'Our first quarter 2021 results were consistent with our expectations across MS, SMA, and biosimilars despite increased competition,' said
'With an anticipated regulatory decision for aducanumab in the
First Quarter 2021 Financial Results
First quarter total revenue of
Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of
SPINRAZA revenue of
Biosimilars revenue of
First quarter GAAP net income and diluted earnings per share (EPS) attributable to
First quarter Non-GAAP net income and diluted EPS attributable to
1. reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release.
Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period's foreign currency revenue values are converted into
First quarter 2021 GAAP amortization and impairment of acquired intangible assets was
First quarter 2021 GAAP and Non-GAAP net expense related to collaboration profit sharing was
First quarter 2021 GAAP other expense was
First quarter 2021 effective GAAP and Non-GAAP tax rates were 9.5% and 15.7%, respectively. The first quarter 2021 effective GAAP tax rate was impacted by non-cash tax favorability from mark-to-market losses.
Financial Position
As of
2. In the first quarter of 2021 Biogen repurchased approximately 2.2 million shares of the Company's common stock for a total value of
For the first quarter of 2021 the Company's weighted average diluted shares were 152 million.
First quarter 2021 cash from operations was
This financial guidance assumes a currency headwind of approximately
This financial guidance continues to assume that aducanumab, an investigational treatment for Alzheimer's disease, will be approved in the
Non-GAAP R&D expense is expected to be between
We expect that we will utilize a portion of the remaining share repurchase authorization of
This financial guidance does not include any impact from potential acquisitions or large business development transactions, as both are hard to predict, or any impact of potential tax or healthcare reform.
Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2021 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.
Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-lookingNon-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; and the ultimate outcome of pending significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.
Recent Events
In
In
Administration approved TECFIDERA (dimethyl fumarate) for the treatment of relapsing MS.
In
324), a GABAA positive allosteric modulator, met its primary endpoint of a statistically significant reduction in tremor score in individuals treated with BIIB124 compared to placebo at Day 29 in adults with essential tremor (p=0.049), corresponding to a 36% reduction in upper limb tremor amplitude from baseline in the BIIB124 group compared to a 21% reduction in the placebo group. Down-titration of dose occurred in 62% of patients who received BIIB124, and discontinuations were noted in 38% of patients receiving BIIB124. Adverse events were generally consistent with the safety profile of BIIB124 seen to date. The most common treatment-emergent adverse events that occurred in ?10% of patients in the BIIB124 treatment group and at a rate at least twice as high as that of patients in the placebo group were: somnolence 68%; dizziness 38%; balance disorder 15%; diplopia 12%; dysarthria 12%; and gait disturbance 12%. Biogen and Sage are currently planning next steps for development of BIIB124.
In
In
In the first quarter of 2021 Biogen submitted a Marketing Authorization Application (MAA) to ANVISA in
In the first quarter of 2021 Biogen announced plans to build a new gene therapy manufacturing facility at its
Conference Call and Webcast
The Company's earnings conference call for the first quarter will be broadcast via the internet at
About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by
Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our strategy and plans; potential of, and expectations for, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our and our collaboration partners' products and investigational therapies; the anticipated benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; 2021 financial guidance; plans relating to share repurchases; and the anticipated completion and timing of the proposed transaction with
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively due to significant product competition in the markets for our products; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our dependence on collaborators, joint venture partners, and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media for our business; failure to obtain, protect, and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; risks relating to technology failures or breaches; risks relating to management and key personnel changes, including attracting and retaining key personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to investment in our manufacturing capacity; problems with our manufacturing processes; fluctuations in our effective tax rate; fluctuations in our operating results; risks related to investment in properties; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; risks relating to access to capital and credit markets; risks related to indebtedness; change in control provisions in certain of our collaboration agreements; environmental risks; risks that the proposed transaction with
These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements.
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