(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)
%
13
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
14
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.