Pharma stock under pressure: Biogen Inc (NASDAQ: BIIB)

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Biogen Inc (NASDAQ: BIIB) stock fell 9.42% on April 22nd, 2020 and continued its bearish momentum, falling over 0.7% on 23rd April, 2020 (as of 10:57 am GMT-4; Source: Google finance)   post the first quarter of FY 20. Biogen has reported the net earnings of $1.39 billion, in the first quarter of 2020, down from $1.41 billion, in the corresponding period a year ago.

But, BIIB in the first quarter of FY 20 has reported the adjusted earnings per share of $8.08, while reported the adjusted revenue growth of 1 percent to $3.53 billion in the first quarter of FY 20. The sales of its spinal muscular atrophy treatment Spinraza grew 9% to $565 million during the first quarter, and the company reported an additional $100 million in revenue from accelerated sales as people picked up prescriptions earlier than anticipated as they prepared for stay-at-home orders, mainly in Europe. The company plans to complete the regulatory filing for its experimental and somewhat controversial Alzheimer’s disease drug aducanumab in the third quarter of this year.

Moreover, during the first quarter, the company has made good progress toward the regulatory filing in the U.S. for aducanumab. The company continues to have constructive engagement with the U.S. FDA. The company now has an open BLA and has started to submit modules of the filing. The company has participated in additional formal interaction using mechanisms such as Type C meetings and are preparing for a pre-BLA meeting currently scheduled for this summer. After that meeting, the company anticipates to complete the filing in Q3. Further, outside the U.S., the company had initial aducanumab discussions with regulators in Europe and Japan, although these interactions are still in the early stages.

In addition, from a manufacturing standpoint, the company is currently anticipate to have adequate supply to meet anticipated demand for aducanumab, which are initially using the facility in RTP North Carolina, which will later be complemented by the large next-generation state-of-the-art facility, the company is building in Solothurn, Switzerland. The construction is complete and its validation is on track. The company anticipates it to be operating by the end of this year and to be producing some of the commercial supply of aducanumab in mid-2021.

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