Two AD new drugs on the market, revenue is negative, Bojian how to recover the loss?

A few days ago, Biogen (Biogen) announced 2023Q1 financial results: Q1 total revenue of $2.463 billion, down 2.7% year on year.

It is worth noting that its core business multiple sclerosis (MS) drug series sales fell sharply, and the AD segment, which launched two new drugs in the past two years, is in deep trouble, with negative revenue.

Core plate performance decline, and deep AD quagmire

By disease segment, multiple sclerosis product line revenue was $1,125.2 million, down 19%, spinal muscular atrophy product revenue was $443 million, down 6%, and biosimilar revenue was $192.4 million, down 1%. Only CDMO and other partnerships saw revenue growth.

As a pioneer in Multiple sclerosis (MS), Biogen has six products on sale, with sales of $5.43 billion in 2022, which was the main source of the company's revenue, but decreased by $667 million year-on-year in 2021. Biogen's revenue in this segment declined again in Q1 2023, with only $1.1 billion in sales. The decline is due to competition from generic and biosimilar drugs, as well as the emergence of new drugs. In 2022, the global sales of CD20 monoclonal antibody Ocrevus reached $6.4 billion, allowing Roche to defeat Biogen and become the new hegemon of MS.

Another area of interest for Biogen is drugs for Alzheimer's disease (AD).

In two years, Biogen has introduced new drugs, Aduhelm and Lecanemab. However, Aduhelm's controversial approval, restricted use after the listing, and sales have been dismal, with a loss of $18 million in Q1 2023.

In January, Biogen and Eisai received accelerated approval from the FDA for a second Alzheimer's treatment, Leqembi. GlobalDataHealthcare analysts estimate that if Leqembi receives full FDA approval and preferential Medicare coverage, cumulative sales could reach $12.9 billion by 2028.

However, Aduhelm's failed marketing experience is still lingering, and the academic community is still skeptical of the "amyloid hypothesis". Whether the drug can be used by Bohealth in the future in the field of Alzheimer's disease is still to be seen.

Laying off workers and cutting down pipelines, where is Biogen's future hope?

In response, Biogen began cutting jobs and pipelines.

Earlier, according to foreign media reports, Biogen will start a new round of layoffs this year.

And Biogen is looking to diversify, overhauling its research and development business. During its first-quarter conference call, Biogen said it planned to cancel three clinical trials and de-prioritize its preclinical gene therapy and ophthalmology programs. Biogen chief executive Chris Viehbacher reiterated his plans to consider mergers and acquisitions, saying he was looking for "something that generates revenue in the short term".

Although Biogen is facing the decline of MS products and new products have not yet taken the lead, as a 45-year-old Biopharma, it still has a rich R&D pipeline involving neuroscience, hematology, immunology, infectious diseases and other fields, and there is still a great possibility of outbreak in the future.

As of February 15, 2023, Biogen has a total of 25 projects in its pipeline: 1 in phase IV; Nine were in stage III; Seven were in the second stage; Eight were in the first stage.

On April 26, Biogen /lonis jointly announced that the FDA had granted accelerated approval for the antisense oligonucleotide therapy Tofersen for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by superoxide dismutase 1 (SOD1) mutations. This is the first FDA-approved therapy for hereditary ALS, and it is the first ALS therapy to receive accelerated approval based on a biomarker.

Biogen and Sage Therapeutics (SAGE) announced on February 6 that the FDA has granted priority review status to their innovative drug Zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). The date of action for the PDUFA has been set at 5 August 2023. Zuranolone is a two-week, once-daily oral drug that belongs to the group of neuroactive steroids (NAS) GABA-A receptor-positive allosteric modulators (PAM). The GABA system is the main inhibitory signaling pathway in the brain and central nervous system, which helps to regulate brain function. Evaluate Pharma and Evaluate Vantage Analytics project global sales of GABA-A modulators at $1.5 billion in 2028.

These two drugs are among the most advanced in Biogen's pipeline. In addition, several early MS drugs are also worth looking forward to, including integrin antibody BIIB107, a new generation of BTK inhibitor BIIB091, and oral BIIB061.

As we all know, the research and development of innovative drugs has a long cycle, high investment and high risk, and no enterprise can always succeed. Through self-research and outsourcing, Biogen hopes to get out of the predicament and once again develop drugs that change the world and benefit mankind.