On October 20, 2021 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2021 financial results (Press release, Biogen, OCT 20, 2021, View Source [SID1234591629]).
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"The potential uptake of ADUHELM in the U.S. is delayed, but we continue to believe in its long-term potential. At the same time, Biogen has continued to execute well across its leading MS, SMA and biosimilars businesses, and we are particularly encouraged by the ongoing launch of VUMERITY," said Michel Vounatsos, Biogen’s Chief Executive Officer. "2021 continues to be a transformative year for Biogen with the launch of ADUHELM and the initiation of the rolling submission for lecanemab in Alzheimer’s disease. In addition, along with Sage Therapeutics we are pursuing a filing for zuranolone in depression."
Third Quarter 2021 Financial Results
• Third quarter total revenue of $2,779 million decreased 18% versus the prior year at both actual currency and constant currency*. o Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of $1,820 million decreased 19% versus the prior year at actual currency and 20% at constant currency. o SPINRAZA revenue of $444 million decreased 10% versus the prior year at actual currency and 11% at constant currency. o ADUHELM revenue was $0.3 million. o Biosimilars revenue of $203 million decreased 2% versus the prior year at actual currency and 4% at constant currency. 2
• Third quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $329 million and $2.22, respectively.
• Third quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $710 million and $4.77, respectively. A 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 U.S. dollars using the average exchange rates from the prior period.Beginning in the second quarter of 2021 material upfront payments and premiums paid on the acquisition of common stock associated with significant collaboration and licensing arrangements along with the related transaction costs incurred are no longer excluded from Non-GAAP R&D and SG&A expenses. Non-GAAP financial results for the third quarter of 2020 have been updated to reflect the $601 million payment related to the collaboration with Denali Therapeutics Inc. along with the associated transaction costs and income tax effect. o Third quarter 2021 GAAP and Non-GAAP R&D expense includes a $125 million upfront payment related to our collaboration with InnoCare Pharma Limited. In addition, during the third quarter we suspended further development of BIIB111 (timrepigene emparvovec) in choroideremia and BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa and recorded $39 million of estimated clinical trial close-out costs and manufacturing commitments. o Third quarter 2021 GAAP and Non-GAAP SG&A expense increased versus the prior year primarily due to investments in support of the launch of ADUHELM. Beginning in the second quarter, upon FDA approval, the reimbursement from Eisai for its share of U.S. ADUHELM SG&A expenses is reflected in collaboration profit sharing rather than SG&A.
3 • Third quarter 2021 GAAP amortization and impairment of acquired intangible assets was $111 million, including an impairment charge of $15 million related to BIIB111 and a $28 million impairment charge related to BIIB112. These amounts are excluded from Non-GAAP financial results. Non-GAAP amortization was $7 million.
• Third quarter 2021 GAAP and Non-GAAP collaboration profit sharing was a net expense of $21 million, which includes a reimbursement of $51 million from Eisai Co., Ltd. (Eisai) related to the commercialization of ADUHELM in the U.S.
• Third quarter 2021 GAAP other expense was $503 million, primarily driven by unrealized losses on our strategic equity investments of $424 million. Third quarter 2021 Non-GAAP other expense was $79 million, primarily driven by interest expense.
• Third quarter 2021 effective GAAP and Non-GAAP tax rates were (8.9%) and 14.5%, respectively. The third quarter 2021 effective GAAP tax rate was impacted by non-cash tax favorability from both the unrealized losses on our strategic equity investments and the previously described impairment charges related to BIIB111 and BIIB112. Financial Position
• As of September 30, 2021, Biogen had $7,271 million in total debt. Cash, cash equivalents, and marketable securities totaled $3,923 million. This resulted in net debt of $3,348 million.
• In the third quarter of 2021 Biogen repurchased approximately 2.2 million shares of the Company’s common stock for a total value of $750 million.
As of September 30, 2021, there was $2,800 million remaining under the share repurchase program authorized in October 2020.
• For the third quarter of 2021 the Company’s weighted average diluted shares were 149 million.
• Third quarter 2021 cash from operations was $805 million. Capital expenditures were $42 million, and free cash flow, defined as cash flow from operations less capital expenditures, was $763 million.