10-Q · May 6, 2026
Zevra Therapeutics reported a strong Q1 2026 with $36.2 million in revenue, up $15.8 million from the previous year, and a significant EPS of $0.60 compared to a loss of $0.06 in Q1 2025. The results were bolstered by…
10-Q · Filed November 3, 2026 · Our reading of the company's report
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Zevra delivered strong Q3 execution, with revenue up 44.9% year over year to $37.756 million and diluted EPS of $0.26, while operating margin expanded to approximately 30.7% from 15.9%. MIPLYFFA remained the principal…
Zevra delivered strong Q3 execution, with revenue up 44.9% year over year to $37.756 million and diluted EPS of $0.26, while operating margin expanded to approximately 30.7% from 15.9%. MIPLYFFA remained the principal commercial driver, and nine-month operating cash flow improved to $33.221 million from $(7.114) million. Offsetting considerations include the negative EMA opinion for MIPLYFFA, limited OLPRUVA revenue, rising development and commercial expenses, and the lack of explicit forward revenue or EPS guidance.
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Q3 revenue was $37.756 million, up $11.693 million, or 44.9%, from $26.063 million in Q3 2025, primarily due to an $11.6 million increase in MIPLYFFA product sales. Revenue was down approximately 5.6% from $40 million in Q2 2026.
Gross margin was approximately 94.4% in Q3 2026 versus 95.3% in Q3 2025 and 96.2% in Q2 2026, reflecting $1.794 million of product costs and $0.315 million of intangible amortization against $37.756 million of revenue.
Income from operations increased to $11.580 million from $4.143 million in Q3 2025, lifting operating margin to approximately 30.7% from 15.9%. Operating margin declined from 42.3% in Q2 2026 as SG&A increased to $19.130 million and R&D rose to $4.937 million.
Net income was $19.208 million versus a $0.544 million net loss in Q3 2025, while diluted EPS was $0.26 versus $(0.01). The quarter benefited from an $8.138 million total other-income contribution, including a $5.143 million fair-value adjustment related to warrant and CVR liabilities.
Operating cash flow was $33.221 million for the first nine months of 2026 versus $(7.114) million in the prior-year period. Cash, cash equivalents and investments totaled $270.9 million at September 30, 2026, providing substantial liquidity.
The company repaid all outstanding term-loan obligations on March 12, 2026; the principal outstanding was approximately $63.1 million, plus $1.4 million of accrued cash interest, and the credit agreement and liens were terminated.
The EMA’s CHMP adopted a negative opinion on the MIPLYFFA marketing authorization application in July 2026. Zevra requested re-examination, but the filing provides no assurance of a favorable outcome; the company also recorded $0.2 million of Q3 OLPRUVA revenue while evaluating strategic alternatives after limited U.S. commercialization success.
Management stated it expects significant expenses and minimal positive or negative operating cash flow in the near future despite $33.221 million of operating cash flow for the first nine months of 2026. It also cautioned that additional financing may be unavailable on acceptable terms and that equity financing could dilute shareholders.
R&D expense increased to $4.937 million in Q3 2026 from $3.432 million, primarily reflecting arimoclomol efforts and continued investment in celiprolol. The Phase 3 celiprolol trial had only 72 enrolled participants as of September 30, 2026, against a planned enrollment of 150.
No quantitative forward revenue or EPS guidance was provided. Management stated that cash, cash equivalents and investments of $270.9 million as of September 30, 2026, together with expected operating cash flow, are sufficient to fund existing and planned capital requirements for at least the next 12 months and the foreseeable future.
Zevra Therapeutics reported a strong Q1 2026 with $36.2 million in revenue, up $15.8 million from the previous year, and a significant EPS of $0.60 compared to a loss of $0.06 in Q1 2025. The results were bolstered by…
Zevra transitioned to a commercial-stage rare-disease company in 2025 driven by the launch of MIPLYFFA, producing substantial top-line growth and a sharp margin inflection in Q4. The company monetized a rare pediatric…
Zevra reported a large revenue ramp to $20,401 (in thousands) in Q1 2025 from $3,425 in Q1 2024, driving a marked improvement in reported EPS to $(0.06) from $(0.40). Gross margins remained high (93.4% on a comparable…
Zevra is a commercial-stage rare-disease company that launched MIPLYFFA (arimoclomol) after FDA approval on September 20, 2024 and made product commercially available November 21, 2024, while continuing…
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