Core Viewpoint - AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics for up to $2.1 billion in cash, aiming to enhance its immunology pipeline with innovative therapies [1][7]. Acquisition Details - The acquisition will incorporate Capstan's lead asset, CPTX2309, which is a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy currently in phase I development for treating B-cell-mediated autoimmune diseases [2][3]. - Capstan's proprietary tLNP platform technology, CellSeeker, will also be added, facilitating RNA delivery to engineer specific cell types within the body [2][7]. - The acquisition is subject to customary closing conditions, including regulatory approvals [3]. AbbVie's Acquisition Strategy - AbbVie has been actively pursuing acquisitions to strengthen its pipeline, particularly in the immunology sector, while also exploring early-stage deals in oncology and neuroscience [4]. - Since the beginning of 2024, AbbVie has signed over 20 early-stage deals, focusing on promising technologies that can enhance care standards in immunology, oncology, and neuroscience [4]. Recent Acquisitions - Earlier in 2024, AbbVie acquired rights to develop GUB014295 (ABBV-295), a long-acting amylin analog for obesity treatment, marking its entry into the obesity market [5]. - In January 2025, AbbVie completed the acquisition of Nimble Therapeutics, adding an investigational oral peptide IL23R inhibitor for psoriasis treatment and a proprietary peptide synthesis platform for autoimmune diseases [8].

[Música] Muito boa tarde, super poderosos. Que prazer estar aqui com vocês hoje. É uma honra para mim poder falar de um tema no qual eu acredito tanto, que é tão transformador, como ativar os seus superperes.Mas antes disso, eu quero trazer para vocês a história de um superherói, do meu superherói, do meu pai, Senr. Carmo José da Silva, que aos 53 anos de idade decidiu realizar um dos seus maiores sonhos, que era cursar a Universidade de Direito. O meu pai naquela altura passou por algumas dificuldades, mas ...

Company Overview - Xenon Pharmaceuticals Inc. is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need [2] - The company is advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression [2] - Azetukalner, a novel, highly potent, selective Kv7 potassium channel opener, is the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications [2] Event Announcement - Xenon Pharmaceuticals will present at the Goldman Sachs 46th Annual Global Healthcare Conference in Miami, FL, from June 9-11, 2025 [1] - The fireside chat presentation is scheduled for June 10, 2025, from 3:20-3:55 PM Eastern Time, with Ian Mortimer, President and CEO, as the presenter [1] - A live audio webcast of the presentation will be available on the "Investors" section of Xenon's website and will be posted for replay following the event [1]

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]

Core Insights - Merck and Pfizer are leading pharmaceutical companies with strong oncology portfolios, but their revenue reliance differs significantly, with oncology accounting for over 50% of Merck's total revenues compared to around 25% for Pfizer [1][2]. Group 1: Pfizer's Position - Pfizer is recovering from a slowdown in 2023/early 2024, with diminishing COVID-related uncertainties leading to reduced revenue volatility [3]. - Non-COVID operational revenues improved in 2024, driven by key products like Vyndaqel, Padcev, and Eliquis, as well as new launches and acquisitions [4]. - Pfizer anticipates cost cuts and restructuring to yield savings of $7.7 billion by the end of 2027, which should enhance profit growth [5]. - Challenges include declining sales of COVID-19 products and significant impacts from patent expirations expected between 2026-2030 [6]. - Pfizer has faced setbacks, including the discontinuation of the GLP-1R agonist danuglipron due to safety concerns [7]. - As of March 31, 2025, Pfizer had cash and cash equivalents of $17.3 billion and long-term debt of $57.6 billion, with a debt-to-capital ratio of 0.41 [8]. Group 2: Merck's Position - Merck has over six blockbuster drugs, with Keytruda being the primary revenue driver, particularly in early-stage non-small cell lung cancer [9]. - The company has made significant regulatory and clinical progress, with its phase III pipeline nearly tripling since 2021 [10]. - However, Merck is heavily reliant on Keytruda, raising concerns about its ability to diversify its product lineup ahead of the drug's patent loss in 2028 [11]. - Merck ended 2024 with cash and cash equivalents of $9.2 billion and long-term debt of $33.5 billion, also with a debt-to-capital ratio of 0.41 [12]. Group 3: Financial Estimates and Performance - The Zacks Consensus Estimate for Pfizer's 2025 sales implies a year-over-year decrease of 0.6%, while Merck's estimates suggest a 0.9% increase [13][17]. - Year-to-date, Pfizer's stock has declined by 10.8%, while Merck's stock has dropped by 22.9%, compared to the industry's decrease of 4.0% [19]. - Pfizer's dividend yield of 7.5% is higher than Merck's 4.3%, and Pfizer's return on equity is 20.3%, lower than Merck's 43.2% [22][23]. Group 4: Market Outlook - Both companies are cheaper than larger drugmakers like AbbVie and Eli Lilly, but Merck's reliance on Keytruda and challenges in other areas raise concerns about its future growth [28]. - Pfizer's improving growth prospects, rising estimates, and higher dividend yield position it as a better investment option compared to Merck [29].

Pipeline Overview - Contineum Therapeutics is advancing internally-developed treatments for neuroscience, inflammation, and immunology indications[6] - The company's pipeline includes PIPE-791 (LPA1R antagonist) for IPF, PrMS, and chronic pain, CTX-343 (LPA1R antagonist) for peripheral indications, and PIPE-307 (M1R antagonist) for RRMS and MDD[8] - Contineum expects to have cash runway through 2027 to support key milestones[6] PIPE-791 (LPA1R Antagonist) - PIPE-791 is being developed for Idiopathic Pulmonary Fibrosis (IPF), a disease affecting over 130,000 patients in the US and 3 million patients globally[13] - In a bleomycin-induced in vivo lung fibrosis model, PIPE-791 at 03 mg/kg showed maximal effect with once-daily dosing, reducing lung collagen[28] - Phase 1 healthy volunteer trials showed no dose-limiting adverse events or toxicity[34] - PIPE-791 achieved EC50 and EC90 receptor occupancy at 24-hour trough after a single 1 mg dose[37] - PIPE-791 is also being developed for Progressive Multiple Sclerosis (PrMS), which affects over 750,000 patients globally[45] PIPE-307 (M1R Antagonist) - Contineum has a partnering agreement with J&J for PIPE-307, potentially worth over $1 billion, for all indications[73, 75] - Phase 2 VISTA trial enrollment in RRMS was completed in December 2024, with topline data expected in 2H25[75, 95] - Phase 1 PET trial established brain receptor uptake and PK relationship at pharmacologically active doses for CNS indications[91]

Company Overview - Xenon Pharmaceuticals Inc. is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapeutics for patients in need [3] - The company is advancing an ion channel product portfolio to address areas of high unmet medical need, including epilepsy and depression [3] - Azetukalner, a novel, highly potent, selective Kv7 potassium channel opener, is highlighted as the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications [3] Event Participation - Xenon Pharmaceuticals will present at the 2025 RBC Capital Markets Global Healthcare Conference in New York, NY, on May 20-21, 2025 [1] - The presentation will take place on May 21, 2025, from 10:30-10:55 AM Eastern Time, featuring Ian Mortimer, President and Chief Executive Officer [2] - A live audio webcast of the presentation will be available on the "Investors" section of Xenon's website and will be posted for replay following the event [2]

Core Viewpoint - Xenon Pharmaceuticals Inc. is set to report its first quarter 2025 financial results and provide a business update on May 12, 2025, after the U.S. financial markets close [1]. Group 1: Financial Reporting - The financial results and business update will be announced after the close of U.S. financial markets on May 12, 2025 [1]. - A conference call and webcast will take place on the same day at 4:30 pm Eastern Time [2]. Group 2: Company Overview - Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to developing therapeutics for conditions such as epilepsy and depression [3]. - The company is advancing an ion channel product portfolio, with Azetukalner being the most advanced potassium channel modulator in late-stage clinical development [3].

Financial Data and Key Metrics Changes - In Q4 2024, total revenue was $259.6 million, up 12% year-over-year, while full year revenue reached $957.8 million, up 32% from the prior year [59] - DAYBUE sales in Q4 were $96.7 million, an 11% increase year-over-year, and full year sales were $348.4 million, a 97% increase compared to $177.2 million in 2023 [60] - NUPLAZID sales in Q4 were $162.9 million, a 13% increase year-over-year, with full year sales of $609.4 million, up 11% from $549.2 million in the prior year [61] Business Line Data and Key Metrics Changes - DAYBUE's gross-to-net was 18.8% for the year, with a sequential growth of 5% in volume and 1% in net price in Q4 [60] - NUPLAZID's gross-to-net for Q4 was 23.2%, with full year gross-to-net at 26.1%, indicating a balanced growth from both volume and net price [61] Market Data and Key Metrics Changes - The company anticipates U.S. net sales for DAYBUE in 2025 to be between $380 million and $405 million, with expected volume growth of 9% to 16% year-over-year [63] - NUPLAZID's 2025 net sales are projected to be in the range of $650 million to $690 million, with growth expected to be split evenly between volume and net price [68] Company Strategy and Development Direction - The corporate strategy focuses on expanding neuroscience and neuro rare disease franchises, with plans to explore additional investments in rare diseases [11] - The company aims to achieve over $1 billion in annual net sales by 2025, joining a select group of biotech companies [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of both DAYBUE and NUPLAZID, highlighting the importance of expanding the prescriber base and patient engagement [20][25] - The company plans to initiate a Phase 2 study for ACP-204 in Lewy body dementia psychosis and expects to see top-line results for ACP-101 in Prader-Willi syndrome in the first half of 2026 [74] Other Important Information - The company has submitted a marketing application for trofinetide in the EU, anticipating approval in Q1 2026 [42] - The cash balance at the end of 2024 was $756 million, significantly up from $438.9 million at the end of 2023, driven by operational cash flows and the sale of a priority review voucher [63] Q&A Session Summary Question: How should we think about the evolution of growth-to-net for DAYBUE and NUPLAZID? - Management indicated that DAYBUE's growth-to-net is expected to remain in the low 20% range, influenced by Medicare Part D redesign [80] - For NUPLAZID, a 300 basis points price benefit is expected in growth-to-net, with gradual increases anticipated over the next several years [81] Question: Is there a target number of patients for DAYBUE by year-end? - Management stated that the patient base is stable, with around 70% of the Rett population yet to try DAYBUE, indicating significant growth potential [91] Question: Can you discuss the increase in diagnosed U.S. Rett patients? - The increase in diagnosed patients from 5,000 to 5,800 is attributed to improved diagnostics and awareness driven by the launch of DAYBUE [95] Question: What are the secondary endpoints for ACP-101 in Prader-Willi syndrome? - Management expressed confidence that multiple mechanisms of action will be needed to treat patients in areas of unmet medical need like Prader-Willi syndrome [118]

Financial Data and Key Metrics Changes - Total net product revenue for 2024 was $386 million, reflecting high double-digit year-over-year growth for Avelity and Sunosi [7][12] - Total product revenues for Q4 2024 were $118.8 million, representing a year-over-year growth of 6688% [12][13] - Net loss for Q4 2024 was $74.9 million, or $1.54 per share, compared to a net loss of $98.7 million, or $2.08 per share for Q4 2023 [17][18] - The company ended 2024 with $315.4 million in cash and cash equivalents, down from $386.2 million at the end of 2023 [18] Business Line Data and Key Metrics Changes - Avelity net product sales were $291.4 million for the full year 2024, representing a year-over-year growth of 89124% [13][14] - Sunosi net product revenues were $94.3 million for the full year 2024, reflecting a year-over-year growth of 1626% [14][15] - Avelity prescriptions reached approximately 158,000 in Q4 2024, showing a 10% quarter-over-quarter growth and 87% growth compared to Q4 2023 [20][21] - Sunosi total prescriptions were approximately 49,000 in Q4 2024, representing 4% sequential growth and 16% growth versus Q4 2023 [22] Market Data and Key Metrics Changes - Avelity access is 78% of all lives across channels and 63% of lives in commercial [21] - Payer coverage for Sunosi in Q4 was stable at 83% of lives covered across channels [22] Company Strategy and Development Direction - The company aims to commercialize seven products or indications through 2027, focusing on CNS conditions [6][9] - The company plans to submit NDAs for AXS-five and AXS-twelve in the second half of 2025 [9][10] - The launch of Simbravo is anticipated to enhance the company's portfolio in the migraine treatment market [8][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2025, supported by sales force expansion and improved market access dynamics [7][19] - The company expects to achieve cash flow positivity based on the current operating plan [18] - Management highlighted the importance of their digital-centric commercialization platform in driving growth [19] Other Important Information - The company completed five pivotal trials and initiated three Phase III trials in 2024, positioning for several important milestones in 2025 [9][11] - The company is actively engaged with payers to expand access for its products in 2025 [21] Q&A Session Summary Question: DTC promotional activities for Avelity and Simbravo - Management plans to launch a broad-based media outreach plan for Avelity in the coming months, considering seasonality in media spending [27][28] Question: Sales force expansion for Avelity - Approximately 40 additional representatives were added to the Avelity sales team, creating potential synergies with the prescriber base for Simbravo [32][34] Question: NDA submission for AXS-five - The submission is a top priority, with updates expected in the second half of the year [35][36] Question: Alzheimer's disease agitation filing - The filing approach has not been confirmed yet, but updates will be provided soon [41][43] Question: Seasonal cadence of scripts and revenues for Avelity - Q1 is expected to be a growth quarter, albeit slower than the previous year, with sales force expansion anticipated to drive growth [52][54] Question: M&A and business development strategy - The company is open to opportunities that complement its pipeline, focusing on both commercial and development-stage assets [58][59] Question: Impact of Medicare Part D restructure on Avelity revenues - No significant impact is expected from the Medicare Part D restructure on Avelity revenues [103][104] Question: Launch trajectory for Simbravo - The company is optimistic about Simbravo's impact on the acute migraine market, with a targeted approach to headache specialists [72][73] Question: Market opportunity for AXS-twelve in narcolepsy - The company sees a compelling market opportunity for AXS-twelve, particularly among patients dissatisfied with existing treatments [100][101]