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AP

Alkermes plc. (ALKS)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $390.7M and GAAP diluted EPS was $0.52; proprietary net sales grew 14% YoY to $307.2M, while manufacturing & royalty revenue declined as expected on INVEGA SUSTENNA® U.S. royalty expiration .
  • Results beat S&P Global consensus: revenue $390.7M vs $356.2M estimate*; GAAP EPS $0.52 vs $0.39 estimate*; EBITDA from continuing ops $101.6M vs $72.6M estimate*; strength was aided by ~$20M one-time gross-to-net tailwind (VIVITROL ~$9M; ARISTADA ~$11M) and broad demand .
  • 2025 guidance reiterated (total revenues $1.34B–$1.43B; GAAP NI $175M–$205M; Adjusted EBITDA $310M–$340M; product net sales ranges unchanged), with management now anticipating finishing toward the high end on revenue and profitability .
  • Near-term stock catalysts: detailed Vibrance-1 (alixorexton) data at World Sleep in September and NT2 topline in the fall; management preparing to initiate global Phase 3 and highlighted strong cash ($1.05B) and no debt, providing optionality .

What Went Well and What Went Wrong

  • What Went Well

    • Strong proprietary portfolio growth: VIVITROL $121.7M (+9% YoY), ARISTADA $101.3M (+18% YoY), LYBALVI $84.3M (+18% YoY) with LYBALVI TRx +22% YoY .
    • Profitability and cash: GAAP net income $87.1M; EBITDA (cont. ops) $101.6M; cash and investments $1.05B; company reiterated 2025 guidance and indicated tracking toward the high end .
    • Alixorexton Phase 2 NT1 success: significant, dose-dependent MWT improvements (p<0.0001 at all doses), robust improvements in fatigue and cognition PROs; management emphasized “no treatment-emergent safety signals” in ophthalmic exams and general tolerability .
  • What Went Wrong

    • Mix headwind: manufacturing & royalty revenue down to $83.4M vs $129.9M in 2Q24 due to expiration of U.S. INVEGA SUSTENNA® royalty in Aug-2024, pressuring non-product revenue contributions .
    • R&D spend stepped up on orexin programs ($77.4M vs $59.6M in 2Q24) with expectations to “step up slightly” in 2H25 as Phase 2 completes and Phase 3 prep begins, tempering near-term margin expansion .
    • Cataplexy endpoint mixed: statistical significance achieved at 6mg dose only; management attributed variability to outliers and assay implementation, planning Phase 3 methodological refinements .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Total Revenues ($M)$430.0 $306.5 $390.7
Proprietary Net Sales ($M)$307.7 $244.5 $307.2
Manufacturing & Royalty Revenues ($M)$122.3 $62.0 $83.4
GAAP Net Income ($M)$146.5 $22.5 $87.1
GAAP Diluted EPS ($)$0.88 (cont. ops) $0.13 $0.52
EBITDA – Continuing Ops ($M)$170.0 $22.8 $101.6
Adjusted EBITDA ($M)n/a$45.6 $126.5

Segment/Product mix – quarterly comparison

MetricQ2 2024Q2 2025
Total Proprietary Net Sales ($M)$269.3 $307.2
VIVITROL Net Sales ($M)$111.9 $121.7
ARISTADA Net Sales ($M)$86.0 $101.3
LYBALVI Net Sales ($M)$71.4 $84.3
Manufacturing & Royalty Revenues ($M)$129.9 $83.4

KPIs and balance sheet

KPIQ1 2025Q2 2025
Cash, Cash Equivalents & Investments ($M)$916.2 $1,054.0
SG&A – Continuing Ops ($M)$171.7 $170.8
R&D – Continuing Ops ($M)$71.8 $77.4
Shares Outstanding – Diluted (k)168,737 168,357

Estimate comparison (S&P Global consensus vs reported)

MetricConsensus (Q2 2025)Reported (Q2 2025)Surprise
Revenue ($M)$356.2*$390.7 +$34.5M (beat)
GAAP EPS ($)$0.39*$0.52 +$0.13 (beat)
EBITDA – Continuing Ops ($M)$72.6*$101.6 +$29.0M (beat)

Values marked with * retrieved from S&P Global.

Drivers of the beat: $20M gross-to-net favorability (Medicaid utilization adjustments) across VIVITROL ($9M) and ARISTADA (~$11M), plus broader demand across the portfolio; no inventory benefit in Q2 .

Guidance Changes

MetricPeriodPrevious Guidance (Feb 12, 2025)Current Guidance (Jul 29, 2025)Change
Total RevenuesFY 2025$1,340–$1,430M $1,340–$1,430M Maintained
VIVITROL Net SalesFY 2025$440–$460M $440–$460M Maintained
ARISTADA Net SalesFY 2025$335–$355M $335–$355M Maintained
LYBALVI Net SalesFY 2025$320–$340M $320–$340M Maintained
COGSFY 2025$185–$205M $185–$205M Maintained
R&D ExpenseFY 2025$305–$335M $305–$335M Maintained
SG&A ExpenseFY 2025$655–$685M $655–$685M Maintained
GAAP Net IncomeFY 2025$175–$205M $175–$205M Maintained
EBITDAFY 2025$215–$245M $215–$245M Maintained
Adjusted EBITDAFY 2025$310–$340M $310–$340M Maintained
Effective Tax RateFY 2025~17% ~17% Maintained

Management indicated performance tracking toward the high end of ranges for revenue and profitability for 2025 .

Earnings Call Themes & Trends

TopicQ4 2024 (Q-2)Q1 2025 (Q-1)Q2 2025 (Current)Trend
Proprietary product growthRecord proprietary product revenue and strong YoY growth across VIVITROL/ARISTADA/LYBALVI .LYBALVI TRx +22% YoY; proprietary net sales $244.5M .Proprietary net sales $307.2M (+14% YoY) ; Q3 guide for portfolio $280–$300M .Positive demand; Q3 sequential step-down post gross-to-net tailwind.
Manufacturing & royaltiesNoted mix includes INVEGA/TRINZA royalties; high in 2023 due to arbitration catch-up .Lower M&R $62.0M .M&R $83.4M; investor slides note SUSTENNA U.S. royalty expiration impacted results .Structural headwind vs 2024.
Gross-to-net dynamicsYear-end GtN/Inventory favored Q4 product revenues .No special tailwind disclosed.One-time GtN tailwind ~$20M (VIVITROL ~$9M; ARISTADA ~$11M) .Temporary benefit; normalizing in H2.
R&D/Orexin programPreparing 2025 orexin readouts and advancement .Vibrance-1 enrollment complete; NT2 mid-year enrollment completion expected .Positive NT1 topline; planning Phase 3; NT2 topline in fall; IH mid-2026 .Accelerating toward registrational program.
Safety (visual AEs)n/an/aManagement emphasized normal ophthalmic exams; DSMB green lights; more data at World Sleep .De-risking the class AE overhang.
Capital allocationEnded 2024 debt-free; $825M cash; repurchased $200M shares in 2024 .Cash $916.2M; debt-free .Cash/investments $1.05B; $200M remaining buyback authorization .Optionality intact.

Management Commentary

  • “Now, no debt and more than $1 billion of cash, we're in a strong financial position with significant optionality.” – CEO Richard Pops .
  • “These factors drove a one-time gross-to-net benefit of approximately $9 million for VIVITROL and approximately $11 million for ARISTADA.” – COO Blair Jackson .
  • “We remain well positioned to achieve our financial guidance for the full year… we now anticipate finishing the year towards the higher end… in terms of both revenue and profitability.” – COO Blair Jackson .
  • “Alixorexton normalized wakefulness and excessive daytime sleepiness… with a generally well tolerated profile… [and] robust… improvements on validated patient-reported measures [fatigue and cognition].” – CMO Craig Hopkinson .

Q&A Highlights

  • Visual AEs/class safety: No treatment-emergent ophthalmic safety signal; DSMB oversight; full safety database lock by mid-August; detailed safety at World Sleep .
  • Cataplexy endpoint: Stat. significance met at 6mg; pre-specified negative binomial model used; variability driven by outliers; Phase 3 to refine methodology; management confident cataplexy signal will support labeling .
  • Phase 3/regulatory: End-of-Phase 2 after NT2; plan likely one 3‑month NT1 and one similar NT2 registrational study; dosing range decisions pending NT2 analyses .
  • Dosing/PK: Confidence in tox profile at 8mg; exposure-response and safety modeling ongoing; no meaningful QD vs BID difference expected for cataplexy measure .
  • Near-term outlook: Q3 proprietary net sales guided to $280–$300M as GtN tailwind normalizes; no Q2 inventory benefit; demand-led growth across all three products .

Estimates Context

  • S&P Global consensus heading into Q2 2025: revenue $356.2M*, GAAP EPS $0.39*, EBITDA (cont. ops) $72.6M*. Reported results: revenue $390.7M, GAAP diluted EPS $0.52, EBITDA (cont. ops) $101.6M – all above consensus .
  • Implications: Street models likely need to reflect stronger proprietary net sales run-rate and the one-time GtN benefit; M&R headwinds and 2H R&D step-up temper longer-term margin trajectory .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Core commercial engine is healthy; proprietary net sales +14% YoY with broad-based demand; mix shift away from royalties continues post SUSTENNA royalty expiry .
  • Q2 beat was partly one-time (~$20M GtN) but underlying demand strength and opex discipline support tracking toward high end of FY revenue and profitability guidance .
  • Alixorexton is emerging as a credible class leader: NT1 Phase 2 met all MWT primaries with strong PROs; safety narrative improving ahead of World Sleep; NT2 topline (fall) is next key readout .
  • Watch Q3: management guides proprietary net sales to $280–$300M as GtN normalizes; this may create a sequential step-down versus Q2 but is within full-year trajectory .
  • Balance sheet strength (>$1B cash, no debt) and $200M repurchase authorization provide strategic flexibility for pipeline acceleration and capital returns .
  • Model adjustments: raise FY revenue/EPS on Q2 beat and high-end bias; reflect higher 2H R&D; incorporate lower M&R run-rate post-royalty expiry .

Additional references:

  • Press release: Q2 2025 results (financials and product details) .
  • 8-K and investor slides (guidance reiteration, SUSTENNA royalty expiration context) .
  • Q1 2025 results for sequential trend .
  • FY 2024/Q4 2024 results and 2025 guidance baseline .
  • Vibrance-1 topline (alixorexton) .