Eli Lilly and Company Q4 2024 Earnings Call Transcript

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q4 twenty twenty four Earnings Call. At this time, all participants are in a listen only mode. Later, we will be conducting a question and answer session and instructions will be given at that time. I would now like to turn the conference over to your host, Mike Zappar, Senior Vice President of Investor Relations. Mike, please go ahead.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Good morning. Thank you for joining us for Eli Lilly and Company's Q4 twenty twenty four earnings call. I'm Mike Sabar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO Doctor. Dan Skrovansky, Chief Scientific Officer and President of Lilly Immunology Lucas Montarce, Chief Financial Officer Anne White, President of Lilly Neuroscience W.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

UFA, President of Lilly International Jake Van Naarden, President of Lilly Oncology and Patrick Johnson, President of Lilly Cardio Metabolic Health and Lilly USA. We're also joined by Mark Heeman, Wes Tall and Wei Huang of

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

the Investor Relations team.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

During the 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 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.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

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

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

the call over to Dave.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Okay. Thanks, Mike. Twenty twenty four was a productive year for Lilly. We grew our top line, advanced our pipeline and invested in our supply chain to meet the increasing demand for our medicines. Most importantly, we delivered for patients by bringing life changing medicines to more people around the world.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

In 2024, full year revenue grew 32% compared to 2023, exceeding our first time guidance by $4,000,000,000 Revenue grew 45% in the most recent quarter as our recently launched products gained momentum. Last year, we announced positive Phase three results for Imlumestrant, insulin elsotora alpha and three additional tirzepatide trials. We also started Phase three programs for lepidisiran, pramternatug and olimaracib based on positive earlier phase data. We continued to complement our pipeline through acquisitions and collaborations. We acquired Morphix Therapeutics and announced a collaboration with OpenAI to invent novel antimicrobials.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

We opened the Lilly Seaport Innovation Center in Boston as a hub for Lilly's genetic medicines efforts and announced a new Lilly Gateway Lab in The UK to collaborate with European research. We advanced our manufacturing agenda, announcing investments to expand our footprint in Indiana, in Wisconsin and in Ireland. Since 2020, our commitments to build, expand and acquire manufacturing facilities now total more than $23,000,000,000 Importantly, we brought innovative new medicines to patients. In 2024, we received regulatory approvals for Kysunla, Eglis and a new indication for ZEP bound in OSA. This progress strengthens our portfolio of new products and enhances our capacity to drive top tier growth and margin expansion.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

As you can see on Slide five, we continue to make progress against our strategic deliverables in Q4. Revenue grew 45% in our new products growing by more than $3,100,000,000 led by a strong uptake of Monjaro and Zepbound. Q4 also saw solid performance across oncology, immunology and neuroscience. Our business excluding Engraton's grew by 20% in the quarter compared to Q4 twenty twenty three, excluding the one time benefits of business development. Since our last earnings call, we achieved several key pipeline milestones.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

We received approval for a new indication of ZEPOUND and Ombo. We submitted Imblumestrant for metastatic breast cancer and tirzepatide for heart failure. We also announced positive Phase III results in the SURMOUNT5 study, where ZEPTOUND demonstrated a 47% greater relative weight loss compared to Wegovy. We strengthened our overall supply position and delivered on our production target to make 1.5 times the saleable doses of INKRA to medicines in the second half of twenty twenty four compared to the second half of twenty twenty three. With more patients using Lilly Direct, the uptake of single use outbound vials increased.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

We had no wholesaler backorders as we closed 2024

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

and

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

wholesalers have been fulfilling orders from pharmacies at very high levels. We continue to augment our internal pipeline with external innovation, announcing plans to acquire Scorpion Therapeutics' mutant selective PI3KA inhibitor program. This transaction will add a clinical stage breast cancer asset to our oncology pipeline. And lastly, we returned $3,000,000,000 to shareholders via dividends and share repurchases. In addition to that, we announced at the end of the year a $15,000,000,000 share repurchase program and the seventh consecutive 15% increase in our quarterly dividend.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

On slide six, you'll see

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

a full list of key events

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

to our Q3 call including the milestones I mentioned here and several other updates. Now, I'd like to turn the call over to Lucas to review our Q4 and 2024 full year results and provide details on the 2025 guidance. Thanks, Dave.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Slide seven summarizes our financial performance in the fourth quarter and Slide eight for the full year. As Dave mentioned, our revenue grew 45% in Q4, primarily driven by Monjaro and Zepa. Performance of our non increasing portfolio was also strong as revenue grew 20% excluding one time payments related to business development. Gross margin as a percentage of revenue increased to 83.2% in Q4, primarily impacted by favorable product mix. R and D expenses increased 18% from continued investment in our early and late state portfolio.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

In total, we started eight new Phase III programs in 2024 and advanced several new assets into the clinic. Marketing, selling and administrative expenses increased 26%, mainly driven by promotional efforts to support ongoing and future launches. This includes U. S. Direct to consumer advertising on Sefana and Moncharo and U.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

S. Launch activities for Quesanla and Netlist. We also increased our commercial investment outside The U. S. To support international launches of Moncharo.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Operating income more than doubled increasing to $5,600,000,000 driven by higher revenue from new products. The effective tax rate was 13.2%. We delivered earnings per share of $5.32 inclusive of $0.19 of acquired IP R and D charges. This compares to $2.49 in Q4 twenty twenty three that includes $0.62 of acquired IP R and D. On Slide nine, we quantify the effect of price, rate and volume on revenue growth.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

U. S. Revenue increased 40% in Q4, driven by robust volume growth of 45%. Ceva and Moncharo were again the largest growth contributors, partially offset by declines in Trulicity. Realized prices decreased 5% in The U.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

S. Due to favorable changes to estimate for rebates and discounts related to Moncharo in Q4 twenty twenty three. Europe revenue grew 82% in constant currency. We continue to be pleased with the uptake of Monjaro and have now launched in all major European markets. In addition to growth from Moncharo, European revenue benefited from one time payment associated with the amendment of our alliance with Boehringer Ingothem.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

This was recorded in Jardiance revenue in Q4. Excluding this one time payment, Europe revenue grew 61%. Japan revenue grew 27% in constant currency. Volume growth was driven by Monjaro, Ombo, Jardiance and Bersenio. In China, revenue increased 13% in constant currency.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Private and Bersenio drove volume growth. Monjaro was recently made available in China and will proceed with a limited launch as supply becomes available. We expect modest initial Monjaro sales in China due to supply limitations, a more meaningful contribution in the second half of twenty twenty five. Revenue in the rest of the world grew 46% in constant currency, driven by volume growth of Moncharo and Bersenia. Slide 10 provides an update on our performance of new and growth products.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

New products more than doubled in Q4 to $5,600,000,000 led by global Moncharos sales of $3,500,000,000 and U. S. CEPAN sales of $1,900,000,000 U. S. CEPAN performance is going very well.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

We began promotional activities this quarter and we continue to see a strong uptake. In Q4, Sepan became the market leader in the anti obesity market as measured by new prescriptions. As shown in ILN 11, we combined U. S. Increase in analog market grew 45% compared to Q4 twenty twenty three.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

We increased three percentage points in share of market in Q4 twenty twenty four. Jipercap worldwide revenue was $114,000,000 adding another solid quarter of sequential revenue growth. Worldwide onboard revenue increased to $57,000,000 With the recent FDA approval in Crohn's disease, we look to drive broader use in an additional patient population. The KYSANDA launch is progressing well and prescriptions in The U. S.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Have been steadily increasing. While it is early, we saw positive momentum across key indications key indicators including volume of diagnostic ordered, access in priority integrated health systems, coverage by Medicare and commercial plans and number of infusion sites placing orders. We are encouraged by the launch of EPLIS in The U. S. We saw early positive receptivity and high levels of physician engagement.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

In addition, we expect commercial access with two of the largest pharma benefit managers beginning in March. We now plan an accelerating investment in commercial activities to drive new patient start. Growth products also performed well as revenue increased by 13% compared to Q4 twenty twenty three. Fresenius growth trajectory continued as U. S.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Total prescription grew by 15%. In addition to strong execution in the early breast cancer indication, Resenio revenue benefited from increased U. S. Wholesalers target at year end. Worldwide Trulicity revenue declined 25%, driven by Monjaro switches and to a lesser extent lower realized prices.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

On Slide 12, we provide an update on capital allocation. Moving to Slide thirteen and fourteen, I will discuss our 2025 financial guidance. As previously shared, we expect 2025 revenue to be between $58,000,000,000 and $61,000,000,000 The midpoint represents approximately 32% growth compared to 2024. We anticipate continued U. S.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Increasing class growth, consistent with the trajectory of total prescriptions seen in 2024. We expect to launch Moncharo in new markets outside The U. S. And Europe throughout the year. Monchar international revenue will contribute to overall performance more significantly in the second part of twenty twenty five.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Given the uptake of newer ingredients, we expect Trulicity volume to continue declining as fewer new patients are starting on Trulicity. We expect oncology, neuroscience and immunology to also grow revenue in 2025 as Epsilis, TIPIRCA, Onbone, Kysandra launch updates continue. At the portfolio level, we anticipate foreign exchange to be a headwind as the dollar has strengthened relative to other currencies. In addition, we forecast overall net prices to decline by mid to high single digits in percentage terms, including U. S.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Part D changes. We continue expanding our manufacturing capacity and estimate to produce 1.6 times the amount of increase in saleable doses during the first half of twenty twenty five compared to the first half of twenty twenty four. Our facility in Concord is anticipated to begin shipping medicines this year and we plan to make continued progress on expanding our manufacturing network. Our expected ratio of gross margin less OpEx divided by revenue is expected to be between 41.543.5%. At the midpoint, this reflects approximately three forty basis points of margin expansion compared to 2024.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

In SG and A, we will continue to invest behind our new launches including direct to consumer efforts in The U. S. To drive new patient activation. In addition, we plan to increase investment outside The U. S.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

To support the launches of Monjaro in new and existing markets. In R and D, we plan to accelerate our investment in early and late phase activities. As Dan will share later, we started eight new Phase three programs in 2024 and anticipate that investment in those programs will run as the studies enroll patients. We also plan to initiate new Phase three programs in 2025. While we keep a high bar for what we advance into clinic dial development, we expect to scale our investment in R and D this year.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Other expenses is expected to be $600,000,000 to 700,000,000 driven by interest expense. We estimate our effective tax rate to be approximately 16%. Earnings per share or EPS is expected to be $22.5 and $24 on a non GAAP basis. This doesn't include a forecast for charges related to IP R and D. Now I will turn the call over to Dan to highlight our progress in R and D and to provide an overview of potential key events we in 2025.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Thanks, Lucas. Lilly R and D had another productive quarter. I'll cover pipeline progress in Q4, then the 2024 key events and finally provide potential key events for 2025. Since our last earnings call, two new indications were approved in The U. S, ZEPOUND for obstructive sleep apnea in adults with obesity and AMBO for moderate to severe Crohn's disease.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Both approvals are important milestones and mark an expansion in the number of patients who can benefit from each of these medicines. Moving to regulatory submissions, we completed submissions in The U. S. And EU for tirzepatide for heart failure and global submissions for imelinesterin for metastatic breast cancer and for J. Perka with the Bruin CLL321 data.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

I'm also pleased to share that we've submitted an update to the Kisonla U. S. Label to include the dosing modification data from Treblazer AL6 and the FDA has granted the submission a priority review. In our Phase three portfolio, we initiated a new program for orforglyphron in obstructive sleep apnea. This program includes two studies under the same master protocol to evaluate if people with obstructive sleep apnea and obesity can benefit from orforglyphron.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

After Zephon was approved in The U. S. As the first and only prescription medicine for obstructive sleep apnea, we're excited to explore if an oral GLP-one can also deliver a benefit in this disease. Earlier in the pipeline, we advanced a second oral GLP-one into Phase two in obesity and advanced eltrecovart into Phase two for ulcerative colitis. Three Phase II assets and one Phase I asset have been discontinued based on clinical readouts.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

In Q4, we also began Phase I studies for four new molecules, one in each of our therapeutic areas. Q4 capped off a productive year of advancing new medicines at Lilly. In total over the year, we started eight new Phase III programs. We disclosed Phase III data from 21 trials, including 17 major publications and top tier medical journals. We received regulatory approvals for two new medicines, at Gleeson Kasimla, as well as many new indications around the world.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

And we added 14 new programs to the early phase pipeline. On Slide 16, we detail these outcomes for our twenty twenty four milestones. I'm pleased that nearly all of our anticipated milestones came to fruition positively in 2024. Turning our focus to 2025, Slide 17 shows key R and D milestones we expect this year. Starting with our late stage portfolio, we expect to initiate two new Phase III programs this year.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

First, in oncology, we'll begin an adjuvant non small cell lung cancer Phase three program for our KRAS G12C inhibitor, olamiracib, building on its ability to be administered with immunotherapy. Our current metastatic program is progressing well and we've aligned with the FDA on our Phase three dose through the Project Optimus pathway. We shared a clinical update at the World Conference on Lung Cancer last fall and we are encouraged by the ability to safely combine olamoracit with other agents. Our new Phase three program will focus on moving to an earlier setting and combining with existing approved agents in both resectable and unresectable KRAS G12C mutant lung cancer to prevent cancer from recurring. The second program is in cardiometabolic health, where we plan to initiate a Phase three trial for orforgliploprot in hypertension, adding to the ongoing trials in Type two diabetes, obesity and obstructive sleep apnea.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

I'm excited that this year we're looking forward to reading out multiple orphaned Lipron trials. We expect to see data from up to five studies in Type two diabetes and two studies in obesity. Our goal is to generate efficacy, safety and tolerability profile that is similar to that of an injectable single acting GLP-one, but through an orally available medicine. The first orforgliopram Phase three trial to read out will be ACHIEVE-one, which is a forty week study in patients with Type two diabetes. These patients have a baseline hemoglobin A1c between 79.5% and a body mass index of 23% or greater.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

The trial utilizes six escalating doses in four week increments to a maximum dose of thirty six milligrams. Based on prior studies of oforgliperone as well as other GLP-one therapies, we expect weight loss in people with diabetes to be significantly less than in people living with obesity who do not have diabetes. We anticipate ACHIEF one will read out in Q2 this year, followed by up to four additional Type two diabetes trials in the second half of twenty twenty five and a potential submission for this indication in 2026. The orforglyphron Phase three trials in people with obesity, ATHAINE one and ATHAINE two are expected to read out in Q3 of this year. These trials will form the basis of our first orforglipron regulatory submissions, which will be for the treatment of obesity and we expect to occur late in 2025.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

This year, we also expect data from the tirzepatide cardiovascular outcome study surpass CBOT. Of course, this is an event based trial and the timeline is dependent on the accrual of cardiovascular events. We anticipate data in Q3. While designed to measure both non inferiority and superiority compared to Trulicity, a positive outcome in either would demonstrate that tirzepatide reduces the risk of cardiovascular outcomes and would support a labeled indication. Late this year, we expect to see the first data from our triple acting incretin, redetrutide, which combines GLP-one, GIP and glucagon.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

We believe this potential new medicine can deliver even more weight loss than tirzepatide and could potentially provide additional health benefits. The initial study to read out TRYMP4 is a sixty eight week study in patients with osteoarthritis of the need who have a body mass index of twenty seven or greater. We'll also see multiple additional JPRCAD data sets this year. Physician feedback is very positive on experience with JPRCA in the currently approved indications and we hope that generating data in earlier lines of therapy will enable broader use within CLL and MCL. We could see data from additional trials in the first line or BTK naive settings this year.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Moving to neurodegeneration, while we don't have a key event listed in 2025 for taneumab, we're closely watching the preclinical Alzheimer's disease study TRAILBLAZER ALS3. This trial screened patients with a blood based diagnostic and utilized a fixed duration of treatment with thanenimab. By moving earlier in disease progression, the goal is to reduce the risks of developing any symptoms of Alzheimer's disease. While the current primary completion is projected for 2027, the study will read out when the target number of progression events are accrued. A new focus area first in 2025 will be to study potential new applications of Inpritin biology across diseases in neuroscience and immunology.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

With a pipeline of InkerTins in clinical development and deep scientific expertise in this space, Lilly is well positioned to match the biologic properties of specific molecules to the desired indications being studied. We plan to start several clinical trials assessing potential benefits of our incretins in areas that could include brain health, substance use disorder, pain, neuropsychiatry and inflammation. We'll be prepared to move rapidly into Phase three trials based on clinical data and where our conviction is high. Lastly, we expect a number of important regulatory submissions in 2025, including oforgliperone for obesity as I detailed, insulin epsitaur alpha for type two diabetes, tirzepatide for cardiovascular outcomes and multiple potential datasets for JAY PIRCA. Twenty twenty five will be another exciting year for Lilly R and D.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

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

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Yes. Thanks, Dan. So we had a strong financial performance in Q4 and throughout 2024. We finished $4,000,000,000 above our first time revenue guide and $4 per share above our first time EPS guide when taking our PR and D charges into account. The incremental market continues to grow rapidly and Manjaro and ZepBound are both gaining share of market.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

We believe both products are still very early in their launch cycle. In addition, our oncology, immunology and neuroscience therapeutic areas continue to progress, launching new medicines and delivering strong revenue growth. We have an exciting outlook for growth in 2025 as well. New indications, new manufacturing capacities, new access opportunities and new markets are all tailwinds to our financial performance. We made significant advances across our pipeline in 2024 and have several exciting readouts, which Dan just highlighted, expected throughout 2025.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

So now let me turn the call over to Mike to moderate our Q and A session.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thanks, Dave. We'd like to take questions from as many callers as possible and conclude our call on time. So to that end, consistent with prior quarters, we will respond to one question per caller and we'll end at 11AM. If you have more than one question, you may reenter the queue and we will get to your question if time allows. Paul, please provide the instructions for the Q and A and we're ready to take the first caller.

Operator

Thank you. At this time, we'll be conducting a question and answer session. And the first question today is coming from Tim Anderson from Bank of America. Tim, your line is live.

Tim Anderson
Tim Anderson
Managing Director, Senior Equity Research Analyst at Bank of America

Thanks so much. Just a question on the guidance, the 2025 guidance. So I think everyone knows the prescription uptake trend didn't show acceleration, hasn't shown it yet. That's been viewed by some as a concern. Does the twenty twenty five guidance require acceleration?

Tim Anderson
Tim Anderson
Managing Director, Senior Equity Research Analyst at Bank of America

Or can you get their scripts just continue on the same trajectory and the slope of that line doesn't change? When I do back of the envelope math, it seems like that's frankly all that needs to occur. And one of your slides suggests that might be the right way to think about it as well. But can you just confirm?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks Tim for the question. We'll go to Lucas to talk about the guidance assumptions.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Yes. What you mentioned in my notes that what we expect to see, Tim, is a continuation of basically the total prescription growth that we have seen in 2024. So that's what we built in our 2025 guide for the market.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Next question please.

Operator

The next question is coming from Terence Flynn from Morgan Stanley. Terence, your line is live.

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Great. Thanks so much. I was just wondering if you could maybe elaborate on your expectations for ZepBound payer dynamics and access this year, particularly the impact from the OSA label? I know you've also filed for heart failure and how you expect that to play out over the course of the year? And then anything on next steps on the compounding litigation that we should be focused on?

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Dangerously close to a two part question there, Terrence. But we'll go to Patrick's talk about access and then come back to Dave to make a quick comment about compounding.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

Thank you very much. When we look at the commercial access, it remains strong with 87% coverage in the commercial space still. And of course, the employer opt in is a second step of high importance. That made progress in 2024, and we expect in terms of employer opt in that we're north of 50% today. OSA remains an opportunity for us to gain access also in the Medicare segment, And CMS confirmed recently that they will reimburse OSA if Plan D plans decides to list it.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

And they have one hundred and eighty days to make that decision from the FDA approval and we're working with plans right now. And we anticipate to get some Medicare coverage by the second half of this year. And similarly, OSA is also an opportunity for us to get more Medicaid states signed in. We expect that PIF when and if approved to have a similar role as OSA, an access opportunity, particularly in Medicare and Medicaid.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Yes. So regarding compounding, I think our position has been pretty clear. We've been in supply since August and FDA took us off the list formally later in Q4. Of course, the compounding associations are suing to delay that. We oppose that and then join that suit.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

I think the next day coming up is February 18, where the FDA said that's when you need to stop one form of compounding. Our position has been clear all along. We don't think there's a place for this because we have full supply and there's no reason to have non approved, kind of illegitimate product out there. So, of course, new sheriff in town, new government and court case pending. So we don't know the outcome of all that.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

But that all said, I mean, I think our business is growing nicely in Q4 and we can see that prescription trends early this year. It's just an unsafe practice that shouldn't exist and long term probably isn't great for innovators. So, we'd like to move on from this and hope that's what the courts and the government decide to do.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, David Vacher. Next caller please.

Operator

The next question is coming from Courtney Breen from Bernstein. Courtney, your line is live.

Courtney Breen
Senior Research Analyst at Bernstein

Hi everyone. Thanks for taking the call today. I just wanted to zoom in to offiglipron, specifically and I think you made took the chance to make the point about diabetes and diabetes population and their weight loss. Can you just talk a little bit more about kind of the potential positioning particularly in the context of kind of that single injectable GLP Q1 kind of anticipated efficacy that you're guiding to?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Courtney. We'll go to Dan to talk about the right comparable to lebron.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Yes, sure. I'll start on the efficacy expectations and then maybe Patrick can talk about the market positioning here. So you're right, it's a single GLP-one and we take pains to mention that because we're not expecting the kinds of efficacy or tolerability actually that we see with tirzepatide, which is a dual acting agent. Still, as you know, monotherapy with GLP-one has provided important benefits to many patients, and so we're setting our sights there. This is a first study in Type II diabetes patients where, as I noted, weight loss is typically quite a bit lower than you see in people without type two diabetes.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

So we sort of index on the efficacy that we've seen in the past with Ozempic and we'll get that data soon and excited to see it. Patrick?

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

And from a positioning perspective, we like the idea of having an oral with an injectable GLP-one like efficacy and there is a big portion of patients that actually have needed for your exatimetry review as to be twenty percent to twenty five percent and also a group of patients that doesn't necessarily need the amount of weight loss or HbA1c reduction as tirzepatide generates. That might be an opportunity in the maintenance space as well. But lastly and very importantly, it's an opportunity to scale in markets outside The U. S. Taking into account that we don't have a need for refrigeration.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Patrick and Dan. Next caller, please.

Operator

The next question is coming from Chris Schott from JPMorgan. Chris, your line is live.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Great. Thanks so much. Just another orforglopram question. You've now launched a pretty wide range of studies, I guess, to say hypertension beyond the initial obesity and Type two diabetes studies. Can you just elaborate a little bit more on what gives you confidence in running such a wide range of programs without having seen those initial readouts, particularly maybe some of the tolerability profiles with the drugs titration, etcetera?

Chris Schott
Chris Schott
Managing Director at JP Morgan

I'm just trying to think how you balance kind of the risk taking there with the confidence in the asset you have right now? Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Chris. I'm going to answer that question.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Yes. Thanks, Chris. It's a smart question. Of course, going into Phase III with any drug, particularly a small molecule such as orforgliperone, the biggest risk is safety. And I think as these trials proceed, even though we're not seeing the safety data, we grow more confident in the overall safety profile of the drug because trials continue uninterrupted.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Of course, we won't know for sure until we get that first data readout and then subsequent data readouts. But it's correct that we grow more and more confident in the success of this molecule as each day passes. As for specifics around tolerability and titration and discontinuation, those don't really factor into our thinking. We haven't had a look at unblinded data for any of those things. So we can't make assumptions on that yet.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Dan. Next question please.

Operator

The next question will be from Geoff Meacham from Citibank. Geoff, your line is live.

Geoff Meacham
Geoff Meacham
Managing Director at Citi

Hey, guys. Thanks for taking the question. Just had one on commercial tirzepatide in bigger settings like diabetes prevention or if the surpassed CVOT is successful, would these be a tipping point on broader reimbursement or excess? I mean, it's clear you have a benefit there, but I wasn't sure if commercial payers or Medicare are looking for yet even more data to support kind of risk benefit. Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Jeff. We'll go to Patrick to talk about the broader landscape there.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

Thank you very much, Jeff. I think, yes, the somewhat one extension is definitely defined as game changing at the provider level and we are in discussions of both with regulatory agencies, but there is no precedent for a Type two prevention as an indication. But the data itself, I think we will utilize to really drive increased employer opt in, seeing the benefits of outcome studies and treatment of people with pre diabetes and obesity.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Maybe just a broader point, which we've said before, Jeff. I think a lot of investors are looking for some single event that will trigger the broad reimbursement or not. And I don't think we've ever really thought of it that way, but rather an accumulation and sort of weight of everything that will grow reimbursement steadily over time. And I think that's actually what we've seen since we launched that bound last year. U.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

S. Commercial insurance picking up several points during the year, and even ex U. S. Now with UK reimbursement, etcetera. But different payers will make different decisions at different times.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

And I think the data sets you mentioned will be some of the more compelling to create moves, but still then the way affordability and budget constraints, etcetera. That all said, by the time we get to the end of the decade, it's hard to imagine we are not using obesity medications to prevent what is the precursor condition to so many chronic diseases. And already the health economics are pretty compelling and there'll be more data coming beyond that. So long term, we remain really, really bullish on this whole category being reimbursed like we expect to reimburse all other medications. Just the schedule for that is going to be more slow and steady, I would say, as you model expectations on a global scale and in The U.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

S. As well because the diversity of

Operator

question will be from Seamus Fernandez from Guggenheim Securities. Seamus, your line is live.

Colleen Garvey
Vice President - Equity Research at Guggenheim Partners

Hi. This is Colleen on for Seamus. Thanks for taking our question. We just wanted to ask on the sustainability of operating margin expansions. Looking at some of the longer term forecasting from sell side consensus, we're seeing estimates nearing 50% by the end of the decade.

Colleen Garvey
Vice President - Equity Research at Guggenheim Partners

Do you view this as realistic? Or how are you thinking about the balance between the margins and then also ensuring you're not underinvestigating on the pipeline?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks for the question, Kalia. I'll go to Lucas to talk about the

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

long term operating margin philosophy. Well, we are very pleased with the results that we've seen in 2024 and Q4 and we provided a guidance for 2025 that is a continuation of that margin expansion with I mentioned three forty basis points expansion in 2025. Thinking more long term, our view is how we continue to drive growth in a sustainable manner. And in order to do so, we believe that if we invest into the business, in particular in R and D to drive that innovation and growth into the future is critical success factor for our business. So from that perspective, we mentioned before that we believe that getting into high 40s or 50% is not actually a good way to drive that sustainable growth into the future.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

So what we are seeing now on that low 40s is in particular at this time, the right basically balance that we have in terms of investment into the business and also the returns that we generate as well.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks Lucas. Next question please.

Operator

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

Conor MacKay
Conor MacKay
Equity Research Senior Associate at BMO Capital Markets

Hi, there. This is Connor McKay on for Evan. Thanks for taking our question. Given some of the slower launches we've seen from peers in the Alzheimer space, can you maybe talk a bit about the lessons you've taken from those? And then as well as sort of your experience early days in the Kysumla launch?

Conor MacKay
Conor MacKay
Equity Research Senior Associate at BMO Capital Markets

Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Connor, for the question. We'll go to Anne to talk about Kysumla.

Anne White
Anne White
EVP & President of Lilly Neuroscience at Eli Lilly

Well, Thanks so much for the question about Kysumla. I'll tell you, we are pleased with our momentum so far. What our system our team is focused on really is system readiness and growth. That's still a significant area of opportunity in the space. So we're partnering with healthcare providers to scale and reach more patients.

Anne White
Anne White
EVP & President of Lilly Neuroscience at Eli Lilly

As far as how it's going so far, Lucas mentioned key indicators that we're watching. To date, we've achieved P and T approvals of over 80% in our key accounts. We have over 800 prescribers. And then an important leading indicator is the diagnostics front, and those results also continue to be encouraging. Aimovid use is more than doubling in the last year and the use of blood diagnostics grows significantly each month as well.

Anne White
Anne White
EVP & President of Lilly Neuroscience at Eli Lilly

The true challenge here is the systems health care systems readiness and I think most critically the capacity to detect and diagnose patients. And so we have a number of solutions that we're working on with the health care providers to help them increase that capacity, increase the throughput for patients, a lot of educational series as well on how to quickly diagnose and treat these patients. Importantly, I think we're hearing a lot of enthusiasm about the profile of Ksenla, and that actually helps with these capacity constraints. The once monthly infusions, the ability to stop dosing once the plaque cleared, all of those positions I've told us are going to help with some of these capacity constraints. So it's been a strong start so far.

Anne White
Anne White
EVP & President of Lilly Neuroscience at Eli Lilly

We definitely learned lessons from the the first launch that went out there and applying that learning to what we're doing now. But it's been really positive so far in the terms of the level of support and collaboration that Lilly has been able to bring with her expertise in the field and our long relationships with these customers.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks Anne. Next question please.

Operator

The next question will be from Umer Raffat from Evercore. Umer, your line is live.

Umer Raffat
Analyst at Evercore

Hi guys. Thanks for taking my question. It's certainly very encouraging to see the range of new Phase III trials being initiated with orforgliplon in the past few months. But there's one trial in particular I noticed has not been initiated or may not be in the plans, which is an outcomes trial. I'm just curious what's the thought process behind that?

Umer Raffat
Analyst at Evercore

Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Umer, for the question. We'll go to Dan to talk about the oral development plan.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Yes. Thanks, Umer. Of course, we're trying to cover a broad landscape of indications here that we think would be important and fit with the advantages an oral medication has sort of primary care, broad use kinds of applications being prioritized. The outcome setting is an interesting idea. The challenges here in maintaining patients on placebo make it more and more difficult to do those kinds of studies in The U.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

S, But it's certainly an idea that we're exploring around the world and have more thinking to come in the future.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thank you, Dan. Next question please.

Operator

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

Steve Scala
Pharmaceutical Analyst at TD Cowen

Thank you so much. I apologize in advance for this question. But over the past six to nine months, there has been a consistent cadence of data points questioning the size of the addressable and accessible obesity market, none of which are news, but include slowing prescription trends, Lilly meeting demand at least a year early, Lilly instituting DTC and extending co pay cards despite struggling to meet demand, Lilly launching in OUS markets despite struggling to meet U. S. Demand and significant stocking fluctuations and challenges and guiding.

Steve Scala
Pharmaceutical Analyst at TD Cowen

So taken collectively, these points are concerning. I think you will say that they all relate to the unprecedented size of the market and meeting its demand. But can you state that there has not been any conversations within Lilly questioning whether we are all significantly over our skis on this market and that the manufacturing build out may simply be too aggressive? Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Steve, thanks for the apology and the question. I'll go to Dave for that one.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Yes. Steve, I think

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

you've been calling into our calls for for most of my career. I've never had the apology upfront, so I appreciate that. I know why you're asking it. And I think the perspective we have is that it's early days on a very, very large opportunity. There's turbulence, I'll own that.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

We always seek to put projections out that we can hit with confidence, but that are also within the range of possibilities. And in the back half of that year, last year, we fell short of that. But everything we've said is true and we continue to believe it. That this is a market with hundreds of millions of people globally, that there is a unique thing here in that we can both prevent a large portion of chronic disease with obesity drugs. And last year, we saw proof points on that from Lilly and our competitor.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

That's not just weight loss, it translates into chronic disease outcomes. You'll hear and see more of that. And people love taking these drugs. We know that because when we run out, which we did last year, they get very angry with us. And so I have been a person who represents to the Board the CapEx decisions, I have zero doubt that we have still more building to do and that the capacity we put in the ground so far is not sufficient to meet global demand.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

You'll hear more about that from us. Of course, as highlighting on this call, we're getting close to, I think, a relief valve on that, which is the idea that you can have an oral, which is scalable in a way that injectable systems just aren't. Really test the question legitimately, what is the edge of the demand curve? But we don't think we're close to it right now. We're still gating promotion and gating launches globally.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

That's a different thing. And we're building facilities as fast as we can to match up those two things, what we can make and what we can sell. And although we're supplying The U. S. Market well right now, we'll need to do more, and I'm pretty confident in that.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

So hopefully that gives you some color on the mindset here and wouldn't over read the turbulence and prediction challenges we have. But long term, we're very bullish and you'll see us act according to that belief.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thank you, Dave. Next question, please.

Operator

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

Mohit Bansal
Mohit Bansal
Analyst at Wells Fargo

Great. Thank you very much for taking my question. And I have a question regarding sleep apnea. Now that you have sleep apnea on ZEP on label, how have the discussions with the prescribers as well as payers have gone so far? The one pushback we hear is that these patients are often treated by sleep specialist and there is general shortage of those specialists here.

Mohit Bansal
Mohit Bansal
Analyst at Wells Fargo

So could you talk a little bit about the call points and then how you're thinking about this?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Mohit. We'll go to Patrick for the question on sleep apnea. What the discussions are like with some of the prescribers and the initial experience so far.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

Thank you very much, Mohit. Yes, you're correct. It's the first pharmacological treatment ever approved for obstructive sleep apnea. There is a lot of lifting on our side and we will approach that as we are approaching any new disease area, partnering with advocacy organization, healthcare providers and massive efforts in terms of medical education. We expect this to go beyond the sleep specialist, but of course, we are starting our efforts with the sleep specialist community.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

And I think that's been very well received so far. And we are meeting with them regularly, conducting speakers trainings, but with the aim to move to primary care, which is a necessity. Cosmetis is also a patient population, but to a large extent remains undiagnosed. So primary care effort is going to be required.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thank you, Patrick. Next caller, please.

Operator

The next question will be from Dave Reisinger from Leerink Partners. Dave, your line is live.

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Thanks very much. So my, Ingleton related questions have been asked. I wanted to just pivot to the long acting relaxant candidate, folin relaxant. And so the company had advanced it into a CKD trial in the fourth quarter, but then recently canceled both the heart failure and CKD programs. Dan, I'm hoping you could provide some more color on what drove the action, plus how you now view the long acting relaxant mechanism, including potential for future development in other cardiopulmonary diseases?

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Thanks very much.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Dave. We'll go to Dan to talk about the VULNRELAXIN program.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Thank you. I was disappointed with the results from the Phase II trial for sure. The RALAXIN is an interesting mechanism, I think sort of validated by normal human physiology during pregnancy. But unfortunately, the results that we got in this trial didn't support proceeding with this molecule. I read that as speaking to the mechanism, but rather than the molecule.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

But I know others are pursuing this mechanism and I wish some success where we didn't have it. So we'll have to wait and see.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thank you, Dan. Next question, please.

Operator

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

Akash Tewari
Akash Tewari
Managing Director at Jefferies

Thanks so much. So at JPMorgan, your team mentioned you expect GLP-one pricing to be relatively stable in 2025. Are you implying that while you'll give additional discounts to the channel to improve access that will be offset by improved adherence or is it more Lilly's reached a steady state on discounts at least until semaglutide gets put under IRA negotiation in 2026? Thanks.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

All right. Thanks, Akash. We'll go to Lucas to talk about GLP-one pricing trends.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

Thanks for the question. In terms of the pricing trends that I alluded to in the JPMorgan conference and getting into 2025, first we talk about the Q4 and into 2025, what we mentioned basically is a continuation of the trends. Remember that we had in the base period in 2023, an uncovered copy that basically created quite a lot of noise on the year on year comparison. So we talk about basically adjusting by that. There's still single digit erosion on our pricing trends and that is same trends that I alluded that will continue into 2025.

Lucas Montarce
Lucas Montarce
Executive VP & CFO at Eli Lilly

In terms of some of the dynamics on the access side, I don't know if you want to comment anything, Patrick, on your side?

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

I think we have really good access on the Mondiarra side, over 90% in commercial and party, and I've already covered the commercial space for a set down. We expect access to continue to improve in 2025 as well. In terms of adherence, I think we just need to reflect on the dynamics that we have experienced in this market, partly due to supply constraints, but we are encouraged with what we see on Mondjaro for patients that started in Q2 twenty twenty three. We actually see a longer adherence with Monjaro than we do with both Trulicity and Endozempic. And as Dave referred earlier in terms of set bound, we expect adherence to be long here based upon the first time experience that consumers have.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thank you, Patrick. Thank you, Lucas. Next caller, please.

Operator

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

Alexandria Hammond
Director, Head of Therapeutics at Wolfe Research LLC

Thanks for taking the question. With the Row partnership, how does Lilly envision this relationship evolving? And a follow-up, can you help frame the opportunity associated with zepbound vials? And how is that expected to shift over time?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Alex. We'll go to Patrick to talk about ZEP bound vials and RAL.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

Yes. We

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

launched the SafePay system with Lilly Direct back in late August and we are pleased with the performance so far. In terms of TRx for ZEP bound, it's still low to mid single digit. But in terms of new therapy starts, it's actually in the low teens, so very good start. The partnership with Ro is not a financial or a marketing partnership at all. It's just the opportunity for eligible patients to have the option of using the Ro platform to purchase FDA approved authentic medicines.

Patrik Jonsson
Patrik Jonsson
EVP & President - Lilly Cardiometabolic Health & Lilly USA at Eli Lilly

And it's really about connecting our software to really direct self pay pharmacy. We will lean into additional partnerships along those lines with partners that really want to ensure that the patients get access to authentic and FDA approved medicines.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thank you, Patrick. Next caller, please.

Operator

The next question will be from Chris Shibutani from Goldman Sachs. Chris, your line is live. Chris, please go ahead with your question. Your line is live.

Chris Shibutani
Chris Shibutani
Analyst at Goldman Sachs

Apologies, I was on mute. For the Orford Lipron launch, you previously stated that you're doing manufacturing scale up to be prepared for a full launch at potential approval. What is embedded in that assumption? Can you talk a little bit about the approach for timing of orthogliptron in terms of diabetes versus obesity? Will it be simultaneous or one before the other?

Chris Shibutani
Chris Shibutani
Analyst at Goldman Sachs

U. S. Versus international, we certainly saw the injectable business do a prioritized U. S. Launch.

Chris Shibutani
Chris Shibutani
Analyst at Goldman Sachs

And then should we also expect the similar kind of new product launch cadence with patient assistance programs and the implementation of channel tools like Lilly Direct, should all those be at the outset? Thanks.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thanks, Chris, for the very detailed question. We'll go to Dave to talk a bit about the ORFO launch prep.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Okay. Waiting for all allowance at some point. Yes, look, the goal here with Orpho because it's using the production systems that are available to us, it's a long cycle of processing to get commercial product, but it's very predictable and we have access to those platforms inside and outside the company. So we are building for a full launch in the normal pharma sense. And here pointing out maybe the flip of the earlier question about demand, we have had to gate all these things to make sure we carefully match supply and demand for the injectables as our competitor.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

We do not plan for that with Orifor. So we will plan to launch or submit and have approvals and then launch in a full sense including activities you're used to seeing for primary care products like sampling, co pay, full formulary access and globalization of orforglutron, as rapidly as possible. And we're building capacities to do that, and hopefully that will begin in early twenty twenty six. I think as Dan mentioned, the first complete package for submission in The U. S.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Will be obesity. But we expect diabetes to shortly follow within these other indications that have been discussed today. Hope

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

that answers the question.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Okay. Thanks, Dave. Next question please.

Operator

The next question will be from James Hsin from Deutsche Bank. James, your line is live.

James Shin
James Shin
Director of Biopharma Equity Research at Deutsche Bank

Thank you. Good morning. Thanks for the question. Another one for Dan on orforglepon. Appreciate the earlier comments on indexing orforglepon's efficacy to Sema and the Phase III titration schedule.

James Shin
James Shin
Director of Biopharma Equity Research at Deutsche Bank

Sorry, excuse me. Can you go over how this titration schedule may impact the Phase two weight loss A1C and safety results published in Lancet and Newland Journal? Thank you.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks James for the question. We'll go to Dan to talk more about ORFO.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Yes. It's a good question, James, and reminiscent of the theme we had when the tirzepatide trials were going. It was a similar transition from a faster titration in Phase II to a more gradual titration in Phase III. I think that strategy served as well in the case of tirzepatide. I'm hopeful for the same kind of outcomes in orprogliperone, which is to say that it mitigated tolerability concerns.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

So the GI side effects that are just known to this class seem to be significantly mitigated by slower titration. And in longer studies, and the first study the readout is not the longest study we have here, in longer studies, we were still able to obtain the sort of plateau kind of efficacy that we expect for the mechanism. So that's what we're hoping for or for a better tolerability and similar efficacy as Phase two.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thank you, Dan. Next question, please.

Operator

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

Trung Huynh
Trung Huynh
Analyst at UBS Group

Hi guys. Thanks for taking my question. So for the first Ortho study on diabetes, thank you so much for the level set there. I have a similar question on retitude side. We noticed in your slides there was a Phase three readout in obesity and overweight patients with osteoarthritis of the knee as a potential event for '25.

Trung Huynh
Trung Huynh
Analyst at UBS Group

So one of the primary endpoints is weight loss. Could that be a reasonable comp for the obesity studies in 2026 unlike what you flagged with ortho and diabetes?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thanks for the question, Tran. We'll go to Dan to talk about Renata Group side.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Yes. I'm glad you asked the question. It's a super smart question. You're probably noticing that the JASTER Auspater's trial is shorter than any of the other ones. We've commented before that bradatrutide is going to need the longer trials.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Most of ours are eighty week plus trials to reach maximum efficacy. This is a sixty eight week trial. I think we also know at least by analogy from the semi trials that looked at osteoarthritis and obesity versus a more pure obesity population that even for similarly like studies, there's a demulation of efficacy in terms of weight loss in the OA population for a number of reasons, including different baseline demographics, male, female, BMI, etcetera. So I think we know how to extrapolate out from the OA population to the general population, but I don't think you should take the OA population as a point estimate for what will be achieved in a broader obesity population. We should do quite a bit better than that.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thanks, Dan. Next question, please.

Operator

The next question will be from Kripa Devarakhanda from Truist Securities. Kripa, your line is live.

Kripa Devarakonda
Kripa Devarakonda
Vice President - Equity Research at Truist Securities

Great. Thanks for taking our question. This is Nicole on for Kripa. Can we see some bema data this year? And do you still see some benefit with a muscle preserving drug?

Kripa Devarakonda
Kripa Devarakonda
Vice President - Equity Research at Truist Securities

The recent data from Veera showed preservation of lean mass, but no incremental weight loss. So bema, do you expect incremental weight loss or weight neutral, but better body composition? Is that what you're looking for?

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Thanks for the question. We'll go to Dan to talk a bit about how we're thinking about the BIMA data.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

Yes. Thanks for good question on bimacramab. I think our thesis here has been in combination with tirzepatide that we could get incremental weight loss or perhaps a similar weight loss. But as you point out with the preservation of what we call lean muscle mass, I think to really show a benefit for combining the two drugs, we're probably going to either need to see the incremental weight loss or we're going to need to see some real functional benefits to lean mass preservation. I think just lean mass on its own, we don't really know how to understand that and we previously noted that we don't see any signs that lean mass changes on tirzepatide or to my knowledge on any incretin are actually adverse in any way.

Daniel Skovronsky
Daniel Skovronsky
EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology at Eli Lilly

On the other hand, growing muscle could be a positive in different ways. So we're looking for new positive effects with bimagrime. The beginning of your question, I realize I didn't come to, which is when do we see the previous Phase two study, which was completed. We haven't been clear on exactly when we'll show that data, but this year is a safe assumption.

Michael Czapar
Michael Czapar
Vice President of Investor Relations at Eli Lilly

Great. Thank you, Dan. I think we have time for one last question.

Operator

The final question today will be a follow-up from Dave Risinger from Leerink Partners. Dave, your line is live.

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Yes, thanks very much. I was just hoping you could clarify the comment earlier. I think there was a comment about additional PBM coverage coming in March. I didn't quite catch that. If you could just provide some more color and quantify the potential impact on the opportunity for script trends following that occurring?

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Thank you.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

Let me cover that and then I'll just close. I think, Dave, that was referred to EMBLIS, which is very new in cycle and we do expect two of the three PBMs to cover it and that gets us excited about activating consumers and raising awareness for that brand. ZEPAD and Montreal have full PPM coverage already. So great, let's conclude it there. Thanks for dialing in everyone and your interest in today's earnings call and of course in everything about Eli Lilly and Company.

David Ricks
David Ricks
Chairman, CEO & President at Eli Lilly

If you've got follow-up questions or things we didn't cover in enough detail today in the Q and A, please follow-up with the IR team. Mike Spar will leave that now and everyone have a great day.

Operator

Thank you. And ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at 1PM today running through March 13 at midnight. You may access the replay system at any time by dialing (800) 332-6854 and and (973) 528-0005 with the access code 443262. Thank you for your participation.

Operator

You may now disconnect your lines.

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Executives
    • David Ricks
      David Ricks
      Chairman, CEO & President
    • Daniel Skovronsky
      Daniel Skovronsky
      EVP, Chief Scientific Officer and President of Lilly Research Laboratories & Lilly immunology
    • Anne White
      Anne White
      EVP & President of Lilly Neuroscience
Analysts
Earnings Conference Call
Eli Lilly and Company Q4 2024
00:00 / 00:00

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