[10-Q] Lantheus Holdings, Inc Quarterly Earnings Report
Lantheus (LNTH) Q2-25 10-Q highlights:
- Revenue slipped 4% YoY to $378.0 M as PYLARIFY sales moderated (-8%) and TechneLite continued to decline ahead of the planned SPECT divestiture. Six-month revenue down 2% to $750.8 M.
- Gross margin held at 64% (241.0/378.0). Opex flat YoY; R&D down 25% as AZEDRA spend ended. Operating income fell 14% to $88.0 M, but lower unrealised equity losses and higher interest income lifted net income 27% to $78.8 M (dil. EPS $1.12).
- Six-month net income dropped 22% to $151.7 M as Q1 faced a sharp mark-to-market equity loss.
- Cash flow from ops was a solid $194.7 M, offset by $296.2 M investing cash outflow, chiefly the $269 M acquisition of radiotherapeutics CDMO Evergreen Theragnostics. Cash & equivalents fell to $695.6 M; net cash still ~>$120 M versus $575 M 2.625% converts.
- Balance sheet adds $116.2 M Evergreen goodwill and $215 M IPR&D; fair-valued contingent consideration booked at $43.0 M.
- SPECT business classified as held-for-sale (assets $73.4 M, liabilities $29.8 M) under agreement with SHINE; no impairment recorded.
- Shareholder returns: repurchased 1.3 M shares for $100 M in Q2; $200 M total under $250 M 2024 program. 68.0 M basic shares outstanding (-2% YoY).
- Leverage covenants remain comfortable (net leverage 0.6×); no borrowings under $750 M revolver.
Outlook: While topline softness persists near term, the Evergreen acquisition broadens manufacturing capacity and adds Octevy & CDMO revenue options; SPECT sale will further concentrate on high-growth PET oncology and diagnostics franchise.
Lantheus (LNTH) evidenze del 10-Q del secondo trimestre 2025:
- I ricavi sono diminuiti del 4% su base annua, attestandosi a 378,0 milioni di dollari, a causa della moderazione delle vendite di PYLARIFY (-8%) e del continuo calo di TechneLite in vista della prevista cessione di SPECT. I ricavi semestrali sono scesi del 2% a 750,8 milioni di dollari.
- Il margine lordo si è mantenuto al 64% (241,0/378,0). Le spese operative sono rimaste stabili rispetto all'anno precedente; la R&S è diminuita del 25% con la conclusione delle spese per AZEDRA. L'utile operativo è calato del 14% a 88,0 milioni di dollari, ma minori perdite non realizzate su partecipazioni e maggiori proventi da interessi hanno portato a un utile netto in crescita del 27% a 78,8 milioni di dollari (utile diluito per azione di 1,12 dollari).
- L’utile netto semestrale è sceso del 22% a 151,7 milioni di dollari, a causa di una significativa perdita di valutazione di mercato su partecipazioni nel primo trimestre.
- Il flusso di cassa operativo è stato solido, pari a 194,7 milioni di dollari, compensato da un deflusso di cassa per investimenti di 296,2 milioni di dollari, principalmente per l’acquisizione da 269 milioni di dollari del CDMO di radioterapici Evergreen Theragnostics. La liquidità e equivalenti sono scesi a 695,6 milioni di dollari; la posizione finanziaria netta rimane positiva, superiore a 120 milioni di dollari rispetto ai 575 milioni di dollari dei convertibili al 2,625%.
- Lo stato patrimoniale include un avviamento di 116,2 milioni di dollari relativo a Evergreen e 215 milioni di dollari per IPR&D; è stata contabilizzata una passività condizionata a fair value per 43,0 milioni di dollari.
- Il business SPECT è stato classificato come disponibile per la vendita (attività 73,4 milioni di dollari, passività 29,8 milioni di dollari) in base all’accordo con SHINE; non sono state registrate svalutazioni.
- Ritorni per gli azionisti: nel secondo trimestre sono state riacquistate 1,3 milioni di azioni per 100 milioni di dollari; 200 milioni di dollari totali nell’ambito del programma 2024 da 250 milioni. Azioni ordinarie in circolazione 68,0 milioni (-2% su base annua).
- I covenant di leva finanziaria restano confortevoli (leva netta 0,6×); nessun utilizzo del revolving da 750 milioni di dollari.
Prospettive: Nonostante la debolezza a breve termine dei ricavi, l’acquisizione di Evergreen amplia la capacità produttiva e aggiunge nuove fonti di ricavi da Octevy e CDMO; la vendita di SPECT consentirà di concentrare maggiormente l’attenzione sul portafoglio in rapida crescita di oncologia e diagnostica PET.
Aspectos destacados del 10-Q del segundo trimestre de 2025 de Lantheus (LNTH):
- Los ingresos cayeron un 4% interanual hasta 378,0 millones de dólares debido a la moderación en las ventas de PYLARIFY (-8%) y la continua disminución de TechneLite antes de la prevista desinversión de SPECT. Los ingresos semestrales bajaron un 2% hasta 750,8 millones de dólares.
- El margen bruto se mantuvo en 64% (241,0/378,0). Los gastos operativos se mantuvieron planos año tras año; I+D bajó un 25% tras finalizar el gasto en AZEDRA. El ingreso operativo cayó un 14% hasta 88,0 millones de dólares, pero menores pérdidas no realizadas en acciones y mayores ingresos por intereses impulsaron el ingreso neto un 27% hasta 78,8 millones de dólares (EPS diluido de 1,12 dólares).
- El ingreso neto semestral disminuyó un 22% hasta 151,7 millones de dólares debido a una fuerte pérdida por valoración de mercado en el primer trimestre.
- El flujo de caja operativo fue sólido, con 194,7 millones de dólares, compensado por un flujo de caja de inversión negativo de 296,2 millones de dólares, principalmente por la adquisición de 269 millones de dólares del CDMO de radioterapéuticos Evergreen Theragnostics. El efectivo y equivalentes disminuyeron a 695,6 millones de dólares; el efectivo neto sigue siendo positivo, alrededor de más de 120 millones de dólares frente a los 575 millones de dólares en convertibles al 2,625%.
- El balance incorpora un goodwill de 116,2 millones de dólares por Evergreen y 215 millones de dólares en I+D interna; se registró una contraprestación contingente valorada a valor razonable de 43,0 millones de dólares.
- El negocio SPECT se clasificó como mantenido para la venta (activos 73,4 millones de dólares, pasivos 29,8 millones de dólares) bajo acuerdo con SHINE; no se registraron deterioros.
- Retornos para accionistas: se recompraron 1,3 millones de acciones por 100 millones de dólares en el segundo trimestre; 200 millones en total bajo el programa 2024 de 250 millones. Acciones básicas en circulación 68,0 millones (-2% interanual).
- Los convenios de apalancamiento permanecen cómodos (apalancamiento neto 0,6×); no se han tomado préstamos bajo la línea revolvente de 750 millones.
Perspectivas: Aunque la debilidad en los ingresos persiste a corto plazo, la adquisición de Evergreen amplía la capacidad de fabricación y añade opciones de ingresos de Octevy y CDMO; la venta de SPECT permitirá enfocarse más en la franquicia de oncología y diagnóstico PET de alto crecimiento.
Lantheus (LNTH) 2025년 2분기 10-Q 주요 내용:
- 수익은 전년 대비 4% 감소한 3억 7,800만 달러로, PYLARIFY 매출이 8% 감소하고 TechneLite가 예정된 SPECT 매각을 앞두고 계속 하락함에 따라 감소했습니다. 6개월 누적 수익은 2% 감소한 7억 5,080만 달러입니다.
- 총이익률은 64%로 유지(241.0/378.0). 영업비용은 전년 동기와 비슷했고, AZEDRA 지출 종료로 연구개발비는 25% 감소했습니다. 영업이익은 14% 감소한 8,800만 달러였으나, 미실현 주식 손실 감소 및 이자 수익 증가로 순이익은 27% 증가한 7,880만 달러(희석 주당순이익 1.12달러)를 기록했습니다.
- 6개월 누적 순이익은 1분기에 큰 시가평가 손실이 발생하며 22% 감소한 1억 5,170만 달러였습니다.
- 영업활동 현금흐름은 견고한 1억 9,470만 달러였으나, 주로 방사선 치료제 CDMO인 Evergreen Theragnostics 인수에 따른 2억 9,620만 달러 투자 현금 유출로 상쇄되었습니다. 현금 및 현금성 자산은 6억 9,560만 달러로 감소했으며, 순현금은 2억 7,500만 달러 전환사채 대비 약 1억 2,000만 달러 이상입니다.
- 대차대조표에는 Evergreen 관련 1억 1,620만 달러의 영업권과 2억 1,500만 달러의 연구개발 무형자산이 추가되었으며, 공정가치로 평가된 우발부채 4,300만 달러가 인식되었습니다.
- SPECT 사업부는 SHINE과의 계약에 따라 매각예정자산으로 분류(자산 7,340만 달러, 부채 2,980만 달러)되었으며, 손상차손은 기록되지 않았습니다.
- 주주 환원: 2분기에 130만 주를 1억 달러에 재매입했으며, 2024년 2억 5,000만 달러 프로그램 중 총 2억 달러를 집행했습니다. 기본 주식수는 6,800만 주로 전년 대비 2% 감소했습니다.
- 레버리지 계약 조건은 안정적이며(순레버리지 0.6배), 7억 5,000만 달러 회전 신용대출은 미사용 상태입니다.
전망: 단기적으로 매출 부진이 지속되지만, Evergreen 인수로 제조 능력이 확대되고 Octevy 및 CDMO 매출 옵션이 추가되었으며, SPECT 매각으로 고성장 PET 종양학 및 진단 분야에 더욱 집중할 수 있게 되었습니다.
Points clés du 10-Q du deuxième trimestre 2025 de Lantheus (LNTH) :
- Le chiffre d’affaires a reculé de 4 % en glissement annuel pour atteindre 378,0 M$, en raison d’un ralentissement des ventes de PYLARIFY (-8 %) et de la poursuite du déclin de TechneLite avant la cession prévue de SPECT. Le chiffre d’affaires semestriel est en baisse de 2 % à 750,8 M$.
- La marge brute est restée stable à 64 % (241,0/378,0). Les dépenses opérationnelles sont restées stables en glissement annuel ; la R&D a diminué de 25 % suite à la fin des dépenses liées à AZEDRA. Le résultat opérationnel a chuté de 14 % à 88,0 M$, mais des pertes non réalisées sur actions moindres et des revenus d’intérêts plus élevés ont permis d’augmenter le résultat net de 27 % à 78,8 M$ (BPA dilué de 1,12 $).
- Le résultat net semestriel a diminué de 22 % à 151,7 M$ en raison d’une forte perte de valorisation des actions au premier trimestre.
- Les flux de trésorerie opérationnels ont été solides à 194,7 M$, compensés par une sortie de trésorerie d’investissement de 296,2 M$, principalement liée à l’acquisition de 269 M$ du CDMO en radiothérapies Evergreen Theragnostics. La trésorerie et équivalents ont diminué à 695,6 M$ ; la trésorerie nette reste positive, supérieure à 120 M$ par rapport aux convertibles à 2,625 % de 575 M$.
- Le bilan intègre un goodwill de 116,2 M$ lié à Evergreen et 215 M$ en IPR&D ; une contrepartie conditionnelle évaluée à la juste valeur de 43,0 M$ a été comptabilisée.
- Le secteur SPECT est classé comme détenu en vue de la vente (actifs 73,4 M$, passifs 29,8 M$) selon un accord avec SHINE ; aucune dépréciation n’a été enregistrée.
- Retour aux actionnaires : 1,3 M d’actions rachetées pour 100 M$ au T2 ; 200 M$ au total dans le cadre du programme 2024 de 250 M$. 68,0 M d’actions ordinaires en circulation (-2 % en glissement annuel).
- Les clauses de levier restent confortables (levier net 0,6×) ; aucun emprunt utilisé sur la ligne de crédit renouvelable de 750 M$.
Perspectives : Malgré une faiblesse persistante du chiffre d’affaires à court terme, l’acquisition d’Evergreen élargit la capacité de production et apporte des options de revenus via Octevy et CDMO ; la cession de SPECT permettra de se concentrer davantage sur la franchise oncologie et diagnostic PET à forte croissance.
Lantheus (LNTH) Highlights des 10-Q für Q2-25:
- Der Umsatz sank im Jahresvergleich um 4 % auf 378,0 Mio. USD, da die Verkäufe von PYLARIFY um 8 % zurückgingen und TechneLite vor der geplanten Veräußerung von SPECT weiter schrumpfte. Der Umsatz für sechs Monate ging um 2 % auf 750,8 Mio. USD zurück.
- Die Bruttomarge blieb bei 64 % (241,0/378,0). Die Betriebskosten blieben im Jahresvergleich stabil; die F&E-Ausgaben sanken um 25 %, da die AZEDRA-Ausgaben endeten. Das Betriebsergebnis fiel um 14 % auf 88,0 Mio. USD, aber geringere nicht realisierte Aktienverluste und höhere Zinserträge hoben den Nettogewinn um 27 % auf 78,8 Mio. USD (verwässertes Ergebnis je Aktie 1,12 USD).
- Der Nettogewinn für sechs Monate sank um 22 % auf 151,7 Mio. USD, da im ersten Quartal ein erheblicher Marktwertverlust auf Aktien verbucht wurde.
- Der operative Cashflow war solide mit 194,7 Mio. USD, ausgeglichen durch einen Investitions-Cashflow-Abfluss von 296,2 Mio. USD, hauptsächlich für die Übernahme des Radiotherapeutika-CDMO Evergreen Theragnostics für 269 Mio. USD. Zahlungsmittel und Äquivalente sanken auf 695,6 Mio. USD; Netto-Cash bleibt mit rund >120 Mio. USD gegenüber 575 Mio. USD Wandelanleihen mit 2,625 % Zins komfortabel.
- Die Bilanz beinhaltet 116,2 Mio. USD Goodwill und 215 Mio. USD IPR&D von Evergreen; eine erfolgswirksam bewertete Eventualverbindlichkeit in Höhe von 43,0 Mio. USD wurde verbucht.
- Das SPECT-Geschäft wurde als zum Verkauf gehalten klassifiziert (Aktiva 73,4 Mio. USD, Passiva 29,8 Mio. USD) gemäß Vereinbarung mit SHINE; keine Wertminderungen erfasst.
- Aktionärsrenditen: Im zweiten Quartal wurden 1,3 Mio. Aktien für 100 Mio. USD zurückgekauft; insgesamt 200 Mio. USD im Rahmen des 2024er Programms von 250 Mio. USD. Grundlegende ausstehende Aktien 68,0 Mio. (-2 % im Jahresvergleich).
- Die Verschuldungsvereinbarungen bleiben komfortabel (Netto-Verschuldung 0,6×); keine Inanspruchnahme der revolvierenden Kreditlinie über 750 Mio. USD.
Ausblick: Obwohl die Umsatzzahlen kurzfristig schwach bleiben, erweitert die Evergreen-Übernahme die Produktionskapazität und fügt Einnahmequellen durch Octevy und CDMO hinzu; der Verkauf von SPECT wird die Konzentration auf das wachstumsstarke PET-Onkologie- und Diagnostik-Portfolio weiter verstärken.
- Net income rose 27% YoY to $78.8 M despite lower revenue, evidencing expense discipline and portfolio shift.
- $194.7 M operating cash flow supports continued R&D and buybacks while keeping net leverage <1×.
- Acquired Evergreen Theragnostics, adding CDMO capacity and late-stage Octevy PET agent, positioning for new growth vectors.
- Initiated SPECT business divestiture to focus on higher-margin PET oncology portfolio.
- Maintained strong liquidity of $695.6 M cash and unused $750 M revolver.
- Revenue declined 4% YoY, with PYLARIFY growth cooling and TechneLite falling ahead of sale.
- Gross profit dollars down 6%; operating margin compressed 280 bps to 23.3%.
- Cash balance fell $217 M on Evergreen deal and buybacks; future $728 M earn-outs could pressure liquidity.
- Share buybacks of $200 M reduce cash that could fund pipeline or mitigate dilution from converts.
- Convertible notes trading above par imply potential dilution if stock sustains >$79.81.
Insights
TL;DR: Mixed print—revenue dips but EPS beats; strategic portfolio reshaping continues.
Q2 revenue decline was modest and largely confined to legacy SPECT assets now held-for-sale. Core PET franchise remains robust: PYLARIFY still >$250 M quarterly despite decelerating growth. Gross margin resilience and sharply lower R&D spend cushioned EPS. Cash deployment is aggressive—$269 M Evergreen deal plus $200 M buybacks trimmed cash by ~24% but net leverage is manageable. Evergreen adds vertical CDMO capability and Octevy, but $727 M potential earn-outs introduce long-dated liability. Pending SPECT sale should be EPS-neutral yet removes low-growth segment and $19 M ARO. Overall, fundamentals steady; watch integration execution and PYLARIFY trajectory.
TL;DR: Acquisition/divestiture combo sharpens strategic focus; valuation hinges on earn-out success.
Evergreen purchase broadens LNTH’s theranostic footprint and secures U.S. isotopes supply—a critical competitive differentiator. Up-front multiple (~8× 2027E EBITDA) looks reasonable, but $728 M contingent milestones could double consideration; model assumes 23% probability (FV $43 M). Offloading SPECT assets simplifies the story and frees capacity at North Billerica; price undisclosed yet ARO relief alone is meaningful. Convertible debt remains the sole funded leverage; no revolver use maintains optionality. Net cash melt manageable, though further buybacks may test covenant headroom if earn-outs trigger.
Lantheus (LNTH) evidenze del 10-Q del secondo trimestre 2025:
- I ricavi sono diminuiti del 4% su base annua, attestandosi a 378,0 milioni di dollari, a causa della moderazione delle vendite di PYLARIFY (-8%) e del continuo calo di TechneLite in vista della prevista cessione di SPECT. I ricavi semestrali sono scesi del 2% a 750,8 milioni di dollari.
- Il margine lordo si è mantenuto al 64% (241,0/378,0). Le spese operative sono rimaste stabili rispetto all'anno precedente; la R&S è diminuita del 25% con la conclusione delle spese per AZEDRA. L'utile operativo è calato del 14% a 88,0 milioni di dollari, ma minori perdite non realizzate su partecipazioni e maggiori proventi da interessi hanno portato a un utile netto in crescita del 27% a 78,8 milioni di dollari (utile diluito per azione di 1,12 dollari).
- L’utile netto semestrale è sceso del 22% a 151,7 milioni di dollari, a causa di una significativa perdita di valutazione di mercato su partecipazioni nel primo trimestre.
- Il flusso di cassa operativo è stato solido, pari a 194,7 milioni di dollari, compensato da un deflusso di cassa per investimenti di 296,2 milioni di dollari, principalmente per l’acquisizione da 269 milioni di dollari del CDMO di radioterapici Evergreen Theragnostics. La liquidità e equivalenti sono scesi a 695,6 milioni di dollari; la posizione finanziaria netta rimane positiva, superiore a 120 milioni di dollari rispetto ai 575 milioni di dollari dei convertibili al 2,625%.
- Lo stato patrimoniale include un avviamento di 116,2 milioni di dollari relativo a Evergreen e 215 milioni di dollari per IPR&D; è stata contabilizzata una passività condizionata a fair value per 43,0 milioni di dollari.
- Il business SPECT è stato classificato come disponibile per la vendita (attività 73,4 milioni di dollari, passività 29,8 milioni di dollari) in base all’accordo con SHINE; non sono state registrate svalutazioni.
- Ritorni per gli azionisti: nel secondo trimestre sono state riacquistate 1,3 milioni di azioni per 100 milioni di dollari; 200 milioni di dollari totali nell’ambito del programma 2024 da 250 milioni. Azioni ordinarie in circolazione 68,0 milioni (-2% su base annua).
- I covenant di leva finanziaria restano confortevoli (leva netta 0,6×); nessun utilizzo del revolving da 750 milioni di dollari.
Prospettive: Nonostante la debolezza a breve termine dei ricavi, l’acquisizione di Evergreen amplia la capacità produttiva e aggiunge nuove fonti di ricavi da Octevy e CDMO; la vendita di SPECT consentirà di concentrare maggiormente l’attenzione sul portafoglio in rapida crescita di oncologia e diagnostica PET.
Aspectos destacados del 10-Q del segundo trimestre de 2025 de Lantheus (LNTH):
- Los ingresos cayeron un 4% interanual hasta 378,0 millones de dólares debido a la moderación en las ventas de PYLARIFY (-8%) y la continua disminución de TechneLite antes de la prevista desinversión de SPECT. Los ingresos semestrales bajaron un 2% hasta 750,8 millones de dólares.
- El margen bruto se mantuvo en 64% (241,0/378,0). Los gastos operativos se mantuvieron planos año tras año; I+D bajó un 25% tras finalizar el gasto en AZEDRA. El ingreso operativo cayó un 14% hasta 88,0 millones de dólares, pero menores pérdidas no realizadas en acciones y mayores ingresos por intereses impulsaron el ingreso neto un 27% hasta 78,8 millones de dólares (EPS diluido de 1,12 dólares).
- El ingreso neto semestral disminuyó un 22% hasta 151,7 millones de dólares debido a una fuerte pérdida por valoración de mercado en el primer trimestre.
- El flujo de caja operativo fue sólido, con 194,7 millones de dólares, compensado por un flujo de caja de inversión negativo de 296,2 millones de dólares, principalmente por la adquisición de 269 millones de dólares del CDMO de radioterapéuticos Evergreen Theragnostics. El efectivo y equivalentes disminuyeron a 695,6 millones de dólares; el efectivo neto sigue siendo positivo, alrededor de más de 120 millones de dólares frente a los 575 millones de dólares en convertibles al 2,625%.
- El balance incorpora un goodwill de 116,2 millones de dólares por Evergreen y 215 millones de dólares en I+D interna; se registró una contraprestación contingente valorada a valor razonable de 43,0 millones de dólares.
- El negocio SPECT se clasificó como mantenido para la venta (activos 73,4 millones de dólares, pasivos 29,8 millones de dólares) bajo acuerdo con SHINE; no se registraron deterioros.
- Retornos para accionistas: se recompraron 1,3 millones de acciones por 100 millones de dólares en el segundo trimestre; 200 millones en total bajo el programa 2024 de 250 millones. Acciones básicas en circulación 68,0 millones (-2% interanual).
- Los convenios de apalancamiento permanecen cómodos (apalancamiento neto 0,6×); no se han tomado préstamos bajo la línea revolvente de 750 millones.
Perspectivas: Aunque la debilidad en los ingresos persiste a corto plazo, la adquisición de Evergreen amplía la capacidad de fabricación y añade opciones de ingresos de Octevy y CDMO; la venta de SPECT permitirá enfocarse más en la franquicia de oncología y diagnóstico PET de alto crecimiento.
Lantheus (LNTH) 2025년 2분기 10-Q 주요 내용:
- 수익은 전년 대비 4% 감소한 3억 7,800만 달러로, PYLARIFY 매출이 8% 감소하고 TechneLite가 예정된 SPECT 매각을 앞두고 계속 하락함에 따라 감소했습니다. 6개월 누적 수익은 2% 감소한 7억 5,080만 달러입니다.
- 총이익률은 64%로 유지(241.0/378.0). 영업비용은 전년 동기와 비슷했고, AZEDRA 지출 종료로 연구개발비는 25% 감소했습니다. 영업이익은 14% 감소한 8,800만 달러였으나, 미실현 주식 손실 감소 및 이자 수익 증가로 순이익은 27% 증가한 7,880만 달러(희석 주당순이익 1.12달러)를 기록했습니다.
- 6개월 누적 순이익은 1분기에 큰 시가평가 손실이 발생하며 22% 감소한 1억 5,170만 달러였습니다.
- 영업활동 현금흐름은 견고한 1억 9,470만 달러였으나, 주로 방사선 치료제 CDMO인 Evergreen Theragnostics 인수에 따른 2억 9,620만 달러 투자 현금 유출로 상쇄되었습니다. 현금 및 현금성 자산은 6억 9,560만 달러로 감소했으며, 순현금은 2억 7,500만 달러 전환사채 대비 약 1억 2,000만 달러 이상입니다.
- 대차대조표에는 Evergreen 관련 1억 1,620만 달러의 영업권과 2억 1,500만 달러의 연구개발 무형자산이 추가되었으며, 공정가치로 평가된 우발부채 4,300만 달러가 인식되었습니다.
- SPECT 사업부는 SHINE과의 계약에 따라 매각예정자산으로 분류(자산 7,340만 달러, 부채 2,980만 달러)되었으며, 손상차손은 기록되지 않았습니다.
- 주주 환원: 2분기에 130만 주를 1억 달러에 재매입했으며, 2024년 2억 5,000만 달러 프로그램 중 총 2억 달러를 집행했습니다. 기본 주식수는 6,800만 주로 전년 대비 2% 감소했습니다.
- 레버리지 계약 조건은 안정적이며(순레버리지 0.6배), 7억 5,000만 달러 회전 신용대출은 미사용 상태입니다.
전망: 단기적으로 매출 부진이 지속되지만, Evergreen 인수로 제조 능력이 확대되고 Octevy 및 CDMO 매출 옵션이 추가되었으며, SPECT 매각으로 고성장 PET 종양학 및 진단 분야에 더욱 집중할 수 있게 되었습니다.
Points clés du 10-Q du deuxième trimestre 2025 de Lantheus (LNTH) :
- Le chiffre d’affaires a reculé de 4 % en glissement annuel pour atteindre 378,0 M$, en raison d’un ralentissement des ventes de PYLARIFY (-8 %) et de la poursuite du déclin de TechneLite avant la cession prévue de SPECT. Le chiffre d’affaires semestriel est en baisse de 2 % à 750,8 M$.
- La marge brute est restée stable à 64 % (241,0/378,0). Les dépenses opérationnelles sont restées stables en glissement annuel ; la R&D a diminué de 25 % suite à la fin des dépenses liées à AZEDRA. Le résultat opérationnel a chuté de 14 % à 88,0 M$, mais des pertes non réalisées sur actions moindres et des revenus d’intérêts plus élevés ont permis d’augmenter le résultat net de 27 % à 78,8 M$ (BPA dilué de 1,12 $).
- Le résultat net semestriel a diminué de 22 % à 151,7 M$ en raison d’une forte perte de valorisation des actions au premier trimestre.
- Les flux de trésorerie opérationnels ont été solides à 194,7 M$, compensés par une sortie de trésorerie d’investissement de 296,2 M$, principalement liée à l’acquisition de 269 M$ du CDMO en radiothérapies Evergreen Theragnostics. La trésorerie et équivalents ont diminué à 695,6 M$ ; la trésorerie nette reste positive, supérieure à 120 M$ par rapport aux convertibles à 2,625 % de 575 M$.
- Le bilan intègre un goodwill de 116,2 M$ lié à Evergreen et 215 M$ en IPR&D ; une contrepartie conditionnelle évaluée à la juste valeur de 43,0 M$ a été comptabilisée.
- Le secteur SPECT est classé comme détenu en vue de la vente (actifs 73,4 M$, passifs 29,8 M$) selon un accord avec SHINE ; aucune dépréciation n’a été enregistrée.
- Retour aux actionnaires : 1,3 M d’actions rachetées pour 100 M$ au T2 ; 200 M$ au total dans le cadre du programme 2024 de 250 M$. 68,0 M d’actions ordinaires en circulation (-2 % en glissement annuel).
- Les clauses de levier restent confortables (levier net 0,6×) ; aucun emprunt utilisé sur la ligne de crédit renouvelable de 750 M$.
Perspectives : Malgré une faiblesse persistante du chiffre d’affaires à court terme, l’acquisition d’Evergreen élargit la capacité de production et apporte des options de revenus via Octevy et CDMO ; la cession de SPECT permettra de se concentrer davantage sur la franchise oncologie et diagnostic PET à forte croissance.
Lantheus (LNTH) Highlights des 10-Q für Q2-25:
- Der Umsatz sank im Jahresvergleich um 4 % auf 378,0 Mio. USD, da die Verkäufe von PYLARIFY um 8 % zurückgingen und TechneLite vor der geplanten Veräußerung von SPECT weiter schrumpfte. Der Umsatz für sechs Monate ging um 2 % auf 750,8 Mio. USD zurück.
- Die Bruttomarge blieb bei 64 % (241,0/378,0). Die Betriebskosten blieben im Jahresvergleich stabil; die F&E-Ausgaben sanken um 25 %, da die AZEDRA-Ausgaben endeten. Das Betriebsergebnis fiel um 14 % auf 88,0 Mio. USD, aber geringere nicht realisierte Aktienverluste und höhere Zinserträge hoben den Nettogewinn um 27 % auf 78,8 Mio. USD (verwässertes Ergebnis je Aktie 1,12 USD).
- Der Nettogewinn für sechs Monate sank um 22 % auf 151,7 Mio. USD, da im ersten Quartal ein erheblicher Marktwertverlust auf Aktien verbucht wurde.
- Der operative Cashflow war solide mit 194,7 Mio. USD, ausgeglichen durch einen Investitions-Cashflow-Abfluss von 296,2 Mio. USD, hauptsächlich für die Übernahme des Radiotherapeutika-CDMO Evergreen Theragnostics für 269 Mio. USD. Zahlungsmittel und Äquivalente sanken auf 695,6 Mio. USD; Netto-Cash bleibt mit rund >120 Mio. USD gegenüber 575 Mio. USD Wandelanleihen mit 2,625 % Zins komfortabel.
- Die Bilanz beinhaltet 116,2 Mio. USD Goodwill und 215 Mio. USD IPR&D von Evergreen; eine erfolgswirksam bewertete Eventualverbindlichkeit in Höhe von 43,0 Mio. USD wurde verbucht.
- Das SPECT-Geschäft wurde als zum Verkauf gehalten klassifiziert (Aktiva 73,4 Mio. USD, Passiva 29,8 Mio. USD) gemäß Vereinbarung mit SHINE; keine Wertminderungen erfasst.
- Aktionärsrenditen: Im zweiten Quartal wurden 1,3 Mio. Aktien für 100 Mio. USD zurückgekauft; insgesamt 200 Mio. USD im Rahmen des 2024er Programms von 250 Mio. USD. Grundlegende ausstehende Aktien 68,0 Mio. (-2 % im Jahresvergleich).
- Die Verschuldungsvereinbarungen bleiben komfortabel (Netto-Verschuldung 0,6×); keine Inanspruchnahme der revolvierenden Kreditlinie über 750 Mio. USD.
Ausblick: Obwohl die Umsatzzahlen kurzfristig schwach bleiben, erweitert die Evergreen-Übernahme die Produktionskapazität und fügt Einnahmequellen durch Octevy und CDMO hinzu; der Verkauf von SPECT wird die Konzentration auf das wachstumsstarke PET-Onkologie- und Diagnostik-Portfolio weiter verstärken.
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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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, 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.
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Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Act) Yes ☐ No
The registrant had
Table of Contents
LANTHEUS HOLDINGS, INC.
TABLE OF CONTENTS
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Page |
PART I. FINANCIAL INFORMATION |
1 |
Item 1. Financial Statements |
1 |
Condensed Consolidated Balance Sheets |
1 |
Condensed Consolidated Statements of Operations |
2 |
Condensed Consolidated Statements of Comprehensive Income |
3 |
Condensed Consolidated Statements of Changes in Stockholders’ Equity |
4 |
Condensed Consolidated Statements of Cash Flows |
5 |
Notes to Condensed Consolidated Financial Statements |
7 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
26 |
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
40 |
Item 4. Controls and Procedures |
40 |
PART II. OTHER INFORMATION |
41 |
Item 1. Legal Proceedings |
41 |
Item 1A. Risk Factors |
41 |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
46 |
Item 3. Defaults Upon Senior Securities |
46 |
Item 4. Mine Safety Disclosures |
46 |
Item 5. Other Information |
46 |
Item 6. Exhibits |
47 |
SIGNATURES |
48 |
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except par value)
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June 30, |
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December 31, |
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2025 |
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2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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Accounts receivable, net |
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Inventory, net |
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Other current assets |
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Assets held for sale |
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Total current assets |
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Investment in equity securities |
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Property, plant and equipment, net |
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Intangibles, net |
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Goodwill |
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Deferred tax assets, net |
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Other long-term assets |
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Total assets |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Current portion of long-term debt and other borrowings |
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Accounts payable |
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Accrued expenses and other liabilities |
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Liabilities held for sale |
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Total current liabilities |
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Asset retirement obligations |
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Long-term debt and other borrowings, net of current portion |
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Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies (Note 17) |
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Stockholders' equity: |
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Preferred stock ($ |
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Common stock ($ |
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Additional paid-in capital |
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Treasury stock at cost; |
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Retained earnings |
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Accumulated other comprehensive loss |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Table of Contents
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
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Three Months Ended |
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Six Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenues |
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Cost of goods sold |
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Gross profit |
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Operating expenses |
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Sales and marketing |
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General and administrative |
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Research and development |
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Total operating expenses |
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Gain on sale of assets |
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— |
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— |
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Operating income |
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Interest expense |
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Investment in equity securities - unrealized (gain) loss |
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Other income |
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Income before income taxes |
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Income tax expense |
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Net income |
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Net income per common share: |
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Basic |
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Diluted |
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Weighted average common shares outstanding: |
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Basic |
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Diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Table of Contents
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Comprehensive Income
(Unaudited)
(in thousands)
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Three Months Ended |
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Six Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Net income |
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$ |
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$ |
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$ |
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Other comprehensive income (loss): |
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Foreign currency translation |
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Comprehensive income |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Table of Contents
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
(in thousands)
|
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Six Months Ended June 30, 2025 |
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Treasury Stock |
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Paid-In |
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Retained |
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Comprehensive |
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Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Earnings |
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Income (Loss) |
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Equity |
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Balance at January 1, 2025 |
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$ |
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$ |
( |
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$ |
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$ |
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$ |
( |
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$ |
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Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Stock option exercises and employee stock plan purchases |
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— |
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— |
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— |
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— |
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Vesting of restricted stock units |
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— |
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— |
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( |
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— |
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— |
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— |
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Shares withheld to cover taxes |
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( |
) |
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( |
) |
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— |
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— |
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( |
) |
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— |
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— |
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( |
) |
Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2025 |
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$ |
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$ |
( |
) |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Net income |
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— |
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— |
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— |
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— |
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— |
|
|
|
|
|
|
— |
|
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Stock option exercises and employee stock plan purchases |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of restricted stock units |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Shares withheld to cover taxes |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Repurchase of common stock, including excise tax |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Balance at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2024 |
|
|||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
Other |
|
|
Total |
|
||||||||
|
|
Common Stock |
|
|
Treasury Stock |
|
|
Paid-In |
|
|
Retained |
|
|
Comprehensive |
|
|
Stockholders' |
|
||||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Earnings |
|
|
Loss |
|
|
Equity |
|
||||||||
Balance at January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Stock option exercises and employee stock plan purchases |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of restricted stock units |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Shares withheld to cover taxes |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Balance at March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Stock option exercises and employee stock plan purchases |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of restricted stock units |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Shares withheld to cover taxes |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Balance at June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Table of Contents
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
|
|
Six Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net income |
|
$ |
|
|
$ |
|
||
Adjustments to reconcile net income to net cash flows from operating activities: |
|
|
|
|
|
|
||
Depreciation, amortization and accretion |
|
|
|
|
|
|
||
Adjustment to the fair value of asset retirement obligation |
|
|
( |
) |
|
|
|
|
Amortization of debt-related costs |
|
|
|
|
|
|
||
Inventory adjustments |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Gain on disposal of assets |
|
|
|
|
|
( |
) |
|
Unrealized loss (gain) on investment in equity securities |
|
|
|
|
|
( |
) |
|
Charges incurred pursuant to acquired in-process research and development |
|
|
|
|
|
|
||
Deferred taxes |
|
|
( |
) |
|
|
( |
) |
Long-term income tax payable and other long-term liabilities |
|
|
( |
) |
|
|
|
|
Other |
|
|
|
|
|
|
||
Changes in operating assets and liabilities, excluding impact of acquisitions: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
( |
) |
|
|
( |
) |
Inventory |
|
|
( |
) |
|
|
( |
) |
Other current and noncurrent assets |
|
|
( |
) |
|
|
|
|
Accounts payable |
|
|
|
|
|
|
||
Accrued expenses and other current and noncurrent liabilities |
|
|
( |
) |
|
|
|
|
Net cash provided by operating activities |
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Capital expenditures |
|
|
( |
) |
|
|
( |
) |
Acquisition of in-process research and development |
|
|
( |
) |
|
|
|
|
Proceeds from sale of assets |
|
|
|
|
|
|
||
Acquisition of assets, net |
|
|
|
|
|
( |
) |
|
Acquisition of Evergreen, net of cash acquired |
|
|
( |
) |
|
|
|
|
Purchases of investment in equity securities |
|
|
( |
) |
|
|
( |
) |
Acquisition of exclusive license option |
|
|
|
|
|
( |
) |
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
||
Payments of long-term debt and other borrowings |
|
|
( |
) |
|
|
( |
) |
Proceeds from stock option exercises |
|
|
|
|
|
|
||
Proceeds from employee stock purchase plan |
|
|
|
|
|
|
||
Payments for minimum statutory tax withholding related to net share settlement of equity awards |
|
|
( |
) |
|
|
( |
) |
Repurchase of common stock |
|
|
( |
) |
|
|
|
|
Net cash used in financing activities |
|
|
( |
) |
|
|
( |
) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
|
|
|
( |
) |
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
|
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
$ |
|
5
Table of Contents
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited)
(in thousands)
|
|
Six Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Reconciliation to amounts within the condensed consolidated balance sheets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash included in other long-term assets |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
|
|
|
Six Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Schedule of non-cash investing and financing activities |
|
|
|
|
|
|
||
Additions of property, plant and equipment included in liabilities |
|
$ |
|
|
$ |
|
||
Contingent consideration liabilities related to the acquisition of Evergreen |
|
$ |
|
|
$ |
|
||
Lease liability settled through transfer of lease |
|
$ |
|
|
$ |
|
||
Modification of lease agreement |
|
$ |
|
|
$ |
|
||
Right-of-use asset obtained in exchange for finance lease obligation |
|
$ |
|
|
$ |
|
||
Excise tax payable on net common stock repurchases |
|
$ |
|
|
$ |
|
||
Acquisition of in-process research and development included in liabilities |
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note Regarding Company References and Trademarks
Unless the context otherwise requires, references to the “Company,” “our Company,” “Lantheus,” “we,” “us” and “our” refer to Lantheus Holdings, Inc. and its direct and indirect wholly-owned subsidiaries; references to “Lantheus Holdings” refer to Lantheus Holdings, Inc. and not to any of its subsidiaries; references to “Lantheus Medical” refer to Lantheus Medical Imaging, Inc., the wholly-owned subsidiary of Lantheus Holdings; references to “Aphelion,” “Lantheus Alpha” and “Meilleur” refer to Aphelion LLC, Lantheus Alpha Therapy, LLC and Meilleur Technologies, Inc., respectively, each a wholly-owned subsidiary of Lantheus Holdings; references to “Cerveau,” “Lantheus Real Estate,” “Progenics,” and “Evergreen,” refer to Cerveau Technologies, Inc.; Lantheus MI Real Estate, LLC; Progenics Pharmaceuticals, Inc. and Evergreen Theragnostics, Inc., respectively, each a wholly-owned subsidiary of Lantheus Medical, and references to “EXINI” refer to EXINI Diagnostics AB, a wholly-owned subsidiary of Progenics.
Solely for convenience, the Company refers to trademarks, service marks and trade names in this Quarterly Report on Form 10-Q (“Form 10-Q”) without the TM, SM and ® symbols. Those references are not intended to indicate, in any way, that the Company will not assert, to the fullest extent permitted under applicable law, its rights to its trademarks, service marks and trade names. Each trademark, trade name or service mark of any other company appearing in this Form 10-Q, is, to the Company’s knowledge, owned by that other company.
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of Lantheus and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions for Form 10-Q and Article 10 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement have been included. The preparation of the Company’s condensed consolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue and expenses, and related disclosures. The results of operations for the three and six months ended June 30, 2025 and 2024 are not necessarily indicative of the results that may be expected for any future period.
The condensed consolidated balance sheet at December 31, 2024 has been derived from the audited consolidated financial statements at that date but does not include all the information and notes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and notes thereto included in Item 8 of the Company’s most recent Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2024 filed with the Securities Exchange Commission (“SEC”) on February 26, 2025.
2. Summary of Significant Accounting Policies
Assets Held for Sale
The Company classifies an asset as held for sale when management, having the authority to approve the action, commits to a plan to sell the asset, the sale is probable within one year and the asset is available for immediate sale in its present condition. The Company also considers whether an active program to locate a buyer has been initiated, whether the asset is marketed actively for sale at a price that is reasonable in relation to its current fair value and whether actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or that the plan will be withdrawn. The Company initially measures an asset that is classified as held for sale at the lower of its (i) carrying amount or (ii) fair value less costs to sell. Any loss resulting from this measurement is recognized in the period in which the held for sale criteria are met. Conversely, gains are not recognized until the date of sale. The Company assesses the fair value of an asset less costs to sell each reporting period that the asset remains classified as held for sale and reports any subsequent changes as an adjustment to the carrying amount of the asset, as long as the new carrying amount does not exceed the carrying amount of the asset at the time it was initially classified as held for sale. Assets are not depreciated or amortized while they are classified as held for sale.
Investments
Equity investments with readily determinable fair values for which the Company does not have significant influence over the investee are measured at fair value on a recurring basis. Equity investments without readily determinable fair values for which the Company does not have significant influence over the investee are measured at cost with adjustments for observable changes in price or impairments (referred to as the measurement alternative). For equity investments for which the Company does not have significant influence over the investee, changes in the value of unsold equity investments are recorded in investment in equity securities – unrealized loss (gain). Equity investments for which the Company has significant influence over the investee are measured using the equity method unless the Company elects to apply the fair value option to account for the investment.
7
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Recent Accounting Pronouncements
The Company has considered all new accounting standards issued by the Financial Accounting Standards Board (“FASB”). The Company has not yet adopted the following standards:
In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-04, “Debt - Debt with Conversion and Other Options (Subtopic 470-20),” which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion rather than as extinguishment of debt. The requirements of ASU 2024-04 are effective for the annual periods beginning after December 15, 2025, including interim periods within those fiscal years. Early adoption is permitted. For the Company, the requirements under ASU 2024-04 will be effective for its Form 10-Q for the first quarter of 2026. The Company is currently in the process of evaluating the effects of this pronouncement on its consolidated financial results and related disclosures.
In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40),” and in January 2025, the FASB issued ASU 2025-01, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date.” ASU 2024-03 requires additional income statement disclosures, including the disaggregation of specific categories of expenses underlying the line items presented on the income statement. Additionally, ASU 2024-03 requires enhanced disclosure of selling expenses. As clarified by ASU 2025-01, the requirements of the guidance are effective for annual periods beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. For the Company, annual reporting requirements under ASU 2024-03 will be effective for its Form 10-K for the year ending December 31, 2027 and interim reporting requirements will be effective beginning in the first quarter of 2028. Early adoption is permitted and the amendments should be applied on a prospective basis, however retrospective application is permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. The requirements of the ASU are effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
3. Revenue from Contracts with Customers
The following table summarizes revenue by source as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Major Products /Service Lines |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product revenue, net(1) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
License and royalty revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company classifies its revenues into
Revenue by product category on a net basis is as follows:
8
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
PYLARIFY |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Other radiopharmaceutical oncology |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total radiopharmaceutical oncology |
|
|
|
|
|
|
|
|
|
|
|
|
||||
DEFINITY |
|
|
|
|
|
|
|
|
|
|
|
|
||||
TechneLite |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other precision diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total precision diagnostics |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Strategic partnerships and other revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
The Company is required to allocate a portion of its revenue received from commercial contracts to future reporting periods to the extent the Company had performance obligations that extended beyond one year. However, the Company’s performance obligations are typically part of contracts that have an original expected duration of one year or less. Therefore, since the Company elected the practical expedient under Accounting Standards Codification (“ASC”) 606-10-50-14, it does not disclose information regarding remaining performance obligations which are part of contracts that have an original expected duration of one year or less.
4. Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability of fair value measurements, financial instruments are categorized based on a hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
The Company’s financial assets and liabilities that are measured at fair value on a recurring basis consist of money market funds, deferred compensation plan liabilities, contingent consideration liabilities and equity investments.
The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets.
9
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis:
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June 30, 2025 |
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Total Fair |
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(in thousands) |
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Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Assets: |
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Money market funds |
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$ |
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$ |
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$ |
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$ |
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Investment securities |
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Total assets |
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$ |
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$ |
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$ |
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$ |
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Liabilities: |
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Deferred compensation plan liabilities |
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$ |
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$ |
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$ |
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$ |
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Contingent consideration liabilities |
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Total liabilities |
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$ |
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$ |
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$ |
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$ |
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December 31, 2024 |
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Total Fair |
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(in thousands) |
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Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Assets: |
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Money market funds |
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$ |
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$ |
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$ |
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$ |
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Investment securities |
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Total assets |
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$ |
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$ |
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$ |
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$ |
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Nonqualified Deferred Compensation Plan
The Company maintains the Lantheus Nonqualified Deferred Compensation Plan (the “LDCP”) for the benefit of certain key, highly-compensated employees and non-employee directors. The assets of the LDCP are currently invested in corporate-owned life insurance ("COLI") at June 30, 2025. There were no assets or liabilities balances in the LDCP at December 31, 2024. The liabilities of the LDCP are presented in other long-term liabilities in the Company’s condensed consolidated balance sheets. See Note 18, “Benefit Plans” for more information on the LDCP.
Perspective Therapeutics Inc. Equity Securities
At June 30, 2025, the Company held
Radiopharm Theranostics Limited Equity Securities
The Company held
Contingent Consideration
Progenics
The Company assumed contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013 (“2013 Acquisition”). These contingent consideration liabilities include potential payments of up to $
10
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
sales targets primarily for AZEDRA and 1095 (also known as 131 I-MIP-1095) and a $
Significant changes in any of the probabilities of success, the probabilities as to the periods in which sales targets and milestones will be achieved, discount rates or underlying revenue forecasts would result in a higher fair value measurement. The Company records the contingent consideration liabilities at fair value with changes in estimated fair values recorded in general and administrative expenses in the condensed consolidated statements of operations. The Company can give no assurance that the actual amounts paid, if any, in connection with the contingent consideration liabilities, will be consistent with any recurring fair value estimate of such contingent consideration liabilities. The Company estimated that the probability of successfully meeting the sales targets and commercialization milestones described above was zero. As a result of this assessment, the Company determined the value of the contingent consideration liabilities to be $
Evergreen Theragnostics, Inc.
Pursuant to the terms of the Agreement and Plan of Merger (the "Evergreen Merger Agreement") with Evergreen and Shareholder Representative Services LLC governing the Company's acquisition of Evergreen in April 2025 (see Note 19, "Acquisitions"), the Company is required to make certain remaining payments of up to $
Significant changes in any of the probabilities of success, the probabilities as to the periods in which sales targets and milestones will be achieved, discount rates or underlying revenue forecasts would result in a higher or lower fair value measurement. The Company records the contingent consideration liabilities at fair value with changes in estimated fair values recorded in general and administrative expenses in the condensed consolidated statements of operations. The Company can give no assurance that the actual amounts paid, if any, in connection with the contingent consideration liabilities, will be consistent with any recurring fair value estimate of such contingent consideration liabilities. As a result of this assessment, the Company determined the value of the contingent consideration liabilities to be $
The recurring Level 3 fair value measurements of the Company's contingent consideration liabilities include the following significant unobservable inputs (in thousands, except percent data):
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Fair Value at |
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Contingent Consideration Liability |
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June 30, |
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Valuation Technique |
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Unobservable Inputs |
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Range |
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Weighted Average |
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Development and commercialization milestones |
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Discounted cash flow |
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Payment discount rate |
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Probability of payment |
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Range of expected payment dates |
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2026 - 2037 |
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N/A |
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Sales milestone |
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Scenario analysis |
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Revenue volatility |
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Revenue discount rate |
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N/A |
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Payment discount rate |
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N/A |
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Total contingent consideration liabilities |
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$ |
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11
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
5. Income Taxes
The Company calculates income taxes at the end of each reporting period based on the estimated effective tax rate for the full year, adjusted for any discrete events which are recorded in the period they occur. Cumulative adjustments to the tax provision are recorded in the reporting period in which a change in the estimated annual effective tax rate is determined.
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Three Months Ended |
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Six Months Ended |
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(in thousands) |
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2025 |
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2024 |
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2025 |
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2024 |
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Income tax expense |
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$ |
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$ |
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$ |
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$ |
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Effective tax rate |
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% |
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% |
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% |
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% |
The decrease in the effective income tax rate for the three months ended June 30, 2025 is primarily due to the change in the valuation allowance related to the fluctuation in value of the Company's investment in equity securities balance, partially offset by the increase in non-deductible stock compensation. There was no material change in the effective tax rate for the six months ended June 30, 2025, when compared to the same period of 2024.
6. Inventory
Inventory, net of related reserves, consisted of the following:
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June 30, |
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December 31, |
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(in thousands) |
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2025 |
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2024 |
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Raw materials |
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$ |
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$ |
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Work in process |
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Finished goods |
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Total inventory, net(1) |
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$ |
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$ |
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The majority of the value of the inventory relates to non-radioactive products. With respect to the Company’s products that are radiopharmaceuticals, due to the limited shelf life of such products, they are generally not held as finished goods.
12
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
7. Property, Plant and Equipment, Net
Property, plant and equipment, net, consisted of the following:
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June 30, |
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December 31, |
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(in thousands) |
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2025 |
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2024 |
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Land |
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$ |
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$ |
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Buildings |
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Machinery, equipment and fixtures |
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Computer software |
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Construction in progress |
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Total gross property, plant and equipment |
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Less - accumulated depreciation and amortization |
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( |
) |
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( |
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Total property, plant and equipment, net |
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$ |
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$ |
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Depreciation and amortization expense related to property, plant and equipment, net, was $
On January 8, 2024, the Company entered into an agreement with Perspective to transfer the sublease for the property at 110 Clyde Rd, Somerset, New Jersey (the “Somerset Facility”) and sell the associated assets at the Somerset Facility for $
See Note 19, “Acquisitions” for further discussion of the Perspective transaction.
8. Assets and Liabilities Held for Sale
SPECT Business
On May 1, 2025, the Company entered into a definitive agreement to sell its single-photon emission computerized tomography (“SPECT”) business to SHINE Technologies, LLC ("SHINE"), a wholly-owned subsidiary of Illuminated Holdings, Inc. Under the terms of the agreement, SHINE will acquire the assets and liabilities associated with the Company’s SPECT business, including its diagnostics agents (TechneLite, NEUROLITE, Xenon Xe-133 Gas, and Cardiolite) and the portion of the North Billerica, Massachusetts campus that manufactures the Company’s SPECT products and SPECT-related Canadian operations. The transaction is subject to customary closing conditions and is expected to be completed around the end of the calendar year.
As of June 30, 2025, assets and liabilities associated with the Company’s SPECT business have been presented in the Company’s condensed consolidated balance sheets as assets and liabilities held for sale as it was determined that these assets and liabilities met the criteria of held-for-sale under ASC 360, “Impairment or disposal of long-lived assets,” and will continue to be classified as such until the transaction is completed. The Company determined that the fair value less costs to sell exceeded the carrying value of the assets and liabilities associated with the SPECT business, and therefore
13
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The table below presents the carrying amounts of assets and liabilities held for sale related to the SPECT transaction:
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June 30, |
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(in thousands) |
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2025 |
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Assets: |
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Accounts receivable, net |
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$ |
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Inventory |
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Other current assets |
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Property, plant and equipment, net |
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Intangible assets, net |
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Goodwill |
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Total assets held-for-sale |
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$ |
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Liabilities: |
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Accounts payable |
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Accrued expenses and other liabilities |
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Asset retirement obligation |
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Total liabilities held-for-sale |
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$ |
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9. Accrued Expenses, Other Liabilities and Other Long-Term Liabilities
Accrued expenses, other liabilities and other long-term liabilities are comprised of the following:
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June 30, |
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December 31, |
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(in thousands) |
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2025 |
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2024 |
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Compensation and benefits |
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$ |
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$ |
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Freight, distribution and operations |
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Accrued rebates, discounts and chargebacks |
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Accrued professional fees |
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Accrued research and development expenses |
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Income taxes payable |
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Other |
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Total accrued expenses and other liabilities |
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$ |
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$ |
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Operating lease liabilities |
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$ |
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$ |
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Long-term contingent consideration liabilities (Note 4) |
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Other long-term liabilities |
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Total other long-term liabilities |
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$ |
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$ |
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10. Asset Retirement Obligations
The Company considers its legal obligation to remediate its facilities upon a potential decommissioning of its radioactive-related operations as an asset retirement obligation (“ARO”). The Company has a production facility that manufactures and processes radioactive materials at its North Billerica, Massachusetts site. As of June 30, 2025, the ARO is measured at the present value of the ARO expected to be incurred and is approximately $
The following table provides a summary of the changes in the Company’s carrying value of its ARO:
(in thousands) |
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Amount |
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Balance at January 1, 2025 |
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$ |
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Revision of estimated decommissioning costs |
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( |
) |
Reclassification to liabilities held-for-sale(1) |
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( |
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Accretion expense |
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Balance at June 30, 2025 |
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$ |
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14
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
In the first quarter of 2025, the Company revised certain inputs to its estimate of decommissioning costs expected to be incurred throughout the period of remediation, which reduced the estimate of remediation costs by $
The Company is required to provide the Massachusetts Department of Public Health financial assurance demonstrating the Company’s ability to fund any decommissioning of its North Billerica, Massachusetts production facility in the event of any closure. The Company has provided this financial assurance in the form of a $
11. Goodwill and Intangibles, Net
Goodwill
The following table represents the change in the carrying value of goodwill for the six months ended June 30, 2025:
(in thousands) |
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Amount |
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Balance at January 1, 2025 |
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$ |
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Acquisition of Evergreen |
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Reclassification to assets held for sale(1) |
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( |
) |
Balance at June 30, 2025 |
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$ |
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Intangibles, net, consisted of the following:
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June 30, 2025 |
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(in thousands) |
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Useful Lives |
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Amortization Method |
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Gross |
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Accumulated |
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Net |
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Amortizable: |
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Trademarks |
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Straight-line |
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$ |
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$ |
( |
) |
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$ |
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Customer relationships |
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Accelerated |
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( |
) |
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Currently marketed products |
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Straight-line |
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( |
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Licenses |
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Straight-line |
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( |
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Developed technology |
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Straight-line |
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( |
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Total amortizable intangibles |
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( |
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Non-amortizable: |
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In-process research and development |
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Indefinite |
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— |
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Total intangibles, net |
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$ |
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$ |
( |
) |
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$ |
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December 31, 2024 |
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(in thousands) |
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Useful Lives |
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Amortization Method |
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Gross |
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Accumulated |
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Net |
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Trademarks |
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Straight-line |
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$ |
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$ |
( |
) |
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$ |
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Customer relationships |
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Accelerated |
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( |
) |
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Currently marketed products |
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Straight-line |
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( |
) |
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Licenses |
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Straight-line |
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( |
) |
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Developed technology |
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Straight-line |
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( |
) |
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Total intangibles, net |
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$ |
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$ |
( |
) |
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$ |
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The Company recorded amortization expense for its intangible assets of $
15
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
On August 2, 2023, the Company sold the right to its RELISTOR royalty asset under its license agreement with Bausch Health Companies, Inc.; the Company retained the rights to future sales-based milestone payments. The Company received an initial payment of approximately $
In the first quarter of 2024, the Company discontinued the production and promotion of AZEDRA and no AZEDRA was manufactured after March 1, 2024, when the Company transferred the tangible assets and associated lease of its Somerset Facility to Perspective. See Note 7, “Property, Plant and Equipment, Net” for impairment analysis.
In June 2024, the Company entered into an agreement with the stockholders of Meilleur (“Meilleur Stockholders”) to purchase all of the outstanding capital stock of Meilleur (which holds the rights under a license agreement to develop and commercialize NAV-4694) for approximately $
The below table summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets:
(in thousands) |
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Amount |
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Remainder of 2025 |
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$ |
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2026 |
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2027 |
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2028 |
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2029 |
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2030 and thereafter |
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Total |
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$ |
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12. Long-Term Debt, and Other Borrowings, Net of Current Portion
The carrying value of the Company’s long-term debt and other borrowings, net of current portion is comprised of the following:
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June 30, |
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December 31, |
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(in thousands) |
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2025 |
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2024 |
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Principal amount |
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$ |
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$ |
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Unamortized debt issuance costs |
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( |
) |
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( |
) |
Finance lease liabilities |
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Total |
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Less: current portion of long-term debt and other borrowings |
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( |
) |
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( |
) |
Total long-term debt and other borrowings, net of current portion |
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$ |
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$ |
|
2022 Revolving Facility
In December 2024, the Company entered into an amendment to its $
The Revolving Loans bear interest, with pricing based from time to time at the Company’s election, at (i) the secured overnight financing rate as published by the Federal Reserve Bank of New York on its website plus an applicable margin that ranges from
16
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company is permitted to voluntarily prepay the Revolving Loans, in whole or in part, or reduce or terminate the Revolving Commitment, in each case, without premium or penalty. On any business day on which the total amount of outstanding Revolving Loans, Letters of Credit, and Swingline Loans exceeds the total Revolving Commitment, the Company must prepay the Revolving Loans in an amount equal to such excess. The Company is not required to make mandatory prepayments under the 2022 Revolving Facility. As of June 30, 2025, there were
The Company has the right to request an increase to the Revolving Commitment in an aggregate principal amount of up to the greater of $
2022 Revolving Facility Covenants
The 2022 Revolving Facility contains a number of affirmative, negative and reporting covenants, as well as financial maintenance covenants pursuant to which the Company is required to be in quarterly compliance, measured on a trailing four quarter basis, with
The 2022 Revolving Facility contains usual and customary restrictions on the ability of the Company and its subsidiaries to: (i) incur additional indebtedness (ii) create liens; (iii) consolidate, merge, sell or otherwise dispose of all or substantially all of its assets; (iv) sell certain assets; (v) pay dividends on, repurchase or make distributions in respect of capital stock or make other restricted payments; (vi) make certain investments; (vii) repay subordinated indebtedness prior to stated maturity; and (viii) enter into certain transactions with its affiliates.
Upon an event of default, the Administrative Agent, as defined in the 2022 Revolving Facility, will have the right to declare the loans and other obligations outstanding under the 2022 Revolving Facility immediately due and payable and all commitments immediately terminated.
The 2022 Revolving Facility is guaranteed by Lantheus Holdings, and certain subsidiaries of Lantheus Medical, including Progenics and Lantheus Real Estate, and obligations under the 2022 Revolving Facility are generally secured by first priority liens over substantially all of the assets of each of Lantheus Medical, Lantheus Holdings, and certain subsidiaries of Lantheus Medical, including Progenics and Lantheus MI Real Estate (subject to customary exclusions set forth in the transaction documents) owned as of December 2, 2022 or thereafter acquired.
On December 8, 2022, the Company issued $
The Notes are senior unsecured obligations of the Company. The Notes are fully and unconditionally guaranteed on a senior unsecured basis by the Guarantor. The Notes bear interest at a rate of
17
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
portion of the Notes, at its option, on or after December 22, 2025 if the closing sale price per share of the Company’s common stock exceeds
The Company evaluated the Notes upon completion of the sale and concluded on the following features:
Holders of the Notes may require the Company to repurchase their Notes upon the occurrence of a fundamental change prior to the maturity at a repurchase price equal to
During the second quarter of 2025, the closing price of the Company’s common stock did not exceed the Stock Price Conversion Threshold, so the Notes are not convertible at the option of the holders of the Notes during the third quarter of 2025. Because the Notes are not considered convertible under the terms of the Notes and pursuant to ASC 470, “Debt,” the Company classified the carrying value of the Notes as long-term debt, net and other borrowings on the Company’s condensed consolidated balance sheets as of June 30, 2025.
As of June 30, 2025, the carrying value of the Notes was $
13. Accumulated Other Comprehensive Loss
The components of accumulated other comprehensive loss, net of tax for the six months ended June 30, 2025 and 2024 consisted of the following:
(in thousands) |
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Foreign |
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Accumulated Other |
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Balance at January 1, 2025 |
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$ |
( |
) |
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$ |
( |
) |
Other comprehensive loss before reclassifications |
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Balance at June 30, 2025 |
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$ |
( |
) |
|
$ |
( |
) |
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Balance at January 1, 2024 |
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$ |
( |
) |
|
$ |
( |
) |
Other comprehensive loss before reclassifications |
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2024 |
|
$ |
( |
) |
|
$ |
( |
) |
18
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
14. Stockholders' Equity and Stock-Based Compensation
In November 2024, the Board of Directors (“Board”) authorized a program to repurchase up to $
The following table presents stock-based compensation expense recognized in the Company’s accompanying condensed consolidated statements of operations:
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Three Months Ended |
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Six Months Ended |
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(in thousands) |
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2025 |
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2024 |
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2025 |
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2024 |
|
||||
Cost of goods sold |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
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||||
Sales and marketing |
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General and administrative |
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Research and development |
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||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
15. Net Income Per Common Share
A summary of net income per common share is presented below:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(in thousands, except per share amounts) |
|
2025 |
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2024 |
|
|
2025 |
|
|
2024 |
|
||||
Net income |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
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||||
Basic weighted-average common shares outstanding |
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||||
Effect of dilutive stock options |
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||||
Effect of dilutive restricted stock |
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|
||||
Effect of convertible notes |
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|
||||
Diluted weighted-average common shares outstanding |
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|
||||
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||||
Net income per common share: |
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|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Diluted |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
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|
||||
Antidilutive securities excluded from diluted net income per common share |
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|
|
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|
|
Impact of the Convertible Notes
The Company considered whether the Notes are participating securities through the two-class method. Per the terms of the Indenture, the Company determined that if a cash dividend is paid that is greater than the stock price, the holder of Notes will receive cash on an if-converted basis. While this feature is considered to be a participating right, basic earnings per share is only impacted if the Company’s earnings per share exceeds the current share price, regardless of whether such dividend is declared. During the three and six months ended June 30, 2025 and 2024, no such dividend was declared. In addition, the Company is required to settle the principal amount of the Notes in cash upon conversion, and therefore, the Company uses the if-converted method for calculating any potential dilutive effect of the conversion option on diluted net income per share, if applicable, unless the application of the two-class method is dilutive. The conversion option has a dilutive impact on net income per share of Common Stock when the average price per share of the Company's common stock for a given period exceeds the conversion price of the Notes of $
19
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
16. Other Income
Other income consisted of the following:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Foreign currency loss |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Interest income |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Revision of estimated decommissioning costs related to asset retirement obligation(1) |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Other |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Total other income, net |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
17. Commitments and Contingencies
Legal Proceedings
From time to time, the Company is a party to various legal proceedings arising in the ordinary course of business. In addition, the Company has in the past been, and may in the future be, subject to investigations by governmental and regulatory authorities, which expose it to greater risks associated with litigation, regulatory or other proceedings, as a result of which the Company could be required to pay significant fines or penalties. The costs and outcome of litigation, regulatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s results of operations or financial condition. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its condensed consolidated financial statements.
As of June 30, 2025, the Company did not have any material ongoing litigation to which the Company was a party.
On January 26, 2024, the Company was sued in the United States District Court for the District of Delaware by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to the filing of the Company’s Abbreviated New Drug Application and Paragraph IV certification in connection with PNT2003, consistent with the process established by the Hatch-Waxman Act. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will ultimately be resolved.
On February 23, 2024, the Company filed a patent infringement lawsuit against a healthcare-related imaging software developer, and that developer filed a motion to dismiss the case based on grounds of invalidity for certain patents and failure to state a claim for infringement for other patents. The court dismissed the developer’s motion to dismiss as to invalidity, and granted the motion as to certain allegations of infringement. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will ultimately be resolved.
Royalties
In 2023, the Company acquired Cerveau. Under the terms of the purchase agreement, in addition to payments already made, the Company could pay up to $
20
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
18. Benefit Plans
Nonqualified Deferred Compensation Plan
In October 2024, the Company adopted the LDCP to provide key, highly-compensated employees and non-employee directors an additional opportunity for personal financial planning by allowing an option to defer a portion of their base salary and variable compensation each year. Under the LDCP, which is an elective nonqualified deferred compensation plan, employee participants are eligible to defer up to
As of June 30, 2025, assets and liabilities held by the Trust were $
19. Acquisitions
Acquisition of Businesses
Evergreen Theragnostics, Inc.
On April 1, 2025 (the “Closing Date”), the Company acquired all the issued and outstanding shares of Evergreen by means of a statutory merger of a subsidiary of the Company with and into Evergreen, with Evergreen surviving as the Company’s wholly-owned subsidiary (the “Evergreen Merger”), pursuant to the terms of the Evergreen Merger Agreement. Evergreen is a clinical-stage radiopharmaceutical company engaged in CDMO services as well as drug discovery and commercialization of proprietary products.
As consideration for the Evergreen Merger, the Company remitted an upfront payment of $
The Company may make additional potential remaining milestone payments of up to $
The acquisition date fair value of the consideration transferred in the acquisition consisted of the following (in thousands):
Cash consideration |
|
$ |
|
|
Fair value of contingent consideration |
|
|
|
|
Total purchase consideration |
|
$ |
|
21
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Evergreen Merger was accounted for as an acquisition of a business under ASC 805, “Business Combinations,” which requires that assets acquired and liabilities assumed on the acquisition date be recognized at their fair value as of the acquisition date. While the Company uses its best estimates and assumptions as part of the purchase price allocation process to value the assets acquired and liabilities assumed, its estimates and assumptions are subject to refinement. Fair value estimates are based on a complex series of judgments about future events and uncertainties and rely heavily on estimates and assumptions. The judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact the Company’s consolidated statements of operations.
The preliminary allocation of purchase price is based on the fair value of assets acquired and liabilities assumed as of the acquisition date. As of June 30, 2025, the purchase accounting for the Evergreen Merger has not been finalized. As additional information becomes available, the Company may further revise its preliminary purchase price allocation during the remainder of the measurement period.
(in thousands) |
|
Estimated Fair Value |
|
|
Assets acquired: |
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
Accounts receivable, other(1) |
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
Property, plant and equipment |
|
|
|
|
Intangibles(2) |
|
|
|
|
Deferred tax assets |
|
|
|
|
Other long-term assets |
|
|
|
|
Total identifiable assets acquired |
|
|
|
|
Liabilities assumed: |
|
|
|
|
Accounts payable |
|
|
( |
) |
Accrued expenses and other liabilities |
|
|
( |
) |
Deferred tax liabilities |
|
|
( |
) |
Other long-term liabilities |
|
|
( |
) |
Total liabilities assumed |
|
|
( |
) |
Net assets acquired |
|
$ |
|
|
Purchase consideration |
|
$ |
|
|
Goodwill(3) |
|
$ |
|
Acquisition-related costs are not included as a component of consideration transferred but are expensed in the periods in which costs are incurred. The Company incurred $
The results of operations attributable to the Evergreen Merger for the three and six months ended June 30, 2025 were not material. Pro forma information has not been included as this acquisition did not have a material impact on the Company’s condensed consolidated statements of operations for the three and six months ended June 30, 2025.
Acquisition of Assets
Strategic Agreements with Perspective Therapeutics, Inc.
22
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
On January 8, 2024, the Company entered into an agreement with Perspective to participate in Perspective’s next qualified financing to purchase Perspective Shares. On January 22, 2024, the Company purchased
Also effective January 8, 2024, the Company obtained certain options and rights from Perspective for an aggregate upfront payment of $
None of these options and rights have been exercised as of June 30, 2025.
Costs of IPR&D projects acquired as part of an asset acquisition that have no alternative future use are expensed when incurred, and therefore, a charge of $
Also effective January 8, 2024, the Company entered into an agreement with Perspective to transfer the Somerset Facility and the associated assets at the Somerset Facility for $
On June 14, 2024, Perspective effected a 1-for-10 reverse stock split, after which the Company held
Exclusive License for Radiopharm Theranostics Limited
On June 15, 2024, the Company entered into an agreement with Radiopharm to acquire all of Radiopharm’s rights to
23
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
In connection with this acquisition, the Company assumed the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations. The Company could pay up to an additional $
During the third quarter of 2024, the Company purchased
Acquisition of NAV-4694
On June 18, 2024, the Company acquired Meilleur, including its asset NAV-4694, an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloids in Alzheimer’s disease. The Company determined that upon review of the Meilleur acquisition, the transaction did not meet the definition of a business combination and is therefore treated as an asset acquisition.
The Company made an upfront payment of approximately $
Research revenue is derived from existing partnerships with pharmaceutical companies and academic institutions that use NAV-4694 in clinical trials. Additionally, the Company could pay the Meilleur Stockholders up to double-digit royalty payments for research revenue and commercial sales.
RM2 Asset Purchase
On July 3, 2024, the Company acquired from Life Molecular Imaging, Inc. ("Life Molecular") the global rights to RM2, a gastrin-releasing peptide receptor-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2, for an upfront payment of $
Costs of IPR&D projects acquired as part of an asset acquisition that have no alternative future use are expensed when incurred, and therefore, charges of $
20. Segment Information
The Company operates as
24
Table of Contents
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The CODM uses net income to monitor budget and forecast versus actual results in assessing segment performance and to evaluate income generated from segment assets in deciding how to allocate resources. The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets.
Significant segment expenses reviewed by the CODM include sales and marketing, general and administrative, and R&D expenses as reported in the Company’s condensed consolidated statements of operations. However, the CODM reviews R&D expenses in more detail for certain expenses related to the Company’s development of new products and clinical programs.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Program third-party research and development expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Other research and development expenses(1) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total research and development expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
21. Subsequent Events
Tax Reform
On July 4, 2025, H.R.1, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. The OBBBA provides for significant U.S. tax law changes, including the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The Company is currently evaluating the OBBBA’s impact on its consolidated financial statements.
Acquisition of Life Molecular Imaging Ltd.
On July 21, 2025, the Company acquired Life Molecular Imaging, Inc. ("Life Molecular") for an upfront payment of $
Share Repurchase Program
On July 31, 2025, the Board authorized a program to repurchase up to $
25
Table of Contents
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
Some of the statements contained in this Quarterly Report on Form 10-Q (“Form 10-Q”) are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements, including, in particular, statements about our plans, strategies, prospects and industry estimates, are subject to risks and uncertainties. These statements identify prospective information and can generally be identified by words such as “anticipates,” “believes,” “can,” “commitment,” “could,” “designed,” “estimates,” “expects,” “generate,” “impact,” “increasing,” “hopes,” “intends,” “launch,” “likely,” “long-term,” “maintain,” “may,” “pipeline,” “plans,” “potential,” “predict,” “remain,” “seek,” “should,” “sustain,” “target,” “will,” “would” and similar expressions, or by express or implied discussions regarding potential or pending acquisitions, dispositions, collaborations, development and commercialization plans described in this Form 10-Q, or regarding potential future revenues and expenses from such acquisitions, collaborations, development and commercialization plans. Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (iii) the availability of raw materials, key components, and equipment, either used in the production of our products and product candidates, or in the use by healthcare professionals (“HCPs”) of our products and product candidates, including, but not limited to positron emission tomography (“PET”) scanners for PYLARIFY, MK-6240 and NAV-4694; (iv) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to MK-6240 and NAV-4694, and to further develop and commercialize MK-6240 and NAV-4694 as approved products, including the timing for any potential regulatory submissions for these investigational assets; (v) our ability to successfully integrate acquisitions, including of Life Molecular Imaging Ltd. (“Life Molecular”) and Evergreen Theragnostics, Inc. (“Evergreen”), including the potential for unforeseen expenses related to integration activities, the accuracy of our financial models, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization; (vi) our ability to obtain U.S. Food and Drug Administration ("FDA") approval for our new formulation of our F-18 PSMA PET imaging agent, to complete the technology transfer across our PMF network for such new formulation, and to obtain adequate coding, coverage and payment, including transitional pass-through payment status (“TPT Status”), for such new formulation; (vii) our ability to complete the sale of our single-photon emission computerized tomography ("SPECT") business to SHINE Technologies, LLC ("SHINE"), a wholly-owned subsidiary of Illuminated Holdings, Inc. on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction, unforeseen expenses related to the divestiture, and failure to realize the expected benefits of the transaction; (viii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 DOTATOC, which may be used in conjunction with a PET scan to stage and localize gastroenteropancreatic neuroendocrine tumors in adults and children, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003; (ix) the cost, efforts and timing for clinical development, regulatory approval, adequate coding, coverage and payment and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; and (x) our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products.
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, such statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. These statements are neither statements of historical fact nor guarantees or assurances of future performance. The matters referred to in the forward-looking statements contained in this Form 10-Q may not in fact occur. We caution you, therefore, against relying on any of these forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2024, and in Part II, Item 1A. “Risk Factors” in this Form 10-Q.
Any forward-looking statement made by us in this Form 10-Q speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
26
Table of Contents
Available Information
Our global Internet site is www.lantheus.com. We routinely make available important information, including copies of our Form 10-K, Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after those reports are electronically filed with, or furnished to, the Securities and Exchange Commission (“SEC”), free of charge on our website at investor.lantheus.com. We recognize our website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with our disclosure obligations under SEC Regulation FD. Information contained on our website shall not be deemed incorporated into, or to be part of this Form 10-Q, and any website references are not intended to be made through active hyperlinks.
Our reports filed with, or furnished to, the SEC are also available on the SEC’s website at www.sec.gov, and for Form 10-Ks and Form 10-Qs, in an Inline Extensible Business Reporting Language (“iXBRL”) format. iXBRL is an electronic coding language used to create interactive financial statement data over the Internet. The information on our website is neither part of nor incorporated by reference into this Form 10-Q.
The following discussion and analysis of our financial condition and results of operations should be read together with the condensed consolidated financial statements and the related notes included in Item 1 of this Form 10-Q as well as the other factors described in Part I, Item 1A. “Risk Factors” in our Form 10-K for the year ended December 31, 2024, and in Part II, Item 1A. “Risk Factors” in this Form 10-Q.
Overview
Our Business
We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. We classify our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Our leading Radiopharmaceutical Oncology products help HCPs Find, Fight and Follow cancer. Our leading Precision Diagnostic products assist HCPs to Find and Follow diseases, with a focus in cardiology. Our Strategic Partnerships include biomarkers and digital solutions in support of our partners’ therapeutic development, out-licensing agreements for non-core assets and optimization of our assets geographically. We are headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland and Sweden.
Our commercial products are used by cardiologists, internal medicine physicians, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists, and urologists working in a variety of clinical settings. We believe that our diagnostic products provide information that enables HCPs to better detect and characterize, or rule out, disease, with the potential to achieve better patient outcomes, reduce patient risk, and limit overall costs.
We produce and market our products throughout the United States (the “United States” or the “U.S.”), selling primarily to hospitals, independent diagnostic testing facilities, and radiopharmacies. We sell our products outside the U.S. through a combination of direct distribution in Canada and third-party distribution relationships in Europe, Canada, Australia, Asia-Pacific, Central America, and South America.
Recent Developments
We continue to execute on our strategy to evolve into a fully integrated radiopharmaceutical company, supported by our increasingly diversified portfolio and our targeted initiatives to expand our pipeline, commercial, development and manufacturing capabilities. Over the past year, we announced multiple strategic transactions, which furthered our goal to focus on new markets and expand and diversify our capabilities and development pipeline with complementary assets.
Share Repurchase Program
On July 31, 2025, our Board of Directors (the “Board”) authorized a program to repurchase up to $400.0 million of shares of our common stock through December 31, 2027 (the “2025 Program”). The 2025 Program replaces the program authorized by the Board in November 2024 to repurchase up to $250 million of our common stock during the twelve months following the authorization (the “2024 Program”), including the remaining unused amounts under the 2024 Program, and authorizes us to purchase shares of our common stock from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The timing, manner, price and amount of any repurchase will be subject to the discretion of our Management. The 2025 Program does not obligate us to acquire any particular amount of its common stock, and we may suspend or discontinue the 2025 Program at any time.
27
Table of Contents
Acceptance of NDA for PSMA PET Imaging Agent
On August 6, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for a new formulation of our F-18 PSMA PET imaging agent, filed by our affiliate Aphelion LLC (“Aphelion”), and that the FDA set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (“PDUFA”). The new formulation was designed to optimize the manufacturing process and increase the batch size of our F-18 PSMA PET imaging agent by approximately 50%. If the NDA is approved, we plan to work closely with clinicians and PMF sites to ensure a smooth rollout of the new formulation, including providing clear guidance on ordering, handling, and clinical use to support continuity of care for patients, and we plan to apply for reimbursement from the Centers for Medicare and Medicaid Services (“CMS”) for the new formulation, including obtaining three years of TPT Status.
Acquisition of Life Molecular Imaging
On July 21, 2025, we acquired Life Molecular for an upfront payment of $350.0 million in cash and up to an additional $400.0 million in potential earn-out and milestone payments, pursuant to the terms of the Sale and Purchase Agreement with Life Medical Group Limited and Life Healthcare Group Holdings Limited. Life Molecular is based in Berlin, Germany and is dedicated to advancing novel PET radiopharmaceutical diagnostics. The acquisition includes Neuraceq, an approved Alzheimer's disease diagnostic.
Previously, on July 3, 2024,we acquired from Life Molecular the global rights to RM2, its clinical stage, gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, previously referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 (and which we now refer to as LNTH-2402 and LNTH-2401, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition (the “RM2 Asset Purchase”). In addition, in March 2025, the Company paid a $5.4 million milestone payment related to regulatory activities. On July 21, 2025, we acquired Life Molecular pursuant to a Sale and Purchase Agreement, dated as of January 12, 2025, with Life Medical Group Limited (the “Seller”) and Life Healthcare Group Holdings Limited (the “Sale and Purchase Agreement”). In connection with the completion of this acquisition, we entered into a Deed of Amendment and Restatement (the “Amendment”) to the Sale and Purchase Agreement, pursuant to which, among other things, the parties agreed to deliver the consideration for the RM2 Asset Purchase to the Seller, rather than to Life Molecular (which was the original party to the agreement pursuant to which the Company purchased the RM2 license). We may be required to pay the Seller additional milestone payments and royalties in connection with the RM2 Asset Purchase. GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers, including prostate, breast and lung. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402. We intend to submit investigational new drug applications in support of a Phase 1b/2 clinical trial with the LNTH-2401/LNTH-2402 theranostic pair in prostate cancer patients in the fourth quarter of 2025.
For more information on the acquisition of the global rights to RM2, see Note 19, “Acquisitions” in our condensed consolidated financial statements herein.
Acquisition of Evergreen Theragnostics
On April 1, 2025 (the “Closing Date”), we acquired all the issued and outstanding shares of Evergreen by means of a statutory merger of a subsidiary of the Company with and into Evergreen, with Evergreen surviving as the Company’s wholly-owned subsidiary (the “Evergreen Merger”), pursuant to the terms of the Agreement and Plan of Merger (the “Evergreen Merger Agreement”) with Evergreen and Shareholder Representative Services LLC. Evergreen is a clinical-stage radiopharmaceutical company engaged in contract development and manufacturing services as well as drug discovery and commercialization of proprietary products.
As consideration for the Evergreen Merger, we remitted an upfront payment of $276.4 million in cash. We may make additional potential milestone payments of up to $727.5 million in cash, which may be adjusted pursuant to the Evergreen Merger Agreement, as described therein.
For more information, see Note 19, “Acquisitions” in our condensed consolidated financial statements herein.
Sale of SPECT business
On May 1, 2025, we entered into a definitive agreement to sell our SPECT business to SHINE, a wholly-owned subsidiary of Illuminated Holdings, Inc. Under the terms of the agreement, SHINE will acquire the assets and liabilities associated with our SPECT business, including its diagnostic agents (TechneLite, NEUROLITE, Xenon Xe-133 Gas, and Cardiolite), the portion of the North Billerica, Massachusetts campus that manufactures our SPECT products and the SPECT-related Canadian operations. The transaction allows us to focus on growing our
28
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commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing our pipeline of radiopharmaceuticals. The transaction is subject to customary closing conditions and is expected to be completed around the end of the calendar year.
Acquisition of NAV-4694
On June 18, 2024, we acquired Meilleur Technologies Inc. (“Meilleur”), including its asset NAV-4694, an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloids in Alzheimer’s disease. Under the terms of the agreement, we paid the stockholders of Meilleur (“Meilleur Stockholders”) an upfront payment of $32.9 million and paid an additional $10.0 million in August 2024 after the successful completion of a technology transfer. We could pay additional milestone payments upon achievement of specified U.S. regulatory and commercial milestones related to NAV-4694. We could also pay a double-digit royalty on research revenue and commercial sales. Research revenue is derived from partnerships with pharmaceutical companies and academic institutions that use NAV-4694 in clinical trials. NAV-4694 is currently in Phase 3 development and is also being used in academic and industry sponsored clinical trials. We expect to submit an NDA for NAV-4694 in 2026. In May 2025, we paid AstraZeneca AB (“AstraZeneca”), a $10.0 million one-time, non-refundable upfront payment to reduce the future royalty obligations owed to AstraZeneca, pursuant to a license agreement between AstraZeneca and Meilleur related to NAV-4694.
For more information, see Note 19, “Acquisitions” in our condensed consolidated financial statements herein.
Exclusive License for Radiopharm Theranostics Limited
On June 15, 2024, we entered into an agreement with Radiopharm to acquire all of Radiopharm’s rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”). We acquired global, exclusive rights to both a leucine-rich repeat-containing protein 15 (“LRRC15”)-targeted monoclonal antibody, which we refer to as LNTH-2403, and a Trophoblast cell surface antigen 2 targeted nanobody, which we refer to as LNTH-2404, each of which is a preclinical therapeutic candidate. LNTH-2403 is our pre-clinical therapeutic targeting LRRC15, which is strongly expressed in multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. We are initially focusing on osteosarcoma, for which the FDA has granted both Orphan Drug and Rare Pediatric Disease designations. Osteosarcoma is a malignant bone tumor that primarily develops in children and teenagers. Osteosarcoma is the most common childhood bone cancer, though it is still rare, with around 1,000 new cases diagnosed annually in the U.S.
In connection with this acquisition, we assumed the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations.
During the third quarter of 2024, we purchased 149,625,180 shares of Radiopharm common stock (“Radiopharm Shares”) at the fair market offering price of approximately $0.03 per share, for an aggregate purchase price of approximately $5.0 million. In January 2025, we purchased an additional 133,333,333 Radiopharm Shares at the fair market price of approximately $0.04, for an aggregate purchase price of approximately $5.0 million. At June 30, 2025, we held 282,958,513 Radiopharm Shares.
For more information, see Note 19, “Acquisitions” and Note 4, “Fair Value of Financial Instruments” in our condensed consolidated financial statements herein.
Strategic Agreements with Perspective Therapeutics, Inc.
On January 8, 2024, we entered into multiple strategic agreements with Perspective, a radiopharmaceutical company that is pursuing advanced treatment applications for cancers throughout the body. Under the agreements, we obtained an option to exclusively license Perspective’s Pb212-VMT-α-NET, a clinical stage alpha therapy in development for the treatment of neuroendocrine tumors, and an option to co-develop certain early-stage therapeutic candidates targeting prostate cancer using Perspective’s innovative platform technology for an aggregate upfront payment of $28.0 million in cash.
On January 22, 2024, we purchased 56,342,355 shares of Perspective’s common stock (“Perspective Shares”) at a purchase price of $0.37 per share in a private placement transaction for approximately $20.8 million in cash. We were also granted certain pro rata participation rights to maintain our ownership position in Perspective in the event that Perspective makes any public or non-public offering of any equity or voting securities, subject to certain exceptions.
On March 1, 2024, we transferred the fixed assets and associated lease for the property at 110 Clyde Rd., Somerset, New Jersey (the “Somerset Facility”) to Perspective, and the parties entered into a transition services arrangement pursuant to which we provided Perspective certain services relating to final disposal of radioactive waste and certain other related services.
On March 6, 2024, we purchased an additional 60,431,039 Perspective Shares at a price of $0.95 per share. The total consideration for this additional purchase was approximately $57.4 million, resulting in Lantheus Alpha holding approximately 19.90% of the outstanding Perspective Shares (or 17.35% on a fully diluted basis) as of March 6, 2024.
On June 14, 2024, Perspective effected a 1-for-10 reverse stock split, after which we held 11,677,339 Perspective Shares.
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For more information, see Note 19, “Acquisitions” in our condensed consolidated financial statements herein.
MK-6240
In 2023, we acquired Cerveau, which holds the rights under a license agreement to develop and commercialize MK-6240, an investigational late-stage F-18-labeled PET imaging agent that targets tau tangles in Alzheimer’s disease. Under the terms of the purchase agreement, the former stockholders of Cerveau are eligible to receive certain development and commercial milestone payments, in addition to the initial payments made in 2023. We will pay double-digit royalty payments for research revenue and commercial sales. Research revenue is derived from partnerships with pharmaceutical companies and academic institutions that use MK-6240 in clinical trials and includes milestone and dose-related payments. In September 2023, MK-6240 was granted Fast Track designation by the FDA.
In 2024, we held a pre-NDA meeting with the FDA, and during the second quarter of 2025, we announced that MK-6240 successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. The data from these two studies will support an NDA submission to the FDA expected to be filed in the third quarter of 2025, but we can provide no assurance that we will meet that expected timeline, that our NDA will be accepted by the FDA, that MK-6240 will be approved by the FDA or, if approved, that we will be successful in commercialization.
For more information, see Note 17, “Commitments and Contingencies” in our condensed consolidated financial statements included herein.
Amendment of Credit Facility
In December 2024, we amended our five-year revolving credit facility (as amended, the “2022 Revolving Facility”). The amendment, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that we may request to add to the increased revolving commitment by $350.0 million. The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum.
Key Factors Affecting Our Results
Our business and financial performance have been, and continue to be, impacted by the following:
PYLARIFY Revenue
PYLARIFY, an F-18-labeled PET imaging agent targeting prostate-specific membrane antigen (“PSMA”), was approved by the FDA in May 2021 and commercially launched in the U.S. in June 2021. PYLARIFY is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated prostate-specific antigen levels. PYLARIFY is available through a diverse, multi-partner network of PET manufacturing facilities (“PMFs”), including both commercial and academic partners.
The successful growth of PYLARIFY is dependent on our ability to maintain PYLARIFY as the most utilized PSMA PET imaging agent in an increasingly competitive space. PYLARIFY’s competition includes three gallium-68-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging. The potential for future generic entrants to the market due to the expiry of PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY. We will continue to make investments necessary to drive PYLARIFY awareness and adoption.
Growth and revenue contribution from PYLARIFY will also depend on our ability to clinically differentiate PYLARIFY from competitive products so that customers continue to choose PSMA PET with PYLARIFY for appropriate patients because of its clinical differentiation and despite the loss of TPT Status and changes to Medicare fee-for-service (“FFS”) hospital outpatient payment. Our Healthcare Procedure Coding System code, which enables streamlined billing, went into effect as of January 1, 2022. In addition, from January 1, 2022 to December 31, 2024, PYLARIFY had TPT Status from CMS in the hospital outpatient setting, enabling traditional Medicare FFS to provide separate payment for PYLARIFY in addition to the payment for the PET/computed tomography (“CT”) procedure in that setting. In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”), which recognized the value and need for broad access to diagnostic radiopharmaceuticals. The CMS 2025 OPPS Rule provided separate payment for those diagnostic radiopharmaceuticals with per day costs greater than $630 based on their mean unit cost (“MUC”) for the approximately 20% of patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting. Effective January 1, 2025, CMS began maintaining separate payment for PYLARIFY based on MUC in the hospital outpatient setting, which is lower than payments based on the average selling price that were made during TPT Status. Although PYLARIFY continues to be paid separately, other competitive PSMA PET imaging agents continue to have TPT Status after December 31, 2024, and hospital use of those products, for the approximately 20% of traditional Medicare FFS patients in the hospital outpatient setting, generally will be paid separately based on ASP plus six percent rather than on MUC. In July 2025, CMS released the proposed rule for its calendar year 2026 Medicare Hospital Outpatient
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Table of Contents
Prospective Payment System (the “CMS 2026 Proposed OPPS Rule”). In the CMS 2026 Proposed OPPS Rule, CMS stated that it continues to believe Average Sales Price (“ASP”) data from manufacturers generally is insufficient for payment and that it is seeking comments on how CMS can ensure more consistent, validated, and universal reporting. We have repeatedly engaged CMS on methodology for reporting ASP, and we will continue to work with coalition partners and CMS to support using ASP to calculate payment for diagnostic radiopharmaceuticals in future years similar to the way Medicare Outpatient Prospective Payment System (“OPPS”) currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals.
Our plan to successfully grow PYLARIFY includes conveying its commercial and clinical value, negotiating and realizing the benefits from strategic contracts with customers in the U.S., expanding PYLARIFY’s use in appropriate new patient populations, and through strategic partnerships and collaborations, including outside of the U.S. Internationally, we previously licensed exclusive rights to Curium Pharma ("Curium") to develop and commercialize piflufolastat F-18 in Europe, where it is being commercialized in the European Union under the brand name PYLCLARI. We have entered into strategic collaborations with pharmaceutical companies for the use of PYLARIFY in connection with the development of PSMA-targeted therapeutics. Additional information on these collaborations are described further under Part I, Item 1. “Business - Strategic Partnerships and Other Revenue – Oncology” in our Form 10-K for the year ended December 31, 2024.
DEFINITY Revenue
We believe we will be able to increase use of DEFINITY through continued education of physicians and HCPs about the benefits of ultrasound enhancing agents in suboptimal echocardiograms. The U.S. market currently has three echocardiography ultrasound enhancing agents approved by the FDA; we estimate that DEFINITY will continue to hold at least an 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures.
As we continue to grow our microbubble platform, our activities include:
Expansion of Strategic Partnerships and Other Revenue
We continue to seek ways to further increase the overall value of our portfolio of products and product candidates. We are evaluating a number of different opportunities to collaborate, in-license or acquire additional products, product candidates, businesses and technologies to drive our future growth. In particular, with respect to our Strategic Partnerships and Other Revenue category, we are focused on radiopharmaceutical diagnostic and therapeutic product opportunities in oncology, neurology, and other strategic areas that will complement our existing portfolio.
Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, Biomarker Solutions and contract development and manufacturing organization (“CDMO”) services and is focused on enabling precision medicine with biomarkers, digital solutions and CDMO services.
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Inventory Supply & Third Party Suppliers
We obtain a substantial portion of our imaging agents from third-party suppliers. Although we manufacture DEFINITY at our facility in North Billerica, Massachusetts, Jubilant HollisterStier (“JHS”) is currently a significant supplier of DEFINITY and our sole source manufacturer of NEUROLITE, CARDIOLITE and evacuation vials, the latter being an ancillary component for our TechneLite generators. Our manufacturing and supply agreement with JHS (the “JHS MSA”) runs through December 31, 2027 and can be further extended by mutual agreement of the parties. The JHS MSA requires us to purchase from JHS specified percentages of our total requirements for DEFINITY, as well as specified quantities of NEUROLITE, CARDIOLITE and evacuation vial products, each year during the contract term. Either party can terminate the JHS MSA upon the occurrence of certain events, including the material breach or bankruptcy of the other party.
Radiopharmaceuticals are decaying radioisotopes with half-lives ranging from a few hours to several days. Radiopharmaceutical finished goods, such as doses of PYLARIFY, cannot be kept in inventory because of their limited shelf lives and are subject to just-in-time manufacturing, processing and distribution, which takes place at multiple PMF manufacturing partner sites that produce and deliver doses for us across the U.S. Our TechneLite generators and Xenon-133 are manufactured at our facilities in North Billerica, Massachusetts.
Research and Development Expenses
To ensure we remain the leading radiopharmaceutical-focused company, we have historically made and will continue to make substantial investments in new product development and lifecycle management for existing products, including:
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See Note 19, “Acquisitions” in our condensed consolidated financial statements herein for additional information on potential milestone and royalty payments related to the product candidates listed above.
Our investments in these additional clinical activities and lifecycle management opportunities will increase our operating expenses and impact our results of operations and cash flow, and we can give no assurances as to whether any of these clinical development candidates or lifecycle management opportunities will be successful.
PNT2002
Under the terms of the PNT2002 License Agreement, we paid POINT Biopharma Global Inc. (“POINT”) an upfront cash payment of $250.0 million. The Phase 3 registrational clinical trial for PNT2002, known as the “SPLASH” study, reached 100% of prespecified overall survival events. The results of the readout were comparable to the previously reported 46% and 75% readouts and remain confounded by the overwhelming number of patients who crossed over within the study to receive PNT2002. While we continue to work closely with our partner, Eli Lilly and Company, to review the full dataset, we do not plan to pursue an NDA or further invest in this asset.
PNT2003
Under the terms of the PNT2003 License Agreement, we paid POINT an upfront payment of $10.0 million, and could pay up to an additional $34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones. POINT is also eligible to receive up to $275.0 million in sales milestone payments upon the achievement of specified annual sales thresholds of PNT2003. In addition, POINT is eligible to receive royalty payments of 15% of net sales of PNT2003.
Our investments in these additional clinical activities and lifecycle management opportunities will increase our operating expenses and impact our results of operations and cash flow, and we can give no assurances as to whether any of these clinical development candidates or lifecycle management opportunities will be successful.
Results of Operations
The following is a summary of our consolidated results of operations:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||||||||||||||||||
(in thousands, except percent data) |
|
2025 |
|
|
2024 |
|
|
Change $ |
|
|
Change % |
|
|
2025 |
|
|
2024 |
|
|
Change $ |
|
|
Change % |
|
||||||||
Revenues |
|
$ |
378,045 |
|
|
$ |
394,091 |
|
|
$ |
(16,046 |
) |
|
|
(4.1 |
%) |
|
$ |
750,809 |
|
|
$ |
764,066 |
|
|
$ |
(13,257 |
) |
|
|
(1.7 |
%) |
Cost of goods sold |
|
|
137,034 |
|
|
|
138,317 |
|
|
|
(1,283 |
) |
|
|
(0.9 |
%) |
|
|
272,098 |
|
|
|
266,446 |
|
|
|
5,652 |
|
|
|
2.1 |
% |
Gross profit |
|
|
241,011 |
|
|
|
255,774 |
|
|
|
(14,763 |
) |
|
|
(5.8 |
%) |
|
|
478,711 |
|
|
|
497,620 |
|
|
|
(18,909 |
) |
|
|
(3.8 |
%) |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Sales and marketing |
|
|
41,041 |
|
|
|
45,035 |
|
|
|
(3,994 |
) |
|
|
(8.9 |
%) |
|
|
83,544 |
|
|
|
90,581 |
|
|
|
(7,037 |
) |
|
|
(7.8 |
%) |
General and administrative |
|
|
66,515 |
|
|
|
47,409 |
|
|
|
19,106 |
|
|
|
40.3 |
% |
|
|
123,331 |
|
|
|
95,304 |
|
|
|
28,027 |
|
|
|
29.4 |
% |
Research and development |
|
|
45,489 |
|
|
|
60,601 |
|
|
|
(15,112 |
) |
|
|
(24.9 |
%) |
|
|
81,803 |
|
|
|
108,625 |
|
|
|
(26,822 |
) |
|
|
(24.7 |
%) |
Total operating expenses |
|
|
153,045 |
|
|
|
153,045 |
|
|
|
— |
|
|
|
0.0 |
% |
|
|
288,678 |
|
|
|
294,510 |
|
|
|
(5,832 |
) |
|
|
(2.0 |
%) |
Gain on sale of assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
N/A |
|
|
|
— |
|
|
|
6,254 |
|
|
|
(6,254 |
) |
|
|
(100.0 |
%) |
|
Operating income |
|
|
87,966 |
|
|
|
102,729 |
|
|
|
(14,763 |
) |
|
|
(14.4 |
%) |
|
|
190,033 |
|
|
|
209,364 |
|
|
|
(19,331 |
) |
|
|
(9.2 |
%) |
Interest expense |
|
|
4,917 |
|
|
|
4,862 |
|
|
|
55 |
|
|
|
1.1 |
% |
|
|
9,721 |
|
|
|
9,721 |
|
|
|
— |
|
|
|
0.0 |
% |
Investment in equity securities - unrealized (gain) loss |
|
|
(14,573 |
) |
|
|
22,537 |
|
|
|
(37,110 |
) |
|
|
(164.7 |
%) |
|
|
289 |
|
|
|
(38,167 |
) |
|
|
38,456 |
|
|
|
(100.8 |
%) |
Other income |
|
|
(6,895 |
) |
|
|
(9,044 |
) |
|
|
2,149 |
|
|
|
(23.8 |
%) |
|
|
(21,023 |
) |
|
|
(17,832 |
) |
|
|
(3,191 |
) |
|
|
17.9 |
% |
Income before income taxes |
|
|
104,517 |
|
|
|
84,374 |
|
|
|
20,143 |
|
|
|
23.9 |
% |
|
|
201,046 |
|
|
|
255,642 |
|
|
|
(54,596 |
) |
|
|
(21.4 |
%) |
Income tax expense |
|
|
25,762 |
|
|
|
22,301 |
|
|
|
3,461 |
|
|
|
15.5 |
% |
|
|
49,346 |
|
|
|
62,503 |
|
|
|
(13,157 |
) |
|
|
(21.1 |
%) |
Net income |
|
$ |
78,755 |
|
|
$ |
62,073 |
|
|
$ |
16,682 |
|
|
|
26.9 |
% |
|
$ |
151,700 |
|
|
$ |
193,139 |
|
|
$ |
(41,439 |
) |
|
|
(21.5 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33
Table of Contents
Comparison of the Periods Ended June 30, 2025 and 2024
Revenues
We classify our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Radiopharmaceutical Oncology includes PYLARIFY and historically included AZEDRA. In the first quarter of 2024, we discontinued the production of AZEDRA. Precision Diagnostics includes DEFINITY, TechneLite, and other diagnostic imaging products. Strategic Partnerships and Other Revenue primarily includes revenue derived from partnerships with pharmaceutical companies and academic institutions that use our investigational products, such as MK-6240 and NAV-4694 in clinical trials as research tools. This category of revenues also includes royalties and other milestone payments received from our strategic partners that have commercialized products pursuant to license arrangements with us as well as CDMO revenue generated by Evergreen, which we acquired on April 1, 2025.
Revenues are summarized by product category on a net basis as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||||||||||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||||||||||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
Change $ |
|
|
Change % |
|
|
|
2025 |
|
|
|
2024 |
|
|
Change $ |
Change % |
|
||||||||
PYLARIFY |
|
$ |
250,642 |
|
|
$ |
273,255 |
|
|
$ |
(22,613 |
) |
|
|
(8.3 |
)% |
|
$ |
508,296 |
|
|
$ |
532,125 |
|
|
$ |
(23,829 |
) |
|
|
(4.5 |
)% |
Other radiopharmaceutical oncology |
|
|
— |
|
|
— |
|
|
— |
|
|
|
— |
% |
|
|
— |
|
|
|
384 |
|
|
|
(384 |
) |
|
|
(100.0 |
)% |
||
Total radiopharmaceutical oncology |
|
|
250,642 |
|
|
|
273,255 |
|
|
|
(22,613 |
) |
|
|
(8.3 |
)% |
|
|
508,296 |
|
|
|
532,509 |
|
|
|
(24,213 |
) |
|
|
(4.5 |
)% |
DEFINITY |
|
|
83,939 |
|
|
|
78,100 |
|
|
|
5,839 |
|
|
|
7.5 |
% |
|
|
163,150 |
|
|
|
154,664 |
|
|
|
8,486 |
|
|
|
5.5 |
% |
TechneLite |
|
|
24,982 |
|
|
|
28,186 |
|
|
|
(3,204 |
) |
|
|
(11.4 |
)% |
|
|
44,693 |
|
|
|
49,900 |
|
|
|
(5,207 |
) |
|
|
(10.4 |
)% |
Other precision diagnostics |
|
|
6,892 |
|
|
|
5,825 |
|
|
|
1,067 |
|
|
|
18.3 |
% |
|
|
12,333 |
|
|
|
11,757 |
|
|
|
576 |
|
|
|
4.9 |
% |
Total precision diagnostics |
|
|
115,813 |
|
|
|
112,111 |
|
|
|
3,702 |
|
|
|
3.3 |
% |
|
|
220,176 |
|
|
|
216,321 |
|
|
|
3,855 |
|
|
|
1.8 |
% |
Strategic partnerships and other revenue |
|
|
11,590 |
|
|
|
8,725 |
|
|
|
2,865 |
|
|
|
32.8 |
% |
|
|
22,337 |
|
|
|
15,236 |
|
|
|
7,101 |
|
|
|
46.6 |
% |
Total revenues |
|
$ |
378,045 |
|
|
$ |
394,091 |
|
|
$ |
(16,046 |
) |
|
|
(4.1 |
)% |
|
$ |
750,809 |
|
|
$ |
764,066 |
|
|
$ |
(13,257 |
) |
|
|
(1.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in revenues for the three and six months ended June 30, 2025, as compared to the same periods of 2024, were primarily driven by a decrease in net sales price of PYLARIFY and a decrease in sales volume of TechneLite. These decreases were partially offset by an increase in DEFINITY sales volumes and contract manufacturing service revenue generated by Evergreen.
In addition, for the six months ended June 30, 2025, the decreases were offset by revenue generated from sales for investigational use of NAV-4694, and milestone achievement for the first commercial sale of Flyrcado by GE Healthcare.
Rebates and Allowances
Estimates for rebates and allowances represent our estimated obligations under contractual arrangements with third parties. Rebate accruals and allowances are recorded in the same period the related revenue is recognized, resulting in a reduction to revenue and the establishment of a liability which is included in accrued expenses and other liabilities in our condensed consolidated balance sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth, Medicaid rebate programs for our products, administrative fees of group purchasing organizations, and certain distributor related commissions. The calculation of the accrual for these rebates and allowances is based on an estimate of the third-party’s expected purchases and the resulting applicable contractual rebate to be earned over a contractual period.
An analysis of the amount of, and change in, reserves for rebates and allowances is summarized as follows:
(in thousands) |
|
Rebates and Allowances |
|
|
Balance at January 1, 2025 |
|
$ |
25,248 |
|
Provision related to current period revenues |
|
|
68,992 |
|
Payments or credits made during the period |
|
|
(42,507 |
) |
Balance at June 30, 2025 |
|
$ |
51,733 |
|
Gross Profit
The decrease in gross profit for the three and six months ended June 30, 2025, as compared to the prior year periods, is primarily due to the decrease in PYLARIFY net sales price, partially offset by an increase in PYLARIFY sales volume and an increase in DEFINITY sales volume. In addition, for the three months ended June 30, 2025, the decrease in gross profit was partially offset by a reduction in vendor costs.
Sales and Marketing
Sales and marketing expenses consist primarily of salaries and other related costs for personnel in field sales, marketing, and customer service functions. Other costs in sales and marketing expenses include the development of advertising and promotional material, professional services, market research, and sales meetings.
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Sales and marketing expenses decreased $4.0 million and $7.0 million for the three and six months ended June 30, 2025, as compared to the prior year periods. This was primarily the result of an overall reduction in employee-related costs, as well a decrease in third party vendor and other marketing spend. In addition, the decrease for the six months ended June 30, 2025 included a one-time investment in a brand campaign launch for PYLARIFY that took place during the three months ended March 31, 2024, as well as the cessation in 2025 of launch support related to PNT2002.
General and Administrative
General and administrative expenses consist of salaries and other related costs for personnel in executive, finance, legal, information technology, and human resource functions. Other costs included in general and administrative expenses are professional fees for information technology services, external legal fees, consulting and accounting services as well as bad debt expense, certain facility and insurance costs, including director and officer liability insurance.
General and administrative expenses increased $19.1 million and $28.0 million for the three and six months ended June 30, 2025, respectively, as compared to prior year periods. This was primarily driven by the impact of the acquisition of Evergreen in April 2025, including nonrecurring post-combination expenses related to the settlement of unvested Evergreen stock awards, which resulted in higher stock-based compensation expense and professional fees. In addition, with the increase in headcount from the acquisition, we incurred higher employee-related costs in the three and six months ended June 30, 2025, as compared to the same prior year periods.
Research and Development
R&D expenses relate primarily to salaries and costs related to the development of product candidates to add to our portfolio and costs related to our medical affairs, medical information and regulatory functions.
R&D expenses decreased $15.1 million for the three months ended June 30, 2025, as compared to the same prior year period. This was primarily driven by an upfront option payment of $36.0 million in cash to Life Molecular to sublicense LNTH-2401 and LNTH-2402, as well as $2.0 million to Radiopharm to sublicense LNTH-2403 and LNTH-2404, in the second quarter of 2024. These decreases were partially offset by a payment to AstraZeneca of $10.0 million in May 2025 to reduce future royalty obligations for NAV-4694, expenses resulting from the acquisition of Evergreen in April 2025 and increases in project costs related to assets acquired in 2024, including LNTH-2401, LNTH-2402, LNTH-2403 and NAV-4694.
R&D expenses decreased $26.8 million for the six months ended June 30, 2025, as compared to the same period of 2024. This was primarily driven by the upfront payment of $36.0 million to Life Molecular to sublicense LNTH-2401 and LNTH-2402, an upfront option payment of $28.0 million to Perspective, as well as $2.0 million to Radiopharm to sublicense LNTH-2403 and LNTH-2404, in each case during the prior year period. These decreases were partially offset by a payment to AstraZeneca of $10.0 million to reduce future royalty obligations for NAV-4694, expenses related to the acquisition of Evergreen, increases in project costs related to assets acquired in 2024 including LNTH-2401, LNTH-2402, LNTH-2403, and NAV-4694, as well as an increase in employee-related costs resulting from an increase in headcount.
Investment in Equity Securities - Unrealized (Gain) Loss
Investment in equity securities - net unrealized (gain) loss increased $37.1 million for the three months ended June 30, 2025, compared to the same period of 2024. Investment in equity securities - net unrealized (gain) loss decreased $38.5 million for the six months ended June 30, 2025, compared to the same period of 2024. Each quarter our investments in equity securities of Radiopharm and Perspective are revalued to market price. For the three months ended June 30, 2025, we recorded an unrealized loss on the investment in Radiopharm of $0.8 million and recorded an unrealized gain on the investment in Perspective of $15.3 million. For the six months ended June 30, 2025, we recorded an unrealized loss on the investment in Radiopharm of $3.3 million and recorded an unrealized gain on the investment in Perspective of $2.9 million. This is compared to unrealized gain on the investment in Perspective of $22.5 million for the three months ended June 30, 2024 and an unrealized loss on the investment in Perspective Shares of $38.2 million for the six months ended June 30, 2024.
Other Income
Other income decreased $2.1 million for the three months ended June 30, 2025 compared to the same period of 2024, primarily due to a decrease in interest income on lower average cash balances after the acquisition of Evergreen in April 2025. Other income increased $3.2 million for the six months ended June 30, 2025, compared to the same period of 2024, primarily due to a $4.7 million adjustment recorded to reduce the previous estimate of remediation costs related to the potential decommissioning of our facilities of their radioactive-related operations. See Note 10, “Asset Retirement Obligations,” for more information on our asset retirement obligation. This was partially offset by a decrease in interest income on lower average cash balances mentioned above.
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Income Tax Expense
Our effective tax rate for each reporting period is presented as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Effective tax rate |
|
|
24.6 |
% |
|
|
26.4 |
% |
|
|
24.5 |
% |
|
|
24.4 |
% |
Our effective tax rate for the three months ended June 30, 2025 differs from the U.S. statutory rate of 21% primarily due to state income taxes and non-deductible stock compensation, partially offset by tax credits and the change in valuation allowance related to the fluctuation in value of our investment in equity securities balance. Our effective tax rate for six months ended June 30, 2025 differs from the U.S. statutory rate of 21% primarily due to state income taxes, partially offset by tax credits and the income tax benefits associated with stock compensation deductions.
The decrease in the effective income tax rate for the three months ended June 30, 2025 is primarily due to the change in the valuation allowance related to the fluctuation in value of our investment in equity securities balance, partially offset by the increase in non-deductible stock compensation. There was no material change in the effective tax rate for the six months ended June 30, 2025, when compared to the same period of 2024.
Liquidity and Capital Resources
Cash Flows
The following table provides information regarding our cash flows:
|
|
Six Months Ended |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Net cash provided by operating activities |
|
$ |
194,669 |
|
|
$ |
211,958 |
|
Net cash used in investing activities |
|
$ |
(296,190 |
) |
|
$ |
(151,615 |
) |
Net cash used in financing activities |
|
$ |
(116,632 |
) |
|
$ |
(16,746 |
) |
Net Cash Provided by Operating Activities
Net cash provided by operating activities of $194.7 million in the six months ended June 30, 2025 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized loss (gain) on investment in equity securities, charges incurred in connection with the RM2 license, adjustments to the fair value of asset retirement obligation, depreciation, amortization and accretion expense, and stock-based compensation expense. The primary working capital sources of cash include an increase in accounts payable and accrued expenses which was attributable to the timing of payments to large vendors. The primary working capital uses of cash include an increase in trade receivables associated primarily with the timing of billings and collections and an increase in inventory related to the timing of batch processes. In addition, the Company recognized a nonrecurring post-combination expense attributed to the acceleration of historical Evergreen stock awards of $7.5 million.
Net cash provided by operating activities of $212.0 million in the six months ended June 30, 2024 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized gain on equity investment, charges incurred in connection with the Perspective IPR&D exclusive license option, charges related to Radiopharma’s licensed assets, charges related to Life Molecular’s RM2 license, depreciation, amortization and accretion expense and stock-based compensation expense. The primary working capital sources of cash were the timing of payments to large vendors. The primary working capital uses of cash were an increase in trade receivables associated primarily with the increase in PYLARIFY revenues, and an increase in inventory related to the timing of batch processes.
Net Cash Used in Investing Activities
Net cash used in investing activities during the six months ended June 30, 2025 was driven by $269.1 million paid to the former holders of Evergreen Shares for the acquisition of Evergreen, $5.0 million used to purchase equity securities, a $5.4 million milestone payment made related to RM2 and $16.7 million of capital expenditures.
Net cash used in investing activities during the six months ended June 30, 2024 was driven by an upfront option payment of $28.0 million to Perspective, $1.0 million upfront payment to Life Molecular, $32.9 million upfront payment to the Meilleur Stockholders, $78.3 million for the purchase of equity securities and $19.4 million of capital expenditures, partially offset by net cash proceeds of $8.0 million from the sale of the Somerset facility sublease and associated assets.
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Net Cash Used in Financing Activities
Net cash used in financing activities during the six months ended June 30, 2025 is primarily attributable to the repurchase of our common stock for approximately $100.0 million, the payments for minimum statutory tax withholding related to net share settlement of equity awards of $24.5 million, offset by proceeds of $8.3 million from stock option exercises and issuance of common stock.
Net cash used in financing activities during the six months ended June 30, 2024 is primarily attributable to the payments for minimum statutory tax withholding related to net share settlement of equity awards of $20.4 million, offset by proceeds of $4.3 million from stock option exercises and issuance of common stock.
External Sources of Liquidity
In December 2024, we entered into an amendment to the 2022 Revolving Facility that, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that Lantheus Medical may request to add to the increased revolving commitment by $350.0 million. The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum. The full terms of the 2022 Revolving Facility are set forth in the Credit Agreement, dated as of December 2, 2022, by and among us, the lenders from time to time party thereto and Citizens Bank, N.A., as administrative agent and collateral agent, as amended. We have the right to request an increase to the 2022 Revolving Facility or request the establishment of one or more new incremental term loan facilities, in an aggregate principal amount of up to the greater of $685.0 million (so that the total amount available is $1.44 billion) or 100% of consolidated earnings before interest, taxes, depreciation and amortization for the four consecutive fiscal quarters most recently ended, plus additional amounts, in certain circumstances.
Under the terms of the 2022 Revolving Facility, the lenders thereunder agreed to extend credit to us from time to time until December 19, 2029 consisting of revolving loans in an aggregate principal amount not to exceed $750.0 million at any time. The 2022 Revolving Facility includes a $40.0 million sub-facility for the issuance of letters of credit (the “Letters of Credit”). The 2022 Revolving Facility includes a $20.0 million sub-facility for swingline loans (the “Swingline Loans”). The Letters of Credit, Swingline Loans and the borrowings under the 2022 Revolving Facility are expected to be used for working capital and other general corporate purposes.
Please refer to Note 12. “Long-Term Debt, Net, and Other Borrowings” to our condensed consolidated financial statements for further details on the 2022 Revolving Facility.
As of June 30, 2025, we were in compliance with all financial and other covenants under the 2022 Credit Agreement.
On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due 2027 (the “Notes”), which includes $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes. The Notes were issued under an indenture, dated as of December 8, 2022 (the “Indenture”), among the Company, Lantheus Medical, as Guarantor, and U.S. Bank Trust Company, National Association, as Trustee. The net proceeds from the issuance of the Notes were approximately $557.8 million, after deducting the initial purchasers’ discounts and offering expenses payable by us.
In November 2024, the Board authorized a program to repurchase up to $250 million of our common stock during the twelve months following the authorization (the “2024 Program”). During the three months ended June 30, 2025, we repurchased 1.3 million shares of our common stock for an aggregate purchase price of approximately $100.0 million. As of June 30, 2025, we have purchased approximately 2.4 million shares of our common stock under the 2024 Program for approximately $200.0 million. On July 31, 2025, the Board authorized the 2025 Program, which replaces the 2024 Program, including the remaining unused portion of the 2024 Program. Pursuant to the 2025 Program, we may repurchase up to $400.0 million in shares of our common stock through December 31, 2027, from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The actual timing, number and dollar amount of repurchase transactions will be determined by our management, in its discretion and will depend on a number of factors, including but not limited to, the market price of our common stock.
Our ability to fund our future capital needs will be affected by our ability to continue to generate cash from operations and may be affected by our ability to access the capital markets, money markets or other sources of funding, as well as the capacity and terms of our financing arrangements.
We may from time to time repurchase or otherwise retire our debt and take other steps to reduce our debt or otherwise improve our balance sheet. These actions may include prepayments of our term loans or other retirements or refinancing of outstanding debt, privately negotiated transactions or otherwise. The amount of debt that may be retired, if any, could be material and would be decided at the sole discretion of our Board and will depend on market conditions, our cash position, and other considerations.
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Funding Requirements
Our future capital requirements will depend on many factors, including:
Disruption in our financial performance could occur if we experience significant adverse changes in product or customer mix, significant changes in our competitive or regulatory environment, broad economic downturns, sustained inflation, adverse industry or company conditions or catastrophic external events, including pandemics, natural disasters and political or military conflict. If we experience one or more of these events in the future, we may be required to implement expense reductions, such as a delay or elimination of discretionary spending in all functional areas, as well as scaling back select operating and strategic initiatives.
If our capital resources become insufficient to meet our future capital requirements, we would need to finance our cash needs through public or private equity offerings, debt financings, assets securitizations, sale-leasebacks or other financing or strategic alternatives, to the extent such transactions are permissible under the covenants of our 2022 Credit Agreement. Additional equity or debt financing, or other transactions, may not be available on acceptable terms, if at all. If any of these transactions require an amendment or waiver under the covenants in our 2022 Credit Agreement, which could result in additional expenses associated with obtaining the amendment or waiver, we will seek to obtain such an amendment or waiver to remain in compliance with those covenants. However, we cannot provide assurance that such an amendment or waiver would be granted, or that additional capital will be available on acceptable terms, if at all.
At June 30, 2025, our only current committed external source of funds is our borrowing availability under our 2022 Revolving Facility. We had $695.6 million of cash and cash equivalents as of June 30, 2025. Our 2022 Revolving Facility contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. Incremental borrowings under the 2022 Revolving Facility may affect our ability to comply with the covenants including the financial covenants restricting consolidated net leverage and interest coverage. Accordingly, we may be limited in utilizing the full amount of our 2022 Revolving Facility as a source of liquidity.
Based on our current operating plans, we believe our balance of cash and cash equivalents, along with cash generated by ongoing operations and continued access to our 2022 Revolving Facility, will be sufficient to satisfy our cash requirements over the next twelve months and beyond.
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Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect our reported assets and liabilities, revenues and expenses, and other financial information. Actual results may differ materially from these estimates under different assumptions and conditions. In addition, our reported financial condition and results of operations could vary due to a change in the application of a particular accounting standard.
There have been no significant changes to our critical accounting policies or in the underlying accounting assumptions and estimates used in such policies in the six months ended June 30, 2025. For further information, refer to our summary of significant accounting policies and estimates in our Form 10-K for the year ended December 31, 2024.
Off-Balance Sheet Arrangements
We are required to provide the Massachusetts Department of Public Health financial assurance demonstrating our ability to fund any decommissioning of our North Billerica, Massachusetts production facility in the event of any closure. We have provided this financial assurance in the form of a $30.3 million surety bond.
We have not engaged in any other off-balance sheet arrangements, including structured finance, special purpose entities or variable interest entities.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
For quantitative and qualitative disclosures about market risk, see Part II, Item 7A. “Quantitative and Qualitative Disclosures About Market Risk,” of our Form 10-K for the year ended December 31, 2024. Our exposures to market risk have not changed materially since December 31, 2024.
Equity Investment Risk
As of June 30, 2025, our recorded carrying value of investments in equity securities was $44.2 million, comprised of our equity investments in Perspective and Radiopharm, and is recorded at fair value, subject to market price volatility. We record our equity investments in public companies at fair value and adjust our equity investments in public companies for observable price changes or impairments. Valuations of public companies are variable and subject to change in share price at the applicable measurement period.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
The Company’s management, with the participation of the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), its principal executive officer and principal financial officer, respectively, has evaluated the effectiveness of the Company’s disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act. Based on that evaluation, the Company’s CEO and CFO concluded that the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) were effective as of the period covered by this report.
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Information with respect to certain legal proceedings is included in Note 17, “Commitments and Contingencies”, to the condensed consolidated financial statements contained in Part I, Item 1. Financial Statements of this Form 10-Q and is incorporated herein by reference.
Item 1A. Risk Factors
There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, except as set forth below:
Risks Related to Our Portfolio of Commercial Products
Our ability to grow PYLARIFY as a commercial product is dependent on (A) the ability of positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY to meet product demand, including ensuring that PYLARIFY is available at the specific time of day preferred by the end-user, (B) our ability to maintain adequate coding, coverage and payment for PYLARIFY, (C) our ability to promote PYLARIFY to customers and to maintain PYLARIFY as the most utilized prostate-specific membrane antigen (“PSMA”) PET imaging agent, which has been impacted by the expiration of transitional pass-through payment status (“TPT Status”) on December 31, 2024, (D) whether and when a potential generic version of PYLARIFY may enter the market and (E) our ability to clinically and commercially differentiate PYLARIFY from an increasing number of potentially competitive products.
To manufacture PYLARIFY, we assembled and qualified a nationwide network of PMFs with radioisotope-producing cyclotrons that make F-18, which has a 110-minute half-life, so PYLARIFY is manufactured and distributed rapidly to end-users. Because each of the PMFs manufacturing these products is deemed by the U.S. Food and Drug Administration (“FDA”) to be a separate manufacturing site, each has to be separately approved by the FDA. Although PYLARIFY is broadly available across the U.S., we continue to seek qualification for additional PMFs in 2025 and can give no assurance that the FDA will continue to approve PMFs in accordance with our expansion plans to meet product demand or that PYLARIFY will be available at the specific time of day preferred by the end-users or that our expansion plans accurately predict demand growth. To the extent that PYLARIFY is not available at preferred times, end users have, in some instances, switched to available competitive products. If FDA approval of manufacturing sites is delayed or withdrawn or if FDA requirements relating to site approval change impacting our ability to meet demand for PYLARIFY or end users scheduling needs or if we invest to extend our PMF network and demand does not grow to meet the expanded capacity, our business, results of operations, financial condition and cash flows would be adversely affected.
Obtaining adequate coding, coverage, and payment for PYLARIFY is critical, including not only coverage from Medicare, Medicaid and other government payors, as well as private payors, but also appropriate payment levels to adequately cover our customers’ costs of using PYLARIFY in PET/computed tomography (“CT”) imaging procedures. The Healthcare Procedure Coding System code for PYLARIFY, which enables streamlined billing, went into effect as of January 1, 2022. PYLARIFY also had TPT Status from January 1, 2022 until December 31, 2024, which enabled traditional Medicare to provide an incremental payment for PET/CT scans performed with PYLARIFY in the hospital outpatient setting. After expiry of TPT Status, diagnostic radiopharmaceuticals, such as, PYLARIFY, historically would not have been separately reimbursed in the hospital outpatient setting but rather would be bundled into the facility payment a hospital receives for a PET/CT imaging procedure, and the facility payment may not have adequately covered the total cost of the procedure with the diagnostic radiopharmaceutical for all hospitals. In November 2024, the Centers for Medicare and Medicaid Services (“CMS”) released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”). The CMS 2025 OPPS Rule became effective on January 1, 2025, pursuant to which previously packaged diagnostic radiopharmaceuticals are now “unbundled” with payments being made separately for any diagnostic radiopharmaceutical with a per day cost greater than $630 based on their mean unit cost (“MUC”). For approximately 20% of traditional Medicare fee-for-service (“FFS”) patients in the hospital outpatient setting, these changes enable hospitals that use innovative diagnostic radiopharmaceuticals, including PYLARIFY, to continue to be paid separately by CMS following the expiry of TPT Status at a rate that reflects MUC. The calendar year 2025 payment rate for PYLARIFY is based on MUC and is less than the Average Sales Price (“ASP”)-based amount that was paid during TPT Status. Although PYLARIFY continues to be paid separately, other competitive PSMA PET imaging agents continue to have TPT Status after December 31, 2024 and hospital use of those products, for the approximately 20% of traditional Medicare FFS patients in the hospital outpatient setting, generally will be paid separately based on ASP plus six percent rather than on MUC. In July 2025, CMS released the proposed rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2026 Proposed OPPS Rule”). In the CMS 2026 Proposed OPPS Rule, CMS stated that it continues to believe ASP data available from manufacturers generally is insufficient as a basis for determining payment and that it is seeking comments on how CMS can ensure more consistent, validated, and universal reporting. We have reported and continue to report ASP for PYLARIFY, have engaged with CMS on the methodology for reporting ASP, and we will continue to work with coalition partners and CMS to support using ASP to calculate payment for diagnostic radiopharmaceuticals in future years similar to the way Medicare Outpatient Prospective Payment System (“OPPS”) currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals. However, we can give no assurances that we will be successful in those efforts or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not continue to impact clinical decision making regarding which product to use for all patient populations, which could have an adverse effect on our business, results of operations, financial condition and cash flows.
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Growth of PYLARIFY is also dependent on our ability to promote PYLARIFY to customers, to clinically and commercially differentiate PYLARIFY from other products on the market, to enter into and realize the benefits of strategic contracts with customers and to maintain PYLARIFY as the most utilized PSMA PET imaging agent in an increasingly competitive environment in which other PSMA PET imaging agents have been approved, for which discounts related to those other agents have been offered to customers and for which TPT Status may be available. PYLARIFY currently competes with three commercially available Ga-68-based PSMA PET imaging agents, two from Telix Pharmaceuticals Limited and one from Novartis AG and an F-18 PSMA PET imaging agent from Blue Earth Diagnostics Ltd. (“Blue Earth”), as well as other non-PSMA PET imaging agents. The potential for future generic entrants to the market due to the expiry of PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY. Growth and revenue contribution from PYLARIFY will also depend on our ability to clinically differentiate PYLARIFY from competitive products so that customers continue to choose PSMA PET with PYLARIFY for appropriate patients because of its clinical differentiation and despite the loss of TPT Status and a potential economic difference that could result for the approximately 20% of traditional Medicare FFS patients in the hospital outpatient setting based on the CMS 2025 OPPS Rule, including through flexible and dependable access to PYLARIFY nationally, a best-in-class customer experience and continued promotion and education regarding PYLARIFY’s clinical and commercial attributes. Our ability to negotiate and realize the benefits from strategic contracts is also key to our ability to maintain and expand market share. Despite these efforts, we have seen net price compression and lost market share to certain competitors that have later approved products with TPT Status at a time when PYLARIFY’s TPT Status has expired, and we may experience further net price compression or lose market share to future competitive products due to reimbursement status as well as due to the impact of any potential generic entrant to the market. Such loss of market share could have an adverse impact on our business, results of operations, financial condition and cash flows.
Our success in growing PYLARIFY also depends, in part, on our successfully establishing the use of PYLARIFY for new patient populations, such as patients with favorable intermediate-risk prostate cancer, and potentially for updates to the label, including for patient selection for PSMA-targeted therapeutics. For example, we are conducting a clinical trial to determine whether PYLARIFY can detect the presence or absence of additional prostate cancer lesions in patients with favorable intermediate-risk prostate cancer, as well as how it may change the patient’s intended management, but cannot predict whether the outcome of this clinical trial will support such a use of PYLARIFY. Similarly, we believe the approval of PLUVICTO for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (“mCRPC”) created a new addressable market for the use of PSMA PET imaging in patient selection for PSMA-targeted therapy. We can give no assurances as to how current clinical practice may evolve. To the extent we are unsuccessful in establishing the use of PYLARIFY in new patient populations, such lack of success could have an adverse impact on our business, results of operations, financial condition and cash flows.
Potential generic competitors may seek to enter the market as a result of regulatory exclusivity expiration of PYLARIFY
PYLARIFY currently has six Orange Book-listed patents, the last of which expires in 2037. PYLARIFY also holds a five-year new chemical entity (“NCE”) regulatory exclusivity, which expires on May 26, 2026. As described further under Part I, Item 1., “Business - Regulatory Matters-Hatch Waxman Act,” of our Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on February 26, 2025, the FDA is allowed to accept an Abbreviated New Drug Application (“ANDA”) or 505(b)(2) application one year prior to the NCE expiration date under certain circumstances, specifically, from a generic challenger that includes a “Paragraph IV” Certification against each of the six patents we have listed in the Orange Book. If a Paragraph IV Certification is made, we could elect to pursue Hatch-Waxman litigation and trigger the 30-month stay described under Part I, Item 1., “Business - Intellectual Property Matters – Patent-related Aspects of Regulatory Matters,” of our Form 10-K for the year ended December 31, 2024 filed with the SEC on February 26, 2025, during which period the FDA would be prohibited from granting full approval to the challenger’s application. As of the date of filing of this Form 10-Q, we have not received any notice of a Paragraph IV Certification, but we can give no assurance that we will not receive notice of a Paragraph IV Certification in the future. If an ANDA or 505(b)(2) applicant were to file prior to the expiration of our NCE regulatory exclusivity, and we were to timely sue pursuant to the Hatch-Waxman Act, then the automatic stay of FDA approval could run until November 26, 2028, calculated as 30 months from the NCE expiration date (May 26, 2026), unless prior to such date the generic challenger successfully invalidates or proves non-infringement of all six Orange Book-listed patents or the lawsuit is otherwise settled. If litigation is ongoing in November 2028, then any generic launch would be at risk of the litigation determining that the generic challenger was infringing one or more of our patents Patent litigation is complex and can be protracted and expensive, so if we were to receive such a notice and to challenge the applicant, this could have a negative effect on our business, results of operations and financial condition.
We may not, or may take longer to, realize the expected benefits and opportunities related to, investments we have made to develop our new formulation of our PSMA PET Imaging Agent.
On August 6, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for a new formulation of our F-18 PSMA PET imaging agent, filed by our affiliate Aphelion, and that the FDA set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (“PDUFA”). The new formulation was designed to optimize the manufacturing process and increase batch size of the F-18 PSMA PET imaging agent by approximately 50%. If the NDA is approved, we plan to work closely with clinicians and PMF sites to ensure a smooth rollout of the new formulation, including providing clear guidance on ordering, handling, and clinical use to support continuity of care for patients, and we plan to apply for CMS reimbursement for the new formulation, including obtaining three years of TPT Status; however, we can provide no assurance that the new formulation will be approved by the FDA, that we will meet our timeline for our planned rollout, or that we will obtain TPT Status.
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Risks Related to Reimbursement and Regulation
Reforms to the U.S. healthcare system, including changes to policies, guidelines and practices of regulatory authorities, may adversely affect our business.
A significant portion of our patient volume is derived from U.S. government healthcare programs, principally Medicare, which are highly regulated and subject to frequent and substantial changes. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Act”) substantially changed the way healthcare is financed by both governmental and private insurers. The law contains a number of provisions that affect coverage and reimbursement of drug products and medical imaging procedures performed in the U.S. Subsequently, the Medicare Access and CHIP Reauthorization Act of 2015 significantly revised the methodology for updating the Medicare physician fee schedule. In 2017, Congress enacted legislation that effectively eliminated the Healthcare Reform Act's “individual mandate” beginning in 2019. On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the “OBBBA”), which will reduce existing patient coverage under Medicaid. The expiration of certain subsidies for Marketplace coverage currently in place under the Healthcare Reform Act at the end of 2025 may also cause material coverage losses. The OBBBA further restricts Medicaid financing, which will decrease federal funds available to state Medicaid agencies and may result in reduced state Medicaid agency reimbursement rates. Congress continues to consider other healthcare reform legislation. There is no assurance that the Healthcare Reform Act, as currently enacted or as amended in the future, will not adversely affect our business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating to healthcare reform will affect our business.
In addition, other legislative changes have been proposed and adopted since the Healthcare Reform Act was enacted. The Budget Control Act of 2011 and subsequent Congressional actions includes provisions to reduce the federal deficit. These provisions have resulted in the imposition of 2% reductions in Medicare payments to providers, which went into effect on April 1, 2013 and will remain in effect through fiscal year 2030. The imposition of the 2% payment adjustment had been suspended through March 31, 2022 and went into effect as of April 1, 2022. The Congressional Budget Office estimates that, absent future action, the OBBBA will lead to $490 billion in Medicare cuts from 2027 to 2034. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented and/or any significant taxes or fees that may be imposed on us, as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, could have an adverse impact on our business, results of operations, financial condition and cash flows.
Further, changes in payor mix and reimbursement by private third-party payors may also affect our business. Rates paid by some private third-party payors are based, in part, on established physician, clinic and hospital charges and are generally higher than Medicare payment rates. Reductions in the amount of reimbursement paid for diagnostic medical imaging procedures, including the elimination of any additional payment such as TPT Status, and changes in the mix of our patients between non-governmental payors and government sponsored healthcare programs and among different types of non-government payor sources, could have a material adverse effect on our business, results of operations, financial condition and cash flows.
The full impact on our business of healthcare reforms and other new laws, or changes in existing laws, the interpretations of those laws, or changes to the way regulations and regulatory guidance has been implemented, amended and interpreted, is uncertain. Nor is it clear whether additional legislative or executive branch changes will be adopted or how those changes would affect our industry in general or our ability to successfully commercialize our products or develop or commercialize new products. For example, recent government actions, including reductions in staff and department reorganizations, including those at the FDA, could adversely affect the timing of anticipated regulatory actions or their outcome, and could change historical practices relating to the application or interpretation of regulations relevant to our operations in ways that could have an adverse effect on our business. It is unclear exactly how changes implemented by the U.S. Government will affect the U.S. healthcare system, and what impact this will have on our business. If the reforms made by the OBBBA are implemented and result in predicted coverage losses, these changes could reduce the overall number of diagnostic medical imaging procedures performed, reduce reimbursement rates, or both.
Risks Related to Our Business Operations and Financial Results
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We may be adversely affected by prevailing economic conditions and financial, business and other factors beyond our control.
Our ability to attract and retain employees and customers, to invest in and grow our business, to maintain our desired levels of costs of goods sold and operating expenses and to meet our financial obligations depends on our operating and financial performance, which, in turn, is subject to numerous factors, including the prevailing economic conditions, changes to financial, business and regulatory expectations, and other factors beyond our control, such as the rate of unemployment, the number of uninsured persons in the U.S., inflationary pressures, escalating prices, including those that may occur as a result of tariff policies. We cannot anticipate all the ways in which the current or future economic climate, financial market conditions and government actions could adversely impact our business. We are exposed to risks associated with reduced profitability and the potential financial instability of our customers, many of which may be adversely affected by conditions in the financial markets. For example, unemployment and underemployment, and the resultant loss of insurance, may decrease the demand for healthcare services and pharmaceuticals, including our products. If fewer patients are seeking medical care because they do not have insurance coverage, our customers may experience reductions in revenues, profitability and/or cash flow that could lead them to modify, delay or cancel orders for our products or seek lower cost alternatives to our products where available. If customers are not successful in generating sufficient revenue, are precluded from securing financing from the financial markets, or lose or cannot secure funding from the government, they may not be able to pay, or may delay payment of, accounts receivable that are owed to us. Research programs that could benefit from our investigational or commercial products may slow or be discontinued if funding cannot be secured or is withdrawn, which could delay when the results of such research becomes available and when or how often our products are purchased by third parties for use in their research programs. This, in turn, could adversely affect our financial condition and liquidity. To the extent prevailing economic conditions result in fewer procedures being performed or fewer research programs being completed, our business, results of operations, financial condition and cash flows could be adversely affected.
In addition, we would expect our costs of goods sold and other operating expenses to change in the future in line with periodic inflationary changes. Because we intend to retain and continue to use our property and equipment, we believe that the incremental inflation related to the replacement costs of those items will not materially affect our operations. However, the rate of inflation affects our expenses, such as those for employee compensation, contract services, and transportation costs, which could increase our level of expenses and the rate at which we use our resources. Similarly, our operations and supply chain may subject us to tariffs and trade policies. For example, the U.S. government has increased, and has indicated a willingness to continue to increase, the use of tariffs by the United States. Such tariffs and any countermeasures taken by other countries could increase the cost of raw materials, components and equipment necessary for our operations, disrupt our global supply chain, create additional operational challenges or adversely impact our customers and business partners. While we generally believe that we will be able to offset the effect of inflationary and other changes by adjusting our product prices and implementing operating efficiencies, any material unfavorable changes in our costs of goods sold or other operating expenses, including from tariffs, could have a material adverse effect on our financial condition, results of operations and cash flows.
An interruption in our ability to fulfill our obligations as a service provider or supplier to third parties, either through our contract development and manufacturing operations and/or in supplying our investigational products in support of research programs being conducted by third parties, may adversely affect our reputation and business.
We have obligations to perform development and manufacturing services for third parties that have contracted with Evergreen for these services. These services are conducted out of a single location. Any disruption in our operations, any failure to timely and cost-effectively secure necessary personnel, components or materials, any failure to comply with the stringent regulations and requirements of the FDA and other regulatory authorities regarding the manufacture and development of radiopharmaceutical products, may cause us to fail to meet our contractual obligations and may adversely affect our business.
We also have contractual commitments to supply our investigational products and certain of our commercial products to third parties as part of their own research programs. Our ability to supply these products may depend upon the ability of PMFs to manufacture the products to meet the requirements of each research program, including that the product be available at the specific time of day required by the third party’s research protocol, which may include locations both within and outside of the United States. We may have limited alternative PMF facilities in certain locations in the event one or more facility is unable to timely manufacture and supply the relevant products, and it may not be possible to timely manufacture the relevant products at required levels or at all, which may cause us to fail to meet our contractual obligations and may adversely affect our business.
Our recent acquisitions, dispositions and other future strategic transactions may disrupt our ongoing business and create distractions for our management. Additionally, the risks related to these transactions, including the risk that we are unable to successfully integrate acquired businesses into our operations, the risk that we are unable to complete dispositions on the proposed terms or on the anticipated timeline, or at all, or are unable to realize the anticipated benefits that each transaction is predicted to bring, could adversely affect our business, financial condition or results of operations.
As a part of our growth strategy, we have made and may continue to make selected acquisitions of complementary businesses, such as our recent acquisitions of Life Molecular Imaging Ltd. (“Life Molecular”) in July 2025 and Evergreen Theragnostics, Inc. (“Evergreen”) in April 2025. In addition, as part of our broader strategy, in May 2025, we announced that we had entered into a definitive agreement to sell our single-photon emission computerized tomography (“SPECT”) business to SHINE Technologies, LLC (“SHINE”). These transactions, in addition to advancing our existing pipeline and focusing our operations, create multiple competing interests that are complex and time-consuming, which may distract our management and disrupt our ongoing business.
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Our completed and any potential future acquisitions involve numerous risks and operational, financial, and managerial challenges, including the following, any of which could adversely affect our business, financial condition, or results of operations:
In addition, the successful integration of acquired businesses requires significant efforts and expense across all operational areas, including research and development, manufacturing, sales and marketing, finance, legal, and information technologies. There can be no assurance that any of our acquisitions will be successful or will be, or will become or remain, profitable. Our failure to successfully address the foregoing risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all.
Further, the pending disposition of our SPECT business to SHINE is subject to customary closing conditions. Such closing conditions may be time consuming, and we may not be able to complete the disposition on the proposed terms or in the anticipated timeline, or at all. Additionally, there may be unforeseen expenses related to this divestiture, or we may fail to realize the expected benefits of this transaction.
We may be unable to successfully integrate Life Molecular’s Alzheimer’s disease radiodiagnostic commercial infrastructure and grow the appropriate use of Neuraceq to detect beta-amyloid plaques in patients evaluated for Alzheimer’s disease.
We completed our acquisition of Life Molecular on July 21, 2025, which included the acquisition of Neuraceq, a globally approved F-18 PET imaging agent used to detect beta-amyloid plaques in patients evaluated for Alzheimer’s disease, as well as the addition of an Alzheimer’s disease radiodiagnostic commercial infrastructure, advanced research and development capabilities, and an established international footprint.
If we are not able to continue to grow Neuraceq sales, which depend, in part, on the expansion of the Alzheimer’s disease therapeutic market, our ability to integrate Life Molecular’s commercial infrastructure, our ability to expand the PMF network where Neuraceq is currently produced in the U.S. and our ability to leverage both the PMF network in place for PYLARIFY in the U.S. and the network in place for Neuraceq to optimize the availability of both products across the U.S., we may not be able to continue to grow the revenue and cash flow of our business, which could have a negative effect on our business, results of operations and financial condition.
Risks Related to Our Capital Structure
Repurchases by us of our common stock may affect the value of our common stock.
We have from time to time engaged in repurchase programs of our common stock. In July 2025, our Board of Directors (the “Board”) authorized a program to repurchase up to $400.0 million of shares of our common stock through December 31, 2027, via open market purchases, privately negotiated transactions, block trades or pursuant to trades intending to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. Such repurchases could increase, or prevent a decrease in, the market price of our common stock, although there can be no assurance that an increase, or prevention of a decrease, would occur, and stockholders could prefer that we allocate our capital in a different manner, which could negatively impact the market price of our common stock.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Repurchases
The following table presents information with respect to purchases of common stock we made during the three months ended June 30, 2025. In November 2024, our Board of Directors (“Board”) authorized a program to repurchase up to $250 million of our common stock (the “2024 Program”). Such repurchases may be made from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The actual timing, number and dollar amount of repurchase transactions will be determined by our management, in its discretion and will depend on a number of factors, including but not limited to, the market price of our common stock.
The 2015 Equity Incentive Plan, adopted by us on June 24, 2015, as amended on April 26, 2016 and as further amended on April 27, 2017, April 24, 2019, April 28, 2021, April 28, 2022, April 25, 2024, October 22, 2024 and April 28, 2025 (the “2015 Plan”), provides for the withholding of shares to satisfy tax withholding obligations and the exercise price of stock options. It does not specify a maximum number of shares that can be withheld for this purpose. The shares of common stock withheld to satisfy tax withholding obligations may be deemed to be “issuer purchases” of shares that are required to be disclosed pursuant to this Item 2.
Period |
|
Total Number of |
|
|
Average Price |
|
|
Total Number of |
|
|
Approximate Dollar |
|||
April 2025 |
|
|
4,230 |
|
|
$ |
102.32 |
|
|
|
— |
|
|
$150.0 million |
May 2025 |
|
|
1,262,751 |
|
|
$ |
79.36 |
|
|
|
1,259,865 |
|
|
$50.0 million |
June 2025 |
|
|
1,686 |
|
|
$ |
77.86 |
|
|
|
— |
|
|
$50.0 million |
Total |
|
|
1,268,667 |
|
|
|
|
|
|
1,259,865 |
|
|
$50.0 million |
Dividend Policy
We did not declare or pay any dividends, and we do not currently intend to pay dividends in the foreseeable future. We currently expect to retain future earnings, if any, for the foreseeable future, to finance the growth and development of our business and to repay indebtedness. Our ability to pay dividends is restricted by our financing arrangements. See Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Liquidity and Capital Resources-External Sources of Liquidity” of this Form 10-Q for further information.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Rule 10b5-1 Trading Plans
During the second quarter of 2025,
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Item 6. Exhibits
|
|
|
|
INCORPORATED BY REFERENCE |
||||||
EXHIBIT NUMBER |
|
DESCRIPTION OF EXHIBITS |
|
FORM |
|
FILE NUMBER |
|
EXHIBIT |
|
FILING DATE |
3.2 |
|
Amended and Rested Bylaws of Lantheus Holdings, Inc. |
|
8-K |
|
001-36569 |
|
3.2 |
|
May 5, 2025 |
10.1*+ |
|
Ninth Amendment to Lantheus Holdings, Inc. 2015 Equity Incentive Plan |
|
|
|
|
|
|
|
|
31.1* |
|
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a). |
|
|
|
|
|
|
|
|
31.2* |
|
Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a). |
|
|
|
|
|
|
|
|
32.1** |
|
Certification pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
|
|
101.INS* |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
|
|
|
|
|
|
|
|
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
|
|
|
|
|
|
|
|
104* |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
|
|
|
|
|
|
|
* Filed herewith.
** Furnished herewith.
+ Indicates management contract or compensatory plan or arrangement.
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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.
LANTHEUS HOLDINGS, INC. |
||
|
|
|
By: |
|
/s/ BRIAN MARKISON |
Name: |
|
Brian Markison |
Title: |
|
Chief Executive Officer |
Date: |
|
August 6, 2025 |
|
||
LANTHEUS HOLDINGS, INC. |
||
|
|
|
By: |
|
/s/ ROBERT J. MARSHALL, JR. |
Name: |
|
Robert J. Marshall, Jr. |
Title: |
|
Chief Financial Officer and Treasurer |
Date: |
|
August 6, 2025 |
48