Resultados del 1er trimestre
Abril 25, 2024 |
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Delivered Double-Digit Net Revenue Growth in Q1 2024; FY 2024 Guidance Reconfirmed • Total net revenue (NR) of $284m (+12% versus Q1 2023); SUBLOCADE® NR of $179m (+36% versus Q1 2023) • FY 2024 guidance reconfirmed - NR and adjusted operating profit expected to accelerate through the year • Board confirms intention to seek shareholder approval in May 2024 to facilitate a primary listing in the U.S. |
Comentario de Mark Crossley, director ejecutivo de Indivior PLC
"Our first quarter results reflect continued double-digit top-line momentum led by SUBLOCADE (buprenorphine extended-release). The underlying demand for this transformative treatment for moderate-to-severe opioid use disorder (OUD) remains strong and our strategy to expand prescribing in the justice system is delivering excellent results. SUBLOCADE's reported growth was, however, adversely impacted by transitory items, including accelerating Medicaid patient disenrollments, a cyberattack on the largest U.S. medical claims processor and abnormal trade destocking. We fully expect these items to resolve as the year progresses and, combined with the benefits of recent commercial investments behind SUBLOCADE, we anticipate an acceleration in our top- and bottom-line growth over the remainder of 2024, particularly in the second half. We therefore reconfirm our 2024 guidance, including SUBLOCADE net revenue of $820m to $880m and approximately 300 basis points of margin expansion at the mid-points of our guidance range.
Lastly, after receiving strong indications of support from our shareholders, we are confirming our intention to seek shareholder approval in May 2024 to facilitate a primary listing in the U.S. while maintaining a secondary listing in the U.K."
Trimestre al 31 de marzo (No auditado) | 2024 $m | 2023 $m | % Cambio |
Ingresos netos | 284 | 253 | 12% |
Beneficio operativo | 65 | 57 | 14% |
Lngresos netos | 47 | 44 | 7% |
BPA diluido ($) | $0.34 | $0.31 | 10% |
Base ajustada |
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adj. Beneficio operativo1 | 70 | 71 | - 1% |
adj. Lngresos netos1 | 51 | 56 | - 9% |
adj. EPS diluido1 ($) | $0.37 | $0.40 | - 8% |
1 Adjusted Basis excludes the impact of exceptional items and other adjustments as referenced and reconciled in the "Adjusted Results" appendix on page 24. Adjusted results are not a substitute for, or superior to, reported results presented in accordance with International Financial Reporting Standards ("IFRS").
La "Compañía" se refiere a Indivior PLC y el "Grupo" se refiere a la Compañía y sus subsidiarias consolidadas.
Aspectos financieros destacados del segundo trimestre de 1
• Q1 2024 total net revenue (NR) of $ 284m aumentado 12% (Q1 2023: $ 253m).
• Q1 2024 reported operating profit was $ 65m (Q1 2023: $ 57m). Q1 2024 adjusted operating profit of $ 70m represented a decrease of 1% (Adjusted Q1 2023: $ 71m).
• Q1 2024 reported net income was $ 47m (Q1 2023: $ 44m). Q1 2024 adjusted net income of $ 51m represented a decrease of 9% (Adjusted Q1 2023: $ 56m).
• Efectivo e inversiones totalizados $ 356m al final de Q1 2024 disponibles (Incluyendo $ 27m restricted for self-insurance) (AF 2023: $ 451m), primarily reflecting the Q1 2024 net cash outflows related to scheduled litigation settlement payments, shares repurchased and canceled, and taxes paid.
Q1 2024 Product Highlights
• SUBLOCALIDAD: Q1 2024 NR of $ 179m (+36% vs. Q1 2023; +2%vs Q4 2023). Continued growth primarily reflects further organized health system (OHS) and justice system channel penetration in the U.S. and increased new U.S. patient enrollments. Q1 2024 U.S. units dispensed were approx. 148,600 (+38% vs. Q1 2023 and +4% vs. Q4 2023). Total U.S. patients on a 12-month rolling basis at the end of Q1 2024 were approximately 150,300 (+59% vs. Q1 2023 and +10% vs. Q4 2023).
• OPVEE®: Q1 2024 NR was modest (under $1m), as expected; near-term launch focus is on supporting foundational policy changes to enable nalmefene opioid rescue treatments.
• PERSERIS®: Q1 2024 NR of $11m (+38% vs. Q1 2023; -8% vs Q4 2023) refleja increasing awareness of the treatment across the U.S. healthcare system versus last year.
• SUBPelícula OXONE® (buprenorfina/naloxona): U.S. share in Q1 2024 promediado 17% (Q1 2023: 19%).
Orientación para el año fiscal 2024
The Group reconfirms its financial guidance for 2024, as set forth in its press release dated February 22, 2024.
Pursuing Shareholder Approval for a Primary Listing in the U.S. in the Summer of 2024
On February 22, 2024, Indivior announced the commencement of shareholder consultations to effect a primary listing in the U.S. in the summer of 2024. The Group believes a primary U.S. listing could be beneficial to Indivior stakeholders as it would better align with the Group's current and future growth opportunities, attract more U.S. investors and analysts, allow for inclusion in U.S. indices over time and better reflect the growing proportion of the Group's share capital owned by U.S. based investors.
Since the February 22, 2024 announcement, the Group has consulted extensively with shareholders and, together with its advisers, has carefully considered the shareholder feedback received. Having largely completed this consultation process, the Board confirms its intention to seek shareholder approval in May 2024 to facilitate a shift to a primary listing in the U.S., which would be expected to take place in the summer of 2024.
The Board intends to maintain Indivior's U.K. listing as a secondary listing following the transition to a primary U.S. listing.
Programa de recompra de acciones
On November 17, 2023, Indivior announced a third share repurchase program of up to $100m. Through April 19, 2024, the Group repurchased and canceled 3,761,052 Indivior ordinary shares, equivalent to approximately 3% of diluted shares outstanding, at a daily weighted average purchase price of 1,373p. The cost was approximately $66m, which includes directly attributable transaction costs. The program is expected to conclude no later than August 30, 2024. Refer to Note 15 for further discussion.
Actualización del mercado OUD de EE. UU.
In Q1 2024, U.S. buprenorphine medication-assisted treatments (BMAT) grew in mid-single digits in volume terms. The Group continues to expect long-term U.S. growth to be sustained in the mid- to high-single digit percentage range due to increased overall public awareness of the opioid epidemic and approved treatments, together with regulatory and legislative actions, such as the late 2022 enactment of the Mainstreaming Addiction Treatment Act, that have expanded OUD treatment funding and treatment capacity. The Group believes these regulatory and legislative actions will help to normalize the view of addiction as a chronic disease and expand access to evidence-based buprenorphine treatment in the U.S. and supports these actions.
Rendimiento financiero en el primer trimestre de 1
Ingreso neto total in Q1 2024 aumentado 12% a $ 284m (Q1 2023: $ 253m) a tipos de cambio reales (+12% a tipos de cambio constantes1).
Ingresos netos de EE. UU. aumentado 15% in Q1 2024 a $ 241m (Q1 2023: $ 209m). Strong year-over-year SUBLOCADE volume growth primarily drove the net revenue increase. Pricing was not a material factor in revenue growth.
Ingresos netos del resto del mundo (ROW) disminuido 2% at actual exchange rates in Q1 2024 a $ 43m (Q1 2023: $ 44m) (-2% at constant exchange rates1). In the period, positive contributions from new products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) were more than offset primarily by the timing of shipments of certain products as well as ongoing generic erosion of the legacy tablet business. Q1 2024 SUBLOCADE / SUBUTEX Prolonged Release net revenue in ROW was $ 12m (Q1 2023: $ 9m) en el actoual exchange rates.
[ 1 ] Los ingresos netos a tipos de cambio constantes son una medida de desempeño alternativa utilizada por la administración para evaluar el desempeño subyacente del negocio y se calcula aplicando el tipo de cambio del año anterior a los ingresos netos en las monedas de las entidades extranjeras.
Margen bruto como se informa en Q1 2024 fue 84% (Segundo trimestre de 1: 85%). Excluyendo $ 3m of other adjustments for amortization of acquired intangible assets within cost of sales primarily related to the acquisition of Opiant, adjusted gross margin in Q1 2024 fue 85%. There were no adjustments to Q1 2023 gross margin. The adjusted gross margin in Q1 2024 primarily reflects an improved product mix from the continued growth of SUBLOCADE offset by cost inflation. Additionally, both periods benefited from favorable manufacturing variances.
Gastos de venta, generales y administrativos como se informa en Q1 2024 were $145m (Q1 2023: $131m). Q1 2024 incluird $ 2m of exceptional integration costs related to the aseptic manufacturing site in Raleigh, NC acquired in November 2023. The Group expects to incur approximately $3m in additional pre-tax integration related costs in FY 2024 which would be recorded as exceptional. Q1 2023 incluido $ 14m of exceptional items related to non-recurring costs associated with the acquisition of Opiant ($ 12m) and the additional U.S. listing ($ 2m).
Excluding exceptional items, Q1 2024 adjusted SG&A expense increased 22% to $ 143m (Adjusted Q1 2023: $117m). The increase in Q1 2024 reflects increased sales and marketing investments primarily related to SUBLOCADE, the addition of the Opiant business, OPVEE launch expenses and cost inflation.
Gastos de I + D in Q1 2024 were $28m (Q1 2023: $27m), an increase of 4%. The increase was primarily due to the progression of pipeline assets partially offset by a reduction in activity related to post-marketing studies for SUBLOCADE.
Otros ingresos operativos netos in Q1 2024 was nil (Q1 2023: $1m).
Beneficio operativo como se informó fue de $ 65 millones in Q1 2024 (Q1 2023: $ 57m). The change on a reported basis reflects higher NR and gross margin as described above, offset by investments in sales and marketing primarily related to SUBLOCADE. The Q1 2023 period included exceptional administrative costs relating to the Opiant acquisition.
Q1 2024 adjusted operating profit decreased 1% to $70m (Q1 2023: $ 71m), excluding exceptional items and other adjustments of $5m and $14m in Q1 2024 y Q1 2023, respectivamente. The decrease primarily reflects increased SG&A expenses, as described above, partly offset by higher total NR and gross margin from an improved product mix.
Gastos financieros netos was $2m in Q1 2024 (Q1 2023: $ 1m income) reflecting a decrease in interest income on lower cash and investment balances.
Gasto fiscal declarado fue $ 16m in Q1 2024 and the effective tax rate was 25% (Q1 2023 tax expense/rate: $ 14m, 24%). Q1 2024 adjusted tax expense was $ 17m, and the adjusted effective tax rate was 25% (Q1 2023 adjusted tax expense/rate: $16m, 22%). The adjusted results exclude tax benefit on exceptional items and other adjustments. The movement in the effective tax rate on adjusted profits is impacted by an increase in the U.K. corporation tax rate from 23.5% to 25%.
Ingresos netos declarados in Q1 2024 fue $ 47m y el ingreso neto ajustado fue $ 51m (Q1 2023 reported net income: $ 44m; Q1 2023 adjusted net income: $ 56m). The 9% decrease in net income on an adjusted basis primarily reflected the increase in operating expense, partly offset by higher total NR.
Ganancias diluidas por acción tuvieron $0.34 sobre una base informada y $0.37 on an adjusted basis in Q1 2024 (Q1 2023: $0.31 diluted earnings per share and $0.40 adjusted diluted earnings per share).
Balance y flujo de caja
Efectivo e inversiones llegaron a un total de $ 356m al final de Q1 2024, una disminución de $ 95m versus el $ 451m position at the end of 2023. The decrease was primarily due to the Group's litigation settlement payments of $70m for the Department of Justice (DOJ), Reckitt Benckiser (RB) and Dr. Reddy's Laboratories (DRL) matters.
Capital de trabajo neto, defined by management as inventory plus trade receivables, less trade and other payables, was negative $342m on March 31, 2024, versus negative $ 347m al final de AF 2023.
Efectivo utilizado en operaciones in Q1 2024 fue $ 25m (Q1 2023 cash used in operations: $ 16m), primarily due to litigation settlement payments, partially offset by income from operations. Before these litigation establecimiento payments, cash generated from operations in the current period was $ 45m. La salida neta de efectivo de las actividades operativas fue $ 55m in Q1 2024 (Q1 2023 cash outflow: $ 36m) que refleja los pagos de impuestos y los intereses pagados sobre la línea de crédito a plazo del Grupo y los pagos de liquidación, parcialmente compensados por los intereses recibidos sobre las inversiones.
Entrada de efectivo de las actividades de inversión fue $ 25m (Q1 2023 cash outflow: $ 127m) reflecting the reduction in invested liquidity. In the prior year period, the outflow from investing activities primarily reflected the Opiant acquisition, net of cash assumed.
Salida de efectivo de actividades de financiación fue $ 38m (Q1 2023 cash outflow: $ 22m) reflecting shares repurchased and canceled, the principal portion of lease payments and quarterly amortization of the Group's term loan facility, partially offset by proceeds received from the issuance of shares for employee compensation agreements. In the prior year period, the outflow from financing activities primarily reflected shares repurchased and canceled and the extinguishment of debt assumed in the Opiant acquisition.
Principal Risks Update
The Board of Directors oversees the approach to risk management so that the principal risks, including those that would threaten the Group's business model, future performance or viability, are effectively managed and/or mitigated. While the Group aims to identify and manage such risks, no risk management strategy can provide absolute assurance against loss. The principal risks facing the Group have not significantly changed over the period and are set out in the Group's Annual Report for the 2023 financial year.
Los tipos de cambio
Los tipos de cambio promedio y de fin de período utilizados para la conversión de monedas a dólares estadounidenses que tienen un impacto más significativo en los resultados del Grupo fueron:
| Q1 2024 | Q1 2023 |
Fin del período en GB £ | 1.2627 | 1.2309 |
GB £ tarifa media | 1.2683 | 1.2149 |
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€ Fin del período en euros | 1.0830 | 1.0828 |
€ Euros de media | 1.0859 | 1.0726 |
Detalles del webcast
A live webcast presentation will be held on April 25, 2024, at 13:00 GMT (8:00 am EDT) hosted by Mark Crossley, CEO. The details are below. All materials will be available on the Group's website prior to the event at www.indivior.com. Please copy and paste the below web links into your browser.
El enlace del webcast: https://edge.media-server.com/mmc/p/hktzzit4
Participants may access the presentation telephonically by registering with the following link (please cut and paste into your browser):
https://register.vevent.com/register/BI2351ee9819db40d1a28c31f75cece519
(Los solicitantes de registro tendrán la opción de que se les devuelva la llamada inmediatamente antes de la llamada o se les proporcione un número de llamada entrante con un código pin único después de su registro)
Para mayor información
Consultas de inversores | Jason Thompson | Vicepresidente de relaciones con inversionistas PLC individual | +1 804 402 7123 |
| Tim Owens | Director, Relaciones con Inversores Indivior PLC | +1 804 263 3978 |
Preguntas de los medios | jonathan sibun
| téneo
Consultas de los medios de EE. UU. | 44 0 20 7353 4200
+1 804 594 0836 |
Web corporativa www.indivior.com
Este anuncio no constituye una oferta de venta, o la solicitud de una oferta para suscribir o adquirir o enajenar acciones del Grupo a cualquier persona en cualquier jurisdicción a la que sea ilegal hacer dicha oferta o solicitud.
Sobre Indivior
Indivior es una compañía farmacéutica global que trabaja para ayudar a cambiar la vida de los pacientes mediante el desarrollo de medicamentos para tratar los trastornos por uso de sustancias (SUD) y las enfermedades mentales graves. Nuestra visión es que todos los pacientes de todo el mundo tengan acceso a un tratamiento basado en la evidencia para las afecciones crónicas y los trastornos concurrentes de SUD. Indivior se dedica a transformar SUD de una crisis humana global a una enfermedad crónica reconocida y tratada. Sobre la base de su cartera global de tratamientos para OUD, Indivior tiene una cartera de productos candidatos diseñados tanto para ampliar su herencia en esta categoría como para abordar potencialmente otras afecciones crónicas y trastornos concurrentes de SUD, incluido el trastorno por consumo de alcohol y el trastorno por consumo de cannabis. Con sede en los Estados Unidos en Richmond, VA, Indivior emplea a más de 1,000 personas en todo el mundo y su cartera de productos está disponible en 37 países de todo el mundo. Visitar www.indivior.com aprender más. Conéctese con Indivior en LinkedIn visitando www.linkedin.com/company/individ .
Importante nota de advertencia sobre las declaraciones prospectivas
This announcement contains certain statements that are forward-looking. Forward-looking statements include, among other things, statements regarding: the Indivior Group's financial guidance including operating and profit margins for 2024 and its medium- and long-term growth outlook; assumptions regarding expected changes in share and expectations regarding the extent and impact of competition; assumptions regarding future exchange rates; strategic priorities, strategies for value creation, and operational goals; expected future growth and expectations for sales levels for particular products, and expectations regarding the future impact of factors that have affected sales in the past; expected growth rates, growing normalization of medically assisted treatment for opioid use disorder, and expanded access to treatment; our product development pipeline and potential future products, expectations regarding regulatory approval of such product candidates, the timing of such approvals, and the timing of commercial launch of such products or product candidates, and eventual annual revenues of such future products; expectations regarding future production at the Group's Raleigh, North Carolina manufacturing facility; our intention to seek shareholder approval in May 2024 to facilitate a primary listing in the U.S. while maintaining a secondary listing in the U.K., and the expected timing and potential benefits of such listing; and other statements containing the words "believe," "anticipate," "plan," "expect," "intend," "estimate," "forecast," "strategy," "target," "guidance," "outlook," "potential," "project," "priority," "may," "will," "should," "would," "could," "can," "outlook," "guidance," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.
Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Various factors may cause differences between Indivior's expectations and actual results, including, among others, the material risks described in the most recent Indivior PLC Annual Report and in subsequent releases; the substantial litigation and ongoing investigations to which we are or may become a party; our reliance on third parties to manufacture commercial supplies of most of our products, conduct our clinical trials and at times to collaborate on products in our pipeline; our ability to comply with legal and regulatory settlements, healthcare laws and regulations, requirements imposed by regulatory agencies and payment and reporting obligations under government pricing programs; risks related to the manufacture and distribution of our products, most of which contain controlled substances; market acceptance of our products as well as our ability to commercialize our products and compete with other market participants; competition; the uncertainties related to the development of new products, including through acquisitions, and the related regulatory approval process; our dependence on third-party payors for the reimbursement of our products and the increasing focus on pricing and competition in our industry; unintended side effects caused by the clinical study or commercial use of our products; our ability to successfully execute acquisitions, partnerships, joint ventures, dispositions or other strategic acquisitions; our ability to protect our intellectual property rights and the substantial cost of litigation or other proceedings related to intellectual property rights; the risks related to product liability claims or product recalls; the significant amount of laws and regulations that we are subject to, including due to the international nature of our business; macroeconomic trends and other global developments such as armed conflicts and pandemics; the terms of our debt instruments, changes in our credit ratings and our ability to service our indebtedness and other obligations as they come due; changes in applicable tax rate or tax rules, regulations or interpretations and our ability to realize our deferred tax assets; and volatility in our share price due to factors unrelated to our operating performance or that may result from the potential move of our primary listing to the U.S.
Las declaraciones prospectivas se refieren solo a la fecha en que se realizan y deben considerarse únicamente como nuestros planes, estimaciones y creencias actuales. Salvo que lo exija la ley, no asumimos y declinamos específicamente cualquier obligación de actualizar, volver a publicar o revisar las declaraciones prospectivas para reflejar eventos o circunstancias futuras o para reflejar la ocurrencia de eventos imprevistos.
Estado de resultados intermedio resumido consolidado no auditado
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| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | Notas | $m | $m |
Ingresos netos | 2 | 284 | 253 |
El costo de ventas |
| (46) | (39) |
Beneficio bruto |
| 238 | 214 |
Gastos de venta, generales y administrativos. | 3 | (145) | (131) |
Gastos de investigación y desarrollo. | 3 | (28) | (27) |
Otros ingresos operativos netos |
| - | 1 |
Beneficio operativo |
| 65 | 57 |
Ingresos financieros | 4 | 7 | 11 |
Gastos financieros | 4 | (9) | (10) |
Net Finance (Expense)/Income |
| (2) | 1 |
Beneficio antes de impuestos |
| 63 | 58 |
Ingreso por gastos de impuesto | 5 | (16) | (14) |
Lngresos netos |
| 47 | 44 |
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Earnings per ordinary share (in dollars) |
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Ganancias básicas por acción | 6 | $0.35 | $0.32 |
Ganancias diluidas por acción | 6 | $0.34 | $0.31 |
Estado de resultados integrales intermedio consolidado condensado no auditado
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Ingresos netos | 47 | 44 |
Otra pérdida integral |
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Partidas que pueden reclasificarse a resultados en años posteriores: |
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Ajuste de conversión de moneda extranjera, neto | (3) | - |
Otra pérdida integral | (3) | - |
Total de ingresos integrales | 44 | 44 |
Las notas son parte integral de estos estados financieros intermedios consolidados condensados no auditados.
Balance intermedio resumido consolidado no auditado
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| 31 de marzo, 2024 | 31 de diciembre de 2023 (Retrospectively adjusted1) |
| Notas | $m | $m |
BIENES |
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Activos no corrientes |
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Activos intangibles | 7 | 230 | 234 |
Propiedad, planta y equipo. |
| 81 | 82 |
Activos por derecho de uso |
| 31 | 33 |
Activos por impuestos diferidos | 5 | 260 | 267 |
Inversiones | 8 | 26 | 41 |
Otros activos | 9 | 29 | 28 |
|
| 657 | 685 |
Activos circulantes |
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Los inventarios |
| 163 | 142 |
Cuentas por cobrar comerciales |
| 249 | 254 |
Otros activos | 9 | 45 | 457 |
Impuesto corriente por cobrar | 5 | 9 | - |
Inversiones | 8 | 82 | 94 |
Efectivo y equivalentes de efectivo |
| 248 | 316 |
|
| 796 | 1,263 |
los activos totales |
| 1,453 | 1,948 |
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PASIVO |
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Pasivo circulante |
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Préstamos | 10 | (3) | (3) |
Provisiones | 11 | (21) | (408) |
Otros pasivos | 11 | (67) | (125) |
Comerciales y otras cuentas a pagar | 14 | (754) | (743) |
Pasivos por arrendamiento |
| (9) | (9) |
Pasivos por impuestos corrientes | 5 | (7) | (18) |
|
| (861) | (1,306) |
Pasivos no corrientes |
|
|
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Préstamos | 10 | (235) | (236) |
Provisiones | 11 | (2) | (5) |
Otros pasivos | 11 | (313) | (367) |
Pasivos por arrendamiento |
| (32) | (34) |
|
| (582) | (642) |
Pasivos totales |
| (1,443) | (1,948) |
Activos netos |
| 10 | - |
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EQUIDAD |
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Capital y reservas |
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Capital social | 15 | 68 | 68 |
Compartir premium |
| 11 | 11 |
Reserva de amortización de capital |
| 8 | 7 |
Otra reserva |
| (1,295) | (1,295) |
Reserva de conversión de moneda extranjera |
| (38) | (35) |
Ganancias retenidas |
| 1,256 | 1,244 |
Equidad total |
| 10 | - |
1The unaudited condensed consolidated interim balance sheet as of December 31, 2023 has been retrospectively adjusted to reflect measurement period adjustments related to the November 2023 acquisition of an aseptic manufacturing facility. Refer to Note 1 and Note 17.
Las notas son parte integral de estos estados financieros intermedios consolidados condensados no auditados.
Estado de cambios en el patrimonio neto condensado consolidado no auditado
Notas | Capital social | Compartir premium | Reserva de amortización de capital | Otra reserva | Reserva de conversión de moneda extranjera | Ganancias retenidas | Equidad total | |
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| $m | $m | $m | $m | $m | $m | $m |
Saldo al 1 de enero de 2023 |
| 68 | 8 | 6 | (1,295) | (39) | 1,303 | 51 |
Ingresos integrales |
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Ingresos netos |
| - | - | - | - | - | 44 | 44 |
Otra pérdida integral |
| - | - | - | - | - | - | - |
Total de ingresos integrales |
| - | - | - | - | - | 44 | 44 |
Transacciones reconocidas directamente en patrimonio |
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Acciones emitidas |
| 1 | 1 | - | - | - | - | 2 |
Planes basados en acciones |
| - | - | - | - | - | 5 | 5 |
Liquidación de impuestos sobre premios en acciones |
| - | - | - | - | - | (21) | (21) |
Shares repurchased and canceled |
| - | - | - | - | - | (11) | (11) |
Pasivo de transferencia a recompra de acciones |
| - | - | - | - | - | 9 | 9 |
Fiscalidad de los planes basados en acciones |
| - | - | - | - | - | (7) | (7) |
Saldo al 31 de marzo de 2023 |
| 69 | 9 | 6 | (1,295) | (39) | 1,322 | 72 |
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Saldo al 1 de enero de 2024 |
| 68 | 11 | 7 | (1,295) | (35) | 1,244 | - |
Ingresos integrales |
|
|
|
|
|
|
|
|
Ingresos netos |
| - | - | - | - | - | 47 | 47 |
Otra pérdida integral |
| - | - | - | - | (3) | - | (3) |
Total de ingresos integrales |
| - | - | - | - | (3) | 47 | 44 |
Transacciones reconocidas directamente en patrimonio |
|
|
|
|
|
|
|
|
Acciones emitidas |
| 1 | - | - | - | - | - | 1 |
Planes basados en acciones |
| - | - | - | - | - | 5 | 5 |
Liquidación de impuestos sobre premios en acciones |
| - | - | - | - | - | (20) | (20) |
Shares repurchased and canceled |
| (1) | - | 1 | - | - | (36) | (36) |
Pasivo de transferencia a recompra de acciones |
| - | - | - | - | - | (9) | (9) |
Transferencia del pasivo de recompra de acciones |
| - | - | - | - | - | 23 | 23 |
Fiscalidad de los planes basados en acciones |
| - | - | - | - | - | 2 | 2 |
Saldo al 31 de marzo de 2024 |
| 68 | 11 | 8 | (1,295) | (38) | 1,256 | 10 |
Las notas son parte integral de estos estados financieros intermedios consolidados condensados no auditados.
Estado de flujo de efectivo consolidado condensado no auditado
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
FLUJOS DE EFECTIVO POR ACTIVIDADES OPERACIONALES |
|
|
Beneficio operativo | 65 | 57 |
Depreciación y amortización de propiedad, planta y equipo y activos intangibles | 7 | 4 |
Depreciación de activos por derecho de uso | 2 | 2 |
Pagos basados en acciones | 5 | 5 |
Impacto de los movimientos de divisas | (3) | - |
Ganancia no realizada en inversiones de capital | - | (1) |
Liquidación del impuesto sobre los premios de los empleados | (20) | (21) |
Disminución de las cuentas por cobrar comerciales | 5 | 7 |
Decrease/(increase) in current and non-current other assets1 | 408 | (23) |
Incremento de inventarios | (21) | (5) |
Aumento de cuentas por pagar comerciales y otras | 13 | 30 |
Disminución de provisiones y otros pasivos1 2 | (486) | (71) |
Efectivo utilizado en operaciones | (25) | (16) |
Pago interesado | (11) | (10) |
Interés recibido | 8 | 11 |
Impuestos pagados | (27) | (21) |
Salida neta de efectivo de las actividades operativas | (55) | (36) |
|
|
|
FLUJOS DE EFECTIVO DE ACTIVIDADES DE INVERSIÓN |
|
|
Acquisition of assets, net of cash acquired | - | (124) |
Compra de propiedad, planta y equipo | (2) | (1) |
Compra de inversiones | (4) | (33) |
Vencimiento de las inversiones | 31 | 36 |
Compra de activo intangible | - | (5) |
Entrada / (salida) de efectivo neta de actividades de inversión | 25 | (127) |
|
|
|
FLUJOS DE EFECTIVO DE LAS ACTIVIDADES DE FINANCIAMIENTO |
|
|
Reembolso de préstamos | (1) | (11) |
Elementos principales de los pagos por arrendamiento | (2) | (2) |
Shares repurchased and canceled | (36) | (11) |
Producto de la emisión de acciones ordinarias | 1 | 2 |
Salida neta de efectivo de las actividades de financiación | (38) | (22) |
|
|
|
Diferencia de cambio de efectivo y equivalentes de efectivo | - | (1) |
|
|
|
Disminución neta de efectivo y equivalentes de efectivo | (68) | (186) |
Efectivo y equivalentes de efectivo al inicio del período | 316 | 774 |
Efectivo y equivalentes de efectivo al final del período | 248 | 588 |
1Changes in the line items current and non-current other assets and provisions and other liabilities for Q1 2024 include the utilization of the Antitrust MDL liabilities (refer to Note 13) and release of related escrow funding following final court approval.
2Changes in the line item provisions and other liabilities for Q1 2024 also include litigation settlement payments totaling $ 70m (Q1 2023: $ 74m). $ 3m of interest paid on the DOJ Resolution in Q1 2024 has been recorded in the interest paid line item (Q1 2023: $ 3m).
Las notas son parte integral de estos estados financieros intermedios consolidados condensados no auditados.
Notas a los estados financieros intermedios consolidados condensados no auditados
1. BASE DE LAS POLÍTICAS DE PREPARACIÓN Y CONTABILIDAD
Indivior PLC (la 'Compañía') es una sociedad anónima constituida el 26 de septiembre de 2014 y domiciliada en el Reino Unido. En estos estados financieros consolidados resumidos no auditados ('Estados financieros resumidos'), la referencia al 'Grupo' significa la Compañía y todas sus subsidiarias.
The Condensed Financial Statements have been prepared in accordance with U.K. adopted International Accounting Standard 34, Información financiera intermedia. The Condensed Financial Statements have been reviewed and are unaudited and do not include all the information and disclosures required in the annual financial statements. Therefore, the Condensed Financial Statements should be read in conjunction with the Group's Annual Report and Accounts for the year ended December 31, 2023, which were prepared in accordance with U.K. adopted International Accounting Standards and in conformity with the Companies Act 2006 aplicable a las empresas que reportan bajo esos estándares. Estos Estados Financieros Resumidos fueron aprobados para su emisión el 24 de abril de 2024.
In preparación de estos Estados Financieros Resumidos, los juicios significativos realizados por la administración al aplicar las políticas contables del Grupo y las principales fuentes de incertidumbre en la estimación fueron los mismos que se aplicaron a los estados financieros consolidados para el año terminado el 31 de diciembre de 2023, except for changes in estimates that are required in determining the provision for income impuestos.
In 2023, the Group acquired an aseptic manufacturing facility which was accounted for as a business combination. As the acquisition was completed in late 2023, a provisional fair value of assets acquired and liabilities assumed at the date of acquisition was disclosed in the consolidated financial statements for the year ended December 31, 2023. In 2024, based on new information obtained about facts and circumstances that existed as of the acquisition date, the Group adjusted the provisional fair values for acquired property, plant and equipment and the assumed onerous contract provision, with an adjustment to goodwill equal to the change in the net assets acquired. These measurement period adjustments have been reflected in the comparative period presented in the Condensed Financial Statements in accordance with IFRS 3 Combinación de negocios. The effect on depreciation and other changes in the related balances from the acquisition date to December 31, 2023 was immaterial. Refer to Note 17 for a reconciliation of the previously reported provisional fair value of net assets acquired to the adjusted provisional fair value.
Effective January 1, 2024, the functional currency of Indivior U.K. Limited, one of the Group's significant subsidiaries, changed from pound sterling to U.S. dollar (USD). This was the result of a change in the primary economic environment in which Indivior U.K. Limited operates, driven by growth of USD-denominated net revenue combined with an increase in USD-denominated costs and culminating with a shift in investing activities to USD securities. The Group determined the USD had become the dominant currency from January 2024.
Los directores have assessed the Group's ability to maintain sufficient liquidity to fund its operations, fulfill financial and compliance obligations as set out in Note 11, and comply with the minimum liquidity covenant in the Group's term loan for the period to September 2025 (the going concern period). A base case model was produced reflecting:
• Board reviewed financial plans for the period; and
• settlement of liabilities and provisions in line with contractual terms.
Los directores también evaluaron un escenario a la baja 'severo pero plausible' que incluía los siguientes cambios clave en el caso base dentro del período de negocio en marcha:
• the risk that SUBLOCADE will not meet revenue growth expectations by modeling a 10% decline on forecasts;
• an accelerated decline in U.S. SUBOXONE Film net revenue to generic analogues; and
• a further decline in rest of world sublingual product net revenues.
Under both the base case and the downside scenario, sufficient liquidity exists and is generated from operations such that all business and covenant requirements are met for the going concern period. As a result of the analysis described above, the Directors reasonably expect the Group to have adequate resources to continue in operational existence for at least one year from the approval of these Condensed Financial Statements and therefore consider the going concern basis to be appropriate for the accounting and preparation of these Condensed Financial Statements.
The financial information contained in this document does not constitute statutory accounts as defined in section 434 and 435 of the Companies Act 2006. The Group's statutory financial statements for the year ended December 31, 2023, were approved by the Board of Directors on March 5, 2024 and will be delivered to the Registrar of Companies in due course. The auditor's report on those accounts was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under section 498 of the Companies Act 2006.
2. INFORMACIÓN POR SEGMENTO
El Grupo se dedica a una única actividad comercial, que es predominantemente el desarrollo, fabricación y venta de medicamentos recetados a base de buprenorfina para el tratamiento de la dependencia de opioides y trastornos relacionados. El director ejecutivo revisa los ingresos netos desglosados por área geográfica y por producto y asigna recursos sobre una base funcional entre Comercial, Suministro, Investigación y Desarrollo y otras funciones del Grupo. Los resultados financieros se revisan de forma consolidada para evaluar el desempeño financiero y asignar recursos. En consecuencia, el Grupo opera en un único segmento reportable.
Ingresos netos
Revenue is attributed geographically based on the country where the sale originates. The following table represents net revenue by country:
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Estados Unidos | 241 | 209 |
Resto del mundo | 43 | 44 |
Total | 284 | 253 |
On a disaggregated basis, the Group's net revenue by major product line:
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
SUBLOCADE® | 179 | 132 |
PERSERIS® | 11 | 8 |
Sublingual / otro1 | 94 | 113 |
Total | 284 | 253 |
1 Net revenue for OPVEE® was not material for the period ended March 31, 2024 and has therefore been included within sublingual/other.
Activos no corrientes
The following table represents non-current assets, net of accumulated depreciation, amortization and impairment, by country. Non-current assets for this purpose consist of intangible assets, property, plant and equipment, right-of-use assets, investments, and other assets.
| Mar 31, | 31 de diciembre de 2023 (Retrospectively adjusted1) |
| $m | $m |
Estados Unidos | 206 | 209 |
Resto del mundo | 191 | 209 |
Total | 397 | 418 |
1 The non-current asset balance in the United States as of December 31, 2023 has been retrospectively adjusted to reflect measurement period adjustments of $2m to property, plant and equipment and $3m to intangible assets related to the November 2023 acquisition of an aseptic manufacturing facility. Refer to Note 17.
3. GASTOS DE FUNCIONAMIENTO
La siguiente tabla muestra los costos operativos seleccionados y la información de gastos:
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Gastos de investigación y desarrollo. | (28) | (27) |
|
|
|
Gastos de venta y comercialización. | (66) | (53) |
Gastos administrativos y generales1 | (79) | (78) |
Gastos de venta, generales y administrativos | (145) | (131) |
|
|
|
Depreciación y amortización2 | (3) | (4) |
1 Administrative and general expenses include acquisition-related costs of $ 12m in Q1 2023 related to the acquisition of Opiant Pharmaceuticals, Inc. ("Opiant"). Refer to Note 16.
2 Depreciation and amortization expense represents amounts included in research and development and selling, general and administrative expenses. In addition, depreciation and amortization expense in Q1 2024 of $ 6m (Q1 2023: $ 2m) for intangible assets and right-of-use assets is included within cost of sales.
4. NET FINANCE (EXPENSE)/INCOME
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Ingresos financieros |
|
|
Ingresos por intereses sobre efectivo y equivalentes de efectivo/inversiones | 6 | 11 |
Otros ingresos financieros | 1 | - |
Ingresos financieros totales | 7 | 11 |
Gastos financieros |
|
|
Gastos por intereses sobre préstamos | (6) | (7) |
Gastos por intereses sobre pasivos por arrendamiento | (1) | (1) |
Interest expense on legal matters, including the effect of discounting | (1) | (2) |
Otros gastos por intereses | (1) | - |
Gasto financiero total | (9) | (10) |
(Gastos) / ingresos financieros netos | (2) | 1 |
5. FISCALIDAD
El Grupo calcula el gasto por impuestos para períodos intermedios utilizando las tasas esperadas para todo el año, considerando la utilidad antes de impuestos y las tasas legales para cada jurisdicción. En la medida de lo posible, se determina una tasa de impuesto sobre la renta efectiva anual promedio estimada por separado para cada jurisdicción fiscal y se aplica individualmente a los ingresos antes de impuestos del período intermedio de cada jurisdicción. De manera similar, si se aplican diferentes tasas de impuestos a las diferentes categorías de ingresos (como ganancias de capital o ingresos obtenidos en industrias particulares), en la medida de lo posible, se aplica una tasa separada a cada categoría individual de ingresos antes de impuestos del período intermedio. El gasto resultante se distribuye entre impuestos corrientes y diferidos con base en el movimiento real del impuesto diferido del trimestre, registrándose el saldo en las cuentas de impuestos corrientes.
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Gasto fiscal total | (16) | (14) |
Tasa efectiva de impuestos (%) | 25% | 24% |
En Tres meses terminados 31 de marzo de 2024, the effective tax rate was primarily driven by statutory tax. In the three months ended March 31, 2023, the effective tax rate was primarily driven by an increase in the U.K. tax rate from 19% to 23.5%, and the temporary reduction in innovation incentives due to 2022 losses.
| Mar 31, | 31 de diciembre de 2023 (Retrospectively adjusted1) |
| $m | $m |
Impuesto corriente por cobrar | 9 | - |
Pasivos por impuestos corrientes | (7) | (18) |
Activos por impuestos diferidos | 260 | 267 |
1 The deferred tax assets balance as of December 31, 2023 has been retrospectively adjusted to reflect a measurement period adjustment related to the November 2023 acquisition of an aseptic manufacturing facility. Refer to Note 17.
El Grupo reconoce activos por impuestos diferidos en la medida en que es probable que existan suficientes ganancias fiscales futuras contra las que poder aplicar dichas deducciones fiscales futuras. En 31 de marzo de 2024, los activos por impuestos diferidos netos del Grupo de $ 260m relate primarily to net operating loss carryforwards, inventory costs capitalized for tax purposes, and litigation liabilities. Recognition of deferred tax assets is reliant on forecast taxable profits arising in the jurisdiction in which the deferred tax asset is recognized. The Group has assessed recoverability of deferred tax assets using Group-level budgets and forecasts consistent with those used for the assessment of viability and asset impairments, particularly in relation to levels of future net revenues. These forecasts are subject to similar uncertainties to those assessments. This is reviewed each quarter and, to the extent required, an adjustment to the recognized deferred tax asset may be made. With the exception of specific assets that are not currently considered realizable, management have concluded full recognition of deferred tax assets to be appropriate and do not believe a significant risk of material change in their assessment exists in the next 12 months from the balance sheet date.
Otros asuntos tributarios
The Group is subject to Pillar Two legislation effective January 1, 2024. As such, the Group performed an assessment of the potential exposure to Pillar Two income taxes including modeling of adjusted accounting data for the period ended December 31, 2023 and a review of forecasts for the year ended December 31, 2024. Based on the assessment, the Group did not record any current tax liability related to Pillar Two. The Group has applied the recent amendment to IAS 12 which provides temporary relief to the recognition of deferred taxes relating to top-up income taxes.
As a multinational group, tax uncertainties remain in relation to Group financing, intercompany pricing, the location of taxable operations, and certain non-recurring costs. Management have concluded tax provisions made to be appropriate and do not believe a significant risk of material change to uncertain tax positions exists in the next 12 months from the balance sheet date. Including matters under audit, an estimate of reasonably possible additional tax liabilities that could arise in later periods on resolution of these uncertainties is in the range from nil to 38 millones de dólares.
6. GANANCIAS POR ACCIÓN
A continuación se presenta la utilidad por acción básica y diluida de cada período:
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $ | $ |
Ganancias básicas por acción | $0.35 | $0.32 |
Ganancias diluidas por acción | $0.34 | $0.31 |
Número medio ponderado de acciones
The weighted average number of ordinary shares outstanding (on a basic basis) for Q1 2024 includes the favorable impact of 1,988k ordinary shares repurchased in Q1 2024 y 1,413k ordinary shares repurchased from April to December 2023. See Note 15 for further discussion. Conditional awards of 1,700k y 1,761k were granted under the Group's Long-Term Incentive Plan in Q1 2024 y Q1 2023, respectivamente.
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | miles | miles |
Acciones promedio ponderadas sobre una base básica | 135,737 | 136,536 |
Dilución de opciones y adjudicaciones de acciones | 2,973 | 4,452 |
Acciones promedio ponderadas sobre una base diluida | 138,710 | 140,988 |
7. ACTIVOS INTANGIBLES
| Mar 31, | 31 de diciembre de 2023 (Retrospectively adjusted1) |
Activos intangibles, netos de amortización acumulada y deterioro | $m | $m |
Productos en desarrollo | 79 | 79 |
productos comercializados | 147 | 150 |
Goodwill | 2 | 2 |
Software | 2 | 3 |
Total | 230 | 234 |
1 The goodwill balance as of December 31, 2023 was retrospectively adjusted to reflect measurement period adjustments related to the November 2023 acquisition of an aseptic manufacturing facility. Refer to Note 17.
8. INVERSIONES
| Mar 31, | Diciembre 31, |
Inversiones corrientes y no corrientes | $m | $m |
Valores de renta variable en FVPL | 10 | 10 |
Valores representativos de deuda mantenidos a coste amortizado | 72 | 84 |
Inversiones totales, corriente | 82 | 94 |
Valores representativos de deuda mantenidos a coste amortizado | 26 | 41 |
Inversiones totales, no corrientes | 26 | 41 |
Total | 108 | 135 |
Las inversiones del Grupo en títulos de deuda y capital no crean un riesgo crediticio significativo, riesgo de liquidez, o riesgo de tipo de interés. Los títulos de deuda mantenidos a costo amortizado consisten en deuda con grado de inversión. A partir de 31 de marzo de 2024, las pérdidas crediticias esperadas para las inversiones del Grupo mantenidas al costo amortizado se consideran inmateriales.
Jerarquía de valor razonable
El valor razonable es el precio que se recibiría por vender un activo o transferir un pasivo en una transacción ordenada entre participantes del mercado en la fecha de medición. Los diferentes niveles se han definido de la siguiente manera:
• Nivel 1: Precios cotizados (no ajustados) en mercados activos para activos o pasivos idénticos
• Nivel 2: Entradas distintas a los precios cotizados incluidos en el Nivel 1 que son observables para el activo o pasivo, ya sea directa o indirectamente
• Nivel 3: Entradas no observables para el activo o pasivo
The Group's only financial instruments which are measured at fair value are equity securities at FVPL. The fair value of equity securities at FVPL is based on quoted market prices on the measurement date. The following table categorizes the Group's financial assets measured at fair value by valuation methodology used in determining their fair value:
Al 31 de marzo de 2024 | Nivel A1 $m | Nivel A2 $m | Nivel A3 $m | Total $m |
Valores de renta variable en FVPL | 10 | - | - | 10 |
Al 31 de diciembre de 2023 | Nivel A1 $m | Nivel A2 $m | Nivel A3 $m | Total $m |
Valores de renta variable en FVPL | 10 | - | - | 10 |
El Grupo también tiene ciertos instrumentos financieros que no se miden a valor razonable. Se supone que el valor en libros del efectivo y equivalentes de efectivo, cuentas por cobrar comerciales, otros activos y cuentas por pagar comerciales y otras se aproxima al valor razonable debido a su naturaleza a corto plazo. A 31 de marzo de 2024, the carrying value of investments held at amortized cost approximated the fair value. The fair value of investments held at amortized cost was calculated based on quoted market prices which would be classified as Level 1 in the fair value hierarchy above.
9. OTROS ACTIVOS CORRIENTES Y NO CORRIENTES
| Mar 31, | Diciembre 31, |
Otros activos corrientes y no corrientes | $m | $m |
Gastos corrientes prepagos | 31 | 23 |
Otros activos corrientes | 14 | 434 |
Total otros activos corrientes | 45 | 457 |
Gastos anticipados no corrientes | 18 | 19 |
Otros activos no corrientes | 11 | 9 |
Total otros activos no corrientes | 29 | 28 |
Total | 74 | 485 |
The decrease in other current assets primarily relates to release of escrow funding of $415m for the Antitrust MDL (direct purchaser and end payor class settlements) since the courts have provided final approval of the settlements. Refer to Note 13. Long-term prepaid expenses primarily relate to payments for contract manufacturing capacity.
10. PASIVOS FINANCIEROS - PRESTAMOS
La siguiente tabla muestra la obligación de la porción corriente y no corriente del préstamo a plazo del Grupo:
| Mar 31, | Diciembre 31, |
Préstamo a plazo | $m | $m |
Préstamo a plazo - actual | (3) | (3) |
Préstamo a plazo - no corriente | (235) | (236) |
Préstamo a plazo total | (238) | (239) |
*El total de los préstamos a plazo refleja el monto principal retirado, incluida la emisión de deuda. costos de $ 5 millones (año fiscal 2023: $ 5m).
At 31 de marzo de 2024, el término valor razonable del préstamo fue apaproximadamente el 100 % (año fiscal 2023: 100%) of par value. The key terms of this loan in effect at 31 de marzo de 2024, son como sigue:
|
| Moneda | Margen de interés nominal | Madurez | Reembolsos anuales requeridos | Longitud Mínima liquidez |
Facilidad de préstamo a plazo |
| USD | SOFR + 0.26% + 5.25% | 2026 | 1% | Larger of $100m or 50% of loan balance |
El plazo del préstamo asciende a $243m (año fiscal 2023: $244m) está garantizado contra los activos de ciertas subsidiarias del Grupo en forma de garantías emitidas por las respectivas subsidiarias.
• El margen de interés nominal se calcula como USD SOFR más 26 bps, sujeto a un piso de 0.75%, más un ajuste del diferencial de crédito de 5.25%.
• Existen no compromisos de crédito renovables.
11. PROVISIONES Y OTRAS RESPONSABILIDADES
Provisiones
|
|
| Total |
|
| Total |
| Current | No actual | 31 de marzo, 2024 | Current | No actual | 31 de diciembre de 2023 (Retrospectively adjusted1) |
Provisiones corrientes y no corrientes | $m | $m | $m | $m | $m | $m |
Reclamaciones estatales y colectivas antimonopolio en varios distritos | - | - | - | (385) | - | (385) |
Contratos onerosos | (17) | - | (17) | (19) | (3) | (22) |
False claims allegations | (4) | - | (4) | (4) | - | (4) |
Otro | - | (2) | (2) | - | (2) | (2) |
Total provisiones | (21) | (2) | (23) | (408) | (5) | (413) |
1 The provision for onerous contracts as of December 31, 2023 has been retrospectively adjusted to reflect a measurement period adjustment related to the November 2023 acquisition of an aseptic manufacturing facility. Refer to Note 17.
Reclamaciones estatales y colectivas antimonopolio en varios distritos
As previously disclosed, settlement agreements were entered into during 2023 with three plaintiff classes to fully resolve certain multi-district antitrust claims. The $385m direct purchaser class settlement received final court approval during the quarter. The provision and related other escrow settlement asset have been offset and Indivior has no further obligations related to this matter.
Contratos onerosos
In November 2023, the Group acquired a business consisting of a manufacturing facility, workforce, and supply contracts. The facility is obligated to fulfill contracts that existed pre-acquisition for which the expected costs are in excess of the consideration expected to be received. The Group recorded a provision for these onerous contracts in the allocation of purchase price, with a balance at the end of the quarter of $ 17m (FY 2023: $22m). During the quarter, net operating losses attributable to the contracts of $6m were recorded against the provision. A measurement period adjustment to this provision as of the acquisition date was recorded during the quarter and the reported December 31, 2023 provision has been adjusted accordingly. Refer to Note 17, Business Combination for additional details on this measurement period adjustment. Product manufacturing under the onerous contracts is expected to be completed prior to March 2025 and the provision is recorded at its discounted value, using a market rate at the time of the transaction determined to be 7.6%.
False Claims Act allegations
The Group carries a provision of $4m (FY 2023: $4m) pertaining to all outstanding False Claims Act allegations as discussed in Note 13. These matters are expected to be settled within the next 12 months.
Otro
Other provisions of $ 2m (año fiscal 2023: $ 2m) represent retirement benefit costs which are not expected to be settled within one year.
Otros pasivos
|
|
| Total |
|
| Total |
| Current | No actual | 31 de marzo, 2024 | Current | No actual | 31 de diciembre de 2023 |
Otros pasivos corrientes y no corrientes | $m | $m | $m | $m | $m | $m |
Resolución DOJ | (50) | (295) | (345) | (53) | (344) | (397) |
Reclamaciones estatales y colectivas antimonopolio en varios distritos | - | - | - | (30) | - | (30) |
Asuntos relacionados con la propiedad intelectual | - | - | - | (11) | - | (11) |
Acuerdo de indemnización de RB | (8) | (7) | (15) | (8) | (15) | (23) |
Recompra de acciones | (9) | - | (9) | (23) | - | (23) |
Otro | - | (11) | (11) | - | (8) | (8) |
Total de otros pasivos | (67) | (313) | (380) | (125) | (367) | (492) |
Acuerdo de resolución del DOJ
In July 2020, the Group settled criminal and civil liability with the United States Department of Justice (DOJ), the U.S. Federal Trade Commission (FTC), and U.S. state attorneys general. Pursuant to the resolution agreement, aggregate payments of $ 263m (including interest) have been made through 31 de marzo de 2024, including a payment of $ 53m in January 2024. Annual installments of $50m plus interest are due every January 15 from 2025 to 2027, with the final installment of $200m due in December 2027. The Group has the option to prepay. Interest accrues at 1.25% on certain portions of the resolution and will be paid with the annual installment payments. For non-interest-bearing portions, the liability has been recorded at the net present value based on timing of the estimated payments using a discount rate equal to the interest rate on the interest-bearing portions. In Q1 2024, the Group recorded interest expense totaling $ 1m (Q1 2023: $ 1m).
Reclamaciones estatales y colectivas antimonopolio en varios distritos
As noted above, certain multi-district antitrust claims were resolved during 2023 through settlement agreements entered into with three classes of plaintiffs. The $30m end payor liability and related other escrow settlement asset have been offset since final court approval was received and Indivior has no further obligations related to this matter.
asuntos relacionados con la PI
Other liabilities for intellectual property related matters relate to the settlement of litigation with DRL in June 2022. Under the settlement agreement, the Group made a final payment to DRL of $12m during the quarter and has no further obligations related to this matter.
Acuerdo de indemnización de RB
Under the RB indemnity settlement, the Group has paid $ 34m of the $50m settlement agreement through 31 de marzo de 2024 including $8m paid in January 2024. Remaining annual installment payments of $8m are due in January 2025 and 2026. The Group carries a liability totaling $ 15m (año fiscal 2023: $ 23m) related to this settlement. This liability has been recorded at the net present value, using a market interest rate at the time of the settlement determined to be 3.75%, considering the timing of payments and other factors. In Q1 2024, el Grupo registró cero of finance expense (Q1 2023: cero) por el valor del dinero en el tiempo sobre el pasivo.
Recompra de acciones
In November 2023, the Group commenced a share repurchase program of $100m. As of 31 de marzo de 2024, the liability of $9m represents the amount to be spent under the program through April 26, 2024, after which date the Company has the ability to modify or terminate the program. As of December 31, 2023, the current liability of $ 23m represented the amount to be spent under the program through February 23, 2024.
Otro
Other liabilities primarily represent employee related liabilities which are non-current as of 31 de marzo de 2024.
12. RESPONSABILIDADES CONTINGENTES
The Group has assessed certain legal and other matters to be not probable based upon current facts and circumstances, including any potential impact the DOJ resolution could have on these matters. Where liabilities related to these matters are determined to be possible, they represent contingent liabilities. Except for those matters discussed in Note 13 under "False Claims Act allegations", for which provisions have been recognized, Note 13 sets out the details for legal and other disputes for which the Group has assessed as contingent liabilities. Where the Group believes that it is possible to reasonably estimate a range for the contingent liability this has been disclosed.
13. PROCEDIMIENTOS LEGALES
There are certain ongoing legal proceedings or threats of legal proceedings in which the Group is a party, but in which the Group believes the possibility of an adverse impact is remote and they are not discussed in this Note.
Litigio antimonopolio y protección al consumidor
• Cases filed by (1) Blue Cross and Blue Shield of Massachusetts, Inc., Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc., (2) Health Care Service Corp., (3) Blue Cross and Blue Shield of Florida, Inc., Health Options, Inc., (4) BCBSM, Inc. (d/b/a Blue Cross and Blue Shield of Minnesota) and HMO Minnesota (d/b/a Blue Plus), (5) Molina Healthcare, Inc., and (6) Aetna Inc. were filed in the Circuit Court for the County of Roanoke, Virginia. Véase Health Care Services Corp. v. Indivior Inc., No. CL20-1474 (Lead Case) (Va. Cir. Ct.) (Roanoke Cnty). In July 2023, Indivior Inc. and BCBSM, Inc. and HMO Minnesota agreed to mutual releases and settlement. The remaining plaintiffs asserted claims under federal and state RICO statutes, state antitrust statutes, state statutes prohibiting unfair and deceptive practices, state statutes prohibiting insurance fraud, and common law fraud, negligent misrepresentation, and unjust enrichment. The Group filed demurrers, which the court sustained in part and overruled in part. Separately, Indivior Inc. filed counterclaims against several plaintiffs alleging violations of certain insurance fraud statutes. The plaintiffs demurred. The court overruled HCSC's demurrer but sustained the demurrers of the remaining plaintiffs named in Indivior Inc.'s counterclaims. A jury trial on the Group's pleas in bar to the remaining plaintiffs' fraud claims was held on October 30 - November 3, 2023. The jury rendered a verdict finding that the plaintiffs' fraud claims are not barred by the statute of limitations. A jury trial on the merits has been set for July 15, 2024 - August 15, 2024. The Group is still in the process of evaluating the claims, believes it has meritorious defenses, and intends to defend itself. No estimate of the range of potential loss can be made at this time.
• Humana, Inc. filed a Complaint in state court in Kentucky on August 20, 2021 with claims substantially similar to those asserted by other end payors in the HCSC consolidated litigation. Véase Humana Inc. contra Indivior Inc., No. 21-CI-004833 (Ky. Cir. Ct.) (Jefferson Cnty). The court lifted a stay on October 30, 2023. Indivior moved to dismiss the complaint in February 2024. The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
• Centene Corporation, Wellcare Healthcare Plans, Inc., New York Quality Healthcare Corp. (d/b/a Fidelis Care), and Health Net, LLC filed a complaint in the Circuit Court for the County of Roanoke, Virginia alleging similar claims on January 13, 2023. Véase Centene Corp. v. Indivior Inc., No. CL23000054-00 (Va. Cir. Ct.) (Roanoke Cnty). Indivior demurred to the complaint and asserted pleas in bar in early February 2024. The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
• As previously disclosed in 2023, Indivior Inc. settled claims of all plaintiff groups in the company's antitrust multi-district litigation ("Antitrust MDL") namely, (i) 41 states and the District of Columbia (the "States"), (ii) end payors, and (iii) direct purchasers (collectively, the "Plaintiffs"). Indivior Inc. reached a settlement with the States for $103m on June 1, 2023. Indivior Inc. entered into a settlement agreement with the end payor class for $30m on August 14, 2023 and received final court approval on December 5, 2023. On October 22, 2023, Indivior Inc. entered into a settlement agreement with the remaining direct purchaser class for $385m, which received final court approval on February 27, 2024.
• In 2013, Reckitt Benckiser Pharmaceuticals Inc. "RBPI," now known as Indivior Inc. received notice that it and other companies were defendants in a lawsuit initiated by writ in the Philadelphia County (Pennsylvania) Court of Common Pleas. See Carefirst de Maryland, Inc. et al. contra Reckitt Benckiser Inc., et al., Case. No. 2875, December Term 2013. The plaintiffs included approximately 79 entities, most of which appeared to be insurance companies or other providers of health benefits plans. The claims of all plaintiffs in the cuidadoprimero action except Humana Inc. and certain of its affiliates were resolved in connection with final approval of the end payor settlement in the Antitrust MDL, and accordingly dismissed on February 14, 2024. The claims of Humana Inc. and certain of its affiliates in the cuidadoprimero action remain pending. The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
Litigio civil por opioides
• El Grupo ha sido acusado en más de 400 demandas civiles que alegan que los fabricantes, distribuidores y minoristas de opioides participaron en una práctica de larga data para comercializar opioides como seguros y eficaces para el tratamiento del dolor crónico a largo plazo para aumentar el mercado. de opioides y sus propias cuotas de mercado de opioides, o alegando reclamaciones individuales por lesiones personales. La mayoría de estos casos se han consolidado y están pendientes en un litigio federal multidistrito ("el MDL de opioides") en el Tribunal de Distrito de EE. UU. para el Distrito Norte de Ohio. Ver In re Litigios Nacionales de Opiáceos Recetados, MDL No. 2804 (N.D. Ohio). Nearly two-thirds of the cases in the Opioid MDL were filed by cities and counties, while nearly one-third of the cases were filed by individual plaintiffs, most of whom assert claims relating to neonatal abstinence syndrome ("NAS"). Litigation against the Group in the Opioid MDL is stayed.
• The court in the Opioid MDL has indicated that it does not intend to set additional bellwether trials for Tier 2 and Tier 3 manufacturer and distributor defendants, provided that those defendants remain actively engaged in mediation.
• Separately, Indivior Inc. was named as one of numerous defendants in civil opioid cases that are not part of the Opioid MDL:
◦ En 2017, Indivior Inc. fue nombrado como uno de los numerosos demandados en Hermandad Internacional de Trabajadores Eléctricos Local 728 Family Healthcare Plan v. Allergan, PLC et al., Case ID: 190303872 (C.P. Phila. Cnty). That case was consolidated with Lead Case No. 2017-008095 in Delaware County and stayed, remanded back to the Philadelphia Court by order dated December 29, 2023, and ultimately dismissed with prejudice as to Indivior Inc. by agreement of the parties on March 27, 2024.
◦ Indivior also was named as one of numerous defendants in various other federal and state court cases that are not in the Opioid MDL and were brought by municipalities. These cases include, for example, 35 actions filed in New York state court that were removed to federal court, as well as cases filed in federal district courts sitting in Alabama, Florida, Georgia, and New Mexico. The plaintiffs filed motions to remand the New York cases, which remain pending. The plaintiffs in the case filed in the Northern District of Alabama have voluntarily dismissed their complaint, subject to certain tolling agreements. The various other federal actions currently are stayed, except Indivior's response to the complaint in San Miguel Hospital Corp. d/b/a Alta Vista Regional Medical Center v. Johnson & Johnson, et al., No. 1:23-cv-00903 (D.N.M.) is due May 2, 2024.
◦ Indivior Inc. fue nombrada demandada en cinco demandas individuales presentadas en el tribunal estatal de Virginia Occidental que fueron transferidas al Panel de Litigios Masivos de Virginia Occidental. See In re Litigio de opioides, No. 22-C-9000 NAS (WV Kanawha Cnty. Cir. Ct.) ("Acción WV MLP"). Los cinco casos de Indivior Inc. en la Acción MLP de WV involucraron reclamos relacionados con NAS. Indivior Inc. tomó medidas para desestimar las cinco quejas sobre January 30, 2023. By order dated April 17, 2023, the court granted Indivior's motions to dismiss. The plaintiffs filed a notice of appeal on June 30, 2023. Appellate briefing in various cases, including the cases involving Indivior, was stayed in view of Rite-Aid's bankruptcy. However, on April 16, 2024, the court of appeals granted the plaintiffs' motion to sever Rite-Aid and lift the stay. Plaintiffs have until May 7, 2024 to perfect their appeal, and the Defendants' response is due by June 21, 2024.
• Dado el estado y la etapa preliminar del litigio tanto en la MDL de opioides como en las acciones judiciales federales y estatales separadas, no se puede hacer ninguna estimación de la posible pérdida en el litigio de opioides en este momento.
Alegaciones de la Ley de Reclamaciones Falsas
• En agosto de 2018, el Tribunal de Distrito de los Estados Unidos para el Distrito Oeste de Virginia reveló un qui tam queja alegando causas de acción bajo las leyes federales y estatales de reclamos falsos contra ciertas entidades dentro del Grupo basadas en problemas de mejor precio y reclamos de represalia. See Estados Unidos ex rel. Miller contra Reckitt Benckiser Group PLC y otros., Case No. 1:15-cv-00017 (W.D. Va.). The suit also seeks reasonable attorneys' fees and costs. The Group filed a Motion to Dismiss in June 2021, which was granted in part and denied in part on October 17, 2023. The relator filed a sixth amended complaint against only Indivior Inc. on December 7, 2023. Indivior answered the sixth amended complaint on March 18, 2024.
• In May 2018, Indivior Inc. received an informal request from the United States Attorney's Office ("USAO") for the Southern District of New York, seeking records relating to the SUBOXONE Film manufacturing process. The Group provided the USAO certain information regarding allegations that the government received regarding SUBOXONE Film. There has been no communication regarding this matter with the USAO since 2022.
U.K. Shareholder Claims
• On September 21, 2022, certain shareholders issued representative and multiparty claims against Indivior PLC in the High Court of Justice for the Business and Property Courts of England and Wales, King's Bench Division. On January 16, 2023, the representative served its Particular of Claims setting forth in more detail the claims against the Group, while the same law firm that represents the representative also sent its draft Particular of Claims for the multiparty action. The claims made in both the representative and multiparty actions generally allege that Indivior PLC violated the U.K. Financial Services and Markets Act 2000 ("FSMA 2000") by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE Tablets to SUBOXONE Film. Indivior PLC filed an application to strike out the representative action. On December 5, 2023, the court handed down a judgment allowing the Group's application to strike out the representative action. The court subsequently awarded certain costs to the Group. On January 23, 2024, the claimants requested permission to appeal the decision to the court of appeals. The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
Dental Allegations
• The Group has been named as a defendant in more than 325 lawsuits that have been consolidated into a multi-district litigation in the Northern District of Ohio ("Dental MDL"). See In Re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092 (N.D. Oh.). The plaintiffs generally allege that the Group failed to properly warn physicians of the risk of dental injury, and further allege that SUBOXONE products were defectively designed. The plaintiffs generally seek compensatory damages, as well as punitive damages and attorneys' fees and costs. Product liability cases such as these typically involve issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual, provable injury and other matters. These cases are in their preliminary stages. The Group is evaluating the claims and its defenses, believes it has meritorious defenses, and intends to defend itself. No estimate of the range of potential loss can be made at this time. These lawsuits follow a June 2022 required revision to the Prescribing Information and Patient Medication Guide about dental problems reported in connection with buprenorphine medicines dissolved in the mouth to treat opioid use disorder. This revision was required by the FDA of all manufacturers of these products. The Group has been informed by its primary insurance carrier that defense costs for the Dental MDL should begin to be reimbursed now that the Group's self-insurance retention has been exhausted. To date, no such reimbursement has occurred. Additionally, the Group's insurance carrier has issued a reservation of rights against payment of any finding of liability costs. The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
• Applications to file class actions based on similar allegations as in the Dental MDL were filed in Quebec and British Columbia against various subsidiaries of the Group, among other defendants, in April 2024. The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
14. COMERCIO Y OTRAS CUENTAS POR PAGAR
| Mar 31, | Diciembre 31, |
| $m | $m |
Acumulación para rebajas, descuentos y devoluciones | (556) | (507) |
Rebates payable | (4) | (28) |
Cuentas por pagar | (40) | (39) |
Devengos y otras cuentas a pagar | (129) | (150) |
Otros impuestos y seguridad social pagaderos | (25) | (19) |
Total comercial y otras cuentas por pagar | (754) | (743) |
15. CAPITAL SOCIAL
| Equity ordinary shares (thousands) | Valor nominal pagado por acción | Valor nominal agregado $m |
Emitido y pagado en su totalidad |
|
|
|
A 1 de enero de 2024 | 136,526 | $0.50 | 68 |
Acciones ordinarias emitidas | 1,356 | $0.50 | 1 |
Shares repurchased and canceled | (1,988) | $0.50 | (1) |
Al 31 de marzo de 2024 | 135,894 |
| 68 |
| Equity ordinary shares (thousands) | Valor nominal pagado por acción | Valor nominal agregado $m |
Emitido y pagado en su totalidad |
|
|
|
A 1 de enero de 2023 | 136,481 | $0.50 | 68 |
Acciones ordinarias emitidas | 1,878 | $0.50 | 1 |
Shares repurchased and canceled | (484) | $0.50 | - |
Al 31 de marzo de 2023 | 137,875 |
| 69 |
Acciones ordinarias emitidas
Durante el periodo, 1,356k acciones ordinarias en $0.50 cada (Q1 2023: 1,878k at $0.50 each) were issued to satisfy vesting/exercises under the Group's Long-Term Incentive Plan, the Indivior U.K. Savings-Related Share Option Scheme, and the U.S. Employee Stock Purchase Plan. In Q1 2024, net settlement of tax on employee equity awards was $ 20m (Q1 2023: $ 21m).
Shares repurchased and canceled
On May 3, 2022, the Group commenced a share repurchase program for an aggregate purchase price up to no more than $100m or 39,699k of ordinary shares, (equivalent shares post share consolidation: 7,940k) which concluded on February 28, 2023. During the prior period, the Company repurchased and canceled 484k ordinary shares with a nominal value of $0.50 each.
On November 17, 2023, the Group commenced a share repurchase program for an aggregate purchase price up to no more than $100m or 13,632k of ordinary shares and ending no later than August 30, 2024. During the period, the Group repurchased and canceled a total of 1,988k ordinary shares at $0.50 per share under this program for an aggregate nominal value of $ 1m.
All ordinary shares repurchased during the period under share repurchase programs were canceled resulting in a transfer of the aggregate nominal value to a capital redemption reserve. The total cost of the purchases made under the share repurchase program during the period, including directly attributable transaction costs, was $ 36m (AF 2023: $ 33m). A net repurchase amount of $ 9m has been recorded as a financial liability and reduction of retained earnings which represents the amount to be spent under the program through April 26, 2024, after which date the Company has the ability to modify or terminate the program. Total purchases under the share repurchase program will be made out of distributable profits.
16. ADQUISICIÓN DE OPIANTE
On March 2, 2023, the Group acquired 100% of the share capital of Opiant for upfront cash consideration of $146m and an additional maximum amount of $8.00 per share in Contingent Value Rights (CVR) to be potentially paid upon achievement of net sales milestones. As a result of the acquisition, the Group added OPVEE (nalmefene nasal spray), an opioid overdose treatment well-suited to confront illicit synthetic opioids like fentanyl, to its addiction science portfolio. OPVEE Fue aprobado por la FDA en mayo de 2023 y lanzado en octubre de 2023.
Since substantially all of the fair value of the gross assets acquired was concentrated in the OPVEE in-process research and development, the Group accounted for the transaction as an asset acquisition and recorded an intangible asset of 126 millones de dólares.
The cash outflow for the acquisition was $124m in Q1 2023, net of cash acquired, and inclusive of direct transaction costs. As part of the acquisition, the Group assumed outstanding debt of $10m which was settled and included as a cash outflow from financing activities.
Additional acquisition-related costs of $12m were incurred in Q1 2023 and included in selling, general, and administrative expenses, primarily relating to severance, acceleration of vesting of Opiant employee share compensation, and short-term retention accruals.
17. COMBINACIÓN DE NEGOCIOS
On November 1, 2023, the Group acquired an aseptic manufacturing facility (the "Facility") in the United States for upfront consideration of $5m in cash and assumption of certain contract manufacturing obligations. The Facility will be further developed to secure the long-term production and supply of SUBLOCADE and PERSERIS.
The acquisition was accounted for as a business combination using the acquisition method of accounting in accordance with IFRS 3 Combinación de negocios. The assets acquired and liabilities assumed were recorded at fair value, with the excess of the purchase price over the fair value of the identifiable assets and liabilities recognized as goodwill. An onerous contract provision was recorded at fair value to reflect the present value of the expected losses from assumed contractual manufacturing obligations. Net operating losses attributable to these contractual obligations will be recorded against the onerous contract provision from the date of acquisition through fulfillment of the contracts in early 2025.
A partir de marzo 31, 2024, committed capital spend for the Facility is approximately $7m.
Activos identificables adquiridos y pasivos asumidos
As the acquisition was completed in late 2023, the provisional fair value of assets acquired and liabilities assumed at the date of acquisition was disclosed in the consolidated financial statements for the year ended December 31, 2023. In 2024, based on new information obtained about facts and circumstances that existed as of the acquisition date, the Group adjusted the provisional fair values for acquired property, plant and equipment and the assumed onerous contract provision, with an adjustment to goodwill equal to the change in the net assets acquired. These measurement period adjustments have been reflected in the comparative period presented in the Condensed Financial Statements in accordance with IFRS 3 Combinación de negocios. La siguiente tabla proporciona una reconciliación from the provisional fair values of assets acquired and liabilities assumed at the date of acquisition as reported in the 2023 annual financial statements to the provisional fair values as adjusted during the quarter:
| Provisional values | ||
| As Previously Reported | Ajuste del período de medición | Como ajustado |
Activos netos adquiridos | $m | $m | $m |
Propiedad, planta y equipo. | 28 | (2) | 26 |
Activos por impuestos diferidos | 2 | (1) | 1 |
Comerciales y otras cuentas a pagar | (1) | - | (1) |
Provisiones | (29) | 6 | (23) |
Total activos netos adquiridos | - | 3 | 3 |
Goodwill
Goodwill arising from the acquisition has been recognized as follows, reflecting the measurement period adjustments:
| Provisional values | ||
| As Previously Reported | Ajuste del período de medición | Como ajustado |
| $m | $m | $m |
Contraprestación transferida | 5 | - | 5 |
Menos: valor razonable de los activos netos adquiridos | - | (3) | (3) |
Goodwill | 5 | (3) | 2 |
The goodwill is primarily attributable to Indivior-specific synergies relating to accelerated in-sourcing of SUBLOCADE production and the skills and technical talent of the Facility's workforce.
DECLARACIÓN DE RESPONSABILIDAD DE LOS DIRECTORES
Los Consejeros declaran que, a su leal saber y entender:
• This set of condensed consolidated interim financial statements, which have been prepared in accordance with U.K. adopted International Accounting Standard 34, Información financiera intermedia, gives a true and fair view of the assets, liabilities, financial position, and profit or loss of Indivior; and
• El informe de gestión intermedio brinda una revisión justa de la información de acuerdo con las normas 4.2.7 y 4.2.8 de las Reglas de Orientación y Transparencia de Divulgación.
Los Consejeros son responsables del mantenimiento y la integridad del sitio web del Grupo. La legislación del Reino Unido que rige la preparación y divulgación de estados financieros puede diferir de la legislación de otras jurisdicciones.
Los detalles de los Directores de Indivior PLC están disponibles en nuestro sitio web en www.indivior.com
Por orden de la Junta
marca crossley | ryan preblick |
Director General | Director Financiero |
Abril 24, 2024
Informe de revisión independiente para Indivior PLC
Informe sobre los estados financieros intermedios consolidados condensados
Nuestra conclusión |
We have reviewed Indivior PLC's condensed consolidated interim financial statements (the "interim financial statements") in the Q1 2024 Financial Results of Indivior PLC for the three month period ended 31 March 2024 (the "period").
Según nuestra revisión, no nos ha llamado la atención nada que nos haga creer que los estados financieros intermedios no están preparados, en todos los aspectos importantes, de acuerdo con la Norma Internacional de Contabilidad 34, 'Información financiera intermedia' adoptada por el Reino Unido.
Los estados financieros intermedios comprenden:
• the Condensed consolidated interim balance sheet as at 31 March 2024;
• the Condensed consolidated interim income statement and Condensed consolidated interim statement of comprehensive income for the three month period then ended;
• the Condensed consolidated interim cash flow statement for the three month period then ended;
• the Condensed consolidated interim statement in changes in equity for the three month period then ended; and
• las notas explicativas a los estados financieros intermedios.
Los estados financieros intermedios incluidos en los resultados financieros del tercer trimestre de 1 de Indivior PLC se han preparado de acuerdo con la Norma Internacional de Contabilidad 2024, "Informes financieros intermedios", adoptada por el Reino Unido.
Base para la conclusión |
Realizamos nuestra revisión de acuerdo con la Norma Internacional sobre Compromisos de Revisión (Reino Unido) 2410, 'Revisión de Información Financiera Intermedia realizada por el Auditor Independiente de la Entidad' emitida por el Consejo de Información Financiera para uso en el Reino Unido ("ISRE (UK) 2410"). Una revisión de la información financiera intermedia consiste en realizar consultas, principalmente a las personas responsables de los asuntos financieros y contables, y aplicar procedimientos analíticos y de revisión.
Una revisión tiene un alcance sustancialmente menor que una auditoría realizada de acuerdo con las Normas Internacionales de Auditoría (Reino Unido) y, en consecuencia, no nos permite obtener la seguridad de que tendremos conocimiento de todos los asuntos importantes que podrían identificarse en una auditoría. En consecuencia, no expresamos una opinión de auditoría.
Hemos leído la otra información contenida en los resultados financieros del primer trimestre de 1 y consideramos si contiene incorrecciones aparentes o inconsistencias materiales con la información en los estados financieros intermedios.
Conclusiones relativas a la empresa en marcha |
Con base en nuestros procedimientos de revisión, que son menos extensos que los realizados en una auditoría como se describe en la sección Bases de la conclusión de este informe, nada ha llegado a nuestra atención que sugiera que los directores hayan adoptado de manera inapropiada la base contable de negocio en marcha o que los directores han identificado incertidumbres materiales relacionadas con la empresa en funcionamiento que no se revelan adecuadamente. Esta conclusión se basa en los procedimientos de revisión realizados de acuerdo con ISRE (UK) 2410. Sin embargo, eventos o condiciones futuras pueden causar que el grupo deje de continuar como un negocio en marcha.
Responsabilidades por los estados financieros intermedios y la revisión |
Nuestras responsabilidades y las de los directores |
Los resultados financieros del tercer trimestre de 1, incluidos los estados financieros intermedios, son responsabilidad de los directores y han sido aprobados por ellos. Los directores son responsables de preparar los resultados financieros del tercer trimestre de 2024 de acuerdo con la Norma Internacional de Contabilidad 1, "Informes financieros intermedios", adoptada por el Reino Unido. Al preparar los resultados financieros del tercer trimestre de 2024, incluidos los estados financieros intermedios, los directores son responsables de evaluar la capacidad del grupo para continuar como empresa en funcionamiento, revelando, según corresponda, las cuestiones relacionadas con la empresa en funcionamiento y utilizando la base contable de empresa en funcionamiento a menos que Los directores tienen la intención de liquidar el grupo o cesar sus operaciones, o no tienen otra alternativa realista que hacerlo.
Nuestra responsabilidad es expresar una conclusión sobre los estados financieros intermedios en los Resultados financieros del tercer trimestre de 1 con base en nuestra revisión. Nuestra conclusión, incluidas nuestras Conclusiones relacionadas con la empresa en funcionamiento, se basa en procedimientos que son menos extensos que los procedimientos de auditoría, como se describe en el párrafo Bases de la conclusión de este informe. Este informe, incluida la conclusión, ha sido preparado para y únicamente para la empresa con el fin de cumplir con la Norma Internacional de Contabilidad 2024, "Informes financieros intermedios" adoptada por el Reino Unido y ningún otro propósito. Al dar esta conclusión, no aceptamos ni asumimos responsabilidad por ningún otro propósito ni hacia ninguna otra persona a quien se muestre este informe o en cuyas manos pueda llegar, salvo que se acuerde expresamente mediante nuestro consentimiento previo por escrito.
PricewaterhouseCoopers LLP
Contadores Públicos
Londres
24 Abril de 2024
APÉNDICE: RESULTADOS AJUSTADOS
Elementos excepcionales y otros ajustes
Las partidas excepcionales y otros ajustes representan gastos o ingresos significativos que no reflejan las operaciones en curso del Grupo o cuyo ajuste puede ayudar con la comparación con períodos anteriores. Las partidas excepcionales y otros ajustes se excluyen de los resultados ajustados de conformidad con los informes internos proporcionados a la gerencia y a los Directores. Ejemplos de tales partidas podrían incluir ingresos o reestructuración y gastos relacionados de la reconfiguración de las actividades y/o estructura de capital del Grupo, amortización de activos intangibles adquiridos, deterioro de activos corrientes y no corrientes, ganancias y pérdidas por la venta de activos intangibles, ciertos costos que surgen como resultado de asuntos regulatorios y de litigios significativos y no recurrentes, y ciertos asuntos relacionados con impuestos.
Los resultados ajustados no son medidas definidas por las NIIF y no sustituyen ni superan los resultados informados presentados de acuerdo con las NIIF. Los resultados ajustados presentados por el Grupo no son necesariamente comparables con medidas con títulos similares utilizadas por otras empresas. Como resultado, estas medidas de desempeño no deben considerarse de forma aislada o como un análisis sustituto de los resultados reportados por el Grupo presentados de acuerdo con las NIIF. La gerencia realiza una evaluación cuantitativa y cualitativa para determinar si un elemento debe considerarse para ajuste. El siguiente cuadro detalla las partidas excepcionales y otros ajustes registrados en cada período:
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Artículos excepcionales y otros ajustes dentro del costo de ventas. |
|
|
Amortización de activos intangibles adquiridos1 | (3) | - |
Total de artículos excepcionales y otros ajustes dentro del costo de ventas | (3) | - |
|
|
|
Partidas excepcionales y otros ajustes dentro de los gastos de venta, generales y administrativos |
|
|
Costos relacionados con la adquisición2 | (2) | (12) |
Costos de cotización en EE. UU.3 | - | (2) |
Total de partidas excepcionales y otros ajustes dentro de gastos de venta, generales y administrativos | (2) | (14) |
|
|
|
Total de partidas excepcionales y otros ajustes antes de impuestos | (5) | (14) |
Impuesto sobre partidas excepcionales y otros ajustes | 1 | 2 |
Total partidas excepcionales y otros ajustes | (4) | (12) |
1. The Group reported adjusted cost of sales to exclude amortization of acquired intangible assets.
2. In Q1 2024, el Grupo reconoció $ 2m of exceptional costs related to the acquisition and integration of the aseptic manufacturing site acquired in November 2023. In Q1 2023, el Grupo reconoció $ 12m of exceptional costs related to the acquisition of Opiant.
3. In Q1 2023, el Grupo reconoció $ 2m of exceptional costs in preparation for an additional listing of Indivior shares on a major U.S. exchange.
Resultados ajustados
Management provides certain adjusted financial measures which may be useful to investors. These adjusted financial measures exclude items which do not reflect the Group's day-to-day operations and therefore may help with comparisons to prior periods or among companies. Management may use these financial measures to better understand trends in the business.
The tables below present the adjustments between reported and adjusted results for both Q1 2024 y Q1 2023.
Conciliación de la utilidad bruta con la utilidad bruta ajustada
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Beneficio bruto | 238 | 214 |
Artículos excepcionales y otros ajustes en el costo de ventas. | 3 | - |
Beneficio bruto ajustado | 241 | 214 |
We define adjusted gross margin as adjusted gross profit divided by net revenue.
Conciliación de los gastos de venta, generales y administrativos con los gastos de venta, generales y administrativos ajustados
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Gastos de venta, generales y administrativos. | (145) | (131) |
Partidas excepcionales y otros ajustes en gastos de venta, generales y administrativos | 2 | 14 |
Gastos de venta, generales y administrativos ajustados | (143) | (117) |
Conciliación de la utilidad operativa con la utilidad operativa ajustada
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Beneficio operativo | 65 | 57 |
Artículos excepcionales y otros ajustes en el costo de ventas. | 3 | - |
Partidas excepcionales y otros ajustes en gastos de venta, generales y administrativos | 2 | 14 |
Beneficio operativo ajustado | 70 | 71 |
We define adjusted operating margin as adjusted operating profit divided by net revenue.
Conciliación de la ganancia antes de impuestos con la ganancia ajustada antes de impuestos
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Beneficio antes de impuestos | 63 | 58 |
Artículos excepcionales y otros ajustes en el costo de ventas. | 3 | - |
Partidas excepcionales y otros ajustes en gastos de venta, generales y administrativos | 2 | 14 |
Beneficio ajustado antes de impuestos | 68 | 72 |
Conciliación del gasto fiscal con el gasto fiscal ajustado
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Gasto de impuestos | (16) | (14) |
Impuesto sobre partidas excepcionales y otros ajustes | (1) | (2) |
Gasto fiscal ajustado | (17) | (16) |
We define adjusted effective tax rate as adjusted tax expense divided by adjusted profit before taxation.
Conciliación de la utilidad neta con la utilidad neta ajustada
| 2024 | 2023 |
Por los tres meses terminados el 31 de marzo | $m | $m |
Ingresos netos | 47 | 44 |
Artículos excepcionales y otros ajustes en el costo de ventas. | 3 | - |
Partidas excepcionales y otros ajustes en gastos de venta, generales y administrativos | 2 | 14 |
Impuesto sobre partidas excepcionales y otros ajustes | (1) | (2) |
Utilidad neta ajustada | 51 | 56 |
Ganancias por acción diluidas ajustadas
Management believes that diluted earnings per share, adjusted for the impact of exceptional items and other adjustments after the appropriate tax amount, may provide meaningful information on underlying trends to shareholders in respect of earnings per ordinary share. Weighted average shares used in computing diluted earnings per share is included in Note 6. A reconciliation of net income to adjusted net income is included above.
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