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Eli Lilly (LLY) Announces Positive Results For Jaypirca In Phase 3 Trial
Eli Lilly (LLY) Announces Positive Results For Jaypirca In Phase 3 Trial

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time2 days ago

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Eli Lilly (LLY) Announces Positive Results For Jaypirca In Phase 3 Trial

Eli Lilly made headlines with positive results from the Phase 3 BRUIN CLL-314 clinical trial for Jaypirca, marking a significant advancement in treatment options for chronic lymphocytic leukemia. The company's 6% share price increase over the past week may have been influenced by investor optimism surrounding these findings, aligning with general market trends which saw the S&P 500 and Nasdaq reach new highs. While broader market dynamics favor strong corporate earnings and positive economic data, Lilly's success and strategic positioning in key therapeutic areas add weight to its recent performance. Be aware that Eli Lilly is showing 2 warning signs in our investment analysis and 1 of those makes us a bit uncomfortable. Rare earth metals are the new gold rush. Find out which 25 stocks are leading the charge. The positive results from the Phase 3 BRUIN CLL-314 trial for Jaypirca may bolster Eli Lilly's strategic positioning in oncological treatment, enhancing long-term growth potential in this high-demand sector. Over the last five years, the company achieved a substantial total shareholder return of over 460%, illustrating its ability to deliver strong returns in tandem with advancing its product pipeline. Compared to the previous year's industry tumble of 6.8%, Lilly's recent stock appreciation positions it favorably within the pharmaceuticals sphere. The new clinical trial outcomes could influence revenue and earnings projections, particularly if future regulatory approvals expedite market entry for various treatments. Analysts' expectations for revenue growth of 14.7% annually suggest favorable prospects, although short-term cash flow impacts from major manufacturing investments might require attention. The stock's recent surge to $808.11, although below the consensus price target of approximately $952.27, could signify market confidence aligned with upcoming catalysts. Yet, this gap suggests room for evaluation by investors regarding the company's potential alignment with analyst forecasts. Gain insights into Eli Lilly's outlook and expected performance with our report on the company's earnings estimates. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include LLY. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@

Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL
Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL

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time3 days ago

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Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL

Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending in favor of pirtobrutinib BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients INDIANAPOLIS, July 29, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This study enrolled patients with treatment-naïve CLL/SLL and those who had been previously treated but were BTK inhibitor-naïve. The study met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations. ORR favored pirtobrutinib with a nominal P-value for superiority1 (p <0.05). Progression free survival (PFS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of pirtobrutinib. A formal PFS analysis testing for superiority is planned at a future analysis. No detriment was observed for overall survival (OS). BRUIN CLL-314 is the first ever head-to-head trial versus ibrutinib in CLL to include treatment-naïve patients. This important subpopulation (n=225) had the longest follow-up and a particularly pronounced PFS effect size in favor of pirtobrutinib. The overall safety profile of pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials. Detailed results will be presented at a medical congress later in 2025. "We launched the pirtobrutinib randomized development program with an ambitious suite of clinical trials, including head-to-head studies against modern standards of care and examinations of patient populations that reflect real world use, such as BTK inhibitor-pretreated patients," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These data mark the second positive Phase 3 study in the program, as we continue to build evidence supporting the potential role of pirtobrutinib in treating people with CLL/SLL and hopefully enabling future regulatory approvals that allow physicians to use the medicine in various disease settings, whether treatment-naïve or BTK inhibitor-pretreated." These data build on the previously reported positive results from the BRUIN Phase 1/2 trial and the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population. The BRUIN CLL-313 Phase 3 study of pirtobrutinib versus chemoimmunotherapy in treatment naïve CLL/SLL is expected to read out later in 2025 and combined with the results of BRUIN CLL-314, will form the basis of regulatory submissions globally. For more information on the BRUIN Phase 3 clinical trial program, please visit About BRUIN CLL-314 BRUIN CLL-314 is a Phase 3, randomized, open-label study of pirtobrutinib versus ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial planned to enroll 650 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or ibrutinib (420 mg orally, once daily). The primary endpoint is overall response rate (ORR) as assessed by blinded independent review committee (IRC). Secondary endpoints include investigator and IRC assessed progression-free survival (PFS), duration of response (DoR) and event-free survival (EFS), and time to next treatment (TTNT), overall survival (OS), safety and tolerability, and patient-reported outcomes (PRO). About Jaypirca (pirtobrutinib) Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.2 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).3,4 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity. INDICATIONS FOR JAYPIRCA (pirtobrutinib)Jaypirca is a kinase inhibitor indicated for the treatment of Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib) Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. In a clinical trial, Grade ≥3 infections occurred in 24% of patients with hematologic malignancies, most commonly pneumonia (14%); fatal infections occurred (4.4%). Sepsis (6%) and febrile neutropenia (4%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor patients for signs and symptoms, evaluate promptly, and treat appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred in 3% of patients, including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (17%). Major hemorrhage occurred in patients taking Jaypirca with (0.7%) and without (2.3%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor patients for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider benefit/risk of withholding Jaypirca 3-7 days pre- and post-surgery depending on type of surgery and bleeding risk. Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. In a clinical trial, Grade 3 or 4 cytopenias, including decreased neutrophils (26%), decreased platelets (12%), and decreased hemoglobin (12%), developed in Jaypirca-treated patients. Grade 4 decreased neutrophils (14%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients who received Jaypirca. In a clinical trial of patients with hematologic malignancies, atrial fibrillation or flutter were reported in 3.2% of Jaypirca-treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.5%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.5%). Patients with cardiac risk factors such as hypertension or previous arrhythmias may be at increased risk. Monitor for signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea) and manage appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Second Primary Malignancies: Second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients. The most frequent malignancy was non-melanoma skin cancer (4.6%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies. Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. Upon confirmation of DILI, discontinue Jaypirca. Embryo-Fetal Toxicity: Jaypirca can cause fetal harm in pregnant women. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of potential fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose. Adverse Reactions (ARs) in Patients Who Received Jaypirca The most common (≥20%) ARs in the BRUIN pooled safety population of patients with hematologic malignancies (n=593) were decreased neutrophil count (46%), decreased hemoglobin (39%), fatigue (32%), decreased lymphocyte count (31%), musculoskeletal pain (30%), decreased platelet count (29%), diarrhea (24%), COVID-19 (22%), bruising (21%), cough (20%). Mantle Cell Lymphoma Serious ARs occurred in 38% of patients. Serious ARs occurring in ≥2% of patients were pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%). Fatal ARs within 28 days of last Jaypirca dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients). Dose Modifications and Discontinuations: ARs led to dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dosage modification in >5% of patients included pneumonia and neutropenia. ARs resulting in permanent discontinuation in >1% of patients included pneumonia. Most common ARs (≥15%), excluding laboratory terms (all Grades %; Grade 3-4 %): fatigue (29; 1.6), musculoskeletal pain (27; 3.9), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), pneumonia (16; 14), bruising (16; -). Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in ≥10% of Patients: hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), calcium decreased (19; 1.6), AST increased (17; 1.6), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), alkaline phosphatase increased (11; -), ALT increased (11; 1.6), potassium increased (11; 0.8). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6). Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Serious ARs occurred in 56% of patients. Serious ARs occurring in ≥5% of patients were pneumonia (18%), COVID-19 (9%), sepsis (7%), and febrile neutropenia (7%). Fatal ARs within 28 days of last Jaypirca dose occurred in 11% of patients, most commonly due to infections (10%), including sepsis (5%) and COVID-19 (2.7%). Dose Modifications and Discontinuations: ARs led to dose reductions in 3.6%, treatment interruption in 42%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dose reductions in >1% included neutropenia; treatment interruptions in >5% of patients included pneumonia, neutropenia, febrile neutropenia, and COVID-19; permanent discontinuation in >1% of patients included second primary malignancy, COVID-19, and sepsis. Most common ARs (≥20%), excluding laboratory terms (all Grades %; Grade 3-4 %): fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), dyspnea (22; 2.7), hemorrhage (22; 2.7), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in ≥20% of Patients: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), platelet count decreased (30; 15), sodium decreased (30; -), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), lipase increased (21; 7), alkaline phosphatase increased (21; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23). Drug Interactions Strong CYP3A Inhibitors: Concomitant use with Jaypirca increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid use of strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dosage according to approved labeling. Strong or Moderate CYP3A Inducers: Concomitant use with Jaypirca decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid concomitant use of Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dosage according to approved labeling. Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Concomitant use with Jaypirca increased their plasma concentrations, which may increase risk of adverse reactions related to these substrates for drugs that are sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling. Use in Special Populations Pregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca and advise use of effective contraception during treatment and for one week after last dose. Presence of pirtobrutinib in human milk is unknown. Advise women not to breastfeed while taking Jaypirca and for one week after last dose. Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age. Renal Impairment: Severe renal impairment increases pirtobrutinib exposure. Reduce Jaypirca dosage in patients with severe renal impairment according to approved labeling. PT HCP ISI MCL_CLL AA JUN2024 Please see Prescribing Information and Patient Information for Jaypirca. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. © Lilly USA, LLC 2025. ALL RIGHTS RESERVED. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jaypirca (pirtobrutinib), as a potential treatment for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who are previously untreated or have received prior therapy but are Bruton's tyrosine kinase (BTK) inhibitor-naïve and as a treatment for adult patients with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor, or adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor, and the timeline for future readouts, presentations, and other milestones relating to Jaypirca and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Jaypirca will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Endnotes and References: ORR superiority was not part of the graphical testing scheme. Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5 Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1 Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7 Refer to: Kyle Owens; owens_kyle@ (332) 259-3932 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

How Will Eli Lilly's Oncology Drugs Perform in Q2 Earnings?
How Will Eli Lilly's Oncology Drugs Perform in Q2 Earnings?

Globe and Mail

time24-07-2025

  • Business
  • Globe and Mail

How Will Eli Lilly's Oncology Drugs Perform in Q2 Earnings?

Eli Lilly LLY offers a diverse range of products that serve multiple therapeutic areas. While the company's primary focus is on diabetes and obesity drugs, the oncology franchise also remains a key contributor to the top line. Sales from the oncology segment accounted for over 15% of Lilly's first-quarter revenues, which grew more than 11% year over year. Our model estimates second-quarter 2025 sales for the overall oncology unit to be $2.4 billion, indicating more than 11% year-over-year growth. A significant portion of these revenues is likely to have been generated from sales of the company's blockbuster breast cancer drug, Verzenio. Sales of this drug are expected to have been driven by increased demand and higher realized prices during the quarter, partially offset by currency headwinds and competitive dynamics. Sales of RET inhibitor Retevmo and newer lymphoma drug Jaypirca are also likely to have contributed positively to top-line growth during the quarter. However, these gains might have been partially offset by the declining sales of older cancer drugs like Alimta and Cyramza, which are being impacted by competition from immuno-oncology agents in the United States. Though Lilly's oncology portfolio is contributing meaningfully, investor focus will largely remain on blockbuster GLP-1 medicines — Mounjaro (for type II diabetes) and Zepbound (for obesity). Investors will closely track their sequential growth and market share trends in the upcoming second-quarter results on Aug. 7. Competition in the Oncology Space Other bigger players in this area are AstraZeneca AZN, Merck MRK and Pfizer PFE. For AstraZeneca, oncology sales now account for nearly 41% of total revenues. Growth in AZN's oncology franchise is being driven by medicines such as Tagrisso, Lynparza, Imfinzi, Calquence and Enhertu (in partnership with Daiichi Sankyo). Merck's key oncology medicines are PD-1 inhibitor, Keytruda and PARP inhibitor, Lynparza, which it markets in partnership with AstraZeneca. Keytruda, approved for several types of cancer, alone accounts for nearly half of Merck's product revenues. Pfizer's oncology segment — comprising drugs like Xtandi, Lorbrena, the Braftovi-Mektovi combination and Padcev — currently accounts for more than 27% of its total revenues. LLY's Price Performance, Valuation and Estimates Shares of Lilly have outperformed the industry year to date, as seen in the chart below. From a valuation standpoint, Eli Lilly is expensive. Based on the price/earnings (P/E) ratio, the company's shares currently trade at 29.66 times forward earnings, higher than its industry's average of 14.91. However, the stock is trading below its five-year mean of 34.54. EPS estimates for 2025 have risen from $21.92 to $21.99, while those for 2026 have declined from $30.91 to $30.79 over the past 30 days. Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.5% per year. So be sure to give these hand picked 7 your immediate attention. See them now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Eli Lilly and Company (LLY): Free Stock Analysis Report

Eli Lilly vs. AstraZeneca: Which Pharma Powerhouse is the Better Buy?
Eli Lilly vs. AstraZeneca: Which Pharma Powerhouse is the Better Buy?

Yahoo

time28-05-2025

  • Business
  • Yahoo

Eli Lilly vs. AstraZeneca: Which Pharma Powerhouse is the Better Buy?

Eli Lilly LLY and AstraZeneca AZN are leading drugmakers with significant involvement in oncology, immunology, and the cardiometabolic disease space. Both are making substantial investments in next-generation therapies such as cancer immunotherapies, treatments for respiratory conditions as well as GLP-1 drugs. With robust, research-driven pipelines and strong growth potential, they represent an intriguing comparison for investors considering large-cap pharmaceutical stocks. Though both companies have a diversified product profile, Lilly's largest segment is Cardiometabolic Health, which accounts for 72% of its total revenues. Lilly has a strong portfolio of medicines to treat diabetes and other cardiometabolic diseases. Its cardiometabolic business is its most successful business, particularly with the success of its popular GLP-1 drugs, Mounjaro for diabetes and Zepbound for obesity. On the other hand, Oncology is AstraZeneca's biggest segment, comprising around 41% of its total revenues. The company is working on strengthening its oncology product portfolio through label expansions of existing products and advancement of oncology pipeline candidates. Both Lilly and AstraZeneca are seeing strong sales and earnings growth. But which one is a better investment today? Let's take a closer look at their fundamentals, growth prospects and challenges to make an informed choice. Lilly boasts a wide range of products that serve a vast number of therapeutic areas. The company focuses primarily on cardiometabolic health, neuroscience, oncology and immunology, which are all high-growth areas with significant commercial potential. Despite being on the market for less than three years, Mounjaro and Zepbound became key top-line drivers for Lilly, with demand rising rapidly. Mounjaro and Zepbound generated combined sales of $6.15 billion in the first quarter of 2025, accounting for around 48% of the company's total revenues. Though sales of Mounjaro and Zepbound were below expectations in the second half of 2024, hurt by slower-than-expected growth and unfavorable channel dynamics, their sales picked up in the first quarter of 2025, driven by launches of the drugs in new international markets and improved supply from ramped-up production. We believe that increased uptake in outside U.S. markets and deeper penetration in the U.S. market will continue to drive Mounjaro and Zepbound's growth in future quarters. Approvals for new indications can also drive sales of Mounjaro and Zepbound higher. Other than Mounjaro and Zepbound, Lilly has gained approvals for some other new drugs in the past couple of years across different therapeutic areas like Omvoh, Jaypirca, Ebglyss and Kisunla (donanemab). Lilly expects its new drugs, Mounjaro, Zepbound, Omvoh, Jaypirca, Ebglyss and Kisunla, along with the expanded use of existing drugs, to drive sales growth in 2025. Lilly is also making rapid pipeline progress in obesity, diabetes and cancer, with several key mid and late-stage data-readouts expected this year. Lilly is investing broadly in obesity and has several new molecules currently in clinical development. In terms of capital allocation, LLY returned $2.5 billion to shareholders in the first quarter via share repurchases and dividends. The board of directors of Lilly approved a new $15 billion stock buyback plan and also announced a 15% increase in its quarterly dividend in 2024. Lilly has its share of problems. Sales of its key medicine, Trulicity, are declining in the United States due to competitive dynamics, including Mounjaro switches and supply constraints. Prices of most of Lilly's products are declining in the United States. Potential competition in the GLP-1 diabetes/obesity market is another headwind. The stock also took a hit this month because CVS Caremark, a major pharmacy benefit manager ('PBM'), announced a partnership with rival Novo Nordisk NVO to make NVO's Wegovy its preferred GLP-1 therapy for weight loss, effective July 1. NVO also recently announced partnerships with telehealth providers Hims & Hers Health to offer Wegovy at a discounted price to cash-paying patients. Though Lilly's CEO, Dave Ricks does not expect CVS' decision to exclude Zepbound in favor of Wegovy to hurt Lilly's revenues, we believe it may hurt Zepbound's market share. Headquartered in Cambridge, the United Kingdom, AstraZeneca boasts a diversified geographical footprint as well as a product portfolio with several blockbuster medicines. AstraZeneca now has 16 blockbuster medicines in its portfolio with sales exceeding $1 billion, including Tagrisso, Fasenra, Farxiga, Imfinzi, Lynparza, Calquence and Ultomiris. These drugs are driving the company's top line, backed by increasing demand trends. The company is confident that the growth will continue in 2025. Almost every new product it has launched in recent years has done well. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap are also expected to continue to contribute to top-line growth in 2025. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate $80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with nine new medicines already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026. AstraZeneca faces its share of challenges. The impact of Part D redesign hurt sales of AZN's older drugs, Tagrisso, Lynparza and Ultomiris, as well as newer drugs, Truqap and Wainua, in the United States in the first quarter of 2025, with the trend expected to continue through the rest of the year. AstraZeneca expects Farxiga and Lynparza to be included in the volume-based procurement plans in China in mid-2025, which can hurt sales of these drugs in the country. Pricing and competitive pressure in Europe and generic competition in some emerging markets are expected to hurt drug sales. In 2025, generic/biosimilar competition in the United States is expected to hurt sales of key drugs like Brilinta and Soliris. Sales in its Rare Disease segment are expected to be slower in 2025 than in 2024. As regards shareholders' returns, AstraZeneca intends to increase its annual dividend per share to $3.20 per share in 2025. The Zacks Consensus Estimate for LLY's 2025 sales and EPS implies a year-over-year increase of 32.6% and 70.0%, respectively. EPS estimates for 2025 as well as 2026 have declined over the past 60 days. Image Source: Zacks Investment Research The Zacks Consensus Estimate for AstraZeneca's 2025 sales and EPS implies a year-over-year increase of 6.7% and 9.3%, respectively. EPS estimates for both 2025 and 2026 have risen over the past 60 days. Image Source: Zacks Investment Research Year to date, while LLY's stock has declined 5.7%, AstraZeneca's stock has risen 9.8%. The industry has declined 4.5% in the said time frame. Image Source: Zacks Investment Research Both Lilly and AZN are priced higher than the industry from a valuation standpoint. Lilly is more expensive than AstraZeneca, going by the price/earnings ratio. Lilly's shares currently trade at 28.31 forward earnings, higher than 15.13 for AZN. However, both AZN and LLY are trading at discounts to their 5-year mean. Image Source: Zacks Investment Research Lilly's dividend yield is 0.8%, while AZN's is much higher at around 2.9%. Image Source: Zacks Investment Research Lilly's return on equity of 85.5% is higher than AZN's 33.1%. Both Lilly and AstraZeneca have a Zacks Rank #3 (Hold), which makes choosing one stock a difficult task. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Lilly is a good stock to have in one's portfolio, considering its diversified product and pipeline portfolio and robust growth prospects despite its expensive valuation. Lilly's tremendous success with Mounjaro and Zepbound has made it the largest drugmaker with a market cap of more than $650 billion. In 2025, Lilly expects to record revenues in the range of $58.0 billion to $61.0 billion, indicating an impressive 32% year-over-year growth. However, considering Lilly's several near-term challenges, AstraZeneca looks like a safer bet for short-term investors, given its price appreciation, cheaper valuation and robust growth prospects. Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. AstraZeneca expects core EPS to increase by a low double-digit percentage. Consistently rising estimates also indicate analysts' optimistic outlook for growth. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research

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