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AP

Alkermes plc. (ALKS)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 topline: revenue $394.2M, GAAP diluted EPS $0.49; company raised full‑year 2025 guidance across revenues, product net sales, GAAP NI, EBITDA and Adj. EBITDA .
  • Results beat S&P Global consensus: revenue $394.2M vs $356.2M est.; Primary EPS $0.651 vs $0.386 est.; Company-reported GAAP diluted EPS was $0.49 (consensus and “Primary EPS” from S&P Global; see Estimates Context) *.
  • Strength driven by proprietary products (VIVITROL $121.1M; ARISTADA $98.1M; LYBALVI $98.2M) and one-time gross‑to‑net favorability (~$8M VIVITROL; ~$5M ARISTADA) offset by lower manufacturing/royalty revenue as U.S. INVEGA SUSTENNA royalties expired Aug-2024 .
  • Strategic catalysts: positive Phase 2 NT2 (Vibrance‑2) results for alixorexton (dual primary endpoints met) on Nov 12, and agreement to acquire Avadel (LUMRYZ) to accelerate sleep portfolio; both reinforce 2026+ growth narrative .

What Went Well and What Went Wrong

  • What Went Well

    • Proprietary portfolio execution: “strong revenue growth and robust profitability,” with Q3 proprietary net sales $317.4M (VIVITROL $121.1M; ARISTADA $98.1M; LYBALVI $98.2M) .
    • LYBALVI momentum: revenues +32% YoY with 25% TRx growth; management attributed performance to expanded psychiatry sales force and efficacy resonance with prescribers .
    • Guidance raised: total 2025 revenue to $1.43–1.49B, GAAP NI to $230–$250M, EBITDA to $270–$290M, Adj. EBITDA to $365–$385M . CFO: “we are raising our full-year 2025 guidance today” .
  • What Went Wrong

    • YoY profitability compression: GAAP NI from continuing ops fell to $82.8M (vs $92.8M) and diluted GAAP EPS to $0.49 (vs $0.56) as royalties declined and R&D/SG&A stepped up .
    • Manufacturing & royalty revenues down YoY to $76.8M (vs $105.1M) given the U.S. INVEGA SUSTENNA royalty expiration in Aug-2024 .
    • Higher R&D ($81.7M vs $59.9M) and SG&A ($171.8M vs $150.4M) driven by orexin Phase 2 programs, next-gen orexin candidates, and psychiatry commercial investments; R&D and SG&A intensity will persist near term .

Financial Results

Overall P&L (company-reported)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($M)$306.5 $390.7 $394.2
GAAP Net Income ($M)$22.5 $87.1 $82.8
GAAP Diluted EPS ($)$0.13 $0.52 $0.49
EBITDA ($M)$22.8 $101.6 $96.9
Adjusted EBITDA ($M)$45.6 $126.5 $121.5

YoY snapshot (Q3)

MetricQ3 2024Q3 2025
Revenue ($M)$378.1 $394.2
GAAP Diluted EPS ($)$0.56 $0.49
GAAP NI from Cont. Ops ($M)$92.8 $82.8

Product and Revenue Mix

Metric ($M)Q1 2025Q2 2025Q3 2025
Total Proprietary Net Sales$244.5 $307.2 $317.4
VIVITROL$101.0 $121.7 $121.1
ARISTADA (incl. INITIO)$73.5 $101.3 $98.1
LYBALVI$70.0 $84.3 $98.2
Manufacturing & Royalty$62.0 $83.4 $76.8
VUMERITY (subcomponent)$27.8 $39.4 $35.6
Long-acting INVEGA royalties (subcomponent)$17.7 $30.3 $30.2

Margins (S&P Global)

MetricQ4 2024Q1 2025Q2 2025Q3 2025
EBITDA Margin %39.43%*6.92%*25.80%*24.65%*
EBIT Margin %37.84%*4.50%*23.80%*22.60%*
Net Income Margin %34.07%*7.33%*22.30%*21.00%*

Values retrieved from S&P Global.

KPI/Drivers (Q3)

KPIQ3 2025 Detail
LYBALVI performanceRevenue $98.2M; TRx +25% YoY; rev +32% YoY
ARISTADA performanceRevenue $98.1M; +16% YoY
VIVITROL performanceRevenue $121.1M; +7% YoY
Gross-to-net favorability~$8M VIVITROL; ~$5M ARISTADA (Medicaid utilization adjustments)
Portfolio Q4 net sales outlookProprietary portfolio net sales expected $300–$320M in Q4, per CFO

Why results looked like this

  • Beat vs estimates: higher proprietary product net sales aided by demand and one-time GTN favorability; CFO quantified ~$13M combined VIVITROL/ARISTADA benefit .
  • YoY headwind: lower manufacturing/royalty revenue tied to U.S. INVEGA SUSTENNA royalty expiry in Aug-2024 (structural decline) .
  • Expense step-up: R&D (+$21.8M YoY) from Vibrance studies and next-gen orexin programs; SG&A (+$21.4M YoY) from field force expansion and Lybalvi promotion .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenues ($B)FY 2025$1.34 – $1.43 $1.43 – $1.49 Raised
VIVITROL Net Sales ($M)FY 2025$440 – $460 $460 – $470 Raised
ARISTADA Net Sales ($M)FY 2025$335 – $355 $360 – $370 Raised
LYBALVI Net Sales ($M)FY 2025$320 – $340 $340 – $350 Raised
Cost of Goods Sold ($M)FY 2025$185 – $205 $195 – $205 Maintained (upper bound)
R&D Expense ($M)FY 2025$305 – $335 $315 – $325 Narrowed
SG&A Expense ($M)FY 2025$655 – $685 $675 – $705 Raised
GAAP Net Income ($M)FY 2025$175 – $205 $230 – $250 Raised
EBITDA ($M)FY 2025$215 – $245 $270 – $290 Raised
Adjusted EBITDA ($M)FY 2025$310 – $340 $365 – $385 Raised
Effective Tax RateFY 2025~17% ~17% Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Orexin program (alixorexton)NT1 Vibrance‑1 enrollment complete; NT2 data fall; IH mid‑2026; building Phase 3 prep Positive NT1 topline; cognition/fatigue signal; NT2 fall; Phase 3 planning; multi‑dose learnings NT2 data expected Nov; Phase 3 early 2026; reiterated broad orexin portfolio incl. AUX4510/7290 Advancing toward registrational
Gross‑to‑net/MedicaidSeasonality; Medicaid ~45–50% mix across brands ~$20M GTN tailwind (Q2) across VIVITROL/ARISTADA ~$13M GTN tailwind (Q3) VIVITROL/ARISTADA; not assuming repeat Tailwinds, non‑recurring
Royalty mixVUMERITY + INVEGA royalties noted Mix still supportive INVEGA SUSTENNA U.S. royalty expired Aug-2024; pressure on non‑product revenue Structural headwind
Commercial executionPsychiatry force expansion planned to drive share of voice Strong sequential growth; exceeded guidance; demand-led Continued demand; LYBALVI breadth + depth, GTN ~28% Q3 Improving
Policy/tariffsU.S.-centric mfg mitigates tariff risk; watch Medicaid/ACA subsidies Similar framing; maintain access focus Stable
BD/M&AOpen to pipeline-bolstering deals Agreement to acquire Avadel; strategic fit, accretive; debt + cash financing Transformational

Management Commentary

  • CEO on quarter and outlook: “Alkermes delivered another successful quarter… raised our financial outlook for 2025… proposed acquisition of Avadel… another potential growth driver” .
  • CFO on drivers: “one-time gross‑to‑net benefit of approximately $8 million for Vivitrol and approximately $5 million for Aristada… raising our 2025 full‑year guidance” .
  • CCO on LYBALVI: “expansion of our psychiatry footprint really drove a strong share of voice… TRX growth ~25% YoY; new patient starts up ~16%” .
  • CEO on orexin program: NT2 data will inform EoP2 and Phase 3; aiming “to be the first to market in narcolepsy type two” .

Q&A Highlights

  • LYBALVI gross‑to‑net: Q3 GTN ~28%; seasonal uptick expected in Q4; 2026 GTN guide to come in Feb .
  • NT2 expectations and endpoints: Dual primaries MWT and ESS; focus on safety/tolerability across doses; phase 3 design post NT2 readout .
  • VIVITROL outlook: Strength in alcohol dependence to continue in Q4; mature-brand dynamics acknowledged .
  • Safety/ocular AEs and dosing: Visual AEs largely mild/transient in NT1; learnings to reduce variability in cataplexy assay; dose‑response considerations for Phase 3 .
  • GTN favorability sustainability: Management not assuming further Medicaid mix favorability beyond Q3/Q2 adjustments .

Estimates Context

MetricS&P Global ConsensusActual (S&P framework)Result
Revenue (Q3 2025)$356.23M*$394.19M*Beat
Primary EPS (Q3 2025)$0.386*$0.651*Beat

Values retrieved from S&P Global. Company-reported GAAP diluted EPS for Q3 2025 was $0.49 .

Where estimates may need to adjust

  • Full‑year raised guidance (revenues, NI, EBITDA, Adj. EBITDA) implies higher run‑rate for proprietary net sales and profitability than previously modeled .
  • Structural reduction in royalty revenue (post INVEGA SUSTENNA U.S. expiry) should shift models toward higher product mix and expense leverage assumptions .
  • Positive NT2 Phase 2 topline (Nov 12) supports including dual-indication Phase 3 pacing in models and potential de‑risked probability for alixorexton .

Key Takeaways for Investors

  • Core brands executing: LYBALVI/ARISTADA/VIVITROL momentum offset royalty step‑down; one‑time GTN helped the beat—normalize GTN in forward quarters .
  • Guidance raised across the board; Q4 proprietary net sales outlook $300–$320M frames year‑end cadence .
  • Pipeline de‑risking: NT2 Phase 2 dual primary success (post‑quarter) plus strong NT1 data underpin Phase 3 start in early 2026; consider increasing PoS for alixorexton .
  • Strategic M&A: Avadel deal adds once‑nightly LUMRYZ and establishes sleep footprint; expected to be accretive at close (1Q26) with debt + cash financing .
  • Watch list: Medicaid mix/GTN normalization, SG&A trajectory (Avadel transaction costs), Phase 3 design choices (doses/assays), and royalty runoff exposure .
  • Medium‑term thesis: Higher proprietary mix plus sleep franchise (LUMRYZ + alixorexton) can support revenue growth and margin expansion post‑2025 if execution continues .

Appendix: Additional Context and Disclosures

  • Balance sheet: Cash, cash equivalents and total investments $1.14B at Sep 30, 2025 (vs $1.05B at Jun 30, 2025) .
  • Operating expense detail (Q3): R&D $81.7M; SG&A $171.8M (cont. ops) .
  • Manufacturing/royalty detail (Q3): VUMERITY $35.6M; long‑acting INVEGA royalties $30.2M .
  • CFO appointment (Sept 12): Joshua Reed named CFO .
  • Positive Vibrance‑2 topline (Nov 12): Alixorexton met dual primaries in NT2; well‑tolerated; Phase 3 to initiate 1Q26 .

Footnotes:

  • S&P Global data used for consensus and “Primary EPS” actuals; values retrieved from S&P Global.