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
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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 .
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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
Segment/Product mix – quarterly comparison
KPIs and balance sheet
Estimate comparison (S&P Global consensus vs reported)
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
Management indicated performance tracking toward the high end of ranges for revenue and profitability for 2025 .
Earnings Call Themes & Trends
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) .