Executive Summary / Key Takeaways

• Focused Growth Engine: Indivior is strategically streamlining its operations to concentrate on SUBLOCADE, its long-acting injectable (LAI) for Opioid Use Disorder (OUD), which delivered record net revenue of $209 million in Q2 2025, up 9% year-over-year. The company aims to accelerate SUBLOCADE's U.S. growth and LAI market penetration, currently under 8% despite a significant unmet need.
• Technological Edge & Enhanced Patient Experience: SUBLOCADE's core differentiation lies in its extended-release buprenorphine formulation, offering sustained therapeutic levels for a full month. Recent label updates for rapid induction and alternate injection sites are critical enhancements, improving patient access and physician flexibility, with payer coverage for the new dosing approach reaching approximately 80% of covered lives.
• Operational Overhaul for Profitability: Under the new "Indivior Action Agenda," the company is undertaking a multi-phase operational roadmap to simplify its complex cost structure, eliminate nonessential activities, and drive significant bottom-line accretion starting in 2026. This includes delisting from the London Stock Exchange and refocusing R&D on two OUD Phase 2 assets.
• Robust Financial Outlook: Indivior has raised its full-year 2025 net revenue guidance to $1.03 billion to $1.08 billion and adjusted EBITDA guidance to $275 million to $300 million, reflecting strong SUBLOCADE performance and U.S. SUBOXONE Film price stability in the first half of the year.
• Competitive Dynamics & Market Opportunity: While facing generic erosion for SUBOXONE Film and competition in the LAI market, SUBLOCADE maintains a stable U.S. market share of approximately 75% and a new patient share over 70%. The vast undertreated OUD population and low LAI penetration present a substantial long-term growth opportunity for Indivior's differentiated offerings.

Indivior's Focused Pursuit of OUD Treatment Leadership

Indivior PLC is a global pharmaceutical company singularly dedicated to transforming the landscape of Opioid Use Disorder (OUD) treatment. Its core mission is to ensure all patients have access to evidence-based therapies, aiming to shift OUD from a global crisis to a recognized and treated chronic disease. The company's strategy is deeply rooted in its specialized portfolio, with SUBLOCADE, a long-acting injectable (LAI) buprenorphine, serving as its primary growth engine. This focus is particularly pertinent given the ongoing opioid epidemic, where approximately 9 million people in the U.S. misuse opioids, yet only 3 million are diagnosed with OUD, and a mere 1.2 million are in medically assisted treatment (BMAT) at any given time.

A critical differentiator for Indivior, and the cornerstone of its investment thesis, is its advanced buprenorphine-based technology, particularly embodied in SUBLOCADE. This extended-release injectable offers sustained therapeutic levels of buprenorphine for a full month, a significant advantage in promoting patient adherence and reducing the risks associated with daily dosing. The tangible benefits of this technology are underscored by recent label updates, which permit alternate sites of injection and rapid patient induction. These enhancements directly address physician feedback, improving the patient experience and offering greater flexibility in treatment initiation. Payer response to the new dosing approach has been positive, with coverage extending to approximately 80% of covered lives.

Indivior's R&D efforts are now exclusively focused on OUD, with two promising Phase 2 assets: INDV-6001, a potential three-monthly long-acting buprenorphine injectable, and INDV-2000, a selective Orexin-1 receptor antagonist representing a non-opioid treatment option. The stated goal for these programs is to expand on Indivior's heritage in OUD, with both Phase 2 studies expected to complete their last subject last visit in late 2025. This technological roadmap aims to solidify Indivior's competitive moat by offering innovative, patient-centric solutions that enhance treatment outcomes and expand market reach, thereby contributing to sustained financial performance and market leadership.

Strategic Evolution and the Indivior Action Agenda

Indivior's journey, incorporated in 2014, has been marked by pioneering efforts in OUD treatment. The launch of SUBLOCADE established the LAI category for OUD, quickly becoming the #1 prescribed LAI treatment and a primary revenue driver. By the end of 2024, SUBLOCADE had reached approximately 171,000 patients, a 25% increase from 2023, demonstrating its growing impact. The company also diversified with the 2022 acquisition of Opiant Pharmaceuticals, adding OPVEE for opioid overdose reversal.

The year 2024, however, presented challenges, including intensified generic competition for SUBOXONE Film and competitive dynamics impacting SUBLOCADE. In response, Indivior made decisive strategic shifts, discontinuing its schizophrenia treatment, PERSERIS, due to profitability concerns, and narrowing its commercial and R&D focus exclusively to OUD. This strategic pivot, coupled with over $100 million in annual cost reductions, aimed to reinvest in SUBLOCADE and its OUD pipeline while delivering significant savings to the bottom line.

Under new CEO Joe Ciaffoni, who assumed the role in May 2025, Indivior has launched the "Indivior Action Agenda," a three-phase operational roadmap designed to maximize business potential through simplification, cost reduction, and improved execution. Phase 1, "Generate Momentum" (May 2025 - end of 2025), focuses on enhancing U.S. SUBLOCADE commercial execution, streamlining the organization, and identifying investments to accelerate LAI market penetration. Phase 2, "Accelerate" (starting January 1, 2026), aims to boost U.S. SUBLOCADE growth and accelerate profitability and cash flow generation at a rate exceeding revenue growth. Finally, Phase 3, "Breakout" (expected H2 2026), will leverage a stronger financial profile for commercial stage acquisitions.

SUBLOCADE: The Enduring Growth Catalyst

SUBLOCADE remains the cornerstone of Indivior's investment thesis, demonstrating robust performance and significant future potential. In Q2 2025, SUBLOCADE achieved record net revenue of $209 million, marking a 9% year-over-year increase. On a sequential basis, net revenue surged 19%, driven by a 9% rise in dispense volume, alongside favorable stocking and gross-to-net dynamics. The U.S. market share for SUBLOCADE has remained stable at approximately 75% in the first half of 2025, and its new patient share has consistently stayed above 70% for three consecutive quarters.

Management is actively enhancing SUBLOCADE's commercial execution in the U.S. This includes sharpening field force messaging, improving productivity, and reinforcing treatment benefits, particularly highlighting the recently approved label updates for rapid induction and alternate injection sites. These updates are crucial for demonstrating SUBLOCADE as a "fit-for-purpose LAI for today's opioid crisis," which is increasingly driven by powerful synthetic opioids like fentanyl.

A significant growth opportunity lies within the commercial channel, where SUBLOCADE currently accounts for only 25% of total patient volume despite commercial patients representing about 60% of covered lives. Indivior is investing in omni-channel digital media and direct-to-consumer (DtC) efforts, recognizing an 80% plus prescription pull-through rate after patient request. The company is also focused on improving dispense yield rates within the specialty pharmacy channel to ensure patients receive their prescribed treatment efficiently.

The Justice System channel, while experiencing near-term funding challenges that impacted Q1 2025 revenue, is viewed as a "tremendously important long-term growth opportunity." These pressures are primarily budget-related, not due to competitive losses, with some large accounts temporarily shifting to oral treatments to serve more patients. Indivior expects growth in this channel to resume on a quarter-over-quarter basis through the balance of 2025, supported by new account activations and the eventual operationalization of Medicaid 1115 Waivers, which are approved in 16 states and expected to alleviate funding constraints starting in 2026.

Diversification and Pipeline: OPVEE and Future OUD Innovations

Beyond SUBLOCADE, Indivior's portfolio includes OPVEE (nalmefene nasal spray) for opioid overdose reversal, acquired through Opiant. OPVEE is uniquely recognized for its effectiveness against synthetic opioids like fentanyl, which cause over 90% of opioid-related overdoses. Despite this differentiation, adoption has been slower than anticipated, largely due to concerns about precipitated withdrawal and a lack of real-world evidence, with the "harm reduction voice" proving influential.

Indivior is actively addressing these challenges by gathering real-world evidence through 170 experience programs and engaging with state and local policymakers. The company has fulfilled two 100,000-unit deliveries in 2024 as part of its 10-year, over $100 million contract with BARDA, and 32 states have updated standing orders to allow access to all overdose reversal agents. For 2025, OPVEE's net revenue is projected at $10 million to $15 million, including an $8 million BARDA order, with other net revenue expected to be immaterial as the company builds trial and adoption.

The R&D pipeline is now sharply focused on two Phase 2 OUD assets: INDV-6001, a potential three-monthly LAI buprenorphine, and INDV-2000, a selective Orexin-1 receptor antagonist. Both studies are underway, with last subject last visit expected in late 2025. This concentrated pipeline aims to deliver future OUD treatment options, building on Indivior's core expertise and addressing unmet needs.

Operational Streamlining and Financial Discipline

Indivior's "Action Agenda" is a testament to its commitment to operational efficiency. The company acknowledges that its operations have been complex, with "nonessential activities inflating the cost structure." The goal is a "meaningful and significant reduction to the overall cost structure," with a full-year effect expected in 2026, leading to immediate bottom-line accretion and improved cash generation.

As part of this simplification, Indivior completed the cancellation of its secondary listing on the London Stock Exchange in July 2025, now trading exclusively on Nasdaq. This move aligns its capital markets presence with its U.S.-centric growth strategy and reduces complexity. The company's inclusion in the U.S. Russell 2000 and 3000 Indexes further enhances its U.S. market alignment. Additionally, Indivior will transition to being subject to SEC rules for U.S. domestic issuers starting January 1, 2026. The termination of a manufacturing agreement with Curia Massachusetts, Inc., effective January 31, 2026, reflects a move to consolidate manufacturing operations, with the Raleigh Manufacturing Facility on track for commercial production in 2026 and expected savings by 2027.

Financially, Indivior reported Q2 2025 total net revenue of $302 million, a 1% increase year-over-year. Gross profit for the quarter was $250 million, resulting in an 83% gross margin. Adjusted EBITDA for Q2 2025 was $88 million.

For the six months ended June 30, 2025, net cash provided by operating activities was $233 million, a significant increase of $182 million year-over-year, partly due to the timing of Medicaid rebate invoices. The company ended Q2 2025 with $538 million in gross cash and investments. While current liabilities exceeded current assets by $106 million, and total liabilities exceeded total assets by $257 million, management believes existing cash, investments, and cash from operations will meet anticipated needs for at least the next twelve months. Capital expenditures are projected at $50 million to $70 million for full-year 2025, primarily for the Raleigh facility.

Competitive Landscape and Positioning

Indivior operates in a competitive pharmaceutical landscape, particularly within the OUD treatment market. Its primary product, SUBLOCADE, competes with other LAI buprenorphine treatments, while SUBOXONE Film faces intense generic competition.

In the LAI segment, SUBLOCADE maintains a strong leadership position. Its market share in the U.S. has remained stable at approximately 75% in the first half of 2025, and its new patient share has consistently been over 70%. Cohort analysis of experienced dual prescribers indicates SUBLOCADE holds a stable share of approximately 65%, suggesting a preference for its differentiated profile. Management emphasizes that efficacy is the most important consideration for prescribers when choosing an LAI. SUBLOCADE's unique rapid induction and alternate injection site options, once fully adopted, are expected to further enhance its competitive edge, especially against competitors whose weekly products may only offer induction on that formulation.

For its sublingual buprenorphine products, particularly SUBOXONE Film, Indivior faces significant generic erosion. U.S. SUBOXONE Film's average market share was 14.4% in Q2 2025, down from 16.3% in Q2 2024. The entry of a fourth generic player in late 2023 led to accelerated pricing declines, with generic prices dropping close to 15% by the end of 2024. Indivior anticipates continued pricing pressure for SUBOXONE Film throughout 2025, regardless of a potential fifth generic entrant. Despite this, the company's Q2 2025 SUBOXONE Film revenue outperformed expectations due to temporary price stability and favorable gross-to-net dynamics.

Indivior's competitive strategy is to leverage SUBLOCADE's strong profile and expand the overall LAI market, which currently has less than 8% penetration despite research suggesting up to 30% of OUD patients could benefit from LAIs. The company's specialized focus on OUD allows for targeted R&D and commercial efforts, potentially offering faster innovation cycles in specific therapies compared to larger, more diversified pharmaceutical companies. While it may lag in overall scale compared to giants like Pfizer (PFE), Indivior's deep expertise in buprenorphine-based therapies and its integrated approach to OUD treatment provide a distinct competitive advantage.

Outlook and Risks

Indivior has raised its full-year 2025 financial guidance, reflecting confidence in its strategic direction and recent performance. Total net revenue is now projected to be between $1.03 billion and $1.08 billion. SUBLOCADE net revenue guidance has been increased to $765 million to $785 million, representing 3% year-over-year growth at the midpoint, with expectations for demand-based sequential growth in the latter half of 2025. Adjusted EBITDA guidance has been raised to $275 million to $300 million, a 20% increase at the midpoint from previous expectations. The effective corporate tax rate for 2025 is now expected to be between 19% and 22%.

This outlook is predicated on several assumptions: continued improving fundamentals for SUBLOCADE, the successful execution of commercial strategies, the positive impact of label updates, and the realization of cost savings from the "Indivior Action Agenda." While SUBOXONE Film pricing is expected to face continued pressure in H2 2025, the company has factored this into its guidance.

Key risks to monitor include the ongoing competitive dynamics in the SUBOXONE Film market and the potential for further generic erosion. For OPVEE, the challenge of overcoming "harm reduction" concerns and generating sufficient real-world evidence remains critical for broader adoption. Regulatory uncertainties, such as the "One Big Beautiful Bill Act" and the "Marketplace Integrity and Affordability Regulation," could impact the business, though Indivior does not currently anticipate significant impacts from the tax law changes. The company also faces continuing uncertainty regarding U.S. federal government tariffs, which could affect revenues and margins, particularly given its U.S.-centric manufacturing and revenue base.

Conclusion

Indivior PLC is undergoing a significant strategic transformation, refocusing its efforts and resources on its core strength: pioneering treatments for Opioid Use Disorder. The "Indivior Action Agenda" represents a clear, multi-phase roadmap to simplify operations, reduce costs, and accelerate growth, particularly for its flagship product, SUBLOCADE. With record SUBLOCADE performance in Q2 2025, a stable market share, and critical label enhancements, the company is well-positioned to capitalize on the vast unmet need in the OUD market and the low penetration of long-acting injectables.

While challenges persist with generic competition for SUBOXONE Film and the slower-than-expected adoption of OPVEE, Indivior's commitment to operational discipline, a streamlined R&D pipeline, and a clear commercial strategy for SUBLOCADE underpin a compelling investment thesis. The upwardly revised 2025 guidance signals management's confidence in its ability to deliver on its commitments and drive significant bottom-line accretion starting in 2026. For discerning investors, Indivior represents an opportunity to invest in a specialized pharmaceutical company with a differentiated technological platform, a strong market position in a critical therapeutic area, and a clear path to enhanced profitability through focused execution.