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Theravance's Q2 Loss Narrower Than Expected, Revenues Rise Y/Y
ZACKS· 2025-08-13 17:36
Core Insights - Theravance Biopharma (TBPH) reported a narrower adjusted net loss of 8 cents per share for Q2 2025, compared to the expected loss of 14 cents and a loss of 13 cents in the same quarter last year [1][7] - Total revenues for Q2 reached $26.2 million, exceeding the Zacks Consensus Estimate of $17 million, and reflecting an 83.2% year-over-year increase driven by collaboration and licensing revenues [2][7] - Year-to-date, Theravance's shares have increased by 26.6%, outperforming the industry average rise of 5.3% [2] Financial Performance - Revenues from the collaboration with Viatris related to Yupelri sales amounted to $18.7 million, marking a 31% increase year-over-year [8] - Viatris reported U.S. net sales of Yupelri at $66.3 million for Q2, a 22% increase year-over-year, indicating strong demand growth [5][7] - The company received a milestone payment of $7.5 million from Viatris following Yupelri's approval in China [8] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $9.5 million, an increase of nearly 8% from the previous year [9] - Selling, general, and administrative expenses (excluding share-based compensation) rose approximately 16.4% year-over-year to $12.8 million [9] - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [10] Pipeline and Strategic Updates - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [11] - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [12] - Theravance sold its remaining royalty interest in Trelegy Ellipta to GSK for $225 million, marking a strategic move to maximize shareholder value [13]
GSK Beats on Q2 Earnings & Sales, Stock Gains on '25 Outlook Raise
ZACKS· 2025-07-30 16:46
Core Insights - GSK plc reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.12, with a year-over-year increase of 7% on a reported basis and 15% at a constant exchange rate (CER) [1][9] - Quarterly revenues rose 1% on a reported basis and 6% at CER to $10.67 billion (£7.99 billion), driven by increased sales of HIV, oncology, and vaccine products, surpassing the Zacks Consensus Estimate of $10.33 billion [2][9] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 15%, while Vaccine sales rose by 9%. General Medicines experienced a decline of 6% [3][9] - HIV sales grew by 12%, supported by increased demand for Dovato and long-acting medications Apretude and Cabenuva, with Apretude and Cabenuva sales rising by 50% and 46%, respectively [4][6] - Oncology sales surged by 42%, driven by strong demand for Jemperli and Ojjaara/Omjjara, with Jemperli sales increasing by 91% [6][7] - Vaccine sales were bolstered by increased uptake of meningitis and shingles vaccines, with Shingrix sales rising by 6% [12] Financial Guidance - GSK raised its 2025 sales and profit guidance, now expecting sales to increase toward the top end of the previously issued range of 3-5%, with Specialty Medicines projected to grow at a low teens percentage at CER [15][16] - The company anticipates core operating profit and core EPS to grow toward the top end of the previously issued guided range of 6-8% [16][17] Long-term Strategy - GSK has prioritized focus on HIV, immunology/respiratory, and oncology therapeutic areas, with 84 assets in clinical development, including 16 candidates in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions in 2025, with three already approved in the first half of the year [25][26]
默沙东、GSK抢着买慢病新药,哪些公司还有BD机会?|焦点分析
3 6 Ke· 2025-07-30 09:05
Core Viewpoint - The recent $5 billion upfront payment by GSK for the overseas rights of HRS-9821 and 11 innovative projects from Heng Rui Pharmaceutical highlights the growing interest and potential in the COPD treatment market, which has seen little innovation for over a decade [1][2]. Group 1: Market Dynamics - The global COPD market is projected to exceed $20 billion by 2024, with HRS-9821 being a significant new entrant after a long period without new mechanisms [1][5]. - The approval of Ensifentrine, a PDE3/4 inhibitor, has revitalized interest in COPD treatments, demonstrating a 36%-43% reduction in acute exacerbation rates [5][6]. - The transaction indicates a shift in focus for Chinese pharmaceutical companies towards common and chronic diseases, revealing untapped value in the respiratory drug market [2][3]. Group 2: Competitive Landscape - Major players in the COPD treatment market include AstraZeneca, GSK, and Boehringer Ingelheim, which have historically dominated with LABA, LAMA, and ICS therapies [3][5]. - The success of PDE3/4 inhibitors is expected to prompt other pharmaceutical companies to explore similar pathways, with companies like Zhengda Tianqing and Haisco making significant progress in their own PDE3/4 inhibitor developments [9][10]. - The market is witnessing a potential consolidation of opportunities, with Chinese companies likely to dominate the remaining PDE3/4 development space [7][9]. Group 3: Future Opportunities - The complexity of COPD's pathophysiology suggests that while PDE3/4 inhibitors are promising, they will not be the only future players, as biologics targeting different mechanisms are also emerging [10][11]. - New therapeutic approaches, including cell therapies and biologics targeting TSLP, are being explored, indicating a diversification in treatment options for COPD [12][14]. - The anticipated market for COPD treatments may evolve into a tiered selection model, where traditional therapies provide foundational care while innovative products address more challenging cases [14].
阿斯利康(AZN.US)新款COPD吸入器获EMA专家组建议批准
智通财经网· 2025-07-25 13:16
Core Viewpoint - AstraZeneca's Trixeo Aerosphere, an environmentally friendly inhaler for chronic lung diseases, has received a positive recommendation from the European Medicines Agency's expert committee for approval [1][2] Group 1: Product Development - The new version of Trixeo Aerosphere will utilize a next-generation propellant developed by Honeywell, aimed at delivering medication effectively to patients' lungs while reducing carbon footprint [1][2] - The previous version of the inhaler has already been approved in Europe for treating adult patients with Chronic Obstructive Pulmonary Disease (COPD) [1] Group 2: Regulatory Approval - The Committee for Medicinal Products for Human Use (CHMP) recommended the product's approval based on clinical trial results, which showed comparable drug delivery to the current version without new safety risks [1][2] - If the European Commission grants formal approval, Trixeo Aerosphere will become the first inhaler in the EU to use this new delivery mechanism [2] Group 3: Market Impact - The inhaler is projected to generate $978 million in revenue for AstraZeneca in 2024 [2] - Competing products in the COPD market include Sanofi/Regenron's Dupixent, GlaxoSmithKline's Trelegy Ellipta, and Verona Pharma's Ohtuvayre [2]
TBPH to Sell Remaining Trelegy Royalty Interest to GSK, Stock Rises
ZACKS· 2025-06-03 16:56
Core Insights - Theravance Biopharma (TBPH) has entered into an agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK plc for $225 million in cash [1][2] - The transaction is part of Theravance's strategic review efforts to maximize shareholder value, with potential additional milestone payments of up to $150 million from Royalty Pharma based on Trelegy Ellipta's net sales in 2025 and 2026 [2][7] - Following the announcement, Theravance's shares increased by 22% [2] Financial Performance - Theravance's stock has increased by 18.5% year-to-date, contrasting with a 1.9% decline in the industry [3] - In February 2025, Theravance received a $50 million milestone payment based on Trelegy Ellipta's net sales of $3.46 billion in 2024, with a similar milestone payment of $150 million contingent on projected sales of approximately $3.41 billion in 2025 and $3.51 billion in 2026 [4][8] Revenue Generation - Theravance generates revenue from its collaboration with Viatris (VTRS) related to the sales of Yupelri, a nebulized therapy for COPD, sharing profits at a ratio of 35% for Theravance and 65% for Viatris [9][10] - In Q1 2025, Theravance reported $15.4 million in collaboration revenues from Yupelri sales, reflecting a year-over-year increase of 6.2% [11] Pipeline Development - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [11] - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [12]
Theravance Biopharma, Inc. Sells Remaining Royalty Interest in Trelegy Ellipta to GSK for $225 Million
Prnewswire· 2025-06-02 10:00
Core Viewpoint - Theravance Biopharma has entered into a definitive agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK for $225 million in cash, translating confidence in Trelegy's sustained success into immediate value for shareholders [1][2] Financial Summary - The sale of Outer Year Royalties will provide Theravance Biopharma with $225 million in cash, in addition to the $1.1 billion received from the initial sale of Trelegy royalty interests in 2022, bringing the total potential lifetime value from Trelegy monetization efforts to $1.525 billion [3][6] - The company retains rights to receive up to $150 million in remaining Trelegy sales-related milestones in 2025 and 2026 from Royalty Pharma, with minimal growth required over 2024 actuals to achieve these milestones [3][6] Strategic Review Committee - This transaction is the first outcome of the ongoing efforts of the Strategic Review Committee formed by the Board of Directors to assess strategic alternatives and enhance shareholder value [4] - The Committee will continue to evaluate various alternatives to maximize shareholder value, although there is no assurance that additional transactions will occur [4] Product Development - Theravance Biopharma is focused on growing YUPELRI and advancing ampreloxetine towards potential regulatory approval and launch, indicating a commitment to developing its product pipeline [2][8]
Buy 5 High Dividend-Paying Giants to Stay Safe Amid Volatile Markets
ZACKS· 2025-05-29 12:11
Market Overview - Wall Street has experienced volatility in 2025 due to overstretched valuations of U.S. stocks, persistent inflation, weak economic data, geopolitical conflicts, and concerns regarding the Trump administration's trade policies [1] - The Federal Reserve's uncertainty over rate cuts, recession fears, and the emergence of a low-cost Chinese AI platform have contributed to investor unease [1] Investment Strategy - It is advisable to invest in high dividend-paying corporate giants, which typically possess strong financial positions, robust business models, and globally recognized brand value [2] - Regular dividend payments from these firms can provide a steady income stream during market fluctuations [2] Company Highlights Philip Morris International Inc. (PM) - Zacks Rank 1, benefiting from strong pricing power and an expanding smoke-free product portfolio, aiming to become substantially smoke-free by 2030 [6][7] - Expected revenue and earnings growth rates of 8.1% and 13.7% respectively for the current year, with a current dividend yield of 3.01% [8] CVS Health Corp. (CVS) - Zacks Rank 2, investing in technology to reduce costs and enhance customer experience, with plans to close 271 stores to save over $500 million in 2025 [9][10] - Expected revenue and earnings growth rates of 3.7% and 12.6% respectively for the current year, with a current dividend yield of 4.34% [10] Energy Transfer LP (ET) - Zacks Rank 2, benefiting from long-term fee-based contracts, with nearly 90% of earnings from such contracts [11][13] - Expected revenue and earnings growth rates of 18.2% and 12.5% respectively for the current year, with a current dividend yield of 7.30% [13] GSK plc (GSK) - Zacks Rank 2, strong position in HIV and Vaccines, with increased sales growth in Specialty Medicines and promising new products [14][15] - Expected revenue and earnings growth rates of 5.1% and 6.7% respectively for the current year, with a current dividend yield of 4.28% [16] NatWest Group plc (NWG) - Zacks Rank 1, providing a range of banking and financial services in the UK and internationally [17][18] - Expected revenue and earnings growth rates of 20.1% and 17.3% respectively for the current year, with a current dividend yield of 5.41% [19]
Theravance's Q1 Loss Wider Than Expected, Revenues Rise Y/Y
ZACKS· 2025-05-09 17:40
Core Viewpoint - Theravance Biopharma reported a wider-than-expected adjusted net loss for Q1 2025, indicating ongoing financial challenges despite a year-over-year revenue increase driven by collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q1 2025 was 17 cents per share, compared to a loss of 11 cents estimated by Zacks Consensus, and a loss of 9 cents in the same quarter last year [1]. - Total revenues for the first quarter were $15.4 million, missing the Zacks Consensus Estimate of $16 million, but representing a 6.2% increase year-over-year due to higher collaboration revenues from Viatris [2]. - The reported loss, including share-based compensation and other expenses, was 27 cents per share, compared to a loss of 24 cents in the prior year [2]. Collaboration and Revenue Sources - Revenues were entirely derived from Viatris' collaboration related to Yupelri (revefenacin) sales, which is used for chronic obstructive pulmonary disease treatment [4]. - Viatris recorded $58.3 million in U.S. net sales of Yupelri for Q1 2025, reflecting a 6% year-over-year increase [6]. - Theravance receives 35% of the profits from Yupelri sales, while Viatris retains 65% [5]. Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) were $10.4 million, up 40.5% from the previous year, while selling, general, and administrative expenses increased by 13.2% to $14.6 million [10]. - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [11]. Pipeline Developments - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [12]. - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [13].
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]
Theravance's Q4 Loss In Line With Estimates, Sales Beat
ZACKS· 2025-02-27 14:45
Financial Performance - Theravance Biopharma reported a fourth-quarter 2024 adjusted net loss of 5 cents per share, consistent with the Zacks Consensus Estimate, compared to earnings of 3 cents per share in the same quarter last year [1] - Total revenues for the quarter were $18.8 million, slightly exceeding the Zacks Consensus Estimate of $18.0 million, and reflecting a year-over-year increase of 6.8% due to higher collaboration revenues from partner Viatris [3] - The reported loss, including share-based compensation, income tax expense, and non-cash interest expense, was 31 cents per share, compared to a loss of 17 cents in the year-ago quarter [2] Collaboration and Revenue Sources - The revenue was entirely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales, which increased by 8% year over year in the fourth quarter [4] - Viatris recorded U.S. net sales of Yupelri at $66.7 million, marking a 10% year-over-year increase [6] - Viatris retains 65% of the profits from Yupelri sales, while Theravance receives 35%, which includes its share of net sales and proportionate costs [5] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $8.1 million, up nearly 23% from the previous year, while selling, general, and administrative expenses increased around 23% year over year to $14.1 million [9] - For 2025, Theravance expects adjusted R&D expenses to be in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million, with share-based compensation expenses projected at $18-$20 million [12] Cash Position and Future Outlook - As of December 31, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $88.4 million, down from $91.4 million as of September 30, 2024 [11] - The company anticipates adjusted losses and cash burn in 2025 to be similar to 2024 levels, with an adjusted loss of $16 million and cash burn of $14 million recorded in 2024 [13] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855), a norepinephrine reuptake inhibitor for treating neurogenic orthostatic hypotension in patients with multiple system atrophy [14] - The phase III CYPRESS study for ampreloxetine was initiated in 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [15]