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RHHBY's Sales Up 7% in First 9 Months of 2025, '25 Earnings View Raised
ZACKS· 2025-10-23 14:06
Core Insights - Roche Holding AG reported third-quarter sales of CHF 14.9 billion for 2025, reflecting a 6% year-over-year increase at constant exchange rates, driven by strong demand for its drugs [1] - For the first nine months of 2025, total sales reached CHF 45.9 billion, up 7% at constant exchange rates, with the Pharmaceuticals Division growing 9% to CHF 35.5 billion [2][8] - The Diagnostics Division's sales totaled CHF 10.3 billion, up 1%, as demand for pathology solutions and molecular diagnostics offset the impact of healthcare pricing reforms in China [3] Pharmaceuticals Division Performance - Key drugs such as Phesgo, Xolair, Hemlibra, Vabysmo, and Ocrevus generated total sales of CHF 15.8 billion, an increase of CHF 2.4 billion at constant exchange rates compared to the first nine months of 2024 [4] - Ocrevus sales reached CHF 5.2 billion, up 7%, while Hemlibra surged 12% to CHF 3.5 billion, and Vabysmo grew 13% to CHF 3 billion [5] - Xolair sales increased by 34% to CHF 2.2 billion, and Phesgo's sales skyrocketed 54% to CHF 1.8 billion [9] Diagnostics Division Performance - The Diagnostics Division's sales were CHF 10.3 billion, with growth driven by pathology solutions and molecular diagnostics [3] Financial Outlook - Roche expects total sales to grow in the mid-single-digit range at constant exchange rates for 2025, with core earnings per share projected to grow in the high single-digit to low double-digit range [12] Pipeline Developments - The FDA approved label expansions for Gazyva/Gazyvaro and Tecentriq, enhancing Roche's treatment options [13] - Positive results from the phase III evERA study on giredestrant for breast cancer were announced, showing significant reductions in disease progression risk [14] - Roche plans to acquire 89bio, Inc. for $3.5 billion to enhance its portfolio in cardiovascular, renal, and metabolic diseases [15] Competitive Landscape - Roche's drugs, particularly Vabysmo and Hemlibra, have shown strong performance, competing effectively against other market players [17][18]
This ETF Changes Its Spots. That May Be a Good Thing
Etftrends· 2025-10-20 13:22
Core Viewpoint - The ALPS O'Shares Europe Quality Dividend ETF has transitioned to the ALPS O'Shares International Developed Quality Dividend ETF, broadening its investment scope beyond Europe to include a wider range of developed markets outside the U.S. [1][2] Group 1: ETF Transition and Structure - The ETF now follows the O'Shares International Developed Quality Dividend Index, which is an international benchmark compared to its previous Europe-focused index [1] - OEFA has shifted from a Europe-specific fund to one that includes a broader set of developed markets, with Japan being the largest country weight at 15.65% [2] - The ETF aims to provide access to high-quality, dividend-paying large- and mid-cap companies in developed markets outside the U.S., selected based on fundamental metrics like return on assets and dividend growth [3] Group 2: Geographic Exposure and Investment Themes - Despite the change, OEFA retains significant exposure to European equities, with France, the U.K., and Switzerland accounting for approximately 40% of the fund's holdings [4] - The ETF's portfolio includes several stocks recognized by Morningstar as top international stocks, indicating potential for future growth [5][6] Group 3: Notable Holdings - Roche, a major player in the healthcare sector, is part of OEFA's portfolio, which has a 14.57% allocation to healthcare [6] - Roche's focus on biologics and innovative pipeline is highlighted as a strength, providing resilience against competition from biosimilars [7]
CORT Files MAA for Relacorilant in Platinum-Resistant Ovarian Cancer
ZACKS· 2025-10-15 16:35
Core Insights - Corcept Therapeutics (CORT) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its lead candidate, relacorilant, aimed at treating platinum-resistant ovarian cancer [1] - The MAA is supported by positive results from the pivotal phase III ROSELLA study and phase II studies, which demonstrated improved progression-free and overall survival when relacorilant was combined with nab-paclitaxel compared to nab-paclitaxel alone [2] - The FDA has accepted a new drug application (NDA) for relacorilant, with a final decision expected on July 11, 2026 [2] Company Performance - Year-to-date, Corcept's shares have increased by 43.1%, significantly outperforming the industry average rise of 7.4% [3] - The company's sole marketed drug, Korlym (mifepristone), generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of 13.2% [7] Ongoing Development Activities - Corcept is also developing relacorilant for Cushing's syndrome, having submitted an NDA to the FDA in December 2024, with a target action date of December 30, 2025 [5][6] - The company is conducting the phase II BELLA study to evaluate the combination of relacorilant with nab-paclitaxel and Roche's Avastin for platinum-resistant ovarian cancer [6] Market Position - A potential approval of relacorilant could expand Corcept's market reach and reduce its dependence on Korlym for future growth [5][7] - Corcept currently holds a Zacks Rank of 5 (Strong Sell), while other biotech stocks like Chemomab Therapeutics and ANI Pharmaceuticals have better rankings [8]
Can Relacorilant Drive Corcept's Long-Term Growth Beyond Korlym?
ZACKS· 2025-10-01 15:41
Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, is approved for treating Cushing's syndrome, and the company's revenue is entirely dependent on Korlym sales [1][2] Sales Performance - In the first half of 2025, Korlym generated sales of $351.6 million, reflecting a year-over-year increase of approximately 13.2% [1][9] - Full-year 2025 sales for Korlym are estimated to reach $857.1 million, indicating a nearly 26% year-over-year growth [1] Revenue Guidance - Management has revised its total revenue guidance for 2025, now expecting revenues between $850 million and $900 million, down from the previous estimate of $900 million to $950 million [3] Pipeline Development - Corcept is developing relacorilant as a potential alternative to reduce dependence on Korlym, with a new drug application submitted to the FDA for Cushing's syndrome [4][5] - The FDA has set a target action date of December 30, 2025, for the relacorilant application for Cushing's syndrome [4][9] Additional Indications - Corcept is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer, with an FDA decision expected on July 11, 2026 [6][9] - The BELLA study is evaluating relacorilant in combination with nab-paclitaxel and Avastin for ovarian cancer treatment [7] - Other studies are assessing relacorilant with Keytruda for adrenal cancer and with Xtandi for early-stage prostate cancer [8]
Roche (OTCPK:RHHB.F) Earnings Call Presentation
2025-09-22 08:00
Financial Performance & Strategy - Roche delivered consistent growth throughout the last decade, increasing diversification with 17 blockbusters in Pharma[9] - HY 2025 Pharma sales reached CHF 24.0 billion, with a YoY CER growth of +10%[25] - The company projects today's on-market Pharma portfolio to deliver growth until 2028, thereafter stable, fully compensating for generic erosion, with no patent cliff ahead[13] - Roche is committed to invest USD 50 billion into R&D and PP&E in the US until the end of the decade, including a new R&D site and a new manufacturing site focusing on CVRM and AI/ML[84] R&D Pipeline & Progress - The company aims to deliver 20 transformative medicines by the end of 2029, with 80% of the pipeline having best-in-disease potential[17] - Significant progress has been made on the Ten-Year Pharma Ambition, with a +55% increase in average peak sales per pipeline project and +40% more patients treated[20] - 55% of NMEs are post "the Bar," indicating a focus on high-quality assets, and 3 key assets have been "fast-tracked"[23] - 8 NMEs new to Ph III in 2025 YTD, increased value potential of post Bar NMEs entering Ph III[149] Therapeutic Area Focus - Oncology/Hematology, Neurology, Immunology, Ophthalmology, and CVRM cover 60% of the total global burden of disease[37] - In Neurology, Ocrevus is firmly established as the global SoC, with 420,000 patients treated globally[56] - In Immunology, the global LN market is expected to grow at a CAGR 2023-30 of 13%[64] - In Ophthalmology, Vabysmo continues to gain market share in the branded IVT market, despite US market contraction[68] - Roche committed to become a top 3 player in Obesity[147]
Can Korlym Drive Corcept's Growth Through the Rest of 2025?
ZACKS· 2025-09-02 15:00
Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, has shown strong sales performance, with $351.6 million in sales for the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [1][9] - The company anticipates full-year 2025 Korlym sales to reach $857.1 million, indicating a nearly 27% increase year-over-year [1][3] - Management expects a significant rise in Korlym prescriptions in the second half of 2025 as vendor issues are resolved [2][3] Sales and Revenue Expectations - Korlym sales were impacted by vendor capacity issues in Q1 2025 but improved in Q2, with expectations for continued growth in H2 2025 [2][3] - Corcept projects total revenues for 2025 to be between $850 million and $900 million [3] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome, with a new drug application submitted to the FDA, and a decision expected by December 30, 2025 [4][9] - Approval of relacorilant is anticipated to broaden the patient base and reduce reliance on Korlym for future growth [5] Additional Indications and Studies - The company is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer and adrenal cancer [6][7] - The BELLA study is evaluating the efficacy of relacorilant combined with nab-paclitaxel and Avastin for ovarian cancer treatment [7] Market Performance and Valuation - Corcept's stock has increased by 38.3% year-to-date, outperforming the industry average of 8.3% [8] - The company's shares are trading at a premium, with a price-to-sales ratio of 11.73 compared to the industry average of 2.38 [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $1.39 to $1.15, and for 2026, it has decreased from $2.08 to $1.71 [11]
Is Beaten-Down Summit Therapeutics Stock a Bad-News Buy?
The Motley Fool· 2025-06-02 09:23
Core Viewpoint - Summit Therapeutics' stock experienced a significant decline of over 30% due to disappointing results from the Harmoni trial of ivonescimab, a bispecific antibody aimed at treating lung cancer [1][2]. Group 1: Clinical Trial Results - The Harmoni trial aimed to evaluate ivonescimab in second-line lung cancer patients, showing a 48% reduction in disease progression risk but failing to demonstrate a statistically significant overall survival benefit [6]. - The treatment reduced the risk of death by 21%, but the results were just outside the 95% confidence interval with a p-value of 0.057, indicating a lack of convincing evidence for overall survival [6][7]. - The FDA is unlikely to approve ivonescimab in the U.S. based on these trial results, as a statistically significant overall survival benefit is required for approval [7]. Group 2: Market Context and Comparisons - Keytruda, a leading treatment for lung cancer, generated $29.5 billion in sales last year, setting a high benchmark for any competing therapies like ivonescimab [9]. - Despite the lack of overall survival data, ivonescimab's ability to shrink tumors suggests potential for future success in different patient populations [9][11]. - The stock of Summit Therapeutics finished May with a market cap exceeding $13.5 billion, despite having no sales and only one candidate in its pipeline [12]. Group 3: Investment Considerations - The lack of convincing overall survival data for ivonescimab diminishes the likelihood of it achieving blockbuster sales, even if it eventually receives FDA approval [11][13]. - Investors may face challenges ahead, as expectations remain high despite the uncertain path for ivonescimab [11].
CORT's Q1 Earnings In Line With Estimates, Revenues Lag, Shares Fall
ZACKS· 2025-05-06 18:15
Core Insights - Corcept Therapeutics reported first-quarter 2025 earnings of 17 cents per share, matching the Zacks Consensus Estimate, but down from 25 cents per share in the same quarter last year [1] - Revenues for the first quarter increased by 7.1% year over year to $157.2 million, but fell short of the Zacks Consensus Estimate of $178 million, primarily driven by sales of the Cushing's syndrome drug, Korlym [2][5] - Year-to-date, Corcept's shares have increased by 46.8%, contrasting with a 0.4% decline in the industry [4] Financial Performance - Korlym sales were impacted by the inability of a specialty pharmacy vendor to meet the surge in demand, leading to lower-than-expected sales and a 7.5% drop in shares during after-hours trading following the earnings announcement [5] - Research and development expenses rose by 3.8% year over year to $60.7 million, while selling, general, and administrative expenses surged by approximately 61.1% to $90.7 million, resulting in total operating expenses increasing by 31.1% to $153.8 million [6] - As of March 31, 2025, cash and investments totaled $570.8 million, down from $603.2 million as of December 31, 2024 [6] 2025 Guidance - Corcept reiterated its total revenue guidance for 2025, expecting revenues in the range of $900-$950 million, with the Zacks Consensus Estimate at $905.7 million [7] Pipeline Developments - Corcept is advancing its lead candidate, relacorilant, for Cushing's syndrome, with a new drug application submitted to the FDA in December 2024 based on positive data from the GRACE study and other trials [8] - The FDA accepted the NDA in March 2025, with a target action date of December 30, 2025 [9] - Corcept is also exploring relacorilant in combination studies for various cancer indications, with the phase III ROSELLA study meeting its primary endpoint for patients with platinum-resistant ovarian cancer [9] Additional Studies - Corcept initiated the phase II BELLA study to evaluate relacorilant in combination with nab-paclitaxel and Avastin for treating platinum-resistant ovarian cancer [10] - The company is also assessing relacorilant plus Xtandi in early-stage prostate cancer patients in collaboration with the University of Chicago [11] - Data from the phase II DAZALS study for dazucorilant in ALS did not meet its primary endpoint, but exploratory analysis showed improved overall survival for treated patients [12][13] Market Position - Corcept currently holds a Zacks Rank 3 (Hold), with better-ranked biotech stocks including ADMA Biologics and Immunocore Holdings, both carrying a Zacks Rank 2 (Buy) [14]
Immunotherapy in Oncology Patent Landscape Report and Forecast 2024-2032: Identify Emerging Therapeutic Targets and Assess the Competitive Landscape
Globenewswire· 2025-03-06 16:00
Core Insights - The immunotherapy in oncology market is valued at USD 119.0 billion in 2023 and is projected to grow at a CAGR of 11.6%, reaching USD 319.5 billion by 2032, driven by substantial investments in novel immunotherapies and increased patent filings [1][17]. Market Overview - The patent landscape analysis for immunotherapy in oncology examines the interplay between innovation and industry growth, highlighting patent filing trends and key players [2]. - The report identifies emerging therapeutic targets and assesses the competitive landscape, providing insights into strategic R&D investments [2][3]. Technological Advancements - Innovations in genetic engineering and biotechnology, such as CRISPR and next-generation sequencing, are enhancing the development of novel immunotherapies, leading to a surge in patent filings [10]. - The increasing incidence of cancer globally necessitates the development of new treatments, stimulating research and related patent activities [10]. Market Segmentation - The patent landscape is segmented into four key types: Monoclonal Antibodies, Cytokines and Immunomodulators, Checkpoint Inhibitors, and Others, each representing significant advancements in cancer treatment [6]. - The landscape spans various cancer indications, including lung cancer, colorectal cancer, melanoma, breast cancer, and prostate cancer, reflecting targeted research efforts [7]. Regional Analysis - The United States, Europe, and Asia-Pacific lead in patent filings, with the U.S. dominating due to its robust R&D infrastructure [8]. - Europe, particularly Germany and the UK, contributes significantly through collaborative research and innovation incentives, while the Asia-Pacific region, especially China and Japan, is rapidly emerging due to increasing healthcare investments [8]. Key Players and Patent Profiles - Genentech Inc. is a pioneer in oncology immunotherapy with a focus on monoclonal antibodies and targeted treatments, holding significant patents for drugs like Avastin and Herceptin [11]. - AstraZeneca PLC focuses on immune checkpoint inhibitors, particularly targeting PD-1/PD-L1 pathways, with notable patents for drugs like Imfinzi [12]. - Immatics Biotechnologies GmbH specializes in T-cell receptor therapies, reflecting its focus on novel therapeutic targets [13]. - F. Hoffmann-La Roche AG has a comprehensive patent portfolio covering a broad spectrum of therapies, including immune checkpoint inhibitors [14]. - Incyte Corp is known for its diverse patent portfolio, actively developing small molecule inhibitors and novel immunotherapies [15]. Market Forecast - The estimated market value for immunotherapy in oncology is projected to be USD 132.8 billion in 2024, with a forecasted value of USD 319.5 billion by 2032, indicating robust growth potential [17].