[10-Q] Alkermes Inc. plc Quarterly Earnings Report
Alkermes (ALKS) Q2-25 10-Q highlights: Net revenue slipped 2% YoY to $390.7 m as a 36% fall in manufacturing & royalty income (-$46.4 m) outweighed a 14% jump in proprietary product sales to $307.2 m. VIVITROL +9% to $121.7 m, ARISTADA franchise +18% to $101.3 m and LYBALVI +18% to $84.3 m.
Earnings & cash: Operating income from continuing ops declined 15% to $93.0 m; diluted EPS fell to $0.52 from $0.55. R&D spending rose 30% to $77.4 m while SG&A was flat. Lower royalties cut gross margin mix but cost-of-goods remained modest at 12.7% of sales. Operating cash flow rose 49% to $249.0 m, lifting cash & equivalents to $521.2 m (vs $291.1 m YE-24); no long-term debt remains, eliminating interest expense.
Balance sheet: Total assets grew to $2.25 bn; equity improved 11% to $1.62 bn. Share count fell 2% YoY to 165.1 m; $200 m of the $400 m buyback authorization is still available.
Key developments: • Royalty stream from long-acting INVEGA products continued to fade after August-24 U.S. expiry. • Medicaid rebate true-ups cut reserves by $30.1 m, aiding cash. • July-25 settlement with Zydus grants first generic VUMERITY entry only immediately prior to patent expiry. • New U.S. patent (12,311,027) extends ARISTADA protection to 2033.
Outlook: Management signals further revenue mix shift toward proprietary brands, higher R&D for pipeline assets (e.g., alixorexton), and materially higher operating cash following recent U.S. tax law changes.
Alkermes (ALKS) Q2-25 10-Q punti salienti: Il fatturato netto è diminuito del 2% su base annua a 390,7 milioni di dollari, poiché una riduzione del 36% dei ricavi da produzione e royalty (-46,4 milioni di dollari) ha superato un aumento del 14% delle vendite di prodotti proprietari, che hanno raggiunto 307,2 milioni di dollari. VIVITROL è cresciuto del 9% a 121,7 milioni, il franchise ARISTADA del 18% a 101,3 milioni e LYBALVI del 18% a 84,3 milioni.
Utili e liquidità: Il reddito operativo dalle attività continuative è calato del 15% a 93,0 milioni; l'utile per azione diluito è sceso da 0,55 a 0,52 dollari. La spesa in R&S è aumentata del 30% a 77,4 milioni, mentre le spese SG&A sono rimaste stabili. Le royalties inferiori hanno ridotto il margine lordo, ma il costo del venduto è rimasto contenuto al 12,7% delle vendite. Il flusso di cassa operativo è cresciuto del 49% a 249,0 milioni, portando la liquidità e equivalenti a 521,2 milioni (rispetto a 291,1 milioni a fine 2024); non ci sono debiti a lungo termine, eliminando così gli oneri finanziari.
Bilancio: Gli attivi totali sono aumentati a 2,25 miliardi; il patrimonio netto è migliorato dell'11% a 1,62 miliardi. Il numero di azioni in circolazione è diminuito del 2% su base annua a 165,1 milioni; sono ancora disponibili 200 milioni dei 400 milioni autorizzati per il riacquisto di azioni.
Sviluppi chiave: • Il flusso di royalty dai prodotti INVEGA a lunga durata è continuato a diminuire dopo la scadenza negli USA nell'agosto 2024. • Le rettifiche dei rimborsi Medicaid hanno ridotto le riserve di 30,1 milioni, migliorando la liquidità. • L'accordo di luglio 2025 con Zydus concede l'ingresso del primo generico VUMERITY solo immediatamente prima della scadenza del brevetto. • Un nuovo brevetto statunitense (12,311,027) estende la protezione di ARISTADA fino al 2033.
Prospettive: La direzione prevede un ulteriore spostamento del mix di ricavi verso i marchi proprietari, un aumento significativo della R&S per gli asset in pipeline (es. alixorexton) e un incremento sostanziale del flusso di cassa operativo a seguito delle recenti modifiche alla legislazione fiscale statunitense.
Aspectos destacados del 10-Q del Q2-25 de Alkermes (ALKS): Los ingresos netos cayeron un 2% interanual a 390,7 millones de dólares, ya que una caída del 36% en los ingresos por fabricación y regalías (-46,4 millones) superó un aumento del 14% en las ventas de productos propios, que alcanzaron los 307,2 millones. VIVITROL subió un 9% a 121,7 millones, la franquicia ARISTADA un 18% a 101,3 millones y LYBALVI un 18% a 84,3 millones.
Ganancias y efectivo: El ingreso operativo de las operaciones continuas disminuyó un 15% a 93,0 millones; el BPA diluido bajó de 0,55 a 0,52 dólares. El gasto en I+D aumentó un 30% a 77,4 millones, mientras que los gastos SG&A se mantuvieron estables. Las regalías más bajas redujeron el margen bruto, pero el costo de bienes vendidos se mantuvo moderado en el 12,7% de las ventas. El flujo de caja operativo aumentó un 49% a 249,0 millones, elevando el efectivo y equivalentes a 521,2 millones (frente a 291,1 millones a fin de 2024); no queda deuda a largo plazo, eliminando los gastos por intereses.
Balance: Los activos totales crecieron a 2,25 mil millones; el patrimonio mejoró un 11% a 1,62 mil millones. El número de acciones disminuyó un 2% interanual a 165,1 millones; aún quedan disponibles 200 millones de los 400 millones autorizados para recompra.
Desarrollos clave: • El flujo de regalías de los productos INVEGA de acción prolongada continuó disminuyendo tras la expiración en EE.UU. en agosto de 2024. • Los ajustes de reembolso de Medicaid redujeron las reservas en 30,1 millones, ayudando al efectivo. • El acuerdo de julio de 2025 con Zydus concede la primera entrada genérica de VUMERITY solo inmediatamente antes de la expiración de la patente. • Una nueva patente estadounidense (12,311,027) extiende la protección de ARISTADA hasta 2033.
Perspectivas: La dirección indica un mayor cambio en la mezcla de ingresos hacia marcas propias, un aumento significativo en I+D para activos en desarrollo (p. ej., alixorexant) y un flujo de caja operativo materialmente mayor tras los recientes cambios en la legislación fiscal de EE.UU.
Alkermes (ALKS) 2025년 2분기 10-Q 주요 내용: 순수익은 전년 대비 2% 감소한 3억 9,070만 달러로, 제조 및 로열티 수입이 36% 감소(-4,640만 달러)한 반면, 독점 제품 판매는 14% 증가한 3억 720만 달러를 기록했습니다. VIVITROL은 9% 증가한 1억 2,170만 달러, ARISTADA 프랜차이즈는 18% 증가한 1억 130만 달러, LYBALVI는 18% 증가한 8,430만 달러를 기록했습니다.
수익 및 현금: 계속 영업에서의 영업이익은 15% 감소한 9,300만 달러, 희석 주당순이익(EPS)은 0.55달러에서 0.52달러로 하락했습니다. 연구개발(R&D) 비용은 30% 증가한 7,740만 달러, 판매관리비(SG&A)는 변동이 없었습니다. 로열티 감소로 인해 총이익률이 하락했으나, 매출원가 비율은 12.7%로 낮은 수준을 유지했습니다. 영업 현금 흐름은 49% 증가한 2억 4,900만 달러로 현금 및 현금성 자산은 5억 2,120만 달러(2024년 말 2억 9,110만 달러 대비)로 상승했으며, 장기 부채가 없어 이자 비용이 없습니다.
재무상태표: 총 자산은 22억 5천만 달러로 증가했고, 자본은 11% 증가한 16억 2천만 달러를 기록했습니다. 주식 수는 전년 대비 2% 감소한 1억 6,510만 주이며, 4억 달러 규모의 자사주 매입 승인 중 2억 달러가 남아 있습니다.
주요 개발 사항: • 장기 지속형 INVEGA 제품의 로열티 수익은 2024년 8월 미국 특허 만료 이후 계속 감소했습니다. • 메디케이드 환급 조정으로 3,010만 달러의 준비금이 줄어 현금 유입에 기여했습니다. • 2025년 7월 Zydus와의 합의는 특허 만료 직전에 첫 제네릭 VUMERITY 진입을 허용합니다. • 새로운 미국 특허(12,311,027)는 ARISTADA의 보호 기간을 2033년까지 연장합니다.
전망: 경영진은 독점 브랜드로의 매출 구성 비중 증가, 파이프라인 자산(예: 알릭소렉산트)에 대한 연구개발 투자 확대, 최근 미국 세법 변경에 따른 영업 현금 흐름의 실질적 증가를 예고하고 있습니다.
Points clés du 10-Q du T2-25 d'Alkermes (ALKS) : Le chiffre d'affaires net a diminué de 2 % en glissement annuel pour atteindre 390,7 millions de dollars, une baisse due à une chute de 36 % des revenus de fabrication et de redevances (-46,4 millions) qui a éclipsé une hausse de 14 % des ventes de produits propriétaires à 307,2 millions. VIVITROL a progressé de 9 % à 121,7 millions, la franchise ARISTADA de 18 % à 101,3 millions et LYBALVI de 18 % à 84,3 millions.
Bénéfices et trésorerie : Le résultat d'exploitation des activités poursuivies a diminué de 15 % à 93,0 millions ; le BPA dilué est passé de 0,55 à 0,52 dollar. Les dépenses en R&D ont augmenté de 30 % à 77,4 millions tandis que les frais SG&A sont restés stables. La baisse des redevances a réduit la marge brute, mais le coût des marchandises vendues est resté modéré à 12,7 % des ventes. Le flux de trésorerie opérationnel a augmenté de 49 % à 249,0 millions, portant la trésorerie et équivalents à 521,2 millions (contre 291,1 millions fin 2024) ; aucune dette à long terme ne subsiste, éliminant ainsi les charges d’intérêts.
Bilan : L’actif total est passé à 2,25 milliards ; les capitaux propres ont progressé de 11 % à 1,62 milliard. Le nombre d’actions en circulation a diminué de 2 % en glissement annuel à 165,1 millions ; 200 millions des 400 millions autorisés pour le rachat d’actions restent disponibles.
Développements clés : • Le flux de redevances des produits INVEGA à longue durée d’action a continué de diminuer après l’expiration du brevet américain en août 2024. • Les ajustements des remises Medicaid ont réduit les provisions de 30,1 millions, améliorant la trésorerie. • Le règlement de juillet 2025 avec Zydus autorise la première entrée générique de VUMERITY uniquement immédiatement avant l’expiration du brevet. • Un nouveau brevet américain (12 311 027) prolonge la protection d’ARISTADA jusqu’en 2033.
Perspectives : La direction indique un nouveau déplacement du mix de revenus vers les marques propriétaires, une augmentation significative de la R&D pour les actifs en développement (ex. alixorexant) et une trésorerie opérationnelle nettement plus élevée suite aux récents changements de la législation fiscale américaine.
Alkermes (ALKS) Q2-25 10-Q Highlights: Der Nettoumsatz sank im Jahresvergleich um 2 % auf 390,7 Mio. USD, da ein Rückgang der Herstellungs- und Lizenzgebührenerlöse um 36 % (-46,4 Mio. USD) einen Anstieg der Umsätze mit eigenen Produkten um 14 % auf 307,2 Mio. USD übertraf. VIVITROL stieg um 9 % auf 121,7 Mio. USD, die ARISTADA-Franchise um 18 % auf 101,3 Mio. USD und LYBALVI um 18 % auf 84,3 Mio. USD.
Gewinn & Cashflow: Das operative Ergebnis aus fortgeführten Geschäftsbereichen sank um 15 % auf 93,0 Mio. USD; das verwässerte Ergebnis je Aktie fiel von 0,55 auf 0,52 USD. Die F&E-Ausgaben stiegen um 30 % auf 77,4 Mio. USD, während die SG&A-Kosten stabil blieben. Niedrigere Lizenzgebühren verringerten die Bruttomarge, jedoch blieben die Herstellungskosten mit 12,7 % des Umsatzes moderat. Der operative Cashflow stieg um 49 % auf 249,0 Mio. USD, wodurch die liquiden Mittel auf 521,2 Mio. USD (gegenüber 291,1 Mio. USD Ende 2024) anstiegen; es besteht keine langfristige Verschuldung mehr, wodurch Zinsaufwendungen entfallen.
Bilanz: Die Gesamtaktiva stiegen auf 2,25 Mrd. USD; das Eigenkapital verbesserte sich um 11 % auf 1,62 Mrd. USD. Die Anzahl der ausstehenden Aktien sank im Jahresvergleich um 2 % auf 165,1 Mio.; von den genehmigten 400 Mio. USD für Aktienrückkäufe sind noch 200 Mio. USD verfügbar.
Wesentliche Entwicklungen: • Die Lizenzstrom-Einnahmen aus den langwirksamen INVEGA-Produkten gingen nach Ablauf des US-Patents im August 2024 weiter zurück. • Medicaid-Rabattanpassungen reduzierten Rückstellungen um 30,1 Mio. USD und verbesserten die Liquidität. • Die Einigung mit Zydus im Juli 2025 erlaubt den ersten generischen Markteintritt von VUMERITY unmittelbar vor Patentauslauf. • Ein neues US-Patent (12.311.027) verlängert den Schutz von ARISTADA bis 2033.
Ausblick: Das Management signalisiert eine weitere Verschiebung des Umsatzmix hin zu eigenen Marken, höhere F&E-Ausgaben für Pipeline-Produkte (z.B. Alixorexant) und einen deutlich höheren operativen Cashflow nach jüngsten Änderungen im US-Steuerrecht.
- Proprietary product sales up 14 % YoY, driven by double-digit growth in VIVITROL, ARISTADA and LYBALVI.
- Operating cash flow surged 49 % to $249 m, boosting cash to $521 m and eliminating net debt.
- New U.S. patent extends ARISTADA exclusivity to 2033, strengthening long-term IP moat.
- VUMERITY generic settlement delays competitive entry until patent expiry, preserving royalty stream.
- Total revenue fell 2 % YoY as manufacturing & royalty income dropped 36 % following INVEGA patent expiry.
- Net income and diluted EPS declined 8 % and 5 % respectively versus Q2-24.
- R&D expenses jumped 30 %, pressuring operating margin and signaling higher future spend.
- Royalty concentration risk remains with further erosion expected in INVEGA franchise royalties.
Insights
TL;DR – Solid brand growth offsets royalty cliff; overall neutral impact.
Product momentum is encouraging: LYBALVI and ARISTADA combined now exceed 50 % of sales and grew double-digits. However, legacy INVEGA royalties fell $48 m YoY and will keep compressing, capping top-line expansion. Operating margin held at 24 % despite a 30 % R&D step-up aimed at late-stage pipeline, indicating good cost discipline. Cash generation and a debt-free balance sheet give flexibility to fund R&D or resume buybacks (remaining $200 m). Net income down 8 % and diluted EPS down $0.03 tempers enthusiasm. On balance, filing is strategically positive long-term but near-term neutral for valuation.
TL;DR – Revenue mix shift highlights transition to self-owned assets.
Rapid erosion of INVEGA royalties post-patent loss was expected; Alkermes’ ability to grow proprietary brands 14 % YoY validates commercial execution. The July settlement delays VUMERITY generic pressure and ARISTADA patent issuance secures a key franchise to 2033, de-risking future cash flows. R&D ramp (now 19 % of revenue) signals management’s confidence in neuroscience pipeline but raises spend profile. With $521 m cash and no debt, Alkermes can absorb increased R&D while maintaining optionality on M&A or shareholder returns. Overall strategic trajectory positive though immediate earnings drag limits short-term upside.
Alkermes (ALKS) Q2-25 10-Q punti salienti: Il fatturato netto è diminuito del 2% su base annua a 390,7 milioni di dollari, poiché una riduzione del 36% dei ricavi da produzione e royalty (-46,4 milioni di dollari) ha superato un aumento del 14% delle vendite di prodotti proprietari, che hanno raggiunto 307,2 milioni di dollari. VIVITROL è cresciuto del 9% a 121,7 milioni, il franchise ARISTADA del 18% a 101,3 milioni e LYBALVI del 18% a 84,3 milioni.
Utili e liquidità: Il reddito operativo dalle attività continuative è calato del 15% a 93,0 milioni; l'utile per azione diluito è sceso da 0,55 a 0,52 dollari. La spesa in R&S è aumentata del 30% a 77,4 milioni, mentre le spese SG&A sono rimaste stabili. Le royalties inferiori hanno ridotto il margine lordo, ma il costo del venduto è rimasto contenuto al 12,7% delle vendite. Il flusso di cassa operativo è cresciuto del 49% a 249,0 milioni, portando la liquidità e equivalenti a 521,2 milioni (rispetto a 291,1 milioni a fine 2024); non ci sono debiti a lungo termine, eliminando così gli oneri finanziari.
Bilancio: Gli attivi totali sono aumentati a 2,25 miliardi; il patrimonio netto è migliorato dell'11% a 1,62 miliardi. Il numero di azioni in circolazione è diminuito del 2% su base annua a 165,1 milioni; sono ancora disponibili 200 milioni dei 400 milioni autorizzati per il riacquisto di azioni.
Sviluppi chiave: • Il flusso di royalty dai prodotti INVEGA a lunga durata è continuato a diminuire dopo la scadenza negli USA nell'agosto 2024. • Le rettifiche dei rimborsi Medicaid hanno ridotto le riserve di 30,1 milioni, migliorando la liquidità. • L'accordo di luglio 2025 con Zydus concede l'ingresso del primo generico VUMERITY solo immediatamente prima della scadenza del brevetto. • Un nuovo brevetto statunitense (12,311,027) estende la protezione di ARISTADA fino al 2033.
Prospettive: La direzione prevede un ulteriore spostamento del mix di ricavi verso i marchi proprietari, un aumento significativo della R&S per gli asset in pipeline (es. alixorexton) e un incremento sostanziale del flusso di cassa operativo a seguito delle recenti modifiche alla legislazione fiscale statunitense.
Aspectos destacados del 10-Q del Q2-25 de Alkermes (ALKS): Los ingresos netos cayeron un 2% interanual a 390,7 millones de dólares, ya que una caída del 36% en los ingresos por fabricación y regalías (-46,4 millones) superó un aumento del 14% en las ventas de productos propios, que alcanzaron los 307,2 millones. VIVITROL subió un 9% a 121,7 millones, la franquicia ARISTADA un 18% a 101,3 millones y LYBALVI un 18% a 84,3 millones.
Ganancias y efectivo: El ingreso operativo de las operaciones continuas disminuyó un 15% a 93,0 millones; el BPA diluido bajó de 0,55 a 0,52 dólares. El gasto en I+D aumentó un 30% a 77,4 millones, mientras que los gastos SG&A se mantuvieron estables. Las regalías más bajas redujeron el margen bruto, pero el costo de bienes vendidos se mantuvo moderado en el 12,7% de las ventas. El flujo de caja operativo aumentó un 49% a 249,0 millones, elevando el efectivo y equivalentes a 521,2 millones (frente a 291,1 millones a fin de 2024); no queda deuda a largo plazo, eliminando los gastos por intereses.
Balance: Los activos totales crecieron a 2,25 mil millones; el patrimonio mejoró un 11% a 1,62 mil millones. El número de acciones disminuyó un 2% interanual a 165,1 millones; aún quedan disponibles 200 millones de los 400 millones autorizados para recompra.
Desarrollos clave: • El flujo de regalías de los productos INVEGA de acción prolongada continuó disminuyendo tras la expiración en EE.UU. en agosto de 2024. • Los ajustes de reembolso de Medicaid redujeron las reservas en 30,1 millones, ayudando al efectivo. • El acuerdo de julio de 2025 con Zydus concede la primera entrada genérica de VUMERITY solo inmediatamente antes de la expiración de la patente. • Una nueva patente estadounidense (12,311,027) extiende la protección de ARISTADA hasta 2033.
Perspectivas: La dirección indica un mayor cambio en la mezcla de ingresos hacia marcas propias, un aumento significativo en I+D para activos en desarrollo (p. ej., alixorexant) y un flujo de caja operativo materialmente mayor tras los recientes cambios en la legislación fiscal de EE.UU.
Alkermes (ALKS) 2025년 2분기 10-Q 주요 내용: 순수익은 전년 대비 2% 감소한 3억 9,070만 달러로, 제조 및 로열티 수입이 36% 감소(-4,640만 달러)한 반면, 독점 제품 판매는 14% 증가한 3억 720만 달러를 기록했습니다. VIVITROL은 9% 증가한 1억 2,170만 달러, ARISTADA 프랜차이즈는 18% 증가한 1억 130만 달러, LYBALVI는 18% 증가한 8,430만 달러를 기록했습니다.
수익 및 현금: 계속 영업에서의 영업이익은 15% 감소한 9,300만 달러, 희석 주당순이익(EPS)은 0.55달러에서 0.52달러로 하락했습니다. 연구개발(R&D) 비용은 30% 증가한 7,740만 달러, 판매관리비(SG&A)는 변동이 없었습니다. 로열티 감소로 인해 총이익률이 하락했으나, 매출원가 비율은 12.7%로 낮은 수준을 유지했습니다. 영업 현금 흐름은 49% 증가한 2억 4,900만 달러로 현금 및 현금성 자산은 5억 2,120만 달러(2024년 말 2억 9,110만 달러 대비)로 상승했으며, 장기 부채가 없어 이자 비용이 없습니다.
재무상태표: 총 자산은 22억 5천만 달러로 증가했고, 자본은 11% 증가한 16억 2천만 달러를 기록했습니다. 주식 수는 전년 대비 2% 감소한 1억 6,510만 주이며, 4억 달러 규모의 자사주 매입 승인 중 2억 달러가 남아 있습니다.
주요 개발 사항: • 장기 지속형 INVEGA 제품의 로열티 수익은 2024년 8월 미국 특허 만료 이후 계속 감소했습니다. • 메디케이드 환급 조정으로 3,010만 달러의 준비금이 줄어 현금 유입에 기여했습니다. • 2025년 7월 Zydus와의 합의는 특허 만료 직전에 첫 제네릭 VUMERITY 진입을 허용합니다. • 새로운 미국 특허(12,311,027)는 ARISTADA의 보호 기간을 2033년까지 연장합니다.
전망: 경영진은 독점 브랜드로의 매출 구성 비중 증가, 파이프라인 자산(예: 알릭소렉산트)에 대한 연구개발 투자 확대, 최근 미국 세법 변경에 따른 영업 현금 흐름의 실질적 증가를 예고하고 있습니다.
Points clés du 10-Q du T2-25 d'Alkermes (ALKS) : Le chiffre d'affaires net a diminué de 2 % en glissement annuel pour atteindre 390,7 millions de dollars, une baisse due à une chute de 36 % des revenus de fabrication et de redevances (-46,4 millions) qui a éclipsé une hausse de 14 % des ventes de produits propriétaires à 307,2 millions. VIVITROL a progressé de 9 % à 121,7 millions, la franchise ARISTADA de 18 % à 101,3 millions et LYBALVI de 18 % à 84,3 millions.
Bénéfices et trésorerie : Le résultat d'exploitation des activités poursuivies a diminué de 15 % à 93,0 millions ; le BPA dilué est passé de 0,55 à 0,52 dollar. Les dépenses en R&D ont augmenté de 30 % à 77,4 millions tandis que les frais SG&A sont restés stables. La baisse des redevances a réduit la marge brute, mais le coût des marchandises vendues est resté modéré à 12,7 % des ventes. Le flux de trésorerie opérationnel a augmenté de 49 % à 249,0 millions, portant la trésorerie et équivalents à 521,2 millions (contre 291,1 millions fin 2024) ; aucune dette à long terme ne subsiste, éliminant ainsi les charges d’intérêts.
Bilan : L’actif total est passé à 2,25 milliards ; les capitaux propres ont progressé de 11 % à 1,62 milliard. Le nombre d’actions en circulation a diminué de 2 % en glissement annuel à 165,1 millions ; 200 millions des 400 millions autorisés pour le rachat d’actions restent disponibles.
Développements clés : • Le flux de redevances des produits INVEGA à longue durée d’action a continué de diminuer après l’expiration du brevet américain en août 2024. • Les ajustements des remises Medicaid ont réduit les provisions de 30,1 millions, améliorant la trésorerie. • Le règlement de juillet 2025 avec Zydus autorise la première entrée générique de VUMERITY uniquement immédiatement avant l’expiration du brevet. • Un nouveau brevet américain (12 311 027) prolonge la protection d’ARISTADA jusqu’en 2033.
Perspectives : La direction indique un nouveau déplacement du mix de revenus vers les marques propriétaires, une augmentation significative de la R&D pour les actifs en développement (ex. alixorexant) et une trésorerie opérationnelle nettement plus élevée suite aux récents changements de la législation fiscale américaine.
Alkermes (ALKS) Q2-25 10-Q Highlights: Der Nettoumsatz sank im Jahresvergleich um 2 % auf 390,7 Mio. USD, da ein Rückgang der Herstellungs- und Lizenzgebührenerlöse um 36 % (-46,4 Mio. USD) einen Anstieg der Umsätze mit eigenen Produkten um 14 % auf 307,2 Mio. USD übertraf. VIVITROL stieg um 9 % auf 121,7 Mio. USD, die ARISTADA-Franchise um 18 % auf 101,3 Mio. USD und LYBALVI um 18 % auf 84,3 Mio. USD.
Gewinn & Cashflow: Das operative Ergebnis aus fortgeführten Geschäftsbereichen sank um 15 % auf 93,0 Mio. USD; das verwässerte Ergebnis je Aktie fiel von 0,55 auf 0,52 USD. Die F&E-Ausgaben stiegen um 30 % auf 77,4 Mio. USD, während die SG&A-Kosten stabil blieben. Niedrigere Lizenzgebühren verringerten die Bruttomarge, jedoch blieben die Herstellungskosten mit 12,7 % des Umsatzes moderat. Der operative Cashflow stieg um 49 % auf 249,0 Mio. USD, wodurch die liquiden Mittel auf 521,2 Mio. USD (gegenüber 291,1 Mio. USD Ende 2024) anstiegen; es besteht keine langfristige Verschuldung mehr, wodurch Zinsaufwendungen entfallen.
Bilanz: Die Gesamtaktiva stiegen auf 2,25 Mrd. USD; das Eigenkapital verbesserte sich um 11 % auf 1,62 Mrd. USD. Die Anzahl der ausstehenden Aktien sank im Jahresvergleich um 2 % auf 165,1 Mio.; von den genehmigten 400 Mio. USD für Aktienrückkäufe sind noch 200 Mio. USD verfügbar.
Wesentliche Entwicklungen: • Die Lizenzstrom-Einnahmen aus den langwirksamen INVEGA-Produkten gingen nach Ablauf des US-Patents im August 2024 weiter zurück. • Medicaid-Rabattanpassungen reduzierten Rückstellungen um 30,1 Mio. USD und verbesserten die Liquidität. • Die Einigung mit Zydus im Juli 2025 erlaubt den ersten generischen Markteintritt von VUMERITY unmittelbar vor Patentauslauf. • Ein neues US-Patent (12.311.027) verlängert den Schutz von ARISTADA bis 2033.
Ausblick: Das Management signalisiert eine weitere Verschiebung des Umsatzmix hin zu eigenen Marken, höhere F&E-Ausgaben für Pipeline-Produkte (z.B. Alixorexant) und einen deutlich höheren operativen Cashflow nach jüngsten Änderungen im US-Steuerrecht.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
For the quarterly period ended
OR
Commission File Number
ALKERMES PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
|
|
|
|
||
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
(Address of principal executive offices)
+
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
|
|
|
Accelerated filer ☐ |
|
Non-accelerated filer ☐ |
|
Smaller reporting company |
|
|
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of the registrant’s ordinary shares, $0.01 par value, outstanding as of July 25, 2025 was
ALKERMES PLC AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2025
|
|
|
|
Page No. |
|
PART I - FINANCIAL INFORMATION |
|
|
Item 1. |
Condensed Consolidated Financial Statements (unaudited): |
|
|
Condensed Consolidated Balance Sheets — June 30, 2025 and December 31, 2024 |
5 |
|
Condensed Consolidated Statements of Income and Comprehensive Income — For the Three and Six Months Ended June 30, 2025 and 2024 |
6 |
|
Condensed Consolidated Statements of Cash Flows — For the Six Months Ended June 30, 2025 and 2024 |
7 |
|
Condensed Consolidated Statements of Shareholders’ Equity — For the Three and Six Months Ended June 30, 2025 and 2024 |
8 |
|
Notes to Condensed Consolidated Financial Statements |
10 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
24 |
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk |
35 |
Item 4. |
Controls and Procedures |
35 |
|
|
|
PART II - OTHER INFORMATION |
|
|
Item 1. |
Legal Proceedings |
36 |
Item 1A. |
Risk Factors |
36 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
37 |
Item 5. |
Other Information |
37 |
Item 6. |
Exhibits |
38 |
Signatures |
39 |
2
Cautionary Note Concerning Forward-Looking Statements
This document contains and incorporates by reference “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, these statements can be identified by the use of forward-looking terminology such as “may,” “will,” “could,” “should,” “would,” “expect,” “anticipate,” “continue,” “believe,” “plan,” “estimate,” “intend” or other similar words. These statements discuss future expectations and contain projections of results of operations or of financial condition, or state trends and known uncertainties or other forward-looking information. Forward-looking statements in this Quarterly Report on Form 10-Q (this “Form 10-Q”) may include, without limitation, statements regarding:
Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-looking statements are subject to risks, assumptions and uncertainties. In light of these risks, assumptions and uncertainties, the forward-looking expectations discussed in this Form 10-Q might not occur. You are cautioned not to place undue reliance on the forward-looking statements in this Form 10-Q, which speak only as of the date of this Form 10-Q. All subsequent written and oral forward-looking statements concerning the matters addressed in this Form 10-Q and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For information about the risks, assumptions and uncertainties of our business, see “Part I, Item 1A—Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”) on February 12, 2025 (our “Annual Report”) and “Part II, Item 1A—Risk Factors” in this Form 10-Q.
3
This Form 10-Q may include data that we obtained from industry publications and third-party research, surveys and studies. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that any industry publications and third-party research, surveys and studies from which data is included in this Form 10-Q are reliable, we have not independently verified any such data. This Form 10-Q may also include data based on our own internal estimates and research. Our internal estimates and research have not been verified by any independent source and are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Part I, Item 1A—Risk Factors” in our Annual Report and “Part II, Item 1A—Risk Factors” in this Form 10-Q. These and other factors could cause our results to differ materially from those expressed or implied in this Form 10-Q.
Note Regarding Company and Product References
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Use of terms such as “us,” “we,” “our,” “Alkermes” or the “Company” in this Form 10-Q is meant to refer to Alkermes plc and its consolidated subsidiaries. Except as otherwise suggested by the context, (a) references to “products” or “our products” in this Form 10-Q include our marketed products, marketed products using our proprietary technologies, our licensed products, our product candidates and product candidates using our proprietary technologies, (b) references to the “biopharmaceutical industry” in this Form 10-Q are intended to include reference to the “biotechnology industry” and/or the “pharmaceutical industry” and (c) references to “licensees” in this Form 10-Q are used interchangeably with references to “partners.”
Note Regarding Trademarks
We are the owner of various U.S. federal trademark registrations (“®”) and other trademarks (“TM”), including ALKERMES®, ARISTADA®, ARISTADA INITIO®, LinkeRx®, LYBALVI®, NanoCrystal® and VIVITROL®.
The following are trademarks of the respective companies listed: BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, RISPERDAL CONSTA®, TREVICTA®, and XEPLION®—Johnson & Johnson or its affiliated companies; FAMPYRATM—Merz Pharmaceuticals, LLC; and VUMERITY®—Biogen MA Inc. (together with its affiliates, “Biogen”). Other trademarks, trade names and service marks appearing in this Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Form 10-Q may be referred to without the ® or TM symbol, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
4
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
|
|
(In thousands, except share and per share amounts) |
|
|||||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Investments—short-term |
|
|
|
|
|
|
||
Receivables, net |
|
|
|
|
|
|
||
Inventory |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Contract assets |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
PROPERTY, PLANT AND EQUIPMENT, NET |
|
|
|
|
|
|
||
INVESTMENTS—LONG-TERM |
|
|
|
|
|
|
||
RIGHT-OF-USE ASSETS |
|
|
|
|
|
|
||
INTANGIBLE ASSETS, NET AND GOODWILL |
|
|
|
|
|
|
||
DEFERRED TAX ASSETS |
|
|
|
|
|
|
||
OTHER ASSETS |
|
|
|
|
|
|
||
TOTAL ASSETS |
|
$ |
|
|
$ |
|
||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
CURRENT LIABILITIES: |
|
|
|
|
|
|
||
Accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
||
Accrued sales discounts, allowances and reserves |
|
|
|
|
|
|
||
Operating lease liabilities—short-term |
|
|
|
|
|
|
||
Contract liabilities—short-term |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
OPERATING LEASE LIABILITIES—LONG-TERM |
|
|
|
|
|
|
||
OTHER LONG-TERM LIABILITIES |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
COMMITMENTS AND CONTINGENT LIABILITIES (Note 16) |
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY: |
|
|
|
|
|
|
||
Preferred shares, par value, $ |
|
|
— |
|
|
|
— |
|
Ordinary shares, par value, $ |
|
|
|
|
|
|
||
Treasury shares, at cost ( |
|
|
( |
) |
|
|
( |
) |
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated other comprehensive loss |
|
|
( |
) |
|
|
( |
) |
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total shareholders’ equity |
|
|
|
|
|
|
||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME
(unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
|
|
(In thousands, except per share amounts) |
|
|||||||||||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Manufacturing and royalty revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of acquired intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
OPERATING INCOME FROM CONTINUING OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
||||
OTHER INCOME, NET: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
INCOME BEFORE INCOME TAXES |
|
|
|
|
|
|
|
|
|
|
|
|
||||
INCOME TAX PROVISION |
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET INCOME FROM CONTINUING OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LOSS FROM DISCONTINUED OPERATIONS, NET OF TAX |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
NET INCOME |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
EARNINGS PER ORDINARY SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Earnings per ordinary share from continuing operations - basic |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Loss per ordinary share from discontinued operations - basic |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
||
Earnings per ordinary share - basic |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Earnings per ordinary share from continuing operations - diluted |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Loss per ordinary share from discontinued operations - diluted |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
||
Earnings per ordinary share - diluted |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
COMPREHENSIVE INCOME: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Holding gain (loss), net of a tax provision (benefit) of $ |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
COMPREHENSIVE INCOME |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
Six Months Ended |
|
|||||
|
|
June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
(In thousands) |
|
|||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
||
Net income |
|
$ |
|
|
$ |
|
||
Adjustments to reconcile net income to cash flows from operating activities: |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Share-based compensation expense |
|
|
|
|
|
|
||
Deferred income taxes |
|
|
( |
) |
|
|
|
|
Gain on sale of the Athlone Facility |
|
|
— |
|
|
|
( |
) |
Other non-cash charges |
|
|
|
|
|
|
||
Changes in assets and liabilities: |
|
|
|
|
|
|
||
Receivables |
|
|
|
|
|
( |
) |
|
Contract assets |
|
|
|
|
|
( |
) |
|
Inventory |
|
|
( |
) |
|
|
( |
) |
Prepaid expenses and other assets |
|
|
|
|
|
( |
) |
|
Right-of-use assets |
|
|
|
|
|
|
||
Accounts payable and accrued expenses |
|
|
|
|
|
( |
) |
|
Accrued sales discounts, allowances and reserves |
|
|
( |
) |
|
|
( |
) |
Contract liabilities |
|
|
( |
) |
|
|
( |
) |
Operating lease liabilities |
|
|
( |
) |
|
|
( |
) |
Other long-term liabilities |
|
|
|
|
|
|
||
Cash flows provided by operating activities |
|
|
|
|
|
|
||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
||
Additions of property, plant and equipment |
|
|
( |
) |
|
|
( |
) |
Proceeds from the sale of property, plant and equipment |
|
|
|
|
|
|
||
Proceeds from the sale of the Athlone Facility |
|
|
|
|
|
|
||
Purchases of investments |
|
|
( |
) |
|
|
( |
) |
Sales and maturities of investments |
|
|
|
|
|
|
||
Cash flows (used in) provided by investing activities |
|
|
( |
) |
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
||
Proceeds from the issuance of ordinary shares under share-based compensation arrangements |
|
|
|
|
|
|
||
Employee taxes paid related to net share settlement of equity awards |
|
|
( |
) |
|
|
( |
) |
Payment for the repurchase of ordinary shares |
|
|
— |
|
|
|
( |
) |
Principal payments of long-term debt |
|
|
— |
|
|
|
( |
) |
Cash flows provided by (used in) financing activities |
|
|
|
|
|
( |
) |
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
|
|
|
|
||
CASH AND CASH EQUIVALENTS—Beginning of period |
|
|
|
|
|
|
||
CASH AND CASH EQUIVALENTS—End of period |
|
$ |
|
|
$ |
|
||
SUPPLEMENTAL CASH FLOW DISCLOSURE: |
|
|
|
|
|
|
||
Non-cash investing and financing activities: |
|
|
|
|
|
|
||
Purchased capital expenditures included in accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(unaudited)
|
|
Ordinary Shares |
|
|
Additional |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Treasury Stock |
|
|
|
|
||||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
(Loss) Income |
|
|
Deficit |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
||||||||
|
|
(In thousands, except share data) |
|
|||||||||||||||||||||||||||||
BALANCE — December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized gain on marketable securities, net of tax provision of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — March 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized gain on marketable securities, net of tax provision of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
|
|
Ordinary Shares |
|
|
Additional |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Treasury Stock |
|
|
|
|
||||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
||||||||
|
|
(In thousands, except share data) |
|
|||||||||||||||||||||||||||||
BALANCE — December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized loss on marketable securities, net of tax benefit of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — March 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Repurchase of Alkermes' ordinary shares |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized gain on marketable securities, net of tax benefit of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
9
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited)
1. THE COMPANY
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio.
In May 2024, the Company completed the sale of its research and development business and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) to Novo Nordisk (“Novo”). The Company and Novo also entered into subcontracting arrangements to continue certain development and manufacturing activities performed at the Athlone Facility for a period of time after the closing of the transaction, which activities may continue through the end of 2025. In connection with the sale of the Athlone Facility, the Company received approximately $
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of the Company for the three and six months ended June 30, 2025 and 2024 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2024. The year-end consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments of a normal recurring nature that are necessary to state fairly the results of operations for the reported periods.
The accompanying condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Annual Report. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for any full fiscal year.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” accompanying the Annual Report. Intercompany accounts and transactions have been eliminated. Columns and rows within tables may not sum due to rounding.
Discontinued Operations
The Company determined that the separation of its oncology business into Mural Oncology plc (“Mural”), a new, independent, publicly-traded company (the “Separation”), completed in November 2023, met the criteria for classification of the oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations (“Topic 205”).
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires that Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including, but not limited to, those related to revenue from contracts with its customers and related allowances, impairment of long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions.
10
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Segment Information
Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company has utilized the management approach to determine that the Company is managed as
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that are adopted by the Company on or prior to the specified effective date. Unless otherwise described in this Form 10-Q, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
In December 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures in order to provide information to assist key stakeholders in better assessing how the Company’s operations and related tax risks and tax planning and operational opportunities affect the Company’s tax rate and prospects for future cash flows. This ASU becomes effective for public companies for annual periods beginning after December 15, 2024. This guidance will be applied on a prospective basis. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income-Expense Disaggregation Disclosures, to improve disclosures about public business entity expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization and depletion) in commonly-presented expense captions, such as cost of sales, selling, general and administrative expenses, and research and development. All disclosure requirements under this guidance are required for public business entities and will be effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted and the amendments in this guidance will be applied prospectively to financial statements for periods after the effective dates. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
11
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
3. DISCONTINUED OPERATIONS
Mural Oncology Separation
In connection with the Separation, the Company and Mural entered into, among other agreements: a separation agreement; a tax matters agreement; and an employee matters agreement, which are described in Note 3, Discontinued Operations in the “Notes to Consolidated Financial Statements” accompanying the Annual Report.
Discontinued Operations
The Company determined that the Separation met the criteria for classification of its former oncology business as discontinued operations in accordance with Topic 205. During the three and six months ended June 30, 2025, the Company recorded no losses from discontinued operations.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||
(In thousands) |
|
June 30, 2024 |
|
|
June 30, 2024 |
|
||
Operating expenses from discontinued operations |
|
|
|
|
|
|
||
Cost of goods manufactured |
|
$ |
— |
|
|
$ |
— |
|
Research and development |
|
|
|
|
|
|
||
Selling, general and administrative |
|
|
— |
|
|
|
— |
|
Total operating expenses from discontinued operations |
|
|
|
|
|
|
||
Operating loss from discontinued operations |
|
|
( |
) |
|
|
( |
) |
Income tax benefit from discontinued operations |
|
|
( |
) |
|
|
( |
) |
Net loss and comprehensive loss from discontinued operations |
|
$ |
( |
) |
|
$ |
( |
) |
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed in accordance with FASB ASC 606, Revenue from Contracts with Customers, or Topic 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations.
Product Sales, Net
The Company’s product sales, net consist of sales in the U.S. of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer.
During the three and six months ended June 30, 2025 and 2024, the Company recorded product sales, net, as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(In thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
VIVITROL |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
ARISTADA and ARISTADA INITIO |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LYBALVI |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total product sales, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
12
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, healthcare providers or payers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from historical practices. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. See the “Revenue from Contracts with Customers” section in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” in the Annual Report for information with respect to the Company’s significant categories of sales discounts and allowances.
Actual Medicaid rebates related to VIVITROL and ARISTADA/ARISTADA INITIO during the six months ended June 30, 2025 were lower than original estimates, and as a result the Company reduced its rebate reserve for each product by approximately $
A rollforward of the Company’s provisions for sales discounts and allowances is as follows:
|
|
Six Months Ended June 30, 2025 |
|
|||||||||||||||||
(In thousands) |
|
Contractual Adjustments(1) |
|
|
Discounts(2) |
|
|
Product Returns |
|
|
Other |
|
|
Total |
|
|||||
Beginning balance — December 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Current provisions relating to sales in current year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Adjustments relating to prior years |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Payments relating to sales in current year |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Payments relating to sales in prior years |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Ending balance — June 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Total revenue-related reserves as of June 30, 2025 and December 31, 2024 included in the accompanying consolidated balance sheets are summarized as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Reduction of accounts receivable |
|
$ |
|
|
$ |
|
||
Components of accrued sales discounts, allowances and reserves |
|
|
|
|
|
|
||
Components of other long-term liabilities |
|
|
|
|
|
|
||
Total revenue-related reserves |
|
$ |
|
|
$ |
|
Manufacturing and Royalty Revenues
During the three and six months ended June 30, 2025 and 2024, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows:
|
|
Three Months Ended June 30, 2025 |
|
|
Six Months Ended June 30, 2025 |
|
||||||||||||||||||
(In thousands) |
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
||||||
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||||
VUMERITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
RISPERDAL CONSTA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
13
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
|
|
Three Months Ended June 30, 2024 |
|
|
Six Months Ended June 30, 2024 |
|
||||||||||||||||||
(In thousands) |
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
||||||
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||||
VUMERITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
RISPERDAL CONSTA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
In August 2024, the Company’s royalty on U.S. net sales of INVEGA SUSTENNA expired. Accordingly, the Company expects royalty revenues from net sales of the long-acting INVEGA products to continue to be lower in 2025, as the royalty revenues related to U.S. net sales of INVEGA SUSTENNA comprised a significant portion of the overall royalty revenues from the long-acting INVEGA products.
Contract Assets
Contract assets include unbilled amounts related to the manufacture of a product that, once complete, will be sold under certain of the Company’s manufacturing contracts. The amounts included in the contract assets table below are classified as “Current assets” in the accompanying condensed consolidated balance sheets, as they relate to manufacturing processes that are completed in
Total contract assets at June 30, 2025 were as follows:
(In thousands) |
|
Contract Assets |
|
|
Contract assets at December 31, 2024 |
|
$ |
|
|
Additions |
|
|
|
|
Transferred to receivables, net |
|
|
( |
) |
Contract assets at June 30, 2025 |
|
$ |
|
Contract Liabilities
Contract liabilities consist of contractual obligations related to deferred revenue. At June 30, 2025 and December 31, 2024, $
Total contract liabilities at June 30, 2025 were as follows:
(In thousands) |
|
Contract Liabilities |
|
|
Contract liabilities at December 31, 2024 |
|
$ |
|
|
Additions |
|
|
|
|
Amounts recognized into revenue |
|
|
( |
) |
Contract liabilities at June 30, 2025 |
|
$ |
|
14
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
5. INVESTMENTS
Investments consist of the following (in thousands):
|
|
|
|
|
Gross Unrealized |
|
|
|
|
|||||||||||
|
|
|
|
|
|
|
|
Losses |
|
|
|
|
||||||||
|
|
Amortized |
|
|
|
|
|
Less than |
|
|
Greater than |
|
|
Estimated |
|
|||||
June 30, 2025 |
|
Cost |
|
|
Gains |
|
|
One Year |
|
|
One Year |
|
|
Fair Value |
|
|||||
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|||
Total short-term investments |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|||
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total long-term investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Total investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|||
Total short-term investments |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|||
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total long-term investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
||
Total investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
At June 30, 2025, the Company’s investments in corporate debt securities had a minimum rating of A2 (Moody’s)/A (Standard and Poor’s), and
15
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows:
|
|
Six Months Ended June 30, |
|
|||||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Proceeds from the sales and maturities of investments |
|
$ |
|
|
$ |
|
||
Realized gains |
|
$ |
|
|
$ |
— |
|
|
Realized losses |
|
$ |
— |
|
|
$ |
— |
|
The Company’s available-for-sale and held-to-maturity securities at June 30, 2025 had contractual maturities in the following periods:
|
|
Available-for-sale |
|
|
Held-to-maturity |
|
||||||||||
|
|
Amortized |
|
|
Estimated |
|
|
Amortized |
|
|
Estimated |
|
||||
(In thousands) |
|
Cost |
|
|
Fair Value |
|
|
Cost |
|
|
Fair Value |
|
||||
Within 1 year |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
After 1 year through 5 years |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
In February 2025, the Company entered into an agreement whereby it is committed to provide up to €
6. FAIR VALUE
The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques that the Company utilized to determine such fair value:
|
|
June 30, |
|
|
|
|
|
|
|
|
|
|
||||
(In thousands) |
|
2025 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
U.S. government and agency debt securities |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
||||
|
|
2024 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
U.S. government and agency debt securities |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There were
16
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The following table is a rollforward of the fair value of the Company’s assets with fair values that were determined using Level 3 inputs at June 30, 2025:
(In thousands) |
|
Fair Value |
|
|
Balance, January 1, 2025 |
|
$ |
— |
|
Purchase of a corporate debt security |
|
|
|
|
Balance, June 30, 2025 |
|
$ |
|
The Company’s investments classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active.
The carrying amounts reflected in the accompanying condensed consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses, sales discounts, allowances and reserves approximate fair value due to their short-term nature.
7. INVENTORY
Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consists of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods(1) |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Land |
|
$ |
|
|
$ |
|
||
Building and improvements |
|
|
|
|
|
|
||
Furniture, fixtures and equipment |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Total property, plant and equipment, net |
|
$ |
|
|
$ |
|
17
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
9. LEASES
Future lease payments under non-cancelable leases at June 30, 2025 consist of the following:
|
|
June 30, |
|
|
(In thousands) |
|
2025 |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Thereafter |
|
|
|
|
Total operating lease payments |
|
$ |
|
|
Less: imputed interest |
|
|
( |
) |
Total operating lease liabilities |
|
$ |
|
At June 30, 2025, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were
10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Accrued other |
|
|
|
|
|
|
||
Total accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
A summary of the Company’s current provision for sales discounts, allowances and reserves was as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Medicaid rebates |
|
$ |
|
|
$ |
|
||
Product discounts |
|
|
|
|
|
|
||
Medicare Part D |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued sales discounts, allowances and reserves |
|
$ |
|
|
$ |
|
Included in accounts payable was approximately $
11. SHAREHOLDERS’ EQUITY
In February 2024, the Company announced approval by its board of directors of a share repurchase program authorizing the Company to repurchase its ordinary shares in an aggregate amount of up to $
18
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
12. SHARE-BASED COMPENSATION
The following table presents share-based compensation expense included in the accompanying condensed consolidated statements of income and comprehensive income:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Cost of goods manufactured and sold |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
At each of June 30, 2025 and December 31, 2024, $
13. EARNINGS PER ORDINARY SHARE
Basic earnings per ordinary share from continuing operations is calculated based upon net income from continuing operations available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. Basic loss per ordinary share from discontinued operations is calculated based upon net loss from discontinued operations available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings (loss) per ordinary share from continuing operations and discontinuing operations, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the potential dilutive effect of outstanding ordinary share equivalents such as stock options and restricted stock unit awards.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income from continuing operations |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Net loss from discontinued operations |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net income |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of ordinary shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Restricted stock unit awards |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Dilutive ordinary share equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Shares used in calculating diluted earnings per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
|
The following potential ordinary share equivalents were not included in the net earnings per ordinary share calculation because the effect would have been anti-dilutive:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Restricted stock unit awards |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
19
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
14. INCOME TAXES
The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In determining future taxable income, the Company is responsible for assumptions that it utilizes, including the amount of Irish and non-Irish pre-tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company uses to manage the underlying business.
The Company recorded income tax provisions on income from continuing operations of $
The Company’s effective tax rate during the six months ended June 30, 2025 and 2024 was
On July 4, 2025, the One Big Beautiful Bill (the “OBB Bill”) was signed into law. This legislation permanently extends, with modifications, several individual, business, and international tax provisions originally enacted under the Tax Cuts and Jobs Act of 2017. The Company performed an initial assessment of the OBB Bill and expects this legislation to result in a material increase in cash flows provided by operating activities and a material decrease in net U.S. deferred tax assets over the next number of years.
15. SEGMENT REPORTING
Segment Information
Following the adoption of ASU 2023-07, the Company is required to disclose significant segment expenses that are regularly provided to its CODM.
20
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The Company’s significant segment expenses are as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
External R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Development programs: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Alixorexton |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LYBALVI |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other external R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total external R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Internal R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Employee-related |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Occupancy |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Depreciation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other internal R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total internal R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total selling, general and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment income (expenses)(1) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
NET INCOME FROM CONTINUING OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LOSS ON DISCONTINUED OPERATIONS, NET OF TAX |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
NET INCOME |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
16. COMMITMENTS AND CONTINGENT LIABILITIES
Litigation
From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At June 30, 2025, there were
21
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
INVEGA TRINZA ANDA Litigation
In September 2020, Janssen Pharmaceutica, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC initiated a patent infringement lawsuit in the U.S. District Court for the District of New Jersey (the “NJ District Court”) against Mylan Laboratories Limited (“Mylan Labs”) and other Mylan entities following the filing by Mylan Labs of an abbreviated new drug application (“ANDA”) seeking approval from the U.S. Food and Drug Administration (“FDA”) to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693 (the “’693 Patent”). Requested judicial remedies include recovery of litigation costs and injunctive relief. In May 2023, the NJ District Court issued an opinion in favor of the Janssen entities on the issues of infringement and validity of the ’693 Patent and the Mylan entities filed a notice of appeal of the decision. In March, 2025, the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit Court”) issued a decision affirming the NJ District Court opinion and in May 2025, Mylan Labs filed a petition for panel rehearing or rehearing en banc. The Company is not a party to this proceeding.
VUMERITY ANDA Litigation
In July 2023, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited (“APIL”) filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (the “DE District Court”) against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”) following the filing by Zydus of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) delayed-release capsules for oral use, 231 mg, before expiration of the Company’s U.S. Patent Nos. 8,669,281; 9,090,558; and 10,080,733 (the “VUMERITY patents”). The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). On July 21, 2025, the parties entered into a confidential settlement agreement, pursuant to which Zydus was granted a license under the VUMERITY patents to engage in the commercial manufacture, use or sale of a generic version of VUMERITY in the United States beginning on an agreed date immediately prior to expiration of the latest to expire of the VUMERITY patents, or earlier under certain customary circumstances. In connection with the settlement agreement, the DE District Court dismissed the litigation pursuant to the parties’ stipulation of dismissal.
Government Matters
The Company has received a subpoena and civil investigative demands from U.S. state and federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations.
Product Liability and Other Legal Proceedings
The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including a product liability case alleging that the FDA-approved VIVITROL labeling was inadequate and that VIVITROL caused the individual to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters.
In addition, in January 2023, Acorda Therapeutics, Inc. (“Acorda”) filed a petition with the U.S. District Court for the Southern District of New York (the “NY Southern District Court”) asking the court to confirm in part and modify in part the final arbitral award rendered by an arbitration panel in October 2022 and, as part of the requested modification, seeking an additional approximately $
Guarantees
In connection with the Separation, the Company entered into an assignment and assumption of lease agreement (the “Assignment”) pursuant to which Alkermes, Inc., a wholly owned subsidiary of the Company, assigned to Mural Oncology, Inc. (“Mural US”), a subsidiary of Mural, an operating lease for approximately
22
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Lease were transferred to Mural US as of November 15, 2023 pursuant to the Assignment, the Company ratified and reaffirmed for the remainder of the lease term its guarantor obligations in respect of the lease under that certain Guaranty dated as of
23
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with the accompanying condensed consolidated financial statements and related notes beginning on page 5 in this Form 10-Q, and “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the audited financial statements and notes thereto accompanying our Annual Report.
Executive Summary
Net income from continuing operations was $87.1 million and $109.6 million or $0.53 and $0.67 per ordinary share—basic and $0.52 and $0.65 per ordinary share—diluted, for the three and six months ended June 30, 2025, respectively, compared to net income from continuing operations of $94.7 million and $133.6 million or $0.56 per and $0.79 ordinary share—basic and $0.55 and $0.78 per ordinary share—diluted, for the three and six months ended June 30, 2024, respectively.
The decreases in net income from continuing operations of $7.6 million and $24.0 million during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, respectively, were primarily due to decreases of $8.5 million and $52.3 million, respectively, in revenues, primarily related to lower manufacturing and royalty revenues, partially offset by increases in product sales, net. During the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, total expenses increased by $8.4 million and decreased by $5.9 million, respectively, and income tax provision decreased by $4.4 million and $9.2 million, respectively.
These items are discussed in greater detail later in the “Results of Operations” section in this “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q.
Products
Marketed Products
The key marketed products discussed below have generated, or are expected to generate, significant revenues for us. See the descriptions of the marketed products below and “Part I, Item 1A—Risk Factors” in our Annual Report and “Part II, Item 1A—Risk Factors” in this Form 10-Q for important factors that could adversely affect our marketed products. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for these marketed products.
24
The following provides summary information regarding our proprietary products that we commercialize:
Proprietary Products
Product |
|
Indication(s) |
|
|
Territory |
|
|
|
|
|
|
|
Initiation or re-initiation of ARISTADA for the treatment of Schizophrenia |
|
|
U.S. |
|
|
Schizophrenia
|
|
|
U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Schizophrenia; Bipolar I disorder
|
|
|
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alcohol dependence; Opioid dependence |
|
|
U.S. |
25
The following provides summary information regarding certain key third-party products using our proprietary technologies under license and our key licensed product, that are commercialized by our licensees:
Key Third-Party Products Using Our Proprietary Technologies
Product |
|
Indication(s) |
|
Licensee |
|
Licensed Territory |
|
|
|
|
|
|
|
INVEGA SUSTENNA / XEPLION |
|
INVEGA SUSTENNA: Schizophrenia; Schizoaffective disorder
XEPLION: Schizophrenia |
|
Janssen Pharmaceutica (together with Janssen Pharmaceuticals, Inc., Janssen International and their affiliates “Janssen”) |
|
Worldwide |
INVEGA TRINZA / TREVICTA |
|
Schizophrenia |
|
Janssen |
|
Worldwide |
INVEGA HAFYERA / BYANNLI |
|
Schizophrenia |
|
Janssen |
|
Worldwide |
Our Key Licensed Product
Product |
|
Indication(s) |
|
Licensee |
|
Licensed Territory |
|
|
|
|
|
|
|
VUMERITY |
|
Multiple sclerosis |
|
Biogen |
|
Worldwide |
Proprietary Products
We have developed and now commercialize products designed to help address the unmet needs of people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for our proprietary products.
ARISTADA and ARISTADA INITIO
ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S. for the treatment of schizophrenia. ARISTADA utilizes our proprietary LinkeRx technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is available in four dose strengths with once-monthly dosing options (441 mg, 662 mg and 882 mg), a six-week dosing option (882 mg) and a two-month dosing option (1064 mg). ARISTADA is packaged in a ready-to-use, pre-filled syringe product format. We exclusively manufacture and commercialize ARISTADA in the U.S.
In May 2025, U.S. Patent No. 12,311,027 relating to ARISTADA was granted. The patent has claims to pharmaceutical compositions that confer long-term stability of the ARISTADA formulation and methods of treating schizophrenia and expires in 2033.
ARISTADA INITIO (aripiprazole lauroxil) leverages our proprietary LinkeRx and NanoCrystal technologies and provides an extended-release formulation of aripiprazole lauroxil in a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and more rapid achievement of relevant levels of aripiprazole in the body. ARISTADA INITIO, combined with a single 30 mg dose of oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. The first ARISTADA dose may be administered on the same day as the ARISTADA INITIO regimen or up to 10 days thereafter. We exclusively manufacture and commercialize ARISTADA INITIO in the U.S.
26
LYBALVI
LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine. We exclusively manufacture and commercialize LYBALVI in the U.S.
VIVITROL
VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved in the U.S. for the treatment of alcohol dependence in patients able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL and for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses our polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. We exclusively manufacture and commercialize VIVITROL in the U.S.
Products Using Our Proprietary Technologies and Licensed Product
We have licensed products to third parties for commercialization and have licensed our proprietary technologies to third parties to enable them to develop, commercialize and/or manufacture products. See the “Proprietary Technology Platforms” and “Patents and Proprietary Rights” sections in “Part I, Item 1—Business” in our Annual Report for information with respect to our proprietary technologies and the IP protection for these products. We receive royalties and/or manufacturing and other revenues from the commercialization of these products under our collaborative arrangements with these third parties. Such arrangements, among others, include the following:
Products Using Our Proprietary Technologies
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
The long-acting INVEGA products are long-acting atypical antipsychotics owned and commercialized worldwide by Janssen. We believe that these products incorporate our technologies.
INVEGA SUSTENNA is approved in the U.S. for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a monotherapy or adjunctive therapy. Paliperidone palmitate extended-release injectable suspension is approved in the European Union (“EU”) and other countries outside of the U.S. for the treatment of schizophrenia and is marketed and sold under the trade name XEPLION. INVEGA SUSTENNA/XEPLION is manufactured by Janssen.
INVEGA TRINZA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA SUSTENNA for at least four months. TREVICTA is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION. INVEGA TRINZA/TREVICTA is manufactured by Janssen.
INVEGA HAFYERA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA SUSTENNA for at least four months or INVEGA TRINZA for at least three months. BYANNLI is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION or TREVICTA. INVEGA HAFYERA/BYANNLI is manufactured by Janssen.
For a discussion of legal proceedings related to certain of the patents covering INVEGA TRINZA, see Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
27
Licensed Product
VUMERITY
VUMERITY (diroximel fumarate) is a novel, oral fumarate with a distinct chemical structure that is approved in the U.S., the EU and several other countries for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Under our license and collaboration agreement with Biogen, Biogen holds the exclusive, worldwide license to develop and commercialize VUMERITY. For more information about the license and collaboration agreement with Biogen, see the “Collaborative Arrangements—Biogen” section in “Part I, Item 1—Business” in our Annual Report. For a discussion of legal proceedings related to certain of the patents covering VUMERITY, see Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
Key Development Program
Our R&D is focused on the development of innovative medicines in the field of neuroscience that are designed to address unmet patient needs. As part of our ongoing R&D efforts, we have devoted, and will continue to devote, significant resources to conducting preclinical work and clinical studies to advance the development of new pharmaceutical products. The discussion below highlights our current key development program. Drug development involves a high degree of risk and investment, and the status, timing and scope of our development programs are subject to change. Important factors that could adversely affect our drug development efforts are discussed in “Part I, Item 1A—Risk Factors” in our Annual Report and “Part II, Item 1A—Risk Factors” in this Form 10-Q. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for our key development program.
Alixorexton (formerly referred to as ALKS 2680)
Alixorexton is a novel, investigational, oral, selective orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy type 1 (“NT1”), narcolepsy type 2 (“NT2”) and idiopathic hypersomnia (“IH”). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH and is currently being evaluated in the phase 2 Vibrance-1, Vibrance-2 and Vibrance-3 studies in patients with NT1, NT2 and IH, respectively. In July 2025, we announced that alixorexton achieved the primary endpoint in the Vibrance-1 study in patients with NT1 and that we are proceeding with plans for initiation of a phase 3 program in narcolepsy.
28
Results of Operations
Product Sales, Net
Our product sales, net, consist of sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. The following table presents the adjustments deducted from product sales, gross to arrive at product sales, net, for sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI during the three and six months ended June 30, 2025 and 2024:
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
||||||||||||||||||||||||||||
|
June 30, |
|
|
|
June 30, |
|
|
||||||||||||||||||||||||||||
(In millions, except for % of Sales) |
2025 |
|
|
% of Sales |
|
|
|
2024 |
|
|
% of Sales |
|
|
|
2025 |
|
|
% of Sales |
|
|
|
2024 |
|
|
% of Sales |
|
|
||||||||
Product sales, gross |
$ |
564.8 |
|
|
|
100.0 |
|
% |
|
$ |
533.0 |
|
|
|
100.0 |
|
% |
|
$ |
1,037.6 |
|
|
|
100.0 |
|
% |
|
$ |
1,000.3 |
|
|
|
100.0 |
|
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Medicaid rebates |
|
(105.2 |
) |
|
|
(18.6 |
) |
% |
|
|
(122.6 |
) |
|
|
(23.0 |
) |
% |
|
|
(199.5 |
) |
|
|
(19.2 |
) |
% |
|
|
(227.6 |
) |
|
|
(22.8 |
) |
% |
Chargebacks |
|
(64.4 |
) |
|
|
(11.4 |
) |
% |
|
|
(56.5 |
) |
|
|
(10.6 |
) |
% |
|
|
(118.3 |
) |
|
|
(11.4 |
) |
% |
|
|
(107.0 |
) |
|
|
(10.7 |
) |
% |
Product discounts |
|
(41.4 |
) |
|
|
(7.3 |
) |
% |
|
|
(38.4 |
) |
|
|
(7.2 |
) |
% |
|
|
(78.7 |
) |
|
|
(7.6 |
) |
% |
|
|
(72.7 |
) |
|
|
(7.3 |
) |
% |
Medicare Part D |
|
(20.5 |
) |
|
|
(3.7 |
) |
% |
|
|
(21.5 |
) |
|
|
(4.0 |
) |
% |
|
|
(38.2 |
) |
|
|
(3.7 |
) |
% |
|
|
(38.9 |
) |
|
|
(3.9 |
) |
% |
Other |
|
(26.1 |
) |
|
|
(4.6 |
) |
% |
|
|
(24.7 |
) |
|
|
(4.6 |
) |
% |
|
|
(51.2 |
) |
|
|
(4.9 |
) |
% |
|
|
(51.3 |
) |
|
|
(5.1 |
) |
% |
Total adjustments |
|
(257.6 |
) |
|
|
(45.6 |
) |
% |
|
|
(263.7 |
) |
|
|
(49.5 |
) |
% |
|
|
(485.9 |
) |
|
|
(46.8 |
) |
% |
|
|
(497.5 |
) |
|
|
(49.8 |
) |
% |
Product sales, net |
$ |
307.2 |
|
|
|
54.4 |
|
% |
|
$ |
269.3 |
|
|
|
50.5 |
|
% |
|
$ |
551.7 |
|
|
|
53.2 |
|
% |
|
$ |
502.8 |
|
|
|
50.2 |
|
% |
The increase in product sales, gross during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was due to increases of 14% and 2% in the number of units sold for LYBALVI and ARISTADA/ARISTADA INITIO, respectively, and a 3% price increase for each of our proprietary products that went into effect on January 1, 2025. These increases were partially offset by a 1% decrease in the number of units sold for VIVITROL.
The increase in product sales, gross during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a 17% increase in the number of LYBALVI units sold and the 3% price increase for each of our proprietary products that went into effect on January 1, 2025. These increases were partially offset by 3% decreases in the number of units sold for each of VIVITROL and ARISTADA/ARISTADA INITIO.
The decreases in Medicaid rebates, as a percentage of sales, during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to actual Medicaid rebates related to VIVITROL and ARISTADA/ARISTADA INITIO, which were lower than original estimates by approximately $9.0 million and $17.7 million for VIVITROL during the three and six months ended June 30, 2025, respectively, and by approximately $7.2 million for ARISTADA/ARISTADA INITIO during the three months ended June 30, 2025.
The following table compares product sales, net earned during the three and six months ended June 30, 2025 and 2024:
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
VIVITROL |
$ |
121.7 |
|
|
$ |
111.9 |
|
|
$ |
9.8 |
|
|
$ |
222.7 |
|
|
$ |
209.5 |
|
|
$ |
13.2 |
|
ARISTADA and ARISTADA INITIO |
|
101.3 |
|
|
|
86.0 |
|
|
|
15.3 |
|
|
|
174.8 |
|
|
|
164.9 |
|
|
|
9.9 |
|
LYBALVI |
|
84.3 |
|
|
|
71.4 |
|
|
|
12.9 |
|
|
|
154.3 |
|
|
|
128.4 |
|
|
|
25.9 |
|
Product sales, net |
$ |
307.2 |
|
|
$ |
269.3 |
|
|
$ |
38.0 |
|
|
$ |
551.7 |
|
|
$ |
502.8 |
|
|
$ |
49.0 |
|
29
Manufacturing and Royalty Revenues
The following table compares manufacturing and royalty revenues earned during the three and six months ended June 30, 2025 and 2024:
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
Manufacturing and royalty revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Long-acting INVEGA products |
$ |
30.3 |
|
|
$ |
78.7 |
|
|
$ |
(48.4 |
) |
|
$ |
48.1 |
|
|
$ |
141.4 |
|
|
$ |
(93.3 |
) |
VUMERITY |
|
39.4 |
|
|
|
35.2 |
|
|
|
4.2 |
|
|
|
67.2 |
|
|
|
66.5 |
|
|
|
0.7 |
|
RISPERDAL CONSTA |
|
3.8 |
|
|
|
3.6 |
|
|
|
0.2 |
|
|
|
12.9 |
|
|
|
6.3 |
|
|
|
6.6 |
|
Other |
|
9.9 |
|
|
|
12.4 |
|
|
|
(2.5 |
) |
|
|
17.2 |
|
|
|
32.5 |
|
|
|
(15.3 |
) |
Manufacturing and royalty revenues |
$ |
83.4 |
|
|
$ |
129.9 |
|
|
$ |
(46.5 |
) |
|
$ |
145.4 |
|
|
$ |
246.7 |
|
|
$ |
(101.3 |
) |
The decreases in royalty revenues related to the long-acting INVEGA products during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to the expiration of our royalty on net sales of INVEGA SUSTENNA in the U.S. in August 2024. We expect royalty revenues from net sales of the long-acting INVEGA products to continue to be lower for the remainder of 2025, as the royalty revenues related to net sales of INVEGA SUSTENNA in the U.S. comprised a significant portion of the overall royalty revenues for the long-acting INVEGA products. In addition, each of INVEGA SUSTENNA and INVEGA TRINZA is currently subject to Paragraph IV litigation in response to companies seeking to market generic versions of such product. Increased competition from new products or generic versions of any one or more of the long-acting INVEGA products may lead to reduced unit sales of the long-acting INVEGA products, including those not yet genericized, and increased pricing pressure. For a discussion of the legal proceedings related to INVEGA TRINZA, see Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to these legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report, and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
The increases in VUMERITY revenue during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were due to increases of $6.6 million and $9.4 million, respectively, in royalty revenue, offset by decreases of $2.5 million and $8.6 million, respectively, in manufacturing revenue. The increases in VUMERITY royalty revenue were primarily due to increases in end-market sales of the product. The decreases in VUMERITY manufacturing revenue were primarily due to reductions in the number of batches manufactured for sale to Biogen. The increase in RISPERDAL CONSTA revenue during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was due to a $6.9 million increase in manufacturing revenue, primarily due to an increase in the number of batches made available to Janssen for sale in the U.S., which has a higher selling price than product sold outside of the U.S. The decreases in Other manufacturing and royalty revenue during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to decreases of $3.1 million and $13.6 million, respectively, in revenue from FAMPYRA, as our manufacturing obligations for FAMPYRA concluded on December 31, 2024.
Costs and Expenses
Cost of Goods Manufactured and Sold
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
Cost of goods manufactured and sold |
$ |
49.5 |
|
|
$ |
61.5 |
|
|
$ |
(12.0 |
) |
|
$ |
98.7 |
|
|
$ |
120.1 |
|
|
$ |
(21.4 |
) |
The decreases in the cost of goods manufactured and sold during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily related to decreases of $13.7 million and $20.7 million, respectively, in the cost of goods manufactured for certain legacy products following the sale of the Athlone Facility in May 2024 and decreases in the cost of goods sold for VIVITROL during each period due to decreases in the number of units sold, as discussed above. These decreases were partially offset by increases in the cost of goods sold for LYBALVI due to increases in the number of units sold in each period, as discussed above.
30
Research and Development Expenses
For each of our R&D programs, we incur both external and internal expenses. External R&D expenses include fees for clinical and preclinical activities performed by contract research organizations, consulting fees, and costs related to laboratory services, the purchase of drug product materials and third-party manufacturing development activities. Internal R&D expenses include employee-related expenses, occupancy costs, depreciation and general overhead. We track external R&D expenses for each of our development programs; however, internal R&D expenses are not tracked by individual program as they can benefit multiple development programs or our products or technologies in general.
The following table sets forth our external R&D expenses for the three and six months ended June 30, 2025 and 2024 relating to our then-current development programs and our internal R&D expenses, listed by the nature of such expenses:
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
External R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Development programs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Alixorexton |
|
$ |
23.8 |
|
|
$ |
12.5 |
|
|
$ |
11.3 |
|
|
$ |
41.6 |
|
|
$ |
23.0 |
|
|
$ |
18.6 |
|
LYBALVI |
|
|
5.0 |
|
|
|
3.8 |
|
|
|
1.2 |
|
|
|
8.9 |
|
|
|
8.8 |
|
|
|
0.1 |
|
Other external R&D expenses |
|
|
10.6 |
|
|
|
10.0 |
|
|
|
0.6 |
|
|
|
21.6 |
|
|
|
18.8 |
|
|
|
2.8 |
|
Total external R&D expenses |
|
|
39.4 |
|
|
|
26.3 |
|
|
|
13.1 |
|
|
|
72.1 |
|
|
|
50.6 |
|
|
|
21.5 |
|
Internal R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Employee-related |
|
|
30.6 |
|
|
|
26.3 |
|
|
|
4.3 |
|
|
|
62.0 |
|
|
|
60.8 |
|
|
|
1.2 |
|
Occupancy |
|
|
3.3 |
|
|
|
2.8 |
|
|
|
0.5 |
|
|
|
6.4 |
|
|
|
5.8 |
|
|
|
0.6 |
|
Depreciation |
|
|
1.5 |
|
|
|
1.4 |
|
|
|
0.1 |
|
|
|
2.9 |
|
|
|
2.8 |
|
|
|
0.1 |
|
Other |
|
|
2.6 |
|
|
|
2.8 |
|
|
|
(0.2 |
) |
|
|
5.8 |
|
|
|
7.3 |
|
|
|
(1.5 |
) |
Total internal R&D expenses |
|
|
38.0 |
|
|
|
33.3 |
|
|
|
4.7 |
|
|
|
77.1 |
|
|
|
76.7 |
|
|
|
0.4 |
|
Research and development expenses |
|
$ |
77.4 |
|
|
$ |
59.6 |
|
|
$ |
17.8 |
|
|
$ |
149.2 |
|
|
$ |
127.3 |
|
|
$ |
21.9 |
|
These amounts are not necessarily predictive of future R&D expenses. In an effort to allocate our spending most effectively, we continually evaluate our products under development based on the performance of such products in preclinical and/or clinical trials, our expectations regarding the likelihood of their regulatory approval and our view of their future potential commercial viability, among other factors.
The increases in expenses related to alixorexton during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to increased spend related to the advancement of the development program for the product, including initiation of our Vibrance-3 phase 2 clinical study and costs related to our long-term extension study for the product, partially offset by the completion of our first-in-human phase 1 clinical study for the product in the first half of 2024. The increase in expenses related to LYBALVI during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was primarily due to increased spend on our pediatric program related to the product. The increase in other external R&D expenses during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to activities associated with our preclinical development programs. The increases in employee-related expenses during the three and six months ended June 30, 2025, as compared to the three and six months ended June 30, 2024, were primarily due to increases in labor and benefits expense related to a 10% increase in R&D-related headcount. The increase in employee-related expenses during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was partially offset by a decrease in share-based compensation expense.
31
Selling, General and Administrative Expense
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
Selling and marketing expense |
|
$ |
121.2 |
|
|
$ |
119.7 |
|
|
$ |
1.5 |
|
|
$ |
244.1 |
|
|
$ |
245.3 |
|
|
$ |
(1.2 |
) |
General and administrative expense |
|
|
49.6 |
|
|
|
48.4 |
|
|
|
1.2 |
|
|
|
98.5 |
|
|
|
102.6 |
|
|
|
(4.1 |
) |
Selling, general and administrative expense |
|
$ |
170.8 |
|
|
$ |
168.1 |
|
|
$ |
2.7 |
|
|
$ |
342.6 |
|
|
$ |
347.9 |
|
|
$ |
(5.3 |
) |
The increase in selling and marketing expense during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was primarily due to an increase of $10.4 million in employee-related expenses, primarily due to a 13% increase in sales and marketing-related headcount, partially offset by a decrease of $8.9 million in marketing spend, primarily related to decreases in media spend for our proprietary products.
The decrease in selling and marketing expense during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a decrease of $13.3 million in in marketing spend, primarily related to decreases in media spend for our proprietary products, partially offset by an increase of $12.1 million in employee-related expenses, primarily due to the increase in sales and marketing-related headcount noted above.
The increase in general and administrative expense during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, was primarily due to an increase of $2.0 million in employee-related expenses, primarily due to a 6% increase in general and administrative-related headcount and an increase of $1.0 million in professional services fees, primarily related to an increase in legal expenses. These increases were offset by a decrease of $1.4 million related to branded prescription drug fees.
The decrease in general and administrative expense during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, was primarily due to a decrease of $1.4 million related to branded prescription drug fees, a decrease of $1.2 million in professional service fees and a decrease of $0.7 million in share-based compensation expense. The decrease in professional service fees was primarily related to the timing of legal expenses. The decrease in share-based compensation expense was partially offset by a $1.1 million increase in salary expense, primarily due to the increase in general and administrative-related headcount noted above.
Other Income, Net
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
Interest income |
|
$ |
11.1 |
|
|
$ |
10.7 |
|
|
$ |
0.4 |
|
|
$ |
21.2 |
|
|
$ |
20.1 |
|
|
$ |
1.1 |
|
Interest expense |
|
|
— |
|
|
|
(5.9 |
) |
|
|
5.9 |
|
|
|
— |
|
|
|
(11.9 |
) |
|
|
11.9 |
|
Other income, net |
|
|
0.8 |
|
|
|
2.0 |
|
|
|
(1.2 |
) |
|
|
2.4 |
|
|
|
2.2 |
|
|
|
0.2 |
|
Total other income, net |
|
$ |
11.9 |
|
|
$ |
6.8 |
|
|
$ |
5.1 |
|
|
$ |
23.6 |
|
|
$ |
10.4 |
|
|
$ |
13.2 |
|
Interest income consists of interest earned on our cash and available-for-sale investments. Interest expense consists of interest incurred on our previously outstanding term loans (the “Former Term Loans”) that were scheduled to become due in 2026 under our former amended and restated credit agreement, which we prepaid in full and terminated in December 2024. See Note 12, Long-Term Debt in the “Notes to Consolidated Financial Statements” accompanying our Annual Report for additional information regarding our Former Term Loans.
Income Tax Provision
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
Income tax provision |
|
|
17.7 |
|
|
|
22.1 |
|
|
$ |
(4.4 |
) |
|
$ |
20.8 |
|
|
$ |
30.0 |
|
|
$ |
(9.2 |
) |
The income tax provisions in each of the three and six months ended June 30, 2025 and 2024 were primarily attributable to taxes on income earned in Ireland.
32
Liquidity and Financial Condition
Our financial condition is summarized as follows:
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||||||||||||||||||
(In millions) |
|
U.S. |
|
|
Ireland |
|
|
Total |
|
|
U.S. |
|
|
Ireland |
|
|
Total |
|
||||||
Cash and cash equivalents |
|
$ |
106.4 |
|
|
$ |
414.8 |
|
|
$ |
521.2 |
|
|
$ |
70.3 |
|
|
$ |
220.8 |
|
|
$ |
291.1 |
|
Investments—short-term |
|
|
204.4 |
|
|
|
290.1 |
|
|
|
494.5 |
|
|
|
203.6 |
|
|
|
256.9 |
|
|
|
460.5 |
|
Investments—long-term |
|
|
18.3 |
|
|
|
20.0 |
|
|
|
38.3 |
|
|
|
24.6 |
|
|
|
48.5 |
|
|
|
73.1 |
|
Total cash and investments |
|
$ |
329.1 |
|
|
$ |
724.9 |
|
|
$ |
1,054.0 |
|
|
$ |
298.5 |
|
|
$ |
526.2 |
|
|
$ |
824.7 |
|
At June 30, 2025 our investments consisted of the following:
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
||||||||
|
|
Amortized |
|
|
Unrealized |
|
|
Allowance for |
|
|
Estimated |
|
||||||||
(In millions) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Credit Losses |
|
|
Fair Value |
|
|||||
Investments—short-term available-for-sale |
|
$ |
492.6 |
|
|
$ |
1.9 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
494.5 |
|
Investments—long-term available-for-sale |
|
|
38.3 |
|
|
|
— |
|
|
|
(0.1 |
) |
|
|
— |
|
|
|
38.2 |
|
Investments—long-term held-to-maturity |
|
|
0.1 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
0.1 |
|
Total |
|
$ |
531.0 |
|
|
$ |
1.9 |
|
|
$ |
(0.1 |
) |
|
$ |
— |
|
|
$ |
532.8 |
|
Sources and Uses of Cash
We generated $249.0 million and $167.1 million of cash from operating activities during the six months ended June 30, 2025 and 2024, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, including capital expenditures, for not less than twelve months following the date from which our financial statements were issued. Subject to market conditions, interest rates and other factors, we may pursue opportunities to obtain financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures.
Our investment objectives are, first, to preserve liquidity and conserve capital and, second, to generate investment income. We mitigate credit risk in our cash reserves by maintaining a well-diversified portfolio that limits the amount of investment exposure as to institution, maturity and investment type. Our available-for-sale investments consist primarily of short and long-term U.S. government and agency debt securities and corporate debt securities. Our held-to-maturity investments consist of investments that are held as collateral under certain letters of credit related to certain of our lease agreements.
We classify available-for-sale investments in an unrealized loss position that do not mature within 12 months as long-term investments. We have the intent and ability to hold these investments until recovery, which may be at maturity, and it is more-likely-than-not that we would not be required to sell these securities before recovery of their amortized cost.
We have no off-balance sheet arrangements that are reasonably likely to have a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources in the next 12 months.
33
Information about our cash flows, by category, is presented in the accompanying condensed consolidated statements of cash flows. The discussion of our cash flows that follows does not include the impact of any adjustments to remove discontinued operations and is stated on a total company consolidated basis. The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:
|
|
Six Months Ended |
|
|||||
|
|
June 30, |
|
|||||
(In millions) |
|
2025 |
|
|
2024 |
|
||
Cash and cash equivalents, beginning of period |
|
$ |
291.1 |
|
|
$ |
457.5 |
|
Cash flows provided by operating activities |
|
|
249.0 |
|
|
|
167.1 |
|
Cash flows (used in) provided by investing activities |
|
|
(20.1 |
) |
|
|
12.0 |
|
Cash flows provided by (used in) financing activities |
|
|
1.2 |
|
|
|
(101.4 |
) |
Cash and cash equivalents, end of period |
|
$ |
521.2 |
|
|
$ |
535.2 |
|
Operating Activities
Cash flows provided by operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting our net income for non-cash operating items such as depreciation, amortization and share-based compensation and changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in our results of operations.
Cash flows provided by operating activities for the six months ended June 30, 2025 primarily consisted of $109.6 million of net income, adjusted for non-cash items, including $47.8 million of share-based compensation, $15.2 million of depreciation and amortization and changes of $74.1 million in working capital.
Cash flows provided by operating activities for the six months ended June 30, 2024 primarily consisted of $128.2 million of net income, adjusted for non-cash items, including $53.4 million of share-based compensation, $14.7 million of depreciation and amortization, $21.7 million of deferred income taxes and a gain of $1.5 million on the sale of the Athlone Facility, partially offset by changes of $51.5 million in working capital.
Investing Activities
Cash flows used in investing activities for the six months ended June 30, 2025 were primarily due to the purchase of $23.1 million of property, plant and equipment, partially offset by $1.3 million in net sales of investments. Cash flows provided by investing activities for the six months ended June 30, 2024 were primarily due to proceeds of approximately $97.9 million related to the sale of the Athlone Facility, which included a payment of approximately $91.0 million for the facility and certain related assets, partially offset by $71.0 million in net purchase of investments and the purchase of $15.5 million of property, plant and equipment.
Financing Activities
Cash flows provided by financing activities for the six months ended June 30, 2025 were due to $31.6 million of cash that we received upon exercises of employee stock options, offset by $30.4 million of employee taxes paid related to the net share settlement of equity awards. Cash flows used in financing activities for the six months ended June 30, 2024 primarily related to $84.7 million used to repurchase our ordinary shares under the Repurchase Program and $29.0 million of employee taxes paid related to the net share settlement of equity awards, partially offset by $13.8 million of cash that we received upon exercises of employee stock options.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates under different conditions or using different assumptions.
See the “Critical Accounting Estimates” section in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report for a discussion of our critical accounting estimates.
34
New Accounting Standards
See the “New Accounting Pronouncements” section in Note 2, Summary of Significant Accounting Policies in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for discussion of certain recent accounting standards applicable to us.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Market risks related to our investment portfolio, and the ways we manage such risks, are summarized in “Part II, Item 7A—Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report. We regularly review our marketable securities holdings and shift our investment holdings to those that best meet our investment objectives, which are to preserve capital, provide sufficient liquidity to satisfy operating requirements and generate investment income. Apart from such adjustments to our investment portfolio, there have been no material changes to our market risks since December 31, 2024, and we do not anticipate any near-term changes in the nature of our market risk exposures or in our management’s objectives and strategies with respect to managing such exposures.
We are exposed to non-U.S. currency exchange risk related primarily to royalty revenues that we receive on certain of our products, partially offset by certain operating costs arising from expenses and payables in connection with our Irish operations that are settled predominantly in euro. These non-U.S. currency exchange rate risks are summarized in “Part II, Item 7A—Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report. There has been no material change in our assessment of our sensitivity to non-U.S. currency exchange rate risk since December 31, 2024.
Item 4. Controls and Procedures
a) Evaluation of Disclosure Controls and Procedures
Our management has evaluated, with the participation of our principal executive officer and interim principal financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2025. Based upon that evaluation, our principal executive officer and interim principal financial officer each concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to provide reasonable assurance that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and interim principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
b) Change in Internal Control Over Financial Reporting
During the three months ended June 30, 2025, there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
35
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
For information regarding legal proceedings, see the discussion of legal proceedings in Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, which discussion is incorporated into this Part II, Item 1 by reference.
Item 1A. Risk Factors
The below risk factor should be read in conjunction with the risk factors disclosed in “Part I, Item 1A—Risk Factors” of our Annual Report.
Changes in global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, could have an adverse effect on our business, results of operations, or financial condition.
As a global biopharmaceutical company, changes in and uncertainties from global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, may have an adverse effect on us. For example, in April 2025, the U.S. government announced the imposition of a baseline 10% tariff on imports from virtually all countries and additional customized tariffs on certain imports (including country-specific and product-specific tariffs), following its imposition of a 25% tariff on certain imports from Mexico and Canada earlier in 2025. In response, certain countries have imposed, or announced intentions to impose, tariffs on U.S. imports. Although some of these tariffs are temporarily paused, their impact has already been seen, and we expect will continue to be seen, in global markets. Our proprietary products are manufactured at our manufacturing facility in the U.S. and are sold exclusively in the U.S.; however, certain materials in our supply chain are sourced internationally and certain of the third-party products from which we derive revenue are manufactured outside the U.S. Our related costs, revenues and/or profits may be impacted to varying degrees by recent or future changes in global trade or other policies. In addition, the recent changes, tensions and uncertainties related to global trade policies have caused, and may continue to cause, significant volatility in global markets, including the market for our ordinary shares. The price of our ordinary shares has fluctuated significantly, and may continue to fluctuate, as a result of these and similar developments. The U.S. government has also indicated that it may impose a supplemental tariff on all pharmaceutical imports or take additional actions in respect of pharmaceutical companies incorporated outside of the U.S., which has caused, and may continue to cause, uncertainty as to the extent of the impacts of changes in global trade on the pharmaceutical industry as a whole and on our business. Additional changes to the policies of the U.S. or other nations that affect the geopolitical landscape or global trade, economic or market conditions, and other direct or indirect impacts of such policies, are uncertain and unpredictable, and could, in the future, have a material adverse effect on our business, results of operations, or financial condition and the market price of our ordinary shares.
36
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table summarizes purchases of our ordinary shares made by or on behalf of us or any of our affiliated purchasers, as defined in Rule 10b-18(a)(3) under the Exchange Act, during the three months ended June 30, 2025:
Period |
|
Total Number of Ordinary Shares Purchased |
|
|
Average Price Paid per Ordinary Share |
|
|
Total Number of Ordinary Shares Purchased as Part of Publicly Announced Program |
|
|
Approximate Dollar Value (in millions) of Ordinary Shares that May Yet Be Purchased Under the Program |
|
||||
April 1, 2025 – April 30, 2025 |
|
|
21,598 |
|
|
$ |
28.12 |
|
|
|
— |
|
|
$ |
200.0 |
|
May 1, 2025 – May 31, 2025 |
|
|
30,590 |
|
|
|
30.59 |
|
|
|
— |
|
|
|
200.0 |
|
June 1, 2025 – June 30, 2025 |
|
|
4,269 |
|
|
|
31.52 |
|
|
|
— |
|
|
|
200.0 |
|
Totals |
|
|
56,457 |
|
|
$ |
29.72 |
|
|
|
— |
|
|
|
|
Item 5. Other Information
During the three months ended June 30, 2025, the following contracts, instructions or written plans for the purchase or sale of the Company’s securities that are or were intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act (each, a “Rule 10b5-1 plan”) were adopted by the officers (as defined in Rule 16a-1(f) under the Exchange Act) and directors of the Company: on
37
Item 6. Exhibits
The following exhibits are filed or furnished as part of this Form 10-Q:
EXHIBIT INDEX
Exhibit No. |
|
Description of Exhibit |
10.1 |
|
Alkermes plc 2018 Stock Option and Incentive Plan, as amended (incorporated by reference from Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299) filed on May 21, 2025. |
31.1 # |
|
Rule 13a-14(a)/15d-14(a) Certification. |
31.2 # |
|
Rule 13a-14(a)/15d-14(a) Certification. |
32.1 |
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.SCH # |
|
Inline XBRL Taxonomy Extension Schema Document with Embedded Linkbase Documents. |
104 # |
|
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibit 101). |
# Filed herewith.
Furnished herewith.
Indicates a management contract or any compensatory plan, contract or arrangement.
38
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
ALKERMES PLC |
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/ Richard F. Pops |
|
|
|
Richard F. Pops |
|
|
|
Chairman and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|||
|
|
|
|
|
By: |
/s/ Blair C. Jackson |
|
|
|
Blair C. Jackson |
|
|
|
Executive Vice President, Chief Operating Officer |
|
|
|
(Interim Principal Financial Officer) |
|
Date: July 29, 2025 |
|
|
|
39