Amicus Therapeutics Inc (FOLD) 2017 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Amicus Q2 results conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Ms. Sara Pellegrino, Senior Director of Investor Relations. Ma'am, you may begin.

Thank you. Good morning, and thank you for joining our conference call to discuss Amicus Therapeutics Second Quarter 2017 Financial Results and Corporate Highlights. Speaking on today's call, we have John Crowley, Chairman and Chief Executive Officer; Bradley Campbell, President and Chief Operating Officer; and Chip Baird, Chief Financial Officer. Dr. Jay Barth, Chief Medical Officer, and Dr. Hung Do, our Chief Science Officer, are also here and available to participate in the Q&A session. On this call, 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 to not to place undue reliance on any forward-looking statement, 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 on Slide 2 of our second quarter 2017 results slide deck, the forward-looking statements and Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2016, as well as our quarterly report on Form 10-Q for the quarter ended June 30, 2017, to be filed later today with the Securities and Exchange Commission. At this time, it is my pleasure to turn the call over to John Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics.

Great. Thank you, Sara, and good morning, everyone. So I'm pleased to host this morning's call, and let's begin on Slide 3. In the beginning of the year at the JP Morgan conference, we outlined 5 key strategic priorities for Amicus in 2017. In the first half of 2017, we've made significant progress across all 5 of these priorities, which we believe create a strong foundation as we approach several important milestones in the second half of this year. First, we are executing very successfully with our international Galafold launch. Galafold, of course, is our oral precision medicine for people living with Fabry disease who have amenable mutations. Growth in patient and physician adoption has picked up significantly over the past 3 months, and we continue to obtain pricing and reimbursement across the country-by-country process in the EU. Brad will review the launch metrics in more detail in a moment, but I'm pleased to say that we now have 179 patients on reimbursed Galafold as of July 31. Of significance, too, we also have seen extremely high rates of compliance and adherence to this oral precision medicine. This momentum reflects continued strength in our initial launch country, Germany, and more recently from several additional countries, notably France, Italy and the United Kingdom. We believe that this successful launch execution is an extension of and an embodiment of the science-driven, patient-centric culture here at Amicus. Our second priority for the year is to complete additional global marketing submissions from migalastat, including our Japanese new drug application, or NDA, which we submitted on schedule during the second quarter of 2017 as well now as our NDA to the U.S. FDA, which is targeted for the fourth quarter of this year. Third, we believe that we're well on our way to establishing definitive proof of concept in the clinic for our highly differentiated treatment approach for Pompe disease, ATB200/AT2221. Pompe, of course, [a] severe, fatal neuromuscular disease with significant unmet medical need. I'll note that ATB200/AT2221 is an important driver at Amicus that leverages our biologics and our proprietary CHART technology to develop chaperone ERT combinations that may benefit patients with lysosomal storage disorders.

In the first half of the year, we announced several positive data points from the ongoing Phase I/II clinical study on safety, tolerability, key biomarkers and reported improvements in tested functional outcomes in both treatment-naive and treatment-experienced Pompe patients. We believe that the initial data set here demonstrates that this novel treatment regimen for Pompe disease may be highly differentiated from any other Pompe treatment approach.

Fourth, we hope to successfully complete this year our Phase III study for epidermolysis bullosa or EB. EB is a rare genetic connective tissue disorder that leads to a breakdown in skin integrity. It can result in severe and chronic wounds and it manifests primarily on the skin. Although, internal organs can also be seriously affected by the disease. EB is one of the most, if not the most, devastating rare diseases that I've ever seen. If imagine -- for those of you who have seen or studied this disease, imagine living with chronic third-degree burns on your body, covering most of your body in the most severe cases, just a devastating disorder. It affects tens of thousands of patients, usually diagnosed during infancy and it can affect all age groups through their lifetimes. There are no approved therapies today for EB. Our novel topical wound healing agent, referred to as SD-101, is currently being investigated in a Phase III pivotal study, the ESSENCE study, and it may become the first approved EB treatment with the potential to address the substantial wound burden of people living with EB.

During the first half of 2017, I'm pleased to report that we made significant progress advancing the Phase III ESSENCE study, which we overenrolled with more than 160 patients representing all major subtypes of EB as well as finalizing our analysis plan for the primary endpoints. As a reminder, study success in this Phase III study will be based on achieving statistical significance with a first primary endpoint time to wound closure within 3 months. Time to wound closure measures the number of days for a target wound to heal, and the goal is to show that target wounds heal faster with SD-101 than with placebo with a statistically significant difference of a p less than or equal to 0.05. Given the constant and often chronic nature of wounds in EB, measuring time to wound closure is clinically relevant in EB and per the FDA guidance is an acceptable efficacy endpoint for wound-related disorders.

And finally, our fifth priority is to remain diligent in maintaining a strong balance sheet by staying focused on execution and groundbreaking science, optimizing value for patients and shareholders alike. With the recent completion of a $258 million equity follow-on public offering, we have a cash runway into at least the second half of 2019.

So these 5 priorities clearly outline the strength of our execution at Amicus. It has, indeed, been a tremendous first half of the year for patients as well as for Amicus shareholders. And I want to emphasize here, we are not done. There is much more work ahead for us here in the second half of 2017, and I believe we have the potential to deliver significantly more value in the next 6 months and into 2018.

So let me outline here next on Slide 4 what's coming next. First, as Brad will highlight in a moment, we are tracking toward our goal of 300 patients on reimbursed Galafold by year-end, led by a world-class leadership and field team, upholding the gold standard of business ethics and compliance. We're also preparing the Galafold NDA to submit to the U.S. FDA in the fourth quarter of this year, following confirmation from the U.S. FDA that we may indeed submit a new drug application based on our existing data set without having to do an additional Phase III study. We are also on track to report the complete data set from our Phase I/II Pompe clinical study in the third quarter of this year and to assemble, we believe, a robust data package and briefing document so that we can discuss the fastest path to a marketing approval so that this truly differentiated treatment option may be available to as many people living with Pompe as soon as possible. We believe that this Pompe program here at Amicus, our flagship in-house biologics program, will be a crucial driver of our emergence as a leader in the treatment of rare diseases. Also before we have the Pompe data set, we look forward to announcing our top line Phase III EB data later in the third quarter of 2017. In that Phase III ESSENCE study, all patients have now completed their schedule of visits during the 3-month primary treatment period and more than 95% of patients who completed this initial 3-month treatment period have elected to continue in the ongoing extension study. It's our vision that patients in this extension study will continue treatment with SD-101 until approval. Through these important milestones and with the strength of our balance sheet, we are well capitalized to continue to build a leading global biotechnology company focused on rare, devastating diseases.

So with that introduction and backdrop, let me go ahead and turn the call over to Brad, who is in London. Brad will continue to live in London for the next couple of weeks before he transitions back to living here stateside. So Brad, let me turn it over to you.

Thanks a lot John. Good morning, everybody. I'll begin on Slide 6 with an update on our launch metrics all as of July 31. The first half of 2017 has been all about opening new markets and continuing to drive successful launches in the markets that are open. And as of today, we've continued to do well on both fronts. First, let me highlight the patient numbers which continue to be the most important metric for our early launch. As John mentioned, there were 179 patients on reimbursed Galafold as of July 31. During the first quarter, most of that growth came from our initial launch country, Germany. In the second quarter and throughout July, we continued to see strong uptake in Germany, where more than a 50% of treated amenable patients are now on Galafold. However, as we anticipated, we're are now seeing a significant number of new patients from our recent launch countries including France, the U.K. and Italy, as well as the number of smaller and midsized markets throughout Europe. In terms of the other important metrics that we've tracked, we've secured pricing and reimbursements in 12 countries, including 4 of the top 5 EU markets, in addition to several of the midsized EU countries as well. We're in the midst of pricing and reimbursement discussions in additional 13 countries, and we have an Amicus footprint either directly or indirectly through partners on the ground in 27 countries as we prepare to expand the launch into additional geographies. We have an ambitious but achievable goal to treat 300 patients with reimbursed Galafold by the end of 2017, and given where we are today, we believe we're right on track to hit that goal. As we now have a number of countries contributing to the launch, we will not provide further country level detail on today's call. But I can provide you some additional color, as our commercial patient demographics continue to be very encouraging across the board. We continue to see adoption from our 3 key patient segments, including patients switching from infused enzyme replacement therapy, which continues to be our largest segment, a smaller but growing portion of treatment naive patients who were previously diagnosed but not treated, and uptake into a number of newly diagnosed patients. We also continue to see a good mix of males and females, classic mutations and late-onset mutations in all countries. So really, overall, we're seeing great utilization across the spectrum of Fabry patients with amenable genetic mutations who meet our EMA level.

Outside of Europe, if you turn to Slide 7, our global regulatory strategy is to reach even more Fabry patients who have amenable mutations. We have 2 Expanded Access Programs underway and expect to open additional Expanded Access Programs during the second half of the year.

Outside of Europe, we've received approval for Galafold in Switzerland and just last month in Israel. And we've successfully completed a total of 7 additional regulatory submissions with potential approvals now pending in Japan, Canada, Australia and other countries as well. And of course, in the U.S. as John mentioned, we are targeting an NDA submission in the fourth quarter this year.

So in closing, the success of the EU launch to-date as well as our global regulatory progress reflect the strength of our data, the significant value of our oral precision medicine approach with migalastat and the unmet medical need among Fabry patients. We do remain committed to providing broad access to Galafold for all Fabry patients with amenable mutations. As for patients with a non-amenable mutations, we continue to evaluate the opportunity to develop a novel, proprietary Fabry enzyme replacement therapy, co-formulated with migalastat to enhance that ERT activity. Our ultimate goal will be for all Fabry patients and physicians to have an Amicus treatment option, driven entirely by the patient's genotype. With that, let me turn the call back to Chip to discuss our second quarter financial results.

Thanks, Bradley. Good morning, everyone. Our financial overview begins on Slide 9 with our income statement for the second quarter. And in the second quarter of 2017, we recorded revenue of $7.2 million, representing a sequential increase of 72% over the total product revenue of $4.2 million recorded in the first quarter of 2017. Total product revenue for both periods represents commercial sales of Galafold as well as Expanded Access Programs.

Moving now to the income statement. Total R&D expense, second quarter of 2017 increased to $32 million as compared to $18.3 million for the second quarter of 2016. The increase here is primarily due to investments in Pompe manufacturing scale-up as well as investments in Pompe Phase I/II study that's ongoing and the Phase III EB clinical study. Total selling, general and administrative expenses, second quarter of 2017 was $19.3 million, which was essentially identical to the $19.3 million we spent on SG&A in the second quarter of 2016. This steady rate of spending reflects our continued focus on carefully managing SG&A expenses. Net loss for the period was $48.2 million or $0.34 per share compared to a net loss of $51.1 million or $0.40 per share for the second quarter of 2016. The narrower loss here is attributed to an increase in net product sales versus the prior period. And as of July 25, 2017, we have approximately 164.6 million shares outstanding which includes the shares issued during the recent follow-on offering.

Moving on to Slide 10. A few comments on our current cash position and 2017 financial guidance. Cash, cash equivalents and marketable securities totaled $227.2 million on June 30, compared to $330.4 million at December 31, 2016. Our balance sheet was further strengthened in July with a $258 million follow-on public offering. Total net cash spend for the first half of 2017 was $103.2 million, so we're tracking well against our full year 2017 expense guidance. I'll note that even with a positive recent update on FDA status for Galafold and our ability to now file an NDA in 2017, we continue to expect full year net operating cash spend of between $175 million to $200 million and full year total net cash spend, including third-party milestone payments and capital expenditures, of between $200 million and $225 million. And with the proceeds from our offering, our current cash position is now expected to fund operations into, at least, the second half of 2019, and as John highlighted, through several key catalysts. So this summarizes our key financials for the second quarter, 2017. Additional details about -- can be found on our annual report 10-K currently on file with the SEC as well as our Form 10-Q, which will be filed later today. I'm happy to address any questions during the Q&A, but for now, we'll turn it back to John.

Thank you, Chip. So again, a lot of work ahead of us, and hopefully, much more value for shareholders ahead and for patients, too. The second half of this year will be a very important period for us here at Amicus as we continue to execute the Galafold launch as well as our global regulatory strategy for migalastat, and as we approach significant clinical data milestones, including top line data from our Phase III EB study later in 3Q, followed by complete data from our Pompe Phase I/II study.

In closing, on Slide 13, we believe that our successful execution in the first half of 2017 has advanced our very bold vision here at Amicus. And that is to build one of the world's leading global biotechnology companies focused on rare, devastating diseases and to measure our success toward that goal by the number of lives that we impact with our medicine. At the end of 2016, there were approximately 250 patients living with Fabry, Pompe,

or EB who are being treated with an Amicus medicine, either on reimbursed Galafold or enrolled in one of our ongoing clinical studies. During the first half of this year, to give you a sense of the momentum in the ongoing -- with the ongoing Galafold launch in addition to patient enrollment in our EB and Pompe clinical studies, there are now approximately 350 patients being treated with an Amicus medicine today. We believe that with continued advancement of our 3 lead programs, that by the end of 2018, we have the potential to impact more than 800 people with an Amicus medicine. That would be a significant achievement for the patient community and is incredibly gratifying, frankly, for me here and for our entire Amicus team. And if we fast-forward to 2023, which may seem like a long time from now, but only 6 years. And we think that upwards of 5,000 patients may be taking an Amicus medicine, the vast majority of them in the postapproval setting. That would put us on par with the leading global rare disease companies and would continue to fulfill our patient focused mission. So with that, operator, ends that summary of our vision ahead and the work ahead for us in the second half of this year, I'm happy to open it up for Q&A.

(Operator Instructions) And our first question comes from Ritu Baral from Cowen.

What are you guys expecting to release with the Q3 Pompe data release? Do you know the number of patients? Will it be the full cohorts? And what are your expectations for the data? What would qualify success on the endpoints, maybe, 6-minute walk time function, PFTs, et cetera?

So with that data set, Ritu, we would expect the full data from the 20 patients. As a reminder, we have 3 different cohorts in that study. We have ERT experienced switch patients in Cohort 1. ERT -- who are ambulatory. We have ERT nonambulatory switch patients in Cohort 2 and treatment-naive ambulatory patients in Cohort 3. We've seen some data now for each of those cohorts. To remind everybody, back in May, we showed data of 10 patients, so half the study set, at 6 months and included safety data, important biomarker data. It also included muscle function data on those 10 patients at 6 months. So fast-forward to the end of this quarter, Ritu, we'd expect data on all of those patients, so similarly to the first 10 patients, where we think we had early proof of concept, to continue to see the same magnitude of improvements. Obviously, the safety profile continues to see -- continuing to see very low infusion-associated reactions, we think, would be very differentiating factor. And in muscle outcome, too, we think what we saw previously, if those trends were to continue with the next cohort, we think that would bode very favorably for this experimental treatment regimen for Pompe patients. In addition, Jay, comment, but I believe we'll have data on some of those first cohort patients at 1 year as well.

That's right. There will be long-term functional data ready, starting to collect that. And patients have been on treatment, as we've said, for as long as 48 weeks, the longest patient, and continuing.

Right. So we haven't seen that with (inaudible) Yes, I'm sorry, go ahead.

Would you expect additional improvement between the month 6 and the month 12 time point?

It would be -- yes, we don't know. We haven't seen -- it would be wonderful if patients continued to improve, that would be a very high bar, indeed, given the level of improvement that we saw in months 0 through month 6. But to see that they were -- that the effect at month 6 was persistent and durable, we think that would be very important to see, and obviously, if they continued improvement, that would certainly be a really important data set as well.

And how should we think about the secondary efficacy measures? There's a lot of discussion around the pulmonary function tests upon first release. Now that there'll be more patients and longer follow-up, what should our expectations be around that?

Yes. Jay, I'll let you comment.

In the data that we reported previously, we saw very good trends in this -- that interim analysis in the motor function test. And it was supported by the pulmonary function test directionally in the cohorts. And we hope to see the same going forward. And I think the motor functions tests are important. The pulmonary function test serve a supportive role as well in assessing the treatment regimen.

Got it. And last -- I'm sorry, go ahead.

No, you go ahead, Ritu.

The last very quick question on the Galafold launch. Can you talk to the progress that you've made on clinical patient conversion to commercial in the U.K., France and Italy? Will that be a continuing tailwind or is that -- have all those patients been captured already?

They have not all been captured, but I'll let Brad comment.

Yes, we're probably 2/3 to 3/4 of the way through, so there's still a little bit left there in those markets and a handful of others. But we made good progress so far. And -- but I would say, the progress that we've made is certainly not just that, but a reflection of the quality of the team and the quality of the strategy and of the product.

And our next question comes from the line of Tazeen Ahmad from Bank of America.

John, just so that I'm clear, did you say that we were definitely going to get the top line EB data before Pompe in 3Q?

Yes, that's our expectation, Tazeen.

And then in terms of what you think the range of pricing could be for EB, I know that we're still a little bit away from doing that, but in terms of market research, what have you found about what kind of level insurance providers will be willing to pay for a drug which really doesn't have any options right now, and then I have a -- one other follow-up.

So Tazeen, we're not yet prepared to talk about pricing. I'll just state that the Amicus pricing philosophy has always been that our medicines be fairly priced and broadly accessible and that philosophy will certainly underline how we approach pricing for EB. We think it's important. Let's get the data set, let's look at the strength of the data, hopefully, and with all the market work that we're doing right now, after that we'll be prepared to talk about more specifically, how we view pricing.

Okay, and then for Brad. Can you talk a little bit about compliance, not so much discontinuation. But what kind of feedback are you getting about how compliant patients are with your therapy? And then for the upcoming countries that you're expecting to launch in. I guess, specifically for Japan, what are the addressable populations, how well identified is Fabry in that market?

Sure, thanks, Tazeen. On the first question, as relates to compliances, as John highlighted in his call, we have seen incredibly high compliance and adherence rates both. So both very few drop-offs and for patients who are on drug, they're adhering to the regimen incredibly well. And that's no accident. So in part, of course, it's a rare chronic disease so there's always some added, I think, compliance factor there. But we've put together a very robust set of patient services, support services and it's different in a country-by-country basis, some countries allow more, some countries allow less. We work very closely through our specialty distributor, with the pharmacies of the hospitals where the patients receive their medicine and very closely with the physicians themselves. So both at the patient level, where allowed, at the distribution level and with the physician level, we worked very closely from very early on to educate the importance of the regimen and also ensure that we are having high compliance. And so far, it's been very high, which is great, and we'll continue to focus on that as a key driver going forward. As related to your second question, which was Japan, correct? In terms of market environment there?

Yes.

So there are about 700 patients treated today in Japan. It's a higher-than-average treatment rate, so it's more penetrated from a treatment perspective. From a amenability perspective, it is in the 30% to 50% range that we have discussed in other markets. So typical from that perspective. It's a very high -- there's a very high awareness of the chaperone and as you may recall, as we've mentioned before, the technology came out of Japan so there's some receptivity there. And importantly, too, we think that there is no home health care in Japan. So we think that in addition, of course, to providing all benefits that we believe that the product can and the data that we've shown so far with a very favorable safety profile, we also think that the reduction in the infusion -- the burdens of the (inaudible) infusion will be particularly meaningful in that market. So we think a very -- obviously, it's a very important market, the third largest -- excuse me, the second-largest individual country market in the world. It also has a number of demographics that we think will be receptive for our launch there.

And the last question on U.S. Galafold. You're planning to submit by year-end. What needs to be done basically between now and then? Has FDA asked you for anything minor to submit between now and then?

No. To remind everybody, the FDA has said, Tazeen, we do not need to generate any additional clinical data. So it is the literally pulling together all of the magnitude of detail required for the highest quality submission to U.S. FDA and that will be completed in the fourth quarter. Our regulatory teams, I assure you, are hard at work.

And our next question comes from Anupam Rama from JP Morgan.

(technical difficulty)

Maybe, operator, we can- if Anupam's not coming through, we could try to work that technical issue out and go to the next call in the meantime.

Yes. And our next question comes from Joseph Schwartz from Leerink Partners.

For EB, can you remind us whether you are having the physicians choose target wounds that are in frictional and nonfrictional zones of the body? And how that's being controlled, if at all. And in addition to your co-primary endpoints of target wound closure and time to wound closure, what do you think -- how much do you think regulators appreciate that this disease is not a single wound in the way the drug is being used? And measured in secondary endpoints, could help secondary endpoints like pain and itching and body surface area improvement?

Jay, I'll put those over to you, please.

For the selection of the target wound by the investigators, that is at their discretion. Of course, it's selected at baseline and then that is the wound that's followed through the remainder of the study. And for the target wound, the FDA had said that the success of the study based on the time to wound closure is based on the target wound as long as that outcome for that primary endpoint has statistical significance, less than or equal to 0.05 per p-value. That's success for the study, irrespective of what's happening with other endpoints. Other secondary points, you mentioned some pain, itching and wound burning overall, are supportive and potentially can enhance the overall effect that demonstrated for the drug. But success of the study is based solely on what the outcome is for the target wound.

Okay. And then turning to Pompe. Where are you in the process of talking to regulators about what the next steps should be for designing a study that could support regulatory submission?

Yes Joe, so as a matter of policy, we're not going to comment on ongoing regulatory discussions. We think they will be ongoing for some time. The most important thing right now for us is to get this additional clinical data. That will certainly help to shape the view of the regulators in terms of next steps for this program. But I assure you, we're deeply engaged in regulatory strategy and planning, discussions, engagement with the top key opinion leaders around the world who'll help us and the regulators, frankly, form an opinion around the fastest way to get this drug to as many patients as quickly as possible toward a marketing approval.

Okay. And while I'm on the subject of your advanced biobetter ERTs. Can you give us an update on your Fabry ERT cell line development, and when would you anticipate entry into the clinic?

Right. So we expect, in the second half of this year, to have some very important preclinical further proof-of-concept data that we think will further distinguish this treatment paradigm. And to remind everybody, Joe, this is our own biologic that under Hung's leadership was developed in our R&D organization and that it incorporates in the biologics formulation, migalastat as a stabilizing agent for the ERT. Again, the notion that it would keep it -- we believe, it would keep it more stable in blood, keep it folded, potentially make it less immunogenic, and once targeted then to the carbohydrates or the proteins, keeping it in the lysosome in a more active form. And what we've seen to date are a substantially higher levels of uptake of the enzyme to target tissues and organs and cell types and significantly better breakdown of the GL-3 substrates. So we'll have more of that in the second half of the year. We're in the process of a final decision on manufacturing timelines and strategies for this, but I would expect all of this in the second half of the year to be very clear, including a timeline to the clinic.

And our next question comes from the line of Michael Ulz from Robert W. Baird.

Maybe with that -- if I can just follow-up on Pompe program here and if you can remind us the current status of large-scale manufacturing there? And when could product be available for start of a Phase III?

So we continue to make great progress, Mike. Remember, we are operating at the 250-liter scale under GMP. That's the scale that's been producing the material for our Phase I/II study. We're now in the process of moving from engineering batches that have been successful to full GMP batches at the 1,000-liter scale. And that will be an ongoing activity through the second half of this year, and we would expect that if it was successful, the material to be available in the first half of the year to mid-2018 for the start of the Phase III study.

Okay, further...

I am very, very pleased with the quality and then also the productivity of the cell line at 1,000 liters with additional work from our team and team at WuXi Biologics. We've seen some terrific success, all the while ensuring that we maintain optimized glycosylation and high levels of mannose-6 phosphate. Yes believe me, if there's one thing that keeps me up at night it's Pompe manufacturing and knock on -- knock the wood, so far, so good.

And at this time, I'm showing no further questions.

Great. Well, thank you, operator. Thanks, everybody, for listening again. We've got an enormous amount of work ahead of us here in the second half of year. It's been a great start, of course, to 2017. But I do believe, finally, we're at the point where we have a terrific portfolio of medicines, a tremendous team and a very strong balance sheet to help us achieve our vision and continue to execute. Thank you. Have a great day.

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may all disconnect. Everyone, have a great day.