Alkermes plc (ALKS): Business Model Canvas [Dec-2025 Updated]

You're digging into the nuts and bolts of Alkermes plc's strategy right now, especially with that big Avadel deal on the table and the latest 2025 guidance out. As someone who's spent two decades mapping out pharma plays, I can tell you their model is a tight balance: driving sales from established neuroscience treatments like VIVITROL and LYBALVI-projected to hit between $\mathbf{\$1.09 \text{ billion}}$ and $\mathbf{\$1.15 \text{ billion}}$ in net sales for 2025-while pouring significant capital, $\mathbf{\$305 \text{ million}}$ to $\mathbf{\$335 \text{ million}}$, into R&D for that next-gen orexin pipeline. Honestly, understanding how they manage those $\mathbf{\$655 \text{ million}}$ to $\mathbf{\$685 \text{ million}}$ in SG&A costs against their royalty streams is key to seeing the full picture. Dive into the nine blocks below for the precise breakdown of how Alkermes plc is structuring its value creation for the near term.

Alkermes plc (ALKS) - Canvas Business Model: Key Partnerships

You're looking at the core relationships that fuel Alkermes plc's current and future revenue streams, which is smart because these deals underpin their financial stability. Here's the breakdown of the key external dependencies and strategic moves as of late 2025.

Proposed acquisition of Avadel Pharmaceuticals

Alkermes plc agreed to acquire Avadel Pharmaceuticals plc in a revised deal structure with a total potential value reaching up to $2.37 billion.

This move is designed to accelerate Alkermes plc's commercial entry into the sleep medicine market.

Royalty and manufacturing agreements with Biogen (VUMERITY)

The relationship with Biogen for VUMERITY (diroximel fumarate) continues to generate significant royalty income, though manufacturing revenue streams are shifting.

• VUMERITY manufacturing and royalty revenues for the third quarter of 2025 were $35.6 million.
• VUMERITY manufacturing and royalty revenues for the fourth quarter of 2024 were $35.0 million.
• Alkermes is entitled to receive a mid-teens percentage royalty on worldwide net commercial sales of VUMERITY.
• VUMERITY end-market sales in 2024 reached $628.0 million.
• Alkermes received a $150 million milestone payment from Biogen upon U.S. Food and Drug Administration approval of VUMERITY.
• FAMPYRA manufacturing and royalty revenues for the fourth quarter of 2024 were $22.9 million; no future revenue is expected from this product.

Royalty agreements with Johnson & Johnson (long-acting INVEGA products)

Royalties from Johnson & Johnson's long-acting INVEGA franchise, which utilizes Alkermes plc's NanoCrystal technology, remain a key component of the royalty business, though some U.S. royalties have expired.

The arbitration win in 2023 secured these ongoing payments.

Clinical trial collaborations for pipeline candidates like alixorexton

Partnerships and collaborations are essential for advancing the pipeline, particularly in the central disorders of hypersomnolence area, which is being bolstered by the Avadel acquisition.

• Alixorexton (formerly ALKS 2680) is in Phase 2 development.
• The Vibrance-1 Phase 2 study evaluated alixorexton in 92 patients with narcolepsy type 1 (NT1).
• Doses tested in Vibrance-1 included 4 mg, 6 mg, and 8 mg.
• Vibrance-3 is a Phase 2 study currently enrolling for idiopathic hypersomnia (IH).
• Alkermes plc is also advancing orexin 2 receptor agonists, ALKS 4510 and ALKS 7290, both currently in Phase I trials.
• The Avadel acquisition is intended to support advancing alixorexton into a Phase 3 program in narcolepsy.

You should track the progression of these Phase I and Phase 2 trials closely.

Alkermes plc (ALKS) - Canvas Business Model: Key Activities

You're looking at the core engine of Alkermes plc as of late 2025, which is heavily weighted toward maximizing the value of its existing neuroscience portfolio while aggressively advancing its next-generation pipeline. The key activities here really boil down to selling what you have, making what you sell, and developing what's next.

Commercialization and promotion of proprietary neuroscience products (VIVITROL, ARISTADA, LYBALVI)

This is where the immediate revenue generation happens. The focus is clearly on driving prescription volume and managing the gross-to-net dynamics for your established products. For the third quarter of 2025, the proprietary portfolio was firing on all cylinders, delivering net sales of $317.4 million.

Here's the quick math on the individual drivers for Q3 2025:

Management has confidence in this momentum, raising the full-year 2025 guidance for proprietary net sales to exceed $1 billion overall. To support this, selling, general and administrative expenses (SG&A) totaled $171.8 million in Q3 2025, up around 14% year-over-year, which reflects the expansion of the psychiatry field organization earlier in the year and increased promotional activities for LYBALVI.

Advanced R&D for the orexin 2 receptor agonist pipeline (e.g., alixorexton)

This activity is all about future value creation, centered on the orexin 2 receptor agonist program. You're investing heavily now to secure a leadership position in treating central disorders of hypersomnolence, like narcolepsy. Research and development expenses reflect this commitment, hitting $81.7 million in Q3 2025, a significant step up from $59.9 million in Q3 2024.

The pipeline work centers on alixorexton (formerly ALKS 2680), which is an investigational, oral, selective orexin 2 receptor (OX2R) agonist. Key milestones achieved or anticipated in late 2025 include:

• Presented detailed positive data from the Vibrance-1 phase 2 study in narcolepsy type 1 (NT1) in September 2025.
• Reported positive topline results from the Vibrance-2 phase 2 study in narcolepsy type 2 (NT2) in November 2025.
• Planning to initiate a global phase 3 clinical program for alixorexton in the first quarter of 2026.
• Advancing other candidates, like ALKS 4510 and ALKS 7290, toward first-in-human studies in 2025.

The data from Vibrance-1 showed statistically significant and clinically meaningful improvements in wakefulness, cognition, and fatigue for alixorexton.

Manufacturing proprietary products at the Ohio facility

You maintain control over the supply chain for your core revenue drivers. A critical activity is the manufacturing of VIVITROL, ARISTADA, and LYBALVI. It's important to note that all proprietary products are manufactured at the Ohio facility and are sold exclusively in the U.S. market. This domestic manufacturing setup provides a distinct advantage, as management noted in early 2025 that it places the company in an advantageous position regarding potential tariffs or foreign reference pricing pressures.

Managing regulatory approvals and intellectual property

This activity underpins the commercial viability of current products and the future potential of the pipeline. For the commercial portfolio, managing gross-to-net adjustments is key; for instance, Q3 2025 saw favorable adjustments of approximately $8.0 million for VIVITROL and $5.0 million for ARISTADA, largely driven by Medicaid utilization adjustments. On the IP and regulatory front for the pipeline, the successful Phase 2 data readouts for alixorexton are directly feeding into the preparation for the planned Phase 3 initiation in Q1 2026. Furthermore, a major strategic move in late 2025 was the announcement of the increased offer to acquire Avadel Pharmaceuticals, which includes the FDA-approved LUMRYZ™, contingent on FDA approval for the idiopathic hypersomnia indication by the end of 2028, showing a clear focus on expanding the central disorders of hypersomnolence franchise through both internal development and strategic M&A. The total consideration for the Avadel acquisition was up to $22.50 per share.

Alkermes plc (ALKS) - Canvas Business Model: Key Resources

The Key Resources for Alkermes plc as of late 2025 are anchored by its commercial product base, its advanced neuroscience pipeline, and its internal manufacturing and intellectual property capabilities.

Proprietary Commercial Portfolio: VIVITROL, ARISTADA, LYBALVI

The core revenue generation relies on the three proprietary commercial products, which collectively generated total proprietary net sales of $551.7 million for the six months ended June 30, 2025. This represented a growth of 5% year-over-year for the first quarter of 2025, reaching $244.5 million in net sales.

You can see the quarterly performance below:

For context, the combined sales of VIVITROL, ARISTADA, and LYBALVI totaled $1,083.5 million in 2024.

Orexin 2 Receptor Agonist Development Pipeline (e.g., ALKS 2680)

The pipeline is centered on the orexin 2 receptor agonist program, with ALKS 2680 (alixorexton) being the lead candidate.

• ALKS 2680 is in phase 2 development for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).
• Topline results from the Vibrance-1 phase 2 study in NT1 patients were announced by July 2025.
• Topline results from the Vibrance-2 study in NT2 patients were announced on November 12, 2025.
• The company is preparing to initiate a global phase 3 program for alixorexton.
• The pipeline also includes ALKS 4510 and ALKS 7290, both listed as being in Phase 1 studies for neuroscience indications.

The company has a broader portfolio of more than 20 commercial drug products.

U.S. Manufacturing Facility in Wilmington, Ohio

The state-of-the-art manufacturing facility in Wilmington, Ohio, is central to delivering FDA-approved medicines.

• The facility employs more than 500 people.
• It occupies a 375,000-square foot site.
• This location manufactures the portfolio of proprietary commercial products, including oral solid dose formulations and long-acting injectable products.
• Alkermes was certified as a Great Place to Work in the United States in both 2024 and 2025.

Extensive Intellectual Property and Drug Formulation Expertise

The company leverages its scientific expertise to develop medicines for psychiatric and neurological disorders. Financially, this expertise is backed by strong liquidity, as cash, cash equivalents, and total investments stood at $1.05 billion as of June 30, 2025. This followed ending 2024 debt-free with approximately $825 million in cash and investments.

Alkermes plc (ALKS) - Canvas Business Model: Value Propositions

You're looking at the core value Alkermes plc (ALKS) delivers right now, grounded in the latest numbers from their Q3 2025 performance. The value propositions center on differentiated treatments across serious mental illness, addiction, and the emerging area of hypersomnolence.

Long-acting injectable treatments for serious mental illness (ARISTADA) represent a key value driver in the psychiatry segment. This formulation helps address adherence challenges common with daily oral medications for conditions like schizophrenia. The financial commitment from the market to this value proposition is clear from the latest sales figures.

Non-addictive treatment for alcohol and opioid dependence (VIVITROL) offers a crucial alternative for patients struggling with substance use disorders, providing a monthly, non-narcotic option. This product continues to be a significant revenue generator for Alkermes plc.

Novel oral treatment for schizophrenia and bipolar I disorder (LYBALVI) provides a newer oral option, showing strong momentum in the market. The growth here is outpacing the other core products, suggesting strong resonance with prescribers for its specific profile.

Here's how the proprietary portfolio stacked up in the third quarter of 2025, showing the immediate value being captured:

The combined net sales from these three proprietary products reached $317.4 million in Q3 2025, contributing to total revenues of $394.2 million for the quarter. Management raised the full-year 2025 total revenue guidance to a range of $1.43 billion to $1.49 billion, reflecting confidence in these value propositions continuing to deliver.

Potential for transformative treatments in central disorders of hypersomnolence speaks to the future value proposition, centered on the investigational oral orexin 2 receptor agonist, alixorexton (ALKS 2680). This program aims to offer a novel mechanism to restore wakefulness for patients with conditions like narcolepsy and idiopathic hypersomnia.

The market need is substantial, based on 2025 prevalence estimates:

• Narcolepsy affects between 25 to 50 per 100,000 individuals globally.
• Idiopathic Hypersomnia (IH) affects approximately 2 to 10.3 per 100,000 individuals.

The company has already demonstrated early clinical value:

• Single doses of ALKS 2680 showed statistically significant, clinically meaningful improvements in mean sleep latency in Phase 2 studies (Vibrance-1).
• Positive data from the Vibrance-1 study in narcolepsy type 1 was presented, with topline results from Vibrance-2 in narcolepsy type 2 expected next month.
• The plan is to initiate a global Phase 3 clinical program in early Q1 2026.

Furthermore, the proposed acquisition of Avadel Pharmaceuticals is positioned to immediately strengthen the pipeline in this area, adding another potential growth driver. Alkermes plc ended Q3 2025 with $1.14 billion in cash, cash equivalents, and total investments, which supports advancing these high-potential, non-dilutive pipeline programs.

Finance: draft 13-week cash view by Friday.

Alkermes plc (ALKS) - Canvas Business Model: Customer Relationships

Dedicated sales force engagement with prescribers (psychiatrists, addiction specialists)

Alkermes plc completed the expansion of its psychiatry sales force in the first quarter of 2025, deploying new positions to focus on maintaining competitive share of voice for LYBALVI and reaccelerating growth for ARISTADA. Selling, General, and Administrative (SG&A) expenses for 2025 are projected to be in the range of $655 to $685 million, which explicitly reflects these investments in the psychiatry sales team expansion and promotional support for commercial products. The engagement strategy is directly tied to driving prescription volume for key neuroscience assets.

• LYBALVI net sales for the third quarter of 2025 were $98.2 million, representing a 32% increase compared to the third quarter of 2024.
• ARISTADA net sales for the third quarter of 2025 reached $98.1 million, marking a 16% increase year-over-year.
• VIVITROL net sales for the third quarter of 2025 were $121.1 million, showing a 7% growth compared to the third quarter of 2024.

Patient support programs for access and adherence to complex therapies

Alkermes plc maintains programs designed to support eligible patients prescribed their medicines, which is critical for complex, long-acting injectable or specialized oral therapies. In 2022, more than 22,000 patients participated in the company's Co-Pay Savings Programs. The company also offers Patient Assistance Programs. The commercial performance of the proprietary portfolio underscores the volume of patients requiring ongoing support for adherence.

Direct communication with payers (government and commercial) for formulary coverage

Direct payer communication is evidenced by the financial impact of utilization adjustments, particularly with government payers. For the third quarter of 2025, Alkermes recorded approximately $8.0 million in VIVITROL revenue related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments. Similarly, ARISTADA recorded approximately $5.0 million in gross-to-net favorability from Medicaid adjustments in the same period. In the second quarter of 2025, the Medicaid adjustments were higher, with VIVITROL recording about $9.0 million and ARISTADA recording about $11.0 million in favorability.

• Total Proprietary Net Sales for the second quarter of 2025 were $307.2 million.
• Total Proprietary Net Sales for the first quarter of 2025 were $244.5 million.
• The company reiterated its 2025 financial expectations in July 2025, following strong Q2 performance.

Alkermes plc (ALKS) - Canvas Business Model: Channels

You're looking at how Alkermes plc gets its neuroscience products and services to the end-user and stakeholders as of late 2025. The channel strategy is a mix of direct engagement, specialized third-party logistics, and strategic partnerships.

Direct commercial sales force targeting U.S. healthcare providers

Alkermes plc maintains a dedicated commercial presence focused on the U.S. market for its proprietary portfolio, which includes VIVITROL, ARISTADA (product family), and LYBALVI. This direct channel is crucial for driving awareness and adoption among prescribing physicians and treatment centers.

While the most recent specific headcount data points to a structure supporting the psychiatry franchise (ARISTADA and LYBALVI) of approximately 315 individuals and a separate force for VIVITROL of about 110 individuals as of early 2023, this structure is what supports the 2025 sales guidance.

The focus of the sales efforts directly correlates with the revenue expectations for the proprietary products in 2025:

• VIVITROL net sales expected in the range of $440 million to $460 million.
• ARISTADA product family net sales expected in the range of $335 million to $355 million.
• LYBALVI net sales expected in the range of $320 million to $340 million.

Specialty pharmacies and distributors for product fulfillment

Product fulfillment relies heavily on established distribution networks, including major pharmaceutical wholesalers and specialty distributors. For VIVITROL specifically, in 2022, sales to Cardinal Health, McKesson Corporation, and AmerisourceBergen accounted for approximately 25%, 22%, and 16% of total gross sales, respectively. This shows a significant reliance on these large entities for getting the product to the point of care.

Furthermore, Alkermes plc actively manages its distribution access through policies like the Contract Pharmacy Policy, which saw updates in 2025 concerning 340B pricing distribution in states like North Dakota and Colorado, effective in mid-2025. This management channel ensures compliance and access for specific patient populations.

The overall commercial execution is translating to solid top-line performance; for instance, Total Revenues for the third quarter of 2025 were reported at $394.2 million, and for the second quarter of 2025, Total Revenues were $390.7 million.

Here's a look at the revenue contribution from the proprietary product channel, based on 2025 guidance:

Licensing partners for non-proprietary product distribution (e.g., Biogen)

Alkermes plc utilizes licensing agreements to distribute certain products, which generates Manufacturing & Royalty Revenues. This channel diversifies reach beyond the direct U.S. commercial focus.

For example, in the second quarter of 2025, Manufacturing and Royalty Revenues totaled $83,422 thousand. In the first quarter of 2025, Manufacturing and Royalty Revenues were $62.0 million, which included revenues of $27.8 million from VUMERITY, a product licensed to Biogen MA Inc.

These royalty streams are a key component of the overall revenue base, which was $1.52 billion trailing twelve months as of September 30, 2025.

Investor relations and medical affairs outreach

The connection with the financial community and healthcare providers outside of the direct sales force is managed through dedicated outreach functions. Investor Relations actively communicates performance and strategy, with management scheduled to participate in conferences like the 8th Annual Evercore Healthcare Conference on December 3, 2025, and the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025.

Medical Affairs focuses on scientific exchange. As of late 2025, Alkermes Medical Affairs was scheduled to attend ASHP 2025 from December 7th to December 11th, and had recently made presentations from NEI 2025 and AMCP Nexus 2025 available.

• Investor Relations contact number: +1 781 873 2402.
• Medical Affairs Adverse Event/Product Complaint reporting line: 888-235-8008.
• The Investor Relations website provides access to quarterly reports like the Form 10-Q for the quarter ended March 31, 2025.

Alkermes plc (ALKS) - Canvas Business Model: Customer Segments

You're looking at the specific groups of people and organizations Alkermes plc targets with its neuroscience-focused portfolio as of late 2025. This is where the revenue actually comes from.

Patients with schizophrenia and bipolar I disorder

This segment is served by the commercial products LYBALVI and ARISTADA. The underlying market size for these conditions in the U.S. is substantial.

• Schizophrenia affects about 1.1% of the U.S. population.
• Bipolar I disorder affects approximately 1% of the adult population in the U.S. in any given year.

Here's how the key products targeting these patients performed in the third quarter of 2025:

Patients with alcohol dependence and opioid dependence

The primary product for this segment is VIVITROL, a long-acting injectable therapy. The broader Opioid Use Disorder (OUD) market shows significant growth potential.

• VIVITROL Q3 2025 Net Sales were $121.1 million, marking a 7% increase year-over-year.
• VIVITROL Q2 2025 Net Sales were $121.7 million.
• The Global Opioid Use Disorder (OUD) Market Size was estimated at USD 3.5 Billion in 2024.
• The OUD Market is anticipated to reach USD 10.6 Billion by 2035, growing at a CAGR of 10.6% between 2025 and 2035.

Healthcare providers (HCPs) specializing in psychiatry and addiction medicine

These are the prescribers and influencers who determine patient access to Alkermes plc's therapies. The company actively engages this group through its commercial and medical affairs teams.

• In a September 2024 survey of HCPs treating these conditions, Alkermes plc included responses from 127 psychiatrists and 126 nurse practitioners (NPs)/physician assistants (PAs) in the U.S..
• Selling, general and administrative expenses in Q3 2025 totaled $171.8 million, up around 14% year-over-year, partly due to the expansion of the psychiatry field organization earlier in 2025.

Patients with narcolepsy and idiopathic hypersomnia (future focus)

This represents a pipeline customer segment for Alkermes plc, centered around the development of alixorexton (ALKS 2680), an orexin 2 receptor agonist. The company is preparing for a significant launch phase.

• Alkermes plc expects to report topline results from the Vibrance-2 study in narcolepsy type 2 in the Fall of 2025.
• The company is preparing to initiate its global phase 3 clinical program in early 2026.

Alkermes plc (ALKS) - Canvas Business Model: Cost Structure

You're looking at the cost side of the Alkermes plc business model as of late 2025. Honestly, the cost structure is dominated by the commercial infrastructure and the pipeline investment, which is typical for a company at this stage of its transformation.

Here are the key cost components based on the initial financial expectations provided for the 2025 fiscal year:

• High Selling, General, and Administrative (SG&A) expenses, expected at $655 million to $685 million in 2025.
• Significant R&D investment, expected at $305 million to $335 million in 2025.
• Cost of Goods Sold (COGS) for proprietary products, expected at $185 million to $205 million in 2025.
• Clinical trial costs for the Phase 2/3 orexin 2 agonist program.

The SG&A figure reflects the investments made to support the growth of the commercial portfolio, like LYBALVI, and the expansion of the psychiatry field sales force. It's a big number, but it's the cost of maintaining and growing the revenue base from VIVITROL, ARISTADA, and LYBALVI.

The Research and Development (R&D) spend is where you see the commitment to future value creation. This investment level is specifically set to accommodate the ongoing clinical programs, most notably the alixorexton (formerly ALKS 2680) Phase 2 studies in narcolepsy and the planning for the Phase 3 initiation. Here's the quick math on how those expectations shifted slightly as the year progressed, based on the latest third-quarter update:

The orexin 2 receptor agonist program, featuring alixorexton, is a major cost driver within that R&D bucket. You're seeing the cost of running global, randomized, double-blind, placebo-controlled Phase 2 studies like Vibrance-1 (in narcolepsy type 1) and Vibrance-2 (in narcolepsy type 2). The company is preparing to initiate a global Phase 3 clinical program for alixorexton in narcolepsy in the first quarter of 2026, so expect these clinical trial costs to remain a significant, if not increasing, part of the R&D outlay moving into 2026.

To be fair, the COGS range reflects a streamlined manufacturing footprint following the sale of the company's manufacturing business in Ireland last year. Still, the costs associated with producing proprietary commercial products are a necessary expense to keep those revenue streams flowing. The key cost drivers you need to watch are:

• SG&A related to sales force expansion for LYBALVI.
• R&D spend tied to advancing alixorexton toward Phase 3.
• The cost of goods for the established proprietary products like VIVITROL and ARISTADA.

Finance: draft 13-week cash view by Friday.

Alkermes plc (ALKS) - Canvas Business Model: Revenue Streams

You're looking at the core ways Alkermes plc brings in cash as of late 2025. It's all about their specialized medicines and the deals they have in place for other companies' drugs. This stream is heavily weighted toward their proprietary neuroscience portfolio.

The overall expectation for Alkermes plc's proprietary product net sales for the full year 2025 is projected to be in the range of $1.09 billion to $1.15 billion.

Drilling down into the key drivers of that proprietary revenue, you see specific targets for their established treatments:

• VIVITROL net sales are expected at $440 million to $460 million in 2025.
• LYBALVI net sales are expected at $320 million to $340 million in 2025.

To give you a sense of the momentum, by the third quarter of 2025, VIVITROL revenues for that quarter alone were $121.1 million, showing a 7% increase compared to Q3 2024. Similarly, LYBALVI posted quarterly revenues of $98.2 million, marking a substantial 32% jump year-over-year.

The ARISTADA product family also contributes significantly to the proprietary stream. While the full-year guidance for ARISTADA net sales was anticipated around $335 million to $355 million (based on earlier 2025 guidance), Q3 2025 revenues for ARISTADA hit $98.1 million, a 16% increase from the prior year's third quarter.

Here is a quick look at the quarterly performance for the main proprietary products as reported for the third quarter of 2025:

Another vital component of the revenue structure is royalty and manufacturing revenues derived from licensed products. This stream provides a steady, less volatile income base based on the success of medicines developed with Alkermes' technology but commercialized by partners. For instance, in the third quarter of 2025, Alkermes plc recorded specific revenues from these arrangements.

The manufacturing and royalty revenues for the third quarter of 2025 included:

• Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA, and INVEGA HAFYERA/BYANNLI totaled $30.2 million.
• Manufacturing and royalty revenues from VUMERITY were $35.6 million.

To put that in perspective, the total manufacturing and royalty revenues reported for the first quarter of 2025 were $62.0 million, which included $27.8 million from VUMERITY and $17.7 million from the long-acting INVEGA products. So, the Q3 run-rate for these royalty/manufacturing streams appears consistent or slightly higher than Q1.

Finance: draft 13-week cash view by Friday.