Financial Data and Key Metrics Changes - Total revenues grew 16% in Q2 2025 and 15% year-over-year compared to the same periods in 2024, driven by strong global demand and new patient starts [13][19] - Non-GAAP diluted earnings per share increased to $1.44, reflecting a growth rate more than three times that of revenue growth [18] - Operating cash flow reached $185 million in Q2, a 55% increase compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - VOXZOGO revenue increased 20% year-over-year to $221 million, supported by global expansion and new patient starts [13][20] - Enzyme Therapies revenue rose 15% year-over-year to $555 million, with Palynziq and Vimizim contributing significantly to growth [15][26] - Rocadian revenue was $9 million in Q2, primarily from the U.S. and Italy [15] Market Data and Key Metrics Changes - The company expects second half VOXZOGO revenue to be higher than the first half, with full-year revenue guidance adjusted to between $900 million and $935 million [14][15] - The company anticipates continued strong growth in the second half of 2025, leading to an increase in full-year guidance for total revenues [11][19] Company Strategy and Development Direction - The company plans to advance BMN 333, a long-acting therapy for achondroplasia, to a registrational Phase 2/3 study in the first half of next year [9][28] - The acquisition of Inozyme broadens the enzyme therapies portfolio, with a focus on BMN 401 for ENPP1 deficiency [10][31] - The company aims to augment its portfolio with strategic business development transactions to diversify growth strategies [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong growth and value creation for stakeholders through the remainder of 2025 and beyond [11][19] - The management highlighted the essential nature of their medicines and strong patient support programs as key factors in maintaining availability for patients [26] Other Important Information - The company expects to account for the Inozyme acquisition as an asset purchase, impacting financial results in 2025 [19] - The company is on track to submit applications for age extension for Palynziq to include adolescents in the U.S. and EU in the second half of this year [30] Q&A Session Summary Question: Clarification on BMN 333 and safety profile - Management confirmed that the agent referred to is Trans Con CNP and stated that no unexpected safety issues have been observed in the healthy volunteer study [36][38] Question: Thoughts on competitive landscape for achondroplasia - Management noted that while early data showed added growth with growth hormone, long-term benefits remain uncertain, and further data is needed to assess the impact of combinations [42][45] Question: Contributions to VOXZOGO guidance - Management explained that the adjustment in guidance is primarily due to shifting large orders and a better understanding of revenue trends as the year progresses [50][52] Question: Update on ITC proceedings - Management expects the initial determination from the ITC on June 8, 2026, with a completion date targeted for October 8, 2026 [56][58] Question: Details on BMN 333 trial design - Management refrained from providing specific details on powering but expressed confidence in the biological hypothesis being tested [58][60] Question: Update on citizen petition with the FDA - Management stated that the FDA is reviewing the citizen petition and no updates are expected until the PDUFA date of November 30 [88][90]

Financial Data and Key Metrics Changes - AbbVie reported adjusted earnings per share of $2.97, which is $0.11 above the guidance midpoint [6] - Total net revenues were $15.4 billion, exceeding expectations by over $400 million, reflecting a 6.5% operational growth [7][36] - The company raised its full-year revenue guidance to $60.5 billion, an increase of $800 million, and adjusted EPS guidance to between $11.88 and $12.08 [8][37] Business Line Data and Key Metrics Changes - Immunology revenues exceeded $7.6 billion, with SKYRIZI global sales at $4.4 billion, up 61.8% operationally [10][11] - RINVOQ global sales reached $2 billion, up 41.2% operationally, with strong uptake in IBD [12][13] - Neuroscience revenues were approximately $2.7 billion, up 24% operationally, driven by Vraylar and UBRELVY [20] - Oncology revenues were nearly $1.7 billion, with IMBRUVICA sales down 9.5% and VENCLEXTA sales up 8.3% [16][17] - Aesthetics revenues were nearly $1.3 billion, down 8% operationally, impacted by economic challenges [18] Market Data and Key Metrics Changes - SKYRIZI continues to capture robust market share in psoriatic disease, leading in the US across all lines of therapy [10][11] - HUMIRA global sales were over $1.1 billion, down 58.2% due to biosimilar competition [15] - The aesthetics market is performing below historical levels, with economic challenges affecting consumer sentiment [18][19] Company Strategy and Development Direction - AbbVie is focused on advancing its pipeline and strategic transactions to support long-term growth, with over 30 business development transactions executed since last year [9] - The company is enhancing its immunology pipeline with innovative therapies and technologies, including the acquisition of Capstan Therapeutics [26][27] - AbbVie aims to leverage its global aesthetics commercial footprint to sell obesity drugs in the future [72][73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong outlook for 2025 and beyond, driven by the performance of SKYRIZI and RINVOQ [10][41] - The company is well-positioned to manage potential impacts from tariffs and is investing in US manufacturing capacity [56] - Management highlighted the importance of external innovation and strategic investments to drive growth in the next decade [66] Other Important Information - AbbVie announced impressive Phase III results for RINVOQ in alopecia areata, indicating significant commercial potential [24][97] - The company is actively working to stabilize and grow the dermal filler market amid economic challenges [99] Q&A Session Summary Question: Impact of Stellara biosimilar on SKYRIZI and RINVOQ - Management noted that while there may be some impact, the core momentum for SKYRIZI and RINVOQ is driven by outstanding data and breadth of indications [44][46] Question: Confidence in SKYRIZI and RINVOQ long-term guidance - Management indicated strong performance and momentum, with updates to long-term guidance expected at appropriate times [52][54] Question: Commercial opportunity for alopecia areata - Management highlighted that the new indications for RINVOQ could add approximately $2 billion to peak year sales, with significant potential for momentum [97] Question: Impact of GLP-1s on aesthetics - Management stated that the overall effect is net neutral, with some potential tailwinds for dermal fillers due to patient concerns about facial aesthetics [90]

Financial Data and Key Metrics Changes - Total company revenues for Q2 2025 were approximately $12.3 billion, reflecting strong demand across the business [19] - The growth portfolio saw a 17% year-over-year increase in sales, primarily driven by demand for key brands [5][19] - Gross margin was approximately 73%, primarily due to product mix, with operating expenses down by approximately $260 million compared to the same period last year [29][30] - Diluted earnings per share was $1.46, which includes a $1.5 billion charge related to the BioNTech strategic partnership [30][34] Business Line Data and Key Metrics Changes - Opdivo global sales were approximately $2.6 billion, up 7%, driven by demand in the U.S. and international markets [20] - REBLOZYL global sales were $568 million in the quarter, with U.S. revenue growth up 30% year-over-year [22] - BRYANZI revenues were $344 million, reflecting a 122% increase due to strong demand across all indications [25] - Kamsiyos global sales were $260 million, growing 86% due to robust demand [26] - Eliquis global sales were $3.7 billion, growing 6% primarily due to strong demand [27] Market Data and Key Metrics Changes - In the U.S., Opdivo revenues were approximately $1.5 billion, largely driven by a strong launch in MSI high colorectal cancer [20] - Outside the U.S., Opdivo revenues grew 7%, driven by volume growth and one-time favorable adjustments [20] - REBLOZYL sales outside the U.S. grew 46%, reflecting continued demand across newly launched markets [23] Company Strategy and Development Direction - The company is focused on reshaping for long-term sustainable growth, optimizing its cost structure, and enhancing its growth portfolio [5][19] - Strategic partnerships with BioNTech and Philochem aim to strengthen immuno-oncology and radiopharmaceutical capabilities [6][11] - The company is prioritizing investments in areas with the strongest potential for high-value assets [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential despite some studies not meeting expectations, emphasizing the importance of upcoming data readouts [39] - The company is entering a data-rich period with seven registration assets and seven lifecycle management opportunities expected in the next 12 to 24 months [13] - Management raised full-year revenue guidance by $700 million, reflecting strong performance and better-than-expected legacy sales [32][34] Other Important Information - The company announced a direct-to-consumer offering for Eliquis in partnership with Pfizer, aimed at increasing patient access and affordability [45][49] - A new Executive Vice President, Chief Medical Officer, and Head of Development will join the company, indicating a focus on pipeline advancements [17] Q&A Session Summary Question: Upcoming data-heavy period and Phase III results - Management acknowledged the importance of upcoming studies and their limited impact on long-term growth, emphasizing confidence in future opportunities [39] Question: Macro pressures and direct-to-consumer offering - The direct-to-consumer offering was implemented to cut out middlemen and provide patients with lower costs and increased transparency [46][49] Question: Launch dynamics for COBENFI - COBENFI is performing in line with expectations, with steady growth anticipated as the company expands its prescriber base [56] Question: Competitive dynamics for Kamsiyos - Management remains confident in Kamsiyos' growth despite upcoming competition, citing strong real-world data and positive feedback on label changes [86] Question: Differentiation of MILVEXIAN - Management believes there is an underappreciation of MILVEXIAN's differentiated dosing and its potential in multiple indications [90][92]

SOUTH SAN FRANCISCO, Calif., July 30, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biotechnology company focused on improving patient outcomes through best- in-class therapies for liver and viral diseases, today announced that it will report the Company's second quarter 2025 financial results on Wednesday, August 6, 2025, after the close of the U.S. financial markets. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company fo ...

Core Insights - Alkermes plc reported earnings from continuing operations of 52 cents per share for Q2 2025, surpassing the Zacks Consensus Estimate of 41 cents and slightly down from 53 cents in the same quarter last year [1] - Total revenues for the second quarter were $390.7 million, a decrease of 2.1% year-over-year, primarily due to lower manufacturing and royalty revenues, but still exceeding the Zacks Consensus Estimate of $339 million [1][6] Financial Performance - Proprietary product sales increased by 14% year-over-year to $307.2 million, driven by strong demand for Vivitrol, Aristada, and Lybalvi, exceeding management's expectations of $260-$280 million [4][6] - Manufacturing and royalty revenues fell by 35.8% year-over-year to $83.4 million, negatively impacting overall revenue performance [6][8] - Research and development expenses rose by nearly 30% year-over-year to $77.4 million, attributed to higher costs related to ongoing studies for the investigational pipeline candidate, alixorexton [9] Product Sales Breakdown - Vivitrol sales grew by 9% year-over-year to $121.7 million, surpassing the Zacks Consensus Estimate of $111 million [7] - Aristada sales increased by 18% year-over-year to $101.3 million, exceeding the Zacks Consensus Estimate of $84 million [7] - Lybalvi generated sales of $84.3 million, up 18% year-over-year, also beating the Zacks Consensus Estimate of $79 million [8] Guidance and Future Outlook - Alkermes reiterated its 2025 financial guidance, expecting total revenues between $1.34 billion and $1.43 billion, with specific net sales targets for Vivitrol, Aristada, and Lybalvi [11] - The company is planning to initiate a global phase III program for alixorexton in patients with narcolepsy type 1 following positive results from the phase II Vibrance-1 study [12][14] Pipeline Development - The phase II Vibrance-1 study showed statistically significant improvements in wakefulness for patients treated with alixorexton compared to placebo [13] - Alixorexton is also being studied for narcolepsy type 2 and idiopathic hypersomnia, with data from the Vibrance-2 study expected in the fall [15][16]

Core Insights - Idorsia Ltd has reported a significant operational turnaround driven by the commercial acceleration of QUVIVIQ and financial discipline, aiming for overall profitability by the end of 2027 [2][3][4] Commercial Operations - QUVIVIQ generated total product sales of CHF 56 million in the first half of 2025, representing over a 140% increase compared to the same period in 2024 [5] - In the EUCAN region, QUVIVIQ net sales reached CHF 44 million, nearly four times the CHF 9 million recorded in the first half of 2024 [6] - QUVIVIQ is positioned to become the standard of care for insomnia in Europe, with a focus on securing public reimbursement and expanding promotional efforts [7] Financial Performance - Total net revenue for H1 2025 was CHF 131 million, significantly up from CHF 26 million in H1 2024, driven by QUVIVIQ sales and contract revenues [24][25] - US GAAP operating income for H1 2025 was CHF 64 million, compared to an operating loss of CHF 64 million in H1 2024 [24] - Net income for H1 2025 was CHF 52 million, a substantial improvement from a net loss of CHF 79 million in H1 2024 [27][28] Funding and Liquidity - The company secured a new money facility of CHF 150 million, extending its cash runway through the end of 2026 [4][32] - At the end of H1 2025, Idorsia's liquidity amounted to CHF 72 million, with total indebtedness of CHF 1.37 billion [33][34] Research and Development - Idorsia is advancing multiple investigational clinical assets, including a Phase 2 study for daridorexant in pediatric insomnia and ongoing discussions with the FDA regarding lucerastat for Fabry disease [15][17][19] - The company is also developing a bacterial vaccine targeting Clostridioides difficile, with initial data showing positive results [23] Financial Guidance - For 2025, Idorsia expects continued acceleration of QUVIVIQ with net sales around CHF 130 million and anticipates a non-GAAP operating loss of approximately CHF 175 million [35][36]

Group 1 - Can-Fite BioPharma Ltd. announced a public offering of 8,333,333 American Depositary Shares (ADSs) at a price of $0.60 per ADS, with short-term warrants to purchase up to 16,666,666 additional ADSs [1][3] - The gross proceeds from the offering are expected to be approximately $5.0 million, with potential additional proceeds of up to $10.0 million from the exercise of short-term warrants [3] - The offering is expected to close on or about July 29, 2025, subject to customary closing conditions [1][3] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The proceeds from the offering will be used for funding research and development, clinical trials, and other working capital and general corporate purposes [3] Group 3 - Can-Fite is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, with a lead drug candidate, Piclidenoson, currently in Phase 3 trials [6] - The company’s liver drug, Namodenoson, is being evaluated in multiple trials for hepatocellular carcinoma and has received Orphan Drug Designation and Fast Track Designation from the FDA [6] - Can-Fite's drug candidates have shown efficacy in various conditions and have been tested in over 1,600 patients in clinical studies [6]

Harmony Biosciences Conference Summary Company Overview - **Company**: Harmony Biosciences (HRMY) - **Industry**: Biotechnology, specifically focusing on treatments for rare neurological disorders, including narcolepsy and epilepsy Key Points and Arguments Commercial Performance - **Wakix Revenue Projections**: Expected to generate revenues of **$714 million** in 2024 and **$870 million** in 2025, with potential to exceed **$1 billion** by 2030 [1][4] - **Patient Growth**: Achieved **7,200 average patients** on therapy as of Q1 2025, with expectations to approach **8,000 patients** by year-end [41][42] - **Market Dynamics**: Wakix is the only FDA-approved nonscheduled treatment for narcolepsy, leading to high physician awareness and steady patient additions [39][40] Pipeline Development - **Late-Stage Pipeline**: Harmony has **eight assets** across **13 development programs**, with up to **six in Phase III** by year-end [5][6] - **ZYN-002 for Fragile X Syndrome**: Anticipated top-line data in Q2 2025, with potential to be the first approved treatment for any symptom domains in Fragile X syndrome [10][18] - **EPX-100 for Epilepsy**: Two pivotal Phase III studies ongoing for Dravet syndrome and Lennox Gastaut syndrome, with top-line data expected in 2026 [72][73] Financial Position - **Strong Balance Sheet**: Over **$600 million** in cash, allowing for flexibility in business development and pipeline expansion [5][25] - **Capital Allocation Plans**: Focus on building out the pipeline through early-stage and potentially on-market assets in the neuro space [25][27] Life Cycle Management - **New Formulations for Wakix**: - **Gastro Resistant (GR)**: Expected PDUFA in 2026, designed to address GI symptoms common in narcolepsy patients [46][47] - **High Dose (HD)**: Targeting fatigue in narcolepsy patients, with PDUFA in 2028 [48][49] Competitive Landscape - **Orexin Receptor Agonist Program**: Positioned as a potent option in the narcolepsy treatment landscape, with plans to initiate first-in-human studies later in 2025 [60][61] - **Market Strategy**: Harmony's unique commercial model and established relationships with healthcare providers are expected to support the successful launch of new products [66][67] Strategic Collaborations - **Research Collaboration with Cirque Biosciences**: Focused on regenerative therapies for neurological disorders, enhancing Harmony's pipeline with innovative approaches [29][30] Additional Important Insights - **Unmet Needs in Epilepsy**: The epilepsy market has significant unmet needs, with many patients on multiple medications experiencing inadequate control of seizures [70][71] - **Differentiation in Safety and Tolerability**: EPX-100 is expected to offer a favorable safety profile without the need for regular monitoring, addressing a critical gap in current epilepsy treatments [74][75] Conclusion - Harmony Biosciences is positioned for significant growth with a robust pipeline and strong commercial performance in the narcolepsy market. The company is focused on advancing late-stage programs and addressing unmet medical needs in rare neurological disorders, aiming for multiple product launches in the coming years [80][81]

Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement of 22 million ordinary shares, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization and global clinical development efforts in the biopharmaceutical sector [1][2]. Group 1: Offshore Placement Details - The offshore placement involved the sale of 22 million ordinary shares at a price of HKD68.60 per share, with the shares representing approximately 6.29% of the company's issued share capital prior to the placement [1]. - The net proceeds from the placement will be utilized for commercialization efforts, global clinical development of core pipeline candidates, and strengthening global operations [2]. Group 2: Regulatory and Transactional Aspects - The offshore placement was conducted outside of the United States and was not offered to the public, complying with Regulation S under the Securities Act of 1933 [3]. - The Replacement Shares will be issued in a transaction not involving a public offering, and the securities have not been registered under the Securities Act [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a rich pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [7].

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]