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MRNA Stock Jumps on CDC's Revised RSV Vaccine Recommendations
ZACKS· 2025-07-03 14:11
Core Viewpoint - The U.S. CDC has adopted new recommendations for RSV vaccinations, lowering the age for eligible recipients, which has positively impacted Moderna's stock price and expanded its market potential for the RSV vaccine, mResvia [1][7]. Group 1: CDC Recommendations - The CDC has revised its recommendations to include adults aged 50-59 at higher risk of severe illness from RSV, advising them to receive a single dose of the vaccine [2][8]. - Previously, the guidance recommended vaccination for individuals aged 75 and older, and those aged 60-74 who were at high risk [2][8]. - The current HHS secretary, Robert F. Kennedy, Jr., officially adopted these recommendations, filling the role of CDC director, which is currently vacant [3]. Group 2: Impact on Moderna - The expanded CDC recommendations increase the addressable market for Moderna's RSV vaccine, mResvia, by including a new segment of eligible patients aged 50-59 [7][8]. - Despite the initial approval of mResvia for individuals aged 60 and older, the FDA recently expanded its label to include high-risk individuals aged 18-59 [9]. - Sales of mResvia have been modest since its commercial launch last year, as it was approved later in the contracting season compared to GSK's and Pfizer's vaccines [9][10]. Group 3: Competitive Landscape - Moderna is competing with GSK and Pfizer, both of which have already received approvals for their RSV vaccines for individuals aged 60 and older, with GSK's Arexvy also approved for high-risk individuals aged 50-59, and Pfizer's Abrysvo approved for high-risk individuals aged 18-59 [11]. - The earlier availability of GSK and Pfizer's vaccines has given them a dominant position in the market over Moderna [10]. Group 4: Stock Performance - Year to date, Moderna's stock has lost 27%, while the industry has only seen a 2% decline [5].
EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy
ZACKS· 2025-06-16 16:20
Key Takeaways GSK's Arexvy may be approved in Europe for adults 18 following EMA's acceptance of its application. The RSV vaccine is currently cleared for adults 60 and high-risk individuals aged 50-59 years. Arexvy sales fell 57% in the first quarter of 2025 due to lower demand in the United States.GSK plc (GSK) announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vacci ...
Moderna(MRNA.US)RSV疫苗覆盖群体扩容 FDA批准扩至60岁以下成年人
智通财经网· 2025-06-13 04:23
Core Viewpoint - The approval of Moderna's RSV vaccine for younger adults indicates a potential easing of the previous administration's resistance to mRNA vaccine technology, allowing the company to target a larger market segment [1][2]. Group 1: Regulatory Approvals - The U.S. FDA has approved Moderna's RSV vaccine for adults under 60 who are at high risk of respiratory syncytial virus (RSV) infection, expanding its market reach [1]. - This approval follows the FDA's earlier authorization of the same vaccine for individuals aged 60 and above, marking the second mRNA vaccine product for Moderna after its COVID-19 vaccine [1][2]. Group 2: Competitive Landscape - Competitors such as Pfizer and GlaxoSmithKline have also received approvals for their RSV vaccines targeting high-risk populations, with Pfizer allowed to sell to those under 60 and GlaxoSmithKline to those aged 50 to 59 [1][2]. - The global market now features three adult RSV vaccines: Moderna's mRNA-1345, Pfizer's Abrysvo™, and GlaxoSmithKline's Arexvy™, each utilizing different technological platforms and formulations [2][3]. Group 3: Vaccine Technology and Efficacy - Moderna's mRNA-1345 vaccine employs a single mRNA strand encoding the pre-F protein, encapsulated in lipid nanoparticles, which allows for rapid updates and high neutralizing antibody titers with a single injection [3]. - In contrast, Pfizer and GlaxoSmithKline utilize recombinant protein vaccines with adjuvants, which may offer better immune persistence but require more complex manufacturing processes [3].
Merck Secures FDA Nod for New RSV Antibody Enflonsia in Infants
ZACKS· 2025-06-10 15:51
Group 1: FDA Approval and Product Launch - Merck announced FDA approval for its long-acting monoclonal antibody, clesrovimab, branded as Enflonsia, for the prevention of RSV in newborns and infants [1][7] - The approval was based on data from the pivotal phase IIb/III CLEVER study, which demonstrated a significant reduction in RSV disease and hospitalization in healthy infants [2][7] - Merck plans to launch Enflonsia in the U.S. ahead of the 2025-26 RSV season, with pricing set at $556 per dose and ordering expected to start next month [3][7] Group 2: Market Competition - Enflonsia will face competition from AstraZeneca/Sanofi's RSV antibody Beyfortus, which was also approved in 2023 and achieved blockbuster status in its first full-year sales [6][7] - Sanofi announced plans to increase the supply of Beyfortus, including shipping the antibody early in the third quarter of 2025 [7] - While multiple RSV vaccines are approved for use in the U.S., only Pfizer's Abrysvo is approved for immunizing infants, contrasting with Enflonsia and Beyfortus, which can be administered directly [8] Group 3: Stock Performance - Year to date, Merck's shares have declined by 20%, while the industry has seen a modest decline of 1% [4]
Pfizer's 7.5% Dividend: Income Haven or House of Cards?
MarketBeat· 2025-05-23 19:21
Core Viewpoint - Pfizer's high dividend yield of 7.5% attracts income-seeking investors, but underlying concerns about future growth and financial stability exist due to revenue declines and patent expirations [1][2][13]. Dividend Overview - Pfizer currently pays an annual dividend of $1.72 per share, translating to a quarterly payment of $0.43 per share, resulting in a dividend yield of 7.5% as of May 22, 2025 [2][3]. - The company has a strong track record of increasing dividends for 16 consecutive years, appealing to investors seeking reliable income [4]. Financial Metrics - Pfizer's annualized 3-year dividend growth stands at 2.50%, with a dividend payout ratio of 124.64% based on trailing earnings, indicating that dividends exceed earnings [4][6]. - The dividend payout consumes approximately 47.69% of its cash flow, suggesting a more sustainable dividend based on cash generation [5]. Revenue Challenges - In Q1 2025, Pfizer's total revenues decreased by 8% year-over-year to $13.7 billion, primarily due to a 75% drop in Paxlovid sales as COVID-19 demand normalized [7]. - The company faces a significant revenue loss of $17-$18 billion annually between 2026 and 2028 due to the impending loss of exclusivity for key drugs like Eliquis and Prevnar [8]. Strategic Initiatives - Pfizer is pursuing a strategy focused on pipeline rejuvenation, particularly in oncology, highlighted by the $43 billion acquisition of Seagen in March 2023, which contributed $3.4 billion to revenue in FY 2024 [9]. - The company has entered a licensing agreement with 3SBio, Inc. for SSGJ-707, with an upfront payment of $1.25 billion, potentially worth up to $6 billion, aiming to launch eight new cancer medicines by 2030 [10]. Pipeline Developments - Positive developments in the oncology pipeline include FDA approval for Adcetris in large B-cell lymphoma and promising clinical data for Padcev in urothelial cancer [11]. - The Abrysvo RSV vaccine has seen expanded recommendations, potentially increasing market reach, although setbacks occurred with the discontinuation of the oral GLP-1 candidate danuglipron [12]. Investment Outlook - Pfizer's stock forecast indicates a 12-month price target of $29.17, representing a 25.08% upside, with a Moderate Buy rating based on 15 analyst ratings [13]. - The current high dividend yield is attractive, but the company faces significant operational challenges and uncertainties regarding future revenue growth [14][15].
5 Low Price-to-Sales Stocks That Can Deliver Big Returns in 2025
ZACKS· 2025-05-22 12:45
Core Insights - Investing in stocks based on valuation metrics, particularly the price-to-sales (P/S) ratio, is a strategic approach for evaluating companies, especially those that are unprofitable or in early growth stages [1][3][5] Group 1: Price-to-Sales Ratio - The price-to-sales ratio is a valuable metric that reflects how much investors pay for each dollar of revenue generated by a company [3] - A P/S ratio below 1 indicates a good bargain, as investors pay less than a dollar for a dollar's worth of revenue [4] - The P/S ratio is often preferred over the price-to-earnings ratio due to the difficulty of manipulating sales figures compared to earnings [5] Group 2: Screening Parameters - Companies should have a price-to-sales ratio less than the median for their industry, along with a price-to-earnings ratio below the industry median [7] - A debt-to-equity ratio less than the industry median is also recommended, as lower debt levels contribute to a stable P/S ratio [8] - Stocks should be trading at a minimum price of $5 and have a Zacks Rank of 1 (Strong Buy) or 2 (Buy) to ensure better performance [8] Group 3: Company Profiles - Green Dot (GDOT) is a pro-consumer bank holding company with a strong position in prepaid cards and Banking-as-a-Service, boasting a Zacks Rank 1 and a Value Score of A [10][11] - JAKKS Pacific (JAKK) has diversified through acquisitions and focuses on online retailing, currently holding a Zacks Rank 2 and a Value Score of A [12][13] - PCB Bancorp (PCB) offers a range of banking products and has a strategic expansion plan, with a Value Score of A and a Zacks Rank 2 [14][15] - Gibraltar Industries (ROCK) focuses on operational improvements and has a Value Score of B with a Zacks Rank 2, benefiting from high demand in agricultural facilities [16][17] - Pfizer (PFE) is committed to developing treatments across various therapeutic areas and expects better non-COVID operational revenue growth, holding a Value Score of A and a Zacks Rank 2 [18][19]
Moderna Sharpens Pipeline Focus as COVID-19 Vaccine Demand Ebbs in Q1
ZACKS· 2025-05-06 14:55
Moderna (MRNA) kicked off 2025 with mixed first-quarter results. While its streamlining efforts improved bottom-line numbers, the steep decline in revenues raises concerns.While sales of its COVID-19 vaccine continue to decline as expected in a post-pandemic market, Moderna is taking proactive steps to reshape its future. The company is swiftly advancing multiple pipeline candidates across late-stage development, with the intent to diversify its existing revenue base and launch multiple new products over th ...
Moderna Beats on Q1 Earnings, Lags on Revenues, Focuses on Cost Cuts
ZACKS· 2025-05-01 16:26
Moderna (MRNA) incurred a loss of $2.52 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $2.92. In the year-ago period, the company had reported a loss of $3.07.Total revenues in the quarter were $108 million, which missed the Zacks Consensus Estimate of $127 million. Revenues declined around 35% year over year, owing to lower net product sales. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)More on MRNA’s Q1 EarningsModerna currently ...
Pfizer Q1 Earnings Beat Estimates, Several Headwinds Hurt Sales
ZACKS· 2025-04-29 16:35
Core Viewpoint - Pfizer reported mixed first-quarter results for 2025, with adjusted earnings per share of 92 cents exceeding estimates but revenues of $13.72 billion falling short of expectations, reflecting a year-over-year decline of 8% [1][2][15]. Revenue Performance - Total revenues were $13.72 billion, down 8% year-over-year, missing the Zacks Consensus Estimate of $13.89 billion, with operationally a decrease of 6% and a negative currency impact of 2% [2]. - International revenues increased by 4% operationally to $5.34 billion, while U.S. revenues declined by 12% to $8.37 billion [3]. Product Segment Analysis - Primary Care segment sales fell 20% operationally to $5.7 billion, with Eliquis sales declining 4% to $1.92 billion due to pricing pressures from the Inflation Reduction Act [4][5]. - Specialty Care sales rose 6% to $4.0 billion, driven by Vyndaqel family revenues increasing by 33% to $1.49 billion [4][10]. - Oncology sales increased by 7% to $3.76 billion, with Padcev sales rising 25% to $426 million, while Ibrance revenues declined by 6% to $977 million [4][12][13]. Key Product Performance - Paxlovid revenues dropped 75% year-over-year to $491 million, missing estimates [8]. - Comirnaty sales rose 62% year-over-year to $565 million, exceeding expectations [7]. - The RSV vaccine, Abrysvo, recorded sales of $131 million, down 6% year-over-year, missing estimates [9]. Cost Management - Adjusted selling, informational, and administrative expenses decreased by 12% to $3.01 billion, while adjusted R&D expenses also fell by 12% to $2.17 billion [3]. 2025 Guidance - Pfizer reaffirmed its 2025 guidance, projecting total revenues between $61.0 billion and $64.0 billion, with adjusted earnings per share expected in the range of $2.80 to $3.00 [14][16]. Market Context - Pfizer's stock has declined 11.7% year-to-date, contrasting with a 1.5% increase in the industry [16]. - The company faces challenges from declining COVID-19 product sales and potential patent expirations impacting key products from 2026 to 2030 [17]. Strategic Outlook - Pfizer anticipates that non-COVID drug sales and new product contributions will drive revenue growth in 2025, alongside cost-cutting measures expected to yield savings of $7.7 billion by the end of 2027 [20].
Pfizer(PFE) - 2025 Q1 - Earnings Call Presentation
2025-04-29 15:04
Francesca DeMartino Chief Investor Relations Officer, Senior Vice President First Quarter 2025 Earnings Teleconference April 29, 2025 1 Introduction First Quarter 2025 Earnings 2 Forward-Looking Statements and Non-GAAP Financial Information First Quarter 2025 Earnings 3 • Our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statem ...