Report
Karen Andersen
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Morningstar | Maintaining Our Biogen FVE Following 2018 Results; Core Franchises Stable and Pipeline Expanding

Biogen reported 2018 results that were broadly in line with our top- and bottom-line expectations, with multiple sclerosis sales holding up slightly better than we had expected, but slightly less growth from biosimilars and Spinraza than we had modeled. In 2019, we now model higher Spinraza and MS sales as well as lower R&D expenses, and our top- and bottom-line estimates are in line with management's guidance. However, we have boosted our SG&A expenses in the long run to account for multiple potential launches in neurology, led by aducanumab in Alzheimer's in 2020, and we're maintaining our $420 fair value estimate. We continue to believe that Biogen's neurology portfolio and pipeline warrant a wide moat rating and that the shares look undervalued, partly due to investor concerns about the outcome of phase 3 trials of aducanumab. We think the shares look undervalued regardless of aducanumab's trial outcome, as Biogen's pipeline is seeing significant progress beyond Alzheimer's in markets like MS (two midstage remyelinating agents), ALS (entering pivotal trial), Parkinson's (phase 2), stroke (phase 3), and pain (entering phase 3 in trigeminal neuralgia).

Biogen's MS franchise is seeing improved stability, in our opinion, and outside of a likely inventory drawdown in the first quarter, we think quarter-over-quarter growth should remain stable. The drain on Tysabri from Roche's Ocrevus appears to be lessening, and delays for Celgene's ozanimod will give Tecfidera and Vumerity another year of relatively minimal changes to the oral MS drug landscape. While Novartis looks poised to launch SMA gene therapy Zolgensma (AVXS-101) this year, we think Spinraza will continue to grow in 2019, as Zolgensma will likely be labeled only for type 1 infants, and our midteens Spinraza growth is in line with Biogen's forecast. We assume average annual declines in the midsingle digits for Spinraza following 2019, due to Zolgensma and Roche's phase 2 oral drug risdiplam.

While the biggest catalyst remains phase 3 aducanumab data in early 2020 (we continue to assign a 60% probability of success), Biogen should also see 2019 catalysts for Vumerity (MS approval and head-to-head data on gastrointestinal tolerability versus Tecfidera), Tysabri (epilepsy data), and tau antibody BIIB092 (data in progressive supranuclear palsy). For a detailed analysis of Biogen's top-line growth prospects and pipeline candidates, please see our healthcare Observer, "Annual Drug Pipeline Report: Moats Remain Secure as Innovation Counters Pricing and Generic Headwinds, but M&A Accelerating."
Underlying
Biogen Inc.

Biogen is a biopharmaceutical company focused on discovering, developing and delivering therapies for people living with neurological and neurodegenerative diseases as well as related therapeutic adjacencies. The company's main growth areas include multiple sclerosis (MS) and neuroimmunology; Alzheimer's disease and dementia; neuromuscular disorders, including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis; movement disorders, including Parkinson's disease; and ophthalmology. The company's marketed products include TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, VUMERITY and FAMPYRA for the treatment of MS, SPINRAZA for the treatment of SMA and FUMADERM for the treatment of severe plaque psoriasis.

Provider
Morningstar
Morningstar

Morningstar, Inc. is a leading provider of independent investment research in North America, Europe, Australia, and Asia. The company offer an extensive line of products and services for individual investors, financial advisors, asset managers, and retirement plan providers and sponsors.

Morningstar provides data on approximately 530,000 investment offerings, including stocks, mutual funds, and similar vehicles, along with real-time global market data on more than 18 million equities, indexes, futures, options, commodities, and precious metals, in addition to foreign exchange and Treasury markets. Morningstar also offers investment management services through its investment advisory subsidiaries and had approximately $185 billion in assets under advisement and management as of June 30, 2016.

We have operations in 27 countries.

Analysts
Karen Andersen

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