Opioids
Search documents
Collegium Pharmaceutical, Inc. (COLL): A Bull Case Theory
Yahoo Finance· 2025-10-08 15:25
Core Thesis - Collegium Pharmaceutical, Inc. is viewed as an undervalued investment opportunity, particularly due to its stable cash-generating pain portfolio and growth potential in the ADHD segment [2][5]. Company Overview - As of September 24th, Collegium's shares were trading at $35.16, with trailing and forward P/E ratios of 32.92 and 4.87 respectively [1]. - The company has historically faced stigma due to its opioid focus but has successfully commercialized products like Xtampa ER, Belbuca®, Symproic, and Nucynta without heavy R&D spending [2]. Recent Developments - The acquisition of BioDelivery Sciences International in 2022 allowed Collegium to bring Belbuca fully in-house, enhancing its control over commercialization and revenue [3]. - Collegium has entered the ADHD market with Jornay PM, which has over 20% market share in its niche and a projected 5-year CAGR of 5-6% [3]. Management and Strategy - The new management team, led by Vikram Karnani and David Dieter, has a strong track record in scaling niche pharmaceuticals through capital-light acquisitions and disciplined capital allocation [4]. - Collegium's pain portfolio funds growth in ADHD while maintaining exclusivity on key products until the early 2030s, creating high barriers to competition [4]. Financial Metrics - The company is trading at under 5x EV/EBITDA with steady double-digit ROIC, indicating it is undervalued compared to peers [5]. - There is a reasonable upside potential to $60 per share, with a bull scenario projecting $120 [5]. Market Position - Collegium is positioned as an overlooked specialty pharma opportunity with significant risk-adjusted upside, driven by a combination of stable cash flow and growth initiatives [5].
X @The Economist
The Economist· 2025-09-10 17:20
Even if the bans on nitazenes are successful, they will not prevent new opioids from springing up and replacing them further down the line. That is a worrying prospect https://t.co/FSNS0YFryV ...
X @Bloomberg
Bloomberg· 2025-07-17 10:10
Healthcare Policy & Legislation - US lawmakers introduce bipartisan legislation to help veterans access alternatives to opioids [1] - The legislation is part of a broader push to promote safer painkillers [1] - The initiative aims to reduce overdose deaths [1]
Makary Reveals What’s Broken Inside the FDA
Bloomberg Television· 2025-07-11 23:06
Opioid Crisis & Regulatory Reform - FDA 承认在阿片类药物监管方面存在失败，并对由此造成的阿片类药物滥用危机表示担忧 [1] - FDA 计划审查 OxyContin 等药物的标签，确保其准确性并与科学依据相符 [2] - FDA 致力于移除咨询委员会中所有可能的行业成员，以维护科学流程的公正性 [3] - FDA 将加强对已批准药物的上市后监测，利用大数据识别潜在的安全信号 [3][4] - FDA 将取消阻止安全流行病学研究的权限，确保安全团队能够自由工作，避免利益冲突 [5] Drug Approval & Transparency - FDA 正在进行全国范围的意见征集，听取 CEO 们对改进 FDA 的想法 [13] - FDA 致力于提高透明度，公开决策信函，使药品开发商能够了解药品未被批准的原因 [14][17] - FDA 正在利用 AI 技术来组织和分析大量的申请文件，以实现现代化 [18] - FDA 推出了一项试点计划，对于符合美国国家优先事项的药物，提供优先审查凭证，将决策时间缩短至 1-2 个月 [20] - FDA 员工数量自 2007 年以来翻了一番，存在大量冗余，需要进行整合 [21] Investment & Deregulation - FDA 采取放松监管的态度，旨在加快审批流程，同时不降低安全标准 [23] - FDA 将与行业保持沟通，确定哪些产品符合国家优先事项，例如满足未满足的公共卫生需求、实现国内生产以及提高药品的可负担性 [24] - FDA 计划对承诺在 OECD 国家和美国之间实现药品价格均等化的公司发放国家优先审查凭证，以激励市场中的良好行为 [25]
