Lawsuit filed for Investors who lost money with shares of Biogen Inc. (NASDAQ: BIIB)

An investor, who purchased shares of Biogen Inc. (NASDAQ: BIIB), filed a lawsuit over alleged violations of Federal Securities Laws by Biogen Inc.

Investors who purchased shares of Biogen Inc. (NASDAQ: BIIB) have certain options and for certain investors are short and strict deadlines running. Deadline: July 22, 2024. NASDAQ: BIIB investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Cambrdige, MA based Biogen Inc. discovers, develops, manufactures, and delivers therapies for
treating neurological and neurodegenerative diseases in the United States, Europe, Germany, Asia, and internationally. Biogen Inc's products include, among others, Leqembi and Aduhelm for the treatment of Alzheimer's disease ("AD"), as well as various drugs for the treatment of multiple sclerosis ("MS"). Biogen's sales of its MS-related products have historically accounted for the majority of the Company's product revenues.

In recent years, increased competition from generic biosimilars of Biogen's MS-related products have eroded those products' revenue growth and led to declining sales. As a result, the Company has increasingly focused on developing new products to bolster its revenues.

In 2021, Biogen Inc. was mired in controversy after investigative reports revealed that the Company had engaged in potentially improper communications with representatives of the U.S. Food and Drug Administration ("FDA") to win regulatory approval of Aduhelm for the treatment of AD, despite concerns regarding, inter alia, the drug's safety and efficacy. Biogen Inc and the FDA's communications and conduct have been the subject of investigations by the U.S. Federal Trade Commission, the U.S. Securities and Exchange Commission ("SEC"), multiple Congressional Committees, and the Office of the Inspector General of U.S. Department of Health and Human Services.

In 2022, the U.S. Department of Justice ("DOJ") announced that Biogen Inc. had agreed to pay $900 million to settle allegations that it had caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe the Company's MS-related drugs.

Biogen Inc. replaced its Chief Executive Officer ("CEO") in November 2022 and has since released compliance, corporate responsibility, and environmental, social, and governance reports.

Biogen's Leqembi product, developed in partnership with Eisai Co., Ltd. ("Eisai"), gained FDA approval as a treatment for AD in 2023. Biogen and Eisai set a goal of having 10,000 patients on Leqembi by the end of March 2024.

In February 2023, Biogen provided non-GAAP diluted earnings-per-share ("EPS") guidance in a range of $15.00 to $16.00 per share for full year ("FY") 2023, and reaffirmed this guidance over multiple quarters.
Then, in July 2023, Biogen Inc. announced that it would acquire Reata Pharmaceuticals, Inc. ("Reata") for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3 billion (the "Reata Acquisition"). The Reata Acquisition represented an important opportunity for Biogen to strengthen its product portfolio and offset declining MS-related treatment sales with the acquisition of Reata's drug Skyclarys, which had been approved in U.S. as the only treatment indicated for patients with Friedreich's ataxia. Biogen represented that the Reata Acquisition would only be "slightly" dilutive to Biogen's non-GAAP diluted EPS in 2023.

Then on November 8, 2023, Biogen Inc. announced its third quarter 2023 results, including negatively revised non-GAAP diluted EPS guidance for FY 2023 in a range of $14.50 to $15.00 per share, significantly below its previous guidance of FY 2023 non-GAAP diluted EPS of $15.00 to $16.00 per share, citing approximately $0.75 of dilution from the Reata Acquisition.

On January 8, 2024, Biogen's CEO attended the J.P. Morgan 42nd Annual Healthcare Conference. While speaking at the conference, Biogen's CEO discussed challenges with the launch of Leqembi and walked back prior expectations of having 10,000 patients on the drug by the end of March 2024.

On January 31, 2024, Biogen Inc. announced that it was discontinuing development and commercialization of Aduhelm and "has recorded a one-time charge of approximately $60 million related to close out costs for the program in the fourth quarter of 2023."
On February 6, 2024, news reports emerged that Eisai was facing challenges with the launch of Leqembi and that only 2,000 patients in the U.S. had been administered the drug.

Then, on February 13, 2024, Biogen Inc. issued a press release announcing its fourth quarter ("Q4") and FY 2023 results, including Q4 non-GAAP EPS of $2.95, missing consensus estimates by $0.23, and Q4 revenue of $2.4 billion, missing consensus estimates by $60 million and representing a 5.5% year-over-year decline. The Company disclosed that Q4 "GAAP and Non-GAAP diluted EPS [was] negatively impacted by $0.35 related to [the] previously disclosed closeout costs for ADUHELM[.]" Moreover, on a subsequent conference call to discuss these results with investors and analysts, Defendant Viehbacher confirmed that "we've got approximately 2,000 patients on [Leqembi] at the moment" and that "we have an indication that there are about 3,800 patients as of last week on the registry"-a far-cry from the 10,000-patient goal set by the Company and Eisai for the end of following month.

Shares of Biogen Inc. (NASDAQ: BIIB) declined from $319.76 per share on June 12, 2023, to as low as $189.44 per share on April 19, 2024.

The plaintiff claims that between February 3, 2022 and February 13, 2024, the Defendants made false and/or misleading statements and/or failed to disclose that Biogen had overstated its efforts to enhance its transparency, corporate governance, and compliance controls and procedures, as well as the efficacy of those controls and procedures, that accordingly, Biogen maintained inadequate compliance controls and procedures in connection with its business operations in foreign countries, that Biogen and/or its employees were engaged in unlawful or otherwise improper conduct in several foreign countries, that the foregoing subjected the Company to a heightened risk of governmental and/or regulatory scrutiny and enforcement action, as well as significant legal, financial, and reputational harm, that Biogen overstated the strength of its AD-related product portfolio, including the Company's and Eisai's efforts and success in launching and providing access to Leqembi, that Biogen also downplayed the negative impact that the Reata Acquisition would have on its FY 2023 non-GAAP diluted EPS, that all the foregoing were likely to have a significant negative impact on Biogen's 2023 results; and that as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Biogen Inc. (NASDAQ: BIIB) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.