Headcount: 9,100
Revenues: $13,445 (-7%)
Net Income: $4,001 (-32%)
R&D: $3,991 (+75%)

TOP SELLING DRUGS

Biogen, focused on innovative therapies for serious neurological and neurodegenerative diseases, as well as related therapeutic adjacencies, has 10 programs either in Phase 3 or filed with regulatory agencies, including in Alzheimer’s disease, neuropsychiatry, amyotrophic lateral sclerosis (ALS) and ophthalmology.

In 2020, the company added or advanced 12 clinical programs, bolstering its early- and late-stage pipelines through both internal development and collaborations.

In March 2020, Biogen acquired BIIB118 (CK1 inhibitor), a novel CNS-penetrant small molecule inhibitor of casein kinase 1, for the potential treatment of behavioral and neurological symptoms across various psychiatric and neurological diseases, from Pfizer. The company is developing BIIB118 for the potential treatment of irregular sleep wake rhythm disorder (ISWRD) in Parkinson’s disease and plans to develop BIIB118 for the potential treatment of sundowning in Alzheimer’s disease.

In April 2020 Biogen closed a collaboration and license agreement with Sangamo Therapeutics, Inc. to develop and commercialize ST-501 for tauopathies, including Alzheimer’s disease; ST-502 for synucleinopathies, including, Parkinson’s disease; a third neuromuscular disease target; and up to nine additional neurological disease targets to be identified and selected within a five-year period. The companies are leveraging Sangamo’s proprietary zinc finger protein technology delivered via adeno-associated virus to modulate the expression of key genes involved in neurological diseases.

Biogen also closed a collaboration and license agreement with Denali Therapeutics to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease. In addition to the LRRK2 program, it also has an exclusive option to license two preclinical programs from Denali’s Transport Vehicle platform, including its Antibody Transport Vehicle (ATV): ATV enabled antiamyloid beta (Abeta) program and a second program utilizing its Transport Vehicle technology. Further, Biogen has a right of first negotiation on two additional Transport Vehicle-enabled therapeutics.

In December 2020 Biogen closed a global collaboration and license agreement with Sage Therapeutics, Inc. to jointly develop and commercialize zuranolone for the potential treatment of major depressive disorder, postpartum depression and other psychiatric disorders, and SAGE-324 for the potential treatment of essential tremor and other neurological disorders.

Of Biogen’s advancing assets, the EMA accepted for review the MAA for SB11, and the FDA accepted the BLA for SB11. Biogen has exclusive rights to commercialize SB11 in major markets pursuant to its 2019 agreement with Samsung Bioepis. SB11 is a proposed ranibizumab biosimilar referencing Lucentis.

Possibly the biggest news of the last year was the recent FDA approval of aducanumab, the first novel therapy for Alzheimer’s disease approved since 2003. Biogen and Japanese partner Eisai developed aducanumab, administered through intravenous infusion to treat early Alzheimer’s disease. The drug was developed for mild cognitive impairment, not severe dementia.

Headcount: 7,400
Revenues: $14,379 (+10%)
Net Income: $5,889 (+33%)
R&D: $2,281 (-12%)

TOP SELLING DRUGS

In its efforts to build a multi-franchise portfolio, Biogen added seven new clinical programs in 2019 and expects 11 mid- to late-stage data by the end of 2021, including several near-term opportunities in Alzheimer’s disease, ALS, stroke, lupus, ophthalmology, and biosimilars.

For $75 million upfront and up to $635 million in potential additional payments, Biogen expanded its pipeline of disease-modifying therapies for Alzheimer’s and Parkinson’s diseases, acquiring from Pfizer, PF-05251749, a CNS-penetrant small molecule inhibitor of casein kinase 1 for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. Biogen plans to develop the Phase I asset for the treatment of Sundowning in Alzheimer’s disease (AD) and Irregular Sleep Wake Rhythm Disorder in Parkinson’s disease (PD).

Complementing its expanding efforts in gene therapy across neurological diseases, a broad collaboration with Sangamo Therapeutics for gene regulation therapies in neurology, will initially focus on development of ST-501 for tauopathies including Alzheimer’s disease, ST-502 for synucleinopathies including Parkinson’s disease, and a neuromuscular target, with exclusive rights for nine additional neurological targets. Biogen paid $350 million upfront, including a license fee and an equity investment. Sangamo is eligible to as much as $2.37 billion in potential milestones and royalties.

Also, in a transaction valued at approximately $800 million, the acquisition of Nightstar Therapeutics added gene therapies focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. NST’s lead assets, NSR-REP1 for the treatment of choroideremia (CHM), a rare, degenerative, X-linked inherited retinal disorder which leads to blindness, and NSR-RPGR, for X-linked retinitis pigmentosa (XLRP), also a rare inherited retinal disease for which there are no approved treatments.

Further, in a significant new transaction with Samsung Bioepis, Biogen acquired commercialization rights to biosimilars of Lucentis (SB11) and Eylea (SB15) in the U.S. and other major markets. Biogen is paying $100 million upfront for the rights and another $210 million in development, regulatory and sales targets. Lucentis was the first VEGF inhibitor approved for wet AMD and grew into a blockbuster with sales of around $3.9 billion last year, with Roche reporting $1.8 billion and Novartis, $2.1 billion. While Regeneron’s rival VEGF Eylea, reported $7.9 billion in sales, up 17% in 2019. Lucentis and Eylea are widely used to treat ophthalmologic conditions and together make up the largest share in the wet AMD market.

Biogen also gained exclusive rights to Samsung’s anti-TNF portfolio under the deal, including BENEPALI (etanercept), FLIXABI (infliximab) and IMRALDI (adalimumab), in China.

Of its advancing assets, VUMERITY, a new oral treatment option for relapsing forms of MS, won FDA approval to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Also, Biogen and Eisai plan to pursue regulatory approval for aducanumab in early Alzheimer’s disease. The Phase III EMERGE Study met its primary endpoint showing a significant reduction in clinical decline on measures of cognition and function. If approved, aducanumab would become the first therapy to reduce the clinical decline of AD and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.

However, the companies discontinued Phase III studies of the investigational oral BACE inhibitor elenbecestat in early AD based on an unfavorable risk-benefit ratio. As part of this decision, the long-term extension of the Phase II trial of elenbecestat will also be discontinued. The program of the anti-amyloid beta (Aβ) protofibril monoclonal antibody BAN2401, and the Phase III Clarity AD trial of BAN2401 will continue.

In other disappointing news, a Phase II study of gosuranemab (BIIB092) for progressive supranuclear palsy (PSP) did not demonstrate efficacy on key clinical endpoints, and as a result, Biogen discontinued development of gosuranemab for PSP and other primary tauopathies. Biogen will continue its ongoing Phase II study of gosuranemab in mild cognitive impairment due to AD or mild AD.

COVID-19 News
Biogen and Vir Biotechnology entered an antibody development and manufacturing agreement to develop Vir’s monoclonal antibodies against coronavirus. Biogen will provide cell line development, process development and clinical manufacturing for Vir’s monoclonal antibodies. Vir has discovered antibodies that bind to the novel coronavirus, and is testing whether they can treat or prevent the infection.

Headcount: 7,800
Revenues: $13,453 (+10%)
Net Income: $4,431 (+75%)
R&D: $2,597  (+15%)

Top Selling Drugs  

A steady growth trajectory has Biogen up in the rankings this year. In addition to its flagship multiple sclerosis franchise, the continued global launch of spinal muscular atrophy drug Spinraza, which contributed $518 million in revenues in the first quarter, up 42%, is driving growth.

Biogen continues to diversify its pipeline in neuromuscular diseases and movement disorders, and, with the recent acquisition of Nightstar Therapeutics, specialty ophthalmology. By the end of 2020 the company expect results across its clinical programs in MS, progressive supranuclear palsy, ALS, Parkinson’s, pain, cognitive impairment in schizophrenia, epilepsy, stroke, and lupus.

In June, Biogen completed the acquisition of Nightstar Therapeutics, a gene therapy company focused on adeno-associated virus (AAV) treatments for inherited retinal disorders, in a transaction valued at approximately $800 million. Biogen added two mid- to late-stage clinical assets as well as preclinical programs in ophthalmology. NST’s lead asset is NSR-REP1 for the treatment of choroideremia, a rare, degenerative, X-linked inherited retinal disorder, which leads to blindness and has no approved treatments. NSR-RPGR is NST’s second clinical program for X-linked retinitis pigmentosa, which is also a rare inherited retinal disease with no approved treatments.

Further investing in its biosimilar business, under an asset transfer deal with its collaboration partner Samsung BioLogics, assets of Samsung Bioepis were transferred to Biogen on November 7th for approximately $677 million. Samsung Bioepis was founded in 2012 as an 85:15 joint venture between Samsung BioLogics and Biogen. Last June Biogen raised its stake in Bioepis, increasing its ownership to 49.9 percent.

Under the successful alliance, Biogen became the first company in Europe with approved biosimilars referencing the three most prescribed anti-TNF biologic treatments, with the launch of IMRALDI, a biosimilar referencing Abbvie’s Humira.

After evaluating its manufacturing strategy, in March, Biogen sold its large-scale biologics manufacturing operations in Hillerød, Denmark, to Fujifilm Corp. for up to $890 million. As part of the deal, Fujifilm will use the Hillerød site to produce commercial products for Biogen, such as TYSABRI, and other third-party products.

In unfortunate R&D news, the discontinuation of aducanumab for Alzheimer’s disease was a big disappointment. Biogen and partner Eisai discontinued global Phase III trials after futility analysis indicated the trials were unlikely to meet their primary endpoint.

On the upside, Biogen is a few months away from expanding its MS franchise with Vumerity, which has an FDA target action date in 4Q19. Recent Phase III study results showed Vumerity significantly reduced disease activity in newly diagnosed relapsing multiple sclerosis patients.

To support research efforts in neurological diseases, an alliance with C4 Therapeutics will investigate the use of C4’s protein degradation platform to develop new treatments for neurological conditions, such as Alzheimer’s and Parkinson’s. Biogen will pay C4 up to $415 million in upfront and potential milestones.      Additionally, Biogen paid $74 million upfront to Skyhawk for research services and an exclusive license to therapeutic candidates for multiple sclerosis, spinal muscular atrophy and other neurological diseases to be developed using SkySTAR platform, which offers a new approach to target neurological conditions using selective RNA-modulating small molecules.

Headcount: 7,300
Revenues: $12,274 (+7%)
Net Income:  $2,539 (-31%)
R&D: $2,254 (+14%)

Top Selling Drugs 

Biogen ended 2017 reporting record revenues following the successful launch of Spinraza, and numerous key executive hires. The company added seven clinical programs to its pipeline, including BIIB098 for multiple sclerosis, BIIB092 for both Alzheimer’s disease and progressive supranuclear palsy, and BIIB076 for Alzheimer’s disease. Gazyva, for previously untreated advanced follicular lymphoma, was approved by the FDA in collaboration with Genentech after positive Phase III results showed the Gazyva-based regimen significantly reduced the risk of disease worsening or death compared to a Rituxan-based regimen by 28 percent.

The year was also eventful on the collaboration front. Biogen and Alkermes entered into a global license and collaboration agreement in November 2017 to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate small drug molecule in Phase III development for the treatment of relapsing forms of multiple sclerosis. In another collaboration, Biogen and Ionis Pharmaceuticals expanded an existing partnership through a new ten-year agreement to develop novel antisense drug candidates for a broad range of neurological diseases. Biogen will pay Ionis $1 billion in cash, which includes $625 million to purchase 11,501,153 shares of Ionis stock, and a $375 million upfront payment. The companies plan to advance programs for a broad range of neurological diseases for which few treatment options exist today, including dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry.

In January 2018, Biogen committed $10 million in a project with Regeneron Pharmaceuticals, Pfizer, AbbVie, AstraZeneca, and Alnylam Pharmaceuticals to collect genetic information on 500,000 people in the UK Biobank database to help accelerate new drug discovery and improve approval success rates.

In clinical trial news, Biogen initiated AFFINITY, a Phase II trial designed to evaluate opicinumab, a human monoclonal antibody targeting LINGO-1—as an investigational add-on therapy in relapsing forms of multiple sclerosis. The trial follows a post-hoc analysis of a Phase II trial involving opicunumab, which identified a specific population of patients with relapsing multiple sclerosis that may be more likely to benefit from the therapy.

Biogen had a very active year with acquisitons. The company entered into an exclusive option agreement with TMS Co., Ltd. to acquire TMS-007 and backup compounds. The agreement included an upfront payment of $4 million and an additional $18 million payment if Biogen exercises its option, with up to $335 million in potential development and commercialization milestones as well as tiered royalties. TMS-007 is a plasminogen activator with a novel mechanism of action associated with breaking down blood clots, and is believed to inhibit local inflammation at the site of thrombosis. Biogen also acquired an experimental ALS drug, KPT-350, from Karyopharm Therapeutics in a transaction worth up to $217 million in upfront and milestone payments.

While there were no billion dollar acquisitions during the year as expected, CEO Michel Vounatsos said in a January 2018 conference call that at the moment in the acquisition space, Biogen is keeping an eye on early assets, where he feels there is the chance to add “tremendous value” to the company.

Headcount: 7,400
Revenues: $11,449 (+6%)
Net Income: $3,703 (+4%)
R&D: $1,973 (-2%)

Top Selling Drugs 

Coming off a year that ended well for Biogen, rumors of a merger with Sanofi arose following the appointment Michel Vounatsos as its new chief executive officer on December 19, and the approval of Spinraza, a potential blockbuster to treat spinal muscular atrophy, on December 23. A Sanofi-Biogen deal would create a 60% stronghold in the oral MS market.

Spinraza, which was developed by Ionis Pharmaceuticals and licensed by Biogen, was approved under Priority Review by the FDA and is the first treatment for spinal muscular atrophy in pediatric and adult patients. Analysts estimate that Spinraza could generate revenues of as much as $428 million in 2017, with sales potentially reaching $2 billion by 2020.

Also in December, Biogen presented positive data from the Phase Ib PRIME study, showing its investigational drug aducanumab slows cognitive decline in patients in the early stages of Alzheimer’s disease, while reducing the amyloid plaque levels compared to the placebo group.

Aducanumab is currently being evaluated in two global Phase III studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in early AD. The success of this drug would add billions in annual sales to Biogen’s top line, but that’s counting chickens before they hatch.

Moreover, Biogen recently paid Bristol Myers-Squibb $300 million upfront, plus as much as $410 million for milestones and potential royalties, for BMS-986168, a Phase II-ready antibody targeting extracellular tau, the protein that forms the deposits in the brain associated with Alzheimer’s Disease and other neurodegenerative tauopathies such as Progressive Supranuclear Palsy. Biogen plans to rapidly initiate Phase II studies for BMS-986168 in both indications.

In another asset acquisition, Biogen acquired Remedy Pharmaceuticals’ Phase III candidate, CIRARA for the potential treatment of large hemispheric infarction, a severe form of ischemic stroke where brain swelling often leads to stroke-related morbidity and mortality. The FDA recently granted CIRARA Orphan Drug status, along with Fast Track designation.

Meanwhile, in the multiple sclerosis space, revenue from Biogen’s top-selling drug, Tecfidera, reached nearly $4.0 billion, up 9%. Even though there was a slight softening in overall market, particularly in the U.S., the European market continues to grow, albeit at a slower pace.

Equally significant, Fampyra was granted marketing authorization in the EU. As the first treatment to address both the unmet need of walking improvement in MS, as well as clinical efficacy in MS, it has potential to substantially impact this market. Biogen has a license from Acorda Therapeutics for rights in all markets outside the U.S.

In the way of strategic business ventures, Bioverativ, the spinoff of Biogen’s global hemophilia business, began trading January 2017. Sales of its hemophilia drugs, Eloctate and Alprolix generated combined revenues of $847 million in 2016, up 53%.

Biogen’s pipeline aims to address some of the greatest challenges in medicine, including Alzheimer’s disease, Parkinson’s, and ALS, let’s hope they succeed. We’ll have to see about Biogen becoming a potential takeover target.

Headcount: 7,350
Revenues: $10,764 (+11%)
Net Income: $3,547 (+21%)
R&D: $2,013 (+6%)

Top Selling Drugs 

Coming off another great year, Biogen continued its growth in 1Q16 with revenues up 7% to $2.7 billion and earnings of $971 million, up 18%. Growth was driven by Tecfidera, up 15% to $946 million, Eloctate sales of $108 million, and Alprolix sales of $75 million. While revenues were partially offset by a 19% drop in Avonex sales, Tysabri brought in $477 million, up 3%.

Among recent pipeline advances, Biogen and AbbVie won FDA approval for Zinbryta (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS). Zinbryta significantly reduced the annualized relapse rate, the primary endpoint of studies, by 45% compared to Avonex and by 54% compared to placebo.

EU approval for Zinbryta is on the horizon as well and some analysts expect the drug to reach peak sales of around $500 million. While Zinbryta offers greater convenience, Biogen already markets its every-two-weeks MS treatment Plegridy, approved in 2014, and both drugs will compete with Avonex.

Biogen’s MS franchise is not without its challenges. Tecfidera, despite impressive sales, has seen a slowing growth rate, and earlier this year Europe revoked one of its key patents. Biogen is appealing the decision but stands to lose as much as $1 billion in annual sales if it fails.

On the biosimilar front, Biogen won key approvals in the EU for Flixabi, an infliximab biosimilar referencing Remicade, developed by the joint venture Samsung Bioepis, and Benepali, the first Etanercept biosimilar referencing Enbrel.

Among Biogen’s late-stage assets, Aducanumab, its investigational drug for early Alzheimer’s disease was accepted into the EMA PRIority MEdicines (PRIME) program, and is currently being evaluated in two global Phase III studies for safety and efficacy in slowing cognitive impairment and disease progression.

Finally, Biogen recently unveiled plans to spin off its hemophilia business as part of an effort to focus on neurology therapies. In January, Biogen and development partner Sobi received EU approval for ELOCTA for the treatment of haemophilia A, and in May, Alprolix, an extended half-life therapy for haemophilia B was approved. The two drugs, previously approved in the U.S., had combined revenues of $640 million during the twelve-month period ended March 31, 2016. Biogen says the spin-off will result in two lean, profitable companies.

Headcount: 7,500
Revenues: $9,703 (+40%)
Net Income: $2,941 (+58%)
R&D: $1,893 (+31%)

TOP SELLING DRUGS

With a mounting market share in multiple sclerosis (MS), successful launches for its hemophilia products, and a promising Phase III-ready Alzheimer’s candidate, Biogen’s momentum seems inexorable. Coming out of the gate strong in 1Q15, with sales up 20% to $2.6 billion, Biogen’s revenue streams are slated to continue to flow.

The company’s main strength in MS has led to a big year. Tecfidera, an oral alternative to widely used injection-based MS therapies, saw $2.9 billion in sales, up an impressive 232%.

While approximately 95% of Biogen’s revenue comes from its MS portfolio, the company is trying to change that. Hemophilia products, Eloctate, a long-lasting therapy for hemophilia A and Alprolix a long-lasting hemophilia B drug, continue to gain market share. Entering the $7 billion annual market in 2014, Alprolix revenues were $76 million and Eloctate revenues were $58 million, and in 1Q15 contributed a combined $96.7 million to sales.

Biogen’s pipeline also includes the promising aducanumab, an Alzheimer’s disease (AD) candidate that in December achieved compelling enough data to advance from Phase Ib directly into Phase III, skipping Phase II entirely. Later this year, Biogen plans to initiate two large Phase III studies in approximately 2,700 patients targeting early-stage AD.

Getting down to the root cause of this devastating disease has proven elusive in the past—namely Eli Lilly’s solanezumab and Pfizer and Johnson & Johnson’s bapineuzumab, both of which failed in late-stage trials. Despite historically high clinical failure rates in AD, the company has committed $2.5 billion to cover Phase III R&D costs, along with a new manufacturing facility to accommodate an anticipated launch of aducanumab into a market with millions of Alzheimer’s patients. Should it prove successful, analysts have predicted that peak sales figures for aducanumab could fall in a record range of $14.5 billion.

Biogen’s biosimilars joint venture with Samsung Biologics is also advancing, having filed for European approval of biosimilars to Enbrel and Remicade, and plans include additional filings. Biogen has a 15% stake in the JV, which could prove lucrative, with Amgen’s Enbrel having brought in $4.7 billion (+11%) in 2014 and Remicade, $4.2 billion (+7%)—both of which have aging patents.

Biogen’s 38% share in the $17 billion annual MS market is certainly the company’s lifeblood. While Eloctate and Alprolix have plenty of room to grow, the goal to further diversify its business will require some (or perhaps just one) significant FDA approval/s. Should aducanumab meet with success in AD, the financial impact would be immeasurable. Let’s hope for all those suffering with AD, this drug takes the cake.

Headcount: 5,950
Biopharma Revenues: $5,542 (33%)
Total Revenues: $6,932 (26%)
Net Income: $1,862 (35%)
R&D Budget: $1,44 (48%)

Top Selling Drugs  

Fast growing Biogen Idec made major headway in 2013, advancing its most promising pipeline candidates and establishing a dominant position in the MS market. In looking at the snowballing numbers, revenues climbed 26% to $6.9 billion powered by sales of new multiple sclerosis (MS) drug, Tecfidera, with sales of $876 million for the year (and a whopping $506 million in 1Q14), along with Tysabri, up 34% to $1.5 billion as a result of recording 100% of revenues after gaining full rights from Elan.

To top it off, the EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that dimethyl fumarate in Tecfidera qualifies as a new active substance (NAS), a designation that provides 10 years of regulatory exclusivity in the EU. Moreover, Elan and Biogen secured additional patent protection on Tysabri, taking exclusivity out to 2020 from 2017.

Hemophilia Wins, Tecfidera Drove Success Last Year
Several big wins for Biogen’s hemophilia assets and Tecfidera drove success in 2013. Eloctate just recently received FDA approval for the control and prevention of bleeding episodes in hemophilia A. Extending the interval between infusions, Eloctate is the first recombinant hemophilia A therapy with prolonged circulation in the body, and the only treatment to reduce the frequency of bleeding episodes. The drug entered a $6 billion hemophilia A market—six times larger than that of hemophilia B treatments—with a survey of analysts by Reuters estimating an average peak sales forecast of $1.5 billion.

Likewise, Alprolix, the first recombinant DNA derived hemophilia B therapy with prolonged circulation in the body, was also approved (U.S. and Canada), marking a significant advance in treatments in more than 17 years. The therapy is shown to reduce bleeding episodes with protective infusions starting at least a week apart.

The hemophilia wins follow the landmark approval for Tecfidera, which has emerged as a new standard therapy. This past February the drug was approved in the EU as a first-line oral treatment in relapsing-remitting multiple sclerosis (RRMS). The drug was first approved in the U.S. in March 2013 and became the number one prescribed oral therapy for relapsing forms of MS after six months, indicating blockbuster potential. Tecfidera was also approved in Canada and Australia in 2013.

Additionally, the EMA issued a positive opinion for Plegridy, a pegylated interferon with extended half-life and prolonged exposure in the body, for adults with RRMS—a decision is expected in the coming months. All of these aforementioned therapies, and then some, will be made available throughout Asia under an exclusive agreement with UCB, leveraging its resources in the region.
Beyond these therapeutic areas, Biogen has several R&D collaborations underway in neurological diseases. Eisai and Biogen entered an Alzheimer’s drug development pact for two of Eisai’s Phase II candidates, E2609 and BAN2401, and two of Biogen’s AD candidates, an anti-amyloid beta (A) antibody BIIB037 and an anti-tau monoclonal antibody. Eisai’s candidates have shown potential to reduce A plaques that form in the brain and to stop the formation of new ones. Should they gain approval in the U.S. and the EU, both companies will promote the products.

Technology Platforms
Biogen also entered into a couple of technology platform pacts with Isis and Sangamo BioSciences, each with potential R&D spend of $320 million. The Isis alliance aims to advance therapies for neurological diseases using Isis’ antisense technology, and the Sangamo alliance, to develop treatments targeting sickle cell disease (SCD) and beta-thalassemia using Sangamo’s zinc finger nuclease (ZFN) genome-editing technology platform. Under each, Biogen will be responsible development and commercialization of any resulting products.

Also, as part of its corporate objective to leverage its manufacturing expertise for biosimilar therapies, Biogen, through its joint venture with Samsung Bioepis, took the deal to the next level, exercising its right to commercialize anti-TNF biosimilar product candidates in Europe, which includes widely used therapies to treat rheumatoid arthritis and Crohn’s disease (most likely Johnson & Johnson’s Remicade and Amgen’s Enbrel). Europe is seen as one of the most accessible markets for biosimilars since their regulatory pathway has been in place since 2005.

Coming off a great year, 2014 promises to bring even greater financial success for the burgeoning biopharma, barring any deleterious side effects for new products. It’s what’s in the pipeline that draws future concern. Alzheimer’s drug development has proven elusive so far, meeting many failures along the way. Let’s hope one of the four candidates that are now in development with Eisai, succeeds for the sake of many.

Headcount: 5,950
Bio/Pharma Revenues: $5,304 (10%)
Total Revenues: $5,51 (69%)
Net Income: $1,380 (12%)
R&D Budget: $1,33 (59%)

Top Selling Drugs

Account for 98% of total biopharma sales, down from 99% in 2011

There were two big stories for Biogen Idec in the past year:

1. It bought out partner Elan from their Tysabri commercialization pact, and
2. It may have an instant blockbuster on their hands.

The Tysabri move, completed in April 2013, gave BI control over its portfolio of multiple sclerosis (MS) treatments. It cost $3.3 billion upfront, along with contingent payments throughout the product’s life cycle ranging from 18% to 25% of net sales, but it eliminates change-of-control issues for both companies, enables BI to streamline its MS salesforce, and lets Elan decide what to do with a pharma company that has no drugs but lots of cash and royalty revenues. Tysabri posted a 15% sales bump in 1Q13 to $456 million.

In March 2013, BI received approval for Tecfidera (dimethyl fumarate), once known as BG-12. Analysts were anticipating a big launch for the new oral MS treatment, but it managed to shatter expectations in its first month, leading some to predict partial-year sales of $1.0 billion and a sound walloping of competitors Gilenya (Novartis) and Aubagio (Sanofi). The frenzy cooled a bit near the end of the second month in terms of prescription growth, but Tecfidera is still on pace for a massive first year.

BI has delayed seeking approval for the drug in Europe because of data exclusivity issues, a market where it may garner 40% of peak revenues. The drug’s API is chemically similar to BI’s Fumaderm, and there are issues over whether it will be treated as a New Active Substance (like an NCE in the U.S.) and given full data protection.

BI isn’t a one-trick (or -indication) pony; the company is awaiting approval for two new hemophilia treatments, along with an injectable pegylated betaferon MS treatment, Plegridy, that was part of the Elan buyout. Neither of those products will help BI hit its 2013 growth target of 16-18%, but with Tecfidera tearing it up, they won’t have to.

Outsourcing News
In December 2012, Biogen Idec and Eisai announced a deal in which BI will lease a portion of Eisai’s facility in RTP, NC, to manufacture oral solid dose products for both companies. Eisai will provide BI with vial-filling services for biologics and packaging services for oral solid dose products. It’s a 10-year lease agreement, cancellable after five years, and gives Biogen Idec the option to purchase the Eisai oral solid dose facility.

Headcount: 4,700
Biopharma Revenues: $3,968 (+30%)
Royalty Revenues: $116 (+14%)
Total Revenues: $4,098 (+29%)
Net Income: $783 (+23%)
R&D Budget: $1,072 (+16%)

Account for 99% of total biopharma sales, same as in 2007.

PROFILE

In 2007, Biogen Idec set 2010 as the date to reach a series of business goals. Now I bet management more concerned about being in business that year. BI saw its biopharma revenues leap by 30% last year, but the company made bigger news in recent months when “activist investor” Carl Icahn agitated to break up the company or sell it off. (I chronicled some of this kerfluffle in last year’s report.) This built up to a rancorous proxy fight and shareholder meeting in which Mr. Icahn succeeded in taking over two seats on the company’s board.

Considering he was involved in pushing MedImmune and ImClone into the arms of AZ and Lilly, respectively, I’d suggest they rent, not buy.

One of those 2010 goals was to have 100,000 patients on Tysabri, the company’s biologic treatment for MS and Crohn’s disease. Unfortunately, the pace of new patients has slowed because of safety concerns. Despite BI and development partner Elan’s fantastic results in trials of MS patients on Tysabri, four cases of progressive multifocal leukoencephalopathy (PML)cropped up in 2008, and two more cases occurred in June 2009.

Three cases of PML during a clinical trial caused BI to pull Tysabri from the market in 2005; this time around, BI’s being cautious but is still promoting the treatment. The company had approximately 40,000 patients using Tysabri by March 2009. Tysabri revenues climbed 44% in 1Q09 to $165 million.

They used to say that when America sneezes, the rest of the world catches a cold. When rolofylline, Merck’s acute heart failure treatment, failed a big Phase III trial in June 2009, I have a feeling that nausea spread through the offices at BI. One of the company’s top small-molecule prospects, Adentri, is in the same category as rolofylline: adenosine A1 antagonists. Adentri entered Phase III in August 2008 in acute decompensated heart failure (ADHF) patients with renal insufficiency.

The question is: will there be a BI by the time that clinical trial concludes?

Headcount: 4,850
Pharma Revenues: $4,547 (7%)
Total Revenues $4,716 (8%)
Net Income  $1,005 (4%)
R&D Budget $1,248 (-3%)

Top-Selling Drugs in 2010

Account for 99% of total biopharma sales, same as in 2009.

PROFILE

Biogen Idec survived the Icahn siege! After years of trying to break up the company or get it sold to a big pharma, Carl Icahn seems to be satisfied! In recent months he reduced his holdings in the company and didn’t nominate any new board members to try to implement his plans. For BI, this is a huge accomplishment.

It wasn’t easy. In November 2010, BI began restructuring under new chief executive officer George Scangos, Ph.D., announcing plans to close its site in San Diego and consolidate its Massachusetts sites, reduce its headcount by 13% (650 people), and focus on neurology and get out of CV and oncology. The moves will cost $115 million — plus another $49 million in R&D charges — and are expected to save BI $300 million annually. Dr. Scangos is also considering moving the BI’s HQ from suburban Weston back to Cambridge, nearer the company’s R&D center.

In October 2010, BI and Genentech renegotiated their anti-CD20 deal, which covers both Rituxan and several other drugs in development, including ocrelizumab (multiple sclerosis) and GA101 (leukemia and lymphoma). Rituxan’s 2010 revenues grew in the U.S., but declined in other markets due to royalty expirations. BI’s Rituxan revenues in 1Q11 were flat at $256 million.

New R&D head Doug Williams wants the company to get very active in licensing and/or acquisitions of Phase I/II assets. BI’s big prospect remains BG-12, its fast-tracked MS drug that some believe could become a $3.0 billion seller. More Phase III data for BG-12 is due in October. In all, the company has seven prospects for approval by 2015, in MS, ALS and hemophilia.

In December 2010, BI and partner Elan filed an sBLA to update the labeling of Tysabri to help weed out the patient population at risk of developing a terrible brain infection from the drug. If they’re able to remove that risk, sales could jump. Tysabri will likely pass the $1.0 billion mark in 2011.

BI has to be happy to be out from the thumb of Mr. Icahn. Now the company has to execute on enough of its neurology bets to keep from getting snapped up by a big player looking for some steady revenues.  —GYR

Headcount: 4,750
Bio/pharma Revenues: $4,247 (+7%)
Royalty Revenues: $124 (+7%)
Total Revenues: $4,377 (+7%)
Net Income: $970 (+24%)
R&D Budget: $1,283 (+20%_

Account for 99% of total bio/pharma sales, same as in 2008.

PROFILE

For the third straight year, Biogen Idec’s story is tied into activist shareholder Carl Icahn’s attempts at getting the company to sell itself for parts. Mr. Icahn gave up his latest proxy fight when BI put one of his nominees on its board. He now has three people on the board, and continues to agitate for breaking up BI into two pieces — neurology and cancer — and selling off to bigger pharma companies.

With a challenge like this, BI could use a sure hand at the rudder. Unfortunately, chief executive officer and 21-year Biogen veteran James C. Mullen retired from the company in June. The company reported that it’s close to naming a successor, but also noted that chief operating officer and 16-year vet Robert A. Hamm will also depart BI at the end of 2010. Moves like this doesn’t leave me optimistic that there’ll be a Biogen Idec in a couple of years.

Shortly before press time, BI announced that its new CEO would be George Scangos, who was previously the chief exec of Exelixis. Critics immediately jumped on Mr. Scangos’ lack of experience running a company with commercial operations, but I think BI has brought the same number of products to market in the past six years that Exelixis has, so maybe he can bring BI a kick in the R&D pants.

BI tried to make a hostile takeover of Facet Biotech in September 2009. The move would have given BI full ownership of MS treatment daclizumab, which it’s co-developing with Facet. Over the weeks, BI raised its bid from $14.50 a share to $17.50, but gave up in December 2009. Three months later, Abbott Labs snapped Facet up at $27 a share, for a net of $450 million. Hello, partner!

So what’s going well for BI? Tysabri continues to add patients, and very few of them are developing the fatal side effect that initially got Tysabri yanked from the market. And with 1Q10 revenues of $292 million (+28%), Tysabri is poised to become BI’s third billion-dollar drug. (Or second, if Rituxan sales continue to slide.) It’s also in the midst of an 1,800-person trial to test the effects of switching MS patients from Copaxone or Rebif to Tysabri.

In September 2009, BI was issued a patent on the use of beta interferon, used in the company’s MS treatment Avonex. In May 2010, it filed an infringement suit against several competitors in its MS arena: Rebif (Pfizer/Serono), Betaseron (Bayer), and Extavia (Novartis). Reportedly, BI is demanding royalties from the other drugs’ sales, not withdrawal from the market. Extavia’s a new release (approved August 2009), but the other two products add up to more than $3 billion in annual sales, so a settlement could lead to a good revenue stream for BI.

Or whoever ends up owning them.

Headcount: 4,200
Biopharma Revenues: $3,063 (+19%)
Royalty Revenues: $109 (+19%)
Total Revenues: $3,172 (+18%)
Net Income: $638 (+193%)
R&D Budget: $925+29%)

Account for 99% of total biopharma sales, same as in 2006.

PROFILE

It’s been a helter-skelter year for Biogen Idec. The company celebrated its 30th anniversary (well, Biogen’s 30th; Idec is a little younger) in May 2008, but only reached that event after failing to consummate a buyout it never really wanted to pursue.

In October 2007, the board announced it was open to selling the company off. Given the prices smaller biopharmas have fetched — $15.5 billion for MedImmune? — it made sense to explore the market. Two months later, the company decided it would stay independent. This announcement incurred the wrath of shareholder Carl Icahn, who was pushing for a buyout all along. Mr. Icahn has gone on to accuse Biogen’s board of misrepresenting and undermining the sales process. The board shot back with some pretty pointed comments about Mr. Icahn’s lack of ideas for improving shareholder value, as the two parties battled over a slate of directors.

Outside of the boardroom fights, how did Biogen Idec perform last year? Not bad! Tysabri began its belated climb up the MS market, Avonex continued to lead the company (despite falling to 9% growth in 2007), and co-promotion revenues and royalties from Rituxan almost reached $1.0 billion.

A month before the sell-out process began, Biogen launched a series of 2010 goals; evidently, the company’s “2015 Vision” became a little blurry. The new targets include

• reaching a 15% compound annual growth rate for revenues,
• sustaining sales of Avonex,
• expanding Rituxan into autoimmune indications,
• getting 100,000 patients on Tysabri,
• getting international business to account for 40% of revenues, and
• launching four new products or major indications and getting six more products into late-stage trials.

The existing product goals have been hit and miss. Avonex sales were up 19% in 1Q08, but Biogen and partner Genentech announced in April 2008 that Rituxan missed endpoints in clinical trials against Lupus and MS. Still, the company (with partner Elan) did manage to get Tysabri approved for second line treatment for Crohn’s disease and finished 1Q08 with 26,000 patients using the drug.

Anticipating large growth in Tysabri’s market, Biogen is finishing up a $300 million large-scale manufacturing facility in Denmark, slated to come online in 2009. Biogen Idec and Elan recently published data showing no new cases of PML, the complication that resulted in Tysabri’s suspension from the market in 2004. Biogen’s share of Tysabri sales in 1Q08 hit $115 million, up 283%.

In June 2008, Biogen Idec’s shareholders voted down Mr. Icahn’s proposed slate of directors, so the company may have gained some traction to pursue those 2010 goals.