Company: ABBV
Filing Date: 2025-02-14
Form Type: 10-K
Source: 0001551152-25-000020
Chunk: 277

Company: AbbVie Inc.
Filing Date: 2025-02-14
Form: 10-K
Item: Item 7
Chunk 277
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 a third-party manufacturer listed in the NDA. The CRL did not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and did not request that AbbVie conduct additional efficacy or safety trials related to the drug or device-related testing.

•In October 2024, AbbVie announced that the FDA approved Vyalev (ABBV-951) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Tavapadon

•In September 2024, AbbVie announced positive top-line results from its Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease.

•In December 2024, AbbVie announced positive top-line results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease. 

Emraclidine

•In November 2024, AbbVie announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale total score compared to the placebo group at week 6.

37     |  2024 Form 10-K

RESULTS OF OPERATIONS

Net Revenues

The comparisons presented at constant currency rates reflect comparative local currency net revenues at the prior year's foreign exchange rates. This measure provides information on the change in net revenues assuming that foreign currency exchange rates had not changed between the prior and current periods. AbbVie believes that the non-GAAP measure of change in net revenues at constant currency rates, when used in conjunction with the GAAP measure of change in net revenues at actual currency rates, may provide a more complete understanding of the company's operations and can facilitate analysis of the company's results of operations, particularly in evaluating performance from one period to another.Percent changeAt actual currency ratesAt constant currency ratesyears ended (dollars in millions)2024202320222024202320242023United States$43,029 $41,883 $45,713 2.7 %(8.4)%2.7 %(8.4)%International13,305 12