Zogenix, Inc.

Thank you for standing by. This is the conference operator. Welcome to the Zojenix Inc. 3rd Quarter 2021 Financial Results Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then 1 on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing stars and zero. I would now like to turn the conference over to Brian Ritchie of Life Science Advisors. Please go ahead, Mr. Ritchie.

Thank you, operator, and thank you all for joining the Zergenics Management Team this afternoon. On today's call, our Chief Executive Officer, Dr. Stephen Farr, Chief Operating Officer, Ashish Sagrolikar, Chief Development Officer, Dr. Gail Farfel, Chief Medical Officer, Dr. Brad Gaylor, and Chief Financial Officer, Michael Smith. This afternoon, Zogenics issued a news release providing a business update and announcing financial results for the three and nine months ended September 30th, 2021. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Zogenics management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with a company's business. These forward-looking statements are qualified by the cautionary statements contained in Zogenics' press release issued today and the company's SEC filings. including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 4, 2021. So Gen X undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I'll turn the call over to Dr. Stephen Farr. Dr. Farr?

Thank you, Brian, and good afternoon to everyone, and thank you for joining us. I'm delighted to be here with you today to provide updates on another strong and productive course of orthogenics as we continue to execute on the commercial launch of Fintepla in Dravet syndrome, prepare for a potential launch in Lennox-Gastaut syndrome, and advance our late-stage development programs for both Fintepla and MT1621. Positive momentum for the launches of Fintepla in the U.S. and Europe continue, And once again, we achieved solid quarter-over-quarter growth in the number of prescribers of, patients on, and net sales of Fintepla in both regions. In a moment, the sheet will provide additional color and perspectives on the Fintepla market dynamics that are leading to success and continued growth. We also remain excited with upcoming opportunities to potentially expand Fintepla as a treatment option in other severe, refractory, childhood-onset epilepsy syndromes. Towards this goal, in September, we submitted a supplemental NDA to the FDA, seeking to expand the label indication of Flintepler to the treatment of seizures associated with Lennox-Gastaut syndrome, or LGS. There are an estimated 30,000 to 50,000 patients suffering from LGS in the United States, and notably, the majority of patients have uncontrolled seizures despite taking existing approved anti-seizure medications. Also, we're now getting close to starting our global phase three trial of endocrine patients with CDKL5 deficiency disorder, or CDD. Several sites in the United States are recently being cleared to begin screening patients, and we anticipate the first patient enrolling in the study within the next few weeks. Gail Farfell, our Chief Development Officer, will provide more detail on both of these programs later on the call. Last, during the quarter, we were pleased with the progress being made through regulatory interactions and ongoing development studies for the MT1621 program on investigational substrate enhancement therapy for thionine kinase 2 deficiency, or TK2D. Brad Gaylor, our chief medical officer, will walk you through this progress in more detail on this call. I also would like to remind you of our upcoming virtual investor event on November the 8th that will feature presentations by key opinion leaders on disease overview and natural history of TK2D and their experience with MT1621 as a treatment option for these TK2D patients. With that, I'll now hand the call over to Ashish. Ashish?