Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience [3] - The company has a portfolio of proprietary commercial products targeting alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [3] - Alkermes is headquartered in Ireland, with additional offices in Massachusetts and a manufacturing facility in Ohio [3] Upcoming Financial Event - Alkermes will host a conference call and webcast presentation on July 29, 2025, at 8:00 a.m. ET to discuss its second quarter financial results [1] - The conference call can be accessed by U.S. callers at +1 877 407 2988 and international callers at +1 201 389 0923 [2] - A replay of the webcast will be available approximately two hours after the event on Alkermes' website [2]

Core Viewpoint - Alkermes (ALKS) shows potential for significant upside, with a mean price target of $40.33 indicating a 33.2% increase from the current price of $30.28 [1] Price Targets and Estimates - The mean estimate consists of 15 short-term price targets with a standard deviation of $6.84, indicating variability among analysts [2] - The lowest estimate is $27.00, suggesting a 10.8% decline, while the highest estimate is $52.00, indicating a potential surge of 71.7% [2] - A low standard deviation among price targets suggests a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates - Analysts have shown increasing optimism about Alkermes' earnings prospects, with a positive trend in earnings estimate revisions [11] - The Zacks Consensus Estimate for the current year has increased by 1% over the past month, with one estimate rising and no negative revisions [12] - Alkermes holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [13] Analyst Behavior and Price Target Reliability - Analysts often set overly optimistic price targets due to business incentives, which can lead to inflated estimates [8] - While price targets can provide some guidance, they should be approached with skepticism, as they may not accurately reflect future stock movements [10]

Industry Overview - The biotech industry has shown resilience amid global trade tensions, with ongoing geopolitical issues presenting challenges, yet the demand for innovative medical treatments remains strong [1] - Strategic collaborations and acquisitions are increasingly common as large pharma and biotech companies seek to expand their product portfolios and pipelines, particularly in the context of AI-driven drug discovery [2][9] - The Zacks Biomedical and Genetics industry is currently ranked 86, placing it in the top 35% of over 246 Zacks industries, indicating a decent outlook driven by consistent demand for medical advancements [15] Market Trends - The focus on high-profile drug performance and innovative pipeline development is critical, with significant R&D expenditures required to create breakthrough treatments [6] - Successful commercialization is essential for drug uptake, often leading smaller biotech firms to collaborate with larger companies for shared sales or royalties [7] - The recent emphasis on AI technology for drug discovery is expected to attract further investment into the biotech sector [11] Company Performance - Exelixis, Inc. (EXEL) is positioned well with its lead drug, Cabometyx, which is gaining traction in the oncology market, and its shares have surged 31% year to date [35][36] - Verona Pharma (VRNA) has seen a 94.8% increase in shares year to date, driven by the uptake of its drug Ohtuvayre for COPD, with further growth anticipated [24] - Alkermes (ALKS) is benefiting from strong sales of its proprietary drugs and has a Zacks Rank of 1, with EPS estimates for 2025 rising to $1.79 [26][27] - Immunocore Holdings (IMCR) focuses on TCR bispecific immunotherapies and has gained 11.4% year to date, with ongoing studies expected to enhance its market position [30][32] - Kiniska Pharmaceuticals (KNSA) is experiencing growth with its FDA-approved drug Arcalyst and has seen a 37.7% increase in shares [39][40]

Core Viewpoint - Alkermes (ALKS) is currently viewed as a better value opportunity compared to CSL Limited Sponsored ADR (CSLLY) based on various financial metrics and analyst outlooks [1][7]. Valuation Metrics - Alkermes has a Zacks Rank of 1 (Strong Buy), indicating a positive earnings estimate revision activity, while CSL Limited has a Zacks Rank of 4 (Sell) [3]. - The forward P/E ratio for ALKS is 16.00, significantly lower than CSLLY's forward P/E of 24.13, suggesting that ALKS may be undervalued [5]. - ALKS has a PEG ratio of 1.30, compared to CSLLY's PEG ratio of 1.93, indicating a more favorable valuation when considering expected earnings growth [5]. - The P/B ratio for ALKS is 3.12, while CSLLY's P/B ratio is 3.73, further supporting the argument that ALKS is a more attractive investment [6]. - Based on these metrics, ALKS holds a Value grade of B, whereas CSLLY has a Value grade of C, reinforcing the perception of ALKS as the superior value option [6].

Summary of Alkermes (ALKS) FY Conference Call - June 09, 2025 Company Overview - Alkermes has evolved from a narrow focus on neuroscience to a broader drug delivery company, now generating a billion-dollar top line revenue driven by proprietary products [3][4][5] - The company aims to create new molecules that address unmet medical needs, particularly in the neuroscience space related to the sleep-wake cycle and circadian rhythm [4][5] Core Business and Pipeline - The current focus is on the REXN portfolio, particularly the orexin opportunity, which is seen as a new frontier in the field [6][7] - The company has a strong technical capability in chemistry, essential for developing complex molecules in the orexin space [5][6] - The commercial business is profitable and funds the pipeline, with expectations for growth and expansion over time [5][6] Clinical Trials and Data - Phase 1b study results showed a clear dose-dependent increase in maintenance of wakefulness in narcolepsy type 1 (NT1) patients, with no discontinuations due to adverse events (AEs) [11][12][32] - Phase 2 studies (Vibrance 1 and 2) are expected to provide further insights into tolerability and efficacy across different doses and patient populations [14][15][18] - The primary endpoints for the Vibrance studies include maintenance of wakefulness test (MWT), cataplexy rates, and sleepiness scales [26][48] Market Opportunity - The prevalence of NT1, NT2, and idiopathic hypersomnia (IH) patients is significant, yet only a fraction are currently treated, indicating a large market opportunity for orexin agonists [48][49] - The company anticipates deep penetration in the NT1 market due to its disease-modifying properties, while NT2 and IH may see varying levels of uptake based on patient needs and drug costs [49][50] - The potential for combination therapy with existing treatments is still under evaluation, with the expectation that orexin agonists could become frontline therapies for NT1 [56][58] Commercial Strategy - Alkermes plans to commercialize the orexin agonist globally, with a focus on maintaining high pricing reflective of its disease-modifying capabilities [66][67] - The company expects a high percentage of commercial payers (around 80%) for NT1, NT2, and IH patients, contrasting with its existing portfolio which is largely Medicaid and Medicare [70][71] - The commercial portfolio is performing well, with growth expected from existing products like Livaldi, ARISTADA, and VIVITROL [72][74] Conclusion - Alkermes is positioned to capitalize on the growing demand for innovative treatments in the sleep disorder market, with a strong pipeline and commercial strategy aimed at addressing significant unmet needs in NT1, NT2, and IH patients [48][49][72]

Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience [2] - The company has a portfolio of proprietary commercial products targeting alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [2] - Alkermes is headquartered in Ireland, with additional offices in Massachusetts and a manufacturing facility in Ohio [2] Upcoming Events - Management will participate in a fireside chat presentation at the Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025, at 10:00 a.m. EDT [1] - The live webcast of the presentation will be accessible under the Investors tab on Alkermes' website and archived for 14 days [1] Contact Information - Investor Relations contact is Jamie Constantine, reachable at +1 781 873 2402 [3]

Group 1 - Alkermes plc presented research at key scientific conferences related to its psychiatry products LYBALVI® and ARISTADA® during Mental Health Awareness Month in May 2025 [1][2] - The company aims to advance patient care and contribute to the body of evidence in neuro-psychiatry, particularly for schizophrenia and bipolar I disorder [2][50] - The presentations included analyses of lipid and glycemic profiles, safety, tolerability, and treatment effects of LYBALVI and ARISTADA across various patient subgroups [5][9] Group 2 - The conferences where Alkermes presented included the American Association of Psychiatric Pharmacists (AAPP), Neuroscience Education Institute (NEI) Spring Congress, and the American Psychiatric Association (APA) among others [4][5] - Specific findings from the presentations included the effects of LYBALVI on negative symptoms of schizophrenia and the efficacy of ARISTADA in patients with varying severity of illness [5][9] - The company highlighted the importance of these findings in understanding treatment patterns and healthcare resource utilization for patients with schizophrenia and bipolar I disorder [5][9] Group 3 - LYBALVI is a once-daily oral atypical antipsychotic approved for treating adults with schizophrenia and bipolar I disorder, combining olanzapine and samidorphan [9][50] - ARISTADA is an injectable atypical antipsychotic approved for the treatment of schizophrenia in adults, available in multiple dosing options [28][50] - Alkermes is focused on developing innovative medicines in neuroscience, with a portfolio addressing alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [50]

Core Viewpoint - Alkermes plc reported disappointing earnings and revenue for the first quarter of 2025, missing consensus estimates and showing a decline in total revenues compared to the previous year [1][2]. Financial Performance - Earnings from continuing operations were 13 cents per share, missing the Zacks Consensus Estimate of 28 cents and down from 21 cents per share in the same quarter last year [1]. - Total revenues for the first quarter were $306.5 million, a decrease of 12.5% year over year, and also below the Zacks Consensus Estimate of $317 million [2]. - The proprietary products portfolio generated sales of $244.5 million, up 4.7% year over year, driven primarily by Lybalvi [5][6]. Product Sales Breakdown - Vivitrol sales increased by 3.4% year over year to $101 million, beating the Zacks Consensus Estimate of $99 million but missing the internal estimate of $103.8 million [6]. - Lybalvi generated sales of $70 million, up 22.8% year over year, but missed both the Zacks Consensus Estimate of $71 million and the internal estimate of $75.1 million [7]. - Aristada sales decreased by 6.8% year over year to $73.5 million, missing the Zacks Consensus Estimate of $79 million [7]. Revenue Sources - Manufacturing and royalty revenues fell by approximately 46.9% year over year to $62 million, with specific contributions from Biogen's Vumerity and other products [7][8]. Expenses and Cash Position - Research and development expenses totaled $71.8 million, up 6.2% year over year, while selling, general, and administrative expenses decreased by 4.4% to $171.7 million [9]. - As of March 31, 2025, Alkermes had cash and cash equivalents of $916.2 million, an increase from $824.8 million as of December 31, 2024 [9]. Guidance and Future Outlook - Alkermes reiterated its financial guidance for 2025, expecting total revenues in the range of $1.34 billion to $1.43 billion, with specific sales expectations for Vivitrol, Aristada, and Lybalvi [10]. - Net sales from proprietary products are anticipated to be between $260 million and $280 million in the second quarter of 2025 [11]. Pipeline Development - The company initiated the phase II Vibrance-3 study for ALKS 2680, targeting idiopathic hypersomnia, with primary endpoints focused on sleepiness reduction compared to placebo [12][13]. - Additional studies for ALKS 2680 are ongoing for narcolepsy type 1 and type 2, with data expected in the latter half of 2025 [14].

Group 1 - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and offers a model portfolio of small and mid-cap stocks [1][2] - The service includes over 600 biotech investing articles and live chat features to assist healthcare investors in making informed decisions [2] - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price [1] Group 2 - The author previously wrote about Alkermes, focusing on potential narcolepsy data that could influence the company's future [2] - The article emphasizes that the author has no financial positions in the companies mentioned, ensuring an unbiased perspective [3]

Part I [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Alkermes' unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, statements of operations, cash flows, and shareholders' equity, are presented with detailed notes Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$2,081,977** | **$2,055,567** | | Cash and cash equivalents | $399,806 | $291,146 | | Total current assets | $1,479,050 | $1,415,355 | | **Total Liabilities** | **$570,394** | **$590,590** | | Total current liabilities | $443,730 | $465,199 | | **Total Shareholders' Equity** | **$1,511,583** | **$1,464,977** | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenues | $306,510 | $350,372 | | Total expenses | $292,718 | $307,063 | | Operating income from continuing operations | $13,792 | $43,309 | | **Net income from continuing operations** | **$22,464** | **$38,948** | | **Net income** | **$22,464** | **$36,828** | | **Diluted EPS from continuing operations** | **$0.13** | **$0.23** | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Cash flows provided by operating activities | $98,811 | $21,108 | | Cash flows provided by (used in) investing activities | $9,102 | $(39,951) | | Cash flows provided by (used in) financing activities | $747 | $(17,873) | | **Net increase (decrease) in cash** | **$108,660** | **$(36,716)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net income from continuing operations decreased to **$22.5 million** in Q1 2025, primarily due to a **$54.8 million** decline in manufacturing and royalty revenues, partially offset by increased product sales and reduced operating expenses - The decrease in net income was primarily due to a **$54.8 million** fall in manufacturing and royalty revenue, partially offset by an **$11.0 million** increase in net product sales and a **$14.4 million** decrease in operating expenses[78](index=78&type=chunk) Net Product Sales (in millions) | Product | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | VIVITROL | $101.0 | $97.7 | $3.3 | | ARISTADA and ARISTADA INITIO | $73.5 | $78.9 | $(5.4) | | LYBALVI | $70.0 | $57.0 | $13.0 | | **Total** | **$244.5** | **$233.5** | **$10.9** | Manufacturing and Royalty Revenues (in millions) | Revenue Source | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Long-acting INVEGA products | $17.7 | $62.7 | $(45.0) | | VUMERITY | $27.8 | $31.3 | $(3.5) | | RISPERDAL CONSTA | $9.1 | $2.7 | $6.4 | | Other | $7.4 | $20.1 | $(12.7) | | **Total** | **$62.0** | **$116.8** | **$(54.8)** | - The decrease in royalty revenues from long-acting INVEGA products was primarily due to the expiration of the U.S. royalty on INVEGA SUSTENNA net sales in August 2024[106](index=106&type=chunk) - R&D expenses increased by **$4.2 million**, driven by a **$7.3 million** increase in spending on the ALKS 2680 development program for narcolepsy and idiopathic hypersomnia[109](index=109&type=chunk)[110](index=110&type=chunk) - Cash and investments increased to **$916.2 million** at March 31, 2025, up from **$824.7 million** at December 31, 2024[115](index=115&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports no material changes to its market risks since December 31, 2024, with key exposures including investment portfolio and Euro currency fluctuations from Irish operations - There have been no material changes to the company's market risks since December 31, 2024[129](index=129&type=chunk) - The company is exposed to non-U.S. currency exchange risk, primarily from Euro-denominated expenses related to its Irish operations[130](index=130&type=chunk) - Investment objectives are to preserve capital, provide liquidity, and generate investment income, managed through a diversified portfolio[117](index=117&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and interim principal financial officer concluded that disclosure controls and procedures were effective as of March 31, 2025[132](index=132&type=chunk) - There were no material changes in the company's internal control over financial reporting during the first quarter of 2025[133](index=133&type=chunk) Part II [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in patent infringement litigation for INVEGA TRINZA and VUMERITY, a government investigation regarding VIVITROL, and product liability claims - The U.S. Court of Appeals affirmed a lower court decision in favor of Janssen regarding the patent for INVEGA TRINZA, a product from which Alkermes receives royalties[70](index=70&type=chunk) - The company is involved in patent infringement litigation against Zydus, which is seeking to market a generic version of VUMERITY, with a bench trial scheduled for July 28, 2025[71](index=71&type=chunk) - The company has received a subpoena and civil investigative demands from U.S. state and federal authorities regarding VIVITROL and is cooperating with the investigations[72](index=72&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor highlights the potential adverse impact of changes in global trade policies, including tariffs, on the company's international supply chain and revenue - A new risk factor was added regarding the adverse effects of changes in global trade policies, including tariffs imposed by the U.S. and other nations[137](index=137&type=chunk) - The company's supply chain for proprietary products and manufacturing of third-party products from which it derives revenue have international components, creating exposure to tariffs and trade policy changes[137](index=137&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Alkermes did not repurchase shares under its public program in Q1 2025, instead acquiring **834,590** shares for tax withholding, with **$200 million** remaining authorized Share Repurchase Activity - Q1 2025 | Period | Total Shares Purchased | Avg. Price Paid | Purchased as Part of Program | Remaining Program Value (millions) | | :--- | :--- | :--- | :--- | :--- | | Jan 2025 | 1,879 | $28.67 | — | $200.0 | | Feb 2025 | 832,359 | $34.50 | — | $200.0 | | Mar 2025 | 352 | $34.40 | — | $200.0 | | **Total** | **834,590** | **$34.49** | **—** | **$200.0** | - All shares purchased during the quarter were acquired to satisfy tax withholding obligations related to the vesting of equity awards, not as part of the public repurchase program[140](index=140&type=chunk) - As of March 31, 2025, **$200.0 million** remains authorized under the share repurchase program announced in February 2024[140](index=140&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) This section details the adoption and termination of Rule 10b5-1 trading plans by company officers and directors during Q1 2025 - Several officers and a director adopted or terminated Rule 10b5-1 trading plans for the sale of company shares during the quarter[141](index=141&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and Interactive Data Files (XBRL) for financial reporting - The exhibits filed with the 10-Q include officer certifications under Rule 13a-14(a)/15d-14(a) and Section 906 of the Sarbanes-Oxley Act, as well as XBRL data files[143](index=143&type=chunk)