Key Takeaways AstraZeneca gained FDA approval to extend Koselugo use to adult NF1 patients with symptomatic, inoperable PN.Koselugo's label was also recently expanded in the EU, Japan and other countries, with more reviews ongoing.AZN's KOMET study showed a 20% overall response rate for Koselugo versus 5% with placebo by cycle 16.AstraZeneca (AZN) announced that the FDA has approved its oral, selective MEK inhibitor, Koselugo (selumetinib), for expanded use. The drug is now indicated to treat symptomatic, i ...

Core Insights - AstraZeneca's third-quarter 2025 core earnings reached $1.19 per American depositary share (ADS), surpassing the Zacks Consensus Estimate of $1.14 per share, with core earnings of $2.38 per share reflecting a 14% year-over-year increase on a reported basis and a 12% increase at constant exchange rates (CER) [1][2] - Total revenues amounted to $15.19 billion, a 12% increase on a reported basis and a 10% increase at CER, driven by higher product sales and alliance revenues, exceeding the Zacks Consensus Estimate of $14.87 billion [1][2] Product Sales & Alliance Revenues - Product sales increased by 9% to $14.37 billion, supported by strong demand trends across all therapy areas and major geographic regions [3] - Alliance revenues, which include royalties and profit share from partnered medicines, rose 44% to $815 million, driven by continued revenue growth from partnered medicines [3] Key Drug Performance - Tagrisso generated revenues of $1.86 billion, up 10% year over year, benefiting from strong demand across all indications and regions, surpassing the Zacks Consensus Estimate of $1.85 billion [5] - Lynparza's total revenues rose 5% to $837 million, although it missed the Zacks Consensus Estimate of $850 million due to market challenges [6] - Imfinzi sales reached $1.60 billion, a 31% increase, driven by strong growth in bladder and lung cancer indications, exceeding the Zacks Consensus Estimate of $1.53 billion [7] - Farxiga recorded product sales of $2.14 billion, up 8%, driven by demand growth in chronic kidney disease and heart failure, beating the Zacks Consensus Estimate of $2.0 billion [8] - Symbicort sales rose 4% to $742 million, benefiting from demand for an authorized generic, surpassing the Zacks Consensus Estimate of $707 million [9][10] - Fasenra achieved sales of $530 million, up 20% year over year, driven by strong demand and market share gains, exceeding the Zacks Consensus Estimate of $498 million [10] Financial Overview - Core selling, general and administrative expenses increased by 4% at CER to $3.82 billion, while core research and development expenses rose 14% to $3.55 billion [12] - Core operating profit increased by 13% to $4.99 billion, with a core operating margin of 33%, up 1 percentage point year over year at CER [12] Future Guidance - AstraZeneca maintained its financial guidance for 2025, expecting total revenues to grow by a high single-digit percentage at CER and core EPS to increase by a low double-digit percentage [13][16] - The company aims to achieve $80 billion in total revenues by 2030, with plans to launch 20 new medicines, anticipating that many will generate over $5 billion in peak-year revenues [17] Strategic Developments - AstraZeneca signed a drug pricing agreement with the Trump administration, committing to cut prescription drug prices and invest $50 billion over the next five years to enhance its U.S. research and production footprint [18] - The company is on track to achieve a mid-30s percentage core operating margin by 2026 [18]

Financial Data and Key Metrics Changes - Total revenue increased by 11% in the first nine months of 2025, driven by strong demand for innovative medicines [6][11] - Core EPS rose by 15%, reflecting robust underlying business momentum [14] - Product sales grew by 9%, while alliance revenue surged by 41% [11][12] - Core gross margin was reported at 83%, with expectations of a slight decrease for the full year due to various factors [12][15] - Operating cash flow increased by 37% to $12.2 billion [14] Business Line Data and Key Metrics Changes - Oncology franchise revenue grew by 16%, with TAGRISSO sales reaching $1.9 billion, marking a 10% increase [17][18] - Biopharmaceuticals revenue rose by 8%, with significant growth in newer medicines offsetting losses from mature brands [7][31] - Rare disease medicines grew by 6%, with Ultomiris and Strensiq showing strong demand [40][41] Market Data and Key Metrics Changes - U.S. revenues increased by 11%, while emerging markets outside of China saw a 21% growth [7] - The U.S. is projected to account for around 50% of total revenue by 2030 [9] - China experienced strong growth throughout the year, although fourth-quarter revenues are expected to be impacted by specific costs [15][16] Company Strategy and Development Direction - The company aims for an $80 billion revenue target by 2030, supported by a rich pipeline of upcoming product launches and regulatory approvals [8][45] - AstraZeneca is expanding its global manufacturing capacity and enhancing its clinical trial footprint in the U.S. [9][10] - The company is focusing on advancing novel therapies into earlier-stage diseases to improve patient outcomes [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the agreement with the U.S. government regarding pricing and innovation sustainability [49] - The company anticipates continued strong revenue momentum in growth brands, despite potential headwinds from product exclusivity losses [15][52] - Management highlighted a unique catalyst-rich period extending through 2026, with significant revenue opportunities from upcoming readouts [45][46] Other Important Information - The company has achieved 31 regulatory approvals across key regions in 2025 [6] - A new facility in Virginia has been established to support manufacturing capacity [10] - The company is harmonizing its listing structure across major stock exchanges to enhance capital access [10] Q&A Session Summary Question: What is the risk of residual activity from the administration regarding pricing? - Management indicated that they have addressed key points in the president's letter and do not expect further issues, expressing confidence in the agreement with the U.S. government [49] Question: Is the $10 billion catalyst potential part of the $80 billion target? - Management clarified that the $10 billion is a peak-year revenue number and contributes to the $80 billion target, with additional readouts expected to add further revenue potential [50] Question: What is the comfort level regarding 2026 margin consensus? - Management noted that while there are pushes and pulls affecting the 2026 margin, they remain committed to investing in growth brands and maintaining strong operating leverage [52][53] Question: Can you discuss the potential impact of the CARDIO-TTRansform study? - Management expressed optimism that the study could meaningfully reshape treatment guidelines for patients with ATTR amyloidosis [62] Question: What are the competitive profiles for the obesity portfolio? - Management is advancing multiple molecules in the weight management portfolio and is focused on developing competitive treatment options [68]

Financial Data and Key Metrics Changes - Total revenue increased by 11% in the first nine months of 2025, driven by strong demand for innovative medicines [6][11] - Core EPS rose by 15%, reflecting robust underlying business momentum [14] - Alliance revenue surged by 41%, primarily due to growth from Enhertu and Tezspire [11] - Core gross margin was reported at 83%, with expectations of a slight decrease for the full year due to various factors [12][15] Business Line Data and Key Metrics Changes - Oncology franchise revenue grew by 16%, with Tagrisso achieving $1.9 billion in sales, marking a 10% increase year-on-year [17][19] - Biopharmaceuticals revenue reached $17.1 billion, reflecting an 8% growth, with significant contributions from Fasenra and Tezspire [31] - Rare disease medicines grew by 6% to $6.8 billion, driven by strong demand for Ultomiris and Koselugo [40] Market Data and Key Metrics Changes - U.S. revenues increased by 19%, while emerging markets outside of China saw a 21% growth [7] - The U.S. is projected to account for around 50% of total revenue by 2030 [9] - China’s revenue growth is anticipated to be affected by stock compensation costs and year-end hospital budget capping [16] Company Strategy and Development Direction - The company aims to achieve $80 billion in revenue by 2030, supported by a rich pipeline of upcoming product launches and regulatory approvals [8][45] - A landmark agreement with the U.S. government aims to provide clarity around pricing and safeguard biopharmaceutical innovation [9] - Continued investment in R&D is planned, with a focus on high-value pipeline opportunities and expanding global manufacturing capacity [15][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s ability to navigate regulatory changes and maintain growth momentum [49] - The company anticipates strong revenue momentum in growth brands to continue, despite potential headwinds from product exclusivity losses [15][52] - Positive results from multiple pivotal studies are expected to reshape clinical practice and drive future growth [23][29] Other Important Information - The company is expanding its manufacturing footprint in the U.S. and has broken ground on a new facility in Virginia [10] - AstraZeneca ordinary shares will be listed on the New York Stock Exchange from February next year, enhancing capital access [10] Q&A Session Summary Question: What is the risk of residual activity from the administration regarding pricing? - Management addressed concerns by stating that the agreement with the U.S. government covers key points and they do not expect further issues [49] Question: Is the $10 billion catalyst potential part of the $80 billion ambition? - The $10 billion is part of the $80 billion peak-year revenue potential, contributing to the overall 2030 goal [50] Question: What is the comfort level regarding 2026 margin consensus? - Management indicated that while there are pushes and pulls, they remain committed to investing in growth brands and maintaining strong margins [51][52]

Financial Data and Key Metrics Changes - Total revenue increased by 11% in the first nine months of 2025, driven by strong demand for innovative medicines [5][11] - Core EPS rose by 15%, reflecting robust underlying business momentum [5][13] - Core gross margin was 83%, with expectations of a slight decrease for the full year due to various factors [11][12] - Cash flow from operating activities increased by 37% to $12.2 billion [13] Business Line Data and Key Metrics Changes - Oncology franchise grew by 16%, with total revenue reaching $18.6 billion [6][17] - Biopharmaceuticals revenue increased by 8% to $17.1 billion, with notable growth in severe asthma and chronic obstructive pulmonary disease (COPD) segments [30] - Rare disease medicines grew by 6% to $6.8 billion, driven by strong demand in neurology indications [39] Market Data and Key Metrics Changes - U.S. revenues increased by 19%, while emerging markets outside of China saw a 21% growth [6][9] - Alliance revenue surged by 41%, primarily due to growth from Enhertu and Tezspire [11] Company Strategy and Development Direction - The company aims to achieve $80 billion in revenue by 2030, supported by a rich pipeline and multiple regulatory approvals [5][8] - A landmark agreement with the U.S. government aims to provide clarity around pricing and safeguard biopharmaceutical innovation [9] - Continued expansion of global manufacturing capacity, including a new facility in Virginia [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the agreement with the U.S. government, expecting it to mitigate risks related to pricing and innovation costs [47] - The company anticipates strong revenue momentum in growth brands to continue, despite potential headwinds from product exclusivity losses [14][51] Other Important Information - The company is in a catalyst-rich period with multiple pivotal data sets expected to reshape clinical practice [43][44] - Significant investments are being made in high-value pipeline opportunities, including oncology and rare diseases [12][30] Q&A Session Summary Question: What is the risk of residual activity from the administration regarding pricing? - Management addressed concerns, stating that the agreement with the U.S. government covers key points and they do not expect further issues [47] Question: Is the $10 billion catalyst potential part of the $80 billion ambition? - Management confirmed that the $10 billion is part of the $80 billion peak-year revenue potential, not a 2030 number [48] Question: What is the level of comfort regarding 2026 margin consensus? - Management indicated that the key headwind for 2026 will be the loss of Farxiga in the U.S. and China, but they remain committed to investing in growth brands [51][52] Question: How does the company view the potential of the CARDIO-TTRansform study? - Management expressed optimism about the study's potential to reshape treatment guidelines for patients with ATTR amyloidosis [62][63]

Core Insights - Merck (MRK) reported Q3 2025 adjusted EPS of $2.58, exceeding the Zacks Consensus Estimate of $2.36, with a year-over-year increase of 64% on a reported basis and 65% excluding foreign exchange [1][10] - Revenues for Q3 increased by 4% year-over-year to $17.28 billion, surpassing the Zacks Consensus Estimate of $17.06 billion [1][10] Sales Performance of Key Products - Keytruda, Merck's leading oncology drug, generated sales of $8.14 billion, an 8% increase year-over-year, but fell short of the Zacks Consensus Estimate of $8.40 billion [3] - Alliance revenues from Lynparza and Lenvima contributed positively, with Lynparza sales rising 12% to $379 million and Lenvima revenues totaling $258 million, up 2% [4] - Welireg recorded sales of $196 million, reflecting a 41% increase due to higher demand in the U.S. and early uptake in Europe [5] - HPV vaccines, Gardasil and Gardasil 9, saw a 25% decline in sales to $1.75 billion, primarily due to lower demand in China and Japan [6] - Capvaxive, a new pneumococcal vaccine, generated $244 million in sales, up from $129 million in the previous quarter [7] - The diabetes drug franchise, Januvia/Janumet, saw a 29% increase in sales to $624 million, driven by higher net pricing in the U.S. [8] Animal Health Segment - The animal health segment generated revenues of $1.62 billion, a 9% increase year-over-year, driven by higher demand for livestock products [11] 2025 Guidance - Merck narrowed its 2025 sales guidance to $64.5-$65.0 billion, reflecting a slight adjustment from the previous range [12] - Adjusted EPS guidance for 2025 was raised to a range of $8.93 to $8.98, incorporating a revised negative impact from foreign exchange [13] - The updated EPS outlook includes benefits from a revised AstraZeneca deal and improved operations, partially offset by costs from the acquisition of Verona Pharma [14][15] Market Reaction - Despite strong Q3 results, Merck's shares fell over 2% in pre-market trading due to Keytruda's weaker-than-expected sales and the narrowed sales guidance [19]

Core Insights - Merck reported revenue of $17.28 billion for the quarter ended September 2025, reflecting a 3.7% increase year-over-year and a surprise of +1.24% over the Zacks Consensus Estimate of $17.06 billion [1] - Earnings per share (EPS) for the quarter was $2.58, compared to $1.57 in the same quarter last year, resulting in a surprise of +9.32% over the consensus estimate of $2.36 [1] Financial Performance - Hospital Acute Care sales for Bridion in the U.S. reached $392 million, exceeding the estimated $379.07 million, marking a +15.6% change year-over-year [4] - Oncology sales for Keytruda internationally were $3.26 billion, slightly below the estimated $3.33 billion, with a year-over-year increase of +11.4% [4] - Sales for Diabetes drug Janumet in the U.S. were $78 million, significantly surpassing the estimated $42.82 million, representing a +420% change year-over-year [4] - Alliance revenue for Lynparza in the U.S. was $184 million, exceeding the estimated $156.52 million, with a +14.3% year-over-year change [4] - Animal health sales totaled $1.62 billion, above the estimated $1.56 billion, reflecting an +8.6% change year-over-year [4] - Cardiovascular sales for Winrevair were $360 million, below the estimated $426.29 million [4] - Oncology sales for Keytruda were $8.14 billion, slightly below the estimated $8.4 billion, with a +9.6% year-over-year change [4] - Sales for Virology drug Lagevrio were $138 million, below the estimated $144.08 million, representing a -64% year-over-year change [4] - Sales for Gardasil vaccines were $1.75 billion, matching the average estimate, but reflecting a -24.2% year-over-year change [4] - Alliance revenue for Lenvima was $258 million, exceeding the estimated $242.44 million, with a +2.8% year-over-year change [4] Stock Performance - Merck's shares have returned -3.9% over the past month, contrasting with the Zacks S&P 500 composite's +3.6% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]

Core Viewpoint - Merck is set to report its third-quarter 2025 earnings on October 30, with consensus estimates for sales at $17.06 billion and earnings per share (EPS) at $2.36. Earnings estimates for 2025 have slightly declined from $8.94 to $8.92 per share over the past month [1][6]. Earnings Performance - Merck has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 3.92%. The most recent quarter showed a 5.97% surprise [3][4]. Factors Influencing Upcoming Results - After a weak first half, Merck anticipates growth in the second half, driven by oncology drugs like Keytruda, Animal Health, and new products, although this may be partially offset by lower sales of Gardasil in China and Japan [6][7]. Oncology Drug Performance - Keytruda is expected to drive significant sales growth, with consensus estimates for its sales at $8.4 billion, while internal estimates are slightly higher at $8.51 billion. The drug's sales are bolstered by its uptake in earlier-stage indications and continued momentum in metastatic indications [8][9]. Vaccine and Other Drug Performance - Sales of Gardasil are projected to decline due to reduced demand in China and Japan, with consensus estimates at $1.75 billion, while internal estimates are at $1.70 billion. Other vaccines have also seen declining sales [11][12]. - The diabetes franchise is facing challenges from lower demand and generic competition, impacting sales of Januvia/Janumet [14]. New Product Contributions - New drugs like Winrevair and Capvaxive are contributing to sales growth, with Winrevair showing strong demand in the U.S. market and Capvaxive gaining traction in retail pharmacies [15][24]. Financial Performance and Valuation - Merck's stock has underperformed the industry and the S&P 500, with a year-to-date loss of 11.5% compared to a 5.7% increase for the industry. However, the company's valuation appears attractive, trading at a forward P/E ratio of 9.42, lower than the industry average of 15.58 [17][20]. Investment Thesis - Merck has a robust portfolio with over six blockbuster drugs, primarily driven by Keytruda. The company has also expanded its pipeline significantly, with plans to launch around 20 new vaccines and drugs in the coming years [23][24]. - Despite concerns about dependency on Keytruda and challenges in the non-oncology business, Merck's strong revenue generation from its existing products supports a long-term investment perspective [26][29].

Core Insights - Eli Lilly (LLY) is a market leader in the GLP-1 segment with its tirzepatide medicines Mounjaro and Zepbound, while also generating significant revenue from its oncology franchise, which accounted for over 15% of its first-half 2025 revenues, growing approximately 10% year over year [1] Oncology Sales Performance - The oncology unit's sales for Q3 2025 are estimated at $2.58 billion, reflecting over 15% year-over-year growth, primarily driven by the blockbuster breast cancer drug Verzenio, which saw increased demand and higher prices, despite currency headwinds and competitive pressures [2][9] - Sales from RET inhibitor Retevmo and lymphoma drug Jaypirca are expected to positively contribute to growth, although this may be partially offset by declining sales of older drugs like Alimta and Cyramza due to competition from immuno-oncology agents [3] New Drug Launch - Eli Lilly received FDA approval for its new breast cancer drug Inluriyo in late September, but the launch is expected to occur in the coming weeks, meaning no sales contribution from this drug in Q3 [4] Market Dynamics - Attention is shifting towards Lilly's oncology unit, which is demonstrating consistent double-digit growth, potentially reassuring investors that the company's earnings are not solely reliant on the obesity segment ahead of Q3 results on October 30 [5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for nearly 43% of total revenues and growing 11% in the first half of 2025, driven by drugs like Tagrisso and Lynparza [6] - Merck's Keytruda accounted for over 48% of its total revenues in the first half of 2025, while Pfizer's oncology revenues grew 9% operationally, driven by drugs like Xtandi and Lorbrena [7] Valuation and Estimates - Eli Lilly's shares are currently trading at a price/earnings (P/E) ratio of 27.99, which is higher than the industry average of 15.56 but below its five-year mean of 34.54 [10] - EPS estimates for 2025 have decreased from $23.15 to $22.86, and for 2026 from $30.82 to $30.78 over the past 30 days [12]

Core Insights - AbbVie has developed a significant oncology franchise, expanding from blood cancer drugs to include therapies for solid tumors, totaling five oncology products [1] - The oncology segment contributed over 11% to AbbVie's revenues in the first half of 2025, with a year-over-year growth of 5% [2] - Third-quarter 2025 oncology sales are estimated at $1.71 billion, reflecting nearly 2% growth year-over-year, despite declining sales of Imbruvica due to competition [3] AbbVie's Oncology Performance - AbbVie's oncology sales are projected to reach $1.71 billion in Q3 2025, with contributions from Venclexta, Epkinly, and Elahere, while Imbruvica continues to face challenges [7] - The recent approval of Emrelis for lung cancer is expected to provide modest revenue contributions in the upcoming quarter [3][7] Competitive Landscape - Major competitors in the oncology market include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for nearly 43% of its total revenues, growing 11% in the first half of 2025 [5] - Merck's Keytruda, a PD-L1 inhibitor, represented over 48% of its total revenues in the first half of 2025, highlighting its significance in the oncology space [6] - Pfizer's oncology revenues grew 9% operationally in the first half of 2025, driven by several key drugs, now making up over 25% of its total revenues [6]