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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2024
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-35565
AbbVie Inc. | | | | | | | | |
(Exact name of registrant as specified in its charter) |
Delaware | | 32-0375147 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. employer identification number) |
1 North Waukegan Road
North Chicago, Illinois 60064-6400
Telephone: (847) 932-7900
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | |
Large Accelerated Filer | ☒ | Accelerated Filer | ☐ |
Non-Accelerated Filer | ☐ | Smaller reporting company | ☐ |
| | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value $0.01 per share | | ABBV | | New York Stock Exchange |
| | | | Chicago Stock Exchange |
0.750% Senior Notes due 2027 | | ABBV27 | | New York Stock Exchange |
2.125% Senior Notes due 2028 | | ABBV28 | | New York Stock Exchange |
2.625% Senior Notes due 2028 | | ABBV28B | | New York Stock Exchange |
2.125% Senior Notes due 2029 | | ABBV29 | | New York Stock Exchange |
1.250% Senior Notes due 2031 | | ABBV31 | | New York Stock Exchange |
As of October 28, 2024, AbbVie Inc. had 1,767,140,323 shares of common stock at $0.01 par value outstanding.
AbbVie Inc. and Subsidiaries
Table of Contents
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA AbbVie Inc. and Subsidiaries
Condensed Consolidated Statements of Earnings (unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
(in millions, except per share data) | | 2024 | | 2023 | | 2024 | | 2023 |
Net revenues | | $ | 14,460 | | | $ | 13,927 | | | $ | 41,232 | | | $ | 40,017 | |
| | | | | | | | |
Cost of products sold | | 4,212 | | | 6,485 | | | 12,508 | | | 14,711 | |
Selling, general and administrative | | 4,205 | | | 3,372 | | | 10,897 | | | 9,679 | |
Research and development | | 2,130 | | | 1,723 | | | 6,017 | | | 5,748 | |
Acquired IPR&D and milestones | | 82 | | | 66 | | | 1,183 | | | 496 | |
Other operating income | | — | | | — | | | — | | | (179) | |
Total operating costs and expenses | | 10,629 | | | 11,646 | | | 30,605 | | | 30,455 | |
Operating earnings | | 3,831 | | | 2,281 | | | 10,627 | | | 9,562 | |
| | | | | | | | |
Interest expense, net | | 591 | | | 398 | | | 1,550 | | | 1,306 | |
Net foreign exchange loss (gain) | | (3) | | | 25 | | | 2 | | | 97 | |
Other expense (income), net | | 1,159 | | | (95) | | | 3,090 | | | 3,121 | |
Earnings before income tax expense | | 2,084 | | | 1,953 | | | 5,985 | | | 5,038 | |
Income tax expense | | 520 | | | 172 | | | 1,676 | | | 989 | |
Net earnings | | 1,564 | | | 1,781 | | | 4,309 | | | 4,049 | |
Net earnings attributable to noncontrolling interest | | 3 | | | 3 | | | 9 | | | 8 | |
Net earnings attributable to AbbVie Inc. | | $ | 1,561 | | | $ | 1,778 | | | $ | 4,300 | | | $ | 4,041 | |
| | | | | | | | |
Per share data | | | | | | | | |
Basic earnings per share attributable to AbbVie Inc. | | $ | 0.88 | | | $ | 1.00 | | | $ | 2.41 | | | $ | 2.27 | |
Diluted earnings per share attributable to AbbVie Inc. | | $ | 0.88 | | | $ | 1.00 | | | $ | 2.41 | | | $ | 2.26 | |
| | | | | | | | |
Weighted-average basic shares outstanding | | 1,769 | | | 1,767 | | | 1,769 | | | 1,768 | |
Weighted-average diluted shares outstanding | | 1,772 | | | 1,771 | | | 1,772 | | | 1,772 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| | | | | |
2024 Form 10-Q | | 1 |
AbbVie Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Income (unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
(in millions) | 2024 | | 2023 | | 2024 | | 2023 |
Net earnings | $ | 1,564 | | | $ | 1,781 | | | $ | 4,309 | | | $ | 4,049 | |
| | | | | | | |
Foreign currency translation adjustments, net of tax expense (benefit) of $25 for the three months and $1 the nine months ended September 30, 2024 and $(17) for the three months and $(11) nine months ended September 30, 2023 | 574 | | | (457) | | | 21 | | | (279) | |
Net investment hedging activities, net of tax expense (benefit) of $(91) for the three months and $(11) for the nine months ended September 30, 2024 and $84 for the three months and $26 nine months ended September 30, 2023 | (330) | | | 302 | | | (39) | | | 89 | |
Pension and post-employment benefits, net of tax expense (benefit) of $(1) for the three months and $3 for the nine months ended September 30, 2024 and $1 for the three months and $11 for the nine months ended September 30, 2023 | (3) | | | 2 | | | 15 | | | 38 | |
Cash flow hedging activities, net of tax expense (benefit) of $(8) for the three months and $(3) for the nine months ended September 30, 2024 and $7 for the three months and $(1) for the nine months ended September 30, 2023 | (62) | | | 52 | | | (26) | | | (2) | |
Other comprehensive income (loss) | 179 | | | (101) | | | (29) | | | (154) | |
Comprehensive income | 1,743 | | | 1,680 | | | 4,280 | | | 3,895 | |
Comprehensive income attributable to noncontrolling interest | 3 | | | 3 | | | 9 | | | 8 | |
Comprehensive income attributable to AbbVie Inc. | $ | 1,740 | | | $ | 1,677 | | | $ | 4,271 | | | $ | 3,887 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| | | | | |
2024 Form 10-Q | | 2 |
AbbVie Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| | | | | | | | | | | |
(in millions, except share data) | September 30, 2024 | | December 31, 2023 |
| (unaudited) | | |
Assets | | | |
Current assets | | | |
Cash and equivalents | $ | 7,257 | | | $ | 12,814 | |
Short-term investments | 28 | | | 2 | |
Accounts receivable, net | 11,472 | | | 11,155 | |
Inventories | 4,450 | | | 4,099 | |
Prepaid expenses and other | 4,578 | | | 4,932 | |
Total current assets | 27,785 | | | 33,002 | |
| | | |
Investments | 267 | | | 304 | |
Property and equipment, net | 5,141 | | | 4,989 | |
Intangible assets, net | 66,646 | | | 55,610 | |
Goodwill | 35,295 | | | 32,293 | |
Other assets | 8,288 | | | 8,513 | |
Total assets | $ | 143,422 | | | $ | 134,711 | |
| | | |
Liabilities and Equity | | | |
Current liabilities | | | |
| | | |
Current portion of long-term debt and finance lease obligations | $ | 12,570 | | | $ | 7,191 | |
Accounts payable and accrued liabilities | 30,492 | | | 30,650 | |
Total current liabilities | 43,062 | | | 37,841 | |
| | | |
Long-term debt and finance lease obligations | 58,509 | | | 52,194 | |
Deferred income taxes | 2,749 | | | 1,952 | |
Other long-term liabilities | 33,031 | | | 32,327 | |
| | | |
Commitments and contingencies | | | |
| | | |
Stockholders' equity | | | |
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,831,415,039 shares issued as of September 30, 2024 and 1,823,046,087 as of December 31, 2023 | 18 | | | 18 | |
Common stock held in treasury, at cost, 64,310,426 shares as of September 30, 2024 and 57,105,354 as of December 31, 2023 | (7,848) | | | (6,533) | |
Additional paid-in capital | 21,160 | | | 20,180 | |
Accumulated deficit | (4,964) | | | (1,000) | |
Accumulated other comprehensive loss | (2,334) | | | (2,305) | |
Total stockholders' equity | 6,032 | | | 10,360 | |
Noncontrolling interest | 39 | | | 37 | |
Total equity | 6,071 | | | 10,397 | |
| | | |
Total liabilities and equity | $ | 143,422 | | | $ | 134,711 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| | | | | |
2024 Form 10-Q | | 3 |
AbbVie Inc. and Subsidiaries
Condensed Consolidated Statements of Equity (unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(in millions) | Common shares outstanding | | Common stock | | Treasury stock | | Additional paid-in capital | | Retained earnings (accumulated deficit) | | Accumulated other comprehensive loss | | Noncontrolling interest | | Total |
Balance at June 30, 2023 | 1,765 | | | $ | 18 | | | $ | (6,528) | | | $ | 19,839 | | | $ | 1,789 | | | $ | (2,252) | | | $ | 32 | | | $ | 12,898 | |
Net earnings attributable to AbbVie Inc. | — | | | — | | | — | | | — | | | 1,778 | | | — | | | — | | | 1,778 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | (101) | | | — | | | (101) | |
Dividends declared | — | | | — | | | — | | | — | | | (2,634) | | | — | | | — | | | (2,634) | |
Purchases of treasury stock | — | | | — | | | (4) | | | — | | | — | | | — | | | — | | | (4) | |
Stock-based compensation plans and other | — | | | — | | | 7 | | | 182 | | | — | | | — | | | — | | | 189 | |
Change in noncontrolling interest | — | | | — | | | — | | | — | | | — | | | — | | | 3 | | | 3 | |
Balance at September 30, 2023 | 1,765 | | | $ | 18 | | | $ | (6,525) | | | $ | 20,021 | | | $ | 933 | | | $ | (2,353) | | | $ | 35 | | | $ | 12,129 | |
| | | | | | | | | | | | | | | |
Balance at June 30, 2024 | 1,766 | | | $ | 18 | | | $ | (7,838) | | | $ | 20,879 | | | $ | (3,768) | | | $ | (2,513) | | | $ | 43 | | | $ | 6,821 | |
Net earnings attributable to AbbVie Inc. | — | | | — | | | — | | | — | | | 1,561 | | | — | | | — | | | 1,561 | |
Other comprehensive income, net of tax | — | | | — | | | — | | | — | | | — | | | 179 | | | — | | | 179 | |
Dividends declared | — | | | — | | | — | | | — | | | (2,757) | | | — | | | — | | | (2,757) | |
Purchases of treasury stock | — | | | — | | | (17) | | | — | | | — | | | — | | | — | | | (17) | |
Stock-based compensation plans and other | 1 | | | — | | | 7 | | | 281 | | | — | | | — | | | — | | | 288 | |
Change in noncontrolling interest | — | | | — | | | — | | | — | | | — | | | — | | | (4) | | | (4) | |
Balance at September 30, 2024 | 1,767 | | | $ | 18 | | | $ | (7,848) | | | $ | 21,160 | | | $ | (4,964) | | | $ | (2,334) | | | $ | 39 | | | $ | 6,071 | |
| | | | | | | | | | | | | | | |
Balance at December 31, 2022 | 1,769 | | | $ | 18 | | | $ | (4,594) | | | $ | 19,245 | | | $ | 4,784 | | | $ | (2,199) | | | $ | 33 | | | $ | 17,287 | |
Net earnings attributable to AbbVie Inc. | — | | | — | | | — | | | — | | | 4,041 | | | — | | | — | | | 4,041 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | (154) | | | — | | | (154) | |
Dividends declared | — | | | — | | | — | | | — | | | (7,892) | | | — | | | — | | | (7,892) | |
Purchases of treasury stock | (12) | | | — | | | (1,969) | | | — | | | — | | | — | | | — | | | (1,969) | |
Stock-based compensation plans and other | 8 | | | — | | | 38 | | | 776 | | | — | | | — | | | — | | | 814 | |
Change in noncontrolling interest | — | | | — | | | — | | | — | | | — | | | — | | | 2 | | | 2 | |
Balance at September 30, 2023 | 1,765 | | | $ | 18 | | | $ | (6,525) | | | $ | 20,021 | | | $ | 933 | | | $ | (2,353) | | | $ | 35 | | | $ | 12,129 | |
| | | | | | | | | | | | | | | |
Balance at December 31, 2023 | 1,766 | | | $ | 18 | | | $ | (6,533) | | | $ | 20,180 | | | $ | (1,000) | | | $ | (2,305) | | | $ | 37 | | | $ | 10,397 | |
Net earnings attributable to AbbVie Inc. | — | | | — | | | — | | | — | | | 4,300 | | | — | | | — | | | 4,300 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | (29) | | | — | | | (29) | |
Dividends declared | — | | | — | | | — | | | — | | | (8,264) | | | — | | | — | | | (8,264) | |
Purchases of treasury stock | (7) | | | — | | | (1,350) | | | — | | | — | | | — | | | — | | | (1,350) | |
Stock-based compensation plans and other | 8 | | | — | | | 35 | | | 980 | | | — | | | — | | | — | | | 1,015 | |
Change in noncontrolling interest | — | | | — | | | — | | | — | | | — | | | — | | | 2 | | | 2 | |
Balance at September 30, 2024 | 1,767 | | | $ | 18 | | | $ | (7,848) | | | $ | 21,160 | | | $ | (4,964) | | | $ | (2,334) | | | $ | 39 | | | $ | 6,071 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| | | | | |
2024 Form 10-Q | | 4 |
AbbVie Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (unaudited)
| | | | | | | | | | | |
| Nine months ended September 30, |
(in millions) (brackets denote cash outflows) | 2024 | | 2023 |
Cash flows from operating activities | | | |
Net earnings | $ | 4,309 | | | $ | 4,049 | |
Adjustments to reconcile net earnings to net cash from operating activities: | | | |
Depreciation | 558 | | | 565 | |
Amortization of intangible assets | 5,726 | | | 6,057 | |
Deferred income taxes | (682) | | | (1,498) | |
Change in fair value of contingent consideration liabilities | 3,492 | | | 3,432 | |
Payments of contingent consideration liabilities | (1,456) | | | (407) | |
Stock-based compensation | 747 | | | 622 | |
Acquired IPR&D and milestones | 1,183 | | | 496 | |
Non-cash litigation reserve adjustments, net of cash payments | 341 | | | (205) | |
Impairment of intangible assets | — | | | 2,824 | |
Other, net | (75) | | | (219) | |
Changes in operating assets and liabilities, net of acquisitions: | | | |
Accounts receivable | (180) | | | (273) | |
Inventories | (191) | | | (513) | |
Prepaid expenses and other assets | 461 | | | 394 | |
Accounts payable and other liabilities | (1,070) | | | 3,661 | |
Income tax assets and liabilities, net | (1,405) | | | (899) | |
Cash flows from operating activities | 11,758 | | | 18,086 | |
| | | |
Cash flows from investing activities | | | |
Acquisitions of businesses, net of cash acquired | (17,493) | | | — | |
Other acquisitions and investments | (1,232) | | | (670) | |
Acquisitions of property and equipment | (683) | | | (572) | |
Purchases of investment securities | (46) | | | (43) | |
Sales and maturities of investment securities | 516 | | | 41 | |
Other, net | (8) | | | 35 | |
Cash flows from investing activities | (18,946) | | | (1,209) | |
| | | |
Cash flows from financing activities | | | |
Proceeds from issuance of other short-term borrowings | 5,008 | | | — | |
Repayments of other short-term borrowings | (5,008) | | | — | |
Proceeds from issuance of long-term debt | 14,963 | | | — | |
Repayments of long-term debt and finance lease obligations | (3,851) | | | (2,355) | |
Debt issuance costs | (99) | | | — | |
Dividends paid | (8,273) | | | (7,913) | |
Purchases of treasury stock | (1,350) | | | (1,969) | |
Proceeds from the exercise of stock options | 204 | | | 149 | |
Payments of contingent consideration liabilities | — | | | (735) | |
Other, net | 56 | | | 50 | |
Cash flows from financing activities | 1,650 | | | (12,773) | |
Effect of exchange rate changes on cash and equivalents | (19) | | | (18) | |
Net change in cash and equivalents | (5,557) | | | 4,086 | |
Cash and equivalents, beginning of period | 12,814 | | | 9,201 | |
| | | |
Cash and equivalents, end of period | $ | 7,257 | | | $ | 13,287 | |
| | | |
| | | |
| | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| | | | | |
2024 Form 10-Q | | 5 |
AbbVie Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements (unaudited)
Note 1 Basis of Presentation Basis of Historical Presentation The unaudited interim condensed consolidated financial statements of AbbVie Inc. (AbbVie or the company) have been prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) have been omitted. These unaudited interim condensed consolidated financial statements should be read in conjunction with the company’s audited consolidated financial statements and notes included in the company’s Annual Report on Form 10-K for the year ended December 31, 2023.
It is management’s opinion that these financial statements include all normal and recurring adjustments necessary for a fair presentation of the company’s financial position and operating results. Net revenues and net earnings for any interim period are not necessarily indicative of future or annual results. Certain other reclassifications were made to conform the prior period interim condensed consolidated financial statements to the current period presentation.
AbbVie completed its previously announced acquisitions of ImmunoGen, Inc. (ImmunoGen) on February 12, 2024 and Cerevel Therapeutics Holdings, Inc. (Cerevel Therapeutics) on August 1, 2024. See Note 4 and Note 8 for additional information regarding these acquisitions.
Recent Accounting Pronouncements
Recent Accounting Pronouncements Not Yet Adopted
ASU No. 2023-09
In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures (Topic 740). The standard requires disaggregation of the effective rate reconciliation into standard categories, enhances disclosure of income taxes paid, and modifies other income tax-related disclosures. The standard will be effective for AbbVie starting in annual periods in 2025, with early adoption permitted. AbbVie is currently assessing the impact of adopting this guidance on its consolidated financial statements.
ASU No. 2023-07
In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting - Improving Reportable Segment Disclosures (Topic 280). The standard requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker (CODM), a description of other segment items by reportable segment, and any additional measures of a segment's profit or loss used by the CODM when deciding how to allocate resources. The ASU also requires all annual disclosures currently required by Topic 280 to be included in interim periods. The standard is effective for AbbVie starting in annual periods in 2024 and interim periods in 2025, with early adoption permitted and requires retrospective application to all prior periods presented in the financial statements. AbbVie is currently assessing the impact of adopting this guidance on its consolidated financial statements.
| | | | | |
2024 Form 10-Q | | 6 |
Note 2 Supplemental Financial InformationInterest Expense, Net | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
(in millions) | | 2024 | | 2023 | | 2024 | | 2023 |
Interest expense | | $ | 720 | | | $ | 555 | | | $ | 2,106 | | | $ | 1,660 | |
Interest income | | (129) | | | (157) | | | (556) | | | (354) | |
Interest expense, net | | $ | 591 | | | $ | 398 | | | $ | 1,550 | | | $ | 1,306 | |
Inventories | | | | | | | | | | | |
(in millions) | September 30, 2024 | | December 31, 2023 |
Finished goods | $ | 1,347 | | | $ | 1,356 | |
Work-in-process | 2,071 | | | 1,643 | |
Raw materials | 1,032 | | | 1,100 | |
Inventories | $ | 4,450 | | | $ | 4,099 | |
Property and Equipment, Net | | | | | | | | | | | |
(in millions) | September 30, 2024 | | December 31, 2023 |
Property and equipment, gross | $ | 12,279 | | | $ | 11,635 | |
Accumulated depreciation | (7,138) | | | (6,646) | |
Property and equipment, net | $ | 5,141 | | | $ | 4,989 | |
Depreciation expense was $191 million for the three months and $558 million for the nine months ended September 30, 2024 and $196 million for the three months and $565 million for the nine months ended September 30, 2023.
| | | | | |
2024 Form 10-Q | | 7 |
Note 3 Earnings Per ShareAbbVie grants certain restricted stock units (RSUs) that are considered to be participating securities. Due to the presence of participating securities, AbbVie calculates earnings per share (EPS) using the more dilutive of the treasury stock or the two-class method. For all periods presented, the two-class method was more dilutive. The following table summarizes the impact of the two-class method: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
(in millions, except per share data) | | 2024 | | 2023 | | 2024 | | 2023 |
Basic EPS | | | | | | | | |
Net earnings attributable to AbbVie Inc. | | $ | 1,561 | | | $ | 1,778 | | | $ | 4,300 | | | $ | 4,041 | |
Earnings allocated to participating securities | | 10 | | | 11 | | | 30 | | | 32 | |
Earnings available to common shareholders | | $ | 1,551 | | | $ | 1,767 | | | $ | 4,270 | | | $ | 4,009 | |
Weighted-average basic shares outstanding | | 1,769 | | | 1,767 | | | 1,769 | | | 1,768 | |
Basic earnings per share attributable to AbbVie Inc. | | $ | 0.88 | | | $ | 1.00 | | | $ | 2.41 | | | $ | 2.27 | |
| | | | | | | | |
Diluted EPS | | | | | | | | |
Net earnings attributable to AbbVie Inc. | | $ | 1,561 | | | $ | 1,778 | | | $ | 4,300 | | | $ | 4,041 | |
Earnings allocated to participating securities | | 10 | | | 11 | | | 30 | | | 32 | |
Earnings available to common shareholders | | $ | 1,551 | | | $ | 1,767 | | | $ | 4,270 | | | $ | 4,009 | |
Weighted-average shares of common stock outstanding | | 1,769 | | | 1,767 | | | 1,769 | | | 1,768 | |
Effect of dilutive securities | | 3 | | | 4 | | | 3 | | | 4 | |
Weighted-average diluted shares outstanding | | 1,772 | | | 1,771 | | | 1,772 | | | 1,772 | |
Diluted earnings per share attributable to AbbVie Inc. | | $ | 0.88 | | | $ | 1.00 | | | $ | 2.41 | | | $ | 2.26 | |
Certain shares issuable under stock-based compensation plans were excluded from the computation of EPS because the effect would have been antidilutive. The number of common shares excluded was insignificant for all periods presented.
| | | | | |
2024 Form 10-Q | | 8 |
Note 4 Licensing, Acquisitions and Other Arrangements Proposed Acquisition of Aliada Therapeutics Holdings, Inc.
Subsequent to September 30, 2024, on October 28, 2024, AbbVie announced that it entered into a definitive agreement to acquire Aliada Therapeutics, Inc. (Aliada) including its lead program ALIA-1758. ALIA-1758 is an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer’s Disease. Under the terms of the agreement, AbbVie will make an upfront cash payment of approximately $1.4 billion to acquire all outstanding equity of Aliada. Closing of the proposed transaction is subject to regulatory approvals and other customary closing conditions.
Acquisition of Cerevel Therapeutics Holdings, Inc.
On August 1, 2024, AbbVie completed its previously announced acquisition of Cerevel Therapeutics. Cerevel Therapeutics is a clinical-stage biotechnology company focused on the discovery and development of differentiated therapies for neuroscience diseases. Cerevel Therapeutics neuroscience pipeline includes multiple clinical-stage and preclinical candidates with the potential to treat several diseases including schizophrenia, Parkinson's disease and mood disorders. Under the terms of the agreement, AbbVie acquired all outstanding shares of Cerevel Therapeutics for $45.00 per share in cash. The total fair value of the consideration transferred to owners of Cerevel Therapeutics common stock was $8.7 billion ($8.3 billion, net of cash acquired).
The acquisition of Cerevel Therapeutics has been accounted for as a business combination using the acquisition method of accounting. The acquisition method requires, among other things, that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. The valuation of assets acquired and liabilities assumed has not yet been finalized as of September 30, 2024. As a result, AbbVie recorded preliminary estimates for the fair value of assets acquired and liabilities assumed as of the acquisition date. Finalization of the valuation during the measurement period could result in a change in the amounts recorded for the acquisition date fair value of intangible assets, goodwill and income taxes among other items. The completion of the valuation will occur no later than one year from the acquisition date.
The following table summarizes the preliminary fair value of assets acquired and liabilities assumed as of the acquisition date: | | | | | |
(in millions) | |
Assets acquired and liabilities assumed | |
Cash and equivalents | $ | 361 | |
Short-term investments | 382 | |
Prepaid expenses and other current assets | 9 | |
Property and equipment, net | 25 | |
Investments | 121 | |
Intangible assets, net | 8,100 | |
| |
| |
| |
Other noncurrent assets | 31 | |
Current portion of long-term debt | (400) | |
Accounts payable and accrued liabilities | (100) | |
Long-term debt | (246) | |
Deferred income taxes | (1,292) | |
Other long-term liabilities | (31) | |
Total identifiable net assets | 6,960 | |
Goodwill | 1,702 | |
Total assets acquired and liabilities assumed | $ | 8,662 | |
Intangible assets relate to $8.1 billion of acquired in-process research and development (IPR&D) associated with products that have not yet received regulatory approval. The estimated fair values of identifiable intangible assets were determined using the "income approach" which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the more significant assumptions inherent in the development of these asset valuations include the estimated net cash flows for each year for each asset or product, the appropriate discount rate necessary to measure the risk inherent in each future cash flow stream, the life cycle of each asset, the potential regulatory and commercial success risk, competitive trends impacting the asset and each cash flow stream, as well as other factors.
| | | | | |
2024 Form 10-Q | | 9 |
The current portion of long-term debt assumed by AbbVie consists of $345 million aggregate principal of 2.5% convertible senior notes due 2027. Upon acquisition, the convertible senior notes became callable and note holders could redeem the convertible senior notes for cash at a premium. As of the acquisition date, the convertible senior notes were recognized as current portion of long-term debt on the condensed consolidated balance sheets at an aggregate fair value of $400 million. Following the acquisition date, the company repaid the convertible senior notes and there were no amounts outstanding as of September 30, 2024.
Long-term debt assumed by AbbVie relates to funding agreements entered into by Cerevel Therapeutics prior to the acquisition. Under the agreements, Cerevel Therapeutics received funding to support development of tavapadon and agreed to repay regulatory milestones, sales milestones and royalties contingent upon approval of tavapadon by the U.S. Food and Drug Administration (FDA). The funding agreements were accounted for as financing arrangements and the fair value of the related financing liability was $246 million as of the acquisition date. The estimated fair value of the financing liability was determined using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for sales milestones and royalty payments, which are then discounted to present value. Assumptions inherent in the development of fair value include discount rates, estimated probabilities and timing of achieving milestones and estimated amounts of future sales. See Note 8 for additional information.
Goodwill was calculated as the excess of the consideration transferred over the fair value of net assets recognized and represents the future economic benefits arising from other assets acquired that could not be individually identified and separately recognized. Specifically, the goodwill recognized from the acquisition of Cerevel Therapeutics represents expected synergies, including the ability to: (i) expand AbbVie’s neuroscience pipeline, (ii) leverage AbbVie’s commercial, regulatory and clinical expertise to maximize Cerevel Therapeutic’s assets and (iii) enhance AbbVie’s existing neuroscience discovery capabilities. The goodwill is not deductible for tax purposes.
AbbVie also assumed a licensing agreement entered into by Cerevel Therapeutics with Pfizer Inc. (Pfizer) prior to the acquisition. Under the agreement, Cerevel Therapeutics was granted an exclusive global license under certain Pfizer patent rights to develop, manufacture and commercialize compounds included in Cerevel Therapeutic’s pipeline. AbbVie could make additional payments of up to $1.6 billion upon achievement of certain regulatory and commercial milestones for all programs. Additionally, AbbVie will pay tiered royalties on net revenues.
Following the acquisition date, the operating results of Cerevel Therapeutics have been included in the condensed consolidated financial statements. For the period from the acquisition date through September 30, 2024, operating losses attributable to Cerevel Therapeutics were $299 million, inclusive of $161 million of cash-settled, post-closing expense for Cerevel Therapeutics employee incentive awards. AbbVie also issued 0.3 million RSUs to holders of Cerevel Therapeutics equity awards based on a conversion factor described in the transaction agreement. Stock compensation expense related to RSUs issued at the acquisition date was not significant.
Acquisition-related expenses, which were comprised primarily of regulatory, financial advisory and legal fees, totaled $44 million for the nine months ended September 30, 2024 and were included in selling, general and administrative (SG&A) expense in the condensed consolidated statements of earnings.
Acquisition of ImmunoGen, Inc.
On February 12, 2024, AbbVie completed its previously announced acquisition of ImmunoGen. ImmunoGen is a commercial-stage biotechnology company focused on the discovery, development and commercialization of antibody-drug conjugates (ADC) for cancer patients. ImmunoGen's oncology portfolio includes its flagship cancer therapy Elahere, a first-in-class ADC approved for platinum-resistant ovarian cancer, and a pipeline of promising next-generation ADC's targeting hematologic malignancies and solid tumors. The combination accelerates AbbVie’s entry into the solid tumor space and strengthens its oncology pipeline. Under the terms of the agreement, AbbVie acquired all outstanding shares of ImmunoGen for $31.26 per share in cash. The total fair value of the consideration transferred to owners of ImmunoGen common stock was $9.8 billion ($9.2 billion, net of cash acquired).
The acquisition of ImmunoGen has been accounted for as a business combination using the acquisition method of accounting. The acquisition method requires, among other things, that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. The valuation of assets acquired and liabilities assumed has not yet been finalized as of September 30, 2024. As a result, AbbVie recorded preliminary estimates for the fair value of assets acquired and liabilities assumed as of the acquisition date. Finalization of the valuation during the measurement period could result in a change in the amounts recorded for the acquisition date fair value of intangible assets, goodwill and income taxes among other items. The completion of the valuation will occur no later than one year from the acquisition date.
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2024 Form 10-Q | | 10 |
The following table summarizes the preliminary fair value of assets acquired and liabilities assumed as of the acquisition date: | | | | | |
(in millions) | |
Assets acquired and liabilities assumed | |
Cash and equivalents | $ | 591 | |
Accounts receivable | 171 | |
Inventories | 211 | |
Prepaid expenses and other current assets | 40 | |
Property and equipment, net | 7 | |
Intangible assets, net | |
Developed product rights | 7,200 | |
License agreements | 125 | |
Acquired in-process research and development | 1,280 | |
Other noncurrent assets | 273 | |
Current portion of long-term debt | (99) | |
Accounts payable and accrued liabilities | (312) | |
Deferred income taxes | (899) | |
Other long-term liabilities | (47) | |
Total identifiable net assets | 8,541 | |
Goodwill | 1,249 | |
Total assets acquired and liabilities assumed | $ | 9,790 | |
The fair value step-up adjustment to inventories of $179 million is being amortized to cost of products sold when the inventory is sold to customers, which is expected to be within approximately one year from the acquisition date.
Intangible assets relate to $7.3 billion of definite-lived intangible assets and $1.3 billion of acquired IPR&D associated with products that have not yet received regulatory approval. The acquired definite-lived intangible assets consist of developed product rights and license agreements and are being amortized over a weighted-average estimated useful life of approximately 12 years using the estimated pattern of economic benefit. The estimated fair values of identifiable intangible assets were determined using the "income approach" which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the more significant assumptions inherent in the development of these asset valuations include the estimated net cash flows for each year for each asset or product, the appropriate discount rate necessary to measure the risk inherent in each future cash flow stream, the life cycle of each asset, the potential regulatory and commercial success risk, competitive trends impacting the asset and each cash flow stream, as well as other factors.
Other noncurrent assets primarily consist of $250 million of deferred tax assets.
The current portion of long-term debt assumed by AbbVie was repaid concurrent with the acquisition at the fair value of $99 million. See Note 8 for additional information.
Goodwill was calculated as the excess of the consideration transferred over the fair value of net assets recognized and represents the future economic benefits arising from other assets acquired that could not be individually identified and separately recognized. Specifically, the goodwill recognized from the acquisition of ImmunoGen represents expected synergies including, the ability to: (i) expand AbbVie’s product portfolio as well as the potential to increase revenue from future growth platforms, (ii) accelerate AbbVie’s clinical and commercial presence in the solid tumor space within oncology, (iii) leverage the respective strengths of each company, and (iv) enhance AbbVie’s existing ADC development efforts. The goodwill is not deductible for tax purposes.
Following the acquisition date, the operating results of ImmunoGen have been included in the condensed consolidated financial statements. For the period from the acquisition date through September 30, 2024, net revenues attributable to ImmunoGen were $396 million and operating losses attributable to ImmunoGen were $582 million, inclusive of $349 million of cash-settled, post-closing expense for ImmunoGen employee incentive awards, $158 million of inventory fair value step-up amortization and $113 million of intangible asset amortization. AbbVie also issued 0.3 million RSUs to holders of ImmunoGen equity awards based on a conversion factor described in the transaction agreement. Stock compensation expense related to RSUs issued at the acquisition date was not significant.
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2024 Form 10-Q | | 11 |
Acquisition-related expenses, which were comprised primarily of regulatory, financial advisory and legal fees, totaled $59 million for the nine months ended September 30, 2024 and were included in SG&A expense in the condensed consolidated statements of earnings.
Pro Forma Financial Information
The following table presents the unaudited pro forma combined results of AbbVie, ImmunoGen and Cerevel Therapeutics for the three and nine months ended September 30, 2024 and 2023 as if the acquisitions of ImmunoGen and Cerevel Therapeutics had occurred on January 1, 2023: | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
(in millions) | 2024 | 2023 | | 2024 | 2023 |
Net revenues | $ | 14,460 | | $ | 14,040 | | | $ | 41,287 | | $ | 40,263 | |
Net earnings | 1,714 | | 1,400 | | | 4,583 | | 2,309 | |
The unaudited pro forma combined financial information was prepared using the acquisition method of accounting and was based on the historical financial information of AbbVie, ImmunoGen and Cerevel Therapeutics. In order to reflect the occurrence of the acquisitions on January 1, 2023 as required, the unaudited pro forma financial information includes adjustments to reflect incremental amortization expense to be incurred based on the current preliminary fair values of the identifiable intangible assets acquired; the incremental cost of products sold related to the fair value adjustments associated with acquisition date inventory; the additional interest expense associated with the issuance of debt to finance the acquisition; and the reclassification of acquisition-related costs incurred during the three and nine months ended September 30, 2024 to the nine months ended September 30, 2023. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations would have been had the acquisitions been completed on January 1, 2023. In addition, the unaudited pro forma financial information is not a projection of future results of operations of the combined company nor does it reflect the expected realization of any synergies or cost savings associated with the acquisitions.
Other Licensing & Acquisitions Activity
Cash outflows related to other acquisitions and investments totaled $1.2 billion for the nine months ended September 30, 2024 and $670 million for the nine months ended September 30, 2023.
The following table summarizes acquired IPR&D and milestones expense:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
(in millions) | | 2024 | | 2023 | | 2024 | | 2023 |
Upfront charges | | $ | 82 | | | $ | 44 | | | $ | 1,088 | | | $ | 396 | |
Development milestones | | — | | | 22 | | | 95 | | | 100 | |
Acquired IPR&D and milestones | | $ | 82 | | | $ | 66 | | | $ | 1,183 | | | $ | 496 | |
Celsius Therapeutics, Inc.
In June 2024, AbbVie acquired Celsius Therapeutics, Inc. (Celsius Therapeutics) including its lead pipeline asset CEL383. Celsius Therapeutics is a clinical-stage biotechnology company focused on the discovery and development of precision medicine in inflammatory bowel disease. The transaction was accounted as an asset acquisition as CEL383 represented substantially all of the fair value of the gross assets acquired. The upfront payment of $250 million was recorded in acquired IPR&D and milestones expense in the condensed consolidated statement of earnings in the second quarter of 2024.
AbbVie entered into several other individually insignificant collaborations, licensing agreements or other asset acquisitions in which the related upfront payments were recorded in acquired IPR&D and milestones expense.
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2024 Form 10-Q | | 12 |
Note 5 CollaborationsThe company has ongoing transactions with other entities through collaboration agreements. The following represent the significant collaboration agreements impacting the periods ended September 30, 2024 and 2023. Collaboration with Janssen Biotech, Inc.
In December 2011, Pharmacyclics, a wholly-owned subsidiary of AbbVie, entered into a worldwide collaboration and license agreement with Janssen Biotech, Inc. and its affiliates (Janssen), one of the Janssen Pharmaceutical companies of Johnson & Johnson, for the joint development and commercialization of Imbruvica, a novel, orally active, selective covalent inhibitor of Bruton’s tyrosine kinase and certain compounds structurally related to Imbruvica, for oncology and other indications, excluding all immune and inflammatory mediated diseases or conditions and all psychiatric or psychological diseases or conditions, in the United States and outside the United States.
The collaboration provides Janssen with an exclusive license to commercialize Imbruvica outside of the United States and co-exclusively with AbbVie in the United States. Both parties are responsible for the development, manufacturing and marketing of any products generated as a result of the collaboration. The collaboration has no set duration or specific expiration date and provides for potential future development, regulatory and approval milestone payments of up to $200 million to AbbVie. The collaboration also includes a cost sharing arrangement for associated collaboration activities. Except in certain cases, Janssen is responsible for approximately 60% of collaboration development costs and AbbVie is responsible for the remaining 40% of collaboration development costs.
In the United States, both parties have co-exclusive rights to commercialize the products; however, AbbVie is the principal in the end-customer product sales. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. Sales of Imbruvica are included in AbbVie's net revenues. Janssen's share of profits is included in AbbVie's cost of products sold. Other costs incurred under the collaboration are reported in their respective expense line items, net of Janssen's share.
Outside the United States, Janssen is responsible for and has exclusive rights to commercialize Imbruvica. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. AbbVie's share of profits is included in AbbVie's net revenues. Other costs incurred under the collaboration are reported in their respective expense line items, net of Janssen's share.
The following table shows the profit and cost sharing relationship between Janssen and AbbVie: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
(in millions) | | 2024 | | 2023 | | 2024 | | 2023 |
United States - Janssen's share of profits (included in cost of products sold) | | $ | 282 | | | $ | 316 | | | $ | 849 | | | $ | 925 | |
International - AbbVie's share of profits (included in net revenues) | | 210 | | | 230 | | | 676 | | | 711 | |
Global - AbbVie's share of other costs (included in respective line items) | | 38 | | | 59 | | | 120 | | | 171 | |
AbbVie’s receivable from Janssen, included in accounts receivable, net, was $233 million at September 30, 2024 and $236 million at December 31, 2023. AbbVie’s payable to Janssen, included in accounts payable and accrued liabilities, was $282 million at September 30, 2024 and $307 million at December 31, 2023.
Collaboration with Genentech, Inc.
AbbVie and Genentech, Inc. (Genentech), a member of the Roche Group, are parties to a collaboration and license agreement executed in 2007 to jointly research, develop and commercialize human therapeutic products containing BCL-2 inhibitors and certain other compound inhibitors which includes Venclexta, a BCL-2 inhibitor used to treat certain hematological malignancies. AbbVie shares equally with Genentech all pre-tax profits and losses from the development and commercialization of Venclexta in the United States. AbbVie pays royalties on Venclexta net revenues outside the United States.
AbbVie manufactures and distributes Venclexta globally and is the principal in the end-customer product sales. Sales of Venclexta are included in AbbVie’s net revenues. Genentech’s share of United States profits is included in AbbVie’s cost of products sold. AbbVie records sales and marketing costs associated with the United States collaboration as part of SG&A expenses and global development costs as part of research and development (R&D) expenses, net of Genentech’s share. Royalties paid for Venclexta revenues outside the United States are also included in AbbVie’s cost of products sold.
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2024 Form 10-Q | | 13 |
The following table shows the profit and cost sharing relationship between Genentech and AbbVie: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
(in millions) | | 2024 | | 2023 | | 2024 | | 2023 |
Genentech's share of profits, including royalties (included in cost of products sold) | | $ | 263 | | | $ | 225 | | | $ | 733 | | | $ | 641 | |
AbbVie's share of sales and marketing costs from U.S. collaboration (included in SG&A) | | 10 | | | 13 | | | 25 | | | 32 | |
AbbVie's share of development costs (included in R&D) | | 21 | | | 24 | | | 63 | | | 82 | |
Note 6 Goodwill and Intangible AssetsGoodwill The following table summarizes the changes in the carrying amount of goodwill: | | | | | |
(in millions) | |
Balance as of December 31, 2023 | $ | 32,293 | |
Additions(a) | 2,951 | |
Foreign currency translation adjustments | 51 | |
Balance as of September 30, 2024 | $ | |