Amicus Therapeutics [FOLD] Conference call transcript for 2022 q2
2022-08-05 03:37:08
Fiscal: 2022 q2
Operator: Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Second Quarter 2022 Financial Results Conference Call and Webcast. . As a reminder, this call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Executive Director of Investor Relations. Please go ahead.
Andrew Faughnan: Thank you, Cole. Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics second 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; Sebastien Martel, Chief Business Officer; and Dr. Jeff Castelli, Chief Development Officer. Joining for Q&A is Dr. Mitchell Goldman. 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 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 events 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 annual report on our Form 10-K and on our quarterly report Form 10-Q for the year ended June 30, 2022, to be filed later today with the Securities and Exchange Commission. At this time, it is my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer. Brad?
Bradley Campbell: Great. Thank you, Andrew, and welcome, everyone, to our second quarter 2022 results conference call. Before we dive into the results of the quarter, I'd just like to start with a deep thank you to John Crowley. Has planned after 17 great years leading Amicus as our founding CEO, John has officially assumed the role of Executive Chairman of Amicus for a two year term, after which he is expected to continue as the Non-Executive Chairman of the Board. It has been an honor working alongside him for 16 of those years and it's been through his leadership and unwavering commitment to all of those living with rare diseases that Amicus is in such a great position today. I'm honored now to assume the role of President and CEO and very excited about the opportunities that lie ahead. Amicus has strong business fundamentals and a positive momentum to build on. We are poised now for the next chapter of our growth as we seek to get our second medicine approved and launched around the world. I firmly believe that we have the right people and the right assets to deliver on our mission to continue to bring great medicines to people living with rare diseases and create great value for our shareholders. Building on our commitment to patients, leadership of rare diseases and global operating platform, I am confident that we can achieve those two objectives. With that, let me get started on today's updates. I'm pleased to highlight the successful first half of the year across our business. And as we did in this morning's press release, let me highlight several key accomplishments. First, Galafold continues its strong performance and remains the cornerstone of our success. We continue to be very pleased with the uptake of Galafold globally, despite the significant foreign currency headwinds that spaced our industry this year. The first half of the year represented 11% reported revenue growth or 18% on an operational revenue growth basis. In the second quarter, operationally, our growth in key performance indicators are meeting or exceeding our objectives in all key geographies, and we are reiterating our guidance at constant exchange rates. Sebastien Martel, our Chief Business Officer, will provide further detail later in the call. We are also excited to announce that the Galafold intellectual property estate continues to grow this quarter. This year alone, we have strengthened our IP estate through the issuance of 17 new patents. There are now 44 orange book listed issued patents related to Galafold in the United States, 28 of which provide protection to 2038 and beyond, and importantly include three newly issued composition of matter patents, bringing the total now to four. We see this patent portfolio, along with our orphan drug exclusivities providing broad and long-term intellectual property rights well into the late 2030s for this novel precision medicine. And importantly, we believe we are well positioned to address any potential generic challenges to our patents. Looking ahead, we expect continued growth for Galafold this year, and with the strength in IP protection, continue to believe it has a long runway well into the next decade. Second, we continue to make progress on our global regulatory filings for AT-GAA, our novel next-generation therapy for Pompe disease. The U.S. and EU regulatory reviews are progressing very well, and we're very pleased with the level of engagement from both regulatory agencies. Clearly, all eyes are on the FDA inspection at the WuXi Biologics facility for ATB200, the biologic component of AT-GAA. We remain in active dialogue with the agency on how best to support an inspection, and we along with our colleagues at WuXi are fully ready to welcome FDA inspectors to the WuXi facility in China. However, as of today, they have not yet conducted their inspection. And if the FDA inspection does not take place in the appropriate time, it goes without saying that it could impact the timing of approval. That being said, the good news is, we are in late stage label discussions and are highly confident in AT-GAA's potential approval in the United States. And at this time, we continue to expect that the two components of AT-GAA will be approved together by the October 29 action date. Importantly, in Europe, we're now actively engaged with the EMA and the marketing authorization applications for AT-GAA. We continue to expect the positive CHMP opinion later this year and commercial launch in early 2023. And as a reminder, the EMA has indicated it does not require an inspection at the WuXi manufacturing site as a condition of their approval. I'm also extremely pleased today with the level of interest we are seeing in our expanded access programs globally. Today, we announced the first reimbursed access to AT-GAA has been granted in France under their compassionate access program, which was formerly known as the nominative ATU program. Additional access programs are in place in the United States, United Kingdom, Germany and Japan with a growing number of patients participating in each. Across all of our ongoing clinical studies and access programs, there are now more than 175 patients on AT-GAA today, which we believe represents 5% or more of the total treated Pompe patients around the world. Our global launch plans continue to move ahead, including prelaunch activities, targeted investments and additional personnel to support the launch, significant investments in the launch in inventory preparations. We are now closer to having another potential treatment option for Pompe -- for patients living with Pompe disease, both in the United States and Europe with further regulatory applications planned in the months ahead. And third, importantly, Amicus has maintained a strong financial position and remain committed to achieving profitability in 2023, as we continue to execute on the global expansion of Galafold and prepare for the global launch of AT-GAA. We are rapidly approaching two pivotal inflection points for Amicus. First, the global launch of a second rare disease medicine with AT-GAA; and second, achieving profitability. These are rare feats that we believe will enable Amicus to truly enter the upper echelon of rare disease focused biotechnology companies. I'll emphasize that we are sharply focused on three key objectives: continuing to advance Galafold to as many patients and as many geographies as possible; securing approvals for and launching AT-GAA globally; and ensuring the financial strength of Amicus. On Slide 5, we see we're well on our way now towards achieving our key strategic priorities for this year, including continuing to drive Galafold to more people living with Fabry with amenable variance in existing and in new markets. We look to achieve double-digit global product revenue growth of 15% to 20% with revenue of $350 million to $365 million at constant exchange rates. This reflects the strong momentum in demand behind this precision medicine globally. We remain steadfast in our commitment to advancing AT-GAA regulatory filings and initiating the anticipated launch of AT-GAA in the United States, leveraging our seasoned global commercial team and experience across all areas needed for an effective drug launch, we are fully prepared and anticipate a very successful launch for AT-GAA. We are strategically advancing our best-in-class next-generation genetic medicines and capabilities. And again, we will continue to maintain a strong financial position as we carefully manage our expenses and investments going forward. With that overview, let me now hand the call over to Sebastien Martel, our Chief Business Officer, who can further highlight the Galafold performance. Sebastien?
Sebastien Martel: Thank you, Bradley, and good morning to everyone on the call. I'll start by providing you with more details on our Galafold performance for the quarter. On Slide 7, as you can see for the second quarter of 2022, total product revenue reached $80.7 million, driven by strong patient accruals, partly offset by foreign currency impact as well as the timing of orders in certain ex-U.S. markets. The geographic breakdown of our revenue during the quarter consisted of $53 million or 66% of revenue generated outside of the U.S., and the remaining $28 million or 34% coming from within the U.S. This is roughly in line with the 70-30 split that we expect as we continue to grow both parts of the business. Turning to Slide 8. Our results in the first half of the year highlight the strength of our global commercial efforts. The business continues to be incredibly resilient with patients added in all major markets and an operational growth rate of 17.8% over the first half of 2021 at constant exchange rates. The negative impact from foreign currencies was 6.9% in the first half of the year. And as a result, Galafold reported revenue growth was 10.9% in the first half of 2022. Just to add a bit of color on our geographical performance. In the first half of the year, our sales in the U.S. grew 16.1% at CER, while our ex-U.S. sales grew 18.5% at CER. So Galafold continues to be the fastest growing product for Fabry disease globally and has been the greatest contributor to global Fabry market growth over the last 12 months. I'm pleased to report that our monthly net patient trends continue to show positive signals. So for example, the three month trend is higher than the six months, which is itself higher than the 12 month. In the U.S. in June, we also delivered the highest number of net new patients and PRFs since April of 2021. And if you look at the growth in net patients on Galafold on a global basis, which is perhaps the truest measure of our underlying business performance, we see greater than 19% growth in patients on Galafold at the end of Q2 this year versus the same period last year. So all indications are the continued demand for Galafold. We ended the second quarter with a little under half of the global market share for treated amenable patients. And while the global mix remains about 55% switch and 45% naive, many, many geographies were starting to see stronger uptake in naive populations. So while we're achieving higher market shares in countries where we've been approved the longest, there's still plenty of opportunity to continue to switch patients over to Galafold and to continue to grow the market as we penetrate into the diagnosed and treated segments and the newly diagnosed segments. All of that is underpinned by impressive compliance and adherence rates that continue to exceed 90%, reiterating our belief that those patients who go on Galafold generally stay on Galafold. We did experience some impact due to the timing of orders in the second quarter, and we expect this nonlinear quarterly growth to continue. This order pattern led to a handful of orders being recognized in the beginning of the third quarter. Importantly, the value of Galafold continues to be recognized by payers, as we have a very strong track record of successfully negotiating and renegotiating reimbursement outside of the U.S. Our relentless focus remains on ensuring access to Galafold for anyone who needs it. Next, on Slide 9. What we've seen so far this year is that Galafold uptake continues to track very well and we're seeing growth across all of our major markets as well as most of our smaller markets. We're on track to achieve full year revenue guidance of 15% to 20% growth at constant exchange rate. And our first half growth of 17.8% at CER is right in the middle of that range. So altogether, we view this as a great first half of the year. Moving to Slide 10. We know that Galafold has the potential to surpass $500 million in annual revenue over the next few years through three key growth drivers: first, continuing to penetrate into existing markets; second, expanding into new geographies; and third, broadening the labels. I'm pleased to share that we're making continued progress on expanding into new markets. And just to name a few examples, we expect marketing authorization in Turkey this year. We have filed in the second quarter in Hong Kong. And in Chile, we're in pricing and reimbursement discussions. In the longer-term, we continue to see significant growth in the overall Fabry market globally. This will be driven by diagnosing patients through a variety of measures, including high-risk screening, newborn screening and other diagnostic initiatives, which we continue to support and invest in as well. And finally, we have orphan exclusivity in the U.S. and Europe, in addition to our now 44 orange book listed patents that give us IP coverage into the late 2030s, 28 of which provide protection through 2038, and that includes three new composition of matter patents. So that gives us opportunity to provide access to Galafold globally for a long time to come. On Slide 11, let's shift gears, and I'll provide you here with an update on our launch preparations for AT-GAA, as we're poised for another successful product launch. So unlike when we launched Galafold, and at the time we were hiring and building the commercial infrastructure from scratch, we now have a presence in over 40 countries around the world, including all the major markets. That team will be largely the same that will launch AT-GAA with only a handful of new FTEs needed, for example, take managers, TLs. We have experience across all areas that are needed for a successful drug launch, from regulatory to commercial, supply chain, experience with payers, reimbursement and access, and in addition, and maybe most importantly, the key relationships with physicians. We're confident in our world-class commercial organization. We will leverage their experience and relationships and deliver AT-GAA to people living with Pompe disease around the world. From the team, the medical education have published Phase III data in the highly regarded Lancet Neurology Journal. Our experience with reimbursement and access around the world, and again, all the strategic planning that we're doing together with our partners at WuXi Biologics, we believe we're in a very strong position for a second successful launch of Amicus. With that, let me now hand the call over to Dr. Jeff Castelli, our Chief Development Officer, to highlight our AT-GAA
