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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]
Will These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?
ZACKS· 2025-07-28 15:31
Industry Overview - The second-quarter 2025 reporting cycle for the Medical sector is commencing, with most firms expected to release earnings results in the next two weeks, primarily consisting of pharma/biotech and medical device companies [1] - The earnings season for the drug and biotech sector began in mid-July, highlighted by Johnson & Johnson's strong performance, which exceeded earnings and sales estimates, leading to raised revenue and earnings expectations for the year [1] Company Performance - Novartis surpassed second-quarter earnings and revenue estimates, driven by a year-over-year increase in sales of key drugs, prompting an upward revision of its annual guidance for core operating income [2] - Roche experienced solid growth in the first half of 2025, with high demand for key drugs offsetting declines in legacy drug sales [2] - As of July 23, 15% of companies in the Medical sector, representing 27.2% of the sector's market capitalization, reported quarterly earnings, with 88.9% outperforming earnings estimates and 100% beating revenue estimates [3] - Overall, second-quarter earnings for the Medical sector are projected to increase by 0.9%, while sales are expected to rise by 7.9% compared to the previous year [3] Upcoming Earnings Reports - Merck, AstraZeneca, Bristol Myers, AbbVie, and Moderna are scheduled to release their quarterly results this week [4] - Merck has a strong earnings track record, beating estimates in the last four quarters with an average surprise of 3.82% [5] - AstraZeneca has a mixed earnings history, beating estimates in three of the last four quarters, with an average surprise of 4.24% [8] - Bristol Myers has consistently beaten earnings estimates, with an average surprise of 20.16% over the last four quarters [11] - AbbVie has also maintained a strong track record, beating estimates in the last four quarters with an average surprise of 2.55% [13] - Moderna has an excellent earnings history, with an average surprise of 31.60% in the last four quarters [15] Sales Drivers - Merck's growth in the second quarter is likely attributed to increased sales of its cancer drug Keytruda, driven by additional indications and patient demand [7] - AstraZeneca's sales are expected to be bolstered by strong demand for its cancer and diabetes medications [10] - Bristol Myers' revenue may be impacted by declines in legacy drug sales, but growth products are expected to partially offset this decline [12] - AbbVie's revenue is anticipated to be driven by strong sales of key drugs and contributions from newer products [14] - Moderna's revenues are expected to be influenced by sales of its COVID-19 vaccine, Spikevax, while the focus is shifting to updates on its broader pipeline [16]
Should You Buy, Hold, or Sell BMY Stock Ahead of Q2 Earnings?
ZACKS· 2025-07-28 14:31
Core Viewpoint - Bristol-Myers Squibb Company (BMY) is set to report its second-quarter 2025 results on July 31, with sales and earnings estimates at $11.38 billion and $1.18 per share, respectively. However, earnings estimates for 2025 and 2026 have seen a decline over the past month [1][5]. Financial Estimates - The current earnings estimate for Q2 2025 is $1.18, down from $1.55 30 days ago, reflecting a decrease of 29.34%. The earnings estimates for 2025 and 2026 have also decreased to $6.37 and $6.03, respectively [2][5]. - BMY has a strong earnings surprise history, beating estimates in the last four quarters with an average surprise of 20.16% [2]. Factors Influencing Q2 Results - Total quarterly revenues are expected to be negatively impacted by declining sales from the legacy portfolio, which includes drugs like Eliquis, Revlimid, and Pomalyst, primarily due to generic competition [4][5]. - Sales for Pomalyst are estimated at $727 million, while Eliquis is projected to generate $3.5 billion in sales [6][7]. Growth Portfolio Performance - The growth portfolio, which includes drugs like Opdivo, Reblozyl, and Camzyos, is expected to partially offset the decline in legacy drug sales. Opdivo sales are estimated at $2.4 billion, while Reblozyl is projected at $546 million [8][10][11]. - New drug Cobenfy for schizophrenia has shown promising sales growth, indicating a positive start for the newly launched product [12][18]. Strategic Initiatives - BMY has announced cost-cutting plans aiming to save $1.5 billion by 2025 and an additional $2 billion annually by 2027, which are expected to improve profitability [5][14]. - The company has entered a strategic collaboration with BioNTech for the co-development of a bispecific antibody, BNT327, which targets solid tumors [19][22]. Stock Performance and Valuation - BMY shares have declined by 14.4% year-to-date, underperforming the industry and the S&P 500 [16]. - The stock currently trades at a price/earnings ratio of 7.84x forward earnings, lower than its historical mean and the large-cap pharma industry average [20].
Is Bristol-Myers Squibb Still An Undervalued Biopharma Play?
Benzinga· 2025-07-14 17:52
Core Viewpoint - Bristol-Myers Squibb is preparing to announce its Q2 2025 earnings, with expectations of adjusted earnings of $1.585 per share and sales of $11.31 billion, despite slight downward revisions in revenue and earnings estimates for 2025 [1][2]. Financial Performance - The company anticipates a low-single-digit percentage increase in total revenue for the later 2020s, primarily due to updated assumptions for its cancer drug Yervoy [2][4]. - Bank of America Securities has revised the company's earnings model, showing a decline of more than 1% in total revenue and EPS for Q2, with similar trends for 2025 [3][4]. Product Performance and Market Dynamics - Key products such as Pomalyst, Revlimid, Camzyos, and Orencia are expected to face significant headwinds due to U.S. drug pricing reforms [5]. - The earnings call will focus on the commercial performance of products like Cobenfy, Camzyos, Reblozyl, and Breyanzi, which are crucial for immediate revenue streams [7][8]. Industry Challenges - The evolving landscape of U.S. drug pricing policies, including the 'most favored nation' rule and potential pharma-specific tariffs, poses systemic pressures on the pharmaceutical industry, affecting Bristol-Myers Squibb [6]. - The company is expected to face several challenging years ahead, with anticipated earnings declines driven by generic competition [10]. Valuation Insights - Bristol-Myers Squibb is considered one of the cheaper companies in large-cap biopharma, with a price-to-earnings ratio of 7 to 8 times expected 2025 earnings, comparable to peers like Pfizer, GSK, Biogen, and Merck [9].
Will Recent Label Expansions of Opdivo Help BMY Gain Momentum?
ZACKS· 2025-07-09 14:20
Core Insights - Bristol Myers' growth portfolio includes key drugs such as Opdivo, Orencia, Yervoy, and others, with Opdivo being the top revenue generator [1][2] Drug Performance - Opdivo generated $2.26 billion in sales in Q1 2025, representing 20% of total revenues, driven by demand in various cancer indications [2][10] - The European Commission approved the subcutaneous formulation of Opdivo for multiple solid tumor indications, expanding its label [3] - The FDA approved the combination of Opdivo and Yervoy as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC) [4] - The FDA also approved the Opdivo combination for microsatellite instability-high or mismatch repair deficient colorectal cancer in adult and pediatric patients [5] Competitive Landscape - Bristol Myers faces significant competition in the oncology space from major pharmaceutical companies like Merck and Roche [6] - Merck's Keytruda accounts for approximately 50% of its pharmaceutical sales and is a leading drug in the immuno-oncology market [7] - Roche's Tecentriq is also a key player, with ongoing and planned studies across various cancer types [8] Financial Performance - Bristol Myers' shares have declined by 13.9% year to date, compared to a 2.1% decline in the industry [9][10] - The company trades at a forward price/earnings ratio of 7.37x, lower than its historical mean of 8.53x and the large-cap pharma industry's average of 14.93x [11] - The bottom-line estimate for 2025 has decreased to $6.76 from $6.89 over the past 60 days [13]