Zevra Therapeutics Q1 2024 Financial Results and Updates

Zevra Therapeutics, Inc., a company specializing in rare disease treatments, has shared its corporate updates and financial results for the first quarter ending March 31, 2024. The company's President and CEO, Neil F. McFarlane, and CFO, R. LaDuane Clifton, emphasized their commitment to advancing their strategic objectives, including the commercialization of OLPRUVA, the potential launch of arimoclomol, and the progression of the KP1077 program aimed at sleep disorders.

The comprehensive commercial launch of OLPRUVA began in late January 2024, engaging with over 90% of specialists at 40 leading centers treating patients with Urea Cycle Disorders (UCD). Zevra saw an enrollment of four new patients and reported a significant increase in reimbursement coverage, reaching nearly 75% of covered lives by May 1, 2024.

Regarding arimoclomol, the FDA extended the Prescription Drug User Fee Act (PDUFA) date to September 21, 2024. The company plans to present the resubmission at an advisory committee meeting. A petition supporting arimoclomol's approval, signed by nearly 1,000 stakeholders from the National Niemann-Pick Disease Foundation and other advocacy groups, was submitted. Zevra is preparing for the U.S. commercial launch of arimoclomol, leveraging the existing infrastructure for OLPRUVA to expedite patient access.

Zevra also reported positive topline data from a Phase 2 trial of KP1077 in treating idiopathic hypersomnia (IH), demonstrating good tolerance and potential clinical benefits. The full data will be presented at the SLEEP 2024 conference in June, with a planned end-of-Phase 2 meeting with the FDA in the third quarter.

The recruitment for the celiprolol Phase 3 trial, known as the DiSCOVER trial, has resumed. This trial focuses on patients with Vascular Ehlers-Danlos Syndrome (VEDS), supporting the current enrollees and maintaining the program's value.

Financially, Zevra reported net revenue of $3.4 million for Q1 2024, slightly up from $3.2 million in Q1 2023. The revenue components included $2.2 million from the French Expanded Access Program for arimoclomol, $1.2 million in royalties under the AZSTARYS® License Agreement, and nominal sales of OLPRUVA. Research and development expenses rose to $12.3 million from $8.7 million in Q1 2023, primarily due to increased spending on the KP1077 Phase 2 trial and ongoing arimoclomol NDA support. Selling, general, and administrative expenses increased to $9.9 million from $7.2 million, influenced by higher personnel costs and professional fees for commercial infrastructure investments.

The net loss for Q1 2024 was $16.6 million, compared to $13.2 million in Q1 2023. As of March 31, 2024, Zevra had 41,850,494 outstanding shares of common stock, and total cash, cash equivalents, and investments of $52.7 million, down from $67.7 million at the end of December 2023. This decrease was due to increased R&D costs for KP1077, reduction in accounts payable from acquiring Acer Therapeutics, and heightened SG&A expenses.

On April 5, 2024, Zevra announced a refinancing deal involving up to $100 million in committed capital, enhancing the company's financial structure. This refinancing, led by Perceptive Advisors and HealthCare Royalty Partners, provided a $60 million initial draw, refinancing existing $43 million debt and adding $14 million in net cash. Additional tranches of $20 million each are available under specific conditions, including the approval of arimoclomol.

Zevra's operating plan and available funds are expected to sustain the company's financial runway into 2026, contingent on compliance with debt covenants. The cash forecast includes projected revenues from OLPRUVA sales, reimbursements for arimoclomol, royalties from AZSTARYS, and investments in arimoclomol's potential launch and KP1077's development.

Overall, Zevra continues to focus on its strategic goals, aiming to become a leading company in the rare disease treatment market while ensuring financial stability and preparing for upcoming product launches.