プレスリリースケンブリッジ、マサチューセッツ州 - 2024年10月30日
バイオジェンは2024年第3四半期の業績を報告し、2024年の完全な財務ガイダンスを引き上げます。
2024年第3四半期の売上高は25億ドル；GAAP希薄化後epsは2.66ドル；Non-GAAP希薄化後epsは4.08ドル
商業ポートフォリオ全体での実行が継続して進行しています
•アルツハイマー病、希少疾患、およびうつ病の製品発売は、それぞれ連続した売上高の成長を達成しました。三半期の製品発売からの総売上高は、多発性硬化症製品の売上高の年間比減少を相殺し続けました。
•LEQEMBIの第三四半期のグローバル市場での売上高は約6700万ドルで、うちアメリカの市場での売上高は約3900万ドルです。EU CHMPの再審査は、今年中に完了する予定です。
•TECFIDERAの欧州特許は、ジメチルフマル酸エステルの投与量をカバーし、2028年2月に満了するが、欧州特許庁の異議申立部門によって維持されました。
開発プログラムはいくつかのマイルストーンを達成し、後期段階のパイプラインの数十億ドル規模の機会を強調しました。
•ダピロリズマブペゴール第3相試験は全身性エリテマトーデスでの主要評価項目を達成しました。詳細なデータは11月に開催されるアメリカリウマトロジー学会の年次大会で発表される予定です。UCbとバイオジェンは2024年に第2相3試験を開始します。
•アルツハイマー病の治療におけるtauを標的とするアンチセンスオリゴヌクレオチドBIIB080の第2相CELIA研究が、2026年に結果を発表する予定で受入れが完了しました。
•Felzartamabは、腎移植患者の抗体介在性拒絶反応の治療に関するFDAのブレイクスルーセラピー指定を受けました。新しいIgA腎症のデータが2024年のAmerican Society of Nephrology Kidney Weekで発表されました。
•ナシンセンの高用量療法は、第2/3相DEVOTE試験の主要コホートで統計的に有意な改善が示されました。バイオジェンは規制当局への申請をグローバルに提出する予定です。
2024年の通期業績予想の引き上げ：非GAAP希薄化後epsは16.10ドルから16.60ドルの間で予想され、2023年の通期に比べて中間値で約11％の非GAAP希薄化後eps成長を表しています
•2024年の通期売上高全体の前年比低一桁パーセンテージの減少を維持し、医薬品のコア売上高は2023年の通期とほぼ横ばいと予想されています
•2023年全体と比較して、営業利益の成長率が高いティーンの割合で成長することを期待しています。営業利益率は中一桁の割合の改善が維持されます。
バイオジェン（ナスダック：BIIB）は、2024年第3四半期の財務結果を報告しました。 四半期についてコメントし、社長兼最高経営責任者のクリストファー・A・ヴィーバッハー氏は述べました:
第3四半期において、バイオジェンは持続可能な成長への目標に向けて引き続き進展しています。継続的な製品ローンチにおいてモメンタムが続いており、当社のパイプラインの可能性にますます期待しています。今四半期は、後期パイプラインの主要分野においていくつかの重要なポジティブな進展があり、患者と株主の両方にとって可能性のある価値を裏付けていると信じています。重要なのは、ジャピロリズマブペゴルのポジティブな結果、さらに最近になってIgANでのフェルザルタマブデータの発表が、私たちが免疫学における業界をリードするパイプラインを開発する取り組みを支援しており、データの洞察を積み重ね、潜在的な将来のローンチに備えるための能力を高めています。
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財務ハイライト
| Q3 '24 | Q3 '23 | △ | r (CC*) | |||||||||||||||||||||||
| 売上高（百万単位） | $2,466 | $2,530 | (3)% | (3)% | ||||||||||||||||||||||
| GAAP希薄化後EPS | $2.66 | $(0.47) | 666% | 該当なし | ||||||||||||||||||||||
| 非GAAP希薄化後EPS | $4.08 | $4.36 | (6)% | 該当なし | ||||||||||||||||||||||
注意: パーセント変化は前年期と比較して有利/(不利)を表しています。
N/A = 該当なし。
* 売上高の増加率は、外貨の為替レートやヘッジ取引の影響を除いた為替取引の変動を示す。外貨の売上高は、前のカレンダー年の終わりからの為替レートを使用して米ドルに換算されます。
GAAPと非GAAPの財務指標の調整は、このニュースリリースの最後の表4に記載されています。
売上高サマリー
| （百万ドル） | Q3 '24 | Q3 '23 | △ | r (CC*) | ||||||||||||||||||||||
多発性硬化症（MS）製品売上高(1) | $1,054 | $1,159 | (9)% | (9)% | ||||||||||||||||||||||
希少疾患売上高(2) | $495 | $450 | 10% | 10% | ||||||||||||||||||||||
| バイオシミラー売上高 | $197 | $194 | 1% | —% | ||||||||||||||||||||||
その他製品売上高(3) | $24 | $2 | 意味のない数字 | 意味のない数字 | ||||||||||||||||||||||
| 製品の合計売上高 | $1,769 | $1,805 | (2)% | (2)% | ||||||||||||||||||||||
| 抗CD20治療プログラムからの売上高 | $446 | $421 | 6% | 6% | ||||||||||||||||||||||
| 契約製造、ロイヤリティ、およびその他の売上高 | $250 | $304 | (18)% | (19)% | ||||||||||||||||||||||
| 合計売上高 | $2,466 | $2,530 | (3)% | (3)% | ||||||||||||||||||||||
ノート：パーセンテージの変化は、前年の期間に対する有利／(不利)を表しています。数値は、四捨五入による計算のため、一致しない場合があります。
NMFは特に意味のある数字ではありません。
(1) 多発性硬化症にはTECFIDERA®、VUMERITY®、AVONEX®、PLEGRIDY®、TYSABRI®およびFAMPYRA™が含まれています。
(2) 希少疾患にはSPINRAZA®、SKYCLARYS®、QALSODY®が含まれます。
(3) その他にはADUHELM®、FUMADERM™、ZURZUVAE™が含まれます。
•2024年第3四半期のZURZUVAEの売上高は約2200万ドルでした。
支出サマリー
| （百万ドル） | Q3 '24 | Q3 '23 | △ | |||||||||||||||||
GAAP原価費用* | $639 | $660 | 3% | |||||||||||||||||
| 総売上高の% | 26% | 26% | ||||||||||||||||||
非GAAP販売原価* | $593 | $660 | 10% | |||||||||||||||||
| 総売上高の% | 24% | 26% | ||||||||||||||||||
| GAAPの研究開発費 | $543 | $736 | 26% | |||||||||||||||||
| 非GAAPの研究開発費 | $491 | $539 | 9% | |||||||||||||||||
| GAAPの販売費および一般管理費 | $588 | $788 | 25% | |||||||||||||||||
| 非GAAPの販売費および一般管理費 | $556 | $553 | (1)% | |||||||||||||||||
注：パーセント変化は前年同期に対する有利/(不利)を表しています
* 取得した無形資産の償却および減損を除く
•2024年第3四半期の総売上高に対するGAAPおよび非GAAP原価の削減は、主に製品ミックスによるものであり、特に新規売上高の年々増加によるものでした。
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製品の発売と契約製造業の売上高の減少、およびアイドル容量料金の低下。
•2024年第3四半期は、2023年第3四半期と比較して、$19400万のGAAP R&Dが減少しました。この減少は、Reata Pharmaceuticals, Inc.（Reata）の買収に関連する2023年に認識された約$197百万の株式報酬費用、2024年に実施された会社のR&Dの重点化とFit for Growthイニシアティブに係るコスト削減策、および2023年に発生した臨床試験と閉会費用への支出の増加に主によるものです。これには、人間免疫生物科学（HI-Bio）の買収に関連する2024年に認識された約$43百万の株式報酬費用が一部相殺されました。
•2024年第3四半期において、2023年第3四半期と比較して、Non-GAAP R&D は約$48百万の減少が主に、2024年における企業のR&Dの優先順位付けとFit for Growthの取り組みに伴うコスト削減策、および2023年に発生した臨床試験と終了費用に対する支出の増加によるものでした。
•2024年の第3四半期は、2023年の第3四半期と比較して、GAAP SG&A費用が約20000万米ドル減少しました。この減少の主な理由は、2023年に認識された約1億9600万米ドルの株式報酬費用と、Reataの買収に関連する2024年のコスト削減措置によるもので、これは会社の成長戦略であるFit for Growth イニシアチブに関連して実現されました。
•2024年第3四半期に関しては、2023年第3四半期と比較して、Non-GAAP SG&A費用が約300万ドル増加したのは、主に新製品の商業化支出の増加に起因し、一部は会社の成長イニシアチブ『Fit for Growth』からの節約によるものです。
その他の財務ハイライト
•2024年第3四半期、GAAPおよび非GAAPにおける協力利益分配は約6900万ドルの純費用になりました。これにはSamsung Bioepisとの協力関係に関連する約6000万ドルと、Sage Therapeutics, Inc. (Sage)との協力関係および米国でのZURZUVAEの商業化に関連する約900万ドルが含まれています。
•2024年第3四半期のGAAPその他の費用は約1億5百万ドルで、主に純利息費用によって支えられ、約3,900万ドルの戦略的株式投資の実現および未実現の利益に部分的に相殺されました。2024年第3四半期のNon-GAAPその他の費用は約5,400万ドルで、主に純利息費用によって支えられました。
•2024年第3四半期の米国一般会計原則（GAAP）および非米国一般会計原則（Non-GAAP）有効税率はそれぞれ13.9%および13.8%でした。2023年第3四半期のGAAPおよびNon-GAAPの有効税率はそれぞれ51.6%および14.7%でした。
財務状況
•2024年第3四半期の運営活動による純現金フローは約936億ドルでした。設備投資は約35億ドルで、フリーキャッシュフロー（運営活動による純現金フローから設備投資を差し引いたもの）は約901億ドルでした。
•2024年9月30日現在、バイオジェンは約17億ドル相当の現金、現金同等物、および流動証券を保有しており、約63億ドルの総負債を抱えており、純負債は約46億ドルです。
•2024年第3四半期には会社の普通株式はリペイされませんでした。2024年9月30日現在、2020年10月に承認されたシェアリペイプログラムの下で約21億ドルが残っています。
•2024年第3四半期における企業の希薄化後株式の加重平均株式数は約14,600万株でした。
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2024年度の財務ガイダンス
2024年のバイオジェンは、希薄化後epsのNon-GAAPガイダンス範囲を以下のように予想しています:
| 従来のFY 2024の予想 | 更新されたFY 2024の予想 | ||||||||||
| 非GAAP希薄化後EPS | $15.75 から $16.25 中間点* で約9% の成長を反映 | $16.10～$16.60 中間点* で約11% の成長を反映 | |||||||||
*2023年の通告された全年
バイオジェンは、総売上高が低一桁の割合で減少し続けると予想しています。コア医薬品売上高（製品売上高に加え、バイオジェンがネットLEQEMBI製品売上高の50％のシェアを含む売上高と売上原価、ロイヤルティを定義）は、新製品の売上高の増加により、2024年に2023年と比較してほぼ横ばいになる見込みであり、多発性硬化症製品の売上高のさらなる減少は相殺されると予想されています。
バイオジェンは、製品ミックスと大幅に低いアイドルキャパシティ料金によって、総売上高に対する販売原価の割合が2023年に比べて改善すると見込まれるため、2024年における総売上高の営業利益率改善を予想しています。
2024年について2023年と比較して、バイオジェンは営業利益が高いティーンの割合で成長し、ミッドシングルデジットの割合で営業利益率が向上することを期待しています。これは、売上高に対する費用の改善によるものであり、また、会社の成長適合およびR&Dの優先事項の取り組みによる営業費用の低下によるものと予想されています。
この財務ガイダンスには、全て極めて予測しにくいため、潜在的な買収やビジネス開発取引、未解決および将来の訴訟、潜在的な税制改革や医療改革の影響は一切含まれていません。
このガイダンスは、2024年10月25日時点の外国為替レートが残りの年にわたって有効であるものと仮定しています。ヘッジ活動を差し引いた状態で、その他のモデリング考慮事項は、会議のコールとウェブキャストで提供されます。
2024年には、バイオジェンは費用を発生させたり、利益や損失を実現したり、その他の出来事や状況を経験するかもしれません。これらの仮定のいずれかが変わる可能性があり、実際の結果がこの財務ガイダンスから変動することがあります。
バイオジェンは売上高以外の米国一般会計原則に基づく財務指標に関する見通しや先行きのノン・ギャップ財務指標を米国一般会計原則における最も直接比較可能な財務指標に調整するための調整表を提供していません。これは、企業が取引、統合、および他の大規模なビジネストランザクションに関連する特定の費用、非通常な利益および損失、将来の潜在的な資産減損、株式証券投資からの利益および損失、および未解決または将来の重要な訴訟の最終的な結果等、要約努力にいたらない範囲でこれらの項目の財務上の影響を合理的な正確さで予測できないためです。これらの項目は不確実であり、さまざまな要因に依存し、見通し期間のGAAP報告結果に対して重大な影響を及ぼす可能性があります。同様の理由から、同社は利用できない情報の重要性に対処できず、これが将来の結果にとって重要である可能性があります。
Key Recent Events
•In October, Biogen and Sage decided they will not pursue further development for zuranolone as a treatment for major depressive disorder.
Conference Call and Webcast
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The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 30, 2024 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities.
We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
We routinely post information that may be important to investors on our website at
www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This press release contains forward-looking statements, 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; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, and efficacy of our and our collaboration partners’ products and investigational therapies; the anticipated benefits and potential of investments, optimization of the cost structure including our "Fit for Growth" program, actions to improve risk profile and productivity of R&D pipeline, collaborations, and business development activities; our future financial and operating results; 2024 financial guidance. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.
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; 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 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; 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 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 technology failures or breaches; problems with our manufacturing processes; risks relating to management, personnel and other organizational changes, including attracting and retaining 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; 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 and artificial
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intelligence based software for our business; results of operations, and financial condition; fluctuations in our operating results; risks related to investment in properties; risks relating to access to capital and credit markets; risks related to indebtedness; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; change in control provisions in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.
These statements speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.
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| MEDIA CONTACT: | INVESTOR CONTACT: | ||||
| Biogen | Biogen | ||||
| Jack Cox | Stephen Amato | ||||
Tel: +1 781-464-3260 | Tel: +1 781-464-2442 | ||||
public.affairs@biogen.com | IR@biogen.com | ||||
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TABLE 1
BIOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF INCOME
(unaudited, in millions, except per share amounts)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Revenue: | ||||||||||||||||||||||||||
| Product, net | $ | 1,769.4 | $ | 1,805.2 | $ | 5,380.9 | $ | 5,414.3 | ||||||||||||||||||
| Revenue from anti-CD20 therapeutic programs | 446.2 | 420.9 | 1,284.7 | 1,253.8 | ||||||||||||||||||||||
| Contract manufacturing, royalty and other revenue | 250.2 | 304.2 | 555.6 | 781.2 | ||||||||||||||||||||||
| Total revenue | 2,465.8 | 2,530.3 | 7,221.2 | 7,449.3 | ||||||||||||||||||||||
| Cost and expense: | ||||||||||||||||||||||||||
| Cost of sales, excluding amortization and impairment of acquired intangible assets | 638.7 | 659.6 | 1,726.9 | 1,915.1 | ||||||||||||||||||||||
| Research and development | 542.7 | 736.3 | 1,509.5 | 1,891.1 | ||||||||||||||||||||||
| Selling, general and administrative | 588.4 | 788.2 | 1,723.7 | 1,941.2 | ||||||||||||||||||||||
| Amortization and impairment of acquired intangible assets | 130.3 | 60.9 | 295.5 | 164.0 | ||||||||||||||||||||||
| Collaboration profit sharing/(loss reimbursement) | 69.3 | 50.5 | 197.3 | 164.5 | ||||||||||||||||||||||
| (Gain) loss on fair value remeasurement of contingent consideration | 23.8 | — | 23.8 | — | ||||||||||||||||||||||
| Restructuring charges | 6.8 | 76.0 | 24.9 | 120.0 | ||||||||||||||||||||||
| Gain on sale of priority review voucher, net | — | — | (88.6) | — | ||||||||||||||||||||||
| Other (income) expense, net | 14.8 | 300.0 | 193.7 | 248.2 | ||||||||||||||||||||||
| Total cost and expense | 2,014.8 | 2,671.5 | 5,606.7 | 6,444.1 | ||||||||||||||||||||||
| Income (loss) before income tax (benefit) expense | 451.0 | (141.2) | 1,614.5 | 1,005.2 | ||||||||||||||||||||||
| Income tax (benefit) expense | 62.5 | (72.9) | 249.0 | 92.6 | ||||||||||||||||||||||
| Net income (loss) | 388.5 | (68.3) | 1,365.5 | 912.6 | ||||||||||||||||||||||
| Net income (loss) attributable to noncontrolling interests, net of tax | — | (0.2) | — | 1.2 | ||||||||||||||||||||||
| Net income (loss) attributable to Biogen Inc. | $ | 388.5 | $ | (68.1) | $ | 1,365.5 | $ | 911.4 | ||||||||||||||||||
| Net income (loss) per share: | ||||||||||||||||||||||||||
| Basic earnings (loss) per share attributable to Biogen Inc. | $ | 2.67 | $ | (0.47) | $ | 9.38 | $ | 6.30 | ||||||||||||||||||
| Diluted earnings (loss) per share attributable to Biogen Inc. | $ | 2.66 | $ | (0.47) | $ | 9.35 | $ | 6.26 | ||||||||||||||||||
| Weighted-average shares used in calculating: | ||||||||||||||||||||||||||
| Basic earnings (loss) per share attributable to Biogen Inc. | 145.7 | 144.8 | 145.5 | 144.7 | ||||||||||||||||||||||
| Diluted earnings (loss) per share attributable to Biogen Inc. | 146.1 | 144.8 | 146.0 | 145.5 | ||||||||||||||||||||||
7
TABLE 2
BIOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in millions)
| As of September 30, 2024 | As of December 31, 2023 | |||||||||||||
| ASSETS | ||||||||||||||
| Cash and cash equivalents | $ | 1,699.2 | $ | 1,049.9 | ||||||||||
| Accounts receivable, net | 1,536.2 | 1,664.1 | ||||||||||||
| Due from anti-CD20 therapeutic programs | 451.9 | 435.9 | ||||||||||||
| Inventory | 2,469.2 | 2,527.4 | ||||||||||||
| Other current assets | 674.0 | 1,182.0 | ||||||||||||
| Total current assets | 6,830.5 | 6,859.3 | ||||||||||||
| Property, plant and equipment, net | 3,210.9 | 3,309.7 | ||||||||||||
| Operating lease assets | 380.4 | 420.0 | ||||||||||||
| Intangible assets, net | 9,805.5 | 8,363.0 | ||||||||||||
| Goodwill | 6,485.8 | 6,219.2 | ||||||||||||
| Deferred tax asset | 968.7 | 928.6 | ||||||||||||
| Investments and other assets | 631.4 | 745.0 | ||||||||||||
| TOTAL ASSETS | $ | 28,313.2 | $ | 26,844.8 | ||||||||||
| LIABILITIES AND EQUITY | ||||||||||||||
| Current portion notes payable and term loan | $ | 1,748.1 | $ | 150.0 | ||||||||||
| Taxes payable | 499.1 | 257.4 | ||||||||||||
| Accounts payable | 422.7 | 403.3 | ||||||||||||
| Accrued expenses and other | 2,755.1 | 2,623.6 | ||||||||||||
| Total current liabilities | 5,425.0 | 3,434.3 | ||||||||||||
| Notes payable and term loan | 4,545.8 | 6,788.2 | ||||||||||||
| Deferred tax liability | 882.4 | 641.8 | ||||||||||||
| Long-term operating lease liabilities | 357.0 | 400.0 | ||||||||||||
| Other long-term liabilities | 744.1 | 781.1 | ||||||||||||
| Equity | 16,358.9 | 14,799.4 | ||||||||||||
| TOTAL LIABILITIES AND EQUITY | $ | 28,313.2 | $ | 26,844.8 | ||||||||||
8
TABLE 3
BIOGEN INC. AND SUBSIDIARIES
PRODUCT REVENUE & TOTAL REVENUE
(unaudited, in millions)
Product Revenue
| For the Three Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||
| 2024 | 2023 | |||||||||||||||||||||||||||||||||||||
| United States | Rest of World | Total | United States | Rest of World | Total | |||||||||||||||||||||||||||||||||
| Multiple Sclerosis (MS): | ||||||||||||||||||||||||||||||||||||||
| TECFIDERA | $ | 40.1 | $ | 192.7 | $ | 232.8 | $ | 58.1 | $ | 181.4 | $ | 239.5 | ||||||||||||||||||||||||||
| VUMERITY | 134.9 | 23.2 | 158.1 | 148.8 | 16.7 | 165.5 | ||||||||||||||||||||||||||||||||
| Total Fumarate | 175.0 | 215.9 | 390.9 | 206.9 | 198.1 | 405.0 | ||||||||||||||||||||||||||||||||
| AVONEX | 115.6 | 60.6 | 176.2 | 148.7 | 63.5 | 212.2 | ||||||||||||||||||||||||||||||||
| PLEGRIDY | 27.9 | 33.4 | 61.3 | 31.4 | 34.1 | 65.5 | ||||||||||||||||||||||||||||||||
| Total Interferon | 143.5 | 94.0 | 237.5 | 180.1 | 97.6 | 277.7 | ||||||||||||||||||||||||||||||||
| TYSABRI | 227.5 | 178.6 | 406.1 | 244.8 | 211.5 | 456.3 | ||||||||||||||||||||||||||||||||
| FAMPYRA | — | 19.4 | 19.4 | — | 20.0 | 20.0 | ||||||||||||||||||||||||||||||||
| Subtotal: MS | 546.0 | 507.9 | 1,053.9 | 631.8 | 527.2 | 1,159.0 | ||||||||||||||||||||||||||||||||
| Rare Disease: | ||||||||||||||||||||||||||||||||||||||
| SPINRAZA | 153.1 | 228.3 | 381.4 | 150.5 | 297.7 | 448.2 | ||||||||||||||||||||||||||||||||
SKYCLARYS(1) | 81.8 | 20.5 | 102.3 | — | — | — | ||||||||||||||||||||||||||||||||
QALSODY(2) | 5.5 | 5.6 | 11.1 | 1.6 | 0.1 | 1.7 | ||||||||||||||||||||||||||||||||
| Subtotal: Rare Disease | 240.4 | 254.4 | 494.8 | 152.1 | 297.8 | 449.9 | ||||||||||||||||||||||||||||||||
| Biosimilars: | ||||||||||||||||||||||||||||||||||||||
| BENEPALI | — | 118.1 | 118.1 | — | 112.8 | 112.8 | ||||||||||||||||||||||||||||||||
| IMRALDI | — | 54.1 | 54.1 | — | 54.4 | 54.4 | ||||||||||||||||||||||||||||||||
| FLIXABI | — | 16.2 | 16.2 | — | 20.2 | 20.2 | ||||||||||||||||||||||||||||||||
BYOOVIZ(3) | 4.1 | 3.9 | 8.0 | 6.1 | 0.8 | 6.9 | ||||||||||||||||||||||||||||||||
TOFIDENCE(4) | 0.2 | — | 0.2 | — | — | — | ||||||||||||||||||||||||||||||||
| Subtotal: Biosimilars | 4.3 | 192.3 | 196.6 | 6.1 | 188.2 | 194.3 | ||||||||||||||||||||||||||||||||
| Other: | ||||||||||||||||||||||||||||||||||||||
ZURZUVAE(5) | 22.0 | — | 22.0 | — | — | — | ||||||||||||||||||||||||||||||||
Other(6) | 0.3 | 1.8 | 2.1 | 0.9 | 1.1 | 2.0 | ||||||||||||||||||||||||||||||||
| Subtotal: Other | 22.3 | 1.8 | 24.1 | 0.9 | 1.1 | 2.0 | ||||||||||||||||||||||||||||||||
| Total product revenue | $ | 813.0 | $ | 956.4 | $ | 1,769.4 | $ | 790.9 | $ | 1,014.3 | $ | 1,805.2 | ||||||||||||||||||||||||||
(1) SKYCLARYS was obtained as part of our acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition. SKYCLARYS was approved and became commercially available in the E.U. during the first quarter of 2024.
(2) QALSODY became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024.
(3) BYOOVIZ became commercially available in certain international markets in 2023.
(4) TOFIDENCE became commercially available in the U.S. during the second quarter of 2024.
(5) ZURZUVAE became commercially available in the U.S. during the fourth quarter of 2023.
(6) Other includes FUMADERM and ADUHELM.
9
| For the Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||
| 2024 | 2023 | |||||||||||||||||||||||||||||||||||||
| United States | Rest of World | Total | United States | Rest of World | Total | |||||||||||||||||||||||||||||||||
| Multiple Sclerosis (MS): | ||||||||||||||||||||||||||||||||||||||
| TECFIDERA | $ | 127.9 | $ | 611.4 | $ | 739.3 | $ | 199.3 | $ | 568.9 | $ | 768.2 | ||||||||||||||||||||||||||
| VUMERITY | 385.0 | 66.4 | 451.4 | 372.6 | 47.3 | 419.9 | ||||||||||||||||||||||||||||||||
| Total Fumarate | 512.9 | 677.8 | 1,190.7 | 571.9 | 616.2 | 1,188.1 | ||||||||||||||||||||||||||||||||
| AVONEX | 344.0 | 193.5 | 537.5 | 397.2 | 207.7 | 604.9 | ||||||||||||||||||||||||||||||||
| PLEGRIDY | 84.7 | 109.8 | 194.5 | 95.4 | 125.4 | 220.8 | ||||||||||||||||||||||||||||||||
| Total Interferon | 428.7 | 303.3 | 732.0 | 492.6 | 333.1 | 825.7 | ||||||||||||||||||||||||||||||||
| TYSABRI | 690.0 | 609.6 | 1,299.6 | 750.1 | 662.1 | 1,412.2 | ||||||||||||||||||||||||||||||||
| FAMPYRA | — | 57.3 | 57.3 | — | 67.5 | 67.5 | ||||||||||||||||||||||||||||||||
| Subtotal: MS | 1,631.6 | 1,648.0 | 3,279.6 | 1,814.6 | 1,678.9 | 3,493.5 | ||||||||||||||||||||||||||||||||
| Rare Disease: | ||||||||||||||||||||||||||||||||||||||
| SPINRAZA | 458.9 | 692.9 | 1,151.8 | 453.0 | 875.6 | 1,328.6 | ||||||||||||||||||||||||||||||||
SKYCLARYS(1) | 230.4 | 49.9 | 280.3 | — | — | — | ||||||||||||||||||||||||||||||||
QALSODY(2) | 14.5 | 6.2 | 20.7 | 2.5 | 0.1 | 2.6 | ||||||||||||||||||||||||||||||||
| Subtotal: Rare Disease | 703.8 | 749.0 | 1,452.8 | 455.5 | 875.7 | 1,331.2 | ||||||||||||||||||||||||||||||||
| 0 | ||||||||||||||||||||||||||||||||||||||
| Biosimilars: | ||||||||||||||||||||||||||||||||||||||
| BENEPALI | — | 354.1 | 354.1 | — | 331.0 | 331.0 | ||||||||||||||||||||||||||||||||
| IMRALDI | — | 162.1 | 162.1 | — | 167.6 | 167.6 | ||||||||||||||||||||||||||||||||
| FLIXABI | — | 47.1 | 47.1 | — | 60.7 | 60.7 | ||||||||||||||||||||||||||||||||
BYOOVIZ(3) | 18.1 | 9.2 | 27.3 | 21.3 | 1.2 | 22.5 | ||||||||||||||||||||||||||||||||
TOFIDENCE(4) | 1.0 | — | 1.0 | — | — | — | ||||||||||||||||||||||||||||||||
| Subtotal: Biosimilars | 19.1 | 572.5 | 591.6 | 21.3 | 560.5 | 581.8 | ||||||||||||||||||||||||||||||||
| Other: | ||||||||||||||||||||||||||||||||||||||
ZURZUVAE(5) | 49.3 | — | 49.3 | — | — | — | ||||||||||||||||||||||||||||||||
Other(6) | 2.0 | 5.6 | 7.6 | 1.9 | 5.9 | 7.8 | ||||||||||||||||||||||||||||||||
| Subtotal: Other | 51.3 | 5.6 | 56.9 | 1.9 | 5.9 | 7.8 | ||||||||||||||||||||||||||||||||
| Total product revenue | $ | 2,405.8 | $ | 2,975.1 | $ | 5,380.9 | $ | 2,293.3 | $ | 3,121.0 | $ | 5,414.3 | ||||||||||||||||||||||||||
(1) SKYCLARYS was obtained as part of our acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and we began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to our acquisition. SKYCLARYS was approved and became commercially available in the E.U. during the first quarter of 2024.
(2) QALSODY became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024.
(3) BYOOVIZ became commercially available in certain international markets in 2023.
(4) TOFIDENCE became commercially available in the U.S. during the second quarter of 2024.
(5) ZURZUVAE became commercially available in the U.S. during the fourth quarter of 2023.
(6) Other includes FUMADERM and ADUHELM.
Total Revenue
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Product revenue | $ | 1,769.4 | $ | 1,805.2 | $ | 5,380.9 | $ | 5,414.3 | ||||||||||||||||||
| OCREVUS royalties | 346.8 | 319.1 | 985.8 | 928.2 | ||||||||||||||||||||||
RITUXAN/GAZYVA®/LUNSUMIO™ revenue | 94.8 | 98.9 | 285.3 | 315.0 | ||||||||||||||||||||||
| Other revenues from anti-CD20 programs | 4.6 | 2.9 | 13.6 | 10.6 | ||||||||||||||||||||||
| Contract manufacturing, royalty and other revenue | 250.2 | 304.2 | 555.6 | 781.2 | ||||||||||||||||||||||
| Total revenue | $ | 2,465.8 | $ | 2,530.3 | $ | 7,221.2 | $ | 7,449.3 | ||||||||||||||||||
10
TABLE 4
BIOGEN INC. AND SUBSIDIARIES
GAAP TO NON-GAAP RECONCILIATION
OPERATING EXPENSE, OTHER (INCOME) EXPENSE, NET, AND INCOME TAX
(unaudited, in millions, except effective tax rate)
We supplement our GAAP consolidated financial statements and GAAP financial measures with other financial measures, such as adjusted net income, adjusted diluted earnings per share, revenue growth at constant currency, which excludes the impact of changes in foreign exchange rates and hedging gains or losses, and free cash flow, which is defined as net cash flow from operations less capital expenditures. We believe that these and other Non-GAAP financial measures provide additional insight into the ongoing economics of our business and reflect how we manage our business internally, set operational goals and form the basis of our management incentive programs. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Cost of Sales: | ||||||||||||||||||||||||||
| Total cost of sales, GAAP | $ | 638.7 | $ | 659.6 | $ | 1,726.9 | $ | 1,915.1 | ||||||||||||||||||
| Less: amortization of Reata inventory fair value step-up | 46.1 | — | 130.6 | — | ||||||||||||||||||||||
| Total cost of sales, Non-GAAP | $ | 592.6 | $ | 659.6 | $ | 1,596.3 | $ | 1,915.1 | ||||||||||||||||||
| Research and Development Expense: | ||||||||||||||||||||||||||
| Total research and development expense, GAAP | $ | 542.7 | $ | 736.3 | $ | 1,509.5 | $ | 1,891.1 | ||||||||||||||||||
| Less: amortization of Reata inventory fair value step-up | 2.4 | — | 47.2 | — | ||||||||||||||||||||||
Less: acceleration of share-based compensation expense & related taxes A | 42.5 | 197.0 | 42.5 | 197.0 | ||||||||||||||||||||||
| Less: restructuring charges and other cost saving initiatives | 6.4 | 0.2 | 19.6 | 0.7 | ||||||||||||||||||||||
| Less: other | 0.1 | — | (1.4) | — | ||||||||||||||||||||||
| Total research and development expense, Non-GAAP | $ | 491.3 | $ | 539.1 | $ | 1,401.6 | $ | 1,693.4 | ||||||||||||||||||
| Selling, General and Administrative Expense: | ||||||||||||||||||||||||||
| Total selling, general and administrative, GAAP | $ | 588.4 | $ | 788.2 | $ | 1,723.7 | $ | 1,941.2 | ||||||||||||||||||
Less: acceleration of share-based compensation expense & related taxes A | 13.9 | 196.4 | 13.9 | 196.4 | ||||||||||||||||||||||
| Less: acquisition-related transaction and integration costs | 5.2 | 29.6 | 15.4 | 29.6 | ||||||||||||||||||||||
| Less: restructuring charges and other cost saving initiatives | 10.7 | 5.9 | 18.0 | 17.4 | ||||||||||||||||||||||
| Less: other | 2.5 | 3.3 | 9.4 | 8.4 | ||||||||||||||||||||||
| Total selling, general and administrative, Non-GAAP | $ | 556.1 | $ | 553.0 | $ | 1,667.0 | $ | 1,689.4 | ||||||||||||||||||
| Amortization and Impairment of Acquired Intangible Assets: | ||||||||||||||||||||||||||
| Total amortization and impairment of acquired intangible assets, GAAP | $ | 130.3 | $ | 60.9 | $ | 295.5 | $ | 164.0 | ||||||||||||||||||
| Less: impairment charges | 20.2 | — | 20.2 | — | ||||||||||||||||||||||
| Less: amortization of acquired intangible assets | 98.3 | 51.5 | 243.1 | 138.8 | ||||||||||||||||||||||
| Total amortization and impairment of acquired intangible assets, Non-GAAP | $ | 11.8 | $ | 9.4 | $ | 32.2 | $ | 25.2 | ||||||||||||||||||
| Other (Income) Expense, net: | ||||||||||||||||||||||||||
| Total other (income) expense, net, GAAP | $ | 14.8 | $ | 300.0 | $ | 193.7 | $ | 248.2 | ||||||||||||||||||
| Less: (gain) loss on equity security investments | (39.1) | 302.1 | 21.9 | 272.7 | ||||||||||||||||||||||
| Less: (gain) loss on sale of equity interest in Samsung Bioepis and other investments | — | 15.2 | — | 15.2 | ||||||||||||||||||||||
| Less: other | — | 9.0 | 0.3 | 9.0 | ||||||||||||||||||||||
| Total other (income) expense, net, Non-GAAP | $ | 53.9 | $ | (26.3) | $ | 171.5 | $ | (48.7) | ||||||||||||||||||
| Income Tax (Benefit) Expense: | ||||||||||||||||||||||||||
| Total income tax (benefit) expense, GAAP | $ | 62.5 | $ | (72.9) | $ | 249.0 | $ | 92.6 | ||||||||||||||||||
| Less: income tax effect related to Non-GAAP reconciling items | (32.5) | (182.7) | (93.3) | (203.1) | ||||||||||||||||||||||
| Total income tax expense, Non-GAAP | $ | 95.0 | $ | 109.8 | $ | 342.3 | $ | 295.7 | ||||||||||||||||||
11
TABLE 4 (continued)
BIOGEN INC. AND SUBSIDIARIES
GAAP TO NON-GAAP RECONCILIATION
NET INCOME ATTRIBUTABLE TO BIOGEN INC. & DILUTED EPS
(unaudited, in millions, except per share amounts)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Effective Tax Rate: | ||||||||||||||||||||||||||
| Total effective tax rate, GAAP | 13.9 | % | 51.6 | % | 15.4 | % | 9.2 | % | ||||||||||||||||||
| Less: impact of GAAP to Non-GAAP adjustments | 0.1 | 36.9 | 0.1 | (5.5) | ||||||||||||||||||||||
| Total effective tax rate, Non-GAAP | 13.8 | % | 14.7 | % | 15.3 | % | 14.7 | % | ||||||||||||||||||
| Net Income (loss) Attributable to Biogen Inc.: | ||||||||||||||||||||||||||
| Total net income (loss) attributable to Biogen Inc., GAAP | $ | 388.5 | $ | (68.1) | $ | 1,365.5 | $ | 911.4 | ||||||||||||||||||
| Plus: amortization of Reata inventory fair value step-up | 48.5 | — | 177.8 | — | ||||||||||||||||||||||
| Plus: impairment charges | 20.2 | — | 20.2 | — | ||||||||||||||||||||||
Plus: acceleration of share-based compensation expense & related taxes A | 56.4 | 393.4 | 56.4 | 393.4 | ||||||||||||||||||||||
| Plus: acquisition-related transaction and integration costs | 5.2 | 29.6 | 15.4 | 29.6 | ||||||||||||||||||||||
| Plus: amortization of acquired intangible assets | 98.3 | 51.5 | 243.1 | 138.8 | ||||||||||||||||||||||
| Plus: restructuring charges and other cost saving initiatives | 23.8 | 82.1 | 62.4 | 138.1 | ||||||||||||||||||||||
| Plus: (gain) loss on fair value remeasurement of contingent consideration | 23.8 | — | 23.8 | — | ||||||||||||||||||||||
| Plus: (gain) loss on equity security investments | (39.1) | 302.1 | 21.9 | 272.7 | ||||||||||||||||||||||
| Plus: (gain) loss on sale of equity interest in Samsung Bioepis and other investments | — | 15.2 | — | 15.2 | ||||||||||||||||||||||
| Plus: income tax effect related to Non-GAAP reconciling items | (32.5) | (182.7) | (93.3) | (203.1) | ||||||||||||||||||||||
| Plus: other | 2.6 | 12.4 | 8.3 | 17.4 | ||||||||||||||||||||||
| Total net income (loss) attributable to Biogen Inc., Non-GAAP | $ | 595.7 | $ | 635.5 | $ | 1,901.5 | $ | 1,713.5 | ||||||||||||||||||
| Diluted Earnings Per Share: | ||||||||||||||||||||||||||
| Total diluted earnings (loss) per share, GAAP | $ | 2.66 | $ | (0.47) | $ | 9.35 | $ | 6.26 | ||||||||||||||||||
| (Less) Plus: adjustments to GAAP net income attributable to Biogen Inc. (as detailed above) | 1.42 | 4.83 | 3.67 | 5.52 | ||||||||||||||||||||||
| Total diluted earnings per share, Non-GAAP | $ | 4.08 | $ | 4.36 | $ | 13.02 | $ | 11.78 | ||||||||||||||||||
A Share-based compensation expense reflects the accelerated vesting of awards previously granted to Human Immunology Biosciences, Inc. (HI-Bio) employees as a result of our acquisition of HI-Bio in the third quarter of 2024 as well as the accelerated vesting of awards previously granted to Reata Pharmaceuticals, Inc. (Reata) employees as a result of our acquisition of Reata in the third quarter of 2023. A portion of the total consideration to former HI-Bio and Reata employees were deemed to be compensation attributable to the post-acquisition service period and recognized as a charge to selling, general and administrative expense and to research and development expense within our consolidated statements of income.
12
TABLE 4 (continued)
BIOGEN INC. AND SUBSIDIARIES
GAAP TO NON-GAAP RECONCILIATION: REVENUE CHANGE AT CONSTANT CURRENCY
(unaudited)
Revenue changes at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.
| Q3 2024 vs. Q3 2023 | YTD 2024 vs. YTD 2023 | |||||||||||||
| Total Revenue: | ||||||||||||||
| Revenue change, as reported | (2.5) | % | (3.1) | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | 0.3 | (0.1) | ||||||||||||
| Revenue change at constant currency | (2.8) | % | (3.0) | % | ||||||||||
| Total Product Revenue: | ||||||||||||||
| Revenue change, as reported | (2.0) | % | (0.6) | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | 0.2 | (0.3) | ||||||||||||
| Revenue change at constant currency | (2.2) | % | (0.3) | % | ||||||||||
| Total MS Product Revenue: | ||||||||||||||
| Revenue change, as reported | (9.1) | % | (6.1) | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | 0.1 | (0.1) | ||||||||||||
| Revenue change at constant currency | (9.2) | % | (6.0) | % | ||||||||||
| Total Rare Disease Revenue | ||||||||||||||
| Revenue change, as reported | 10.0 | % | 9.1 | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | 0.1 | (1.2) | ||||||||||||
| Revenue change at constant currency | 9.9 | % | 10.3 | % | ||||||||||
| Total Biosimilars Product Revenue: | ||||||||||||||
| Revenue change, as reported | 1.2 | % | 1.7 | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | 1.0 | 0.5 | ||||||||||||
| Revenue change at constant currency | 0.2 | % | 1.2 | % | ||||||||||
| Total Revenue from Anti-CD20 Therapeutic Programs Revenue: | ||||||||||||||
| Revenue change, as reported | 6.0 | % | 2.5 | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | — | 0.1 | ||||||||||||
| Revenue change at constant currency | 6.0 | % | 2.4 | % | ||||||||||
| Total Contract Manufacturing, Royalty and Other Revenue: | ||||||||||||||
| Revenue change, as reported | (17.8) | % | (28.9) | % | ||||||||||
| Less: impact of foreign currency translation and hedging gains / losses | 1.0 | 0.8 | ||||||||||||
| Revenue change at constant currency | (18.8) | % | (29.7) | % | ||||||||||
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TABLE 4 (continued)
BIOGEN INC. AND SUBSIDIARIES
GAAP TO NON-GAAP RECONCILIATION
FREE CASH FLOW
(unaudited, in millions)
We define free cash flow as net cash provided by (used in) operating activities in the period less capital expenditures made in the period. The following table reconciles net cash provided by (used in) operating activities, a GAAP measure, to free cash flow, a Non-GAAP measure.
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| Cash Flow: | ||||||||||||||||||||||||||
| Net cash provided by (used in) operating activities | $ | 935.6 | $ | 592.4 | $ | 2,114.6 | $ | 1,534.7 | ||||||||||||||||||
| Net cash provided by (used in) investing activities | (1,181.1) | (1,742.2) | (780.6) | (3,448.7) | ||||||||||||||||||||||
| Net cash provided by (used in) financing activities | (6.6) | 848.6 | (691.4) | 795.4 | ||||||||||||||||||||||
| Net increase (decrease) in cash and cash equivalents | $ | (252.1) | $ | (301.2) | $ | 642.6 | $ | (1,118.6) | ||||||||||||||||||
| Net cash provided by (used in) operating activities | $ | 935.6 | $ | 592.4 | $ | 2,114.6 | $ | 1,534.7 | ||||||||||||||||||
| Less: Purchases of property, plant and equipment | 35.0 | 74.2 | 114.4 | 211.8 | ||||||||||||||||||||||
| Free cash flow | $ | 900.6 | $ | 518.2 | $ | 2,000.2 | $ | 1,322.9 | ||||||||||||||||||
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Use of Non-GAAP Financial Measures
We supplement our GAAP consolidated financial statements and GAAP financial measures with other financial measures, such as adjusted net income, adjusted diluted earnings per share, revenue growth at constant currency, which excludes the impact of changes in foreign exchange rates and hedging gains or losses, and free cash flow, which is defined as net cash flow from operations less capital expenditures. We believe that these and other Non-GAAP financial measures provide additional insight into the ongoing economics of our business and reflect how we manage our business internally, set operational goals and form the basis of our management incentive programs. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
Our “Non-GAAP net income attributable to Biogen Inc.” and “Non-GAAP earnings per share - Diluted” financial measures exclude the following items from “GAAP net income attributable to Biogen Inc.” and “GAAP earnings per share - Diluted”:
1. Acquisitions and divestitures
We exclude transaction, integration and certain other costs related to the acquisition and divestiture of businesses and items associated with the initial consolidation or deconsolidation of variable interest entities. These adjustments include, but are not limited to, the amortization and impairment of intangible assets, charges or credits from the fair value remeasurement of our contingent consideration obligations and losses on assets and liabilities held for sale.
2. Restructuring, business transformation and other cost saving initiatives
We exclude costs associated with our execution of certain strategies and initiatives to streamline operations, achieve targeted cost reductions, rationalize manufacturing facilities or refocus research and development activities. These costs may include employee separation costs, retention bonuses, facility closing and exit costs, asset impairment charges or additional depreciation when the expected useful life of certain assets have been shortened due to changes in anticipated usage and other costs or credits that management believes do not have a direct correlation to our ongoing or future business operations.
3. (Gain) loss on equity security investments
We exclude unrealized and realized gains and losses related to our equity security investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
4. Other items
We evaluate other items of income and expense on an individual basis and consider both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to our ongoing business operations and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. We also include an adjustment to reflect the related tax effect of all reconciling items within our reconciliation of our GAAP to Non-GAAP net income attributable to Biogen Inc. and earnings per share - diluted.
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