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ZT

ZEVRA THERAPEUTICS, INC. (ZVRA)·Q2 2025 Earnings Summary

Executive Summary

  • Revenue and commercial traction accelerated: net revenue grew to $25.9M in Q2 2025 from $20.4M in Q1 and $4.4M in Q2 2024, driven by MIPLYFFA net revenue of $21.5M and broader market access at 52% of covered lives .
  • Reported GAAP diluted EPS was $1.21, buoyed by $148.3M net proceeds from the PRV sale; excluding the PRV and OLPRUVA impairment/obsolescence, adjusted net loss was $(3.2)M with adjusted EPS of $(0.06) .
  • S&P Global consensus for Q2 2025 revenue ($22.49M*) was beaten; however, consensus Primary EPS ($1.61*) contrasted with S&P’s actual Primary EPS of $(0.06)*, signaling a large headline miss if consensus assumed PRV-related gains. Clarify GAAP vs adjusted framing for investors [Values retrieved from S&P Global].
  • Strategic catalysts: EU MAA submission for arimoclomol (MIPLYFFA) was filed, meeting 2H25 guidance, and European EAP expanded to 89 patients, setting up for potential country-by-country pull-through post approval .
  • Risk/concern: OLPRUVA adoption remained slow (one enrollment in Q2), triggering a $58.7M non-cash intangible impairment and $11.7M inventory write-down; watch competitive dynamics and payer posture .

What Went Well and What Went Wrong

What Went Well

  • Commercial momentum in MIPLYFFA: net revenue increased 26% Q/Q to $21.5M; covered lives rose to 52% with strong conversion/retention through patient services and medical exceptions .
  • EU expansion: arimoclomol MAA submitted to EMA, meeting 2H25 timing; European EAP reached 89 patients, supporting future conversion upon country reimbursement .
  • Balance sheet strength: $148.3M net PRV proceeds recognized as other income; cash, cash equivalents and securities at $217.7M; total debt ~$60.7M, providing flexibility independent of capital markets .

Quoted management:

  • “Q2 net revenue reached $25,900,000… We completed the sale of our PRV for $150,000,000 and strengthened our balance sheet.”
  • “We believe the remarkable performance in the second quarter sets a strong foundation for continued momentum.”
  • “Our commercial organization has reached critical mass… prioritizing and executing on key strategies to deliver value [to] patients living with rare diseases.”

What Went Wrong

  • OLPRUVA softness: only one Q2 enrollment, continued slow adoption; coverage at 79% but market dynamics (authorized generic) shifting against uptake .
  • Non-cash charges: $58.7M impairment of OLPRUVA-related intangibles and $11.7M inventory write-down; cost of product revenue elevated to $14.0M including amortization and obsolescence .
  • Operating losses before PRV: excluding the PRV gain and non-cash charges, the quarter reflects an adjusted net loss of $(3.2)M; SG&A elevated due to proxy-related professional fees and commercial launch activities .

Financial Results

Core P&L (GAAP) – Quarter-over-quarter and Year-over-year

MetricQ2 2024Q1 2025Q2 2025
Revenue, Net ($USD Millions)$4.449 $20.401 $25.881
GAAP Diluted EPS ($USD)$(0.48) $(0.06) $1.21
Net Income (Loss) ($USD Millions)$(19.925) $(3.099) $74.707
Operating Expenses ($USD Millions)$23.125 $22.803 $24.215
Other Income ($USD Millions)$3.940 $3.445 $147.945

Cost Structure Detail

MetricQ2 2024Q1 2025Q2 2025
Cost of Product Revenue ($USD Millions)$3.573 $1.345 $12.379
Intangible Asset Amortization ($USD Millions)$1.546 $1.615 $1.616

Q2 2025 Revenue Composition

ComponentQ2 2025
MIPLYFFA Net Revenue ($USD Millions)$21.5
OLPRUVA Net Revenue ($USD Millions)$0.3
French EAP (arimoclomol) Net Reimbursements ($USD Millions)$2.6
AZSTARYS Royalties/Other Reimbursements ($USD Millions)$1.2
Upfront from out-license ($USD Millions)$0.3

Adjusted vs GAAP (Q2 2025)

MetricQ2 2025
Adjusted Net Loss ($USD Millions)$(3.2)
Adjusted EPS ($USD)$(0.06)
GAAP Net Income ($USD Millions)$74.707
GAAP Diluted EPS ($USD)$1.21
One-time PRV Net Proceeds ($USD Millions)$148.3
Intangible Impairment (OLPRUVA) ($USD Millions)$58.7
Inventory Obsolescence Charge ($USD Millions)$11.7

Actual vs S&P Global Consensus (Q2 2025)

MetricConsensusActual
Revenue ($USD)$22,493,250*$25,881,000*
Primary EPS ($USD)$1.6125*$(0.06)*

Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent UpdateChange
Arimoclomol (MIPLYFFA) EU MAA timing2025Submit in 2H 2025 Submitted to EMA on Aug 12, 2025 Achieved/on track
Liquidity outlookMulti-yearCash runway into 2029 (excludes PRV proceeds) $217.7M cash/securities; sufficient to execute independent of capital markets Maintained/strengthened

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 & Q1 2025)Current Period (Q2 2025)Trend
MIPLYFFA launch trajectory109 enrollments at YE 2024; coverage forming; 122 total enrollments by Q1; 38% covered lives 7 new enrollments in Q2; 129 total since launch; covered lives at 52%; strong conversion/retention Improving
EU strategy (MAA & EAP)MAA targeted 2H25; EAP ~85 patients MAA submitted; EAP 89 patients; plan for country-by-country reimbursement conversion Advancing
OLPRUVA adoption5 enrollments in Q1; 78% coverage; refined adult/OTC focus 1 enrollment in Q2; 79% coverage; impairment & inventory write-down; competitive authorized generic headwind Weakening
Payer access dynamicsEarly denials typical; medical exception success; 38% coverage in Q1 Faster benefit conversion (some in 72 hours); 52% coverage; medical exception pathways widely effective Improving
VEDS (celiprolol) Phase 3 DISCOVER32 enrolled in Q1; genetic testing program launched 39 enrolled in Q2; expanding referrals from centers; expect improved traction Gradual progress
Data/publicationsMechanism paper; OLE durability data emphasized OLE 48-month data published; CLEAR network gene expression data highlighted Strengthening evidence

Management Commentary

  • “We are demonstrating our ability to execute… Q2 net revenue reached $25,900,000… We completed the sale of our PRV for $150,000,000…” .
  • “As the only treatment that has been shown to halt disease progression… we are invigorated by the meaningful impact MIPLYFFA is bringing…” .
  • “Coverage reached fifty two percent of all covered lives… and for patients not immediately covered, we’ve achieved reimbursement through medical exception pathways.” .
  • “We have recognized a non cash charge of $58,700,000 for impairment of intangible assets and an inventory write down of $11,700,000…” .
  • “As of 06/30/2025, total cash, cash equivalents and investments were $217,700,000… Total debt was approximately $60,700,000…” .

Q&A Highlights

  • Prescriber mix and penetration: Early prescribers were neurologists/pediatricians and medical geneticists; prescriber base expanding to clinicians with 1–2 NPC patients per year .
  • Time from enrollment to paid drug: Conversions improving; some patients covered within ~72 hours, though variability remains by plan type .
  • Retention and reimbursement: High retention across cohorts; combination therapy with miglustat is label-based and seeing minimal reimbursement pushback; 52% covered lives with effective medical exception pathways .
  • EU EAP conversion: 89 European EAP patients at Q2; expect country-by-country variability post approval but durability supports pull-through .
  • OLPRUVA strategy and spend: Commercial infrastructure is synergistic across products; OLPRUVA investment largely overlaps SG&A supporting MIPLYFFA .

KPIs

KPIQ1 2025Q2 2025
MIPLYFFA prescription enrollment forms13 7
Total MIPLYFFA enrollments since launch122 129
MIPLYFFA covered lives (%)38% 52%
OLPRUVA prescription enrollment forms5 1
OLPRUVA covered lives (%)78% 79%
EU arimoclomol EAP patients~85 89

Estimates Context

  • Q2 2025 revenue beat S&P Global consensus ($25.881M* vs $22.493M*), reflecting strong MIPLYFFA uptake and improved payer access [Values retrieved from S&P Global].
  • S&P’s Primary EPS consensus ($1.6125*) contrasted with Primary EPS actual of $(0.06)*; investors should note Zevra’s reported GAAP diluted EPS of $1.21 driven by PRV proceeds, while adjusted EPS was $(0.06), aligning with S&P’s “Primary EPS” actual [Values retrieved from S&P Global].
  • Model updates: raise MIPLYFFA revenue trajectory and coverage assumptions; maintain cautious OLPRUVA contribution given competitive landscape and impairment signals .

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Revenue momentum and payer traction for MIPLYFFA continue to improve; expect further pull-through as more plans formalize coverage and medical exceptions remain effective .
  • Headline EPS requires careful parsing: GAAP EPS reflects one-time PRV proceeds; underlying adjusted EPS and cash generation profile are more informative for run-rate performance .
  • Revenue beat vs S&P Global suggests consensus underappreciated near-term commercial execution; monitor Q3 for sustained growth and conversion metrics [Values retrieved from S&P Global].
  • EU MAA submission and expanding EAP provide a tangible pipeline-to-commercial catalyst; country-level reimbursement timelines will shape European revenue ramp .
  • OLPRUVA remains a drag; impairment and inventory write-down underscore adoption risk amid changing competitive dynamics—limit near-term contribution in models .
  • Balance sheet is robust post-PRV; ~$217.7M in liquidity and ~$60.7M debt support execution independent of capital markets—a positive for pipeline and launch investment .
  • Near-term trading lens: focus on continued MIPLYFFA coverage growth, Q3 enrollment cadence, and any EMA review milestones; downside risks center on OLPRUVA uptake and SG&A intensity .