Eli Lilly and Co Q4 2025 Eli Lilly & Co Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 Eli Lilly & Co Earnings Call
Speaker #1: Entering a listen-only mode. Later, we will be conducting a question-and-answer session and instructions will be given at that time. Should you request assistance during the call, please press star, then zero, and an operator will assist you offline.
Speaker #1: I would now like to turn the conference over to your host, Mike Czapar. Senior Vice President of Investor Relations. Please go
Speaker #1: ahead. Good morning.
Speaker #2: Thank you for joining us for ELI LILLY & Company's Q4 2025 earnings call. I'm Mike Czapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Lucas Montarce, Chief Financial Officer, Dan Skovronsky, Chief Scientific and Product Officer, Adrienne Brown, President of Lilly Immunology, Dr. Carol Ho, President of Lilly Neuroscience, Ilya Yufa, President of Lilly USA and Global Customer Capabilities, Jake Van Naarden, President of Immunology and Head of Business Development, Patrick Johnson, President of Lilly International, and Ken Custer, President of Lilly Cardiometabolic Health.
Speaker #2: We're also joined by Mark Keeman, Susan Hedgeland and Wes Tall of the Investor Relations team. During this conference call, we anticipate making projections and forward-looking statements based on our current expectations.
Speaker #2: Our actual results could differ materially due to several factors, including those listed on slide four. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K, subsequent filings with the SEC.
Speaker #2: The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional. It is not sufficient for our prepared remarks, please note that our prescribing decisions.
Speaker #2: As we transition to commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over
Speaker #2: to Dave. Thank you,
Speaker #3: Mike. 2025 was a strong year for Lilly. We delivered robust revenue growth, advanced our pipeline, expanded our manufacturing footprint, and helped over 70 million people around the world.
Speaker #3: In 2025 full-year revenue grew 45% compared to 2024, driven by our key products. We launched new medicines like Inlurio, secured new indications for Envo and Jayperca, and entered new markets as we completed the international rollouts of both Mounjaro and Kisunlo.
Speaker #3: We generated positive clinical data in more than 25 phase three trials, including registrational trials to support two new incretins: Forlopron and Ritatrutide. We submitted Orfolopron for obesity in the US and in more than 40 countries globally.
Speaker #3: We started 14 new phase three programs over the past few months, including Aloralintide and Brinepatide. And we have one of the largest clinical stage pipelines in our company's history.
Speaker #3: We executed 39 business development transactions across all our therapeutic areas and added multiple clinical stage assets through transactions. Scorpion for site one at Verum and the upcoming acquisition of Ventex.
Speaker #3: We continue investing in artificial intelligence to discover and develop new medicines. In addition to our new supercomputer, we recently announced a new collaboration with NVIDIA to open a co-innovation AI lab.
Speaker #3: This project will combine Lilly's scientific expertise with NVIDIA's leading technology to accelerate drug discovery. We progressed our manufacturing expansion efforts and announced plans to build multiple new manufacturing sites in the US and Europe.
Speaker #3: We increased our manufacturing capacity and began making medicine at our new sites in Wisconsin and North Carolina. We exceeded our goal to produce 1.8 times the number of incretin doses in the second half of '25 compared to the second half of '24.
Speaker #3: Since 2020, we've committed over $55 billion to the largest manufacturing buildout in company history. We provide access to obesity medicines to millions of Americans with insurance through Medicare and Medicaid.
Speaker #3: We're proud of our ability to bring these important medicines to patients at a cost of only $50 per month out of pocket. The number of people engaging with our US direct-to-patient platform, LillyDirect, increased to over 1 million patients in 2025.
Speaker #3: Our most popular offering, the Zepbound self-pay vials, now makes up one-third of new patient starts who start on any brand of obesity medication. Lastly, we distributed $1.3 billion in dividends and $1.5 billion in share repurchases.
David Ricks: Able to produce 1.8 times the number of Incruse doses in the second half of 2025, compared to the second half of 2024. Since 2020, we've committed over $55 billion, the largest manufacturing build-out in company history. We announced an agreement with the US government to provide access to obesity medicines to millions of Americans with insurance through Medicare and Medicaid. We're proud of our ability to bring these important medicines to patients at a cost of only $50 per month out of pocket. The number of people engaging with our US direct-to-patient platform, Lilly Direct, increased to over 1 million patients in 2025. Our most popular offering, the Zepbound self-pay vials, now makes up 1/3 of new patient starts who start on any brand of obesity medication.
David A. Ricks: Able to produce 1.8x the number of Incruse doses in the second half of 2025, compared to the second half of 2024. Since 2020, we've committed over $55 billion, the largest manufacturing build-out in company history. We announced an agreement with the US government to provide access to obesity medicines to millions of Americans with insurance through Medicare and Medicaid. We're proud of our ability to bring these important medicines to patients at a cost of only $50 per month out of pocket. The number of people engaging with our US direct-to-patient platform, Lilly Direct, increased to over 1 million patients in 2025. Our most popular offering, the Zepbound self-pay vials, now makes up 1/3 of new patient starts who start on any brand of obesity medication.
Speaker #1: To produce 1.8 times the number of Inkerton doses in the second half of '25 compared to the second half of '24. Since 2020, we've committed over 55 billion dollars to the largest manufacturing buildout in company history.
Speaker #3: We also strengthened our leadership team with the addition of two new executives, and I welcome both Carol Ho and Adrienne Brown to this call for the first time.
Speaker #3: Now, I'll turn it over to Lucas to review our Q4 results and share details on the 2026 guide.
Speaker #1: We announced an agreement with the U.S. government to provide access to obesity medicines to millions of Americans with insurance through Medicare and Medicaid. We're proud of our ability to bring these important medicines to patients at a cost of only $50 per month out of pocket.
Speaker #4: Thanks, Dave. We deliver robust financial performance in 2025. Our full-year revenue of $65.2 billion increased by 45% compared to 2024, and earnings per share grew by 86% to $24.21.
Speaker #1: The number of people engaging with our U.S. direct-to-patient platform, LILLY Direct, increased to over 1 million patients in 2025. Our most popular offering, the Zepbound Self-Pay vials, now makes up one-third of new patient starts who start on any brand of obesity medication.
Speaker #4: Q4 financial performance was also strong as shown on slide 43% compared to Q4 2024, driven by our key products. Gross margin as a percentage of revenue was 83.2%, consistent with Q4 2024.
Speaker #1: Lastly, we distributed $1.3 billion in dividends and $1.5 billion in share repurchases. We also strengthened our leadership team with the addition of two new executives, and I welcome both Carol Ho and Adrian Brown to this call for the first time.
David Ricks: Lastly, we distributed $1.3 billion in dividends and $1.5 billion in share repurchases. We also strengthened our leadership team with the addition of two new executives, and I welcome both Carole Ho and Adrienne Brown to this call for the first time. Now I'll turn it over to Lucas to review our Q4 results and share details on the 2026 guide.
David A. Ricks: Lastly, we distributed $1.3 billion in dividends and $1.5 billion in share repurchases. We also strengthened our leadership team with the addition of two new executives, and I welcome both Carole Ho and Adrienne Brown to this call for the first time. Now I'll turn it over to Lucas to review our Q4 results and share details on the 2026 guide.
Speaker #4: Favorable product mix and improved production costs were offset by lower realized prices. R&D expenses increased by 26%, driven by continued investments in our early and late-stage portfolio.
Speaker #1: Now I'll turn it over to Lucas to review our Q4 results and share details on the 2026 guide.
Speaker #4: Marketing, selling, and administrative expenses increased 29%, driven by promotional efforts to support our ongoing and future launches. Our non-GAAP performance margin was 47.2%, an increase of 4.2 percentage points compared to Q4 2024.
Speaker #2: Thanks, Dave. We deliver robust financial performance in 2025. Our full-year revenue of $65.2 billion increased by 45% compared to 2024, and earnings per share grew by 86% to $24.21.
Lucas Montarce, M.D.: Thanks, Dave. We delivered robust financial performance in 2025. Our full-year revenue of $65.2 billion increased by 45% compared to 2024, and earnings per share grew by 86% to $24.21. Q4 financial performance was also strong, as shown on slide 7. Revenue grew 43% compared to Q4 2024, driven by our key products. Gross margin as a percentage of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved production costs were offset by lower realized prices. R&D expenses increased by 26%, driven by continued investments in our early and late-stage portfolio. Marketing, selling, and administrative expenses increased 29%, driven by promotional efforts to support our ongoing and future launches.
Lucas Montarce: Thanks, Dave. We delivered robust financial performance in 2025. Our full-year revenue of $65.2 billion increased by 45% compared to 2024, and earnings per share grew by 86% to $24.21. Q4 financial performance was also strong, as shown on slide 7. Revenue grew 43% compared to Q4 2024, driven by our key products. Gross margin as a percentage of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved production costs were offset by lower realized prices. R&D expenses increased by 26%, driven by continued investments in our early and late-stage portfolio. Marketing, selling, and administrative expenses increased 29%, driven by promotional efforts to support our ongoing and future launches.
Speaker #4: Our effective tax rate was 19.7%, and earnings per share were $7.54, inclusive acquired IPR&D of 52 cents of charges. These compared to earnings per share of $5.32 in Q4 2024, which included 19 cents of acquired IPR&D charges.
Speaker #2: Q4 financial performance was also strong as shown on slide 7. Revenue grew 43% compared to Q4 2024, driven by our key products: gross margin as a percentage of revenue was 83.2%, consistent with Q4 2024.
Speaker #2: Favorable product mix and improved production costs were offset by lower realized prices. R&D expenses increased by 26%, driven by continued investments in our early- and late-stage portfolio.
Speaker #4: On slide eight, we quantified the effect of price, rate, and volume on revenue. US revenue increased 43% in Q4, driven by volume growth of Mounjaro and Zepbound, partially offset by a 7% decline in price.
Speaker #2: Marketing, selling, and administrative expenses increased 29%, driven by promotional efforts to support our ongoing and future launches. Our non-GAAP performance margin was 47.2%, an increase of 4.2 percentage points compared to Q4 2024.
Speaker #4: Revenue growth was strong outside the US as well, driven by double-digit volume growth in Europe, Japan, and China. In the rest of the world, volume doubled, driven by the launch of Mounjaro in new markets.
Lucas Montarce, M.D.: Our non-GAAP performance margin was 47.2%, an increase of 4.2 percentage points compared to Q4 2024. Our effective tax rate was 19.7%, and earnings per share were $7.54, inclusive of $0.52 of acquired IPR&D charges. This compares to earnings per share of $5.32 in Q4 2024, which included $0.19 of acquired IPR&D charges. On slide 8, we quantify the effect of price, rate, and volume on revenue. US revenue increased 43% in Q4, driven by volume growth of Mounjaro and Zepbound, partially offset by a 7% decline in price. Revenue growth was strong outside the US as well, driven by double-digit volume growth in Europe, Japan, and China. In rest of the world, volume doubled, driven by the launch of Mounjaro in new markets.
Lucas Montarce: Our non-GAAP performance margin was 47.2%, an increase of 4.2 percentage points compared to Q4 2024. Our effective tax rate was 19.7%, and earnings per share were $7.54, inclusive of $0.52 of acquired IPR&D charges. This compares to earnings per share of $5.32 in Q4 2024, which included $0.19 of acquired IPR&D charges. On slide 8, we quantify the effect of price, rate, and volume on revenue. US revenue increased 43% in Q4, driven by volume growth of Mounjaro and Zepbound, partially offset by a 7% decline in price. Revenue growth was strong outside the US as well, driven by double-digit volume growth in Europe, Japan, and China. In rest of the world, volume doubled, driven by the launch of Mounjaro in new markets.
Speaker #4: On slide nine, we provide an update on the performance of our key products. We've contributed over $13 billion to revenue this quarter and grew by 91% compared to Q4 2024.
Speaker #2: Our effective tax rate was 19.7%, and earnings per share were $7.54, inclusive of $0.52 of acquired IPR&D and $5.32 in Q4 2024, which included $0.19 of.
Speaker #4: Beginning with neuroscience, Kisunla recently became the US market leader in the amyloid targeting therapy space, with more than 50% share of total prescriptions. Revenue was $109 million driven by overall market growth, increased awareness, and diagnosis of Alzheimer's disease, as well as increased prescriber adoption based on Kisunla's clinical profile.
Speaker #2: Included $0.19 of acquired IPR&D charges. On slide 8, we quantified the earnings per share effect of price, rate, and volume on revenue. These compared to prior periods.
Speaker #2: U.S. revenue increased 43% in Q4, driven by volume growth of Mounjaro and a decline in price. Zepbound was strong outside the U.S., partially offset by a 7% revenue growth.
Speaker #4: In immunology, Epgliss delivers solid performance in atopic dermatitis, where it used total prescriptions increased 25% compared to Q3 2025. Bombo continued its uptake and global revenue increased 55% compared to the fourth quarter in 2024.
Speaker #2: as well, driven by double-digit volume growth in Europe, Japan, and China. In the rest of the world, volume doubled, driven by the launch of Mounjaro in new markets.
Speaker #2: On slide 9, we provide an update on the performance of our key products. We contributed over $13 billion to revenue this quarter and grew by 91% compared to Q4 2024.
Lucas Montarce, M.D.: On slide 9, we provide an update on the performance of our key products, which contributed over $13 billion to revenue this quarter and grew by 91% compared to Q4 2024. Beginning with neuroscience, Kisunla recently became the US market leader in the amyloid-targeting therapy space, with more than 50% share of total prescriptions. Revenue was $109 million, driven by overall market growth, increased awareness and diagnosis of Alzheimer's disease, as well as increased prescriber adoption based on Kisunla's clinical profile. In immunology, Ebglyss delivers solid performance in atopic dermatitis, where U.S. total prescriptions increased 25% compared to Q3 2025. Omvoh continued its uptake, and global revenue increased 55% compared to the fourth quarter in 2024. Jaypirca posted another strong quarter of sales performance, and global sales grew 30% compared to Q4 2024.
Lucas Montarce: On slide 9, we provide an update on the performance of our key products, which contributed over $13 billion to revenue this quarter and grew by 91% compared to Q4 2024. Beginning with neuroscience, Kisunla recently became the US market leader in the amyloid-targeting therapy space, with more than 50% share of total prescriptions. Revenue was $109 million, driven by overall market growth, increased awareness and diagnosis of Alzheimer's disease, as well as increased prescriber adoption based on Kisunla's clinical profile. In immunology, Ebglyss delivers solid performance in atopic dermatitis, where U.S. total prescriptions increased 25% compared to Q3 2025. Omvoh continued its uptake, and global revenue increased 55% compared to the fourth quarter in 2024. Jaypirca posted another strong quarter of sales performance, and global sales grew 30% compared to Q4 2024.
Speaker #4: Jaipirka posted another strong quarter of sales performance, and global sales grew 30% compared to Q4 2024. We recently received an expanded US indication to include people previously treated with a covalent BTK inhibitor, significantly increasing the number of people who can benefit from this medicine.
Speaker #2: Beginning with neuroscience, Kisunla recently became the U.S. market leader in the amyloid-targeting therapy space, with more than 50% share of total prescriptions. Revenue was $109 million, driven by overall market growth, increased awareness and diagnosis of Alzheimer's disease, as well as increased prescriber adoption based on Kisunla's clinical profile.
Speaker #4: Vercenio Global Sales increased 3%, driven by volume growth outside the US. Vercenio remains the market leader in its early breast cancer indication, however, overall market penetration has reached a plateau, as reflected in US trends.
Speaker #2: In immunology, EBGLIS delivers solid performance in atopic dermatitis, where its total Q3 prescriptions increased 25% in 2025 compared to the previous year. ONVO continued its uptake, and global revenue increased 55% compared to the fourth quarter in 2024.
Speaker #4: Finally, in cardiometabolic health, Zepbound and Mounjaro both deliver strong results. Outside the US, the positive uptake trends of Mounjaro continued, particularly in our newest launch countries in Latin America and Asia.
Speaker #4: We have launched in all major markets and are now the increased share of market leader outside the US as well. Moving to the US, as shown on slide 10, we combine increasing analog market continued robust growth trajectory.
Speaker #2: JAYPIRCA posted another strong quarter of sales performance, and global sales grew 30% compared to Q4 2024. We recently received an expanded U.S. indication to include people previously treated with a covalent BTK inhibitor.
Lucas Montarce, M.D.: We recently received an expanded US indication to include people previously treated with a covalent BTK inhibitor, significantly increasing the number of people who can benefit from this medicine. Verzenio global sales increased 3%, driven by volume growth outside the US. Verzenio remains the market leader in its early breast cancer indication. However, overall market penetration has reached a plateau, as reflected in US trends. Finally, in cardiometabolic health, Zepbound and Mounjaro both delivered strong results. Outside the US, the positive uptake trends of Mounjaro continued, particularly in our newest launch countries in Latin America and Asia. We have launched in all major markets and are now the market share leader outside the US as well. Moving to the US, as shown on slide 10, the combined incretin analog market continues its robust growth trajectory, with total prescriptions increasing by 33% compared to Q4 2024.
Lucas Montarce: We recently received an expanded US indication to include people previously treated with a covalent BTK inhibitor, significantly increasing the number of people who can benefit from this medicine. Verzenio global sales increased 3%, driven by volume growth outside the US. Verzenio remains the market leader in its early breast cancer indication. However, overall market penetration has reached a plateau, as reflected in US trends. Finally, in cardiometabolic health, Zepbound and Mounjaro both delivered strong results. Outside the US, the positive uptake trends of Mounjaro continued, particularly in our newest launch countries in Latin America and Asia. We have launched in all major markets and are now the market share leader outside the US as well. Moving to the US, as shown on slide 10, the combined incretin analog market continues its robust growth trajectory, with total prescriptions increasing by 33% compared to Q4 2024.
Speaker #4: Total prescriptions increasing by 33% compared to Q4 2024. As market penetration within the eligible population of people with obesity is only mid-single digits, we believe there is room for market expansion and sustained market growth in the quarters and years to come.
Speaker #2: Significantly increasing the number of people who can benefit from this medicine. Verzenio Global Sales increased 3%, driven by volume growth outside the U.S. Verzenio remains the market leader in its early breast cancer indication, however, overall market penetration has reached a plateau, as reflected in U.S.
Speaker #4: US Zepbound revenue more than doubled compared to Q4 2024, Zepbound continues to be the market leader in the branded obesity market with nearly 70% share of new prescriptions.
Speaker #2: Trends. Finally, in cardiometabolic health, Zepbound and Mounjaro both deliver strong results. Outside the U.S., the positive uptake trends of Mounjaro continued, particularly in our newest launch countries in Latin America and Asia.
Speaker #4: US total prescription growth for Zepbound was robust, both in auto injectors and vials. We are encouraged to see sustained growth uptake of Zepbound vials, which represented approximately one-third of total Zepbound prescriptions and nearly 50% of new Zepbound prescriptions in Q4.
Speaker #2: We have launched in all major markets and are now the Inkert share of market leader outside the U.S. as well. Moving to the U.S., as shown on slide 10, we combine Inkertine analog market continued its robust growth trajectory.
Speaker #4: In the US, Mounjaro expanded market leadership in the type 2 diabetes increasing market, exiting the new prescriptions. On slide 11, we provide an quarter with over 55% of update on capital allocation.
Speaker #2: With total prescriptions increasing by 33% compared to Q4 2024, and market penetration within the eligible population of people with obesity still only in the mid-single digits, we believe there is room for market expansion and sustained market growth in the quarters and years to come.
Lucas Montarce, M.D.: As market penetration within the eligible population of people with obesity is only mid-single digits, we believe there is room for market expansion and sustained market growth in the quarters and years to come. US Zepbound revenue more than doubled compared to Q4 2024. Zepbound continues to be the market leader in the branded obesity market, with nearly 70% share of new prescriptions. US total prescription growth for Zepbound was robust, both in auto-injectors and vials. We are encouraged to see sustained growth uptake of Zepbound vials, which represented approximately 1/3 of total Zepbound prescriptions and nearly 50% of new Zepbound prescriptions in Q4. In the US, Mounjaro expanded market leadership in the type two diabetes incretin market, exiting the quarter with over 55% of new prescriptions. On slide 11, we provide an update on capital allocation.
Lucas Montarce: As market penetration within the eligible population of people with obesity is only mid-single digits, we believe there is room for market expansion and sustained market growth in the quarters and years to come. US Zepbound revenue more than doubled compared to Q4 2024. Zepbound continues to be the market leader in the branded obesity market, with nearly 70% share of new prescriptions. US total prescription growth for Zepbound was robust, both in auto-injectors and vials. We are encouraged to see sustained growth uptake of Zepbound vials, which represented approximately 1/3 of total Zepbound prescriptions and nearly 50% of new Zepbound prescriptions in Q4. In the US, Mounjaro expanded market leadership in the type two diabetes incretin market, exiting the quarter with over 55% of new prescriptions. On slide 11, we provide an update on capital allocation.
Speaker #4: Moving to slide 12 and 13, we share our 2026 financial guidance and highlight key factors that will impact our financial outlook. We expect revenue to be between $80 and $83 billion.
Speaker #2: U.S. Zepbound revenue more than doubled compared to Q4 2024. Zepbound continues to be the market leader in the branded obesity market, with nearly 70% share of new prescriptions.
Speaker #4: The midpoint of our revenue range is an increase of 25% compared to 2025. We expect to deliver industry-leading volume growth driven by our key products, partially offset by lower realized prices.
Speaker #2: U.S. total prescription growth for Zepbound was robust, both in autoinjectors and vials. We are encouraged to see sustained growth uptake of Zepbound vials, which represented approximately one-third of total Zepbound prescriptions and nearly 50% of new Zepbound prescriptions in Q4.
Speaker #4: Price is expected to be a drag on growth in the low to mid-teens, three factors will impact US price. The medicines, updated direct-to-patient Zepbound pricing, and lower Medicaid prices for later lifecycle medicines.
Speaker #2: In the U.S., Mounjaro expanded market leadership in the type 2 diabetes Inkertine market. Exiting the quarter with over 55% of new prescriptions. On slide 11, we provide an update on capital allocation.
Speaker #4: Pricing outside the US will be impacted by Mounjaro's, inclusion on China national reimbursement drug list for type 2 diabetes. We believe this price concessions will be more than offset by increased volume over time, as we expand the number of people who can benefit from LILY medicines.
Speaker #2: Moving to slides 12 and 13, we share our 2026 financial guidance and highlight key factors that will impact our financial outlook. We expect revenue to be between $80 and $83 billion.
Lucas Montarce, M.D.: Moving to slide 12 and 13, we share our 2026 financial guidance and highlight key factors that will impact our financial outlook. We expect revenue to be between $80 and 83 billion. The midpoint of our revenue range is an increase of 25% compared to 2025. We expect to deliver industry-leading volume growth driven by our key products, partially offset by lower realized prices. Price is expected to be a drag on growth in the low to mid-teens. Three factors will impact US price: the government access agreement for obesity medicines, updated direct-to-patient Zepbound pricing, and lower Medicaid prices for later lifecycle medicines. Pricing outside the US will be impacted by Mounjaro's inclusion on China National Reimbursement Drug List for type 2 diabetes.
Lucas Montarce: Moving to slide 12 and 13, we share our 2026 financial guidance and highlight key factors that will impact our financial outlook. We expect revenue to be between $80 and 83 billion. The midpoint of our revenue range is an increase of 25% compared to 2025. We expect to deliver industry-leading volume growth driven by our key products, partially offset by lower realized prices. Price is expected to be a drag on growth in the low to mid-teens. Three factors will impact US price: the government access agreement for obesity medicines, updated direct-to-patient Zepbound pricing, and lower Medicaid prices for later lifecycle medicines. Pricing outside the US will be impacted by Mounjaro's inclusion on China National Reimbursement Drug List for type 2 diabetes.
Speaker #4: As I shared earlier, we continue to see robust growth trends in the US increasing analogs market, and we expect a similar trajectory to continue in 2026.
Speaker #2: The midpoint of our revenue range is an increase of 25% compared to 2025. We expect to deliver industry-leading volume growth, driven by our key products.
Speaker #4: As seen with other new launches, we expect the launch of oral GLP-1s to expand the addressable market. We expect our Folgipron to launch for chronic weight management in the US, during the second quarter of 2026, and to launch in most international markets during 2027.
Speaker #2: Partially offset by lower realized prices. Price is expected to be a drag on growth in the low- to mid-teens. Three factors will impact U.S.
Speaker #2: price. The government access agreement for obesity Zepbound pricing, and lower medicines, updated direct-to-patient Medicaid prices for later life cycle medicines. Pricing outside the U.S.
Speaker #4: We anticipate new Medicare access to no later than July 1st, obesity medicines will become effective 2026. While we anticipate a reduction in Medicaid access in 2026 due to key states like California removing obesity coverage, we expect new states will add coverage for people with Medicaid in 2027.
Speaker #2: will be impacted by Mounjaro's inclusion on China, national reimbursement drug list for type 2 diabetes. We believe this price concessions will be more than offset by increased volume over time, as we expand the number of people who can benefit from Lilly Medicines.
Lucas Montarce, M.D.: We believe these price concessions will be more than offset by increased volume over time as we expand the number of people who can benefit from Lilly medicines. As I shared earlier, we continue to see robust growth trends in the US incretin analogs market, and we expect a similar trajectory to continue in 2026. As seen with other new launches, we expect the launch of oral GLP-1s to expand the addressable market. We expect Orforglipron to launch for chronic weight management in the US during Q2 2026, and to launch in most international markets during 2027. We anticipate new Medicare access to obesity medicines will become effective no later than 1 July 2026.
Lucas Montarce: We believe these price concessions will be more than offset by increased volume over time as we expand the number of people who can benefit from Lilly medicines. As I shared earlier, we continue to see robust growth trends in the US incretin analogs market, and we expect a similar trajectory to continue in 2026. As seen with other new launches, we expect the launch of oral GLP-1s to expand the addressable market. We expect Orforglipron to launch for chronic weight management in the US during Q2 2026, and to launch in most international markets during 2027. We anticipate new Medicare access to obesity medicines will become effective no later than 1 July 2026.
Speaker #4: Within revenue, we anticipate Epgliss Jaipirka in Lurio, Kisunla, and Ombo will all contribute to growth, whereas late lifecycle products like Trulicity, Talsen, Vercenio, are expected to be flat or decline.
Speaker #2: As I shared earlier, we continue to see robust growth trends in the U.S. Inkertine analogs market, and we expect a similar trajectory to continue in 2026.
Speaker #4: We expect our non-GAAP performance margin to be between 46 and 47.5%. Across the P&L, there are pushes and pulls that we anticipate will impact our performance margin expectations.
Speaker #2: As seen with other new launches, we expect the launch of oral GLP-1s to expand their addressable market. We expect our fulgupron to launch for chronic weight management in the U.S., during the second quarter of 2026, and to launch in most international markets during 2027.
Speaker #4: We expect gross margin will be relatively stable, to slightly down compared to Q4 2025. As favorable product mix and increased productivity are offset by price and new facilities coming online.
Speaker #2: We anticipate new Medicare access to obesity medicines will become effective no later than July 1, 2026. While we anticipate a reduction in Medicaid access in 2026, due to key states like California removing obesity coverage, we expect new states will add coverage for people with Medicaid in 2027.
Lucas Montarce, M.D.: While we anticipate a reduction in Medicaid access in 2026 due to key states like California removing obesity coverage, we expect new states will add coverage for people with Medicaid in 2027. Within revenue, we anticipate Ebglyss, Jaypirca, Inluriyo, Kisunla, and Omvoh will all contribute to growth, whereas late life cycle products like Trulicity, Taltz, and Verzenio are expected to be flat or decline. We expect our non-GAAP performance margin to be between 46 and 47.5%. Across the P&L, there are pushes and pulls that we anticipate will impact our performance margin expectations. We expect gross margin will be relatively stable to slightly down compared to Q4 2025, as favorable product mix and increased productivity are offset by price and new facilities coming online. Consistent with our strategy to invest in innovation, we expect R&D expenses will scale up in 2026.
Lucas Montarce: While we anticipate a reduction in Medicaid access in 2026 due to key states like California removing obesity coverage, we expect new states will add coverage for people with Medicaid in 2027. Within revenue, we anticipate Ebglyss, Jaypirca, Inluriyo, Kisunla, and Omvoh will all contribute to growth, whereas late life cycle products like Trulicity, Taltz, and Verzenio are expected to be flat or decline. We expect our non-GAAP performance margin to be between 46 and 47.5%. Across the P&L, there are pushes and pulls that we anticipate will impact our performance margin expectations. We expect gross margin will be relatively stable to slightly down compared to Q4 2025, as favorable product mix and increased productivity are offset by price and new facilities coming online. Consistent with our strategy to invest in innovation, we expect R&D expenses will scale up in 2026.
Speaker #4: Consistent with our strategy to invest in innovation, we expect R&D expenses will scale up in 2026. We have 36 active phase 3 programs in our pipeline, and plan to initiate even more new programs in 2026.
Speaker #2: Within revenue, we anticipate EBGLIS, JYPIRCA, INLURIO, Kisunla, and ONVO will all contribute to growth, whereas late life cycle products like Trulicity, TALS, and Verzenio are expected to be flat or decline.
Speaker #4: With one of the largest clinical stage pipeline in company history, we are investing to maximize the impact of this potential new medicines. Marketing, selling, and administrative expenses are expected to grow as we invest to support new launches across therapeutic areas.
Speaker #2: We expect our non-GAAP performance margin to be between 46% and 47.5%. Across the P&L, there are pushes and pulls that we anticipate will impact our performance margin expectations.
Speaker #4: As we launch new medicines, we will fully invest in valuable expenses while controlling fixed costs by leveraging our existing commercial footprint. We expect earnings per share of between $33.50 and $35, setting us up for another year of strong top line and bottom line growth.
Speaker #2: We expect gross margin will be relatively stable to slightly down compared to Q4 2025, as favorable product mix and increased productivity are offset by price and new facilities coming online.
Speaker #4: Nana will turn the call over to Dan to highlight our progress on
Speaker #2: Consistent with our strategy to invest in innovation, we expect R&D expenses will scale up in 2026. We have 36 active phase 3 programs in our pipeline, and plan to initiate even more new programs in 2026.
Speaker #4: R&D. Thanks, Lucas.
Speaker #2: Since our last R&D call, we've made significant progress in R&D. I'll share updates by therapeutic area, including select data highlights from recent phase 3 announcements, a final update on 2025 key events, and the potential 2026 outcomes on which we are now focused.
Lucas Montarce, M.D.: We have 36 active phase 3 programs in our pipeline and plan to initiate even more new programs in 2026. With one of the largest clinical stage pipeline in company history, we are investing to maximize the impact of these potential new medicines. Marketing, selling, and administrative expenses are expected to grow as we invest to support new launches across therapeutic areas. As we launch new medicines, we will fully invest in variable expenses while controlling fixed costs by leveraging our existing commercial footprint. We expect earnings per share of between $33.50 and $35, setting us up for another year of strong top line now and bottom line growth. Now, I will turn the call over to Dan to highlight our progress on R&D.
Lucas Montarce: We have 36 active phase 3 programs in our pipeline and plan to initiate even more new programs in 2026. With one of the largest clinical stage pipeline in company history, we are investing to maximize the impact of these potential new medicines. Marketing, selling, and administrative expenses are expected to grow as we invest to support new launches across therapeutic areas. As we launch new medicines, we will fully invest in variable expenses while controlling fixed costs by leveraging our existing commercial footprint. We expect earnings per share of between $33.50 and $35, setting us up for another year of strong top line now and bottom line growth. Now, I will turn the call over to Dan to highlight our progress on R&D.
Speaker #2: With one of the largest clinical stage pipeline in company history, we are investing to maximize the impact of this potential new medicines. Marketing, selling, and administrative expenses are expected to grow as we invest to support new launches across therapeutic areas.
Speaker #2: Beginning with immunology, just a few weeks ago, we released top-line data from Together PSA, a randomized controlled phase 3B trial evaluating exocismab plus tirzepatide as compared to exocismab alone, in people with psoriatic arthritis and obesity.
Speaker #2: As we launch new medicines, we will fully invest in valuable expenses while controlling fixed costs by leveraging our existing commercial footprint. We expect earnings per share of between $33 and $0.50 and $35.
Speaker #2: This first-of-its-kind study assessed whether a concomitant treatment with an incretin could deliver additional efficacy when added to an existing immunology treatment. As shown on slide 14, the combination not only achieved its primary endpoints, at least 50% reduction in psoriatic arthritis activity plus 10% weight reduction, but also showed a 64% relative increase in the proportion of patients achieving a 50% reduction in their psoriatic arthritis symptoms compared to exocismab alone.
Speaker #2: Setting us up for another year of strong top line and bottom line growth. Nana will turn the call over to Dan to highlight
Speaker #1: . Data Thanks , . It's our last earnings call . Lucas progress on significant progress in R&D . I'll share updates by R&D therapeutic from select data recent including area , highlights phase three announcements , a final update progress in I'll share updates by therapeutic area , including R&D .
Daniel Skovronsky: Thanks, Lucas. Since our last earnings call, we've made significant progress in R&D. I'll share updates by therapeutic area, including select data highlights from recent phase 3B announcements, a final update on key events, and the potential 2026 outcomes on which we are now focused. Beginning with immunology. Just a few weeks ago, we released top-line data from TOGETHER-PSA, a randomized controlled phase 3B trial evaluating ixekizumab plus tirzepatide, as compared to ixekizumab alone, in people with psoriatic arthritis and obesity. This first-of-its-kind study assessed whether concomitant treatments with an incretin could deliver additional efficacy when added to an existing immunology treatment.
Daniel M. Skovronsky: Thanks, Lucas. Since our last earnings call, we've made significant progress in R&D. I'll share updates by therapeutic area, including select data highlights from recent phase 3B announcements, a final update on key events, and the potential 2026 outcomes on which we are now focused. Beginning with immunology. Just a few weeks ago, we released top-line data from TOGETHER-PSA, a randomized controlled phase 3B trial evaluating ixekizumab plus tirzepatide, as compared to ixekizumab alone, in people with psoriatic arthritis and obesity. This first-of-its-kind study assessed whether concomitant treatments with an incretin could deliver additional efficacy when added to an existing immunology treatment.
Speaker #2: An important finding from the study was the potential effect of tirzepatide, when added to exocismab, on psoriatic arthritis symptoms via both weight-dependent and also weight-independent mechanisms.
Speaker #1: highlights from recent phase three announcements , a final update on 2025 key events , and the potential 2026 outcomes on which we are now focused , beginning with immunology ago , we few weeks released top data from .
Speaker #2: These results further support existing treatment guidelines for psoriatic arthritis that recommend treatment of comorbid obesity. Instead of further light on how incretins may have a positive effect on other diseases independent from weight loss, we look forward to publishing these data in more detail in a peer-reviewed journal and presenting them at an upcoming medical meeting.
Speaker #1: Line PSA, randomized together phase 3 trial controlled evaluating Ixekizumab plus just tirzepatide compared to Ixekizumab alone with people, arthritis psoriatic.
Speaker #2: With this important result in hand, we are encouraged exocismab and tirzepatide in psoriasis. In two separate studies of myrcinium and tirzepatide in Crohn's disease and ulcerative colitis, we also advanced our new GIP GLP-1 agonist for hepatitis into a phase 2 study of asthma.
Speaker #1: A first-of-its-kind study assessed whether a concomitant treatment with an incretin could deliver additional efficacy to an existing immunology therapy. As shown on slide 14, the primary endpoint was achieved: at least a 50% reduction in psoriatic arthritis activity, plus a 10% weight reduction. The study also showed a 64% relative increase in the number of patients achieving a 50% reduction in arthritis symptoms compared to Ixekizumab alone.
Daniel Skovronsky: As shown on slide 14, the combination not only achieved its primary endpoint, at least 50% reduction in psoriatic arthritis activity plus 10% weight reduction, but also showed a 64% relative increase in the proportion of patients achieving a 50% reduction in their psoriatic arthritis symptoms compared to ixekizumab alone. An important finding from the study was the potential effect of tirzepatide when added to ixekizumab on psoriatic arthritis symptoms via both weight-dependent and also weight-independent mechanisms. These results further support existing treatment guidelines for psoriatic arthritis that recommend treatment of comorbid obesity and shed further light on how incretins may have a positive effect on other diseases independent from weight loss. We look forward to publishing these data in more detail in a peer-reviewed journal and presenting them at an upcoming medical meeting....
Daniel M. Skovronsky: As shown on slide 14, the combination not only achieved its primary endpoint, at least 50% reduction in psoriatic arthritis activity plus 10% weight reduction, but also showed a 64% relative increase in the proportion of patients achieving a 50% reduction in their psoriatic arthritis symptoms compared to ixekizumab alone. An important finding from the study was the potential effect of tirzepatide when added to ixekizumab on psoriatic arthritis symptoms via both weight-dependent and also weight-independent mechanisms. These results further support existing treatment guidelines for psoriatic arthritis that recommend treatment of comorbid obesity and shed further light on how incretins may have a positive effect on other diseases independent from weight loss. We look forward to publishing these data in more detail in a peer-reviewed journal and presenting them at an upcoming medical meeting.
Speaker #2: Another serious immunologic disease that we think may benefit from dual GIP GLP-1 therapy. Moving to oncology, the FDA granted full approval for pertobrutinib, including the expanded indication for treatment of adults with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor.
Speaker #1: An important finding from this study was the effect of tirzepatide when added to ixekizumab on arthritis symptoms, via both psoriatic, weight-dependent, and also weight-independent mechanisms.
Speaker #1: Independent results. These further support treatment, the guidelines for psoriatic arthritis that recommend treatment of obesity comorbid, and shed further light on how incretins may effect positive other from diseases.
Speaker #2: This label update significantly increases the number of eligible patients and allows physicians to extend the use of BTK inhibitors to control disease longer we also share detailed data from two phase 3 pertobrutinib trials, BRU and CLL/313 and BRU and CLL/314.
Speaker #1: weight loss Independent . We look forward to publishing these data in more detail in our peer reviewed journal and presenting them at an upcoming medical meeting .
Daniel Skovronsky: With this important result in hand, we are encouraged about our ongoing trial studying ixekizumab and tirzepatide in psoriasis. In two separate studies of mirikizumab, tirzepatide, Crohn's disease, and ulcerative colitis, we also advanced our new GIP/GLP-1 agonist, prasetamide, into a phase 2 study of asthma, another serious immunologic disease that we think may benefit from dual GIP/GLP-1 therapy. Moving to oncology, the FDA granted full approval for pirtobrutinib, including the expanded indication for treatment of adults with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor. This label update significantly increases the number of eligible patients and allows physicians to extend the use of BTK inhibitors to control disease longer. We also shared detailed data from two phase 3 pirtobrutinib trials, BRUIN-CLL-313 and BRUIN-CLL-314.
Daniel M. Skovronsky: With this important result in hand, we are encouraged about our ongoing trial studying ixekizumab and tirzepatide in psoriasis. In two separate studies of mirikizumab, tirzepatide, Crohn's disease, and ulcerative colitis, we also advanced our new GIP/GLP-1 agonist, prasetamide, into a phase 2 study of asthma, another serious immunologic disease that we think may benefit from dual GIP/GLP-1 therapy. Moving to oncology, the FDA granted full approval for pirtobrutinib, including the expanded indication for treatment of adults with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor. This label update significantly increases the number of eligible patients and allows physicians to extend the use of BTK inhibitors to control disease longer. We also shared detailed data from two phase 3 pirtobrutinib trials, BRUIN-CLL-313 and BRUIN-CLL-314.
Speaker #2: As shown on the left side of slide 15, in BRU and CLL/313, pertobrutinib improved progression-free survival reducing the risk of progression or death by 80% versus bendamustine plus rituximab in treatment naive CLL/SLL patients.
Speaker #1: With this in hand, it's important that we are encouraged about our ongoing studying trial, ixekizumab and in psoriasis. In two separate studies of epithelial disease and ulcerative Merkin colitis growth.
Speaker #2: This risk reduction is among the most compelling ever observed for single-agent BTK inhibitor in a front-line CLL study. In the second study shown on the right side of slide 15, BRU and CLL/314, pertobrutinib was compared to a covalent BTK inhibitor, ibrutinib, in treatment naive or BTK inhibitor naive patients.
Speaker #1: We also our advanced new GIP , GLP one agonist for into a phase two study of asthma . Another serious immunologic disease that we think may benefit from dual GIP , GLP one therapy .
Speaker #1: Moving to oncology, the FDA granted full approval for NIB, including the expanded indication for the treatment of adults with relapsed or refractory CLL.
Speaker #2: The study met the primary endpoint of non-inferiority of overall response rate. And while progression-free survival data were immature, they trended in favor of pertobrutinib.
Speaker #1: SLL , who have previously been treated with a covalent BTK inhibitor . This label update significantly increases the eligible number of patients and allows physicians to extend the use of BTK control inhibitors to disease .
Speaker #2: Notably, in the early analysis of the treatment naive subpopulation, as shown here, pertobrutinib reduced the risk of progression or death by 76% compared to ibrutinib.
Speaker #1: Longer shared We also detailed data . two phase three trials , Bruin CLL 303 and Bruin four , as Ccl3 one shown on the left side of slide 15 .
Daniel Skovronsky: As shown on the left side of slide 15, in BRUIN-CLL-313, pirtobrutinib improved progression-free survival, reducing the risk of progression or death by 80% versus bendamustine plus rituximab in treatment-naive CLL/SLL patients. This risk reduction is among the most compelling ever observed for a single-agent BTK inhibitor in a frontline CLL study. In the second study, shown on the right side of slide 15, BRUIN-CLL-314, pirtobrutinib was compared to a covalent BTK inhibitor, ibrutinib, in treatment-naive or BTK-inhibitor-naive patients. The study met the primary endpoint of non-inferiority of overall response rate, and while progression-free survival data were immature, they trended in favor of pirtobrutinib. Notably, in the early analysis of the treatment-naive subpopulation, as shown here, pirtobrutinib reduced the risk of progression or death by 76% compared to ibrutinib.
Daniel M. Skovronsky: As shown on the left side of slide 15, in BRUIN-CLL-313, pirtobrutinib improved progression-free survival, reducing the risk of progression or death by 80% versus bendamustine plus rituximab in treatment-naive CLL/SLL patients. This risk reduction is among the most compelling ever observed for a single-agent BTK inhibitor in a frontline CLL study. In the second study, shown on the right side of slide 15, BRUIN-CLL-314, pirtobrutinib was compared to a covalent BTK inhibitor, ibrutinib, in treatment-naive or BTK-inhibitor-naive patients. The study met the primary endpoint of non-inferiority of overall response rate, and while progression-free survival data were immature, they trended in favor of pirtobrutinib. Notably, in the early analysis of the treatment-naive subpopulation, as shown here, pirtobrutinib reduced the risk of progression or death by 76% compared to ibrutinib.
Speaker #2: Both data sets were presented at the American Society of Hematology annual meeting, and were simultaneously published in the Journal of Clinical Oncology. We submitted these results to regulatory authorities to potentially enable the use of pertobrutinib in earlier lines of therapy.
Speaker #1: In Bruin 313 . For nib . Improved progression survival free , reducing the risk of progression or death by 80% versus Bendamustine plus rituximab in treatment .
Speaker #2: Later this year, we expect results from an additional phase 3 pertobrutinib trial, BRU and CLL/322. This trial evaluates pertobrutinib in addition to a fixed duration regimen of venetoclax and rituximab, in previously treated CLL/SLL patients.
Speaker #1: Naive patients . This risk among the reduction is most compelling ever single observed for agent BTK a inhibitor in frontline CLL study . In the second study , shown on the right side of slide 15 , grew in Cl3 one four was compared to covalent BTK inhibitor ibrutinib .
Speaker #2: If successful, this could form the basis for an additional regulatory submission later this year. We also presented updated combination data of imlunestrin with abemaciclib in metastatic breast cancer which showed additional benefit compared to imlunestrin alone.
Speaker #1: treatment In naive or BTK inhibitor naive patients . The study met the primary endpoint of noninferiority of overall response rate . And while progression survival free data were they in trended favor of NIB , notably in the early analysis of the treatment .
Speaker #2: We submitted these data to regulators, and are seeking to expand the imlunestrin. While we're encouraged by these new data for patients with metastatic breast cancer, we're even more excited about the opportunity for imlunestrin in adjuvant breast cancer.
Speaker #1: Naive subpopulation . As shown here reduced , NIB the risk progression or death of by 76% compared to ibrutinib . Both data sets were presented at the American Society of annual Hematology meeting , and were published in the Journal of Clinical Oncology simultaneously .
Daniel Skovronsky: Both datasets were presented at the American Society of Hematology annual meeting and were simultaneously published in the Journal of Clinical Oncology. We submitted these results to regulatory authorities to potentially enable the use of Pirtobrutinib in earlier lines of therapy. Later this year, we expect results from an additional phase 3 Pirtobrutinib trial, BRUIN-CLL-322. This trial evaluates Pirtobrutinib in addition to a fixed-duration regimen of Venetoclax and Rituximab in previously treated CLL/SLL patients. If successful, this could form the basis for an additional regulatory submission later this year. We also presented updated combination data of Imlunestrant with Abemaciclib in metastatic breast cancer, which showed additional benefit compared to Imlunestrant alone. We submitted these data to regulators and are seeking to expand the Imlunestrant label.
Daniel M. Skovronsky: Both datasets were presented at the American Society of Hematology annual meeting and were simultaneously published in the Journal of Clinical Oncology. We submitted these results to regulatory authorities to potentially enable the use of Pirtobrutinib in earlier lines of therapy. Later this year, we expect results from an additional phase 3 Pirtobrutinib trial, BRUIN-CLL-322. This trial evaluates Pirtobrutinib in addition to a fixed-duration regimen of Venetoclax and Rituximab in previously treated CLL/SLL patients. If successful, this could form the basis for an additional regulatory submission later this year. We also presented updated combination data of Imlunestrant with Abemaciclib in metastatic breast cancer, which showed additional benefit compared to Imlunestrant alone. We submitted these data to regulators and are seeking to expand the Imlunestrant label.
Speaker #2: Our ongoing 8,000-patient adjuvant breast cancer trial, EMBER-4, is fully enrolled, and it will be the next phase 3 readout of an oral SIRD for patients with early breast cancer.
Speaker #1: submitted We these results to regulatory authorities to potentially enable the use of earlier NIB in lines of therapy . Later this year , we expect results from an phase three additional trial .
Speaker #2: In other oncology updates, we advanced sofetuvart mepotecan, our next-generation antibody drug conjugate targeting folate receptor alpha into phase 3 testing for women with platinum-resistant ovarian cancer.
Speaker #1: NIB Bruin CLL 322 . trial evaluates NIB in addition This to a fixed regimen of duration venetoclax and rituximab in previously treated SLL CLL .
Speaker #2: We believe this program has the potential to benefit a broad population of patients with ovarian cancer regardless of folate receptor alpha expression level, and may also offer improved tolerability compared to currently available antibody drug conjugates.
Speaker #1: patients . This successful , this could form the basis for an additional regulatory submission later this year . We also presented updated combination data of MLU with Abemaciclib in breast metastatic cancer , which showed additional compared to Emlyn benefit alone .
Speaker #2: We plan to initiate a study in platinum-sensitive ovarian cancer later this year. We're excited that this medicine received breakthrough therapy designation from FDA earlier this year.
Daniel Skovronsky: While we're encouraged by these new data for patients with metastatic breast cancer, we're even more excited about the opportunity for Imlunestrant in adjuvant breast cancer. Our ongoing 8,000-patient adjuvant breast cancer trial, EMBER-4, is fully enrolled, and it will be the next phase 3 readout of an oral SERD for patients with early breast cancer. In other oncology updates, we advanced sofetobart mipitecan, our next-generation antibody-drug conjugate, targeting folate receptor alpha, into phase 3 testing for women with platinum-resistant ovarian cancer. We believe this program has the potential to benefit a broad population of patients with ovarian cancer, regardless of folate receptor alpha expression level, and may also offer improved tolerability compared to currently available antibody-drug conjugates. We plan to initiate a study in platinum-sensitive ovarian cancer later this year. We're excited that this medicine received breakthrough therapy designation from FDA earlier this year.
Daniel M. Skovronsky: While we're encouraged by these new data for patients with metastatic breast cancer, we're even more excited about the opportunity for Imlunestrant in adjuvant breast cancer. Our ongoing 8,000-patient adjuvant breast cancer trial, EMBER-4, is fully enrolled, and it will be the next phase 3 readout of an oral SERD for patients with early breast cancer. In other oncology updates, we advanced sofetobart mipitecan, our next-generation antibody-drug conjugate, targeting folate receptor alpha, into phase 3 testing for women with platinum-resistant ovarian cancer. We believe this program has the potential to benefit a broad population of patients with ovarian cancer, regardless of folate receptor alpha expression level, and may also offer improved tolerability compared to currently available antibody-drug conjugates. We plan to initiate a study in platinum-sensitive ovarian cancer later this year. We're excited that this medicine received breakthrough therapy designation from FDA earlier this year.
Speaker #1: These data to regulators we submitted, seeking to expand the Inland Eastern. While we're encouraged by these new data for patients with metastatic breast cancer, we're even more excited about the opportunity for enlistment in breast cancer adjuvant.
Speaker #2: We also expect to initiate new phase 3 programs for two other oncology small cells. The first is tersolizumab, our mutant selective PI3 kinase alpha inhibitor.
Speaker #1: Our ongoing adjuvant 8000 patient breast cancer trial , Amber , for , is enrolled , and fully it will be the next phase three readout of an oral serd for patients with early breast cancer .
Speaker #2: We believe this program could represent the next generation of PI3 kinase alpha targeting agents, by selectively targeting the pathway in cancerous but not in healthy medicines.
Speaker #2: cells. key limitation of currently available Thus overcoming a potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability. The second is vepugratinib.
Speaker #1: In other oncology updates , we advanced sofferto Bart Mepivicaine our next generation antibody drug conjugate targeting folate receptor alpha , into phase three testing for women with platinum resistant ovarian cancer .
Speaker #2: An FGFR3 inhibitor that we believe may improve on the tolerability profile of existing agents and enable combination therapy in first-line metastatic urothelial carcinoma. In neuroscience, we began several trials exploring the use of incretins to treat substance use disorders in psychiatric conditions.
Speaker #1: We believe the program has the potential to benefit this broad population of patients with ovarian cancer, regardless of folate receptor alpha expression level, and may also offer improved tolerability compared to currently available antibody-drug conjugates.
Speaker #1: We plan to initiate a study in platinum-sensitive ovarian cancer later this year. We're excited that this medicine received Breakthrough Therapy designation from the FDA earlier this year.
Speaker #2: Last quarter, we announced plans to initiate a phase 3 program of brenepatide in alcohol use disorder. Since then, we've begun dosing patients in this trial and we have also launched additional brenepatide phase 2 trials in tobacco use disorder, in bipolar disorder.
Daniel Skovronsky: We also expect to initiate new Phase 3 programs for two other oncology molecules. The first is Tersolisimab, our mutant selective PI3 kinase alpha inhibitor. We believe this program could represent the next generation of PI3 kinase alpha-targeting agents by selectively targeting the pathway in cancerous, but not in healthy cells, thus overcoming a key limitation of currently available medicines. This approach could potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability. The second is Vepugratinib, an FGFR3 inhibitor that we believe may improve on the tolerability profile of existing agents and enable combination therapy in first-line metastatic urothelial carcinoma. In neuroscience, we began several trials exploring the use of incretins to treat substance use disorders and psychiatric conditions. Last quarter, we announced plans to initiate a Phase 3 program of Brenipatide in alcohol use disorder.
Daniel M. Skovronsky: We also expect to initiate new Phase 3 programs for two other oncology molecules. The first is Tersolisimab, our mutant selective PI3 kinase alpha inhibitor. We believe this program could represent the next generation of PI3 kinase alpha-targeting agents by selectively targeting the pathway in cancerous, but not in healthy cells, thus overcoming a key limitation of currently available medicines. This approach could potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability. The second is Vepugratinib, an FGFR3 inhibitor that we believe may improve on the tolerability profile of existing agents and enable combination therapy in first-line metastatic urothelial carcinoma. In neuroscience, we began several trials exploring the use of incretins to treat substance use disorders and psychiatric conditions. Last quarter, we announced plans to initiate a Phase 3 program of Brenipatide in alcohol use disorder.
Speaker #1: We also expect to initiate new phase three programs for two other oncology molecules . The first is Terso tip . Our mutant selective PI3 kinase alpha inhibitor .
Speaker #2: We expect to initiate several more phase 2 and phase 3 trials in 2026, exploring how brenepatide may be able to treat other conditions. Including a phase 3 trial for major depressive disorder.
Speaker #1: We believe this program could represent the next generation of Pi alpha three kinase targeting agents by targeting the selectively in pathway cancerous . in But not healthy cells , thus overcoming a key limitation of currently available medicines .
Speaker #2: Testing if brenepatide can prevent relapse of disease. In Alzheimer's disease, we continue to look forward to the results from trailblazer ALS 3, our study of denenimab in people with normal cognition but a positive blood test for Alzheimer's disease.
Speaker #1: approach This could potentially offer better disease control through deeper pathway as well as tolerability improved The second is brigatinib . , an Fgfr3 inhibitor that we believe may improve the tolerability profile of existing agents and enable combination therapy in first line metastatic urothelial carcinoma .
Speaker #2: This trial screened volunteers with a blood test for PTAU and randomized participants to a nine-month course of treatment with denenimab. By moving earlier in disease, even prior to individuals having any objective symptoms of Alzheimer's disease, the goal is to reduce the risks of them ever developing any impairment due to Alzheimer's.
Speaker #1: In neuroscience , we began several trials use of exploring the incretins to treat substance use disorders in conditions psychiatric . Last quarter , we announced plans to initiate a phase brain appetite in three program of alcohol use disorder .
Daniel Skovronsky: Since then, we've began dosing patients in this trial, and we have also launched additional Brenipatide phase 2 trials in tobacco use disorder and bipolar disorder. We expect to initiate several more phase 2 and phase 3 trials in 2026, exploring how Brenipatide may be able to treat other conditions, including a phase 3 trial for major depressive disorder, testing if Brenipatide can prevent relapse of disease. In Alzheimer's disease, we continue to look forward to the results from TRAILBLAZER-ALZ 3, our study of donanemab in people with normal cognition but a positive blood test for Alzheimer's disease. This trial screened volunteers with a blood test for p-tau and randomized participants to a 9-month course of treatment with donanemab.
Daniel M. Skovronsky: Since then, we've began dosing patients in this trial, and we have also launched additional Brenipatide phase 2 trials in tobacco use disorder and bipolar disorder. We expect to initiate several more phase 2 and phase 3 trials in 2026, exploring how Brenipatide may be able to treat other conditions, including a phase 3 trial for major depressive disorder, testing if Brenipatide can prevent relapse of disease. In Alzheimer's disease, we continue to look forward to the results from TRAILBLAZER-ALZ 3, our study of donanemab in people with normal cognition but a positive blood test for Alzheimer's disease. This trial screened volunteers with a blood test for p-tau and randomized participants to a 9-month course of treatment with donanemab.
Speaker #2: The primary completion is projected for 2027. However, the study will read out what the target number of progression events are accrued. Moving to cardiometabolic health, we had another busy quarter.
Speaker #1: Since then , we've began dosing patients . In this trial , and we have also launched additional phase two trials in tobacco use and bipolar disorder disorder .
Speaker #2: We were excited to announce positive top-line results from the 18 maintained trial, evaluating orfogliprin for weight maintenance. This unique phase 3 trial was designed to answer a common question from doctors and patients: can people successfully maintain weight loss achieved on maximum tolerated dose of injectable incretins by switching to an oral GLP-1 therapy?
Speaker #1: We expect to initiate several more phase two and phase three trials in 2026, exploring how brain appetite may be able to treat other conditions, including a phase three trial for major depressive disorder.
Speaker #1: Testing of appetite can prevent relapse of disease in Alzheimer's disease. We continue to look forward to the results of Trailblazer, our study of donanemab in people with three.
Speaker #2: Participants in 18 maintained were previously on injectable semaglutide or tirzepatide, then switched to orfogliprin or placebo. As shown on slide 16, orfogliprin helped people maintain weight loss that they had achieved on injectable therapies.
Speaker #1: normal from positive blood test for Alzheimer's disease . This trial , screened volunteers with a blood test tau and for participants randomized to a nine month course of treatment with Donanemab by moving earlier in disease , even prior to having any individuals objective symptoms of Alzheimer's disease , the goal is to reduce the risks of them ever developing any to impairment due Alzheimer's .
Daniel Skovronsky: By moving earlier in disease, even prior to individuals having any objective symptoms of Alzheimer's disease, the goal is to reduce the risks of them ever developing any impairment due to Alzheimer's.... The primary completion is projected for 2027. However, the study will read out when the target number of progression events are accrued. Moving to cardiometabolic health, we had another busy quarter. We were excited to announce positive top-line results from the MAINTAIN trial, evaluating orforglipron for weight maintenance. This unique phase III trial was designed to answer a common question from doctors and patients: Can people successfully maintain weight loss achieved on maximum tolerated dose of injectable incretins by switching to an oral GLP-1 therapy? Participants in the MAINTAIN were previously on injectable semaglutide or tirzepatide, then switched to orforglipron or placebo.
Daniel M. Skovronsky: By moving earlier in disease, even prior to individuals having any objective symptoms of Alzheimer's disease, the goal is to reduce the risks of them ever developing any impairment due to Alzheimer's.... The primary completion is projected for 2027. However, the study will read out when the target number of progression events are accrued. Moving to cardiometabolic health, we had another busy quarter. We were excited to announce positive top-line results from the MAINTAIN trial, evaluating orforglipron for weight maintenance. This unique phase III trial was designed to answer a common question from doctors and patients: Can people successfully maintain weight loss achieved on maximum tolerated dose of injectable incretins by switching to an oral GLP-1 therapy? Participants in the MAINTAIN were previously on injectable semaglutide or tirzepatide, then switched to orforglipron or placebo.
Speaker #2: And the study met all primary and secondary endpoints. People who switched from semaglutide to orfogliprin maintained their previously achieved weight loss with an
Speaker #1: An average difference of just This suggests that as an oral GLP one therapy , or for May . provide similar weight loss maintenance as the maximum tolerated dose , and may provide similar weight loss maintenance as the maximum tolerated dose of the injectable GLP one therapy .
Speaker #1: The primary completion is projected for 2027 . the study , Over will read out with target number of progression events are accrued . Moving to cardiometabolic health .
Speaker #1: We had another busy quarter. We were, announce, excited to top positive line the results from 18. Maintain trial evaluating Orforglipron for weight maintenance.
Speaker #1: Semaglutide . As expected , those who switched from maximum tolerated doses of the dual GIP , GLP one agonist to Tirzepatide oral GLP one monotherapy maintained weight much of their although with a loss , higher average difference of five kilograms .
Speaker #1: This unique phase three trial was designed to answer a common question from doctors and patients. Can people successfully maintain weight loss achieved on maximum tolerated doses of injectable incretins by switching to an oral GLP-1 therapy?
Speaker #1: We expect to share detailed results later this year . Other Orforglipron updates since our last call include submission of Orforglipron to the FDA for of treatment obesity , with approval expected in two of this year .
Speaker #1: Participants in attain maintain were previously on injectable semaglutide or tirzepatide , then switched to Orforglipron or placebo . As shown on slide 16 , Orforglipron helped people maintain weight loss that they had achieved on injectable therapies , and the study met all primary and secondary endpoints .
Daniel Skovronsky: As shown on slide 16, Orforglipron helped people maintain weight loss that they had achieved on injectable therapies, and the study met all primary and secondary endpoints. People who switched from semaglutide to Orforglipron maintained their previously achieved weight loss with an average difference of just 0.9kg. This suggests that as an oral GLP-1 therapy, Orforglipron may provide similar weight loss maintenance as the maximum tolerated dose of the injectable GLP-1 therapy semaglutide. As expected, those who switched from maximum tolerated doses of the dual GIP GLP-1 agonist Tirzepatide to oral GLP-1 monotherapy, maintained much of their weight loss, although with a higher average difference of 5kg. We expect to share detailed results later this year.
Daniel M. Skovronsky: As shown on slide 16, Orforglipron helped people maintain weight loss that they had achieved on injectable therapies, and the study met all primary and secondary endpoints. People who switched from semaglutide to Orforglipron maintained their previously achieved weight loss with an average difference of just 0.9kg. This suggests that as an oral GLP-1 therapy, Orforglipron may provide similar weight loss maintenance as the maximum tolerated dose of the injectable GLP-1 therapy semaglutide. As expected, those who switched from maximum tolerated doses of the dual GIP GLP-1 agonist Tirzepatide to oral GLP-1 monotherapy, maintained much of their weight loss, although with a higher average difference of 5kg. We expect to share detailed results later this year.
Speaker #1: Submission of Orforglipron for obesity and for type two diabetes , and a number of other countries around the world . Initiation of Orforglipron phase three cardiovascular outcomes trials and initiation of Orforglipron phase three for treatment .
Speaker #1: People who switch from Semaglutide to Orforglipron maintained their previously achieved weight loss , with an average difference of just 0.9kg . This suggests that as an oral GLP one therapy , or for gliptin may provide similar weight loss maintenance as the maximum tolerated dose of the injectable one therapy .
Speaker #1: Peripheral artery disease . We look forward to completing the US regulatory submission of Orforglipron for type two diabetes later this year . After the achieved for trial is complete .
Speaker #1: We also announced new data for our GIP , GLP glucagon , one , triple agonist Retatrutide . In the first phase three trial to complete triumph for .
Speaker #1: GLP Semaglutide . As expected , those who switched from maximum tolerated doses of the dual GIP , GLP one agonist Tirzepatide to oral GLP one monotherapy maintained their weight much of loss , although with a higher average difference of five kilograms .
Speaker #1: evaluated We Retatrutide in adults with obesity and knee osteoarthritis , which is taking Retatrutide 12mg , lost an average of 29% of their body weight at 68 weeks , while many people will not need this level of weight loss , we see an important potential role for molecules such as retatrutide in helping people higher baseline with BMIs or with more severe obesity related comorbidities .
Daniel Skovronsky: Other orforglipron updates since our last call include submission of orforglipron to the FDA for treatment of obesity, with approval expected in Q2 of this year. Submission of orforglipron for obesity and for type 2 diabetes in a number of other countries around the world. Initiation of orforglipron Phase III cardiovascular outcomes trial, and initiation of orforglipron Phase III for treatment for peripheral artery disease. We look forward to completing the US regulatory submission of orforglipron for type 2 diabetes later this year after the Achieve four trial is complete. We also announced new data for our GIP, GLP-1 glucagon triple agonist, retatrutide. In the first Phase III trial to complete, Triumph four, we evaluated retatrutide in adults with obesity and knee osteoarthritis. Participants taking retatrutide 12 mg lost an average of 29% of their body weight at 68 weeks.
Daniel M. Skovronsky: Other orforglipron updates since our last call include submission of orforglipron to the FDA for treatment of obesity, with approval expected in Q2 of this year. Submission of orforglipron for obesity and for type 2 diabetes in a number of other countries around the world. Initiation of orforglipron Phase III cardiovascular outcomes trial, and initiation of orforglipron Phase III for treatment for peripheral artery disease. We look forward to completing the US regulatory submission of orforglipron for type 2 diabetes later this year after the Achieve four trial is complete. We also announced new data for our GIP, GLP-1 glucagon triple agonist, retatrutide. In the first Phase III trial to complete, Triumph four, we evaluated retatrutide in adults with obesity and knee osteoarthritis. Participants taking retatrutide 12 mg lost an average of 29% of their body weight at 68 weeks.
Speaker #1: We expect to share detailed results year later this . Other Orforglipron updates since our last call include submission of Orforglipron to the FDA for treatment of obesity , with approval expected in June .
Speaker #1: Two of this year: submission of Orforglipron for obesity and for type 2 diabetes, and a number of other countries around the world.
Speaker #1: Accordingly , we were pleased to see that Retatrutide reduced womac pain by scores average of 4.5 points , representing a 76% reduction in pain , and this was accompanied by a significant improvement in physical function .
Speaker #1: Initiation of Orforglipron phase three cardiovascular outcomes trials and initiation of Orforglipron phase three for treatment for peripheral artery disease . We look forward to completing the US regulatory submission of Orforglipron for type two diabetes later this year .
Speaker #1: Impressively , more than 1 in 8 treated Retatrutide patients were completely free pain from knee . At the end of this trial . The safety profile was generally consistent with other incretins , with gastrointestinal events being most common We .
Speaker #1: After the achieved four trial is complete , we also announced new data our for GIP , GLP one , glucagon , agonist . Retatrutide In the first to complete triumph for , we evaluated retatrutide adults with obesity and knee osteoarthritis in .
Speaker #1: observed higher discontinuation rates due to adverse events in people with lower baseline BMI , including participants who perceived discontinued for excessive weight loss , as shown on slide 17 .
Daniel Skovronsky: While many people will not need this level of weight loss, we see an important potential role for molecules such as retatrutide in helping people with higher baseline BMIs or with more severe obesity-related comorbidities. Accordingly, we were pleased to see that retatrutide reduce WOMAC pain scores by an average of 4.5 points, representing a 76% reduction in pain. And this was accompanied by a significant improvement in physical function. Impressively, more than 1 in 8 retatrutide-treated patients were completely free from knee pain at the end of this trial. The safety profile was generally consistent with other incretins, with gastrointestinal events being most common. We observed higher discontinuation rates due to adverse events in people with lower baseline BMI, including participants who discontinued for perceived excessive weight loss.
Daniel M. Skovronsky: While many people will not need this level of weight loss, we see an important potential role for molecules such as retatrutide in helping people with higher baseline BMIs or with more severe obesity-related comorbidities. Accordingly, we were pleased to see that retatrutide reduce WOMAC pain scores by an average of 4.5 points, representing a 76% reduction in pain. And this was accompanied by a significant improvement in physical function. Impressively, more than 1 in 8 retatrutide-treated patients were completely free from knee pain at the end of this trial. The safety profile was generally consistent with other incretins, with gastrointestinal events being most common. We observed higher discontinuation rates due to adverse events in people with lower baseline BMI, including participants who discontinued for perceived excessive weight loss.
Speaker #1: Participants taking Retatrutide 12mg lost an average of 29% of their body weight at 68 weeks . While many people will not need this level of weight loss , we've see an important potential role for molecules such as retatrutide in helping people with higher baseline BMIs or with more severe obesity related comorbidities Accordingly , we are pleased to see that Retatrutide reduced Womac pain .
Speaker #1: Patients with a baseline BMI of 35 or higher , which represented 84% of the trial population . At discontinuation rates due to adverse events .
Speaker #1: Persistent with those observed in clinical trials of other injectable agents . to read out six additional phase three trials for Retatrutide in 2026 , including the remainder of the corps registration package for both the Triumph Obesity program and the Transcend Type two diabetes program .
Speaker #1: average of 4.5 points , representing a 76% reduction in pain , and this was accompanied by a significant in improvement physical function . Impressively , more than 1 in 8 Retatrutide treated patients were completely free from knee pain trial .
Speaker #1: Also Q4 , we started a phase three trial in high risk metabolic dysfunction associated steatotic liver disease . Marcel , studying red tide as well as tirzepatide for treatment of this disease .
Speaker #1: We're planning to submit the results of the core triumph program in 2026 to support applications for overweight and obesity . Obstructive sleep apnea and osteoarthritis of the knee for retatrutide we've seen the data .
Speaker #1: safety generally consistent . The At the end with other incretins , of this gastrointestinal events being most common . We observed higher discontinuation rates due to adverse events in people with lower baseline BMI participants who discontinued for perceived excessive weight , including loss , as shown on slide 17 .
Daniel Skovronsky: As shown on slide 17, patients with a baseline BMI of 35 or higher, which represented 84% of the trial population, had discontinuation rates due to adverse events, consistent with those observed in clinical trials of other injectable incretins. We expect to read out 6 additional Phase III trials for retatrutide in 2026, including the remainder of the core registration package for both the Triumph obesity program and the Transcend type 2 diabetes program. Also in Q4, we started a Phase III trial in high-risk metabolic dysfunction-associated steatotic liver disease, MASLD, studying retatrutide as well as tirzepatide for treatment of this disease. We're planning to submit the results of the core Triumph program in 2026 to support applications for overweight and obesity, obstructive sleep apnea, and osteoarthritis of the knee for retatrutide.
Daniel M. Skovronsky: As shown on slide 17, patients with a baseline BMI of 35 or higher, which represented 84% of the trial population, had discontinuation rates due to adverse events, consistent with those observed in clinical trials of other injectable incretins. We expect to read out 6 additional Phase III trials for retatrutide in 2026, including the remainder of the core registration package for both the Triumph obesity program and the Transcend type 2 diabetes program. Also in Q4, we started a Phase III trial in high-risk metabolic dysfunction-associated steatotic liver disease, MASLD, studying retatrutide as well as tirzepatide for treatment of this disease. We're planning to submit the results of the core Triumph program in 2026 to support applications for overweight and obesity, obstructive sleep apnea, and osteoarthritis of the knee for retatrutide.
Speaker #1: , depending these so Based on far upcoming data we readouts , believe Retatrutide may have the potential to become an important new treatment option for patients with significant weight With certain complications .
Speaker #1: Patients with a baseline BMI of 35 or which higher , 84% of the trial population at discontinuation rates due to adverse events consistent with those observed in clinical trials of other injectable agents .
Speaker #1: Moving to Trizepatide . We're pleased that Zepbound was recently approved in the US in a multi-use quick pen device . This presentation of Tirzepatide is already available in many countries around the world as a convenient offering that includes four doses in a single pen .
Speaker #1: We expect to read out six additional Phase 3 trials for Retatrutide in 2026, including the remainder of the core registration package for both the TRIUMPH obesity program and the TRANSCEND program.
Speaker #1: We look forward to launching this new Zepbound offering in the US within the next few weeks . Slide 18 shows pipeline movements since our last earnings call .
Speaker #1: Also in Q4, we started a phase three trial in high-risk metabolic dysfunction associated steatotic liver disease, MASLD, studying retatrutide as well as tirzepatide for treatment of the disease. This, we're planning to submit the results of the CORE Triumph program in support of applications for overweight and obesity, obstructive sleep apnea, and osteoarthritis of the knee for retatrutide.
Speaker #1: The slide 19 shows the full list of key events achieved in 2025 . Notably , we achieved positive outcomes for nearly all R&D key events in 2025 , a rare set of results in this industry .
Speaker #1: Slide 20 shows key events expected in 2026 , with potential for data readouts and regulatory actions across our areas therapeutic . In addition to the we're making substantial in progress immunology , neuroscience and oncology .
Daniel Skovronsky: Based on the data we've seen so far, and pending these upcoming data readouts, we believe retatrutide may have the potential to become an important new treatment option for patients with significant weight loss with certain complications. Moving to tirzepatide, we're pleased that Zepbound was recently approved in the US in a multi-use quick pen device. This presentation of tirzepatide is already available in many countries around the world as a convenient offering that includes 4 doses in a single pen. We look forward to launching this new Zepbound offering in the US within the next few weeks. Slide 18 shows pipeline movement since our last earnings call, and slide 19 shows the full list of key events achieved in 2025. Notably, we achieved positive outcomes for nearly all R&D key events in 2025, a rare set of results in this industry.
Daniel M. Skovronsky: Based on the data we've seen so far, and pending these upcoming data readouts, we believe retatrutide may have the potential to become an important new treatment option for patients with significant weight loss with certain complications. Moving to tirzepatide, we're pleased that Zepbound was recently approved in the US in a multi-use quick pen device. This presentation of tirzepatide is already available in many countries around the world as a convenient offering that includes 4 doses in a single pen. We look forward to launching this new Zepbound offering in the US within the next few weeks. Slide 18 shows pipeline movement since our last earnings call, and slide 19 shows the full list of key events achieved in 2025. Notably, we achieved positive outcomes for nearly all R&D key events in 2025, a rare set of results in this industry.
Speaker #1: on the data we've Based seen so far , the pending these upcoming data readouts , we believe red tide may have the potential become important new treatment option for with significant weight loss , with certain complications .
Speaker #1: want to take We a moment to reflect on our incretin and obesity portfolio . Of course , there's been a lot of focus on Tirzepatide and orforglipron , which I well .
Speaker #1: Moving to tirzepatide. We're pleased that Zepbound was recently approved in the US in a multi-use KwikPen device. This presentation of tirzepatide is already available in many countries around the world.
Speaker #1: Now excitement is growing for Retatrutide as well . I see each of these as an example of a leading model within its own class .
Speaker #1: Behind these three incretin innovations . We have a robust pipeline of further further inventions with potential to address patient needs , including our selective Amylin agonist Alarelin , which is currently in phase three , as well as our next generation GIP , GLP one dual agonist , which is also now in phase three trials .
Speaker #1: As a convenient offering that includes four doses in a single pen. We look forward to launching this new Zepbound offering in the US within the next few weeks.
Speaker #1: Slide 18 shows pipeline movements since our last earnings call. Slide 19 shows the full list of key events achieved in 2025.
Speaker #1: Notably , we achieved outcomes positive for nearly all our R&D key events in 2025 . rare set of results in this industry . Slide 20 shows key events expected in 2026 , with potential for data readouts and regulatory actions across our therapeutic areas .
Daniel Skovronsky: Slide 20 shows key events expected in 2026, with potential for data readouts and regulatory actions across our therapeutic areas. In addition to the substantial progress we're making in immunology, neuroscience, and oncology, I want to take a moment to reflect on our growing incretin and obesity portfolio. Of course, there's been a lot of focus on tirzepatide and orforglipron, which I think is well warranted. Now excitement is growing for retatrutide as well. I see each of these as an example of a leading model within its own class. Behind these three incretin innovations, we have a robust pipeline of further inventions with potential to address patient needs, including our selective amylin agonist, eloralintide, which is currently in phase 3, as well as our next generation GIP, GLP-1 dual agonist brenipatide, which is also now in phase 3 trials.
Daniel M. Skovronsky: Slide 20 shows key events expected in 2026, with potential for data readouts and regulatory actions across our therapeutic areas. In addition to the substantial progress we're making in immunology, neuroscience, and oncology, I want to take a moment to reflect on our growing incretin and obesity portfolio. Of course, there's been a lot of focus on tirzepatide and orforglipron, which I think is well warranted. Now excitement is growing for retatrutide as well. I see each of these as an example of a leading model within its own class. Behind these three incretin innovations, we have a robust pipeline of further inventions with potential to address patient needs, including our selective amylin agonist, eloralintide, which is currently in phase 3, as well as our next generation GIP, GLP-1 dual agonist brenipatide, which is also now in phase 3 trials.
Speaker #1: Behind these , we have a number of earlier stage molecules that could similarly lead with a new mechanisms and new classes of therapeutics for treatment of obesity .
Speaker #1: We've built a substantial lead in this field scientific , and we aim to the distance through widen our R&D in this past year was busy and productive , and we expect more of the same in 2026 as we continue to create meaningful medicines on behalf of the patients that need us .
Speaker #1: In addition to the substantial progress we're making in immunology, neuroscience, and oncology, we want to take a moment to reflect on our growing incretin and obesity portfolio.
Speaker #1: Of course , there's been a lot of focus on Tirzepatide and think is orforglipron , which I well warranted now . growing for Excitement is Retatrutide as well .
Speaker #1: I'll now turn the call back to Dave for quick . Okay . Thanks , Dan . We're pleased with all the progress in Q4 and throughout 2025 .
Speaker #1: I see each of these as an example of a leading model within its own class . Behind these three Incretin innovations . We have a robust pipeline of further further inventions with potential to address patient needs , including our selective Amylin agonist Alarelin , is which currently in phase three , as next well as our generation GIP .
Speaker #1: It was a year of strong execution for Lilly . We delivered exceptional business results , invested in our future , and helped millions of people around the world improve their health .
Speaker #1: Now , I'll turn the call over to Mike to moderate the Q&A session . Thanks , Dave . We'd like to take questions from as many callers as possible , so consistent with prior quarters .
Daniel Skovronsky: Behind these, we have a number of earlier stage molecules that could similarly lead with new mechanisms and new classes of therapeutics for treatment of obesity. We've built a substantial scientific lead in this field, and we aim to widen the distance through our R&D. This past year was busy and productive, and we expect more of the same in 2026 as we continue to create meaningful medicines on behalf of the patients that need us. I'll now turn the call back to Dave for conclusion.
Daniel M. Skovronsky: Behind these, we have a number of earlier stage molecules that could similarly lead with new mechanisms and new classes of therapeutics for treatment of obesity. We've built a substantial scientific lead in this field, and we aim to widen the distance through our R&D. This past year was busy and productive, and we expect more of the same in 2026 as we continue to create meaningful medicines on behalf of the patients that need us. I'll now turn the call back to Dave for conclusion.
Speaker #1: agonist GLP one dual , which is also now in phase three trials . Behind these , we have a number of earlier stage molecules that could similarly lead with a new mechanisms and new classes of therapeutics for treatment of obesity .
Speaker #1: We will respond to one question per caller and then the call promptly at 11 . If you have more than one question , you can reenter the queue and we will get your question .
Speaker #1: If allows . Please provide the instructions Q&A session and then we are for the the ready for first caller .
Speaker #1: We've built a substantial scientific lead in this field , and we aim to widen the distance through our R&D . This past year was busy and productive , and we expect more of the same in 2026 .
Speaker #2: Thank you . time , we'll be conducting a question and answer session . If you have any questions , please press star one on your phone at time .
Speaker #2: this We ask that participants limit themselves to today's one question on call . If you do have a follow up question , please rejoin the queue by pressing star one at any time .
Speaker #1: As we continue to create meaningful medicines on behalf of the patients that need us, I'll now turn the call back to Dave for Q&A.
Patrik Jonsson: Okay, thanks, Dan. We're pleased with all the progress in Q4 and throughout 2025. It was a year of strong execution for Lilly. We delivered exceptional business results, invested in our future, and helped millions of people around the world improve their health. Now I'll turn the call over to Mike to moderate the Q&A session.
David A. Ricks: Okay, thanks, Dan. We're pleased with all the progress in Q4 and throughout 2025. It was a year of strong execution for Lilly. We delivered exceptional business results, invested in our future, and helped millions of people around the world improve their health. Now I'll turn the call over to Mike to moderate the Q&A session.
Speaker #2: We also ask that while posing your question , you please pick up your handset . If listening on speakerphone to provide optimum sound quality , please hold while we poll for questions .
Speaker #1: Dan, thanks. We're pleased with all the progress in Q4 and throughout 2025. It was a year of strong performance for Lilly.
Speaker #2: And the first question today is coming from Evan Seigerman from BMO Capital Markets . Your line is live .
Speaker #1: We delivered exceptional business results , invested in our future , and helped millions of execution people around the world improve their health . Now , I'll turn the call over to Mike to moderate the Q&A session .
Michael Czapar: Thanks, Dave. We'd like to take questions from as many callers as possible. So consistent with our quarters, we will respond to one question per caller and end the call promptly at 11. If you have more than one question, you can reenter the queue, and we will get to your question if time allows. Paul, please provide the instructions for the Q&A session, and then we are ready for the first caller.
Mike Czapar: Thanks, Dave. We'd like to take questions from as many callers as possible. So consistent with our quarters, we will respond to one question per caller and end the call promptly at 11. If you have more than one question, you can reenter the queue, and we will get to your question if time allows. Paul, please provide the instructions for the Q&A session, and then we are ready for the first caller.
Speaker #3: guys . Thank Hi , you so much for taking my question . And congratulations . So a year from now on , this call , I'd love for you to characterize what you would for for good launch .
Speaker #1: Dave . We'd like to take Thanks , questions from as many callers as possible . So consistent with quarters , we prior will respond one question per caller to and then the call promptly at 11 .
Speaker #3: Specifically , what are some of the you're looking to metrics that meet and you're not going to give guidance , but some qualitative kind of commentary would be most helpful .
Speaker #1: If you have more than one question, you can re-enter the queue and we will take your question, if time allows. Please provide the instructions for the Q&A session, and then we are ready for the first caller.
Speaker #3: Thank you .
Operator: Thank you. At this time, we'll be conducting a question and answer session. If you have any questions, please press star one on your phone at this time. We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star one at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. The first question today is coming from Evan Segerman from BMO Capital Markets. Evan, your line is live.
Operator: Thank you. At this time, we'll be conducting a question and answer session. If you have any questions, please press star one on your phone at this time. We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star one at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. The first question today is coming from Evan Segerman from BMO Capital Markets. Evan, your line is live.
Speaker #1: Great . Thanks for Evan . the question , A little bit , but I think you're asking about a year from now where some things tracking on for will be think for Orforglipron .
Speaker #1: for that So I question , go maybe we'll to Ken to maybe talk about some things that we'll be looking at . Sure .
Speaker #2: Thank you. At this time, we will be conducting a question and answer session. If you have any questions, please press star one on your phone at this time.
Speaker #4: Thanks for the question about we're really excited to have this medicine submitted , not just in the US , but now 40 countries and looking forward to launches beginning this year .
Speaker #2: We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star one at any time.
Speaker #4: As I think success about factors for us going forward , maybe towards the end of the year , we'll be looking at a few things .
Speaker #2: We also ask that while posing your question , you up your please pick handset . If speakerphone to provide optimum sound quality , while we listening on poll for questions .
Speaker #4: The first of which is expansion . We're very we're encouraged by what seeing with oral Wegovy , as it validates our belief that there's a number of people with overweight and obesity who've been sitting on the sidelines waiting for an option .
[Analyst] (BMO Capital Markets): Hi, guys. Thank you so much for taking my question, and congratulations. So a year from now on this call, I'd love for you to characterize what you would... Specifically, what are some of the metrics that you're looking to meet? I know you're not going to give guidance, but some qualitative kind of commentary would be most helpful. Thank you.
Evan Seigerman: Hi, guys. Thank you so much for taking my question, and congratulations. So a year from now on this call, I'd love for you to characterize what you would... Specifically, what are some of the metrics that you're looking to meet? I know you're not going to give guidance, but some qualitative kind of commentary would be most helpful. Thank you.
Speaker #2: And the first question today is coming from Evan from Sugerman BMO Capital Markets . Having your line is live .
Speaker #4: It looks like these oral are mostly new starts . That means it's expanding the market , and that's good news for Lilly . We feel really good about the competitiveness of our profile .
Speaker #3: Hi , guys . Thank you so much for taking my question . And congratulations . So a year on this call , I'd love for from now you to what you characterize would for for good .
Speaker #4: We've talked about that a lot on previous calls . I think we're at the point now where we're going to pivot to how do the world results play out .
Speaker #3: what are some Specifically , of the metrics that you're looking to meet and you're not going to give guidance , but some qualitative kind of be most helpful .
Michael Czapar: Great. Thanks for the question, Evan. Kind of a little bit, but I think you were just asking about a year from now, what are some things we'll be tracking on for orforglipron. So I think for that question, maybe we'll go to Ken, to maybe talk about some things that we'll be looking at.
Mike Czapar: Great. Thanks for the question, Evan. Kind of a little bit, but I think you were just asking about a year from now, what are some things we'll be tracking on for orforglipron. So I think for that question, maybe we'll go to Ken, to maybe talk about some things that we'll be looking at.
Speaker #4: We think this is going to be about patient satisfaction and our which is profile , simple with no restrictions on food big intake , could make a and water difference in the real world .
Speaker #3: commentary would you .
Speaker #1: Evan . And cut for the Great . Thanks bit , but I think you're just asking about question . a out a little year from now where some things will be on for tracking Orforglipron .
Speaker #4: excited to get off to the races here . See this market expand , and So we're really look at overall patient satisfaction scores and real world efficacy with these agents .
Kenneth L. Custer: Sure. Thanks for the question about orforglipron. We're really excited to have this medicine submitted, not just in the US, but now 40 countries, and looking forward to launches beginning this year. You know, as I think about success factors for us going forward, maybe towards the end of the year, we'll be looking at a few things, first of which is market expansion. We're very encouraged by what we're seeing with oral Wegovy, as it validates our belief that there's a substantial number of people with overweight and obesity who've been sitting on the sidelines waiting for an oral option. It looks like these are mostly new starts. That means it's expanding the market, and that's good news for Lilly. We feel really good about the competitiveness of our profile.
Kenneth Custer: Sure. Thanks for the question about orforglipron. We're really excited to have this medicine submitted, not just in the US, but now 40 countries, and looking forward to launches beginning this year. You know, as I think about success factors for us going forward, maybe towards the end of the year, we'll be looking at a few things, first of which is market expansion. We're very encouraged by what we're seeing with oral Wegovy, as it validates our belief that there's a substantial number of people with overweight and obesity who've been sitting on the sidelines waiting for an oral option. It looks like these are mostly new starts. That means it's expanding the market, and that's good news for Lilly. We feel really good about the competitiveness of our profile.
Speaker #1: So, I think for that question, maybe we'll go to Ken to maybe talk about some things that we'll be looking at.
Speaker #4: Thanks .
Speaker #1: Great . Thank you Ken . Paul . Ready for the next question .
Speaker #1: Sure .
Speaker #4: Thanks for the question about Orforglipron . We're really excited to have this medicine . Submitted , not just in the US , but now 40 countries and looking forward to launches beginning this year , as I think success factors for us going forward , maybe towards the end of the year , few we'll be things , the first of which is looking at a expansion .
Speaker #2: The next question will be Courtney Breen from from Bernstein . Courtney , your line is live .
Speaker #5: Hi everyone . Everyone . Thanks so much for taking the question today . Just building on on the question around ortho . You mentioned that you have submitted in 40 countries .
Speaker #5: Traditionally , you tend to think about kind of a full year cycle for most approvals in many countries around the world . Can you just help us understand if you're anticipating any kind of accelerated pathways that you might be able to access in these countries that would enable launch in 2026 for Orforglipron , similar to some of the pathways that are available in the US .
Speaker #4: We're very encouraged by what we're seeing with Oral. It validates our belief that there's a substantial number of people with overweight and obesity who've been sitting on the sidelines, waiting for an oral option.
Kenneth L. Custer: We've talked about that a lot on previous calls. I think we're at the point now where we're going to pivot to how do the real world results play out? We think this is going to be about patient satisfaction, and our profile, which is simple, with no restrictions on food and water intake, could make a big difference, in the real world. So we're excited to get off to the races here, see this market expand, and really look at overall patient satisfaction scores and real-world efficacy with these agents. Thanks.
Kenneth Custer: We've talked about that a lot on previous calls. I think we're at the point now where we're going to pivot to how do the real world results play out? We think this is going to be about patient satisfaction, and our profile, which is simple, with no restrictions on food and water intake, could make a big difference, in the real world. So we're excited to get off to the races here, see this market expand, and really look at overall patient satisfaction scores and real-world efficacy with these agents. Thanks.
Speaker #4: It looks like these are new mostly starts . That means expanding the it's that's good news Lilly . for We feel really good profile .
Speaker #4: We've talked about lot on that a competitiveness of our previous we're at the point now calls . I think to about the the how do real world results play out .
Speaker #5: And you've been able to them . Thank you so much
Speaker #5: garner one of .
Speaker #4: think this We is going to be about patient satisfaction and our profile , which is simple with no restrictions on food and water could make intake , a big difference in the real world .
Speaker #1: the how we're thinking about us Thanks , Courtney . about question
Speaker #1: the how we're thinking about us Thanks , Courtney . about question Great .
Speaker #1: regulatory approval timelines , we'll go to Patrick .
Speaker #4: So we're off to the excited to get races here . market See this expand , and look at overall patient satisfaction scores and real world agents .
Michael Czapar: Great. Thank you, Ken. Paul, ready for the next question?
Mike Czapar: Great. Thank you, Ken. Paul, ready for the next question?
Speaker #6: very much , Thank you Courtney . As I think we shared in the prepared remarks outside the US , it's mainly going to be a matter of launching the first half of 2027 .
Operator: The next question will be from Courtney Breen from Bernstein. Courtney, your line is live.
Operator: The next question will be from Courtney Breen from Bernstein. Courtney, your line is live.
Speaker #4: Thanks .
Speaker #1: Thank you, great. Ken, ready for the next, Paul. Question.
Speaker #1: Thank you, great. Ken, ready for the next, Paul. Question.
Daniel Skovronsky: Hi, everyone. Everyone, thanks so much for taking the question today. Just building on, on the question around Orfo, you mentioned that you have submitted in 40 countries. Traditionally, you tend to think about kind of a, a full year cycle for most approvals in many countries around the world. Can you just help us understand if you're anticipating any kind of accelerated pathways that you might be able to access in these ex-US countries that would enable launch in 2026, for Orforglipron, similar to, to some of the pathways that are available in the US, and you've been able to, to garner one of them? Thank you so much.
Daniel M. Skovronsky: Hi, everyone. Everyone, thanks so much for taking the question today. Just building on, on the question around Orfo, you mentioned that you have submitted in 40 countries. Traditionally, you tend to think about kind of a, a full year cycle for most approvals in many countries around the world. Can you just help us understand if you're anticipating any kind of accelerated pathways that you might be able to access in these ex-US countries that would enable launch in 2026, for Orforglipron, similar to, to some of the pathways that are available in the US, and you've been able to, to garner one of them? Thank you so much.
Speaker #2: The next from question will be Courtney Breen efficacy with these Bernstein . is Courtney , from your line .
Speaker #6: There will be a few markets late 26 and a few exceptions for countries like for example , the UAE , but might reference an FDA approved of orgalutran .
Speaker #5: Hi everyone . Everyone , thanks so much for taking the question today . Just building on on the around ortho , you mentioned that you have submitted in 40 countries .
Speaker #6: So mainly a play late 2624 international markets .
Speaker #1: Great . Thank you Patrick . Next caller please .
Speaker #5: you tend to think Traditionally , about kind of full year a for most approvals in many countries around the world . Can you just help us understand if you're anticipating any kind of accelerated that you pathways might be able to in these access countries , enable launch in 2026 for Orforglipron , similar to some of the pathways that that would are available in the you've been US .
Speaker #2: The next question will be from Chris Schott from JP Morgan . Chris , your line is live .
Speaker #7: Great . Thanks so much for the question and congrats on all the progress here . Can I just ask about international This seemed like this very significant upside driver at least relative to street numbers in and I'm just interested in your thoughts on the ramp from here .
Michael Czapar: Great. Thanks, Courtney. And so, for the question about how we're thinking about OUS, regulatory approval timelines, we'll go to Patrick.
Mike Czapar: Great. Thanks, Courtney. And so, for the question about how we're thinking about OUS, regulatory approval timelines, we'll go to Patrick.
Speaker #7: As we think about the 3.3 billion for Q result you just reported , I know last year was about a lot of new and now you're in those market launches , markets .
Speaker #5: able to And garner one of them . Thank you so much .
Patrik Jonsson: Well, thank you very much, Courtney. As I think we shared in the prepared remarks, outside the US, it's mainly going to be a matter of launching the first half of 2027. There will be a few markets, late 2026, and a few exceptions, for countries like, for example, the UAE, but might reference an FDA approval of Orforglipron. So mainly a play late 2026, 2027 for the international markets.
Patrik Jonsson: Well, thank you very much, Courtney. As I think we shared in the prepared remarks, outside the US, it's mainly going to be a matter of launching the first half of 2027. There will be a few markets, late 2026, and a few exceptions, for countries like, for example, the UAE, but might reference an FDA approval of Orforglipron. So mainly a play late 2026, 2027 for the international markets.
Speaker #1: Thanks , so for the Great . Courtney . And question about how we're thinking about us timelines , we'll go to regulatory approval .
Speaker #1: Thanks , so for the Great . Courtney . And question about how we're thinking about us timelines , we'll go to regulatory approval Patrick
Speaker #7: How do we think about kind of sequential growth from from these levels ? Thank you .
Speaker #6: Thank you much , very Courtney . As I think we shared in the prepared remarks outside the US , it's mainly be a matter of launching the first going to of 2027 .
Speaker #1: Great . Thank you , Chris , for the question on Manjaro performance and the ramp from here . We'll go back to Patrick .
Speaker #6: Thank you very much , Chris . Well , you are right . Q4 was a very strong quarter for Mounjaro also outside the US .
Speaker #6: There will be a few markets 26 and late a few exceptions for countries like for example , the UAE , but might reference an approved of org .
Speaker #6: And as Lucas referred to , we became the shadow market leader for total Incretins also internationally . When you look at 2026 , I would just reflect back on 25 .
Michael Czapar: Great. Thank you, Patrick. Next caller, please.
Mike Czapar: Great. Thank you, Patrick. Next caller, please.
Speaker #6: FDA So mainly a play late 2624 international markets .
Operator: The next question will be from Chris Schott from JP Morgan. Chris, your line is live.
Operator: The next question will be from Chris Schott from J.P. Morgan. Chris, your line is live.
Speaker #6: We had major launches , more or less in every quarter with the exception of Q4 . So I would actually forward as a base for the 2026 growth , but also consider that there was a slight impact in Q4 , driven by the NREL listing in China , effective one one 2026 , with slightly impacts .
Speaker #7: Great .
Speaker #1: Thank Patrick . Next caller please .
[Analyst] (JP Morgan): Great. Thanks so much for the question and congrats on all the progress here. Can I just ask about international Mounjaro? This seemed like this was a very significant upside driver, at least relative to street numbers in 2025, and I'm just interested in your thoughts on the ramp from here as we think about the $3.3 billion Q4 result just reported. I know last year was about a lot of new market launches. Now you're in those markets. How do we think about kind of sequential growth from these levels? Thank you.
Christopher Schott: Great. Thanks so much for the question and congrats on all the progress here. Can I just ask about international Mounjaro? This seemed like this was a very significant upside driver, at least relative to street numbers in 2025, and I'm just interested in your thoughts on the ramp from here as we think about the $3.3 billion Q4 result just reported. I know last year was about a lot of new market launches. Now you're in those markets. How do we think about kind of sequential growth from these levels? Thank you.
Speaker #2: Next question will be Chris Schott from J.P. Morgan. Chris, your line is live.
Speaker #8: so much Great . Thanks
Speaker #8: question . for the . And progress Can I just ask about international seemed like this was a very significant upside driver , at least relative to street numbers in 2025 , and I'm just interested in your thoughts on the from here .
Speaker #6: The purchasing pattern in China in December . So CEA , Q4 as a base for 2025 to 2026 . Moving forward , our business now for us is 75% chronic weight management , and that's pretty much out of pocket .
Speaker #8: As we ramp Manjaro ? think about the This result you just reported , I know last about a lot of year was new market launches , and now you're markets .
Michael Czapar: Great. Thank you, Chris. Well, for the question on OUS Mounjaro performance and the ramp from here, we'll go back to Patrick.
Mike Czapar: Great. Thank you, Chris. Well, for the question on OUS Mounjaro performance and the ramp from here, we'll go back to Patrick.
Speaker #8: How do you think of sequential growth from these levels?
Speaker #6: 25% is reimbursed for type two diabetes . So the for priorities 2026 will pretty much be market expansion , driving more penetration through patient activation .
Patrik Jonsson: Thank you very much, Chris. Well, you are right, Q4 was a very strong quarter for Mounjaro outside the US, and as Lucas referred to, we became the shadow market leader for total incretins, also internationally. When you look at 2026, I would just reflect back on 2025. We had major launches more or less in every quarter, with the exception of Q4. So I would actually look forward as a base for the 2026 growth, but also consider that there was a slight impact in Q4, driven by the NRDL listing in China, effective 1 January 2026, which slightly impacts the purchasing pattern in China in December. So see Q4 as a base for 2025, 2026. Moving forward, our business non-US is 75% chronic weight management, and that's pretty much out of pocket.
Patrik Jonsson: Thank you very much, Chris. Well, you are right, Q4 was a very strong quarter for Mounjaro outside the US, and as Lucas referred to, we became the shadow market leader for total incretins, also internationally. When you look at 2026, I would just reflect back on 2025. We had major launches more or less in every quarter, with the exception of Q4. So I would actually look forward as a base for the 2026 growth, but also consider that there was a slight impact in Q4, driven by the NRDL listing in China, effective 1 January 2026, which slightly impacts the purchasing pattern in China in December. So see Q4 as a base for 2025, 2026. Moving forward, our business non-US is 75% chronic weight management, and that's pretty much out of pocket.
Speaker #1: Great. Thank you, Chris. On the question of Manjaro performance and the ramp from here, we'll go back to Patrick.
Speaker #6: Thank you very much Chris . Well right . you are Q4 very was a quarter for Mounjaro . outside the US . And as we became referred to , Lukas shadow total market leader for .
Speaker #6: When it comes to chronic weight management . For type two , we are leaning in to gain reimbursement in more countries where currently reimbursed in nine , with last one being China with needle .
Speaker #6: Also internationally . When you look at 2026 , I reflect would just back We had on 25 . major launches , more or less in every quarter with exception of Q4 would actually .
Speaker #6: And we will do that with a maintained discipline in terms of pricing . So I think overall we are well positioned for for a continued growth for Mounjaro outside the US in 2026 .
Speaker #6: Looking forward at the growth, 2026 is the base. But also, I consider that there was a slight—
Speaker #1: Thanks , Patrick . Patrick , next question please . Paul .
Speaker #6: in impact Q4 , driven by the about kind Noida listing in China effective one , one 2026 , which slightly impacts the purchasing pattern in China .
Speaker #2: The next question will be from Seamus Fernandez from Guggenheim . Seamus , your line is live .
Speaker #3: Great . Thanks so much for the question . So I'm actually going to ask a non obesity question . So while you can't take your the ball on obesity just wondering why you couldn't attack immunology broadly in the same way as you obesity investing earlier faster and more aggressively , given the substantial generation that we're starting to see from the overall portfolio , what are the issues that would prevent you from doing something like this , whether it be via your internal efforts or perhaps a more aggressive development approach ?
Speaker #6: In So CEA , Q4 as for 2025 2026 , moving December . forward , our business now our US is 75% chronic weight management , and that's much out of pretty pocket .
Patrik Jonsson: 25% is reimbursed for Type 2 diabetes. So the priorities for 2026 will pretty much be market expansion, driving more penetration through patient activation when it comes to chronic weight management. And for Type 2, we are leaning in to gain reimbursement in more countries. We're currently reimbursed in 9, with the last one being China, with the NRDL. And we will do that with a maintained discipline in terms of pricing. So I think overall, we are well positioned for a continued growth for Mounjaro outside the US in 2026.
Patrik Jonsson: 25% is reimbursed for Type 2 diabetes. So the priorities for 2026 will pretty much be market expansion, driving more penetration through patient activation when it comes to chronic weight management. And for Type 2, we are leaning in to gain reimbursement in more countries. We're currently reimbursed in 9, with the last one being China, with the NRDL. And we will do that with a maintained discipline in terms of pricing. So I think overall, we are well positioned for a continued growth for Mounjaro outside the US in 2026.
Speaker #6: Twenty-five percent is reimbursed for two types, so the priorities for 2026 will pretty much be market expansion, driving more patient activation. When it comes to penetration through weight chronic management—
Speaker #6: And for type two , we are leaning in to gain reimbursement in countries where currently reimbursed in nine , with last one being China with the needle .
Speaker #3: Just because it seems like this is a , know , sort cash driven opportunity where there's a lot of spend but a huge amount of upside opportunity with $170 billion of total market out there to access .
Speaker #6: And we will do that with a maintained discipline in terms of pricing. So I think overall, we are well positioned, continued, for growth for Mounjaro outside the US in 2026.
Michael Czapar: Thanks, Patrick. Patrick, next question, please, Paul.
Mike Czapar: Thanks, Patrick. Patrick, next question, please, Paul.
Operator: The next question will be from Seamus Fernandez from Guggenheim. Seamus, your line is live.
Operator: The next question will be from Seamus Fernandez from Guggenheim. Seamus, your line is live.
Speaker #1: Thanks, Patrick. Next question, please. Paul.
[Analyst] (Guggenheim): Great. Thanks so much for the question. So I'm actually gonna ask a non-obesity question. So while you can't take your eye off the ball on obesity, just wondering why you couldn't attack immunology broadly in the same way as you have obesity, investing earlier, faster, and more aggressively, given the substantial generation that we're starting to see from the overall portfolio. What are the issues that would prevent you from doing something like this, whether it be by your internal efforts or perhaps a more aggressive business development approach? Just because it seems like this is a, you know, sort of cash-driven opportunity where there's a lot of spend, but a huge amount of upside opportunity with $170 billion of total market out there to access.
Seamus Fernandez: Great. Thanks so much for the question. So I'm actually gonna ask a non-obesity question. So while you can't take your eye off the ball on obesity, just wondering why you couldn't attack immunology broadly in the same way as you have obesity, investing earlier, faster, and more aggressively, given the substantial generation that we're starting to see from the overall portfolio. What are the issues that would prevent you from doing something like this, whether it be by your internal efforts or perhaps a more aggressive business development approach? Just because it seems like this is a, you know, sort of cash-driven opportunity where there's a lot of spend, but a huge amount of upside opportunity with $170 billion of total market out there to access.
Speaker #1: Great . Thanks , Seamus . And extra credit for the nano obesity question . We'll go to Dan to talk about our approaches on attacking immunology early .
Speaker #2: next question The will be Seamus from Fernandez from Guggenheim . Seamus ,
Speaker #2: is live .
Speaker #3: Great. Thanks so much for the question.
Speaker #3: Question. So I'm actually going to ask Patrick a non-obesity question on your line. So while you can't take your eye off the ball on obesity, just wondering—are there reasons why you couldn't attack immunology broadly in the same way as you have with obesity—investing earlier, faster, and more aggressively—given the substantial cash you're starting to see from the generation in your overall portfolio? What are the issues that would prevent you from doing something like this, whether it be via your internal efforts or perhaps a more aggressive business development, just because of that approach?
Speaker #1: Yeah .
Speaker #8: No
Speaker #8: thanks . question . great And It's a actually I'll come to immunology in a second . But let me first point out that across our non obesity work , which is of course ontology neuroscience and immunology , we have our thumb on the scale for investment decisions .
Speaker #8: We see lots of good opportunities in those areas . And we're reinvesting some of the proceeds from the obesity opportunity to make sure we can further accelerate growth in those promising areas .
Speaker #8: So today you heard me talk a lot about the oncology portfolio , which I think is really blossoming right now . I have high hopes for immunology behind it .
Speaker #3: Seems like it's a sort of cash opportunity, where there's a lot of spend but, you know, a huge amount driven opportunity with a market total of $170 billion out to access there.
Speaker #8: I think really promising breaking science , including treating immunologic diseases earlier and our research labs are doing everything in our power to to harness that science .
Michael Czapar: Great. Thanks, Seamus, and extra credit for the non-obesity question. We'll go to Dan to talk about our approaches on attacking immunology early.
Mike Czapar: Great. Thanks, Seamus, and extra credit for the non-obesity question. We'll go to Dan to talk about our approaches on attacking immunology early.
Speaker #8: Today I talked a little bit about some trials that are ongoing for Incretins and immunology , which I think is promising as our number of other combination therapies that we now our late stage clinical trials .
Speaker #1: Great . Thanks , Seamus . And extra credit for the non obesity question . We'll go to Dan about our approaches on attacking to talk immunology early .
Daniel Skovronsky: No, thanks, Seamus. It's a great question, and actually, I'll come to immunology in a second, but let me just first point out that across our non-obesity work, which is, of course, oncology, neuroscience, and immunology, we have our thumb on the scale for investment decisions. We see lots of good opportunities in those areas, and we're reinvesting some of the proceeds from the obesity opportunity to make sure we can further accelerate growth in those promising areas. So today, you heard me talk a lot about the oncology portfolio, which I think is really blossoming right now. I have high hopes for immunology behind it.
Daniel M. Skovronsky: No, thanks, Seamus. It's a great question, and actually, I'll come to immunology in a second, but let me just first point out that across our non-obesity work, which is, of course, oncology, neuroscience, and immunology, we have our thumb on the scale for investment decisions. We see lots of good opportunities in those areas, and we're reinvesting some of the proceeds from the obesity opportunity to make sure we can further accelerate growth in those promising areas. So today, you heard me talk a lot about the oncology portfolio, which I think is really blossoming right now. I have high hopes for immunology behind it.
Speaker #1: Yeah, I know. It's a great—thanks. Question.
Speaker #8: So I'm excited both early , about what late we can do . Immunology . Great .
Speaker #9: And actually I'll come to immunology in a second . But let me just first point out non work , which across our is of course obesity oncology , neuroscience and immunology , we have the scale for our thumb on decisions .
Speaker #1: Thank you Dan .
Speaker #1: Next caller and Paul .
Speaker #2: The next question will be from Terence Flynn from Morgan Stanley . Terrance , your line is live .
Speaker #9: Great . Congrats on the quarter . I had a question on the guidance . High level . Lucas . Just wondering if you can talk about what's embedded for Medicare volume ramp in the back half year and how of the might drive the range .
Speaker #9: We see lots of good opportunities in those areas . And we're reinvesting some of the proceeds from the obesity to opportunity make sure can we further accelerate in those promising areas .
Speaker #9: We're seeing on the revenue side . if And then had any impact on employer opt ins on the commercial side , I know you guys previously talked about how that might have some impact to get some of the other employers over the hurdle on coverage .
Speaker #9: So heard me talk a lot about today you the oncology portfolio , which I blossoming right really now . I have high hopes for immunology behind it .
Daniel Skovronsky: I think there's really promising breaking science, including treating immunologic diseases earlier, and our research labs are doing everything in our power to harness that science. Today, I talked a little bit about some trials that are ongoing for incretins in immunology, which I think is promising, as are a number of other combination therapies that we now have in our late-stage clinical trials. So I'm excited both early and late about what we can do in immunology.
Daniel M. Skovronsky: I think there's really promising breaking science, including treating immunologic diseases earlier, and our research labs are doing everything in our power to harness that science. Today, I talked a little bit about some trials that are ongoing for incretins in immunology, which I think is promising, as are a number of other combination therapies that we now have in our late-stage clinical trials. So I'm excited both early and late about what we can do in immunology.
Speaker #9: I think there's really promising science , including treating diseases . Earlier and labs are doing our research everything in our to to power harness that science .
Speaker #9: So just wondering the over if you're starting to see that yet .
Speaker #1: Thanks , for the question on guidance and kind of Medicare ramp in the back half of the year , as well as if there's any commercial opt in , we'll go to Lucas .
Speaker #9: Today I talked a little bit about some trials that are ongoing for incretins in immunology, which I think is promising, as our number of therapies that are combination immunologic, we now have in our late-stage clinical trials.
Speaker #8: Yeah . Terrance . Thank you . Thank you for the question . starting with Medicare highlighted in the in the call text . Basically , we are expecting that Maybe as access to be granted no later than And July 1st .
Michael Czapar: Great. Thank you, Dan. Next caller, Paul.
Mike Czapar: Great. Thank you, Dan. Next caller, Paul.
Speaker #9: So, I'm excited—both early and late—about what we can do in immunology. Great.
Operator: The next question will be from Terence Flynn from Morgan Stanley. Terence, your line is live.
Operator: The next question will be from Terence Flynn from Morgan Stanley. Terence, your line is live.
Speaker #1: Thank you. Next caller, Paul.
Patrik Jonsson: Great. Congrats on the quarter. I had a question on the guidance, high level. Lucas, just wondering if you can talk about what's embedded for Medicare volume ramp in the back half of the year, and how that might drive the range we're seeing on the revenue side. Then if that's had any impact on employer opt-ins on the commercial side. I know you guys previously talked about how that might have some impact to get some of the other employers over the hurdle on coverage, so just wondering if you're starting to see that yet?
Patrik Jonsson: Great. Congrats on the quarter. I had a question on the guidance, high level. Lucas, just wondering if you can talk about what's embedded for Medicare volume ramp in the back half of the year, and how that might drive the range we're seeing on the revenue side. Then if that's had any impact on employer opt-ins on the commercial side. I know you guys previously talked about how that might have some impact to get some of the other employers over the hurdle on coverage, so just wondering if you're starting to see that yet?
Speaker #8: as I mentioned all along , this will take time to build over time . But we feel very , very positive about the opportunity to bring anti-obesity medications to patients in Medicare .
Speaker #2: The next question will be from Morgan Stanley. Terence, your line is live.
Speaker #10: Great, congrats on the quarter. I had a question on the guidance. Hi, Lucas. Just at a high level, I was wondering if you can talk about what's embedded for Medicare volume ramp in the back half of the year, how that might drive the range.
Speaker #8: As I mentioned again , the co-pay $50 for the patients will be a compelling value proposition as well . There is a volume of of patients that we have nowadays in direct business that we believe are also Medicare patients .
Speaker #10: We're seeing on the side... and revenue then, if that's had any impact on employer opt-ins on the commercial side. I know you guys previously talked about how that might have some impact to get some of the other employers over the... over the on coverage.
Speaker #8: So expect that bolus , I think , is between 10 to 20% will actually move into the Medicare space . I think that will happen relatively fast .
Michael Czapar: Great. Thanks, Terence. For the question on guidance and kind of Medicare ramp in the back half of the year, as well as if there's any commercial opt-in, we'll go to Lucas.
Mike Czapar: Great. Thanks, Terence. For the question on guidance and kind of Medicare ramp in the back half of the year, as well as if there's any commercial opt-in, we'll go to Lucas.
Speaker #10: So, just wondering if you're starting to see hurdles that—
Speaker #8: And we will continue to build on top of that . So that's kind of the driver start to think about again , the penetration .
Speaker #10: yet
Speaker #1: for the question on guidance and kind of Medicare ramp in the back half of the year , as well there's any commercial as if opt in , we'll go to Lucas .
Lucas Montarce, M.D.: Yeah, Terence, thank you. Thank you for the question. Maybe starting with Medicare, as highlighted in the, in the call text, basically, we are expecting that access to be granted no later than July 1. As I mentioned all along, this will take time to build over time, but we feel very, very positive about the opportunity to bring anti-obesity medications to patients in Medicare. As I mentioned, again, the copay, $50 for the patients would be a compelling value proposition as well. There is a bolus of patients that we have nowadays in Lilly Direct business, that we believe are also Medicare patients. So expect that bolus, I think it's between 10 to 20% will actually move into the Medicare space.
Lucas Montarce: Yeah, Terence, thank you. Thank you for the question. Maybe starting with Medicare, as highlighted in the, in the call text, basically, we are expecting that access to be granted no later than July 1. As I mentioned all along, this will take time to build over time, but we feel very, very positive about the opportunity to bring anti-obesity medications to patients in Medicare. As I mentioned, again, the copay, $50 for the patients would be a compelling value proposition as well. There is a bolus of patients that we have nowadays in Lilly Direct business, that we believe are also Medicare patients. So expect that bolus, I think it's between 10 to 20% will actually move into the Medicare space.
Speaker #8: But we'll build over time . We think about again more about the size of the opportunity . Medicare , thinking about . was about second part of your question 2027 as well opt in .
Speaker #9: Yeah . Terence . Thank you . the question . Thank you for starting with as Maybe highlighted in Medicare in the call text .
Speaker #8: The the I have Ilya right next to me here to talk about but as well as you said , of course , again , the practice on physicians prescribing this medicine will become more natural , more broader in the anti-obesity medications , and physicians will be , again , more broadly , basically also thinking prescribing this in about commercial , how that will then impact employer side .
Speaker #9: Basically , we are expecting that to be No granted . later than July 1st . mentioned all along , this this will take time to build over time And as I .
Speaker #9: But we feel very , very about the opportunity to bring positive anti-obesity medications to patients in Medicare . As I mentioned co-pay be a $50 for the patients will value proposition as well .
Speaker #8: think I the message is clear . Right . Again , there is a clear recognition of the class as a chronic disease . And basically that will , in my eyes will will propel also employers also to think about again , this class and also employees to look for this class of medicines as well to be covered as well .
Speaker #9: There is a volume of of patients that we have nowadays in Lilly direct , again , the business that we believe are also Medicare compelling patients .
Speaker #9: So expect that bolus , I think is between 10 to 20% will actually move into the Medicare space . I think that will happen fast , relatively and we will continue to top build on of that .
Lucas Montarce, M.D.: I think that will happen relatively fast, and we will continue to build on top of that. So that's kind of the driver, start to think about, again, the penetration, but we'll build over time. We think about, again, more about the size of the opportunity in Medicare, thinking about 2027 as well. The second part of your question was about the employer opt-in. I have Ilya right next to me here as well to talk about it. But as Solano you said, of course, again, the practice on physicians prescribing this medicine will become more natural, more broader in the anti-obesity medications. And physicians will be, again, more broadly, basically also thinking about prescribing this in commercial. How that will then impact the employer side, I think the message is clear, right?
Lucas Montarce: I think that will happen relatively fast, and we will continue to build on top of that. So that's kind of the driver, start to think about, again, the penetration, but we'll build over time. We think about, again, more about the size of the opportunity in Medicare, thinking about 2027 as well. The second part of your question was about the employer opt-in. I have Ilya right next to me here as well to talk about it. But as Solano you said, of course, again, the practice on physicians prescribing this medicine will become more natural, more broader in the anti-obesity medications. And physicians will be, again, more broadly, basically also thinking about prescribing this in commercial. How that will then impact the employer side, I think the message is clear, right?
Speaker #8: But I don't know if it's anything else that you would like to add . Ileum .
Speaker #10: Yeah , maybe just some additional context . On commercial opt in . Obviously we start the year roughly on balance , relatively stable .
Speaker #9: So that's kind of the drivers start to think about again , the penetration . But we'll build over time . We think about again about more size of the the Medicare , opportunity in thinking about 2027 as well .
Speaker #10: There's some employers adding coverage , some removing some coverage , but we're additional focus in the employer space . up a We've stood team and also working with a number of third parties to actually provide alternative access channels to have some flexibility in design , transparency in the pricing and the initial conversations .
Speaker #9: The second part of your question was about the employer opt-in. I have Ilya right next to me here as well to talk about it.
Speaker #9: But as you said , of course , again , the practice on physicians prescribing this medicine will become more more broader in the natural , anti-obesity medications and be , again , more broadly , basically also thinking about prescribing in this commercial , how that will then impact employer side .
Speaker #10: And feedback has been positive . Of course , a lot of those decisions are for the following year . We having some of those decisions and coverage over time .
Lucas Montarce, M.D.: Again, there is a clear recognition of the class as a chronic disease, and basically that will, in my eyes, propel also employers-
Lucas Montarce: Again, there is a clear recognition of the class as a chronic disease, and basically that will, in my eyes, propel also employers-
Speaker #9: I think the message is clear . Right . Again , there is a clear recognition of the class as a chronic disease . And basically that will in my eyes will will propel employers also also to think about again , this class and also employees to look for this class of medicines as well to be covered as well .
Speaker #10: And the employer space as we head into the back end of this year , and mostly into 2027 .
[Analyst] (Wells Fargo): ... also to think about, again, this class, and also employees to look for these class of medicines as well to be covered as well. But I don't know if it's anything else that you would like to add, Ilya?
Mohit Bansal: ... also to think about, again, this class, and also employees to look for these class of medicines as well to be covered as well. But I don't know if it's anything else that you would like to add, Ilya?
Speaker #1: Great . Thanks , Lucas and Ilya . Next question please . Paul .
Speaker #2: The next question will be from Geoffrey Meacham , from city . Jeff , your line is live .
Ilya Yuffa: Yeah, maybe just some additional context, Terence, on commercial opt-in. Obviously, we start the year roughly on balance, relatively stable. There are some employers adding coverage, some, removing some coverage, but we're putting additional focus in the employer space. We've stood up a team and also working with a number of third parties to actually provide alternative access channels to have some flexibility in design, transparency in the pricing, and the initial conversations and feedback has been positive. Of course, a lot of those decisions are for the following year. We anticipate, having some of those decisions and increased coverage over time in the employer space as we head into the back end of this year and mostly into 2027.
Ilya Yuffa: Yeah, maybe just some additional context, Terence, on commercial opt-in. Obviously, we start the year roughly on balance, relatively stable. There are some employers adding coverage, some, removing some coverage, but we're putting additional focus in the employer space. We've stood up a team and also working with a number of third parties to actually provide alternative access channels to have some flexibility in design, transparency in the pricing, and the initial conversations and feedback has been positive. Of course, a lot of those decisions are for the following year. We anticipate, having some of those decisions and increased coverage over time in the employer space as we head into the back end of this year and mostly into 2027.
Speaker #11: Great morning everyone . Thanks for the question . Congrats on the quarter . Dan . I had one for you that together results are really super interesting .
Speaker #9: But I don't know if it's anything else that you add.
Speaker #9: would like to Ilia yeah ,
Speaker #11: just some maybe additional context . Terrence on opt in . commercial Obviously we start the year roughly on balance , relatively stable . There's some employers adding coverage , some removing coverage , but we're putting additional focus in the employer We've space .
Speaker #11: How are you thinking about the potential for combo therapies with Zepbound and either Iiai or oncology or neuro ? I wasn't sure what you know drives the investment priorities , or the the drug whether it's indication .
Speaker #11: And if there's a clear path to a to a labeling claim . Thank you .
Speaker #11: stood up a team and working also with a number parties of third actually provide alternative to access channels to have flexibility some in design in the pricing , transparency and the initial conversations and feedback has been positive .
Speaker #1: Yeah , thanks , Jeff . Again , another not an question . So lots of extra credit on this call . We'll go to Adrian to talk about some of the combination approaches and therapy some of the strategy .
Speaker #1: There .
Speaker #12: Sure . We see this as a significant opportunity . Obviously , you know , more than a billion people worldwide have immune diseases like atopic dermatitis , psoriasis , IBD and asthma .
Speaker #11: Of course, a lot of those decisions are for the following year. We anticipate having some of those decisions and increased time.
Michael Czapar: Great. Thanks, Lucas and Ilya. Next question, please, Paul.
Mike Czapar: Great. Thanks, Lucas and Ilya. Next question, please, Paul.
Speaker #12: patients who have both But immune diseases and obesity tend to have a higher disease burden . So we're really excited about the opportunity to find new ways to combat the underlying inflammation .
Speaker #11: And the employer space as we head back into this year and into 2027.
Operator: The next question will be from Jeff Meacham from Citi. Jeff, your line is live.
Operator: The next question will be from Geoff Meacham from Citi. Jeff, your line is live.
Speaker #1: Thanks , Great . Lucas and Ilya . Next question Paul . please .
[Analyst] (Citi): Great, morning, everyone. Thanks for the question. Dan, I had one for you. The Together results are really super interesting. How are you thinking about the potential for combo therapies with Zepbound and either INI or oncology or neuro? I wasn't sure, you know, what drives the investment priorities, whether it's the drug or the indication, and if there is a clear path to a labeling claim. Thank you.
Geoff Meacham: Great, morning, everyone. Thanks for the question. Dan, I had one for you. The Together results are really super interesting. How are you thinking about the potential for combo therapies with Zepbound and either INI or oncology or neuro? I wasn't sure, you know, what drives the investment priorities, whether it's the drug or the indication, and if there is a clear path to a labeling claim. Thank you.
Speaker #12: These diseases and potentially unlock better , longer lasting results for these patients . So we have broad efforts underway to look at additional combinations .
Speaker #2: Next, the question will be from Geoff Meacham from Citi. Geoff, your line is live.
Speaker #12: everyone . for the Thanks morning Great question . Congrats quarter on the . Dan That had one for you . together results are really super .
Speaker #12: We have the together . So trial evaluating the use of Taltz and Zepbound for adults with moderate to severe plaque psoriasis and obesity or overweight .
Speaker #12: interesting How are you thinking about the potential therapies combo for with Zepbound and either Iiai or oncology or neuro ? I wasn't sure you know what drives the investment priorities , whether it's the drug or the indication , and if there's a clear to path labeling claim .
Speaker #12: expect results in the of 2026 . We're also looking at the PSA and We first half line together those top together amplified amplify .
Michael Czapar: Yeah, thanks, Jeff. Again, another non-obesity question, so lots of extra credit on this call. We'll go to Adrienne to talk about some of the, the combination therapy approaches and some of the strategy there.
Mike Czapar: Yeah, thanks, Jeff. Again, another non-obesity question, so lots of extra credit on this call. We'll go to Adrienne to talk about some of the, the combination therapy approaches and some of the strategy there.
Speaker #12: So studies assessing the effectiveness of adding zepbound after starting Taltz for adults with PSA and moderate to severe plaque psoriasis , we also have the phase three commit studies in both ulcerative colitis as well as Crohn's disease , where we're looking at the concomitant use of omvoh and zepbound and addressing outcomes for those patients .
Speaker #12: Thank you .
Speaker #1: Yeah . Thanks , Jeff . Again , another non-obese question . So lots of extra credit on this call . We'll go to Adrian to talk about some of the combination therapy approaches and some of the strategy .
Adrienne Brown: Sure. We see this as a significant opportunity. Obviously, you know, more than a billion people worldwide have immune diseases like atopic dermatitis, psoriasis, IBD, and asthma. But patients who have both immune diseases and obesity tend to have a higher disease burden. So we're really excited about the opportunity to find new ways to combat the underlying inflammation of these diseases and potentially unlock better, longer-lasting results for these patients. So we have, you know, broad efforts underway to look at additional combinations. We have the Together PSO trial evaluating the use of Taltz and Zepbound for adults with moderate to severe plaque psoriasis and obesity or overweight. We expect those top-line results in the first half of 2026.
Adrienne Brown: Sure. We see this as a significant opportunity. Obviously, you know, more than a billion people worldwide have immune diseases like atopic dermatitis, psoriasis, IBD, and asthma. But patients who have both immune diseases and obesity tend to have a higher disease burden. So we're really excited about the opportunity to find new ways to combat the underlying inflammation of these diseases and potentially unlock better, longer-lasting results for these patients. So we have, you know, broad efforts underway to look at additional combinations. We have the Together PSO trial evaluating the use of Taltz and Zepbound for adults with moderate to severe plaque psoriasis and obesity or overweight. We expect those top-line results in the first half of 2026.
Speaker #1: There .
Speaker #13: Sure . We see this as a significant opportunity . Obviously , you know , more than a billion people worldwide have immune diseases like atopic psoriasis , IBD and dermatitis , asthma .
Speaker #12: And then the phase two study of benefit for people living with uncontrolled asthma . So we're excited to continue to pursue the applications of incretins and unlocking better outcomes for people with immune diseases .
Speaker #13: But patients who have both immune diseases and obesity tend to have a higher disease burden. So we're really seeing an opportunity to find new ways to combat the underlying inflammation.
Speaker #13: These diseases and potentially unlock better , longer lasting results for these patients . So we have , you know , broad efforts underway to look at additional combinations .
Speaker #1: Great . Thanks , Adrian . Thanks for the question . Next caller , Paul .
Speaker #2: The next question will be from Asad Haider from Goldman Sachs . Asad , your line is live .
Speaker #13: Great . Thanks for taking the question and congrats on all the progress . Back to obesity . With apologies , Mike . Maybe just given the focus on can you dynamics , just pricing talk about what you're seeing in the environment ?
Speaker #13: We have the together . So trial evaluating the use of and zepbound for Taltz adults with moderate to severe plaque psoriasis and obesity or overweight .
Adrienne Brown: We're also looking at the Together Amplify PSA and Together Amplify PSO studies, assessing the effectiveness of adding Zepbound after starting Taltz for adults with PSA and moderate to severe plaque psoriasis. We also have the Phase 3b COMMIT studies in both ulcerative colitis as well as Crohn's disease, where we're looking at the concomitant use of Omvoh and Zepbound, and addressing outcomes for those patients, and then the Phase 2 study of Brenipatide for people living with uncontrolled asthma. So we're excited to continue to pursue the applications of incretins and unlocking better outcomes for people with immune diseases.
Adrienne Brown: We're also looking at the Together Amplify PSA and Together Amplify PSO studies, assessing the effectiveness of adding Zepbound after starting Taltz for adults with PSA and moderate to severe plaque psoriasis. We also have the Phase 3b COMMIT studies in both ulcerative colitis as well as Crohn's disease, where we're looking at the concomitant use of Omvoh and Zepbound, and addressing outcomes for those patients, and then the Phase 2 study of Brenipatide for people living with uncontrolled asthma. So we're excited to continue to pursue the applications of incretins and unlocking better outcomes for people with immune diseases.
Speaker #13: We expect those top-line results in the first half of 2026. We're also looking at the together Amplified-PSA and together Amplify.
Speaker #13: Broadly speaking , contracting the portfolio ? And also what's your view on price elasticity in the cash channel as the year progresses ? Thank you .
Speaker #13: So studies assessing the effectiveness of adding Zepbound after starting Taltz for adults with PsA and moderate to severe plaque psoriasis. We also have the phase 3 Commit studies in both ulcerative colitis as well as Crohn's disease, where we're looking at the concomitant use of Omvoh and Zepbound and addressing outcomes for those patients.
Speaker #1: Thanks for the question . To through . go Kind of pricing in the US and price elasticity . We'll go to Ilya .
Speaker #10: Yeah , sure . Thanks for the question . Maybe just for the first part , in terms of the commercial access and contracting , obviously we start the year with similar coverage as we ended 2025 .
Speaker #10: We continue to coverage for Zepbound have in two of the three large PBMs . We conversations continue the around expanding access in those PBMs for obviously , the introduction of Orforglipron in Q2 .
Speaker #13: And then the phase for two study people living with uncontrolled asthma . So we're excited to continue to pursue the applications of incretins and unlocking better outcomes for people with immune diseases .
Michael Czapar: Great. Thanks, Adrienne. Thanks for the question. Next caller, Paul.
Mike Czapar: Great. Thanks, Adrienne. Thanks for the question. Next caller, Paul.
Operator: The next question will be from Asad Hyder from Goldman Sachs. Asad, your line is live.
Operator: The next question will be from Asad Hyder from Goldman Sachs. Asad, your line is live.
Speaker #1: Great . Thanks , question . for the Adrian . Thanks Paul Next caller , .
[Analyst] (Goldman Sachs): Great. Thanks for taking the question, and congrats on all the progress. Back to obesity, with apologies, Mike. Maybe just given the focus on pricing dynamics, can you just talk about what you're seeing in the contracting environment, broadly speaking, across the incretin portfolio? And also, what's your view on price elasticity in the cash channel as the year progresses? Thank you.
Asad Haider: Great. Thanks for taking the question, and congrats on all the progress. Back to obesity, with apologies, Mike. Maybe just given the focus on pricing dynamics, can you just talk about what you're seeing in the contracting environment, broadly speaking, across the incretin portfolio? And also, what's your view on price elasticity in the cash channel as the year progresses? Thank you.
Speaker #2: The next question will be from Asad Haider from Goldman Sachs. Asad, your line is live.
Speaker #10: So we're in active discussions there from a pricing standpoint . We've been pretty transparent on pricing for 2026 as it relates to part D , as well as our to patient direct which we implemented at the end of December .
Speaker #14: Great . Thanks for taking the question and congrats on all the progress . obesity with apologies , Mike Back to . Maybe just given the focus on pricing dynamics , can just talk about what you're seeing in you contracting the environment ?
Michael Czapar: Yeah, Asad, thanks for the question. To go through kind of pricing in, in the US and price elasticity, we'll go to Ilya.
Mike Czapar: Yeah, Asad, thanks for the question. To go through kind of pricing in, in the US and price elasticity, we'll go to Ilya.
Speaker #14: Broadly speaking , across the also what's your view on price elasticity in the portfolio ? And cash the year progresses ? Thank you channel as .
Speaker #10: And then pricing , continuing access in the commercial segment in terms of price elasticity , we've seen over time , both in the US and outside of the US , that affordability and opportunity on the entry , as well as predictability of cost for patients , matter .
Ilya Yuffa: Yeah, sure. Thanks for the question. Maybe just for the first part, in terms of the commercial access and contracting, obviously, we start the year with similar coverage as we ended 2025. We continue to have coverage for Zepbound in two of the three large PBMs. We continue the conversations around expanding access in those PBMs for, obviously, the introduction of orforglipron in Q2, so we're in active discussions there. From a pricing standpoint, we've been pretty transparent on pricing for 2026 as it relates to Part D, as well as our direct-to-patient pricing, which we implemented at the end of December. And then we have ongoing conversations with improving and continuing access in the commercial segment.
Ilya Yuffa: Yeah, sure. Thanks for the question. Maybe just for the first part, in terms of the commercial access and contracting, obviously, we start the year with similar coverage as we ended 2025. We continue to have coverage for Zepbound in two of the three large PBMs. We continue the conversations around expanding access in those PBMs for, obviously, the introduction of orforglipron in Q2, so we're in active discussions there. From a pricing standpoint, we've been pretty transparent on pricing for 2026 as it relates to Part D, as well as our direct-to-patient pricing, which we implemented at the end of December. And then we have ongoing conversations with improving and continuing access in the commercial segment.
Speaker #1: Thanks for the question to go through kind of pricing, and price elasticity. We'll go to Ilya, US.
Speaker #11: Yeah , sure . Thanks for the question . Maybe just for the first part , in terms of the commercial access and contracting , obviously we start the year with similar coverage as we ended 2025 .
Speaker #10: That's why the out of pocket in part D of $50 is an affordable option , as well . As we've seen , an increase in utilization of even Zepbound vial at the end of the year when we implemented improved entry price of 299 for Zepbound .
Speaker #11: We continue to have coverage for Zepbound in two of the three large PBMs. We continue the conversations around We access in those PBMs for introduction of, obviously, Orforglipron in Q2.
Speaker #10: So we continue to see that . And obviously we're seeing significant and encouraging uptake in the oral market , which is expansive and bringing new patients to obesity treatment .
Speaker #11: So we're in active there discussions from a pricing standpoint , we've been pretty transparent on pricing for 2026 as it relates D , as well as our direct to patient pricing , which we implemented at the end of December .
Speaker #10: And we're excited to Orforglipron soon with launch the entry entry price similar being to oral Sima .
Ilya Yuffa: In terms of price elasticity, we've seen over time, both in the US and outside the US, that affordability and opportunity on the entry, as well as predictability of cost for patients matter. That's why the out-of-pocket in Part D of $50 is an affordable option, as well as we've seen an increase in utilization of even Zepbound vial at the end of the year when we implemented improved entry price of $299 for Zepbound. So we continue to see that, and obviously, we're seeing significant encouraging uptake in the oral market, which is expansive and bringing new patients to obesity treatment. And we're excited to launch orforglipron soon with the entry, entry price being similar to oral seven.
Ilya Yuffa: In terms of price elasticity, we've seen over time, both in the US and outside the US, that affordability and opportunity on the entry, as well as predictability of cost for patients matter. That's why the out-of-pocket in Part D of $50 is an affordable option, as well as we've seen an increase in utilization of even Zepbound vial at the end of the year when we implemented improved entry price of $299 for Zepbound. So we continue to see that, and obviously, we're seeing significant encouraging uptake in the oral market, which is expansive and bringing new patients to obesity treatment. And we're excited to launch orforglipron soon with the entry, entry price being similar to oral seven.
Speaker #11: And then we have ongoing conversations with improving and continuing access in commercial the segment . In terms of price elasticity , we've seen over time , both in the US and outside of the US , that affordability and opportunity on the entry , as well as predictability of cost for patients , matter .
Speaker #1: Thank Great . you . Ilya . Ready for the next question , please ?
Speaker #2: . The Paul next question will be from Mohit Bansal from Wells Fargo . Mohit , your line is live .
Speaker #14: Great . Thank you very much for taking my question . So a strategic one . So I would love to understand what is your latest on the thinking importance of getting obesity related indications on the label ?
Speaker #11: That's why pocket, the out-of-in part D of $50, is an affordable option as well. As we've seen, there was an increase in utilization of Zepbound vials at the end of the year when we implemented the improved entry price of $299 for Zepbound.
Speaker #14: Because we kind of get the mixed message , a little bit of message when we talk to payers , because they kind of think that these drugs are just for obesity .
Speaker #14: For now , with Nash , they are still covering for obesity with Nash . But do you think this could be an over time , long term here ?
Speaker #11: So, we see that continue to—and obviously we're seeing significant and encouraging uptake in the oral market, which is expansive and bringing new patients to obesity treatment.
Speaker #14: Now that you are going into indications like Eni as well , at this Thank you .
Speaker #14: Now that you are going into indications like Eni as well , at this Thank you .
Speaker #1: Mohit . Thanks for question , the So to kind of think about and address our strategy on obesity and expansion of indications , more , more broadly , we'll go to , to Ilya to go .
Speaker #11: And we're excited to launch run soon with entry . Entry our the price being to similar oral Semma .
Michael Czapar: Great. Thank you, Ilya. Ready for the next question, please, Paul.
Mike Czapar: Great. Thank you, Ilya. Ready for the next question, please, Paul.
Operator: The next question will be from Mohit Bansal from Wells Fargo. Mohit, your line is live.
Operator: The next question will be from Mohit Bansal from Wells Fargo. Mohit, your line is live.
Speaker #1: And then Ken , you can add if you have any other thoughts . Sure .
Speaker #1: Great . Thank you , Ilya . Ready for the next question , please , Paul .
Speaker #10: Thanks for the question . What we've seen thus even far , with Zepbound and looking at Medicare , population around sleep an apnea or seeing increase in utilization and thinking about obesity beyond weight and looking at outcomes related to obesity , and a lot of comorbidities is Dan had mentioned , even in our arthritis trial with Taltz , when we talk to employers well as payers , they think about the multiple aspects of obesity and what that means for coverage and cost long term .
[Analyst] (Wells Fargo): Great. Thank you very much for taking my question. So a strategic one. So I would love to understand what is your latest thinking on the importance of getting obesity-related indications on the label? Because we kind of get the mixed message, a little bit of mixed message when we talk to payers, because they kind of think that these drugs are just for obesity for now. With NASH, they're still covering for obesity, with NASH.
Mohit Bansal: Great. Thank you very much for taking my question. So a strategic one. So I would love to understand what is your latest thinking on the importance of getting obesity-related indications on the label? Because we kind of get the mixed message, a little bit of mixed message when we talk to payers, because they kind of think that these drugs are just for obesity for now. With NASH, they're still covering for obesity, with NASH.
Speaker #2: Question will be from Mohit from Wells Fargo. Mohit, your line is live.
Speaker #15: Thank you very much for that, great. My question is a strategic one, so I would love to understand what is your latest thinking on the importance of getting related indications on the label?
Speaker #15: Because we kind of mixed message a bit message get the we talk to payers , because , a mixed they kind of think that these drugs are just for obesity .
Patrik Jonsson: ... but do you think this could be an over time long-term differentiator here, now that you are going into indications like INI as well at this point? Thank you.
Patrik Jonsson: ... but do you think this could be an over time long-term differentiator here, now that you are going into indications like INI as well at this point? Thank you.
Speaker #15: with Nash , they For now , are still covering for Nash obesity with do you think . But this could be an over time , term long differentiator here ?
Michael Czapar: Thanks for the question, Mohit. So to kind of think about and address our strategy on obesity and expansion of indications more, more broadly, we'll go to, to Ilya to go, and then, Ken, you can add if you have any other development thoughts.
Mike Czapar: Thanks for the question, Mohit. So to kind of think about and address our strategy on obesity and expansion of indications more, more broadly, we'll go to, to Ilya to go, and then, Ken, you can add if you have any other development thoughts.
Speaker #15: Now that you are going into indications, any as well at this point? Like, thank you.
Speaker #10: So we do see growing body of evidence to support covering obesity medications for population and having a positive impact to public health beyond just weight .
Speaker #1: Thanks for the question , Mohit . So to kind of about address our strategy on and think and obesity expansion of indications , more more , we'll go to to Ilya broadly to go .
Ilya Yuffa: Sure. Thanks, Mohit, for the question. You know, what we've seen thus far, even with Zepbound and looking at Medicare population around sleep apnea, we're seeing an increase in utilization and thinking about obesity beyond weight and looking at outcomes related to obesity and a lot of comorbidities, as Dan had mentioned in our psoriatic arthritis trial with pulse. When we talk to employers as well as payers, they think about the multiple aspects of obesity and what that means for coverage and cost long term. So we do see a growing body of evidence to support covering obesity medications for population and having a positive impact to public health beyond just weight.
Ilya Yuffa: Sure. Thanks, Mohit, for the question. You know, what we've seen thus far, even with Zepbound and looking at Medicare population around sleep apnea, we're seeing an increase in utilization and thinking about obesity beyond weight and looking at outcomes related to obesity and a lot of comorbidities, as Dan had mentioned in our psoriatic arthritis trial with pulse. When we talk to employers as well as payers, they think about the multiple aspects of obesity and what that means for coverage and cost long term. So we do see a growing body of evidence to support covering obesity medications for population and having a positive impact to public health beyond just weight.
Speaker #1: Ken, you can, and then add if you have any other thoughts. Sure.
Speaker #4: So thanks for the question . On other potential avenues of worry as it relates to complications and comorbidities . As our Incretin portfolio and Amylin portfolio expands , we're always facing the question of do we spend our resources replicating findings from previous incretins on comorbidities and complications , where we know these drugs are efficacious , or do we push into new areas and generate new evidence ?
Speaker #11: Thanks for the know what we've seen thus far with Zepbound. In looking at the question, you mention the Medicare population around sleep apnea. We're seeing an increase in utilization and thinking about obesity beyond weight, and looking at outcomes related to obesity.
Speaker #11: And a lot at of comorbidities as Dan had mentioned , even in our arthritis trial with Taltz , when we talk to as employers as payers , well they think about multiple the obesity and aspects of what that means for coverage and cost long term .
Speaker #4: You've probably seen with Orforglipron , we're actually starting to explore new ideas like stress urinary incontinence , peripheral artery disease , and hypertension .
Speaker #4: We'll continue to look for new incretins in addition to what we've talked about in the Ini space , but we do also understand that with new molecules and new mechanisms , it's important to generate some data to continue to give prescribers and patients these confidence that medicines preserve the benefits previous class of medicines .
Speaker #4: of the continue to do that too . So we But very pleased , I think , with our overall balance of investment across the portfolio in both sort of established and emerging mechanisms of diseases of interest .
Speaker #11: So we do see a growing body of evidence to support covering obesity medications for the population and having a positive impact on public health beyond just weight.
Kenneth L. Custer: Great. So thanks for the question on other potential avenues of exploration as it relates to complications and comorbidities. You know, as our incretin portfolio and amylin portfolio expands, we're always facing the question of: Do we spend our resources replicating findings from previous incretins on comorbidities and complications where we know these drugs are efficacious, or do we push into new areas and generate new evidence? You've probably seen with liraglutide, we're actually starting to explore new ideas like stress urinary incontinence, peripheral artery disease, and hypertension. We'll continue to look for new incretins in addition to what we talked about in the INI space.
Kenneth Custer: Great. So thanks for the question on other potential avenues of exploration as it relates to complications and comorbidities. You know, as our incretin portfolio and amylin portfolio expands, we're always facing the question of: Do we spend our resources replicating findings from previous incretins on comorbidities and complications where we know these drugs are efficacious, or do we push into new areas and generate new evidence? You've probably seen with liraglutide, we're actually starting to explore new ideas like stress urinary incontinence, peripheral artery disease, and hypertension. We'll continue to look for new incretins in addition to what we talked about in the INI space.
Speaker #4: Great .
Speaker #1: Thank you both . Ready for the next question , please , Paul .
Speaker #2: The next question will be from Umer Raffat from Evercore Umar . Your line is live .
Speaker #4: So thanks for the question . On other potential of avenues explore as it relates to complications and as our incretin comorbidities , portfolio and Amylin portfolio expands , we're always facing the question of do we spend our resources replicating findings from previous incretins on comorbidities and complications , where we know these drugs are efficacious , or do we push into new generate new evidence ?
Speaker #15: Thank you guys . Cash pay I feel like has been a very important driver of growth among other drivers . And I'm just trying to think out loud what the long term implications of that could look like , especially with all the competition coming on , the one side , obviously there's going to be tremendous brand loyalty , which is very important in cash pay .
Speaker #4: areas and You've probably with seen Orforglipron , we're actually starting to explore new ideas like stress urinary incontinence , peripheral artery disease , and hypertension .
Speaker #15: But on the other side , the traditional PBM contracts and rebate not apply . So I'm will may just trying to think out loud how you're thinking about retention and cash share pay in the long run .
Kenneth L. Custer: But we do also understand that with new molecules and new mechanisms, it's important to generate some data to continue to give prescribers and patients confidence that these medicines preserve the benefits of the previous class of medicines. So we continue to do that, too, but very pleased, I think, with our overall balance of investment across the incretin portfolio in both sort of established and emerging mechanisms of interest or diseases of interest.
Kenneth Custer: But we do also understand that with new molecules and new mechanisms, it's important to generate some data to continue to give prescribers and patients confidence that these medicines preserve the benefits of the previous class of medicines. So we continue to do that, too, but very pleased, I think, with our overall balance of investment across the incretin portfolio in both sort of established and emerging mechanisms of interest or diseases of interest.
Speaker #4: We'll continue to look at incretins in what we've talked about for new Eni addition to in the space, but we do also understand that with new mechanisms, it's important to generate some data to continue to give molecules and prescribers and patients confidence that these medicines preserve the benefits of the previous class of medicines.
Speaker #15: Thank you .
Speaker #1: Yep . Thanks for the question , Umar . To discuss a bit about sort cash pay of the I'll ask actually , Ilya and Patrick to discuss how it plays out internationally and as well in the US .
Speaker #1: Patrick , you want So to start
Speaker #4: So we continue to do that too . But very think , with our pleased , I balance of overall investment across the portfolio in both sort of established and emerging mechanisms of diseases of interest .
Speaker #6: I You know ,
Speaker #6: think what we have been building first . over the last couple of learning years , from the a lot US , has really been the consumer centricity .
Michael Czapar: Great. Thank you both. We're ready for the next question, please, Paul.
Mike Czapar: Great. Thank you both. We're ready for the next question, please, Paul.
Operator: The next question will be from Umair Rafat, from Evercore. Umair, your line is live.
Operator: The next question will be from Umer Raffat, from Evercore. Umair, your line is live.
Speaker #6: And I think it's a matter of building platforms along the lines , as we have done in the US with Lilly Direct , where we are providing the opportunity for patients both to seek start and to statement .
Speaker #1: Great. Thank you for the next question, please, Paul.
Speaker #1: both
[Analyst] (Evercore): Thank you, guys. Cash pay, I feel like, has been a very important driver of growth among other drivers, and I'm just trying to think out loud what the long-term implications of that could look like, especially with all the competition coming. On the one side, obviously, there's going to be tremendous brand loyalty, which is very important in cash pay, but on the other side, the traditional PBM contracts and rebate wall may not apply. So I'm just trying to think out loud how you're thinking about share retention and cash pay in the long run. Thank you.
Umer Raffat: Thank you, guys. Cash pay, I feel like, has been a very important driver of growth among other drivers, and I'm just trying to think out loud what the long-term implications of that could look like, especially with all the competition coming. On the one side, obviously, there's going to be tremendous brand loyalty, which is very important in cash pay, but on the other side, the traditional PBM contracts and rebate wall may not apply. So I'm just trying to think out loud how you're thinking about share retention and cash pay in the long run. Thank you.
Speaker #2: We'll be from Umair Raffat from Evercore. Umair, your line is live.
Speaker #6: So I think that's a massive that we need to continue to develop .
Speaker #16: Thank you guys . Cash pay I feel like has been a very important driver of growth among other drivers . And I'm just trying to think out loud what the long term implications of that could like , especially with look all the competition coming on the one side , obviously there's going to be tremendous brand loyalty , which is very in cash important pay .
Speaker #10: just Yeah , to add on , I think we've learned quite a bit . There are frictions in the system for a number of diseases in the US and globally .
Speaker #10: Obviously , we've seen that happen in obesity . What we've built within Lilly Direct as a pretty significant scaled direct to consumer platform that helps address some of the frictions .
Speaker #16: on the But other side , the traditional PBM contracts and rebate wall may not apply . So I'm just trying to think out loud how you're about share thinking retention and cash pay in the long Thank you run .
Michael Czapar: Okay. Thanks for the question, Umair. To discuss a bit about sort of the cash pay dynamics, I'll ask actually, Ilya and Patrik to discuss how it plays out internationally and, well, as well in the US. So Patrik, you want to start first?
Mike Czapar: Okay. Thanks for the question, Umair. To discuss a bit about sort of the cash pay dynamics, I'll ask actually, Ilya and Patrik to discuss how it plays out internationally and, well, as well in the US. So Patrik, you want to start first?
Speaker #10: Of course , we can continue to think about how we evolve that consumer experience and make this more seamless . At the same time , growing access across the different segments .
Speaker #16: .
Speaker #1: thanks for the Yeah , question , Umar . To discuss a bit about sort of the cash pay dynamics . I'll ask actually Ilya and Patrick to discuss how it plays out internationally and as So US .
Patrik Jonsson: Well, you know what, I think what we have been building over the last couple of years, learning a lot from the US, has really been the consumer centricity. And I think it's a matter of building platforms along the lines as we have done in the US with LillyDirect, where we are providing the opportunity for patients both to seek, start, and to stay on. So I think that's a must that we need to continue to develop.
Patrik Jonsson: Well, you know what, I think what we have been building over the last couple of years, learning a lot from the US, has really been the consumer centricity. And I think it's a matter of building platforms along the lines as we have done in the US with LillyDirect, where we are providing the opportunity for patients both to seek, start, and to stay on. So I think that's a must that we need to continue to develop.
Speaker #10: so both will play an . role And important we continue to look for ways for us to scale as well as improve on the experience over time .
Speaker #1: Patrick, you want to start first.
Speaker #6: You know , I think what we have been building over the last couple of years , learning a lot from the US , has really been the consumer centricity .
Speaker #1: Thanks both for the comments . Let's go to the next question , please . Paul .
Speaker #6: And I think it's a matter of building platforms along the lines , as we have done in the US with Lilly Direct , where we are providing the opportunity for patients both to seek start and to statement .
Speaker #2: The next question will be from Alex Hammond from Wolfe Research . Alex , your line is live .
Speaker #16: Hey guys , thanks for taking the question . One on Alarelin . So the weight loss results , you guys year look presented last really strong .
Ilya Yuffa: Yeah. Yeah, just to add on, I think we've learned quite a bit. There are frictions in the system for a number of diseases in the US and globally. Obviously, we've seen that happen in obesity. What we've built within Lilly Direct as a pretty significant scaled direct-to-consumer platform that helps address some of the frictions. Of course, we can continue to think about how we evolve that consumer experience and make this more seamless, at the same time, growing access across the different segments. And so, and both will play an important role, and we continue to look for ways for us to scale as well as improve on the experience over time.
Ilya Yuffa: Yeah. Yeah, just to add on, I think we've learned quite a bit. There are frictions in the system for a number of diseases in the US and globally. Obviously, we've seen that happen in obesity. What we've built within Lilly Direct as a pretty significant scaled direct-to-consumer platform that helps address some of the frictions. Of course, we can continue to think about how we evolve that consumer experience and make this more seamless, at the same time, growing access across the different segments. And so, and both will play an important role, and we continue to look for ways for us to scale as well as improve on the experience over time.
Speaker #6: So I think that's a massive that we need to continue to develop .
Speaker #16: But given prescribers and patients seem more interested in more favorable tolerability , how should we think about the potential for lower doses of Alara and lower dose combos of trizepatide to potentially achieve a titration placebo free like tolerability with weight loss ?
Speaker #11: Yeah, just to add on, I think we've learned quite a bit. There are frictions in the system for a number of diseases in the U.S. and globally.
Speaker #11: Obviously , we've seen that happen in obesity . What we've built within Lilly Direct as a pretty significant scaled consumer direct to platform that helps address some of the frictions .
Speaker #16: Let's say comparable to monotherapy , GLP one . Thank you .
Speaker #1: Thanks , Alex . We'll go to Ken to talk about the allure development strategies and different ideas . We're assessing .
Speaker #11: Of we can continue to think about how we course , evolve that consumer experience and make this more seamless . At the same time , growing access across the different segments .
Speaker #4: Yeah , thanks for the question , Alex . tied in future On avenues . There . We were really excited about the data we shared at obesity last week where patients achieved up to 20.1% weight loss with the lower with tied was tolerability .
Speaker #11: And so both will play an important role . And we continue to look for ways for us to scale as well as improve on the experience over time .
Speaker #4: excellent That improved with titration . In fact , in the 3.69mg titration group , I think we only had one incidence of vomiting out of more than 50 patients .
Michael Czapar: Great. Thanks, both, for the comments. Let's go to the next question. Please, Paul.
Mike Czapar: Great. Thanks, both, for the comments. Let's go to the next question. Please, Paul.
Operator: The next question will be from Alex Hammond, from Wolfe Research. Alex, your line is live.
Operator: The next question will be from Alex Hammond, from Wolfe Research. Alex, your line is live.
Speaker #4: So that compares , we think really favorable versus the existing Incretin class . So we see a big opportunity for a lower tide in patients who maybe just can't tolerate incretin .
Speaker #11: Great .
Speaker #1: Thanks both for the comments . Let's go to the next question , please . Paul .
[Analyst] (Wolfe Research): Hey, guys. Thanks for taking the question. One on all our incretins. So the weight loss results you guys presented last year looked really strong, but given prescribers and patients seem more interested in more favorable tolerability, how should we think about the potential for lower doses of orforglipron and lower dose combos of tirzepatide to potentially achieve a titration-free, placebo-like tolerability with weight loss, let's say, comparable to monotherapy GLP-1? Thank you.
Alexandria Hammond: Hey, guys. Thanks for taking the question. One on all our incretins. So the weight loss results you guys presented last year looked really strong, but given prescribers and patients seem more interested in more favorable tolerability, how should we think about the potential for lower doses of orforglipron and lower dose combos of tirzepatide to potentially achieve a titration-free, placebo-like tolerability with weight loss, let's say, comparable to monotherapy GLP-1? Thank you.
Speaker #2: The next question will be from Alex Hammond from Wolfe. Alex, your line is live.
Speaker #4: We know that 5 to 10% of patients in our trials tend to discontinue on the Incretin class , suggesting a pretty opening given big the size of the city market .
Speaker #17: thanks for Hey guys , taking the question . One on Laura Tide . So the weight loss results , you guys presented last year look really strong .
Speaker #17: But given prescribers and patients seem more interested in more favorable tolerability, how should we think about the potential for lower doses of Alara and lower dose combos of tirzepatide to potentially achieve a titration-free, placebo-like tolerability with weight loss?
Speaker #4: Of course , we're also interested in thinking about oral in combination with other mechanisms of action and what you alluded to with GIP plus GLP one plus Amylin .
Michael Czapar: Thanks, Alex. We'll go to Ken to talk about the Eloralintide development strategies and different ideas we're assessing.
Mike Czapar: Thanks, Alex. We'll go to Ken to talk about the Eloralintide development strategies and different ideas we're assessing.
Speaker #4: It's a very sort of physiological construct . Three nutrient stimulated hormones , and we've shared that we are exploring that idea in the clinic .
Speaker #17: Let's say, comparable to monotherapy, GLP-1, you think.
Kenneth L. Custer: Yeah, thanks for the question, Alex, on eloralintide and future avenues.
Kenneth Custer: Yeah, thanks for the question, Alex, on eloralintide and future avenues.
Speaker #1: Thanks, Alex. We'll go to Ken to talk about the Allure talk development strategies and different ideas. We're assessing.
Speaker #4: Nothing to share yet , but stay tuned . Maybe towards the end of this year we're testing other possible combinations , including a GIP agonist , Mucopeptide tide as well .
Michael Czapar: Yeah.
Mike Czapar: Yeah.
Kenneth L. Custer: We were really excited about the data we shared at Obesity last week, where patients achieved up to 20.1% weight loss with eloralintide, with excellent tolerability that was improved with titration. In fact, in the 3, 6, 9 mg titration group, I think we only had 1 incident of vomiting out of more than 50 patients. So, that compares, we think, really favorable versus the existing incretin class. So we see a big opportunity for eloralintide in patients who maybe just can't tolerate an incretin. We know that 5% to 10% of patients in our trials tend to discontinue on the incretin class, suggesting a pretty big opening given the size of the obesity market.
Kenneth Custer: We were really excited about the data we shared at Obesity last week, where patients achieved up to 20.1% weight loss with eloralintide, with excellent tolerability that was improved with titration. In fact, in the 3, 6, 9 mg titration group, I think we only had 1 incident of vomiting out of more than 50 patients. So, that compares, we think, really favorable versus the existing incretin class. So we see a big opportunity for eloralintide in patients who maybe just can't tolerate an incretin. We know that 5% to 10% of patients in our trials tend to discontinue on the incretin class, suggesting a pretty big opening given the size of the obesity market.
Speaker #4: the question , on Yeah , thanks for Tide and future avenues . There . We were really excited about the data we shared at obesity last week .
Speaker #4: Where patients achieved up to 20.1% weight loss with the tide , with excellent tolerability . That was improved with titration . In fact , in the 3.69mg titration group , I think we only had one incidence of vomiting out of more than 50 patients .
Speaker #4: And so really just trying to range of and like understand the options you said , is there really an optimal very simple permutation of mechanisms that could allow minimal or no titration with competitive efficacy ?
Speaker #4: So that compares , we think really favorable versus the existing Incretin class . So we see a big opportunity for a lower tide in patients who maybe just can't tolerate incretin .
Speaker #1: Thank you . Ken . Paul . Ready for the next question , please .
Speaker #2: The next question will be from James Shin from Deutsche Bank . James , your line is live . .
Speaker #14: Hey , guys .
Speaker #15: Hey good morning .
Speaker #17: One for David for CMS upcoming obesity demonstration . David , can you share any similarities or differences you foresee from what you went through previously during the part D Senior savings model for insulins $35 copay rollout .
Speaker #4: We know that 5 to 10% of patients in our trials tend to discontinue on the Incretin class , suggesting a pretty big opening given the size of the market .
Kenneth L. Custer: Of course, we're also interested in thinking about eloralintide in combination with other mechanisms of action and what you alluded to with GIP plus GLP-1 plus amylin. It's a very sort of physiological construct, three nutrient-stimulated hormones, and we've shared that we are exploring that idea in the clinic. Nothing to share yet, but stay tuned, maybe towards the end of this year.
Kenneth Custer: Of course, we're also interested in thinking about eloralintide in combination with other mechanisms of action and what you alluded to with GIP plus GLP-1 plus amylin. It's a very sort of physiological construct, three nutrient-stimulated hormones, and we've shared that we are exploring that idea in the clinic. Nothing to share yet, but stay tuned, maybe towards the end of this year.
Speaker #4: Of course, we're also interested in thinking about allantoin in combination with other mechanisms of action and what you alluded to with GIP.
Speaker #17: Thank you .
Speaker #1: Great . Thanks , James , and we'll welcome Dave to get in the box score for the Q&A . Hey , share any similarities on the CMS obesity pilot versus the part D Senior Savings ?
Speaker #4: GLP one plus Amylin . It's a very sort of physiological construct . Three nutrient stimulated hormones , and we've are shared that we exploring that idea in the clinic .
[Analyst] (TD Cowen): ... We're testing other possible combinations, including a GIP agonist, Macugotide with eloralintide as well. And so really just trying to understand the range of options, and like you said, is there really a, an optimal, very simple, permutation of mechanisms that could allow minimal or no titration with, competitive efficacy?
Stephen Scala: ... We're testing other possible combinations, including a GIP agonist, Macugotide with eloralintide as well. And so really just trying to understand the range of options, and like you said, is there really a, an optimal, very simple, permutation of mechanisms that could allow minimal or no titration with, competitive efficacy?
Speaker #1: Yeah , I mean , I think there are quite a quite a number of analogies to mean , draw . I first arriving at a what perceived as a relatively would be low out of pocket is an important fact by know in case we're not from this moving while we itself .
Speaker #4: Nothing to share yet, but stay tuned. Maybe towards the end of this year we're testing other possible combinations, including a GIP agonist.
Speaker #1: And high out of pocket to low , only moving from covered , plus low out of pocket , and I think who may be patients using Glp1 and the have is data we that are using these drugs at a lower rate than general population , maybe because income in will benefit from that lower cost every month of $50 .
Speaker #4: As well, and so really trying to just understand the range of options and, like you said, is there really an optimal, very simple permutation of mechanisms that could allow minimal or no titration with competitive efficacy?
Michael Czapar: Thank you, Ken. Paul, ready for the next question, please.
Mike Czapar: Thank you, Ken. Paul, ready for the next question, please.
Operator: The next question will be from James Shin from Deutsche Bank. James, your line is live.
Operator: The next question will be from James Shin from Deutsche Bank. James, your line is live.
Speaker #1: Thank you, Ken Paul. Ready for the next question, please.
[Analyst] (Deutsche Bank): Thanks, guys. Hey, good morning. One for David. For CMS's upcoming OBC demonstration, David, can you share any similarities or differences you foresee from what you went through previously during the Part D Senior Savings Model for insulin's $35 copay rollout? Thank you.
James Shin: Thanks, guys. Hey, good morning. One for David. For CMS's upcoming OBC demonstration, David, can you share any similarities or differences you foresee from what you went through previously during the Part D Senior Savings Model for insulin's $35 copay rollout? Thank you.
Speaker #2: The next question will be from James Shin from Deutsche Bank. James, your line is live.
Speaker #15: Thanks , guys .
Speaker #16: Hey .
Speaker #18: Good morning . One for David for CMS upcoming obesity demonstration . David , can you share any similarities or differences you foresee from what you went through previously during the Senior savings part D model for insulins $35 copay rollout .
Speaker #1: I think that's very expansionary to the class . And we'll draw a interest from lot of primary care prescribers who are concerned about the comorbidities of kind of lifetime overweight and obesity , which tend to manifest after 65 at a much higher rate .
Michael Czapar: Great. Thanks, James, and I will welcome Dave to get in the box score for the Q&A.
Mike Czapar: Great. Thanks, James, and I will welcome Dave to get in the box score for the Q&A.
David Ricks: Hey.
David A. Ricks: Hey.
Michael Czapar: Can you share any similarities on the CMS OBC pilot versus the Part D Senior Savings?
Mike Czapar: Can you share any similarities on the CMS OBC pilot versus the Part D Senior Savings?
Speaker #18: Thank you .
Speaker #1: Great . Thanks , James , and we'll welcome Dave to get in the box score for the Q&A . Hey , can you any similarities on the CMS pilot obesity versus the part D Senior Savings ?
Speaker #1: The second thing is the consistency . And I think when we negotiated this with the government , we wanted to make sure that we just weren't building a program that went into the normal part .
David Ricks: Yeah, I mean, I think there are quite a number of analogies to draw. I mean, first, arriving at a what would be perceived as a relatively low out-of-pocket is an important fact by itself. While we know in this case, we're not moving from high out-of-pocket to low, only moving from covered plus low out-of-pocket. I think patients who may be using GLP-1, and the data we have is that seniors are using these drugs at a lower rate than the general population, maybe because income, in particular, will benefit from that lower cost every month of $50.
David A. Ricks: Yeah, I mean, I think there are quite a number of analogies to draw. I mean, first, arriving at a what would be perceived as a relatively low out-of-pocket is an important fact by itself. While we know in this case, we're not moving from high out-of-pocket to low, only moving from covered plus low out-of-pocket. I think patients who may be using GLP-1, and the data we have is that seniors are using these drugs at a lower rate than the general population, maybe because income, in particular, will benefit from that lower cost every month of $50.
Speaker #1: Yeah , I mean , I think there are quite a quite a number of analogies to draw . I mean , first arriving at a what would be perceived as a relatively low out of pocket is an important fact by itself .
Speaker #1: D math in terms of out of pocket costs . But had a kind of that consistency independent of the absolute amount people They get pay .
Speaker #1: frustrated with different amounts month to month . another think that's So I important feature . Thirdly , like the insulin deal , it's to all open innovators .
Speaker #1: And , well , we know in this case we're not moving from high out of pocket to only low , moving from covered .
Speaker #1: And I think that's an important concept doctor and the patient choose the best therapy could be one from us , one from our competitor .
Speaker #1: Plus low out of pocket . think And I patients who may be using Glp1 and the data we have is that seniors are using these drugs at a lower rate than the general population , maybe because of income in particular will benefit from that lower cost every month of $50 .
David Ricks: I think that's very expansionary to the class and will draw a lot of interest from primary care prescribers who are concerned about the comorbidities of kind of lifetime overweight and obesity, which tend to manifest after 65 at a much higher rate. The second thing is the consistency variance, and I think when we negotiated this with the government, we wanted to make sure that we weren't just building a program that went into the normal Part D math in terms of out-of-pocket costs, but had a kind of that, consistency. Independent of the absolute amount people pay, they get very frustrated with different amounts month to month. So I think that's another important feature.
David A. Ricks: I think that's very expansionary to the class and will draw a lot of interest from primary care prescribers who are concerned about the comorbidities of kind of lifetime overweight and obesity, which tend to manifest after 65 at a much higher rate. The second thing is the consistency variance, and I think when we negotiated this with the government, we wanted to make sure that we weren't just building a program that went into the normal Part D math in terms of out-of-pocket costs, but had a kind of that, consistency. Independent of the absolute amount people pay, they get very frustrated with different amounts month to month. So I think that's another important feature.
Speaker #1: So I think that also has a parallel to what we did with insulin . If you look back at that insulin pilot utilization rates increased pretty dramatically in part D and frustration levels with that issue .
Speaker #1: I think that's very expansionary to the class, and will draw a lot of interest from primary care prescribers.
Speaker #7: Who are .
Speaker #1: I'm concerned about the comorbidities of lifelong overweight and obesity, which tend to manifest after age 65 at a much higher rate. The second thing is the consistency.
Speaker #1: Basically disappeared . I think this has similar promise to be both enormously popular a lot , drive of new uptake . As I said , suppressed in the senior population who could probably benefit most , at least in the short term , from GLP one therapy .
Speaker #1: And I think when negotiated this with the government, wanted to make sure that we weren't just building a program that went into the normal part.
Speaker #1: D math in terms of out costs , but had a kind of that consistency independent of the absolute amount people pay . They get very frustrated with different amounts month to month .
Speaker #1: And I believe and I know the CMS does as well , that few years within a we'll demonstrate cost savings significant to the Medicare program .
David Ricks: Thirdly, like the insulin deal, it's open to all innovators, and I think that's an important concept, that the doctor and the patient choose the best therapy, which could be one from us, one from our competitor; it could be oral, could be injectable, could include future therapies from Lilly or others, like retatrutide or eloralintide when they're approved. So, I think that also has a parallel to what we did with insulin. If you look back at that insulin pilot, you know, utilization rates increased pretty dramatically in Part D, and frustration levels with that issue basically disappeared. I think this program has similar promise to be both enormously popular, drive a lot of new uptake, as I said, it's suppressed in the senior population, who could probably benefit most, at least in the short term, from GLP-1 therapy.
David A. Ricks: Thirdly, like the insulin deal, it's open to all innovators, and I think that's an important concept, that the doctor and the patient choose the best therapy, which could be one from us, one from our competitor; it could be oral, could be injectable, could include future therapies from Lilly or others, like retatrutide or eloralintide when they're approved. So, I think that also has a parallel to what we did with insulin. If you look back at that insulin pilot, you know, utilization rates increased pretty dramatically in Part D, and frustration levels with that issue basically disappeared. I think this program has similar promise to be both enormously popular, drive a lot of new uptake, as I said, it's suppressed in the senior population, who could probably benefit most, at least in the short term, from GLP-1 therapy.
Speaker #1: So that is insulin different than the part . But that's associated with new products being added . excited to So we're We expect this to be effective by July 1st .
Speaker #1: So I think that's another important feature . Thirdly , like the insulin deal , it's open to all innovators . And I think that's an important concept that the doctor and the patient choose the best therapy , which could be one from us , one from our competitor , it could be oral , it could be injectable , could include future therapies from Lilly or others like Retatrutide or Laurentide when they're approved .
Speaker #1: And working through the details with with the administration now . And you'll hear more maybe on our Q1 call . Thank you Dave .
Speaker #1: Ready for the next question , please , Paul .
Speaker #2: The next question will be from Steve Scala from TD Cowen . Steve , your line is live .
Speaker #1: So I think that also has a parallel to what we did with insulin. If you look back at that insulin pilot, utilization rates increased pretty dramatically in Part D, and frustration levels with that issue.
Speaker #18: Well , so thank you much . 2026 revenue guidance is 15 to 20 billion higher than that delivered in 2025 . Mounjaro and Zepbound are doing great , but we can kind of see their trajectory .
Speaker #1: Basically disappeared , I think this program has similar promise to be both enormously popular , drive a uptake . As I said , lot of new it's suppressed in the senior population who could probably benefit most , at the short least in term , from GLP one therapy .
Speaker #18: Are there scenarios where these incremental sales can be delivered without or forego being a $5 billion product in 2026 , and does the guidance tell us that Lilly believes orals will grow the market and not cannibalize ?
David Ricks: I believe, and I know that CMS does as well, that within a few years, we'll demonstrate significant cost savings to the Medicare program. So, that is different than the insulin part, but that's associated with, you know, new products being added. So we're excited to get going. We expect this to be effective by July 1. Working through the details with the administration now, and you'll hear more maybe on our Q1 call.
David A. Ricks: I believe, and I know that CMS does as well, that within a few years, we'll demonstrate significant cost savings to the Medicare program. So, that is different than the insulin part, but that's associated with, you know, new products being added. So we're excited to get going. We expect this to be effective by July 1. Working through the details with the administration now, and you'll hear more maybe on our Q1 call.
Speaker #18: Thank you .
Speaker #1: And I believe and I know the CMS does as well , that within a few years we'll demonstrate significant cost savings to the Medicare program .
Speaker #1: questions . Lucas to talk a bit about the revenue guide and moving are Steve , for parts that Great the great some of the that .
Speaker #1: So, that is different than the insulin part, but that's associated with new products being added. So we're excited to get going.
Speaker #8: Yeah , thank you for the Steve about the . Thinking guide again . You can do the math on that perspective . But when we think about the process , maybe from start there .
Speaker #1: We expect this to be effective by July 1st. Working through the details with the administration now. And you'll hear more, maybe on our Q1 call.
Michael Czapar: Thank you, Dave. Ready for the next question, please, Paul.
Mike Czapar: Thank you, Dave. Ready for the next question, please, Paul.
Operator: The next question will be from Steve Scala from TD Cowen. Steve, your line is live.
Operator: The next question will be from Steve Scala from TD Cowen. Steve, your line is live.
Speaker #8: As do a bottom up always , we approach on what we see in the marketplace . And then across all the therapeutic areas and geographies well .
[Analyst] (TD Cowen): Well, thank you so much. 2026 revenue guidance is $15 to 20 billion higher than that delivered in 2025. Mounjaro and Zepbound are doing great, but we can kind of see their trajectory. Are there scenarios where these incremental sales can be delivered without orforglipron being a $5 billion product in 2026? And does the guidance tell us that Lilly believes orals will grow the market and not cannibalize? Thank you.
Stephen Scala: Well, thank you so much. 2026 revenue guidance is $15 to 20 billion higher than that delivered in 2025. Mounjaro and Zepbound are doing great, but we can kind of see their trajectory. Are there scenarios where these incremental sales can be delivered without orforglipron being a $5 billion product in 2026? And does the guidance tell us that Lilly believes orals will grow the market and not cannibalize? Thank you.
Speaker #1: Thank you, Dave. Ready for the next question, please, Paul.
Speaker #2: The next question will be from Steve Scala from TD Cowen. Steve, your line is live.
Speaker #8: And we have , again , a point of their guidance as kind of what is goal our for the year to start with .
Speaker #19: Well , thank you so much . 2026 Revenue guidance is 15 to 20 billion higher than that delivered in 2025 . Mounjaro and Zepbound are doing great , but we can kind of see their trajectory .
Speaker #8: There are many multiples pushes and pull , and I described that during call the text as well . Talking about again , the expansion in Medicare that Dave just covered , talking about the launch of Orforglipron as well , and a continuation of that growth we expect to see both in the US and our US markets .
Speaker #19: Are there scenarios where these incremental sales can be delivered forego or without being a $5 billion product in 2026 , and does the guidance tell us that Lilly believes orals will grow the market and not cannibalize ?
Michael Czapar: Great. Thanks, Steve, for the great questions as always. We'll go to Lucas to talk a bit about the revenue guide and some of the moving parts that are contained within that.
Mike Czapar: Great. Thanks, Steve, for the great questions as always. We'll go to Lucas to talk a bit about the revenue guide and some of the moving parts that are contained within that.
Speaker #8: I think it's fair to go back as well about the basically the price component as well , that is embedded into the guide as well .
Speaker #19: Thank you .
Lucas Montarce, M.D.: Yeah, thank you for the question, Steve. Thinking about the guide, again, you can do the math on that perspective, but when we think about the process, maybe start from there. As always, we do a bottom-up approach on what we see in the marketplace and then across all the therapeutic areas and geographies as well. We have, again, a point of the guide as kind of what is our goal for the year to start with. There are many multiples, pushes and pulls, and I described that during the call text as well, talking about again the expansion in Medicare that Dave just covered, talking about the launch of orforglipron as well, and a continuation of growth that we expect to see both in the US and our US markets.
Lucas Montarce: Yeah, thank you for the question, Steve. Thinking about the guide, again, you can do the math on that perspective, but when we think about the process, maybe start from there. As always, we do a bottom-up approach on what we see in the marketplace and then across all the therapeutic areas and geographies as well. We have, again, a point of the guide as kind of what is our goal for the year to start with. There are many multiples, pushes and pulls, and I described that during the call text as well, talking about again the expansion in Medicare that Dave just covered, talking about the launch of orforglipron as well, and a continuation of growth that we expect to see both in the US and our US markets.
Speaker #1: Great . Thanks , Steve , for the great questions . As always , we'll go to Lucas to talk a bit about the revenue guide and some of the moving parts that are contained within that .
Speaker #8: That's another component that is going to be actually accelerated in That erosion 2026 . versus 2025 . And I call out basically the low to mid teens .
Speaker #9: Yeah . Thank you for the question , Steve . Thinking about the guide again , you can do the math on that perspective .
Speaker #8: That's a new component to basically some of the math that you were thinking about 2025 , that you need to factor as when you are doing those forecasting and models that you describe in terms of your follow up question .
Speaker #9: But when we think about the process , maybe start from there . As always , we do a bottom up approach on what we see in the marketplace .
Speaker #9: And then across all the therapeutic areas and geographies as well . And we have , again , a point of their guidance as kind of what our is goal for the year to start with , there are many multiples pushes and pull , and I described that during the call text as well .
Speaker #8: I think it's important to highlight , looking at even just the last four weeks of the data of the competitor is mainly launch expansion of the market .
Speaker #8: So we are very , very encouraged again , the seeing that first month of data , and it's very much consistent with our expectations and our guide .
Speaker #8: We will see how much again , that class will continue to grow over the years . And we will update our guide throughout the year , depending on that .
Speaker #9: Talking about again , the expansion in Medicare that Dave just talking covered , launch of about the Orforglipron as well , and a continuation of growth that we expect to see both in the US and our US markets .
Lucas Montarce, M.D.: I think it's fair to go back as well about the, basically the price component as well, that is embedded into the guide as well. That's another component that is gonna be actually accelerated in 2026, that erosion versus 2025. And I call out basically low to mid-teens. That's a new component to basically some of the math that you were thinking about 2025, that you need to factor as when you're doing those, forecasting and models that you described. In terms of your Orforglipron question, I think it's important to highlight, looking at even just the last four weeks of the data of the competitor launch is mainly expansion of the market. So we are very, very encouraged from, again, the first month of seeing that data, and it's very much consistent with our expectations and our guide.
Lucas Montarce: I think it's fair to go back as well about the, basically the price component as well, that is embedded into the guide as well. That's another component that is gonna be actually accelerated in 2026, that erosion versus 2025. And I call out basically low to mid-teens. That's a new component to basically some of the math that you were thinking about 2025, that you need to factor as when you're doing those, forecasting and models that you described. In terms of your Orforglipron question, I think it's important to highlight, looking at even just the last four weeks of the data of the competitor launch is mainly expansion of the market. So we are very, very encouraged from, again, the first month of seeing that data, and it's very much consistent with our expectations and our guide.
Speaker #8: .
Speaker #1: Great . Thanks , Lucas . With time for a couple quick ones . If we could do the next question please . Paul .
Speaker #2: The next question will be from Akash Tewari from Jefferies . Akash , your line is live .
Speaker #9: I think it's hard to go back as well about the basically the price component as well . That is embedded into the guide as well .
Speaker #19: Hey , thanks so much . So , Dave , you've mentioned that investors are really understand Lilly recognize it's a consumer stock . Can you talk about some consumer analogs .
Speaker #9: That's another component that is going to be actually accelerated in 2026. That erosion versus 2025. And I call out basically the low to mid teens.
Speaker #19: You'd point investors towards when you're thinking about long term penetration for both the US and us . For your weight loss product . And then maybe just on the cannibalization point , is it fair to say your guide isn't expecting meaningful cannibalization of the oral and injectable obesity products versus what we've seen with Novo ?
Speaker #9: That's a new component to basically some of the math that you were thinking about 2025 that you need to factor as when you're doing those forecasting and models that you describe in terms of your Lupron question , I think it's important to highlight looking at even just the last four weeks of the data of the competitor launch is mainly expansion of the market .
Speaker #19: Thank you .
Speaker #1: Definitely a two part of their cash . So we'll get to talk about the consumer analogs . Well I you know I think Lucas covered the cannibalization .
Speaker #9: So we are very , very encouraged from , again , the first month of seeing that data and is very much consistent with our expectations and our guide .
Lucas Montarce, M.D.: We will see how much, again, that class will continue to grow over the years, and we will update our guide throughout the year, depending on that.
Lucas Montarce: We will see how much, again, that class will continue to grow over the years, and we will update our guide throughout the year, depending on that.
Speaker #1: With what we're seeing right now . And nor is it what we really expect in a way though , just strategically , it doesn't really matter to us .
Michael Czapar: Great. Thanks, Lucas. We have time for a couple quick ones, so if we can do the next question, please, Paul.
Mike Czapar: Great. Thanks, Lucas. We have time for a couple quick ones, so if we can do the next question, please, Paul.
Speaker #9: We will see much class will again , that continue how to grow years , and we will update our guide throughout the year .
Speaker #1: I think we're interested in having people on the medicine that they think , and their doctor think is best for them , and if it comes from Lilly , that's that's our goal .
Operator: The next question will be from Akash Tiwari from Jefferies. Akash, your line is live.
Operator: The next question will be from Akash Tewari from Jefferies. Akash, your line is live.
Speaker #9: Depending on that . .
Speaker #1: Great, thanks. We have time, Lucas, for a couple of quick ones, so if we could do the next question, please.
Speaker #1: So we're not too concerned about that . But I don't actually expect a ton of cannibalization , to be honest . In terms of the consumer analogs , difficult it's a question .
Ilya Yuffa: ... Hey, thanks so much. So Dave, you've mentioned that investors who really understand Lilly recognize it's a consumer stock. Can you talk about some consumer analogs you'd point investors towards when you're thinking about long-term penetration for both the US and ex-US for your weight loss product? And then maybe just on the cannibalization point, is it fair to say your guide isn't expecting meaningful cannibalization of the oral and injectable obesity products versus what we've seen with Novo? Thank you.
Ilya Yuffa: Hey, thanks so much. So Dave, you've mentioned that investors who really understand Lilly recognize it's a consumer stock. Can you talk about some consumer analogs you'd point investors towards when you're thinking about long-term penetration for both the US and ex-US for your weight loss product? And then maybe just on the cannibalization point, is it fair to say your guide isn't expecting meaningful cannibalization of the oral and injectable obesity products versus what we've seen with Novo? Thank you.
Speaker #1: Paul .
Speaker #2: The next question will be from Akash Tewari from Jefferies. Akash, your line is live.
Speaker #20: Hey , thanks so much . So Dave , you've mentioned that investors are really understand Lilly recognize it's a consumer stock . Can you talk about some consumer analogs .
Speaker #1: to your feedback We on this . We spent a lot of time modeling out the trajectory of the of the out-of-pocket business . Patrick and Elia commented on that .
Speaker #20: You'd point investors towards when you're thinking about long term penetration for both the US US , for and your weight loss product . And then maybe just on the cannibalization point , is it fair to say your guide isn't expecting meaningful cannibalization of the oral and injectable obesity products versus what we've seen with Novo ?
Speaker #1: I think at the JP Morgan conference , I spoke about this . I think it is a bit of a wild card in our short and mid-term outlook I am , because hard think of pressed to an analog where you have this many people paying out of pocket for a prescription medication .
Michael Czapar: Definitely a two-parter there, Akash. So we'll get Dave to talk about the consumer analogs.
Mike Czapar: Definitely a two-parter there, Akash. So we'll get Dave to talk about the consumer analogs.
Speaker #20: Thank you .
Speaker #1: People could look back at the wars and the drugs we were part of that . We've learned some things from that , but it's not the same as this .
David Ricks: Well, I, you know, I think Luke has covered the cannibalization, but it's not what we're seeing right now, and nor is it what we really expect. In a way, though, just strategically, it doesn't really matter to us. I think we're interested in having people on the medicine that they think and their doctor think is best for them. And if it comes from Lilly, that's, that's our goal. So we're not too concerned about that, but I don't actually expect a ton of cannibalization, to be honest. In terms of the consumer analogs, it's a difficult question. We... I'd be open to your feedback on this. We spent a lot of time modeling out the trajectory of the out-of-pocket business. Patrick and Ilya commented on that. I think at the JP Morgan conference, I spoke about this.
David A. Ricks: Well, I, you know, I think Luke has covered the cannibalization, but it's not what we're seeing right now, and nor is it what we really expect. In a way, though, just strategically, it doesn't really matter to us. I think we're interested in having people on the medicine that they think and their doctor think is best for them. And if it comes from Lilly, that's, that's our goal. So we're not too concerned about that, but I don't actually expect a ton of cannibalization, to be honest. In terms of the consumer analogs, it's a difficult question. We... I'd be open to your feedback on this. We spent a lot of time modeling out the trajectory of the out-of-pocket business. Patrick and Ilya commented on that. I think at the JP Morgan conference, I spoke about this.
Speaker #1: Definitely a two part of their Akash . So we'll get Dave to talk about the consumer analogs . Well I you know I think Lucas covered the cannibalization .
Speaker #1: You can look at cosmetics and aesthetics , quite where it's common , but that also has some overlap , but not complete because here you have , you know , really profound health benefits .
Speaker #1: But summer we're seeing right now and nor is it what we really expect . In a way though , just it doesn't to think matter really us .
Speaker #1: I we're interested people in having on the medicine that they think and their doctor think is best for them , and if it comes from Lilly , that's that's our goal .
Speaker #1: And , you know , noticeable results that , that really drives a success cycle for people in their lives . That's kind of different .
Speaker #1: So we're not too concerned about that . But I don't actually expect a ton of cannibalization , to be honest . In terms of the analogs , it's a consumer difficult question .
Speaker #1: So I think it's that . What can do hard for about we us to think is take learnings from other industries . They were able to reduce consumer friction , unlock the power of first party data in marketing .
Speaker #1: We I'd be open to your feedback on this . We spent a lot of time modeling out the trajectory of the of the out of pocket business .
Speaker #1: Consider a platform and an interface with consumers that allows us to bring our really robust and deep pipeline that Ken's been talking about .
David Ricks: I think it is a bit of a wild card in our short and midterm outlook because I am hard-pressed to think of an analog where you have this many people paying out of pocket for a prescription medication. People could look back at the PDE wars and the ED drugs. We were part of that. We've learned some things from that, but it's not the same as this. You can look at cosmetics and aesthetics, where it's quite common, but that also has some overlap, but not complete, because here you have, you know, really profound health benefits, and, you know, noticeable results that really drives a success cycle for people in their lives. It's kind of different. So I think it's hard for us to think about that.
David A. Ricks: I think it is a bit of a wild card in our short and midterm outlook because I am hard-pressed to think of an analog where you have this many people paying out of pocket for a prescription medication. People could look back at the PDE wars and the ED drugs. We were part of that. We've learned some things from that, but it's not the same as this. You can look at cosmetics and aesthetics, where it's quite common, but that also has some overlap, but not complete, because here you have, you know, really profound health benefits, and, you know, noticeable results that really drives a success cycle for people in their lives. It's kind of different. So I think it's hard for us to think about that.
Speaker #1: Patrick and Elia commented on that . I think at the JP Morgan conference , I spoke about this . I think it is a bit of a wild card in our short and mid-term outlook , because I am hard pressed to think of an analog where you have this many people paying out of pocket for a prescription medication .
Speaker #1: You know , to market in a way that might be quite differentiated over time . Play with pricing opportunities , subscription models , these kinds of things , all that is in our future .
Speaker #1: And I think Lilly direct , direct discussion out of pocket business all enables those things . It's pretty interesting strategically because I don't think there's analog a good in our industry , and we're working through that .
Speaker #1: People could look back at the wars and the Ed drugs we were part of that . We've learned some things from that , but it's not the same as this .
Speaker #1: You can look at cosmetics and aesthetics , where it's quite common , but that also has some overlap , but not because here complete you have , you know , really profound health benefits .
Speaker #1: And excited by the potential we already see , you know , a million people in the US , hundreds of thousands more outside the US choosing this way to buy a medicine like Zepbound and Mounjaro .
Speaker #1: And , you know , noticeable results that that really drives a success cycle for people in their lives . It's kind of different .
Speaker #1: Great . Thanks , Dave . I will do one last question and then we'll close the have to .
David Ricks: What we can do is take learnings from other industries that were able to reduce consumer friction, unlock the power of first-party data and marketing, consider, you know, a platform and an interface with consumers that allows us to bring our really robust and deep pipeline that Ken's been talking about, you know, to market in a way that might be quite differentiated over time, play with pricing opportunities, subscription models, these kinds of things. All that is in our future, and I think, LillyDirect, direct discussion, out-of-pocket business, all enables those things.
David A. Ricks: What we can do is take learnings from other industries that were able to reduce consumer friction, unlock the power of first-party data and marketing, consider, you know, a platform and an interface with consumers that allows us to bring our really robust and deep pipeline that Ken's been talking about, you know, to market in a way that might be quite differentiated over time, play with pricing opportunities, subscription models, these kinds of things. All that is in our future, and I think, LillyDirect, direct discussion, out-of-pocket business, all enables those things.
Speaker #1: call Okay ,
Speaker #2: the final question today is coming from Michael from UBS . Michael , your line is live .
Speaker #1: So I think it's hard for us to about that . can What we think do is take learnings from other industries . They were able to reduce consumer friction , unlock the power of first party data in marketing .
Speaker #20: Thank you . Just Great . wanted to ask your expectation on the launch , general view of unit volume scripts vis a vis the Tirzepatide launch and how you think either access or other channels are different here versus Tirzepatide think about and how you the launch here versus Tirzepatide for ortho .
Speaker #1: Consider a platform and an interface with consumers that allows us to bring our really robust and deep pipeline that Ken's been talking about.
Speaker #1: You know , to market in a way that might be quite differentiated over time . Play with pricing opportunities , subscription models , these kinds of things , all that is in our future .
Speaker #20: Thank you .
Speaker #1: Thanks , Mike . We'll go to Ilya Zubkov in about the audio launch .
David Ricks: It's pretty interesting strategically, 'cause I don't think there's a good analog in our industry, and we're working through that and excited by the potential, as you know, we already see, you know, 1 million people in the US, hundreds of thousands more outside the US, choosing this way to, to buy a medicine like Zepbound and Mounjaro.
David A. Ricks: It's pretty interesting strategically, 'cause I don't think there's a good analog in our industry, and we're working through that and excited by the potential, as you know, we already see, you know, 1 million people in the US, hundreds of thousands more outside the US, choosing this way to, to buy a medicine like Zepbound and Mounjaro.
Speaker #1: And I think Lilly Direct , direct discussion out of pocket business all enables those things . It's pretty interesting strategically because I don't think there's a good analog in our industry .
Speaker #10: Yeah , thanks for the question . Obviously , we're excited about launching Orforglipron , assuming in Q2 , you know , as we think about the overall market and every launch in this space , you're launching in a larger market and more greater consumer and provider awareness .
Speaker #1: And we're working through that . by the excited And potential . You know , we already see , you know , million people in the US , hundreds of thousands more outside the US choosing this way to to buy a medicine Zepbound and like Mounjaro .
Speaker #10: We recognize that . And we look for learning from how we've launched previously . I think what's different here and people on the call have discussed this is that there is a typically in the cycle of you launches , start access , with build , access over time , and you see gradual uptake .
Michael Czapar: Great. Thanks, Dave. I will do one last question, then we'll have to close the call.
Mike Czapar: Great. Thanks, Dave. I will do one last question, then we'll have to close the call.
Operator: Okay, final question today is coming from Michael Yee from UBS. Michael, your line is live.
Operator: Okay, final question today is coming from Michael Yee from UBS. Michael, your line is live.
Speaker #1: Thanks , Great . Dave . I will do one last question and then we'll have to close the call .
[Analyst] (UBS): Great, thank you. Just wanted to ask your expectation on the Orforglipron launch, general view of unit volume scripts, vis-à-vis, the tirzepatide launch, and how you think either access or other channels are different here versus tirzepatide, and how you think about the launch here versus tirzepatide for Orforglipron. Thank you.
Michael Yee: Great, thank you. Just wanted to ask your expectation on the Orforglipron launch, general view of unit volume scripts, vis-à-vis, the tirzepatide launch, and how you think either access or other channels are different here versus tirzepatide, and how you think about the launch here versus tirzepatide for Orforglipron. Thank you.
Speaker #2: Okay . The final question today is from coming Michael Yee from UBS . Michael , your line is live .
Speaker #21: Great . Thank you . Just wanted to ask your expectation on the audio launch , general view of unit volume scripts vis a vis the Tirzepatide and how you launch think either access or other channels are different here versus Tirzepatide and how you think about the launch year versus Tirzepatide for ortho .
Speaker #10: What we've seen in this space in particular , and obviously we have a scaled direct to consumer platform as part of that . You also have a significant self-pay and consumer awareness in this category .
Michael Czapar: Yep. Thanks, Mike. We'll go to Ilya to talk a bit about the Orforglipron launch.
Mike Czapar: Yep. Thanks, Mike. We'll go to Ilya to talk a bit about the Orforglipron launch.
Speaker #10: so And our expectations are high in terms of what we expect for Orforglipron in our launch . And we again , we expect this to be market expansive and bring new people to therapy for obesity .
Ilya Yuffa: Yeah, thanks for the question. Obviously, we're excited about launching Orforglipron, assuming in Q2. You know, as we think about the overall market in every launch in this space, you're launching in a larger market and more greater consumer and provider awareness. We recognize that, and we look for learning from how we've launched previously. I think what's different here, and people on the call have discussed this, is that there is a... Typically in the cycle of launches, you start with access, build access over time, and you see gradual uptake. What we've seen in this space in particular, and obviously we have a scaled direct-to-consumer platform as part of that, you also have a significant self-pay and consumer awareness in this category.
Ilya Yuffa: Yeah, thanks for the question. Obviously, we're excited about launching Orforglipron, assuming in Q2. You know, as we think about the overall market in every launch in this space, you're launching in a larger market and more greater consumer and provider awareness. We recognize that, and we look for learning from how we've launched previously. I think what's different here, and people on the call have discussed this, is that there is a... Typically in the cycle of launches, you start with access, build access over time, and you see gradual uptake. What we've seen in this space in particular, and obviously we have a scaled direct-to-consumer platform as part of that, you also have a significant self-pay and consumer awareness in this category.
Speaker #21: Thank you .
Speaker #1: Thanks , Mike . We'll go to Ilya to talk a bit about the launch .
Speaker #11: Yeah , thanks for the question . Obviously , we're excited about launching or for Glp1 , assuming in Q2 , you know , as we think about the overall market in every launch in space , this you're in larger a market and more greater consumer and provider awareness .
Speaker #10: So that's our expectation for for glucagon over time .
Speaker #1: Thanks , Ilya . Dave , over to you for the close . Great . Well , as always , we appreciate your participation in today's earnings call .
Speaker #1: And of course , your interest in Eli Lilly and Company . Please follow up with the IR team if you have any questions that we did not address today .
Speaker #11: We recognize that . And we look for learning from how we've launched previously . I think what's different here and people on the call have discussed this is that there is a typically in the cycle of launches , you start with access , build access over time , and you see gradual uptake .
Speaker #1: And otherwise have a great rest of your day . Take care .
Speaker #2: Thank you . And gentlemen , this does our conclude conference for today . This conference will be made available for replay beginning at 1 p.m.
Speaker #2: today . Running through March 10th at You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 331160 .
Speaker #11: Seen in this, what we have is space in particular. And obviously, we have a scaled direct-to-consumer platform as part of that. You also have a significant self-pay and consumer awareness in this category.
Ilya Yuffa: Our expectations are high in terms of what we expect for Orforglipron in our launch, and we again expect this to be market expansive and bring new people to therapy for obesity. So that's our expectation for Orforglipron over time.
Ilya Yuffa: Our expectations are high in terms of what we expect for Orforglipron in our launch, and we again expect this to be market expansive and bring new people to therapy for obesity. So that's our expectation for Orforglipron over time.
Speaker #2: International Dialers can call (973) 528-0005 . Again , those numbers are 803 3268549735280005 , with access code 331160 . Thank you for your participation .
Speaker #11: And so our expectations are high in terms of what we expect for Orforglipron in our launch. And again, we expect this to be market expansive and bring new people to therapy for obesity.
Michael Czapar: Thanks, Ilya. Dave, over to you for the close.
Mike Czapar: Thanks, Ilya. Dave, over to you for the close.
David Ricks: Great. Well, as always, we appreciate your participation in today's earnings call and, of course, your interest in Eli Lilly and Company. Please follow up with the IR team, if you have any questions that we did not address today. And otherwise, have a great rest of your day. Take care.
David A. Ricks: Great. Well, as always, we appreciate your participation in today's earnings call and, of course, your interest in Eli Lilly and Company. Please follow up with the IR team, if you have any questions that we did not address today. And otherwise, have a great rest of your day. Take care.
Speaker #11: So that's our expectation for for glycron over time .
Speaker #1: Thanks , Ilya . Dave , over to you for the close . Great . Well , as always , we today's participation in earnings call .
Speaker #1: And of course , your interest in Eli Lilly and Company . Please follow up with the IR team if you have any questions that we did not address today and otherwise have a great rest of your day .
Operator: Thank you. And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00 PM today, running through 10 March at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 331160. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854, 973-528-0005, with the access code 331160. Thank you for your participation. You may now disconnect your lines.
Operator: Thank you. And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00 PM today, running through 10 March at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 331160. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854, 973-528-0005, with the access code 331160. Thank you for your participation. You may now disconnect your lines.
Speaker #1: Take care .
Speaker #2: Thank you. And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1 p.m.
Speaker #2: Today, running through March 10th at midnight. You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 331160.
Speaker #2: International Dialers can call (973) 528-0005 . Again , those numbers are 800 33268549735280005 , with the access code 331160 . your Thank you for participation .
