Q3 2025 Eli Lilly & Co Earnings Call

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.

Dave Ricks: Right back with you.

I'd now like to turn the conference over to your host Mike Sapar Senior Vice President of Investor Relations. Please go ahead.

Good morning, Thank you for joining us for I believe the company's Q3 2025 earnings call and Mike <unk> Senior Vice President of Investor Relations join.

Joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Lucas <unk>, Chief Financial Officer, Dr. Dan <unk>, Chief Scientific Officer, and President of Lilly Immunology, and White President of Lilly Neuroscience, <unk> President of Lilly USA and global customer capabilities, Jacob <unk> President of Lilly oncology.

Speaker #2: Thank you for holding . We look forward to talking with you soon . Please hold the line and we'll be right back with you .

Anne White: Thank you for holding. We look forward to talking with you soon. Please hold the line and we'll be right back with you.

Patrik Jonsson, President of <unk> International and Ken <unk>, President of Lilly Cardio metabolic health.

We're also joined by Mark Human Susan <unk>, and West Paul of the Investor Relations team.

Speaker #3: Ladies and gentlemen , thank you for standing by . And welcome to the Lilly Q3 2025 Earnings Conference Call . At this time , all participants are on a listen only mode .

Operator: Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q3 2025 earnings conference call. At this time, all participants are on 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 would now like to turn the conference over to your host, Mike Czapar, Senior Vice President of Investor Relations. Please go ahead.

During this call, we anticipate making projections and forward looking statements based on our current expectations. Our actual results could differ materially due to several factors, including those listed on slide four additional information.

Permission concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K, and subsequent filings with the SEC.

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

Mike Czapar: Good morning. Thank you for joining us for Eli Lilly and Company's Q3 2025 earnings call. I'm Mike Czapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Lucas Montarce, Chief Financial Officer, Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly USA and Global Customer Capabilities, Jacob Van Naarden, President of Lilly Oncology, Patrik Jonsson, President of Lilly International, and Kenneth L. Custer, President of Lilly Cardiometabolic Health. We're also joined by David Hyman, Susan Hedgeland, and Wes Paul of the Investor Relations team. During this call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to several factors including those listed on slide 4.

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

Now I will turn the call over to Dave.

Dave will turn the call over to you.

Alright.

Thanks, Mike appreciate it Q3 was another strong quarter for Lilly, we made progress across all of our strategic deliverables, we delivered compelling financial results advanced our pipeline and achieved key milestones to expand our manufacturing footprint.

As all as shown on slide six.

Q3 revenue grew 54% compared to the same period last year revenue from key products more than doubled as our medicines continued to increase their global impact.

Mike Czapar: Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note that our commentary will focus on non-GAAP financial measures. Now I'll turn the call over to Dave.

In the U S, where we gained market share in the anchor 10 analogs market for the fifth consecutive quarter.

Medicines account for nearly six out of 10 prescriptions within this large and growing class.

Outside the U S <unk> performance accelerated driven by robust uptake around the world.

As a result of our strong financial performance, we raised our revenue and earnings per share guidance Lucas will cover this in more detail later in the call.

Since our last earnings call, we achieved several key milestones, including U S. FDA approval for <unk> under the brand name <unk> for HR positive <unk> negative ESR, one mutated advanced or metastatic breast cancer.

Lucas Montarce: Dave, we'll turn the call over to you.

Dave Ricks: Thanks, Mike. Appreciate it. Q3 was another strong quarter for Lilly. We made progress across all our strategic deliverables. We delivered compelling financial results, advanced our pipeline, and achieved key milestones to expand our manufacturing footprint. This is all shown on slide 6. In Q3, revenue grew 54% compared to the same period last year. Revenue from key products more than doubled as our medicines continued to increase their global impact. In the U.S., Lilly gained market share in the incretin analogs market for the fifth consecutive quarter. Lilly medicines account for nearly 6 out of 10 prescriptions within this large and growing class. Outside the U.S., Mounjaro performance accelerated, driven by robust uptake around the world. As a result of our strong financial performance, we raised our revenue and earnings per share guidance. Lucas will cover this in more detail later in the call.

The EU approved to sunlight for early symptomatic Alzheimer's disease.

Positive results from our phase III trial of <unk> in treatment of naive.

Paul.

Positive overall survival data for <unk> in high risk early breast cancer.

Positive results from the second phase III trial of <unk> in obesity, enabling now global submissions to begin later this year.

Positive results from three additional phase III trials of <unk> in type two diabetes, including one trial that demonstrated head to head superiority versus oral <unk>.

We also made good progress executing our manufacturing expansion agenda, we announced plans to build two new U S. U S facilities that will make active pharmaceutical ingredients and the expansion of an existing facility in Puerto Rico.

Dave Ricks: Since our last earnings call, we achieved several key milestones including U.S. FDA approval for imlunestrant under the brand name Inlurio for HR-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The EU approved Kisunla for early symptomatic Alzheimer's disease. Positive results from a Phase 3 trial of Jaypirca in treatment-naive CLL, positive overall survival data for Verzenio in high-risk early breast cancer, positive results from the second Phase 3 trial of orforglipron in obesity enabling now global submissions to begin later this year, and positive results from three additional Phase 3 trials of orforglipron in type 2 diabetes, including one trial that demonstrated head-to-head superiority versus oral semaglutide. We also made good progress executing our manufacturing expansion agenda. We announced plans to build two new U.S. facilities that will make active pharmaceutical ingredients and the expansion of an existing facility in Puerto Rico.

The new facility in Virginia will support our bio conjugated monoclonal antibody portfolio and the new facility in Texas and the expansion in Puerto Rico will support our small molecule portfolio, including or forego product.

We plan to announce uptake on our remaining new U S manufacturing facilities in the coming months.

During the quarter, we distributed $1 3 billion in dividends and executed approximately $700 million in share repurchases.

Now I will turn the call over to Lucas to review the Q3 results.

Thanks, Dave.

As shown on slide seven Q3 was another strong quarter of financial performance revenue grew 54% compared to Q3 2024, driven by our key products.

Gross margin as a percentage of revenue was 83, 6% in Q3, an increase of one four percentage points versus the same quarter last year.

This improvement was driven by favorable product mix, partially offset by lower realized prices.

Our research and development expenses increased 27% driven by continued investments in our portfolio.

Dave Ricks: The new facility in Virginia will support our bioconjugate and monoclonal antibody portfolio, and the new facility in Texas and the expansion in Puerto Rico will support our small molecule portfolio, including orforglipron. We plan to announce updates on our two remaining new U.S. manufacturing facilities in the coming months. During the quarter, we distributed $1.3 billion in dividends and executed approximately $700 million in share repurchases. Now I'll turn the call over to Lucas to review the Q3 results.

We have initiated 16, new phase III programs since the start of 2024 and continued to advance our pipeline.

Marketing selling and administrative expenses increased 31% as we continue to increase investment to support ongoing and future launches gross it up it to carry us on geographies.

Our non-GAAP performance margin, which we define as gross margin less R&D marketing selling and administrative expenses as a percentage of revenue was 48, 3%.

Lucas Montarce: Thanks, Dave. As shown on Slide 7, Q3 was another strong quarter of financial performance. Revenue grew 54% compared to Q3 2024 driven by our key products. Gross margin as a percentage of revenue was 83.6% in Q3, an increase of 1.4 percentage points versus the same quarter last year. This improvement was driven by favorable product mix, partially offset by lower realized prices. Research and development expenses increased 27% driven by continued investments in our portfolio. We have initiated 16 new Phase 3 programs since the start of 2024 and continue to advance our pipeline. Marketing, selling, and administrative expenses increased 31% as we continue to increase investment to support ongoing and future launches across therapeutic areas and geographies. Our non-GAAP performance margin, which we define as gross margin less R&D, marketing, selling, and administrative expenses as a percentage of revenue, was 48.3%.

<unk> margin increased by more than eight percentage points from Q3 of 2024 driven by revenue growth.

At the bottom line earnings per share increased to $7 <unk>.

Inclusive of 71 of our acquired IP R&D charges.

This compares to $1 19 in Q3, 2024, which included $3 and <unk> acquired IP R&D charges.

On slide eight we quantified the effect of price rate and volume on revenue growth.

U S revenue increased 45% in Q3, driven by strong volume growth offset by non mortgage genre, partially offset by a 15% decline in price.

Price was negatively impacted by a favorable onetime adjustment to estimates for rebates and discounts in Q3 2024.

Excluding these base period effect U S price declined by high single digits.

marketing selling and administrative expenses. Increase 31% as we continue to increase investment to support ongoing and future launches across the rapid areas and geographies.

In Europe revenue increased by over 100% in constant currency.

Reflecting the strong uptake of <unk> genre.

Lucas Montarce: Performance margin increased by more than 8 percentage points from Q3 2024 driven by revenue growth. At the bottom line, earnings per share increased to $7.02 inclusive of $0.71 of acquired IPR&D charges. This compares to $1.18 in Q3 2024, which included $3.08 of acquired IPR&D charges. On Slide 8, we quantified the effect of price, rate, and volume on revenue growth. U.S. revenue increased 45% in Q3 driven by strong volume growth of Zepbound and Mounjaro, partially offset by a 15% decline in price. Price was negatively impacted by a favorable one-time adjustment to estimates for rebates and discounts. In Q3 2024, excluding this base period effect, U.S. price declined by high single digits. In Europe, revenue increased by over 100% in constant currency, reflecting the strong uptake of Mounjaro. Revenue was positively impacted by a $380 million one-time benefit related to a milestone payment and business development.

Our non-GAAP performance margin, which we define as gross margin less R&D, marketing, selling, and administrative expenses, as a percentage of revenue, was 48.3%.

Revenue was positively impacted by a concentrated at 380 million dollar one time benefit related to a milestone payment on business development.

Performance margin increased by more than 8 percentage points from Q3 2024 driven by Revenue growth.

Excluding this impact revenue grew 81% in constant currency.

Japan, and China and rest of the award delivered constant currency revenue growth of 24%, 22% and 51%, respectively, driven by Moen Giro volume growth.

At the bottom line, earnings per share, increase to $72 inclusive of 71 cents of acquired, ibrd charges.

this compares to $1 and 18 cents in Q3 2024 which included 3.8 cents of acquired IP R&D charges

On slide nine we provide an update on the performance of our key products.

<unk> accounted for $12 billion of revenue within the quarter.

1, slide 8, we quantify the effect of price rate and volume on Revenue growth.

Beginning with immunology.

<unk> delivered strong performance in atopic dermatitis as U S. Total prescriptions increased by 41% compared to Q2 of 2025.

U.S. revenue increased 45% in Q3, driven by strong volume growth of 7% and Monaro, partially offset by a 15% decline in price.

We sold increase using the first line setting, which now accounts for more than 50% of new <unk> patients.

Price was negatively impacted by a favorable, 1-time adjustment to estimates for rebates and discounts in Q3 2024.

<unk>, continuing a steady uptake and the newly published four year data in ulcerative colitis show long term safety and efficacy benefits.

Excluding this base period affect us price declined by high single digits.

In Europe, Revenue increased by over 100% in constant currency.

Within oncology <unk> continued to build momentum both in the marketplace and with new data from phase III trials.

Reflecting the strong uptake of Morrow.

Lucas Montarce: Excluding this impact, revenue grew 81% in constant currency. Japan, China, and rest of the world delivered constant currency revenue growth of 24%, 22%, and 51% respectively, driven by Mounjaro volume growth. On Slide 9, we provide an update on the performance of our key products, which accounted for $12 billion of revenue within the quarter. Beginning with immunology. Lebrikizumab delivered strong performance in atopic dermatitis and as U.S. total prescriptions increased by 41% compared to Q2 2025, we saw increased use in the first-line setting which now accounts for more than 50% of new lebrikizumab patients onboard. Continued steady uptake and the newly published four-year data in ulcerative colitis show long-term safety and efficacy benefits. Within oncology, Jaipirca continued to build momentum both in the marketplace and with new data from Phase 3 trials. Dr. Dan Skovronsky will talk more about this later during the R&D update.

Don will talk more about this later during the R&D update.

Revenue was positively impacted by 100, 380 million 1 time, benefit related to a milestone payment and business development.

<unk> remains the market leader in the U S for the node positive.

Including this impact, Revenue grew 81% in constant currency.

High risk early breast cancer population reflective of its position as a standard of care in this setting.

In the U S prescription grew by 3% compared to Q3 2024 and international volume grew by 14%.

Japan, China, and the rest of the world delivered constant currency revenue growth of 24%, 22%, and 51%, respectively, driven by Monjaro volume growth.

In neuroscience Keystone that total prescriptions grew by 50% compared to Q2 of 2025 and continue to increase share of market versus the competition.

On a slide 9, we provide an update on the performance of our key products. Which accounted for 12 billion dollars of Revenue within the quarter,

We also recently received marketing authorization by the European Commission and we are in active reimbursement discussion across Europe, and expect lunches, beginning this quarter and throughout 2026.

Beginning with Immunology, at least delivered strong performance in a topic dermatitis as us. Total prescriptions increased by 41% compared to Q2 2025.

The first line setting which now accounts for more than 50% of new applications.

Finally, moving to cardio metabolic <unk>.

<unk> Giro both posted strong global performance.

Beginning outside the U S. When gyro performance was robust we have now launching 55 countries in all major markets.

Combo continue a steady uptake and the newly published 4-year data in alter colitis, show, long-term safety and efficacy benefits.

Within oncology Jerica continue to build momentum.

We have seen a strong reception globally and have gained significant share in most major markets as a result.

both in the marketplace and with new data from phase 3 trials,

Lucas Montarce: Verzenio remains the market leader in the U.S. for the node-positive high-risk early breast cancer population, reflective of its position as standard of care in this setting. In the U.S., prescriptions grew by 3% compared to Q3 2024 and international volume grew by 14%. In neuroscience, Kisunla total prescriptions grew by 50% compared to Q2 2025 and continue to increase share of market versus the competition. We also recently received marketing authorization by the European Commission and we are in active reimbursement discussion across Europe and expect launches beginning this quarter and throughout 2026. Finally, moving to cardiometabolic health, Zepbound and Mounjaro both posted strong global performance. Beginning outside the U.S., Mounjaro performance was robust. We have now launched in 55 countries and all major markets. We have seen a strong reception globally and have gained significant share in most major markets as a result.

Dan will talk more about this later during the R&D update.

While obesity reimbursement remains limited internationally, we are encouraged by the strong uptake.

Versus Senior Remains, the market leader in the U.S. for the note positive.

Approximately 75% of Mone Giro revenue outside of the U S is coming from people with obesity.

High rest, early, breast cancer population, reflective of each position as standard of care in this setting.

Heading out of pocket.

Demonstrating a high level of clinical need and high willingness to pay.

Moving to the U S. Stefan prescription triple in Q3 2025 compared to the same period last year.

In the US prescription Group by 3%. Compared to Q3 2024 and international volume grew by 14%.

While the impact of the Cvs template formulary change was disruptive to patients and physicians the.

In Neuroscience Ka total prescription grew by 50% compared to Q2 2025 and continued to increase share of Market versus the competition.

The impact on segment performance was modest.

Share of total U S prescriptions in the branded anti obesity market declined by approximately two percentage points compared to Q2 2025.

We also recently received marketing authorization by the European commission, and we are inactive reimbursement, discussion across Europe, and expect launches beginning, this quarter and throughout 2026.

However performance is back to Q2 levels on setbacks exited Q3 with 71% share of new prescriptions.

Finally moving to cardio, metabolic Health, span and monjaro both posted strong Global performance.

We saw strong uptake of <unk> in vials, which comprise approximately 30% of total U S <unk> prescriptions and over 45% of new prescriptions in Q3.

Beginning outside the US. Monaro performance was robust.

We have now launched in 55 countries and all major markets.

Mon Giro posted robust Q3 in the U S.

Lucas Montarce: While obesity reimbursement remains limited internationally, we are encouraged by the strong uptake. Approximately 75% of Mounjaro revenue outside the U.S. is coming from people with obesity paying out of pocket, demonstrating a high level of clinical need and high willingness to pay. Moving to the U.S., Zepbound prescriptions tripled in Q3 2025 compared to the same period last year. While the impact of the CVS template formulary change was disruptive to patients and physicians, the impact on Zepbound performance was modest. Share of total U.S. prescription in the branded anti-obesity market declined by approximately 2 percentage points compared to Q2 2025. However, performance is back to Q2 levels and Zepbound exited Q3 with 71% share of new prescriptions. We saw strong uptake of Zepbound in vials which comprise approximately 30% of total U.S. Zepbound prescriptions and over 45% of new prescriptions in Q3.

We have seen a strong reception globally and have gained significant share in most major markets as a result.

Total prescriptions grew by over 60%.

<unk> also gained share of market in the type two diabetes in creating analog market, increasing by four percentage points compared to Q2 2025.

While obesity reimbursement remains Limited in international, we are encouraged by the strong update.

Approximately 75% of Monaro Revenue outside. The US is coming from people with obesity.

When gyro is the most widely prescribed in creating for people with type two diabetes in the U S.

Paying out of pocket, demonstrating a high level of clinical need and a high willingness to pay.

As shown on slide 10, the combined U S increased nine out of market growth was strong increasing by 36% in Q3 compared to the same period in 2024.

Moving to the US Stefan prescription triple in Q3 2025 compared to the same period last year.

While the impact of the, CBS template formula, change was disruptive to patients and Physicians.

<unk> gained share of market compared to Q2 2025 on approximately two out of every three new prescription in the increase in analog market is ideally medicine.

The impact on 7 performance was modest.

Share of total us prescription in the Brandy and the Obesity Market declined by approximately 2 percentage points compared to Q2 2025.

When it's 90 11, we provide an update on capital allocation.

Moving to slide 12, we share our updated expectations for least 2025 financial results.

However, performance is back to Q2 levels, and we exited Q3 with 71% share of new prescriptions.

Based on the strong underlying performance and the favorable impact of foreign exchange rates, we are increasing the midpoint of our revenue range by over $2 billion.

Lucas Montarce: Mounjaro posted robust Q3 in the U.S. as total prescriptions grew by over 60%. Mounjaro also gained share of market in the type 2 diabetes incretin analog market, increasing by 4% compared to Q2 2025. Mounjaro is the most widely prescribed incretin for people with type 2 diabetes in the U.S. As shown on slide 10, the combined U.S. incretin analog market growth was strong, increasing by 36% in Q3 compared to the same period in 2024. Lilly Incretins gained share of market compared to Q2 2025 and approximately 2 out of every 3 new prescriptions in the incretin analog market is a Lilly medicine. On slide 11, we provide an update on capital allocation. Moving to slide 12, we share our updated expectations for Lilly's 2025 financial results.

we saw strong, uptake of 7 in BIOS, which comprise approximately 30% of total us, 7, prescriptions and over 45% of new prescriptions in Q3

And now anticipate our full year revenue will be between 63 and $63 5 billion.

Morrow posted robas Q3 in the US.

As total prescriptions grew by over 60%.

Given our updated expectations for revenue growth and performance margin over the first nine months of the year. We now expect non-GAAP performance margin to be between 45 and 40.

Monaro also gain share of Market in the type 2 diabetes. Incurred in analog Market increasing by 4 percentage points compared to Q2 2025.

46% of revenue.

On the bottom line, we have increased our outlook for non-GAAP earnings per share and expect EPS of <unk> 23 to $23 70.

Monarch is the most widely prescribed medication for people with type 2 diabetes in the U.S.

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

As shown on the slide 10. The combined Us Secret in analog market growth was strong increasing by 36% in Q3 compared to the same period in 2024.

Thanks Lucas.

Newly R&D had another productive quarter I'll summarize progress by therapeutic area, beginning with cardio metabolic health.

Lily in incretins, gained share of Market compared to Q2 2025, and approximately 2 out of every 3. New prescription in the increase in analog Market is a lily medicine.

Since our last call, we announced results from four additional positive phase III trials for <unk> of.

On a 911. We provide an update on Capital allocation

Of note one of those trials was attained two in people with both obesity and type two diabetes.

Lucas Montarce: Based on a strong underlying performance and the favorable impact of foreign exchange rates, we are increasing the midpoint of our revenue range by over $2 billion and now anticipate our full year revenue will be between $63 billion and $63.5 billion. Given our updated expectations for revenue growth and performance margin over the first nine months of the year, we now expect non-GAAP performance margin to be between 45% and 46% of revenue. At the bottom line, we have increased our outlook for non-GAAP earnings per share and expect EPS of $23 to $23.70. Now I will turn the call over to Dr. Dan Skovronsky to highlight our progress on R&D.

Moving to slide 12, we share our updated, expectations for Lily's 2025 Financial results.

As a reminder, patients with obesity and type two diabetes are less responsive to weight loss on <unk> monotherapy than those without type two diabetes.

For example in the step two clinical trial of people with obesity and type two diabetes <unk> tied at two four milligrams and one milligram resulted in 10, 6% weight loss and seven 6% weight loss respectively.

Based on a strong, underlying performance. And the favorable impact of foreign exchange rates. We are increasing the midpoint of our Revenue range by over 2 billion dollars. And now anticipate our full year Revenue will be between 63 and 63.5 billion.

On slide 13, <unk>, two demonstrated 10, 5% weight loss and seven 8% way offset the 36 milligram and 24 milligram doses of <unk>, respectively.

Giving our updated expectations for Revenue, growth and performance margin of the first 9 months of the year we now, expect non-gaap performance marching to be between 45 and 46% of Revenue.

Aligned with our goal to deliver efficacy similar to injectable <unk>, one monotherapy in an easy to use daily pill.

at the bottom line, we have increased our outlook for non-gaap earnings per share and expect EPS of 23 to 23.70

Anne White: Thanks.

Dan Skovronsky: Lucas Montarce: Lilly had another productive quarter. I'll summarize progress by therapeutic area beginning with cardiometabolic health. Since our last call, we announced results from four additional positive Phase 3 trials for orforglipron. Of note, one of those trials was Attain 2 in people with both obesity and type 2 diabetes. As a reminder, patients with obesity and type 2 diabetes are less responsive to weight loss on GLP-1 monotherapy than those without type 2 diabetes.

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

This trial completed the clinical package required to initiate global regulatory submissions for the treatment of obesity.

Next, Lucas Montarce from R&D had another productive quarter. I'll summarize progress by therapeutic area, beginning with cardio and metabolic health.

These submissions are beginning imminently, and we anticipate launching or for glib, Brian in the U S for treatment of obesity next year.

We also made great progress on our forklift Ron for taking two diabetes since the last call with positive results from achieve two and achieve three or for good Brian demonstrated superior glycemic control and weight loss compared to <unk>, <unk> and achieved two and compared to oral <unk> and achieved three.

Since our last call we announced results from 4, additional positive phase 3, trials for or for gyprone of Note, 1 of those trials was attained to in people with both obesity and type 2 diabetes.

Dan Skovronsky: For example, in the STEP 2 clinical trial of people with obesity and type 2 diabetes, semaglutide at 2.4 mg and 1 mg resulted in 10.6% weight loss and 7.6% weight loss, respectively, as shown on Slide 13. Attain 2 demonstrated 10.5% weight loss and 7.8% weight loss at the 36 mg and 24 mg doses of orforglipron, respectively, aligned with our goal to deliver efficacy similar to injectable GLP-1 monotherapy in an easy-to-use daily pill. This trial completed the clinical package required to initiate global regulatory submissions for the treatment of obesity. These submissions are beginning imminently and we anticipate launching orforglipron in the U.S. for treatment of obesity next year. We also made great progress on orforglipron for type 2 diabetes since the last call with positive results from Achieve 2 and Achieve 3.

Are less responsive to weight loss on glp1 monotherapy than those without type 2 diabetes.

As shown on slide 14, and achieved three both the 12 milligram and 36 milligram doses of <unk> were superior to the highest available dose of oral <unk> on both a one <unk> reduction and on weight loss.

For example, in the Step 2, clinical trial of people with obesity and type 2 diabetes. Semaglutide at 2.4 milligrams and 1 milligram resulted in 10.6% weight loss and 7.6% weight loss respectively.

People, taking Harper clip Ron so on average a one <unk> reduction of two 2% from baseline and lost nearly 20 pounds on the highest dose of our clipper.

We also announced the results from achieve five.

Which demonstrated that <unk> has the potential to provide benefit as an add on therapy to titrated insulin <unk>.

As shown on slide 13, we obtained 10.5% weight loss at the 36 milligram dose and 7.8% weight loss at the 24 milligram dose of 44 Lapan, respectively. This is aligned with our goal to deliver efficacy similar to injectable GLP-1 monotherapy in an easy-to-use daily pill.

With four positive phase III diabetes trials now completed we believe <unk> has the potential to be a foundational treatment for type two diabetes. We now await results from achieve four which will trigger submission of <unk> for treatment of type two diabetes anticipated in the first half of 2026.

This child completed the clinical package required to initiate Global regulatory submissions for the treatment of obesity.

These submissions are beginning imminently and we anticipate launching or for libron in the US for treatment of obesity next year.

Dan Skovronsky: Orforglipron demonstrated superior glycemic control and weight loss compared to dapagliflozin in Achieve 2 and compared to oral semaglutide in Achieve 3 as shown on Slide 14. In Achieve 3, both the 12 mg and 36 mg doses of orforglipron were superior to the highest available dose of oral semaglutide on both A1C reduction and on weight loss. People taking orforglipron saw an average A1C reduction of 2.2% from baseline and lost nearly 20 pounds on the highest dose of orforglipron. We also announced results from Achieve 5, which demonstrated that orforglipron has the potential to provide benefit as an add-on therapy to titrated insulin glargine. With four positive Phase 3 diabetes trials now completed, we believe orforglipron has the potential to be a foundational treatment for type 2 diabetes.

With data from over 8000 participants across six completed phase III <unk> trials, we have observed benefits across multiple cardio metabolic health measures as well as consistent safety and Tolerability.

We also made great progress on offer for Jaren for type 2 diabetes, since the last call with positive results from a chief 2 and Achieve 3, or for Jaren, demonstrated Superior, glycemic control, and weight loss, compared to dapple flowin and a chief 2 and compared to oral semaglutide, and Achieve 3.

Overall or for <unk> has developed and delivered a profile consistent with our goal of developing an oral and scalable small molecule <unk>, one with efficacy safety and tolerability comparable to injectable monotherapy.

As shown on slide, 14 and Achieve 3, both the 12 milligram and 36 milligram doses of or for Gipper were superior to the highest available dose of oral semaglutide on both A1C reduction and on weight loss.

<unk> for treatment of obesity and type two diabetes.

people taking, or for grip on saw an average A1C reduction of 2.2% from Baseline and lost nearly 20 pounds on the highest dose of aurrera

Outside of the core Registrational programs for these two important indications we have several additional ongoing phase III <unk> trials shown on slides 15, and 16, including new phase III starts for treatment of osteoarthritis pain.

We also announced results from a chief 5.

Which demonstrated that, or for Grifon, has the potential to provide benefit as an add-on therapy to titrate insulin glaring.

And for treatment of stress urinary incontinence, and new indication that we think could benefit from weight loss seen with offer clip rod.

Dan Skovronsky: We now await results from Achieve 4, which will trigger submission of orforglipron for treatment of type 2 diabetes, anticipated in the first half of 2026. With data from over 8,000 participants across six completed Phase 3 orforglipron trials, we've observed benefits across multiple cardiometabolic health measures as well as consistent safety and tolerability. Overall, orforglipron has delivered a profile consistent with our goal of developing an oral and scalable small molecule GLP-1 with efficacy, safety, and tolerability comparable to injectable monotherapy GLP-1s for treatment of obesity and type 2 diabetes. Outside of the core registrational programs for these two important indications, we have several additional ongoing Phase 3 orforglipron trials shown on slides 15 and 16, including new Phase 3 starts for treatment of osteoarthritis pain and for treatment of stress urinary incontinence, a new indication that we think could benefit from weight loss seen with orforglipron.

The next study to readout will be 18 maintained the phase III study of weight loss maintenance.

With 4 positive phase 3 diabetes trials. Now completed we believe orpha lapan has the potential to be a foundational treatment for type 2 diabetes. We now await results from a cheap 4 which will trigger submission of or for lapon for treatment of type 2 diabetes. Anticipated in the first half of 2026

Study is the first of its kind, it's designed to measure the impact of switching from injectable <unk> tied or injectable tours appetite.

with data from over 8,000 participants across 6 completed phase 3 or for lapon trials.

The oral or forklift truck.

Our goal in this novel trial is to measure what level of weight loss patients can maintain after switching from an injectable incretin to offer clipboard.

We've observed benefits across multiple cardio, metabolic Health measures as well as consistent safety and tolerability.

Since the patients in this trial were previously escalated to a maximal tolerated dose of <unk> appetite and treated for 72 weeks. This is a very ambitious trial for those people switching from <unk> maintaining weight loss after switching to offer clip Ron is a high bar given the strong efficacy of <unk>.

Overall or for Jaren, has delivered a profile consistent with our goal of developing, an oral and scalable small molecule glp1 with efficacy safety and tolerability comparable to injectable monotherapy. The glp 1's for treatment of obesity and type 2 diabetes.

Outside of the core. Registrational programs for these 2 important indications.

<unk> is a dual <unk> agonist.

As this trial includes moving patients off of an active therapy onto a placebo maintenance arm attained maintain allows patients who were randomized to placebo to switch to offer <unk> as a rescue therapy, if we regain exceeds the specified threshold.

Dan Skovronsky: The next study to read out will be Attain Maintain, a Phase 3 study of weight loss maintenance. This study is the first of its kind. It's designed to measure the impact of switching from injectable semaglutide or injectable tirzepatide to oral orforglipron. Our goal in this novel trial is to measure what level of weight loss patients can maintain after switching from an injectable incretin to orforglipron. Since the patients in this trial were previously escalated to a maximal tolerated dose of semaglutide or tirzepatide and treated for 72 weeks, this is a very ambitious trial for those people switching from tirzepatide. Maintaining weight loss after switching to orforglipron is a high bar given the strong efficacy of tirzepatide as a dual incretin agonist.

We have several additional ongoing phase 3 or peripheral trials, shown on slides, 15 and 16, including new phase 3 starts for treatment of osteoarthritis pain, and for treatment of stress urinary incontinence, the new indication that we think could benefit from weight loss seen with, or for lipro.

This will be a rich data package and we look forward to seeing the results in the coming months either late this year or early next year.

The next study to read out will be a 10 maintain a phase 3 study of weight loss maintenance.

Moving to read a true tied our Gi P. <unk>, one glucagon triple agonist we.

We expect results from the up to six phase III studies by the end of 2026 to support the obesity and related complications program called trial.

This study is the first of its kind. It's designed to measure the impact of switching from injectable semaglutide or injectable too-rapid to oral or for glyca.

Our goal in this novel trial is to measure what level of weight loss patients can maintain after switching from an injectable, an to, or for gipro.

And the type two diabetes program called transcend.

With its first of a kind triple acting mechanism, we expect red <unk> can deliver deeper and more rapid weight loss than existing obesity medicines, even more than <unk> appetite.

Since the patients in this trial were previously escalated to a maximal tolerated, dose of semaglutide or tappity-tap.

Of course, not all patients may need this potentially very high level of efficacy and we believe ready to tide will likely be best suited for patients with a very high BMI or with obesity related complications that require a high degree of weight loss.

Dan Skovronsky: As this trial includes moving patients off of an active therapy onto a placebo maintenance arm, Attain Maintain allows patients who are randomized to placebo to switch to orforglipron as a rescue therapy if weight regain exceeds a specified threshold. This will be a rich data package and we look forward to seeing the results in the coming months, either late this year or early next year. Moving to retatrutide, our GIP/GLP-1/glucagon triple agonist, we expect results from up to six Phase 3 studies by the end of 2026 to support the obesity and related complications program called TRIUMPH and the type 2 diabetes program called Transcend. With its first-of-a-kind triple acting mechanism, we expect retatrutide can deliver deeper and more rapid weight loss than existing obesity medicines, even more than tirzepatide.

For those people switching from tze maintaining weight loss, after switching to orthel is a high bar, given the strong efficacy of trepadeira.

While the global development program for <unk> includes people with a broad range of pmi's spanning across overweight and obesity.

As this trial includes moving patients off of an active therapy onto a placebo maintenance arm, ATTEND, maintain allows patients who are randomized to placebo to switch to or for giper as a rescue therapy if weight regain exceeds the specified threshold.

We anticipate we will be focused on the clinical profile of this medicine in patients where the clinical needs are at the highest.

this will be a rich data package and we look forward to seeing the results in the coming months. Either late this year, or early next year,

The first trial to readout train four compares <unk> to placebo in patients with obesity in knee osteoarthritis pain.

Moving to read a true tied. Our Gip glp1 glucagon triple Agonist

The 68 week study is designed primarily as a pain relief study to support an indication for treatment of knee osteoarthritis pain in combination with other trials in the <unk> program.

When we look forward to sharing top line results from trying to four later this year.

Transcend.

Given this is the first phase III trial for <unk>, we will be cautious not to over extrapolate from these results.

We have seven more phase III trials reading out in 2026 and 2027.

Dan Skovronsky: Of course, not all patients may need this potentially very high level of efficacy and we believe retatrutide will likely be best suited for patients with a very high BMI or with obesity-related complications that require a high degree of weight loss. While the global development program for retatrutide includes people with a broad range of BMIs, such as spanning across overweight and obesity, we anticipate we'll be focused on the clinical profile of this medicine in patients where the clinical needs are the highest. The first trial to read out, TRIUMPH-4, compares retatrutide to placebo in patients with obesity and knee osteoarthritis pain. This 68-week study is designed primarily as a pain relief study to support an indication for treatment of knee osteoarthritis pain in combination with other trials in the TRIUMPH program. We look forward to sharing top line results from TRIUMPH-4 later this year.

With its first of a Kind triple-acting mechanism. We expect Retreat can deliver deeper and more rapid weight loss than existing obesity medicine even more than tpat.

Of course not all patients. May need this potentially very high level of efficacy.

And we will likely need to see data from at least a few of these before we more fully understand the profile of this medicine across a wide range of patients.

For the obesity indication specifically, we look forward to results from three additional phase III studies in the second half of 2026.

and we believe Retreat will likely be best suited for patients with a very high BMI or with obesity related complications that require a high degree of weight loss

While the global development program for Reich includes people with a broad range of BMIs spanning across overweight and obesity.

Moving now to move a lap Lynn, which is our once daily oral small molecule inhibitor of life of protein a or LTA.

We anticipate will be focused on the clinical profile of this medicine in patients where the clinical needs are the highest.

<unk> as a biomarker associated with increased cardiovascular risk in phase II move of Lapland demonstrated over 85% reduction of this biomarker at the highest dose compared to placebo based.

The first trial to read out try and 4. Compare is read a true tied to Placebo in patients with obesity and knee osteoarthritis pain.

Based on these data we've now initiated a phase III study in people with elevated LP levels and atherosclerotic cardiovascular disease known as the move LTA trial move a lap when is the first small molecule approach to LTA and our second program in phase III development against this important target.

The 68 week study is designed primarily as a pain relief, study to support an indication for treatment of any osteoarthritis pain in combination. With other trials, in the Triumph program,

Dan Skovronsky: Given this is the first Phase 3 trial for retatrutide, we'll be cautious not to over-extrapolate from these results. We have seven more Phase 3 trials reading out in 2026 and 2027, and we'll likely need to see data from at least a few of these before we more fully understand the profile of this medicine across a wide range of patients for the obesity indication. Specifically, we look forward to results from three additional Phase 3 studies in the second half of 2026. Moving now to muvalaplin, which is our once daily oral small molecule inhibitor of lipoprotein(a), or Lp(a). Lp(a) is a biomarker associated with increased cardiovascular risk. In Phase 2, muvalaplin demonstrated over 85% reduction of this biomarker at the highest dose compared to placebo.

we look forward to sharing Topline results from Triumph 4 later this year.

In other updates from cardio metabolic health, we submitted our once weekly insulin called insulin <unk> Alfa in the U S for treatment of type two diabetes, and we announced plans to initiate two phase III trials with bear sitting nib in type one diabetes.

Given this is the first fee-for-service trial per vet, a true tide will be cautious not to over-extrapolate from these results.

We have 7 more phase 3 trials, reading out in 2026 and 2027.

And we'll likely need to see data from at least a few of these before we more fully understand the profile of this medicine across a wide range of patients.

From the early phase portfolio, we look forward to presenting phase II data from our selective amylin agonist, a lower land tied at obesity week in November.

For the obesity indication, we look forward to results from three additional Phase 3 studies in the second half of 2026.

Moving to oncology, we're very pleased to have received U S. FDA approval of <unk> under the brand name and L'oreal as a monotherapy for ER positive her two negative ESR, one mutated metastatic breast cancer.

<unk> is also being studied in an ongoing phase III trial called Denver, four which compares to inland ask Jen to the standard of care endocrine therapy in high risk early breast cancer. This 8000 patient trial is the largest oncology trial, we've ever conducted and it is on track to be fully enrolled by early 2026.

Dan Skovronsky: Based on these data, we've now initiated a Phase 3 study in people with elevated Lp(a) levels and atherosclerotic cardiovascular disease, known as the MOVE Lp(a) trial. Muvalaplin is the first small molecule approach to Lp(a) and our second program in Phase 3 development against this important target. In other updates from Lilly Cardiometabolic Health, we submitted our once weekly insulin called insulin efsitora alfa in the U.S. for treatment of type 2 diabetes, and we announced plans to initiate two Phase 3 trials with baricitinib in type 1 diabetes from the early phase portfolio. We look forward to presenting Phase 2 data from our selective amylin agonist eloralintide at Obesity Week in November. Moving to oncology, we're very pleased to have received U.S. FDA approval of imlunestrant under the brand name Inlurio as a monotherapy for ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer.

Moving. Now to move a Lapland, which is our once daily oral small molecule inhibitor of lipoprotein, a or LPA. LPA is a biomarker associated with increased cardiovascular risk in Phase 2 mobile app, and demonstrated over 85% reduction of this biomarker at the highest dose compared to placebo.

Based on these data, we've now initiated a phase 3 study in people with elevated LPA levels and atherosclerotic cardiovascular disease known as the move LPA trial.

The positive results in the metastatic setting provided an important signal that <unk> could have a role in early breast cancer, where we believe an oral <unk> could have the largest patient impact.

Move. A Lapland is the first small molecule approach to LPA and our second program in Phase 3 development against this important Target.

Also in oncology, we topline the study readout from the third positive phase III trial of <unk> in the brew and <unk> development program.

In other updates from cardio, metabolic Health, we submitted our once weekly insulin called insulin epura Alpha in the US for treatment of type 2 diabetes. And we announced plans to initiate 2 phase 3, trials, with bare Sid. In type 1, diabetes.

In brewing CLO, III <unk> III trial of <unk> compared to chemo immunotherapy in treatment naive CLO SLO Proto brute nib demonstrated a highly statistically significant and clinically meaningful improvement in progression free survival.

From the early phase portfolio, we look forward to presenting Phase 2 Data from our selective. Amalin Agonist Elora Lind tide at obesity week in November

<unk> demonstrated the most compelling effect size ever observed for a single <unk> inhibitor and a treatment naive CLO studied compared to this comparator.

Dan Skovronsky: Imlunestrant is also being studied in an ongoing Phase 3 trial called EMBER-4, which compares imlunestrant to the standard of care endocrine therapy in high-risk early breast cancer. This 8,000 patient trial is the largest oncology trial we've ever conducted, and it is on track to be fully enrolled by early 2026. The positive results in the metastatic setting provide an important signal that imlunestrant could have a role in early breast cancer, where we believe an oral SERD could have the largest patient impact. Also in oncology, we top-lined the study readout from the third positive Phase 3 trial of pirtobrutinib in the BRUIN CLL development program. In BRUIN CLL-313, a trial of pirtobrutinib compared to chemoimmunotherapy in treatment-naive CLL/SLL, pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival.

We look forward to sharing these data at an upcoming medical meeting.

moving to oncology. We're very pleased to have received us FDA approval of Inland under the brand name in L'Oreal as a monotherapy for ER positive, her2 negative vsr1, mutated metastatic breast cancer.

As we continue to build the evidence supporting the potential role for <unk> in treatment naive CLO. We expect these data in combination with brew in CLO 314 to form the basis of regulatory submissions globally.

We also presented updates from our early stage oncology portfolio at the recent European Society for medical oncology meeting, including data on our mutant selective Pi three kinase alpha inhibitor for people with invest advanced breast cancer and Pi three kinase Alpha mutations.

In lines is ALS being studied in an ongoing, phase 3 trial called Ember 4, which Compares Inland to the standard of care. Endocrine therapy in high-risk early breast cancer. This 8,000, patient trial is the largest oncology trial we've ever conducted and it is on track to be fully enrolled by early 2026.

Positive results in the metastatic setting provided an important signal that immune could have a role in early breast cancer where we believe an oral s could have the largest patient impact.

Our fully receptor alpha antibody drug conjugate for treatment of ovarian cancer.

<unk> nib, our FGF are three selective inhibitor for FGF are three alternative metastatic bladder cancer.

also an oncology we Topline, the study read out from the third positive phase 3, trial of pirtobrutinib in the Bruin, CLL development program

We continue to be encouraged by the emerging clinical profile, we have observed across each of these three programs.

Dan Skovronsky: Pirtobrutinib demonstrated the most compelling effect size ever observed for a single BTK inhibitor in a treatment-naive CLL study compared to this comparator. We look forward to sharing these data at an upcoming medical meeting as we continue to build evidence supporting the potential role for pirtobrutinib in treatment-naive CLL. We expect these data in combination with BRUIN CLL-314 to form the basis of regulatory submissions globally. We also presented updates from our early-stage oncology portfolio at the recent European Society for Medical Oncology meeting, including data on our mutant-selective PI3 kinase alpha inhibitor for patients with advanced breast cancer and PI3 kinase alpha mutations, our folate receptor alpha antibody-drug conjugate for treatment of ovarian cancer, and vepafestinib, our FGFR3-selective inhibitor for FGFR3-altered metastatic bladder cancer.

In Bruins CLL, 313 a trial of perter nib compared to chemoimmunotherapy in treatment knee Eve CLL. SLL per statistically significant and clinically meaningful Improvement in progression-free survival.

And we plan to initiate phase III trials for these medicines in 2026, if not sooner.

In neuroscience, we received EU marketing authorization for cause somewhat importantly, this approval came with a modified trade patient dosing in the label.

For a brood nip, demonstrated the most compelling effect size ever observed for a single BTK inhibitor in a treatment. Naive, CLL study compared to this comparative.

Which is also approved in the U S and now approved in Japan.

We look forward to sharing these data at an upcoming medical meeting, as we continue to build evidence supporting the potential role for pirtobrutinib in treatment, naive CLL.

<unk> dosing schedule is thus approved in most major geographies and we're pleased that it's being used to further lower the risk of ARIA.

We expect these data in combination with brew and CLL 314 to form the basis of regulatory submissions globally.

Our phase III trial with <unk> is also progressing well and we've now completed enrollment and trail runner <unk>, three which is evaluating subcutaneous from 10, a tug in treatment of preclinical Alzheimer's disease with a similar time to event design as we are pursuing with the ongoing trailblazer III ALS trial for <unk>.

We also presented updates from our early stage oncology portfolio at the recent European Society for medical oncology meetings, including data on our mutant selective, pi3 kinase Alpha inhibitor for people with invest Advanced Breast Cancer and pi3 kinase Alpha mutations.

For treatment of ovarian cancer.

Separately, we are.

I'm pleased to announce that we've initiated our phase III program in alcohol use disorder with Britain appetite the Gi <unk> dual agonist that we believe could have the optimal properties for neuroscience indications.

Dan Skovronsky: We continue to be encouraged by the emerging clinical profiles we've observed across each of these three programs, and we plan to initiate Phase 3 trials for these medicines in 2026, if not sooner. In neuroscience, we received the EU marketing authorization for Kisunla. Importantly, this approval came with the modified titration dosing in the label, which is also approved in the U.S. and now approved in Japan. The modified dosing schedule is thus approved in most major geographies, and we're pleased that it's being used to further lower the risk of ARIA. Our Phase 3 trial with remternetug is also progressing well, and we've now completed enrollment in TRAILRUNNER-ALZ 3, which is evaluating subcutaneous remternetug in treatment of preclinical Alzheimer's disease with a similar time-to-event design as we are pursuing with the ongoing TRAILBLAZER-ALZ 3 trial for donanemab.

In February, our fgfr3 selective inhibitor for fgfr3, altered metastatic bladder cancer.

We continue to be encouraged by the emerging clinical profiles. We've observed across each of these 3 programs.

Growing evidence from real World clinical studies suggest that <unk> therapy may reduce cravings and observation that is supported by non clinical studies that show decreased dopamine release and reward pathways after treatment with <unk> therapy given.

And we plan to initiate Phase 3 trials for these medicines in 2026, if not sooner.

In Neuroscience, we received the EU marketing authorization for Casa.

Given the data we've observed thus far with burn appetite. We believe it has the potential to treat a range of diseases. We expect to initiate several additional phase II and phase III trials in the coming months <unk>.

Importantly, this approval came with the modified tradition dosing in the label.

Which is also proved in the US and now approved in Japan.

Including testing this medicine and important but extremely challenging unmet medical needs such as opioid use disorder.

The modified dosing schedule is thus approved in most major geographies. And we're pleased that it's being used to further lower the risk of Arya.

In addition to neuroscience applications, we will test for an appetite and immunologic disease, including a phase II trial in asthma, which has recently begun enrolling patients.

Also in immunology, new data were presented for <unk> at the 2025 fall clinical Dermatology conference <unk> deliver durable disease control in people with moderate to severe atopic dermatitis when dosing was reduced from once every four weeks to once every eight weeks.

Dan Skovronsky: Separately, we're pleased to announce that we've initiated our Phase 3 program in alcohol use disorder with brunepatide, the GIP/GLP-1 dual agonist that we believe could have the optimal properties for neuroscience indications. Growing evidence from real-world clinical studies suggests that incretin therapies may reduce cravings, an observation that is supported by nonclinical studies that show decreased dopamine release in reward pathways after treatment with incretin therapy. Given the data we've observed thus far with brunepatide, we believe it has the potential to treat a range of diseases. We expect to initiate several additional Phase 2 and Phase 3 trials in the coming months, including testing this medicine in important but extremely challenging unmet medical needs such as opioid use disorder. In addition to neuroscience applications, we will test brunepatide in immunologic disease, including a Phase 2 trial in asthma, which has recently begun enrolling patients.

Our phase 3 trial with the rat is also progressing, well, and we've now completed enrollment in trailrunner ALS 3, which is evaluating subcutaneous from tanit tug in treatment of pre-clinical Alzheimer's disease, with a similar time to event design as we are pursuing with the ongoing, Trailblazer 3 S trial for genetic.

Reducing the number of maintenance doses to as few as six doses per year could provide flexibility and reduce the treatment burden on patients.

separately, we're pleased to announce that we've initiated our phase 3 Program in alcohol use disorder with

We have not submitted these data to the FDA for a potential label update and continue to explore opportunities for even less frequent dosing of this medicine for people with atopic dermatitis.

Growing evidence from Real World, clinical studies suggest that incretin therapies May reduce Cravings. An observation that is supported by non-clinical studies, that show decreased dopamine release in reward Pathways after treatment with in therapy.

While we continue to pursue innovative modalities across several immunological disorders. We're also developing combination therapies with the potential to deliver differentiated efficacy. We recently began two new studies, combining <unk> with <unk> and people with ulcerative colitis and people with Crohn's disease.

Given the data we've observed thus far with Burnaby, we believe it has the potential to treat a range of diseases.

We expect to initiate several additional Phase 2 and phase 3 trials in the coming months.

Including testing this medicine in important but extremely challenging, unmet medical needs such as opioid, use disorder.

These two new studies.

Mint. The previously initiated together studies of <unk>, plus <unk> appetite in people with psoriasis and Psoriatic arthritis.

Dan Skovronsky: Also in immunology, new data were presented for lebrikizumab at the 2025 Fall Clinical Dermatology Conference. Lebrikizumab delivered durable disease control in people with moderate to severe atopic dermatitis when dosing was reduced from once every four weeks to once every eight weeks. Reducing the number of maintenance doses to as few as six doses per year could provide flexibility and reduce the treatment burden on patients. We've now submitted these data to the FDA for a potential label update and continue to explore opportunities for even less frequent dosing of this medicine for people with atopic dermatitis. While we continue to pursue innovative modalities across several immunological disorders, we're also developing combination therapies with the potential to deliver differentiated efficacy. We recently began two new studies combining mirikizumab with tirzepatide in people with ulcerative colitis and people with Crohn's disease.

In addition to Neuroscience applications, we will test for an appetite and immunologic disease, including a phase 2, trial and Asthma, which is recently begun, enrolling patients.

We expect the first data from the together trials to read out in the next six months.

Slide 16 shows additional milestones and updates to our clinical portfolio.

Also an Ami new data represented for labor. Kism map at the 2025 fall clinical dermatology conference laboris delivered durable Disease Control in people with moderate to severe atopic dermatitis.

It has been a very productive period since our last earnings call and we still have an ambitious R&D agenda for the last two months of 2025 Slide 17 shows the remaining list of potential key events expected yet this year.

when dosing was reduced from once every 4 weeks to once every 8 weeks,

Reducing the number of maintenance doses to as few as 6 doses per year, could provide flexibility and reduce the treatment burden on patients.

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

Thanks, a lot Dan.

Talk about there in the pipeline, we're pleased with all the progress in 2025, and we've had another quarter of really strong execution, both in driving the business results and making investments that will help us discover and develop new Lilly medicines to help more people around the world.

We've now submitted these data to the FDA for a potential label update, and continue to explore opportunities for even less frequent dosing of this medicine for people with atopic dermatitis.

While we continue to pursue Innovative modalities across several immunological disorders. We're also developing combination therapies with the potential to deliver differentiated efficacy.

Now I will turn the call over to Mike who will moderate our Q&A session.

<unk>.

Yeah, Thanks, Dave we'd like to take questions from as many callers as possible. So consistent with prior quarters, we will respond to one question per caller and end the call promptly by 11.

we recently began 2, new studies combining merch with tati, and people with ulcerative colitis,

Dan Skovronsky: These two new studies complement the previously initiated TOGETHER studies of ixekizumab plus tirzepatide in people with psoriasis and psoriatic arthritis. We expect the first data from the together trials to read out in the next six months. Slide 16 shows additional milestones and updates to our clinical portfolio. It has been a very productive period since our last earnings call, and we still have an ambitious R&D agenda for the last two months of 2025. Slide 17 shows the remaining list of potential key events expected yet this year. I'll now turn the call back to Dave for some closing remarks.

And people with crohn's disease.

More than one question you can reenter the queue and we will get to you as time allows.

These 2 new studies complement. The previously initiated together studies of exochem Plus tze in people with psoriasis and psoriatic arthritis.

Paul Please provide instructions for the Q&A and then we're ready for the first caller.

We expect the First Data from the together trials, to read out in the next 6 months.

Certainly at this time, we will be conducting a question and answer session. If you have any questions. Please press star one on your phone at this time, we ask that participants limit themselves to one question on today's call. If you do have a follow up question. Please rejoin the queue by pressing star one at anytime we also ask that while posing your question. Please pickup your handset listen on speaker phone to provide.

To slide 16 shows additional milestones and updates to our clinical portfolio.

It has been a very productive period since our last earnings call and we still have an ambitious R&D agenda for the last 2 months of 2025 slide 17 shows the remaining list of potential key events expected yet this year.

Dave Ricks: Thanks a lot, Dan. A lot to talk about there in the pipeline. We're pleased with all the progress in 2025, and we've had another quarter of really strong execution both in driving the business results and making investments that will help us discover and develop new Lilly medicines to help more people around the world. Now I'll turn the call over to Mike, who will moderate our Q&A session. Mike?

I'll now turn the call back to Dave, for some closing remarks.

Optimum sound quality, please hold while we poll for questions.

And the first question today is coming from Terence Flynn from Morgan Stanley Your.

Your line is live.

Thanks, so much for taking the question really appreciate it and congrats on the quarter.

A lot of focus obviously on or for clip, Ron and path to market.

Thanks a lot, Dan, a lot to talk about there in the pipeline. We're pleased with all the progress in 2025, and we've had another quarter of really strong execution, both in driving the business results and making Investments that will help us discover and develop new Lily medicines to help more people around the world.

Mike Czapar: Yeah, thanks, Dave. We'd like to take questions from as many callers as possible. Consistent with prior quarters, we will respond to one question per caller and end the call promptly by 11:00 A.M. If you have more than one question, you can reenter the queue and we will get to you as time allows. Paul, please provide instructions for the Q&A and then we're ready for the first caller.

Surprised that it wasn't on the first list of the Commissioners National Priority review Voucher program and so maybe you could just comment on kind of if you guys are seeking that voucher and then if.

Now, I'll turn the call over to Mike. Who will moderate our Q&A session? Mike?

If not why not and then how to think about timelines for launch and some of the puts and takes as we think about maybe consensus expectations for 2026. Thank you.

Yeah, thanks, Dave. Uh, we'd like to take questions from as many callers as possible, so, consistent with prior quarters, we will respond to one question per caller and then the call promptly by 11. If you have more than one question, you can enter the queue and we will get to you as time allows.

Operator: Certainly. At this time we will be conducting a question and answer session. If you have any questions, please press star 1 on your phone at this time. We ask that participants limit themselves to one question on today's call. If you do have a follow up question, please rejoin the queue by pressing star 1 at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. The first question today is coming from Terrence Flynn from Morgan Stanley. Terrence, your line is live.

Uh, Paul, please provide instructions for the Q&A and then we're ready for the first caller.

Alright, great. Thanks for the question Terence We will go to David talk a bit about offers upfront.

Certainly at this time, we'll be conducting a question and answer session. If you have any questions, please press star 1 on your phone at this time.

Yes, hi, Thanks, Terence for the call I think as we've said before we are interested in getting <unk> to as many patients around the world as fast as we can including those in the U S. So.

Without commenting on specific vehicles, I think investors can expect us to be pursuing and all of the above strategy to get get the medicine out more quickly.

That, while posing your question, you please pick up your handset if listening on speakerphone to provide Optimum sound quality. Please hold while we pull for questions.

So I pointed out that.

You look at the.

This new.

Dave Ricks: Hi, thanks so much for taking the question. Really appreciate it. Congrats on the quarter. A lot of focus obviously on orforglipron and path to market. I was surprised that it wasn't on the first list of the Commissioner's National Priority Review Voucher program. Could you comment on if you are seeking that voucher, and if not, why not? How should we think about timelines for launch and some of the puts and takes as we consider maybe consensus expectations for 2026? Thank you.

Voucher program I think our program upon checks at least three or four of the boxes laid out. So yes, we will we will see obviously, a government decision about which path.

And the first question today is coming from Terrence Flynn from Morgan Stanley, Terrence, your line is live.

That way they choose and the review time itself, but.

We're focused on speed here and we're ready to launch so the.

The package will go in in the quarter and we hope to get approval as soon as we can after that.

Great. Thank you, Dave, but I'm ready for the next question Paul the.

The next question is coming from Chris Schott from JP Morgan, Chris Your line is live.

Great. Thanks, so much for the question I, just wanted to touch base a bit more on the majority of international ramp. It's obviously had a pretty impressive step up in sales. This past two quarters can you just elaborate a little bit more on how some of these new country launches are trending relative to your expectations how to think about growth off of this new higher base.

Mike Czapar: All right, great. Thanks for the question, Terrence. We'll go to Dave to talk a bit about orforglipron. Yeah, hi.

Hi, thanks so much for taking the question. I really appreciate it, and congrats on the quarter. Um, I a lot of focus obviously on Orphan and and path to Market. Um, I was surprised that it wasn't on the first list of the commissioner's National priority, review voucher um program. And so maybe you could just comment on kind of, if you guys are seeking that voucher and then um, if not why not. And then how to think about timelines for uh launched and uh some of the puts and takes as we think about maybe consensus, expectations for 2026. Thank you.

All right, great. Thanks. Uh, for the question Terence, we'll go to Dave to talk a bit about Orford lip Ron.

Dave Ricks: Thanks, Terence, for the call. I think, as we've said before, we're interested in getting orforglipron to as many patients around the world as fast as we can, including those in the U.S. Without commenting on specific vehicles, I think investors can expect us to be pursuing an all of the above strategy to get the medicine out more quickly. Also, I'd point out that if you look at this new voucher program, I think orforglipron checks at least three or four of the boxes laid out. We'll see. It's obviously a government decision about which pathway they choose and the review time itself, but we're focused on speed here and we're ready to launch. The package will go in in the quarter and we hope to get approval as soon as we can after that.

And is there any meaningful stocking as we appreciate the kind of look at these numbers just a little bit more color on whats been driving the SPIC step up thank you.

Great. Thanks, Chris Thanks for the question on Hulu International will go to Patrick let's talk a bit about <unk> uptake new country launches growth.

Yeah. Hi uh thanks Terence for the call I think, as we've said before we're interested in getting or for lapon to as many patients around the world as fast as we can including those in the US. So without commenting on specific vehicles, I think investors can expect us to be pursuing and all the above strategy to get, get the medicine out more quickly. Also, I'd point out that, uh, you know, if you look at the this new um,

Thank you very much Chris.

I think we are very encouraged what we're seeing outside of the U S.

And maybe a sense as to which had nearly 75% of the bulk get them, 25% that.

Type two diabetes.

And whilst we have seen is of course, an NHL stocking in both markets, where we launched and we referred to the big ones being in Q2 in China, Brazil, Mexico, and India <unk> seen at least in the and the performance was in those markets in Q3, and a continued very strong performance globally.

Mike Czapar: Great. Thank you, Dave. We're ready for the next question.

About your program. I think our program checks at least 3 or 4 of the boxes laid out. So, yeah, we we'll, um, we'll see. It's a obviously government decision about which pathway they choose and the review time itself. But, um, we're focused on speed here and we're ready to launch. So, um, the package, um, will go in in the quarter and we hope to get approval as soon as we can after that.

Operator: Paul, the next question is coming from Chris Schott from JP Morgan. Chris, your line is live.

Great. Thank you. Dave, we're ready for the next question, Paul.

Dave Ricks: Great. Thanks so much for the question. I just wanted to touch base a bit more on the Mounjaro International ramp. It's obviously had a pretty impressive step up in sales these past two quarters. Can you just elaborate a little bit more on how some of these new country launches are trending relative to your expectations, how to think about growth off of this new higher base, and is there any meaningful stocking as we appreciate? Kind of look at these numbers, just a little bit more color on what's been driving this big step up. Thank you.

The next question is coming from Chris Shot from JP Morgan. Chris, your line is live.

Looking forward I think the major opportunity number one insight to.

<unk> market and we will continue those efforts.

Uh, great thanks so much for the question. I just wanted to touch base a bit more on the morrow International ramp. It's obviously had a pretty impressive Step Up in sales. These past 2 quarters, can you just elaborate a little bit more on how some of these new country launches are trending relative to your expectations?

Ross all of U S markets, but thats going to take some time.

The big opportunity when it comes to US, it's really about patient activation and we will lean on Carnival is therefore also in 2026.

Mike Czapar: Great, thanks, Chris. Thanks for the question on Lilly International. We'll go to Patrik for that to talk a bit about Mounjaro uptake, new country launches, growth.

How to think about growth off of this new higher base and is just there, any meaningful stocking, as we appreciate the kind of. Look at these numbers just a little bit more color on what's been driving this this this big step up. Thank you.

When you look at international it's important though right. It's one nine and the income statements.

Patrik Jonsson: Thank you very much, Chris. I think we are very encouraged by what we're seeing outside of the U.S. and the business that we shared earlier is 75% out of pocket and 25% type 2 diabetes. What we have seen is, of course, an initial stocking in both markets where we launched and we refer to the big ones being in Q2 in China, Brazil, Mexico, and India. Since then we have seen a lift in the performance also in those markets in Q3 and a continued very strong performance globally. Looking forward, I think the major opportunities is number 1 in type 2, we have reimbursement currently in eight markets and will continue those efforts across all of U.S. markets. That's going to take some time.

Great that. Thanks Chris. Thanks for the question, on L International. We'll go to Patrick for that talk. A bit about a major update new country launches growth.

Floating to more than 55 countries and different market dynamics.

Thank you very much, Chris. I think we are very encouraged by what we're seeing outside of the US.

Current buying patterns SaaS, we have seen over the last several quarters, it's not going to be a straight line.

All significant opportunities outside of U S ortho moving forward across type two and chronic weight management.

Great. Thank you Patrick I will go to the next question Paul.

The next question will be from Seamus Fernandez from Guggenheim Seamus Your line is live.

And the business as we shared earlier is 75% out of pocket and 25% type 2 diabetes. Uh, what we have seen is, of course, an initial stocking in both markets where we launched and we referred to the big ones being in Q2 in China, Brazil, Mexico, and India.

Thanks, so much for taking the question so minus actually on some of the behaviors that we're seeing in the market around.

Since band we have seen at least in the in the performance was in those markets in Q3 and a continued very strong performance globally.

M&A and how the competitors dynamics are playing out and how you Dave and Dan see the market evolving from here you've commented on Red a true tied perhaps segmenting the.

Patrik Jonsson: Secondly, the big opportunity when it comes to obesity, it's really about patient activation and we will lean in on all of those efforts. Also, in 2026, when you look at international, it's important to, while it's one line in the income statement, we are referring to more than 55 countries and our different market dynamics, different buying patterns. As we have seen over the last several quarters, it's not going to be a straight line, but there are significant opportunities outside of U.S. also moving forward across type 2 and chronic weight management.

Uh, looking forward, I think the major opportunity is is number 1 inside 2. Uh, we have reimbursement currently in 8 markets and will continue those efforts uh across all of us markets, but that's going to take some time.

Heavier patient population with greater Comorbidities.

Do you have or flip Ron potentially targeting a maintenance and lower end portion of the market. That's massively scalable and you also have <unk> appetite kind of blowing the numbers out and potentially cornering the competitor to some degree in other markets.

And secondly, the big opportunity when it comes to obesity is really about patient activation, and we will lean in on all of those efforts also in 2026.

Just wanted to get a sense of.

If that behavior would be concerning to you. If you don't really spend much time thinking about it.

Mike Czapar: Great, thank you, Patrik. We'll go to the next question.

Because you are so focused on your own business.

Uh, when you look at International, it's important to while it's 1 line in the income statement. We are referring to more than 55 countries and our different market dynamics and different buying patterns. So as we have seen over the last several quarters, it's not going to be a straight straight line but there are significant opportunities out there of us. Also moving forward across type 2 and chronic weight management.

Operator: Paul, the next question will be from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Or if there are other considerations as you work to further segment the market and take the deeper leadership position. Thanks, so much.

Great. Thank you, Patrick. We'll go to the next question. Paul.

Ilya Yuffa: Thanks so much for taking the question. Mine is actually on some of the behaviors that we're seeing in the market around MA and how the competitor dynamics are playing out and how you, Dave and Dan, see the market evolving from here. You've commented on retatrutide, perhaps segmenting the heavier patient population with greater comorbidities. You have orforglipron potentially targeting a maintenance and lower end portion of the market that's massively scalable. You also have tirzepatide kind of blowing the numbers out and potentially cornering the competitor to some degree in other markets. I just wanted to get a sense of if that behavior would be concerning to you, if you don't really spend much time thinking about it because you're so focused on your own business, or if there are other considerations as you work to further segment the market and take.

The next question will be from Sheamus. Fernandez, from Guggenheim Sheamus, your line is live

Thanks for the very long and involved question there Seamus.

I think we.

We will go to.

Dan actually to talk about that.

Yes sure. Thanks Seamus for question.

Of course, it really has been focused on the obesity opportunity for quite some time, we have a very strong R&D engine behind it I think when you look at where the science leads us in sort of every kind of reasonable or logical target to pursue.

We have robust programs against those targets and in nearly every case.

I think we have either a best molecule or first molecule or for both actually.

I like our portfolio clearly the late stage clinical molecules at the street is paying attention to it we like where they are but behind it I can assure you there is a robust pipeline that we like.

No surprise, then that every probably just about every other company in this industry looks at that and.

Who wants to improve their own position.

Dan Skovronsky: A deeper leadership position. Thanks so much.

That doesn't surprise us that we watch that.

Other markets. Um, just wanted to get a sense of, uh, if that behavior would be concerning to you. If you don't really spend much time thinking about it, um, because you're so focused on your own business, um, or if there are other uh, considerations, as you work to further segment, the market and take the uh a deeper leadership position. Thanks so much.

Mike Czapar: Thanks for the very long and involved question there, Seamus. I think we'll go to Dr. Dan Skovronsky actually to talk about that.

Of course pay attention, but we haven't seen anything that changes our view about the competitiveness of our portfolio or the lead that we have.

Dan Skovronsky: Yeah, sure. Thanks, Seamus, for the good question. Of course, Lilly's been focused on the OPCD opportunity for quite some time. We have a very strong R&D engine behind it. I think when you look at where the science leads us and sort of every kind of reasonable or logical target to pursue, we have robust programs against those targets. In nearly every case, I think we have either a best molecule or first molecule or both, actually. I like our portfolio. Clearly, the late-stage clinical molecules that the street is paying attention to, we like where they are. Behind it, I can assure you there's a robust pipeline that we like. No surprise then that probably just about every other company in this industry looks at that and wants to improve their own position. That doesn't surprise us that we watch that and of course pay attention.

Thanks for the uh, very, very long and involved question there. There she is. Um, I think we'll, uh, we'll go to, um, Dan actually to talk about that.

In this space, which we intend to maintain through robust investments not just in research and development, but as you've seen today.

Multiple phase three trials in new indications.

Okay. Thanks, I think that's sorry, Mike maybe just to add I think that's a great answer I think for a long time, we've all been saying we're focused on every logical target in pursuing the full extent of what these medicines can do for various conditions I mean, today's call highlights that with some of the new study as Dan highlighted but it is also important.

To note. In addition to innovation you need to execute this is a highly scaled business.

Reaching potentially tens or even hundreds of millions of people in.

And here also I think Lilly has really done well, it's a combination of those two things that I think.

The lead we have in.

Yeah, sure. Thanks James for for a good question. You know, of course that Lily's been focused on the OPC opportunity for quite some time. We have a very strong R&D engine behind it. I think when you look at where the science leads us and sort of every kind of reasonable or logical Target to pursue. We have robust programs against those targets and in nearly every case, uh, I think we have either a best molecule or a first molecule or, or both actually. So I, I like our portfolio. It clearly the late stage clinical molecules that the street is playing attention to write that we like where they are but behind it, I can assure you, there's a robust pipeline that we like it. No surprise. Then that every probably just about every other company, in this industry, looks at that and wants to improve their own position. Um, so that

We are very focused on both of them both the innovation Dan talked about but also executing with manufacturing build out in market performance new ways to reach consumers.

Dan Skovronsky: We haven't seen anything that changes our view about the competitiveness of our portfolio or the lead that we have in this space, which we intend to maintain through robust investment, not just in research and development, but as you've seen today in multiple Phase 3 trials and new indications.

Of course, everybody would like to be in our position, but we are focused on defending it and mostly just executing the play we have so it's a good question, we'll probably see more dynamics that noise from other.

Other pharmaceutical manufacturers that's normal what we need to do is run the strategy out that we've outlined.

Dave Ricks: Maybe just to add, I think that's a great answer. I think for a long time we've all been saying we're focused on every logical target and pursuing the full extent of what these medicines can do for various conditions. I mean, today's call highlights that with some of the new studies Dan highlighted. It's also important to note in addition to innovation, you need to execute. This is a highly scaled business and reaching potentially tens or even hundreds of millions of people. Here also I think Lilly's really done well. It's a combination of those two things that's built the lead we have and we are very focused on both of them, both the innovation Dan talked about, but also executing with manufacturing, build out in market performance, new ways to reach consumers.

Doesn't surprise us that we watch that, and of course, pay attention. But we haven't seen anything that changes our view about the competitiveness of our portfolio or the lead that we have, um, in this space, which we intend to maintain through robust Investments, uh, not just in research and development, but as you've seen today, uh, in multiple phase 3, trials, and and new indications,

Thanks for the question.

Great. Thank you Dave Thank you Dan Paul already for the next question next.

Our next question will be from James Chen from Deutsche Bank James Your line is live.

Good morning. Thank you for the question I got one for David.

David You previously mentioned narrowing the gap between list and net pricing Cigna recently announced drug rebates will be replaced with GPO fees and it sounded like they will lead to greater discounts as well as more employer opt ins. So does that suggest greater GTS pressure.

But normally have with rebates and just any clinical profiles more relevant to formulary positioning our access like what kind of changes should we expect.

Great. Thanks, James we'll go to Dave to talk about some of the recent announcements from Pbms on business model.

Yes, I think youre talking about the Cigna move and there is also I would also point out increasing share in large employer market from kind of non traditional pbms I guess, we call them.

Dave Ricks: Of course everybody would like to be in our position, but we're focused on defending it and mostly just executing the play we have. It's a good question. We'll probably see more dynamics and noise from other pharmaceutical manufacturers. That's normal. What we need to do is run the strategy out that we've outlined. Thanks for the question.

Maybe just, I think that's sorry. Mike, maybe just to add. I think that's a great answer. I think for a long time, we've all been saying we're focused on every logical Target and pursuing, you know, the full extent of what these medicines can do for various conditions. I mean today's call highlights that with some of the new studies Dan Dan highlighted but it's also important to note. In addition to Innovation you need to execute. This is a highly scaled business uh and reaching, you know, potentially tens or even hundreds of millions of people and here. Also, you know, I think Lily is really done. Well, it's a combination of those 2 things that I think both the, the lead we have and we we are very focused on both of them, both The Innovation and talked about, but also, executing with Manufacturing buildout in market performance, new ways to reach consumers. Um, of course, everybody would like to be in our position, but we're we're focused on defending it and mostly just executing the play. We have so it's a good

I applaud this I think it's a good move for innovators. It's a good move for patients. It's a good move for payers for the commercial players.

And probably smart of Cigna to make this first move too.

Question. Um, we'll probably see more Dynamics and noise from other, uh, other pharmaceutical manufacturers. That's, that's normal. What we need to do is is run the, the strategy out that that we've outlined

Mike Czapar: Great, thank you, Dave. Thank you, Dan. Paul, ready for the next question?

Thanks for the question.

Recoup market share gain market share.

Operator: Next question will be from James Chin from Deutsche Bank. James, your line is live.

Great. Thank you. Dave. Thank you. Dan, Paul. Ready for the next question?

I think everyone wants more transparency and lower out of pocket for patients in this kind of model will produce both of those and what we want is to make the basis of competition.

Dave Ricks: Morning. Thank you for the question. I got one for David. David, you previously mentioned narrowing the gap between list and net pricing. Cigna recently announced drug rebates would be replaced with GPO fees. It sounds like it's going to lead to greater discounts as well as more employer opt ins. Does that suggest greater GTN pressure than what you normally have with rebates? Does this make clinical profiles more relevant to formulary positioning or access? What kind of changes should we expect?

Next question will be from James chin from DEA Bank. James, your line is live.

One of clinical differentiation that doctors and patients both appreciate.

In a way.

Morning, thank you for the question. I got 1 for David David. You previously mentioned narrowing the gap between list and net pricing signal. Recently announced drug rebates would be replaced with GPO fees and it sounds like so it leads to Greater discounts as well as more employer options.

Nontransparent rebates and other.

Hind the scenes activities that determined which medicine a patient gets is not in our interest so as an innovator.

Mike Czapar: Great, thanks, James. We'll go to Dave to talk about some of the recent announcements from PBMs on business model.

So does that suggest greater gtn pressure than what would normally have with the rebates and just make clinical profiles more relevant to form like positioning or assess? Like what kind of changes should we expect?

Probably the leading spender on innovation in the sector coming up.

For this I think David and his team at Cigna did a good thing here and we hope others follow and the market in the U S can rapidly transition to such a system.

Dave Ricks: Yeah, I think you're talking about the Cigna move and there's also, I'd also point out increasing share in large employer market from kind of non-traditional PBMs I guess we call them. I applaud this. I think it's a good move for innovators, it's a good move for patients, it's a good move for payers, for the commercial payers. Probably smart of Cigna to make this first move to recoup market share, gain market share. I think that everyone wants more transparency and lower out-of-pocket for patients and this kind of model will produce both of those. What we want is to make the basis of competition one of clinical differentiation that doctors and patients both appreciate in a way non-transparent rebates and other behind-the-scenes activities that determine which medicine apparently patient gets is not in our interest.

Great. Thanks James. Uh, we'll go to Dave to talk about some of the recent announcements from pbms on business model.

Think that per se that reads through to some pricing effect.

Yeah, I think you're talking about the sigma move and um there's also I'd also point out, you know, increasing share in um large employer Market, from kind of non-traditional pbms I guess we call them.

I hope is that more valuable medicines, we will have.

That value recognized in pricing and less valuable medicines, we will have a harder time competing now because you can't just rebate away some number and find formulary position ahead of a better medicine. So we're for this and again, it's a good move hats off to David and the team and hopefully others.

I I I applaud this, I think it's a it's a good move for innovators, it's a good move for patients. It's a good move for payers for the commercial payers and probably smart of Cigna to make this first move to um, you know, recoup market share or gain market share. I think that everyone wants more transparency and lower.

Rapid follow up.

Great. Thanks, Dave next question please Paul.

The next question will be from Geoff Meacham from city, Jeff Your line is live.

Good morning, guys. Thanks, so much the question just had another one on orphan lift from when you guys think about commercial strategy would you characterize it as more consumer centric through literally direct or should we think about it as a more typical pharma launch with.

Out of pocket for patients and this kind of model will produce both of those. And what we want is to make the basis of competition um 1 of clinical differentiation that doctors and patients both appreciate

Dave Ricks: As an innovator, probably the leading spender on innovation in the sector coming up, we're for this. I think David and his team at Cigna did a good thing here and we hope others follow and the market in the U.S. can rapidly transition to such a system. I don't think that per se that reads through to some pricing effect. What I hope is that more valuable medicines will have that value recognized in pricing and less valuable medicines will have a harder time competing now because you can't just rebate away some number and find formulary position ahead of a better medicine. We're for this and again it's a good move. Hats off to David Cordani and the team and hopefully others rapidly follow.

PVM and payer negotiations being really critical on day, one and I guess, the puts and takes of both of those thank you.

Okay, great. Thanks for the question Jeff.

The problem is kind of a U S bench that will go to <unk> to talk about some of the ortho launch thinking sure Jeff. Thanks for the question. Obviously, we're excited about the profile of <unk>.

To commercialize it in the U S.

Outside the U S as well, obviously, we think about this similarly to how we view zeff out where we need to drive great commercial and overall access for patients for accessibility, but we also recognize that there is significant demand.

The consumer segment related to finding ways to get outside some of the friction in the health care system and so we see both.

Mike Czapar: Great, thanks Dave. Next question please.

Probably the the leading spender on innovation in the sector coming up. Um we're we're for this. Uh I think David and his team at Cigna at a good thing here and we hope others follow in the market in the US can rapidly transition to such a system. I don't think um, that per se that reads through to some pricing affect. What I hope is that more valuable medicines will have, um, you know, that value recognized in pricing and less valuable. Medicines will have a harder time competing now because you can't just rebate away some number and find formulary position ahead of a better medicine. So we're for this and again it's a good move hats off to David cordani and the team and hopefully others um rapidly follow.

Operator: Paul, the next question will be from Jeff Meacham from Citi. Jeff, your line is live.

Great. Thanks, Dave. Next question, please call.

Dave Ricks: Morning guys. Thanks so much for the question. Just had another one on orforglipron. You know, when you guys think about commercial strategy, would you characterize it as more consumer centric through Lilly Direct, or should we think about it as a more typical pharma launch with PBM and payer negotiations being really critical on day one? I guess the puts and takes of both of those. Thank you.

The next question will be from Jeff Meacham from City. Jeff, your line is live.

Looking at broad coverage.

As well as looking at expanding how we do our direct to consumer platform and <unk>.

Ensuring that every patient has the ability to access.

Medicines across the portfolio.

Great. Thanks next question please Paul.

The next question will be from Steve Scala from TD Count Steve Your line is live.

Lucas Montarce: Okay, great.

Great. Uh, morning guys. Uh, thanks so much for the question, just had another 1 on Orphan. You know, when you guys think about commercial strategy, you know, would you characterize it as more consumer Centric through Lily direct or, or should we think about it as a more typical Pharma launched with, you know, PBM and payer negotiations being really critical on day 1 and I guess the puts and takes of both of those. Thank you.

Mike Czapar: Thanks for the question, Jeff. Orforglipron is kind of a U.S. bent, so we'll go to Ilya to talk about some of the ORFO launch thinking.

Thank you so much I know, it's <unk> policy not to comment on Interims, but it's also a bit unusual for Lilly to speak about them in some detail and Lilly has spoken in some detail about the trailblazer ALS three interim on both the Q1 'twenty five in Q4, 'twenty four calls and likely other forms as well so with that.

Ilya Yuffa: Sure, Jeff, thanks for the question. Obviously we're excited about the profile of orforglipron and how to commercialize it in the U.S. and outside the U.S. as well. Obviously we think about this similarly to how we've viewed Zepbound, where we need to drive great commercial and overall access for patients for accessibility. We also recognize that there's significant demand in the consumer segment related to finding ways to get outside some of the frictions in the healthcare system. We see both looking at broad coverage as well as looking at expanding how we do our direct to consumer platform and ensuring that every patient has the ability to access medicines across the portfolio.

Okay, great. Thanks for the question, Jeff. Uh, I work with lip brown, it's kind of a US bent so we'll go to Ilya to talk about some of the ortho launch thinking. Sure, Jeff, thanks for the question. Obviously, we're excited about the profile of or for glipon and

Said has the trailblazer <unk> III interim already been taken.

The initiation of return of tug and sell in the same setting would not seem the best sign for <unk>.

<unk> and Alzheimer's prevention. Thank you.

Great well, thanks, Steve and thanks for the question on Alzheimer's, We will go to Ann to talk about some of our clinical trials in early Alzheimer's great well. Thanks for the question, Yes, I think we're all looking forward to these results as you know we tend not to comment on interim as we've shared previously we have completed enrollment and translates to three so now it just continues to be.

Matter of reaching.

Mike Czapar: Great, thanks Celia. Next question please.

How to commercialize it in the U.S. and, um, outside the U.S. as well. Obviously, we think about this similarly to how we've viewed, um, Zapout, where we need to drive great commercial, um, and overall access for patients for accessibility. But we also recognize that there's significant demand in the consumer segments related to finding ways to, um, get outside some of the frictions in the healthcare system. And so we see both looking at broad coverage, uh, as well as looking at expanding how we do our direct-to-consumer platform and ensuring that every patient has the ability to access, uh, medicines across the portfolio.

Question number of events.

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

A trial in clinical trials to date.

Great. Thanks Julia. Uh next question please Paul.

Dave Ricks: Oh, thank you so much. I know it's Lilly's policy not to.

2027, so it could be earlier than that.

Dan Skovronsky: Comment on interims, but it's also a.

We are pleased though so and I think we can comment on to see momentum and awareness in the space.

Operator: Bit unusual for Lilly to speak.

Dan Skovronsky: About them in some detail.

Operator: and Company has spoken in some detail.

Really evidenced by the enthusiastic enrollment in our <unk> preclinical study as well and as Dan mentioned, we have the opportunity there is to innovate with the sub Q dosing formulation monthly.

Dave Ricks: About the TRAILBLAZER-ALZ 3 interim on both.

Operator: The Q1 2025 and Q4 2024 calls and likely other forms as well. With that said, has the Trailblazer-ALZ 3 interim already been taken? The initiation of remternetug in the same setting would not seem the best sign for donanemab in Alzheimer's prevention. Thank you.

Dosing in Canada fixed duration dosing paradigm. So we continue to innovate in the Alzheimers space and you'll see us continue to commit to that even as we build on the foundation of very strong performance.

The next question will be from Steve Scala from TD County. Steve! Your line is live. Oh, thank you so much. I know it's Lily's policy. Not to comment on interims, but it's also a bit unusual for Lily to speak about them in some detail. And Lily has spoken in some detail about the Trailblazer L3 interim on both the q125 and Q4 24 calls and likely other forms as well. So with that said,

Has the Trailblazer LS3 interim. Already been taken.

Um, the initiation of return the tug in some, in the same setting.

Would not seem the best sign for.

Performance.

A couple of things that we're doing right now to make sure that we're ready for this readout will mention in preclinical because it does require a few fundamental shift.

Anne White: Great.

Mike Czapar: Thank you, Steve, and thanks for the question on Alzheimer's. We'll go to Anne to talk about some of our clinical trials and early Alzheimer's.

It's Anonymous in Alzheimer's, prevention. Thank you.

It requires awareness and education on the importance of treating in that earlier stage of disease and the need to be proactive truly around greenhouse and very importantly requires that all and accessible blood tests to make the diagnosis in the preclinical stage, which is also referred to it.

Anne White: Great. Thanks for the question. Yes, I think we're all looking forward to these results. As you know, we tend not to comment on interims. As we've shared previously, we have completed enrollment in Trailblazer 3. Now it just continues to be a matter of reaching the sufficient number of events. This is an event-based trial. In ClinicalTrials.gov, we list a date, excuse me, of 2027, though it could be earlier than that. We are pleased, and this is what I think we comment on, to see momentum and awareness in the space. I think that was really evidenced by the enthusiastic enrollment in our remternetug preclinical study as well. As Dr. Dan Skovronsky mentioned, what we have the opportunity there is to innovate with a subcutaneous dose formulation as well as a monthly dosing and again in a fixed duration dosing paradigm.

<unk> wanted to so there's quite a bit to do so you'll hear us continue to talk about the readiness that we need to do to get ready for this readout that more to come in the future great.

Great. Thank you and our next question please Paul.

Great. Well, thanks Steve. And thanks for the question on Alzheimer's. We'll go to an to talk about some of our clinical trials and early Alzheimer's. Great. Well, thanks for the question. Yes. I think we're all looking forward to these results. As you know, we tend not to comment on interims as we've shared previously we have completed enrollment in Trailblazer 3. So now it's just continues to be a matter of reaching the sufficient number of events. And this is an event-based trial in clinical trials, that go up, we list a date, excuse me of 2027. So it could be earlier than that.

The next question will be from Mohit Bansal from Wells Fargo Mohit Your line is live.

Great. Thank you very much for taking my question and congrats on all the progress I would love to understand.

So your thoughts around.

Evil trial, and DLP Vips in General partners Atlas disease.

Anne White: We continue to innovate in the Alzheimer's space and you'll see us continue to commit to that even as we build on the foundation of a very strong Kisunla performance. There are a couple things that we're doing right now to make sure that we're ready for this readout. I will mention in preclinical because it does require a few fundamental shifts. It requires awareness and education on the importance of treating in that earlier stage of disease and the need to be proactive really around brain health. Very importantly, it requires a simple and accessible blood test to make the diagnosis in the preclinical space, which is also referred to as stage one and two. There's quite a bit to do. You'll hear us continue to talk about the readiness work that we need to do to get ready for this readout, but more to come in the future.

How do you think about this space evolving and could benefit died.

<unk>.

The ending.

Be a drug for <unk> given that this is new properties. Thank you.

Great. Thanks for the question about <unk> as well as just for hepatitis. So we'll go to Dan to take both of those.

Um, we are pleased though and this is what I think we comment on to see momentum and awareness in the space. I think that was really evidenced by the enthusiastic enrollment in our room turnout pre-clinical study as well. And as Dan mentioned, what we have the opportunity there is to innovate with the subq dosing formulation as well as a monthly, um, dosing in a uh, and again, in a fixed duration, uh, dosing Paradigm. So we continue to innovate in the Alzheimer's space and you'll see us continue to commit to that even as we build on the foundation of a very strong, uh, kasama performance. There's a couple of things that we're doing right now to make sure that we're ready for this readout. I will mention in pre-clinical because it does require a few fundamental shifts. It requires awareness

Yeah. Thanks, Mike obviously, we follow this space closely I think we are leaders in Alzheimer's disease and also leaders in acreage in therapy, you correctly point out that burn appetite as.

And education on the importance of treating in that earlier stage of disease, and the need to be proactive really around Greenhouse.

and very importantly, it requires a simple and accessible blood test to make the diagnosis in the preclinical space which is also referred to as

It got some of the attributes that make us excited about it for use for CNS indications that could be inclusive of Alzheimer's disease, Although we haven't laid.

Anne White: Great.

Mike Czapar: Thank you, Anne. Next question, please.

Stage 1 and 2. So there's quite a bit to do. So you'll hear us continue to talk about the Readiness work that we need to do to get ready for this readout but more to come in the future.

Lucas Montarce: Paul.

Laid out any any plans there yet.

Operator: The next question will be from Mohit Mansal from Wells Fargo. Mohit, your line is live.

Great, thank you. And next question, please Paul.

We're sort of.

On the verge of seeing I believe evoke data that will be very informative.

Patrik Jonsson: Great.

Dan Skovronsky: Thank you very much for taking my question and congrats on all the progress. I would love to understand or think through your thoughts around the EVO trial and GIPs in general for Alzheimer's disease. How do you think about this space evolving, and could brunepatide, the new GLP/GIP, be a drug for Alzheimer's given that this has neural properties? Thank you.

Next question will be from Mohit manal from Wells, Fargo Mohit. Your line is live?

<unk> given our strength in our portfolio almost regardless of that outcome, we have opportunities to build there.

Create something that could potentially be more meaningful for patients. So we will see that and then you can expect us to.

Talk in more detail about our next steps.

Thanks, Dan next question please Paul.

The next question will be from Courtney <unk> from Alliance Bernstein Your line of sight.

Anne White: Great.

Mike Czapar: Thanks, Mohit, for the question about evoke as well as just brunepatide. We'll go to Dr. Dan Skovronsky to take both of those.

And I think, think through your thoughts around evil trial and glp Gip in general, for us disease. Uh, how do you think about this, this space evolving and could, uh, benefited the new glp Gip be an, uh, be a drug for us given that this has neuro properties. Thank you.

Okay. Thank you.

Yeah.

Dan Skovronsky: Yeah, thanks, Mohita. Obviously, we follow the space closely. I think we are leaders in Alzheimer's disease and also leaders in incretin therapy. You correctly point out that brunepatide has got some of the attributes that make us excited about it for use for CNS indications that could be inclusive of Alzheimer's disease. Although we haven't laid out any plans there yet, we're on the verge of seeing, I believe, evoke data that'll be very informative. I think given our strength in our portfolio, almost regardless of that outcome, we have opportunities to build there and create something that could potentially be more meaningful for patients. We'll wait, we'll see that, and then you can expect us to talk in more detail about our next steps.

I wanted to loop back.

Great. Thanks. Mo for the question uh, about it evoke as well as just uh for an appetite. So we'll go to dance and take both of those.

Thanks.

That's perfect. Thanks, Sean.

Seems to be preparing for a very large scale bonds and buyouts observations on the bulk of this is wonderful.

Comments that while we could have enough doses.

<unk> 5 million.

Thanks, Tom.

All right.

I think David mentioned.

Thats all.

Can you help us understand kind of a possible extension.

Paul.

Second we will slow down.

Rooftops.

Hello.

Yes. According I was a little hard to hear but I think some of the questions was it's about thinking about how to expand the market for different indications different opportunities. So we'll go to Ken to talk a bit about some of our ambitions for <unk>.

Good morning. Thanks for the question now with six Phase III studies in hand, I think we really understand the profile of this emerging medicine.

Mike Czapar: Thanks, Dan. Next question, please.

Yeah, thanks Marita. Obviously we we follow the space closely. I think we are leaders in Alzheimer's disease and also leaders in in in in therapy you correctly point out that the ban appetite is. It got some of the attributes that make us excited about it for use for CNS indications, that could be inclusive of Alzheimer's disease, although we haven't laid out any any plans there yet we're sort of, you know, on the, the verge of of seeing I believe Evoque data that'll be very informative. I think given our strength and our portfolio, almost regardless of that outcome, we have opportunities to build there and create something that could potentially be more meaningful for patients. So, we'll wait. We'll see that. And, and then you can expect us to to talk in more detail about our, our next steps.

Operator: Paul, the next question will be from Courtney Breen from AllianceBernstein. Courtney, your line is live.

<unk> continues to recapitulate, the efficacy and safety of Injectables youll be ones in fact and recap some of that during the early part of the call recapping. The 18, two data, which seem very consistent with that too as well as the achieved three data showing superiority versus growth from appetite. So we think this is a great profile youre getting glucose benefits weight benefits improvement.

Thanks Dan next question, please. Paul

Anne White: Hi guys. Thank you so much for taking the question today. I wanted to loop back to orforglipron, which I know lots of focus on. You seem to be preparing for a very large scale launch, and by our calculations, on the basis of some of the comments you've made, you could have enough doses to support at least 5 million patients for a full year based on the inventory already built. I think Dave, you've mentioned kind of this could be the GLP-1 for all. Can you help us understand kind of the potential for expansion to the market with orforglipron, and should we expect to see a slowdown in get down new starts during the initial period of that orforglipron?

The next question will be from Courtney Breen from AllianceBernstein. Courtney, your line is live.

And blood pressure lipids inflammatory markers all that in a simple once daily pill with no restrictions on food water and of course, which we can manufacture and distribute at scale. So we tend to think a different magnitude about the opportunity here than historically, what we've done with <unk> in the United States, There's probably eight or $8 5 million people on acreage.

Instead of maybe $170 million and might benefit and globally. That's a much bigger number probably measured in the hundreds of millions billions. So this is now I think the generational opportunity to figure out how to get an anchor tend to a much larger group of people. We can do that to the simplicity of the profile, which is also easier to manufacture and distribute so really our plan will be.

Hi there. Thank you so much for taking the question today. Um, I wanted to loop back to offer Theron which which I know help you focus on. Um, you seem to be preparing for a very large scale launch. And by our calculations on the basis of some of the comments we've made, you could have enough doses to support at least 5 million patients for a full year based on the inventory already built. Um, and I think Dave you've mentioned kind of this could be the glp 1 for all. Um, can you help us understand? Kind of the potential for expansion for the market with office? And should we expect to see a Slowdown and get down new starts during the initial period of that offer? Look,

Mike Czapar: Yeah, Courtney, it was a little hard to hear, but I think some of the question was about thinking about how to expand the market for orforglipron. Different indications, different opportunities. We'll go to Ken to talk a bit about some of our ambitions for orforglipron.

Kenneth L. Custer: Sure, Courtney, thanks for the question. Now, with six Phase 3 studies in hand, I think we really understand the profile of this emerging medicine. It continues to recapitulate the efficacy and safety of injectable GLP-1s. In fact, Dr. Dan Skovronsky recapped some of that during the early part of the call, recapping the ATTAIN-2 data which seemed very consistent with STEP 2 as well as the ACHIEVE-3 data showing superiority versus oral semaglutide. We think this was a great profile. You're getting glucose benefits, weight benefits, improvements in blood pressure, lipids, inflammatory markers, all that in a simple once-daily pill with no restrictions on food and water. Of course, we can manufacture and distribute at scale. We tend to think at a different magnitude about the opportunity here than historically what we've done with incretins.

Yeah, Courtney, it was a little hard to hear, but I think some of the questions was about thinking about, how, to expand the market for orafo different, uh, indications different opportunities. So, we'll go to Ken to talk a bit about some of our Ambitions for, or forgive Braun.

About accomplishing that and international level getting it out there as quickly as possible of course, we're also developing <unk> in a lot of other settings beyond obesity and diabetes and recap some of those new Nymex.

Announcement of course.

To recap as well, we see an opportunity not just as a starter <unk> year with Oracle the problem, but also something you could potentially be used for patients to continue the success they've had with a drug like <unk> were set boundaries.

Sure uh Courtney thanks for the the question. Um, now with 6, phase 3 studies in hand, I think we really understand the profile of this emerging medicine. Um, it continues to recapitulate the efficacy and safety of injectables UOP. Ones in fact and recap some of that during the early part of the call, should recapping the attaining 2 data which seemed very consistent with step 2 as well as the achieve 3 data showing superiority versus, uh, world smat. So we think this was a great profile. You're getting glucose benefits weight benefits.

Assessing that now and you can't maintain study and look forward to sharing those data later this year great. Thank you Ken Paul We're ready for the next question. Please. The next question will be from SaaS Haidar from Goldman Sachs. Aside your line is live.

Great. Thanks for taking the question and congrats on all the ongoing ongoing progress.

Kenneth L. Custer: In the United States, there's probably 8 or 8.5 million people on incretins out of maybe 170 million who might benefit. Globally, that's a much bigger number, probably measured in the high hundreds of millions or even billions. This is now, I think, the generational opportunity to figure out how to get an incretin to a much larger group of people. We can do that through the simplicity of the profile, which is also easier to manufacture and distribute. Our plan will be about accomplishing that at an international level, getting it out there as quickly as possible. We're also developing orforglipron in a lot of other settings beyond obesity and diabetes. Dr. Dan Skovronsky recapped some of those new NILEX that we've announced.

Sticking with Ophir kept around maybe given its importance just high level question on pricing and volume dynamics ahead of the launch so the cash pay channel is where youre continuing to see the most rapid growth of the obesity market that bond vials on almost 40% of new scripts.

Unrelated on ex U S price elasticity, you saw a shift in volumes in the UK wingman genre prices increase so I guess what are the learnings from this for the <unk> ramp next year as it relates to the elasticity of demand across different price points and I guess my question is specifically related to how youre thinking about U S versus all U S volume unlocks for Altra.

Benefits improvements in blood pressure. Lipids inflammatory markers all that in a simple once daily pill with no restrictions on on food and water and of course, which we can manufacture and distribute, uh, at scale. So we, we tend to think at a different magnitude about the opportunity here than historically what we've done with inerts, you know, in the United States. There's probably 8, or 8 and a half million people on ingrains out of maybe 170 million, who might benefit and globally. That's a much bigger. Number probably measured in the hundreds of millions or even billions. So this is now I think the generational opportunity to figure out how to get anchored in to a much larger group of people we can do that through the Simplicity of the profile, which is also easier to manufacture and distribute. So really our plan will be about

Kenneth L. Custer: Just to recap as well, we see an opportunity not just as a starter incretin here with orforglipron, but also something that could potentially even be used for patients to continue the success they've had with a drug like Wegovy or Zepbound. We're assessing that now in the ATTAIN-MAINTAIN study and look forward to sharing those data later this year.

Ron as launches.

As it launches into one of the potential MFN equilibrium prices. Thank you.

Okay. Thanks, Aside I think we will maybe you will start with Elliott to discuss some of the U S dynamics and then maybe Patrick if you want to add a couple of brief comments about some of the O U S earnings from the UK as well.

Accomplishing that and international level getting it out. There is as quickly as possible. Of course, we're also developing worth of LeBron and a lot of other settings, Beyond, obesity, and diabetes and recap. Some of those new NYX that we've announced and of course just to, to recap as well, we see an opportunity not just as a starter uh anchored in here with local LeBron, but also something you could potentially even

Mike Czapar: Great, thank you Ken. Paul, we're ready for the next question, please.

Yes. Thank you for the question, obviously, we have experienced significant growth overall in the total market. So you've seen sequential growth in the.

Operator: The next question will be from Asad Haider from Goldman Sachs. Asad, your line is live.

Dave Ricks: Great, thanks for taking the question and congrats on all the ongoing progress. Just sticking with orforglipron maybe given its importance. Just high level question on pricing and.

For patients, uh, to continue the success. They've had with the drug lake with Gobi. Where is that found where, uh, assessing that now in the attained maintained study and looking forward to sharing those data later this year? Great. Thank you, Ken Paul. We're ready for the next question, please. The next question will be from Assad Hider from Goldman, Sachs Assad. Your line is live

Covered.

Overall, the sequential growth is 15%, but we are seeing significant more volume go through a direct to consumer platform with really direct.

Dan Skovronsky: Volume dynamics ahead of the launch. The cash pay channel is where.

Dave Ricks: You're continuing to see the most rapid growth in the obesity market.

<unk> says a lot about one what consumers and patients as well as providers see.

Dan Skovronsky: Zepbound 30 mg vials are now almost 40% of new scripts and related on ex-U.S. price elasticity.

<unk> is the benefit of that bound in particular and also the ability to remove some of the friction and the ability to have accessibility to medicine and so we see this channel as a significant channel.

Dave Ricks: You saw a shift in volumes in the UK when Mounjaro prices increased.

Dan Skovronsky: I guess what are the learnings.

Dave Ricks: From this for the orforglipron ramp.

Dan Skovronsky: Next year as it relates to the.

Dave Ricks: Elasticity of demand across different price points.

Dan Skovronsky: My question is specifically.

Dave Ricks: Related to how you're thinking about U.S. versus all U.S. volume unlocks for orforglipron as it launches in a.

Now into the future and then as part of that obviously, having more offerings whether you.

Dan Skovronsky: World of potential MFN equilibrium prices.

Dave Ricks: Thank you.

Include.

Being able to pick up your debt down at a local Walmart, which we announced.

Mike Czapar: Okay, thanks Assad. I think maybe we'll start with Ilya to discuss some of the U.S. dynamics, and then maybe Patrik, if you want to make a couple brief comments about some of the OUS learnings from the UK as well.

Run as it launches, uh, as it launches in a world of potential MFN, equilibrium prices. Thank you.

Yesterday or expanding the offering on having another treatment like <unk>, that's an important element for us to expand the ability for patients to get treated that as the main.

Ilya Yuffa: Yeah, thank you for that question. Obviously we have experienced significant growth overall in the total market, so we've seen even sequential growth in the covered. Overall, the sequential growth is 15% but we're seeing significant more volume go through a direct to consumer platform with Lilly Direct, which says a lot about what consumers and patients as well as providers see as the benefit of Zepbound in particular and also the ability to remove some of the friction and the ability to have accessibility to medicine. We see this channel as a significant channel now and into the future.

Thanks Assad. I think we'll maybe we'll start with iot to discuss some of the US Dynamics and then maybe Patrick if you want to make a couple brief comments about some of the OS learnings from the UK as well.

Goal that we have is to improve overall health outcomes, and we have multiple medicines and different platforms to achieve that.

Patrick maybe just a few additions from <unk> perspective, I think first and foremost in the UK with the raise in price that was effective September 1st I think we've done pretty much what we expected to be.

David will take the UK price they never.

Right to the level of a European price and even if there are regulations in the U K, we actually saw exports of magazines out of UK to other market. So that would probably start with the intervention. We did put in place. Secondly, we're also learning something about consumer pricing elasticity is about <unk>.

Ilya Yuffa: As part of that, obviously having more offerings, whether you include being able to pick up your Zepbound vial at a local Walmart, which we announced yesterday, or expanding the offering on having another treatment like orforglipron, that's an important element for us to expand the ability for patients to get treated. That is the main goal that we have, to improve overall health outcomes, and we have multiple medicines and different platforms to achieve that.

Most importantly, I think of homegrown, we'd meet the slightly different needs of the marketplace. We know that obesity is a heterogeneous disease and for people with a BMI of below 35 million that might not need to wait till <unk>, we believe that it's a significant opportunity.

Yeah, thank you for that question. Obviously, we have the experienced significant growth overall in the total market, so we've seen even sequential growth in the covered. Uh, overall, the sequential growth is 15% but we're seeing significant, uh, more volume go through a director of consumer platform with really direct, which says a lot about. Uh, 1, what consumers, um, and patients, as well as providers, uh, see as the benefit of Zep Bound in particular, and also, uh, the ability to remove some of the friction and the ability to have accessibility, uh, to medicine. And so, we see this channel as, as a significant Channel, um, and now and into the future and then as part of that, obviously, having more offerings, whether you, um include, um, being able to pick up your Zep bound vial at a local Walmart, which we announced, uh, yesterday,

Also driven by the other features of Canada.

The opportunity to scale and reach of our patient populations.

No need.

Day or expanding the offering on having another treatment. Like, or for good fun. That's an important element for us to expand the ability for patients to get treated. That is the main

Duration et cetera, so we see those as being very complementary and the <unk> business setting us with.

Patrik Jonsson: Patrik, maybe just a few additions from an OUS perspective. I think first and foremost in the UK with a raise in price that was effective September 1, I think we learned pretty much what we expected to learn. What we did was just to take the UK price at the level of, rated to the level of a European price. Even if there were regulations in the UK, we actually saw export of medicines out of the UK to other markets. That has probably stopped with the intervention we did put in place. Secondly, we're also learning something about consumer pricing elasticity. That exists. Most importantly, I think orforglipron will meet a slightly different need in the marketplace.

Great. Thank you both the next question please Paul.

goal that we have is to improve overall health outcomes. Then we have multiple medicines and different platforms to achieve that.

Next question will be from Tim Anderson from Bank of America, Tim Your line is live.

Thank you.

Quick question on <unk> pricing.

With novo's, we get an IRR a negotiated price within the next month.

My sense from talking with some industry folks we've got that negotiating price may be more favorable.

The investment community is expecting meaning less degradation to the current net price versus the goods for everyone in the space.

What is Lilly picking up on this and whatever that level of discount ends up being would you agree that it's quite likely.

Patrik Jonsson: We know that obesity is a heterogeneous disease and for people with a BMI below 35 that might not need the weight loss of tirzepatide, we believe that it's a significant opportunity OUS and also driven by the other features that Ken referred to earlier, the opportunity to scale here and to reach other patient populations and with no need of refrigeration, etc. We see those as being very complementary in the OUS business setting as well.

Has a direct impact on pricing <unk> own product from 2000, 2500 or do you think some of the negotiated price just won't translate across.

Okay. Thanks for the question Tim.

We'll go to Eric to talk a bit about some of the broad thinking about semi IRA negotiation technology were not part of the discussion.

Validation from an OS perspective, I think, first and foremost in the UK with a raise in price that was effective September 1st. I think we learned pretty much what we expected to learn. Uh, what we did was just to take the UK prize at the level of rated to the level of a European price. And even if that were regulations in the UK, we actually saw export of medicines out of the UK, to other market. So that is probably stopped with the intervention we did put in place. Secondly, we're also learning something about consumer pricing, elasticity so that exists. But most importantly, I think of ugly Brown will meet a slightly different need of a Marketplace. We know that obesity is a heterogeneous disease and for people with a BMI below 45 and that might not need the weight loss of their hepatite. We believe that is a significant opportunity or us and also driven by the other features that can refer to earlier the opportunity to scale here and to reach other patient populations. And with no need of refrigeration Etc. So uh we see those as being

Sure. Thanks, Tim for the question, obviously, we're we.

Mike Czapar: Great. Thank you both. Next question, please. Paul.

Somebody complimentary in the US business setting as well.

I don't know that.

Operator: Next question will be from Tim Anderson from Bank of America. Tim, your line is live.

They negotiate at the same time there are several things that are important to note one.

Perfect. Thank you. Both the next question, please Paul.

Ilya Yuffa: Thank you. I have a question on GLP-1 pricing. With Novo Nordisk's semaglutide, we get IRA negotiated price within the next month. My sense from talking to some industry folks is that that negotiated price may be more favorable than the investment community is expecting, meaning less degradation to the current net price. That of course would be good for everyone in the space. What is Lilly picking up on this and whatever that level of discount ends up being? Would you agree that it quite likely has a direct impact on pricing of Lilly's own products in 2027? Do you think Novo Nordisk's negotiated price just won't translate across?

Next question will be from Tim Anderson, from Bank of America. Tim, your line is live.

Only applies to semi in part D. Beginning in 2027.

Overall, if you take a look at our volumes Medicare part D is a small proportion of our overall volume obviously.

Predominantly in type two diabetes since theres lack of coverage in obesity.

Probably the most important elements.

To conclude here event tours appetite have demonstrated superior efficacy versus semi in head to head trials.

Which is a strong foundation for any value based discussions that we have with payers.

Only in our data that you see that as well.

Provider preference as well as patient preference that you see in the market Great and then David you want to add a couple of comments.

Mike Czapar: Okay, thanks for the question, Tim. We'll go to Ilya to talk a bit about some of the broad thinking about semi IRA negotiation technology where we're not part of the discussion.

Uh, thank you. Uh, I have a question on Griff 1 pricing, so with, uh, with novo's summer, we get Ira negotiated price within the next month. My sense from talking to some industry, folks, is that, that negotiated price may be more favorable than the investment Community is. Expecting meaning less degradation to the current net price and that of course, would be good for everyone in the space. Uh, what is Lily picking up on this and whatever that level of discount ends up being, would you agree that it quite likely? Uh, has a direct impact on pricing of Lily's own products in 2027? Or do you think some of the negotiated price just won't translate across

Hi, everyone.

Maybe just one thing because we've been talking about our further product in its upcoming launch.

We think about single acting GOP ones, as one category and double and triple acting as others.

Ilya Yuffa: Sure. Thanks, Tim, for the question. Obviously, we don't know the price that's being negotiated. At the same time, there are several things that are important to note. One, that it only applies to FEMA in Part D beginning in 2027. Overall, if you take a look at our volumes, Medicare Part D is a small proportion of our overall volume. Obviously, it's predominantly in type 2 diabetes since there's lack of coverage in obesity. Probably the most important element to include here is that tirzepatide has demonstrated superior efficacy versus FEMA in head-to-head trials, which is a strong foundation for any value-based discussions that we have with payers. Not only in our data, but you see that as well in provider preference as well as patient preference that you see in the market.

Okay. Uh, thanks for the question, Tim. Um, we'll go to talk a bit about some of the broad thinking about the semi Ira negotiations acknowledging. We're not part of the discussion.

Probably both weight loss and clinical value will be quite different between.

These these medicines and of course, we're paying close attention to the semi price, but it is early you said, it's pretty only channels. So.

Sure, thanks Tim for the question. Obviously, we don't know. That price is being negotiated at the same time. There are several things that are important to note: 1. It only applies to semi in our D beginning in 2027.

Let's let it all play out I think we are in a good position because we have so many options.

Great. Thank you both on our next call at ball.

The next question will be from Alex Hammen from Wolfe Research Alex Your line is live.

Thanks for taking the question can you walk us through the importance of the upcoming attain maintain trial to offer to the bronze commercial opportunity and is there an outcome that might meaningfully changed your view on how quickly okay. Great brands launched may scale.

Uh, overall, if you take a look at our, our volumes Medicare Part D is a small proportion of our overall volume, obviously, uh, predominantly in type 2 diabetes. Since there's lack of coverage in obesity, uh, probably the most important element.

uh, to

Transit has demonstrated superior efficacy versus Semma in head-to-head trials.

Great. Thanks, Alex for the question on AR attained maintained we'll go to Ken. Thanks for the question Alex on attain maintain this is it.

Anne White: Great.

Mike Czapar: David, do you want to add a couple comments?

It really first of its kind study and we're looking forward to these data later this year, we took advantage of the opportunity to re randomize patients for this amount five study were maximally tolerated on either magnified or <unk> randomize them to work with <unk> or placebo and were going to measure the percentage of the weight that they lost over the course of 72 weeks that they keep off while taking.

Dave Ricks: I think he covered it well. Maybe just one thing because we've been talking about it before in its upcoming launch. We think about single acting GLP-1s as one category, and double and triple acting as others. Probably both weight loss and clinical value will be quite different between these medicines. Of course, we're paying close attention to the SEMA price, but as Ilya said, it's a Part D only channel. Let's let it all play out. I think we're in a good position because we have so many options.

Which is a strong foundation for any value based, uh, discussions that we have with payers, uh, not only in our data, but you see that as well in, uh, provider preference, as well as patient preference that you see in the market. Great. And then Dave is you want to add a couple comments.

Of course this is a first of its kind study, we don't know exactly what the results will be but we're hopeful that the problem will provide a simple once daily oral option that lets patients keep the majority of the weight off.

So we think this is really an opportunity to expand.

Mike Czapar: Great, thank you both. Next caller, Paul, the next question.

GOP ones as 1 category and double and triple acting as others and probably both weight loss. And clinical value will will be quite different between, uh, these these medicines. And, of course, we're paying close attention to the semi price. But as Ilya said, it's a, it's a party only channel. So let's let it all play out. I think we're in a good position because we have so many options.

The market even further political coupon of course, we have very bullish expectations for it as a first line startup anchor tenant but also this is an opportunity.

Operator: will be from Alex Hammond from Wolfe Research. Alex, your line is live.

Great, thank you. Both the next. Next caller, Paul.

Anne White: Thanks for taking the question. Can you walk us through the importance of the upcoming Attain Maintain trial to orforglipron commercial opportunity, and is there an outcome that might meaningfully change your view on how quickly orforglipron's launch may scale?

The next question will be from Alex Hammond from Wolfe Research. Alex, your line is live.

Need to grow that I don't think as we think about it because we don't think about sort of cannibalization in that way. This is an opportunity to grow the market at a very different right and we think the data from attained maintained could be really exciting boost and allow us to have some medical information.

Thanks for taking the call.

Dave Ricks: Great.

Maintain trial to orphic LeBron's commercial opportunity, and is there an outcome that might meaningfully change your view on how quickly or for LeBron's launch May scale?

Mike Czapar: Thanks, Alex. For the question on Attain Maintain, we'll go to Ken.

To do so many to physicians about how they can help patients switch from drugs like <unk>, but of course, we also know that all.

Anne White: Sure.

Kenneth L. Custer: Thanks for the question, Alex. On Attain Maintain, this is a really first-of-its-kind study and we're looking forward to these data later this year. We took advantage of the opportunity to re-randomize patients from the SURMOUNT-5 study who were maximally tolerated on either semaglutide or tirzepatide. We randomized them to orforglipron or placebo, and we're going to measure the % of the weight that they lost over the course of 72 weeks that they keep off while taking orforglipron. Of course, this is a first-of-its-kind study. We don't know exactly what the results will be, but we're hopeful that orforglipron will provide a simple once-daily oral option that lets patients keep the majority of their weight off. We think this is really an opportunity to expand the market even further for orforglipron.

Management drugs are indicated for maintenance. So these are just to help us.

<unk> patients died between persons.

Thanks, Ken next question. Please the next question will be from <unk> <unk> from Evercore.

<unk> good morning, guys I just wanted to touch upon glib.

Great. Thanks. Alex for the question on attain maintain. We'll go to Ken. Sure, thanks for the question. Alex on attain maintain. Uh, this is a, a really first of its kind study and we're looking forward to these data later. This year, we took advantage of the opportunity to re randomize patients for this amount. 5 study who are maximally tolerated on either smag or tabitite. We randomize them to Orphan or Placebo and we're going to measure the percentage of the weight that they lost over the course of 72 weeks that they keep off.

Lip pricing.

And on the one hand, there's a lot of commentary on.

Some of the expectations, you've laid out an awful glitter on pricing frameworks. If you could expand on that but then also on the other hand, there is a lot of actions and changes that your main competitor over the last few months and I almost wonder do you think they will stay a mature player from a pricing front or would that no longer be a base case for us. Thank you.

Kenneth L. Custer: We have very bullish expectations for it as a first-line starter incretin, but also this is an opportunity to continue to grow. I don't think, as we think about orforglipron, we don't think about sort of cannibalization in that way. This is an opportunity to grow the market at a very different rate, and we think the data from Attain Maintain could be really just an exciting boost and allow us to have some medical information to disseminate to physicians about how they can help patients switch from drugs like Wegovy and Zepbound. We also know that all weight management drugs are, of course, indicated for maintenance. These are just data to help HCPs and patients guide between these medicines.

Great. Thanks, <unk> for the question on the GOP on pricing, maybe we'll hear from Lucas to weigh in on those dynamics.

Thank you for the question Omar maybe just thinking about the pricing dynamics.

When you are trying to unpack, our Q3 or four months.

You'll see that actually that we're pricing continued to our format. What do we expect it right. So I think you said would that are pulling off toward the Cvs move that we didn't see again, a significant price erosion, but actually it was very much in line to what we said early in the year for the full year as well. So maybe just to add a good data point that you can take from that perspective.

Mike Czapar: Excellent. Thanks, Ken. Next question, please.

Or taking or for clip Ron. Of course, this is the first of, its kind study. We don't know exactly what the results will be. Uh, but we're hopeful that orphan, will provide a simple once daily oral option that lets patients keep the majority of their weight off. Um, and so we think this is really an opportunity to expand, uh, the market even further for if a good brand, of course, we have very bullish, uh, expectations for it as a, as a first line starter incretin. But also, this is an opportunity to continue to grow that. I don't think, uh, as we think about our government, we don't think about sort of cannibalization. And that way, this is an opportunity to grow the market at a very different rate. And we think the data from attain maintain could be uh really just an exciting boost and allow us to have some medical information uh to uh disseminate the positions about how they can, how patients switch from uh drugs. Like we go be in depth on, but of course, we also know that all, uh, uh, weight management drugs are are, of course, indicated for maintenance. So these are just dated to help, uh, um, hcps and patients, the guy between these medicines.

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

Excellent. Thanks. Ken next question, please.

Im.

Thinking more broadly about the competition in the marketplace again, we always pay close attention on.

Dave Ricks: Morning guys. I just wanted to touch up on GLP pricing and on the one hand there's a lot of commentary on some of the expectations you've laid out on orforglipron pricing frameworks if you could expand on that. Also, on the other hand there's a lot of actions and changes at your main competitor over the last few months and I almost wonder do you think they will stay a mature player from a pricing front or would that no longer be a base case for us? Thank you.

The next question will be from Ume Refaat from Evercore. Your line is live.

Competition in the marketplace, but also how we differentiate both commercially but also on the label of the product.

Don can mentioning about de differentiation and youll see that in the marketplace, though if you take for example, a good proxy that for me really direct we have been price over the last maybe six months already starting point at 349 going to 499.

Morning guys, I just wanted to touch up on Gip pricing. Um, and on the 1 hand, there's a lot of commentary on. Um, some of the expectations you've laid out on oral giper on pricing Frameworks if you could expand on that. But then also on the other hand there's a lot of actions and changes that your main competitor over the last few months and I almost wonder do you think they will stay a mature player from a pricing front or would that no longer be a base case for us?

Mike Czapar: Great. Thanks, Umar, for the question on GLP-1 pricing. Maybe we'll hear from Lucas to weigh in on those dynamics.

Thank you.

We maintain that price and you see the penetration and the competition is placed at the same level as well. So we don't see materially changing the dynamics that we see from that perspective, as we continue to penetrate the market and mobilize patients to seek more treatment.

Lucas Montarce: Thank you for the question, Umar. Maybe just thinking about the pricing dynamics, when you actually unpack our Q3 performance, you see that actually our pricing continued to perform as we expected. I think it's a good data point after the CVS move that we didn't see a significant price erosion, but actually it was very much in line with what we said early in the year for the full year as well. Maybe just a good data point that you can take from that perspective. Thinking more broadly about the competition in the marketplace, we always pay close attention to the competition in the marketplace, but also how we differentiate both commercially and also on the label of the product. Ilya, Dan, and Ken mentioned the differentiation and you see that in the marketplace.

Great. Thanks, Lucas next question please Paul.

Our next question will be from a cash tomorrow from Jefferies. Your line is live.

Hey, thanks, so much so at the <unk> Summit, Dave You noted if Oracle was priced at $100 a month, there would be no incentive for new medicines in that category to kind of create the next thing a few weeks later in Chicago, you mentioned, how Lilly has already made billions of doses for ortho and it could have an impact on human health at a global level <unk> achieved.

Both goals kind of preserving continuous innovation in obesity, and having orfield via drunk for hundreds of millions of patients with the parity pricing model between the U S and rest of world. Thanks, So much.

Lucas Montarce: If you take, for example, a good proxy that for me is really direct, we have been priced over the last maybe six months already at that starting point at $349, going to $499, maintained that price, and you see the penetration and the competition is placed at the.

Alright, Thanks for cash will go to address those two comments.

Great. Uh, thanks. Numer for the question on. Go on pricing. Maybe we'll hear from Lucas to weigh in on those Dynamics. Yeah. Uh, thank you for the question Omar. Um, maybe just thinking about the the pricing Dynamics, uh, when you actually unpack our Q3 performance, uh, you see that actually our pricing continue to perform as what we expected, right? So I think it's a good data point after the CVS move that we didn't see, again a significant price erosion, but actually was very much in line to what we said early in the year for the full year as well. So, uh, maybe just a good data point that you can take from, from that perspective and, uh, thinking more more broadly about the competition in the marketplace. Again, we, we always pay close attention on, uh, the competition in the marketplace, but also how we differentiate both commercially, but also on the level of the product and Ilya than Ken mentioned it about the differentiation, and you see that in the marketplace, though, if you take, for example, a good proxy. That

Yes, thanks, and thanks for tuning into all my podcasts.

<unk> event.

So yes, our strategy.

Kenneth L. Custer: Same level as well.

To bridge, both we think.

Lucas Montarce: We don't see materially changing the dynamics that we see from that perspective, and as we continue to penetrate the market and mobilize patients to seek more treatment.

Youre pointing out that flatter pricing between the U S. Other developed countries is important but there is like three ways that this works and I think one important thing here that just pointed out on all of these pricing questions. There is.

Mike Czapar: Great. Thanks, Lucas. Next question, please.

For me is really direct. We have been priced over the last, maybe 6 months already at that. Starting point at 349 going to 4.99 and maintain that price and you see the penetration and the competition is placed at the same level as well. So we don't see materially changing the Dynamics that we see from that perspective. And as we continue to penetrate the market and mobilize patients to seek more treatment,

Operator: Paul, the next question will be from Akash Tiwari from Jefferies. Akash, your line is live.

In this GOP one category.

Great. Thanks, Lucas. Next question, please, Paul.

Is the consumer self pay channel, we haven't really seen that scale in other categories and it certainly is a channel here, partly because of under insurance, but partly because the benefits of these medicines manifest so consistently there really aren't that many non responders at all and <unk>.

Dave Ricks: Hey, thanks so much. At the All In Summit, Dave, you noted if orforglipron was priced at $100 a month, there'd be no incentive for new medicines in that category to kind of create the next big thing. A few weeks later in Chicago, you mentioned how Lilly's already made billions of doses for orforglipron and it could have an impact on human health at a global level. Can Lilly achieve both goals of kind of preserving continuous innovation in obesity and having orforglipron be a drug for hundreds of millions of patients with the parity pricing model between the U.S. and rest of the world? Thanks so much.

The next question will be from Akash tari, from Jeffreys cash. Your line is live.

Produce a very desirable short term effect. In addition to enhancing long term health benefits. It really is a unique situation.

So we have seen price elasticity as was mentioned and that is.

Mike Czapar: All right, thanks, Akash. We'll go to Dave to address those two comments.

On the one hand enter in our interest to offer consumers a compelling price that where they can afford to self pay. It's also in our interest to continue to build out indications for chronic diseases, Ken and Dan we're outlining earlier.

Hey, thanks so much. So at the all-in summit, Dave, you noted if orpah was priced at a hundred dollars a month, they'd be no incentive for new medicines in that category uh to kind of create the next big thing. Um, a few weeks later in Chicago, you mentioned how Lily's already made billions of doses for Oro? And it could have an impact on human health at a global level can Lily achieve both goals of kind of preserving continuous innovation in obesity. And having Oro, be a drug for hundreds of millions of patients with the parody pricing model between the US and Russia World. Thanks so much.

Dave Ricks: Yeah, thanks. Thanks for tuning in to all my podcasts and public events. Our strategy is to bridge both. We think, as you're pointing out, that flatter pricing between the U.S. and other developed countries is important, but there are like three ways that this works. I think one important thing here to point out on all these pricing questions that is different in this GLP-1 category is the consumer self-pay channel. We haven't really seen that scale in other categories, and it certainly is a channel here, partly because of underinsurance but partly because the benefits of these medicines manifest so consistently. There really aren't that many non-responders at all, and they produce a very desirable short-term effect in addition to enhancing long-term health benefits. It really is a unique situation.

All right, thanks. Ah, we'll go to Dave, to to address those 2 comments.

And we are committed to doing both having a strong consumer offering but also.

Moving the health benefit and that should not compete for consumer dollars, but for but for health care dollars either government or from private payers. So it's a both end and I do think these can bridge because we have so much evidence coming of long term benefit we should compete with other classes of medicines.

In chronic diseases or even create whole new classes.

And at the same time, we will probably continue to see consumer self pay demand whether it be for prevention or there are other other needs. So I think it's entirely possible to do both and I think Ken mentioned earlier some of the numbers that we are literally just scratching the surface of global treatment here and there is there's really is.

Dave Ricks: We have seen price elasticity, as was mentioned, and it's on the one hand in our interest to offer consumers a compelling price where they can afford to self-pay. It's also in our interest to continue to build out indications for chronic disease, as Ken and Dan were outlining earlier. We are committed to doing both, having a strong consumer offering but also proving the health benefit. That should not compete for consumer dollars but for healthcare dollars, either government or from private payers. It's a both-and, and I do think these can bridge because we have so much evidence coming of long-term benefit. We should compete with other classes of medicines in chronic diseases or even create whole new classes. At the same time, we'll probably continue to see consumer self-pay demand, whether it be for prevention or there are other needs.

Yeah, thanks and thanks for tuning in to all my podcasts and, uh, public events. Um, so, uh, I mean, yes, our strategy is to is to bridge both. We think, um, as you're pointing out that flatter pricing between the Us and other developed countries is important, but there's like 3 ways that this works. And I think 1 important thing here that just to point out on all these pricing questions that is different in this GOP. 1 category is the consumer self-pay Channel. We haven't really seen that a scale in other categories. And it certainly is a channel here, partly, because of, under insurance, but partly because the benefits of these medicines manifest so consistently, there really aren't that many non-responders at all and, um, produce a very desirable short-term effect. In addition, to enhancing long-term health benefits, it really is a unique situation.

Ah.

Tremendous opportunity to reach.

Tens or even hundreds of millions of more people in the coming years and that's our goal.

Great. Thanks, Dave <unk> squeeze in at least one more quick one.

Okay. The next question is coming from and some <unk> from BMO capital markets. Your line is live.

Hi, guys. Thank you so much for taking my question. Dan You recently commented that you were Super excited about your medical Alzheimers program. Appreciate that you want to comment on an interim look but could you expand on what drives the two and how it has changed since we initiated the program.

So we have seen price elasticity as was mentioned and that it's, um, on the 1 hand inter in our interest to offer consumers a compelling price that where they can afford to self-pay. It's also in our interest to continue to build out indications for chronic disease as can and Dan were outlining earlier and we are uh committed to doing both having a a strong consumer offering but also proving the health benefits and that should not compete for Consumer dollars. But for but for healthcare dollars, either government or uh, from private

Okay, great a double back on the recent fact cymer. So we'll go to.

And talk a bit about that.

Good fit.

Okay.

Sorry, sorry.

Can you go ahead.

Okay. Thanks, Kevin.

Dave Ricks: I think it's entirely possible to do both. I think Ken mentioned earlier some of the numbers. We are literally just scratching the surface of global treatment here. There really is a tremendous opportunity to reach tens or even hundreds of millions of more people in the coming years, and that's our goal.

I apologize I didn't say Super excited on this call I am still super excited about.

Alzheimer's opportunity here to treat in the preclinical space the reasons for my excitement go back to the data that we saw.

Actually and Trailblazer, one in tripoli's or two and both of those trials were rooting symptomatic patients we saw the largest treatment effect.

<unk>.

Mike Czapar: Great, thanks Dave.

Patients who were the earliest in their disease course, whether you measured early in disease course by symptoms or pathology et.

Payers. So um it's a both and and I do think these can Bridge because we have so much evidence coming of long-term benefit. We should compete with other classes of medicines and chronic diseases or even create whole new classes and at the same time we'll probably continue to see consumer self-paid demand, whether it be for prevention or there are other other needs. So I think it's entirely possible to do both and I think Ken mentioned earlier some of the numbers we are literally just scratching the surface of global treatment here and there's a there's really is a a a a tremendous opportunity to reach uh tens or even hundreds of millions of more people in the coming years. And that that's our goal.

Lucas Montarce: Paul.

Mike Czapar: We'll try to squeeze in at least one more quick one.

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

Great. Thanks Dave. Uh Paul will try to squeeze in at least 1 more quick 1

Et cetera.

That's where the drug had the biggest effect and in fact, we looked at prevention of progression as an outcome in that trial and those patients really profound results I actually expect the same in trailblazer, three as well as trail runner three which is the trial with.

Dave Ricks: Hi guys. Thank you so much for taking my question. Dan, you recently commented that you were super excited about your presymptomatic Alzheimer's program. Appreciate that you want to comment on an interim look, but could you expand on what drives this view and how it has changed since the initiation of the program?

Okay, the next question is coming from Ederman from Bingo Capital Markets. Evan, your line is live.

<unk>. So I remain extremely excited no change here at all to my level of enthusiasm or confidence success.

Hi guys, thank you so much for taking my question. Then you recently commented that you were super excited. About your presymptomatic Alzheimer's program, appreciate it. I want to comment on an interim look. But if you expand on what drives this to you and how it has changed, since the initiation of the program,

Mike Czapar: Okay, great. Double back on the presymptomatics of Alzheimer's. We'll go to Anne to talk.

Lucas Montarce: A bit about that.

Anne White: Yeah, thanks.

Okay. Uh great. A double back on the back. So we'll go to um to and talk a bit about that.

Great. Thanks with that we will close the Q&A and Dan go Dave for you for a couple of closing remarks.

Yeah, well, thanks for your interest.

Dan Skovronsky: Sorry Anne, you take it. Apologies.

Anne White: No, please Dan, you go ahead.

Hey, Thanks, Mike.

Dan Skovronsky: Okay, thanks. Evan, I apologize I didn't say super excited on this call. I'm still super excited about the Alzheimer's opportunity here to treat in the preclinical space. The reasons for my excitement go back to the data that we saw actually in Trailblazer 1 and Trailblazer 2. In both of those trials where we were treating symptomatic patients, we saw the largest treatment effect on patients who were the earliest in their disease course. Whether you measured early in disease course by symptoms or pathology, et cetera, that's where the drug had the biggest effect. In fact, we looked at prevention of progression as an outcome in that trial. In those patients, we had really profound results. I actually expect the same in Trailblazer 3 as well as Trailrunner 3, which is the trial with remternetug. I remain extremely extreme.

Sorry, sorry, I need you to take it apologies. No, no, please can you go ahead?

Everyone, who called in today and for the excellent questions from the sell side community.

We appreciate everyones participation here and as always follow up with our excellent IR team. If you have questions that didn't get answered today and have a great rest of your day take care.

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

This conference will be made available for replay beginning at one P. M. Today running through December 4th at Midnight, you May access the replay system at anytime by dialing 803, three to six to 854 and entering the access code 787 three to seven.

Okay, yeah, thanks Evan. I apologize. I didn't say super excited on this call. I'm still super excited about the Alzheimer's opportunity here to treat in the pre-clinical space. The, the reasons for my excitement, go back to the data that we saw, um, actually in trouble. These are 1 in troubles, are 2 in both of those trials where we're treating symptomatic patients, we saw the largest treatment effect on, um,

International Dialers can call nine 735, 280005 again those numbers are 833 to 6854 and 90 735280005 with the access code 790 $732 seven.

Dan Skovronsky: No change here at all to my level of enthusiasm or confidence and success.

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

Patients, who were the earliest in their disease course? Whether you me measured early in the disease course by symptoms or pathology Etc. That's where the, the drug had the biggest effect and in fact, we looked at prevention of progression as an outcome in that trial and and those patients we had really profound results. I actually expect the same in in Trailblazer 3, as well as Trail Runner, 3, which is the trial with um uh, REM Tara tug. So it I I remain extremely excited that no change here.

At all.

Mike Czapar: Great, thanks. With that, we'll close the Q&A. Dan, Dave, to you for a couple of closing remarks.

To enthusiasm or confidence success.

Dave Ricks: Hey, thanks Mike. Thanks to everyone who called in today and for the excellent questions from the Sell side community. We appreciate everyone's participation here. As always, follow up with our excellent IR team if you have questions that didn't get answered today. Have a great rest of your day. Take care.

Great, thanks. Uh, with that. We'll close the Q&A and Dan go, Dave, to you for a couple closing remarks.

Hey, thanks, Mike, and, uh, thanks to everyone who called in today. And, uh, for the excellent questions from the Southside community. We appreciate everyone's participation here, and as always, follow up with our excellent IR team if you have questions that didn't get answered today. Have a great rest of your day. Take care.

Operator: Thank you. Ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1:00 P.M. today, running through December 4 at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 797327. International dialers can call 973-528-0005. Again, those numbers are 800-332-6854 and 973-528-0005 with the access code 797327. Thank you for your participation. You may now disconnect your lines.

Thank you. And ladies and gentlemen, this is conclude or conference for today.

797,327, thank you for your participation. You may now disconnect your lines.