AMGN 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• Letter, including the Administration’s MFN pricing requests. We also announced the expansion of our direct-to-patient program. As part of the Administration’s MFN pricing initiative, CMS also announced the GENEROUS Model, under which we and other participating manufacturers will provide additional s…

• In June 2026, we announced that the European Commission has granted marketing authorization for IMDYLLTRA as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-b…

• Total product sales increased 9% for the three months ended June 30, 2026, driven by volume growth. Total product sales increased 7% for the six months ended June 30, 2026, driven by volume growth of 9%, partially offset by lower net selling price.

• For the six months ended June 30, 2026, U.S. volume grew 9% and ROW volume grew 10%, driven by certain brands, including Repatha, EVENITY, IMDELLTRA/IMDYLLTRA, UPLIZNA, PAVBLU and TEZSPIRE.

• Other revenues increased 27% and 34% for the three and six months ended June 30, 2026, respectively, driven by higher corporate partner revenue and royalty income.

相对上期删除的文字 · 来源:10-Q · 2026-05-01

• light of such evolving regulatory and policy expectations. See Part II, Item 1A. Risk Factors—Changing U.S. federal coverage and reimbursement policies and practices have affected, and are likely to continue to affect, access to, pricing of, and sales of our products, of this Quarterly Report on For…

• In April 2026, we announced positive topline results from a Phase 3 trial of TEPEZZA administered by subcutaneous injection via an on-body injector (OBI) in participants with moderate-to-severe active thyroid eye disease (TED) that demonstrated that TEPEZZA OBI provides comparable efficacy to intrav…

• On March 31, 2026, the FDA issued a DSC in which it alerted patients and health care professionals about serious liver injury cases, including fatal cases, of DILI associated with TAVNEOS. The DSC is based on data available through October 9, 2024 and provides information about DILI and VBDS associa…

• Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements, and Part II, Item 1A. Risk Factors—Our current products and products in development cannot be sold without regulatory approval, of this Quarterly Report on Form 10-Q.

• Total product sales increased 4% for the three months ended March 31, 2026, driven by volume growth of 9%, partially offset by declines in net selling price of 2% and 2% from lower wholesaler and end user inventory.

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• At the state level, legislation, government actions and ballot initiatives can also affect how our products are covered and reimbursed and/or create additional pressure on our pricing decisions. Existing and proposed state pricing laws, which may move forward more rapidly than similar efforts at the…

• States continue to pursue laws related to price controls, referencing the IRA and seeking to regulate and prohibit restrictions on the 340B Program. For example, following the passage of the IRA, bills have been proposed in multiple states that would apply the drug price caps set by HHS for Medicare…

• The Administration has also taken steps to streamline the drug importation program and ease the process for states to obtain FDA authorization. In June 2026, the FDA authorized Colorado’s drug importation program. Maine, New Hampshire, New Mexico, Texas and Vermont have also enacted state importatio…

• Failure to obtain coverage and reimbursement for our products, a deterioration in their existing coverage and reimbursement, or a decline in the timeliness or certainty of payment by payers to hospitals and other providers, has negatively affected, and may further negatively affect, the ability or w…

• services. In the past, a security incident affecting such a third-party provider exposed several hundred corporate customers to potential unauthorized access to systems and data. Although that breach did not have a significant effect on our business, there can be no assurance that a similar future b…

相对上期删除的文字 · 来源:10-Q · 2026-05-01

• At the state level, legislation, government actions and ballot initiatives can also affect how our products are covered and reimbursed and/or create additional pressure on our pricing decisions. Existing and proposed state pricing laws, which may

• move forward more rapidly than similar efforts at the federal level, have added complexity to the pricing of drugs. A number of states have adopted, and many other states are considering, PDABs, drug importation programs, reference pricing schemes and other drug pricing actions, including proposals …

• States continue to pursue laws related to price controls, referencing the IRA and seeking to regulate and prohibit restrictions on the 340B Program. For example, following the passage of the IRA, bills have been proposed in multiple states that would apply the drug price caps set by HHS for Medicare…

• Additionally, in 2024, the FDA authorized Florida to move forward with its importation program proposal, though the state has not yet completed any significant steps towards importation within the two-year authorization window. Colorado, Maine, New Hampshire, New Mexico, Texas and Vermont have also …

• continue to seek, price discounts or rebates in connection with the placement of our products on their formularies or those they manage, and to also impose restrictions on access to, or usage of, our products (such as Step Therapy), require that patients receive the payer’s prior authorization befor…