Zevra Therapeutics, Inc.
zevra.comWhat Do They Do?
Sells MIPLYFFA, a treatment for Niemann-Pick disease type C, for patients with rare diseases, and develops medicines for other rare conditions.
10-K for FY2025, filed Mar 9, 2026On September 20, 2024, the FDA approved the NDA for MIPLYFFA, an orally-delivered treatment, for NPC. MIPLYFFA, the first FDA-approved…View ↗
To commercialize MIPLYFFA in the United States, we have built, or have arrangements with third parties to perform, marketing, sales…View ↗
Our strategic plan is focused on transforming Zevra into a leading rare-disease company. We are prioritizing the commercialization and…View ↗
How Do They Make Money?
Most revenue comes from MIPLYFFA sales to a specialty pharmacy, with product-sale revenue earned when the pharmacy receives it; Zevra also receives reimbursements through its expanded access program.
10-K for FY2025, filed Mar 9, 2026Net revenues from product sales are recognized at the transaction price when the customer obtains control of the Company's product, which…View ↗
Our revenue is, and will be, primarily derived from sales of our approved products or any of our product candidates for which we obtain…View ↗
Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under an expanded access program (“EAP”) in France, and…View ↗
$106.5M
-
10-K for FY2025, filed Mar 9, 2026
$106.5M ↗
| Segment | Share | Revenue | How money arrives |
|---|---|---|---|
|
OLPRUVA
Sold outright
|
0.8% |
OLPRUVA, FY2025
$800K Sources
|
Sold outright |
|
MIPLYFFA
Sold outright
10-K for FY2025, filed Mar 9, 2026 |
82% |
MIPLYFFA, FY2025
$87.4M Sources
|
Sold outright |
Who Are Their Customers?
A specialty pharmacy is the sole distributor and product-sales customer for MIPLYFFA and OLPRUVA; the medicines are for people with NPC or urea cycle disorders. The global expanded access program also makes MIPLYFFA available to patients in France and select territories outside Europe.
10-K for FY2025, filed Mar 9, 2026The Company currently utilizes a single specialty pharmacy provider as its sole distributor for both MIPLYFFA and OLPRUVA. The Company also…View ↗
OLPRUVA (sodium phenylbutyrate) for oral suspension is approved in the United States as adjunctive therapy to standard of care, which…View ↗
Effective therapies to treat NPC are desperately needed, and, for this reason, MIPLYFFA is currently being made available to NPC patients…View ↗
Do Revenues Turn Into Profits?
Yes. It kept 78 cents of every revenue dollar as net income in FY2025, but spent more cash than it brought in: free cash flow was −$2.4M.
10-K for FY2025, filed Mar 9, 2026
−$62.9MView ↗
10-K for FY2025, filed Mar 9, 2026
$83.2MView ↗
10-K for FY2025, filed Mar 9, 2026
−$2.4MView ↗
How Are They Changing?
10-Q for Q2 FY2026, filed Aug 5, 2026
Open tableView ↗
-
Mar 16, 2026
Sells SDX portfolio to Commave
Commave bought AZSTARYS and KP1077 for $50.0 million, and the parties ended the license agreement and settled litigation.
Sources
8-K, filed Mar 16, 2026
Pursuant to the Agreement, Commave has agreed to pay the Company a total of $50.0 million in cash, and the Company has agreed to sell…View ↗
Growing. Revenue grew 3.7x in 4 years, from $28.7M in FY2021 to $106.5M in FY2025, about 39% a year.
Arimoclomol reaches market
The earlier report described arimoclomol as an investigational treatment available through early-access programs; the latest says it is approved in the United States and sold as MIPLYFFA.
10-K for FY2022, filed Mar 7, 2023 10-K for FY2025, filed Mar 9, 2026Our most advanced product candidate, arimoclomol, is being developed for the treatment of NPC, a lysosomal storage disease, or LSD. NPC is…View ↗
Who Do They Compete With?
Competes with IntraBio, Mandos, Cyclo Therapeutics, Amgen, Horizon Therapeutics, Medunik USA, Par, Lupin, Jazz Pharmaceuticals, J&J Innovative Medicines, Supernus Pharmaceuticals, Tris Pharma, Novartis, UCB, Noven Therapeutics, Aytu BioScience, Collegium Pharmaceutical, and Adlon Therapeutics
10-K for FY2025, filed Mar 9, 2026Soon after approval of MIPLYFFA, the FDA approved a second therapy for NPC, AQNEURSA, which is approved for the treatment of neurological…View ↗
Loading...
