LaDuane Clifton
Management
Thank you, Neil, and good afternoon. While I will provide a detailed financial overview during today's call, I encourage you to review Zevra's quarterly report on Form 10-Q for more detailed information, which we intend to file post market tomorrow, November 13, 2024. In the third quarter, we reported net revenue of $3.7 million, which includes $2.6 million in net reimbursements from the French EAP for arimoclomol and $1.1 million of royalties and other reimbursements under the AZSTARYS license. As a reminder, for our commercial products, MIPLYFFA and OLPRUVA, we recognize commercial product revenue when shipments are received by the specialty pharmacy. In the third quarter, net revenue for OLPRUVA was de minimis and we expect to have our initial shipment for MIPLYFFA in Q4. Our R&D expenses for the third quarter were $10.9 million, which was an increase of 4% compared to the second quarter of this year. Selling, general and administrative expenses were $16.2 million during the third quarter, representing an increase of 28.6% from the second quarter of this year. This includes a non-cash stock compensation expense of $6.1 million during the quarter, of which $2.5 million was performance-based vesting upon the approval of MIPLYFFA. Overall, this increase is in line with our projections as we transition to full commercial stage operations. The net loss for the third quarter was $33.2 million, or $0.69 per basic and diluted share, compared to $10.4 million, or $0.30 per basic and diluted share in the same quarter a year ago. In the third quarter, we completed an underwritten public offering of more than 10.6 million shares of our common stock at a price of $6.50 per share. The total net proceeds were approximately $64.5 million after deducting underwriting discounts, commissions and offering expenses. The proceeds from the offering support our commercial and clinical development operations with an emphasis on the launch activities for our commercial products and pipeline. As of September 30, total cash, cash equivalents and investments were $95.5 million, which was an increase of $46.2 million compared to June 30 of this year. Use of cash during the period was $18.2 million. Total long-term debt was $58.9 million. Based on our current operating forecast, existing resources extend our cash runway into 2027, subject to continued compliance with debt covenants. Our cash runway guidance is based on our current operating plan, available cash, cash equivalents and investments and includes revenue from MIPLYFFA sales, reimbursements from the French EAP, royalties under the AZSTARYS license agreement and continued investments into our development pipeline programs. It does not include potential proceeds from a PRV sale. As we wind down the year, we are pleased with our strong financial footing and our continued ability to be capital efficient with our operations and deliver value to shareholders. As Neil said earlier, we are well on our way to becoming a leading patient-focused rare disease therapeutics company. Now we will open the call to questions. Operator?