Zevra Therapeutics Q2 2024 Financial Results and Highlights

Zevra Therapeutics, Inc., a company focused on rare disease therapeutics, disclosed its corporate updates and financial results for the second quarter ending June 30, 2024. The firm highlighted significant progress in its strategic initiatives, including favorable developments with the U.S. Food and Drug Administration (FDA) and advancements in its product pipeline.

During the second quarter, Zevra received positive feedback from the FDA's Genetic Metabolic Diseases Advisory Committee regarding arimoclomol's efficacy in treating Niemann-Pick disease type C (NPC). Although the committee's vote is non-binding, it is a crucial factor in the FDA's final decision-making process. Zevra plans to continue working closely with the FDA and expects to meet with them to discuss a pivotal Phase 3 trial for KP1077 in idiopathic hypersomnia by the end of the third quarter.

The company has also made strides with OLPRUVA, transitioning to Orsini as its specialty pharmacy partner and increasing reimbursement coverage to 75% of covered lives. Nine new patients were enrolled in the second quarter, either through the Quick Start program or paid dispenses.

In terms of financial performance, Zevra reported a net revenue of $4.4 million for Q2 2024, a decrease from $8.5 million in Q2 2023. The reduction in revenue was attributed to several factors, including inflated costs of goods sold due to a $3.2 million reserve for OLPRUVA inventory nearing expiration. Research and development expenses rose to $10.5 million from $7.4 million in the previous year, driven by increased spending on the KP1077 Phase 2 clinical trial and higher personnel-related costs. Selling, general, and administrative expenses also saw a significant increase to $12.6 million from $6.6 million, reflecting the costs associated with the commercial team and patient service activities for OLPRUVA.

The net loss for the quarter was $19.9 million, or $0.48 per share, compared to a loss of $2.6 million, or $0.08 per share, in Q2 2023. As of June 30, 2024, the company's total cash, cash equivalents, and investments stood at $49.3 million, a decrease from $52.7 million at the end of March 2024. This decrease was primarily due to higher third-party R&D costs and increased SG&A expenses.

On the corporate front, Zevra entered into a $100 million credit facility in April 2024 with Perceptive Advisors and Healthcare Royalty Partners, strengthening its balance sheet and providing capital flexibility. The company also announced new executive appointments to support its growth trajectory.

In August, Zevra completed an underwritten public offering, raising net proceeds of $64.5 million. Combining these funds with existing resources, the company’s pro forma cash, cash equivalents, and investments totaled $113.8 million as of June 30, 2024. This financial position is expected to extend Zevra's cash runway into the first quarter of 2027.

The company continues to focus on its strategic objectives, including the development and commercialization of treatments for rare diseases. Zevra plans to utilize its commercial team for the potential launch of arimoclomol, pending FDA approval. The firm is also advancing its clinical programs, with ongoing efforts in the Phase 3 DiSCOVER trial of celiprolol for Vascular Ehler-Danlos Syndrome (VEDS).

Zevra’s commitment to addressing unmet medical needs in rare diseases remains steadfast, as evidenced by its continued investment in R&D and strategic partnerships. The company aims to deliver transformative therapies and generate long-term value for its stakeholders.