Cullen Capital Management, LLC, operating under the name Schafer Cullen Capital Management, Inc. (SCCM), has released its “SCCM Value Equity Strategy” third-quarter investor letter. A copy of the letter can be downloaded here. The US equity market continued the rally in the third quarter, with the S&P 500 returning 8.1% and the Russell 1000 Value surging 5.3%. The value equity strategy returned 6.9% (gross of fees) and 6.8% (net of fees) in the quarter, while the Russell 1000 Value and S&P 500 returned 5.3% ...

Cytokinetics Conference Call Summary Company Overview - **Company**: Cytokinetics (NasdaqGS:CYTK) - **Focus**: Translating muscle biology into new pharmacology, particularly in specialty cardiology - **Pipeline**: Led by myosin modulators, with aficamten as the cornerstone, pending regulatory review for obstructive hypertrophic cardiomyopathy (OHCM) [1][2] Key Points Regulatory and Commercialization Plans - **PDUFA Date**: Aficamten has a PDUFA date set for December 26, 2025, with potential approvals in China expected in Q4 2025 and EMA approval anticipated early next year [1][2] - **Market Strategy**: Aficamten could be commercialized across three continents for OHCM, with plans for a supplemental NDA for non-obstructive hypertrophic cardiomyopathy (NHCM) by the end of 2026 [2][3] Clinical Data and Efficacy - **Clinical Trials**: The Sequoia study showed significant effects on clinical endpoints in OHCM patients, while the Maple study demonstrated aficamten's superiority over standard care [4][5] - **Market Potential**: The NHCM market is growing rapidly, and if the Acacia study yields positive results, Cytokinetics believes it could dominate this market [5][6] Financial Position - **Capital Structure**: Cytokinetics expects to end the year with over $1 billion, closer to $1.2 billion, providing a strong cash runway to support business ambitions [6] Differentiation and Market Adoption - **Differentiated Profile**: Aficamten is expected to have a differentiated risk mitigation profile, with advantages in dosing flexibility and reduced treatment interruptions compared to existing therapies [8][10] - **Current Prescribing Landscape**: Approximately 10,000 cardiologists treat HCM, with less than 20% currently using cardiac myosin inhibitors (CMIs) [11][12] - **Barriers to Adoption**: Administrative burdens associated with risk management programs (REMS) are seen as a key impediment to wider adoption of CMIs [11][12] Launch Expectations - **Launch Trajectory**: The launch is expected to be gradual, similar to previous products, with potential acceleration if Acacia data is positive [13][15] - **Metrics for Success**: Key metrics will include the number of prescribing physicians, new prescribers, and patients on therapy, with a focus on converting free drug patients to paid prescriptions [19][20] Market Dynamics - **Impact of Maple Study**: The Maple study is anticipated to influence prescribing behaviors and potentially expand the CMI market, with expectations for increased patient adds in 2026 and beyond [31][32] - **Guideline Recommendations**: The Maple data may lead to updated treatment guidelines, potentially elevating aficamten's position in treatment protocols [24][26] Strategic Positioning - **Value Creation**: Cytokinetics is focused on executing its strategy to build shareholder value, with a strong pipeline and competitive positioning in the market [43][44] - **Increased Urgency in Biotech**: There is a noted increase in urgency and competition for valuable assets in the biotech space, which may benefit Cytokinetics in potential partnerships or acquisitions [44][45] Conclusion Cytokinetics is poised for significant developments in the specialty cardiology market with aficamten, supported by strong clinical data and a solid financial position. The company is navigating regulatory pathways and preparing for a strategic launch while addressing barriers to adoption and aiming for a differentiated market presence.

Core Insights - Bristol Myers Squibb's growth portfolio performed strongly in Q3 2025, offsetting declines in legacy drug sales [1][8] - The growth portfolio includes key drugs such as Opdivo, Reblozyl, and Breyanzi, contributing significantly to revenue [1][4] Growth Portfolio Performance - Opdivo remains the top revenue generator, with strong sales driven by its launch in MSI-high colorectal cancer and growth in first-line non-small cell lung cancer in the U.S. [2] - Opdivo Qvantig's approval for subcutaneous use has enhanced the immuno-oncology portfolio, with projected global sales growth in the high single-digit to low double-digit range [3] - Reblozyl is annualizing over $2 billion in sales, driven by demand in various treatment settings [4] - Breyanzi sales have surpassed $1 billion, reflecting strong growth in large B-cell lymphoma [4] - Camzyos sales are increasing due to robust demand, and Cobenfy has shown encouraging initial uptake with $105 million in sales year to date [5] Competitive Landscape - The immuno-oncology market is competitive, with Merck's Keytruda dominating and accounting for around 50% of Merck's pharmaceutical sales [6] - Pfizer is also a significant player in oncology, with a diverse product portfolio including antibody-drug conjugates and biosimilars [7] Financial Performance and Valuation - Bristol Myers' shares have declined by 13.2% year to date, contrasting with the industry's growth of 15.9% [10] - The company is trading at a price/earnings ratio of 8.07x forward earnings, lower than its historical mean and the large-cap pharma industry's average of 16.42x [12] - The Zacks Consensus Estimate for 2025 earnings per share has remained unchanged, while estimates for 2026 have decreased [13]

Core Insights - Bristol Myers Squibb (BMY) has seen a 7.2% increase in stock price over the past month, outperforming the industry growth of 3.8% and the S&P 500 Index [1][2][8] - The company's strong performance is attributed to better-than-expected Q3 results driven by increased demand for key drugs such as Opdivo, Breyanzi, Reblozyl, and Camzyos, leading to an upward revision in revenue guidance [3][8] - Despite recent gains, BMY's year-to-date stock performance has been disappointing, with a decline from a 52-week high of $63.33 in March to a low of $42.52 in late October [4] Financial Performance - BMY's Growth Portfolio, which includes drugs like Opdivo and Reblozyl, reported an 18% year-over-year sales increase, totaling $6.9 billion [5] - Opdivo sales in the U.S. are driven by strong launches in specific cancer indications, while global sales are expected to grow in the high single-digit to low double-digit range [6][8] - The thalassemia drug Reblozyl has annualized sales exceeding $2 billion, and Breyanzi's sales are also strong, exceeding $1 billion annually [9][10] Drug Approvals and Pipeline - BMY's recent approval of Opdivo Qvantig for subcutaneous use has enhanced its immuno-oncology portfolio, with strong initial uptake [6] - The company has also launched Cobenfy, a new treatment for schizophrenia, which has generated $105 million in sales year-to-date and is expected to contribute significantly to revenue in the future [10][11] Legacy Portfolio and Challenges - The Legacy Portfolio continues to decline, with a 12% decrease in sales to $5.4 billion, primarily due to generic competition affecting drugs like Revlimid and Pomalyst [12] - BMY anticipates a further decline of approximately 15% to 17% in the Legacy Portfolio by 2025 [13] Strategic Collaborations and Acquisitions - BMY announced the acquisition of Orbital Therapeutics for $1.5 billion, which will add a promising RNA immunotherapy candidate to its pipeline [14][15] - The company has also partnered with BioNTech for the co-development of a bispecific antibody targeting cancer, indicating a focus on innovative treatment approaches [16][17] Valuation and Estimates - BMY's current price/earnings ratio stands at 7.67x, below its historical mean and the large-cap pharma industry's average of 15.57x, suggesting it may be undervalued [18] - The Zacks Consensus Estimate for 2025 EPS has slightly decreased to $6.48 from $6.51 over the past month [20] Investment Outlook - BMY's strong performance in the first nine months of 2025, driven by key drugs, positions it as a relatively safe investment in the biotech sector [22] - The company offers an attractive dividend yield of 5.31%, which may appeal to existing investors [22]

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]

Alnylam Pharmaceuticals - Alnylam's market worth exceeded many large-cap drugmakers, indicating a challenging position due to high expectations from investors [1] - The company reported quarterly revenues of approximately $1.25 billion, surpassing analyst estimates by nearly $300 million, and boosted its financial forecasts [4] - Amvuttra generated $685 million in sales, exceeding the expected $622 million, indicating growing demand among patients with transthyretin amyloidosis [4] - Despite strong earnings, Alnylam shares fell nearly 7%, attributed to high share prices and elevated investor expectations [3] Biogen - Biogen's latest earnings report showed revenues just above $2.5 billion, narrowly exceeding Wall Street expectations [7] - The company’s aging multiple sclerosis drugs accounted for about 40% of total revenue, while new product launches showed muted performance [8] - Biogen revised its revenue forecast for the year to flat to up 1%, but lowered annual earnings per share estimates to $14.50 to $15 [9] Neurocrine Biosciences - Neurocrine reported a 28% year-over-year increase in net sales, totaling $785 million, but shares fell by 9% following the announcement [11] - The company plans to invest an additional $150 million in expanding sales teams, raising concerns about future margins [12] - Neurocrine received a civil investigative demand from the DOJ regarding Ingrezza, which may have unsettled investors despite a solid quarterly performance [13][14] Bristol Myers Squibb - Bristol Myers' earnings report was positive overall, but the performance of its schizophrenia drug Cobenfy was seen as underwhelming compared to other products [15][16] - Cobenfy sales reached $43 million in the third quarter, with ongoing trials testing its efficacy in treating Alzheimer's-related psychosis [18] - Despite uncertainties surrounding Cobenfy, Bristol Myers' shares rose 7% due to improved financial guidance and quarterly revenue performance [20]

Core Insights - Bristol-Myers Squibb Company (BMY) reported third-quarter 2025 adjusted earnings per share (EPS) of $1.63, exceeding the Zacks Consensus Estimate of $1.48, but down from $1.80 in the same quarter last year [1] - Total revenues reached $12.2 billion, surpassing the Zacks Consensus Estimate of $11.8 billion, and reflecting a 3% increase year-over-year [1] - The stock price increased following the release of these better-than-expected quarterly results [1] Revenue Breakdown - U.S. revenues increased by 1% to $8.3 billion, while international revenues rose by 6% year-over-year to $3.9 billion [3] - Revenues from the Growth Portfolio totaled $6.9 billion, marking an 18% year-over-year increase, driven by the immuno-oncology portfolio and drugs like Reblozyl, Camzyos, and Breyanzi [4] - Sales of the immuno-oncology drug Opdivo increased by 7% year-over-year to $2.5 billion, surpassing estimates [5] - Other notable sales included Yervoy at $739 million (up 15%), Reblozyl at $615 million (up 37%), and Breyanzi at $359 million (up 60%) [6][9] Legacy Portfolio Performance - The Legacy Portfolio saw a 12% decline in revenues to $5.4 billion, primarily due to generic competition affecting drugs like Revlimid and Pomalyst [11] - Eliquis, however, surged by 25% to $3.7 billion, making it the top revenue generator for BMY [11] Cost and Margin Analysis - Gross margin decreased to 72.9% from 76% year-over-year due to product mix changes [14] - Adjusted R&D expenses rose by 3% to $2.4 billion, while adjusted marketing and administrative expenses decreased by 10% to $1.8 billion [14] Guidance and Future Outlook - BMY raised its annual revenue guidance to $47.5-$48 billion from $46.5-$47.5 billion, reflecting strong Growth Portfolio performance [15] - Adjusted earnings guidance was updated to a range of $6.40-$6.60, slightly lower than previous estimates due to an unfavorable impact from acquired charges [15][16] Pipeline and Acquisitions - The FDA accepted a supplemental biologics license application for Breyanzi, with a target action date set for December 5, 2025 [17] - BMY announced the acquisition of Orbital Therapeutics for $1.5 billion, which will enhance its pipeline with OTX-201, a next-generation CAR T-cell therapy [19][20] Strategic Initiatives - BMY's strategic productivity initiatives are positively impacting the bottom line, while ongoing collaborations, such as with BioNTech for bispecific antibodies, are expected to broaden its pipeline [21][22]

Core Insights - Merck's third-quarter performance exceeded expectations, but challenges with Gardasil and a mixed sales outlook led to a 2.4% decline in stock price [2][10] - Bristol Myers Squibb also reported strong results, raising its full-year sales outlook, while investors are focused on upcoming clinical trial results [2][11] Merck Performance - Merck reported $17.28 billion in sales, a 4% increase, surpassing forecasts of $16.97 billion [7] - Adjusted earnings were $2.58 per share, exceeding expectations of $2.35, with a 64% year-over-year increase [7] - Keytruda, Merck's leading cancer treatment, generated $8.14 billion in sales, a 10% increase, but fell short of the expected $8.2 billion [8] - Sales of Januvia, a diabetes drug, rose 29% to $624 million, significantly exceeding forecasts of $531 million [9] - Merck's sales guidance for the year is now $64.5 billion to $65 billion, slightly narrowed from previous guidance [9][10] New Drug Developments - Winrevair, a new drug for pulmonary arterial hypertension, saw sales of $360 million, a 141% increase, although it missed the $380 million expectation [4][5] - The patient base for Winrevair is growing, with potential market expansion into other forms of pulmonary hypertension [5] Bristol Myers Squibb Performance - Bristol Myers reported adjusted earnings of $1.63 per share and $12.22 billion in sales, both exceeding expectations [11] - Sales growth was driven by its growth portfolio, which increased 18% year-over-year to $6.9 billion [12] - The company raised its full-year sales outlook to $47.5 billion to $48 billion, up from a previous estimate [14]

Financial Data and Key Metrics Changes - Total company sales for Q3 2025 were approximately $12.2 billion, reflecting strong demand across the business [17] - The growth portfolio saw a 17% year-over-year increase in sales, driven by multiple products including the IO portfolio, Reblozyl, Camzyos, and Breyanzi [6][17] - Gross margin was approximately 73%, primarily due to product mix, with operating expenses decreasing by approximately $100 million to roughly $4.2 billion compared to the same period last year [22] Business Line Data and Key Metrics Changes - Opdivo global sales were approximately $2.5 billion, up 6%, driven by demand in the U.S. and expanded indications [17] - Reblozyl global sales were $615 million, reflecting a 38% increase in the U.S. and a 31% increase outside the U.S. [18][19] - Breyanzi sales were $359 million, growing 58% globally, with U.S. sales up 45% [19] - Camzyos global sales increased 88% to $296 million, with U.S. sales up 76% [20] - Eliquis global sales were $3.7 billion, growing 23%, with U.S. sales up 29% [21] Market Data and Key Metrics Changes - The U.S. market showed strong growth across multiple brands, with significant contributions from the oncology and hematology segments [17][18] - Outside the U.S., sales growth was driven by demand in newly launched markets, particularly for Reblozyl and Breyanzi [19] Company Strategy and Development Direction - The company is focused on long-term sustainable growth, with a strategy to enhance its growth portfolio and align its cost structure with business needs [6][15] - Recent acquisitions, such as Orbital Therapeutics, aim to strengthen the cell therapy franchise and expand the company's capabilities in RNA technology [10][11] - The company anticipates introducing 10 new medicines to the market by the end of the decade, alongside 30 significant life cycle management opportunities [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth portfolio's performance and the ability to navigate through the operating environment, emphasizing financial discipline and strategic investments [15][24] - The company is optimistic about the upcoming data readouts and the potential for new product launches to drive future growth [14][24] Other Important Information - The company is maintaining its full-year revenue guidance, increasing it by $750 million to a range of $47.5 billion to $48 billion [24] - The effective tax rate for the quarter was 22.3%, reflecting the earnings mix [22] Q&A Session Summary Question: Updates on ADEPT program and confidence in studies - Management reiterated confidence in the Cabenfi development program, with ongoing studies and expected results by the end of the year [31][32] Question: Commercialization of Cabenfi and prescriber engagement - The company is pleased with Cabenfi's progress, noting positive physician feedback and a growing number of new trialists [40][41] Question: Competitive landscape for PD-1/VEGF bispecifics - Management expressed confidence in the partnership with BioNTech and the potential of pomitomig to become a new standard of care [50][51] Question: Barriers to adoption for Cabenfi - Management acknowledged the entrenched market dynamics but highlighted positive feedback from physicians and ongoing efforts to educate prescribers [58][59] Question: Cost management and strategic productivity initiatives - The company is on track for $1 billion in cost savings this year and is focused on balancing investments for growth while maintaining financial discipline [66][69]

Financial Data and Key Metrics Changes - Total company sales for Q3 2025 were approximately $12.2 billion, reflecting strong demand across the business, with a 17% year-over-year increase in the growth portfolio [15][4] - Gross margin was approximately 73%, primarily due to product mix, and operating expenses decreased by approximately $100 million to roughly $4.2 billion compared to the same period last year [19][20] - The company generated cash flow from operations of about $6.3 billion in Q3, with nearly $17 billion in cash, cash equivalents, and marketable securities as of September 30 [20][21] Business Line Data and Key Metrics Changes - The oncology portfolio saw Opdivo global sales of approximately $2.5 billion, up 6%, driven by demand in various indications [15][16] - Reblozyl global sales were $615 million, reflecting a 38% increase in the U.S. and a 31% increase outside the U.S. [17] - Breyanzi sales grew 58% globally to $359 million, with U.S. sales up 45% [17] - Camzyos global sales increased 88% to $296 million, while Eliquis global sales were $3.7 billion, growing 23% [18] Market Data and Key Metrics Changes - The U.S. market saw strong growth in multiple brands, with Opdivo and Qvantig both contributing positively to sales [15][16] - Outside the U.S., sales growth was driven by demand in newly launched markets, particularly for Reblozyl and Breyanzi [17] Company Strategy and Development Direction - The company is focused on long-term sustainable growth, with a strategy to enhance and sustain growth through a robust pipeline and business development activities [4][12] - Recent acquisitions, such as Orbital Therapeutics, aim to strengthen the cell therapy franchise and expand the company's capabilities in RNA technology [9][10] - The company anticipates introducing 10 new medicines to the market by the end of the decade, alongside 30 significant life cycle management opportunities [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate through the current operating environment, emphasizing strong execution and financial discipline [14][22] - The company is optimistic about the potential of its pipeline, particularly in addressing unmet medical needs in various therapeutic areas [8][12] Other Important Information - The company is maintaining its full-year revenue guidance, increasing it by $750 million to a range of $47.5 billion to $48 billion, while expecting a decline in the legacy portfolio [22][23] - The effective tax rate for the quarter was 22.3%, and diluted earnings per share were reported at $1.63 [19][20] Q&A Session Summary Question: Updates on clinical site reviews and ADEPT program confidence - Management reiterated confidence in the Cabenfi development program, with ongoing studies and positive external data supporting their outlook [36][37] Question: Commercial characterization of Cabenfi's reimbursement speed - The company is pleased with Cabenfi's progress, noting strong physician feedback and access, while acknowledging the need for continued education and expansion of prescribing [51][52] Question: Competitive landscape for PD-1/VEGF bispecifics - Management expressed confidence in the partnership with BioNTech and the potential of pomitomig to become a new standard of care, with ongoing trials across multiple indications [66][67] Question: Barriers to adoption for Cabenfi - Feedback from physicians has been positive, with ongoing efforts to educate on switching from D2 blockers to Cabenfi, and the company is tracking ahead of recently launched D2s in schizophrenia [72][75] Question: Cost management and strategic productivity initiatives - The company is on track for $1 billion in cost savings this year, with a clear line of sight to $2 billion by 2027, while balancing investments in growth and maintaining financial discipline [86][87]