=Biogen (BIIB) reported earnings on Tue 22 Oct 2019 (b/o)

• Earnings + experimental Alzheimer's therapy -- the same drug was considered a failure in March 2019

Biogen plans to pursue regulatory approval for aducanumab for early Alzheimer's disease -- Company plans to submit Biologics License Application in early 2020

The co and Eisai (ESALY) announced that, after consulting with the U.S. Food and Drug Administration (FDA), Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease (AD). The Phase 3 EMERGE Study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the Phase 3 ENGAGE Study who received sufficient exposure to high dose aducanumab support the findings from EMERGE. Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language.

• Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer's disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
• Based on discussions with the FDA, the Company plans to file a Biologics License Application (BLA) in early 2020 and will continue dialogue with regulatory authorities in international markets including Europe and Japan. The BLA submission will include data from the Phase 1/1b studies as well as the complete set of data from the Phase 3 studies.

Biogen beats by $0.95, beats on revs

Reports Q3 (Sep) earnings of $9.17 per share, excluding non-recurring items, $0.95 better than the S&P Capital IQ Consensus of $8.22; revenues rose 4.7% year/year to $3.6 bln vs the $3.53 bln S&P Capital IQ Consensus.

"SPINRAZA continued on a strong trajectory, particularly outside the U.S., and we are preparing for the expected launch of VUMERITY, which we believe will be an important addition to our market-leading multiple sclerosis portfolio. In addition to the recent news on aducanumab, we made strong progress in our pipeline as we initiated new clinical programs targeting Parkinson's disease and brain contusion, and we look forward to nine important data readouts by the end of next year. We continue to believe that our core focus on neuroscience will lead to new innovative treatments for patients and will maximize long-term returns for our shareholders."

Recent Events

• In October 2019 the U.S. Food and Drug Administration (FDA) issued a tentative approval for VUMERITYTM (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of MS.
• In August 2019 Biogen discontinued the Phase 2b study of BG00011 for IPF due to safety concerns.

In the third quarter of 2019 Biogen recognized a GAAP-only impairment charge of approximately $216 million and a GAAP-only gain of $61 million on fair value remeasurement of contingent consideration, both related to the discontinuation of BG00011.

Shares are currently +39% after the company announced positive results from an Alzheimer's study and disclosed plans to pursue regulatory approval following discussions with the FDA.