A：The Achieve one trial in Pogo Pro for patients with type 2 diabetes met expectations and represented the first step toward Eli Lilly's goal of creating a medicine with injectable GLP-1 efficacy, safety, and tolerability, but with the convenience of a once-daily pill. It has the potential to impact hundreds of millions of people with chronic diseases and is expected to deliver phase 3 data across type 2 diabetes and obesity over the next 12 months.

A：Revenue grew 45% in Q1 compared to Q1 of 2024, with key products such as Jardiance, Humalog, Kexeva, Enbrel, and Zyprexa contributing to a revenue increase of more than $4 billion, now accounting for $7.5 billion of the company's revenue.

A：Key pipeline milestones in Q1 included the approval of Jyveka in the EU for CLL, Ovo in the US, EU, and Japan for Crohn's disease, and the initiation of a phase 3 program for Olimar acid in resected adjuvant non-small cell lung cancer.

A：Eli Lilly supports the US government's goals to increase domestic investment but does not believe tariffs are the right mechanism. They suggest that enhanced tax incentives or the extension of the Tax Cut and Job Act would better achieve these goals. They emphasize the negative effect of tariffs on the company, which has a large US manufacturing footprint with ongoing projects to build and expand new sites, and urge the administration to negotiate deals with key trading partners to remove harmful tariffs and non-starter market access barriers.

A：The currently announced tariffs do not materially change Eli Lilly's 2025 financial outlook. However, an expansion of tariffs to other geographies or increases in retaliatory tariffs would negatively impact the company.

A：Q1 2025 financial performance showed revenue growth of 45%, gross margin as a percentage of revenue at 83.5%, an increase of 1% from the same quarter last year, and a non-GAAP adjusted performance margin of 42.6%, an increase of over 11 percentage points from Q1 2024. The Q1 effective tax rate was 20.2%, and earnings per share were $3.34, inclusive of a negative impact from acquisition IP and D charges of $1.72 per share.

A：Revenue growth in Q1 was driven by strong volume growth of key products like Sypora and Monaterro in the US, a one-time benefit from further restructuring the alliance with Al in Europe, and volume growth from Manjaro in Japan and China.

A：Key products' performance contributed to Q1 revenue through strong uptake in Immunology with Otezla for psoriasis and dermatitis, new patient starts for Crohn's disease, and the launch of Opyli in Europe for relapse or refractory CLL. In Oncology, Opyli was approved in Europe and is expected to launch in the second quarter. Cardiometabolic health saw robust performance with both Monaterro and Manjaro, driven by strong sales and new prescriptions.

A：The updated 2025 financial guidance is not specifically detailed in the provided text; however, it is mentioned that the company has maintained strong performance in Q1, and as a result, the revenue and performance margin guidance for non-GAAP earnings per share remains unchanged, aside from Q1 charges related to IPR and D.

A：The recently completed orpha glip phase 3 trial, named Achieve one, showed that orpha gliptin could deliver efficacy, safety, and tolerability similar to the best seen for available GLP 1 monotherapy injectables. It exhibited an average reduction of 1.3% to 1.6% in hemoglobin A1c, with more than 65% of patients achieving an A1C of 6.5% or less, which is below the American Diabetes Association's threshold for diabetes. At the highest dose, patients lost approximately 7.9% of their body weight, in line with existing injectable GLP 1s in patients with diabetes. The most common adverse events were gastrointestinal, and the safety profile was consistent with the GLP-1 class, with low discontinuations due to adverse events.

A：Upcoming clinical trials related to orpa glip include studies in people with obesity without diabetes and with obesity and diabetes, as well as trials in hypertension. The company expects to present full results from Achieve one at the Ada's 85th Scientific sessions and publish them in a peer-reviewed journal. Over the next 12 months, they expect to get results from four additional diabetes trials and two obesity phase 3 trials. Assuming success, they plan to submit orpa glip for obesity in Q4 and type 2 diabetes in the first half of 2026.

A：The company's response to the PBM dynamics concerning their obesity drug has been to focus on making better and more accessible medicines, and they are excited about the oral potential of orpa glip for wide distribution. They are pursuing a strategy that does not involve reducing access and choice for doctors and patients but aims to expand it. They are committed to driving share and preference for their brand while addressing the impact of PBMs and working through the situation.

A：The potential indications for orpa glip beyond weight loss include a broad cardiovascular indication, combinations, and possibly areas such as immunology and neuroscience. The molecule has shown potential in type 2 diabetes and obesity, and there are plans to explore other therapeutic areas. The company is also pursuing multifunctional orals and has another molecule in development.

A：The envisioned role of orpa glip in the core obesity and diabetes market is to play a significant part by leveraging its oral convenience and broader applicability. While the exact market share orfor glip will take over time is not specified, the company's strategy includes challenging the injectable market and expanding its reach within the market. However, detailed insights into the long-term market share expectations for orpa glip are not provided in the transcript.

A：The potential benefits of oral medications over injectables include reaching a global market that's more challenging with injectables alone, providing a significant opportunity for the company, and potentially offering a benefit from a manufacturing perspective.

A：The indications being considered for the oral medication in weight loss include switching patients from injectable to oral treatments for maintaining weight loss and reaching segments of the population with comorbid risk factors who have overweight but not obesity and need sustained lower body weight for health reasons.

A：The company aims to move away from high list prices and deep discounts towards more transparent pricing. They plan to continue narrowing the gap between list and actual prices to provide a more similar basis for cost-sharing between patients and payers. This approach is expected to reduce gross to net spreads and rebate flows, resulting in more transparent overall pricing. It's part of their strategy to have a portfolio of weight loss medications in 2026.

A：The company views the introduction of a new competitor in the atopic dermatitis market positively, especially regarding opt-in rates among smaller employers. They believe that more opt-in rates could lead to a net good for the business, as most employers who opt in tend not to opt out. They also highlight the importance of maintaining a wide range of choices for patients.

A：The progress in the preclinical trial for Alzheimer's disease is based on the number of progression events accrued. A successful trial would be indicated by a significant reduction in the risk of patients experiencing symptoms of Alzheimer's disease, as measured by the CDR global score.

A：The company has high aspirations for the new medication, which is a great medicine with amazing data from clinical trials. They see strong uptake in the market and positive feedback from physicians, especially in the atopic dermatitis market. Despite heavy competitive dynamics, the company is confident in the breadth of the label and the perceived efficacy differentiation. They expect to overcome competitive challenges and achieve broad access and continued acceleration of uptake.

A：The speaker is asking about the percentage of covered lives using the one of one approach in formulary positioning and the likelihood of this trend evolving going forward.

A：Some payers are adopting the one of one formulary approach as a method to manage spend. The approach is seen as an evolution in the market, and it's expected to continue across various segments like PDMS, Medicaid, and Medicare, as well as self-pay patients.

A：The FDA wants multiple trials to support the indication for the TITI and Hep test, as the strong performance seen in the study was not sufficient on its own.

A：The market response to the new obesity indication has been positive, with strong growth noted in the first quarter. However, the challenges with the TITI and Hep test update and potential investment curtailment in this area are noted as negative aspects.

A：The company reaffirmed its guidance for the full year, indicating a midpoint in the 32% range for price erosion. They saw consistent high single-digit price erosion in the first quarter, with a 6% decrease in price.

A：There were no significant hepatic safety signals or imbalances inALT above five times the upper limit of normal or in diarrhea rates observed in the clinical trials. Although diarrhea rates were higher in the study, they were also higher in the placebo group and varied by country. Rates of diarrhea were not the main focus for assessing tolerability, and discontinuations due to adverse events were considered more important.

A：Formulary positioning was used as a lever to reduce choice against other competitors. This strategy resulted in one of one formulary placement for the brand, but it was not the preferred strategy. The company aimed for multiple choices in the market, especially given the high level of innovation in the category.

A：The company does not have a specific number of patients on Zaltrap covered by CVS Caremark to share. However, they mentioned that it is a subset of accounts and emphasized the low level of employer enrollment in those plans.

A：There have been discussions regarding the Trump administration's interests in having drug manufacturers record more profits in the U.S. and generate more tax revenue. The focus has been on national security aspects through Section 232 investigations and the repatriation of supply chains, as well as the potential for raising revenue through a reconciliation process.

A：The 232 review has merit as it addresses the issue of commonly used generic medications, some of which were invented by Lilly or other innovative companies, moving toward offshore single-source competition. The branded industry would like to help with the problem of no real good pricing available, which results in a lack of onshore presence. The review could help determine if tariffs could shift the supply chain.

A：Lilly has decided to move away from just a pure efficiency focus to a more resilient position by rebalancing its sourcing. This means they have more choices and could potentially mitigate the transient effect on Lilly from global trade imbalances, although the long-term impact is not significantly affected.

A：Tax reform is key to resolving the income tax situation that has led to trade imbalances. Lilly has made investments to contain the tax issues internally, but真正的解决办法是通过税制改革调整国内与国外的税率差异。

A：Lilly notes that due to the 2017 tax reform, there are provisions for a minimum global tax, which means they already pay tax on foreign-sourced income. Consequently, whether they move operations back to the U.S. or not, the company would still face an increase in income taxes in third countries.

A：Lilly has been pleased with the performance in its sales pay segment and is removing friction for patients. They intend to continue adding products and services to further enable patients to access medications at a relatively competitive price. While no specific announcement was made, the company's focus is on expanding access and affordability for patients.

A：Lilly's new obesity treatment is a monotherapy GLP-1 agonist, not a dual agonist, which is expected to result in weight loss distinct from that seen with dual agonists. The company anticipates around a 13.7% weight loss with the GLP-1 monotherapy based on past results. As for tolerability, the study anticipates about a 21% incidence of vomiting, which is a reliable indicator. Discontinuations and tolerability events are expected to occur early in the study when patients increase their dose.

A：Lilly acknowledges that discussing drug pricing risk is not coherent without also discussing real net pricing versus Europe. The company suggests that the discussion should involve PBM reform and the 340B program. The long-term goal is to change how drugs are priced in Europe and have the U.S. pay more for R&D costs. The focus is currently on fixing the IRA problem with small molecules. While acknowledging the risk, Lilly aims to manage it as it addresses policy changes in the background.

A：Lilly has made significant progress in formulary access, starting with about 50% of employers at the beginning of 2024 and reaching mid to the high 70s by the end. In Medicaid, the number of states covering the company's products increased from 11 to 14. The company also anticipates progress in America for OSA during the second half of the year. With a strong market presence and a price point of $349 being competitive, Lilly expects to continue executing and making progress.

A：Lilly's Mama phase 2 trial data was discussed, noting that the data from the first phase 2 trial, conducted before the acquisition of the assets and in combination with semaglutide, would be disclosed first. The data from the ongoing trial in combination with tzip is of greater interest, but no specific timeline was provided. The goal of the trials is to observe positive effects on lean mass and a decrease in fat mass.