# ZEVRA THERAPEUTICS, INC. (ZVRA)

Informational only - not investment advice.

CIK: 0001434647
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-03-09
SEC page: https://www.sec.gov/edgar/browse/?CIK=1434647
Filing source: https://www.sec.gov/Archives/edgar/data/1434647/000143464726000011/zvra-20251231.htm

## At a glance

FY2025 · period end 2025-12-31 · filed 2026-03-09 · accession 0001434647-26-000011 · source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001434647.json

| Metric | Value | FY | Provenance |
| --- | ---: | ---: | --- |
| Revenue | 106,470,000 USD | 2025 | verified |
| Net income | 83,229,000 USD | 2025 | verified |
| Assets | 284,731,000 USD | 2025 | verified |
| Free cash flow | -2,433,000 USD | 2025 | computed |
| Net margin | 78.17% | 2025 | computed |
| Operating margin | -59.12% | 2025 | computed |
| Revenue YoY | +350.91% | 2025 | computed |
| ROE | 53.82% | 2025 | computed |

Computed values are grepcent-computed from the verified facts above and may differ from ratios the company itself reports. Free cash flow = operating cash flow − capital expenditures. Net margin = net income ÷ revenue. Operating margin = operating income ÷ revenue. Revenue YoY = FY2025 revenue ÷ FY2024 revenue − 1 (consecutive fiscal years only). ROE = net income ÷ period-end stockholders' equity.

No market price, no rating, no forecast on this site. Not investment advice.

### Peer percentile fingerprint

| Ratio | ZVRA | Peer median | Percentile | N |
| --- | ---: | ---: | ---: | ---: |
| Net margin | 78.2% | 1.0% | 97 | 107 |
| Operating margin | -59.1% | -1.3% | 25 | 100 |
| Revenue growth | 350.9% | 14.7% | 90 | 127 |
| FCF margin | -2.3% | -14.0% | 56 | 127 |
| ROE | 53.8% | -30.7% | 96 | 171 |
| ROA | 29.2% | -21.8% | 98 | 187 |
| Liabilities / equity | 0.84 | 0.38 | 65 | 173 |
| Current ratio | 5.68 | 4.89 | 55 | 188 |

Percentile = share of the N covered peers reporting that ratio whose value is lower (ties counted half); computed among grepcent-covered companies in SIC industry 2834 Pharmaceutical Preparations, not the whole market. A higher percentile means a higher value of the ratio, not a better company. Ratios with fewer than 8 reporting peers are omitted. Latest reported values per company; fiscal periods may differ. Descriptive arithmetic - not a score, rating, or ranking.

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 106470000 | USD | 2025 | 2026-03-09 |
| Net income | 83229000 | USD | 2025 | 2026-03-09 |
| Assets | 284731000 | USD | 2025 | 2026-03-09 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-09. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001434647.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue |  |  |  | 12,839,000 | 13,288,000 | 28,650,000 | 10,161,000 | 27,461,000 | 23,612,000 | 106,470,000 |
| Net income | -16,516,000 | -43,386,000 | -56,466,000 | -24,522,000 | -12,760,000 | -8,555,000 | -26,772,000 | -46,049,000 | -105,511,000 | 83,229,000 |
| Operating income | -37,482,000 | -33,366,000 | -55,903,000 | -20,337,000 | -5,609,000 | 7,729,000 | -42,565,000 | -49,604,000 | -87,003,000 | -62,943,000 |
| Diluted EPS |  |  |  |  | -3.21 | -2.11 |  |  | -2.28 | 1.35 |
| Operating cash flow | -29,772,000 | -33,100,000 | -54,203,000 | -23,737,000 | -1,939,000 | 10,439,000 | -18,717,000 | -33,535,000 | -69,665,000 | -1,598,000 |
| Capital expenditures | 643,000 | 181,000 | 21,000 | 26,000 | 33,000 | 102,000 | 93,000 | 296,000 | 0.00 | 835,000 |
| Share buybacks |  |  |  |  | 0.00 | 2,814,000 | 4,723,000 | 3,447,000 | 0.00 |  |
| Assets | 84,887,000 | 52,456,000 | 26,746,000 | 10,507,000 | 11,209,000 | 132,941,000 | 115,340,000 | 172,327,000 | 178,127,000 | 284,731,000 |
| Liabilities | 103,583,000 | 109,972,000 | 93,312,000 | 84,963,000 | 77,621,000 | 5,823,000 | 40,220,000 | 110,463,000 | 138,461,000 | 130,074,000 |
| Stockholders' equity | -18,696,000 | -57,516,000 | -66,566,000 | -74,456,000 | -66,412,000 | 101,660,000 | 75,120,000 | 61,864,000 | 39,666,000 | 154,657,000 |
| Cash and cash equivalents | 16,762,000 | 10,871,000 | 18,409,000 | 3,217,000 | 4,213,000 | 112,346,000 | 65,466,000 | 43,049,000 | 33,785,000 | 62,406,000 |
| Free cash flow | -30,415,000 | -33,281,000 | -54,224,000 | -23,763,000 | -1,972,000 | 10,337,000 | -18,810,000 | -33,831,000 | -69,665,000 | -2,433,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net margin |  |  |  |  | -96.03% | -29.86% |  |  |  | 78.17% |
| Operating margin |  |  |  |  | -42.21% | 26.98% |  |  |  | -59.12% |
| Return on equity |  |  |  |  |  | -8.42% | -35.64% | -74.44% | -266.00% | 53.82% |
| Return on assets | -19.46% | -82.71% |  |  | -113.84% | -6.44% | -23.21% | -26.72% | -59.23% | 29.23% |
| Liabilities / equity |  |  |  |  |  | 0.06 | 0.54 | 1.79 | 3.49 | 0.84 |
| Current ratio | 11.19 | 3.99 | 1.98 | 1.28 | 1.11 | 27.20 | 7.72 | 1.18 | 2.53 | 5.68 |

## As-reported value updates

4 tracked differences above grepcent's stated thresholds were found between the earliest XBRL-filed value and the value currently on file for the same fiscal period.

Ledger: /company/ZVRA/revisions/


## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-08-05. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001434647.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2018-Q2 | 2018-06-30 |  |  | -0.91 | reported discrete quarter |
| 2019-Q2 | 2019-06-30 |  |  | -0.33 | reported discrete quarter |
| 2019-Q3 | 2019-09-30 |  |  | 0.06 | reported discrete quarter |
| 2020-Q2 | 2020-06-30 |  |  | 0.01 | reported discrete quarter |
| 2020-Q3 | 2020-09-30 |  |  | -0.04 | reported discrete quarter |
| 2021-Q1 | 2021-03-31 |  |  | -2.49 | reported discrete quarter |
| 2021-Q2 | 2021-06-30 |  |  | -0.40 | reported discrete quarter |
| 2021-Q3 | 2021-09-30 |  |  | -0.06 | reported discrete quarter |
| 2023-Q3 | 2023-09-30 | 2,895,000 | -14,045,000 |  | reported discrete quarter |
| 2023-Q4 | 2023-12-31 | 13,217,000 | -15,153,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 | 3,425,000 | -16,622,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 | 4,449,000 | -19,925,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 | 3,695,000 | -33,225,000 |  | reported discrete quarter |
| 2024-Q4 | 2024-12-31 | 12,043,000 | -35,739,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 | 20,401,000 | -3,099,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 | 25,881,000 | 67,909,000 | 1.21 | reported discrete quarter |
| 2025-Q3 | 2025-09-30 | 26,063,000 | -544,000 | -0.01 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 | 34,125,000 | 11,830,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 36,220,000 | 36,317,000 | 0.60 | reported discrete quarter |
| 2026-Q2 | 2026-06-30 | 39,663,000 | 8,393,000 | 0.14 | reported discrete quarter |

## Filed narrative (10-K & 10-Q)

## Business

Verbatim Item 1 Business section from ZVRA's latest 10-K: [/company/ZVRA/business/](/company/ZVRA/business/).

## Risk Factors

Verbatim Item 1A Risk Factors from ZVRA's latest 10-K: [/company/ZVRA/risk-factors/](/company/ZVRA/risk-factors/).

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1434647/000143464726000068/zvra-20260630.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary.
Confidence: high
Filing date: 2026-08-05
Report date: 2026-06-30

ITEM 2.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q and Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 9, 2026, as supplemented in Part II, Item 1A. “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 6, 2026, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapeutics to people living with rare diseases. We are focused on broadening access through geographic expansion opportunities, progressing our pipeline toward key milestones, and delivering meaningful therapeutics. Our vision is realized through disciplined execution of our strategic plan and our core values — patient centricity, integrity, accountability, innovation, and courage — which guide our efforts to deliver long-term value. The commercialization of our lead product, marketed in the United States for Niemann-Pick disease type C ("NPC"), a rare, progressive neurodegenerative disorder, provides a strong corporate foundation and demonstrates our ability to advance therapies from development to market.

In February 2023, we changed our name to Zevra Therapeutics, Inc. Zevra is the Greek word for zebra, which is the internationally recognized symbol for rare disease. This name reflects our intense focus and dedication to developing transformational, patient-focused therapies for rare diseases with limited or no treatment options available, or treatment areas with significant unmet needs.

Our strategic plan is focused on transforming Zevra into a leading rare-disease company. We are prioritizing the commercialization and global expansion of our lead product, MIPLYFFA (arimoclomol), while OLPRUVA remains commercially available. We are also advancing the development of our clinical stage asset, celiprolol, and plan to further expand our pipeline through inorganic growth. We intend to become the preferred partner for assets that we believe will allow us to leverage the expertise and infrastructure that we have built to help mitigate risk and enhance our probability of success.

On September 20, 2024, the U.S. Food and Drug Administration (“FDA”) approved the New Drug Application (“NDA”) for MIPLYFFA, for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older, and MIPLYFFA became commercially available for dispense in the United States in November 2024. In connection with this approval, we received a transferable rare pediatric disease priority review voucher (“PRV”). On April 1, 2025, we consummated the sale of the PRV, resulting in net proceeds of $148.3 million to us. Arimoclomol has also been granted orphan medicinal product designation for the treatment of NPC by the European Commission. We are pursuing regulatory approval of arimoclomol in Europe and filed a Marketing Authorization Application (“MAA”) with the European Medicines Agency (“EMA”) in July 2025. In July 2026, we announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion regarding the MAA. Under European regulatory procedures, we have requested a re-examination of the CHMP opinion.

On November 17, 2023, we completed the acquisition of Acer Therapeutics, Inc. (“Acer”), pursuant to which Acer became a wholly-owned subsidiary of Zevra. This included the acquisition of OLPRUVA (sodium phenylbutyrate) for oral suspension, which was approved by the FDA on December 27, 2022, for the treatment of certain urea cycle disorders (“UCDs”). In addition, we acquired Acer's pipeline of investigational product candidates, including celiprolol for the treatment of Vascular Ehlers-Danlos syndrome (VEDS) in patients with a confirmed type III collagen (COL3A1) mutation.

On March 13, 2026, we entered into an Asset Purchase and Settlement Agreement (the “Commave Settlement Agreement”) with Commave Therapeutics SA (“Commave”) to sell all of our rights to certain assets relating to our SDX portfolio, including AZSTARYS and KP1077, to Commave and to resolve pending litigation related to claims arising under the Collaboration and License Agreement between the parties dated September 3, 2019, as amended (the “AZSTARYS License Agreement”). Under the Commave Settlement Agreement, the AZSTARYS License Agreement was terminated in its entirety.

While we have recently had several quarters of positive net cash flows from operations, we previously had recurring negative net operating cash flows, and we cannot guarantee that we can continue to generate positive net cash flows from operations. Net cash provided by (used in) operating activities for the six months ended June 30, 2026, and 2025, was $23.2 million and $(11.8) million,

30

Table of Contents

respectively. We expect to continue to incur significant expenses and minimal positive net cash flows from operations or negative net cash flows from operations for the near future, and those expenses and losses may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will fluctuate substantially as we:

•continue building and maintaining our ongoing commercial capabilities to support the commercialization of our approved products;

•continue clinical trials for celiprolol or initiate preclinical studies, clinical trials and product development activities for future product candidates;

•seek regulatory approvals for any product candidates that may successfully complete clinical trials;

•seek to discover, license or acquire, and develop additional product candidates;

•adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;

•maintain, expand and protect our intellectual property portfolio;

•incur additional legal, accounting and other expenses in operating as a public company; and

•add operational systems and personnel, if needed, to support any future commercialization efforts.

Our Product Candidates and Approved Products

Our current commercial products and active development assets are summarized in the table below:

Active Zevra Commercial and Active Development Assets

[[GREPCENT_TABLE]]
[["Parent Drug","Indication","Product / Candidate","Status and IP"],["Arimoclomol","Niemann-Pick disease type C (NPC)","MIPLYFFA","FDA Approval: Sep. 20, 2024; Orphan Drug Exclusivity (\u201cODE\u201d) through 2031; IP through 2041"],["Arimoclomol","NPC","Arimoclomol","Global Expanded Access Program (\u201cEAP\u201d)Marketing Authorisation Application (\u201cMAA\u201d) for arimoclomol under review by EMA, Submitted July 28, 2025"],["Sodium phenylbutyrate","Urea Cycle Disorders (UCD)","OLPRUVA","FDA Approval: Dec. 22, 2022; IP through 2036"],["Celiprolol","Vascular Ehlers Danlos Syndrome (VEDS)","Celiprolol","Clinical - Phase 3 trial ongoing; IP potential through 2038"]]
[[/GREPCENT_TABLE]]

MIPLYFFA

NPC is an ultra-rare and progressive neurodegenerative disease characterized by an inability of the body to transport cholesterol and lipids inside of cells. Symptoms of NPC include a progressive impairment of mobility, cognition, speech, and swallowing, often culminating in premature death. The incidence of NPC is estimated to be one in 100,000 to 130,000 live births. We estimate that there are approximately 2,000 individuals with NPC in the United States and Europe combined, of which approximately 900 are in the United States and 1,100 are in Europe, where there is a mature market with an approved treatment available for NPC. Of this estimated population, approximately 300 to 350 people have been diagnosed in the United States. NPC is clinically heterogenous, with significant variability in symptom presentation and rate of progression. Although it has traditionally been considered a pediatric disease due to its genetic origins, nearly half of the people treated with MIPLYFFA are adults. Low diagnostic rates may affect the number of potential patients, and we believe that the availability of treatment options in the United States could increase awareness of the disease and assist in more accurately identifying patients.

31

Table of Contents

On September 20, 2024, the FDA approved the NDA for MIPLYFFA, an orally-delivered treatment, for NPC. MIPLYFFA, the first FDA-approved treatment for NPC, is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients two years of age and older. In addition, we received a transferable rare pediatric disease PRV in conjunction with the approval. On April 1, 2025, we completed the sale of the PRV and received net proceeds of $148.3 million.

Effective therapies to treat NPC are desperately needed, and, for this reason, arimoclomol is currently being made available to NPC patients in France, Germany, and other EU member states, along with select territories outside of Europe under our global EAP. Arimoclomol has also been granted orphan medicinal product designation for the treatment of NPC by the European Commission. In July 2025, we filed an MAA. In July 2026, we announced that the CHMP of the EMA adopted a negative opinion regarding the MAA. We have requested a re-examination of the CHMP opinion.

In June 2026, Zevra published positive results of an open-label pediatric substudy in the peer reviewed journal Molecular Genetics and Metabolism Reports. This multicenter substudy evaluated arimoclomol, in addition to concomitant miglustat, in five children with NPC aged 12 to 24 months at enrollment over up to 36 months of treatment. Arimoclomol was generally well tolerated, with no new safety signals, and pharmacokinetic results were consistent with older pediatric populations. Developmental assessments showed variable delays, reflecting underlying phenotypic heterogeneity. Although limited by small sample size, the study provides preliminary evidence supporting initiation of MIPLYFFA in this age group.

As of June 30, 2026, there were a total of 184 enrollments to receive MIPLYFFA. For MIPLYFFA, an enrollment is a prescription submitted to our specialty pharmacy, initiating the benefits investigation process to determine reimbursement and can lead to a 30-day paid dispense of MIPLYFFA. Our commercial plans focus on raising awareness among people who are living with NPC that are diagnosed and untreated, or undiagnosed.

To commercialize MIPLYFFA in the United States, we have built in-house capabilities, and have arrangements with third parties, to perform, marketing, sales, medical affairs, distribution, managerial and other non-technical capabilities. Zevra holds global rights to develop and commercialize MIPLYFFA.

MIPLYFFA summary:

•Demonstrated halting of disease progression. MIPLYFFA in combination with miglustat demonstrated a clinically significant improvement compared to placebo as early as 12 weeks and a halting of progression

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A (excerpt)

Latest 10-K Item 7 source: https://www.sec.gov/Archives/edgar/data/1434647/000143464726000011/zvra-20251231.htm
Complete FY 2025 MD&A: /company/ZVRA/mda/fy2025/

Extracted from a substantive MD&A body after the formal Item 7 span was a TOC or reference stub.
Confidence: high
Filing date: 2026-03-09
Report date: 2025-12-31

Overview

We are a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapeutics to people living with rare diseases. We are focused on expanding patient access, progressing our pipeline toward key milestones, and delivering meaningful therapeutics. Our vision is realized through disciplined execution of our strategic plan and our core values — patient centricity, integrity, accountability, innovation, and courage — which guide our efforts to deliver long-term value. The commercialization of our lead product, marketed in the United States for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disorder, provides a strong corporate foundation and demonstrates our ability to advance therapies from development to market.

In February 2023, we changed our name to Zevra Therapeutics, Inc. Zevra, is the Greek word for zebra, which is the internationally recognized symbol for rare disease. This name reflects our intense focus and dedication to developing transformational, patient-focused therapies for rare diseases with limited or no treatment options available, or treatment areas with significant unmet needs.

Our strategic plan is focused on transforming Zevra into a leading rare-disease company. We are prioritizing the commercialization and global expansion of our lead product, MIPLYFFA, while OLPRUVA remains commercially available. We are also advancing the development of our clinical stage asset, celiprolol, and plan to further expand our pipeline through inorganic growth. We intend to become the preferred partner for assets that we believe will allow us to leverage the expertise and infrastructure that we have built to help mitigate risk and enhance our probability of success.

On September 20, 2024, the U.S. Food and Drug Administration (“FDA”) approved the New Drug Application (“NDA”) for MIPLYFFA, for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older, and MIPLYFFA became commercially available for dispense in the United States in November 2024. In connection with this approval, we received a transferable rare pediatric disease priority review voucher (“PRV”). On April 1, 2025, we consummated the sale of the PRV, resulting in net proceeds of $148.3 million to us. MIPLYFFA has also been granted orphan medicinal product designation for the treatment of NPC by the European Commission. We are pursuing regulatory approval in Europe and filed a Marketing Authorization Application (“MAA”) with the European Medicines Agency (“EMA”) in July 2025; the application is currently under review.

On November 17, 2023, we completed the acquisition of Acer Therapeutics, Inc. (“Acer”), pursuant to which Acer became a wholly-owned subsidiary of Zevra. This included the acquisition of OLPRUVA (sodium phenylbutyrate) for oral suspension, which was approved by the FDA on December 27, 2022, for the treatment of certain urea cycle disorders (“UCDs”). In addition, we acquired Acer's pipeline of investigational product candidates, including celiprolol for the treatment of Vascular Ehlers-Danlos syndrome (VEDS) in patients with a confirmed type III collagen (COL3A1) mutation.

We have had recurring negative net operating cash flows throughout our operating history, and we cannot guarantee or predict when we may begin to consistently generate positive net cash flows from operations, or if at all. Net cash used in operating activities for the years ended December 31, 2025, and 2024, was $(1.6) million and $(69.7) million, respectively. We expect to continue to incur significant expenses and minimal positive net cash flows from operations or negative net cash flows from operations for the near future, and those expenses and losses may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will fluctuate substantially as we:

•continue building and maintaining our ongoing commercial capabilities to support the commercialization of our approved products, MIPLYFFA and OLPRUVA, in the United States;

•continue or initiate preclinical studies, clinical trials and product development activities for our pipeline of product candidates;

•seek regulatory approvals for any product candidates that may successfully complete clinical trials;

55

Table of Contents

•seek to discover, license or acquire, and develop additional product candidates;

•adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;

•maintain, expand and protect our intellectual property portfolio;

•incur additional legal, accounting and other expenses in operating as a public company; and

•add operational systems and personnel, if needed, to support any future commercialization efforts.

License Agreements

XOMA License Agreement (MIPLYFFA)

In May 2022, we purchased all the assets and operations of Orphazyme A/S (“Orphazyme”) related to arimoclomol. Prior to this acquisition, Orphazyme had entered into an asset purchase agreement with LadRx Corporation, which was assigned to XOMA (US) LLC, a wholly-owned subsidiary of XOMA Corporation (“XOMA”), in June 2023 (“XOMA License Agreement”). Under the XOMA License Agreement, XOMA is entitled to a mid-single digit percentage royalty with respect to net sales of MIPLYFFA as well as milestone payments based on future potential sales and regulatory milestones, including a $4.0 million regulatory milestone payment upon approval in the E.U.

Relief License Agreement (OLPRUVA)

In connection with our acquisition of Acer, Acer and Relief entered into an exclusive license agreement on August 30, 2023 (the “Relief License Agreement”), which was assumed by Zevra. Pursuant to the Relief License Agreement, Zevra is obligated to pay royalties of 10% of U.S. net sales up to a maximum of $45.0 million, plus specified regulatory milestones, for total payments to Relief of up to $56.5 million. On April 10, 2025, the rights to this royalty were sold to Soleus Capital Management L.P.

Pursuant to the Relief License Agreement, Relief will hold exclusive development and commercialization rights for OLPRUVA in the EU, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia (“Geographical Europe”). We have the right to receive a royalty of up to 10% of the net sales of OLPRUVA in Geographical Europe.

Aquestive Termination Agreement (AZSTARYS)

Under our March 2012 termination agreement with Aquestive Therapeutics (“Aquestive”), Aquestive has the right to receive a royalty amount equal to 10% of any value generated by AZSTARYS and any product candidates containing SDX. We pay Aquestive a royalty equal to 10% of the quarterly royalty payments and of the regulatory and net sales milestones we receive from Commave under the AZSTARYS License Agreement.

Components of our Results of Operations

Revenue

Our revenue is, and will be, primarily derived from sales of our approved products or any of our product candidates for which we obtain regulatory approval, and reimbursements under our global expanded access program (“EAP”) in France, and in select territories outside Europe. We expect that our other sources of revenues will be through payments arising from our license agreements, and through any other future arrangements related to one of our product candidates.

To date, we have generated revenue from product sales of MIPLYFFA and limited sales of OLPRUVA, reimbursements received under our global EAP, royalties or net sales milestone payments generated under the AZSTARYS License Agreement, and consulting agreements. We cannot guarantee that we will continue to receive reimbursements under the global EAP or the extent of our success in commercializing MIPLYFFA or OLPRUVA. While we have received milestone payments under the AZSTARYS License Agreement, we cannot guarantee that we will earn any additional milestone or royalty payments under this agreement in the future. We also do not know when, if ever, any other product candidate will be commercially available.

56

Table of Contents

Cost of Product Revenue

The components of cost of product revenue are royalties and expenses directly attributable to revenue. Under the Aquestive Termination Agreement, we pay Aquestive a royalty equal to 10% of the upfront license payment and all regulatory milestone and royalty payments we received from Commave under the AZSTARYS License Agreement. Under the XOMA License Agreement, we paid a $6.0 million regulatory milestone payment earned by XOMA upon the approval of MIPLYFFA on September 20, 2024. XOMA is also entitled to a mid-single digit royalty on net sales of MIPLYFFA, as well as certain net sales and regulatory milestone payments. We also owe a 10% royalty on net sales of OLPRUVA under the Relief License Agreement. Other components of cost of product revenue include $3.9 million of non-cash intangible asset amortization related to the MIPLYFFA and OLPRUVA capitalized assets and $11.7 million in inventory obsolescence reserve expense related to OLPRUVA inventory during the year ended December 31, 2025.

Operating Expenses

We classify our operating expenses into two categories: research and development expenses and selling, general and administrative expenses. Salaries and personnel-related costs, including benefits, bonuses and stock-based compensation expense, comprise a significant component of each of these expense categories.

Research and Development Expense

Research and development expense consists of expenses incurred while performing research and development activities to discover and develop potential product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Our research and development expense primarily consists of:

•salaries and personnel-related costs, including benefits and any stock-based compensation, for our scientific personnel performing research and development activities;

•costs related to executing preclinical studies and clinical trials;

•fees paid to consultants and other third parties who support our product candidate development;

•other costs in seeking regulatory approval of our products; and

•allocated facility-related costs and overhead.

We typically use our employee, consultant and infrastructure resources across our development programs. We track outsourced development costs by product candidate or development program, but we do not allocate personnel costs, other internal costs or external consultant costs to specific product candidates or development programs.

57

Table of Contents

The following table summarizes our research and development costs for the years ended December 31, 2025 and 2024 (in thousands):

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]

Read the full FY 2025 MD&A: /company/ZVRA/mda/fy2025/
All MD&A years: /company/ZVRA/mda/


## MD&A history

Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. Each year's full verbatim text is on its own sub-page.

- [FY 2024 MD&A](/company/ZVRA/mda/fy2024/): filed 2025-03-12; accession 0001437749-25-007320 (https://www.sec.gov/Archives/edgar/data/1434647/000143774925007320/zvra20241231_10k.htm)
- [FY 2023 MD&A](/company/ZVRA/mda/fy2023/): filed 2024-04-01; accession 0001437749-24-010430 (https://www.sec.gov/Archives/edgar/data/1434647/000143774924010430/zvra20231231_10k.htm)
- [FY 2022 MD&A](/company/ZVRA/mda/fy2022/): filed 2023-03-07; accession 0001437749-23-005703 (https://www.sec.gov/Archives/edgar/data/1434647/000143774923005703/kmph20221231_10k.htm)
- [FY 2021 MD&A](/company/ZVRA/mda/fy2021/): filed 2022-03-31; accession 0001437749-22-007725 (https://www.sec.gov/Archives/edgar/data/1434647/000143774922007725/kmph20211231_10k.htm)


## FDA-approved drug applications

Applications listed under this company's exact-matched sponsor name. Approved applications only.

No resolved FDA applications were found for this company under the exact-unique, approved-only publish rule.

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

This list covers FDA applications whose listed sponsor name maps to this company by an exact-unique match; applications listed under sponsor names not mapped to this company (subsidiaries, name variants, joint ventures) are absent.


## Macro cross-references

Indicators mapped to this company's SIC classification (industry 2834 Pharmaceutical Preparations) by grepcent's deterministic macro-sector crosswalk. A navigational mapping, not a statistical or causal claim.

- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm

Macro-to-micro threads including this sector: [Inflation (CPI / PCE / PPI)](/thread/inflation-cpi-pce-ppi/), [US labor market](/thread/us-labor-market/), [Growth & output](/thread/growth-output/), [Money & trade](/thread/money-trade/), [Government finances](/thread/government-finances/), [Sector employment](/thread/sector-employment/), [Industrial orders & inventories](/thread/industrial-orders/), [Trade & external](/thread/trade-external/).

All macro indicators: /indicators/


## For LLMs & downloads

Markdown twin: /company/ZVRA.md · JSON record: /company/ZVRA.json · verified financials: /company/ZVRA/financials.json / /company/ZVRA/financials.csv · machine TOC for the whole site: /llms.txt