Q1 2024 Eli Lilly & Co Earnings Call

April 30, 2024

Okay.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q1 2024 earnings call. [Operator Instructions] I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead. Thank you, Paul, and good morning, everyone. Thank you for joining us for Eli Lilly & Company's Q1 2024 earnings call. I'm Joe Fletcher, Senior Vice President of Investor Relations. And joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Anat Ashkenazi, Chief Financial Officer, Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly International, Jake Van Naarden, President of Loxo at Lilly, and Patrik Jonsson, President of Lilly Diabetes and Obesity and Lilly USA.

Speaker Change: Ladies and gentlemen, thank you for semi by and welcome to the Lilly Q1 2024 earnings call at.

At this time all participants are in 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 operator assistance during the call. Please press Star then zero and an operator will assist you offline I would now like to turn the conference over to your host Joe Fletcher Senior Vice President of Investor Relations. Please go ahead.

Joe Fletcher: Thank you, Paul, and good morning, everyone. Thank you for joining us for Eli Lilly & Company's Q1 2024 Earnings Call. I'm Joe Fletcher; Senior Vice President of Investor Relations. And joining me on today's call are Dave Ricks; Lilly's Chair and CEO, Anat Ashkenazi; Chief Financial Officer, Dr. Dan Skovronsky; Chief Scientific Officer and President of Lilly Immunology, Anne White; President of Lilly Neuroscience, Ilya Yuffa; President of Lilly International, Jake Van Naarden; President of Loxo at Lilly, and Patrik Jonsson; President of Lilly Diabetes and Obesity and Lilly U.S.A. We're also joined by Michaela Irons; Mike Springer, and Lauren Zierke of the IR team.

Joe Fletcher: I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Thank you, Paul, and good morning, everyone. Thank you for joining us for Eli Lilly & Company's Q1 2024 earnings call. I'm Joe Fletcher, Senior Vice President of Investor Relations. And joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Anat Ashkenazi, Chief Financial Officer, Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly International, Jake Van Naarden, President of Loxo at Lilly, and Patrik Jonsson, President of Lilly Diabetes and Obesity and Lilly USA.

Joe Fletcher: Thank you Paul and good morning, everyone. Thank you for joining us for Eli Lilly and the company's Q1 2024 earnings call I'm, Joe <unk> Senior Vice President of Investor Relations and joining me on today's call are Dave Ricks, Lilly's, Chairman and CEO and that Ashkenazi Chief Financial Officer, Dr. Dan <unk>, Chief Scientific officer, and President of Lilly Immunology and <unk>.

<unk> President of Lilly Neuroscience, <unk> President of Lilly International Jacob <unk>, President of locks about Lilly and Patrik Jonsson, President of Lilly diabetes, and obesity and Louis USA. We're also joined by Mike Makayla Irons, Mike's, bringing other and more than <unk> of the IR team.

Joe Fletcher: We're also joined by Michaela Irons, Mike Sprengnether, and Lauren Zierke of the IRT. During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. However, actual results could differ materially due to several factors, including those listed on slide two.

We're also joined by Michaela Irons, Mike Sprengnether, and Lauren Zierke of the IRT.

During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Actual results could differ materially due to several factors, including those listed on slide 2. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and is not sufficient for prescribing decisions.

Joe Fletcher: During this conference call, we anticipate making projections and forward looking statements based on our current expectations actual results could differ materially due to several factors, including those listed on slide two.

Joe Fletcher: Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and is not sufficient for prescribing decisions.

Joe Fletcher: Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K, and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and is not sufficient for prescribing decisions.

The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave. Okay, thanks, Joe. We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses. Our focus is to bring innovative medicines to people in need. And in 2024, we're investing in our people, our launches, expanding our pipeline of new medicines, including through business development and, of course, accelerating the needed capacity in our manufacturing network.

The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and is not sufficient for prescribing decisions.

Joe Fletcher: As we transition to our prepared remarks, please note our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave. Okay, thanks, Joe. We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses. Our focus is to bring innovative medicines to people in need. And in 2024, we're investing in our people, our launches, expanding our pipeline of new medicines, including through business development and, of course, accelerating the needed capacity in our manufacturing network.

Joe Fletcher: As we transition to our prepared remarks. Please note our commentary will focus on our non-GAAP financial measures now I'll turn the call over to Dave. Okay. Thanks, Joe We're pleased with our Q1 results and the continued momentum momentum in our business, which positions us well for accelerated growth as this year progresses.

As we transition to our prepared remarks, please note our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave. Okay, thanks, Joe. We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses. Our focus is to bring innovative medicines to people in need. And in 2024, we're investing in our people, our launches, expanding our pipeline of new medicines, including through business development and, of course, accelerating the needed capacity in our manufacturing network.

As we transition to our prepared remarks, please note our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave.

As we transition to our prepared remarks, please note our commentary will focus on our non-GAAP financial measures.

Now, I'll turn the call over to Dave.

David Ricks: Okay, thanks, Joe. We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses. Our focus is to bring innovative medicines to people in need. And in 2024, we're investing in our people, our launches, expanding our pipeline of new medicines, including through business development and, of course, accelerating the needed capacity in our manufacturing network. Results this quarter represent a continuation of the strong growth we delivered in 2023.

Joe Fletcher: Focus is to bring innovative medicines to people in need and in 'twenty four we're investing in our people our launches <unk>.

Dave Ricks: Spanning our pipeline of new medicines, including through business development and of course accelerating the needed capacity and our manufacturing network.

Joe Fletcher: Results this quarter represent a continuation of the strong growth we delivered in 2023. On slide 4, you can see details of the financial performance and progress related to our strategic deliverables. Revenue grew 26% in Q1, with our new products growing nearly $1.8 billion compared with the same period last year. We achieved several key pipeline milestones, including positive phase two results for terzapatide in moderate to severe obstructive sleep apnea. The approval of our multi-dose quick pen delivery device for Manjaro in Europe.

Results this quarter represent a continuation of the strong growth we delivered in 2023.

Speaker Change: Results this quarter represent a continuation of strong growth we delivered in 2023.

Speaker Change: On slide four you can see details of the financial performance and progress related to our strategic deliverables.

On slide 4, you can see details of the financial performance and progress related to our strategic deliverables. Revenue grew 26% in Q1, with our new products growing nearly $1.8 billion compared with the same period last year. We achieved several key pipeline milestones, including the positive Phase II results for TIRZEPATIDE in moderate to severe obstructive sleep apnea. The approval of our multi-dose KWIKPEN delivery device for MOUNJARO in Europe. Submission of MIRIKIZUMAB in the U.S. and in the E.U. for moderately to severely active Crohn's disease, the resubmission of LEBRIKIZUMAB in the U.S. for moderate to severe atopic dermatitis and the initiation of our Phase III study for LEPODISIRAN, evaluating efficacy and reducing cardiovascular risk. Booey's top priority is to ensure that we execute on our ambitious manufacturing expansion agenda.

Speaker Change: <unk> grew 26% in Q1 with our new products growing nearly one 8 billion.

Speaker Change: Compared with the same period last year.

Speaker Change: We achieved several key pipeline milestones, including the positive phase three results for <unk> in moderate to severe obstructive sleep apnea.

Speaker Change: The approval of our multi dose quick turn delivery device for <unk> in Europe.

Dave Ricks: Submission of Mirakizumab in the U.S. and in the E.U. for moderately to severely active Crohn's, and the resubmission of leperchizumab in the U.S. for moderate to severe atopic dermatitis and the initiation of our phase 3 study for lepidocerum, evaluating efficacy and reducing cardiovascular risk Booey's top priority is to ensure that we execute on our ambitious manufacturing expansion agenda.

Joe Fletcher: Submission of <unk> in the U S and in the EU for moderately to severely active crohns disease with.

Joe Fletcher: The resubmission of <unk> in the U S for moderate to severe atopic dermatitis and the initiation of our phase III study for <unk> <unk>.

Joe Fletcher: <unk> efficacy in reducing cardiovascular risk.

Lilly's top priority is to ensure we execute on our ambitious manufacturing expansion agenda. We recently signed an agreement to acquire an injectable medicine facility from Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin. This state-of-the-art facility has been FDA approved, and we are targeting to initiate production at the end of 2025. We broke ground earlier this month on our previously announced parenteral manufacturing site in Germany. And in existing facilities, we are working to maximize output and productivity to meet demand.

Joe Fletcher: So at least top priority is to ensure we execute on our ambitious manufacturing expansion agenda. We recently signed an agreement to acquire an injectable medicine facility from Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin.

Dave Ricks: We recently signed an agreement to acquire an injectable medicine facility from Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin. This state-of-the-art facility has been FDA approved, and we are targeting to initiate production at the end of 2025. We broke ground earlier this month on our previously announced parenteral manufacturing site in Germany. And in existing facilities, we are working to maximize output and productivity to meet demand.

Joe Fletcher: This state of the art facility has been FDA approved and we are targeting to initiate production at the end of 2025.

Joe Fletcher: We broke ground earlier this month on our previously announced parental manufacturing site in Germany.

Joe Fletcher: And in existing facilities, we are working to maximize output.

Joe Fletcher: And in productivity to meet demand.

Dave Ricks: The recent EMA approval and upcoming launch of our multi-dose KWIKPEN delivery device for MOUNJARO will unlock new supply capacity for Europe and other international markets, while we are also seeing meaningful progress in the ramp of new lines in existing Lilly and CDMO sites for the United States. We continue to make progress against our plans to increase manufacturing capacity, the most ambitious expansion plan in our company's history. Lastly, we distributed over $1 billion in dividends during the first quarter. On slide 5, you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates.

The recent EMA approval and upcoming launch of our multi-dose KWIKPEN delivery device for MOUNJARO will unlock new supply capacity for Europe and other international markets, while we are also seeing meaningful progress in the ramp of new lines in existing Lilly and CDMO sites for the United States. We continue to make progress against our plans to increase manufacturing capacity, the most ambitious expansion plan in our company's history. Lastly, we distributed over $1 billion in dividends during the first quarter.

Joe Fletcher: The recent EMA approval and upcoming launch of our multi dose pen delivery device for my Charl will unlock new supply capacity for Europe and other international markets.

Joe Fletcher: We are also seeing meaningful progress in the ramp up new mines and existing Lilly and CMO sites for the United States.

Joe Fletcher: We continue to make progress against our plans to increase manufacturing capacity. The most ambitious expansion plan in our company's history.

Joe Fletcher: Lastly, we distributed over $1 billion in dividends during the first quarter.

On slide 5, you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates.

Dave Ricks: On slide 5, you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates. So now, let me turn the call over to Anat to review our Q1 financials results. Thanks Dave. Slide 6 summarizes financial performance in the first quarter of 2024. First quarter revenue growth of 26% was driven by new products, primarily Montreal and ZEPP. Gross margin as a percent of revenue increased from 78.4% in Q1 2023 to 82.5% in Q1 2024.

On slide 5, you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates.

Speaker Change: On slide five you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates. So now let me turn the call over to and not to review our Q1 financial results.

So now, let me turn the call over to Anat to review our Q1 financials results. Thanks Dave. Slide 6 summarizes financial performance in the first quarter of 2024. First quarter revenue growth of 26% was driven by new products, primarily Montreal and ZEPP. Gross margin as a percent of revenue increased from 78.4% in Q1 2023 to 82.5% in Q1 2024.

So now, let me turn the call over to Anat to review our Q1 financials results.

Speaker Change: Thanks, Dave.

Speaker Change: Six summarizes <unk> financial performance in the first quarter of 2024.

Anat Ashkenazi: Thanks, Dave. Slide 6 summarizes financial performance in the first quarter of 2024. First quarter revenue growth of 26% was driven by new products, primarily MOUNJARO and ZEPBOUND. Gross margin as a percent of revenue increased from 78.4% in Q1 2023 to 82.5% in Q1 2024. Gross margin in the quarter benefited from higher realized prices, variable product mix, and to a lesser extent, improved production costs.

Speaker Change: First quarter revenue growth of 26% was driven by new products, primarily <unk> Charles.

Dave Ricks: Gross margin as a percent of revenue increased from 78, 4% in Q1 2023 to 82, 5% in Q1 2024.

Speaker Change: Gross margin in the quarter benefited from higher realized prices favorable product mix and to a lesser extent improved production costs.

Dave Ricks: Gross margin in the quarter benefited from higher realized prices, a bearable product mix, and to a lesser extent, improved production costs. Marketing, selling, and administrative expenses increased 12%, primarily driven by promotional efforts supporting current and future launches, as well as increased compensation and benefits costs. R&D expenses increased 27%, driven by higher development expenses for late-stage assets and additional investments in early-stage research, as well as a one-time charge of approximately $75 million associated with the termination of the Bresenio Pro State program. In Q1, we recognized the acquired IPRD charge of $111 million, which negatively impacted EPS by 10 cents. Operating income increased 63% in Q1, driven by higher revenue from new products partially offset by operating expense growth.

Gross margin in the quarter benefited from higher realized prices, a bearable product mix, and to a lesser extent, improved production costs.

Speaker Change: Marketing selling and administrative expenses increased 12%, primarily driven by promotional effort supporting current and future launches as well as increased compensation and benefit costs.

Marketing, selling, and administrative expenses increased 12%, primarily driven by promotional efforts supporting current and future launches, as well as increased compensation and benefits costs. R&D expenses increased 27%, driven by higher development expenses for late-stage assets and additional investments in early-stage research, as well as a one-time charge of approximately $75 million associated with the termination of the VERZENIO prostate program. In Q1, we recognized the acquired IPRD charge of $111 million, which negatively impacted EPS by 10 cents. Operating income increased 63% in Q1, driven by higher revenue from new products partially offset by operating expense growth.

Speaker Change: R&D expenses increased 27% driven by higher development expenses for late stage assets and additional investments in early stage research.

Speaker Change: Well as a one time charge of approximately $75 million associated with the termination of that first Daniel prostate program.

Speaker Change: In Q1, we recognized the acquired IP R&D charge of $111 million, which negatively impacted EPS by 10%.

Speaker Change: Operating income increased 63% in Q1, driven by higher revenues from net from new products, partially offset by operating expense growth.

Speaker Change: Our Q1 effective tax rate was 11, 9% compared to $12 eight in Q1 2023, driven by a larger net discrete tax benefit reflected in Q1 2024 compared with the same period in 2023.

In Q1, we recognized the acquired IPR&D charge of $111 million, which negatively impacted EPS by $0.10. Operating income increased 63% in Q1, driven by higher revenue from new products partially offset by operating expense growth. Our Q1 effective tax rate was 11.9% compared to 12.8% in Q1 2023, driven by a larger nondiscrete tax benefit reflected in Q1 2024 compared with the same period in 2023. We delivered earnings per share of $2.58 in Q1, a 59% increase compared to Q1 2023, inclusive of the negative impact of $0.10 from acquired IPR&D charges in both periods. On slide seven, we quantify the effect of price, rate, and volume on revenue growth.

Speaker Change: We delivered earnings per share of $2 58 in Q1, 59% increase compared to Q1 2023 inclusive of the negative impact of Tencent from acquired IP R&D charges in both periods.

Anat Ashkenazi: Our Q1 effective tax rate was 11.9% compared to 12.8% in Q1 2023, driven by a larger nondiscrete tax benefit reflected in Q1 2024 compared with the same period in 2023. We delivered earnings per share of $2.58 in Q1, a 59% increase compared to Q1 2023, inclusive of the negative impact of $0.10 from acquired IPRD charges in both periods. On slide seven, we quantify the effect of price, rate, and volume on revenue growth.

Speaker Change: On slide seven we quantify the effect of price rate and volume on revenue growth.

Speaker Change: U S revenue increased 28% in Q1, driven by growth at <unk> and Bruce.

Speaker Change: Unprecedented demand for our innovative medicines to wholesaler back orders up solicited months and sat down at quarter end.

Speaker Change: Realized prices in the U S decreased 16% largely driven by one child excess and savings card dynamics.

Speaker Change: Moving to Europe revenue growth was once again strong increasing 29% in constant currency, driven primarily by volume from Brazil and mantra as.

On slide 7, we quantify the effect of price, rate, and volume on revenue growth. U.S. revenue increased 28% in Q1, driven by growth in MOUNJARO, ZEPBOUND, and VERZENIO. Unprecedented demand for our incredible medicines led to wholesaler backorders of TRULICITY, MOUNJARO, and ZEPBOUND at quarter end. Realized prices in the U.S. increased 16%, largely driven by MOUNJARO access and savings card dynamics.

Speaker Change: As well as payments associated with distribution and divestiture agreement.

Speaker Change: Japan revenue grew 2% in constant currency volume growth of 7% was driven by month's euro and personnel, partially offset by decreased volumes for <unk> and our partnership milestone in the base period. Thanks.

Anat Ashkenazi: U.S. revenue increased 28% in Q1, driven by growth in Moncharo, Setbound, and Resenio. Unprecedented demand for our incredible medicines led to wholesaler backorders of Trlicity, Montero, and ZepBound at quarter end. Realized prices in the U.S. increased 16%, largely driven by Montero excess and savings card dynamics.

Speaker Change: Price declined 5% in the quarter.

Speaker Change: Moving to China, Q1 revenue increased 4% in constant currency.

Speaker Change: Volume growth was driven by tight rate, partially offset by Illumina and CLS.

Speaker Change: Revenue in the rest of the world increased 31% in constant currency.

Anat Ashkenazi: Moving to Europe, revenue growth was once again strong, increasing 29% in constant currency, driven primarily by volume from VERZENIO and MOUNJARO, as well as payments associated with the distribution and divestiture agreement. Japan revenue grew 2% in constant currency. Volume growth of 7% was driven by MOUNJARO and VERZENIO, partially offset by decreased volume for TRULICITY and a partnership milestone in the base period. Price declined 5% in the quarter.

Speaker Change: Primarily driven by volume growth from <unk> and to a lesser extent <unk> and target.

Speaker Change: Okay.

Speaker Change: <unk> provides additional perspective.

Speaker Change: Across our product categories.

Speaker Change: First I would like to highlight presenting them when sell worldwide sale increased 40% in Q1, driven by continued volume growth and the early breast cancer indication.

Speaker Change: To improve our revenue increased to $50 million worldwide represented an acceleration in sequential quarterly growth. Following the December 2000, 22023 approval for the CLO indication.

Speaker Change: We're looking forward to potentially making this medicine available to even more patients as future phase III trials readout.

Anat Ashkenazi: Moving to China, Q1 revenue increased 4% in constant currency. Volume growth being driven by TYVYT, partially offset by OLUMIANT and CIALIS. Revenue in the rest of the world increased 31% in constant currency, primarily driven by volume growth from MOUNJARO and to a lesser extent, VERZENIO and JARDIANCE.

Speaker Change: Next in queue, one launch ourselves were one 8 billion globally.

Speaker Change: $1 5 billion in the U S.

Speaker Change: Up from $568 million and 536 million Q1 2023, respectively.

Speaker Change: Sequential quarter over quarter revenue from onshore in the U S was impacted by a onetime benefit from changes in estimates for rebates and discounts in Q4 2023.

Anat Ashkenazi: Slide 8 provides additional perspectives across our product categories. First, I would like to highlight VERZENIO, which saw a worldwide cell increase of 40% in Q1, driven by continued volume growth in the early breast cancer indication. JAYPIRCA revenue increased to $50 million worldwide, representing an acceleration in sequential quarterly growth following the December 2023 approval for the CLL indication. We're looking forward to potentially making this medicine available to even more patients as future Phase III trials read out. Next, in Q1, Montreal sales were $1.8 billion globally and $1.5 billion in the U.S., up from $568 million and $536 million in Q1 2023, respectively.

Slide 8 provides additional perspectives across our product categories. First, I would like to highlight VERZENIO, which saw a worldwide cell increase of 40% in Q1, driven by continued volume growth in the early breast cancer indication. JAYPIRCA revenue increased to $50 million worldwide, representing an acceleration in sequential quarterly growth following the December 2023 approval for the CLL indication. We're looking forward to potentially making this medicine available to even more patients as future Phase III trials read out.

Speaker Change: Lower inventory in the channel in Q4, 2024, and a strong demand.

Speaker Change: Access level across commercial and R&D were consistent with high levels, we communicated on our last earnings call and your parity with the established injectable medicines.

Speaker Change: Okay.

Speaker Change: The demand for <unk> appetite is very strong and each week hundreds of thousands of people fill scripts from one Charles and.

Speaker Change: Yes, we understand the frustration from those facing prescription delays or uncertainties get their medicine.

Speaker Change: Well, we are working tirelessly to rent supply and expect meaningful increases in shipment volumes in the second half of the year demand continues to outstrip even increased supply.

Speaker Change: We remain on track to meet expectations. We set earlier this year the production of cell doses of increment in medicine in the second half of 2024 will be at least one five times the cell doses in the second half of 2023.

Next, in Q1, MOUNJARO sales were $1.8 billion globally and $1.5 billion in the U.S., up from $568 million and $536 million in Q1 2023, respectively. Sequential quarter-over-quarter revenue for MOUNJARO in the U.S. was impacted by a one-time benefit from changes in estimates for rebates and discounts in Q4 2023, as well as lower inventory in the channel in Q4 2024 and in strong demand. Access levels across commercial and Part D were consistent with high levels we communicated on our last earnings call and near parity with established injectable incretin medicines. The demand for ter In each week, hundreds of thousands of people fill the strips from Montero and Zeppel.

Speaker Change: In the short to midterm, we expect sales growth.

Speaker Change: Barely dysfunction of the quantities, we can produce and ship.

Anat Ashkenazi: Sequential quarterly-over-quarter revenue for Montero in the U.S. was impacted by a one-time benefit from changes in estimates for rebates and discounts in Q4 2023, as well as lower inventory in the channel in Q4 2024 and in strong demand. Access levels across commercial and R&D were consistent with high levels we communicated on our last earnings call and your parity with established injectable increments in medicine. The demand for ter In each week, hundreds of thousands of people fill the strips from Montero and Zeppel.

Speaker Change: Outside the U S. We're delighted that the multi dose pen delivery device from trial was recently approved in the EU, adding to the UK approval earlier this year.

Speaker Change: This approval applies to both type two diabetes and chronic weight management indication and they are under the single brand in Europe.

Speaker Change: Well the planning for launch will vary by country, we expect to start launching in the EU in coming weeks.

Speaker Change: In Q1 worldwide <unk> revenue declined 26%.

Speaker Change: <unk> revenue decreased 3% driven by lower volume, primarily due to supply constraints and competitive dynamics.

Speaker Change: In addition sales in international markets were impacted by measures, we have taken to minimize disruption to existing patients, including communicated to health care professionals to not start new patients on soliciting.

The demand for TIRZEPATIDE is very strong. And each week, hundreds of thousands of people fill the scripts from MOUNJARO and ZEPBOUND. Yet we understand the frustration from those facing prescription delays or uncertainties yet in their medicine. While we are working tirelessly to ramp supply and expect meaningful increases in shipment volumes in the second half of the year, demand continues to outstrip even increased supply. We remain on track to meet expectations we set earlier this year, the production of saleable doses of incretin medicine in the second half of 2024 will be at least 1.5x the saleable doses in the second half of 2023. In the short to midterm, we expect sales growth to primarily be a function of the quantities we can produce and ship.

Speaker Change: Turning to slide nine we have seen exceptionally strong U S launch progress present them with over half a billion dollars in sales in Q1.

Anat Ashkenazi: Yet we understand the frustration from those facing prescription delays or uncertainties about their medicine. While we are working tirelessly to ramp supply and expect meaningful increases in shipment volumes in the second half of the year, demand continues to outstrip even increased supply. We remain on track to meet expectations we set earlier this year. For example, the production of salable doses of Incretin medicine in the second half of 2024 will be at least one and a half times the salable doses in the second half of 2023. In the short to midterm, we expect sales growth to primarily be a function of the quantities we can produce and ship.

Speaker Change: We're rapidly building now access present bound into the U S and as of April one we have approximately 67% access in the commercial segment.

Speaker Change: As a reminder, patients access to this market is a two step process typically require individual employers to opt in to an anti obesity medicine rider.

Speaker Change: <unk> coverage.

Speaker Change: We're continuing to focus on broadening access both with Pbms and through employer opt ins and early project progress is encouraging.

Speaker Change: On slide 10, we provide an update on capital allocation.

Speaker Change: Slide 11 shows updated 2024 financial guidance.

Speaker Change: Given the strength, we're seeing in our business and projections for continued acceleration expected in the second half of the year.

Anat Ashkenazi: Outside the U.S., we're delighted that the multi-dose KWIKPEN delivery device from MOUNJARO was recently approved in the E.U., adding to the U.K. approval earlier this year. This approval applies to both type 2 diabetes and chronic weight management indications as they are under a single brand in Europe. While timing for launch will vary by country, we expect to start launching in the E.U. in coming weeks. In Q1, worldwide TRULICITY revenue declined 26%. U.S. TRULICITY revenue decreased 30% driven by lower volume primarily due to supply constraints and competitive dynamics.

Speaker Change: We're increasing our full year revenue outlook by $2 billion on the top and bottom end of the range to be between $42 $4 billion to $43 6 billion.

Speaker Change: This increase is primarily due to strong performance of my child, and sat down and greater visibility and confidence into our production expansion for the remainder of 2024.

Speaker Change: With this update year over year revenue growth for the company is now expected to be approximately 26% at the midpoint or approximately 35% for the core business, which excludes the impact from global divestitures.

Anat Ashkenazi: In addition, sales in international markets were impacted by measures we have taken to minimize disruption to existing patients, including communicating to healthcare professionals to not start new patients for TRULICITY. Turning to slide 9, we have seen exceptionally strong U.S. launch progress for ZEPBOUND, with over $0.5 billion in sales in Q1. We're rapidly building that access for ZEPBOUND in the U.S., and as of April 1st, we have approximately 67% access in the commercial segment.

In addition, sales in international markets were impacted by measures we have taken to minimize disruption to existing patients, including communicating to healthcare professionals to not start new patients for TRULICITY.

Speaker Change: Given the update to revenue guidance, we now expect the ratio of gross margin less opex divided by revenue to be in the range of 32% to 34% on a reported basis and 33% to 35% on a non-GAAP basis, representing further margin expansion.

Turning to slide 9, we have seen exceptionally strong U.S. launch progress for ZEPBOUND, with over $0.5 billion in sales in Q1. We're rapidly building that access for ZEPBOUND in the U.S., and as of April 1st, we have approximately 67% access in the commercial segment.

Speaker Change: We are reaffirming guidance for other income and expense and tax rate, which now takes into consideration Q1 results.

Speaker Change: Based on these updates and inclusive of Q1, I see R&D charges of <unk> 10 per share.

Speaker Change: And now expect EPS to be in the range of $13 five to $13 55 on a reported basis and <unk>.

Anat Ashkenazi: As a reminder, patients' access to this market is a two-step process, typically requiring individual employers to opt-in to an anti-obesity medicine rider on PBM coverage. We are continuing to focus on broadening access both with PBMs and through employer opt-ins, and early progress is encouraging. On slide 10, we provide an update on capital allocation, and slide 11 shows an updated 2024 financial guide. Given the strengths we're seeing in our business and projections for continued acceleration expected in the second half of the year, we're increasing our full-year revenue outlook by $2 billion on the top and bottom ends of the range, to be between $42.4 billion and $43.6 billion.

As a reminder, patients' access to this market is a two-step process, typically requiring individual employers to opt-in to an anti-obesity medicine rider on PBM coverage. We are continuing to focus on broadening access both with PBMs and through employer opt-ins, and early progress is encouraging.

Speaker Change: $13 50 to $14 on a non-GAAP basis.

Speaker Change: Now I'll turn the call over to Dan to highlight progress in R&D. Thanks, Scott, Let me start with our exciting announcement from earlier. This month that was a positive phase III results from the surmount OSA studies, which evaluated tours appetite for treatment of adults with obesity and moderate to severe obstructive sleep apnea known as OSA.

Speaker Change: Let's say, it's a sleep related breathing disorder characterized by complete or partial collapse of the upper airway during sleep.

On slide 10, we provide an update on capital allocation. Slide 11 shows an updated 2024 financial guide. Given the strengths we're seeing in our business and projections for continued acceleration expected in the second half of the year, we're increasing our full-year revenue outlook by $2 billion on the top and bottom ends of the range, to be between $42.4 billion and $43.6 billion.

On slide 10, we provide an update on capital allocation.

Slide 11 shows an updated 2024 financial guide. Given the strengths we're seeing in our business and projections for continued acceleration expected in the second half of the year, we're increasing our full-year revenue outlook by $2 billion on the top and bottom ends of the range, to be between $42.4 billion to $43.6 billion. This increase is primarily due to the strong performance of MOUNJARO and ZEPBOUND and greater visibility and confidence into our production expansion for the remainder of 2024. With this update, year-over-year revenue growth for the company is now expected to be approximately 26% at the midpoint, or approximately 35% for the core business, which excludes the impact of global divestiture. Given the update to revenue guidance, we now expect the ratio of gross margin less OPEX divided by revenue to be in the range of 32% to 34% on a reported basis and 33% to 35% on a non-GAAP basis, representing further margin expansion.

Speaker Change: They can have serious cardio metabolic complications contributing to hypertension coronary heart disease stroke heart failure, atrial fibrillation and even type two diabetes.

Dan: The need is significant OSA impacts 80 million people in the U S with more than 20 million people suffering from moderate to severe OSA.

Dan: We also know that a substantial majority approximately 70% people with OSA also linked with obesity.

Dan: While there are pharmaceutical treatments for the excessive daytime sleepiness associated with OSA tours appetite could potentially be the first pharmacological treatment for the underlying disease.

Anat Ashkenazi: This increase is primarily due to the strong performance of Monjaro and ZepFountain and greater visibility and confidence into our production expansion for the remainder of 2024. With this update, year-over-year revenue growth for the company is now expected to be approximately 26% at the midpoint, or approximately 35% for the core business, which excludes the impact of global divestiture. Given the update to revenue guidance, we now expect the ratio of gross margin less off X divided by revenue to be in the range of 32 to 34% on a reported basis and 33 to 35% on a non-GAAP basis, representing further margin expansion.

Speaker Change: As shown on slide 12, surmount OSA was comprised of two separate trials run under one Master Protocol study one evaluated there's appetite and participants not currently on positive airway pressure or pack therapy.

Speaker Change: One study to evaluate <unk> in patients who introduced path for at least three months prior to the study and plan to continue Pap therapy during the entire course of the trial.

Speaker Change: The total of 469 participants were enrolled across these studies each study randomized participants to either maximum tolerated dose approved pictures appetite, which could be 10 milligrams or 15 milligrams or placebo.

Given the update to revenue guidance, we now expect the ratio of gross margin less OPEX divided by revenue to be in the range of 32% to 34% on a reported basis and 33% to 35% on a non-GAAP basis, representing further margin expansion. We're reaffirming guidance for other income and expense and tax rates, which now takes into consideration Q1 results. Based on these updates and inclusive of Q1 IPR&D charges of $0.10 per share, we now expect EPS to be in the range of $13.05 to $13.55 on a reported basis and $13.50 to $14 on a non-GAAP basis.

Speaker Change: When patients were followed on therapy for 52 weeks.

Speaker Change: On Slide 13, we show the results of study one.

Speaker Change: For the efficacy estimate on mean apnea hypopnea index or AHRI.

Anat Ashkenazi: We're reaffirming guidance for other income and expense and tax rates, which now takes into consideration Q1 results. Based on these updates and inclusive of Q1 ICR&D charges of $0.10 per share, we now expect EPS to be in the range of $13.05 to $13.55 on a reported basis and $13.50 to $14 on a non-gap basis.

Speaker Change: <unk> appetite led to a mean reduction of $27 four events per hour compared to a <unk> reduction of $4 eight events per hour for placebo. This difference was highly statistically significant.

Speaker Change: Hei baseline values were $52 nine nahi was reduced by 55% and the trees appetite arm.

Speaker Change: We also saw a mean body weight reduction of 18, 1%, but theres appetite treatment consistent with our expectations for the study.

Speaker Change: This was of course also statistically significant versus placebo.

Speaker Change: On Slide 14, we show the results of study two in this population for the efficacy estimate there's appetite led to a mean reduction of 34 events per hour.

Dan Skovronsky: Now I'll turn the call over to Dan to highlight progress in R&D. Thanks, Sinad. Let me start with our exciting announcement from earlier this month. That was positive phase three results from the Surmount OSA studies, which evaluated terzepatide for treatment of adults with obesity and moderate to severe obstructive sleep apnea, known as OSA. OSA is a sleep-related breathing disorder characterized by complete or partial collapse of the upper airway during sleep.

Now I'll turn the call over to Dan to highlight progress in R&D.

Speaker Change: <unk> reduction of 6.0 events per hour for placebo.

Daniel M. Skovronsky: Thanks, Anat. Let me start with our exciting announcement from earlier this month. That was the positive Phase III results from the SURMOUNT-OSA studies, which evaluated TIRZEPATIDE for treatment of adults with obesity and moderate to severe obstructive sleep apnea, known as OSA. OSA is a sleep-related breathing disorder characterized by complete or partial collapse of the upper airway during sleep. OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and even type 2 diabetes.

Speaker Change: The baseline Hei was $46, one and there is appetite arm and mean ehi reduction was 62, 8%.

Speaker Change: Again, we saw impressive weight loss with a mean body weight reduction of 21% from baseline.

Speaker Change: These results were also all highly statistically significant.

Speaker Change: In both studies the overall safety profile was similar to previously reported surmounted surpass trials.

Speaker Change: The most commonly reported adverse events were gastrointestinal related generally mild to moderate in severity.

Speaker Change: The most commonly reported gastrointestinal adverse events for patients treated with <unk> being diarrhea, nausea, vomiting and constipation.

Dan Skovronsky: OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and even type 2 diabetes. The need is significant. OSA impacts 80 million people in the U.S., with more than 20 million people suffering from moderate to severe OSA. We also know that a substantial majority, approximately 70% of people with OSA, also live with obesity. While there are pharmaceutical treatments for the excessive daytime sleepiness associated with OSA, terzapatite could potentially be the first pharmacological treatment for the underlying disease.

OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and even type 2 diabetes. The need is significant. OSA impacts 80 million people in the U.S., with more than 20 million people suffering from moderate to severe OSA.

OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and even type 2 diabetes.

Speaker Change: Prior to this study readout, we noted investor questions about what level of weight loss, we would see given several factors that were uniquely combined in this study. If there is appetite first the primary aim of the study was not treatment of obesity.

The need is significant. OSA impacts 80 million people in the U.S., with more than 20 million people suffering from moderate to severe OSA. We also know that a substantial majority, approximately 70% of people with OSA, also live with obesity. While there are pharmaceutical treatments for the excessive daytime sleepiness associated with OSA, TIRZEPATIDE could potentially be the first pharmacological treatment for the underlying disease.

Speaker Change: But the population was approximately 70% males, and whom weight loss can be harder to achieve with acreage medicines.

We also know that a substantial majority, approximately 70% of people with OSA, also live with obesity. While there are pharmaceutical treatments for the excessive daytime sleepiness associated with OSA, terzapatite could potentially be the first pharmacological treatment for the underlying disease.

Speaker Change: Third there was a particularly high baseline BMI in this population.

Speaker Change: Finally, the use of the 10% or 15 milligram maximum tolerated dose approach.

Speaker Change: We were therefore highly reassured to see weight loss observed across the two studies at 52 weeks with nearly 20%. Despite this difficult to treat population.

Dan Skovronsky: As shown on slide 12, SURMOUNT-OSA was comprised of two separate trials run under one master protocol. Study 1 evaluated TIRZEPATIDE in participants not currently on positive airway pressure or PAP therapy. While Study 2 evaluated TIRZEPATIDE in patients who had used PAP for at least 3 months prior to the study and planned to continue PAP therapy during the entire course of the trial. A total of 469 participants were enrolled across these studies. Each study randomized participants to either maximum tolerated dose approved for TIRZEPATIDE, which could be 10 milligrams or 15 milligrams, or to placebo. And patients were followed on therapy for 52 weeks.

Speaker Change: Consistent with other phase III studies, such as appetite at the 52 week time point, we did not see weight loss plateau.

Speaker Change: We will present detailed results of surmount OSA during a symposium at Ada on June 21.

Speaker Change: Additionally, we plan to submit to the FDA and other global regulatory agencies, beginning mid year.

Speaker Change: Okay.

Speaker Change: Moving to the other updates across our portfolio of slide 15 shows select pipeline opportunities as of April 26, and slide 16 shows potential key events for the year.

Speaker Change: We're pleased to share that results were positive for the first phase III study of insulin <unk> to our outlook our once weekly basal insulin.

Speaker Change: This study evaluated <unk> compared to insulin <unk> in adult participants with type two diabetes, who are in multiple daily insulin injections.

Speaker Change: In the coming weeks, we expect to report top line results from <unk>, four as well as to which is evaluating <unk> compared to <unk> in adults with type two diabetes, who are naive to basal insulin <unk>.

Dan Skovronsky: And patients were followed on therapy for 52 weeks. On slide 13, we show the results of study 1, for the Efficacy Essay, on the Mean Apnea Hypopnea Index (AHI). Terzapatite led to a mean reduction of 27.4 events per hour compared to a mean AHI reduction of 4.8 events per hour for placebo. This difference was highly statistically significant. AHI baseline values were 52.9, and AHI was reduced by 55% in the trizepatite arm.

And patients were followed on therapy for 52 weeks.

On slide 13, we show the results of study 1. For the efficacy estimate, on the Mean Apnea Hypopnea Index or (AHI). TIRZEPATIDE led to a mean reduction of 27.4 events per hour compared to a mean AHI reduction of 4.8 events per hour for placebo. This difference was highly statistically significant. AHI baseline values were 52.9, and AHI was reduced by 55% in the TIRZEPATIDE arm. We also saw a mean body weight reduction of 18.1%, for TIRZEPATIDE treatment, consistent with our expectations for the study. This was, of course, also statistically significant versus placebo.

Speaker Change: Together. These are the first two of five studies in the asset to our phase III program.

Speaker Change: Additional updates in our late stage diabetes and obesity pipeline include results of the impact study showing <unk> had a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization due to heart failure or all cause mortality versus placebo, which did not reach statistical significance.

Speaker Change: We've completed enrollment for surmount MMO with over 15000 participants.

Dan Skovronsky: We also saw a mean body weight reduction of 18.1%, which was appetite treatment, consistent with our expectations for the study. This was, of course, also statistically significant versus placebo. On slide 14, we show the results of study 2. In this population, for the efficacy estermand, terzapatide led to a mean HI reduction of 30.4 events per hour, compared to a mean HI reduction of 6.0 events per hour for

We also saw a mean body weight reduction of 18.1%, which was appetite treatment, consistent with our expectations for the study. This was, of course, also statistically significant versus placebo.

Speaker Change: And for both or for <unk> studies in chronic weight management <unk>, one <unk>, two which together enrolled 4500 participants.

Speaker Change: Finally, we've now initiated the transcend to phase III program studying <unk> in type two diabetes.

Speaker Change: In the cardiovascular disease area. We're excited to have initiated the phase III trial for lipodystrophy with subcutaneous injectable <unk> RNA <unk>.

On slide 14, we show the results of Study 2. In this population, for the efficacy estermand, TIRZEPATIDE led to a mean HI reduction of 30.4 events per hour, compared to a mean HI reduction of 6.0 events per hour for placebo. The baseline AHI was 46.1 in the TIRZEPATIDE arm, and mean AHI reduction was 62.8%. Again, we saw impressive weight loss with a mean body weight reduction of 20.1% from baseline. These results were also all highly statistically significant.

Speaker Change: This study will evaluate the efficacy and improving cardiovascular outcomes for participants with highlights of protein a.

Speaker Change: Who have cardiovascular disease or at a risk of heart attack or stroke.

Speaker Change: We are evaluating the efficacy of leopard discipline in both secondary and high risk primary prevention.

Dan Skovronsky: The baseline AHI was 46.1 in the terzapatite arm, and the mean AHI reduction was 62.8%. Again, we saw impressive weight loss with a mean body weight reduction of 20.1% from baseline. These results were also all highly statistically significant. In both studies, the overall safety profile was similar to previously reported surmount and surpass trials. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, with the most commonly reported gastrointestinal adverse events for patients treated with tercepatide being diarrhea, nausea, vomiting, and constipation.

The baseline AHI was 46.1 in the terzapatite arm, and the mean AHI reduction was 62.8%. Again, we saw impressive weight loss with a mean body weight reduction of 20.1% from baseline. These results were also all highly statistically significant.

Speaker Change: Hope this will one day offer health care providers, a treatment option for a broad group of patients at increased cardiovascular risk due to high LP levels.

Speaker Change: Earlier in our diabetes and obesity pipeline, we've now initiated a phase II monotherapy study evaluating a Laura Lynn tied our selective amylin receptor agonist in obesity.

Speaker Change: Turning to oncology, we made the decision to terminate for futility the phase III cycling three trial evaluating <unk> in metastatic hormone sensitive prostate cancer following an interim analysis.

In both studies, the overall safety profile was similar to previously reported SURMOUNT and SURPASS trials. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, with the most commonly reported gastrointestinal adverse events for patients treated with TIRZEPATIDE being diarrhea, nausea, vomiting, and constipation.

Speaker Change: This concludes development of presenting them in prostate cancer. Following last quarter's announcement that the cycle in two studies did not meet its primary endpoint.

Speaker Change: In early oncology development, we've initiated phase one trials for two new assets. The first is our.

Speaker Change: <unk> <unk> ADC, which came from our acquisition of emergence therapeutics.

Speaker Change: The second is PMT to 001, which came from our acquisition of <unk> Biopharma.

Speaker Change: We're encouraged by what we're seeing in our oncology portfolio and we expect 2020 for it to be particularly productive.

Dan Skovronsky: Prior to the study readout, we noted investor questions about what level of weight loss we would see, given several factors that were uniquely combined in the study of TIRZEPATIDE. First, the primary aim of the study was not the treatment of obesity. Second, that the population was approximately 70% males, in whom weight loss can be harder to achieve with incretin medicines. Third, there was a particularly high baseline BMI in this population. And finally, the use of the 10 or 15 milligram maximum tolerated dose approach.

Speaker Change: Along with <unk> and for <unk>, ADC and PMT to 001 start we expect at least three other new molecules to enter the clinic this year.

Speaker Change: We look forward to sharing more details with the investment community at an oncology focused investor event hosted by Lilly oncology team.

Speaker Change: We will take place on the evening of Sunday June 2nd in Chicago in conjunction with the <unk> annual meeting we will also be available via webcast.

Speaker Change: We plan to provide an update on our oncology strategy and pipeline opportunities additional details will be available soon regarding this event.

Speaker Change: Turning to neuroscience last month, we announced that the FDA plans to convene a meeting of the peripheral in CNS drugs Advisory Committee to discuss the net of map and early symptomatic Alzheimer's disease. We expect the Advisory Committee meeting will take place in mid 2024, but the exact date will be confirmed when it appears in the Federal Register we.

Dan Skovronsky: We were therefore highly reassured to see weight loss observed across the 2 studies at 52 weeks was nearly 20% despite this difficult-to-treat population. Consistent with other Phase III studies with TIRZEPATIDE at the 52-week time point, we did not see weight loss plateau. We'll present detailed results of SURMOUNT-OSA during a symposium at ADA on June 21st. Additionally, we plan to submit to the FDA and other global regulatory agencies beginning mid-year.

Speaker Change: We expect the focus to be around the safety and efficacy profile of genetic map along with unique aspects of the clinical program.

Speaker Change: We remain confident in <unk> potential to offer very meaningful benefits to patients and look forward to addressing the fda's questions in this forum.

Speaker Change: Additionally, we made the decision to discontinue investigation of GBA, one our gene therapy asset and GAAP shade disease type two.

Dan Skovronsky: Moving to the other updates across our portfolio, slide 15 shows select pipeline opportunities as of April 26th, and slide 16 shows potential key events for the year. We're pleased to share that results were positive in QWINT-4, the first Phase III study of INSULIN EFSITORA ALFA, or once weekly basal insulin. This study evaluated Efsitora compared to insulin glargine in adult participants with type 2 diabetes who are on multiple daily insulin injections.

Speaker Change: Phase III studies in Parkinson's disease, and Gaucher disease type one are still underway and have not been impacted by this decision.

Speaker Change: Finally in immunology, we submitted mirror kiss map to the FDA and EMA for approval for use in adults with moderately to severely active crohns disease.

Speaker Change: In the U S. We've resubmitted <unk> application to the FDA for moderate to severe atopic dermatitis.

Speaker Change: This is following the complete response letter based on inspection findings at a third party manufacturer.

Speaker Change: As a reminder, the letter stated no concerns with the clinical data package safety our label, we expect regulatory action in the second half of this year.

Speaker Change: We're also announcing that in the coming months, we'll be initiating phase III studies evaluating <unk>, two new indications chronic rhinosinusitis nasal polyposis, an allergic rhinitis due to perennial allergens.

Dan Skovronsky: In the coming weeks, we expect to report top-line results from QWINT-4 as well as QWINT-2, which is evaluating EFSITORA compared to DEGLUDEC in adults with Type 2 diabetes who are naive to basal insulin. Together, these are the first 2 of 5 studies in the FSITORA Phase III program. Additional updates in our late-stage diabetes and obesity pipeline include results from the EMPACT-MI study showing JARDIANCE had a 10% relative risk reduction in the primary composite endpoint of time-to-first hospitalization due to heart failure or all-cause mortality versus placebo, which did not reach statistical significance. We've completed enrollment for SURMOUNT MMO with over 15,000 participants. And for both ORFORGLIPRON studies in chronic weight management, ATTAIN-1 and ATTAIN-2, which together enrolled 4,500 participants.

Speaker Change: <unk> will be the first biologic to be evaluated in phase III for allergic rhinitis, where.

Speaker Change: We're optimistic about the potential of <unk> to be an important treatment option in these patient populations as well as in atopic dermatitis.

Speaker Change: In earlier stage immunology development, we advanced our CD 19 antibody into a phase II for multiple sclerosis.

Speaker Change: I will turn the call back to Dave for closing remarks, Okay. Thanks, Dan before we go to Q&A, Let me briefly sum up the progress in our first quarter.

Dave Ricks: <unk> revenue growth in Q1 was driven by our recent product launches, primarily mondro et cetera.

Dave Ricks: We expect acceleration in revenue growth through the second half year.

Dave Ricks: <unk> acreage and medicines continues to ramp.

Speaker Change: Significant advances in our pipeline include topline data from Giuseppettite instrument in OSA.

Dave Ricks: Approval of equipment delivery device from a <unk> in the EU submission America's demand and Leverages map as well as initiation of <unk>.

Dave Ricks: This or I'm, sorry phase.

Dan Skovronsky: Finally, we've now initiated the TRANSCEND Phase III program, studying RETRATUTIDE in Type 2 diabetes. In the cardiovascular disease area, we're excited to have initiated the Phase III trial for LEPODISIRAN, the subcutaneous injectable siRNA. This study will evaluate the efficacy in improving cardiovascular outcomes for participants with high lipoprotein A, who have cardiovascular disease or are at risk of heart attack or stroke.

Dave Ricks: <unk> Phase II study as Dan just mentioned.

Dave Ricks: We are continuing to invest in recent and upcoming launches internal and external pipeline development and our manufacturing expansion agenda.

Dave Ricks: This is to sustain our long term growth outlook. So now let me turn the call over to Joe to moderate the Q&A session.

Joe Fletcher: Thanks, Dave we'd like to take questions from as many callers as possible and to conclude our call in a timely manner. So consistent with prior quarters will respond to one question per caller. So ask that you limit to one question per caller as we'll end the call at 11 a M.

Dan Skovronsky: We are evaluating the efficacy of LEPODISIRAN in both secondary and high-risk primary prevention, and we hope this will one day offer health care providers a treatment option for a broad group of patients at increased cardiovascular risk due to high LP(a) levels. Earlier in our diabetes and obesity pipeline, we've now initiated a Phase II monotherapy study evaluating ELORALINTIDE, our selective amylin receptor agonist in obesity. Turning to oncology, we made the decision to terminate for futility the Phase III CYCLONE 2 trial evaluating VERZENIO in metastatic hormone-sensitive prostate cancer following an interim analysis. This concludes the development of VERZENIO on prostate cancer following last quarter's announcement that the CYCLONE 2 study did not meet its primary end goal.

We are evaluating the efficacy of LEPODISIRAN in both secondary and high-risk primary prevention, and we hope this will one day offer health care providers a treatment option for a broad group of patients at increased cardiovascular risk due to high LP(a) levels. Earlier in our diabetes and obesity pipeline, we've now initiated a Phase II monotherapy study evaluating ELORALINTIDE, our selective amylin receptor agonist in obesity.

Dave Ricks: If you have more than one question you can reenter the queue and we'll get to your question of time allows so Paul please provide instructions for the Q&A session and then we're ready for our first caller.

Paul: 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, we ask that participants limit themselves to one question on today's call.

Paul: If you do have a follow up question. Please rejoin the queue by pressing star one at anytime.

Paul: You also asked about while posing your question. Please pick up your handset if listening on speaker phone to provide optimum sound quality. Please hold while we poll for questions.

Turning to oncology, we made the decision to terminate for futility the Phase III CYCLONE 2 trial evaluating VERZENIO in metastatic hormone-sensitive prostate cancer following an interim analysis. This concludes the development of VERZENIO on prostate cancer following last quarter's announcement that the CYCLONE 2 study did not meet its primary end point.

Paul: On the first question today is coming from Chris Schott from Jpmorgan, Chris Your line is live.

Chris Schott: Great. Thanks, so much and congrats on all the progress here.

Chris Schott: Got a question just was hoping you could elaborate a bit more on the capacity dynamics that are leading to the guidance raise today I specifically just looking for little more color or is this more U S or international and should we read this as more.

Dan Skovronsky: In early oncology development, we've initiated Phase I trials for 2 new assets. The first is our NECTIN-4 ADC, which came from our acquisition of Emergence Therapeutics. The second is PNT2001, which came from our acquisition of POINT Biopharma. We're encouraged by what we're seeing in our oncology portfolio and expect 2024 to be particularly productive. Along with the NECTIN-4 ADC and PNT2001 start, we expect at least 3 other new molecules to enter the clinic this year.

Chris Schott: More capacity in the system than you expected or just a faster ramp of the new plant and maybe the same overall capacity as you exit the year. Thanks, so much.

Speaker Change: Thanks, Chris ill handover to not talk about the guidance raise.

Speaker Change: For the question Chris.

Speaker Change: As I as we've mentioned earlier in the year when we issued guidance.

Speaker Change: We said that we expect capacity and supply and to ramp towards the second half of the year and that's what we're seeing now.

Speaker Change: As a reminder, we do have quite a large number of nodes across our supply chain that have to come online or brand capacity. We are if you look at everything we have under construction or ramping up we have six sites right now between the two sites in North Carolina Aside in Ireland to sites in Indiana side in Germany.

Dan Skovronsky: We look forward to sharing more details with the investment community at an oncology-focused investor event hosted by the Lilly Oncology team. This event will take place on the evening of Sunday, June 2nd in Chicago in conjunction with the ASCO annual meeting. It will also be available via webcast. We plan to provide an update on our oncology strategy and pipeline opportunities. Additional details will be available soon regarding this event.

Speaker Change: And then a seven point that we just purchased.

Speaker Change: They are all either ramping up or under construction.

Speaker Change: And there are multiple nodes across that supply chain that has to become operational which requires approval et cetera for three products, depending on which product fronts on which line.

Dan Skovronsky: We plan to provide an update on our oncology strategy and pipeline opportunities. Additional details will be available soon regarding this event. Turning to neuroscience, last month we announced that the FDA plans to convene a meeting of the Peripheral and CNS Drugs Advisory Committee to discuss Denenimab in early symptomatic Alzheimer's disease. We expect the advisory committee meeting will take place in mid-2024, but the exact date will be confirmed when it appears in the federal register.

We plan to provide an update on our oncology strategy and pipeline opportunities. Additional details will be available soon regarding this event.

Speaker Change: That are planned throughout the year now now that we're four months into the year, we have greater visibility into that into these notes that capacity and feel more confident.

Turning to neuroscience, last month we announced that the FDA plans to convene a meeting of the Peripheral and CNS Drugs Advisory Committee to discuss DONANEMAB in early symptomatic Alzheimer's disease. We expect the Advisory Committee meeting will take place in mid-2024, but the exact date will be confirmed when it appears in the federal register.

Speaker Change: One example of the approval of the quick turn in Europe that just came in.

Speaker Change: Slightly ahead of our expectation it gives us additional confidence in our ability to launch <unk> for patients in Europe.

Speaker Change: So it is across our sites globally as well as ramping up capacity with partners or <unk>.

Speaker Change: Laws in existing sites, where we're making investments to expand where we can ramp up capacity.

Dan Skovronsky: We expect the focus to be around the safety and efficacy profile of DONANEMAB, along with unique aspects of the clinical program. We remain confident in DONANEMAB's potential to offer very meaningful benefits to patients and look forward to addressing the FDA's questions in this forum. Additionally, we made the decision to discontinue investigation of GBA1, our gene therapy acid, in Gaucher disease type 2. Phase II studies in Parkinson's disease and Gaucher disease Type 1 are still underway and have not been impacted by this decision.

Speaker Change: It's across our supply chain.

Speaker Change: Thanks next caller Paul.

Paul: Thank you. The next question is coming from Mohit Bansal from Wells Fargo Mohit Your line is live.

Mohit Bansal: Great. Thank you very much for taking my question and congrats on the progress.

Mohit Bansal: Have a question regarding the pricing if you look at the script trend.

Mohit Bansal: It seems like there was a little bit of adverse relationship.

Dan Skovronsky: Finally, in immunology, we've submitted MIRIKIZUMAB to the FDA and EMA for approval for use in adults with moderately to severely active Crohn's disease. In the U.S., we've resubmitted LEBRIKIZUMAB's application to the FDA for moderate to severe atopic dermatitis. This is following a complete response letter based on inspection findings by a third-party manufacturer. As a reminder, the letter stated no concerns with the clinical data package safety or label. We expect regulatory action in the second half of this year.

Mohit Bansal: The pricing, what's the fourth quarter can you comment on that and how should we think about the cadence of price volume over the quarters for the year. Thank you.

Speaker Change: Thanks Mohit you.

Speaker Change: You didn't say it but I assume youre talking about in the Giro and ends up bounce I'll hand over to Patrick to make some commentary on price.

Patrick: Thank you very much Jim when you look at the pricing of <unk>, John I think it's important to take into account at the end of Q4 earnings we announced a one time adjustment for majority in Q4 that was quite significantly.

Patrick: That's a one time adjustment in the days of Q4, when we look forward for the first half of 2024.

Dan Skovronsky: We expect regulatory action in the second half of this year. We're also announcing that in the coming months, we'll be initiating phase three studies, evaluating labratizumab in two new indications, chronic rhinocitis with nasal polyposis and allergic rhinitis due to perennial allergies. Leverkismab will be the first biologic to be evaluated in Phase 3 for allergic rhinitis. We're optimistic about the potential of leverkizumab to be an important treatment option in these patient populations, as well as in atopic dermatitis. In earlier stage immunology development, we advanced our CD19 antibody into phase 2 for multiple squarers.

We expect regulatory action in the second half of this year.

Speaker Change: It's important to have in mind, but we also terminated the $25 savings card six <unk> to 'twenty, two 'twenty, three but patients thats, where our own are grandfathered until it takes for the 2024, so that would probably be some benefits during the first half of 2024 foot Mongiardo thrombus second half.

We're also announcing that in the coming months, we'll be initiating Phase III studies, evaluating LEBRIKIZUMAB in 2 new indications, chronic rhinosinusitis with nasal polyposis and allergic rhinitis due to perennial allergies. LEBRIKIZUMAB will be the first biologic to be evaluated in Phase III for allergic rhinitis. We're optimistic about the potential of LEBRIKIZUMAB to be an important treatment option in these patient populations, as well as in atopic dermatitis. In earlier stage immunology development, we advanced our CD19 antibody into Phase II for multiple sclerosis.

Mohit Bansal: Half of this year, we should expect to see typical pricing headwinds from a guy who is with.

Speaker Change: Thank you your next question Paul.

Paul: Thanks. The next question is coming from Omar <unk> from Evercore. Your line is live.

Omar: Hi, guys. Thanks for taking my question I wanted to focus a quick second one part D reimbursement dynamics, if I may and my question is to.

Omar: Wolters appetite would be considered differently than a quote unquote weight loss drug to secure part D reimbursement and the new indications like sleep apnea will they be considered an applicable drug and not get lumped up as abroad weight loss drug quote unquote. Thank you.

Dave Ricks: I now turn the call back to Dave for closing remarks. Okay, thanks, Dan. Before we go to Q&A, let me briefly sum up the progress in our first quarter. Strong revenue growth in Q1 was driven by our recent product launches, primarily Manjaro and Zepcal.

I now turn the call back to Dave for closing remarks.

David Ricks: Okay, thanks, Dan. Before we go to Q&A, let me briefly sum up the progress in our first quarter. Strong revenue growth in Q1 was driven by our recent product launches, primarily MOUNJARO and ZEPBOUND. We expect acceleration in revenue growth through the second half of the year, as supply of increase in medicines continues to ramp. Significant advances in our pipeline include top-line data from TIRZEPATIDE and SURMOUNT-OSA, approval of the KWIKPEN delivery device for MOUNJARO in the E.U., submission of MIRIKIZUMAB and LEBRIKIZUMAB, as well as the initiation of LEPODISIRAN, sorry, Phase II study, as Dan just mentioned. We are continuing to invest in recent and upcoming launches, internal and external pipeline development, and our manufacturing expansion agenda. This is to sustain our long-term growth outlook.

Speaker Change: Thanks to the MRO, but Patrick for that question.

Dave Ricks: We expect acceleration in revenue growth through the second half of the year, as supply of increase in medicines continues to ramp. Significant advances in our pipeline include top-line data from Tercepatan and Surmount OSA, Approval of the QuickPen Delivery Device for Monjaro in the EU, Submission of Merikizumab and Leberkizumab, as well as the initiation of Lepidocin, Lepidocin, I'm sorry, Phase II study at the, We are continuing to invest in recent and upcoming launches, internal and external pipeline development, and our manufacturing expansion.

Mohit Bansal: Goodbye.

Mohit Bansal: I think we the announcement made by the CMS said early April to reimburse Comorbidities for <unk> based upon the select trial. We're also confident that with the new data that we presented just weeks ago in terms of obstructive sleep apnea that that's going to be reimbursed in Medicare part D and we expect.

Mohit Bansal: Similarly for our other comorbid DSM readout of half path, assuming thats positive unapproved and later on with the morbidity and mortality outcomes save our true north is really to get the twilio or a treat and reduce obesity act costs and we strongly believe thats not the macro events, but when they don't see it like it's a pause in 2020.

Dave Ricks: This is to sustain our long-term growth outlook. Now, I will turn the call over to Joe to moderate the Q&A session. Thanks, Dave. We'd like to take questions from as many callers as possible and conclude our call in a timely manner. Consistent with prior quarters, we'll respond to one question per caller. So, ask that you limit yourself to one question per caller as we'll end the call at 11 a.m. If you have more than one question, you can re-enter the queue, and we'll get to your question within the time allowed.

This is to sustain our long-term growth outlook.

Now, I will turn the call over to Joe to moderate the Q&A session. Thanks, Dave. We'd like to take questions from as many callers as possible and conclude our call in a timely manner. Consistent with prior quarters, we'll respond to one question per caller. So, ask that you limit yourself to one question per caller as we'll end the call at 11 a.m. If you have more than one question, you can re-enter the queue, and we'll get to your question within the time allowed.

Now, I will turn the call over to Joe to moderate the Q&A session.

Mohit Bansal: I hope I've already stated as more of like smart iqos, but thats going to happen.

Joe Fletcher: Thanks, Dave. We'd like to take questions from as many callers as possible and conclude our call in a timely manner. Consistent with prior quarters, we'll respond to one question per caller. So, ask that you limit to one question per caller as we'll end the call at 11 a.m. If you have more than one question, you can re-enter the queue, and we'll get to your question if time allows. So Paul, please provide instructions for the Q&A session, and we're ready for our first caller.

Speaker Change: Thanks, Patrick next question Paul Thank.

Paul: Thank you. The next question is coming from Seamus Fernandez from Guggenheim Seamus Your line is live.

Seamus Fernandez: Great. Thanks for the question so.

Seamus Fernandez: Really just wanted to ask Dan as you have assessed the phase two.

Seamus Fernandez: Surmount.

Seamus Fernandez: Data in Nash.

Seamus Fernandez: Just interested to know how you are thinking about that.

Seamus Fernandez: Data and the opportunity for <unk> appetite in that setting or perhaps if read a true tied remains the.

Joe Fletcher: So Paul, please provide instructions for the Q&A session, and we're ready for our first caller. Thank you. At this time, we will be conducting a question and answer session. If you have any questions, please press star 1 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 1 at any time. We also ask that while asking your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality.

So Paul, please provide instructions for the Q&A session, and we're ready for our first caller.

Operator: [Operator Instructions] The first question today is coming from Chris Schott from J.P. Morgan. Chris, your line is live

Seamus Fernandez: Right target molecule to move forward there.

Seamus Fernandez: We've had a lot of speculation around some of the comments from the last quarter and just trying to firm that up and also when we're likely to see those data I believe their expected useful but if that is possible to confirm thanks. So much.

Speaker Change: Yes. Thanks.

Speaker Change: Thanks, David So I'll start with the last part there yet.

Speaker Change: Abstract was accepted and will be presented to ESL.

Speaker Change: Early June.

Operator: Please hold while we poll for questions. The first question today is coming from Chris Schott from J.P. Morgan. Chris, your line of... All right, great.

Please hold while we poll for questions. The first question today is coming from Chris Schott from J.P. Morgan.

Speaker Change: So that there'll be an opportunity to see the full Nash package from that phase two trial like we said last call really exciting data we shared some of the top line.

Chris, your line of... All right, great.

Chris, your line of...

Christopher Schott: All right, great. Thanks so much. And congratulations on all the progress here. I just had a question, just I was hoping you could elaborate a bit more on the capacity dynamics that are leading to the guidance raised today. I specifically was looking for little more color, is this more US or international. And should we read this as more capacity in the system than you expected? Or just a faster ramp of the new plant and maybe the same overall capacity as you exit the year? Thanks so much.

Chris Schott: Thanks so much. And congratulations on all the progress here. I just had a question. I was hoping you could elaborate a bit more on the capacity dynamics that are leading to the guidance raised today. I specifically was looking for a little more color on whether this is more US or international.

Speaker Change: I think there's appetite can have a profound effect on this disease. It's a phase II trial next steps here to discuss with the FDA, what the best path forward could be purchase appetite.

Speaker Change: Youre pointing out.

Speaker Change: We have another choice and Red tide.

Chris Schott: And should we read this as more capacity in the system than you expected? Or just a faster ramp-up of the new plant and maybe the same overall capacity as you exit the year? Thanks so much.

Speaker Change: Based on biomarker data from earlier studies could also have a profound effect on this disease.

Speaker Change: That molecule has the addition of glucagon.

Anat Ashkenazi: Thanks, Chris. I'll hand over to Anat to talk about guidance for you. Thanks for the question, Chris. And as we mentioned earlier in the year, when we issued guidance, we said that we expect capacity and supply to ramp up towards the second half of the year. And that's what we're seeing. Now, as a reminder, we do have quite a large number of nodes across our supply chain that have to come online or ramp up capacity.

Joe Fletcher: Thanks, Chris. I'll hand over to Anat to talk about the guidance raise.

Speaker Change: It's likely to have additional benefits in the liver.

Thanks for the question, Chris. And as we mentioned earlier in the year, when we issued guidance, we said that we expect capacity and supply to ramp towards the second half of the year. And that's what we're seeing. Now, as a reminder, we do have quite a large number of nodes across our supply chain that have to come online or ramp capacity.

Anat Ashkenazi: Thanks for the question, Chris. And as we mentioned earlier in the year, when we issued guidance, we said that we expect capacity and supply to ramp towards the second half of the year. And that's what we're seeing.

Seamus Fernandez: So important.

Seamus Fernandez: Opportunities ahead, good to have options as we go into these discussions with regulators I think for mash like other obesity related or metabolic related.

Seamus Fernandez: But diseases.

Now, as a reminder, we do have quite a large number of nodes across our supply chain that have to come online or ramp capacity. We are--if you look at everything we have under construction or ramping up, we have 6 sites right now between the 2 sites in North Carolina, a site in Ireland, 2 sites in Indiana, a site in Germany, and then a seventh one that we just purchased. They're all either ramping up or under construction. And there are multiple nodes across that supply chain that have to become operational, which requires approval, etc. for 3 products, depending on which product runs on which line that are planned throughout the year.

Seamus Fernandez: Lilly has a pretty broad portfolio and we'll just continue to push the science to make the best possible medicines for patients.

Anat Ashkenazi: You know, we are, if you look at everything we have under construction or ramping up, we have six sites right now between the two sites in North Carolina, a site in Ireland, two sites in Indiana, a site in Germany, and then a seventh one that we just purchased. They're all either ramping up or under construction. And there are multiple nodes across that supply chain that have to become operational, which requires approval, etc. for three products, depending on which product runs on which line that is planned throughout the year.

Speaker Change: Thanks, Dan Paul next question.

Seamus Fernandez: The next question will be from Tim Anderson from Wolfe Research Tim Your line is live.

Tim Anderson: Thank you you showed a slide that <unk> has and be Rx share market of 57% end of Q1 that makes it pretty clear that the strongest drug wins, so on that topic.

Tim Anderson: Just your latest thinking on upcoming competitor Readouts and how those stack up to that down on metrics of weight loss and blood sugar. So specific route CAGR stoma from Nova and Amgen is 133 I know, it's just the best guess, but it's but we get asked to do thank you.

And there are multiple nodes across that supply chain that have to become operational, which requires approval, etc. for 3 products, depending on which product runs on which line that are planned throughout the year.

Anat Ashkenazi: Now that we're 4 months into the year, we have greater visibility into these nodes of capacity and feel more confident. Just as one example, the approval of KWIKPEN in Europe, which just came in, slightly ahead of our expectations, gives us additional confidence in our ability to launch KWIKPEN for patients in Europe. So it is across our sites globally, as well as ramping up capacity with partners or CDMOs, as well as in existing sites where we're making investments to expand where we can or ramp up capacity. So it's across our supply chain.

Speaker Change: Thanks, Tim Okay, I'll, maybe hand to Dan for some comments, yes sure Tim.

Dan: Permanently Moor your job than ours to speculate on competitor Readouts, but I'll take a stab at it.

Dan: I think on AMG 133, we've just seen really a small amount of data so probably anything is possible.

Dan Skovronsky: But like you will be interested to see their results.

Dan: Of course, there's arguments that can be heard about <unk> agonism versus antagonism, we've placed our bets and we like the data we got with the CIP agonism.

Anat Ashkenazi: So it's across our supply chain. Thanks. Next caller, Paul.

So it's across our supply chain.

Dan: Calgary semi of.

Dan: Of course, adding more.

Joe Fletcher: Thanks. Next caller, Paul.

Dan: The agonism on different pathways on top of <unk> is a good idea. That's what we have <unk> appetite is a dual agonist.

Operator: Thank you. The next question is coming from Mohit Bansal from Wells Fargo. Mohit, your line is live.

Dan: Cary sentiment makes sense and then Youll note that.

Dan: We've advanced our ammo an agonist in phase II.

Mohit Bansal: Great, thank you very much for taking my question and congrats on the progress. I have a question regarding the pricing. So if you look at the script trend, it seems like there was a little bit of an adverse relationship in the pricing versus fourth quarter. Can you comment on that? And how should we think about the cadence of price volume over the quarters for the year? Thank you. Thanks, Mohit. You didn't say it, but I assume you're talking about Manjaro and ZepBounce.

Dan: There is appetite already has the dual agonist to Red X, which is already a triple agonist theres, probably more we could do here at Lilly.

Dan: Think across our portfolio in phase, one and phase II, we have nine assets that are marked for diabetes or obesity many of them could lead to.

Dan: Additive weight loss on top of established mechanisms plus two more phase III of course, so we have a strong portfolio here I think tours appetite still has unsurpassed efficacy at a weight loss.

Joe Fletcher: Thanks, Mohit. You didn't say it, but I assume you're talking about MOUNJARO and ZEPBOUND. So I'll hand over to Patrik to make some commentary on that price.

Dan: But we're preparing for our next generation assets as well.

Speaker Change: Thanks, Scott Dan.

Mohit Bansal: I'll hand over to Patrik to make some commentary on that price. Thank you very much, Mohit. When you look at the pricing for Monjaro, I think it's important to take into account that in our Q4 earnings, we announced a one-time adjustment for Monjaro in Q4 that was quite significant.

I'll hand over to Patrik to make some commentary on that price.

Speaker Change: Our next question.

Speaker Change: The next question will be from Terence Flynn from Morgan Stanley. Your line is live.

Patrik Jonsson: Thank you very much, Mohit. When you look at the pricing of MOUNJARO, I think it's important to take into account that in the Q4 earnings, we announced a one-time adjustment for MOUNJARO in Q4 that was quite significant.

Terence Flynn: Great. Congrats on all the progress just was wondering if you can tell us if the IQ via prescription data is an accurate representation of tours appetite volumes or if its been underrepresented at all given Lilly direct and what you know about how much is flowing through that channel and if it is underrepresented can you help quantify any delta for us.

Patrik Jonsson: So it was a one-time adjustment in the days of Q4. When we look forward to the first half of 2024, it's important to have in mind that we also terminated the $25 saving card on 6/30/2023. But patients that were or are grandfathered until 6/30/2024, so there will probably be some benefit during the first half of 2024 for MOUNJARO. But from the second half of this year, we should expect to see typical pricing headwinds for MOUNJARO as well.

Speaker Change: Thank you.

Speaker Change: Thanks for the question Terence I'll hand to Patrick for commentary on <unk> direct well. Thank you very much tenants.

Patrick: When calculated I ranked I think we're very pleased with the start and that when we look at the utilization by consumers, it's gaining traction by weeks here.

Speaker Change: If we look at the Trs state up to I think a lot of a safe bound.

Patrick: Relatively low volume that goes through linear dynamic slightly high in terms of <unk>.

Patrick: It's our understanding that what goes through really a direct is not to buy a full of captured by IQ via Thank you behalf methodology in place to estimate what goes through late I've asked us with.

Operator: Thank you. Next question, Paul. Thanks. The next question is coming from Umer Raffat from Evercore. Umer, your line is live.

Joe Fletcher: Thank you. Next question, Paul.

Operator: Thanks. The next question is coming from Umer Raffat from Evercore. Umer, your line is live.

Umer Raffat: Hi guys, thanks for taking my question. I wanted to focus a quick second on Part D reimbursement dynamics, if I may. And my question is, will TIRZEPATIDE be considered differently than a quote-unquote weight-loss drug to secure Part D reimbursement? And the new indications like sleep apnea will they be considered an applicable drug and not get lumped up as a broad weight-loss drug? Thank you.

Speaker Change: Thank you Patrick our next question.

Cash: The next question will be from a cash tomorrow from Jefferies. Your line is live.

Cash: Hey, thanks, so much so your team presented data on a monotherapy <unk> agonists at Ada last year, but it looks like you are moving the analytical phase two can you talk about why and when might be preferred versus debt as the maintenance regimen for obesity and how your product could differ versus the others. When it comes to half life and preferential agonism versus calcitonin amylin.

Umar Rafat: Thank you, Thanks Umar, I'll go to Patrik for that question. Thank you very much, Umer. I think with the announcement made by the CMS early April to reimburse co-morbidities for obesity based upon the select trial, we're also confident that with the new data that we presented just weeks ago in terms of obstructive sleep apnea, that that's going to be reimbursed in Medicare Part E. And we expect similarly for other co-morbidities and the readout of HF-PF assuming that's positive and approved, and later on with the mobility mortality outcome study.

Thank you, Thanks Umar, I'll go to Patrik for that question.

Thank you,

Joe Fletcher: Thanks Umer. I'll go to Patrik for that question.

Speaker Change: Thank you Akash I'll hand to Dan for a commentary on our ammo in it.

Patrik Jonsson: Thank you very much, Umer. I think with the announcement made by the CMS early April to reimburse comorbidities for obesity based upon the select trial, we're also confident that with the new data that we presented just weeks ago in terms of obstructive sleep apnea, that that's going to be reimbursed in Medicare Part D. And we expect similarly for other comorbidities and the readout of HFpEF assuming that's positive and approved, and later on with the mobility mortality outcome study.

Dan: Yes, there are a lot of good questions in there. Thanks. Thanks for following sides. So closely on the Gi P. The long acting molecule I think.

Dan: Primarily in that experiment, we were excited to show the benefits of isolated CIP agonism, just to answer some mechanism action questions around tours appetite, but.

Dan: As you point out there is potential for that molecule.

Dan: For the.

Dan: The other other indications or as a monotherapy or combination with other.

Umar Rafat: Still, our true north is really to get the true of the Treat and Reduce Obesity Act cost. And we strongly believe that's not a matter of if, but when. We don't see it likely to pass in 2024, but there is still a small likelihood that that's going to happen.

Dan: Mechanisms.

Dan: But of course since Theres appetite already includes CIP agonism.

Dan: Also excited to explore other mechanisms, so that's where the lira, which is one of the.

Dan: Different mechanisms as I said a moment ago.

Dan: There were exploring the long acting amylin.

Dan: Forward to phase III.

Patrik Jonsson: Thanks, Patrick. Next question, Paul. Thank you. The next question is coming from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Joe Fletcher: Thanks, Patrick. Next question, Paul.

Dan: That has potential perhaps as a combination therapy, perhaps as a maintenance therapy, perhaps as a monotherapy theres a lot to explore its still very early as it is for all of our mechanism. So we'll keep investing in as we have data to share with you we'll do that.

Operator: Thank you. The next question is coming from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Seamus Fernandez: Great, thanks for the question. So really just wanted to ask, Dan, as you have assessed the Phase II SURMOUNT data in NASH, just interested to know how you are thinking about those data and the opportunity for TIRZEPATIDE in that setting, or perhaps if RETATRUTIDE remains the right target molecule to move forward there? We've had a lot of speculation around some of the comments from the last quarter, and just trying to firm that up and also when we're likely to see those data, I believe they're expected at EASL, but if that is possible to confirm. Thanks so much.

Speaker Change: Thanks, Dan.

Paul: Paul next question.

Dan: The next question will be from Trung Nguyen from UBS. Your line is nice.

Trung Huynh: Yeah, Hi, Thanks for my question just back on the CMS recently broadening its coverage would go veith assessing heart conditions. I. Appreciate you mentioned that <unk> is the main goal, but do you expect that bound to get added to CMS in a similar way as with Obi.

Dan Skovronsky: Dan? Yeah. Thanks, Seamus. I'll start with the last part there. Yeah, the abstract was accepted and will be presented at EASL in early June. So that'll be an opportunity to see the full NASH package from that Phase 2 trial. Like we said on the last call, really exciting data. We shared some of the top line. I think trisepatide can have a profound effect on this disease.

Joe Fletcher: Dan?

Trung Huynh: And yes.

Daniel M. Skovronsky: Yes. Thanks, Seamus. I'll start with the last part there. Yes, the abstract was accepted and will be presented at EASL in early June. So that'll be an opportunity to see the full NASH package from that Phase II trial. Like we said on the last call, really exciting data. We shared some of the top line. I think TIRZEPATIDE can have a profound effect on this disease. It's a Phase II trial, and the next steps here are to discuss with the FDA what the best path forward could be for TIRZEPATIDE. You're pointing out, though, that we have another choice in RETATRUTIDE, which, based on biomarker data from earlier studies, could also have a profound effect on this disease. That molecule has the addition of glucagon, which is likely to have additional benefits in the liver. So important opportunities ahead and good to have options as we go into these discussions with regulators.

Trung Huynh: When when could this happen could this be after the heart failure data in <unk> or do we have to wait for the cbot data.

Speaker Change: Thanks very much.

Speaker Change: Thanks Troy.

Speaker Change: Patrick response, Thanks, ROM and know based upon what CMS stated early April we actually expect to get the obstructive sleep apnea for Sip on covered by year by CMS and Medicare at the time of launch and the next one then would be assuming a positive readout on approval and the third one would be the MMO.

Dan Skovronsky: It's a Phase 2 trial, and the next steps here are to discuss with the FDA what the best path forward could be for trisepatide. You're pointing out, though, that we have another choice in ratatrutide, which, based on biomarker data from earlier studies, could also have a profound effect on this disease. That molecule has the addition of glucagon, which is likely to have additional benefits in the

Speaker Change: <unk> indication and that's the sequence of the of our plans assuming everything goes according to plan and we get the approval.

Daniel M. Skovronsky: You're pointing out, though, that we have another choice in RETATRUTIDE, which, based on biomarker data from earlier studies, could also have a profound effect on this disease. That molecule has the addition of glucagon, which is likely to have additional benefits in the liver. So important opportunities ahead and good to have options as we go into these discussions with regulators.

Speaker Change: Thanks, Patrick.

Speaker Change: Next question.

Speaker Change: The next question will be from Geoff Meacham from Bank of America, Jeff Your line is live.

Geoff Meacham: Good morning, guys. Thanks for the question.

Geoff Meacham: We have been asked this before I'm sure, but can you just review the rationale and utilizing the quick turn just for outside the U S markets like Europe I wasn't sure why this couldnt apply to the U S market and if this also could be a means to to relieve capacity looking forward. Thank you.

Dan Skovronsky: Important opportunities ahead and good to have options as we go into these discussions with regulators. I think for MASH, like other obesity-related or metabolic-related diseases, Lilly has a pretty broad portfolio and will just continue to push the science to make the best possible medicines. [inaudible] Thanks, Dan. Paul, next question. The next question will be from Tim Anderson from Wolfe Research. Tim, your line is live.

Important opportunities ahead and good to have options as we go into these discussions with regulators.

I think for MASH, like other obesity-related or metabolic-related diseases, Lilly has a pretty broad portfolio and will just continue to push the science to make the best possible medicines for patients. [inaudible] Thanks, Dan. Paul, next question. The next question will be from Tim Anderson from Wolfe Research. Tim, your line is live.

Speaker Change: Thanks, Jeff for the question, Paul Dave and Wan Yeah sure.

Thanks, Dan. Paul, next question. The next question will be from Tim Anderson from Wolfe Research. Tim, your line is live.

Joe Fletcher: Thanks, Dan. Paul, next question.

Operator: The next question will be from Tim Anderson from Wolfe Research. Tim, your line is live.

Speaker Change: Neely I can add to this as we've said on several calls now our goal is to pursue all of the above but basically as it relates to supply options, recognizing the tremendous demand and unmet need and the.

Tim Anderson: Thank you. You showed a slide, ZEPBOUND has NBRx share market of 57% end of Q1, that makes it pretty clear that the strongest drug wins. So on that topic, just your latest thinking on upcoming competitor readouts and how they'll stack up to ZEPBOUND on metrics of weight loss and blood sugar, so specifically CagriSema from Novo and Amgen's 133. I know it's just a best guess, but it's what we get asked to do. Thanks, Tim. Okay, I'll maybe hand it to Dan for some comments. Yeah, sure, Tim.

Timothy Anderson: Thank you. You showed a slide, ZEPBOUND has NBRx share market of 57% end of Q1, that makes it pretty clear that the strongest drug wins. So on that topic, just your latest thinking on upcoming competitor readouts and how they'll stack up to ZEPBOUND on metrics of weight loss and blood sugar, so specifically CagriSema from Novo and Amgen's 133. I know it's just a best guess, but it's what we get asked to do.

Speaker Change: Constraints that exist in scaling our supply chain. So quick then uses.

Speaker Change: <unk> assets. So there was less time lag.

Speaker Change: We.

Geoff Meacham: Should this.

Neely: First in the U K and now in Europe, as a way to meet the needs of those patients, but we haven't rolled it out in other jurisdictions and so we'll continue to look at every option we can too.

Geoff Meacham: <unk>.

Geoff Meacham: The needs of patients.

Geoff Meacham: With obesity and overweight as well as with diabetes.

Thanks, Tim. Okay, I'll maybe hand to Dan for some comments. Yeah, sure, Tim.

Joe Fletcher: Thanks, Tim. Okay, I'll maybe hand to Dan for some comments.

Speaker Change: Thanks, Dave Paul next question next.

Geoff Meacham: The next question is from Kerry Holford from Bahrenburg carrier Your line is live.

Daniel M. Skovronsky: Yes, sure, Tim. It's probably more your job than ours to speculate on competitor readouts. But I'll take a stab at it since you asked. I think on AMG 133, we've just seen a small amount of data. So, probably anything is possible, and like you will be interested to see their results. Of course, there is arguments that can be heard about GIP agonism versus antagonism. We've placed our bets, and we like the data we got with GIP agonism. On CagriSema, of course, adding more agonism on different pathways on top of GLP-1 is a good idea. That's what we have with TIRZEPATIDE. It's a dual agonist. So CagriSema makes sense. And you'll note that we've advanced our amylin agonist into Phase II.

Dan Skovronsky: It's probably more your job than ours to speculate on competitor readouts. But I'll take a stab at it since, yes, I think on AMG 133, we've just seen a small amount of data. So, pretty much anything is possible.

Kerry Holford: Oh hi.

Kerry Holford: Okay. Thank you.

Kerry Holford: Yes.

Kerry Holford: Okay.

Kerry Holford: Yeah.

Kerry Holford: Wow.

Kerry Holford: Taking into phase three.

Kerry Holford: Can you confirm that you've published.

Dan Skovronsky: And you will be interested to see their results. You know, of course, there are arguments that can be heard about GIP agonism versus antagonism. We've placed our bets, and we like the data we got with GIP agonism. On Cagri-Sema, you know, of course, adding more agonism on different pathways on top of GLP-1 is a good idea. That's what we have with Terzapotai. It's a dual agonist. So Cagri-Sema makes sense.

Speaker Change: Thanks, Tom.

Speaker Change: If I'm correct.

Speaker Change: Mike you will see that pop.

Speaker Change: And can you confirm what case and frequency of administration you are looking at.

Speaker Change: For that phase III study.

Speaker Change: And I guess, what you had paid to the physicians said that wrong.

Speaker Change: Would be interested to hear how you expect.

Speaker Change: Talk to the differential.

Speaker Change: So it's a complex connect sensor right.

Dan Skovronsky: And you'll note that we've advanced our amylin agonist into phase two. Terzapatide is already a dual agonist, and reticulotide is already a triple agonist.

And you'll note that we've advanced our amylin agonist into phase two.

Speaker Change: Thanks.

Speaker Change: Thanks, Gary So a good multipart question, but on LP Little a happy to talk about what produce around so Dan you want to comment on this yes. Thanks Kerry for the good questions here, you're right we haven't yet.

TIRZEPATIDE is already a dual agonist. RETATRUTIDE is already a triple agonist. There's probably more we could do here at Lilly. I think across our portfolio in Phase I and Phase II, we have 9 assets that are marked for diabetes or obesity, many of them could lead to additive weight loss on top of established mechanisms, plus 2 more in Phase III, of course. We have a strong portfolio here. I think TIRZEPATIDE still has unsurpassed efficacy for weight loss, but we're preparing for our next generation assets as well. Thanks again.

Dan Skovronsky: There's probably more we could do here at Lilly. I think across our portfolio in Phase 1 and Phase 2, we have nine assets that are marked for diabetes or obesity, and many of them could lead to additive weight loss on top of established mechanisms, plus two more in Phase 3, of course.

Dan: The phase II data, but I think we just recently were able to publish the phase one data.

Dan: That was really exciting and well received I think one of the things that people noted in our phase one data was a very long durability of action in the very deep reduction in helping delay.

Dan Skovronsky: We have a strong portfolio here. I think Terzapatide still has unsurpassed efficacy for weight loss, but we're preparing for our next generation assets as well. Thanks again.

Dan: Following a single dose of.

Dan: Let the district.

Dan: We now have.

Dan: Of course, our phase II data in hand and.

Dan: Use that to design and to begin the phase III trial, I think we havent quite to disclose to dose or frequency, yet, but I'm sure.

Joe Fletcher: Thanks again, Dan. Paul, next question.

Dan Skovronsky: All next questions. The next question will be from Terence Flynn from Morgan Stanley. Terence, your line is live.

All next questions.

Operator: The next question will be from Terence Flynn from Morgan Stanley. Terence, your line is live.

Dan: That will happen in time.

Dan: You asked about differentiation I think there's probably a couple of different potentials for differentiation here.

Terence Flynn: Great, congrats on all the progress. I just was wondering if you can tell us if the IQVIA prescription data is an accurate representation of TIRZEPATIDE volumes, or if it's been underrepresented at all given LillyDirect and what you know about how much is flowing through that channel, and if it is underrepresented, can you help quantify any delta for us? Thank you. Thanks for the question, Terence. I'll hand it to Patrik for commentary on IQVIA and Lilly Direct.

Dan: Versus a shorter acting ASO.

Dan: SA RNA that are both phase III studies, maybe first is.

Dan: The depth of clearance of LP Little a we don't know how much you have to reduce LP delay.

Dan: It leads to benefits in cardiovascular outcomes and whether there is.

Joe Fletcher: Thanks for the question, Terence. I'll hand it to Patrik for commentary on IQVIA and LillyDirect.

Dan: A threshold a factor or a floor to this so the depth of.

Dan: Clearances won the second.

Patrik Jonsson: Thanks very much, Terence. When it comes to LillyDirect, I think we are very pleased with the start, and when we look at the utilization by consumers, it's gaining traction by weeks here. If we look at the TRx data of Q1, particularly for ZEPBOUND, it's relatively low volume that goes through LillyDirect, slightly higher in terms of NBRx. It's our understanding that what goes through LillyDirect is not by default captured by IQVIA. But IQVIA has methodology in place to estimate what goes through LillyDirect as well. Thank you, Patrik. All next questions. The next question will be from Akash Tewari from Geoffrey's. Akash, your line is live. Hey, thanks so much.

Dan: You asked about could be frequency of administration or durability of action.

Dan: Those two being closely linked and the third of course is population that's been studied it.

Dan: I noted, we're studying secondary as well as primary prevention here. So I think we have a good package with multiple opportunities for differentiation and eager to test the hypothesis here. This phase III study.

Speaker Change: Thanks for the question Kerry Paul next question.

Patrik Jonsson: It's our understanding that what goes through Lilly Direct is not, by default, captured by IQVIA, but IQVIA has methodology in place to estimate what goes through Lilly Direct as well. Thank you, Patrik. All next questions. The next question will be from Akash Tewari from Geoffrey's. Akash, your line is live. Hey, thanks so much.

Speaker Change: The next question will be from Steve Scala from TD Count Steve Your line of life.

Steve Scala: Thank you very much given that based on all available metrics surpassed cbot interim likely already has passed can you confirm that the only way the trial would have stopped us if there were either a survival benefit or futility and not simply non inferiority and anything you can.

Thank you, Patrik. Paul, next question. The next question will be from Akash Tewari from Jefferies. Akash, your line is live. Hey, thanks so much.

Thank you, Patrik. Paul, next question. The next question will be from Akash Tewari from Jefferies. Akash, your line is live.

Joe Fletcher: Thank you, Patrik. Paul, next question.

Operator: The next question will be from Akash Tewari from Jefferies. Akash, your line is live.

Hey, thanks so much. So your team presented data on a monotherapy GIP agonist at ADA last year, but it looks like you are moving the amylin into Phase II. Can you talk about why amylin might be preferred versus GIP as a maintenance regimen for obesity? And how your product could differ versus others when it comes to half-life and preferential agonism versus calcitonin and amylin? Thanks. Thank you, Akash. I'll hand it to Dan for commentary on our amylin.

Akash Tewari: Hey, thanks so much. So your team presented data on a monotherapy GIP agonist at ADA last year, but it looks like you are moving the amylin into Phase II. Can you talk about why amylin might be preferred versus GIP as a maintenance regimen for obesity? And how your product could differ versus others when it comes to half-life and preferential agonism versus calcitonin and amylin? Thanks.

Akash Tewari: So your team presented data on a monotherapy GIF agonist at ADA last year, but it looks like you are moving the amylin into phase two. Can you talk about why amylin might be preferred versus GIF as a maintenance regimen for obesity and how your product could differ versus others when it comes to half-life and preferential agonism versus calcitonin and amylin? Thanks. Thank you, Akash. I'll hand it to Dan for commentary on our amylin.

Steve Scala: Say regarding your confidence in eventually hitting superiority based on what you know so far thank you.

Dan: Thanks, Steve Dan you want to take the question on surpassed Cbot sure.

Dan: Steve as you know, we do our best not to comment on interim analyses, although many of our different trials can incorporate interim analyses, but when we do talk about them at risks unintentional unwinding of results.

Joe Fletcher: Thank you, Akash. I'll hand to Dan for commentary on our amylin.

Dan Skovronsky: Yes, there are a lot of good questions in there. Thanks for following the science so closely. So on GIP, the long-acting molecule, I think, primarily in that experiment, we were excited to show the benefits of isolated GIP agonism just to answer some mechanism of action questions around TIRZEPATIDE. But as you point out, there's potential for that molecule for other indications or as a monotherapy or in combination with other mechanisms. But of course, since TIRZEPATIDE already includes GIP agonism, we're also excited to explore other mechanisms.

Daniel M. Skovronsky: Yes, there are a lot of good questions in there. Thanks for following the science so closely. So on GIP, the long-acting molecule, I think, primarily in that experiment, we were excited to show the benefits of isolated GIP agonism just to answer some mechanism of action questions around TIRZEPATIDE. But as you point out, there's potential for that molecule for other indications or as a monotherapy or in combination with other mechanisms.

Steve Scala: For that reason, we prefer not to do that you are right that the primary analysis of the study and the design surround non inferiority versus where we are ready to go to be a very good drug that reduces cardiovascular risk and that is true.

Steve Scala: So it's.

Steve Scala: But design does not inferiority trial of course, when the final data come we would.

Speaker Change: I'd be delighted to see even superiority.

Speaker Change: You asked about our confidence our confidence continues to increase for this readout in fact.

But of course, since TIRZEPATIDE already includes GIP agonism, we're also excited to explore other mechanisms. So that's where the [Inaudible], which is one of 9 different mechanisms, as I said a moment ago, that we're exploring the long-acting amylin move forward to Phase II. That has potential, perhaps as a combination therapy, perhaps as a maintenance therapy, perhaps as a monotherapy. There's a lot to explore. It's still very early, as it is for all of our mechanisms, so we'll keep investing and as we have data to share, we'll do that.

Speaker Change: <unk> disclosed in the prepared remarks today.

Speaker Change: We got additional data here, even from the OSA study that should make us feel more confident.

Dan Skovronsky: So that's where the LARA, which is one of nine different mechanisms, as I said a moment ago, that we're exploring the long-acting amylin move forward to phase two. That has potential, perhaps as a combination therapy, perhaps as a maintenance therapy, perhaps as a monotherapy. There's a lot to explore.

Speaker Change: Not just the benefit of sleep apnea, which itself could lead to cardiovascular benefits, but actually the weight loss and.

Speaker Change: I think there are some concerns about weight loss in different populations and different trials.

Steve Scala: <unk> females et cetera. So.

Steve Scala: Some of that was discharge share.

Dan Skovronsky: It's still very early, as it is for all of our mechanisms, so we'll keep investing. And as we have data to share, we'll do that. Thanks, Dan. Paul, next question. The next question will be from Trung Huynh from UBS. Trung, your line is live.

It's still very early, as it is for all of our mechanisms, so we'll keep investing. And as we have data to share, we'll do that.

Steve Scala: So remain excited and look forward to getting that data and studies.

Speaker Change: Thanks, Dan Paul next question. The next question will be from <unk> <unk> from BMO capital markets. Kevin Your line is flat.

Thanks, Dan. Paul, next question. The next question will be from Trung Huynh from UBS. Trung, your line is live.

Joe Fletcher: Thanks, Dan. Paul, next question.

Operator: The next question will be from Trung Huynh from UBS. Trung, your line is live.

Kevin: Thank you so much for taking my question I wanted to touch on the nano mab with the AD com approaching can you discuss higher comp if youre confident this change in the asset and maybe any specific point will hope will be addressed during the discussion with these outside expert. Thank you so much.

Trung Huynh: Yes, hi, thanks for my question. Just back on CMS recently broadening its coverage for WEGOVY for certain heart conditions. I appreciate you mentioned that TROA is the main goal. But do you expect ZEPBOUND to get added to CMS in a similar way as WEGOVY? And when could this happen? Could this be after the heart failure data in 3Q? Or do we have to wait for the CVOT data? Thanks very much.

Speaker Change: Thanks, Kevin and discuss the Don and AD Com, yes. Thanks, so much for the question and we are incredibly confident and minimize potential.

Speaker Change: It offers very meaningful benefits to people.

Trung Huynh: Could this be after the heart failure data in 3Q? Or do we have to wait for the CVOT data? Thanks very much. Thanks, Tram; I'll let the others know.

Could this be after the heart failure data in 3Q? Or do we have to wait for the CVOT data? Thanks very much.

Speaker Change: <unk> and just the overall approve ability of the package. We do look forward to seeing those questions. We havent received those yet I think that's what we'll anticipate really is discussions throughout the safety and efficacy in banana and.

Joe Fletcher: Thanks, Trung; I'll let Patrik respond.

Patrik Jonsson: Thanks, Trung. Now, based upon what CMS stated early April, we actually expect to get obstructive sleep apnea for ZEPBOUND covered by CMS and Medicare at the time of launch. And the next one then would be HFpEF, assuming a positive readout and approval. And the third one would be the MMO indication. That's the sequence of our plans, assuming everything goes according to plan and we get the approval for both.

Speaker Change: The safety and efficacy profile remained very consistent with what we published and presented.

Speaker Change: So nothing new there we do expect Theres a couple of unique aspects to our trial that we anticipate they'll want to discuss one is around limited duration dosing. We think this is incredibly important feature of bananas at the chance to stop dosing when you've cleared the plaques and jinan about clear some robustly and rapidly. So we think that allows for this.

Operator: That's the sequence of our plans, assuming everything goes according to plan and we get the approval for both. Thanks, Patrick. Paul, next question. The next question will be from Geoff Meacham from Bank of America. Geoff, your line is open.

That's the sequence of our plans, assuming everything goes according to plan and we get the approval for both.

Thanks, Patrick. Paul, next question. The next question will be from Geoff Meacham from Bank of America. Geoff, your line is open.

Joe Fletcher: Thanks, Patrick. Paul, next question.

Operator: The next question will be from Geoff Meacham from Bank of America. Geoff, your line is live.

Speaker Change: Limited duration dosing approach. So we really do look forward to getting into that data and having the advisers see that and respond to it. Another unique aspect is assessing talent baseline. This is an important for the field. So that we understand the prognostic factor of talent that was able to be firmed, but what we saw in the trial all patients benefit regardless of channel level.

Geoff Meacham: Morning, guys. Thanks for the question. You guys have been asked on this before, I'm sure, but can you just review the rationale in utilizing KWIKPEN just for outside the U.S. markets like Europe? I wasn't sure why this couldn't apply to the U.S. market and if this also could be a means to relieve capacity looking forward. Thank you. Paul, Dave, want to weigh in? Yeah, sure. And Ilya, I can add to this.

Geoff Meacham: I wasn't sure, you know, why this couldn't apply to the U.S. market and if this also could be a means to relieve capacity looking forward. Thank you. Paul, Dave, want to weigh in? Yeah, sure. And Ilya, I can add to this.

Speaker Change: Those early in the disease doing even better it's one of the reasons that we remain enthusiastic about trailblazers tree and wealthy and had mentioned that in his remarks I think <unk>.

Thanks, Geoff, for the question. Paul--Dave, you want to weigh in? Yeah, sure. And Ilya, I can add to this.

Joe Fletcher: Thanks, Geoff, for the question. Paul--Dave, you want to weigh in?

Speaker Change: <unk> and <unk>.

Yes. Sure. And Ilya can add to this. As we think we've said on several calls now, our goal is to pursue all of the above, basically as it relates to supply options, recognizing the tremendous demand and unmet need and the constraints that exist in scaling the supply chain. So, KWIKPEN uses existing assets, so there's less time lag. We should this--first in the U.K. and now in Europe as a way to meet the needs of those patients. But we haven't ruled it out in other jurisdictions. And so we'll continue to look at every option we can to meet the needs of patients with obesity and overweight as well as with diabetes. Thanks, Dave. All next questions. The next question is from Kerry Holford from Barenburg. Kerry, your line is open.

David Ricks: Yes. Sure. And Ilya can add to this. As we think we've said on several calls now, our goal is to pursue all of the above, basically as it relates to supply options, recognizing the tremendous demand and unmet need and the constraints that exist in scaling the supply chain. So, KWIKPEN uses existing assets, so there's less time lag. We should this--first in the U.K. and now in Europe as a way to meet the needs of those patients. But we haven't ruled it out in other jurisdictions. And so we'll continue to look at every option we can to meet the needs of patients with obesity and overweight as well as with diabetes.

Speaker Change: And even more enthusiastic about the opportunity to intervene earlier based on what we saw in that early population of people with low.

Dave Ricks: As we said on several calls now, our goal is to pursue all of the above, basically as it relates to supply options, recognizing the tremendous demand and unmet need and the constraints that exist in scaling the supply chain. So, QuickBend uses existing assets, so there's less time lag. We should just...

Speaker Change: And those that had no tao with such strong biomarker results that you'd probably remember the Ada that patients in the earliest part of our study had a 60% slowing and we believe that could be even stronger as you get into.

Speaker Change: The earlier patients that our preclinical, but maybe just one more market in the meantime, though this is not time loss will continue to make sure the health care system is ready.

Dave Ricks: The first in the UK and now in Europe as a way to meet the needs of those patients, but we haven't ruled it out in other jurisdictions, and so we'll continue to look at every option we can to meet the needs of patients. Thanks, Dave. All next questions. The next question is from Kerry Holford from Barenburg. Kerry, your line is open.

Speaker Change: Sure that we launch into an even stronger market potential approval. So we're making the most of this time and look forward to that common stance in mid 'twenty four it answering any questions that they have.

Speaker Change: Thank you Anne Paul next question.

Speaker Change: The next question will be from David Risinger from Leerink partners, David Your line is live.

Thanks, Dave. Paul, next question. The next question is from Kerry Holford from Barenburg. Kerry, your line is open.

Joe Fletcher: Thanks, Dave. Paul, next question.

Operator: The next question is from Kerry Holford from Berenberg. Kerry, your line is live.

David R. Risinger: Thanks, very much and let me add my congrats.

Kerry Holford: Hi. I'm going to take a different topic here. Looking at LP(a), your new product, you've now said that you're taking into Phase III. Can you confirm whether you've published any Phase II data? I haven't found any. So if I'm correct there, when might we see that published? And can you confirm what dose and frequency of administration you're looking at for that Phase III study? And I guess as you appear to be positioned third in that race, we'll be interested to hear how you expect your drug to be differentiated versus the competitor as that's already in Phase III. Thank you. Thanks, Kerry. It's a good multi-part question, but on LP, I'm happy to talk about Lepidoceran.

David R. Risinger: Progress in the guidance raise so.

David R. Risinger: My question is on orphan <unk> Novo Nordisk has raised some concerns about the scale ability of ore for glib brand manufacturing given its complexity.

David R. Risinger: Havent spoken to novo directly but someone told me that they mentioned there are 35 steps in the process I don't know if thats true, but could you. Please discuss how Lilly is building out its manufacturing capacity and whether the company is.

Kerry Holford: And can you confirm what dose and frequency of administration you're looking at for that phase three study? And I guess as you appear to be positioned third in that race, we'll be interested to hear how you expect your drug to be differentiated versus the compacto acids already in phase 3. Thank you. Thanks, Kerry. It's a good multi-part question, but on LP, I'm happy to talk about Lepidoceran.

David R. Risinger: Expects to be able to meet global demand in the western World After launch in 2026 or whether we the investment community should expect supply constrained.

Joe Fletcher: Thanks, Kerry. So a good multi-part question, but on LP(a), happy to talk about LEPODISIRAN. So, Dan, you want to comment on this?

David R. Risinger: And should be guarded about how we try to model or for glib brands ramp after launch. Thank you.

Dan Skovronsky: So, Dan, you want to comment on this? Yeah, thanks, Kerry, for the good questions here. You're right.

So, Dan, you want to comment on this?

Speaker Change: Thanks, Dave ill handover to our Dave Ricks here, Okay, great good to hear from you.

Yes, thanks, Kerry, for the good questions here. You're right. We haven't yet published the Phase II data. I think we just recently were able to publish the Phase I data, and that was really exciting and well received. I think one of the things that people noted in our Phase I data was a very long durability of action and a very deep reduction in LP(a) levels following a single dose of LEPODISIRAN. We now have, of course, Phase II data in hand, and use that to design and begin the Phase III trial. I think we haven't quite disclosed a dose or frequency yet, but I'm sure that will happen in time. You asked about differentiation

Daniel M. Skovronsky: Yes, thanks, Kerry, for the good questions here. You're right. We haven't yet published the Phase II data. I think we just recently were able to publish the Phase I data, and that was really exciting and well received. I think one of the things that people noted in our Phase I data was a very long durability of action and a very deep reduction in LP(a) levels following a single dose of LEPODISIRAN. We now have, of course, Phase II data in hand, and use that to design and begin the Phase III trial.

Dave Ricks: First of all it is true that our forbid problem is a complicated large small molecule or large molecule. If you were and there are many steps in the process you can read about them in our patent filings I think.

Dan Skovronsky: We haven't yet published the phase two data. I think we just recently were able to publish the phase one data, and that was really exciting and well received.

Dave Ricks: But lilly maybe unlike other companies we've made small molecules for a long time.

Dan Skovronsky: I think one of the things that people noted in our phase one data was a very long durability of action and a very deep reduction in LP little levels following a single dose of Lepidoceran. We now have, of course, phase two data in hand, and we can use that to design and begin the phase three trial. I think we haven't quite disclosed a dose or frequency yet, but I'm sure that will happen in time. You asked about differentiation.

Speaker Change: We're capable of doing it we understand how to put them together and we've got a defined process to do it.

Speaker Change: Bob.

Speaker Change: So the API production well a long process.

Speaker Change: It may be complicated, but also to other small molecules is something we're super confident in and have our arms around.

Speaker Change: The fill finished processes really the big advance over using injectables because here, we're just tablet staffing our calvert capsule, making which are dry processes, we understand extremely well.

I think we haven't quite disclosed a dose or frequency yet, but I'm sure that will happen in time. You asked about differentiation. I think there's probably a couple of different potentials for differentiation here versus a shorter acting ASO and a siRNA that are both in Phase III studies. Maybe first is the depth of clearance of LP(a), we don't know how much you have to reduce LP(a) to lead to benefits and cardiovascular outcomes and whether there's a threshold effect or a floor to this. So the depth of clearance is one; the second, as you asked about, could be frequency of administration or durability of action, those 2 being closely linked. And the third, of course, is the population that's being studied. I noted we're studying secondary as well as primary prevention here. So I think we have a good package with multiple opportunities for differentiation and eager to test the LP(a) hypothesis here, in this Phase III study.

Speaker Change: I think the big gain here will be the fact that both for synthetic chemistry and.

Dan Skovronsky: I think there's probably a couple of different potentials for differentiation here versus a shorter acting ASO and a siRNA that are both in phase three studies. Maybe first is. The depth of clearance of alveoli; we don't know how much you have to reduce alveoli to lead to benefits and cardiovascular outcomes and whether there's a threshold effect or a floor to this. So the depth of clearance is one; the second, as you asked about, could be frequency of administration or durability of action, those two being closely linked.

Speaker Change: Capstone, making tablet, making there was already capacity on planet Earth that that is significant and so unlike the parental side, where we've been talking about injectables and new capacity needs to be built and which we're doing aggressively is it not commented on earlier.

Speaker Change: Here there is a lot of partners, we can access as well as our own substantial network.

Speaker Change: Dry product.

Speaker Change: Finish and API production so.

Speaker Change: Pretty confident here now we stick the landing on exact doses in quantities.

Speaker Change: In every instance, we're not guaranteeing that but I think the picture will be quite a bit different.

Speaker Change: Should prove.

Speaker Change: Proved to be safe and effective in the phase III studies.

Dan Skovronsky: And the third, of course, is the population that's being studied. I noted we're studying secondary as well as primary prevention here. So I think we have a good package with multiple opportunities for differentiation and eager to test the LP(a) hypothesis here, in this Phase III study. Thanks for the question, Kerry.

And the third, of course, is the population that's being studied. I noted we're studying secondary as well as primary prevention here. So I think we have a good package with multiple opportunities for differentiation and eager to test the LP(a) hypothesis here, in this Phase III study.

Speaker Change: Again Thats 25, so we can expect launch maybe a year after that.

Speaker Change: That's an important.

Speaker Change: Event and the <unk>.

Speaker Change: The anchor tenant class.

Speaker Change: Thanks, Dave and thanks, Dave Risinger for the question.

Speaker Change: Next question Paul.

Paul: The next question is coming from Louise Chen from Cantor.

Joe Fletcher: Thanks for the question, Kerry. Paul, next question.

Louise Chen: Luis Your line is less.

Operator: Paul, next question. The next question will be from Steve Scala from TD Count. Steve, your line is live.

Paul, next question.

Operator: The next question will be from Steve Scala from TD Cowen. Steve, your line is live.

Louise Chen: Thanks for taking my question I just wanted to ask you about your next wave of obesity drugs looks like you're about half a dozen of these in development and where do you think you can most differentiate yourself. Thank you.

Steve Scala: Thank you very much. Given that, based on all available metrics, the SURPASS-CVOT interim likely already has passed, can you confirm that the only way the trial would have stopped was if there were either a survival benefit or futility, and not simply non-inferiority? And anything you can say regarding your confidence and eventually hitting superiority based on what you know so far? Thank you.

Louise Chen: Thanks, Dan you want to comment on earlier phase of obesity, yes. Thanks, Luis we're excited about the portfolio of earlier stage RBC molecules I think theres, a number of opportunities for improvement over even a excellent drug like <unk> appetite.

Louise Chen: We think about the quality of weight loss is one aspect. So for example.

Dan: Even on tours appetite, we see the ratio of bleeding to fat mass improve patients'.

Dan Skovronsky: Thank you, Thanks, Steve. Dan, you want to take a question on surpass CVOT? Sure.

Thank you,

Thanks, Steve. Dan, do you want to take the question on SURPASS-CVOT? Sure.

Joe Fletcher: Thanks, Steve. Dan, do you want to take the question on SURPASS-CVOT?

Louise Chen: Lose weight on these drugs could we make it improve even faster with the muscle stimulating agents like <unk> and.

Daniel M. Skovronsky: Sure. Thanks, Steve. As you know, we do our best not to comment on interim analyses, although many of our different trials can incorporate interim analyses. But when we do talk about the risks unintentional unblinding of results, for that reason, we prefer not to do that.

Dan Skovronsky: Thanks, Steve. As you know, we do our best not to comment on interim analyses, although many of our different trials can incorporate interim analyses. But when we do talk about them, it risks unintentional unblinding of results. And for that reason, we prefer not to do that.

Speaker Change: Maybe that's that's under investigation.

Louise Chen: <unk> is very well tolerated, but some people stop taking it because of Gi side effects could we have drugs that have fewer side effects, maybe that could be possible.

Paul: There is appetite is given as a once weekly injection most patients.

Paul: Find that to be acceptable, but probably with.

Dan Skovronsky: You're right that the primary analysis of the study and the design is around non-inferiority versus what we are ready to know to be a very good drug that reduces cardiovascular risk. And that's TRULICITY. So it's designed as a non-inferiority trial. Of course, when the final data come, we would be delighted to see even superiority. You asked about our confidence. Confidence continues to increase for this readout. In fact, as disclosed in the prepared remarks today, we got additional data here, even from the OSA study, that should make us feel more confident not just the benefit in sleep apnea, which itself could lead to cardiovascular benefits, but actually the weight loss. And I think there are some concerns about weight loss in different populations in different trials. And males, females, etc. So some of that has been discharged here. So remain excited and look forward to getting that data when the study's complete.

You're right that the primary analysis of the study and the design is around non-inferiority versus what we are ready to know to be a very good drug that reduces cardiovascular risk. And that's TRULICITY. So it's designed as a non-inferiority trial. Of course, when the final data come, we would be delighted to see even superiority.

Paul: The less frequent injections that could lower the burden on manufacturing and make it make it easier to use for patients. So that's another avenue of exploration.

Paul: There are some patients who don't achieve their desired levels of weight loss, even on a powerful drug that there's appetite and so.

Paul: That's another Avenue.

Paul: Finally across different indications and I spoke earlier of mash.

Paul: That are related to metabolic disease, there could be different activities that proved more or less beneficial for these other related.

You asked about our confidence. Confidence continues to increase for this readout. In fact, as disclosed in the prepared remarks today, we got additional data here, even from the OSA study, that should make us feel more confident not just the benefit in sleep apnea, which itself could lead to cardiovascular benefits, but actually the weight loss. And I think there are some concerns about weight loss in different populations in different trials. And males, females, etc. So some of that has been discharged here. So remain excited and look forward to getting that data when the study's complete.

Paul: Diseases.

Paul: No.

Paul: That's another avenue of differentiation I think we're just at the beginning of.

Paul: Hopefully what will be seen as.

Paul: Multi decade investment to treating abnormal metabolism and all that come with that.

Paul: Really.

Paul: Routed and pleased.

Paul: That really has what must be the strongest pipeline in this area in the industry.

Speaker Change: Thank you Dan Paul next question.

Paul: The next question is from Chris <unk> from Goldman Sachs. Chris Your line is live.

Evan Seigerman: So some of that has been discharged here. So remain excited and look forward to getting that data when it's released. Thanks, Dan. Paul, next question. The next question will be from Evan Seigerman from BMO Capital Markets. Evan, your line is live.

So some of that has been discharged here. So remain excited and look forward to getting that data when it's released.

Chris Schott: Okay. Thanks, Chris Paul next question.

Chris: Ups can you hear me.

Thanks, Dan. Paul, next question. The next question will be from Evan Seigerman from BMO Capital Markets. Evan, your line is live.

Joe Fletcher: Thanks, Dan. Paul, next question.

Chris: Oh, Yes sure go.

Chris: Go ahead. Thank you.

Operator: The next question will be from Evan Seigerman from BMO Capital Markets. Evan, your line is live.

Chris: Wanted to ask about the supply and dynamic.

Speaker Change: Demand and when those two might come closer together previously or not <unk> been quite specific in their vocabulary and saying that that was something that could possibly happen. In 2025 gave you were in front of a group that we hosted and I think you gave a little bit of a broader range. What's the latest that you would like to communicate based upon all the progress that you make.

Evan Seigerman: Hi all, thank you so much for taking my question. I wanted to touch on DONANEMAB with the AdCom approaching. Can you discuss how your--if your confidence has changed in the asset? And maybe any specific points that you would hope will be addressed during this discussion with these outside experts? Thank you so much.

Speaker Change: The acquisition of Wisconsin facility et cetera.

Speaker Change: About a potential timing for that supply demand dynamic to come closer together.

Speaker Change: Thanks, Chris.

Speaker Change: Yes.

Speaker Change: Yeah.

Anne E. White: Anne, you want to discuss Donna Adcombe? Yeah, thanks so much for the question. And we are incredibly confident in Dynamab's potential and the fact that it offers very meaningful benefits to people with early symptomatic Alzheimer's disease and just the overall approvability of the package. We do look forward to seeing those questions. We haven't received those yet.

Joe Fletcher: Thanks, Evan. Anne, you want to discuss DONANEMAB and AdCom?

Speaker Change: Let me start on that so.

Speaker Change: So I would say that as I said in my prepared remarks, we expect that the supply demand situation, we're being quite tight in the near term as well as the mid term and just to clarify it's not that we have a production issue our manufacturing facilities are progressing incredibly well and I'm incredibly proud of the work done by our and then Q colleague.

Anne E. White: Yes, thanks so much for the question. And we are incredibly confident in DONANEMAB's potential and the fact that it offers very meaningful benefits to people with early symptomatic Alzheimer's disease and just the overall approvability of the package. We do look forward to seeing those questions. We haven't received those yet. I think that what we'll anticipate really is discussions around the safety and efficacy of DONANEMAB. And the safety and efficacy profile remain very consistent with what we've published and presented. So nothing new there.

Speaker Change: Around the world literally we have sites working 24, seven we're doing construction overnight, we're making the right investments to ensure we're progressing rapidly as you've seen evidenced by the results as well as the raise we did for the year.

Anne E. White: I think that what we'll anticipate really is discussions around the safety and efficacy of Dynamab. And the safety and efficacy profile remain very consistent with what we've published and presented. So there's nothing new there.

Speaker Change: The demand is strong.

Speaker Change: But shouldnt be a surprise given the health benefits of these products provide to patients highly efficacious and safe medicine.

Anne E. White: We do expect there's a couple of unique aspects to our trial that we anticipate they'll want to discuss. One is around limited duration dosing. We think this is an incredibly important feature of DONANEMAB, the chance to stop dosing when you've cleared the plaques. And DONANEMAB clears them robustly and rapidly. So we think that allows for this limited duration dosing approach. So we really do look forward to getting into that data and having the advisors see that and respond to it. Another unique aspect is assessing tau at baseline.

We do expect there's a couple of unique aspects to our trial that we anticipate they'll want to discuss. One is around limited duration dosing. We think this is an incredibly important feature of DONANEMAB, the chance to stop dosing when you've cleared the plaques. And DONANEMAB clears them robustly and rapidly. So we think that allows for this limited duration dosing approach. So we really do look forward to getting into that data and having the advisors see that and respond to it.

Speaker Change: And I expect that this will continue through the year, even with a significant ramp that we had and we will add more supply.

Speaker Change: And across different presentations, both with the auto injector as well as the quite pan, but even with that I expect that the demand will be well outpaced supply through this year potentially next year, obviously, we will see what we're continuing to invest in rent as we go into next year, but it could be quite some time, we talked earlier about orphan lupron should we have.

Anne E. White: So we think that allows for this limited duration dosing approach. We really do look forward to getting into that data and having the advisors see that and respond to it. Another unique aspect is assessing tau at baseline.

Speaker Change: Positive phase III readout that provides another relief valve in terms of just offering a different presentation that Steve mentioned, which utilizes a different set.

Another unique aspect is assessing tau at baseline. This is important for the field that we understand the prognostic factor of tau, and that was able to be confirmed. But what we saw in the trial was all patients benefited, regardless of tau level, with those earlier in the disease doing even better. It's one of the reasons that we remain so enthusiastic about TRAILBLAZER-3. And while Dan didn't mention that in his remarks, I think we remain even more enthusiastic about the opportunity to intervene earlier based on what we saw in that early population, the people with low tau and those that had no tau with such strong biomarker results. And you probably remember the data that patients in that earliest part of our study had a 60% slowing. And we believe that could be even stronger to get into the earlier patients that are preclinical.

Anne E. White: This is important for the field so that we understand the prognostic factor of tau, and that was able to be confirmed. But what we saw in the trial was all patients benefited, regardless of tau level, with those earlier in the disease doing even better. It's one of the reasons that we remain so enthusiastic about tribolias for tree.

Speaker Change: Set of infrastructure within our manufacturing organization available capacity globally. So it will be in a state you are in a stepwise fashion will continue to update.

Speaker Change: Investors as we progressed through the year and coming years.

Speaker Change: Yes.

Paul: Thanks, Paul.

Speaker Change: Paul next question.

Paul: Next question will be from Carter Gould from Barclays Carter Your line is live.

Anne E. White: And while Dan didn't mention that in his remarks, I think we remain even more enthusiastic about the opportunity to intervene earlier based on what we saw in that early population, the people with low tau and those that had no tau with such strong biomarker results. And you probably remember the data that patients in that earliest part of our study had a 60% slowing. And we believe that could be even stronger to get into the earlier patients that are preclinical. But maybe just one more remark. In the meantime, though, this is not time lost.

And while Dan didn't mention that in his remarks, I think we remain even more enthusiastic about the opportunity to intervene earlier based on what we saw in that early population, the people with low tau and those that had no tau with such strong biomarker results. And you probably remember the data that patients in that earliest part of our study had a 60% slowing. And we believe that could be even stronger to get into the earlier patients that are preclinical.

Carter Gould: Thanks, Good morning, Congrats on all the progress I wanted to dive into <unk>.

Carter Gould: The phase II.

Carter Gould: Ada forthcoming and can you talk a bit around the importance of showing.

Carter Gould: Sig or clear dose response sponsor Cros, the composition of the weight loss drivers and maybe as well.

Carter Gould: The importance of not blunting, the overall weight loss as you contemplate a move to phase III potentially thank you.

But maybe just one more remark. In the meantime, though, this is not time lost. We'll continue to make sure that the healthcare system is ready. We're going to make sure that we launch into an even stronger market with potential approval. So we're making the most of this time and look forward to the outcome, as Dan said, in mid-'24 and answering any questions that they have. Thank you, Anne.

Speaker Change: Thanks Carter for the question Daniel coming out of the backroom App, yes. Thanks Carter. It's a good question <unk> is a very different mechanism of.

Anne E. White: We'll continue to make sure that the healthcare system is ready. We're going to make sure that we launch into an even stronger market with potential approval. So we're making the most of this time and look forward to the outcome, as Dan said, in mid-24 answering any questions that they have. Thank you, Anne.

Speaker Change: Weight loss versus <unk>.

Daniel: But one that we think could be important in combination with <unk>. So.

Speaker Change: <unk>.

Daniel: We think we'll likely have important effects on.

Speaker Change: Adipose tissue as well as muscle mass so our hope is to see increased.

Joe Fletcher: Thank you, Anne. Paul, next question.

Operator: Follow-up next question? The next question will be from David Risinger from Lyrinc Partners. David's your line.

Follow-up next question?

Operator: The next question will be from David Risinger from Leerink Partners. David your line is live.

Speaker Change: Muscle mass.

Speaker Change: Increased increase.

David R. Risinger: Thanks very much. And let me add my congrats on the progress and the guidance raise. So, my question is about ORFORGLIPRON. Novo Nordisk has raised some concerns about the scalability of ORFORGLIPRON manufacturing given its complexity. I haven't spoken to Novo directly, but someone told me that they mentioned there are 35 steps in the process. I don't know if that's true, but could you please discuss how Lilly is building out its manufacturing capacity and whether the company expects to be able to meet global demand in the Western world after launch in 2026? Or whether we, the investment community, should expect supply constraints and should be guarded about how we try to model ORFORGLIPRON's ramp after launch. Thank you. Thanks, Dave. I'll hand over to our Dave Ricks here.

David Risinger: Thanks very much. And let me add my congrats on the progress and the guidance raise. So, my question is about ORFORGLIPRON. Novo Nordisk has raised some concerns about the scalability of ORFORGLIPRON manufacturing given its complexity. I haven't spoken to Novo directly, but someone told me that they mentioned there are 35 steps in the process. I don't know if that's true, but could you please discuss how Lilly is building out its manufacturing capacity and whether the company expects to be able to meet global demand in the Western world after launch in 2026? Or whether we, the investment community, should expect supply constraints and should be guarded about how we try to model ORFORGLIPRON's ramp after launch. Thank you.

Speaker Change: Ratio I should say.

Speaker Change: Lean to fat mass.

Speaker Change: By combining <unk> with acreage at this present study its being evaluated doses monotherapy and combination with <unk>.

Speaker Change: At different doses, so we'll see if weight loss.

Speaker Change: The effects on fat tissue stack, and we'll see if the effects on lean body mass that were seeing in previous <unk> monotherapy studies.

Speaker Change: Work in combination with acreage and looking forward to seeing that data.

Speaker Change: Thanks, Dan Paul next question.

Paul: The next question is coming from <unk> <unk> from <unk> Securities creep by your line is live.

unknown: Hey, guys. Thank you so much for taking my question and congrats on all the progress.

Anonymous: I have a question if I can video pharma pipeline, you mentioned PMT to turn your oncology pipeline can you talk about how you see that advancing and given what you've seen so far where you see this being placed in the landscape in terms of market share.

Joe Fletcher: Thanks, Dave. I'll hand over to our Dave Ricks here.

Speaker Change: Thank you.

Dave Ricks: OK. Great, Dave, great to hear from you. I mean, first of all, it is true that ORFORGLIPRON is a complicated, large, small molecule, a large, small molecule, if you were. And there are many steps in the process. You can read about them in our patent filings, I think. But, you know, Lilly, maybe unlike other companies, we've made small molecules for a long time. We're capable of doing it.

David Ricks: OK. Great, Dave, great to hear from you. I mean, first of all, it is true that ORFORGLIPRON is a complicated, large, small molecule, a large, small molecule, if you were. And there are many steps in the process. You can read about them in our patent filings, I think.

Speaker Change: Thanks for the question Jake calling you to maybe opine a little bit on our video radio <unk> efforts <unk> 2001 in particular.

Jake: Yeah happy to thanks for the question, we're really excited about bringing radiopharmaceuticals into the portfolio by way of the acquisition of <unk> Biopharma.

Dave Ricks: You can read about them in our patent filings, I think. But, you know, Lilly, maybe unlike other companies, we've made small molecules for a long time. We're capable of doing it.

But, Lilly, maybe unlike other companies, we've made small molecules for a long time. We're capable of doing it. We understand how to put them together, and we've got a defined process to do it for ORFORGLIPRON. So the API production, while a long process and maybe complicated relative to other small molecules, is something we're super confident in and have our arms around. The finished process is really, the big advance over using injectables because here, we're just tablet stamping or tablet-- capsule making, which are dry processes we understand extremely well.

Speaker Change: We are supplementing that acquisition.

Speaker Change: With additional work through our discovery labs, and the ability to make these medicines ourselves.

Dave Ricks: We understand how to put them together, and we've got a defined process to do it for forgorpron. So the API production, while a long process and maybe complicated relative to other small molecules, is something we're super confident in and have our arms around. The finished process.

Jake: So I expect we will have more to talk about in terms of additional medicines over the course of the next couple of years. In addition to <unk> 2001, but specific to that question 2001 is a <unk> directed therapy for prostate cancer conjugated to actinium, the alpha emitter and I think.

Dave Ricks: Really, the big advance over using injectables because here we're just doing tablet stamping or capsule making, which are dry processes we understand extremely well. I think the big gain here will be the fact that both for synthetic chemistry and capsule making and tablet making, there is already capacity on planet Earth that is significant. And so, unlike the parenteral side, where we've been talking about injectables, new capacity needs to be built, and we do it aggressively, as Anat commented on earlier. Here, there are a lot of partners we can access as well as our own substantial network. Dry Product, Phil Finnish, and API Production. I'm pretty confident here.

Really, the big advance over using injectables because here we're just doing tablet stamping or capsule making, which are dry processes we understand extremely well.

Speaker Change: Actinium holds a lot of promise over lutetium, particularly in the context of creating double stranded DNA breaks versus single stranded in the ability to perhaps drive more efficacy for patients with prostate cancer I think one of the limitations of the existing agents.

I think the big gain here will be the fact that both for synthetic chemistry and capsule making and tablet making, there is already capacity on planet earth that is significant. And so, unlike the parenteral side, where we've been talking about injectables, a new capacity needs to be built, in which we're doing aggressively, as Anat commented on earlier. Here, there's a lot of partners we can access as well as our own substantial network for dry product finish, and API production. So pretty confident here.

Speaker Change: Probably cause too much salivary gland toxicity to be real durable products and so the point team designed a novel P. SMA directed ligand with increased tumor uptake relative to the Cerro Verde and.

Speaker Change: In order to drive more therapeutic index using actinium as the payload. So we're just getting started with the phase one experience right. Now is I don't have a lot to say about what we're seeing just yet, but the preclinical package looks really interesting and differentiated from the other <unk> ligand that exist out there. So we're looking forward to.

Dave Ricks: Now, will we stick the landing on exact doses and quantities in every instance? We're not guaranteeing that, but I think the picture will be quite a bit different should ORFORGLIPRON prove to be safe and effective in the Phase III studies. Again, that's in '25, so we can expect it to launch maybe a year after that, and that's an important event in the time course of the incretin class. Thanks, Dave. Thanks, Dave. Risinger for the question. Next question, Paul.

Now, will we stick the landing on exact doses and quantities in every instance? We're not guaranteeing that, but I think the picture will be quite a bit different should ORFORGLIPRON prove to be safe and effective in the Phase III studies. Again, that's in '25, so we can expect it to launch maybe a year after that, and that's an important event in the time course of the incretin class.

Speaker Change: Putting it through its phase one paces and we'll see what we have depending on the clinical profile I think theres the potential to improve outcomes in patients.

Speaker Change: And then I've already seen although TCM based agent maybe.

Speaker Change: Maybe go ahead of that and compete with the lutetium based agents so perhaps even go even earlier in therapy.

Joe Fletcher: Thanks, Dave. Thanks, Dave Risinger for the question. Next question, Paul.

Speaker Change: As.

Speaker Change: <unk> expression that really exist in the continuum of prostate cancer care, so more to come on that as we define the clinical profile and the phase one.

Operator: The next question is coming from Louise Chen from Canter. [inaudible] Hi, thanks for taking my question. I just wanted to ask you about your next wave of obesity drugs. Looks like you've got half a dozen of these in development, and where do you think you can most differentiate yourself? Thanks.

Operator: The next question is coming from Louise Chen from Cantor. Louise, your line is live.

Louise Chen: Hi, thanks for taking my question. I just wanted to ask you about your next wave of obesity drug. It looks like you've got half a dozen of these in development. And where do you think you can most differentiate yourself? Thank you.

Speaker Change: Thanks Jake.

Speaker Change #102: Paul I think we've got time for maybe one more question. We're right at 11, So maybe final question in queue.

Speaker Change: Okay and the final question today is coming from Jamie Shen from Deutsche Bank James Your line is live.

Jamie Shen: Hey, good morning, guys. Thanks for the question.

Louise Chen: Dan, you want to comment on earlier phase obesity? Yeah, thanks, Luis. We're excited about the portfolio of earlier stage obesity molecules. I think there are a number of opportunities for improvement over even an excellent drug like terzapatide. We think about the quality of weight loss as one aspect. So, for example, even on terzapatide, we see the ratio of lean to fat mass improve as patients lose weight on these drugs. Could we make it improve even faster with a muscle stimulating agent like bimagramab? Maybe that's under investigation.

Joe Fletcher: Thanks. Dan, do you want to comment on earlier phase obesity?

Jamie Shen: Wanted to try and reconcile the guidance with the one five times available dose is being maintained.

Daniel M. Skovronsky: Yes, thanks, Louise. We're excited about the portfolio of earlier stage obesity molecules. I think there's a number of opportunities for improvement over even an excellent drug like TIRZEPATIDE. We think about the quality of weight loss as one aspect. So, for example, even on TIRZEPATIDE, we see the ratio of lean to fat mass approved as patients lose weight on these drugs. Could we make it improve even faster with a muscle stimulating agent like BIMAGRUMAB? Maybe, that's under investigation.

Jamie Shen: Okay, James maybe ill give tend not to talk about guidance and how the guidance raise.

Jamie Shen: It relates to that one and a half dose.

James: Those comments, so let's start with the one and a half dose available dose comment that I've made on the guidance call in February so that reference is not a number of devices. The number of sellable doses and as we ramp up capacity for quick turn recall that unlike the single use vial or the auto injector that put tenants in a multi dose device. It has multiple dose.

James: This available for patients.

James: Dot com and referring to the second half of this year versus the second half of last year. So we're expecting that total sellable doses. This year in the second half will be at least one five times, where we were second half of last year.

Dan Skovronsky: TIRZEPATIDE is very well tolerated, but some people stop taking it because of GI side effects. Could we have drugs that have fewer side effects? Maybe that could be possible. TIRZEPATIDE is given as a once-weekly injection, and most patients find that to be acceptable, but probably with less frequent injections that could lower the burden on manufacturing and make it easier to use for patients. So that's another avenue of exploration. There are some patients who don't achieve their desired levels of weight loss even on a powerful drug like TIRZEPATIDE. And so that's another avenue. Finally, across different indications, and I spoke earlier of MASH that are related to metabolic disease, there could be different activities that prove more or less beneficial for these other related diseases.

TIRZEPATIDE is very well tolerated, but some people stop taking it because of GI side effects. Could we have drugs that have fewer side effects? Maybe that could be possible. TIRZEPATIDE is given as a once-weekly injection, and most patients find that to be acceptable, but probably with less frequent injections that could lower the burden on manufacturing and make it easier to use for patients. So that's another avenue of exploration. There are some patients who don't achieve their desired levels of weight loss even on a powerful drug like TIRZEPATIDE. And so that's another avenue.

James: It remains unchanged.

Dan Skovronsky: Tergepatite is given as a once-weekly injection, and most patients find that to be acceptable, but probably with less frequent injections that could lower the burden on manufacturing and make it easier to use for patients. So that's another avenue of exploration. There are some patients who don't achieve their desired levels of weight loss even on a powerful drug like terzapatide, and so that's another avenue. Finally, across different indications, and I spoke earlier of MASH that are related to metabolic disease, there could be different activities that prove more or less beneficial for these other related diseases.

James: The confidence we have in our ability to.

James: <unk> progressed on each note of our capacity that's coming online.

James: Get approved et cetera has just increased their or multiple of these throughout the year multiple of these have occurred somewhat occur and I gave a quick tenants. One example.

James: Think about a construction on the site for example, Concord, North Carolina, which we said will become operational by end of the year and we will start seeing product next year that construction has concluded lines are installed.

Finally, across different indications, and I spoke earlier of MASH that are related to metabolic disease, there could be different activities that prove more or less beneficial for these other related diseases. So that's another avenue of differentiation.

James: And we need to run qualifications get approval et cetera. There are multiple knows that these across our own manufacturing sites as well as external and then they all need to come online.

James: To get to where we need in terms of the full year guidance, but our confidence as the year progresses.

Dan Skovronsky: So that's another avenue of differentiation. I think we're just at the beginning of probably what will be seen as a multi-decade investment in treating abnormal metabolism and all diseases that come with that. And I'm really proud and pleased that Lilly has what must be the strongest pipeline in this area in the industry. Thank you, Dan. Follow-up next question? The next question is from Chris Shibutani from Goldman Sachs. Chris, your line is live.

So that's another avenue of differentiation.

James: Your has progressed our confidence in that has has increased but it remains the one at least $1 five.

I think we're just at the beginning of probably what will be seen as a multi-decade investment in treating abnormal metabolism and all diseases that come with that. And I'm really proud and pleased that Lilly has what must be the strongest pipeline in this area in the industry. Thank you, Dan. Follow-up next question? The next question is from Chris Shibutani from Goldman Sachs. Chris, your line is live.

Speaker Change: Great well thanks for your time today, everyone and we appreciate you participating in todays earnings call and your interest in our companies. Please follow up with the IR team. If you have any additional questions. We didn't address today and have a great day.

Speaker Change: Thank you and ladies and gentlemen, this does conclude our conference for today.

Thank you, Dan. Follow-up next question? The next question is from Chris Shibutani from Goldman Sachs. Chris, your line is live.

Joe Fletcher: Thank you, Dan. Paul, next question.

Operator: The next question is from Chris Shibutani from Goldman Sachs. Chris, your line is live.

Speaker Change: This conference will be made available for replay beginning at one P. M. Today running through June 4th at Midnight.

Chris Shibutani: Okay. Thank you, Chris. Paul, next question. Oops, can you hear me?

Joe Fletcher: Okay. Thank you, Chris. Paul, next question.

Speaker Change: You may access the replay system at anytime by dialing 803, three to 60 854 and entering the access code 307, 750 International Dialers can call nine 735, 280005 again those numbers are 833 to 6854 and 97 three.

Chris Shibutani: Can you hear me?

Chris Shibutani: Oh yeah, there you are. Great, thank you. I wanted to ask about the supply and demand and when those two might come closer together. Previously, Anat, you were quite specific in your vocabulary and said that that was something that could possibly happen in 2025.

Joe Fletcher: Oh, yes, there you are. Go ahead, Chris.

Great, thank you. I wanted to ask about the supply and dynamic and the demand and when those 2 might come closer together? Previously, Anat, you've been quite specific in your vocabulary and saying that, that was something that could possibly happen in 2025. Dave, you were in front of a group that we hosted, and I think you gave a little bit of a broader range. What's the latest that you would like to communicate based upon all the progress that you're making, the acquisition of the Wisconsin facility, et cetera, about a potential timing for that supply-demand dynamic to come closer together? Chris and Anat.

Chris Shibutani: Great, thank you. I wanted to ask about the supply and dynamic and the demand and when those 2 might come closer together? Previously, Anat, you've been quite specific in your vocabulary and saying that, that was something that could possibly happen in 2025. Dave, you were in front of a group that we hosted, and I think you gave a little bit of a broader range. What's the latest that you would like to communicate based upon all the progress that you're making, the acquisition of the Wisconsin facility, et cetera, about a potential timing for that supply-demand dynamic to come closer together?

Speaker Change: Five to 80005 with the access code 300 17750.

Chris Shibutani: Dave, you were in front of a group that we hosted, and I think you gave a little bit of a broader range. What's the latest that you would like to communicate based upon all the progress that you're making, the acquisition of the Wisconsin facility, et cetera, about the potential timing for that supply-demand dynamic to come closer together? Chris and Anat.

Speaker Change #103: Thank you for your participation you may now disconnect your lines.

Joe Fletcher: Thanks, Chris. Anat?

Anat Ashkenazi: Yes. Let me start on this. So I would say that, as I said in my prepared remarks, we expect that the supply and demand situation will remain quite tight in the near term, as well as in the midterm. And just to clarify, it's not that we have a production issue; our manufacturing facilities are progressing incredibly well. And I'm incredibly proud of the work done by our M&Q colleagues around the world. Clearly, we have sites working 24-7, we're doing construction overnight. We're making the right investments so we're progressing rapidly, as you've seen evidenced by the results, as well as the raise we did for the year.

Anat Ashkenazi: But the demand is strong, which shouldn't be a surprise given the health benefits that these products provide to patients, highly efficacious and safe medicines. And I expect that this will continue through the year, even with the significant ramp that we have, and we'll add more supply across different presentations, both with the auto injector, as well as the KWIKPEN. But even with that, I expect that demand will be-- will outpace supply for this year.

Speaker Change #103: Okay.

Anat Ashkenazi: Potentially next year, obviously, we'll see, we'll continue to invest in ramp as we go into next year, but it could be quite some time. We talked earlier about ORFORGLIPRON, should we have a positive Phase III readout, that provides another relief valve in terms of just offering a different presentation, as Dave mentioned, which utilizes a different set of infrastructure within our manufacturing organization available capacity globally. So it will be in a stepwise fashion; we'll continue to update investors as we progress through the year and the coming years. Thanks a lot.

Potentially next year, obviously, we'll see, we'll continue to invest in ramp as we go into next year, but it could be quite some time. We talked earlier about ORFORGLIPRON, should we have a positive Phase III readout, that provides another relief valve in terms of just offering a different presentation, as Dave mentioned, which utilizes a different set of infrastructure within our manufacturing organization available capacity globally. So it will be in a stepwise fashion; we'll continue to update investors as we progress through the year and the coming years.

Joe Fletcher: Thanks, Anat. Paul, next question.

Operator: All next questions. The next question will be from Carter Gould from Barclays. Carter, your line of, great.

All next questions.

Operator: Next question will be from Carter Gould from Barclays. Carter, your line is live.

Carter Gould: Thanks. Good morning. Congratulations on all the progress. I wanted to dive into BIMAGRUMAB ahead of the Phase IIb data forthcoming. Can you talk for a bit around the importance of showing stat sig or clear dose response across the composition of the weight loss drivers and maybe as well as the importance of not blunting the overall weight loss as you contemplate a move to Phase III, potentially? Thank you. Carter, for the question. Dan, you want to comment on the MagRMAP? Yeah, thanks, Carter. It's a good question.

Carter, for the question. Dan, you want to comment on the MagRMAP? Yeah, thanks, Carter. It's a good question.

Joe Fletcher: Thanks, Carter, for the question. Dan, you want to comment on the BIMAGRUMAB?

Daniel M. Skovronsky: Yes, thanks, Carter. It's a good question. BIMAGRUMAB is a very different mechanism of weight loss versus to incretins. But one that we think could be important in combination with incretins. So BIMAGRUMAB, we think will likely have important effects on adipose tissue as well as muscle mass. So our hope is to see increased muscle mass and increased ratio, I should say of lean to fat mass by combining BIMAGRUMAB with incretins. In this present study, it's being evaluated both as monotherapy and in combination with SEMAGLUTIDE at different doses. So we'll see if weight loss effects on fat tissue stack, and we'll see if effects on lean body mass that were seen in previous BIMAGRUMAB monotherapy studies work in combination with incretin. Looking forward to seeing that data.

Dan Skovronsky: The MagRMAP is a very different mechanism of weight loss compared to incretins, but one that we think could be important in combination with incretins. So the MagRMAP, you know, we think will likely have important effects on adipose tissue as well as muscle mass. So our hope is to see increased muscle mass and an increased increase, or ratio, I should say of lean to fat mass by combining BMAGRA-MAP with incretins. In this present study, it's being evaluated both as monotherapy and in combination with semaglutide at different doses.

Speaker Change #103: [music].

Dan Skovronsky: So we'll see if weight loss effects on fat tissue stack, and we'll see if effects on lean body mass that were seen in previous BIMAGRUMAB monotherapy studies work in combination with incretin. Looking forward to seeing that data. Thanks, Dan.

So we'll see if weight loss effects on fat tissue stack, and we'll see if effects on lean body mass that were seen in previous BIMAGRUMAB monotherapy studies work in combination with incretin. Looking forward to seeing that data.

Joe Fletcher: Thanks, Dan. Paul, next question?

Operator: All next questions? The next question is coming from Creepa Devarakonda from Truist Securities. Creepa, your line is live.

All next questions?

Operator: The next question is coming from Kripa Devarakonda from Truist Securities. Kripa, your line is live.

Kripa Devarakonda: Hey, guys. Thank you so much for taking my question and congrats on all the progress. I have a question about your radiopharma pipeline. You mentioned PNT2002 in your oncology pipeline. Can you talk about how you see that advancing and, given what you've seen so far, where you see this being placed in the landscape in terms of market share? Thank you.

Jacob S. Van Naarden: Thanks, Kripa, for the question. Jake, calling you to maybe opine a little bit on our radioligand efforts, PNT2001 in particular? Yeah, happy to.

Joe Fletcher: Thanks, Kripa, for the question. Jake, calling you to maybe opine a little bit on our radioligand efforts, PNT2001 in particular?

Jake Van Naarden: Yes, happy to. Thanks for the question. We're really excited about bringing radiopharmaceuticals into the portfolio by way of the acquisition of POINT Biopharma. And we are supplementing that acquisition with additional work through our discovery labs and the ability to make these medicines ourselves. So I expect we'll have more to talk about in terms of additional medicines over the course of the next couple years, in addition to PNT2001. But specific to that question, 2001 is a PSMA-directed therapy for prostate cancer conjugated to actinium, the alpha emitter.

Jacob S. Van Naarden: Thanks for the question. We're really excited about bringing radiopharmaceuticals into the portfolio by way of the acquisition of Point Biopharma. And we are supplementing that acquisition with additional work through our discovery labs and the ability to make these medicines ourselves. So I expect we'll have more to talk about in terms of additional medicines over the course of the next couple years, in addition to TNT 2001. But specific to that question, 2001 is a PSMA-directed therapy for prostate cancer conjugated to actinium, the alpha emitter.

Jacob S. Van Naarden: And I think, while actinium holds a lot of promise over lutetium, particularly in the context of creating double-stranded DNA breaks versus single-stranded and the ability to perhaps drive more efficacy for patients with prostate cancer, I think one of the limitations of the existing agents is that they probably cause too much salivary gland toxicity to be real durable products. And so the POINT team designed a novel PSMA-directed ligand with increased tumor uptake relative to the salivary gland in order to drive more therapeutic index using actinium as the payload.

Jacob S. Van Naarden: So we're just getting started with the Phase I experience right now, so I don't have a lot to say about what we're seeing just yet. But the preclinical package looked really interesting and differentiated from the other PSMA ligands that exist out there. So we're looking forward to putting it through its Phase I paces, and we'll see what we have. Depending on the clinical profile, I think there's the potential to improve outcomes in patients that have already seen a lutetium-based agent, maybe go ahead of that and compete with the lutetium-based or perhaps even go even earlier in therapy as PSMA expression really exists in the continuum of prostate cancer care. So more to come on that as we define the clinical profile in Phase I. Thanks Jake.

So we're just getting started with the Phase I experience right now, so I don't have a lot to say about what we're seeing just yet. But the preclinical package looked really interesting and differentiated from the other PSMA ligands that exist out there. So we're looking forward to putting it through its Phase I paces, and we'll see what we have. Depending on the clinical profile, I think there's the potential to improve outcomes in patients that have already seen a lutetium-based agent, maybe go ahead of that and compete with the lutetium-based or perhaps even go even earlier in therapy as PSMA expression really exists in the continuum of prostate cancer care. So more to come on that as we define the clinical profile in Phase I.

Joe Fletcher: Thanks Jake. Paul, I think we've got time for maybe one more question. We're right at 11. So maybe the final question in the queue.

Operator: Paul, I think we've got time for maybe one more question. We're right at 11. So maybe the final question in the queue. Okay, the final question today is coming from James Shin from Deutsche Bank. James, your line is live.

Paul, I think we've got time for maybe one more question. We're right at 11. So maybe the final question in the queue.

We're right at 11. So maybe the final question in the queue. Okay, the final question today is coming from James Shin from Deutsche Bank. James, your line is live.

We're right at 11. So maybe the final question in the queue.

Operator: Okay. The final question today is coming from James Shin from Deutsche Bank. James, your line is live.

James Shin: Good morning guys, thanks for the question. I just wanted to try and reconcile the guidance lift with the 1.5x scalable doses being maintained. Thank you. Okay, James, maybe I'll give time now to talk about the guidance and how the guidance raised relates to the one-and-a-half and sellable-dose comments. So let's start with the one-and-a-half dose, sellable dose comment that I made on the guidance call in February. So that reference is not a number of devices but the number of sellable doses, and as we ramp up capacity for QuickPen, recall that, unlike the single-use vial or the autoinjector, QuickPen is a multi-dose device that has multiple doses available for patients.

James Shin: Good morning guys, thanks for the question. I just wanted to try and reconcile the guidance lift with the 1.5x scalable doses being maintained. Thank you.

Okay, James, maybe I'll give time now to talk about the guidance and how the guidance raised relates to the one-and-a-half and sellable-dose comments. So let's start with the one-and-a-half dose, sellable dose comment that I made on the guidance call in February. So that reference is not a number of devices but the number of sellable doses, and as we ramp up capacity for QuickPen, recall that, unlike the single-use vial or the autoinjector, QuickPen is a multi-dose device that has multiple doses available for patients.

Joe Fletcher: Okay. James, maybe I'll give time now to talk about the guidance and how the guidance raised relates to the 1.5x dose comments.

Anat Ashkenazi: So let's start with the 1.5 dose--sellable dose comment that I made on the guidance call in February. So that reference is not a number of devices but the number of sellable doses, and as we ramp up capacity for KWIKPEN, recall that, unlike the single-use vial or the autoinjector, that KWIKPEN is a multi-dose device that has multiple doses available for patients.

Anat Ashkenazi: That comment referred to the second half of this year versus the second half of last year, so we're expecting that total saleable doses this year in the second half will be at least 1.5x where we were in the second half of last year. That remains unchanged. But the level of confidence we have in our ability to progress on each node of our capacity that's coming online or will get approved, et cetera, has just increased. There are multiple of these throughout the year. Multiple of these have occurred. Some will occur, and I gave the KWIKPEN as one example.

Anat Ashkenazi: Think about the construction of a site, for example, Concord in North Carolina, which we said would become operational by the end of the year, and we'll start seeing products next year. That construction has concluded. Lines are installed, and we need to run qualifications, get approval, etc. There are multiple nodes of these across our own manufacturing sites as well as external, and they all need to come online to get to where we need in terms of full-year guidance. But our confidence as the year progresses--as the year has progressed our confidence has increased, but it remains at least 1.5. Thanks a lot. Great. Well, thanks for your time today, everyone.

Think about the construction of a site, for example, Concord in North Carolina, which we said would become operational by the end of the year, and we'll start seeing products next year. That construction has concluded. Lines are installed, and we need to run qualifications, get approval, etc. There are multiple nodes of these across our own manufacturing sites as well as external, and they all need to come online to get to where we need in terms of full-year guidance. But our confidence as the year progresses--as the year has progressed our confidence has increased, but it remains at least 1.5.

Anat Ashkenazi: And we need to run qualifications, get approval, etc. There are multiple nodes of these across our own manufacturing sites as well as external ones, and they all need to come online to get to where we need in terms of full-year guidance. But our confidence as the year progresses, as the year has progressed, has increased, but it remains at least one and a half. Thanks a lot. Great. Well, thanks for your time today, everyone.

Joe Fletcher: Thanks, Anat. Great. Well, thanks for your time today, everyone. And we appreciate you participating in today's earnings call and your interest in our company. Please follow up with the IR team if you have any additional questions that we didn't address today. And have a great day. Thank you.

Operator: And we appreciate you participating in today's earnings call and your interest in our company. Please follow up with the IR team if you have any additional questions that we didn't address today. And have a great day. Thank you.

Speaker Change #103: [music].

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 p.m. today, running through June 4th at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 317750. International dialers can call 973-528-0005. Thank you for your participation. You may now disconnect your lines.

Operator: Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 317750. Thank you for your participation. You may now disconnect your lines.

Operator: [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??.. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q1 2024 earnings call. At this time, all participants are on a listen-only mode.

Joe Fletcher: Later, we will be conducting a question and answer session, and instructions will be given at that time. Should you request operator assistance during the call, please press star then zero, and an operator will assist you also. I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Thank you, Paul, and good morning, everyone. Thank you for joining us for Eladolini Company's Q1 2024 earnings call.

Joe Fletcher: I'm Joe Fletcher, Senior Vice President of Investor Relations, and joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Anat Ashkenazi, Chief Financial Officer, Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly International, Jake Van Naarden, President of Lox We're also joined by Michaela Irons, Mike Sprengnether, and Lauren Zierke of the IRT.

Joe Fletcher: During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. However, actual results could differ materially due to several factors, including those listed on slide two. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note, our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave.

Dave Ricks: Okay, thanks, Joe. We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses. Our focus is to bring innovative medicines to people in need. And in 2024, we're investing in our people, our launches, expanding our pipeline of new medicines, including through business development and, of course, accelerating the needed capacity in our manufacturing network. Results this quarter represent a continuation of the strong growth we delivered in 2023. On slide four, you can see details of the financial performance and progress related to our strategic deliverables.

Speaker Change #103: [music].

Speaker Change #105: Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q1 2024 earnings call.

Speaker Change #104: At this time all participants are in a listen only mode. Later, we will be conducting a question and answer session and instructions will be given at that time.

Dave Ricks: Revenue grew 26% in Q1, with our new products growing nearly $1.8 billion compared with the same period last year. We achieved several key pipeline milestones, including positive phase two results for terzapatide in moderate to severe obstructive sleep apnea, the approval of our multi-dose QuickPen delivery device for Manjaro in Europe, and submission of Mirakizumab in the U.S. and in the E.

Speaker Change #104: Could you request operator assistance during the call. Please press Star then zero and an operator will assist you offline I would now like to turn the conference over to your host Joe Fletcher Senior Vice President of Investor Relations. Please go ahead.

Joe Fletcher: Thank you Paul and good morning, everyone. Thank you for joining us for the leading companies Q1 2024 earnings call I'm, Joe <unk> Senior Vice President of Investor Relations and joining me on today's call are Dave Ricks, Lilly's, Chairman and CEO, Annette Ashkenazi Chief Financial Officer, Dr. Dan <unk>, Chief Scientific officer, and President of Lilly Immunology and white.

Dave Ricks: for moderately to severely active Crohn's, and the resubmission of leperchizumab in the U.S. for moderate to severe atopic dermatitis and the initiation of our phase 3 study for lepidocerum, evaluating efficacy and reducing cardiovascular risk. Lilly's top priority is to ensure we execute on our ambitious manufacturing expansion agenda. We recently signed an agreement to acquire an injectable medicine facility from Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin. This state-of-the-art facility has been FDA approved, and we are targeting to initiate production at the end of 2025. We broke ground earlier this month on our previously announced parenteral manufacturing site in Germany. And in existing facilities, we are working to maximize output and productivity to meet demand.

Speaker Change #104: President of Lilly neuroscience.

Speaker Change #104: President of Lilly International Jake Vanorden, President of blocks about Lilly and Patrik Jonsson, President of Lilly diabetes, and obesity and LOE USA. We're also joined by Mike Makayla Irons makes bringing other and more than <unk> of the IR team.

Speaker Change #104: During this conference call, we anticipate making projections and forward looking statements based on our current expectations actual results could differ materially due to several factors, including those listed on slide two additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K, and subsequent filings with the SEC. The information we provide about our products.

Speaker Change #104: Pipeline is for the benefit of the investment community, it's not intended to be promotional and is not sufficient for prescribing decisions.

Dave Ricks: The recent EMA approval and upcoming launch of our multi-dose QuickPen delivery device for Moncharo will unlock new supply capacity for Europe and other international markets, while we are also seeing meaningful progress in the ramp of new lines in existing Lilly and CDMO sites for the United States. We continue to make progress against our plans to increase manufacturing capacity, the most ambitious expansion plan in our company's history. Lastly, we distributed over $1 billion in dividends during the first quarter.

Speaker Change #104: As we transitioned our prepared remarks. Please note our commentary will focus on our non-GAAP financial measures now I will turn the call over to Dave. Okay. Thanks, Joe We're pleased with our Q1 results and the continued momentum momentum in our business, which positions us well for accelerated growth as this year progresses.

Dave: Our focus is to bring innovative medicines to people in need and in 2024, we're investing in our people our launches expanding our pipeline of new medicines, including through business development and of course accelerating the needed capacity and our manufacturing network.

Dave Ricks: On slide five, you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates. So now let me turn the call over to Anat to review our Q1 financial, Thanks, Dave. Slide six summarizes financial performance in the first quarter of 2024. First quarter revenue growth of 26% was driven by new products, primarily Montreal and ZEPP Gross margin as a percent of revenue increased from 78.4% in Q1 2023 to 82.5% in Q1 2024 Gross margin in the quarter benefited from higher realized prices, bearable product mix, and to a lesser extent, improved production costs, Marketing, sound and administrative expenses increased 12%, primarily driven by promotional efforts supporting current and future launches, as well as increased compensation and benefits costs.

Dave: Results this quarter represent a continuation of the strong growth we delivered in 2023.

Dave: On slide four you can see details of the financial performance and progress related to our strategic deliverables.

Dave: Revenue grew 26% in Q1 with our new products growing nearly one $8 billion compared with the same period last year.

Dave: We achieved several key pipeline milestones, including the positive phase II results for <unk> in moderate to severe obstructive sleep apnea.

Dave: The approval of our multi dose quick turn delivery device for <unk> in Europe.

Dave: Submission of <unk> in the U S and in the EU for moderately to severely active crohns disease.

Dave: The resubmission of <unk> in the U S for moderate to severe atopic dermatitis.

Dave: And the initiation of our phase III study evaluating.

Dave: Evaluating efficacy in reducing cardiovascular risk.

Dave: Those top priority is to ensure we execute on our ambitious manufacturing expansion agenda. We recently signed an agreement to acquire an injectable medicine facility from Nexus Pharmaceuticals in Pleasant Prairie, Wisconsin.

Dave Ricks: R&D expenses increased 27%, driven by higher development expenses for late-stage assets and additional investments in early-stage research, as well as a one-time charge of approximately $75 million associated with the termination of the Bresenio Pro State Program. In Q1, we recognized the acquired IPRD charge of $111 million, which negatively impacted EPS by 10 cents. Operating income increased 63% in Q1, driven by higher revenue from new products partially offset by operating Our Q1 effective tax rate was 11.9% compared to 12.8% in Q1 2023, driven by a larger net discrete tax benefit reflected in Q1 2024 compared with the same period in 2023.

Dave: This state of the art facility has been FDA approved and we are targeting to initiate production at the end of 2025.

Speaker Change #104: We broke ground earlier this month on our previously announced parental manufacturing site in Germany.

Speaker Change #104: And in existing facilities, we are working to maximize output and productivity to meet demand.

Speaker Change #104: The recent EMA approval and upcoming launch of our multi dose pen delivery device for my Charl will unlock new supply capacity for Europe and other international markets. While we are also seeing meaningful progress in the ramp up new lines and existing Lilly and CMO sites for the United States.

Speaker Change #104: We continue to make progress against our plans to increase manufacturing capacity. The most ambitious expansion plan in our company's history.

Anat Ashkenazi: We delivered earnings per share of $2.58 in Q1, a 59% increase compared to Q1 2023, inclusive of the negative impact of $0.10 from acquired IPRD charges in both periods. On slide seven, we quantify the effect of price, rate, and volume on revenue growth. U.S. revenue increased 28% in Q1, driven by growth in Moncharo, Setbound, and Resenio. Unprecedented demand for our incredible medicines led to wholesaler backorders of Trlicity, Montero, and ZepBound at quarter end.

Speaker Change #104: Lastly, we distributed over $1 billion in dividends during the first quarter.

Speaker Change #108: On slide five you'll see a list of the key events since our Q4 earnings call, including the milestones I mentioned earlier and several other important updates. So now let me turn the call over to and not to review our Q1 financial results. Thanks.

Speaker Change #111: Thanks, Dave Slide six summarizes <unk> financial performance in the first quarter of 2024.

Speaker Change #112: First quarter revenue growth of 26% was driven by new products, primarily one Charlie.

Speaker Change #109: Gross margin as a percent of revenue increase from 78, 4% in Q1 2023 to 82, 5% in Q1 2024.

Anat Ashkenazi: Realized prices in the U.S. increased 16%, largely driven by Montreux excess and savings card dynamics. Moving to Europe, revenue growth was once again strong, increasing 29% in constant currency, driven primarily by volume from Bresenio and Montero, as well as payments associated with the distribution and divestiture agreement. Penn revenue grew 2% in constant currency. Volume growth of 7% was driven by Montero and Fresenio, partially offset by decreased volume for Trlicity and a partnership milestone in the base period. The price declined 5% in the quarter.

Speaker Change #106: Margin in the quarter benefited from higher realized prices favorable product mix and to a lesser extent improved production cost.

Speaker Change #106: Marketing selling and administrative expenses increased 12%, primarily driven by promotional effort supporting current and future launches as well as increased compensation and benefit cost.

Speaker Change #106: R&D expenses increased 27% driven by higher development expenses for late stage assets and additional investments in early stage research as well as a onetime charge of approximately $75 million.

Speaker Change #106: Associated with the termination of the <unk> prostate program.

Speaker Change #106: In Q1, we recognized the acquired IP R&D charge of $111 million, which negatively impacted EPS by 10%.

Anat Ashkenazi: Moving to China, Q1 revenue increased 4% in constant currency. Volume growth was driven by Tyvek, partially offset by Illumines and Cialis. Revenue in the rest of the world increased 31% in constant currency, primarily driven by volume growth from Manjaro and to a lesser extent from Xenu and Jardian. Slide 8 provides additional perspectives across our product categories. First, I would like to highlight Resenio, which saw a worldwide still increase of 40% in Q1, driven by continued volume growth in the early breast cancer indication.

Speaker Change #106: Operating income increased 63% in Q1, driven by higher revenues from net from new products, partially offset by operating expense spread.

Speaker Change #106: Our Q1 effective tax rate was 11, 9% compared to $12 eight in Q1 2023, driven by a larger net discrete tax benefit reflected in Q1 2024 compared with the same period in 2023.

Speaker Change #106: We delivered earnings per share of $2 58 in Q1, 59% increase compared to Q1 2023 inclusive of the negative impact of Tencent from acquired IP R&D charges in both periods.

Anat Ashkenazi: JPRCA revenue increased to $50 million worldwide, representing an acceleration in sequential quarterly growth following the December 2023 approval for the CLO indication. We're looking forward to potentially making this medicine available to even more patients as future phase 3 trials read out. Next, in Q1, Montreal sales were $1.8 billion globally and $1.5 billion in the U.S., up from $568 million and $536 million in Q1 2023, respectively.

Speaker Change #106: On slide seven we quantify the effect of price rate and volume on revenue growth.

Speaker Change #106: <unk> revenue increased 28% in Q1 driven by growth at <unk>.

Speaker Change #106: Bruce.

Speaker Change #106: Unprecedented demand for our <unk> medicines, but to wholesaler back orders up solicited months and sat down at quarter end.

Speaker Change #106: <unk> prices in the U S increased 16% largely driven by Montreal excess and savings card dynamics.

Speaker Change #106: Moving to Europe revenue growth was once again strong increasing 29% in constant currency, driven primarily by volume from <unk> and <unk> as.

Speaker Change #106: As well as payments associated with the distribution and divestiture agreement.

Speaker Change #106: Japan revenue grew 2% in constant currency volume growth of 7% was driven by Monteiro enforced Danielle partially offset by decreased volumes for <unk> and our partnership milestone in the base period, okay. Thanks.

Anat Ashkenazi: Sequential quarterly-over-quarter revenue for Montero in the U.S. was impacted by a one-time benefit from changes in estimates for rebates and discounts in Q4 2023, as well as lower inventory in the channel in Q4 2024 and strong demand. Access levels across commercial and R&D were consistent with high levels we communicated on our last earnings call, and your parity with established injectable increment medicine. Demand for terzapatit In each week, hundreds of thousands of people fill the strips from Montero and Zeppel.

Speaker Change #106: <unk> declined 5% in the quarter.

Speaker Change #106: Moving to China, Q1 revenue increased 4% in constant currency.

Speaker Change #106: Volume growth was driven by pilot, partially offset by Illumina and CLS.

Speaker Change #106: Revenue in the rest of the world increased 31% in constant currency.

Speaker Change #106: Primarily driven by volume growth from Mcdonalds and to a lesser extent <unk> and target.

Speaker Change #106: Okay.

Speaker Change #106: <unk> provides additional perspective.

Speaker Change #106: Across our product categories.

Speaker Change #110: First I would like to highlight for us Danielle when sell worldwide sale increased 40% in Q1, driven by continued volume growth and the early breast cancer indication.

Speaker Change #113: <unk> revenue increased to $50 million worldwide represented an acceleration in sequential quarterly growth. Following the December 2000, 22023 approval for the CLO indication.

Speaker Change #110: We're looking forward to potentially making this medicine available to even more patients as future phase III trials readout.

Speaker Change #110: Next the Q1 launch of our sales were $1 8 billion globally.

Speaker Change #110: $1 5 billion in the U S up from $568 million and 536 million in Q1 2023, respectively.

Speaker Change #110: Sequential quarter over quarter revenue from <unk> in the U S was impacted by a onetime benefit from changes in estimates for rebates and discounts in Q4 2023.

Speaker Change #110: Lower inventory in the channel in Q4, 2024, and a strong demand.

Anat Ashkenazi: Outside the U.S., we're delighted that the multi-dose Qutkan delivery device from Majora was recently approved in the EU, adding to the U.K. approval earlier this year. This approval applies to both type 2 diabetes and chronic weight management indications as they are under a single brand in Europe. While planning for launch will vary by country, we expect to start launching in the EU in the coming weeks. In Q1, worldwide transaction revenue declined 26%. US real estate revenue decreased 30% driven by lower volume primarily due to supply constraints and competitive dynamics.

Speaker Change #110: Access level across commercial and R&D were consistent with high levels, we communicated on our last earnings call and your parity with the established injectable medicines.

Speaker Change #110: Okay.

Speaker Change #110: The demand for tours appetite is very strong and each week hundreds of thousands of people fill scripts from Ontario, and they found.

Speaker Change #110: Yes, we understand the frustration from those facing prescription delays or uncertainties get their medicine.

Speaker Change #110: Well, we are working tirelessly to rent supply and expect meaningful increases in shipment volumes in the second half of the year demand continues to outstrip even increased supply.

Speaker Change #110: We remain on track to meet expectations. We set earlier this year the production of cell doses of important medicines in the second half of 2024 will be at least one five times to sell at low doses in the second half of 2023.

Anat Ashkenazi: In addition, sales in international markets were impacted by measures we have taken to minimize disruption to existing patients, including communicating to healthcare professionals to not start new patient funds for eliciting. Turning to slide 9, we have seen exceptionally strong U.S. launch progress for ZepBalance with over half a billion in sales in Q1. We're rapidly building that access for ZEP customers bound in the U.S., and as of April 1st, we have approximately 67 percent access in the commercial segment.

Speaker Change #110: In the short to midterm, we expect sales growth.

Speaker Change #110: Barely dysfunction of the quantities, we can produce and ship.

Speaker Change #110: Outside the U S. We're delighted that the multi dose pen delivery device from Charl was recently approved in the EU, adding to the UK approval earlier this year.

Speaker Change #110: This approval applies to both type two diabetes and product weight management indication and they are under the single brand in Europe.

Speaker Change #110: While the timing for launch will vary by country, we expect to start launching in the EU in coming weeks.

Anat Ashkenazi: As a reminder, patients' access to this market is a two-step process, typically requiring individual employers to opt in to an anti-obesity medicine rider on PVM coverage. We are continuing to focus on broadening access, both with PVMs and through employer opt-ins, and early progress is encouraging. On slide 10, we provide an update on capital allocation, and slide 11 shows an updated 2024 financial guide. Given the strengths we're seeing in our business and projections for continued acceleration expected in the second half of the year, we're increasing our full year revenue outlook by $2 billion on the top and bottom ends of the range, to be between $42.4 billion and $43.6 billion.

Speaker Change #110: In Q1 worldwide Felicity revenue declined 26%.

Speaker Change #110: U S for Lithia revenue decreased 3% driven by lower volume, primarily due to supply constraints and competitive dynamics.

Speaker Change #110: In addition sales in international markets were impacted by measures, we have taken to minimize disruption to existing patients, including communicated to health care professionals to not start new patients on <unk>.

Speaker Change #110: Turning to slide nine we have seen exceptionally strong U S launch progress present them with over half a billion dollars in sales in Q1.

Speaker Change #110: We're rapidly building now access for <unk> in the U S and as of April one we have approximately 67% axis in the commercial segment.

Speaker Change #110: As a reminder, patients access to this market is a two step process typically require individual employers to opt in to an anti obesity medicine rider.

Speaker Change #110: <unk> coverage.

Speaker Change #110: We're continuing to focus on broadening access both with Pbms and through employer opt ins and early project progress is encouraging.

Anat Ashkenazi: This increase is primarily due to the strong performance of Monjaro and Set Fountain and greater visibility and confidence into our production expansion for the remainder of 2024. With this update, year-over-year revenue growth for the company is now expected to be approximately 26% at the midpoint, or approximately 35% for the core business, which excludes the impact of global divestiture.

Speaker Change #110: On slide 10, we provide an update on capital allocation.

Speaker Change #110: Slide 11 shows updated 2024 financial guidance.

Speaker Change #110: Given the strength, we're seeing in our business and projections for continued acceleration expected in the second half of the year.

Speaker Change #110: We're increasing our full year revenue outlook by $2 billion.

Speaker Change #110: On the top and bottom end of the range to be between $42 $4 billion to $43 6 billion.

Speaker Change #110: This increase is primarily due to strong performance of <unk>, Charles and sat down and greater visibility and confidence into our production expansion for the remainder of 2024.

Anat Ashkenazi: Given the update to revenue guidance, we now expect the ratio of gross margin less off X divided by revenue to be in the range of 32 to 34% on a reported basis and 33 to 35% on a non-GAAP basis, representing further margin expansion. We're reaffirming guidance for other income and expense and tax rates, which now takes into consideration Q1 results. Based on these updates, and inclusive of Q1 ICR&D charges of $0.10 per share, we now expect EPS to be in the range of $13.05 to $13.55 on a reported basis, and $13.50 to $14 on a non-GAAP basis. Now, I'll turn the call over to Dan to highlight progress in R&D. Thanks, Anat.

Speaker Change #110: With this update year over year revenue growth for the company is now expected to be approximately 26% at the midpoint.

Speaker Change #110: Approximately 35% for the core business, which excludes the impact from global divestitures.

Speaker Change #110: Given the update to revenue guidance, we now expect the ratio of gross margin less opex divided by revenue to be in the range of 32% to 34% on a reported basis and 33% to 35% on a non-GAAP basis, representing further margin expansion.

Speaker Change #110: We are reaffirming guidance for other income and expense and tax rate, which now takes into consideration Q1 results.

Speaker Change #110: Based on these updates and inclusive of Q1 IP R&D charges of <unk> 10 per share. We now expect EPS to be in the range of $13 five to $13 55 on a reported basis and $13 50 to $14 on a non-GAAP basis.

Dan Skovronsky: Let me start with our exciting announcement from earlier this month. That was positive phase three results from the Surmount OSA studies, which evaluated terzepatide for treatment of adults with obesity and moderate to severe obstructive sleep apnea, known as OSA. OSA is a sleep-related breathing disorder characterized by complete or partial collapse of the upper airway during sleep. OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and even type 2 diabetes. The need is significant

Speaker Change #110: Now I'll turn the call over to Dan to highlight progress in R&D. Thanks, Scott let.

Dan: Let me start with our exciting announcement from earlier. This month that was a positive phase III results from the surmount OSA studies, which evaluated <unk> appetite for treatment of adults with obesity and moderate to severe obstructive sleep apnea known as OSA.

Dan: But let's say, it's a sleep related breathing disorder characterized by complete or partial collapse of the upper airway during sleep OSA can have serious cardio metabolic complications contributing to hypertension coronary heart disease stroke heart failure, atrial fibrillation and even type two diabetes.

Dan Skovronsky: OSA impacts 80 million people in the U.S., with more than 20 million people suffering from moderate to severe OSA. We also know that a substantial majority, approximately 70% of people with OSA, also live with obesity. While there are pharmaceutical treatments for the excessive daytime sleepiness associated with OSA, terzapatite could potentially be the first pharmacological treatment for the underlying disease. As shown on slide 12, Surmount OSA was comprised of two separate trials run under one master protocol.

Dan: The need is significant OSA impacts 80 million people in the U S with more than 20 million people suffering from moderate to severe OSA we.

Dan: We also know that a substantial majority approximately 70% people with OSA also lift with obesity.

Dan: As shown on slide 12, surmount OSA was comprised of two separate trials run under one Master Protocol study, one evaluating <unk> appetite and participants not currently on positive airway pressure or Pap therapy.

Dan Skovronsky: Study one evaluated drizepatide in participants not currently on positive airway pressure or PAP therapy, while study two evaluated trishepatide in patients who had used PAP for at least three months prior to the study and planned to continue PAP therapy during the entire course of the trial. A total of 469 participants were enrolled across these studies.

Dan: One study to evaluate Trish appetite in patients who introduced path for at least three months prior to the study.

Speaker Change #110: Plans to continue Pap therapy during the entire course of the trial.

Speaker Change #110: The total of 469 participants were enrolled across these studies each study randomized participants to either maximum tolerated dose approved pictures appetite, which can be 10 milligrams or 15 milligrams or to placebo and patients were followed on therapy for 52 weeks.

Dan Skovronsky: Each study randomized participants to either the maximum tolerated dose approved for terzapatide, which could be 10 milligrams or 15 milligrams, or to placebo, and patients were followed on therapy for 52 weeks. On slide 13, we show the results of study 1, for the Efficacy Essay, on Mean Apnea Hypopnea Index (or AHI). Terzapatite led to a mean reduction of 27.4 events per hour compared to a mean AHI reduction of 4.8 events per hour for placebo. This difference was highly statistically significant.

Speaker Change #110: On Slide 13, we show the results of study one.

Speaker Change #110: For the efficacy estimate on mean apnea hypopnea index or AHRI.

Speaker Change #110: <unk> appetite led to a mean reduction of $27 four events per hour compared to EMEA nahi reduction of $4 eight events per hour for placebo. This difference was highly statistically significant.

Dan Skovronsky: AHI baseline values were 52.9, and AHI was reduced by 55% in the trizepatite arm. We also saw a mean body weight reduction of 18.1%, which is appetite treatment, consistent with our expectations for the study. This was, of course, also statistically significant versus placebo. On slide 14, we show the results of study 2. In this population, for the efficacy estermand, TERS appetite led to a mean HI reduction of 30.4 events per hour compared to a mean HI reduction of 6.0 events per hour for placebo.

Speaker Change #110: Hei baseline values were $52 nine nahi was reduced by 55% and <unk> appetite arm.

Speaker Change #110: We also saw a mean body weight reduction of 18, 1%, but theres appetite treatment consistent with our expectations for the study.

Speaker Change #110: This was of course also statistically significant versus placebo.

Speaker Change #110: On Slide 14, we show the results of study two in.

Speaker Change #110: This population for the efficacy estimate.

Speaker Change #110: There is appetite led to a mean reduction of 34 events per hour.

Speaker Change #110: Compared to a mean IHI reduction of 6.0 events per hour for placebo.

Dan Skovronsky: The baseline AHI was 46.1 in the trazepatide arm, and the mean AHI reduction was 62.8%. Again, we saw impressive weight loss with a mean body weight reduction of 20.1% from baseline. These results were also all highly statistically significant. In both studies, the overall safety profile was similar to previously reported surmount and surpass trials. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, with the most commonly reported gastrointestinal adverse events for patients treated with tercepatide being diarrhea, nausea, vomiting, and constipation.

Speaker Change #110: The baseline Hei was $46, one and there is appetite arm and mean ehi reduction was 62, 8%.

Speaker Change #110: Again, we saw impressive weight loss with a mean body weight reduction of 21% from baseline.

Speaker Change #110: These results were also all highly statistically significant.

Speaker Change #110: In both studies the overall safety profile was similar to previously reported surmounted surpass trials the.

Speaker Change #110: The most commonly reported adverse events were gastrointestinal related and generally mild to moderate severity with the most commonly reported gastrointestinal adverse events for patients treated with <unk> being diarrhea, nausea, vomiting and constipation.

Dan Skovronsky: Prior to the study readout, we noted investor questions about what level of weight loss we would see, given several factors that were uniquely combined in the study of trisepatitis. First, the primary aim of the study was not the treatment of obesity. Second, that the population was approximately 70% males, in whom weight loss can be harder to achieve with Inkerton Medicine. Third, there was a particularly high baseline BMI in this population. And finally, the use of the 10 or 15 milligram maximum tolerated dose approach.

Speaker Change #110: Prior to this study readout, we noted investor questions about what level of weight loss, we would see given several factors that we are uniquely combined in this study. If there is appetite first the primary aim of the study was not treatment of obesity.

Speaker Change #110: But the population was approximately 70% males between weight loss can be harder to achieve with acreage medicines.

Speaker Change #110: Third there was a particularly high baseline BMI in this population.

Speaker Change #110: And finally, the use of the 10% or 15 milligram maximum tolerated dose approach.

Dan Skovronsky: We were therefore highly reassured to see weight loss observed across the two studies at 52 weeks was nearly 20% despite this difficult-to-treat population. Consistent with other phase 3 studies such as EPITIDE at the 52 week time point, we did not see weight loss plateau, and will present detailed results of Surmont OSA during a symposium at ADA on June 21st. Additionally, we plan to submit to the FDA and other global regulatory agencies beginning mid-year. Moving to the other updates across our portfolio, slide 15 shows select pipeline opportunities as of April 26, and slide 16 shows potential key events for the year.

Speaker Change #110: We were therefore highly reassured to see weight loss observed across the two studies at 52 weeks was nearly 20%. Despite this difficult to treat population.

Speaker Change #110: Consistent with other phase III studies, such as appetite at the 52 week time point, we did not see weight loss plateau.

Speaker Change #110: We will present detailed results of surmount OSA during a symposium at Ada on June 21.

Speaker Change #110: Additionally, we plan to submit to the FDA and other global regulatory agencies, beginning mid year.

Speaker Change #110: Moving to the other updates across our portfolio of slide 15 shows select pipeline opportunities as of April 26, and slide 16 shows potential key events for the year.

Dan Skovronsky: We're pleased to share that results were positive in QUINT4, the first phase 3 study of insulin F-sitora alpha, our once weekly basal insulin. This study evaluated F-sitora compared to insulin glargine in adult participants with type 2 diabetes who are on multiple daily insulin injections. In the coming weeks, we expect to report top-line results from QUINT4 as well as QUINT2, which is evaluating F-sitora compared to Denglidec in adults with type 2 diabetes who are naive to basal insulin.

Speaker Change #110: We're pleased to share the results were positive and for the first phase III study of insulin <unk> to our alpha our once weekly basal insulin. This study evaluated <unk> compared to insulin <unk> in adult participants with type two diabetes, who are on multiple daily insulin injections.

Speaker Change #110: In the coming weeks, we expect to report topline results from <unk>, four as well as to which is evaluating <unk> compared to <unk> in adults with type two diabetes, who are naive to basal insulin.

Dan Skovronsky: Together, these are the first two of five studies in the Absentaur Phase III program. Additional updates in our late-stage diabetes and obesity pipeline include results from the MPACT-MI study showing Jardians had a 10% relative risk reduction in the primary composite endpoint.

Speaker Change #110: Together. These are the first two of five studies in the asset to our phase III program.

Speaker Change #110: Additional updates in our late stage diabetes and obesity pipeline include results of the impact in the <unk> study showing <unk> had a 10% relative risk reduction in the primary composite endpoint.

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