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Can Label Expansion of Cabometyx Fuel Further Growth for EXEL?
ZACKS· 2025-08-26 14:36
Core Insights - Exelixis' lead drug, Cabometyx, has received FDA approval for label expansion to treat adult and pediatric patients aged 12 and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (NET) in March 2025, marking a significant advancement for the company [1][10] Product Overview - Cabometyx is the first and only systemic treatment FDA approved for previously treated NET, applicable regardless of primary tumor site, grade, somatostatin receptor expression, and functional status [2] - The drug is noted as the first broadly applicable new oral small molecule therapy for NET in nine years [2] Market Demand and Performance - Initial uptake for Cabometyx's new indication is strong, capturing 35% of the new patient share for oral therapies in this indication, with demand just over 4% of total demand for cabozantinib in Q2 [3][10] - Exelixis expects Cabometyx to be widely used across various patient and tumor characteristics, including those with NET from the pancreas, GI tract, and lung [5] Regulatory Approvals - In July, Exelixis announced that its partner Ipsen received regulatory approval for Cabometyx for adult patients with unresectable or metastatic well-differentiated extra-pancreatic and pancreatic NET in the EU [4] Competitive Landscape - Cabometyx faces competition from Novartis' Lutathera, which is also used for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [6] - In the renal cell carcinoma (RCC) space, Cabometyx competes with Merck's Keytruda and Inlyta, as well as Merck's Welireg [7][8] Financial Performance - Exelixis shares have gained 13.8% year-to-date, outperforming the industry growth of 4% [9][10] - The company's valuation is considered high, with a price/sales ratio of 4.07x forward sales, above its mean of 3.64x and the biotech industry's 1.58x [11] Earnings Estimates - The bottom-line estimate for 2025 has increased from $2.65 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.08 over the past 30 days [12]
Exelixis Gains 15.6% YTD: How Should You Play the Stock?
ZACKS· 2025-08-14 14:16
Core Insights - Exelixis (EXEL) has shown strong year-to-date performance with a 15.6% increase in share price, significantly outperforming the industry growth of 2.9% [1] - Despite reaching a 52-week high of $49.62 on June 23, 2025, shares dipped following mixed quarterly results reported on July 28 [1][4] - The company’s lead drug, Cabometyx, continues to perform well in the renal cell carcinoma (RCC) market, supported by strong demand and recent label expansions [5][6] Company Performance - Exelixis' stock has outperformed both the sector and the S&P 500 Index during the year [1] - The company reported a revenue miss in the second quarter, which has affected investor sentiment [8][20] - Cabometyx remains the leading tyrosine kinase inhibitor (TKI) for RCC, with strong sales driven by its combination with Bristol Myers' Opdivo [5][6] Drug Pipeline and Developments - Zanzalintinib, an investigational TKI, has shown positive results in the STELLAR-303 study, meeting a key endpoint for overall survival in metastatic colorectal cancer [10][12] - The company has decided not to proceed with the phase III portion of the STELLAR-305 trial for zanzalintinib due to emerging competition and a focus on larger commercial opportunities [14] - Exelixis is actively expanding its pipeline with three ongoing phase I studies and has received FDA clearance for a new IND application [15] Financial Outlook - Exelixis shares are currently trading at a price/sales ratio of 4.14x forward sales, higher than the biotech industry average of 1.59x [16] - The bottom-line estimate for 2025 has increased slightly from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 [17] Competitive Landscape - Cabometyx faces significant competition in the RCC market, particularly from Merck's Keytruda and Pfizer's Inlyta [20][21] - Keytruda is a leading drug in the RCC space, accounting for approximately 50% of Merck's pharmaceutical sales [21]
Will Zanzalintinib Ease Out EXEL's Reliance on Cabometyx for Growth?
ZACKS· 2025-08-13 13:55
Core Insights - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor (TKI) targeting receptor tyrosine kinases involved in cancer growth, with recent studies showing positive data [1] Study Results - In June 2025, Exelixis announced positive top-line results from the STELLAR-303 study, a phase III trial involving 901 patients with metastatic colorectal cancer, comparing zanzalintinib plus Tecentriq against regorafenib [2] - The STELLAR-303 study met one of its dual primary endpoints, showing a statistically significant improvement in overall survival (OS) for the intent-to-treat population treated with zanzalintinib plus Tecentriq compared to regorafenib [3] - Enrollment for the STELLAR-304 study was completed in May 2025, evaluating zanzalintinib in combination with Opdivo versus sunitinib in advanced non-clear cell renal cell carcinoma [4] - Exelixis has opted not to proceed with the phase III portion of the STELLAR-305 trial based on emerging data and competition in advanced squamous cell carcinoma [5] - The company initiated the phase III STELLAR-311 study in advanced neuroendocrine tumors, comparing zanzalintinib to everolimus [6] Competitive Landscape - The competitive environment for renal cell carcinoma (RCC) is intensifying, with significant competition for Exelixis's lead drug, Cabometyx, from various immunotherapy-TKI combinations [7] - Keytruda, approved for advanced RCC, accounts for approximately 50% of Merck's pharmaceutical sales, highlighting the competitive pressure in the market [10] Financial Performance - Exelixis shares have increased by 14% year-to-date, contrasting with a 0.9% decline in the biotech industry [11] - The company's shares are currently trading at a price/sales ratio of 4.09x forward sales, above its historical mean of 3.64x and the biotech industry's average of 1.59x [13] - The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 over the past 30 days [14]
3 Reasons Pfizer's 7%-Yielding Dividend Is Getting Safer
The Motley Fool· 2025-08-13 08:51
Core Viewpoint - Pfizer's dividend yield of 7% is becoming more sustainable due to improved cash flow, lower leverage, and new product launches that can offset revenue losses from patent expirations [2][3][9]. Group 1: Free Cash Flow Improvement - Pfizer's free cash flow was $571 million in the first half of 2025, while dividends paid amounted to $4.9 billion, raising concerns about sustainability [3]. - The company expects improved cash flows in the second half of 2025, aided by a $2.1 billion tax payment and a payment to BioNTech [4]. - Pfizer anticipates $7.7 billion in savings from cost-cutting initiatives by the end of 2027, with a portion reinvested in pipeline development, potentially boosting free cash flow [5]. Group 2: Financial Flexibility and Leverage - Pfizer's capital allocation strategy prioritizes maintaining and growing the dividend, reinvesting in the business, and stock buybacks [6]. - The company has reduced its gross leverage ratio to approximately 2.7 from a previous target of 3.25, allowing for more financial flexibility [7]. - Improved cash generation post-Seagen acquisition enhances the ability to maintain and grow the dividend [8]. Group 3: New Products and Patent Cliff - Pfizer faces a patent cliff with several key drugs losing exclusivity, which poses a risk to revenue and dividend payments [9][10]. - However, strong revenue growth from recent product launches and acquisitions is expected to offset these losses [12]. - Notable products include Elrexfio, projected to become a standard treatment for multiple myeloma, and Sigvotatug vedotin, targeting non-small-cell lung cancer [12][13].
If You'd Invested $1,000 in Pfizer (PFE) Stock 3 Years Ago, Here's How Much You'd Have Today
The Motley Fool· 2025-08-12 01:16
Group 1 - The core performance of Pfizer has been disappointing, with a $1,000 investment made on August 8, 2022, worth only $585 by August 8, 2025, compared to a $1,615 value for the S&P 500 index over the same period [1] - Future performance is crucial for current and potential investors, and Pfizer's outlook appears promising due to ongoing investments and strategic planning [2] - Past exceptional performance was driven by the COVID-19 vaccine and treatments, but demand has decreased, and several key products are losing patent protection soon [3] Group 2 - Pfizer is actively investing in its pipeline, which includes over 100 active programs, particularly in oncology, to counteract the loss of patent protection on major products [3] - The company has been receiving additional drug approvals and implementing cost-cutting measures to enhance profitability [3] - Pfizer offers a significant dividend yield of 7%, providing returns to investors while they await the benefits of the company's investments [4]
Here's What Key Metrics Tell Us About Pfizer (PFE) Q2 Earnings
ZACKS· 2025-08-05 14:32
Core Insights - Pfizer reported revenue of $14.65 billion for the quarter ended June 2025, reflecting a 10.3% increase year-over-year and a surprise of +6.35% over the Zacks Consensus Estimate of $13.78 billion [1] - The earnings per share (EPS) for the quarter was $0.78, which is an increase from $0.60 in the same quarter last year, resulting in an EPS surprise of +34.48% compared to the consensus estimate of $0.58 [1] Revenue Performance by Segment - Oncology revenue from Elrexfio was $50 million, exceeding the average estimate of $34.33 million [4] - Primary Care revenue from Comirnaty in the United States was $176 million, significantly higher than the average estimate of $62.19 million [4] - Primary Care revenue from the Prevnar family internationally was $523 million, slightly below the estimate of $536.11 million, representing a -0.8% change year-over-year [4] - Primary Care revenue from the Prevnar family in the United States was $860 million, surpassing the estimate of $826.39 million, with a year-over-year increase of +3.4% [4] - Oncology revenue from Ibrance worldwide was $1.05 billion, matching the average estimate, but showing a -7.2% year-over-year decline [4] - Specialty Care revenue from Xeljanz worldwide was $322 million, exceeding the estimate of $219.35 million, with a +6.3% year-over-year increase [4] - Specialty Care revenue from Inflectra worldwide was $139 million, surpassing the estimate of $101.04 million, reflecting a +43.3% change year-over-year [4] - Oncology revenue from Xtandi worldwide was $566 million, exceeding the estimate of $528.19 million, with a +14.3% year-over-year increase [4] - Oncology revenue from Inlyta worldwide was $243 million, above the estimate of $205.85 million, but showing a -3.6% year-over-year decline [4] - Total Specialty Care revenue was $4.38 billion, exceeding the estimate of $4.19 billion, with a +7.2% year-over-year increase [4] - Total Primary Care revenue was $5.54 billion, surpassing the estimate of $5.11 billion, reflecting an +11.9% change year-over-year [4] - Primary Care revenue from the Prevnar family worldwide was $1.38 billion, slightly above the estimate of $1.36 billion, with a +1.8% year-over-year increase [4] Stock Performance - Pfizer's shares have returned -6.8% over the past month, contrasting with the Zacks S&P 500 composite's +1% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]
Stay Ahead of the Game With Pfizer (PFE) Q2 Earnings: Wall Street's Insights on Key Metrics
ZACKS· 2025-07-31 14:16
Analysts on Wall Street project that Pfizer (PFE) will announce quarterly earnings of $0.58 per share in its forthcoming report, representing a decline of 3.3% year over year. Revenues are projected to reach $13.78 billion, increasing 3.7% from the same quarter last year. The consensus EPS estimate for the quarter has been revised 0.2% lower over the last 30 days to the current level. This reflects how the analysts covering the stock have collectively reevaluated their initial estimates during this timefram ...
Why I Just Bought More of This Beaten-Down 7%-Yielding Dividend Stock
The Motley Fool· 2025-06-17 08:49
Group 1 - Pfizer's share price has declined over various time frames, but there is a belief that the negatives are fully reflected in the current valuation [1][2][4] - The company faces significant challenges, including a sharp decline in COVID-19 product sales, with Comirnaty generating $5.35 billion in 2022 compared to $37.8 billion in 2021 [2][3] - Pfizer is approaching a patent cliff, losing exclusivity for several blockbuster drugs by 2028, which poses a risk to future revenue [3][4] Group 2 - Despite the challenges, Wall Street analysts maintain a positive outlook, with an average 12-month price target indicating a 19% upside potential [5][6] - Pfizer's operational efficiencies are expected to yield $7.2 billion in net cost savings by the end of 2027, contributing to earnings growth [6][8] - The company has a robust pipeline with 108 programs, including 30 in late-stage development, and anticipates four regulatory decisions this year [7][8] Group 3 - Pfizer offers a forward dividend yield of 7%, providing an attractive return while investors wait for potential growth [10][11] - The company generates sufficient free cash flow to sustain its dividend, supported by cost-cutting initiatives and management's commitment to maintaining and growing the dividend [11]
1 Ultra-High-Yield Dividend Stock Down 57% to Buy Hand Over Fist
The Motley Fool· 2025-05-24 08:51
Core Viewpoint - Pfizer's stock has significantly declined, presenting a potential buying opportunity despite underlying challenges [2][3][7] Company Challenges - Pfizer's stock decline is primarily due to rapidly decreasing sales of COVID-19 products, compounded by vaccine skepticism and reduced pandemic concerns [3] - The company faced setbacks with product withdrawals, including the sickle cell disease therapy Oxbryta and the oral obesity drug danuglipron due to safety concerns [4] - Patent expirations for key drugs, such as Inlyta, Xeljanz, and Eliquis, are imminent, which could impact revenue [5] - Potential regulatory challenges from the Trump administration, including tariffs and international reference pricing, add to the uncertainty [6][12] Market Sentiment - Despite the challenges, there is a level of optimism among analysts, with 8 out of 25 rating Pfizer as a buy or strong buy, and an average 12-month price target indicating a 28% upside potential [7] - Pfizer's reliance on COVID-19 product sales has decreased, with these products accounting for less than 7.7% of total revenue in Q1 2025 [8] Growth Prospects - Pfizer is exploring patent term extensions and has several promising products in its pipeline that could offset revenue losses from expiring patents [9] - The company is actively seeking business development opportunities, including licensing agreements and potential acquisitions to enhance its product offerings [11] Financial Metrics - Pfizer's shares are trading at over 8 times forward earnings, with a low price-to-earnings-to-growth (PEG) ratio of 0.6, indicating attractive valuation relative to growth prospects [14] - The forward dividend yield stands at 7.47%, and despite a high payout ratio of 122.5%, Pfizer has sufficient free cash flow and anticipates $7.2 billion in cost savings by 2027 [15] Conclusion - Overall, Pfizer is positioned to navigate its challenges effectively, with a low stock price and high dividend yield suggesting solid total return potential [16][17]
Curious about Pfizer (PFE) Q1 Performance? Explore Wall Street Estimates for Key Metrics
ZACKS· 2025-04-24 14:20
Core Viewpoint - Pfizer is expected to report quarterly earnings of $0.64 per share, reflecting a 22% decline year-over-year, with revenues projected at $13.88 billion, a decrease of 6.7% compared to the previous year [1]. Earnings Estimates - Analysts have not revised the consensus EPS estimate for the quarter in the past 30 days, indicating a stable outlook among analysts [1]. - Changes in earnings estimates are crucial for predicting investor reactions to the stock [2]. Revenue Projections - Analysts estimate 'Revenues- Oncology- Ibrance- Worldwide' at $898.97 million, down 14.7% from the prior year [4]. - 'Revenue- Specialty Care- Cibinqo' is projected to reach $71.20 million, an increase of 69.5% year-over-year [4]. - 'Revenues- Specialty Care- Xeljanz- Worldwide' is expected to be $141.92 million, down 26.9% from the previous year [5]. - 'Revenues- Oncology- Inlyta- Worldwide' is estimated at $207.30 million, indicating a 12.5% decline year-over-year [5]. Regional Revenue Insights - 'Revenues- Oncology- Ibrance- United States' is projected at $565.50 million, down 16.7% from the year-ago quarter [6]. - 'Revenues- Specialty Care- Xeljanz- Total International' is expected to be $101.82 million, reflecting a 15.2% decrease [6]. - 'Revenues- Oncology- Ibrance- Total International' is estimated at $333.47 million, down 11.1% year-over-year [7]. - 'Revenues- Specialty Care- Xeljanz- United States' is projected to be $40.10 million, indicating a significant decline of 45.8% [7]. Additional Revenue Metrics - 'Revenues- Oncology- Inlyta- Total International' is expected to reach $91.42 million, down 4.8% year-over-year [8]. - 'Revenues- Oncology- Inlyta- United States' is projected at $115.88 million, reflecting a 17.8% decline [8]. - 'Revenue- Primary Care- Prevnar family- United States' is estimated at $1.14 billion, a slight decrease of 0.4% from the prior year [9]. - 'Revenue- Primary Care- Prevnar family- Total International' is projected to be $550.39 million, indicating a year-over-year increase of 1.6% [9]. Stock Performance - Over the past month, Pfizer shares have returned -11.2%, compared to the Zacks S&P 500 composite's -5.1% [9]. - Pfizer currently holds a Zacks Rank 2 (Buy), suggesting potential outperformance in the near future [10].