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)
YoY snapshot (Q3)
Product and Revenue Mix
Margins (S&P Global)
Values retrieved from S&P Global.
KPI/Drivers (Q3)
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
Earnings Call Themes & Trends
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
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.