Good afternoon, everyone, and thank you for joining us today. On the call with me from Orphazyme are Christophe Bourdon, Chief Executive Officer, Anders Vadsholt, Chief Financial Officer, and Thomas Kindler, Chief Medical Officer. The slides for this call will be available for download on the investor relations section of our website. Please note that the Q&A will take place at the end of the presentation via conference call. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Orphazyme's future expectations, plans, prospects, public strategy, and performance, which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this webcast, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. Now I'll turn the call over to Christophe. Christophe? Thank you, Amy. Welcome everyone, and thank you for joining us. The last few months have been a profound and intensive period for Orphazyme. As you know, on June 18th, we reported receipt of a complete response letter, or CRL, for arimoclomol for Niemann-Pick disease type C from the U.S. FDA. This very disappointing news forced us to make a series of difficult decisions regarding our business and our people, and I would like to take this opportunity to thank everyone, in particular, the departing and remaining employees at Orphazyme and the NPC patient community for their continued support. We made those hard decisions based on one fact and one conviction. Fact is, as we sit here today, the unmet need for patients with NPC remains very high. Fact is, there is still no approved therapy in the U.S. for this rare genetic, progressively debilitating, and often fatal neurodegenerative disease. Our conviction is and remains that arimoclomol could provide significant therapeutic benefits for NPC patients, alone or in combination with miglustat in Europe and in the U.S. This conviction is supported by the strength of the arimoclomol data. Indeed, arimoclomol has demonstrated statistically significant and clinically meaningful effects on the disease progression in NPC. It has shown durable response and has demonstrated a good safety profile up to 36 months in the open label extension study. On August 21st of this year, the results of our pivotal 002 study were published in the Journal of Inherited Metabolic Disease. We're very pleased with this publication, and it provides validation of our program through a robust peer-reviewed scientific process. Our early access program in the U.S., Germany, and France is still on the way, and we will continue to recruit new patients. We now have more than 100 patients in our Early Access Program, evenly split between Europe and the U.S., we expect to prolong the Early Access Program until arimoclomol becomes commercially available in these markets, which is very important to the patient community. Over the last few months, we've been working diligently to ensure a successful path forward to approval. We are focused only on NPC and have discontinued development of arimoclomol for ALS and IBM and are in the process of discontinuing our trial in Gaucher. EMA's review of arimoclomol in NPC is still underway in Europe, we expect a CHMP opinion by the end of this year, with potential marketing authorization in the beginning of next year. In the U.S., we plan to request a Type A meeting with the FDA in the coming weeks. In summary, we've gone through a lot of changes in the first half of this year. We acted swiftly and decisively. We restructured our business to conserve capital, maintaining our guidance announced on June 18th in order to focus on our two registration priorities and are focused on leveraging our existing position to secure registration for arimoclomol. With that, I turn the call over to Anders to review the numbers in more detail, and then I wrap up the call. Anders? Thank you, Christophe. For the first half of the year, our strategy was to prepare for potential launch of arimoclomol in NPC. With the receipt of the CRL, we have taken many steps to conserve capital. As you can see from this slide, in June, we began working on our corporate restructuring. We anticipate an approximate 60% cost reduction in total operating expenses for the restructuring, while being able to retain our core capabilities to support our medical, regulatory, and pre-commercial activities. We'll continue to incur some expenses relating to our restructuring program in the second half, but we anticipate a significant reduction in our operating expenses by the end of 2021. Here's the financial pictures for the first half. Orphazyme recorded net revenues of DKK 13.2 million in the first half of 2021. The revenue relates to the sales of arimoclomol in France as part of the ongoing remunerated early access program. We'll continue to record revenues in this region on an ongoing basis. Our operating expenses increased to DKK 479 million in the first half of 2021 compared to the prior year due to commercialization planning for arimoclomol. R&D expenses were DKK 265 million in the first six months of this year, an increase of DKK 98 million compared to the same period of the prior year. This increase was largely due to the expenses relating to the ALS and IBM ahead of the trial readouts, as well as cost for the production of inventory. General administrative expenses were DKK 240 million in the first six months of 2021, an increase of DKK 136 million compared to the same period in 2020. The increase was primarily due to the build-up of our commercial organization, including launch preparations ahead of the potential approval for our arimoclomol NPC and personnel and support functions to enable our business growth. Overall, our net loss was DKK 251 in the first half of 2020 compared to a loss of DKK 464 million in the first half of 2021. We ended the first half of 2021 with DKK 334 million in cash compared to DKK 727 million at the end of December 2020. As you see here on slide nine, the operating loss, operating expense, and cash flow guidance we provided on June 18th remains the same. For 2021, we anticipate net revenues of between DKK 30 million and DKK 40 million relating to our arimoclomol sales from the ongoing EAP in France. While the net revenues are positive to our balance sheet, we'll need additional capital to advance arimoclomol to those patients. We're exploring options to secure funds in the second half of this year. With that, I will hand over the call to Christophe. Thanks, Anders. As we look ahead into the second half of the year, we are focused on executing on our two major priorities, EMA approval and a path forward in the U.S. for arimoclomol. Our strategy is clear and focused. We've taken hard decisions. We've completed the restructuring, and we are assessing financing options to secure additional capital for commercialization. In the next six months and in 2022, we have several pivotal milestones that could create significant value for Orphazyme. First, in Europe, the review of arimoclomol is ongoing, and we do continue to anticipate an opinion from the CHMP in Q4 of 2021. We will continue to record revenues and book sales. Our pre-commercial activities to gain reimbursement in priority EU markets ahead of potential approval are ongoing. We also expect EMA and UK MHRA approval decisions in the first half of 2022. In the U.S., we will request a Type A meeting in the next few weeks to align our regulatory path forward with the FDA. Despite the headwinds over the last few months, we do remain committed to our mission to improve the life of NPC patients by delivering our novel therapy, arimoclomol, as quickly as we can. We look forward to keeping you updated on our progress in the months ahead. Now I would like to hand the call back to the moderator for the Q&A session. Loreal, back at you. Thank you, sir. Once again, if you would like to ask question, just press star one, and if you want to cancel it, just press the hash key. Once again, please press star one for question. Sir, your first question comes from the line of Yatin Suneja from Guggenheim. Please go ahead. Your line is open. Hi. Morning, guys. This is Eddie. I'm for Yatin. Thanks for taking my question. Your focus has been arimoclomol. Can you talk about any of the work you're doing on the BD front to sort of partner with other programs or sort of bring in other assets and how you're thinking about BD over the next 6 to 12 months? Thank you. Thanks, Eddie. Christophe here. As I said, at the moment, we are solely focused on delivering on our two registration milestones, one in Europe and one in the U.S. Once we have more clarity on this, we're going to assess what options we have, that's really the focus of ours at the moment. Thank you. Once again, if you would like to ask question, just press star one, and if you want to withdraw it, just press the hash key. No more question at this time. Back to you, Christophe. Perfect. With that, we close the call. Thank you very much. Have a good day, everyone. Bye-bye.
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