Eli Lilly and Company - Q2 2024

Transcript

Operator (participant)

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q2 2024 Earnings Call. At this time, all participants are on a listen-only mode. Later, we will be conducting a question and answer session, and instructions will be given at that time. Should you request assistance during the call, please press star, then zero, and an operator will assist you offline. I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Paul, and good morning, everyone. Thanks for joining us for Eli Lilly and Company's Q2 2024 Earnings call. I'm Joe Fletcher, Senior Vice President of Investor Relations, and joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Dr. Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology, Gordon Brooks, Interim Chief Financial Officer, Anne White, President of Lilly Neuroscience, Ilya Yuffa, President of Lilly International, Jake Van Naarden, President of Lilly Oncology, and Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA. And we're also joined by Michaela Irons, Mike Sprengnether, and Lauren Zierke of the IR team. During this conference 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.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

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

David Ricks (CEO)

Thanks, Joe. It's an exciting time here at Lilly as our growth trajectory accelerated in the second quarter. Our investments in advancing innovative medicines and our focus on manufacturing expansion are bringing Lilly medicines to more people around the world. On Slide 5, you can see details of the financial performance in the second quarter and progress related to our strategic deliverables. Revenue grew 36% in Q2, with our new products growing nearly $3.5 billion compared to the same period last year. U.S. demand for Mounjaro and Zepbound is strong and growing as access and supply continue to expand. While weekly prescription volume was volatile in the first half of the year due to challenges fulfilling high demand, our progress on supply gives us confidence in our outlook. Q2 saw impressive performance across other areas of the business as well.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

Excluding the sale of the rights to Baqsimi last year, non-incretin growth was 17% worldwide, with growth spread across geographies, including 25% growth in the United States. Our $3 billion increase in revenue guidance reflects our expectation that momentum will accelerate through the balance of the year. We achieved several key pipeline milestones, including the approval of Kisunla, the brand name for donanemab in the US for the treatment of Alzheimer's disease, the approval of Jaypirca in Japan for people with relapse or refractory mantle cell lymphoma who are resistant or intolerant to other BTK inhibitors, the submission of tirzepatide in the US and the EU for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, and the positive top-line results from the SUMMIT phase III trial evaluating tirzepatide in adults with heart failure with preserved ejection fraction and obesity.

Lilly now has a significant opportunity to create new medicines through a broad internal portfolio and active business development to support our long-term growth. In obesity, our strategy is to comprehensively address this global public health crisis, pursuing opportunities against every rational mechanism, indication, and dosage form. We are investing broadly in this disease and now have 11 new molecules currently in the clinic across multiple indications. We're also investing in a wide range of late-stage Phase III programs. We recently shared the positive data of tirzepatide in OSA and HFpEF. Orforglipron, our oral GLP-1 small molecule, has a comprehensive Phase III program underway in diabetes and obesity, with nine trials currently running and readout starting mid-next year.

With retatrutide, our GIP, GLP-1 glucagon tri-agonist, we have initiated a broad phase III development program studying the molecule in obesity, OSA, osteoarthritis, cardiovascular, and renal outcomes, as well as type 2 diabetes. These readouts start in 2026. A top priority remains executing on our ambitious manufacturing expansion agenda. In May, we announced plans to invest an additional $5.3 billion in our Lebanon, Indiana, manufacturing site, bringing our total investment there to $9 billion. We believe this is the largest single investment in synthetic medicine active pharmaceutical ingredient manufacturing in the history of the United States. Importantly, this expansion will enhance capacity to manufacture active pharmaceutical ingredients for Zepbound and Mounjaro. Since 2020, we have committed more than $18 billion to build, upgrade, or acquire facilities in the US and Europe, and we've begun to see the benefit of these investments.

We are making near-term progress to ramp production, including at new sites like Research Triangle Park, existing Lilly sites, and at contract manufacturing organizations. Our Concord, North Carolina, site is progressing well. We're in the process of running validation and expect this facility will initiate production by the end of 2024, with product available to ship in 2025. We also continue to make progress on different presentations for tirzepatide.... We've now launched our multi-dose KwikPen in multiple markets outside the U.S., with positive early indicators of patient adoption. And in Gordon's remarks, he will preview our plans to launch vials here in the U.S. Lastly, in terms of external innovation, in July, we announced a definitive agreement to acquire Morphic, a biopharma company developing oral integrin therapies for treatment of serious chronic diseases, including a phase II asset being evaluated in inflammatory bowel disease.

On Slide 6, you'll see a list of key events since our Q1 call, including the milestones I mentioned earlier and several other important updates. As we announced in June, Anat Ashkenazi resigned as Lilly's Chief Financial Officer to become the CFO of Alphabet. We wish Anat well in her new role and thank her for her partnership and leadership of our financial organization over the last 3 years. We have named Gordon Brooks interim CFO, as an internal and external search for Anat's successor is currently underway. Gordon has been with the company for 29 years and also serves as our controller and the leader of the corporate strategy group for the company. In other leadership news, Alonzo Weems, our Executive Vice President of Enterprise Risk Management and our Chief Ethics and Compliance Officer, will retire at the end of the year after 27 years of service.

David Ricks (CEO)

Melissa Seymour has joined the company as Executive Vice President of Global Quality and a member of the company's executive committee, following Johna Norton's recent retirement. I want to thank Alonzo for his many years of service and welcome Melissa to the Lilly team. Now let me turn the call over to Gordon to review our Q2 financial results.

Gordon Brooks (Interim CFO)

Thanks, Dave. So I'm on Slide 7, which summarizes the financial performance in the second quarter of 2024. Second quarter revenue growth of 36% was primarily driven by Mounjaro and Zepbound, as well as Verzenio. When excluding revenue from the sale of rights to Baqsimi, in Q2 of last year, revenue grew 46%. Gross margins as a percent of revenue increased from 79.8% in Q2 of 2023, to 82% in Q2 of 2024. Gross margin in the quarter benefited from favorable product mix and higher realized prices, partially offset by higher production costs. R&D expenses increased 15%, driven by a continued investment in our portfolio and in our people. Marketing, selling, and administrative expenses increased 10%, primarily driven by promotional efforts associated with ongoing and future launches, as well as investment in our people.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

Operating income increased 90% in Q2, driven by higher revenue from new products, partially offset by operating expense growth. The effective tax rate on a non-GAAP basis was 16.5% in Q2 of 2024, compared with 16.1% in Q2 of 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rates reflected the impact of earnings from the sale of rights for Baqsimi. At the bottom line, we delivered earnings per share of $3.92 in Q2, an 86% increase compared to the prior year. Q2 2024 results include the negative impact of $0.14 from acquired IPR&D charges, compared to $0.09 in the prior quarter, Q2 of 2023. On Slide 9, we quantify the effects of price, rate, and volume on revenue growth.

US revenue increased 42% in Q2. Volume growth of 27% was driven by Zepbound, Mounjaro, and Verzenio, partially offset by the sale of rights for Baqsimi in Q2 of 2023 and declines in Trulicity. Realized prices increased 15%, largely driven by Mounjaro access and savings card dynamics. As noted in our Q1 2024 earnings call, unprecedented demand for our incretin medicines led to wholesaler back orders at the end of Q1. In Q2, we fulfilled the majority of these back orders, improving wholesaler stocking levels. We estimate that US Mounjaro and Zepbound aggregate sales in the second quarter were positively impacted by channel stocking, that we estimate totaled high teens to mid-twenties as a % of US sales, as we rebuilt inventory from extremely low levels in the spring and to account for the growth of these brands.

We are pleased that the improved supply situation is reflected on the FDA shortage website, which currently shows all doses of Mounjaro and Zepbound listed as available, and the two lower doses of Trulicity listed as available. While wholesaler back orders in the US have been reduced substantially, it's important to note that the pharmaceutical supply chain is complex, more so for medicines that require refrigeration and offer several different doses. These factors may continue to result in variability in the patient experience at the pharmacy counter. While supply and demand have come into better balance, we expect increases in demand may result in periodic supply tightness for certain presentations and dose levels. We have a continued broad agenda to further increase supply, and we'll continue to look at all options.

Today, we are excited to announce plans to further expand access for Zepbound with the launch of the 2.5 milligram and 5 milligram single-dose vials in the coming weeks, with more details to come at that time. In Europe, revenue grew 20% in constant currency, primarily driven by Mounjaro launch uptake in the UK and Germany. We also had strong volume growth from Verzenio and Jardiance, which was partially offset by decreased volume from Trulicity. Japan performance was strong in the second quarter, with 15% revenue growth in constant currency. Volume growth of 21% was driven by uptake of Mounjaro and Verzenio. Moving to China, Q2 revenue increased 1% in constant currency. Growth was driven by Tyvyt, Olumiant, and Taltz, partially offset by Trulicity and Cialis. Mounjaro was recently approved in China for type 2 diabetes and chronic weight management.

We have not yet announced expected launch timing in this market. Revenue in Rest of World increased 61% in constant currency, primarily driven by Mounjaro volume growth from demand and channel dynamics. Slide 10 provides additional perspective on performance across our product categories. Verzenio had solid growth in the second quarter across major geographies, with worldwide sales increasing 44%, driven by the early breast cancer indication. Jaypirca revenue increased to $92 million worldwide, which included a $19 million partner milestone payment related to Japan. Jaypirca continued impressive quarter-over-quarter growth, building on the brand's uptake from both the MCL and CLL patient populations. Omvoh was launched in the U.S. and 14 international markets, with sales of $26 million in Q2.

These launches continue to progress well with increasing patient starts, and in the U.S., we expect sales to accelerate as the product-specific J-Code went live on July 1. Mounjaro sales in Q2 were $3.1 billion globally, with $2.4 billion in the U.S. Revenue growth in the U.S. reflected continued strong demand, as well as the improved channel dynamics discussed earlier. We're seeing solid uptake of Mounjaro outside the U.S., with sales in Q2 totaling $677 million. In the first half of the year, we launched the QuickPen presentation in the U.K., Germany, and the UAE. So far in Q3, we've also launched Mounjaro QuickPen in Spain and plan to launch in additional markets throughout 2024. In Q2, worldwide Trulicity revenue declined 31%.

U.S. Trulicity revenue decreased 36%, driven by lower volume, primarily due to competitive dynamics and supply constraints, partially offset by improved wholesaler stocking levels on certain doses. Turning to Slide 11, we have an update on the U.S. launch of Zepbound. We've seen exceptional growth trends for Zepbound that have accelerated as production has ramped, leading to sales of over $1.2 billion in Q2. We are rapidly building out formulary coverage for Zepbound in the U.S., and as of July the first, had approximately 86% access in the commercial segment. We estimate over 50% of employers have opted in to anti-obesity medicine coverage and see that modestly growing as we work to expand coverage. On Slide 12, we provide an update on our capital allocation. Slide 13 shows our updated 2024 financial guidance.

We're raising our full-year revenue outlook by $3 billion to be between $45.4 billion and $46.6 billion. This increase is due to strong performance across our non-incretin medicines as well as Mounjaro and Zepbound. Additionally, we've improved clarity into the timing and phase of our production expansion and Mounjaro launches outside the U.S. We achieved a number of supply-related milestones in Q2 and have increased confidence regarding our expectation that production of salable doses of incretin medicines in the second half of 2024 will be at least 1.5 times the salable doses in the second half of 2023. Based on the midpoint of the range, our updated guidance implies revenue growth of 38% in the second half of the year, following 31% in the first half.

In the second half of the year, we're expecting more significant growth in Q4 compared to Q3. Given the update to revenue guidance, we now expect the ratio of gross margin less OpEx divided by revenue to be in the range of 36%-38% on a reported basis and 37%-39% on a non-GAAP basis. For our other income and expense, we now expect between $525 million and $425 million of expense on a reported basis, and between $400 million and $300 million of expense on a non-GAAP basis. Both ranges reflect lower expected net interest expense, and the reported range reflects net losses on investments in equity securities through 2Q 2024.

We've increased our estimated effective tax rate to be approximately 15%, driven by changes in our forecasted mix of earnings in higher tax jurisdictions. Earnings per share is now expected to be in the range of $15.10-$15.60 on a reported basis, and $16.10-$16.60 on a non-GAAP basis. Both ranges reflect the updates mentioned earlier, as well as acquired IPR&D charges through Q2 of $0.24. The reported range includes a charge in Q2 of $0.24 associated with anticipated litigation payments. Now I'll turn the call over to Dan to highlight our progress on R&D.

Daniel Skovronsky (Chief Scientific Officer)

Thanks, Gordon. It's been another busy quarter. I'll start with comments on the Kisunla FDA approval, then the tirzepatide heart failure phase III readout, and finally, I'll cover the rest of the updates for the quarter. We are, of course, very excited about the FDA approval of Kisunla for treatment of Alzheimer's disease. This followed the June advisory committee meeting, where we had another chance to present and discuss the compelling data package characterizing the safety and efficacy of this medicine.... We were pleased by the discussion of the FDA advisors, particularly with regard to our data supporting stopping of Kisunla therapy when amyloid plaques are removed to minimal levels. In our trial, nearly half of study participants completed their course of treatment with Kisunla in 12 months.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

We believe limited duration therapy, along with a once monthly infusion schedule, could result in lower patient out-of-pocket treatment costs and fewer infusions required. The vote was unanimously positive on all questions presented, and a few weeks later, the FDA approved Kisunla, including labeling, that physicians may consider stopping dosing of Kisunla based on reduction of amyloid plaques. Following the July approval, we launched Kisunla, and we're delighted to see that patients have already begun receiving this new Lilly medicine as part of clinical practice. We note that Kisunla is broadly covered for Medicare patients through approved CED registries. Regulatory reviews continue around the world, with potential action yet this year in several countries. We're pleased to have recently received a positive opinion for donanemab from the Pharmaceuticals and Medical Devices Agency in Japan. And finally, our phase III prevention study, TRAILBLAZER-ALZ 3, continues to progress as planned.

Moving to tirzepatide, on Slide 14, you'll see the recent positive results of our SUMMIT phase III trial, which evaluated tirzepatide for the treatment of heart failure with preserved ejection fraction and obesity. This study demonstrated statistically significant improvements in both primary endpoints for tirzepatide, maximum tolerated dose compared to placebo. In the first primary endpoint, tirzepatide reduced the risk of worsening heart failure by 38% compared to placebo, as measured by a composite outcome of heart failure, urgent visit or hospitalization, oral diuretic intensification, or cardiovascular death. The median follow-up for this endpoint was 104 weeks. In the second primary endpoint, tirzepatide significantly improved heart failure symptoms and physical limitations compared to placebo, as measured by the Kansas City Cardiomyopathy Questionnaire, KCCQ, clinical summary score.

Mean changes from baseline in this measurement is 24.8 points for tirzepatide, while placebo was 15 points, based on the efficacy estimate at 52 weeks. All key secondary endpoints were met in the study, including mean body weight reduction of 15.7%, compared to 2.2% for placebo. The overall safety profile of tirzepatide in the SUMMIT trial was consistent with previously reported tirzepatide studies, including SURMOUNT and SURPASS. We will present detailed results at an upcoming medical meeting and submit to a peer review journal. We plan to submit results to the FDA and other regulatory agencies starting later this year. In other updates across our portfolio, Slide 15 shows select pipeline opportunities as of August 6, and Slide 16 shows potential key events for the year.

I'll start with updates in cardiometabolic health, which is the new name of our internal business, formerly known as Lilly Diabetes and Obesity. In June, we published detailed results for our phase III trials of tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity in the New England Journal of Medicine, and we presented results at the American Diabetes Association meeting. All primary and key secondary endpoints were achieved in these studies. Notably, in one of our key secondary endpoints, as shown on Slide 17, tirzepatide demonstrated that up to 51.5% of participants met the criteria for disease resolution of sleep apnea. We've now submitted tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity to the FDA, as well as the EMA.

We are pleased that the FDA has granted Breakthrough Therapy Designation, and we expect US regulatory action as early as the end of 2024, which will be dependent on the FDA granting priority review. Also in June, we published results in the New England Journal from our phase II trial of tirzepatide for metabolic dysfunction-associated steatohepatitis, or MASH, with stage 2 or 3 fibrosis, and we presented these results at the European Association for the Study of the Liver. We were pleased to show that in a secondary endpoint, more than half of the patients taking tirzepatide achieved improvement in fibrosis at 52 weeks, as shown on Slide 18. We're engaged with regulatory authorities on a potential phase III registration strategy, and we're also encouraged by the potential read-through of these results to retatrutide, which also showed significant improvements in liver fat in phase II.

This quarter, we also announced top-line data from two phase III trials for our once-weekly insulin called efsitora alfa. The QWINT-2 and QWINT-4 trials for the treatment of type 2 diabetes each met their primary endpoints of non-inferior A1C reduction. QWINT-2 efsitora alfa to once-daily insulin degludec for 52 weeks in insulin-naive adults. QWINT-4 efsitora alfa to insulin glargine for 26 weeks in adults previously treated with daily basal insulin and at least two injections per day of mealtime insulin. In both QWINT-2 and efsitora alfa was safe and well tolerated. Detailed trial results will be presented in September at the European Association for the Study of Diabetes annual meeting. We look forward to sharing additional data from the QWINT program later this year.

We are pleased with our progress to provide breakthrough innovation to patients who require insulin, progressing our glucose-sensing insulin receptor agonist molecule in phase I and investing in approaches aimed at disease modification for type 1 diabetes, such as islet cell therapy. In other late-phase updates, we've initiated TRIUMPH OUTCOMES, the phase III trial evaluating cardiovascular outcomes and renal function for patients taking retatrutide. Earlier in our cardiometabolic pipeline, you'll see additional incretin molecules in phase I. Incretins are an important part of our portfolio strategy... and having multiple molecules in clinical development offers us potential optionalities as we look at opportunities to help patients across mechanisms, indications, dosages, formulations, and treatment schedules. To highlight a few, GLP-1 NPA2 is a small molecule, non-peptide agonist of the GLP-1 receptor designed for once-daily oral administration.

We expect this asset to move to phase II later this year, so we now identify it on our pipeline slide, whereas it had previously been listed as not disclosed. Given the diversity of indications to potentially pursue with incretins, we are excited about the possibility of having another oral option to help more patients with different diseases. We also highlight today, dual GLP-1 co-agonist III, which is a next generation dual agonist molecule, and we are planning to explore weekly and monthly dosing given its longer half-life. Elsewhere in our cardiometabolic health portfolio, we have stopped development of an NRG4 agonist as the profile was insufficient for further clinical development. Turning to oncology, we are pleased that Jaypirca has now been approved in Japan for people with relapsed or refractory mantle cell lymphoma, who are resistant or intolerant to other BTK inhibitors.

In early phase oncology, we've initiated the phase I trial for second Nectin-4 ADC. We view this as an important target, and having two compounds in the clinic provides more opportunities to improve outcomes for patients. We've also initiated a phase I trial for our ADC targeting the folate receptor. This asset, which came from our acquisition of MabLink, is a next generation construct designed to have efficacy at all folate receptor expression levels and with an improved therapeutic index relative to existing agents. We're also announcing that we've terminated the LOXO-783 program, which targeted PI3 kinase alpha. We evaluated the ongoing clinical data for the program and compared the molecule to next generation candidates that we have progressed from our discovery efforts. We believe our next molecules have greater potential to benefit patients.

We look forward to putting our next candidate into the clinic in 2025 and sharing more about its profile later this year. In immunology, we've now submitted mirikizumab for the treatment of moderately to severely active Crohn's disease in Japan. We've terminated development for our GITR agonist antagonist due to insufficient efficacy. We also announced our acquisition of Morphic, and pending completion of the deal, we plan to reflect the oral alpha 4 beta 7 integrin inhibitor MORF-057 in phase II for ulcerative colitis and Crohn's disease. Finally, in neuroscience, our anti-tau small molecule OGA inhibitor recently concluded its phase II study in early symptomatic Alzheimer's disease. OGA failed to meet the primary endpoint of decreasing the change from baseline, as measured by iADRS, in either of the 2 dose levels tested.

We're reviewing the data for presentation of detailed results of the study at the Clinical Trials and Alzheimer's Disease conference later this year. While this negative outcome was disappointing, we remain committed to tau as a high conviction target in Alzheimer's disease and plan to continue studying tau biology. I'll turn the call back to Dave for closing remarks.

David Ricks (CEO)

Thanks, Dan. Before we go to Q&A, let me briefly sum up our progress in the second quarter. Exceptional revenue growth in Q2 was driven by Mounjaro, Zepbound, and Verzenio. We are pleased with the ramp in production in the first half of the year and expect continued expansion ahead. Significant advances in our pipeline include the approval of Kisunla for Alzheimer's disease, the submission of tirzepatide for moderate to severe obstructive sleep apnea and obesity in the U.S. and Europe, and positive results from the phase III study of tirzepatide for heart failure with preserved ejection fraction and obesity. We are investing in product launches, the advancement of our pipeline, as well as our ambitious manufacturing expansion agenda.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

All of this, and the incredible work of our teams around the world, give Lilly leadership confidence that we have a very bright future ahead and better opportunity than at any time in our house history to impact human health on a global scale. Now I'll turn the call over to Joe to moderate the Q&A session.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Dave. We'd like to take questions from as many callers as possible and conclude our call in a timely manner. So consistent with prior quarters, we'll respond to one question per caller, so I ask that you limit to one question per caller, as we'll end the call at 11:00 A.M. If you have more than one question, you can reenter the queue, and we'll get to your question if time allows. So, Paul, please provide the instructions for the Q&A, and we're ready for the first caller.

Operator (participant)

Thank you. At this time, we'll be conducting a question and answer session. If you have any questions, please press star one on your phone at this time. We ask that participants limit themselves to one question on today's call. If you do have a follow-up question, please rejoin the queue by pressing star one at any time. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we pull for questions. The first question today is coming from Seamus Fernandez from Guggenheim. Seamus, your line is live.

Seamus Fernandez (Senior Managing Director and Senior Analyst)

Oh, great. Thanks so much, and just, I'll stick with my one question. It really is on your awareness of ASP movements in the market, so the average selling price. By our calculations, when we sort of look at the ASP averages, removing rebates, inventory, et cetera, relative to comments made yesterday on Novo's call, I'm just trying to get a better understanding of what you're seeing in the market with regard to average selling price. The prices look actually reasonably close to us with the tirzepatide franchise having higher, you know, sort of ASP per script.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

... but not dramatically higher, you know, given concerns of real pricing deterioration. I guess the only question that I have here is, what are you seeing from an ASP perspective? And do you see this as kind of the natural evolution of this market as competition emerges, as we saw with Ozempic historically and Trulicity in 2019? Thanks so much.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Seamus. I think I'll go to, Gordon, do you want to touch on that, or Patrik?

Gordon Brooks (Interim CFO)

Sure, I'll cover that. Seamus, thanks for the question. Yeah, so just on, on, price trends, initial favorability in the first half of the year was driven by Mounjaro. That goes away in the second half of the year as the co-pay program moves out of the base period. In terms of pricing, we see stable pricing sequentially across quarters in 2024, so nothing unusual Q1 to Q2, and our guidance Q3 and Q4 continues stable sequential pricing. For the second half of the year, when you don't have the Mounjaro dynamic, pricing, the second half will be similar to prior year pricing. So those are kind of the dynamics we, we see in pricing.

Joe Fletcher (Senior VP of Investor Relations)

Good. Paul, next question?

Operator (participant)

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

Terence Flynn (Managing Director, Senior US Pharma, and Biotech Analyst)

Great. Thanks for taking the question. Congrats on all the progress on the manufacturing. Maybe just a two-part for me on that one. Just wondering if your initial guidance for the, at least 1.5-fold increase in sellable doses, include the Zepbound starter vials that you're rolling out in the U.S., or if that's a potential driver of upside. And then, as we think about RTP, I know you're continuing to make progress there. The scripts suggest you're at about a third of the way through the ramp to peak, but this inventory restock that you talked about today suggests maybe more of a meaningful step-up. So just can you quantify for us where you are in the ramp in RTP? Thank you.

Joe Fletcher (Senior VP of Investor Relations)

Yeah, sure. I think, Dave, you want to hop in?

David Ricks (CEO)

Yeah, I can just handle it and add. So I think what we're saying today is just reiterating the 1.5 is sort of like a floor on how we think about second half volume. I would say the vials are part of that, but, you know, given the, we have about, you know, 20 weeks left in the year, so, there's a limit to how much of that will ship anyway. But they certainly open up a node of the most constrained part of the supply chain, which is still finished in the final container closure, and it uses different, lines, obviously, than syringes or cartridges. So it just adds to our, capacity.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

Probably the most meaningful part of that will show up in early 2025, to be honest, as that new form ramps and details on that rollout will be coming in the coming weeks. As it relates to RTP, I do. I wouldn't read through that the Q2 step up in volume we shipped was primarily due to RTP. That site is on track, and we are steadily escalating production per our goals. I also mentioned Concord is doing well against its time schedule, and we expect product out of that site end of this year, early next year. But rather, maybe performance out of the totality of the network that allowed us to recover wholesaler inventory levels in Q2 and now come off the FDA shortage list.

It's more just overall performance across many, many nodes of our supply network.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Dave. Paul, next question.

Operator (participant)

The next question will be from Chris Schott from J.P. Morgan. Chris, your line is live.

Chris Scott (Managing Director and Senior Equity Research Analyst)

Great. Thanks so much for the question, and congrats on all the progress. There seems to be a broader debate on the role emerging earlier stage competition in the OBC market could play, where that fits in the market broadly. I'm sure you're not surprised by the breadth of agents being developed in this space, but just finish in your latest views in terms of barriers to entry you see for some of these newer competitors, and how you think about defending Lilly's market position over time. Thank you.

Joe Fletcher (Senior VP of Investor Relations)

Maybe, Dan, do you want to start on that, and then-

David Ricks (CEO)

Yeah, I'll start with some R&D comments on barriers to entry. The first, I think, is having a successful drug in phase III clinical trials and getting it approved. You can see that we've invested thoroughly, I would say, in our phase III portfolios, often pursuing multiple indications in multiple populations at once. Just being able to get to that point, you know, I know investors have gotten excited about various releases of phase I data, but it's still a challenging space to develop drugs, and we usually wait until we've seen pretty robust phase II data before we get too excited about a particular molecule.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

So that's the first thing, and I think a lot of the news that we've seen from different companies will probably sort out as we get to see phase two data, and which molecules make it and which have the right profile and which don't. But I wouldn't be expecting 100% success here.

Patrik Jonsson (President of Lilly Cardiometabolic Health and Lilly USA)

Maybe a few additional comments. I think when we look at the marketplace, there are two very important barriers. We have been extremely successful in gaining access across both Mounjaro, where we have currently 93% access in commercial and 89 in Part D. Similarly, for Zepbound, 86% after 7 months in the marketplace. That's quite significant. The second piece is the amount of outcome indications. We are investing heavily in both Mounjaro and Zepbound, and similarly for the phase three assets of our Orforglipron and retatrutide. So I think overall, we think that we are extremely well positioned to compete here, and we are not surprised to see that most of the firms are actually leaning into this very important space.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

With the cost we have in our hands in the market today, the phase III assets and what we referred to in the prepared remarks, we are well positioned to compete today and tomorrow. That goes across both different indications, assets, length of therapy, et cetera. All hands on deck on our side.

Joe Fletcher (Senior VP of Investor Relations)

Maybe one last thing not to pile on, but, you know, here we're highlighting our-

David Ricks (CEO)

... pipeline gap of 11 assets, all different targets. But maybe just a reminder, Chris, we had our phase I MAD data for tirzepatide in 2016. So that was 8 years ago. And that's a massive lead, I think, over other, GIP, GLP agonists that are behind us. On the oral side, you can get more in, category differentiation based on target engagement, safety profiles, et cetera. But here, again, we have the most advanced program, and as Dan highlighted today, a follow-on program, to add to that sort of portfolio we have there. Finally, one other, I don't know if it's a barrier, but certainly it's work to do, is scaling manufacturing. The volume is really high in this category.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

Probably will end up being one of the highest volume categories in the history of the industry, and you're talking about making things on the billion scale, which takes time and is technically difficult and very capital intensive. So, you know, of course, competitors will come, but there's a road ahead for all these that the two leading companies have already walked in large part.

Joe Fletcher (Senior VP of Investor Relations)

Thank you all. Next question, Paul.

Operator (participant)

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

Tim Anderson (Research Analyst)

Thank you. I have a question on compounders of GLP-1s, including, you know, but not limited to your tirzepatide. So companies like Hims or anyone else, how can this not infringe patent protection? And is this something that is likely to get adjudicated in the courts, meaning that you and presumably Novo sue? An article, you know, just yesterday in The New York Times talked about patients getting upside down with compounded GLP-1s. I think they used the term overdosing on these compounded formulations. So, you know, not only do compounders take away sales from you guys, but it could also tarnish the reputation of the class. So what can we expect Lilly to do about it?

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Tim. Dan, you want to start with some comments?

Daniel Skovronsky (Chief Scientific Officer)

Yeah. Thanks for raising this important topic, Tim. Of course, we've been watching this carefully, not, you know, really out of concern that they're taking away our business. As you know, we've been largely supply constrained here, but rather the impact it's having on patient health. We often are able to secure samples from these kinds of compounding labs and analyze them in our own labs. And what we find, for the most part, in most instances, is this isn't compounded tirzepatide at all. Our drug is not available to compounders. Rather, they're purchasing either other chemicals entirely, which we often find, or fake producers of tirzepatide that is, you know, often full of impurities, sometimes contaminated by bacteria.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

This is a safety risk to patients that we take seriously and trying to do everything we can to make patients aware of the potential dangers here, so that we can help them.

David Ricks (CEO)

Yeah, and just from a policy standpoint, I mean, you can expect us to be active here. We've taken public positions. We're obviously engaged with regulators and considering all kinds of legal actions and have filed some. Of course, you know, compounding is a long-standing practice under the 503A provisions of FDA, which is meant to customize doses for individual patient needs. That we don't—it's not clear to me medically what that would be for tirzepatide, but, I guess that's legal in a sense. It's the mass production that's concerning, and we don't see a lot of that with our medicine, more with the other one. You know, I think if we just step back and reflect on why this is happening, there's just—there's shortages because of parenteral manufacturing constraints in the industry and in the leading companies.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

A lot of that constraint is investing and proving those processes are compliant with the GMP standards that the FDA and Europe under Annex 1 have enforced. And we agree, by the way, with that strict enforcement. So it's a little odd that the answer to that constraint, which is about raising the standards of the industry to have sterile product, is to create another industry that has non-sterile product. So we're just pointing that out, and I think you can see Lilly on the front foot here over the coming months to address this. But ultimately, the real thing to address is increasing coverage on insurance and increasing supply. We've made a lot of strides on supply.

We'll step that up another notch with the availability of vials, and we need to work with primarily, the government as well as, employers to expand coverage, so obesity medicines are affordable. I think when we get to those points, this will be a non-issue, but in the meantime, people can get hurt, and as Dan said, it's pretty concerning what's happening.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Paul. Next question.

Operator (participant)

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

Umer Raffat (Senior Managing Director and Senior Analyst)

Hi, guys. Thanks for taking my question. I wanna ask on operating leverage, if I may. I know in first quarter, when you guys raised the guidance by $2 billion on top line, it dropped down to EPS by $1.30. This quarter, guidance went up by $3 billion, but it dropped down at a much higher leverage at 2.16 EPS, almost a 90% incremental margin. My question is not so much what your operating leverage is gonna be in 2025 or a forward year guidance, but instead, I'm basically asking, if you annualize the momentum of your 4Q numbers per this year's guidance, the EPS upside implied to consensus could be almost as much as half of Lilly's entire full year EPS, where it stands right now.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

I'm just trying to think through, how do you plan on spending on various functions and what the incremental margins could look like as the revenue momentum really kicks in with the improving supply? Thank you.

Joe Fletcher (Senior VP of Investor Relations)

... Thanks, Umer. There's a lot of, a lot of financial mechanics that I'll hand to Gordon to comment on, I think, effectively capital allocation considerations.

Gordon Brooks (Interim CFO)

Good. Thanks, Umair. I appreciate the question. Yeah, I mean, we've been speaking for a long time about operating margins and getting to the mid- to high-30% range. As we've, you know, as we've seen this year, Mounjaro and Zepbound, they're taking an inflection point upwards, and so we're seeing ourselves at the top end of that range. For the first half, you know, margins are a little inflated. We haven't yet leaned into all of our promotional channels on incretins. You don't see, for instance, TV commercials on the incretins. We haven't done that, looking at the, you know, given the supply situation. And on R&D, it takes time to scale R&D thoughtfully, so it doesn't always move exactly in sync quarter by quarter with revenue.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

That said, you know, our guidance for the year does indicate we will stay in the upper 30% range for the full year, with growth first half, if you look at the first half, is the two quarters growth into the second half. And you should also expect to see within that mix, stronger sales and marketing growth as we get to new launches in the second part of the year, and R&D continue to scale and grow from what we've seen thus far. So those are the dynamics we see, on operating margin for 2024.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Gordon. Paul, next question.

Operator (participant)

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

Mohit Bansal (Biopharma Equity Research)

Great. Thank you very much for taking my question, and congrats on the quarter. My question is regarding the rest of the world sales for incretins. It seems like Mounjaro is doing quite well there, and if I take out the, like, 15% or so for stocking in the US, it seems like XUS is already about 33% this early in the launch. So I would love to understand how has been your experience so far, and is there going to be any different uptake for XUS versus your prior generation incretins for both Mounjaro and Zepbound, given that these are really efficacious drugs?

Joe Fletcher (Senior VP of Investor Relations)

Yeah. Thanks, Mohit, for the question. Ilya, do you wanna comment on OUS rollout for Mounjaro?

Ilya Yuffa (President of Lilly International)

Sure. Thanks, Mohit, for the question. You know, we've seen some great progress with the launch of Mounjaro outside of the US. I think what you've seen in terms of growth in the earlier launch countries, such as the UK, UAE, and Saudi. UAE and Saudi are both key markets that make up the rest of world, have already achieved a leading share and continue to drive momentum and overall market growth. And so as you take a look at Q2, the main driver of that growth has been in Mounjaro, in markets where we've already launched earlier in the cycle, and majority of that coming from the QuickPen presentation, with a lot of that in the UAE. Some of that is channel dynamics similar to the US.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

At the same time, if you take a look at Q2 and the trajectory for Q2, relative to kind of historical peak sales of any of our brands, it's already surpassed that with limited number of markets where we've launched. So as we look at the coming quarters, obviously, we just recently launched in Germany and now also Spain with a QuickPen presentation. We'll also look to monitor the demand and also supply capacity and expect to launch in new markets. The near-term growth, I would expect predominantly coming from already launched markets of Mounjaro.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Ilya. Paul, next question.

Operator (participant)

The next question will be from Alex Hammond, from Bank of America. Alex, your line is live.

Alex Hammond (Biotech and Pharma Equity Analyst)

Thanks for taking the question. In the prepared remarks, Dan mentioned engagement with regulatory authorities on a potential pivotal trial MASH. Can you provide any color on these discussions and how Lilly is thinking about tirzepatide versus retatrutide for this indication? When could we receive updates? Thank you.

Joe Fletcher (Senior VP of Investor Relations)

Dan?

Daniel Skovronsky (Chief Scientific Officer)

Yeah, thanks for the question. We're really excited about the opportunity to help patients suffering from MASH. I think the data that we shared in phase II for tirzepatide is really quite profound in terms of the size of effect we can have. There's a couple issues in MASH drug development that we're trying to tackle, probably the most significant of which is the current standard of liver biopsy to identify the patients to enroll in these trials, and also to measure the outcome. Liver biopsy is obviously an invasive procedure and difficult to find patients to consent to these trials, and of course, there's risk to patients.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

We're working hard to develop non-invasive biomarkers that can be used to identify the right patients to enroll in MASH studies, and also potentially could be used as an outcome to know if a drug's working. My hope is that we could develop those kinds of biomarkers that could be used for both purposes and could be suitable for accelerated or approval of MASH drugs in the future. Of course, you know, long-term traditional approval for MASH drugs still requires demonstration of outcomes. So in that environment, we have two drugs that I think could both be great MASH drugs, and we'll have to decide whether to invest in one or both of those drugs, depending on the regulatory paths we see.

We'll keep investors updated as we make decisions about the future of these molecules in MASH.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Paul. Next question.

Operator (participant)

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

Evan Seigerman (Managing Director, Head of Healthcare Research, and Senior Research Analyst)

Hi, guys. Thank you so much for taking my question. I wanted to touch on manufacturing, specifically on, the concern that you raised back in February around the, proposed acquisition of Catalent, by Novo Holdings and the subsequent sale to Novo Nordisk. Are you still as concerned as you were in February, or given what you've been able to do with your own footprint, is this less of an issue? Thank you so much.

David Ricks (CEO)

... Yeah, I can take it. You know, we remain concerned about that transaction. I don't think it was ever really about the trajectory of our ramp, although, as we've disclosed, we do rely on one of the Catalent sites for GLP-1 and other diabetes production. It's more the oddity of your main competitor being your also your contract manufacturer, and how to resolve that situation. There's also an industry structure issue. You know, CDMOs are important for managing capacity across the sector, and if we ended up in an outcome where that sector didn't really exist, they all became captive of large pharma, it would really constrain, I think, availability and the development of medicines, particularly out of biotechs.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

So we've, you know, aired those concerns publicly and privately since the proposed transaction was announced, and we're waiting to see what happens. But in terms of, you know, the long-term outlook for our company, as you may have noticed, we're building aggressively ourselves. Our primary strategy is self-run sites, and we've got $18 billion we've announced in the last several years, you know, probably not done there. And we're quite comfortable building and operating sites, and as the newest large sites have begun to come online, you know, we know we can execute that drill and repeat it, and that's our base plan.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Evan, for the question. Paul, next?

Operator (participant)

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

Dave Risinger (Senior Managing Director, Senior Research Analyst, and Biopharma Equity Research)

Yes, thanks so much, and, let me add my congrats on the results as well and the corporate update. So Zepbound's breadth of health and work or productivity benefits seem to be underappreciated by many. You know, there are articles from time to time that say that, you know, patients need an off-ramp from therapy, et cetera. And, my question is: what is Lilly doing to encourage patients to stay persistent with therapy? And how does Lilly intend to better communicate not just Zepbound's health benefits, but its worker productivity benefits to employers in order to drive much greater employer inclusion of obesity drugs as part of employee benefits? Thanks very much.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Dave. Patrik, do you want to comment on persistency and benefits?

Patrik Jonsson (President of Lilly Cardiometabolic Health and Lilly USA)

Absolutely. You know what? I think first of all, when we look at persistency, it's very early after the launch, but based upon the feedback we hear from providers and from patients as well, this is a drug that patients want to stay on because they experience the benefits firsthand of weight loss and also the downstream implications on comorbidities. You are right, the employer opt-in efforts are extremely key, and we believe that our outcome data, OSA, now HFpEF, will help us tremendously and more readout to come over the coming years. We're also having value-based agreement with several of the payers, where we're looking into the benefits of tirzepatide in the workplace in terms of reduced absenteeism, increased productivity, et cetera, as well, and that has gained a lot of interest.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

In terms of the consumer, yes, the easy start and stay on is a key priority for us. And there, we're working with consumer, improving our consumer platforms and also digital channels to really enable patients to experience the benefits that Zepbound provides, over time.

Joe Fletcher (Senior VP of Investor Relations)

Thanks, Patrick. Paul, next question.

Operator (participant)

The next question will be from Kerry Holford from Berenberg. Kerry, your line is live.

Kerry Holford (Managing Director and Senior Equity Research Analyst)

Oh, thank you for taking my question. Just going back to the margin question earlier, given you're now expecting your 2024 operating-

Operator (participant)

Apologies, team. We will get Kerry reconnected with a better line momentarily, and we'll move on to the next question in the meantime, if that's okay, from Chris Shibutani from Goldman Sachs.

Chris Shibutani (Managing Director, Senior Analyst, and Biotechnology Equity Research)

Thanks, Paul.

Operator (participant)

Chris, your line is live.

Chris Shibutani (Managing Director, Senior Analyst, and Biotechnology Equity Research)

Yes, thank you. With all the different, oral mechanisms, in particular, variations on it from yourselves as well as competitors, can you update us on your thinking on what the basis of competition is going to be, and what kind of opportunities do you really envision? I think there has been, for a while now, a comparison on the basis of % weight loss, particularly for the injectables. But as we move into orals, it seems as if tolerability profiles really matter. So how are you thinking about it, and how do you recommend investors think when we compare data sets across these other oral, products in development, even if the mechanisms are different, how do we get smarter about differentiating and interpreting data? Thank you.

Joe Fletcher (Senior VP of Investor Relations)

Dan, you want to chime in?

David Ricks (CEO)

Yeah. Thanks, Chris. I'll start, and then we'll see if Patrick has anything to add on commercial differentiation. But in the clinical trials, I think, you know, first of all, as I was saying before, just take some caution on these small, short phase I trials. There's more to see. Most of the drugs that we've seen actually aren't different mechanisms. They're GLP-1 agonists, and in this class, I don't expect there to be differentiation in terms of efficacy, weight loss. You can pretty much dial in the amount of weight loss you want, depending on how aggressively you dose it and what population. Tolerability is another issue that usually comes along with the efficacy.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

The faster you ramp to higher doses, the less tolerability you have. Then the different companies will have to work through their own escalation of dosing to match the desired efficacy with some reasonable tolerability. The variable that links those two things together is often the half-life of the molecule. So shorter half-life molecules will give you bigger peak trough excursions in the pharmacokinetics of the drug, and we think that's what drives the tolerability issues. So what you want is a long half-life molecule that can be dose escalated more smoothly. So that probably will be the differentiation rather than anything that the companies are currently talking about in terms of efficacy.

Daniel Skovronsky (Chief Scientific Officer)

... As I said before, it's a long road from early data to phase III clinical trials like we have with orforglipron, and we can expect some attrition. I'm pretty excited also about next generation molecules. All these ones that we've been talking about now are GLP-1s, and they'll offer efficacy sort of in the range of injectable semaglutide. I think ultimately, we'd like to see drugs that offer efficacy and tolerability that exceeds that, things that could combine multiple incretins, like tirzepatide does, and we are certainly working on orals that could also agonize GIP-1, for example. So exciting progress there and more to come on that in the future from us. Just from a commercial point of view, we are regularly conducting both consumer and provider market research.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

And when we look into their preferences, the true drivers today is still the degree of weight loss and safety and tolerability. And when we look at the needs beyond that, it's actually the need of an oral, and an oral with an injectable-like efficacy. So that's probably the need that comes beyond what we're currently serving today, and particularly to serve those patients that have a fear of injections. When we look at other aspects, I think what comes beyond that would be the composition of weight loss, lean mass versus fat and durability. And I think we're looking into all of those aspects as well. Thank you, and thanks for the answers. Paul, next question.

Joe Fletcher (Senior VP of Investor Relations)

I know we're running short on time, so we'll do our best to kind of compress our answers as we get through as many questions as possible. Paul?

Operator (participant)

Thank you. And we have Kerry Holford from Berenberg reconnected. Kerry, your line is live.

Kerry Holford (Managing Director and Senior Equity Research Analyst)

Lovely. Thank you for taking my question. Hopefully, you can hear me better this time around.

Daniel Skovronsky (Chief Scientific Officer)

Much better.

Kerry Holford (Managing Director and Senior Equity Research Analyst)

Lovely. My question was on margin. So given you are now landing, expecting to land in that mid- to high-30s range this year, so soon after Tirzepatide launches, where can we expect your midterm operating margin to land? You know, is the margin in the mid-40s, perhaps higher, achievable? And Dave, I know you've previously suggested that an operating margin above 40% is not sustainable for an innovation-focused company. But given your progress so far, I wonder if you've changed your view on that. Thank you.

Daniel Skovronsky (Chief Scientific Officer)

Gordon, you want to touch on that briefly?

Gordon Brooks (Interim CFO)

Will do. Thanks, Kerry, appreciate the question. Yeah, I think, you know, as we said in our guidance, as I said earlier, we do expect to end in that upper thirties range this year. There's still a lot at play here. Yes, on the top line, we see inflection points on revenue, but through the first half, you've had an inflated position. We haven't yet leaned into any of our promotional channels. That, that's gonna be a dynamic that we lean into more, starting in the second half. And R&D, we do intend to scale that, and that, that's not going quarter by quarter, exactly in line with, with revenue. So all of those things are still going to play through.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

You know, I think that said, at this point, we're just talking about 2024, and when we do guidance for 2025, we'll chat about the longer-term picture then.

Daniel Skovronsky (Chief Scientific Officer)

Thanks. Next question, Paul.

Operator (participant)

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

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

Hey, thanks so much. So we're starting to see that myostatin may not be the only way to kind of preserve lean muscle mass. In particular, it looks like amylin GIP GLP combos are showing the potential for maybe 90% versus 10% fat versus muscle loss. Can you talk about what you think an Oloralintide tirzepatide combo could show, both in terms of absolute weight loss, but also the quality of that weight loss? And then where would myostatin fit in a world where next gen amylin triplets could show that level of muscle preservation? Thank you.

Gordon Brooks (Interim CFO)

Okay. Dan can focus on that first question about Oloralintide. Yeah. Thanks. So we have multiple mechanisms in play here. Starting maybe with the amylin, we have a molecule phase II called Oloralintide, which is a pure amylin agonist, and we're evaluating that both as monotherapy and in combination with tirzepatide, GIP, GLP. So that'll be interesting to see. I don't have a strong preconceived notions about what to expect in terms of lean versus fat mass loss with that particular combination. Probably the people who have the most data about that would be the scientists at Novo, since they've investigated cagrilintide in combination with semaglutide.

Daniel Skovronsky (Chief Scientific Officer)

I think that brings us probably to another mechanism, which is dual amylin calcitonin agonism, which, cagrilintide probably is a dual agonist, and we have a molecule like that in phase I, called DACRA. And we'll also investigate that, and composition of body mass will be a one of the aspects in which we evaluate it. And then, finally, you talk of myostatin. We have a molecule in this family, and that's the bimagrumab that we acquired from Versanis, which is an antibody against the receptor, and that's proceeding in a phase II trial in combination with semaglutide. And we look forward to having data to share with that in the future.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

All of these mechanisms, I think, could have variable effects on body mass composition, but I point out that so far, we've not seen any disadvantages to the types of weight loss that we get with Tirzepatide. In fact, patients show improved functional outcomes on a variety of things, including lung function and heart failure, we just demonstrated. So could we have further improvements with even more higher ratio of fat to lean mass? That's the question these trials will answer.

Joe Fletcher (Senior VP of Investor Relations)

Good. Paul, next question.

Operator (participant)

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

Trung Huynh (Executive Director and Equity Research)

Hi, guys. Thanks for taking my question. Just following on from the previous question on ex-US GLP-1, you saw Mounjaro ex-US sales this quarter jump to six-

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

... $77 million from $286 million. Can you give us some color on how ex-US reimbursement is going with the bigger countries? And is this more of an out-of-pocket drug in these countries? And what percentage of the $677 million is obesity sales versus diabetes? Thanks very much.

David Ricks (CEO)

Okay. On that second one, I don't think we'll probably give much of a good answer on that, so I'll maybe ask Ilya to weigh in just on that first question around how ex-US reimbursement is going.

Ilya Yuffa (President of Lilly International)

Sure. Well, first, I think the momentum overall is progressing quite nicely in both the reimbursed as well as the out-of-pocket segments. We have achieved reimbursement in the UK. We have reimbursement in Germany, and we're continuing to look for reimbursement and expand reimbursement in other markets that we've launched. We have some reimbursement in UAE and Saudi as well in Type 2 diabetes, and we continue to expand on that in the markets that we will enter. But a lot of that momentum is covering both the Type 2 and chronic weight management market, and both in the reimbursed and out-of-pocket segment. And we're seeing both the progress in share as well as market expansion in the markets that we've been in.

David Ricks (CEO)

Thanks, Ilya. Paul, I know we have a lot in the queue. Maybe we'll just have two more questions and then wrap things up.

Operator (participant)

Certainly. The next question is coming from Steve Scala from TD Cowen. Steve, your line is live.

Steve Scala (Managing Director and Senior Research Analyst, Pharmaceutical, and Healthcare Equity Research)

Oh, thank you so much. The FDA definition of shortage seems clear, and tirzepatide no longer meeting the definition of shortage seems to imply Lilly is meeting demand. I assume you will say that that's not the case, but the definition, at least in black and white, is quite clear. I assume this is FDA's determination. So does Lilly agree with FDA's conclusion? How is demand being met? How is demand being measured? And what does demand look like? Thank you.

David Ricks (CEO)

Yeah, thanks for the important question, and, you know, as we think about the compounding question, is important as well. We... As we've said earlier, we're available in all dosage forms in the U.S. What that means is, as you, as you know, we can fill orders as they're received, which is what we're doing. That does not mean that any pharmacy, or certainly every pharmacy, has all 12 dosage forms sitting on their shelf. That's infeasible economically, probably for a lot of them, and even logistically. So I think we'll continue to see, because there's not an abundance of supply, it's more of a real-time fulfillment situation, patients going to pharmacy counters and being told to wait a few days while their order is fulfilled. But product is flowing, and it's flowing at a pretty high rate.

Akash Tewari (Managing Director and Global Head of Biopharmaceutical Research)

You know, we're shipping quite a bit, and you can see that in these results from the quarter. So, bios will add to that picture, but demand will increase as well. So I think we're doing well, given the situation, but the end pharmacy experience will continue to be choppy. We point that out to the FDA, so that means people may call and say, "I couldn't get what I wanted on the moment I wanted it at the pharmacy I choose to." That's not the definition that we think applies here. So we'll continue to work with channel partners and the agency to try to clear up the confusion and improve the consumer experience, which is our responsibility, along with theirs.

Joe Fletcher (Senior VP of Investor Relations)

Thanks. Paul, last question?

Operator (participant)

The last question today will be from Louise Chen from Cantor. Louise, your line is live.

Louise Chen (Managing Director and Senior Research Analyst, Specialty Pharmaceuticals, Biopharma, and Large‑Cap Healthcare Equity Research)

Hi, thank you for taking my question. I wanted to ask you how excited you are about these muscle-preserving obesity drugs and if you see that as a true unmet need? Thank you.

David Ricks (CEO)

Thanks. Dan, anything to add on?

Daniel Skovronsky (Chief Scientific Officer)

Yeah, no, thanks for the question, Lisa. I think it's an interesting area of science, for sure. Too soon to know exactly how these kinds of mechanisms will translate into benefits for patients. At a high level, we know that the ratio of of lean mass to fat mass is really important in determining metabolic health, probably more important as an indicator of overall metabolic health than, for example, BMI. And so that's what spurs these kinds of efforts to increase lean mass while causing fat mass loss. And we'll wait to see data from our own bimagrumab and wait to see how that translates into health benefits for patients.

Joe Fletcher (Senior VP of Investor Relations)

Great. So I think we'll wrap up. Dave, closing remarks?

David Ricks (CEO)

Great. Thanks, Joe, and thanks to the team here. We appreciate your participation in today's earnings call and your interest in Eli Lilly and Company. Please follow up with the investor relations team if you have any questions we didn't address, and it sounds like there's a few that we're holding. Happy to answer all those. Have a great day, everyone.

Operator (participant)

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 September 12th at midnight. You may access the replay system at any time by dialing 800-332-6854 and entering the access code 297484. International dialers can call 979-...