Q3 2023 Eli Lilly and Co Earnings Call

November 2, 2023

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Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2023 earnings call. 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. To request 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.

Operator 3: Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2023 earnings call. 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. To request 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.

Unknown: Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q3 2023 earnings call. 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 assistance during the call. Please press Star then zero and an operator will assist you offline. I will.

Operator: Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q3 2023 earnings call. 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 assistance during the call. Please press Star then zero and an operator will assist you offline.

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.

Could you request assistance during the call. Please press Star then zero and an operator will assist you offline I will.

Unknown: I would now I like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead.

Now I'd like to turn the conference over to your host Joe Fletcher Senior Vice President of Investor Relations. Please go ahead.

David Ricks: Ahead.

Ahead.

David Ricks: Good morning, and thank you, Paul. Thanks, everybody, for joining us for Eli Lilly and Company's Q3 2023 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 and Medical Officer, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly International, Jake Van Naarden, President of Loxo@Lilly, Mike Mason, President of Lilly Diabetes and Obesity, and Patrik Jonsson, President of Lilly Immunology and Lilly USA. We're also joined by Michaela Irons, Mike Springnether, and Lauren Zierke of the IR team. 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 3.

Joe Fletcher: Good morning, and thank you, Paul. Thanks, everybody, for joining us for Eli Lilly and Company's Q3 2023 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 and Medical Officer, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly International, Jake Van Naarden, President of Loxo@Lilly, Mike Mason, President of Lilly Diabetes and Obesity, and Patrik Jonsson, President of Lilly Immunology and Lilly USA. We're also joined by Michaela Irons, Mike Springnether, and Lauren Zierke of the IR team. 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 3.

Joe Fletcher: Good morning, and thank you Paul. Thanks, everybody for joining us for Eli Lilly Company's Q3, 2023 earnings call. I'm, Joe Fletcher, Senior Vice President of Investor Relations and joining me on today's call are Dave Ricks, Lilly's, Chairman and CEO, Anat Ashkenazi, Chief Financial Officer, Dr. Dan Skovronsky, Chief scientific and medical Officer, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly's International, Jake Van Naarden, President of Loxo@Lilly, Mike Mason, President of Lilly Diabetes and Obesity and Patrik Jonsson, President of Lilly Immunology and Lilly USA. We're also joined by [inaudible] of the IR team.

And white President of Lilly neuroscience.

I didn't have Louis International Jacob <unk> President of lock so at Lilly, Mike Mason, President of Lilly diabetes, and obesity and Patrik Jonsson, President of Lilly Immunology and Lula USA. We're also joined by Mackellar Irons make spring another and more than <unk> of the IR team.

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 3. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K, and subsequent forms 10-Q, and 8-K filed with the securities and exchange commission.

David Ricks: Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission. 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 that our commentary will focus on non-GAAP financial measures. Now I'll turn the call over to Dave. Thanks, Joe. In Q3, Lilly continued the progress we made so far this year. We delivered strong financial results, continued to advance our R&D pipeline, and invested in our future through several business development transactions.

Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission. 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 that our commentary will focus on non-GAAP financial measures. Now I'll turn the call over to Dave.

Joe Fletcher: 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 that our commentary will focus on non-GAAP financial measures. Now I'll turn the call over to Dave.

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 that our commentary will focus on non-GAAP financial measures now I'll turn the call over to Dave.

Dave Ricks: Thanks, Joe. In Q3, Lilly continued the progress we made so far this year. We delivered strong financial results, continued to advance our R&D pipeline, and invested in our future through several business development transactions.

Dave Ricks: Thanks, Joe. In Q3 Lilly continued the progress we've made so far this year. We delivered strong financial results continued to advance our R&D pipeline and invested in our future through several business development transactions. As you can see on Slide 4, we continue to make progress against our strategic deliverables this quarter. Excluding revenue from the Olanzapine portfolio and COVID-19 antibodies, revenue grew 24%.

David Ricks: As you can see on Slide 4, we continue to make progress against our strategic deliverables this quarter. Excluding revenue from the Olanzapine portfolio, COVID-19 antibodies, revenue grew 24%. Our new products and growth products combined contributed approximately 17 percentage points toward volume growth, with over 12 percentage points coming from our growth products.

As you can see on Slide 4, we continue to make progress against our strategic deliverables this quarter. Excluding revenue from the Olanzapine portfolio, COVID-19 antibodies, revenue grew 24%. Our new products and growth products combined contributed approximately 17 percentage points toward volume growth, with over 12 percentage points coming from our growth products.

As you can see on slide four we continue to make progress against our strategic deliverables this quarter.

Excluding revenue from the Olanzapine portfolio and COVID-19 antibodies.

Revenue grew 24%.

Dave Ricks: Our new products and growth products combined contributed approximately 17 percentage points towards volume growth. With over 12 percentage points coming from our growth products. Last week, we announced that the FDA approved Omvoh for the treatment of moderately to severely active ulcerative colitis in adults. This marks Lilly's first approval in the U.S for type of inflammatory bowel disease, and it's important for Lilly's growth and its immunology portfolio.

With over 12 percentage points coming from our growth products.

David Ricks: Last week we announced that the FDA approved Omvoh for the treatment of moderately to severely active ulcerative colitis in adults. This marks Lilly's first approval in the US for a type of inflammatory bowel disease, and it's important for Lilly's growth in its immunology portfolio. In addition to the FDA approval for Omvoh, we had several other important pipeline updates since our last earnings call. Specifically, Jardiance was approved by the FDA for the treatment of adults with chronic kidney disease at risk of progression, and we reported positive phase 3 results from the VIVID-1 trial which evaluated the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease. In Q3, we announced that the FDA issued a complete response letter for lebrikizumab based on inspection findings at a third-party manufacturer.

Last week we announced that the FDA approved Omvoh for the treatment of moderately to severely active ulcerative colitis in adults. This marks Lilly's first approval in the US for a type of inflammatory bowel disease, and it's important for Lilly's growth in its immunology portfolio. In addition to the FDA approval for Omvoh, we had several other important pipeline updates since our last earnings call. Specifically, Jardiance was approved by the FDA for the treatment of adults with chronic kidney disease at risk of progression, and we reported positive phase 3 results from the VIVID-1 trial which evaluated the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease. In Q3, we announced that the FDA issued a complete response letter for lebrikizumab based on inspection findings at a third-party manufacturer.

Last week, we announced that the FDA approved <unk> for.

For the treatment of moderately to severely active ulcerative colitis in adults.

This marks <unk> first approval.

In the U S for type of inflammatory bowel disease, and it's important for <unk> growth and its immunology portfolio.

Dave Ricks: In addition to the FDA approval for Omvoh, we had several other important pipeline updates since our last earnings call. Specifically, Jariance was approved by the FDA for the treatment of adults with chronic kidney disease at risk of progression. And we reported positive phase III results from the Vivid I trial, which evaluated the safety and efficacy of Mirikizumab for the treatment of adults with moderately to severely active Crohn's disease.

Efficacy of Mira <unk> mab for the treatment of adults with moderately to severely active crohns disease.

Dave Ricks: In Q3, we announced that the FDA issued a complete response letter for Lebrikizumab based on inspection findings at a third party manufacturer. The letter stated no concerns with the clinical data package, the safety, or the label. We will continue to work with the third party manufacturer and the FDA to address the findings to make Lebrikizumab available to patients as quickly as possible. In terms of business development, we once again had a very active quarter. In Q3, we completed the divestiture of the Olanzapine portfolio, which will further enable us to focus on our current and new product launches. The financial impact of this transaction is reflected in the Q3 results.

David Ricks: The letter stated no concerns with the clinical data package, the safety, or the label. We will continue to work with the third party manufacturer and the FDA to address the findings to make Lebrikizumab available to patients as quickly as possible. In terms of business development, we once again had a very active quarter. In Q3 we completed the divestiture of the Olanzapine portfolio which will further enable us to focus on our current and new product launches. The financial impact of this transaction is reflected in the Q3 results. Additionally, within the quarter we completed the acquisition of two clinical stage companies adding to our Phase 2 portfolio, Dice Therapeutics and Versanis Bio, as well as the acquisition of Emergence Therapeutics and Sigilon Therapeutics.

The letter stated no concerns with the clinical data package, the safety, or the label. We will continue to work with the third party manufacturer and the FDA to address the findings to make Lebrikizumab available to patients as quickly as possible. In terms of business development, we once again had a very active quarter. In Q3 we completed the divestiture of the Olanzapine portfolio which will further enable us to focus on our current and new product launches. The financial impact of this transaction is reflected in the Q3 results. Additionally, within the quarter we completed the acquisition of two clinical stage companies adding to our Phase 2 portfolio, Dice Therapeutics and Versanis Bio, as well as the acquisition of Emergence Therapeutics and Sigilon Therapeutics.

The letter stated no concerns with the clinical data package the safety for the label.

We will continue to work with the third party manufacturer and the FDA to address the findings to make <unk> available to patients as quickly as possible.

In terms of business development, we once again had a very active quarter in Q3, we completed the divestiture of the Olanzapine portfolio, which will further enable us to focus on our current and new product launches the.

Dave Ricks: The financial impact of this transaction is reflected in the Q3 results.

Dave Ricks: Additionally, within the quarter, we completed the acquisition of two clinical stage companies, adding to our phase II portfolio, Dice Therapeutics and Versanis Bio. As well as the acquisition of Emergence Therapeutics and Sigilon Therapeutics. We also announced that we reached an agreement to acquire Point Biopharma, which if approved, hs the potential to expand our oncology capabilities into next generation radio ligand therapies.

David Ricks: We also announced that we reached an agreement to acquire Point Biopharma, which if approved has the potential to expand our oncology capabilities into next-generation radioligand therapies. Lastly, we distributed over $1 billion in dividends this quarter. On slide 5, you'll see a list of key events since our Q2 call, including several important regulatory, clinical, and other updates we are sharing today. Now let me turn the call over to Anat to review our Q3.

We also announced that we reached an agreement to acquire Point Biopharma, which if approved has the potential to expand our oncology capabilities into next-generation radioligand therapies. Lastly, we distributed over $1 billion in dividends this quarter. On slide 5, you'll see a list of key events since our Q2 call, including several important regulatory, clinical, and other updates we are sharing today. Now let me turn the call over to Anat to review our Q3.

Potential to expand our oncology capabilities into next generation radio ligand therapies.

Dave Ricks: And lastly, we distributed over $1 billion in dividends this quarter. On Slide 5 you'll see a list of key events since our Q2 call, including several important regulatory clinical and other updates we are sharing today. Now, let me turn the call over to Anat to review our Q3 results.

On slide five Youll see a list of key events since our Q2 call, including several important regulatory clinical and other updates we are sharing today now.

Now, let me turn the call over to or not to review our Q3 results.

Anat Ashkenazi: Results. Thanks, Dave. Slide 6 summarizes financial performance in the third quarter of 2023. I'll focus my comments on non-GAAP performance. We're pleased with the strong financial performance this quarter, highlighted by continued acceleration of revenue growth representing robust momentum in our core business. Q3 revenue increased 37% versus Q3 2022, excluding revenue from the Olanzapine portfolio and from the COVID-19 antibodies. Revenue increased 24% in Q3. This represents a core of a core acceleration revenue growth driven by Mounjaro and the continued strong performance of Verzenio and Jardiance. Gross margin as a percent of revenue increased to 81.7%. Gross margin in the quarter benefited from the divestiture of the Olanzapine portfolio. The absence of COVID-19 antibody sales in Q3 2023 and high realized prices partially offset by increases in manufacturing expenses.

Anat Ashkenazi: Thanks, Dave. Slide 6 summarizes financial performance in the third quarter of 2023, I'll focus my comments on non-GAAP performance. We're pleased with our strong financial performance this quarter, highlighted by continued acceleration of revenue growth. Representing robust momentum in our core business. Q3 revenue increased 37% versus Q3 2022, excluding revenue from the Olanzapine portfolio and from the COVID-19 antibody, revenue increased 24% in Q3.

Slide six summarizes <unk> financial performance in the third quarter of 2023, I'll focus my comments on non-GAAP performance.

We're pleased with our strong financial performance. This quarter highlighted by continued acceleration of revenue growth representing robust momentum in our core business Q3 revenue increased 37% versus Q3 2022, excluding revenue from the Olanzapine portfolio and from the COVID-19 antibody revenue increased 24 person.

Anat Ashkenazi: This represents the core of the core acceleration revenue growth, driven by Mounjaro and the continued strong performance of Verzenio and Jariance. Gross margin as a percent of revenue increased to 81.7%. Gross margin in the quarter benefited from the divestiture of the Olanzapine portfolio. The absence of COVID-19 antibody sales in Q3 2023 and higher realized prices, partially offset by increases in manufacturing expenses.

This represents the core of the core acceleration revenue growth driven by <unk> and the continued strong performance of <unk>.

Gross margin as a percent of revenue increased to 81, 7%.

Gross margin in the quarter benefited from the divestiture of the Olanzapine portfolio. The absence of COVID-19 antibody sales in Q3 2023.

Higher realized prices, partially offset by increases in manufacturing expenses.

Anat Ashkenazi: Marketing, sales, and administrative expenses increased 12%, primarily driven by higher expenses associated with new product launches, and additional indications, as well as compensation and benefit costs. R&D expenses increased 34%, primarily driven by higher development expenses for late-stage assets and additional investments in early-stage research. This quarter, we recognized acquired IPR&D charges of $2.98 billion, which negatively impacted EPS by $3.29. In Q3 2022, acquired IPR&D charges totaled $62 million or $0.06 of EPS.

Marketing, sales, and administrative expenses increased 12%, primarily driven by higher expenses associated with new product launches, and additional indications, as well as compensation and benefit costs. R&D expenses increased 34%, primarily driven by higher development expenses for late-stage assets and additional investments in early-stage research. This quarter, we recognized acquired IPR&D charges of $2.98 billion, which negatively impacted EPS by $3.29. In Q3 2022, acquired IPR&D charges totaled $62 million or $0.06 of EPS.

Anat Ashkenazi: Marketing selling and administrative expenses increased 12%, primarily driven by higher expenses associated with new product launches in additional indications, as well as compensation and benefit costs. R&D expenses increased 34%, primarily driven by higher development expenses for late stage asset and additional investments in early stage research. This quarter, we recognized acquired IPR&D charges of $2.98 billion, which negatively impacted EPS by $3,29.

R&D expenses increased 34%, primarily driven by higher development expenses for late stage asset and additional investments in early stage research.

This quarter, we recognized acquired IP R&D charges of $2 $98 billion, which negatively.

<unk> impacted EPS by $3 in 2009.

Anat Ashkenazi: In Q3, 2022 acquired IPR&D charges totaled $62 million or 6c of EPS. Operating income decreased 71% in Q3, driven by acquired IPR&D charges, partially offset by higher revenue associated with the divestiture of the Olanzapine portfolio. Operating income as a percent of revenue was approximately 6% for the quarter and reflected a negative impact of approximately 31 percentage points, attributable to acquired IPR&D charges. Our Q3 effective tax rate was 84.6%.

Anat Ashkenazi: Operating income decreased 71% in Q3 driven by acquired IPR&D charges, partially offset by higher revenue associated with the divestiture of the Olanzapine portfolio. Operating income as a percent of revenue was approximately 6% for the quarter and reflected a negative impact of approximately 31 percentage points attributable to acquired IPR&D charges. Our Q3 effective tax rate was 84.6%. This represents an increase of approximately 74 percentage points compared to the same period in 2022. The increase in the effective tax rate was primarily driven by the non-deductible acquired IPR&D charges incurred this quarter. Other than the impact of acquired IPR&D, the underlying tax rate was consistent with previously provided guidance.

Operating income decreased 71% in Q3 driven by acquired IPR&D charges, partially offset by higher revenue associated with the divestiture of the Olanzapine portfolio. Operating income as a percent of revenue was approximately 6% for the quarter and reflected a negative impact of approximately 31 percentage points attributable to acquired IPR&D charges. Our Q3 effective tax rate was 84.6%. This represents an increase of approximately 74 percentage points compared to the same period in 2022. The increase in the effective tax rate was primarily driven by the non-deductible acquired IPR&D charges incurred this quarter. Other than the impact of acquired IPR&D, the underlying tax rate was consistent with previously provided guidance.

Operating income decreased 71% in Q3, driven by acquired IP R&D charges, partially offset by higher revenue associated with the divestiture of the Olanzapine portfolio.

Operating income as a percent of revenue was approximately 6% for the quarter and reflected a negative impact of approximately 31 percentage points attributable to acquired IP R&D charges.

Our Q3 effective tax rate was 84, 6%.

Anat Ashkenazi: This represents an increase of approximately 74 percentage points compared to the same period in 2022. The increase in the effective tax rate was primarily driven by the nondeductible acquired IPR&D charges incurred this quarter. Other than the impact of the acquired IPR&D the underlying tax rate was consistent with previously provided guidance. At the bottom line, we delivered earnings per share of 10c in Q3, and 95 decrease versus Q3 2022, inclusive of an increase of $1.22 of EPS associated with the divestiture of the Olanzapine portfolio and a negative impact of $3,29. From the acquired IPR&D charges. On slide eight we quantify the effect of price rate and volume and revenue growth. This quarter U S revenue increased 21% when excluding revenue from the Olanzapine portfolio in COVID-19 antibody U S revenue grew 32% driven by robust growth of <unk> and <unk>. Net price in the U S increased 13% for the quarter, driven by Monteiro axis and savings cards dynamics. Excluding <unk> net price in the U S decreased by high single digits.

The increase in the effective tax rate was primarily driven by the nondeductible acquired IP R&D charges incurred this quarter.

Other than the impact of the acquired IP R&D the underlying tax rate was consistent with previously provided guidance.

Anat Ashkenazi: At the bottom line, we delivered earnings per share of $0.10 in Q3, a 95% decrease versus Q3 2022, inclusive of an increase of $1.22 of EPS associated with the divestiture of the Olanzapine portfolio and a negative impact of $3.29 from the acquired IPR&D charges.

At the bottom line, we delivered earnings per share of $0.10 in Q3, a 95% decrease versus Q3 2022, inclusive of an increase of $1.22 of EPS associated with the divestiture of the Olanzapine portfolio and a negative impact of $3.29 from the acquired IPR&D charges.

At the bottom line, we delivered earnings per share of <unk> 10 in Q3, and 95 decrease versus Q3 2022 inclusive of an increase of $1.22 of EPS associated with the divestiture of the Olanzapine portfolio and a negative impact of $3 29.

Anat Ashkenazi: From the acquired IPR&D charges. On slide eight we quantify the effect of price rate and volume and revenue growth. This quarter U S revenue increased 21% when excluding revenue from the Olanzapine portfolio in COVID-19 antibody U S revenue grew 32% driven by robust growth of <unk> and <unk>. Net price in the U S increased 13% for the quarter, driven by Monteiro axis and savings cards dynamics. Excluding <unk> net price in the U S decreased by high single digits.

Anat Ashkenazi: On slide 8, we quantify the effect of price, rate, and volume on revenue growth this quarter. US revenue increased 21% when excluding revenue from the Olanzapine portfolio and COVID-19 antibodies. US revenue grew 32% driven by robust growth of Mounjaro, Verzenio, and Jardiance. Net price in the US increased 13% for the quarter driven by Mounjaro access and savings cards dynamics. Excluding Mounjaro, net price in the US decreased by high single digit. As mentioned in prior earnings calls, we expected Mounjaro access and savings card dynamics to have a meaningful impact on reported US price changes in the second half of 2023, which was evident in Q3.

On slide 8, we quantify the effect of price, rate, and volume on revenue growth this quarter. US revenue increased 21% when excluding revenue from the Olanzapine portfolio and COVID-19 antibodies. US revenue grew 32% driven by robust growth of Mounjaro, Verzenio, and Jardiance. Net price in the US increased 13% for the quarter driven by Mounjaro access and savings cards dynamics. Excluding Mounjaro, net price in the US decreased by high single digit. As mentioned in prior earnings calls, we expected Mounjaro access and savings card dynamics to have a meaningful impact on reported US price changes in the second half of 2023, which was evident in Q3.

Anat Ashkenazi: On Slide 8 we quantify the effect of price rate and volume and revenue growth. This quarter U.S revenue increased 21%, when excluding revenue from the Olanzapine portfolio and COVID-19 antibodies, U.S revenue grew 32%, driven by robust growth of Mounjaro, Verzenio and Jardiance. Net price in the U.S increased 13% for the quarter, driven by Mounjaro axis and savings cards dynamics. Excluding Mounjaro, net price in the U.S decreased by high single digits.

On slide eight we quantify the effect of price rate and volume and revenue growth. This quarter U S revenue increased 21% when excluding revenue from the Olanzapine portfolio in COVID-19 antibody U S revenue grew 32% driven by robust growth of <unk> and <unk>.

Net price in the U S increased 13% for the quarter, driven by Monteiro axis and savings cards dynamics.

Excluding <unk> net price in the U S decreased by high single digits.

Anat Ashkenazi: As mentioned in prior earnings calls, we expected Mounjaro axis and saving card dynamics to have a meaningful impact on reported U.S price changes in the second half of 2023, which was evident in Q3. Europe continued to post robust growth again this quarter. Excluding revenue from the Olanzapine divestiture, revenue was up 7% in constant currency driven by volume growth of 11% primarily from Verzenio, Jardiance and Taltz. For Japan, Q3 revenue decreased 16% in constant currency.

Anat Ashkenazi: Europe continued to post robust growth again this quarter excluding revenue from the Olanzapine divestiture. Revenue was up 7% in constant currency driven by volume growth of 11% primarily from Verzenio, Jardiance, and Taltz. For Japan, Q3 revenue decreased 16% in constant currency excluding Mounjaro, which had a one-time upfront payment associated with the sales collaboration agreement in the base period. Revenue in Japan decreased 3% in constant currency driven primarily by customer buying patterns related to Emgality. Moving to China, revenue increased 20% in constant currency with volume growth of 25% partially offset by price decline. Volume growth in Q3 was driven by Tyvyt and Verzenio. We're encouraged by the growth we have seen this year in China. Revenue in the rest of the world increased 23% in constant currency as volume growth of 28% was driven by Mounjaro, Verzenio, and Jardiance.

Europe continued to post robust growth again this quarter excluding revenue from the Olanzapine divestiture. Revenue was up 7% in constant currency driven by volume growth of 11% primarily from Verzenio, Jardiance, and Taltz. For Japan, Q3 revenue decreased 16% in constant currency excluding Mounjaro, which had a one-time upfront payment associated with the sales collaboration agreement in the base period. Revenue in Japan decreased 3% in constant currency driven primarily by customer buying patterns related to Emgality. Moving to China, revenue increased 20% in constant currency with volume growth of 25% partially offset by price decline. Volume growth in Q3 was driven by Tyvyt and Verzenio. We're encouraged by the growth we have seen this year in China. Revenue in the rest of the world increased 23% in constant currency as volume growth of 28% was driven by Mounjaro, Verzenio, and Jardiance.

Europe continued to post robust growth against this again this quarter excluding revenue from the Olanzapine divestiture revenue was up 7% in constant currency driven by volume growth of 11% primarily from presenting a majority of <unk>.

For Japan, Q3 revenue decreased 16% in constant currency.

Anat Ashkenazi: Excluding Mounjaro, which had a one time upfront payment associated with the sales collaboration agreement in the base period, revenue in Japan decreased 3% in constant currency, driven primarily by customer buying patterns related to Emgality. Moving to China, revenue increased 20% in constant currency with volume growth of 25%, partially offset by price declines.

Moving to China revenue increased 20% in constant currency with volume growth of 25%, partially offset by price declines.

Anat Ashkenazi: Volume growth in Q3 was driven by [inaudible] and Verzenio. We're encouraged by the growth we have seen this year in China. Revenue in the rest of the world increased 23% in constant currency, as volume growth of 28% was driven by Mounjaro, Verzenio and Jardiance. Slide 9 shows the contribution to worldwide volume growth by product category. As you can see, the new products and growth product categories combined contributed approximately 17 percentage points of volume growth for the quarter.

We're encouraged by the growth we have seen this year in China.

Revenue in the rest of the world increased 23% in constant currency as volume growth of 28% was driven by my child, Virginia and Giants.

Anat Ashkenazi: Slide 9 shows the contribution to worldwide volume growth by product category. As you can see, the new products and gross product categories combined contribute approximately 17 percentage points of volume growth for the quarter. The absence of revenue from COVID-19 antibodies compared to the base period was a headwind of nearly 6 percentage points to volume in Q3. This headwind will abate as COVID-19 antibody sales were minimal after the third quarter of 2022. Lastly, revenue from the sales of rights to the Olanzapine Portfolio delivered nearly 22 percentage points of growth this quarter.

Slide 9 shows the contribution to worldwide volume growth by product category. As you can see, the new products and gross product categories combined contribute approximately 17 percentage points of volume growth for the quarter. The absence of revenue from COVID-19 antibodies compared to the base period was a headwind of nearly 6 percentage points to volume in Q3. This headwind will abate as COVID-19 antibody sales were minimal after the third quarter of 2022. Lastly, revenue from the sales of rights to the Olanzapine Portfolio delivered nearly 22 percentage points of growth this quarter.

Slide nine shows the contribution to worldwide volume growth by product category.

As you can see the new products and growth product categories combined contributed approximately 17 percentage points of volume growth for the quarter.

Anat Ashkenazi: The absence of revenue from COVID-19 antibodies compared to the base period was a headwind of nearly 6 percentage points to volume in Q3. This headwind will abate as COVID-19 antibody sales were minimal after the third quarter of 2022.

This headwind will abate as COVID-19 antibody sales were minimal after the third quarter of 2022.

Anat Ashkenazi: Lastly, revenue from the sales of rights to the Olanzapine portfolio delivered nearly 22 percentage points of growth this quarter. Slide 10 provides additional perspective across our product categories. First, I would like to highlight Verzenio, which is a worldwide sales growth of 68% in Q3, driven by robust volume growth. The continued posted positive momentum is driven by the early breast cancer indication, with steady performance in the metastatic indication.

Anat Ashkenazi: Slide 10 provides additional perspective across our product categories. First, I would like to highlight Verzenio, which saw worldwide sales growth of 68% in Q3 driven by robust volume growth. The continued positive momentum is driven by the early breast cancer indication with steady performance in the metastatic indication. Jardiance continued its strong 2023 performance with worldwide revenue growth of 22% for the quarter. As you heard earlier in Q3, Jardiance was approved by the FDA for the treatment of adult with chronic kidney disease at risk of progression.

Slide 10 provides additional perspective across our product categories. First, I would like to highlight Verzenio, which saw worldwide sales growth of 68% in Q3 driven by robust volume growth. The continued positive momentum is driven by the early breast cancer indication with steady performance in the metastatic indication. Jardiance continued its strong 2023 performance with worldwide revenue growth of 22% for the quarter. As you heard earlier in Q3, Jardiance was approved by the FDA for the treatment of adult with chronic kidney disease at risk of progression.

Slide 10 provides additional perspective across our product categories.

First I would like to highlight for us any of them, which is a worldwide sales growth of 68% in Q3, driven by robust volume growth there.

The continued posted positive momentum is driven by the early breast cancer cancer indication with steady performance in the metastatic indication.

Anat Ashkenazi: Jardiance continued its strong 2020 performance with worldwide revenue growth of 22% for the quarter. As you heard earlier, in Q3 to Jardiance was approved by the FDA for the treatment of adults with chronic kidney disease at risk of progression. In Q3, we sell worldwide Trulicity revenue declined 10% as volume growth in the U.S was more than offset by lower prices, driven by changes to estimates for rebates and discounts in both periods. As well as unfavorable segment mix and higher contracted rebates.

As you heard earlier in Q3 to audience was approved by the FDA for the treatment of adults with chronic kidney disease at risk of progression.

Anat Ashkenazi: In Q3, we saw worldwide Trulicity revenue decline 10% as volume growth in the US was more than offset by lower prices driven by changes to estimates for rebates and discounts in both periods, as well as unfavorable segment mix and higher contracted rebates in international markets. Trulicity volume continues to be affected by measures we have taken to minimize potential disruption to existing patients, including communications to healthcare professionals not to start new patients on Trulicity. Moving to Slide 11, we continue to be pleased with the strong performance of Mounjaro as more type 2 diabetes patients benefit from the medicine. Mounjaro revenue grew to just over $1.4 billion globally this quarter, up from $980 million the previous quarter. In Q3, we continue to make progress in expanding access to Mounjaro.

In Q3, we saw worldwide Trulicity revenue decline 10% as volume growth in the US was more than offset by lower prices driven by changes to estimates for rebates and discounts in both periods, as well as unfavorable segment mix and higher contracted rebates in international markets. Trulicity volume continues to be affected by measures we have taken to minimize potential disruption to existing patients, including communications to healthcare professionals not to start new patients on Trulicity. Moving to Slide 11, we continue to be pleased with the strong performance of Mounjaro as more type 2 diabetes patients benefit from the medicine. Mounjaro revenue grew to just over $1.4 billion globally this quarter, up from $980 million the previous quarter. In Q3, we continue to make progress in expanding access to Mounjaro.

In Q3, we sell worldwide <unk> revenue declined 10% as volume growth in the U S was more than offset by lower prices driven by changes to estimates for rebates and discounts in both periods as well as unfavorable segment mix and higher contracted rebates.

Anat Ashkenazi: In international markets, Trulicity volume continues to be affected by measures we have taken to minimize potential disruption to existing patients, including communications to health care professionals, not to start new patients on Trulicity. Moving to Slide 11, we continue to be pleased with the strong performance of Mounjaro as more type two diabetes patients benefit from the medicine. Mounjaro revenue grew to just over $1.4 billion globally this quarter, up from $980 million the previous quarter.

Moving to slide 11, we continue to be pleased with the strong performance of <unk> is more type two diabetes patients benefit from the medicine.

<unk> revenue grew to just over $1 $4 billion globally, this quarter up from $980 million the previous quarter.

Anat Ashkenazi: In Q3, we continued to make progress in expanding access to Mounjaro. As of October 1st, access for patients with type two diabetes in the U.S reached 78% in aggregate across commercial and part D, including 85% access for commercial patients. This expanded access gives more patients the opportunity to start therapy on Mounjaro for type 2 diabetes. As communicated last quarter, since the $25 non-covered copay card program expired on June 30th, we now considered all prescriptions paid.

Anat Ashkenazi: As of 1 October, access for patients with type 2 diabetes in the US reached 78% in aggregate across commercial and Part D, including 85% access for commercial patients. This expanded access gives more patients the opportunity to start therapy on Mounjaro for type 2 diabetes. As communicated last quarter. Since the $25 non-covered copay card program expired on 30 June, we now consider all prescriptions paid. As a reminder, we define paid scripts as those prescriptions outside of the $25 non-covered copay card but inclusive of the $25 covered copay card. We expect Mounjaro net price will continue to benefit from the higher percentage of paid prescriptions, but we'll also continue to face a headwind from more rebated volume as access improves. Looking forward to the end of the year with increased access, we expect to continue to see overall growth in prescription trends.

As of 1 October, access for patients with type 2 diabetes in the US reached 78% in aggregate across commercial and Part D, including 85% access for commercial patients. This expanded access gives more patients the opportunity to start therapy on Mounjaro for type 2 diabetes. As communicated last quarter. Since the $25 non-covered copay card program expired on 30 June, we now consider all prescriptions paid. As a reminder, we define paid scripts as those prescriptions outside of the $25 non-covered copay card but inclusive of the $25 covered copay card. We expect Mounjaro net price will continue to benefit from the higher percentage of paid prescriptions, but we'll also continue to face a headwind from more rebated volume as access improves. Looking forward to the end of the year with increased access, we expect to continue to see overall growth in prescription trends.

This expanded access gives more patients the opportunity to start therapy on <unk> for type two diabetes.

As communicated last quarter since the $25 non covered copay card program expired on June 30, we now considered all prescriptions paid.

Anat Ashkenazi: As a reminder, we define paid scripts as those prescriptions outside of the 25 dollar non covered copay card, but inclusive of the $25 cover copay card. We expect Mounjaro net price will continue to benefit from the higher percentage of paid prescriptions, but we'll also continue to face a headwind from more related volume as access improves. Looking forward to the end of the year with increased access we expect to continue to see overall growth in prescription trends.

But inclusive of the $25 cover copay card.

We expect much of our net price will continue to benefit from the higher percentage of paid prescriptions, but we'll also continue to face a headwind from more related volume as access improves.

Looking forward to the end of the year with increased access we expect to continue to see overall growth in prescription trends.

Anat Ashkenazi: In terms of Mounjaro supply, we're continuing to make progress on our manufacturing expansion agenda. Given strong demand, we continue to experience tight supply throughout most of Q3, which impacted results for the quarter. Most recently, US product shipments have increased and inventory levels at US wholesalers have improved with all doses of Mounjaro now listed as available on the FDA Shortage website.

In terms of Mounjaro supply, we're continuing to make progress on our manufacturing expansion agenda. Given strong demand, we continue to experience tight supply throughout most of Q3, which impacted results for the quarter. Most recently, US product shipments have increased and inventory levels at US wholesalers have improved with all doses of Mounjaro now listed as available on the FDA Shortage website.

Anat Ashkenazi: In terms of Mounjaro supply, we're continuing to make progress on our manufacturing expansion agenda. Given strong demand, we continued to experience tight supply throughout most of Q3, which impacted results for the quarter. Most recently, U.S product shipments have increased inventory levels at U.S wholesalers have improved with all doses of Mounjaro now listed as available on the FDA shortage website. While supply constraints have eased in the U.S, outside the U.S Trulicity and Mounjaro supply remains tight, which materially impacted performance in these regions.

Given strong demand, we continued to experience tight supply throughout most of Q3, which impacted results for the quarter.

Most recently U S product shipments have increased inventory levels at U S. Wholesalers have improved with all doses of <unk> are now listed as available on the FDA shortage website.

Anat Ashkenazi: While supply constraints have eased in the US, outside the US, Trulicity and outside the US, Mounjaro supply remains tight, which materially impacted performance in these regions. With device assembly online at RTP, we are on track to achieve our goal of doubling capacity by the end of this year from where we were a year ago and we're gradually increasing production each quarter. We're also continuing to focus on other parts of the supply chain as demand is expected to remain high and production bottlenecks may shift over time.

While supply constraints have eased in the US, outside the US, Trulicity and outside the US, Mounjaro supply remains tight, which materially impacted performance in these regions. With device assembly online at RTP, we are on track to achieve our goal of doubling capacity by the end of this year from where we were a year ago and we're gradually increasing production each quarter. We're also continuing to focus on other parts of the supply chain as demand is expected to remain high and production bottlenecks may shift over time.

While supply constraints have eased in the U S outside the U S to listed in outside the U S are lifted and much of our supply remains tight which materially impacted performance in these regions.

Anat Ashkenazi: With device Assembly online at RTP, we are on track to achieve our goal of doubling capacity by the end of this year from where we were a year ago. And we are gradually increasing production each quarter. We're also continuing to focus on other parts of the supply chain as demand is expected to remain high and production bottlenecks may shift over time. As we mentioned in last quarter's earnings call, we are moving forward with different presentation of Mounjaro to reach more patients around the world faster.

We're also continuing to focus on other parts of the supply chain as the man is expected to remain high and production bottlenecks may shift over time.

Anat Ashkenazi: As we mentioned in last quarter's earnings call, we are moving forward with different presentation of Mounjaro to reach more patients around the world faster. We have launched with a single-dose vial in Australia and plan to launch in other markets outside the US in the coming weeks and months. The introduction of a single-dose vial presentation in these geographies is intended to serve as a bridge to a multi-dose KwikPen which we expect will be available starting in 2024.

As we mentioned in last quarter's earnings call, we are moving forward with different presentation of Mounjaro to reach more patients around the world faster. We have launched with a single-dose vial in Australia and plan to launch in other markets outside the US in the coming weeks and months. The introduction of a single-dose vial presentation in these geographies is intended to serve as a bridge to a multi-dose KwikPen which we expect will be available starting in 2024.

As we mentioned in last quarter's earnings call. We are moving forward with different presentation of <unk> to reach more patients around the world faster.

Anat Ashkenazi: We have launched with the single dose vial in Australia and plan to launch in other markets outside the U.S in the coming weeks and months. The introduction of a single dose vial presentation these geographies is intended to serve as a bridge to a multi dose quick pen, which we expect will be available starting in 2024. We're also preparing for a potential launch of Tirzepatide for obesity in the U.S later this year. Our auto injector capacity and output continues to increase and we look forward to bring Tirzepatide to more patients in the months and years ahead.

The introduction of a single dose vial presentation. These geographies is intended to serve as a bridge to a multi dose quick pen, which we expect will be available starting in 2024.

Anat Ashkenazi: We're also preparing for a potential launch of Tirzepatide for obesity in the US later this year. Our auto injector capacity and output continues to increase and we look forward to bringing Tirzepatide to more patients in the months and years ahead.

We're also preparing for a potential launch of Tirzepatide for obesity in the US later this year. Our auto injector capacity and output continues to increase and we look forward to bringing Tirzepatide to more patients in the months and years ahead.

We're also preparing for a potential launch if there is appetite for obesity in the U S. Later this year.

Our auto injector capacity and output continues to increase and we look forward to bring <unk> to more patients in the months and years ahead.

Anat Ashkenazi: On slide 12, we provide an update on capital allocation in the first nine months of 2023. We invested nearly $12 billion in our future growth through a combination of R&D expenditures, capital investments, and business development outlays. In addition, we returned nearly $4 billion to shareholders in dividends and share repurchases.

On slide 12, we provide an update on capital allocation in the first nine months of 2023. We invested nearly $12 billion in our future growth through a combination of R&D expenditures, capital investments, and business development outlays. In addition, we returned nearly $4 billion to shareholders in dividends and share repurchases.

Anat Ashkenazi: On slide 12, we provide an update on capital allocation. In the first nine months of 2023, we invested nearly $12 billion in our future growth through a combination of R&D expenditures, capital investments and business development outlays. In addition, we returned nearly $4 billion to shareholders in dividends and share repurchases.

In addition, we returned nearly $4 billion to shareholders in dividends and share repurchases.

Anat Ashkenazi: Slide 13 presents our updated 2023 financial guidance.

Slide 13 presents our updated 2023 financial guidance.

Anat Ashkenazi: Slide 13 presents our updated 2023 financial guidance. Guidance for the first four line items, including revenue gross margin percent, marketing selling and administrative expenses and R&D expense is unchanged. I would note that we are trending towards the higher end of our estimates for gross margin and the top end of our ranges for operating expense categories. You'll see that we've updated guidance for acquired IPR&D charges, OID tax rate and EPS to reflect the inclusion of IPR&D charges for completed transactions through Q3 and year to date results and equity investments in GAAP guidance.

Anat Ashkenazi: Guidance for the first four line items including revenue, gross margin, percent marketing, selling, and administrative expenses, and R&D expense is unchanged. I would note that we are trending towards the higher end of our estimates for gross margin and the top end of our ranges for operating expense categories. You'll see that we've updated guidance for acquired IPR&D charges, effective tax rate, and EPS to reflect the inclusion of IPR&D charges for completed transactions through Q3 and year-to-date results and equity investments in GAAP guidance. These updates do not include the effect of potential charges associated with pending or future business development transaction. After Q3, we will provide our initial 2024 guidance when we report Q4 results. Now I will turn the call over to Dan to highlight our progress.

Guidance for the first four line items including revenue, gross margin, percent marketing, selling, and administrative expenses, and R&D expense is unchanged. I would note that we are trending towards the higher end of our estimates for gross margin and the top end of our ranges for operating expense categories. You'll see that we've updated guidance for acquired IPR&D charges, effective tax rate, and EPS to reflect the inclusion of IPR&D charges for completed transactions through Q3 and year-to-date results and equity investments in GAAP guidance. These updates do not include the effect of potential charges associated with pending or future business development transaction. After Q3, we will provide our initial 2024 guidance when we report Q4 results. Now I will turn the call over to Dan to highlight our progress.

Guidance for the first four line items, including revenue gross margin percent marketing selling and administrative expenses and R&D expense is unchanged.

Note that we are trending towards the higher end of our estimates for gross margin and the top end of our ranges for operating expense categories.

You'll see that we've updated guidance for acquired IP R&D charges OID tax rate and EPS to reflect the inclusion of IP R&D charges for completed transactions through Q3 and year to date results and equity investments in GAAP guidance.

Anat Ashkenazi: These updates do not include the effect of potential charges associated with pending or future business development transaction after Q3. We will provide our initial 2024 guidance when we report Q4 results. Now I will turn the call over to Dan to highlight our progress in R&D. This quarter, we had significant pipeline progress as well as a high volume of activity at the major medical Congresses, where he presented new data on multiple products across all of our therapeutic areas.

We will provide our initial 2024 guidance when we report Q4 results.

Now I will turn the call over to Dan to highlight our progress in R&D.

Daniel Skovronsky: In R&D. Thanks, Anat. This quarter we had significant pipeline progress as well as a high volume of activity at the major medical congresses where we presented new data on multiple products across all of our therapeutic areas, starting with oncology. Since our last earnings call, we announced top-line results from the Libretto-531 study evaluating Retevmo versus physician's choice of multikinase inhibitors as an initial treatment for patients with advanced or metastatic RET-mutant medullary thyroid cancer. As we presented at ESMO, the study met its primary endpoint, demonstrating a 72% improvement in progression-free survival compared to cabozantinib or vandetanib. These data should establish Retevmo as the standard of care for the initial systemic treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer, and we have work to do to ensure that all of these patients are identified and properly diagnosed.

Dan Skovronsky: In R&D. Thanks, Anat. This quarter we had significant pipeline progress as well as a high volume of activity at the major medical congresses where we presented new data on multiple products across all of our therapeutic areas, starting with oncology. Since our last earnings call, we announced top-line results from the Libretto-531 study evaluating Retevmo versus physician's choice of multikinase inhibitors as an initial treatment for patients with advanced or metastatic RET-mutant medullary thyroid cancer. As we presented at ESMO, the study met its primary endpoint, demonstrating a 72% improvement in progression-free survival compared to cabozantinib or vandetanib. These data should establish Retevmo as the standard of care for the initial systemic treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer, and we have work to do to ensure that all of these patients are identified and properly diagnosed.

Daniel M. Skovronsky: Thanks, Anat. This quarter, we had significant pipeline progress, as well as a high volume of activity at the major medical congresses, where he presented new data on multiple products across all of our therapeutic areas. Starting with oncology, since our last earnings call, we announced topline results from the Libretto 531 study evaluating Retevmo versus physicians choice of multi kinase inhibitors as an initial treatment for patients with advanced or metastatic ret-mutant medullary thyroid cancer.

This quarter, we had significant pipeline progress as well as a high volume of activity at the major medical Congresses, where he presented new data on multiple products across all of our therapeutic areas.

Starting with oncology since our last earnings call, we announced topline results from the libretto 531 study evaluating <unk> versus physicians choice of multi kinase inhibitors as an initial treatment for patients with advanced or metastatic ret mutant medullary thyroid cancer.

Daniel Benjamin Ziment: As we presented at ESMO, the study met its primary endpoint, demonstrating a 72% improvement in progression free survival compared to cabozantinib or vendetanib. These data should establish Retevmo as the standard of care for the initial systemic treatment of patients with progressive advanced ret-mutant medullary thyroid cancer. And we have work to do to ensure that all of these patients are identified and properly diagnosed.

These data should establish <unk> as the standard of care for the initial systemic treatment of patients with progressive advanced Ret mutant medullary thyroid cancer and we have work to do to ensure that all of these patients are identified and properly diagnosed.

Daniel Skovronsky: We also shared detailed data from the Phase 3 Libretto 431 study at ESMO in October showing that Retevmo more than doubled progression-free survival compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic RET fusion-positive non-small cell lung cancer. We hope these data, in addition to others recently published for other driver-positive lung cancers, will help accelerate genomic profiling at lung cancer diagnosis to guide initial treatment selection. The results of Libretto 531 and of Libretto 431 were each simultaneously published in the New England Journal of Medicine. Also at ESMO, we shared landmark five-year results from a preplanned interim analysis of the Phase 3 Monarch E study evaluating Verzenio in combination with endocrine therapy compared to endocrine therapy alone in patients with HR-positive, HER2-negative, node-positive early breast cancer at a high risk of recurrence.

We also shared detailed data from the Phase 3 Libretto 431 study at ESMO in October showing that Retevmo more than doubled progression-free survival compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic RET fusion-positive non-small cell lung cancer. We hope these data, in addition to others recently published for other driver-positive lung cancers, will help accelerate genomic profiling at lung cancer diagnosis to guide initial treatment selection. The results of Libretto 531 and of Libretto 431 were each simultaneously published in the New England Journal of Medicine. Also at ESMO, we shared landmark five-year results from a preplanned interim analysis of the Phase 3 Monarch E study evaluating Verzenio in combination with endocrine therapy compared to endocrine therapy alone in patients with HR-positive, HER2-negative, node-positive early breast cancer at a high risk of recurrence.

Daniel M. Skovronsky: We also shared detailed data from the phase III Libretto 431 study at ESMO in October, showing that Retevmo more than doubled progression free survival, compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic ret-fusion positive non small cell lung cancer. We hope these, data in addition to others recently published for other driver positive lung cancers will help accelerate genomic profiling at lung cancer diagnosis, to guide to initial treatment selection.

We hope these data in addition to others recently published for other driver positive lung cancers will help accelerate genomic profiling at lung cancer diagnosis to guide to initial treatment selection.

Daniel M. Skovronsky: The results of Libretto 531 and of Libretto 431 were each simultaneously published in the New England Journal of Medicine. Also at ESMO, we showed landmark five year results from a preplanned interim analysis of the phase III monarchE study evaluating Verzenio in combination with endocrine therapy. Compared to endocrine therapy alone in patients with HR positive, HER-2 negative node positive early breast cancer at a high risk of recurrence.

Also at ESMO, We showed landmark five year results from a pre planned interim analysis of the phase III monarch E study evaluating <unk> in combination with endocrine therapy.

Paired to endocrine therapy alone in patients with HR positive her two negative node positive early breast cancer at a high risk of recurrence.

Daniel Skovronsky: The impact of two years of Verzenio treatment is observed well beyond the treatment period, reducing the risk of long-term recurrence by 32% at 5 years. These data reinforced two years of Verzenio plus endocrine therapy as the standard of care for high-risk early breast cancer patients. Lastly, we shared data on Imlunestrant, our oral SERD being studied in Phase 3 as a single agent and in combination therapy. The data shared included the first clinical data for imlunestrant in combination with everolimus or Alpelisib, as well as updated monotherapy from the Phase 1 EMBER study in patients with ER-positive HER2-negative advanced breast cancer. We hope that Imlunestrant could be an important future endocrine therapy backbone in certain settings of breast cancer, and these new data show that the medicine can be safely combined with other agents utilized with endocrine therapy in advanced breast cancer.

The impact of two years of Verzenio treatment is observed well beyond the treatment period, reducing the risk of long-term recurrence by 32% at 5 years. These data reinforced two years of Verzenio plus endocrine therapy as the standard of care for high-risk early breast cancer patients. Lastly, we shared data on Imlunestrant, our oral SERD being studied in Phase 3 as a single agent and in combination therapy. The data shared included the first clinical data for imlunestrant in combination with everolimus or Alpelisib, as well as updated monotherapy from the Phase 1 EMBER study in patients with ER-positive HER2-negative advanced breast cancer. We hope that Imlunestrant could be an important future endocrine therapy backbone in certain settings of breast cancer, and these new data show that the medicine can be safely combined with other agents utilized with endocrine therapy in advanced breast cancer.

Daniel Benjamin Ziment: The impact of two years of Verzenio treatment is observed well beyond the treatment period, reducing the risk of long term recurrence by 32% at five years. These data reinforce two years of Verzenio plus endocrine therapy as the standard of care for high risk early breast cancer patients.

These data reinforce two years of residual plus endocrine therapy.

The standard of care for high risk early breast cancer patients.

Daniel M. Skovronsky: Lastly, we shared data on Imlunestrant, our oral [inaudible] being studied in phase III, as a single agent and in combination therapy. The data shared included the first clinical data for Imlunestrant in combination with Everolimus or Apelisib, as well as updated monotherapy from the phase I [inaudible] study in patients with ER positive, HER-2 negative advanced breast cancer. We hope that Imlunestrant could be an important future endocrine therapy backbone in certain settings of breast cancer. And these new data showed that the medicine can be safely combined with other agents, utilized with endocrine therapy in advanced breast cancer.

The data shared included the first clinical data for inland estrogen in combination with everolimus or ALP illicit as well as updated monotherapy from the phase <unk> study in patients with ER positive her two negative advanced breast cancer.

We hope that inland upstream could be an important future under can therapy backbone in certain settings of breast cancer and these new data showed that the medicine can be safely combined with other agents utilize with endocrine therapy in advanced breast cancer.

Daniel Skovronsky: Looking earlier in our oncology pipeline, we shared preclinical data on three of our new pipeline agents at the Triple Meeting on Molecular Targets in Cancer Therapeutics in October. We shared preclinical data for first, a highly potent inhibitor of KRAS G12D that is selective against wild-type KRAS, second, a highly potent and isoform-selective pan-KRAS inhibitor which with activity against a broad spectrum of the most common activating KRAS mutations and high selectivity over wild-type HRAS and NRAS, and third, a fully human monoclonal anti-Nectin-4 antibody conjugated to a topoisomerase inhibitor. These programs are among the next slate of oncology agents we expect to enter the clinic over the next year. They represent years of focused work to create potentially differentiated molecules against exacting target product profiles.

Looking earlier in our oncology pipeline, we shared preclinical data on three of our new pipeline agents at the Triple Meeting on Molecular Targets in Cancer Therapeutics in October. We shared preclinical data for first, a highly potent inhibitor of KRAS G12D that is selective against wild-type KRAS, second, a highly potent and isoform-selective pan-KRAS inhibitor which with activity against a broad spectrum of the most common activating KRAS mutations and high selectivity over wild-type HRAS and NRAS, and third, a fully human monoclonal anti-Nectin-4 antibody conjugated to a topoisomerase inhibitor. These programs are among the next slate of oncology agents we expect to enter the clinic over the next year. They represent years of focused work to create potentially differentiated molecules against exacting target product profiles.

Daniel M. Skovronsky: Looking earlier in our oncology pipeline, we shared preclinical data on three of our new pipeline agents at the Triple meeting on molecular targets and cancer therapeutics in October. We shared preclinical data for first, a highly potent inhibitor of KRAS G12D that is selective against wild type KRAS.

We shared preclinical data for first a highly potent inhibitor of <unk> that is selective against wild type kers.

Daniel M. Skovronsky: Second, our highly potent and isoform selective pan-KRAS inhibitor with activity against a broad spectrum of the most common activating KRAS mutations and high selectivity over wild type HRAS and NRAS. And third, a fully human, monoclonal, anti nectin 4 antibody, conjugated to a towboat summaries inhibitor. These programs are among the next slate of oncology agents, we expect to enter the clinic over the next year. They represent years of focused work to create potentially differentiated molecules against exacting target product profiles.

And third a fully human monoclonal anti <unk> four antibody conjugated to a towboat summaries inhibitor.

These programs are among the next slate of oncology agents, we expect to enter the clinic over the next year.

Daniel M. Skovronsky: They represent years of focused work to create potentially differentiated molecules against exacting target product profiles.

Daniel Skovronsky: Turning to our diabetes and obesity portfolio in Q3, we announced the FDA approval of Jardiance for treatment of adults with chronic kidney disease at risk of progression. In the EMPA Kidney phase 3 trial, Jardiance significantly reduced the risk of kidney disease progression and cardiovascular deaths in adults with CKD. This approval adds to the treatment options for the more than 35 million adults in the US affected by chronic kidney disease since the last earnings call. We presented detailed results from the SURMOUNT-3 phase 3 clinical trial at the Obesity Week conference in October with the results simultaneously published in Nature Medicine. Also in October, we presented detailed results from the SURMOUNT-4 study at EASD. These results will be subsequently published in a top-tier peer-reviewed medical journal.

Turning to our diabetes and obesity portfolio in Q3, we announced the FDA approval of Jardiance for treatment of adults with chronic kidney disease at risk of progression. In the EMPA Kidney phase 3 trial, Jardiance significantly reduced the risk of kidney disease progression and cardiovascular deaths in adults with CKD. This approval adds to the treatment options for the more than 35 million adults in the US affected by chronic kidney disease since the last earnings call. We presented detailed results from the SURMOUNT-3 phase 3 clinical trial at the Obesity Week conference in October with the results simultaneously published in Nature Medicine. Also in October, we presented detailed results from the SURMOUNT-4 study at EASD. These results will be subsequently published in a top-tier peer-reviewed medical journal.

Turning to our diabetes and obesity portfolio.

In Q3, we announced the FDA approval of <unk> for treatment of adults with chronic kidney disease at risk of progression.

In the <unk> kidney phase III trial, Jordi and significantly reduced the risk of kidney disease progression and cardiovascular deaths in adults with C. J D.

This approval adds to the treatment options for the more than 35 million adults in the U S affected by chronic kidney disease.

Daniel M. Skovronsky: Turning to our diabetis and obesidy portfolio. In Q3, we announced the approval of Jardiance for treatment of adults with chronic kidney disease, at risk of progression. In the [inaudible] kidney phase III trial, Jardiance significantly reduced the risk of kidney disease progression in cardiovascular deaths in adults with CKD. This approval adds to the treatment options for the more than 35 million adults in the U.S affected by chronic kidney disease. Since the last earnings call. We presented detailed results from the surmount three phase III clinical trial at the obesity week conference in October with the results simultaneously published in nature Medicine.

Daniel M. Skovronsky: Since the last earnings call, we presented detailed results from the surmount 3 phase III clinical trial at the obesity week conference in October, with the results simultaneously published in Nature Medicine. Also in October, we presented detailed results from the surmount 4 study at EASD. These results will be subsequently published in a top tier peer reviewed medical journal. Data from these phase III trials of Tirzepatide showed that participants achieved up to 26.6% total mean weight loss.

Also in October we presented detailed results from the surmount four study at Eas D.

These results will be subsequently published in a top tier peer reviewed medical journal.

Daniel Skovronsky: Data from these phase 3 trials of tirzepatide showed that participants achieved up to 26.6% total mean weight loss. The detailed results from these studies clearly show the importance of continued therapy for sustained weight management and that if approved, tirzepatide could be an important part of obesity management for those having difficulty maintaining weight loss with diet and exercise alone.

Data from these phase 3 trials of tirzepatide showed that participants achieved up to 26.6% total mean weight loss. The detailed results from these studies clearly show the importance of continued therapy for sustained weight management and that if approved, tirzepatide could be an important part of obesity management for those having difficulty maintaining weight loss with diet and exercise alone.

Data from these phase III trials of tours appetite showed that participants achieved up to 26, 6% total mean weight loss.

Daniel M. Skovronsky: The detailed results from these studies clearly show the importance of continued therapy for sustained weight management. And that if approved, Trizepatide could be an important part of obesity management for those having difficulty maintaining weight loss with diet and exercise alone. Our pipeline, as shown on Slide 14, now includes a high dose Tirzepatide [inaudible] in phase two, since we've initiated the study exploring higher doses of Tirzepatide in participants with type two diabetes and obesity.

And that if approved <unk> appetite could be an important part of obesity management for those having difficulty maintaining weight loss with diet and exercise alone.

Daniel Skovronsky: Our pipeline, as shown on slide 14, now includes a high-dose tirzepatide next in phase 2 since we have initiated a study exploring higher doses of tirzepatide in participants with type 2 diabetes and obesity. Earlier in the pipeline, we presented phase 1 data on muvalaplin at the European Society of Cardiology Congress with simultaneous publication in JAMA. Muvalaplin is the first oral agent specifically developed to lower LP(a) levels. In this phase 1 study, muvalaplin was well tolerated by participants and resulted in dose-dependent lowering of LP(a) of up to 65%. Muvalaplin is currently in phase 2 as shown on slide 14. We have advanced our SCAP siRNA into phase 1 for NASH. We've also completed our acquisition of Versanis and now show bimagrumab in phase 2. We are excited about the potential combination of bimagrumab and tirzepatide.

Our pipeline, as shown on slide 14, now includes a high-dose tirzepatide next in phase 2 since we have initiated a study exploring higher doses of tirzepatide in participants with type 2 diabetes and obesity. Earlier in the pipeline, we presented phase 1 data on muvalaplin at the European Society of Cardiology Congress with simultaneous publication in JAMA. Muvalaplin is the first oral agent specifically developed to lower LP(a) levels. In this phase 1 study, muvalaplin was well tolerated by participants and resulted in dose-dependent lowering of LP(a) of up to 65%. Muvalaplin is currently in phase 2 as shown on slide 14. We have advanced our SCAP siRNA into phase 1 for NASH. We've also completed our acquisition of Versanis and now show bimagrumab in phase 2. We are excited about the potential combination of bimagrumab and tirzepatide.

Our pipeline as shown on slide 14, now includes a high dose <unk> appetite in ilex and phase two since we've initiated the study exploring higher doses of <unk> appetite and participants with type two diabetes and obesity.

Daniel M. Skovronsky: Earlier in the pipeline, we presented phase I data on Muvalaplin at the European Society of Cardiology Congress with simultaneous publication in Jama. Muvalaplin is the first oral agent specifically developed to lower LP little A levels. In this phase one study, Muvalaplin was well tolerated by participants and resulted in dose dependent lowering of LP little A of up to 65%. Muvalaplin is currently in phase II.

<unk> is the first oral agent specifically developed to lower LP little a levels in.

In this phase one study <unk> was well tolerated by participants and resulted in dose dependent lowering of LP little a of up to 65% <unk> is currently in phase II.

Daniel M. Skovronsky: As shown on slide 14, we've advanced our [inaudible] into phase one for Nash. We've also completed our acquisition of [inaudible] and now show Bimagrumab in phase two. We are excited about the potential combination of Bimagrumab and Tirzepatide. Lastly, we're happy to share that since our last earnings call, the [inaudible] trial phase III core registration trials are now all actively enrolling to pursue simultaneous indications for chronic weight management, obstructive sleep apnea and knee osteoarthritis.

We've also completed our acquisition of <unk> and now <unk> in phase two.

We are excited about the potential combination of <unk> and tours appetite.

Daniel Skovronsky: Lastly, we're happy to share that since our last earnings call, the retatrutide TRIUMPH Phase 3 Core Registration Trials are now all actively enrolling to pursue simultaneous indications for chronic weight management, obstructive sleep apnea, and knee osteoarthritis.

Lastly, we're happy to share that since our last earnings call, the retatrutide TRIUMPH Phase 3 Core Registration Trials are now all actively enrolling to pursue simultaneous indications for chronic weight management, obstructive sleep apnea, and knee osteoarthritis.

Lastly, we're happy to share that since our last earnings call. The <unk> trial phase III core registration trials are now all actively enrolling to pursue simultaneous indications for chronic weight management obstructive sleep apnea in knee osteoarthritis.

Daniel Skovronsky: Turning to our neuroscience portfolio, the FDA has shared with us that the donanemab review will extend into Q1 2024. Needing additional time to complete their review, we've completed submissions in Europe and Japan, and submissions to other global regulatory authorities are either completed or underway. Recently, at the Clinical Trials on Alzheimer's Disease meeting, we presented new insights from donanemab development program during a symposium session. As part of this symposium, we shared ARIA data from a pooled analysis that included more than 2,000 participants dosed with donanemab and explored ARIA-E association across a number of baseline variables, highlighting a few key factors most strongly associated with ARIA risk, including baseline amyloid levels, evidence of a prior bleed, and high blood pressure. Interestingly, this data also suggested use of antihypertensives decreased the risk of ARIA.

Turning to our neuroscience portfolio, the FDA has shared with us that the donanemab review will extend into Q1 2024. Needing additional time to complete their review, we've completed submissions in Europe and Japan, and submissions to other global regulatory authorities are either completed or underway. Recently, at the Clinical Trials on Alzheimer's Disease meeting, we presented new insights from donanemab development program during a symposium session. As part of this symposium, we shared ARIA data from a pooled analysis that included more than 2,000 participants dosed with donanemab and explored ARIA-E association across a number of baseline variables, highlighting a few key factors most strongly associated with ARIA risk, including baseline amyloid levels, evidence of a prior bleed, and high blood pressure. Interestingly, this data also suggested use of antihypertensives decreased the risk of ARIA.

Daniel M. Skovronsky: Turning to our neuroscience portfolio. The FDA has shared with us their Donanemab review will extend into Q1 2024, needing additional time to complete their review. We've completed submissions in Europe, and Japan, and submissions to other global regulatory authorities are either completed or underway. Recently, at the clinical trials on Alzheimer's disease meeting, we presented new insights from Donanemab development program during a symposium session.

We've completed submissions in Europe, and Japan, and submissions to other global regulatory authorities are either completed or underway.

Recently at the clinical trials on Alzheimer's disease meeting, we presented new insights from genetic Mab development program during a symposium session.

Daniel M. Skovronsky: As part of the symposium, we shared ARIA data from a pooled analysis that included more than 2.000 participants dosed with Donanemab and explored to ARIA E Association across a number of baseline variables, highlighting a few key factors most strongly associated with ARIA risk, including baseline amyloid levels, evidence of a prior bleed and high blood pressure. Interestingly, this data also suggested use of anti hypertensive decrease the risk of ARIA.

Interestingly. This data also suggested use of anti hypertensive decrease the risk of ARIA.

Daniel Skovronsky: Additionally, we shared analyses from our open label addendum of over 1,000 patients treated with donanemab. These results included a post hoc analysis of patients with no brain tau and demonstrated similar or even stronger biomarker results than our main TRAILBLAZER-ALZ 2 study. In a separate post hoc analysis from the TRAILBLAZER-ALZ 2 phase 3 study related to activities of daily living and independence in people with early symptomatic Alzheimer's disease, we showed that compared to placebo, people treated with donanemab preserved more of their ability to perform many of the items measured, including their ability to make meals, to use appliances, keep appointments, perform pastimes, and be safely left unattended. We also shared an update on our validation data for our plasma p-tau217 test for identifying amyloid-positive patients demonstrating robust performance of this immunoassay.

Additionally, we shared analyses from our open label addendum of over 1,000 patients treated with donanemab. These results included a post hoc analysis of patients with no brain tau and demonstrated similar or even stronger biomarker results than our main TRAILBLAZER-ALZ 2 study. In a separate post hoc analysis from the TRAILBLAZER-ALZ 2 phase 3 study related to activities of daily living and independence in people with early symptomatic Alzheimer's disease, we showed that compared to placebo, people treated with donanemab preserved more of their ability to perform many of the items measured, including their ability to make meals, to use appliances, keep appointments, perform pastimes, and be safely left unattended. We also shared an update on our validation data for our plasma p-tau217 test for identifying amyloid-positive patients demonstrating robust performance of this immunoassay.

Daniel M. Skovronsky: Additionally, we shared analyses from our open label addendum of over 1.000 patients treated with Donanemab. These results included a post hoc analysis of patients with no brain Tau and demonstrated similar or even stronger biomarker results than our main trailblazer ALZ II study. And a separate post hoc analysis from the Trailblazer ALZ II phase III study related to activities of daily living and independents in people with early symptomatic Alzheimer's disease, we showed that compared to placebo, people treated with Donanemab preserved more of their ability to perform many of the items measured, including their ability to make meals, to use appliances, keep appointments, perform pass times and be safely left unattended.

And a separate post hoc analysis from the Trailblazer ALS II phase III study related to activities of daily living and independents and people with early symptomatic Alzheimer's disease, we showed that compared to placebo people treated with <unk> nanometer preserved more of their ability to perform many of the items measured including their ability to make meals to use apply.

<unk> keep appointments performed past times and be safely left unattended.

Daniel M. Skovronsky: We also shared an update on our validation data for our Plasma P Tau 217 test for identifying amyloid positive patients demonstrating robust performance of this immunoassay. We expect to have this test commercially available in a phased approach first, as a laboratory developed test by the end of this year.

Daniel Skovronsky: We expect to have this test commercially available in a phased approach first as a laboratory developed test by the end of this year. As you recall, we used plasma p-tau217 to identify presymptomatic individuals for a TRAILBLAZER-ALZ 3 trial. This is an event-driven trial, and we've now recruited a sufficient number of qualifying presymptomatic participants and expect to have efficacy results within three years.

We expect to have this test commercially available in a phased approach first as a laboratory developed test by the end of this year. As you recall, we used plasma p-tau217 to identify presymptomatic individuals for a TRAILBLAZER-ALZ 3 trial. This is an event-driven trial, and we've now recruited a sufficient number of qualifying presymptomatic participants and expect to have efficacy results within three years.

We expect to have this test commercially available in a phased approach first as a laboratory developed test by the end of this year.

Daniel M. Skovronsky: As you recall, we use Plasma P Tau 207 to identify pre symptomatic individuals for our Trailblazer ALZ III trial. This is an event driven trial and we have now recruited a sufficient number of qualifying pre-symptomatic participants and expect to have efficacy results within three years. We're excited to announce today that our Otoferlin Gene therapy asset from Akouos has begun dosing patients in a Phase 1/2 trial for hearing loss.

This is an event driven trial and we have now recruited a sufficient number of qualifying pre symptomatic participants and expect to have efficacy results within three years.

Daniel Skovronsky: We're excited to announce today that our Otoferlin gene therapy asset from Akouos has begun dosing patients in a phase 1/2 trial for hearing loss.

We're excited to announce today that our Otoferlin gene therapy asset from Akouos has begun dosing patients in a phase 1/2 trial for hearing loss.

We're excited to announce today that our <unk> gene therapy asset from <unk> has begun dosing patients in a phase one two trial for hearing loss.

Daniel Skovronsky: In immunology. As Dave noted, we're happy to have FDA approval for Omvoh for the treatment of moderately to severely active ulcerative colitis in adults. This approval offers new hope for patients who are searching for an effective option that can offer rapid and lasting improvements.

In immunology. As Dave noted, we're happy to have FDA approval for Omvoh for the treatment of moderately to severely active ulcerative colitis in adults. This approval offers new hope for patients who are searching for an effective option that can offer rapid and lasting improvements.

Daniel M. Skovronsky: In immunology, as Dave noted, we're happy to have FDA approval for Omvoh for the treatment of moderately to severely active ulcerative colitis in adults. This approval offers new hope for patients, who are searching for an effective option that can offer rapid and lasting improvements. Omvoh will be available to patients in the U.S in the coming weeks.

This approval offers new hope for patients who are searching for an effective option that can offer rapid and lasting improvements.

Daniel Skovronsky: Omvoh will be available to patients in the US in the coming weeks. We were also excited to have the phase 3 readout for this molecule, mirikizumab, in Crohn's disease. In the VIVID-1 phase 3 study, mirikizumab met the co-primary and all major secondary endpoints compared to placebo. Mirikizumab demonstrated clinical remission and endoscopic response for patients with moderately to severely active Crohn's disease through 52 weeks. We were thrilled to see that more than half of participants on mirikizumab achieved clinical remission at one year and that robust efficacy was seen in both participants who are naive to biological therapy as well as participants who previously failed a prior biologic therapy. Helping patients achieve long-term clinical remission is a key goal for us in our pursuit of treatments for inflammatory bowel disease.

Omvoh will be available to patients in the US in the coming weeks. We were also excited to have the phase 3 readout for this molecule, mirikizumab, in Crohn's disease. In the VIVID-1 phase 3 study, mirikizumab met the co-primary and all major secondary endpoints compared to placebo. Mirikizumab demonstrated clinical remission and endoscopic response for patients with moderately to severely active Crohn's disease through 52 weeks. We were thrilled to see that more than half of participants on mirikizumab achieved clinical remission at one year and that robust efficacy was seen in both participants who are naive to biological therapy as well as participants who previously failed a prior biologic therapy. Helping patients achieve long-term clinical remission is a key goal for us in our pursuit of treatments for inflammatory bowel disease.

<unk> will be approved available to patients in the U S in the coming weeks.

Daniel M. Skovronsky: We were also excited to have the phase III readout for this molecule, mirikizumab in Crohn's disease. In the VIVID 1 Phase III study, mirikizumab met the co-primary in all major secondary endpoints compared to placebo. Mirikizumab demonstrated clinical remission and endoscopic response for patients with moderately to severely active Crohn's disease through 52 weeks. We were thrilled to see that more than half of participants on mirikizumab achieved clinical remission at one year, and that robust efficacy was seen in both participants who are naive to biologic therapy, as well as participants who previously failed a prior biologic therapy.

And the vivid one phase III study mirror Kismet met the co primary and all major secondary endpoints compared to placebo.

<unk> Mab demonstrated clinical remission and endoscopic response for patients with moderately to severely active crohns disease through 52 weeks.

We were thrilled to see that more than half of participants on <unk> achieved clinical remission at one year and that robust efficacy was seen in both participants who are naive to biologic therapy as well as participants who previously failed prior biologic therapy.

Daniel M. Skovronsky: Helping patients achieve long term clinical remission is a key goal for us in our pursuit of treatments for inflammatory bowel disease. These new data in Crohn's Disease build on the high levels of long term remission seen with mirikizumab for ulcerative colitis, and help reinforce the differentiation of this important potential medicine. This successful phase III trial will be the basis of global regulatory submissions for Crohn's Disease.

Daniel Skovronsky: These new data in Crohn's disease build on the high levels of long term remission seen with mirikizumab for ulcerative colitis and help reinforce the differentiation of this important potential medicine. This successful phase 3 trial will be the basis of global regulatory submissions for Crohn's disease. As Dave noted earlier in Q3, we announced that the FDA issued a complete response letter for lebrikizumab based on findings at a third party manufacturer. In Q3 we completed the acquisition of DICE and now reflect the two oral IL17 assets, DICE853, and DICE806, in phase 1 and phase 2 of our pipeline respectively. Additionally, two new molecules began phase 2 studies in immunology this quarter. First, our CD200R monoclonal antibody known as Eusirprobart for atopic dermatitis, and second, our RIPK1 inhibitor for rheumatoid arthritis. We've removed our BTLA monoclonal antibody agonist from phase 2 in our pipeline.

These new data in Crohn's disease build on the high levels of long term remission seen with mirikizumab for ulcerative colitis and help reinforce the differentiation of this important potential medicine. This successful phase 3 trial will be the basis of global regulatory submissions for Crohn's disease. As Dave noted earlier in Q3, we announced that the FDA issued a complete response letter for lebrikizumab based on findings at a third party manufacturer. In Q3 we completed the acquisition of DICE and now reflect the two oral IL17 assets, DICE853, and DICE806, in phase 1 and phase 2 of our pipeline respectively. Additionally, two new molecules began phase 2 studies in immunology this quarter. First, our CD200R monoclonal antibody known as Eusirprobart for atopic dermatitis, and second, our RIPK1 inhibitor for rheumatoid arthritis. We've removed our BTLA monoclonal antibody agonist from phase 2 in our pipeline.

These new data in Crohn's disease build on the high levels of long term remissions seem with Mira <unk> Mab for ulcerative colitis and help reinforce the differentiation of this important potential medicine.

This successful phase III trial will be the basis of global regulatory submissions for Crohn's disease.

Daniel M. Skovronsky: As Dave noted earlier in Q3, we announced that the FDA issued a complete response letter for lebrikizumab, based on findings at a third party manufacturer. In Q3 we completed the acquisition of Dice and now reflect the two oral IL-17 assets, Dice 853 and Dice 806 in phase I and phase II of our pipeline respectively. Additionally, two new molecules began phase II studies in immunology this quarter. First, our CD200R monoclonal antibody, known as Ucenprubart for atopic dermatitis, and second, our RIPK1 inhibitor for rheumatoid arthritis.

In Q3, we completed the acquisition of dice and now reflect the two oral IL 17 assets dice 853, dice 806 in phase, one and phase two of our pipeline respectively.

Additionally, two new molecules begin phase II studies in immunology this quarter.

First our CD 200 of our monoclonal antibody known as improve art for atopic dermatitis and second our <unk> inhibitor for rheumatoid arthritis.

Daniel M. Skovronsky: We've removed our <unk> monoclonal antibody agonist from phase two in our pipeline after the phase Iia study failed to demonstrate efficacy. Q3 was another productive quarter for R&D at Lilly. I'll now turn the call back to Dave for closing remarks. Thank you Dan before we go to Q&A, Let me briefly sum up our progress in the third quarter.

Daniel M. Skovronsky: We've removed our BTLA monoclonal antibody agonist from phase II in our pipeline, after the phase II A study failed to demonstrate efficacy. Q3 was another productive quarter for R&D at Lilly. I'll now turn the call back to Dave for closing remarks.

Daniel Skovronsky: After the phase 2a study failed to demonstrate efficacy.

After the phase 2a study failed to demonstrate efficacy.

Daniel Skovronsky: Q3 was another productive quarter for R and D at Lilly. I'll now turn the call back to Dave for closing.

Q3 was another productive quarter for R and D at Lilly. I'll now turn the call back to Dave for closing.

Q3 was another productive quarter for R&D at Lilly.

David Ricks: Remarks. Thank you, Dan. Before we go to Q and A, let me briefly sum up our progress. In the third quarter, this quarter, revenue growth accelerated as our recently launched product portfolio continued to gain momentum, of course led by Mounjaro. Excluding revenue from the divestiture of the Olanzapine portfolio and the sale of COVID-19 antibodies in 2022, revenue grew 24%, driven again by Mounjaro, Verzenio, as well as Jardiance. By continuing to invest in recent and upcoming launches, late-stage medicines, and early-phase capabilities, as well as in business development, we are confident that we have positioned ourselves for growth now and in the coming years. With the opportunity for continued margin expansion.

Dave Ricks: Remarks. Thank you, Dan. Before we go to Q and A, let me briefly sum up our progress. In the third quarter, this quarter, revenue growth accelerated as our recently launched product portfolio continued to gain momentum, of course led by Mounjaro. Excluding revenue from the divestiture of the Olanzapine portfolio and the sale of COVID-19 antibodies in 2022, revenue grew 24%, driven again by Mounjaro, Verzenio, as well as Jardiance. By continuing to invest in recent and upcoming launches, late-stage medicines, and early-phase capabilities, as well as in business development, we are confident that we have positioned ourselves for growth now and in the coming years. With the opportunity for continued margin expansion.

I'll now turn the call back to Dave for closing remarks. Thank you Dan before we go to Q&A, Let me briefly sum up our progress in the third quarter.

Dave Ricks: Thank you, Dan. Before we get to Q&A, let me briefly sum up our progress in the third quarter. This quarter revenue growth accelerated as our recently launched product portfolio continued to gain momentum, of course led by Mounjaro. Excluding revenue from the divestiture of the olanzapine portfolio and the sale of COVID-19 antibodies in 2022, revenue grew 24%, driven again by Mounjaro, Verzenio, as well as Jardiance.

This quarter revenue growth accelerated as our recently launched product portfolio continued to gain momentum of course led by Monteiro.

Excluding revenue from the divestiture of the Olanzapine portfolio and the sale of COVID-19 antibodies in 2022 revenue grew 24% driven again by <unk> <unk> as well as <unk>.

Dave Ricks: By continuing to invest in recent and upcoming launches, late stage medicines and early phase capabilities, as well as in business development, we are confident that we have positioned ourselves for growth now and in the coming years, with the opportunity for continued margin expansion. We achieved meaningful advances in our late stage pipeline, with the FDA approval of Omvoh for the treatment of moderately to severely active ulcerative colitis, as well as Jardiance for the treatment of adults with chronic kidney disease, and the positive phase III Vivid 1 results for mirikizumab for adults with moderately to severely active Crohn's disease.

Late stage medicines in early phase capabilities as well as in business development. We are confident that we have positioned ourselves for growth now.

And in the coming years with the opportunity for continued margin expansion.

David Ricks: We achieved meaningful advances in our late-stage pipeline with the FDA approval of Omvoh for the treatment of moderately to severely active ulcerative colitis, as well as Jardiance for the treatment of adults with chronic kidney disease, and the positive phase 3 VIVID-1 results for mirikizumab for adults with moderately to severely active Crohn's disease. Looking forward, we are expecting regulatory responses before the end of the year on our submissions for pirtobrutinib in accelerated approval and CLL, as well as tirzepatide for obesity. In Q3, we completed several targeted acquisitions intended to bolster our early- and mid-stage portfolio. Directly following the quarter, we also announced an agreement to acquire Point Biopharma, which will further expand our R&D capabilities in oncology. Lastly, we returned over $1 billion to shareholders via the dividend.

We achieved meaningful advances in our late-stage pipeline with the FDA approval of Omvoh for the treatment of moderately to severely active ulcerative colitis, as well as Jardiance for the treatment of adults with chronic kidney disease, and the positive phase 3 VIVID-1 results for mirikizumab for adults with moderately to severely active Crohn's disease. Looking forward, we are expecting regulatory responses before the end of the year on our submissions for pirtobrutinib in accelerated approval and CLL, as well as tirzepatide for obesity. In Q3, we completed several targeted acquisitions intended to bolster our early- and mid-stage portfolio. Directly following the quarter, we also announced an agreement to acquire Point Biopharma, which will further expand our R&D capabilities in oncology. Lastly, we returned over $1 billion to shareholders via the dividend.

We achieved meaningful advances in our late stage pipeline with the FDA approval of <unk> for the treatment of moderately to severely active ulcerative colitis as well as <unk> for the treatment of adults with chronic kidney disease.

And the positive phase III vivid one results for <unk> for adults with moderately to severely active crohns disease.

Dave Ricks: Looking forward, we are expecting regulatory responses before the end of the year on our submissions for pirtobrutinib, and accelerated approval in CLL as well as tirzepatide for obesity. In Q3, we completed several targeted acquisitions, intended to bolster our early and mid stage portfolio. Directly following the quarter we also announced an agreement to acquire Point Biopharma, which will further expand our R&D capabilities in oncology.

Obesity.

In Q3, we completed several targeted acquisitions intended to bolster our early and mid stage portfolio.

Directly following the quarter, we also announced an agreement to acquire point Biopharma, which will further expand our R&D capabilities in oncology.

Dave Ricks: Lastly, we returned over $1 billion to shareholders via the dividend. A few weeks ago, we announced several leadership changes. Mike Mason, our Executive Vice President and President of Lilly Diabetes and Obesity will retire from the company at the end of 2023 after 34 years with Lilly. In his current role, Mike is overseeing Tirzepatide, late stage development and an unprecedented type 2 diabetes launch. Mike leaves behind an enduring legacy that reflects his deep compassion for patients and his commitment to our people. With this being Mike's last earnings call, I would like to thank him for his many years of outstanding service to Lily and wish him all the best in his next chapter of life.

David Ricks: A few weeks ago we announced several leadership changes. Mike Mason, our Executive Vice President and President of Lilly Diabetes and Obesity, will retire from the company at the end of 2023 after 34 years. With Lilly in his current role, Mike has overseen Tirzepatide's late-stage development and an unprecedented type 2 diabetes launch. Mike leaves behind an enduring legacy that reflects his deep compassion for patients and his commitment to our people. With this being Mike's last earnings call, I would like to thank him for his many years of outstanding service to Lilly and wish him all the best in his next chapter of life.

A few weeks ago we announced several leadership changes. Mike Mason, our Executive Vice President and President of Lilly Diabetes and Obesity, will retire from the company at the end of 2023 after 34 years. With Lilly in his current role, Mike has overseen Tirzepatide's late-stage development and an unprecedented type 2 diabetes launch. Mike leaves behind an enduring legacy that reflects his deep compassion for patients and his commitment to our people. With this being Mike's last earnings call, I would like to thank him for his many years of outstanding service to Lilly and wish him all the best in his next chapter of life.

A few weeks ago, we announced several leadership changes, Mike Mason, our executive Vice President and President of Lilly diabetes, and obesity will retire from the company at the end of 2023 after 34 years with Lilly.

In his current role Mike has overseen Giuseppettite late stage development in an unprecedented type two diabetes launch.

Dave Ricks: Mike leaves behind an enduring legacy that reflects his deep compassion for patients and his commitment to our people. With this being Mike's last earnings call, I would like to thank him for his many years of outstanding service to Lily and wish him all the best in his next chapter of life.

Leaves behind an enduring legacy that reflects as deep compassion for patients and his commitment to our people.

With this being Mikes last earnings call I would like to thank him for his many years of outstanding service to Lilly and wish him all the best in his next chapter of life.

David Ricks: Patrik Jonsson will assume leadership of Lilly Diabetes and Obesity in addition to his current responsibilities as President of Lilly USA, and Dan Skovronsky, our Chief Scientific Officer and President of Lilly Research Labs, will take on the additional role of President of Lilly Immunology from Patrik, and in a related move, David Hyman is assuming the role of Chief Medical Officer for the company from Dan, overseeing the full Lilly portfolio. Leigh Ann Pusey, our Executive Vice President for Corporate Affairs and Communications, has decided to leave the company at the end of 2023. Leigh Ann has left a lasting impact on Lilly and the patients we serve, and we're grateful for her many contributions over the past six years.

Patrik Jonsson will assume leadership of Lilly Diabetes and Obesity in addition to his current responsibilities as President of Lilly USA, and Dan Skovronsky, our Chief Scientific Officer and President of Lilly Research Labs, will take on the additional role of President of Lilly Immunology from Patrik, and in a related move, David Hyman is assuming the role of Chief Medical Officer for the company from Dan, overseeing the full Lilly portfolio. Leigh Ann Pusey, our Executive Vice President for Corporate Affairs and Communications, has decided to leave the company at the end of 2023. Leigh Ann has left a lasting impact on Lilly and the patients we serve, and we're grateful for her many contributions over the past six years.

Dave Ricks: Patrik Jonsson will assume leadership of Lilly Diabetes and Obesity. In addition to his current responsibilities as President of Lilly USA Dan Skovronsk, our Chief Scientific Officer and president of Lilly Research Labs will take on the additional role of President of Lilly Immunology from Patrik. And in a related move, David Hyman is assuming the role of Chief Medical Officer for the company from Dan, overseeing the full Lilly portfolio. Leigh Ann Pusey, our Executive Vice President for Corporate Affairs and Communications has decided to leave the company at the end of 2023. Leigh Ann has left a lasting impact on Lilly and the patients we serve. And we're grateful for her many contributions over the past six years.

And in a related move David Hyman is assuming the role of Chief Medical Officer for the company from Dan overseas overseeing the full Louis portfolio.

Dave Ricks: Leigh Ann Pusey, our Executive Vice President for Corporate Affairs and Communications has decided to leave the company at the end of 2023. Leigh Ann has left a lasting impact on Lilly and the patients we serve. And we're grateful for her many contributions over the past six years.

We <unk>, our executive Vice President for Corporate Affairs, and Communications has decided to leave the company at the end of 2023, Leann has left a lasting impact on Lilly and the patients we serve and we're grateful for her many contributions over the past six years.

David Ricks: So as we begin this new chapter of growth for our company, we are very confident that our deep experience of our leadership team will allow us to continue to accelerate our efforts to make medicines and be more effective and more innovative in the years ahead. So now let me turn the call over to Joe, and he'll moderate the Q&A session. Thanks, Dave. We'd like to take questions from as many callers as possible and conclude the call in a timely manner. So, consistent with last quarter, we'll respond to one question per caller, so ask that you limit to one question per caller, as we'll aim to end the call at 10:00AM. If you have more than one question, you can re-enter the queue, and we'll get to your question if time allows.

So as we begin this new chapter of growth for our company, we are very confident that our deep experience of our leadership team will allow us to continue to accelerate our efforts to make medicines and be more effective and more innovative in the years ahead. So now let me turn the call over to Joe, and he'll moderate the Q&A session.

Dave Ricks: So, as we begin this new chapter of growth for our company, we are very confident that our deep experience of our leadership team will allow us to continue to accelerate our efforts to make medicines and be more effective and more innovative in the years ahead. So, now let me turn the call over to Joe and he will moderate the Q&A session.

So now let me turn the call over to Joe and he will moderate the Q&A session.

Joe Fletcher: Thanks, Dave. We'd like to take questions from as many callers as possible and conclude the call in a timely manner. So, consistent with last quarter, we'll respond to one question per caller, so ask that you limit to one question per caller, as we'll aim to end the call at 10:00AM. If you have more than one question, you can re-enter the queue, and we'll get to your question if time allows.

Joe Fletcher: Thanks, Dave. We'd like to take questions from as many callers as possible and conclude the call in a timely manner. So, consistent with last quarter we will respond to one question per caller. So, ask that you limit to one question per caller. As we'll aim to end the call at 10 am. If you have more than one question you can reenter the queue, and we'll get to your question if time allows. So, Paul, please provide the instructions for the Q&A session and we're ready for the first caller.

As will aim to end the call at 10 a M.

More than one question you can reenter the queue and we'll get to your question of time allows so Paul please provide the instructions for the Q&A session and we are ready for the first caller.

David Ricks: Paul, please provide the instructions for the Q and A session and.

Paul, please provide the instructions for the Q and A session and.

Daniel Skovronsky: We're ready for the first.

We're ready for the first.

Operator: Thank you. At this time, we'll be conducting a Q&A 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 after that at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions.

Operator 3: Thank you. At this time, we'll be conducting a Q&A 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 after that at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions.

Operator: Thank you at this time, we'll be conducting a Q&A session. If you have any questions, please press star one on your phone at this time, we ask that participants limit themselves to one question on today's call. If you do have a follow up question, please rejoin the queue by pressing star one at any time. We also ask that while posing your question, please pickup your handset assisting on speaker phone to provide optimum sound quality. Please hold while we poll for questions. On the first question today is coming from Tim Anderson from Wolfe Research. Tim, your line is live.

Have any questions. Please press star one on your phone at this time, we ask that participants limit themselves to one question on today's call. If you do have a follow up question. Please rejoin the queue by pressing star one at any time.

We also ask that while posing your question. Please pickup your handset assisting on speaker phone to provide optimum sound quality.

Please hold while we poll for questions.

Operator: The first question today is coming from Tim Anderson from Wolfe Research. Tim, your line is.

The first question today is coming from Tim Anderson from Wolfe Research. Tim, your line is.

On the first question today is coming from Tim Anderson from Wolfe Research your.

Tim Anderson: Live.

Live.

Your line is live.

Tim Anderson: Thank you so much. I have a question on obesity and.

Tim Anderson: Thank you so much. I have a question on obesity and persistence on therapy, which I think has been a big question mark. I know you haven't formally launched yet, but guessing you might have some idea, a best guess if nothing else. So, in your view is this going to be like most other drug categories where persistence on therapy is often low? I think the rule of thumb is that at the one year mark 50% of patients drop off chronic medicines.

Tim Anderson: Persistence on therapy, which I think has been a big question mark. I know you haven't formally launched yet, but guessing you might have some idea, a best guess if nothing else. So, in your view, is this going to be like most other drug categories where persistence on therapy is often low? I think the rule of thumb is that at the one year mark, 50% of patients drop off chronic medicines. So really the question is if you took 100 patients who start on one of these contemporary obesity drugs, how many of that initial hundred would likely still be on therapy? Let's say three or four or five years down the.

Persistence on therapy, which I think has been a big question mark. I know you haven't formally launched yet, but guessing you might have some idea, a best guess if nothing else. So, in your view, is this going to be like most other drug categories where persistence on therapy is often low? I think the rule of thumb is that at the one year mark, 50% of patients drop off chronic medicines. So really the question is if you took 100 patients who start on one of these contemporary obesity drugs, how many of that initial hundred would likely still be on therapy? Let's say three or four or five years down the.

And persistence on therapy, which I think has been a big question Mark I know you haven't formally launched yet, but guessing you might have some idea.

Cast if nothing else. So is there in your view is this going to be like most other drug categories, where persistence on therapy.

Often low I think the rule of thumb is that at.

The one year mark of 50% of patients drop off chronic medicines.

Tim Anderson: So, really, the question is, if you took 100 patients who start on one of these contemporary obesity drugs, how many of that initial 100 would likely still be on therapy, let's say three or four or five years down the road.

How many of that initial hundred would likely to still be on therapy, let's say three or four or five years down the road.

David Ricks: Road.

Road.

David Ricks: Thanks, Tim. Mike, would you like to weigh in on the persistence of therapy on?

Joe Fletcher: Thanks, Tim. Mike, would you like to weigh in on the persistence of therapy on?

Joe Fletcher: Thanks, Tim. Mike, you would you like to weigh in on the persistence of therapy on obesity?

Thanks, Tim Mike do you enjoy to weigh in on the persistence of therapy.

Mike Mason: Obesity?

Obesity?

Mike Mason: Yeah, thanks for the question. Maybe I'll first answer. With the data that we do have, it was hard to speculate on what it's going to be for obesity. You know, the best data we have for Tirzepatide is in type 2 diabetes patients who started Mounjaro prior to our savings card changes last fall. Mounjaro's persistency for those patients is tracking higher than those patients that were started on Trulicity and Ozempic over that same period of time. So while it's too early to project the average length of therapy or how many out of 100 will still be on therapy after a couple of years, I think that this early data is encouraging. You know, as for bcd, you know, time was going to tell.

Obesity.

Michael B. Mason: Yes. Thanks for the question, maybe I'll first answer with the data that we do have because it's hard to speculate on what it's going to be for obesity. The. The best data, we have for <unk> appetite is in type two diabetes patients who started manganaro prior to our savings card changes last fall. Mcdonald's persistency for those patients use tracking higher than those patients that were started on <unk> and <unk> over that same period of time. So while it's too early to project the average length of therapy or how many out of 100, we will still be on therapy. After a couple of years I think this early data.

Michael B. Mason: Yeah, thanks for the question. Maybe I'll first answer with the data that we do have, because it's hard to speculate on what it's going to be for obesity. The best data we have for Tirzepatide is in Type 2 diabetes patients who started Mounjaro prior to our savings card changes last fall, Mounjaro persistency for those patients is tracking higher than those patients that were started on Trulicity and Ozempic, over that same period of time.

The best data, we have for <unk> appetite is in type two diabetes patients who started manganaro prior to our savings card changes last fall.

Mcdonald's persistency for those patients use tracking higher than those patients that were started on <unk> and <unk> over that same period of time. So while it's too early to project the average length of therapy or how many out of 100, we will still be on therapy. After a couple of years I think this early data.

Michael B. Mason: So, while it's too early to project the average length of therapy or how many out of 100 will still be on therapy after a couple of years, I think that this early data is encouraging. As for obesity, time was time was going to tell. I think we've all looked at Wegovy data, but I don't think this is the right benchmark at this point because of novel supply constraints. And there's been just a very dynamic market. I think, as you said, having persistency on a chronic treatment isn't just an issue for anti-obesity medications. It's a goal for all chronic treatments.

Is encouraging.

As for BCD time was probably was going to tell I think we've all looked at we Gobi data, but I don't think this is the right benchmark at this point because of novel supply constraints and.

Mike Mason: I think, you know, we've all looked at Wegovy data, but I don't think this is the right benchmark at this point because of Novo supply constraints and.

I think, you know, we've all looked at Wegovy data, but I don't think this is the right benchmark at this point because of Novo supply constraints and.

Mike Mason: There's been just a very dynamic market. You know, I think as you said, you know, this, you know, having persistency on a chronic treatment isn't just an issue for anti-obesity medications. You know, it's a goal for all chronic treatments. Now I think what's different about obesity is that on many chronic treatments, consumers don't feel differently or experience any acute impacts from stopping treatments. So what we've seen in the SURMOUNT clinical trials with Tirzepatide is that some consumers will feel their appetite increase and experience weight regain when they stop Tirzepatide. And so this should help reinforce treatment adherence. Seeing in our market research how important it is for people who live with obesity to lose weight and maintain it, I do think you're gonna see just a high motivation that people have lost weight, that they do wanna maintain it.

There's been just a very dynamic market. You know, I think as you said, you know, this, you know, having persistency on a chronic treatment isn't just an issue for anti-obesity medications. You know, it's a goal for all chronic treatments. Now I think what's different about obesity is that on many chronic treatments, consumers don't feel differently or experience any acute impacts from stopping treatments. So what we've seen in the SURMOUNT clinical trials with Tirzepatide is that some consumers will feel their appetite increase and experience weight regain when they stop Tirzepatide. And so this should help reinforce treatment adherence. Seeing in our market research how important it is for people who live with obesity to lose weight and maintain it, I do think you're gonna see just a high motivation that people have lost weight, that they do wanna maintain it.

There's been just a very dynamic market.

I think as you said.

This.

Sure.

Having persistency on a chronic treatment is it just an issue for anti obesity medications.

It's a goal for all chronic treatments.

Michael B. Mason: I think what's different about obesity is that, on many chronic treatments, consumers don't feel differently or experience any acute impacts from stopping treatments. So, what we've seen in this surmount clinical trials, with Tirzepatide is that some consumers will feel their appetite increase and experience weight regain when they stopped Tirzepatide. And so this should help reinforce treatment adherence, seeing in our market research, how important it is for people who live with obesity to lose weight and maintain it.

The appetite increase and experienced weight regain when they stopped <unk> appetite and so this should help reinforce treatment <unk>.

As seen in our market research how important it is for people, who live with obesity to lose weight and maintain it I.

Michael B. Mason: I do think you're going to see just a high motivation as people have lost weight that they do want to maintain it. And we do know for our surmount program that, chronic use of Tirzepatide is a good component, an important component of maintaining weight loss. So, it's too early to project it. But I do think there's things that's rolling in favor of Tirzepatide having a good length of therapy in the obesity patient.

Mike Mason: We do know from our SURMOUNT program that chronic use of tirzepatide is a good component, an important component of maintaining weight loss. So, it's too early to project it, but I do think there's things that's rolling in favor of tirzepatide having a good length of therapy in the obesity.

We do know from our SURMOUNT program that chronic use of tirzepatide is a good component, an important component of maintaining weight loss. So, it's too early to project it, but I do think there's things that's rolling in favor of tirzepatide having a good length of therapy in the obesity.

Our surmount program that.

Ronnie use of cruise appetite is a good component an important component of maintaining weight loss. So it's too early to projected but I do think theres things, that's that's rolling in favor of.

Trish appetite, having a good length of therapy and the obesity patients.

David Ricks: Thanks, Mike. Next.

Joe Fletcher: Thanks, Mike. Next.

Operator: Question. Paul, the next question is coming from Seamus Fernandez from Guggenheim. Seamus, your line is.

Question. Paul,

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

Operator 3: The next question is coming from Seamus Fernandez from Guggenheim. Seamus, your line is.

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

Daniel Skovronsky: Live. Great, thanks so much for the question. So I really wanted to drill into orforglipron and those phase 3 programs. You know, Dan, I was just hoping that you could clarify for the market.

Live.

Seamus Fernandez: Great, thanks so much for the question. So I really wanted to drill into orforglipron and those phase 3 programs. You know, Dan, I was just hoping that you could clarify for the market.

Seamus Fernandez: Great. Thanks so much for the question. So, I really wanted to drill into Orforglipron, and those phase III programs. Dan, I was just hoping that you could clarify for the market, if there's any monitoring in that study related to liver enzyme elevations. I think there was one case in the phase II diabetes study that you conducted. Just wanted to know if there's any related concerns associated with that. Or if this is kind of as expected, an all hands on deck moving forward opportunity. Thanks.

Thanks, so much for the question, so I really wanted to drill into.

<unk>, Ron and those phase III programs.

Dan I was just hoping that you could clarify for the market.

Daniel Skovronsky: If there's any monitoring in that study related to liver enzyme elevations, I think there was one case in the phase 2 diabetes study that you conducted. Just wanted to know if there's any related concerns associated with that or if this is kind of as expected, you know.

If there's any monitoring in that study related to liver enzyme elevations, I think there was one case in the phase 2 diabetes study that you conducted. Just wanted to know if there's any related concerns associated with that or if this is kind of as expected, you know.

If there is any.

Monitoring and that study related to liver enzyme elevations I think there was one.

In the phase two diabetes study that you conducted.

I just wanted to know if there is any related concerns associated with that or.

If this is kind of as expected.

Daniel Skovronsky: An all-hands-on-deck, moving-forward opportunity. Thanks.

An all-hands-on-deck, moving-forward opportunity. Thanks.

And all.

All hands on deck moving forward.

Opportunity. Thanks.

Daniel Skovronsky: Thanks, Seamus. Yeah, I like the way you phrase it. All hands on deck, moving forward on orforglipron. We're really excited about this molecule in terms of, you know, liver safety. I think we commented before that what we saw in phase 2 is what, you know, we thought would probably be typical for.

Dan Skovronsky: Thanks, Seamus. Yeah, I like the way you phrase it. All hands on deck, moving forward on orforglipron. We're really excited about this molecule in terms of, you know, liver safety. I think we commented before that what we saw in phase 2 is what, you know, we thought would probably be typical for.

Daniel M. Skovronsky: Thanks, Seamus, yes, I like the way you phrased it all hands on deck moving forward on <unk>, we're really excited about this molecule. In terms of liver safety I think we commented before that what we saw in phase two as well. We thought it would be probably be typical for. Ah trial of that nature in this population so not a heightened level of concern but always.

Daniel M. Skovronsky: Thanks, Seamus. Yeah, I like the way you phrase it, all hands on deck moving forward on Orforglipron. We're really excited about this molecule. In terms of, liver safety, I think we commented before that, what we saw in phase II is what we thought would be probably be typical for a trial of that nature in this population.

In terms of liver safety I think we commented before that what we saw in phase two as well.

We thought it would be probably be typical for.

Daniel Skovronsky: A trial of that nature in this population. So not a heightened level of concern, but always concerned about safety going into phase 3 from a variety of factors including for all small molecules, especially.

A trial of that nature in this population. So not a heightened level of concern, but always concerned about safety going into phase 3 from a variety of factors including for all small molecules, especially.

Ah trial of that nature in this population so not a heightened level of concern but always.

Daniel M. Skovronsky: So, not a heightened level of concern, but always concerned about safety going into phase III from a variety of factors, including for all small molecules, especially liver function. So, it's routine in our phase III studies across the portfolio to monitor liver function. And sure we're doing that in orforglipron, but not aware of any special precautions there. So, super excited that that program is going fast.

Concerned about safety going into phase III from a variety of factors.

Including for all small molecules, especially.

Daniel Skovronsky: Liver function. So it's routine in our phase 3 studies across the portfolio to monitor liver function, and I'm sure we're doing that in orforglipron, but not aware of any special precautions there. So super excited that that program's going.

Liver function. So it's routine in our phase 3 studies across the portfolio to monitor liver function, and I'm sure we're doing that in orforglipron, but not aware of any special precautions there. So super excited that that program's going.

The liver.

Function. So it's routine in our phase II studies across the portfolio to monitor liver function.

Sure, we're doing that in <unk>, but not aware of any special precautions. There. So super excited that program is growing fast.

David Ricks: Fast. Thanks Dan. Paul, next.

Fast.

Seamus Fernandez: Thanks Dan.

Joe Fletcher: Paul, next.

Operator: Question. The next question is from Terence Flynn from Morgan Stanley. Terence, your line is.

Question.

Operator 3: The next question is from Terence Flynn from Morgan Stanley. Terence, your line is.

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

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

David Ricks: Live. Great, thanks so much for taking the questions. Anat, you had mentioned shifting the date of your 2024 guidance early next year. Just want to know what drove that change, and if you can assure us that there are no issues with the Tirzepatide obesity review and or manufacturing. Thank.

Live.

Terence Flynn: Great, thanks so much for taking the questions. Anat, you had mentioned shifting the date of your 2024 guidance early next year. Just want to know what drove that change, and if you can assure us that there are no issues with the Tirzepatide obesity review and or manufacturing. Thank.

Terence Flynn: Great, thanks so much for taking the questions. Anat you had mentioned shifting the date of your 2024 guidance call early next year. Just want to know what drove that change? And if you can assure us that there are no issues with Tirzepatide obesity review and/or manufacturing? Thank you.

You had mentioned shifting the date of your 2024 guidance called early next year just wanted to know what drove that change and if you can assure us that there are no issues with the turns appetite obesity review <unk> manufacturing. Thank you.

Anat Ashkenazi: You.

You.

Anat Ashkenazi: Sure. So let me first start with reassuring you that there are no issues behind our decision to move the guidance date to or have it aligned with our Q4 earnings call. What it does do is it does help us have the year-end full results when we provide guidance for 2024. So previously, if we didn't have that, investors had to look at guidance range for the year and estimates based on midpoints, et cetera. This does enable us to close the year and then have a full view into 2024. It is aligned with our internal planning processes as well, and obviously is the way most companies, and I believe all companies in our industry, do that. So nothing unique going into that other than just having the full data set for.

Anat Ashkenazi: Sure. So let me first start with reassuring you that there are no no issues behind our decision to move the guidance day to. Or have it aligned with our Q4 earnings call. It does do is it does help us have the year end full results when we provide guidance for 2024. So previously if we didn't have that. <unk> had to look at guidance range for the year and estimates based on midpoint et cetera. This does enable us to close the year and then have a full view into 2024. It is aligned with our internal planning processes as well and obviously there is the the way most companies and I believe all companies in our <unk>. Industry do that so nothing unique going into that other than just having the full data set for 2023.

Anat Ashkenazi: Sure. So, let me first start with reassuring you that there are no issues behind our decision to move the guidance date, or have it aligned with our Q4 earnings call. What it does do is it does help us have the yearend full results when we provide guidance for 2024. So, previously, if we didn't have that, investors had to look at guidance range for the year and estimates based on midpoint, etc. This does enable us to close the year and then have a full view into 2024. It is aligned with our internal planning processes as well. And obviously is the way most companies and I believe all companies in our industry do that. So, nothing unique going into that other than just having the full data set for 2023.

Or have it aligned with our Q4 earnings call.

It does do is it does help us have the year end full results when we provide guidance for 2024. So previously if we didn't have that.

<unk> had to look at guidance range for the year and estimates based on midpoint et cetera. This does enable us to close the year and then have a full view into 2024. It is aligned with our internal planning processes as well and obviously there is the the way most companies and I believe all companies in our <unk>.

Industry do that so nothing unique going into that other than just having the full data set for 2023.

Anat Ashkenazi: So, nothing unique going into that other than just having the full data set for 2023.

David Ricks: 2023. Thank you. Anant Paul, next.

2023.

Joe Fletcher: Thank you. Anant Paul, next.

Operator: Question: The next question is coming from Mohit Bansal from Wells Fargo. Mohit, your line is open.

Question.

Operator 3: The next question is coming from Mohit Bansal from Wells Fargo. Mohit, your line is open.

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

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

Daniel Skovronsky: Great. Thank you very much for taking my question. And my question is regarding the p-tau217 biomarker data you have shown at CTAD. Seems like the predictability is getting to 94% with these tests. Even C2N was pretty good. So do you have any thoughts on at this point, how close are we to actually make this bring this to prime time? And when donanemab gets approved, do you think this could be the test doctors use or it would still take some time to get.

Mohit Bansal: Great. Thank you very much for taking my question. And my question is regarding the p-tau217 biomarker data you have shown at CTAD. Seems like the predictability is getting to 94% with these tests. Even C2N was pretty good. So do you have any thoughts on at this point, how close are we to actually make this bring this to prime time? And when donanemab gets approved, do you think this could be the test doctors use or it would still take some time to get.

Mohit Bansal: Great. Thank you very much for taking my question. And my question is regarding the P documents seven biomarker data you have shown at CTAD. It seems like the predictability is getting to 94% of these tests, even C2N was pretty good. So, do you have any thoughts on at this point, how close are we to actually make this, bring this to prime time? And when the Donanemab gets approved do you think this could be the test doctors use? Or it will still take some time to get to that?

My question is regarding the feedstock seven biomarker data shown at <unk>.

It seems like the predictability of getting to 94% of these tests.

<unk> was pretty good do you have any thoughts on this point, how can we use IV <unk>.

<unk> Prime time and goodbye.

But do not.

Do you think this could be the best doctors use.

David Ricks: To.

To.

To take some time to get to.

David Ricks: Thanks Mohit for the question. You broke up a little bit there, but I think we got the gist. I'll hand off to.

Joe Fletcher: Thanks Mohit for the question. You broke up a little bit there, but I think we got the gist. I'll hand off to Anne.

Joe Fletcher: Thanks Mohit, for the question. You broke up a little bit there. But I think we got the gist. I'll hand off to Anne.

Anne White: Yes, as we shared at CTAD, we were pleased with the data that we saw, and we're also pleased to see progress across the field in blood biomarkers. We definitely believe that this is incredibly important to drive access and early diagnosis in Alzheimer's disease. So you've seen us invest in a number of fronts: our own p-tau217, but also partnering with others who are working on good tests to elevate the area. So it's a strategy of raising all boats. But yes, we did share our data, and we intend to make this available in a phased approach commercially as an LDT starting at the end of this year in a couple of sites and then continuing to expand over 2024. But at the same time, you'll see us continue to publish the data.

Anne E. White: Yes. We shared at <unk>, we were pleased with the data that we saw and we're also pleased to see progress across the field and blood Biomarkers. We definitely believe that this is incredibly important to drive access and early diagnosis in Alzheimer's disease. So you've seen us invest in a number of fronts our own Pete how 2017, but also partnering with others who are working on. Good tests to elevate the area. So the strategy of raising all boats, but yes, we did share our data and we intend to make this available in a phased approach commercially as an <unk> starting at the end of this year in a couple of sites and then continuing to span expand over 2020 four.

Anne E. White: Yes. So, we shared at CTAD, we were pleased with the data that we saw. And we're also pleased to see progress across the field in blood biomarkers. We definitely believe that this is incredibly important to drive access and early diagnosis in Alzheimer's disease. So, you've seen us invest in a number of fronts, our own P Tau 217, but also partnering with others who are working on good tests to elevate the area. So, it's a strategy of raising all boats.

We shared at <unk>, we were pleased with the data that we saw and we're also pleased to see progress across the field and blood Biomarkers. We definitely believe that this is incredibly important to drive access and early diagnosis in Alzheimer's disease. So you've seen us invest in a number of fronts our own Pete how 2017, but also partnering with others who are working on.

Good tests to elevate the area. So the strategy of raising all boats, but yes, we did share our data and we intend to make this available in a phased approach commercially as an <unk> starting at the end of this year in a couple of sites and then continuing to span expand over 2020 four.

Anne E. White: but yes, we did share our data and we intend to make this available in a phased approach commercially as an <unk> starting at the end of this year in a couple of sites and then continuing to span expand over 2020 four. But at the same time Youll see us continue to publish the data we think that what's incredibly important in the field is that good correlated data, particularly with amyloid pet which is the gold standard in diagnosis is published in shares. So that we can continue to make sure that we have high quality tests out there. So that's part of our goal with delivering this test is to really sad.

Anne E. White: But yes, we did share our data. And we intend to make this available in a phased approach commercially as an LDT starting at the end of this year, in a couple of sites, and then continuing to expand over 2024. But at the same time, you'll see us continue to publish the data. We think that what's incredibly important in the field, is that good correlative data, particularly with amyloid PET, which is the gold standard in diagnosis is published and shared so that we can continue to make sure that we have high quality tests out there.

But at the same time Youll see us continue to publish the data we think that what's incredibly important in the field is that good correlated data, particularly with amyloid pet which is the gold standard in diagnosis is published in shares. So that we can continue to make sure that we have high quality tests out there. So that's part of our goal with delivering this test is to really sad.

Anne White: We think that what's incredibly important in the field is that good correlated data, particularly with amyloid PET, which is the gold standard for diagnosis, is published and shared so that we can continue to make sure that we have high quality tests out there. So that's part of our goal with delivering this test, is to really set a standard for what blood tests should look like. So look forward to hearing more over the next coming months as we publish that data and then make that more broadly.

We think that what's incredibly important in the field is that good correlated data, particularly with amyloid PET, which is the gold standard for diagnosis, is published and shared so that we can continue to make sure that we have high quality tests out there. So that's part of our goal with delivering this test, is to really set a standard for what blood tests should look like. So look forward to hearing more over the next coming months as we publish that data and then make that more broadly.

Anne E. White: So, that's part of our goal with delivering this test is to really set a standard for what blood tests should look like. So, look forward to hearing more over the next coming months as we publish that data and then make that more broadly available.

<unk> for what blood tests should look like so it look forward to hearing more over the next coming months as we published that data and then make that more broadly available.

David Ricks: Available. Thanks, Anne. Thanks, Mohit for the question. Paul, next.

Available.

Joe Fletcher: Thanks, Anne. Thanks, Mohit for the question. Paul, next.

Joe Fletcher: Thanks, Anne, and thanks Mohit for the question. Paul, next question.

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

Question.

Operator 3: The next question is coming from Louise Chen from Cantor. Louise, your line is.

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

Anat Ashkenazi: Hi. Thanks for taking my question. So I wanted to ask you, do you think the approval of additional oral diabetes drug could impact the pricing for injectables? Why or why not? Thank.

Louise Chen: Hi. Thanks for taking my question. So I wanted to ask you, do you think the approval of additional oral diabetes drug could impact the pricing for injectables? Why or why not? Thank.

Louise Chen: Hi, thanks for taking my question. So, I want to ask you, do you think the approval of additional oral potential approval of additional oral diabetes drug could impact the pricing for injectables? Why or why not? Thank you.

Ask you do you think the approval additional oral potential approval of additional oral diabetes drug to impact the pricing for injectables why or why not thank you.

David Ricks: You.

You.

David Ricks: Thanks, Luisa, for the question. I'll hand over to Mike about the potential approval for other oral diabetes drugs and potential impact on.

Joe Fletcher: Thanks, Luisa, for the question. I'll hand over to Mike about the potential approval for other oral diabetes drugs and potential impact on.

Joe Fletcher: Thanks, Louise, for the question. I'll hand over to Mike about the potential approval for other oral diabetes drugs and potential impact on injectables?

Mike Mason: Injectables.

Injectables.

Potential impact on Injectables.

Mike Mason: No, I don't think that'll have an impact. I mean, traditionally we don't see a new class of diabetes agents coming in and affecting a current class. Usually the competition happens within a specific class within the diabetes.

Michael B. Mason: No, I don't think that'll have an impact. Traditionally, we don't see a new class of diabetes agents coming in and affecting a current class. Usually the competition happens within a specific class within a diabetes market.

A new class of diabetes agents coming in and affecting our current class uses the competition happens within a Pacific class within the diabetes market.

David Ricks: Market.

Market.

David Ricks: Thanks, Mike. Paul, next.

Joe Fletcher: Thanks, Mike. Paul, next.

Okay.

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

Question.

Operator 3: The next question is from Geoff Meacham from Bank of America. Geoff, your line is.

Joe Fletcher: Thanks, Mike. Paul, next question. The next question is from Geoff Meacham from Bank of America, Jeff Your line is live.

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

Joe Fletcher: The next question is from Geoff Meacham from Bank of America. Geoff, your line is live.

David Ricks: Live. Morning.

Live.

Geoff Meacham: Morning.

Daniel Skovronsky: Everyone. Thanks for the.

Everyone. Thanks for the.

David Ricks: Just had one on tirzepatide supply. I know you guys have, you know, a plan in North Carolina and another one coming online next year. But, you know, if you look beyond that, if you have demand anywhere near what's modeled and even outside of obesity and diabetes, you know, obviously supply could remain tight. So the question is, is there a threshold of treated patients, like, in the near term, that will inform your, your decision on adding manufacturing capacity and how much does the outlook for orforglipron have on.

Geoff Meacham: Good morning, everyone. Thanks for the question. Just had one on Iirzepatide supply. I know you guys have, a plant in North Carolina and another one coming online next year. But if you look beyond that, if you have demand anywhere near what's modeled, and even outside of obesity and diabetes, obviously, supply could remain tight. So, the question is, is there a threshold of treated patients like in the near term that will inform your decision on adding manufacturing capacity? And how much does the outlook for or Orforglipron have on that? Thank you.

Just had one on tirzepatide supply. I know you guys have, you know, a plan in North Carolina and another one coming online next year. But, you know, if you look beyond that, if you have demand anywhere near what's modeled and even outside of obesity and diabetes, you know, obviously supply could remain tight. So the question is, is there a threshold of treated patients, like, in the near term, that will inform your, your decision on adding manufacturing capacity and how much does the outlook for orforglipron have on.

Even outside of obesity and diabetes obviously.

Supply could remain types of the questions is there a threshold.

Of treated patients like in the near term that will inform your your decision on adding manufacturing capacity and how much does the outlook for orphan blip Ron.

Mike Mason: That? Thank.

That? Thank.

David Ricks: You.

You.

Thank you.

David Ricks: Thanks, Jeffrey, for the question. I'll hand over to David. Yeah, thanks, Jeffrey. Obviously, hot topic. We work on this multiple hours every day. You're citing the announcements we've made, and, as Anat mentioned, we made great progress this year on manufacturing agenda. RTP is sort of on track to deliver on its goal as we exit the year, and then that kind of in market volume following that. Concord, which is a few hours away, kind of a replica site, also well on track for coming online in 2024.

Joe Fletcher: Thanks, Jeffrey, for the question. I'll hand over to David.

Joe Fletcher: Thanks, Geoff for the question. I'll hand over to Dave.

Dave Ricks: Yeah, thanks, Jeffrey. Obviously, hot topic. We work on this multiple hours every day. You're citing the announcements we've made, and, as Anat mentioned, we made great progress this year on manufacturing agenda. RTP is sort of on track to deliver on its goal as we exit the year, and then that kind of in market volume following that. Concord, which is a few hours away, kind of a replica site, also well on track for coming online in 2024.

Dave Ricks: Yes, Thanks, Jeff, obviously, a hot topic and we work on this multiple hours every day. You're citing the announcements we've made and we've made is not mentioned great progress. This year on manufacturing agenda RTP sort of on track to deliver on its goal as we exit the year and then that kind of in market volume following that. Concord, which is few hours away kind of a replica site. Also well on track before. Coming online in 'twenty four so that's good news in the <unk> presentation, which is the what we call our auto injector that you know from <unk> and with the current presentation from a driver in the U S. We've announced previously. We're introducing now a single use vial presentation ex U S. So that we arent basically sitting on approvals and can have patients have access to the medication that will followed then by a multi use injector that uses different property plant and equipment than what we're talking about here. So.

Dave Ricks: Yeah, thanks, Geoff. Obviously a hot topic. We work on this multiple hours every day. You're citing the announcements we've made and as mentioned great progress is showing manufacturing agenda RTP on track to deliver on its goal. But as we exit the year, and then that kind of in market volume following that Concord, which is a few hours away, and kind of a replica site also, well on track for coming online in '24. So, that's good news in the ERMA presentation, which is what we call our auto injector, from Trulicity, and the current presentation from Mounjaro in the U.S. We've announced previously that we're introducing now single use vial presentation ex-U.S, so that we aren't basically sitting on approvals and connect patients have access to the medication.

You're citing the announcements we've made and we've made is not mentioned great progress. This year on manufacturing agenda RTP sort of on track to deliver on its goal as we exit the year and then that kind of in market volume following that.

Concord, which is few hours away kind of a replica site.

Also well on track before.

David Ricks: So that's good news in the IRMAA presentation, which is what we call our auto-injector that you know from Trulicity and the current presentation from Mounjaro in the US. We've announced previously that we're introducing now a single-use vial presentation ex-US so that we aren't basically sitting on approvals and can have patients have access to the medication that will follow then by a multi-use injector that uses different property plant equipment than what we're talking about here. So a couple things to point out. You're noting kind of new greenfield site expansions we've rightfully made a big deal out of. We're not done with those. I think you might hear more about that in the future. Of course we are aggressively planning that and not banking on orforglipron to rescue us from this.

So that's good news in the IRMAA presentation, which is what we call our auto-injector that you know from Trulicity and the current presentation from Mounjaro in the US. We've announced previously that we're introducing now a single-use vial presentation ex-US so that we aren't basically sitting on approvals and can have patients have access to the medication that will follow then by a multi-use injector that uses different property plant equipment than what we're talking about here. So a couple things to point out. You're noting kind of new greenfield site expansions we've rightfully made a big deal out of. We're not done with those. I think you might hear more about that in the future. Of course we are aggressively planning that and not banking on orforglipron to rescue us from this.

Coming online in 'twenty four so that's good news in the <unk> presentation, which is the what we call our auto injector that you know from <unk> and with the current presentation from a driver in the U S. We've announced previously.

Dave Ricks: So, that's good news in the ERMA presentation, which is what we call our auto injector, from Trulicity, and the current presentation from Mounjaro in the U.S. We've announced previously that we're introducing now single use vial presentation ex-U.S, so that we aren't basically sitting on approvals and connect patients have access to the medication.

We're introducing now a single use vial presentation ex U S.

So that we arent basically sitting on approvals and can have patients have access to the medication that will followed then by a multi use injector that uses different property plant and equipment than what we're talking about here. So.

Dave Ricks: That will follow them by a multi use injector that uses different property plant and equipment than what we're talking about here. So, a couple of things to point out. You're noting kind of new greenfield site expansions. We've rightfully made a big deal out of. We're not done with those. I think you might hear more about that in the future. Of course, we are aggressively planning that and not banking on or forced upon to rescue us from this. We think that there is a need to take up parenteral incretin supply pretty dramatically from the current levels. And we plan to do that.

A couple of things to point out you're noting.

Kind of a new Greenfield site expansions.

Rightfully made a big deal out of we're not done with those I think you might hear more about that in the future of course, we are aggressively planning that and not banking on our Forbes ponder to rescue us from this we think.

David Ricks: We think that there is a need to take up parenteral incretin supply pretty dramatically from the current levels, and we plan to do that. But that will be in a combination of the current syringe-based auto injector, the vial capacity. We've already talked about the multi-use injector, which will come online sometime next year and is a highly efficient play for us because it uses current systems and different ones from the auto injector. And then there's third-party agreements that have been ongoing in the background. And to point out here, we're not relying on one. We have a diverse portfolio of third parties, recognizing that the probability of full supply from any one is probably less than 1, but buying up as much capacity as available in all those systems. So we've got, I think, the all hands on deck phrase was used earlier.

We think that there is a need to take up parenteral incretin supply pretty dramatically from the current levels, and we plan to do that. But that will be in a combination of the current syringe-based auto injector, the vial capacity. We've already talked about the multi-use injector, which will come online sometime next year and is a highly efficient play for us because it uses current systems and different ones from the auto injector. And then there's third-party agreements that have been ongoing in the background. And to point out here, we're not relying on one. We have a diverse portfolio of third parties, recognizing that the probability of full supply from any one is probably less than 1, but buying up as much capacity as available in all those systems. So we've got, I think, the all hands on deck phrase was used earlier.

That there is a need to take a parenteral anchor tenant supply pretty dramatically from the current levels and we plan to do that.

Dave Ricks: But that will be in a combination of the current syringe-based auto injector, the vial capacity, we've already talked about. The multi use injector, which will come online sometime next year, and is a highly efficient play for us because it uses current systems and different ones from the auto injector. And then there's third party agreements that have been ongoing in the background. And to point out here, we are not relying on one. We have a diverse portfolio of third parties, recognizing that, the probability of full supply from any one is probably less than one. But buying up as much capacity as available in all those systems.

Syringe based auto injector, the vial capacity, we've already talked about the multi use injector, which will come online sometime next year and is a highly efficient play for us because it uses current systems and different ones from the auto injector.

And then there's third party agreements that have been ongoing in the background and to point out here, we're not relying on one we have a diverse portfolio of third parties recognizing that the probability of.

Full supply from any one is probably less than one.

But buying up as much capacity is available in all of those systems. So.

Dave Ricks: We've got a I think the all hands on deck Fraser's use earlier I mean, this is really all hands on deck and it's a problem. We work every day. So we're not at all happy with the capacity, we have announced already you'll see more some we don't announce that will just layer in to the volume we ship. And of course long term new. Presentations like solid oral opens up even more possibilities, but we need to do everything we can now given the huge potential for global obesity treatment. For our medicines to play a key role in that and then ultimately impact. Hundreds of millions of people. So a lot of work to do here yet ahead. Thanks for the question.

Dave Ricks: So, we've got all hands on deck, phrase was used earlier. This is really all hands on deck. And it's a problem we work every day. So, we're not at all happy with the capacity. We've announced already, you'll see more. Some we don't announce that we'll just layer in to the volume we ship. And of course, long term new presentations like solid oral opens up even more possibilities, but we need to do everything we can now given the huge potential for global obesity treatment for our medicines to play a key role in that, and then ultimately impact hundreds of millions of people. So, a lot of work to do here yet ahead. Thanks for the question.

David Ricks: I mean, this is really all hands on deck, and it's a problem we work on every day. So we're not at all happy with the capacity we've announced already. You'll see more. Some we don't announce that will just layer into the volume we ship. And of course long term new.

I mean, this is really all hands on deck, and it's a problem we work on every day. So we're not at all happy with the capacity we've announced already. You'll see more. Some we don't announce that will just layer into the volume we ship. And of course long term new.

And of course long term new.

David Ricks: Presentations like solid oral opens up even more possibilities. But we need to do everything we can now, given the huge potential for global obesity treatment, for our medicines to play a key role in that, and then ultimately impact hundreds of millions of people. So a lot of work to do here yet ahead. Thanks for the question, Paul. Next.

Presentations like solid oral opens up even more possibilities. But we need to do everything we can now, given the huge potential for global obesity treatment, for our medicines to play a key role in that, and then ultimately impact hundreds of millions of people. So a lot of work to do here yet ahead. Thanks for the question,

Presentations like solid oral opens up even more possibilities, but we need to do everything we can now given the huge potential for global obesity treatment.

For our medicines to play a key role in that and then ultimately impact.

Hundreds of millions of people. So a lot of work to do here yet ahead. Thanks for the question.

Dave Ricks: So a lot of work to do here yet ahead. Thanks for the question.

Joe Fletcher: Paul. Next.

Operator: Question. The next question is from Luisa Hector from Berenberg. Luisa, your line is.

Question.

Operator 3: The next question is from Luisa Hector from Berenberg. Luisa, your line is.

Joe Fletcher: Paul, next question.

Operator: The next question is from Laura Hindley from Berenberg. Laura, your line is live.

Anat Ashkenazi: Live.

Live.

Anat Ashkenazi: Hi, thanks for taking my question. So I think it's clear from your results that the mix shift to Mounjaro is rapidly in progress. But how should we think about the ex-US Trulicity contribution going forward, which did look weak this quarter but at the moment you're still supply restricted? Can we expect a return to growth into next year as constraints ease or should we now assume Trulicity is ex-growth as you push the shift into Mounjaro? Thank.

Laura Hindley: Hi, thanks for taking my question. So I think it's clear from your results that the mix shift to Mounjaro is rapidly in progress. But how should we think about the ex-US Trulicity contribution going forward, which did look weak this quarter but at the moment you're still supply restricted? Can we expect a return to growth into next year as constraints ease or should we now assume Trulicity is ex-growth as you push the shift into Mounjaro? Thank.

Laura Hindley: Hi, thanks for taking my question. So, I think it's clear from your results that the next steps in Mounjaro is rapidly in progress. But how should we think about the ex-U.S Trulicity contribution going forward, which did look weak this quarter? But at the moment you're still supply restricted? Can we expect a return to growth into next year as constraints ease or should we now assume Trulicity is ex-growth as you push the shift into Mounjaro? Thank you.

So I think it's clear from your results that the mix.

The majority is rapidly and progress.

How should we think about the ex U S to see contribution going forward, which kept the weakness caused that.

Amendment, you'll still supply restricted can we expect everytime integrate into next yes constraints ease or should we not have seen T as X Grace.

David Ricks: You. Thanks, Laura. For the question, I'll hand over to Ilya Yuffa, President of Lilly International. Ilya, do you want to address Trulicity ex-US contributions in the quarter and going.

You.

Joe Fletcher: Thanks, Laura. For the question, I'll hand over to Ilya Yuffa, President of Lilly International. Ilya, do you want to address Trulicity ex-US contributions in the quarter and going.

<unk>. Thank you.

Joe Fletcher: Thanks, Laura for the question. I'll hand over to Ilya Yuffa, President of Lilly International. Iliya, do you want to address Trulicity ex-U.S. contributions in the quarter and going forward?

Daniel Skovronsky: Forward? Sure, yeah. First, thanks for the question. Listen, I think from a Trulicity standpoint we had healthy growth coming into.

Forward?

Ilya Yuffa: Sure, yeah. First, thanks for the question. Listen, I think from a Trulicity standpoint we had healthy growth coming into.

Ilya Yuffa: Sure, first, thanks for the question. From a Trulicity standpoint, we had healthy growth coming into later part of last year. And we've been pretty transparent with both physicians as well as regulators that due to the tight supply, we are encouraged not to start new patients. We continue with that, to be transparent. We think it's the right thing to do. And as we think about the growth in incretin, we're looking as we build up capacity, as David mentioned.

Thanks for the question.

From a publicity standpoint, we had healthy growth coming into.

Daniel Skovronsky: Later part of last year, and we've been pretty transparent with both physicians, as well as regulators, that due to tight supply we encourage not to start new patients. We continue with that to be transparent. We think that's the right thing to do. As we think about growth in incretin, we're looking as we build up capacity, as David mentioned.

Later part of last year, and we've been pretty transparent with both physicians, as well as regulators, that due to tight supply we encourage not to start new patients. We continue with that to be transparent. We think that's the right thing to do. As we think about growth in incretin, we're looking as we build up capacity, as David mentioned.

Later part of last year.

Been pretty transparent with both physicians as well as regulators that.

Due to tight supply.

It's not to start new patients, we continue with that to be transparent with you. That's the right thing to do.

And as we think about growth in <unk>, we're looking as we build up capacity as David mentioned.

Daniel Skovronsky: As we increase capacity both in the single-use vial and introduce Mounjaro in additional markets as we have in Australia and will continue over the next number of weeks and months in other markets, and then transition towards a multi-use platform of KwikPen in introducing Mounjaro. So the overall growth in incretin will be mainly driven by as we are able to launch Mounjaro in new markets; that's probably where we'll get the growth. Thank you for the.

As we increase capacity both in the single-use vial and introduce Mounjaro in additional markets as we have in Australia and will continue over the next number of weeks and months in other markets, and then transition towards a multi-use platform of KwikPen in introducing Mounjaro. So the overall growth in incretin will be mainly driven by as we are able to launch Mounjaro in new markets; that's probably where we'll get the growth. Thank you for the.

Ilya Yuffa: As we increase capacity both in the single use vial and introduce Mounjaro in additional markets as we have in Australia and we will continue over the next number of weeks and months in other markets and then transition towards a multi-use platform in quick time in introducing Mounjaro. And so the overall growth in incretin will be mainly driven by as we are able to launch Mounjaro in new markets that's probably will go get the growth. Thank you for the question.

Single use vial and introduce.

John in additional markets.

In Australia and will continue over the next number of weeks and months and.

In other markets and then transition towards a multi use platform, our quick and introducing non Jonathan so the overall growth in <unk> will be mainly driven by as we are able to launch gyro and new markets that's public.

David Ricks: Question. Thanks Ilya. Paul, next.

Question.

Joe Fletcher: Thanks Ilya. Paul, next.

Thank you for your question.

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

Question.

Operator 3: The next question is coming from Umer Raffat from Evercore. Umer, your line is.

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

Operator: The next question is coming from Umar Rafat from Evercore. Umar, your line is live.

Daniel Skovronsky: Live. Hi guys. Thanks for taking my question. I realize Mounjaro is not approved in obesity yet, but I'm just very curious how you're thinking about the pros and cons heading into that pricing decision, if there is any, because Novo does have that price premium, as you know, on Wegovy over Ozempic. So on the one hand while Mounjaro price could be the same because the dose is the same, but on the other hand Novo has this dynamic where it can offer a lot more rebate for the obesity indication than you can if you leave the price unchanged. I'm just curious what your thought process is heading into.

Live.

Umer Raffat: Hi guys. Thanks for taking my question. I realize Mounjaro is not approved in obesity yet, but I'm just very curious how you're thinking about the pros and cons heading into that pricing decision, if there is any, because Novo does have that price premium, as you know, on Wegovy over Ozempic. So on the one hand while Mounjaro price could be the same because the dose is the same, but on the other hand Novo has this dynamic where it can offer a lot more rebate for the obesity indication than you can if you leave the price unchanged. I'm just curious what your thought process is heading into.

Umar Rafat: Hi, guys. Thanks for taking my question. I realize Mounjaro has not approved in obesity yet. But I'm just very curious how you're thinking about the pros and cons heading into that pricing decision, if there is any, because Novo does have that price premium, as you know, on Wegovy or Ozempic. So, on the one hand, while Mounjaro price could be the same because the dose is the same, but on the other hand, Novo has this dynamic where it can offer a lot more rebate for the obesity indication than you can, if you leave the price unchanged. I'm just curious what your thought process is heading into that.

A lot more rebate for the obesity indication then you can if you leave the price on changed I'm. Just curious what are your thought processes heading into that.

David Ricks: That.

That.

David Ricks: I'll hand over to.

Joe Fletcher: I'll hand over to.

Mike Mason: Mike.

Mike.

Joe Fletcher: I'll hand over to Mike.

Mike Mason: Yeah, thanks for the question. Obviously we're not going to talk about price prior to approval. We're evaluating every scenario. We'll make the right decision for patients who live with obesity.

Michael B. Mason: Yeah, thanks for the question. Obviously, we're not going to talk about price prior to approval. We're evaluating every scenario. We will make the right decision for patients who live with obesity. Thanks.

David Ricks: Thanks.

Thanks.

David Ricks: Paul. Next.

Joe Fletcher: Paul. Next.

Operator: Question. The next question is coming from David Risinger from Leerink. David, your line is.

Question.

Operator 3: The next question is coming from David Risinger from Leerink. David, your line is.

Joe Fletcher: Paul, next question.

Operator: The next question is coming from David Risinger from Leerink. David, your line is live.

David Ricks: Live.

Live.

David R. Risinger: Yes, thanks very much. And thanks for all the updates today. So, some major payers seem to under appreciate the broad health savings potential that incretins offer the non-diabetic obese population, and instead focus on criticizing drug pricing. So, ahead of the results from Mounjaro's morbidity and mortality outcomes trial in 2027, how does Lilly plan to better inform payers about Mounjaro's health economics benefits in non-diabetic obese patients? Thanks very much.

David Ricks: Yes, thanks very much, and thanks.

David Risinger: Yes, thanks very much, and thanks.

Yes, thanks very much.

Mike Mason: For all the updates today. Some major payers seem to underappreciate the broad health savings potential that incretins offer.

For all the updates today. Some major payers seem to underappreciate the broad health savings potential that incretins offer.

Thanks for all the updates today so.

Some major payers seem to under appreciate the broad health savings potential that and curtains offer.

Mike Mason: The non-diabetic obese population and instead focus on criticizing drug pricing. So ahead of the results from Mounjaro's morbidity and mortality outcomes trial in.

The non-diabetic obese population and instead focus on criticizing drug pricing. So ahead of the results from Mounjaro's morbidity and mortality outcomes trial in.

The non diabetic obese population and instead focus on Criticising drug pricing.

So ahead of the results from gyros morbidity and mortality outcomes trial in 2027, how does <unk> plan to better inform payers about <unk> health economics benefits and non diabetic obese patients. Thanks very much.

David Ricks: 2027, how does Lilly plan to better?

2027, how does Lilly plan to better?

Mike Mason: Inform payers about Mounjaro's health economics benefits in non-diabetic obese.

Inform payers about Mounjaro's health economics benefits in non-diabetic obese.

David Ricks: Patients? Thanks very much. Thanks, Dave, for the question. Mike, do you want to talk a little bit about that? About the longer term appreciation for the broader health benefits of medicines like.

Patients? Thanks very much.

Joe Fletcher: Thanks, Dave, for the question. Mike, do you want to talk a little bit about that? About the longer term appreciation for the broader health benefits of medicines like.

Joe Fletcher: Thanks, Dave for the question. Mike, do you want to talk a little bit about that, about the longer term appreciation for the broader health benefits of medicines, like Tirzepatide?

But longer term appreciation for the broader health benefits of.

Mike Mason: Tirzepatide? Yeah, no, David, it's a good question. One that we've obviously spent a ton of time on and done a lot of internal analysis and a lot of planning on. We will have a whole suite of real-world evidence and pragmatic trials so that we can answer this question clearly for payers and other stakeholders. You know, in our conversations with payers, you know, while they're concerned about the short term, you know, budget impact, they do understand that.

Tirzepatide?

Mike Mason: Yeah, no, David, it's a good question. One that we've obviously spent a ton of time on and done a lot of internal analysis and a lot of planning on. We will have a whole suite of real-world evidence and pragmatic trials so that we can answer this question clearly for payers and other stakeholders. You know, in our conversations with payers, you know, while they're concerned about the short term, you know, budget impact, they do understand that.

Medicines like tours appetite.

Michael B. Mason: Yeah, no, David, it's a good question. One that we've obviously spent a ton of time on and done a lot of internal analysis and a lot of planning on. We will have a whole suite of real world evidence and pragmatic trials so that we can answer this question clearly for payers and other stakeholders. In our conversations with payers, while they're concerned about the short term budget impact, they do understand that losing weight will have benefits. It's not that hard of a sale, because they do understand the benefits are intuitive.

A lot of planning on.

We will have a whole suite of real.

World evidence and pragmatic trials, so that we can answer this question clearly.

Sure.

Payers and other stakeholders.

In our conversations with payers, while they're concerned about the short term.

Budget impact.

They do understand that.

Mike Mason: Losing weight will have benefits. You know, it's not that hard of a sale cause they do understand the benefits are intuitive. If you look at the total number of obesity-related complications, there's over 200. And you look at some of these are just really devastating and very costly like type 2 diabetes, coronary heart disease, hypertension, dyslipidemia, and then when you look at the cost of these, in the US alone, there's $370 billion in direct medical costs associated with obesity-related comorbidities and over $1 trillion in indirect annual costs. When payers see that people living with obesity and overweight drive 2.7 times greater healthcare costs than normal weight individuals, that data does get their attention. And so I think over time we'll continue to provide health economics data. But also I think the voice of those living with obesity will be very important in this.

Losing weight will have benefits. You know, it's not that hard of a sale cause they do understand the benefits are intuitive. If you look at the total number of obesity-related complications, there's over 200. And you look at some of these are just really devastating and very costly like type 2 diabetes, coronary heart disease, hypertension, dyslipidemia, and then when you look at the cost of these, in the US alone, there's $370 billion in direct medical costs associated with obesity-related comorbidities and over $1 trillion in indirect annual costs. When payers see that people living with obesity and overweight drive 2.7 times greater healthcare costs than normal weight individuals, that data does get their attention. And so I think over time we'll continue to provide health economics data. But also I think the voice of those living with obesity will be very important in this.

That losing weight will have benefits.

It's not that hard of a sale because they do understand the bench.

That's our intuitive if.

Michael B. Mason: If you look at the total number of obesity rate of complications, there's over 200. And you look at - some of these are just really devastating and very costly, like type 2 diabetes, coronary heart disease, hypertension, dyslipidemia. And then, when you look at the cost of these, on the U.S alone, there's $370 billion in direct medical costs associated with obesity-related comorbidities, and over a trillion in indirect annual cost. When payers see that, people living with obesity and overweight, drive 2.7 times greater healthcare costs, than normal individuals, that data does get their attention.

When you look at some of these are just really devastating and very costly like type two diabetes coronary heart disease hypertension, Dyslipidemia and then when you look at the cost of these.

The U S alone Theres $371 billion in direct medical costs associated with obesity related comorbidities and over a trillion dollars and indirect annual cost when.

When payers see that people living with obesity and overweight draw.

Drive two seven times, greater health care costs and normally in individuals that data does get their attention.

Michael B. Mason: And so I think overtime, we will continue to provide health economics data, but also I think the voice of those living with obesity. We will be very important in this this is a disease. That. That really materially impact someone's, both health and mental functioning. And is really important for people who live with obesity. Their goal is to us. Lose weight and maintain that so they can help the long term health benefits and they're going to have a loud voice in this I think both. Commercial insurance as well as. States and federal government and so I do I am confident over time that we will see increase in access I think are the most recent report shows that there is 50 million people in the U S. It as excess or obesity medications. So it will take time, but I think do think more and more payers are appreciating the value that.

Michael B. Mason: And so, I think over time will continue to provide health economics data, but also I think the voice of those living with obesity will be very important in this. This is a disease that, that really materially impacts someone's both health and mental functioning. And is really important for people who live with obesity. Their goal is to is to lose weight and maintain that, so they can help their long term health benefits. And they're going to have a loud voice in this. I think both in commercial insurance as well as in states and the federal government. And so, I am confident over time that we will see increase in access.

Mike Mason: This is a disease that.

This is a disease that.

We will be very important in this this is a disease.

Mike Mason: Really materially impacts someone's both health and mental functioning and is really important for people who live with obesity. Their goal is to lose weight and maintain that so they can help their long-term health benefits, and they're going to have a loud voice in this I think both in commercial insurance as well as in states and the federal government. So I do, I am confident over time that we will see increase in access. I think the most recent report shows that there's 50 million people in the US that has access to obesity medications. So it will take time but I do think more and more payers are appreciating the value that anti-obesity medications especially when we get approval for Tirzepatide we'll offer them.

Really materially impacts someone's both health and mental functioning and is really important for people who live with obesity. Their goal is to lose weight and maintain that so they can help their long-term health benefits, and they're going to have a loud voice in this I think both in commercial insurance as well as in states and the federal government. So I do, I am confident over time that we will see increase in access. I think the most recent report shows that there's 50 million people in the US that has access to obesity medications. So it will take time but I do think more and more payers are appreciating the value that anti-obesity medications especially when we get approval for Tirzepatide we'll offer them.

That.

That really materially impact someone's, both health and mental functioning.

And is really important for people who live with obesity.

Their goal is to us.

Lose weight and maintain that so they can help the long term health benefits and they're going to have a loud voice in this I think both.

Commercial insurance as well as.

States and federal government and so I do I am confident over time that we will see increase in access I think are the most recent report shows that there is 50 million people in the U S. It as excess or obesity medications. So it will take time, but I think do think more and more payers are appreciating the value that.

Michael B. Mason: I think the most recent report shows that there's 50 million people in the U.S that has access to obesity medication. So, it will take time, but I think more and more payers are appreciating the value that anti-obesity medications, especially when we get approval for Tirzepatide will offer them. Thanks.

WC medications, especially when.

When we get approval from FERC, there's appetite will offer them. Thanks.

David Ricks: Thanks. Thank you Mike. Paul, next.

Thanks.

Joe Fletcher: Thank you Mike. Paul, next.

Operator: Question. The next question is coming from Evan Seigerman from BMO Capital Markets. Evan, your line is.

Question.

Operator 3: The next question is coming from Evan Seigerman from BMO Capital Markets. Evan, your line is.

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

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

Daniel Skovronsky: Live. Kyle, thank you so much for giving me the question and congrats on the progress. So given the executive changes announced in October, how should we think about.

Live.

Evan Seigerman: Kyle, thank you so much for giving me the question and congrats on the progress. So given the executive changes announced in October, how should we think about.

Evan Seigerman: Hi, thank you so much for giving me the question and congrats on the progress. So, given the executive changes announced in October, how should we think about the direction of the immunology business now with Dan at the helm? Thank you guys.

Mike Mason: The direction of the immunology business now with Dan at the helm? Thank you.

The direction of the immunology business now with Dan at the helm? Thank you.

David Ricks: Guys.

Guys.

David Ricks: Thanks, Evan. Dave, do you want to take that? Sure, I can start and let Dan comment. Look, we've been really pleased with this business, which I think it's important to take the long view here. I mean I was involved in creating this like 10 years ago, and both Taltz, Emgality, and now Mirikizumab, and hopefully soon Lebrikizumab, will form a really core portfolio for us. You know, really exploiting ideas that we had some time ago. You know what's next, and you see here today advancing another checkpoint agonist into phase 2 is a lot of decisions about okay, what's next to take immunology to the next level.

Joe Fletcher: Thanks, Evan. Dave, do you want to take that?

Dave Ricks: Sure, I can start and let Dan comment. Look, we've been really pleased with this business, which I think it's important to take the long view here. I mean I was involved in creating this like 10 years ago, and both Taltz, Emgality, and now Mirikizumab, and hopefully soon Lebrikizumab, will form a really core portfolio for us. You know, really exploiting ideas that we had some time ago. You know what's next, and you see here today advancing another checkpoint agonist into phase 2 is a lot of decisions about okay, what's next to take immunology to the next level.

Dave Ricks: Look we've. <unk> been really pleased with this business, which I think it's important to take the long view here I mean I was involved in creating this like 10 years ago in both Tulsa linear and now <unk> and hopefully soon <unk> mab. Form a really core portfolio for us. Really exploiting ideas that we had some time ago Whats next and you see here today advancing another checkpoint. Agonist in the phase II is a lot of decisions about okay. What's next to take immunology to the next level and that's largely going to be about key decisions, both internal portfolio and potentially externally like with our dice acquisition. To find a new set of either single agent or combinations that can raise the standard of care in tough immunology diseases, noting in particular in <unk>. IBD in RA. Array the standard of care is hardly satisfied today, we measure pretty low performance status of success.

Dave Ricks: Sure, I can start and let Dan comment. Look, we've been really pleased with this business, which I think is important to take the long view here. I mean, I was involved in creating this like 10 years ago, and both [indiscernible] and now mirikizumab, and hopefully soon Lebrikizumab will form a really core portfolio for us, really exploiting ideas that we had some time ago. What's next, and you see here today advancing another checkpoint agonist into Phase 2 is a lot of decisions about, okay, what's next to take immunology to the next level. And that's largely going to be about key decisions, both internal portfolio and potentially externally, like with our DICE acquisition, to find a new set of either single agent or combinations that can raise the standard of care in tough immunology diseases, noting, in particular in IBD and RA, the standard of care is hardly satisfied today.

Dave Ricks: Sure, I can start and let Dan comment. Look, we've been really pleased with this business, which I think is important to take the long view here. I was involved in creating this like 10 years ago, in both Taltz and Olumiant and now Mirikizumab, and hopefully soon Lebrikizumab will form a really core portfolio for us, really exploiting ideas that we had some time ago.

<unk> been really pleased with this business, which I think it's important to take the long view here I mean I was involved in creating this like 10 years ago in both Tulsa linear and now <unk> and hopefully soon <unk> mab.

Form a really core portfolio for us.

Really exploiting ideas that we had some time ago Whats next and you see here today advancing another checkpoint.

Dave Ricks: What's next, and you see here today advancing another checkpoint agonist into phase II is a lot of decisions about, okay, what's next to take immunology to the next level. And that's largely going to be about key decisions, both internal portfolio and potentially externally, like with our Dice acquisition, to find a new set of either single agent or combinations that can raise the standard of care in tough immunology diseases, noting, in particular in IBD and RA, the standard of care is hardly satisfied today.

Agonist in the phase II is a lot of decisions about okay. What's next to take immunology to the next level and that's largely going to be about key decisions, both internal portfolio and potentially externally like with our dice acquisition.

David Ricks: And that's largely going to be about key decisions, both internal portfolio and potentially externally, like with our DICE acquisition, to find a new set of either single agent or combinations that can raise the standard of care in tough immunology diseases, noting in particular in IBD and RA. The standard of care is hardly satisfied today. We measure pretty low performance status as success. So that's the mission that Dan and we've hired Mark Genovese to the company and others to really build the portfolio of the future. I don't know Dan, if you.

And that's largely going to be about key decisions, both internal portfolio and potentially externally, like with our DICE acquisition, to find a new set of either single agent or combinations that can raise the standard of care in tough immunology diseases, noting in particular in IBD and RA. The standard of care is hardly satisfied today. We measure pretty low performance status as success. So that's the mission that Dan and we've hired Mark Genovese to the company and others to really build the portfolio of the future. I don't know Dan, if you.

To find a new set of either single agent or combinations that can raise the standard of care in tough immunology diseases, noting in particular in <unk>.

IBD in RA.

Array the standard of care is hardly satisfied today, we measure pretty low performance status of success.

Dave Ricks: We measure real pretty low performance status of success. So, that's the mission that Dan and we've hired Mark Genovese to the company and others to really build a portfolio the future. So I don't Dan, if you want to...

So that's the mission that Dan and we've hired Mark John of easy to the company and others.

To really build the portfolio of the future. So Dan if you want to.

Daniel Skovronsky: I'm very excited about the opportunity. There's lots of work to do in immunology given the depth of unmet medical needs, and the science is breaking here. So, I hope we can continue to bring great drugs to market as we're doing with Mirikizumab and we hope to do with Lebrikizumab soon and more to.

Dan Skovronsky: I'm very excited about the opportunity. There's lots of work to do in immunology given the depth of unmet medical needs, and the science is breaking here. So, I hope we can continue to bring great drugs to market as we're doing with Mirikizumab and we hope to do with Lebrikizumab soon and more to.

Daniel M. Skovronsky: No, excited about the opportunity. There's lots of work to do in immunology, given the depth of unmet medical needs and the science is great here. So, I hope we can continue to bring great drugs to market as we're doing with Mirikizumab. And we hope to do with Lebrikizumab soon and more to come.

With mirror because I mab.

And we hope to do with <unk> soon and more to come.

David Ricks: Come. Thanks, Evan, for the question. Next.

Come.

Joe Fletcher: Thanks, Evan, for the question. Next.

Operator: Question. Paul, the next question is coming from Chris Schott from J.P. Morgan. Chris, your line is.

Question.

Paul,

Joe Fletcher: Thanks, Evan, for the question. Next question, Paul.

Operator 3: The next question is coming from Chris Schott from J.P. Morgan. Chris, your line is.

Operator: The next question is coming from Chris Schott from JPMorgan. Chris, your life is live.

Daniel Skovronsky: Live. Great, thanks so.

Live.

Chris Schott: Great, thanks so.

Mike Mason: Just as we're thinking about the upcoming tirzepatide obesity approval, just interested in your perspective of how we should anticipate commercial coverage ramping as we think of maybe the first couple quarters post launch versus where it could be in a year or two from now, just how quickly can we think about coverage coming on board? Thank you.

Just as we're thinking about the upcoming tirzepatide obesity approval, just interested in your perspective of how we should anticipate commercial coverage ramping as we think of maybe the first couple quarters post launch versus where it could be in a year or two from now, just how quickly can we think about coverage coming on board? Thank you.

Chris Schott: Great. Thanks so much. Just as we're thinking about the upcoming Tirzepatide obesity approval, just interested in your perspective of how we should anticipate commercial coverage ramping, as we think of maybe the first couple of quarters post launch versus where it could be in a year or two from now, a business how quickly can we think about coverage coming on board? Thank you.

David Ricks: Thank you, Chris. I'll hand over to Mike to comment on anticipation of commercial coverage over time.

Joe Fletcher: Thank you, Chris. I'll hand over to Mike to comment on anticipation of commercial coverage over time.

Joe Fletcher: Thanks, Chris. I'll hand over to Mike to comment on anticipation of commercial coverage over time, Mike?

Mike Mason: Mike? Yeah, no, it's a good question. It will ramp up. We'll, you know, we're trying to be disciplined, and we're trying to make sure that we bring on access as quickly as is prudent. And so, just like we did with Mounjaro, we'll take and make sure that we sometimes access has to materialize at an organic pace where it makes sense, and we'll make sure and use our judgment. So, just like with Mounjaro, while we'd love to get out of the gate quickly, most, most importantly as a setup for long-term success. So, you'll see kind of a natural ramp up that you would with, with any new product.

Mike?

Mike Mason: Yeah, no, it's a good question. It will ramp up. We'll, you know, we're trying to be disciplined, and we're trying to make sure that we bring on access as quickly as is prudent. And so, just like we did with Mounjaro, we'll take and make sure that we sometimes access has to materialize at an organic pace where it makes sense, and we'll make sure and use our judgment. So, just like with Mounjaro, while we'd love to get out of the gate quickly, most, most importantly as a setup for long-term success. So, you'll see kind of a natural ramp up that you would with, with any new product.

Michael B. Mason: Yes. Good question. It will ramp up. We're trying to be disciplined and we're trying to make sure that we bring on access as quickly as is prudent and so just like we did with one Dara will take. And make sure that we sometimes access has to materialize. On organic pace, where it makes sense and we'll make sure and use our judgment. So just like with one Darryl while we'd love to get out of the gate quickly. Most most importantly, as a set up for long term success. So youll see kind of a natural ramp up that you would with any new product I think it's important as you look. In the first quarter of our launch last. January when you saw we go be resupply may re supplying into a market where they already had capacity. So I think when you look at our access and you look at our volume as we head into next year, you'll see a ramp up in volume as you see a ramp up in our access.

Michael B. Mason: It's a good question. It will ramp up. We're trying to be disciplined. And we're trying to make sure that we bring on access as quickly, as is prudent. And so, just like we did with Mounjaro we will take and make sure that we sometimes access has to materialize at an organic pace where it makes sense. And we'll make sure and use our judgment. So, just like with Mounjaro, while we'd love to get out of the gate quickly, most importantly, as a setup for long term success. So, you'll see a kind of a natural ramp up that you would with any new product. And I think it's important, as you look in the first quarter of our launch last January, when you saw Wegovy resupply. They were resupplying into a market where they already had capacity.

Good question.

It will ramp up.

We're trying to be disciplined and we're trying to make sure that we bring on access as quickly as is prudent and so just like we did with one Dara will take.

And make sure that we sometimes access has to materialize.

On organic pace, where it makes sense and we'll make sure and use our judgment. So just like with one Darryl while we'd love to get out of the gate quickly. Most most importantly, as a set up for long term success. So youll see kind of a natural ramp up that you would with any new product I think it's important as you look.

Michael B. Mason: So, you'll see a kind of a natural ramp up that you would with any new product. And I think it's important, as you look in the first quarter of our launch last January, when you saw Wegovy resupply. They were resupplying into a market where they already had capacity. So, I think when you look at our access, and you look at our volume as we head into next year, you'll see a ramp up in volume, as you see a ramp up in our access.

Mike Mason: I think it's important, you know, as you look in, you know, the first quarter of our launch, you know, last January when you saw Wegovy resupply, they were resupplying into a market where they already had capacity. I think when you look at our access and you look at our volume as we head into next year, you'll see a ramp up in volume as you see a ramp up in our.

I think it's important, you know, as you look in, you know, the first quarter of our launch, you know, last January when you saw Wegovy resupply, they were resupplying into a market where they already had capacity. I think when you look at our access and you look at our volume as we head into next year, you'll see a ramp up in volume as you see a ramp up in our.

In the first quarter of our launch last.

January when you saw we go be resupply may re supplying into a market where they already had capacity. So I think when you look at our access and you look at our volume as we head into next year, you'll see a ramp up in volume as you see a ramp up in our access.

Michael B. Mason: So I think when you look at our access and you look at our volume as we head into next year, you'll see a ramp up in volume as you see a ramp up in our access.

David Ricks: Access.

Access.

David Ricks: Thanks, Mike. Paul, next.

Joe Fletcher: Thanks, Mike. Paul, next.

Operator: Question. The next question is from Steve Scala from TD Cowen. Steve, your line is.

Question.

Operator 3: The next question is from Steve Scala from TD Cowen. Steve, your line is.

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

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

Daniel Skovronsky: Live. Thank you very much. Question on why Lilly is evaluating higher doses of Tirzepatide. There is risk an adverse event is uncovered and taints the franchise. And of course, there are IRA considerations.

Live.

Steve Scala: Thank you very much. Question on why Lilly is evaluating higher doses of Tirzepatide. There is risk an adverse event is uncovered and taints the franchise. And of course, there are IRA considerations.

Steve Scala: Thank you very much. A question on why Lilly is evaluating higher doses of Tirzepatide. There is risk and adverse event is uncovered and taints the franchise, and of course there are IRA considerations. Does this suggest some reservation about the pipeline either Triple G or Orforglipron, the former, which has safety signals, the latter of which took five years to get to phase III. It would also be interesting to know whether it's the exact same molecule or it's been enhanced in some way. Thank you.

There is risk in adverse event is uncovered in the franchise and of course there are.

Our considerations.

Daniel Skovronsky: Does this suggest some reservation about the pipeline? Either triple G or orforglipron, the former which has safety signals, the latter of which took five years to get to phase 3. It would also be interesting to know whether it's the exact same molecule or it's been enhanced in some way. Thank.

Does this suggest some reservation about the pipeline? Either triple G or orforglipron, the former which has safety signals, the latter of which took five years to get to phase 3. It would also be interesting to know whether it's the exact same molecule or it's been enhanced in some way. Thank.

Does this suggest some reservation about the pipeline either triple G orphan <unk>, the former which is safety signals the latter of which took five years to get to phase three.

It would also be interesting to know whether it's the exact same molecule or it's been enhanced in some way. Thank you.

David Ricks: Thanks, Steve, for the question.

Joe Fletcher: Thanks, Steve, for the question.

Daniel Skovronsky: Okay, I'll take all of that. I think. I'm not sure exactly what the safety signals you're referring to on retatrutide, I think, but we're excited about both retatrutide and orforglipron, which are both in phase 3 and both advancing quickly. We've invested quite a lot in those phase 3 programs. They're robust, covering multiple indications, so there's no hesitation or trepidation there at all. I think though, you know, notwithstanding those two molecules, which I expect to be great and important, you know, contributors to human health.

Dan Skovronsky: Okay, I'll take all of that. I think. I'm not sure exactly what the safety signals you're referring to on retatrutide, I think, but we're excited about both retatrutide and orforglipron, which are both in phase 3 and both advancing quickly. We've invested quite a lot in those phase 3 programs. They're robust, covering multiple indications, so there's no hesitation or trepidation there at all. I think though, you know, notwithstanding those two molecules, which I expect to be great and important, you know, contributors to human health.

Joe Fletcher: Thanks, Steve, for the question. Dan?

Daniel M. Skovronsky: Take all of that. I think. I'm not sure exactly what the safety signals, you're referring to on on <unk> I think. But. We were excited about both Brad and <unk>, which are both in phase III in both advancing quickly. We've invested quite a lot in those phase III programs that are robust covering multiple indications. So there's no hesitation or trepidation there at all.

Daniel M. Skovronsky: Okay, I'll take all that. I'm not sure exactly what the safety signals you are referring to [inaudible], I think. But we were excited about both RADA and Orforglipron , which are both in phase III, and both advancing quickly. We've invested quite a lot in those phase III programs that are robust, covering multiple indications. So, there's no hesitation or trepidation there at all. I think though notwithstanding those two molecules, which I expect to be great and important contributors to human health, we have, Tirzepatide.

I think.

I'm not sure exactly what the safety signals, you're referring to on on <unk> I think.

But.

We were excited about both Brad and <unk>, which are both in phase III in both advancing quickly.

We've invested quite a lot in those phase III programs that are robust covering multiple indications. So there's no hesitation or trepidation there at all.

Daniel M. Skovronsky: So, there's no hesitation or trepidation there at all. I think though notwithstanding those two molecules, which I expect to be great and important contributors to human health, we have, Tirzepatide. I'm not exactly sure if we've maximized the dose response, if we hit the flat part of the dose response curve yet. It looks like we might be close. But we want to explore it. And so we're testing the higher doses in phase II. I think we've had enough patients on this drug for long enough that I expect the risk of uncovering a new safety signal with sort of marginally higher doses is extremely low. So, not worried about that at all.

I think though notwithstanding those two molecules, which I expect to be great and important contributors to human health.

Daniel Skovronsky: We have Tirzepatide. I'm not exactly sure if we've maximized the dose response. If we hit the flat part of the dose response curve yet. It looked like we might be close, but we want to explore it. And so we're testing the higher doses in phase 2. I think we've had enough patients on this drug for long enough that, that I expect the risk of uncovering a new safety signal with sort of marginally higher doses is extremely low. So not worried about that at.

We have Tirzepatide. I'm not exactly sure if we've maximized the dose response. If we hit the flat part of the dose response curve yet. It looked like we might be close, but we want to explore it. And so we're testing the higher doses in phase 2. I think we've had enough patients on this drug for long enough that, that I expect the risk of uncovering a new safety signal with sort of marginally higher doses is extremely low. So not worried about that at.

Daniel M. Skovronsky: I'm not exactly sure if we've maximized the dose response, if we hit the flat part of the dose response curve yet. It looks like we might be close. But we want to explore it. And so we're testing the higher doses in phase II. I think we've had enough patients on this drug for long enough that I expect the risk of uncovering a new safety signal with sort of marginally higher doses is extremely low. So, not worried about that at all.

We have <unk> appetite I'm not exactly sure if we'd maximize the dose response, if we hit the flat part of the dose response curve yet it looks like we might be close, but we want to explore it and so we're testing the higher doses in phase II I think we've had enough patients on this drug for long enough that I expect the risk of uncover.

A new safety signal with <unk>.

Sort of marginally higher doses is extremely low so so not worried about that at all maybe.

David Ricks: All. Maybe just jump in here because we have questions like this, and you know, we have a number of research projects in obesity and related mechanisms, and some people ask, well, how does this one affect that? Or whatever. That's not really the mindset in which we're pursuing this. We're, we see ourselves as a leader in this space and have a unique opportunity, and our goal is to exploit every single idea until we get data that says we shouldn't. And so high dose Tirzepatide is just another version of that, but it doesn't have a read through to other things. We're just in all the above mode in obesity.

All.

Dave Ricks: Maybe just jump in here because we have questions like this, and you know, we have a number of research projects in obesity and related mechanisms, and some people ask, well, how does this one affect that? Or whatever. That's not really the mindset in which we're pursuing this. We're, we see ourselves as a leader in this space and have a unique opportunity, and our goal is to exploit every single idea until we get data that says we shouldn't. And so high dose Tirzepatide is just another version of that, but it doesn't have a read through to other things. We're just in all the above mode in obesity.

Joe Fletcher: Let me just jump in here maybe on questions like this. And we have a number of research projects in obesity and related mechanisms. In some people ask, how does this one affect that or whatever. That's not really the mindset in which we're pursuing this. We see ourselves a leader in the space and have a unique opportunity. And our goal is to exploit every single idea till we get data that says we shouldn't. And so, high dose tirzepatide just another version of that. But it doesn't have a read through to other things. Were just in all the above mode in obesity.

Questions like this and you know we have a number of research projects in obesity and related mechanisms.

And some people ask well how does this one effect that or whatever that's not really the mindset in which we're pursuing this.

We see ourselves as a leader in this space and have a unique opportunity and our goal is to exploit every single idea till we get data that says we should.

And so a high dose precipitate as just another version of that.

But it doesn't have a read through to other things. We're just in all of the above mode and obesity.

David Ricks: Thank you, Paul. Next.

Joe Fletcher: Thank you, Paul. Next.

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

Question.

Joe Fletcher: Paul, next question.

Operator 3: The next question is from Chris Shibutani from Goldman Sachs. Chris, your line is.

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

Daniel Skovronsky: Live. Thank.

Live.

Chris Shibutani: Thank.

David Ricks: You. Good.

You. Good.

Daniel Skovronsky: Morning. In about a week or so, we'll get detailed results from the Select Cardiovascular Outcomes Trial at the American Heart meeting. Can you share with us what perhaps three key questions that the Lilly team will be looking at when we get detailed?

Morning. In about a week or so, we'll get detailed results from the Select Cardiovascular Outcomes Trial at the American Heart meeting. Can you share with us what perhaps three key questions that the Lilly team will be looking at when we get detailed?

Chris Shibutani: Thank you. Good morning. In about a week or so we'll get detailed results from the Select cardiovascular outcomes trial, the American Heart meeting. Can you share with us what perhaps three key questions that the Lilly team will be looking at when we get detailed results?

David Ricks: Results?

Results?

David Ricks: Dan, do you want to weigh in?

Joe Fletcher: Dan, do you want to weigh in?

Daniel Skovronsky: Oh, I don't know. I could start. Maybe Mike has some to add here. Look, I'm excited to see that data, of course, as everyone else is, but the top line looked good for me. I think we're sort of creating now data points on a line that connect the level of weight loss with the degree of cardiovascular benefit. I think this point fits on that line reasonably well. That line, which shows greater health benefits, including better, fewer MACE outcomes.

Joe Fletcher: Dan, do you want to weigh in on that?

Dan Skovronsky: Oh, I don't know. I could start. Maybe Mike has some to add here. Look, I'm excited to see that data, of course, as everyone else is, but the top line looked good for me. I think we're sort of creating now data points on a line that connect the level of weight loss with the degree of cardiovascular benefit. I think this point fits on that line reasonably well. That line, which shows greater health benefits, including better, fewer MACE outcomes.

Daniel M. Skovronsky: I don't know. I can start maybe. Maybe Mike has some to add here. Look, I'm excited to see that data, of course, as everyone else is. But the top line looks good. For me, I think we're creating now data points on a line that connect the level of weight loss with the degree of cardiovascular benefit. I think this point fits on that line reasonably well. That line, which was greater health benefits, including better, fewer mace outcomes with greater degrees of weight loss bodes very well for Mounjaro data, given the very high degrees of weight loss that we saw in our trials. I'll leave it at that. See if Mike wants to add.

Could start maybe Mike has some to add here.

Im excited to see that data of course as everyone else's, but the top line looks good.

For me I think we're sort of creating now data points on a line that connects the level of weight loss with a degree of cardiovascular benefit.

At this point fits on that line are reasonably well.

That line, which shows a greater health benefits, including better a fewer mace outcomes.

Daniel Skovronsky: With greater degrees of weight loss, bodes very well for Mounjaro data, given the very high degrees of weight loss that we saw in our trials. I'll leave it at that. See if Mike wants to.

With greater degrees of weight loss, bodes very well for Mounjaro data, given the very high degrees of weight loss that we saw in our trials. I'll leave it at that. See if Mike wants to.

With greater degrees of weight loss bodes very well for Majora data given the very high degrees of weight loss that we saw in our trials.

Mike Mason: Add.

Add.

I'll leave it at that and see if Mike wants to add.

Mike Mason: Yeah, probably the key question I'm looking at is like, how much of the effect was driven by drug effect versus weight loss is probably the key question we're looking.

Michael B. Mason: Probably, the key question I'm looking at is like how much of the effect was driven by drug effect versus weight loss, is probably the key question we're looking at.

David Ricks: At.

At.

David Ricks: Thanks, Dan and Mike.

Joe Fletcher: Thanks, Dan and Mike.

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

David Ricks: Paul, next.

Paul, next.

Operator: Question. The next question is coming from Carter Gould from Barclays. Carter, your line is.

Question.

Operator 3: The next question is coming from Carter Gould from Barclays. Carter, your line is.

Paul next question the.

Operator: The next question is coming from Carter Gould from Barclays. Carter, your line is live.

Daniel Skovronsky: Live. Great. Good.

Live.

Carter Gould: Great. Good.

David Ricks: Morning.

Morning.

Carter Gould: Great. Good morning. Congrats on the progress. May be following on on the prior question, but maybe more on sort of the impact of the flow data, and your thoughts there. Specifically, you guys have taken a different approach with your more recent assets there, in terms of targeting that population. Is Lily's view that those benefits will accrue to the class and maybe just talk about how you think about targeting that segment down the road? Thank you.

David Ricks: Following on the prior question, but maybe more on sort of the.

Following on the prior question, but maybe more on sort of the.

Congrats on the progress maybe following on that on the prior question, but maybe more on sort of the impact of the flow data and your thoughts there.

Daniel Skovronsky: Impact of the flow data and, you know, your thoughts there. Specifically, you guys have taken sort of a different approach with your more recent assets there in terms of targeting that population. Is Lilly's view that those benefits will accrue to the class, and maybe just talk about how you think about targeting that segment down the.

Impact of the flow data and, you know, your thoughts there. Specifically, you guys have taken sort of a different approach with your more recent assets there in terms of targeting that population. Is Lilly's view that those benefits will accrue to the class, and maybe just talk about how you think about targeting that segment down the.

Typically you guys have taken a sort of a different approach.

More recent assets there in terms of targeting that population as well we view that those benefits will accrue to the class and maybe just talk about how you think about targeting that segment down the road. Thank you.

Operator: Road. Thank.

Road. Thank.

David Ricks: You.

You.

David Ricks: Thanks, Carter, for the question. Dan, do you want to comment on the flow.

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

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

Thanks Carter for the question Dan do you want to comment on the flow data, so youre asking about kidney disease I think the.

Daniel Skovronsky: Data? Yeah. So you're asking here about kidney disease. I think the profound effect that incretins seem to be having on the kidney is really a nice and important additive benefit here.

Data?

Dan Skovronsky: Yeah. So you're asking here about kidney disease. I think the profound effect that incretins seem to be having on the kidney is really a nice and important additive benefit here.

Daniel M. Skovronsky: Yes, so you're asking about kidney disease. I mean, I think the profound effect that incretin seem to be having on the kidneys is really a nice and important additive benefit here. This is something that's been observed with multiple class members now and they expect it will extend into our incretins as well. So, it's exciting and I think proof that these drugs perhaps in addition to weight loss and A1C control, could have other direct metabolic benefits including the kidney.

Nice and important additive benefit here.

Daniel Skovronsky: This is something that's been observed with multiple class members now and they expect it will extend into our incretins as well. So it's exciting and I think proof that these drugs, perhaps in addition to weight loss and A1C control, could have other direct metabolic benefits, including the.

This is something that's been observed with multiple class members now and they expect it will extend into our incretins as well. So it's exciting and I think proof that these drugs, perhaps in addition to weight loss and A1C control, could have other direct metabolic benefits, including the.

This is something that's been observed with multiple class members now and.

Expect it will extend into our and curtains as well so it's exciting and I think proof of that.

These drugs, perhaps in addition to the weight loss and C control.

Could have other direct a metabolic benefits, including in the kidney.

David Ricks: Kidney.

Kidney.

David Ricks: Paul, next.

Joe Fletcher: Paul, next.

Operator: Question. The next question is coming from Trung Huynh from UBS. Trung, your line is.

Question.

Joe Fletcher: Paul, next question.

Operator 3: The next question is coming from Trung Huynh from UBS. Trung, your line is.

Operator: The next question is coming from Trung Huynh from UBS. Trung your line is live.

Daniel Skovronsky: Live.

Live.

Trung Huynh: Good morning, all. Thanks for squeezing me in. Just one on Mounjaro U.S. pricing. So, by our calculations, we think that 3Q '23 the net price is around 440 per TRX. For the rest of the year do you think that net price can continue to go up and above the saving card price of 450. Although, payers willing to pay for this, or is this broadly capped now until that saving card ends? And for next year, can you just give us your thoughts on if net price can meaningfully keep increasing? Thanks.

Daniel Skovronsky: Morning all. Thanks for squeezing me in just one on Mounjaro US pricing. So by our calculations, we think at Q3 2023, the net price is around.

Trung Huynh: Morning all. Thanks for squeezing me in just one on Mounjaro US pricing. So by our calculations, we think at Q3 2023, the net price is around.

Good morning. Thanks.

Thanks for squeezing me in just one of mom's genre U S pricing. So by our calculations. We think it's <unk> 23, the net prices around 440 T Rx.

Operator: 440 per TRX for the rest of the.

440 per TRX for the rest of the.

Daniel Skovronsky: Yeah. Do you think that net price can continue to go up and above the savings card price of $450? Are there payers wanting to pay for this or is this broadly capped now until that savings card ends and for next year? Can you just give us your thoughts on if net price can meaningfully keep increasing?

Yeah. Do you think that net price can continue to go up and above the savings card price of $450? Are there payers wanting to pay for this or is this broadly capped now until that savings card ends and for next year? Can you just give us your thoughts on if net price can meaningfully keep increasing?

For the rest of the year do you think that net price can continue to go up and above the saving cost price of 450.

He is willing to pay for this or is this broadly cat now until that saving comp ends and for next year can you just give us your thoughts on net price can meaningfully keep increasing.

David Ricks: Thanks. Thanks, Trung. Mike, do you want to make any comments around.

Thanks.

Joe Fletcher: Thanks, Trung. Mike, do you want to make any comments around.

Okay.

Thanks.

Joe Fletcher: Thanks, Trung. Mike, do you want to make any comments around Mounjaro pricing?

David Ricks: Manjaro.

Manjaro.

Mike Mason: Pricing? Yeah, no, I'd be happy to do that. You know, I think maybe at a macro level, I would say that our gross-to-net for Mounjaro in Q3 kind of normalized. You know, before then we had a number of savings card changes that, you know, made our gross-to-net rate, you know, dynamic. Our last.

Pricing?

Mike Mason: Yeah, no, I'd be happy to do that. You know, I think maybe at a macro level, I would say that our gross-to-net for Mounjaro in Q3 kind of normalized. You know, before then we had a number of savings card changes that, you know, made our gross-to-net rate, you know, dynamic. Our last.

Majority of pricing.

Michael B. Mason: I'd be happy to do that. I think, maybe at a macro level, I would say that our gross to net for Mounjaro in Q3, that kind of normalized. Before then, we had a number of saving card changes that made our gross to net rate dynamic. Our last and copay card change occurred late in Q2, so, at the end of June. And so, Q3 was a kind of a pure quarter, where we didn't have any other copay card changes. And I would say that our Mounjaro rate normalized at that point. Going forward, I think what you'll see is what you see normally for a product at this point in the lifecycle that as we pursue gaining access, there'll probably be some pricing pressure related to that. But we don't have any other coping card changes planned in the near future.

I think.

Maybe on a macro level I would say that our gross to net.

Form on <unk> in Q3 kind of normalized.

Before then we had our numbers they've been card changes that that.

Made our gross and net rate dynamic.

Our last.

Mike Mason: card change occurred late in.

card change occurred late in.

Copay card change occurred late and.

Mike Mason: Q2, so at the end of June. And so Q3 was a kind of a pure quarter where we didn't have any other copay card changes. And I would say that our Mounjaro rate normalized at that point. You know, going forward, I think what you'll see is what you see normally for a product at this point in the life cycle, that as we pursue gaining access, there'll probably be some pricing pressure related to that. But we don't have any other copay card changes planned in the near.

Q2, so at the end of June. And so Q3 was a kind of a pure quarter where we didn't have any other copay card changes. And I would say that our Mounjaro rate normalized at that point. You know, going forward, I think what you'll see is what you see normally for a product at this point in the life cycle, that as we pursue gaining access, there'll probably be some pricing pressure related to that. But we don't have any other copay card changes planned in the near.

In Q2, so at the end of June and so.

Q3 was kind of a pure quarter, where you didn't have any other co pay card changes and I would say that our marginal rate normalized at that point going forward I think what Youll see is what you would see normally at a for a product at this point in the lifecycle of that as we.

Pursue gaining access.

That would be some pricing pressure related to that but.

But we don't have any other.

Our copay card changes planned in the near future.

David Ricks: Future.

Future.

David Ricks: Thanks, Mike. Paul, next.

Joe Fletcher: Thanks, Mike. Paul, next.

Operator: Question. The next question is coming from Robyn Karnauskas from Truist Securities. Robyn, your line is.

Question.

Joe Fletcher: Thanks, Mike. Paul, next question. The next question is coming from Robin <unk> from Truest Securities Robin Your line of sight.

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

Operator 3: The next question is coming from Robyn Karnauskas from Truist Securities. Robyn, your line is.

Operator: The next question is coming from Robyn Karnauskas. From Truist Securities. Robyn, your line is live.

Anat Ashkenazi: Live. Good morning. Thanks for taking your question. This is Nicole on from Robyn, just going back to obesity. How are you thinking through the impact on Mounjaro if IRA stays and Wegovy and Ozempic prices decline in the 2026, 2027.

Live.

[Analyst] (Truist Securities): Good morning. Thanks for taking your question. This is Nicole on from Robyn, just going back to obesity. How are you thinking through the impact on Mounjaro if IRA stays and Wegovy and Ozempic prices decline in the 2026, 2027.

Robyn Kay Shelton Karnauskas: Good morning. Thanks for taking our question. This is Nicole on, for Robyn. Going back to obesity, how are you thinking through the impact on Mounjaro if IRA stays and Wegovy and Ozembic prices decline in the 2026-20 27 time frame?

Back to obesity, how are you thinking through the impact on <unk>.

<unk> and authentic prices decline in the 2012 2027 timeframe.

David Ricks: Timeframe?

Timeframe?

Okay.

David Ricks: Thanks Nicole, for the question. I think if I heard you right, you're thinking about IRA impacts to maybe semaglutide and potential impacts to Mounjaro. Mike, do you want to comment on that.

Joe Fletcher: Thanks Nicole, for the question. I think if I heard you right, you're thinking about IRA impacts to maybe semaglutide and potential impacts to Mounjaro. Mike, do you want to comment on that.

Joe Fletcher: Thanks, Nicole for the question. I think, if I heard you right, you're thinking about IRA impacts to maybe semaglutide and potential impacts to Mounjaro. Mike, do you want to comment on that briefly?

I think if I heard you right youre thinking about IRA impacts to maybe some igloo tied and potential impacts to <unk>.

Mike Mason: Briefly? Yeah, no, I'm happy to do that. You know, obviously it's too early to really impact how IRA will have an impact and the impact it will have in other products within the class. I think what's important for Tirzepatide is it is the first dual-acting incretin and we do think it has a unique profile and in head-to-head results in type 2 diabetes, it did show superior both A1C and weight to semaglutide. And so at the end of the day I think the profile of the product will carry the day and obviously more to come on the IRA as.

Briefly?

Mike do you want to comment on that briefly.

Mike Mason: Yeah, no, I'm happy to do that. You know, obviously it's too early to really impact how IRA will have an impact and the impact it will have in other products within the class. I think what's important for Tirzepatide is it is the first dual-acting incretin and we do think it has a unique profile and in head-to-head results in type 2 diabetes, it did show superior both A1C and weight to semaglutide. And so at the end of the day I think the profile of the product will carry the day and obviously more to come the IRA as.

Michael B. Mason: I'll be happy to do that, Obviously, it's too early to really impact how IRA will have an impact and the impact will have another product within the class. I think what what's important for Tirzepatide is it is the first dual acting incretin. And we do think it has a unique profile. And in head to head results in type 2 diabetes, it did show superior, both I1C and weight to semaglutide. And so, at the end of the day, I think the profile of the product will carry the day. And obviously more to come on the IRA. As the first products go through the negotiation, we see the impact, but we're confident in the profile of Tirzepatide.

What's important for <unk>.

There is appetite as it is the first dual acting.

Clinton and we do think it has a unique profile and.

In head to head results and type two diabetes.

<unk> superior.

Both agency and wait to two.

<unk> tight and so.

At the end of the day I think the profile of the product will carry the day and night.

Obviously more to come on the entre as as.

Mike Mason: The first products go through the negotiation. We see the impact, but we're confident in the profile of our tirzepatide.

The first products go through the negotiation. We see the impact, but we're confident in the profile of our tirzepatide.

The first products go through the negotiation, we see the impact, but we're confident in the profile of <unk> appetite.

David Ricks: Appetite. Thank you, Mike. Paul, I think we have two calls left in the queue. Why don't we go through those two quickly, and then we'll wrap.

Joe Fletcher: Thank you, Mike. Paul, I think we have two calls left in the queue. Why don't we go through those two quickly, and then we'll wrap.

Joe Fletcher: Thank you, Mike and Paul I think we have two calls left in the queue. When we go through those too quickly and then we'll wrap up certainly I have the first one is a follow up from Seamus Fernandez from Guggenheim Seamus Your line is live.

Joe Fletcher: Thank you Mike. Paul, I think we have two calls left in the queue. Why don't we go through those two quickly, and then we'll wrap up?

Operator: Up. Certainly the first one is a follow up from Seamus Fernandez from Guggenheim. Seamus, your line is.

Up.

Operator 3: Certainly the first one is a follow up from Seamus Fernandez from Guggenheim. Seamus, your line is.

Operator: Certainly. The first one is a follow up from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Daniel Skovronsky: Live. Oh great. Thanks for the follow-up question. So, you know, just in terms of how you're thinking about the introduction of oral treatments and the importance of pushing for what would be hopefully a maintenance type regimen. Is Lilly, you know, looking at oral therapies as more of a maintenance regimen opportunity or do you see a broader opportunity here perhaps bringing in other mechanisms that perhaps could aid in pursuing I guess the ever elusive metabolic set.

Live.

Seamus Fernandez: Oh great. Thanks for the follow-up question. So, you know, just in terms of how you're thinking about the introduction of oral treatments and the importance of pushing for what would be hopefully a maintenance type regimen. Is Lilly, you know, looking at oral therapies as more of a maintenance regimen opportunity or do you see a broader opportunity here perhaps bringing in other mechanisms that perhaps could aid in pursuing I guess the ever elusive metabolic set.

Seamus Fernandez: Great. Thanks for the follow up question. So, just in terms of how you're thinking about the introduction of oral treatments, and the importance of pushing for what would be hopefully a maintenance type regimen. Is Lily looking at oral therapies as more of a maintenance regimen opportunity, or do you see a broader opportunity here, perhaps bringing in other mechanisms that perhaps could aid in pursuing, I guess, the ever elusive metabolic set point? Thanks.

Thanks for the follow up question so.

Just in terms of how youre thinking about the <unk>.

Introduction of oral treatments.

And the importance of pushing for.

What would be hopefully a maintenance type regimen.

Is lilly.

Looking at oral therapies as more of a maintenance regimen opportunity or do you see a broader opportunity here.

Perhaps bringing in other mechanisms that perhaps could.

<unk> and pursuing I guess the ever elusive metabolic at that point.

Mike Mason: Point?

Point?

David Ricks: Thanks.

Thanks.

David Ricks: Dan. Do you want to comment on?

Joe Fletcher: Dan. Do you want to comment on?

Daniel Skovronsky: That? Yeah, thanks Seamus. Maybe to paraphrase Dave's previous answer is sort of an all of the above here. I think there's great opportunities on the oral as a standalone therapy for initiation of therapy also. Yes, for maintenance therapy globally and also yes, for potential combinations. You know, I point out the obvious fact that this is a GLP-1 monotherapy. So we benchmark it against the best injectable GLP-1 monotherapy. But I don't expect as an oral it will achieve the same levels of efficacy we can see with dual agonism like tirzepatide. So the future certainly will hold combinations like that. Thank.

That?

Dan Skovronsky: Yeah, thanks Seamus. Maybe to paraphrase Dave's previous answer is sort of an all of the above here. I think there's great opportunities on the oral as a standalone therapy for initiation of therapy also. Yes, for maintenance therapy globally and also yes, for potential combinations. You know, I point out the obvious fact that this is a GLP-1 monotherapy. So we benchmark it against the best injectable GLP-1 monotherapy. But I don't expect as an oral it will achieve the same levels of efficacy we can see with dual agonism like tirzepatide. So the future certainly will hold combinations like that. Thank.

Joe Fletcher: Dan do you want to comment on that yes, thanks, Seamus maybe to paraphrase David previous answer it's sort of an all of the above here I think there's great opportunities on the oral as a standalone therapy for initiation of therapy also yes for maintenance therapy globally.

Joe Fletcher: Dan, do you want to comment on that?

Daniel M. Skovronsky: Yeah, thanks, Seamus. Maybe to paraphrase Dave's previous answers, it's sort of in all of the above here, I think there's great opportunities on the oral as a standalone therapy for initiation of therapy. Also, yes, for maintenance therapy, globally. And also, yes, for potential combinations. I point out the obvious fact that this is a GLP1 monotherapy. So, we benchmark it against the best injectable GLP1 monotherapy. But I don't expect as an oral it will achieve the same levels of efficacy we can see with dual agonism like Tirzepatide. So, the future certainly will hold combinations like that. Thank you.

And also yes for potential combinations.

I point out the obvious fact that this is a G. L. P. One mono therapy, so we benchmark it against the best injectable <unk> monotherapy.

But I don't expect as an oral it will achieve the same levels of efficacy, we can see with dual agonism tours appetite so that the future certainly we'll hold combinations like that.

David Ricks: And last question, Paul from the.

Joe Fletcher: And last question, Paul from the.

Thank you.

Operator: Q. Certainly, the last question will be a follow up from Tim Anderson from Wolfe Research. Tim, your line is.

Queue.

Joe Fletcher: And the last question, Paul from the queue

Operator 3: Certainly, the last question will be a follow up from Tim Anderson from Wolfe Research. Tim, your line is.

Operator: Certainly. The last question will be a follow up from Tim Anderson from Wolfe Research. Tim, your line is live.

Tim Anderson: Live.

Live.

Tim Anderson: Thank you. What's the latest thinking on the topic of GIP agonism versus antagonism? So tirzepatide is the former, Amgen's drug is the latter. I've never seen two drugs in any category that have a similar clinical effect, but opposing underlying activity. The biologic drug target Amgen says GIP antagonism is the way to go, supported by their genetic analyses. What does Lilly think? Have you looked similarly at genetic analyses to inform your.

Tim Anderson: Thank you. What's the latest thinking on the topic of get agonism versus antagonism. Tirzepatide is the former Amgen drug is the latter. I've never seen two drugs in any category that have a similar clinical effect but opposing underlying activity the biologic target. Amgen says get antagonism is the way to go supported by their genetic analyses. What is Lily saying? Have you looked similarly at genetic analyses to inform your view?

The latest thinking on the topic of Gip agonism versus antagonism. So uptight at the former amgen's drug as the ladder I have never seen two drugs in any category.

And I have a similar clinical effect, but opposing underlying.

Pivoting to biologic target Amgen, so gift antagonism is the way to go supported by their genetic analyses.

As Louis thing have you look similarly genetic analyses to inform your view.

David Ricks: View? Thank you, Tim, for the last question.

View?

Joe Fletcher: Thank you, Tim, for the last question.

Daniel Skovronsky: Dan? Yeah, I'll take that. Of course we have now, I think, more data on GIP agonism than anyone in the world. Starting with tirzepatide of course, which is a combo GLP-1 GIP agonist, and the head-to-head study against a pure GLP-1 agonist. You can see some profoundly different effects here. Looking at, for example, efficacy relative to tolerability, it looks like the GIP is boosting efficacy while also reducing the side effects that limit tolerability. So that was our initial evidence in human trials that involved. Well, now tens of thousands of patients have been on tirzepatide in trials, and then we went out to sort of prove this point by creating a pure GIP agonist that just agonizes GIP to see what that could do alone.

Dan?

Joe Fletcher: Thank you, Tim, for the last question. Dan. Yes, I'll take that of course.

Joe Fletcher: Thank you, Tim, for the last question. Dan.

Dan Skovronsky: Yeah, I'll take that. Of course we have now, I think, more data on GIP agonism than anyone in the world. Starting with tirzepatide of course, which is a combo GLP-1 GIP agonist, and the head-to-head study against a pure GLP-1 agonist. You can see some profoundly different effects here. Looking at, for example, efficacy relative to tolerability, it looks like the GIP is boosting efficacy while also reducing the side effects that limit tolerability. So that was our initial evidence in human trials that involved. Well, now tens of thousands of patients have been on tirzepatide in trials, and then we went out to sort of prove this point by creating a pure GIP agonist that just agonizes GIP to see what that could do alone.

Daniel M. Skovronsky: Yeah, I'll take that. Of course, say we have now I think more data on GLP agonism than anyone in the world and starting with Tirzepatide, of course, which is a combo GLP1 GIP agonist and the head to head study against a pure GLP1 agonist and you can see some profoundly different effects here looking at, for example, efficacy relative to tolerability. It looks like the GIP is boosting efficacy while also reducing the side effects that limit tolerability. So, that was our initial evidence in human trials that involved, now, tens of thousands of patients have been on Tirzepatide in trials.

We have now I think more data on GIC Agonism then.

Than anyone in the world and <unk>.

Starting with <unk> appetite of course, which is a combo <unk> agonist and.

The head to head study against <unk>, one agonists and you can see some.

Profoundly.

Effects here looking at for example, efficacy relative to Tolerability it looks like the Gi Gi piece.

As boosting efficacy, while also reducing the side effects that limit tolerability. So that was our initial evidenced in human trials that involved.

While now tens of thousands of patients have been on hunters appetite in trials.

Daniel M. Skovronsky: And then, we went out to sort of prove this point by creating a pure GIP 1 agonist that just agonizes GIP to see what that could do alone. And again, we saw a very highly tolerated drug consistent with what we understand about the mechanism of GIP 1 that probably could suppress actually nausea, vomiting that led to weight loss. So, I think human data trumps everything here, and we've got a ton of that. So, we're pretty excited about gap agonism. I can't really say what will happen with antagonism, but like you said, it's pretty unusual to have opposing mechanisms both work in similar ways.

That just agonizes Gi Pete it to see what that could do alone and again, we saw a very highly tolerated drug consistent with what we understand about the mechanism of <unk>.

Daniel Skovronsky: And again we saw a very highly tolerated drug consistent with what we understand about the mechanism of GLP-1 that probably could suppress, actually, nausea and vomiting that led to weight loss. So I think human data trumps everything here and we've got a ton of that. So we're pretty excited about GIP agonism. I can't really say what will happen with antagonism, but like you said, it's pretty unusual to have opposing mechanisms both work in similar.

And again we saw a very highly tolerated drug consistent with what we understand about the mechanism of GLP-1 that probably could suppress, actually, nausea and vomiting that led to weight loss. So I think human data trumps everything here and we've got a ton of that. So we're pretty excited about GIP agonism. I can't really say what will happen with antagonism, but like you said, it's pretty unusual to have opposing mechanisms both work in similar.

It probably could suppress actually nausea, and vomiting that lead to weight loss.

I think human data trumps everything here and we've got a ton of that so we're pretty excited about CIP agonism.

I can't really say, what will happen with antagonism, but like you said, it's pretty unusual to have opposing mechanisms both work in similar ways.

David Ricks: Thanks, Dan, for the last one, Dave. Okay, thanks, Joe. We appreciate everyone's participation in today's earnings call and, of course, your ongoing interest in Eli Lilly and Company. As I said, it's been a very productive year for Lilly so far, and we look forward to continuing this momentum through a busy end of year and fourth quarter. So, thanks for dialing in today. Please follow up with the IR team if you have questions we did not address on the call, and hope everyone has a great rest of the week and rest of the day today. Take.

Joe Fletcher: Thanks, Dan, for the last one, Dave.

Dave Ricks: Okay, thanks, Joe. We appreciate everyone's participation in today's earnings call and, of course, your ongoing interest in Eli Lilly and Company. As I said, it's been a very productive year for Lilly so far, and we look forward to continuing this momentum through a busy end of year and fourth quarter. So, thanks for dialing in today. Please follow up with the IR team if you have questions we did not address on the call, and hope everyone has a great rest of the week and rest of the day today. Take.

Joe Fletcher: Thanks, Dan for the last one, Dave.

Dave Ricks: Okay, thanks, Joe. We appreciate everyone's participation in today's earnings call and of course your ongoing interest in Eli Lilly and Company. As I said, it's been a very productive year for Lilly so far, and we look forward to continuing this momentum through a busy end of year in fourth quarter. So, thanks for dialing in today. Please follow up with the IR team if you have questions we did not address on the call. And hope everyone has a great rest of the week and rest of the day today. Take care.

We appreciate everyones participation in todays earnings call and of course your ongoing interest in Eli Lilly <unk> company as I said, it's been a very productive year for Lilly So far and we look forward to continuing this momentum through a busy end of year and fourth quarter. So thanks for dialing in today. Please follow up with the IR team. If you have questions. We did not address on the call.

Hope everyone has a great rest of the week and rest of the day to day take care.

Operator: Care.

Care.

Operator: Thank you. Ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00PM today, running through 7 December at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 544467. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 5 4.

Operator 3: Thank you. Ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00PM today, running through 7 December at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 544467. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 5 4.

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 pm today running through December 7 at midnight. You may access the replay system at any time by dialing 800-332-6854, and entering the access code 544467. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 544467. Thank you for your participation. You may now disconnect your lines.

This conference will be made available for replay beginning at one P. M. Today running through December 7th at Midnight.

May access the replay system at anytime by dialing $803 three to six eight by four.

During the access code five four for $4 67.

International Dialers can call 9735280005 again those numbers are 833 to six eight by four.

970, 35280005 with the access code five four for $4 six seven. Thank you for your participation you may now disconnect your lines.

Operator: Thank you for your participation. You may now disconnect your.

Thank you for your participation. You may now disconnect your.

Daniel Skovronsky: Lines.

Lines.

Daniel Skovronsky: Sam.

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Anat Ashkenazi: Sa.

Sa.

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Daniel Skovronsky: Sa.

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Daniel Skovronsky: Sa.

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Q3 2023 Eli Lilly and Co Earnings Call

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