LLY Eli Lilly and Company

The current filing discusses updated risks linked to changes in Medicaid rebate calculations and rebates to 340B covered entities, potentially increasing obligations and decreasing prices, with impact on business. Prior filing mentions increased rebates but less detail.

The 2026 filing adds detailed tables on the clinical development pipeline status for numerous compounds, including approvals, submissions, and phase 3 trial initiations for cardiometabolic, immunology, neuroscience, and oncology products, with more extensive mentions of clinical trials ongoing and regulatory statuses compared to the 2025 filing.

The 2026 filing notes a U.S. Commissioner’s National Priority Voucher for orforglipron and submissions to the FDA under expedited review pathways, which were not mentioned in the 2025 filing.

The 2026 filing details capital expenditures amounting to $7.8 billion in 2025, increased manufacturing capacity efforts, and contractual obligations up to $10 billion if purchase commitments are unmet, updating the 2025 filing's $5.06 billion capital expenditures and $14 billion commitments with updated figures and focus.

2025 filing explains IRA's price-setting process and its negative implications including discount percentages, and newer policies like the BIOSECURE Act under consideration; 2026 filing instead describes ongoing risks from government pricing, pricing concessions, Medicaid impacts, with a forward-looking perspective on negotiations and their uncertain outcomes, reflecting updated regulatory conditions and agreements.

The 2026 filing updates revenue growth to 45% in 2025, $65.179 billion total revenue, $20.64 billion net income and other updated financial metrics, whereas 2025 filling reports 32% revenue growth in 2024 with $45.042 billion revenue and $10.59 billion net income, reflecting updated and new fiscal year data.

2026 filing reports acquired in-process research and development expenses of $2.91 billion in 2025 related to acquisitions including Scorpion Therapeutics and SiteOne, and outlines pending acquisitions <$3 billion in 2026; 2025 filing reports $3.28 billion IPRD in 2024, primarily from Morphic acquisition, and detailed amounts paid in 2024.

2026 filing shows total debt at $42.5 billion as of Dec 31, 2025, with cash and equivalents at $7.3 billion; 2025 filing shows total debt at $33.6 billion as of Dec 31, 2024, and cash equivalents at $3.3 billion.

2025 filing focuses on tirzepatide supply-demand dynamics and variable quarterly revenue, noting supply sometimes exceeding demand and disruptions; 2026 filing highlights incretin medicines representing 56% of revenue, pricing agreements with U.S. government, expected Medicare access by mid-2026, and regulatory concerns over counterfeit incretins, indicating a more mature market position and regulatory engagement.

In November 2025, the company announced preliminary voluntary agreements with the U.S. government to lower Medicaid and certain other drug prices and to launch new medicines with balanced pricing approaches. This is new language not in the prior filing, with associated risks and uncertainties.

Additional products such as Trulicity and Verzenio were selected for government-set prices starting in 2026 and later 2028, with a statement that more products will be selected in future years accelerating revenue erosion. This level of detail is new compared to the prior filing.

Added language warning that inadequately regulated e-commerce may increase dangerous counterfeit or mass-compounded products, impacting patient safety and the company's reputation.

The current filing has more detailed discussion on pricing pressures including the November 2025 agreements with the U.S. government, potential delays and adverse impacts from pricing concessions, and international pricing strategies, while the prior filing discusses these risks more generally without reference to such agreements.

The current filing states Mounjaro and Zepbound accounted for 56% of total revenues in 2025 and collectively six products accounted for 82% of revenues; prior filing provided 48% for Mounjaro, Trulicity, Zepbound in 2024 and 75% for six products overall. The newer filing updates these figures with 2025 data and different product grouping.

Current filing reflects ongoing and increased competition for qualified individuals and necessity to develop workforce in and outside the U.S., while prior mentions expansion but is less detailed.

Revised language highlights intensified scrutiny including risks from a shifting regulatory environment, novel programs like FDA Commissioner's voucher pilot program, and increased complexity and enforcement compared to prior.

Current filing includes discussion of climate change, greenhouse gas emissions, human rights, sustainability matters and potential negative impacts on reputation and legal risks; prior filing mentions some of these briefly but less extensively.