. FDA accepted for review the BLA for cipaglucosidase alfa and the NDA for miglustat, the two components of AT-GAA. As Bradley summarized earlier, following the recent FDA deferred action which was due solely to COVID-related inspection delays, the company is now actively engaged with the FDA and at the Agency’s direction has requested a Type A meeting with the Office of Pharmaceutical Quality to develop plans and logistics for the pre-approval inspection. We continue to expect that the two components of AT-GAA will be approved together and once we have more clarity, we’ll be able to give more color on estimated approval timing. We have also shared previously that the MAA has been submitted to the European Medicines Agency and is now in the later stages of review. Following an upcoming oral explanation in November, the CHMP opinion is expected at the December meeting. Of note, the EMA has indicated in writing that based on the extensive and prior manufacturing inspections of the WuXi facility, that an inspection is not required prior to AT-GAA approval. We now have multiple expanded access programs in place, including in the U.S., the U.K., Germany, France, Japan, and other countries. This includes the EAMS framework, of which we had previously announced that AT-GAA was granted a positive scientific opinion through the Early Access to Medicine Scheme by the U.K.’s MHRA. We are seeing significant enthusiasm for AT-GAA under the EAMS mechanism with multiple physicians having requested access across the leading Pompe centers in the U.K. and dozens of patients now receiving AT-GAA through this program. With this growth in our access programs, as Bradley noted, we are pleased to report that approximately 190 patients worldwide are now being treated with AT-GAA across our clinical extension study and expanded access programs. For the younger Pompe community, we continue to enroll the ongoing open label study in children up to 18 years of age living with LOPD and expect to expand into patients with infantile onset Pompe disease later this year. Importantly, in response to the many requests for treatment that we continue to receive for children living with LOPD and IOPD, our expanded access programs, continue to increase. With that, I would like now to turn the call over to Daphne Quimi, our Chief Financial Officer to review our financial results, guidance and outlook. Daphne?

Thank you Jeff, and good morning everyone. Our financial overview begins on Slide 20 with an overview of our third quarter revenue performance and FX impacts. For the third quarter, we achieved total revenue of $81.7 million, which is a 3% increase over the same period in 2021. This includes operational revenue growth of 14% offset by a negative currency impact of 11%. Given a majority of Galafold revenue is generated outside the U.S., we see significant FX exposure to our reported revenue numbers. The euro, British pound, and Japanese yen are the currencies we are most exposed to, and on a year-to-date basis these have declined 14%, 18% and 20% respectively. Applying average October 2022 exchange rates, the FX impact on 2022 full year Galafold reported sales would be a negative impact of approximately 9% or $28.5 million. Slide 21 outlines our income statement for the third quarter ending September 30, 2022. Cost of goods sold as a percentage of net sales was 16% in the quarter as compared to 15% for the prior year period. Total GAAP operating expenses were $102.1 million in the third quarter as compared to $110.2 million in the third quarter of 2021. The decrease reflects the reprioritization of the gene therapy portfolio. On a non-GAAP basis, total operating expenses were $85.5 million in the third quarter as compared to $93.6 million in the third quarter of 2021. We define non-GAAP operating expense as research and development, SG&A expenses excluding share-based compensation expense, loss on impairment of assets, changes in fair value of contingent consideration, and depreciation. Net loss for the third quarter of 2022 was $33.3 million or $0.12 per share as compared to a net loss of $50.3 million or $0.19 per share for the prior year period. Driven by the revenue growth of Galafold and expense management, we continue to make progress towards our path to profitability in the second half of next year. At September 30, 2022, we had approximately 281 million shares outstanding. We are updating our full year 2022 non-GAAP operating expense guidance from $470 million to $485 million to $430 million to $440 million, driven by prudent expense management while maintaining AT-GAA manufacturing and pre-launch activities. Importantly, in 2023 and beyond we continue to expect non-GAAP operating expense levels to decline below levels we saw in 2021. Turning now to Slide 22, we continue to operate from a position of financial strength and our goal remains to achieve non-GAAP profitability in the second half of 2023, as defined in our press release. Profitability is dependent on a number of factors, including the timing of approval and launch of AT-GAA. We will focus the majority of our investments on our core value driving franchises in Fabry disease and Pompe disease by continuing to deliver on the global growth of Galafold, securing approval and launching AT-GAA globally, as well as driving efficiencies, cost savings and careful expense management. As a good financial housekeeping measure, today we entered into an at-the-market, or ATM equity program of up to $250 million. We have no current intention to use the ATM this year. In 2023 and beyond, we will be strategic and judicious about any use of the ATM. A few comments about our cash position and 2022 financial guidance. Cash, cash equivalents and marketable securities were $354.7 million at September 30, 2022 compared to $482.5 million at December 31, 2021. Our full year Galafold revenue guidance is $350 million to $365 million at constant foreign currency exchange rates, in addition to our non-GAAP operating expense guidance of $430 million to $440 million. With that, let me turn the call back to Bradley for closing remarks.

Great, thanks Daphne, Jeff, Sébastien for highlighting all the great progress of the quarter. Thanks to everybody at Amicus and all of our employees around the world, who work so tirelessly for people living with rare diseases. With that, Operator, we can now open the call to questions.

[Operator instructions] Your first question comes from the line of Ritu Baral with Cowen. Your line is now open.

Good morning guys. Thanks for taking the question.

Good morning Ritu.

Good morning. It’s basically on the timeline of AT-GAA approval. I guess you outlined today that you’re going to request a Type A meeting.

Correct.

Can you tell us when you plan on requesting the Type A meeting? Do you need to put a briefing book like usual together in advance, or can this be done more ad hoc, and what those timelines might be? Then I have a quick follow-up.

Sure, great questions. The request actually has already gone in, so that’s already been submitted, and that was at the direction of the Agency. I think that’s important--this is really the appropriate vehicle for us to have formal conversations, and we were careful to highlight it’s with the Office of Pharmaceutical Quality. We had talked when we put the press release out last week about why we felt confident this was really an active step to get to a solution around conducting the inspection. I think having this formal vehicle really helps put a fine point on that. In terms of when we might have an update, and then I’ll come to your next question, in terms of when we might have an update, we still hope to have an update in the coming weeks. As I mentioned last week, as soon as we have more clarity, we can provide some expectations on when we might see an approval; but again, we think this is a very important step that we’re having this discussion, and the request indeed already went into the agency.

Got it, and my quick follow-up is on Europe. Have you responded to the 180 day questions, and were there any surprises or differential content from U.S. review issues for the EMA review? Thanks.

Yes, thanks Ritu. Jeff, do you want to talk to the progress we’re making in Europe and where we are with the oral explanation and the expectation for December?

Yes, thanks Brad, and thanks Ritu. We are in very late stage review with CHMP. There have been no, I would say, surprises in terms of the remaining topics being discussed. Well have explanation coming up here shortly and then we still have a lot of confidence that we have an approvable filing, and we expect that opinion at the December meeting, but very consistent so far with a lot of the U.S. reviewing questions.

Great, thanks.

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

Hey guys, thanks so much for taking the questions. If I remember correctly, you guys did provide sort of forward year guidance at an investor conference in January. With the CHMP decision on the horizon, would you be in a place to give some guidance and metrics around AT-GAA, or should we just be thinking it will be focused on Galafold and expenses? Thanks so much.

Yes, thanks Anupam. It’s a great question. I think we will be, as you said, able to give some color on Galafold and expenses. Let us get a little bit more certainty around the timing of the approvals, which as you said, we should have more clarity here relatively soon, especially in Europe and hopefully in the U.S. as well. We’ll certainly give some metrics to follow in terms of the launch and the launch progress, but stay tuned on exactly what those look like. We’ll do our best to provide the street with some sense for how to make sure we’re tracking the progress of the launch.

Thanks so much for taking our question.

Thanks Anupam.

Thank you. Our next question comes from the line of Joseph Schwartz with SVB Securities. Your line is now open.

Hi, thanks so much. I guess I’ll ask on the inspection situation as well. What is your understanding for why the FDA has not been receptive to a hybrid inspection to this point? Is an in-person inspection the only path forward, and what plans and logistics will you propose to the FDA in order to get WuXi, the process there inspected? Do you have any reason to believe that they’ll be receptive to any particular solutions?

Yes, thanks Joe. A couple things. First of all, I can’t speak on behalf of the Agency, but we have said all along that despite what we believe are multiple types of inspections the Agency could use to satisfy this PLI for AT-GAA, they have always signaled to us that they would like to inspect in person. Now, whether that’s in person from Maryland or in person from a hybrid team, I don’t know, but they have always said that they’d like to inspect in person. Specifically, what we’re working on now is exactly that, which is coming up with logistics and a plan to enable the agency to inspect the WuXi facility in China in person, and I think the biggest difference here versus some of the commentary we’ve given over the course of the summer as we approached this latest PDUFA date is that now we have active dialog and now formal dialog through this Type A meeting request, and again that was at the Agency’s direction. I think what’s changed here is, number one, we are actively discussing the logistics, in particular how to navigate the COVID situation on the ground in China, and that it was at the Agency’s request that we have this formal meeting and they are now actively engaged in that dialog, so we feel a high degree of confidence that we now have an engaged discussion, that we have specifics of a plan and logistics that are being discussed, and our hope here again is that in the coming weeks, we can finalize that and then we can provide more clarity externally on timing for when an approval might happen.

Okay, thanks. Then what are you able to do during this time while you’re waiting for FDA approval to get in front of Pompe physicians and patients in a compliant manner, in order to ensure that you can really hit the ground running and not lose too much ground to competition once you’re approved in the U.S.?

Yes, I think what Jeff highlighted on the call is really the most important way to do that is really through medical education at ongoing medical conferences. We have a great presence at the World Muscle Society, presented a host of new data there. I don’t know, Jeff, do you want to remind us just at a high level, the Pompe data in particular that was presented there, and then kind of a general medical education publication posted abstract, etc.?

Yes, thanks Brad, and hi, Joe. As I summarized briefly on the call, we had a very active presence at World Muscle, we presented four year long term data from the Phase I/II trial. We presented some new indirect treatment comparisons from available data across different ERT products, and we continue to keep planning for upcoming conferences - you know, World LVN and then other meetings early next year, to continue to have lots of new evidence presented and data presented on AT-GAA. Of course, we’re having appropriate disease education. Our teams, both the sales team and medical team are all ready to go with materials and messages, so we can do everything that you typically would do prior to an approval, and we’re going to continue to get ready for the launch. We are ready in many ways, but we’ll be even more ready with the extra time.

The only other thing I would add there, Joe, is I think this is a highly anticipated development program and regulatory process, and so the good news here is I think the community - physicians, patients, etc. are well aware that AT-GAA is going through this process, and so I think there’s a lot of anticipation as well in addition to the medical education activities that Jeff highlighted.

Thanks for taking my questions.

Thanks Joe.

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

Good morning, thanks so much for taking my question. Just want to get your thoughts. I know you’re not talking about the specifics of what a label language could look like, but in the event that you do get the specification about the switch data patients, how do you think that would impact your ability to gain traction against your key competitor, who’s been marketing really without that language, and longer term, how should we think about the split between U.S. and ex-U.S. sales for AT-GAA? Thank you.

Great, thanks Sébastien.

Thank you. Our next question comes from the line of Ellie Merle with UBS. Your line is now open.

Hi, this is Sarah on for Ellie. Thanks for taking our question. I think two quick ones from us. In terms of the Type A meeting with the FDA, I guess anything we know historically about--you know, now that the request is submitted, how long it may take to start conversations and the duration, maybe, of that process? Then looking at ex-U.S. growth in Galafold, what are the key regions that you see driving growth in ’23 and sort of maybe cadence of expanding geographically over 2023 as well? Thanks.

Great, thanks Sébastien.

Thank you. Our next question comes from the line of Dae Gon Ha with Stifel. Your line is now open.

Hey, good morning guys. Thanks for taking the question. I’ll stick with one. Just going back to AT-GAA, there have been some rumblings on unverified reports of China maybe reopening, given the impact of the tech sector and that economy. I guess if you can speak to two different scenarios, one is what’s your guess as to the timeline towards them reopening, and two, in a bear case where they don’t, what’s the real hypothetical here given that the U.S. Chamber of Commerce was still able to inspect WuXi in the whole zero COVID policy era, what should we be thinking about in that case? Thanks so much.

Yes, thanks Dae Gon. Two things, so first of all, I think we’re hearing the same thing you’re hearing, which is perhaps at the margins, things are getting better, or there’s still some hope that there might be a very different or more permissive policy around COVID. That being said, the plan we’re working on right now actually does not require any change to the official COVID policy, so we’re working on plans with the Agency that would allow them to conduct the inspection in the current environment. Maybe that is the bear case, but I think we’re being conservative there. Again, the intent is that this is something that can happen within a finite amount of time. I know that the key question is exactly what that amount of time looks like, and I wish we had more color there, but we are actively working on it and, again, we feel like in the coming weeks, we’ll have some more line of sight there and then we can provide a better update. But again, this is assuming that the current COVID travel and quarantine restrictions remain in place and we’re working to execute on a plan that will allow the Agency to inspect in those conditions.

Great, thanks so much.

Thanks.

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

Good morning, thanks for taking my question. I know with regard to the launch around Pompe, there was a question about cadence, but could you speak to how you think the launch will play out in terms of the competitive dynamics with Sanofi and how you think patients will be triaged between the drugs?

Yes, so first and foremost, I think from a European perspective, as Sanofi went through the review process and the appeal process around the new active substance, I think that significantly shortened the time between their launch and ours, so I think that gives us, I think, good confidence that effectively we’ll be launching roughly contemporaneously based on the timelines that we’re on, so that, I think is a very different scenario. As it relates to the U.S., as we’ve mentioned, I think what’s important about AT-GAA is we have a very differentiated data set, and if you look at a number of the market research polls and a number of the sell side research that’s been published out there, I think you do see an alignment around the indicated--or sorry, the populations that were studied, and so some alignment around AT-GAA in the switch population and the other products in the naïve population, so I think that data set that Jeff highlighted on the call today is really the key for us, that we can show an improvement in patients who switch from enzyme replacement therapy on both six-minute walk and forced vital capacity, and we think those are the data that are really going to be compelling for physicians and look forward to having the opportunity to get out there and promote the product on the other side of an approval.

Thank you.

Thank you. Our next question comes from the line of Yun

Hi, thank you. Sorry, I didn’t hear my name. Good morning, thank you very much for taking the question. My question is on AT-GAA. Can you remind us if the launch in Europe is going to be supported by the Ireland site solely, or is that going to be supported the WuXi site as well? Also, what was your plan in terms of how you were going to coordinate between the two sites, and given that you had this issue on inspection, has that changed your plan in terms of how you’re going to coordinate between the two sites going forward?

Yes, great question, so just as a reminder, as you suggested, we do have the current manufacturing facility in WuXi City in China, and that’s where we’ve been manufacturing ATP200, which is the biologic, throughout the course of the development. That will support the initial launch in both the United States and Europe; however, WuXi has also now completed the build-out and we’re now actually in engineering runs for manufacturing of ATP200 at a site in Dundalk, Ireland. That site has actually more capacity than the site in China, and so our anticipation is that material from that site will enter into the commercial supply chain sometime in the ’24 timeframe, and that was always the intention. But once that site comes onboard, it’s likely that it will supply the majority of product for both Europe and the U.S., and rest of world for that matter, with likely a minority of product coming out of China. We are not too far away here from having dual site manufacturing, which is critically important, but also increasing the capacity, and the intention was for that capacity to come online into the commercial supply chain when you’re starting to really get into the meat of the global launch expansion, which would again be in kind of that ’24 timeline. Hopefully that gives some clarity in terms of the plan there, and it hasn’t really changed in the context of the situation right now with the Agency and the inspection.

Great, thank you.

Thank you. Our next question comes from the line of Gil Blum with Needham & Company. Your line is now open.

Hi, good morning everyone. Congrats on your progress. I have a quick one. Do you think that any of those 190 patients on AT-GAA could potentially convert to commercial product once it’s approved? Thank you.

Yes, it’s a great question, and the answer very much is yes. As soon as we get regulatory approvals, then we look to convert our clinical trial or expanded access patients as quickly as possible. What we’ve given is just kind of rough numbers in terms of the breakout of those patients, so probably about half of the 190 are in Europe with a big portion of those coming from the U.K., Germany, and the EU5. The U.K. with the EAMS program is now the largest number of patients on AT-GAA today, and then likewise in the United States we have said that 20 or so patients in the U.S. are in our clinical trials and other ongoing access programs, and so again there too, that would be a population we would look to switch very quickly. With Galafold, the goal was to be able to switch patients from either development drug or expanded access drug within 90 days, and we would have a similar goal here.

Thank you.