Zevra signals continued MIPLYFFA momentum with 26% revenue growth and $150M PRV sale strengthening balance sheet

Earnings Call Insights: Zevra Therapeutics (ZVRA) Q2 2025

MANAGEMENT VIEW

* Neil F. McFarlane, President and CEO, highlighted that "Q2 net revenue reached $25.9 million, reflecting robust demand and effective operational execution." He emphasized the completion of the PRV sale for $150 million as a "strategic transaction that strengthened our balance sheet." The submission of the marketing authorization application (MAA) for arimoclomol in Europe was cited as a key milestone for geographic expansion. McFarlane also reported rapid uptake of MIPLYFFA in the U.S., with 129 prescription forms through the end of Q2, noting, "we have been able to reach over 1/3 of those diagnosed with NPC in the United States."
* Joshua M. Schafer, Chief Commercial Officer, stated that "in the second quarter, our coverage reached 52% of all covered lives," and noted a 26% quarter-over-quarter increase in product net revenue for MIPLYFFA. Schafer explained, "our AmplifyAssist program, which is a centralized resource that assists clinicians' offices and patients in navigating the reimbursement challenges...has been well received."
* R. LaDuane Clifton, CFO, reported, "net income for the quarter was $74.7 million or $1.24 per basic share and $1.21 per diluted share," adding, "excluding the onetime PRD sale, the onetime noncash impairment charge and the inventory obsolescence charge recognized during the quarter, adjusted net loss was $3.2 million or $0.06 adjusted net loss per basic and diluted share for Q2 2025."

OUTLOOK

* Management confirmed the focus remains on executing the launch of commercial products and supporting both the arimoclomol MAA in Europe and the ongoing Phase III trial for celiprolol. McFarlane stated, "our focus remains on executing the launch of our commercial products and on the development of our pipeline," and indicated confidence that "our existing capital resources continue to be sufficient to allow us to execute on our strategic priorities independent of the capital markets."
* The company highlighted efforts to expand MIPLYFFA's reach in Europe, with approximately 1,100 people estimated to be living with NPC in that region. The recent MAA submission was described as "another significant and timely milestone for Zevra."

FINANCIAL RESULTS

* Net revenue for Q2 2025 was reported at $25.9 million, with $21.5 million from MIPLYFFA, $300,000 from OLPRUVA, $2.6 million in net reimbursements from the French EAP for arimoclomol, $1.2 million from royalties and other reimbursements under the AZSTARYS license, and an upfront payment of $300,000 from the out-license of dextrorphan.
* Cost of product revenue for Q2 2025 was $14 million, including $1.6 million of noncash intangible asset amortization. The company recognized a noncash charge of $58.7 million for impairment of intangible assets and an inventory write-down of $11.7 million related to OLPRUVA.
* Other income for the quarter included $148.3 million in net proceeds from the PRD asset sale. As of June 30, 2025, total cash, cash equivalents and investments were $217.7 million, and total debt was approximately $60.7 million.

Q&A

* Brandon Richard Folkes, H.C. Wainwright: Asked about U.S. MIPLYFFA enrollment trends and specialties contributing to new enrollments. McFarlane highlighted, "In Q1, we had MIPLYFFA revenue of about $17.1 million and a 26% growth from Q1 to Q2 with $21.5 million," attributing it to strong pull-through by the patient services and field reimbursement teams. Schafer noted initial enrollments were from neurologists and pediatricians, with growing involvement from medical geneticists and psychiatrists.
* Kristen Brianne Kluska, Cantor Fitzgerald: Inquired about diagnosed patients not on therapy and reimbursement for MIPLYFFA. Schafer explained these are often patients whose symptoms were not severe enough for treatment initially but are now returning for care. McFarlane added that mapping referral patterns beyond centers of excellence is key to expanding reach. Schafer reported high conversion and retention rates for paid patients and minimal pushback on reimbursement for combination therapy with miglustat.
* Jason Nicholas Butler, Citizens: Questioned time from enrollment to paid drug and patient retention. Schafer indicated the timeframe is being reduced, with some patients covered within 72 hours, and retention rates are high across both EAP and new patients.
* Sumant Satchidanand Kulkarni, Canaccord: Asked about growth in patient enrollment and impact of a competing therapy. Schafer focused on data-driven differentiation for MIPLYFFA and ongoing initiatives to identify undiagnosed patients. Kulkarni also asked about enrollment in the DiSCOVER trial for celiprolol, with Chief Medical Officer Adrian Quartel expressing optimism about the impact of genetic testing initiatives.
* Samantha Danielle Corwin, William Blair: Inquired about unique prescribers and covered lives. Schafer stated the number of unique prescribers continues to grow as outreach expands, and the 52% coverage is expected to increase as more plans review MIPLYFFA.
* Francis Edward Hickman, Guggenheim: Asked about the cadence of new patient enrollments. Schafer said it is too early to provide trends but highlighted the ongoing conversion and retention efforts.

SENTIMENT ANALYSIS

* Analysts expressed a positive to slightly positive tone, frequently congratulating management on progress and seeking clarification on growth trajectories and market penetration. Their focus was on enrollment, reimbursement, and competitive dynamics.
* Management maintained a confident tone throughout, particularly in prepared remarks, with statements such as "we are incredibly proud of the work our team is doing" (McFarlane) and "the retention rate of these patients is also really quite high" (Schafer). In Q&A, management was forthcoming but cautioned on providing specific forward-looking metrics, with occasional phrases like "it's really early in the launch to be able to give you any sense of that."
* Compared to the previous quarter, both analysts and management demonstrated increased confidence, with more concrete performance and operational achievements highlighted in the current period.

QUARTER-OVER-QUARTER COMPARISON

* Net revenue increased from $20.4 million in Q1 2025 to $25.9 million in Q2 2025, with MIPLYFFA revenue rising from $17.1 million to $21.5 million and coverage growing from 38% to 52% of covered lives.
* The PRV sale was completed for $150 million in Q2, significantly strengthening the balance sheet.
* The MIPLYFFA launch showed continued strong performance and increased physician adoption, while OLPRUVA saw limited uptake, resulting in a noncash impairment charge and inventory write-down.
* Management's tone shifted from early launch optimism in Q1 to highlighting concrete commercial traction and strategic milestones in Q2. Analyst questions became more focused on operational details such as conversion rates, time to therapy, and competitive landscape.

RISKS AND CONCERNS

* Management acknowledged slow adoption of OLPRUVA, leading to the recognition of a noncash impairment charge and inventory write-down.
* Reimbursement challenges persist, but the company reported success with medical exception pathways and ongoing discussions with payers to secure coverage.
* The European expansion carries market access and reimbursement timing risks, as McFarlane noted, "reimbursement in Europe is going to be by country. So it's variable in regards to making that happen."

FINAL TAKEAWAY

Zevra Therapeutics delivered robust commercial execution in Q2 2025, marked by strong MIPLYFFA revenue growth, expanded payer coverage, and the completion of a major asset sale to reinforce financial flexibility. The company is focused on further U.S. market penetration, European expansion, and advancing its clinical pipeline, while addressing challenges in OLPRUVA uptake and navigating payer dynamics. Management maintains confidence in its ability to deliver on strategic priorities for sustained growth and value creation.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/zvra/earnings/transcripts]

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