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GSK's Specialty Medicines Unit on a Strong Footing: Here's Why
ZACKS· 2025-07-09 14:20
Core Insights - GSK's Specialty Medicines segment is a significant contributor to its sales, accounting for nearly 40% of total revenue and expected to exceed 50% by 2031 [6] Sales Growth - The Specialty Medicines unit has experienced a 17% sales increase in Q1 2025, driven by successful launches in Oncology and long-acting HIV medicines [2][10] - Key products such as Nucala and Dovato are major revenue drivers, alongside new long-acting HIV treatments like Cabenuva and Apretude, and oncology drugs Jemperli and Ojjaara [3] Research and Development - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [4] - The approval of Blujepa for uncomplicated urinary tract infections and Nucala for chronic obstructive pulmonary disease (COPD) supports the growth trajectory [4][10] Regulatory Approvals - Regulatory applications for Blenrep combinations for multiple myeloma and depemokimab for chronic rhinosinusitis and asthma are under review, with FDA decisions expected in 2025 [5] Competitive Landscape - GSK faces significant competition in the Specialty Medicines segment from major pharmaceutical companies such as AstraZeneca, Merck, and Pfizer [7][8] Stock Performance and Valuation - GSK's stock has increased by 16.3% year-to-date, outperforming the industry average of 0.3% [9] - The company's shares are trading at a forward price/earnings ratio of 8.34, which is lower than the industry average of 14.93 and below its 5-year mean of 10.21 [12] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings per share has risen from $4.38 to $4.41 for 2025, while the estimate for 2026 has slightly declined [14]
Incyte Gains 9.2% in Three Months: Buy, Hold or Sell the Stock?
ZACKS· 2025-07-01 14:36
Core Viewpoint - Incyte (INCY) has demonstrated strong performance over the past three months, with a 9.2% increase in share price, outperforming the industry which saw a decline of 1.3% [1][2][9] Pipeline and Regulatory Updates - Positive pipeline and regulatory updates have contributed to INCY's stock performance, including the FDA's approval of Monjuvi (tafasitamab-cxix) for a new cancer indication [3][4] - Monjuvi, in combination with Rituxan and Revlimid, is now approved for treating adult patients with relapsed or refractory follicular lymphoma, which is expected to boost sales [5] - Incyte secured worldwide exclusive rights for tafasitamab from MorphoSys AG in February 2024, enhancing its oncology portfolio [5] - A new collaboration with Qiagen aims to develop a diagnostic panel for myeloproliferative neoplasms (MPNs), supporting INCY's pipeline [6][7] Drug Performance - The FDA approved label expansions for both Monjuvi and Zynyz, further strengthening Incyte's oncology offerings [9] - Zynyz (retifanlimab-dlwr) received approval for use in combination with platinum-based chemotherapy for treating locally recurrent or metastatic squamous cell carcinoma of the anal canal [10] - The approval of Jakafi, a lead drug, continues to show strong sales across various indications, contributing significantly to revenue [13][14] Financial Estimates - INCY's shares currently trade at a price/sales ratio of 2.66x forward sales, lower than its historical mean of 4.23x but higher than the biotech industry average of 1.64x [20] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has decreased to $5.78 from $5.81 over the past 60 days, with a similar downward trend for 2026 [22] Market Position and Challenges - Despite recent successes, INCY remains heavily dependent on Jakafi, which accounts for over 65% of total revenues, and faces increasing competition [16][24] - The company has appointed a new CEO, Bill Meury, which may influence future strategic directions and pipeline developments [24]
FDA Extends INCY's Application for Opzelura Label Expansion
ZACKS· 2025-06-23 14:56
Core Insights - Incyte's supplemental new drug application (sNDA) for ruxolitinib cream has had its FDA review period extended by three months to September 19, 2025, to allow for additional data review [1][2][7] - The sNDA aims to secure approval for treating children aged 2-11 years with mild to moderate atopic dermatitis (AD) [1][4] - Ruxolitinib cream, marketed as Opzelura, is already approved for patients aged 12 and older for the treatment of non-segmental vitiligo [3][5] Company Performance - Year-to-date, Incyte's shares have decreased by 0.9%, while the industry has seen a decline of 2.5% [2] - First-quarter net revenues from Opzelura cream reached $119 million, reflecting a 38% increase [5] Clinical Data - The sNDA is supported by data from the phase III TRuE-AD3 study, which demonstrated that a higher percentage of patients treated with Opzelura achieved treatment success compared to those using a non-medicated cream [4][7] - The study also met a secondary endpoint, with at least 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 [4] Portfolio Diversification - Incyte is actively working to diversify its portfolio and reduce reliance on its leading drug, Jakafi (ruxolitinib) [8] - The company has seen strong sales across all indications, with recent approvals of drugs like Pemazyre, Monjuvi, and Tabrecta contributing to this diversification [10] Competitive Landscape - Jakafi faces increasing competition, particularly from GSK's Ojjaara, which reported strong sales growth of £112 million in the first quarter of 2025 [13] - The patent protection for Jakafi is expected to expire in the coming years, which may impact future revenue [14]
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
ZACKS· 2025-06-18 15:25
Core Insights - GSK stock has increased by 21.5% over the past six months, driven by strong performance in the Specialty Medicines unit, regulatory successes, and a positive long-term outlook despite challenges in the Vaccines unit and economic pressures [2][22]. Specialty Medicines Unit Performance - The Specialty Medicines unit has shown significant sales growth, with a 19% increase in 2024 and a 17% rise in Q1 2025, primarily due to successful launches in Oncology and long-acting HIV medicines [3][4]. - Key products driving growth include Nucala, Dovato, Cabenuva, Apretude, Jemperli, and Ojjaara, with expectations for low double-digit sales growth in 2025 despite the Inflation Reduction Act's impact [4][9]. - Specialty Medicines currently accounts for approximately 40% of GSK's sales and is projected to exceed 50% by 2031 [4]. Promising Pipeline Developments - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [5]. - Recent approvals include the pentavalent MenABCWY vaccine and Blujepa for UTI treatment, with Nucala receiving approval for COPD in May 2025 [5][6]. - GSK anticipates launching five new products in 2025, including Blenrep and depemokimab, with several already approved in the U.S. [7]. Vaccine Sales Challenges - Vaccine sales declined by 6% in Q1 2025, primarily due to lower demand for the RSV vaccine Arexvy and shingles vaccine Shingrix [8][10]. - Shingrix sales fell by 21% in Q1 2025, and Arexvy's global sales dropped by 57%, attributed to revised vaccination recommendations and challenges in reaching consumers [10][11]. - The company expects a low single-digit percentage decline in Vaccine sales for 2025 due to macroeconomic challenges and potential policy changes [12]. Stock Performance and Valuation - GSK stock has outperformed the industry and S&P 500, rising 20.1% year-to-date compared to a 4.0% industry increase [13]. - The stock trades at a forward P/E of 8.63, below the industry average of 15.63, indicating an attractive valuation relative to peers [17]. - Earnings estimates for 2025 have increased from $4.26 to $4.42 per share, reflecting analysts' positive outlook for future growth [20]. Future Growth Expectations - GSK anticipates over 7% sales growth and more than 11% core operating profit growth on a CAGR basis from 2021 to 2026, driven by Specialty Medicines and improvements in General Medicines [23]. - The company has resolved most Zantac litigations, alleviating a significant overhang on the stock [25].
GSK to Report First-Quarter Earnings: Is a Beat in Store?
ZACKS· 2025-04-28 14:15
Core Viewpoint - GSK plc is expected to exceed earnings expectations in the first quarter of 2025, with a consensus estimate for sales at $9.54 billion and earnings at $1.08 per American depositary share (ADS) [1] Factors Shaping GSK's Upcoming Results - GSK's financial performance is segmented into Specialty Medicines, Vaccines, and General Medicines [1] - Newer products such as Cabenuva, Juluca, Dovato, Nucala, Ojjaara, Jemperli, and Trelegy Ellipta are anticipated to drive sales, compensating for declines in older HIV drugs and respiratory medicines due to generic competition [2] - The HIV portfolio is projected to generate sales of £1.71 billion, driven by strong growth in two-drug regimens Dovato and Juluca, as well as long-acting regimens Cabenuva and Apretude [3] - Vaccine sales are expected to decline, with projections of £2.2 billion, influenced by lower demand for Shingrix and restrictive recommendations for Arexvy [4][5] - Oncology sales are likely to grow, with expectations of £380 million from Jemperli, Zejula, and Ojjaara, alongside respiratory drugs Trelegy Ellipta and Nucala contributing £677 million and £403 million, respectively [6] GSK's Earnings Surprise History - GSK has consistently surpassed earnings estimates in the past four quarters, achieving an average surprise of 11.44% [7] - Year-to-date, GSK's shares have increased by 11%, outperforming the industry, which has seen a 5% decline [7] Earnings Prediction Model - GSK has a positive Earnings ESP of +3.16% and a Zacks Rank of 3, indicating a strong likelihood of an earnings beat [9]