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Bristol Myers' New Treatments Drive Q3 Beat — And The Company's Raising Its Outlook
Benzinga· 2025-10-30 18:55
Core Insights - Bristol Myers Squibb Co. reported Q3 2025 revenues of $12.22 billion, exceeding consensus estimates of $11.81 billion, marking a 3% year-over-year increase [1] Revenue Breakdown - Growth Portfolio revenues reached $6.9 billion, an 18% increase, or 17% when excluding foreign exchange effects, driven by the immuno-oncology portfolio, Reblozyl, Camzyos, and Breyanzi [1] - Legacy Portfolio revenues declined to $5.4 billion, a 12% decrease, or 13% Ex-FX, with Eliquis sales increasing to $3.75 billion, up 25%, but this was offset by the impact of generics on the rest of the Legacy Portfolio [2] Product Performance - Sales of Opdivo increased by 7% to $2.53 billion, while Orencia generated $964 million, up 3%. Yervoy sales rose 15% to $739 million, and Reblozyl saw a 37% increase to $615 million [3] Financial Metrics - Adjusted earnings per share were reported at $1.63, surpassing the consensus of $1.51 [3] - Gross margin on a GAAP basis was 71.9%, and on a non-GAAP basis, it was 72.9%, down from 75.1% and 76.0% respectively from the previous year, indicating a change in product mix [4] Guidance and Market Reaction - The company narrowed its fiscal 2025 earnings guidance to $6.40-$6.60, compared to the consensus of $6.38, and raised its sales guidance to $47.5 billion-$48 billion, above the consensus of $47.33 billion, reflecting strong Growth Portfolio performance [5] - Following the earnings report, Bristol-Myers Squibb shares rose by 4.40% to $44.47 [5]
What's in Store for These 5 Pharma Bigwigs This Earnings Season?
ZACKS· 2025-10-27 16:06
Core Insights - The third-quarter 2025 reporting cycle for the Medical sector is commencing, with major firms expected to release earnings results in the coming weeks, particularly in pharma/biotech and medical devices [1] - Johnson & Johnson has set a positive tone for the earnings season by exceeding estimates and raising its sales expectations for 2025 [1] - Roche has reported solid growth in the first nine months of 2025, driven by high demand for key drugs, leading to an upward revision of its earnings per share growth expectations for 2025 [2] Earnings Trends - As of October 22, 13.3% of Medical sector companies, representing 26.8% of the sector's market capitalization, have reported earnings, with 87.5% exceeding earnings estimates and the same percentage surpassing revenue expectations [3] - Year-over-year earnings increased by 7.4%, while revenues rose by 9.8%. However, third-quarter earnings for the Medical sector are projected to decrease by 4.3%, with sales expected to rise by 8.1% compared to the previous year [3] Company Performance Expectations - Eli Lilly is expected to report strong results driven by demand for GLP-1 drugs and other oncology and immunology products, with a consensus estimate of $16.01 billion in sales and $6.02 per share in earnings [7][8] - Merck is anticipated to see growth from its cancer drug Keytruda, with estimates of $17.06 billion in sales and $2.36 per share in earnings [12] - AbbVie is projected to benefit from sales of Rinvoq, Skyrizi, and newer drugs, with estimates of $15.59 billion in sales and $1.80 per share in earnings [13][14] - Bristol Myers is expected to report revenues influenced by growth portfolio sales, with estimates of $11.83 billion in sales and $1.51 per share in earnings [15][16] - Gilead Sciences is likely to see revenue support from its HIV therapies, with estimates of $7.46 billion in sales and $2.15 per share in earnings, although impacted by changes in Medicare Part D [19][20]
REPL Stock Plunges 54% in 3 Months After FDA Rejects Skin Cancer Drug
ZACKS· 2025-09-24 16:11
Core Insights - Replimune Group's share price has decreased by 54.2% over the past three months following the FDA's complete response letter (CRL) regarding its biologics license application (BLA) for RP1 in combination with Opdivo for advanced melanoma treatment [1][5] - The FDA's CRL was based on the inadequacy of data from the IGNYTE study, which did not meet the standards for a well-controlled clinical investigation, although no safety concerns were raised [2][5] - The setback has created significant uncertainty regarding the regulatory path for RP1, delaying Replimune's prospects of launching its first approved product and establishing a revenue stream [3][4] Company Developments - Replimune has completed a Type A meeting with the FDA to discuss the CRL and is currently reviewing the agency's feedback to determine next steps, although a clear regulatory path remains uncertain [6][7] - The BLA for RP1 in combination with Opdivo was initially accepted for review under the FDA's Priority Review pathway in January 2025, based on the IGNYTE study's primary analysis data [8] - Replimune is also exploring RP1 for other indications, including non-melanoma skin cancers and as a monotherapy for solid organ transplant recipients with skin cancers [11] Market Context - Year-to-date, Replimune's shares have fallen by 64.2%, contrasting with a 3.6% growth in the broader industry [4] - The company is facing challenges in delivering on its lead program, which has raised broader investor concerns about its future performance [3]
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]
Option Care Health (OPCH) 2025 Conference Transcript
2025-05-13 16:00
Summary of Option Care Health (OPCH) Conference Call Company Overview - **Company**: Option Care Health (OPCH) - **Industry**: Home Infusion Services - **Event**: 2025 Conference on May 13, 2025 Key Points Strong Performance and Growth Expectations - The company reported a strong first quarter, exceeding internal performance measures despite challenges such as bag shortages and competitive exits [2][3] - Excluding the impact of Stelara, the company anticipates approximately 20% EBITDA growth for the year [4][6] Drivers of Growth - Growth is expected to come from acute therapies and capitalizing on competitive exits in the market [6][7] - The company is seeing growth not only in exit markets but also in other areas due to reliable partnerships with hospitals and health systems [7][8] - The focus on high-quality care at lower costs positions the company favorably with payers, especially in managing total care costs [9][10] Managed Care Relationships - The company is actively engaging with managed care plans to facilitate patient transitions from higher-cost inpatient settings to home or infusion suites [9][10] - There is an increasing interest from payers in utilizing home infusion services to manage costs effectively [13] Investment in Infrastructure - Annual capital expenditures range from $30 million to $40 million, focusing on expanding pharmacy infrastructure and infusion suite capabilities [15][16] - The company operates over 750 infusion chairs across the U.S. and is investing in advanced care practitioner models to manage more complex patients [16][17] Therapeutic Focus - The company is expanding into areas such as oncology and complex conditions like Alzheimer's, leveraging advanced practitioner models [19][20] - There is a focus on rare and orphan products, with ongoing efforts to partner with manufacturers for new product launches [24][25] Biosimilars and Market Dynamics - The company is preparing for the impact of biosimilars entering the market, particularly concerning Stelara, but emphasizes that most patients served require intravenous administration rather than self-injection [27][28] - The company retains a majority of its Stelara patients, and while profitability is affected, it remains a viable therapy [29] Executive Order and Drug Pricing - The recent executive order aimed at reducing drug costs presents uncertainties, but the company is monitoring its potential impacts on pricing and reimbursement [36][37] - The company operates with a diverse pricing strategy, with less than 50% of revenue tied to contracts based on average selling price (ASP) [38][39] Free Cash Flow and Capital Deployment - The company generated over $250 million in free cash flow last year and expects to maintain similar levels this year [49][50] - Capital deployment strategies include mergers and acquisitions, as well as share repurchases, with significant investments made in both areas recently [51][52] Conclusion - Option Care Health is well-positioned for continued growth through strategic investments, strong managed care relationships, and a focus on high-quality, cost-effective care solutions. The company is actively navigating market dynamics, including the introduction of biosimilars and regulatory changes, while maintaining a robust capital deployment strategy.
BMY Beats on Q1 Earnings and Sales, Raises 2025 Outlook
ZACKS· 2025-04-24 16:55
Core Viewpoint - Bristol-Myers Squibb Company (BMY) reported strong first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.80, exceeding expectations, despite a decline in overall revenues due to legacy portfolio sales [1][20]. Financial Performance - Adjusted EPS of $1.80 beat the Zacks Consensus Estimate of $1.51 and improved from an adjusted loss of $4.40 in the same quarter last year [1]. - Total revenues reached $11.2 billion, surpassing the Zacks Consensus Estimate of $10.7 billion, although down 6% from the previous year [1]. - U.S. revenues decreased 7% to $7.9 billion, while international revenues fell 2% year over year to $3.3 billion [3]. Growth Portfolio - Revenues from the Growth Portfolio amounted to $5.6 billion, reflecting a 16% increase year over year, driven by strong demand for key drugs [4]. - Notable sales growth was observed in Opdivo ($2.26 billion, up 9%), Reblozyl ($478 million, up 35%), and Breyanzi ($263 million, up 146%) [5][6][7]. - The Growth Portfolio's performance was bolstered by higher demand for Opdivo, Reblozyl, Breyanzi, Camzyos, Yervoy, and Opdualag [4]. Legacy Portfolio - Revenues from the Legacy Portfolio declined 20% to $5.64 billion, primarily due to generic competition affecting drugs like Revlimid and Pomalyst [10]. - Eliquis sales were $3.56 billion, down 4%, but exceeded expectations [10]. - Revlimid revenues plummeted 44% to $936 million, while Pomalyst and Sprycel also saw significant declines [12]. Cost Management - Gross margin decreased to 73.1% from 75.5% in the previous year, attributed to product mix changes [13]. - Adjusted R&D expenses decreased 5% to $2.2 billion, and adjusted marketing, selling, and administrative expenses fell 20% to $1.6 billion due to cost-cutting initiatives [13]. Guidance Update - The company raised its annual revenue guidance to $45.8-$46.8 billion, up from $45.5 billion, reflecting strong Growth Portfolio performance and favorable foreign exchange impacts [17]. - Adjusted EPS guidance was also increased to a range of $6.70-$7, compared to the previous guidance of $6.55-$6.85 [18]. Pipeline Developments - The FDA approved Opdivo plus Yervoy as a first-line treatment for unresectable or metastatic hepatocellular carcinoma [16]. - Updates on Camzyos and Cobenfy indicated some challenges in clinical trials, with the latter not meeting statistical significance for its primary endpoint [15].