Opdivo Qvantig
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Merck vs. Bristol Myers: Which Pharma Stock Is a Better Pick in 2026?
ZACKS· 2026-02-20 18:06
Key Takeaways Bristol Myers emerges as the stronger near-term pick over Merck.BMY's new drugs, label expansions and $2B cost-savings plan support 2026 margins.MRK faces Gardasil weakness, Keytruda exclusivity loss and a $2.5B generic headwind.Merck & Co. (MRK) and Bristol Myers Squibb (BMY) are major global drugmakers with expansive, diversified portfolios.Merck stands out for its leadership in oncology, complemented by strong positions in infectious diseases and vaccines.Bristol Myers, meanwhile, concentra ...
Halozyme(HALO) - 2025 Q4 - Earnings Call Transcript
2026-02-17 22:32
Financial Data and Key Metrics Changes - Total revenue for 2025 grew by 38% to $1.4 billion, with royalty revenue increasing by 52% to $868 million, reflecting strong performance from ENHANZE-enabled products [9][17] - Net income for the full year was $316.9 million, down from $444.1 million in 2024, impacted by a $285 million acquired IP R&D expense [19] - Adjusted EBITDA was $657.6 million, compared to $632.2 million in 2024, indicating operational strength despite the IP charge [19] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenue, a 29% year-over-year growth, with total sales reaching $14.4 billion [10] - PHESGO's royalty revenue increased by 51% to $105.6 million, with total sales growing 48% year-over-year to approximately $3 billion [11] - VYVGART and VYVGART Hytrulo saw a 444% year-over-year growth in royalty revenues to $157.2 million, with total sales reaching $4.15 billion [12] Market Data and Key Metrics Changes - ENHANZE now has 10 global blockbuster opportunities, with significant approvals in the U.S., Japan, and China for various products [8][16] - The subcutaneous formulations of Ocrevus, Opdivo, RYBREVANT, and Tecentriq represent a combined market opportunity of approximately $30 billion by 2028 [13] Company Strategy and Development Direction - The company aims to expand its ENHANZE pipeline, projecting 6 new programs to enter phase one in 2026, bringing the total development portfolio to 15 products [24] - The strategy includes pursuing additional licensing agreements and evaluating new drug delivery technologies to enhance long-term revenue streams [27][28] - Hypercon technology is expected to meet the demand for lower volume, auto-injector-ready therapies, with projections of approximately $1 billion in royalty revenue within five years of the first launches [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, emphasizing the durability of royalty revenue and the potential for exceptional value creation [23] - The company anticipates continued strong growth driven by existing products and new collaborations, with a focus on expanding into new therapeutic areas [25][36] Other Important Information - The company completed acquisitions of Elektrofi and Surf Bio, enhancing its drug delivery capabilities and extending IP into the mid-2040s [6][27] - The balance sheet was strengthened with the issuance of convertible notes and an upsized revolving credit facility, reducing near-term refinancing risk [21] Q&A Session Summary Question: Regarding the DARZALEX collaboration with J&J - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, emphasizing the importance of the partnership [42] Question: On the ADC strategy and regulatory paths - The regulatory pathway for converting ADCs from IV to subcutaneous is expected to follow traditional PK non-inferiority studies, with additional trials for unapproved products [50] Question: Update on Hypercon products and clinical testing - Two Hypercon products are on track for phase 1 clinical testing in 2026, with completion of clinical scale-up batches and IND filings underway [66] Question: Potential incremental royalty opportunities from Merus's petosemtamab - Management highlighted the potential for expanded indications and the importance of subcutaneous formulations in enhancing patient treatment experiences [58]
Halozyme(HALO) - 2025 Q4 - Earnings Call Transcript
2026-02-17 22:32
Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [9][17][19] - Net income for the full year was $316.9 million, compared to $444.1 million in 2024, while adjusted EBITDA was $657.6 million, up from $632.2 million in 2024 [19][20] - GAAP diluted EPS was $2.50, down from $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared to $4.23 in 2024 [19][20] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenue, a 29% year-over-year growth, with total sales reaching $14.4 billion [10][19] - Phesgo's royalty revenue increased 51% year-over-year to $105.6 million, with total sales growing 48% to approximately $3 billion [11][19] - VYVGART and VYVGART Hytrulo saw a 444% year-over-year growth in royalty revenues to $157.2 million, with total sales reaching $4.15 billion [12][19] Market Data and Key Metrics Changes - ENHANZE-enabled products now include 10 global blockbuster opportunities, with significant approvals in multiple markets including the U.S., Japan, and China [8][16] - The subcutaneous formulations of Ocrevus, Opdivo, RYBREVANT, and Tecentriq represent a combined market opportunity of approximately $30 billion by 2028 [13][16] Company Strategy and Development Direction - The company aims to expand its ENHANZE portfolio with six new programs entering phase I in 2026, bringing the total development portfolio to 15 products [24][35] - Hypercon technology is expected to meet the demand for lower volume, auto-injector-ready therapies, with projections of approximately $1 billion in royalty revenue within five years of the first launches [26][27] - The company plans to pursue strategic acquisitions to enhance its drug delivery portfolio while maintaining financial discipline [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers and the durability of royalty revenue [23][39] - The company anticipates continued strong growth from existing products and new launches, with a focus on expanding into new therapeutic areas [24][35] Other Important Information - The company completed acquisitions of Elektrofi and Surf Bio, enhancing its drug delivery capabilities with long-duration IP [6][27] - The company expects to maintain a strong balance sheet and reduce net debt to below 1x by the end of 2026 [21][22] Q&A Session Summary Question: Regarding the mechanics of DARZALEX collaboration with J&J - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, emphasizing the importance of the partnership [42][43] Question: On the ADC strategy and regulatory paths - Management indicated that the regulatory pathway for converting IV to subcutaneous delivery would likely follow traditional PK non-inferiority studies [49][50] Question: Update on Hypercon products and clinical testing - Management confirmed that two Hypercon products are on track for phase I clinical testing in 2026, with completion of clinical scale-up batches underway [63][64] Question: Expectations for new partnerships in auto-injectors - Management anticipates progress with high-volume auto-injectors and expects to see interest from both current and new partners [75][76]
Halozyme(HALO) - 2025 Q4 - Earnings Call Transcript
2026-02-17 22:30
Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [7][15][17] - Net income for the full year was $316.9 million, compared to $444.1 million reported in 2024 [17] - Adjusted EBITDA was $657.6 million, compared to $632.2 million in 2024 [17] - GAAP diluted EPS was $2.50, compared with $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared with $4.23 in 2024 [17][18] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenues, representing 29% year-over-year growth, with total sales growing 22% to $14.4 billion [8][9] - PHESGO delivered $105.6 million in royalty revenue, reflecting 51% year-over-year growth, with total sales increasing 48% to approximately $3 billion [9][10] - VYVGART and VYVGART Hytrulo generated $157.2 million in royalty revenue, representing 444% year-over-year growth, with total sales growing 90% to $4.15 billion [10][11] Market Data and Key Metrics Changes - The company now has 10 ENHANZE-enabled global blockbuster opportunities, with significant approvals in the U.S., Japan, and China [6][12] - Roche reported that there are now 17,500 patients on Ocrevus Zunovo, a 5,000 patient increase from the third quarter [11] - Analysts project that PHESGO will reach CHF 3.6 billion in 2028, and Ocrevus franchise sales expectations have been increased to CHF 9 billion, or approximately $11.5 billion [10][12] Company Strategy and Development Direction - The company expanded its portfolio from two to four subcutaneous drug delivery technologies through acquisitions, positioning itself as a one-stop shop for biopharma subcutaneous drug delivery [5][6] - The focus is on advancing the ENHANZE pipeline, with projections for 6 new ENHANZE programs entering phase one in 2026 [21][32] - The company aims to continue strategic M&A to enhance its drug delivery portfolio and maintain financial discipline while investing in long-term value creation [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers that will support durable royalty revenue [20][36] - The company anticipates continued strong growth from its existing blockbusters and new product launches, with a focus on expanding into new therapeutic areas [20][21] - Management expects to enter discussions with Johnson & Johnson to extend the DARZALEX collaboration agreement closer to its expiration in 2032 [39][40] Other Important Information - The company signed three new ENHANZE collaboration and licensing agreements, expanding its reach beyond oncology into obesity and inflammatory bowel disease [6][7] - The acquisition of Surf Bio is expected to enhance the company's hyperconcentration technology capabilities [24] - The company ended the year with a net debt to EBITDA ratio of 2.1x, with expectations to deleverage to below 1x by the end of 2026 [19] Q&A Session Summary Question: Can you elaborate on the mechanics of the DARZALEX collaboration with J&J? - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, as they do not anticipate J&J seeking another source of API [39][40] Question: What are the regulatory paths for ADCs with ENHANZE? - The regulatory pathway for converting from IV to subcutaneous is expected to follow traditional PK non-inferiority studies, while additional benefits would require phase trials [46][47] Question: What is the progress on Hypercon products? - The company is on track to support two partners in advancing to phase 1 clinical testing in 2026, with clinical scale-up batches being completed [61][62] Question: How will sales from auto-injectors be reported? - Sales from auto-injectors will be recognized similarly to API sales, with royalties recognized on commercial sales [76]
Is Bristol Myers Squibb a Buy, Sell, or Hold in 2026?
Yahoo Finance· 2025-12-30 16:05
Core Insights - Bristol Myers Squibb has faced significant challenges over the past five years, including the loss of patent exclusivity for key products like Revlimid, leading to poor financial results and stock performance [1] - The company is expected to encounter additional patent cliffs for Eliquis and Opdivo by the end of the decade, which could further impact its revenue [2] Financial Performance - For the first nine months of 2025, Eliquis generated $11 billion in sales, an 8% year-over-year increase, while Opdivo's revenue rose by 8% to $7.4 billion, contributing to a combined total of $18.4 billion, which represents over half of Bristol Myers Squibb's total revenue of $35.7 billion [3] - Despite the growth in sales for Eliquis and Opdivo, the overall revenue for Bristol Myers Squibb declined by 1% compared to the previous year, indicating a concerning trend [4] Strategic Initiatives - Bristol Myers Squibb has introduced a new subcutaneous version of Opdivo, named Opdivo Qvantig, which offers greater convenience and flexibility for patients and healthcare providers, potentially mitigating losses from the original formulation once it loses patent protection [5][6] - The new formulation is designed to maintain comparable efficacy while being faster to administer, which could help sustain the Opdivo franchise in the face of upcoming patent expirations [6] Overall Outlook - The company’s financial results have been underwhelming in recent years due to patent cliffs, but new product launches, pipeline developments, and a dividend program may still present attractive investment opportunities [7]
BMY Gains on News of Continuation of Alzheimer's Disease Study
ZACKS· 2025-12-04 16:31
Core Insights - Bristol Myers Squibb (BMY) shares increased by 5.62% following the announcement to continue the phase III ADEPT-2 study on Cobenfy for psychosis associated with Alzheimer's disease, contrary to investor expectations of a study failure [1][2][7] - The ADEPT-2 study's data readout has been postponed to next year, but the continuation of the study has reassured investors [2][7] - BMY's shares have declined by 9.9% year-to-date, while the industry has seen a growth of 19.9% [2] Study Details - The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in patients with Alzheimer's disease dementia-related psychosis [4] - The primary endpoint focuses on changes in the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, with a key secondary endpoint of Clinical Global Impression-Severity [5] - Irregularities were identified at a few study sites, leading to the exclusion of their data from the primary analysis after consultation with the FDA and a data monitoring committee (DMC) [6][7] Future Prospects - The DMC has recommended continuing the study by enrolling additional patients, and BMY will proceed with patient enrollment while remaining blinded to the study data [8] - Additional results from the ADEPT program, including ADEPT-1 and ADEPT-4, are expected by the end of 2026 [9] Portfolio Diversification - BMY is actively working to diversify its portfolio due to the negative impact of generics on its legacy drugs like Revlimid and Pomalyst [10] - The approval of Cobenfy has further diversified BMY's portfolio, with sales reaching $105 million year-to-date, and it is expected to be a significant growth driver as the company seeks label expansions [11] - The FDA has granted Fast Track Designation to BMS-986446, a potential anti-microtubule binding region-tau antibody currently in phase II development for early Alzheimer's disease [12]
Is Bristol-Myers Stock Underperforming the S&P 500?
Yahoo Finance· 2025-11-28 09:21
Core Insights - Bristol-Myers Squibb Company (BMY) is a leading biopharmaceutical firm focused on innovative medicines for serious diseases, particularly in oncology, immunology, cardiovascular conditions, and blood disorders [1] - The company has a market capitalization of approximately $100.3 billion, positioning it in the large-cap category, which includes firms valued at $10 billion or more [2] Financial Performance - Over the past three months, BMY's stock has increased by about 4.3%, underperforming the S&P 500 Index, which returned 5.1% during the same period [3] - The stock reached a 52-week high of $63.33 in March but has since declined by roughly 22.2% [3] - In the last 12 months, BMY's shares have decreased by about 16.2%, and in 2025, they have fallen approximately 13% [4] Technical Analysis - BMY has recently approached its 200-day moving average after being below this level since April, indicating a potential shift in momentum [5] Revenue Challenges - The company faces challenges from generic competition affecting its older blockbuster drugs, including Revlimid, Pomalyst, Sprycel, and Abraxane [6] - In the Q3 earnings update on October 30, management reported a 12% year-over-year decline in revenue from its legacy portfolio, totaling $5.4 billion, primarily due to significant generic erosion in Revlimid [6]
BMY's Growth Portfolio Shines in Q3: Turning Point Ahead?
ZACKS· 2025-11-13 19:45
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]
Will Opdivo and Opdivo Qvantig Drive BMY's Top-Line Growth?
ZACKS· 2025-09-02 15:11
Core Insights - Bristol Myers (BMY) has a robust oncology portfolio featuring key drugs such as Opdivo, Opdivo Qvantig, and Yervoy, which are crucial for the company's growth strategy [1][9] - Opdivo's sales in the U.S. are significantly driven by its successful launch in MSI-high colorectal cancer and ongoing growth in first-line non-small cell lung cancer, while international sales are supported by volume growth [2] - The European Commission approved the subcutaneous formulation of Opdivo for multiple solid tumor indications, enhancing its market presence [3] - Opdivo Qvantig has also received approval for subcutaneous use, with strong initial uptake in the U.S. across all indicated tumor types [4] - BMY anticipates global sales for Opdivo and Qvantig to grow in the mid to high single-digit range in 2025, supported by strong performance in the first half of the year [5] Competitive Landscape - The immuno-oncology market is highly competitive, with Merck's Keytruda and Roche's Tecentriq being significant competitors. Keytruda accounts for approximately 50% of Merck's pharmaceutical sales [6] - Roche's Tecentriq is approved for various oncology indications and has also received approval for subcutaneous administration, further intensifying competition [7] Financial Performance and Valuation - BMY's shares have declined by 13.6% year-to-date, contrasting with the industry's growth of 4.3% [8] - The company is trading at a price/earnings ratio of 7.60x forward earnings, which is below the industry average of 14.78x, indicating a potential undervaluation [10] - The bottom-line estimate for 2025 has increased to $6.50 from $6.41, while the estimate for 2026 has slightly decreased to $6.07 from $6.08 [11]
2 Beaten-Down Dividend Stocks to Buy Right Now
The Motley Fool· 2025-06-16 08:25
Group 1: Target - Target has faced a challenging year with subpar financial results, including a revenue decline and weak guidance, leading to a sell-off of its stock [4] - Economic uncertainty and a recent boycott related to diversity initiatives have compounded Target's difficulties, but the company is expected to weather these challenges [5] - Target has launched an Enterprise Acceleration Office to enhance productivity and efficiency, and its digital sales have shown growth, with a 4.7% increase in digital comparable sales [6][8] - The company's forward P/E ratio of 13.7 is attractive compared to the consumer staples average of 22.6, and it has a strong dividend profile with a yield of 4.6% [9][10] - Target is a Dividend King, having raised its payouts for 53 consecutive years, with a cash payout ratio of 45.7% [10] Group 2: Bristol Myers Squibb - Bristol Myers Squibb is facing significant patent cliffs, particularly for its top-selling cancer drug Opdivo, which will lose U.S. patent exclusivity in 2028 [11] - The company has developed a subcutaneous version of Opdivo, named Opdivo Qvantig, to extend its patent life, which has received FDA approval [12] - New product approvals, such as Reblozyl and Opdualag, have shown strong sales growth, with Reblozyl sales increasing by 35% year over year to $478 million [13] - Despite a 6% revenue decline to $11.2 billion in the first quarter, the company is expected to recover as newer products gain traction [14] - Bristol Myers Squibb offers a forward yield of 5.2% and has increased its payouts by 67.6% over the past decade, with a low forward P/E of 7 compared to the healthcare sector average of 16 [14][15]