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Edited Transcript of ORPHA.CO earnings conference call or presentation 28-Feb-20 10:00am GMT

Q4 2019 Orphazyme A/S Earnings Call

KOEBENHAVN Mar 5, 2020 (Thomson StreetEvents) -- Edited Transcript of Orphazyme A/S earnings conference call or presentation Friday, February 28, 2020 at 10:00:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Anders Fink Vadsholt

Orphazyme A/S - CFO

* Kim Stratton

Orphazyme A/S - CEO

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Conference Call Participants

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* Anders Hedlund

Redeye AB, Research Division - Equity Analyst

* Jesper Ilsoe

Carnegie Investment Bank AB, Research Division - Research Analyst

* Thomas Schultz Bowers

Danske Bank Markets Equity Research - Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by and welcome to the Orphazyme Annual Report 2019 Conference Call. (Operator Instructions) I must advise you that this conference is being recorded today on Friday, the 28th of February, 2020.

I would now like to turn the conference over to your first speaker today, Anders Vadsholt, Chief Financial Officer. Please go ahead, sir.

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Anders Fink Vadsholt, Orphazyme A/S - CFO [2]

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Thank you very much. Good morning, and welcome to Orphazyme's Full Year 2019 Financial Results Conference Call and Webcast. I'm Anders Vadsholt, CFO of Orphazyme, and I'm joined here on the call today by our CEO, Kim Stratton. The slides for the call is available for download on our website. Please note that the Q&A will take place at the end of the presentation via conference call. If you would like to ask a question, please use the dial-in provided in our press release earlier today.

And on Slide 2, before we begin, I would like to remind you that some of the statements made during this call are forward-looking statements, including statements regarding the expectations for 2020 financial outlook, pipeline development plans and our commercialization strategy. These forward-looking statements are subject to a number of risk and uncertainties that may cause our actual results to differ materially. Further information about these risks can be found in our annual report for 2019 as well as our latest prospectus, which can be found on our website.

I will now hand over the call to Kim to provide a business update before I return to you with more details on the financial results.

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Kim Stratton, Orphazyme A/S - CEO [3]

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Thanks, Anders. Hello, everybody. Welcome. Thanks for joining us today. As you know, or as many of you know, I joined as CEO in Orphazyme in October last year. So I'm really delighted to be here with you today and to share the company's progress in the past year and to give you an outline of our 2020 priorities and the long-term outlook.

So we see on Slide 4, the team here has made significant advances towards our goal of bringing arimoclomol to patients suffering from neurodegenerative orphan diseases around the world. The team has delivered on the key priorities. We've hit the important milestones across all of the late-stage programs. And in Niemann-Pick type C, we've mapped out the path to approval in both U.S. and Europe, and we continue to do so.

We've got some promising data as you've seen from our Phase II/III study in NPC. And earlier in the year, we reported the 12-month data from the open-label extension study. So we are well positioned, and we're on track to submit our first filings in U.S. in the first half and in Europe in the second half of this year.

As you also know, we were delighted to receive the breakthrough therapy designation from the FDA for NPC at the end of last year. And as many of you know, so this initiative helps us a lot. It helps to expedite the development of the drugs for serious diseases where there is preliminary clinical evidence and indicating the substantial kind of improvement over available therapies, and in particular, in the U.S., where there isn't any. There are currently no medicines, as I've just said, in the U.S. for the treatment of NPC. And our top priority is ensuring that we advance this product and this indication as quickly as possible.

With this in mind, we decided to make arimoclomol available as a treatment option for patients in the U.S. through an early access program, or EAP, as you may see. And we launched that or started that process in January of this year. It's a good process because it does provide a way for patients who are lacking alternative therapies to gain access to investigational drugs before they're approved. And just to manage the expectations for our patients, the EAP does take a few months to set up with each of the key institutions, and that's what the team is currently working on. And then what we'll also start to look at, and indeed, we've started the process is to continue this work in looking at early access programs to more countries around the world.

Now during 2019, we also made significant progress in executing the clinical objectives in both sporadic inclusion body myositis, or sIBM, and also in amyotrophic lateral sclerosis, or ALS, as it's also known. We completed enrollment in both of the late-stage trials during 2019. And we also received fast-track designation for arimoclomol in sIBM. We've seen and we're receiving significant interest now about arimoclomol in both sIBM and ALS communities. And we look forward to sharing the data of these trials, and that will happen in the first half of next year.

Our earlier-stage programs also continued to move forward. We've got -- we had the completion of the enrollment in the Gaucher disease trial. We very much see this trial as a proof of concept in Gaucher disease, and those results will also come out during the first half of this year. We are particularly interested in the impact of arimoclomol on key biomarkers. We're looking at a few of the biomarkers and specifically at the enzyme glucocerebrosidase. And this will be also helpful -- this study will also be helpful in guiding us for our future plans in Gaucher and other related diseases.

I also couldn't leave this slide without thanking our shareholders, both existing and new, for their support or continued support and confidence in Orphazyme. Just this month, we raised growth proceeds of DKK 745 million, that's approximately $110 million in an oversubscribed directed share issue and private placement. And this is significant for us because this funding gives us the cash runway as we progress arimoclomol towards the market in the U.S. in the early next year and also to actually see the results from both the ALS and the IBM studies. As I've said, they will readout midway through the first half of 2021.

In the next few slides, I just wanted to take a moment to tell you a little bit more about arimoclomol, why we're excited about it and also as

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we see for arimoclomol in NPC and beyond.

I wanted to just take a moment to remind you about the key attributes of arimoclomol. We do see this drug candidate as a potential game changer for neurodegenerative diseases. Arimoclomol will be the first-in-class heat-shock protein amplifier. It enhances the cell's natural cellular stress defense system, and it will -- it helps to correct protein folding -- misfolding, it helps to break down protein aggregates and also improve lysosomal function, all of these are important underlying issues in a wide array of neurodegenerative diseases.

Arimoclomol is available in oral forms, so it has a low burden of treatment. It can be easily administered via tablet or in meals and also used with nasogastric or gastric tubes. So this is important for our patients as many of our patients have difficulty with swallowing. Furthermore, the product crosses the blood-brain barrier. And I think most importantly, for any new product, we've now had arimoclomol exposed to more than 540 patients and also healthy volunteers. We've got a really good safety and tolerability profile.

Now a lead indication for arimoclomol is Niemann-Pick disease type C. As you know, this is an ultra-orphan disease affecting around 2,000 patients across EU and U.S. Now NPC is a progressive lysosomal disorder. It's characterized by the accumulation of lipids in the cells of the brain, liver, spleen and lungs. It's a devastating impact on the lives of patients and also their families. And many of the affected are children, and these children, many of whom still don't make it through their teenage years.

And as I've already said, there were no approved drugs in the U.S., specifically for the treatment of NPC. And in Europe, miglustat is approved and used in about 80% of patients. So there still remains a huge unmet need in this area.

I wanted to share, again, just one slide looking at the efficacy of arimoclomol. We -- as you know, we received encouraging data from the Phase II/III trial. And we recently announced a post hoc analysis of the data. In this, we're looking at the efficacy of arimoclomol, excluding the double null patients. And in NPC, as you know, there is either a faulty or no expression of certain proteins such as NPC1 and NPC2, which are involved in the lipid metabolism.

And if you have the presence of double null mutations, simply put, you don't have any NPC protein. It's very rare in individuals with NPC. And it's strongly predictive of early onset and also rapid disease progression. Now there were 3 such patients in the study. All of these patients were under 4, and all of these patients were actually randomized to the arimoclomol treatment group.

In the post hoc analysis, when taking these patients into account and excluding these patients, you then see that we see nearly an 80% reduction in disease progression. And again, when you look at the statistical significance here, you see that we also achieved a good p-value of 0.024. When we are also looking at the effect of arimoclomol on top of sounded treatment, which includes miglustat, we also see the same marked effect. So clearly, we're excited about these data, and we believe that they demonstrate the attractive profile of arimoclomol in NPC. And this will give hope to many patients and their families around the world.

We are now obsessing on the submission of arimoclomol file in both the U.S. and EU. And obviously, we're preparing to commercialize the product ourselves in these key markets. Our primary focus now is actually getting to approval in the U.S. We have a number of regulatory meetings during the coming months and plan to submit our file in the first half of 2020.

We'll swiftly follow that U.S. submission with a marketing application in Europe planned for the second half of 2020. In parallel with our regulatory plans, we are, obviously, preparing for a positive regulatory outcome and really working on setting the stage in both the U.S. and also the rest of world.

So from a U.S. perspective, it's all about preparing the physicians, working with the U.S. advisory groups, building the medical education program. In terms of patient support, I've already mentioned the early access program, but also working very much with the patient groups in this area. And in terms of preparing Orphazyme, we've now appointed, obviously, the U.S. President, Molly Painter, from January this year. And now we've already recruited a team of around 20, building up our MSLs, building up the back office in the U.S., building up our key account and marketing team to make sure that we've got the right skills there, both -- from both a medical perspective and also from a market and patient access perspective.

From an EU perspective, we're really focusing on the first 2 markets of France and Germany, and very much exploring early access programs in the rest of the world and also looking at partnering for Japan and Asia.

Finally, if we look at our horizon chart here, obviously, our immediate focus has to be NPC. And that's really what we're obsessed about. But I think it's always worth noting that there is significant potential to leverage the heat-shock protein response beyond NPC and across a wide range of neurodegenerative orphan diseases, such as sIBM and ALS and beyond with neurological Gaucher and GCase in Parkinson's.

So -- and here, you see on this slide how we start off with, again, our ultra-orphan, but how we have then the potential to reach many more patients across these diseases around the world.

So with that, I will hand back to you, Anders, for a run through of the financials for 2019. Thank you.

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Anders Fink Vadsholt, Orphazyme A/S - CFO [4]

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Thank you, Kim. So moving on to Slide 11. You can see a summary of our financial position at the end of '19. As you would expect, our 4 ongoing clinical late-stage trials, preparations for filing and investments in precommercial activities to support the potential launch, our costs have increased compared to the same period of -- in '18. The net result for '19 was a loss of DKK 337.5 million compared to a loss of DKK 229.6 million in the same -- in the comparable period in '18. The increased loss was primarily due to the continued investment in R&D activities, the hiring of new employees as well as the production of arimoclomol. The operating loss was DKK 335.9 million compared to DKK 231.6 million in 2018.

Research and development expenses were DKK 285.4 million in '19 compared to DKK 197 million for the same period in '18. The increase was primarily due to the ramp up, as Kim described, in the IBM trials and also the Phase III trial in ALS as well as the initiation of the open-label extension trials in these indications. In addition, we also needed precommercial activities -- sorry, preclinical activities in regard to the trials in order to support the filing of arimoclomol in 2020. We also grew our organization from 47 to 70 full-time employees in the R&D activities by the end of 2019. This year will be more precommercial and commercial activities that will drive the increase in employees.

As of 31st, 2019 (sic) [31 December, 2019], Orphazyme had a cash position of DKK 23.6 million (sic) [DKK 123.6 million] compared to DKK 394.7 million at the end of December 2018. We'll come back to the cash position as it looks now.

On Slide 12, I'll jump now into a more detailed snapshot of the profit and loss. Aside from the items just described above, I would like to note the following here. The G&A expenses, these were high in '19 due to the rise of employees, and also the addition of new members to the management and also other employees to assist these functions.

We also ramped up the precommercial activities to prepare for the group for potential launches and increased our investor relation activities, which also paid off now with the capital increase in the early part of this year. The net result was an expense of DKK 7 million in 2019 compared to DKK 3.5 million in 2018. The increase was due to the recognition of interest expenses from the lease obligations due to a new IFRS standard and borrowings from Kreos Capital that we took in September of '19. These were not in place in 2018.

If you go to the balance sheet, you can see a bit more of the IFRS lease standard. So if we're digging in to the numbers, the key change compared to previous years relate to the standard. The right-of-use assets were DKK 13.9 million related to this new standard. And then if we look on the current liabilities on -- yes, the next slide -- on the other side of the table, this is an increase of DKK 13 million compared to last year, and that is primarily due to the Kreos loan. So that's the 2 drivers on the balance sheet, the new changed IFRS standard and then the Kreos loan.

Then if you go to Slide 14, that's the cash flow. Net cash flow from operating activities amounted to an outflow of DKK 337 million for the 12 months of 2019. And that's -- I would say, that's -- compared to the year before, of course, that's an increase.

And if you look on Slide 15, that is the outlook for the year. Looking ahead, we expect the operating loss for the period ending December 2020 in the range of DKK 500 million to DKK 550 million and anticipated cash position by the end of the year in excess of DKK 300 million. This forecast takes into account the net proceeds from the capital increase, which was completed earlier this month. And this concludes the presentation or focus on financial statement.

I will hand over to Kim for closing remarks.

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Kim Stratton, Orphazyme A/S - CEO [5]

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Thanks, Anders. Again, thank you, everyone, for joining us today. If you have any questions, we will go to the Q&A now. And I think Yola, we'll hand back to you to adjudicate, I guess.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Thomas Bowers from Danske Bank.

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Thomas Schultz Bowers, Danske Bank Markets Equity Research - Analyst [2]

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I have a couple of questions. Just to kick off with some financial and I have some follow-up on the pipeline. So first of all, on the guidance, you widened the spread to DKK 550 million. So just wondering any material reason for the small adjustment? And then secondly, the readout of the Gaucher trial, would that have any impact on guidance in any direction? I mean we lose already -- have you included some costs for Phase III preparation in the current guidance? And then maybe just to continue going into '21, just to get some color. Now you're guiding for plus DKK 500 million spend in '20. So this guidance also reflects some front-end loaded costs that is -- that maybe have some impact for the continued preparation of the launch in '21. So maybe just a bit of color on how we should see costs in '21 when you exclude IBM and ALS trial outcomes?

And then thirdly, just moving into the pipeline. On ALS, when should we actually expect the FDA decision on the fast-track designation? And also, could this actually have some potential effect on timing of the Voucher sales following the approval in the -- effect approval in the NPC? And then finally, just regarding the top line Gaucher data, I'm just wondering are you going to report on all biomarkers or just the (inaudible) as the primary endpoint biomarker. So I mean, how well do you actually know the mechanism of action impact on (inaudible) changes compared to what you expect to see in GCase? I think that's it.

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Kim Stratton, Orphazyme A/S - CEO [3]

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Maybe I'll take the last one first on -- from a Gaucher perspective. So yes, we will report on all of the biomarkers actually in the study. We have -- we're looking at the 4 biomarkers actually in the Gaucher. We'll report on all of those. No comment at this stage about the difference or the relevance. I think that's what we'll find out from the study itself. I think with respect to your question about the ALS fast-track designation, we should hear something, if we're going to hear something over the kind of coming weeks. And with respect to the Voucher, obviously, we need to wait until we actually get the approval of NPC. Then also see what we have in terms of fast-track designation for ALS, and then we'll sort of see what happens from -- with respect to the Voucher.

And Anders, do you want to talk about the costs and -- the 2019 costs?

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Anders Fink Vadsholt, Orphazyme A/S - CFO [4]

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Yes. Definitely. So -- and also, just to comment on what Thomas asked for 2021. So for this year, with the -- increase the spend to DKK 50 million -- to DKK 500 million to DKK 550 million. As you said, it was a lower spend but also going from DKK 500 million to DKK 540 million, up to DKK 550 million, it's more for us to be conservative. But also the fact that some of the activities, we were able to get right people in earlier for some of the precommercial and commercial activities, but also be more prepared to be able to launch. So we need to be prepared, of course, to launch the product earlier than we anticipate to get through. So that's why you see a very small increase in cost here. So -- but the number of the costs for this year, which you also referred to is related to launch costs. So we will hire or already have hired a number of people required for us to be able to launch in the U.S. and that's reflected in the outlook for this year.

And then on the cost for next year, if we disregard ALS and IBM, much of the cost at the end of this year will be on the same level in Q1 and Q2. Next year, we will have many of the people required to launch. But of course, what we are waiting for by the mid of the first half of 2021 is, of course, the ALS and IBM data. And that could be a game changer for us. So that's why we will not go into details for 2021. But the cost will be pretty stable in the first quarter or second quarter based on the end of this year's cost per month.

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Kim Stratton, Orphazyme A/S - CEO [5]

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And I think, Thomas, at this stage, the focus is very much just building that organization that's bespoke for an ultra-orphan product. And then as Anders has said, once we actually get the ALS and IBM results, then we'll know if we're building a much bigger organization.

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Thomas Schultz Bowers, Danske Bank Markets Equity Research - Analyst [6]

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Okay. And then just on the Gaucher readout, so assuming positive readout here in the coming weeks or months, so will you have some additional -- potential additional costs for '20 if you go into Phase III proration this year?

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Kim Stratton, Orphazyme A/S - CEO [7]

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I think that, that is to be kind of determined to be confirmed. At the moment, no, we don't expect to increase the costs of -- because of Gaucher. But I think we need to really wait until we see the readout of the data. And again, if it's compelling, then maybe we need to move faster, but otherwise no.

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Operator [8]

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(Operator Instructions) Your next question comes from the line of Anders Hedlund from Redeye.

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Anders Hedlund, Redeye AB, Research Division - Equity Analyst [9]

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So I was wondering if we could have a little bit of a high discussion regarding the prevalent cases of NPC in the U.S. and EU. We are often mentioning numbers such as that there are 2,000 prevalent cases approximately. But since now arimoclomol is getting closer to market, and there might be a treatment option available for them. It's not uncommon to see that -- for ultra-rare diseases that the prevalent cases increase due to the rise of awareness and maybe a lower rate of misdiagnosis. What -- how would you think -- how would you say that the real figure here is of the prevalent cases? Or is there a large -- is it likely to increase? Or is this -- is it a huge hit the number here?

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Kim Stratton, Orphazyme A/S - CEO [10]

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Yes. Thanks, Anders, for your question. So the 2,000 number for U.S. and EU does really represent what we think the actual prevalence should be. When we look at feedback from physicians in the marketplace about what -- the number of patients that are diagnosed and/or treated, then we see that number roughly around 1,000 across U.S. and greater Europe. We think that it's about a 40%, 50% kind of diagnosed untreated rate. So that's kind of roughly around the 300 mark for U.S. and around the 600 mark for Greater Europe. And I would agree. I mean you do -- when you start to have a product available in the market and more awareness around it, then yes, you do start to sort of see the amount of patients that are diagnosed. But I think in the first instance, for us, it's very much focusing on reaching those diagnosed and/or treated patients now. And then once we get to a substantial kind of patient share of the patients that are currently diagnosed, then we can also support the patient groups and the physicians in terms of a greater kind of awareness and a greater level of diagnosis.

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Operator [11]

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Your next question comes from the line of Jesper Ilsoe from Carnegie.

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Jesper Ilsoe, Carnegie Investment Bank AB, Research Division - Research Analyst [12]

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Just to continue on the Niemann-Pick questions. Just high level, key risk into the weak -- to the approval decision once we have filed. So given what you have seen in the primary analysis and also in the post hoc analysis and the discussions you've had with regulators so far, so what should we really focus on here when we look at the risk into the approval decision because it do look -- it does look encouraging, once you have shown this post hoc analysis? So that's the first question. And then second question is just on the expanded access. Anything you can share there? I know it's very early, but you're probably getting some data on this on a continuing basis.

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Kim Stratton, Orphazyme A/S - CEO [13]

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So thanks, Jesper. I think that we don't really have a particular area of the file that we think is risk. I think with -- it's really just when we are meeting with the FDA that we've done our homework, that we've got the right questions that we're listening to their feedback, listening to their guidance. And I think the other one is that we're a small organization. And so we've done a lot of work here to pop these people in a room and try to kind of protect them from distraction and keep them very much kind of focused and supported and making sure that they've got the resources and the time to really do a good job of it. So no, nothing particularly stands out. It's more making sure your collaboration, making sure you're listening, making sure the team is focused.

From an EAP perspective, as I kind of mentioned, I think we've got about 12 sites now that -- where we've actually drawn up kind of contracts, the institutions. We've got the protocol in. And then again, that's being done in collaboration with the kind of key thought leaders in the state. You should allow about 30 days for that protocol to be reviewed by the FDA. And at the same time, these institutions have actually submitted the protocol to their local science, ethics and finance committees. And it's really -- there's -- we know that they've identified quite a number of patients. But you now really have to just go through the -- if you like, the bureaucracy of each institution, making sure that you've done the checklist from an ethics, from a scientific and also from a financial perspective. And that the relevant support is actually given to the patients and their families because quite often, they have to travel quite long distances to actually get into the center, to see the position, to actually who does the review -- the clinical review of the patient and then -- and onboarding of the patient onto treatment. And as you can imagine, we get a lot of interest from patients and their families, this can't happen soon enough. But unfortunately, these key steps have to be made. And of course, this is hands off by us because this is between the physician and the patient. So we can try to support the physician and the institutions as much as we can in an appropriate and compliant way, but really, they have to kind of lead the process and make it happen. And I think...

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Jesper Ilsoe, Carnegie Investment Bank AB, Research Division - Research Analyst [14]

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That's really helpful, Kim. Yes. Sorry.

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Kim Stratton, Orphazyme A/S - CEO [15]

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Yes. I think, Jesper -- I mean, I think what we're looking at and what we're talking with patients is, is that probably they should start to see this open up for the patients some time during quarter 2. And obviously, we're trying to do everything we can to make sure it's early in quarter 2. But I think just to manage your expectations and theirs, that's what was the feedback that we're getting from the institutions.

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Operator [16]

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(Operator Instructions) And we have another question from the line of Thomas Bowers from Danske Bank.

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Thomas Schultz Bowers, Danske Bank Markets Equity Research - Analyst [17]

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Just a follow-up question on -- so just to get an understanding on this planned submission here to the FDA. So we have a proof-of-therapy meeting here in -- here next month. And I assume, will you then soon afterwards to -- plan to start rolling submission? Or will you compile the whole filing package during the first half? Or -- and then secondly, are you able to submit all data? I know you're still doing some PK/PD work, among others. So will there be any data submitted later on, so maybe in connection with the mid-cycle review? So I'm just trying to figure out whether we should see any potential risk of FDA doing a 3-month delay potentially or anything like that? So any color on this, please.

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Kim Stratton, Orphazyme A/S - CEO [18]

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Yes. Thanks, Thomas. So -- yes, so we've got a B2B meeting in March. And then in early Q2, we've then got the pre-NDA meeting. So the team is very much focused on those 2 meetings and getting that set up. I think it's a really good question about the rolling submission. If you look at other sponsors who have received a breakthrough-therapy designation, about half of those sponsors take the opportunity to do a rolling submission. It particularly helps small companies like us to actually do a rolling submission because you can break it up and it's -- the workload becomes more manageable as well. So we will -- we are kind of really looking into this to see this actually may suit us better, but this is something that we're actually doing our homework on literally as we speak. In terms of the PK/PD, those studies in terms of the special population studies are looking good. They're all on track. And yes, as you say, very much looking at having that data ready for the kind of mid-cycle review, and that -- but that seems to be all on track. And can't comment about the risk of delay at this stage. No red flags at this stage, Thomas. But if we have them, obviously, we will flag it.

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Operator [19]

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Another question from the line of Anders Hedlund from Redeye.

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Anders Hedlund, Redeye AB, Research Division - Equity Analyst [20]

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So I was wondering, given that we know -- so regarding the Gaucher results, given that we know when the -- given that we know the last patient in and the treatment period, can you be any more specific of when the results will be presented or why aren't you more specific than it is in H1 '20? And then I was also thinking with regards to previous question on that you will present results of all the biomarkers. But first press release, I would say, I guess, we focus on the top line. So yes, please confirm.

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Kim Stratton, Orphazyme A/S - CEO [21]

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So Anders, I think we stick to the guidance in terms of the -- what we've said about that they'll be ready midway through the first half of this year. So I think that's kind of on track. So it really is kind of midway through the first half of this year. In terms of the biomarkers, that's really how the study was set up to actually look at the kind of 4 biomarkers there. So no change there. I mean, as you know, there are -- all of these patients are treatment naive, both ERT and SRT. It was what 39 patients all fully enrolled as of August. We had about 30 patients on arimoclomol, 10 on placebo. We have the 3 active dose arms. So remember, this was also helping us look at a bit of -- a bit more dose finding in Gaucher at 100, 200 and 400 all t.i.d. And the 4 kind of biomarkers that we were looking at, and we were looking at trying to get as much CSF data for these biomarkers as well as blood. And so we were looking at the key dose, 3 dose a day, the HSP70, the GCase activity and also the Lyso-Gb1. So that's -- as always, was presented.

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Anders Hedlund, Redeye AB, Research Division - Equity Analyst [22]

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Yes. But -- so -- but when the first press release comes out from you guys, I guess it will be around the top line or the primary measure? That was sort of my question.

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Anders Fink Vadsholt, Orphazyme A/S - CFO [23]

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I think the -- So Anders, so from my view, I think for this is a Phase II. I think it will be best to have the full overview of the trial. So preferably, I would like to get the data when we have it all because it's -- yes, so it -- yes.

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Kim Stratton, Orphazyme A/S - CEO [24]

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It only adds a few weeks, Andres, between when you get the very initial top line, which in a Phase II study is not so meaningful. Actually, what's probably more meaningful is to wait -- and again, normally, it takes 3 to 4 weeks. It's more meaningful for us. And I think it's more meaningful to everybody else to wait till you get the full data set, have done your homework on it and then sort of say, okay, this is what we think it means for Gaucher in type 1 and type 3. Remember, it's looking also at type 1 and type 3. So it's -- they're 2 quite different populations as well.

Is that -- we got to be just got cut off, I think. Hello?

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Operator [25]

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Anders was -- has just been cut off.

We have no further questions at this time. (Operator Instructions) We have no further questions. Please continue.

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Kim Stratton, Orphazyme A/S - CEO [26]

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Okay. Thanks, Yola. Okay. Again, thanks for your questions, everybody, really much appreciated for you actually joining us today. And again, please don't hesitate to contact us if we haven't been able to answer your questions fully or appropriately. Our next call with the -- of this nature with the first half results will be on August 28. Looking forward to speaking with you much sooner than that, of course. And I wish you a very good weekend. Thanks, everybody. Bye now.

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Operator [27]

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That does conclude our conference for today. Thank you for participating. You may all disconnect.