☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 36-0781620 | |||||||||||||
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
|||||||||||||
One Baxter Parkway, | Deerfield, | Illinois | 60015 | |||||||||||
(Address of Principal Executive Offices) | (Zip Code) |
224. | 948.2000 | ||||||||||||||||
(Registrant’s telephone number, including area code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Common Stock, $1.00 par value | BAX (NYSE) | New York Stock Exchange | ||||||||||||
Chicago Stock Exchange | ||||||||||||||
0.4% Global Notes due 2024 | BAX 24 | New York Stock Exchange | ||||||||||||
1.3% Global Notes due 2025 | BAX 25 | New York Stock Exchange | ||||||||||||
1.3% Global Notes due 2029 | BAX 29 | New York Stock Exchange | ||||||||||||
3.95% Global Notes due 2030 | BAX 30 | New York Stock Exchange | ||||||||||||
1.73% Global Notes due 2031 | BAX 31 | New York Stock Exchange |
Large accelerated filer | x | Accelerated filer | o | |||||||||||
Non-accelerated filer | o | Smaller reporting company | ☐ | |||||||||||
Emerging growth company | ☐ |
Page Number | ||||||||
Item 1A. | ||||||||
September 30,
2021 |
December 31,
2020 |
|||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 3,258 | $ | 3,730 | ||||
Accounts receivable, net of allowances of $115 in 2021 and $125 in 2020
|
2,074 | 2,007 | ||||||
Inventories | 2,025 | 1,916 | ||||||
Prepaid expenses and other current assets | 810 | 758 | ||||||
Total current assets | 8,167 | 8,411 | ||||||
Property, plant and equipment, net | 4,582 | 4,722 | ||||||
Goodwill | 3,098 | 3,217 | ||||||
Other intangible assets, net | 1,876 | 1,671 | ||||||
Operating lease right-of-use assets | 581 | 603 | ||||||
Other non-current assets | 1,503 | 1,395 | ||||||
Total assets | $ | 19,807 | $ | 20,019 | ||||
Current liabilities: | ||||||||
Short-term debt | $ | 301 | $ | — | ||||
Current maturities of long-term debt and finance lease obligations | 209 | 406 | ||||||
Accounts payable | 999 | 1,043 | ||||||
Accrued expenses and other current liabilities | 1,932 | 1,884 | ||||||
Total current liabilities | 3,441 | 3,333 | ||||||
Long-term debt and finance lease obligations | 5,446 | 5,786 | ||||||
Operating lease liabilities | 484 | 501 | ||||||
Other non-current liabilities | 1,621 | 1,673 | ||||||
Total liabilities | 10,992 | 11,293 | ||||||
Commitments and contingencies | ||||||||
Equity: | ||||||||
Common stock, $1 par value, authorized 2,000,000,000 shares, issued 683,494,944 shares in 2021 and 2020
|
683 | 683 | ||||||
Common stock in treasury, at cost,182,847,640 shares in 2021 and 178,580,208 shares in 2020
|
(11,529) | (11,051) | ||||||
Additional contributed capital | 6,131 | 6,043 | ||||||
Retained earnings | 16,967 | 16,328 | ||||||
Accumulated other comprehensive (loss) income | (3,482) | (3,314) | ||||||
Total Baxter stockholders’ equity | 8,770 | 8,689 | ||||||
Noncontrolling interests | 45 | 37 | ||||||
Total equity | 8,815 | 8,726 | ||||||
Total liabilities and equity | $ | 19,807 | $ | 20,019 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||
Net sales | $ | 3,226 | $ | 2,972 | $ | 9,270 | $ | 8,492 | |||||||||
Cost of sales | 1,905 | 1,777 | 5,571 | 5,096 | |||||||||||||
Gross margin | 1,321 | 1,195 | 3,699 | 3,396 | |||||||||||||
Selling, general and administrative expenses | 680 | 601 | 1,982 | 1,819 | |||||||||||||
Research and development expenses | 129 | 123 | 396 | 386 | |||||||||||||
Other operating expense (income), net | (1) | 1 | (6) | (19) | |||||||||||||
Operating income | 513 | 470 | 1,327 | 1,210 | |||||||||||||
Interest expense, net | 50 | 39 | 118 | 96 | |||||||||||||
Other expense, net | 12 | 16 | 15 | 32 | |||||||||||||
Income before income taxes | 451 | 415 | 1,194 | 1,082 | |||||||||||||
Income tax (benefit) expense | (1) | 56 | 141 | 143 | |||||||||||||
Net income | 452 | 359 | 1,053 | 939 | |||||||||||||
Net income attributable to noncontrolling interests | 2 | 3 | 7 | 5 | |||||||||||||
Net income attributable to Baxter stockholders | $ | 450 | $ | 356 | $ | 1,046 | $ | 934 | |||||||||
Earnings per share | |||||||||||||||||
Basic | $ | 0.90 | $ | 0.70 | $ | 2.08 | $ | 1.83 | |||||||||
Diluted | $ | 0.89 | $ | 0.69 | $ | 2.06 | $ | 1.81 | |||||||||
Weighted-average number of shares outstanding | |||||||||||||||||
Basic | 500 | 511 | 503 | 509 | |||||||||||||
Diluted | 506 | 518 | 509 | 517 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||
Net income | $ | 452 | $ | 359 | $ | 1,053 | $ | 939 | |||||||||
Other comprehensive income (loss), net of tax: | |||||||||||||||||
Currency translation adjustments, net of tax expense (benefit) of $3 and $18 for the three months ended September 30, 2021 and 2020, respectively, and $16 and $12 for the nine months ended September 30, 2021 and 2020, respectively
|
(137) | 127 | (257) | (43) | |||||||||||||
Pension and other postretirement benefits, net of tax expense of $8 and $0 for the three months ended September 30, 2021 and 2020, respectively, and $19 and $7 for the nine months ended September 30, 2021 and 2020, respectively
|
22 | — | 63 | 26 | |||||||||||||
Hedging activities, net of tax expense (benefit) of $3 and $5 for the three months ended September 30, 2021 and 2020, respectively, and $8 and ($33) for the nine months ended September 30, 2021 and 2020, respectively
|
9 | 22 | 26 | (112) | |||||||||||||
Total other comprehensive income (loss), net of tax | (106) | 149 | (168) | (129) | |||||||||||||
Comprehensive income | 346 | 508 | 885 | 810 | |||||||||||||
Less: Comprehensive income attributable to noncontrolling interests | 2 | 3 | 7 | 5 | |||||||||||||
Comprehensive income attributable to Baxter stockholders | $ | 344 | $ | 505 | $ | 878 | $ | 805 |
For the three months ended September 30, 2021 | ||||||||||||||||||||||||||||||||
Baxter International Inc. stockholders' equity | ||||||||||||||||||||||||||||||||
Common stock shares | Common stock |
Common stock shares
in treasury |
Common stock in
treasury |
Additional contributed capital | Retained earnings |
Accumulated other comprehensive
income (loss) |
Total Baxter stockholders' equity | Noncontrolling interests | Total equity | |||||||||||||||||||||||
Balance as of July 1, 2021 | 683 | $ | 683 | 184 | $ | (11,561) | $ | 6,090 | $ | 16,658 | $ | (3,376) | $ | 8,494 | $ | 41 | $ | 8,535 | ||||||||||||||
Net income | — | — | — | — | — | 450 | — | 450 | 2 | 452 | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | — | (106) | (106) | — | (106) | ||||||||||||||||||||||
Stock issued under employee benefit plans and other | — | — | (1) | 32 | 41 | — | — | 73 | — | 73 | ||||||||||||||||||||||
Dividends declared on common stock | — | — | — | — | — | (141) | — | (141) | — | (141) | ||||||||||||||||||||||
Change in noncontrolling interests | — | — | — | — | — | — | — | — | 2 | 2 | ||||||||||||||||||||||
Balance as of September 30, 2021
|
683 | $ | 683 | 183 | $ | (11,529) | $ | 6,131 | $ | 16,967 | $ | (3,482) | $ | 8,770 | $ | 45 | $ | 8,815 |
For the nine months ended September 30, 2021
|
||||||||||||||||||||||||||||||||
Baxter International Inc. stockholders' equity | ||||||||||||||||||||||||||||||||
Common stock shares | Common stock | Common stock shares in treasury | Common stock in treasury | Additional contributed capital | Retained earnings | Accumulated other comprehensive income (loss) | Total Baxter stockholders' equity | Noncontrolling interests | Total equity | |||||||||||||||||||||||
Balance as of January 1, 2021 | 683 | $ | 683 | 179 | $ | (11,051) | $ | 6,043 | $ | 16,328 | $ | (3,314) | $ | 8,689 | $ | 37 | $ | 8,726 | ||||||||||||||
Net income | — | — | — | — | — | 1,046 | — | 1,046 | 7 | 1,053 | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | — | (168) | (168) | — | (168) | ||||||||||||||||||||||
Purchases of treasury stock | — | — | 7 | (600) | — | — | — | (600) | — | (600) | ||||||||||||||||||||||
Stock issued under employee benefit plans and other | — | — | (3) | 122 | 88 | — | — | 210 | — | 210 | ||||||||||||||||||||||
Dividends declared on common stock | — | — | — | — | — | (407) | — | (407) | — | (407) | ||||||||||||||||||||||
Change in noncontrolling interests | — | — | — | — | — | — | — | — | 1 | 1 | ||||||||||||||||||||||
Balance as of September 30, 2021
|
683 | $ | 683 | 183 | $ | (11,529) | $ | 6,131 | $ | 16,967 | $ | (3,482) | $ | 8,770 | $ | 45 | $ | 8,815 |
For the three months ended September 30, 2020 | ||||||||||||||||||||||||||||||||
Baxter International Inc. stockholders' equity | ||||||||||||||||||||||||||||||||
Common stock shares | Common stock | Common stock shares in treasury | Common stock in treasury | Additional contributed capital | Retained earnings | Accumulated other comprehensive income (loss) | Total Baxter stockholders' equity | Noncontrolling interests | Total equity | |||||||||||||||||||||||
Balance as of July 1, 2020 | 683 | $ | 683 | 173 | $ | (10,597) | $ | 5,975 | $ | 16,055 | $ | (3,988) | $ | 8,128 | $ | 32 | $ | 8,160 | ||||||||||||||
Net income | — | — | — | — | — | 356 | — | 356 | 3 | 359 | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | — | 149 | 149 | — | 149 | ||||||||||||||||||||||
Stock issued under employee benefit plans and other | — | — | — | 26 | 34 | — | — | 60 | — | 60 | ||||||||||||||||||||||
Dividends declared on common stock | — | — | — | — | — | (126) | — | (126) | — | (126) | ||||||||||||||||||||||
Balance as of September 30, 2020 | 683 | $ | 683 | 173 | $ | (10,571) | $ | 6,009 | $ | 16,285 | $ | (3,839) | $ | 8,567 | $ | 35 | $ | 8,602 |
For the nine months ended September 30, 2020
|
||||||||||||||||||||||||||||||||
Baxter International Inc. stockholders' equity | ||||||||||||||||||||||||||||||||
Common stock shares | Common stock | Common stock shares in treasury | Common stock in treasury | Additional contributed capital | Retained earnings | Accumulated other comprehensive income (loss) | Total Baxter stockholders' equity | Noncontrolling interests | Total equity | |||||||||||||||||||||||
Balance as of January 1, 2020 | 683 | $ | 683 | 177 | $ | (10,764) | $ | 5,955 | $ | 15,718 | $ | (3,710) | $ | 7,882 | $ | 30 | $ | 7,912 | ||||||||||||||
Adoption of new accounting standards | — | — | — | — | — | (4) | — | (4) | — | (4) | ||||||||||||||||||||||
Net income | — | — | — | — | — | 934 | — | 934 | 5 | 939 | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | — | (129) | (129) | — | (129) | ||||||||||||||||||||||
Stock issued under employee benefit plans and other | — | — | (4) | 193 | 54 | — | — | 247 | — | 247 | ||||||||||||||||||||||
Dividends declared on common stock | — | — | — | — | — | (363) | — | (363) | — | (363) | ||||||||||||||||||||||
Balance as of September 30, 2020
|
683 | $ | 683 | 173 | $ | (10,571) | $ | 6,009 | $ | 16,285 | $ | (3,839) | $ | 8,567 | $ | 35 | $ | 8,602 |
Nine months ended
September 30, |
||||||||
2021 | 2020 | |||||||
Cash flows from operations | ||||||||
Net income | $ | 1,053 | $ | 939 | ||||
Adjustments to reconcile net income to cash flows from operations: | ||||||||
Depreciation and amortization | 645 | 610 | ||||||
Deferred income taxes | (98) | (45) | ||||||
Stock compensation | 93 | 97 | ||||||
Net periodic pension and other postretirement costs | 77 | 59 | ||||||
Intangible asset impairment | — | 17 | ||||||
Other | 46 | 54 | ||||||
Changes in balance sheet items: | ||||||||
Accounts receivable, net | (128) | (108) | ||||||
Inventories | (149) | (305) | ||||||
Prepaid expenses and other current assets | (51) | (60) | ||||||
Accounts payable | 14 | (28) | ||||||
Accrued expenses and other current liabilities | 91 | 64 | ||||||
Other | (64) | (136) | ||||||
Cash flows from operations – continuing operations | 1,529 | 1,158 | ||||||
Cash flows from operations – discontinued operations | — | (2) | ||||||
Cash flows from operations | 1,529 | 1,156 | ||||||
Cash flows from investing activities | ||||||||
Capital expenditures | (508) | (472) | ||||||
Acquisitions, net of cash acquired, and investments | (463) | (466) | ||||||
Other investing activities, net | 38 | 23 | ||||||
Cash flows from investing activities | (933) | (915) | ||||||
Cash flows from financing activities | ||||||||
Repayments of debt | (407) | — | ||||||
Issuances of debt | 50 | 1,240 | ||||||
Net increase (decrease) in debt with original maturities of three months or less | 251 | (226) | ||||||
Cash dividends on common stock | (390) | (348) | ||||||
Proceeds from stock issued under employee benefit plans | 135 | 180 | ||||||
Purchases of treasury stock | (600) | — | ||||||
Debt issuance costs | (37) | (3) | ||||||
Other financing activities, net | (33) | (45) | ||||||
Cash flows from financing activities | (1,031) | 798 | ||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (40) | (8) | ||||||
Increase (decrease) in cash, cash equivalents and restricted cash | (475) | 1,031 | ||||||
Cash, cash equivalents and restricted cash at beginning of period (1)
|
3,736 | 3,335 | ||||||
Cash, cash equivalents and restricted cash at end of period (1)
|
$ | 3,261 | $ | 4,366 |
September 30, 2021 | December 31, 2020 | September 30, 2020 | |||||||||
Cash and cash equivalents | $ | 3,258 | $ | 3,730 | $ | 4,359 | |||||
Restricted cash included in prepaid expenses and other current assets | 3 | 6 | 7 | ||||||||
Cash, cash equivalents and restricted cash | $ | 3,261 | $ | 3,736 | $ | 4,366 |
(in millions) | |||||
Assets acquired | |||||
Inventory | $ | 16 | |||
Goodwill | 1 | ||||
Other intangible assets | 67 | ||||
Total assets acquired | $ | 84 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Interest expense, net of capitalized interest | $ | 54 | $ | 42 | $ | 128 | $ | 112 | |||||||||
Interest income | (4) | (3) | (10) | (16) | |||||||||||||
Interest expense, net | $ | 50 | $ | 39 | $ | 118 | $ | 96 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Foreign exchange (gains) losses, net | $ | — | $ | 23 | $ | 5 | $ | 44 | |||||||||
Pension and other postretirement benefit plans | 4 | — | 11 | (2) | |||||||||||||
Change in fair value of marketable equity securities | 9 | (9) | 2 | (9) | |||||||||||||
Other, net | (1) | 2 | (3) | (1) | |||||||||||||
Other expense, net | $ | 12 | $ | 16 | $ | 15 | $ | 32 |
Three months ended
September 30, |
Nine months ended
September 30, |
|||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | ||||||||||
Balance at beginning of period | $ | 117 | $ | 120 | $ | 125 | $ | 112 | ||||||
Adoption of new accounting standard | — | — | — | 4 | ||||||||||
Charged to costs and expenses | 2 | 3 | (1) | 15 | ||||||||||
Write-offs | (2) | (3) | (3) | (4) | ||||||||||
Currency translation adjustments | (2) | 2 | (6) | (5) | ||||||||||
Balance at end of period | $ | 115 | $ | 122 | $ | 115 | $ | 122 |
(in millions) |
September 30,
2021 |
December 31,
2020 |
||||||
Raw materials | $ | 479 | $ | 460 | ||||
Work in process | 219 | 196 | ||||||
Finished goods | 1,327 | 1,260 | ||||||
Inventories | $ | 2,025 | $ | 1,916 |
(in millions) |
September 30,
2021 |
December 31,
2020 |
||||||
Property, plant and equipment, at cost | $ | 11,171 | $ | 11,271 | ||||
Accumulated depreciation | (6,589) | (6,549) | ||||||
Property, plant and equipment, net | $ | 4,582 | $ | 4,722 |
(in millions) | Americas | EMEA | APAC | Total | ||||||||||
Balance as of December 31, 2020 | $ | 2,574 | $ | 406 | $ | 237 | $ | 3,217 | ||||||
Reallocation of goodwill | 81 | (81) | — | — | ||||||||||
Acquisitions | 4 | 1 | — | 5 | ||||||||||
Currency translation | (103) | (12) | (9) | (124) | ||||||||||
Balance as of September 30, 2021 | $ | 2,556 | $ | 314 | $ | 228 | $ | 3,098 |
(in millions) | Developed technology, including patents | Other amortized intangible assets | Indefinite-lived intangible assets |
Total |
||||||||||
September 30, 2021 | ||||||||||||||
Gross other intangible assets | $ | 3,019 | $ | 498 | $ | 207 | $ | 3,724 | ||||||
Accumulated amortization | (1,502) | (346) | — | (1,848) | ||||||||||
Other intangible assets, net | $ | 1,517 | $ | 152 | $ | 207 | $ | 1,876 | ||||||
December 31, 2020 | ||||||||||||||
Gross other intangible assets | $ | 2,713 | $ | 495 | $ | 169 | $ | 3,377 | ||||||
Accumulated amortization | (1,374) | (332) | — | (1,706) | ||||||||||
Other intangible assets, net | $ | 1,339 | $ | 163 | $ | 169 | $ | 1,671 |
(in millions) | CTA | Pension and OPEB plans | Hedging activities | Total | ||||||||||
Gains (losses) | ||||||||||||||
Balance as of December 31, 2020
|
$ | (2,587) | $ | (574) | $ | (153) | $ | (3,314) | ||||||
Other comprehensive income (loss) before reclassifications | (257) | 13 | 5 | (239) | ||||||||||
Amounts reclassified from AOCI (a) | — | 50 | 21 | 71 | ||||||||||
Net other comprehensive income (loss) | (257) | 63 | 26 | (168) | ||||||||||
Balance as of September 30, 2021 | $ | (2,844) | $ | (511) | $ | (127) | $ | (3,482) |
(in millions) | CTA | Pension and OPEB plans | Hedging activities | Total | ||||||||||
Gains (losses) | ||||||||||||||
Balance as of December 31, 2019 | $ | (2,954) | $ | (715) | $ | (41) | $ | (3,710) | ||||||
Other comprehensive income (loss) before
reclassifications |
(43) | (9) | (110) | (162) | ||||||||||
Amounts reclassified from AOCI (a) | — | 35 | (2) | 33 | ||||||||||
Net other comprehensive income (loss) | (43) | 26 | (112) | (129) | ||||||||||
Balance as of September 30, 2020 | $ | (2,997) | $ | (689) | $ | (153) | $ | (3,839) |
Amounts reclassified from AOCI (a) | |||||||||||
(in millions) | Three months ended September 30, 2021 |
Nine months ended
September 30, 2021 |
Location of impact in income statement | ||||||||
Amortization of pension and OPEB items | |||||||||||
Amortization of net losses and prior service costs or credits | $ | (21) | $ | (62) | Other expense, net | ||||||
Less: Tax effect | 4 | 12 | Income tax expense | ||||||||
$ | (17) | $ | (50) | Net of tax | |||||||
Gains (losses) on hedging activities | |||||||||||
Foreign exchange contracts | $ | (5) | $ | (23) | Cost of sales | ||||||
Interest rate contracts | (1) | (4) | Interest expense, net | ||||||||
(6) | (27) | Total before tax | |||||||||
Less: Tax effect | 1 | 6 | Income tax expense | ||||||||
$ | (5) | $ | (21) | Net of tax | |||||||
Total reclassifications for the period | $ | (22) | $ | (71) | Total net of tax |
Amounts reclassified from AOCI (a) | |||||||||||
(in millions) | Three months ended September 30, 2020 | Nine months ended September 30, 2020 | Location of impact in income statement | ||||||||
Amortization of pension and OPEB items | |||||||||||
Amortization of net losses and prior service costs or credits | $ | (14) | $ | (44) | Other expense, net | ||||||
Less: Tax effect | 3 | 9 | Income tax expense | ||||||||
$ | (11) | $ | (35) | Net of tax | |||||||
Gains on hedging activities | |||||||||||
Foreign exchange contracts | $ | (2) | $ | 2 | Cost of sales | ||||||
Less: Tax effect | 1 | — | Income tax expense | ||||||||
$ | (1) | $ | 2 | Net of tax | |||||||
Total reclassifications for the period | $ | (12) | $ | (33) | Total net of tax |
(in millions) |
September 30,
2021 |
December 31,
2020 |
||||||
Contract manufacturing services | $ | 73 | $ | 47 | ||||
Software sales | 38 | 40 | ||||||
Bundled equipment and consumable medical products contracts | 82 | 47 | ||||||
Contract assets | $ | 193 | $ | 134 |
(in millions) |
September 30,
2021 |
December 31,
2020 |
||||||
Prepaid expenses and other current assets | $ | 104 | $ | 70 | ||||
Other non-current assets | 89 | 64 | ||||||
Contract assets | $ | 193 | $ | 134 | ||||
Accrued expenses and other current liabilities | $ | 39 | $ | 32 | ||||
Other non-current liabilities | 52 | 34 | ||||||
Contract liabilities | $ | 91 | $ | 66 |
Three Months Ended September 30, | ||||||||||||||||||||
2021 | 2020 | |||||||||||||||||||
(in millions) | U.S. | International | Total | U.S. | International | Total | ||||||||||||||
Renal Care 1
|
$ | 222 | $ | 759 | $ | 981 | $ | 216 | $ | 739 | $ | 955 | ||||||||
Medication Delivery 2
|
490 | 257 | 747 | 419 | 246 | 665 | ||||||||||||||
Pharmaceuticals 3
|
188 | 401 | 589 | 209 | 330 | 539 | ||||||||||||||
Clinical Nutrition 4
|
88 | 156 | 244 | 87 | 147 | 234 | ||||||||||||||
Advanced Surgery 5
|
135 | 114 | 249 | 138 | 97 | 235 | ||||||||||||||
Acute Therapies 6
|
69 | 116 | 185 | 72 | 105 | 177 | ||||||||||||||
BioPharma Solutions 7
|
109 | 97 | 206 | 84 | 57 | 141 | ||||||||||||||
Other 8
|
18 | 7 | 25 | 19 | 7 | 26 | ||||||||||||||
Total Baxter | $ | 1,319 | $ | 1,907 | $ | 3,226 | $ | 1,244 | $ | 1,728 | $ | 2,972 |
Nine Months Ended September 30, | ||||||||||||||||||||
2021 | 2020 | |||||||||||||||||||
(in millions) | U.S. | International | Total | U.S. | International | Total | ||||||||||||||
Renal Care 1
|
$ | 655 | $ | 2,212 | $ | 2,867 | $ | 629 | $ | 2,115 | $ | 2,744 | ||||||||
Medication Delivery 2
|
1,345 | 751 | 2,096 | 1,262 | 686 | 1,948 | ||||||||||||||
Pharmaceuticals 3
|
550 | 1,137 | 1,687 | 637 | 899 | 1,536 | ||||||||||||||
Clinical Nutrition 4
|
255 | 460 | 715 | 241 | 426 | 667 | ||||||||||||||
Advanced Surgery 5
|
405 | 317 | 722 | 369 | 258 | 627 | ||||||||||||||
Acute Therapies 6
|
211 | 369 | 580 | 204 | 315 | 519 | ||||||||||||||
BioPharma Solutions 7
|
218 | 306 | 524 | 186 | 185 | 371 | ||||||||||||||
Other 8
|
58 | 21 | 79 | 60 | 20 | 80 | ||||||||||||||
Total Baxter | $ | 3,697 | $ | 5,573 | $ | 9,270 | $ | 3,588 | $ | 4,904 | $ | 8,492 |
(in millions) | Three months ended September 30, 2021 | Nine months ended September 30, 2021 | ||||||
Sales-type lease revenue | $ | 3 | $ | 19 | ||||
Operating lease revenue | 21 | 90 | ||||||
Variable lease revenue | 27 | 59 | ||||||
Total lease revenue | $ | 51 | $ | 168 |
(in millions) | Three months ended September 30, 2020 | Nine months ended September 30, 2020 | ||||||
Sales-type lease revenue | $ | 11 | $ | 27 | ||||
Operating lease revenue | 16 | 44 | ||||||
Variable lease revenue | 19 | 57 | ||||||
Total lease revenue | $ | 46 | $ | 128 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Restructuring charges | $ | 32 | $ | 26 | $ | 67 | $ | 58 | |||||||||
Costs to implement business optimization programs | 4 | 6 | 14 | 19 | |||||||||||||
Total business optimization charges | $ | 36 | $ | 32 | $ | 81 | $ | 77 |
Three months ended September 30, 2021 | ||||||||||||||
(in millions) | COGS | SG&A | R&D | Total | ||||||||||
Employee termination costs | $ | 11 | $ | 8 | $ | — | $ | 19 | ||||||
Contract termination and other costs | — | 2 | — | 2 | ||||||||||
Asset impairments | 11 | — | — | 11 | ||||||||||
Total restructuring charges | $ | 22 | $ | 10 | $ | — | $ | 32 |
Three months ended September 30, 2020 | ||||||||||||||
(in millions) | COGS | SG&A | R&D | Total | ||||||||||
Employee termination costs | $ | 4 | $ | 15 | $ | 1 | $ | 20 | ||||||
Contract termination and other costs | 1 | 3 | — | 4 | ||||||||||
Asset impairments | — | 2 | — | 2 | ||||||||||
Total restructuring charges | $ | 5 | $ | 20 | $ | 1 | $ | 26 |
Nine months ended September 30, 2021 | ||||||||||||||
(in millions) | COGS | SG&A | R&D | Total | ||||||||||
Employee termination costs | $ | 35 | $ | 14 | $ | — | $ | 49 | ||||||
Contract termination and other costs | — | 2 | — | 2 | ||||||||||
Asset impairments | 16 | — | — | 16 | ||||||||||
Total restructuring charges | $ | 51 | $ | 16 | $ | — | $ | 67 |
Nine months ended September 30, 2020 | ||||||||||||||
(in millions) | COGS | SG&A | R&D | Total | ||||||||||
Employee termination costs | $ | 9 | $ | 34 | $ | (1) | $ | 42 | ||||||
Contract termination and other costs | 3 | 3 | — | 6 | ||||||||||
Asset impairments | 8 | 2 | — | 10 | ||||||||||
Total restructuring charges | $ | 20 | $ | 39 | $ | (1) | $ | 58 |
(in millions) | |||||
Liability balance as of December 31, 2020 | $ | 113 | |||
Charges | 54 | ||||
Payments | (62) | ||||
Reserve adjustments | (3) | ||||
Currency translation | (6) | ||||
Liability balance as of September 30, 2021 | $ | 96 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Pension benefits | |||||||||||||||||
Service cost | $ | 22 | $ | 20 | $ | 66 | $ | 61 | |||||||||
Interest cost | 18 | 24 | 54 | 71 | |||||||||||||
Expected return on plan assets | (36) | (40) | (108) | (121) | |||||||||||||
Amortization of net losses and prior service costs | 23 | 19 | 69 | 57 | |||||||||||||
Net periodic pension cost | $ | 27 | $ | 23 | $ | 81 | $ | 68 | |||||||||
OPEB | |||||||||||||||||
Interest cost | $ | 1 | $ | 2 | $ | 3 | $ | 4 | |||||||||
Amortization of net loss and prior service credit | (2) | (5) | (7) | (13) | |||||||||||||
Net periodic OPEB cost (income) | $ | (1) | $ | (3) | $ | (4) | $ | (9) |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Basic shares | 500 | 511 | 503 | 509 | |||||||||||||
Effect of dilutive securities | 6 | 7 | 6 | 8 | |||||||||||||
Diluted shares | 506 | 518 | 509 | 517 |
Gain (loss) recognized in OCI |
Location of gain (loss)
in income statement |
Gain (loss) reclassified from AOCI into income | ||||||||||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||||
Cash flow hedges | ||||||||||||||||||||||||||
Interest rate contracts | $ | — | $ | 31 | Interest expense, net | $ | (1) | $ | — | |||||||||||||||||
Foreign exchange contracts | 6 | (6) | Cost of sales | (5) | (2) | |||||||||||||||||||||
Net investment hedges | 60 | (103) | Other expense, net | — | — | |||||||||||||||||||||
Total | $ | 66 | $ | (78) | $ | (6) | $ | (2) |
Location of gain (loss) in income statement | Gain (loss) recognized in income | |||||||||||||
(in millions) | 2021 | 2020 | ||||||||||||
Undesignated derivative instruments | ||||||||||||||
Foreign exchange contracts | Other expense, net | $ | (7) | $ | 7 |
Gain (loss) recognized in OCI |
Location of gain (loss)
in income statement |
Gain (loss) reclassified from AOCI
into income |
|||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Cash flow hedges | |||||||||||||||||
Interest rate contracts | $ | — | $ | (144) | Interest expense, net | $ | (4) | $ | — | ||||||||
Foreign exchange contracts | 7 | 1 | Cost of sales | (23) | 2 | ||||||||||||
Net investment hedges | 143 | (104) | Other expense, net | — | — | ||||||||||||
Total | $ | 150 | $ | (247) | $ | (27) | $ | 2 |
Location of gain (loss)
in income statement |
Gain (loss) recognized in income | ||||||||||
(in millions) | 2021 | 2020 | |||||||||
Undesignated derivative instruments | |||||||||||
Foreign exchange contracts | Other expense, net | $ | (26) | $ | 22 |
Derivatives in asset positions | Derivatives in liability positions | ||||||||||||||||
(in millions) | Balance sheet location | Fair value | Balance sheet location | Fair value | |||||||||||||
Derivative instruments designated as hedges | |||||||||||||||||
Foreign exchange contracts | Prepaid expenses and other current assets | $ | 7 | Accrued expenses and other current liabilities | $ | 2 | |||||||||||
Total derivative instruments designated as hedges | 7 | 2 | |||||||||||||||
Undesignated derivative instruments | |||||||||||||||||
Foreign exchange contracts | Prepaid expenses and other current assets | 2 | Accrued expenses and other current liabilities | 6 | |||||||||||||
Total derivative instruments | $ | 9 | $ | 8 |
Derivatives in asset positions | Derivatives in liability positions | ||||||||||||||||
(in millions) | Balance sheet location | Fair value | Balance sheet location | Fair value | |||||||||||||
Derivative instruments designated as hedges | |||||||||||||||||
Foreign exchange contracts | Prepaid expenses and other current assets | $ | — | Accrued expenses and other current liabilities | $ | 17 | |||||||||||
Total derivative instruments designated as hedges | — | 17 | |||||||||||||||
Undesignated derivative instruments | |||||||||||||||||
Foreign exchange contracts | Prepaid expenses and other current assets | 11 | Accrued expenses and other current liabilities | 2 | |||||||||||||
Total derivative instruments | $ | 11 | $ | 19 |
September 30, 2021 | December 31, 2020 | ||||||||||||||||
(in millions) | Asset | Liability | Asset | Liability | |||||||||||||
Gross amounts recognized in the consolidated balance sheet | $ | 9 | $ | 8 | $ | 11 | $ | 19 | |||||||||
Gross amount subject to offset in master netting arrangements not offset in the consolidated balance sheet | (2) | (2) | (6) | (6) | |||||||||||||
Total | $ | 7 | $ | 6 | $ | 5 | $ | 13 |
Carrying amount of hedged item |
Cumulative amount of fair value hedging adjustment included
in the carrying amount of the hedged item (a) |
||||||||||||||||
(in millions) | Balance as of September 30, 2021 | Balance as of December 31, 2020 | Balance as of September 30, 2021 | Balance as of December 31, 2020 | |||||||||||||
Long-term debt | $ | 102 | $ | 102 | $ | 4 | $ | 5 |
Basis of fair value measurement | ||||||||||||||
(in millions) | Balance as of September 30, 2021 |
Quoted prices in active markets for identical assets
(Level 1) |
Significant other
observable inputs (Level 2) |
Significant
unobservable inputs (Level 3) |
||||||||||
Assets | ||||||||||||||
Foreign exchange contracts | $ | 9 | $ | — | $ | 9 | $ | — | ||||||
Debt securities | 30 | — | 30 | — | ||||||||||
Marketable equity securities | 15 | 15 | — | — | ||||||||||
Total | $ | 54 | $ | 15 | $ | 39 | $ | — | ||||||
Liabilities | ||||||||||||||
Foreign exchange contracts | $ | 8 | $ | — | $ | 8 | $ | — | ||||||
Contingent payments related to acquisitions | 61 | — | — | 61 | ||||||||||
Total | $ | 69 | $ | — | $ | 8 | $ | 61 |
Basis of fair value measurement | ||||||||||||||
(in millions) | Balance as of December 31, 2020 |
Quoted prices in active markets for identical assets
(Level 1) |
Significant other
observable inputs (Level 2) |
Significant
unobservable inputs (Level 3) |
||||||||||
Assets | ||||||||||||||
Foreign exchange contracts | $ | 11 | $ | — | $ | 11 | $ | — | ||||||
Debt securities | 13 | — | 13 | — | ||||||||||
Marketable equity securities | 17 | 17 | — | — | ||||||||||
Total | $ | 41 | $ | 17 | $ | 24 | $ | — | ||||||
Liabilities | ||||||||||||||
Foreign exchange contracts | $ | 19 | $ | — | $ | 19 | $ | — | ||||||
Contingent payments related to acquisitions | 30 | — | — | 30 | ||||||||||
Total | $ | 49 | $ | — | $ | 19 | $ | 30 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Fair value at beginning of period | $ | 34 | $ | 39 | $ | 30 | $ | 39 | |||||||||
Additions | 28 | — | 52 | 4 | |||||||||||||
Change in fair value recognized in earnings | (1) | 1 | (6) | (2) | |||||||||||||
Payments | — | (10) | (16) | (11) | |||||||||||||
Currency translation | — | — | 1 | — | |||||||||||||
Fair value at end of period | $ | 61 | $ | 30 | $ | 61 | $ | 30 |
Book values | Fair values(a) | ||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Liabilities | |||||||||||||||||
Short-term debt | $ | 301 | $ | — | $ | 301 | $ | — | |||||||||
Current maturities of long-term debt and finance lease obligations | 209 | 406 | 213 | 409 | |||||||||||||
Long-term debt and finance lease obligations | 5,446 | 5,786 | 5,950 | 6,471 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Net sales: | |||||||||||||||||
Americas | $ | 1,727 | $ | 1,606 | $ | 4,911 | $ | 4,640 | |||||||||
EMEA | 779 | 720 | 2,300 | 2,077 | |||||||||||||
APAC | 720 | 646 | 2,059 | 1,775 | |||||||||||||
Total net sales | $ | 3,226 | $ | 2,972 | $ | 9,270 | $ | 8,492 | |||||||||
Operating income:
|
|||||||||||||||||
Americas | $ | 676 | $ | 611 | $ | 1,907 | $ | 1,726 | |||||||||
EMEA | 167 | 126 | 461 | 364 | |||||||||||||
APAC | 166 | 161 | 456 | 432 | |||||||||||||
Total segment operating income | $ | 1,009 | $ | 898 | $ | 2,824 | $ | 2,522 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Total segment operating income | $ | 1,009 | $ | 898 | $ | 2,824 | $ | 2,522 | |||||||||
Corporate and other | (496) | (428) | (1,497) | (1,312) | |||||||||||||
Total operating income | 513 | 470 | 1,327 | 1,210 | |||||||||||||
Interest expense, net | 50 | 39 | 118 | 96 | |||||||||||||
Other expense, net | 12 | 16 | 15 | 32 | |||||||||||||
Income before income taxes | $ | 451 | $ | 415 | $ | 1,194 | $ | 1,082 |
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Gross Margin | |||||||||||||||||
Intangible asset amortization expense | $ | (68) | $ | (57) | $ | (199) | $ | (165) | |||||||||
Intangible asset impairment1
|
— | — | — | (17) | |||||||||||||
Business optimization items2
|
(20) | (6) | (51) | (24) | |||||||||||||
Acquisition and integration expenses3
|
(1) | — | (1) | (11) | |||||||||||||
European medical devices regulation4
|
(11) | (8) | (30) | (22) | |||||||||||||
Investigation and related costs5
|
— | — | — | (3) | |||||||||||||
Total Special Items | $ | (100) | $ | (71) | $ | (281) | $ | (242) | |||||||||
Impact on Gross Margin Ratio | (3.1 pts) | (2.4 pts) | (3.0 pts) | (2.8 pts) | |||||||||||||
Selling, General and Administrative (SG&A) Expenses | |||||||||||||||||
Business optimization items2
|
$ | 16 | $ | 25 | $ | 30 | $ | 53 | |||||||||
Acquisition and integration expenses3
|
21 | — | 23 | 7 | |||||||||||||
Investigation and related costs5
|
3 | 2 | 31 | 18 | |||||||||||||
Total Special Items | $ | 40 | $ | 27 | $ | 84 | $ | 78 | |||||||||
Impact on SG&A Ratio | 1.3 pts | 0.9 pts | 0.9 pts | 0.9 pts | |||||||||||||
Research and Development (R&D) Expenses | |||||||||||||||||
Business optimization items2
|
$ | — | $ | 1 | $ | — | $ | — | |||||||||
Acquisition and integration expenses3
|
— | — | — | 22 | |||||||||||||
Investigation and related costs5
|
— | — | — | 1 | |||||||||||||
Total Special Items | $ | — | $ | 1 | $ | — | $ | 23 | |||||||||
Impact on R&D Ratio | 0.0 pts | 0.0 pts | 0.0 pts | 0.2 pts | |||||||||||||
Other Operating Expense (Income), net | |||||||||||||||||
Business optimization items2
|
$ | — | $ | — | $ | — | $ | (17) | |||||||||
Acquisition and integration expenses3
|
(1) | 1 | (6) | (2) | |||||||||||||
Total Special Items | $ | (1) | $ | 1 | $ | (6) | $ | (19) | |||||||||
Interest Expense, net | |||||||||||||||||
Acquisition and integration expenses3
|
$ | 18 | $ | — | $ | 18 | $ | — | |||||||||
Total Special Items | $ | 18 | $ | — | $ | 18 | $ | — | |||||||||
Income Tax (Benefit) Expense | |||||||||||||||||
Tax matters6
|
$ | (58) | $ | — | $ | (36) | $ | — | |||||||||
Tax effects of special items7
|
(33) | (25) | (76) | (73) | |||||||||||||
Total Special Items | $ | (91) | $ | (25) | $ | (112) | $ | (73) | |||||||||
Impact on Effective Tax Rate | (15.0 pts) | (2.2 pts) | (4.3 pts) | (2.2 pts) |
Three Months Ended September 30, | Percent change | ||||||||||||||||
(in millions) | 2021 | 2020 |
At actual
currency rates |
At constant currency rates | |||||||||||||
United States | $ | 1,319 | $ | 1,244 | 6 | % | 6 | % | |||||||||
International | $ | 1,907 | 1,728 | 10 | % | 8 | % | ||||||||||
Total net sales | $ | 3,226 | $ | 2,972 | 9 | % | 7 | % |
Nine Months Ended September 30, | Percent change | ||||||||||||||||
(in millions) | 2021 | 2020 |
At actual
currency rates |
At constant currency rates | |||||||||||||
United States | $ | 3,697 | $ | 3,588 | 3 | % | 3 | % | |||||||||
International | $ | 5,573 | 4,904 | 14 | % | 8 | % | ||||||||||
Total net sales | $ | 9,270 | $ | 8,492 | 9 | % | 6 | % |
Three Months Ended September 30, | Percent change | ||||||||||||||||
(in millions) | 2021 | 2020 | At actual currency rates | At constant currency rates | |||||||||||||
Renal Care
|
$ | 981 | $ | 955 | 3 | % | 1 | % | |||||||||
Medication Delivery
|
747 | 665 | 12 | % | 11 | % | |||||||||||
Pharmaceuticals
|
589 | 539 | 9 | % | 7 | % | |||||||||||
Clinical Nutrition
|
244 | 234 | 4 | % | 3 | % | |||||||||||
Advanced Surgery
|
249 | 235 | 6 | % | 5 | % | |||||||||||
Acute Therapies
|
185 | 177 | 5 | % | 3 | % | |||||||||||
BioPharma Solutions | 206 | 141 | 46 | % | 45 | % | |||||||||||
Other
|
25 | 26 | (4) | % | (8) | % | |||||||||||
Total Baxter | $ | 3,226 | $ | 2,972 | 9 | % | 7 | % |
Nine months ended September 30, | Percent change | ||||||||||||||||
(in millions) | 2021 | 2020 | At actual currency rates | At constant currency rates | |||||||||||||
Renal Care
|
$ | 2,867 | $ | 2,744 | 4 | % | 1 | % | |||||||||
Medication Delivery
|
2,096 | 1,948 | 8 | % | 5 | % | |||||||||||
Pharmaceuticals
|
1,687 | 1,536 | 10 | % | 4 | % | |||||||||||
Clinical Nutrition
|
715 | 667 | 7 | % | 3 | % | |||||||||||
Advanced Surgery
|
722 | 627 | 15 | % | 13 | % | |||||||||||
Acute Therapies
|
580 | 519 | 12 | % | 8 | % | |||||||||||
BioPharma Solutions | 524 | 371 | 41 | % | 36 | % | |||||||||||
Other
|
79 | 80 | (1) | % | (3) | % | |||||||||||
Total Baxter | $ | 9,270 | $ | 8,492 | 9 | % | 6 | % |
Three months ended September 30, | ||||||||||||||||||||
2021 | % of net sales | 2020 | % of net sales | $ change | % change | |||||||||||||||
Gross margin | $ | 1,321 | 40.9 | % | $ | 1,195 | 40.2 | % | $ | 126 | 10.5 | % | ||||||||
SG&A | $ | 680 | 21.1 | % | $ | 601 | 20.2 | % | $ | 79 | 13.1 | % | ||||||||
R&D | $ | 129 | 4.0 | % | $ | 123 | 4.1 | % | $ | 6 | 4.9 | % |
Nine months ended September 30, | ||||||||||||||||||||
2021 | % of net sales | 2020 | % of net sales | $ change | % change | |||||||||||||||
Gross margin | $ | 3,699 | 39.9 | % | $ | 3,396 | 40.0 | % | $ | 303 | 8.9 | % | ||||||||
SG&A | $ | 1,982 | 21.4 | % | $ | 1,819 | 21.4 | % | $ | 163 | 9.0 | % | ||||||||
R&D | $ | 396 | 4.3 | % | $ | 386 | 4.5 | % | $ | 10 | 2.6 | % |
Net sales | Operating income (loss) | ||||||||||||||||||||||||||||||||||
Three months ended September 30, | Nine months ended September 30, | Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||
(in millions) | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||||||||||
Americas | $ | 1,727 | $ | 1,606 | $ | 4,911 | $ | 4,640 | $ | 676 | $ | 611 | $ | 1,907 | $ | 1,726 | |||||||||||||||||||
EMEA | 779 | 720 | 2,300 | 2,077 | 167 | 126 | 461 | 364 | |||||||||||||||||||||||||||
APAC | 720 | 646 | 2,059 | 1,775 | 166 | 161 | 456 | 432 | |||||||||||||||||||||||||||
Total segments | 3,226 | 2,972 | 9,270 | 8,492 | 1,009 | 898 | 2,824 | 2,522 | |||||||||||||||||||||||||||
Corporate and other | — | — | — | — | (496) | (428) | (1,497) | (1,312) | |||||||||||||||||||||||||||
Total | $ | 3,226 | $ | 2,972 | $ | 9,270 | $ | 8,492 | $ | 513 | $ | 470 | $ | 1,327 | $ | 1,210 |
Nine months ended September 30, | |||||||||||
(in millions) | 2021 | 2020 | |||||||||
Cash flows from operations - continuing operations | $ | 1,529 | $ | 1,158 | |||||||
Cash flows from investing activities | (933) | (915) | |||||||||
Cash flows from financing activities | (1,031) | 798 |
•
|
demand for and market acceptance risks for and competitive pressures related to new and existing products (including challenges with our ability to accurately predict these pressures and the resulting impact on customer inventory levels and the impact of reduced hospital admission rates and elective surgery volumes), and the impact of those products on quality and patient safety concerns;
|
•
|
product development risks, including satisfactory clinical performance, the ability to manufacture at appropriate scale, and the general unpredictability associated with the product development cycle;
|
•
|
our ability to finance and develop new products or enhancements on commercially acceptable terms or at all;
|
•
|
our ability to identify business development and growth opportunities and to successfully execute on business development strategies (including the proposed acquisition of Hillrom);
|
•
|
product quality or patient safety issues, leading to product recalls, withdrawals, launch delays, warning letters, import bans, sanctions, seizures, litigation, or declining sales;
|
|||||||
•
|
the impact of global economic conditions (including potential trade wars) and continuing public health crises, pandemics and epidemics, such as the COVID-19 pandemic, including related resurgences, on us and our employees, customers and suppliers, including foreign governments in countries in which we operate; |
•
|
the continuity, availability and pricing of acceptable raw materials and component supply, and the related continuity of our manufacturing and distribution (including impacts from COVID-19);
|
• | inability to create additional production capacity in a timely manner or the occurrence of other manufacturing, sterilization or supply difficulties (including as a result of natural disaster, public health crises and epidemics/pandemics, regulatory actions or otherwise); |
•
|
breaches or failures of our information technology systems or products, including by cyber-attack, data leakage, unauthorized access or theft (as a result of increased remote working arrangements or otherwise);
|
•
|
future actions of (or failures to act or delays in acting by) FDA, the European Medicines Agency or any other regulatory body or government authority (including the SEC, DOJ or the Attorney General of any State) that could delay, limit or suspend product development, manufacturing or sale or result in seizures, recalls, injunctions, monetary sanctions or criminal or civil liabilities, including the SEC's investigation of the misstatements in previously reported non-operating income related to foreign exchange gains and losses or the continued delay in lifting the warning letter at our Ahmedabad facility;
|
•
|
failures with respect to our quality, compliance or ethics programs;
|
•
|
future actions of third parties, including third-party payers, the impact of healthcare reform and its implementation, suspension, repeal, replacement, amendment, modification and other similar actions undertaken by the United States or foreign governments, including with respect to pricing, reimbursement, taxation and rebate policies; legislation, regulation and other governmental pressures in the United States or globally, including the cost of compliance and potential penalties for purported noncompliance thereof, all of which may affect pricing, reimbursement, taxation and rebate policies of government agencies and private payers or other elements of our business, including new or amended laws, rules and regulations (such as the California Consumer Privacy Act of 2018, the European Union’s General Data Protection Regulation and proposed regulatory changes of the U.S. Department of Health and Human Services in kidney health policy and reimbursement, which may substantially change the U.S. end stage renal disease market and demand for our peritoneal dialysis products, necessitating significant multi-year capital expenditures, which are difficult to estimate in advance); |
•
|
the outcome of pending or future litigation, including the opioid litigation and current or future ethylene oxide litigation; | |||||||
• | failure to achieve our long-term financial improvement goals; |
•
|
the impact of competitive products and pricing, including generic competition, drug reimportation and disruptive technologies;
|
•
|
global regulatory, trade and tax policies;
|
•
|
the ability to protect or enforce our owned or in-licensed patent or other proprietary rights (including trademarks, copyrights, trade secrets and know-how) or patents of third parties preventing or restricting our manufacture, sale or use of affected products or technology;
|
•
|
the impact of any goodwill or other intangible asset impairments on our operating results;
|
•
|
any failure by Baxalta or Shire to satisfy their obligations under the separation agreements, including the tax matters agreement, or that certain letter agreement entered into with Shire and Baxalta;
|
•
|
fluctuations in foreign exchange and interest rates;
|
•
|
any changes in law concerning the taxation of income (whether with respect to current or future tax reform), including income earned outside the United States and potential taxes associated with the Base Erosion and Anti-Abuse Tax;
|
•
|
actions by tax authorities in connection with ongoing tax audits;
|
•
|
loss of key employees or inability to identify and recruit new employees;
|
•
|
other factors identified elsewhere in this report and other filings with the SEC, including those factors described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, all of which are available on our website.
|
BAXTER INTERNATIONAL INC. | ||||||||
(Registrant) | ||||||||
Date: October 28, 2021 | ||||||||
By: | /s/ James K. Saccaro | |||||||
James K. Saccaro
Executive Vice President and Chief Financial Officer (duly authorized officer and principal financial officer) |
/s/ José E. Almeida | |||||
José E. Almeida | |||||
Chairman of the Board and | |||||
Chief Executive Officer |
/s/ James K. Saccaro | |||||
James K. Saccaro | |||||
Executive Vice President and Chief Financial Officer |
/s/ José E. Almeida | |||||
José E. Almeida | |||||
Chairman of the Board and | |||||
Chief Executive Officer |
/s/ James K. Saccaro | |||||
James K. Saccaro | |||||
Executive Vice President and Chief Financial Officer |