Biogen Update September 12th, 2023
This is not a recommendation or proposal to do anything. The data written in this article is not guarranteed. It is my private personal opinion. I`m not independing as I own a position of Biogen shares.
My personal knowledge about pharmacy is very limited. It is difficult for me to evaluate medicine in terms of efficacy, market position, potential pricing and potential revenues. Hence I`m perhaps not the best analyst for pharmaceutical companies.
Biogen, Symbol: BIIB, is one of the largest biotech companies with revenues of about 10 bn$ and a market capitalization of nearly 40 bn$ (share price 277$). The company’s product line consists of a handful of very expensive and highly effective drugs used to treat serious diseases including multiple sclerosis (MS), leukemia, Alzheiner(new) and hemophilia. It adds a smaller less profitable biosimilar business. The biggest business is the MS business. The biggest new product is Aduhelm.
Biogen is going to acquire Reata Pharmaceuticals for 7.3 bn$. It is a rare disease drug developer. It includes the newly approved drug Skyclarys, which is the only medicine approved to treat Friedreich's ataxia.
Biogen is considering selling its Biosimilar business to Samsung Bioepis (26). Biogen has more than 70 biosimilars approved in Europe and 35 in the US. The division generated revenue of $751M in fiscal 2022, according to its website. Indian drugmaker Intas Pharmaceuticals is reportedly readying a bid for Biogen’s biosimilars business at up to $1B. This might be a first step to make itself a take-over candidate.
Chances & Risks
The numbers of Biogen are below that of 2021 and 2022. The guidance for 2023 shows a further decline. Revenues, profits slipped with the loss of the patent protection of Tecfidera and declining of other MS drug sales.
Biogen business numbers look like a Stuka in the dive.
"Aduhelm, the recently-approved FDA medication developed by Biogen and Eisai led to brain swelling among 35% of patients who received the drug at the recommended dose, the company researchers said in a study. With the drug available for a wider patient population following the FDA approval, the researchers are now evaluating the potential consequences of its side effects known as amyloid-related imaging abnormalities (ARIA)" (20). The big hope for Biogen Aduhelm, the first drug against Alzheimer is gone. In the meantime lecanemab took its place. A further Alzheimer drug is in phase II.
The general challenges for drug makers are...
- Many countries like the Europeans regulate the prices of drugs and thus limit the profits.
- Other countries as India often break the patents if the drugs seems too expensive.
- The duration of patents is limited
- It is to fear that the USA will regulate drug prices following the European example
Existing pharmaceutics loosing sooner or later their patent protection or are replaced by better ones. That means the revenues from the existing portfolio are declining sooner or later. The main question is if there are enough new products in the pipeline to replace the declining revenues from existing products.
Acc. to BIIB presentation the company has 30 new products in clinical trials or filed. As a rule of thumb...For every 10 that head into clinical trials with high hopes, one will get to market. It needs in average 7 years to get a product thru the clinical trials. It is the question how many of these products are getting into the market and how well these products perform. But anyhow even if the lost revenues should not become replaced completly....the risk is limited as the share price is not high.
A reason to buy BIIB is the high return to the shareholders. BIIB does not pay a dividend but buys back plenty of its shares.
Some more reasons to buy BIIB:
Are its products relevant after 5 years? Yes. (+)
Short Product Development Cycle? No (-)
Long product cycle? Yes (+)
High Moats vs. competition? Yes (+)
Cyclical? No. People need medicine in good and bad economy. (+)
PE less than industry? Yes 10 less than 19.01(+)
Book Value growing? (+)
PEG ratio? -
Revenue per Share : (+)
Outstanding shares reducing? Yes, through buyback (+)
Some Data:
Number of Shares: 220,508,784 Outstanding 145 mio. Remainder treasury Shares. That is at a share price of 277$ a market capitalization of 40 bn$ (July, 2023).
The core MS business with the no 1 product Tecfidera dived down since 2020.
Pipeline
3 new drugs are launched in 2023
Informations:
News
Feb08, 2023 The (FDA) has accepted a new drug application (NDA) filing by Biogen and Sage for their investigational drug zuranolone to treat major depressive disorder (MDD) and postpartum depression (PPD) (25).
Jan28, 2022, Samsung Biologics has reached an agreement with Biogen to buy out the US biotechnology firm’s stake in Samsung Bioepis for $2.3 billion
Dec. 20, 2021 BIIB reduced the price of an annual dose of Aduhelm (Alzheimer) to 28.200$ (23)
Nov. 17, 2021 BIIB announced that it received a negative trend vote regarding the marketing authorization application for Alzheimer’s therapy aducanumab in Europe. (19).
October 11, 2021 Roche got a Breakthrough Therapy Designation by the FDA. It seems that the Roche Gantenerumab is easier to apply as the Biogen Aduhelm (18).
September 28, 2021 "Biogen accused of illegal practices to boost sales of multiple sclerosis drugs". "According to a lawsuit filed by the health insurer Humana (NYSE:HUM), the company is alleged to have offered the drugs Tysabri, Avonex, and Tecfidera for free on a temporary basis for multiple sclerosis patients who lacked medical insurance. After a few months, the company would encourage patients to sign-up for government-funded healthcare and then channel the “illegal copayment assistance to those same patients under the guise of unrestricted charitable giving,” Bloomberg reported quoting Humana (17)
March 08,2020 BIIB signed a partnership agreement with Sangamo for the use of zinc-finger technology to progress various neurological disease candidates. BIIB paid $350m in cash plus buying shares (13).
June 07,2019 BIIB announced that it bought Nightstar Therapeutics (NST), a clinical-stage gene therapy company, focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. As a result Biogen got ded two mid- to late-stage clinical assets, as well as preclinical program, in ophthalmology. BIIB paid $800 million(5).
Shareholders from market screener (4)
Name %
PRIMECAP Management Co. 7.38%
The Vanguard Group, Inc. 7.20%
BlackRock Fund Advisors 5.40%
ClearBridge Investments LLC 4.39%
SSgA Funds Management, Inc. 4.39%
Wellington Management Co. LLP 2.75%
Fidelity Management & Research Co. 2.04%
AllianceBernstein LP 1.55%
AQR Capital Management LLC 1.50%
Northern Trust Investments, Inc. 1.38%
The big asset managers hold an important share of Biogen
References:
Biogen investor relations
(26) 2023/08/04 https://www.fiercepharma.com/pharma/biogen-set-sell-its-biosimilars-unit-longtime-ally-samsung-bioepis-report
(25) 2023/02/08 https://www.pharmaceutical-business-review.com/news/fda-nda-filing-biogen-sage-zuranolone/
(24) 2022/01/28 http://www.koreaherald.com/view.php?ud=20220128000539&np=1&mp=1
(21) 2021/12/01 https://endpts.com/appeals-court-puts-the-final-nail-in-the-coffin-for-tecfidera-patent-adding-to-biogens-burgeoning-setbacks/
(18) 2021/10/11 https://handelszeitung.ch/unternehmen/nun-hat-auch-roche-seinen-durchbruch-bei-alzheimer?utm_source=Handelszeitung+Newsletter&utm_campaign=d9c3088586-LUNCH_TOPICS_2021_10_11&utm_medium=email&utm_term=0_c1505081ea-d9c3088586-92780129
(15) 2020/07/28 https://www.fool.com/investing/2020/07/25/heres-why-biogen-just-blew-its-q2-earnings-out-of.aspx
(14) 2020/07/20 https://www.biopharmadive.com/news/biogen-loses-tecfidera-patent-case-mylan/580096/
(11) 2019/10/25 https://seekingalpha.com/article/4298721-biogen-amyloid-alzheimers-disease-rabbit-hole?dr=1
(10) 2019/10/25 https://seekingalpha.com/article/4298768-biogen-aducanumab-reversal-stunning-expect-repeat-alzheimers-drugs?dr=1
(7) 2019/10/22 https://seekingalpha.com/article/4297782-biogen-inc-2019-q3-results-earnings-call-presentation?dr=1
(6) 2019/07/26 https://seekingalpha.com/filing/4570750
(4) 2019/05/21 https://www.marketscreener.com/BIOGEN-4853/company/
(3) 2019/05/03 https://seekingalpha.com/article/4258810-biogens-share-price-will-likely-pressure-zolgensma-receives-fda-approval
(2) 2019/01/24 https://seekingalpha.com/news/3453349-biogen-1-percent-q1-beat-strong-spinraza-sales?dr=1#email_link
(1) 2019/01/29 https://seekingalpha.com/article/4236192-biogen-inc-2018-q4-results-earnings-call-slides?app=1&dr=1
2018/10 https://www.fool.com/investing/2018/10/23/cornings-growth-accelerates-as-investments-begin-t.aspx