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    ALKS
    Earnings call· Jun 2026(Q2 FY26)

    Alkermes plc. Q2 FY26 earnings call ALKS

    Jul 28, 2026 Source

    Executive summary

    Alkermes Q2 FY26 — Orexin Platform Leadership and Commercial Strength

    Alkermes is solidifying its leadership in orexin development with a robust pipeline across narcolepsy, ADHD, and fatigue, alongside a strong commercial portfolio. The company reported significant growth in proprietary product sales, driven by successful integration of LUMRYZ and expanded access for LYBALVI. Strategic decisions regarding VIVITROL's generic entry and ongoing clinical advancements position Alkermes for continued growth and innovation in neuroscience.

    Highlights

    5

    • Proprietary product net sales increased 34% year-over-year to $411.7 million.

    • LYBALVI access expanded to cover over 80% of insured lives, including major Part D plans.

    • LUMRYZ generated net sales of $96.6 million in its first full quarter post-acquisition, with 3,900 patients on therapy.

    • VIVITROL agreement with Amneal terminated, confirming no authorized generic in 2027.

    • Positive Phase 3 results for LUMRYZ in idiopathic hypersomnia (IH), enabling sNDA submission by year-end.

    Concerns

    2

    • LYBALVI gross-to-net adjustments are expected to expand in the second half of the year, reaching the high 30s for the full year.

    • Q3 total revenues are expected to be lower than Q2, in the range of $450 million to $470 million, partly due to reduced CONSTA revenue and LUMRYZ inventory timing.

    Guidance & targets

    13
    CategoryTargetConfidence
    VIVITROL net sales
    $460 million to $480 million
    medium materiality
    High
    ARISTADA net sales
    $365 million to $385 million
    medium materiality
    High
    LYBALVI net sales
    $380 million to $400 million
    medium materiality
    High
    LUMRYZ total net sales
    $350 million to $370 million
    medium materiality
    High
    LUMRYZ net sales (Alkermes portion)
    $315 million to $335 million
    medium materiality
    High
    LYBALVI gross-to-net adjustments
    high 30s
    medium materiality
    Medium
    Total revenues
    $450 million to $470 million
    high materiality
    High
    Cost of goods sold
    $85 million to $95 million
    medium materiality
    High
    R&D expenses
    $120 million to $130 million
    medium materiality
    High
    SG&A expenses
    $215 million to $225 million
    medium materiality
    High
    Adjusted EBITDA
    $80 million to $100 million
    high materiality
    High
    GAAP net loss
    $95 million to $115 million
    high materiality
    High
    EBITDA
    $75 million to $95 million
    high materiality
    High

    Segment performance

    5
    SegmentRevenueYoYQoQMargin
    Proprietary Product Portfolio
    Reflects solid demand across psychiatry and addiction portfolios and first full quarter of LUMRYZ contribution.
    		$411.7 million34%——
    VIVITROL
    Driven by growth in alcohol dependence market and $4 million gross-to-net favorability from patient mix.
    		$124.5 million———
    ARISTADA Product Family
    Reflected solid underlying demand and $4 million gross-to-net favorability from patient mix.
    		$96.7 million———
    LYBALVI
    Driven by sustained momentum in new patient starts and expanded prescriber breadth. Access expanded to over 80% of insured lives.
    Underlying TRx growth: 18% year-over-yearGross-to-net adjustments: approximately 36%
    		$94 million12%——
    LUMRYZ
    First full quarter post-acquisition, strong performance driven by new patient additions, returning patients, new-to-oxybate patients, and switch patients. Included $7 million benefit from wholesaler inventory timing.
    Patients on therapy: 3,900HCP breadth growth: 24% year-over-year
    		$96.6 million———

    Operational metrics

    18
    Gross-to-net favorability
    $4 million
    Q2 FY26

    Primarily related to favorable patient mix.

    Gross-to-net favorability
    $4 million
    Q2 FY26

    Primarily related to favorable patient mix.

    Gross-to-net adjustments
    36%
    Q2 FY26

    Expected to expand in the second half of the year.

    Wholesaler inventory timing benefit
    $7 million
    Q2 FY26

    Expected to impact Q3.

    Manufacturing and royalty revenues
    $84.3 million
    Q2 FY26

    $20.9 million from CONSTA represents the majority of expected CONSTA manufacturing revenues for 2026.

    Cost of goods sold
    $98.1 millionvs $49.5 million in Q2 prior year
    Q2 FY26

    Includes purchase price fair value accounting of LUMRYZ inventory.

    R&D expenses
    $112.9 millionvs $77.4 million in Q2 prior year
    Q2 FY26

    Reflects continued advancement of orexin portfolio, including Phase 3 alixorexton, Vibrance-3, ALKS 7290 Phase 1b, and ALKS 4510 preparations.

    SG&A expenses
    $217.6 millionvs $170.8 million in Q2 prior year
    Q2 FY26

    Primarily reflects the addition of Avadel commercial infrastructure.

    Amortization of intangibles
    $22.6 million
    Q2 FY26
    Net interest expense
    $20.6 million
    Q2 FY26
    Change in fair value of contingent consideration
    $26.4 million
    Q2 FY26

    Related to CVR milestone for Avadel acquisition, deemed more likely after positive LUMRYZ IH Phase 3 results.

    GAAP net income
    $0.5 million
    Q2 FY26
    EBITDA
    $49 million
    Q2 FY26
    Adjusted EBITDA
    $139.2 million
    Q2 FY26

    Believed to be more representative of cash generated.

    Cash and total investments
    $690 million
    Q2 FY26

    Ended the second quarter in a strong position.

    Patients on therapy
    3,900net add of about 300 quarter-over-quarter
    Q2 FY26 exit

    Strong growth trend.

    HCP breadth growth
    24%year-over-year
    Q2 FY26

    Continues to expand.

    Insured lives coverage
    80%
    Q2 FY26

    Expanded strategically through new contracting arrangements, particularly in Part D plans.

    Industry KPIs

    7
    MetricValueDetails
    Launch access metrics80%%
    Pipeline read out calendarMultiple readouts and completions
    Product franchise net sales$96.6 millionUSD
    Regulatory approvals filingssNDA submission planned
    Prescription volume new starts18%%
    Clinical trial efficacy safety dataSustained improvements
    Cumulative patients uptake since launch3,900patients

    Deals & partnerships

    2
    AmnealTermination of agreement for an authorized generic of VIVITROL.

    Announced earlier this month.

    AvadelAcquisition of Avadel and the LUMRYZ brand.

    Integration proceeded exceptionally well.

    Risks & headwinds

    3
    Expansion of LYBALVI gross-to-net adjustmentsH2 FY26

    Expected to expand in the second half of the year, reaching "high 30s" for the full year.

    Mitigation: Strategic investment in the brand's long-term growth potential through expanded access.

    Reduced manufacturing revenue from RISPERDAL CONSTAH2 FY26

    $20.9 million in Q2, with no meaningful revenues expected for the remainder of 2026.

    Mitigation: Diversified commercial portfolio and strong operating performance.

    Potential impact of CMMI demonstration projects (GLOBE and GUARD) on drug pricingNear-term (potential final rule soon), long-term (litigation if implemented)

    Could introduce foreign reference pricing into Medicare/Medicaid programs.

    Mitigation: Alkermes is not directly impacted as it does not have foreign reference pricing, but it is a significant industry concern.

    What to watch in Q3 FY26

    5

    ALKS 7290 Phase 1b topline data

    End of Q3 FY26
    CurrentActively enrolling
    TargetTopline results

    Why it matters

    This will be the first clinical evaluation of an orexin 2 receptor agonist in ADHD patients, providing initial proof-of-concept and insights into its activity.

    ALKS 7290 in adult ADHD, we have made substantial progress in our Phase Ib study, and we now expect topline results by the end of the third quarter.

    Q&A highlights

    7

    Inquired about the translatability of adult ADHD data to pediatrics, the implications of a 2-week endpoint for tachyphylaxis and overall efficacy, and confirmation of AISRS inclusion.

    Blair Jackson stated that adult data is highly translatable to adolescents and children via bridging PK studies. The 2-week endpoint in the Phase 1b is for safety and translation, not full dose-ranging, with a larger Phase 2 study for that. AISRS will be included, along with EEG and behavioral markers, to assess target engagement and dimensionality of response.

    “The study that we get this year will be our translational study, our Phase 1b study that we'll have by the end of the third quarter.”

    asked by Umer Raffat · answered by Blair Jackson

    2 min read5 chapters

    Detailed Narrative

    01

    Orexin Platform Expansion

    Alkermes is establishing itself as a leader in orexin development, expanding beyond narcolepsy into ADHD and fatigue. The company views orexin as a platform with potential for a broad range of serious conditions, including psychiatric, neurodevelopmental, and neurodegenerative diseases. This strategy is supported by the advancement of ALKS 7290 in ADHD and ALKS 4510 in fatigue, with initial data expected in the near future.

    02

    Alixorexton Clinical Progress

    Alixorexton, an orexin 2 receptor agonist, has demonstrated efficacy and tolerability in narcolepsy type 1 (NT1) and type 2 (NT2) Phase 2 studies, with sustained improvements in wakefulness, cognition, and fatigue for up to nine months in the long-term extension study. The Phase 3 narcolepsy program is on track for completion next year, and the Vibrance-3 Phase 2 study in idiopathic hypersomnia (IH) is actively enrolling, including a split-dose arm to extend pharmacodynamic effects.

    03

    Commercial Portfolio Strength

    The proprietary product portfolio grew 34% year-over-year to $411.7 million, driven by strong performance across psychiatry, addiction, and sleep medicine. LYBALVI achieved significant access expansion, now covering over 80% of insured lives, which is expected to drive long-term prescription growth despite near-term gross-to-net expansion. VIVITROL's commercial life is extended with the termination of the authorized generic agreement for 2027.

    04

    LUMRYZ Integration and Growth

    The acquisition and integration of Avadel and the LUMRYZ brand have been successful, with LUMRYZ generating $96.6 million in net sales in its first full quarter and 3,900 patients on therapy. Positive Phase 3 results for LUMRYZ in IH position the company for an sNDA submission by year-end and a potential launch in March 2028, further expanding its growth opportunity.

    05

    ADHD and Fatigue Programs

    ALKS 7290 is enrolling adults with ADHD, with Phase 1b data expected by Q3-end, representing the first clinical evaluation of an orexin 2 receptor agonist in this population. ALKS 4510 is planned to enter Phase 2 for fatigue in patients with multiple sclerosis or Parkinson's disease later this year, addressing a significant unmet need in neurological disorders.

    AI-generated summary of the company’s earnings call. Not investment advice.