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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2020
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from ________ to ________
Commission File No. 0-19731
GILEAD SCIENCES, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware |
94-3047598 |
(State or Other Jurisdiction of Incorporation or
Organization) |
(IRS Employer Identification No.) |
333 Lakeside Drive, Foster City, California 94404
(Address of principal executive offices) (Zip Code)
650-574-3000
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value, $0.001 per share |
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GILD |
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The Nasdaq Global Select Market |
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
x 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
x 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
x
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
x
Number of shares outstanding of the issuer’s common stock, par
value $0.001 per share, as of October 30, 2020:
1,253,528,149
GILEAD SCIENCES, INC.
INDEX
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PART I. |
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Item 1. |
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Item 2. |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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We own or have rights to various trademarks, copyrights and trade
names used in our business, including the following:
GILEAD®,
GILEAD SCIENCES®,
AMBISOME®,
ATRIPLA®,
BIKTARVY®,
CAYSTON®,
COMPLERA®,
DESCOVY®,
DESCOVY FOR PREP®,
EMTRIVA®,
EPCLUSA®,
EVIPLERA®,
GENVOYA®,
HARVONI®,
HEPSERA®,
JYSELECA®,
LETAIRIS®,
ODEFSEY®,
RANEXA®,
SOVALDI®,
STRIBILD®,
TECARTUSTM,
TRODELVY®,
TRUVADA®,
TRUVADA FOR PREP®,
TYBOST®,
VEKLURY®,
VEMLIDY®,
VIREAD®,
VOSEVI®,
YESCARTA®
and ZYDELIG®.
This report also includes other trademarks, service marks and trade
names of other companies.
PART I. FINANCIAL
INFORMATION
Item 1. CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in millions, except per share amounts)
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September 30, 2020 |
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December 31, 2019 |
Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
12,886 |
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$ |
11,631 |
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Short-term marketable securities |
11,089 |
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12,721 |
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Accounts receivable, net of allowances of $714 and $758,
respectively
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3,913 |
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3,582 |
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Inventories |
1,008 |
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922 |
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Prepaid and other current assets |
2,030 |
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1,440 |
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Total current assets |
30,926 |
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30,296 |
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Property, plant and equipment, net |
4,810 |
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4,502 |
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Long-term marketable securities |
2,074 |
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1,488 |
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Intangible assets, net |
12,939 |
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13,786 |
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Goodwill |
4,117 |
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4,117 |
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Other long-term assets |
6,012 |
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7,438 |
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Total assets |
$ |
60,878 |
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$ |
61,627 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ |
527 |
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$ |
713 |
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Accrued government and other rebates |
3,343 |
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3,473 |
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Other accrued liabilities |
4,141 |
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3,074 |
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Current portion of long-term debt |
1,498 |
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2,499 |
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Total current liabilities |
9,509 |
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9,759 |
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Long-term debt, net |
27,792 |
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22,094 |
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Long-term income taxes payable |
5,020 |
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|
6,115 |
|
Other long-term obligations |
1,086 |
|
|
1,009 |
|
Commitments and contingencies (Note 10) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, par value $0.001 per share; 5 shares authorized;
none outstanding
|
— |
|
|
— |
|
Common stock, par value $0.001 per share; 5,600 shares authorized;
1,253 and 1,266 shares issued and outstanding,
respectively
|
1 |
|
|
1 |
|
Additional paid-in capital |
3,712 |
|
|
3,051 |
|
Accumulated other comprehensive income |
23 |
|
|
85 |
|
Retained earnings |
13,709 |
|
|
19,388 |
|
Total Gilead stockholders’ equity |
17,445 |
|
|
22,525 |
|
Noncontrolling interest |
26 |
|
|
125 |
|
Total stockholders’ equity |
17,471 |
|
|
22,650 |
|
Total liabilities and stockholders’ equity |
$ |
60,878 |
|
|
$ |
61,627 |
|
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
6,493 |
|
|
$ |
5,516 |
|
|
$ |
17,027 |
|
|
$ |
16,323 |
|
Royalty, contract and other revenues |
|
84 |
|
|
88 |
|
|
241 |
|
|
247 |
|
Total revenues |
|
6,577 |
|
|
5,604 |
|
|
17,268 |
|
|
16,570 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
1,141 |
|
|
1,035 |
|
|
3,174 |
|
|
2,992 |
|
Research and development expenses |
|
1,158 |
|
|
1,030 |
|
|
3,461 |
|
|
2,956 |
|
Acquired in-process research and development expenses |
|
1,171 |
|
|
3,960 |
|
|
5,792 |
|
|
4,251 |
|
Selling, general and administrative expenses |
|
1,106 |
|
|
1,052 |
|
|
3,421 |
|
|
3,177 |
|
Total costs and expenses |
|
4,576 |
|
|
7,077 |
|
|
15,848 |
|
|
13,376 |
|
Income (loss) from operations |
|
2,001 |
|
|
(1,473) |
|
|
1,420 |
|
|
3,194 |
|
Interest expense |
|
(236) |
|
|
(250) |
|
|
(717) |
|
|
(752) |
|
Other income (expense), net |
|
(940) |
|
|
222 |
|
|
(848) |
|
|
817 |
|
Income (loss) before income taxes |
|
825 |
|
|
(1,501) |
|
|
(145) |
|
|
3,259 |
|
Income tax expense (benefit) |
|
472 |
|
|
(333) |
|
|
1,310 |
|
|
584 |
|
Net income (loss) |
|
353 |
|
|
(1,168) |
|
|
(1,455) |
|
|
2,675 |
|
Net loss attributable to noncontrolling interest |
|
(7) |
|
|
(3) |
|
|
(27) |
|
|
(15) |
|
Net income (loss) attributable to Gilead |
|
$ |
360 |
|
|
$ |
(1,165) |
|
|
$ |
(1,428) |
|
|
$ |
2,690 |
|
Net income (loss) per share attributable to Gilead common
stockholders - basic |
|
$ |
0.29 |
|
|
$ |
(0.92) |
|
|
$ |
(1.14) |
|
|
$ |
2.12 |
|
Shares used in per share calculation - basic |
|
1,255 |
|
|
1,267 |
|
|
1,257 |
|
|
1,271 |
|
Net income (loss) per share attributable to Gilead common
stockholders - diluted |
|
$ |
0.29 |
|
|
$ |
(0.92) |
|
|
$ |
(1.14) |
|
|
$ |
2.10 |
|
Shares used in per share calculation - diluted |
|
1,261 |
|
|
1,267 |
|
|
1,257 |
|
|
1,278 |
|
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(LOSS)
(unaudited)
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Net income (loss) |
|
$ |
353 |
|
|
$ |
(1,168) |
|
|
$ |
(1,455) |
|
|
$ |
2,675 |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Net foreign currency translation gain (loss), net of
tax |
|
23 |
|
|
(27) |
|
|
(12) |
|
|
(19) |
|
Available-for-sale debt securities: |
|
|
|
|
|
|
|
|
Unrealized gain (loss), net of tax |
|
(9) |
|
|
4 |
|
|
42 |
|
|
53 |
|
Reclassifications to net income (loss), net of tax |
|
(4) |
|
|
— |
|
|
(17) |
|
|
— |
|
Net change
|
|
(13) |
|
|
4 |
|
|
25 |
|
|
53 |
|
Cash flow hedges: |
|
|
|
|
|
|
|
|
Unrealized gain (loss), net of tax |
|
(46) |
|
|
70 |
|
|
(25) |
|
|
99 |
|
Reclassifications to net income (loss), net of tax |
|
(11) |
|
|
(32) |
|
|
(50) |
|
|
(96) |
|
Net change
|
|
(57) |
|
|
38 |
|
|
(75) |
|
|
3 |
|
Other comprehensive income (loss) |
|
(47) |
|
|
15 |
|
|
(62) |
|
|
37 |
|
Comprehensive income (loss) |
|
306 |
|
|
(1,153) |
|
|
(1,517) |
|
|
2,712 |
|
Less: Comprehensive (loss) attributable to noncontrolling
interest |
|
(7) |
|
|
(3) |
|
|
(27) |
|
|
(15) |
|
Comprehensive income (loss) attributable to Gilead |
|
$ |
313 |
|
|
$ |
(1,150) |
|
|
$ |
(1,490) |
|
|
$ |
2,727 |
|
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(unaudited)
(in millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2020 |
|
|
Gilead Stockholders’ Equity |
|
Noncontrolling
Interest |
|
Total
Stockholders’
Equity |
|
Common Stock
|
|
Additional
Paid-In
Capital |
|
Accumulated
Other
Comprehensive
Income
|
|
Retained
Earnings |
|
|
Shares |
|
Amount |
|
|
Balance at June 30, 2020 |
|
1,254 |
|
|
$ |
1 |
|
|
$ |
3,511 |
|
|
$ |
70 |
|
|
$ |
14,445 |
|
|
$ |
115 |
|
|
$ |
18,142 |
|
Change in noncontrolling interest (Note 6) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(82) |
|
|
(82) |
|
Net income (loss) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
360 |
|
|
(7) |
|
|
353 |
|
Other comprehensive income (loss), net of tax |
|
— |
|
|
— |
|
|
1 |
|
|
(47) |
|
|
(1) |
|
|
— |
|
|
(47) |
|
Issuances under employee stock purchase plan |
|
1 |
|
|
— |
|
|
34 |
|
|
— |
|
|
— |
|
|
— |
|
|
34 |
|
Issuances under equity incentive plans |
|
2 |
|
|
— |
|
|
2 |
|
|
— |
|
|
— |
|
|
— |
|
|
2 |
|
Stock-based compensation |
|
— |
|
|
— |
|
|
173 |
|
|
— |
|
|
— |
|
|
— |
|
|
173 |
|
Repurchases of common stock |
|
(4) |
|
|
— |
|
|
(9) |
|
|
— |
|
|
(229) |
|
|
— |
|
|
(238) |
|
Dividends declared ($0.68 per share)
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(866) |
|
|
— |
|
|
(866) |
|
Balance at September 30, 2020 |
|
1,253 |
|
|
$ |
1 |
|
|
$ |
3,712 |
|
|
$ |
23 |
|
|
$ |
13,709 |
|
|
$ |
26 |
|
|
$ |
17,471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2020 |
|
|
Gilead Stockholders’ Equity |
|
Noncontrolling
Interest |
|
Total
Stockholders’
Equity |
|
Common Stock
|
|
Additional
Paid-In
Capital |
|
Accumulated
Other
Comprehensive
Income
|
|
Retained
Earnings |
|
|
Shares |
|
Amount |
|
|
Balance at December 31, 2019 |
|
1,266 |
|
|
$ |
1 |
|
|
$ |
3,051 |
|
|
$ |
85 |
|
|
$ |
19,388 |
|
|
$ |
125 |
|
|
$ |
22,650 |
|
Cumulative effect from the adoption of new accounting standard
(Note 1) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(7) |
|
|
— |
|
|
(7) |
|
Change in noncontrolling interest (Note 6) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(72) |
|
|
(72) |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,428) |
|
|
(27) |
|
|
(1,455) |
|
Other comprehensive income (loss), net of tax |
|
— |
|
|
— |
|
|
1 |
|
|
(62) |
|
|
(1) |
|
|
— |
|
|
(62) |
|
Issuances under employee stock purchase plan |
|
2 |
|
|
— |
|
|
100 |
|
|
— |
|
|
— |
|
|
— |
|
|
100 |
|
Issuances under equity incentive plans |
|
10 |
|
|
— |
|
|
148 |
|
|
— |
|
|
— |
|
|
— |
|
|
148 |
|
Stock-based compensation |
|
— |
|
|
— |
|
|
482 |
|
|
— |
|
|
— |
|
|
— |
|
|
482 |
|
Repurchases of common stock |
|
(25) |
|
|
— |
|
|
(70) |
|
|
— |
|
|
(1,644) |
|
|
— |
|
|
(1,714) |
|
Dividends declared ($2.04 per share)
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,599) |
|
|
— |
|
|
(2,599) |
|
Balance at September 30, 2020 |
|
1,253 |
|
|
$ |
1 |
|
|
$ |
3,712 |
|
|
$ |
23 |
|
|
$ |
13,709 |
|
|
$ |
26 |
|
|
$ |
17,471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2019 |
|
|
Gilead Stockholders’ Equity |
|
Noncontrolling
Interest |
|
Total
Stockholders’
Equity |
|
Common Stock
|
|
Additional
Paid-In
Capital |
|
Accumulated
Other
Comprehensive
Income
|
|
Retained
Earnings |
|
|
Shares |
|
Amount |
|
|
Balance at June 30, 2019 |
|
1,267 |
|
|
$ |
1 |
|
|
$ |
2,684 |
|
|
$ |
102 |
|
|
$ |
19,829 |
|
|
$ |
135 |
|
|
$ |
22,751 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,165) |
|
|
(3) |
|
|
(1,168) |
|
Other comprehensive income, net of tax |
|
— |
|
|
— |
|
|
— |
|
|
15 |
|
|
— |
|
|
— |
|
|
15 |
|
Issuances under employee stock purchase plan |
|
1 |
|
|
— |
|
|
27 |
|
|
— |
|
|
— |
|
|
— |
|
|
27 |
|
Issuances under equity incentive plans |
|
2 |
|
|
— |
|
|
10 |
|
|
— |
|
|
— |
|
|
— |
|
|
10 |
|
Stock-based compensation |
|
— |
|
|
— |
|
|
160 |
|
|
— |
|
|
— |
|
|
— |
|
|
160 |
|
Repurchases of common stock |
|
(4) |
|
|
— |
|
|
(11) |
|
|
— |
|
|
(241) |
|
|
— |
|
|
(252) |
|
Dividends declared ($0.63 per share)
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(807) |
|
|
— |
|
|
(807) |
|
Balance at September 30, 2019 |
|
1,266 |
|
|
$ |
1 |
|
|
$ |
2,870 |
|
|
$ |
117 |
|
|
$ |
17,616 |
|
|
$ |
132 |
|
|
$ |
20,736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2019 |
|
|
Gilead Stockholders’ Equity |
|
Noncontrolling
Interest |
|
Total
Stockholders’
Equity |
|
Common Stock
|
|
Additional
Paid-In
Capital |
|
Accumulated
Other
Comprehensive
Income
|
|
Retained
Earnings |
|
|
Shares |
|
Amount |
|
|
Balance at December 31, 2018 |
|
1,282 |
|
|
$ |
1 |
|
|
$ |
2,282 |
|
|
$ |
80 |
|
|
$ |
19,024 |
|
|
$ |
147 |
|
|
$ |
21,534 |
|
Cumulative effect from the adoption of accounting
standard |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
8 |
|
|
— |
|
|
8 |
|
Net income (loss) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,690 |
|
|
(15) |
|
|
2,675 |
|
Other comprehensive income, net of tax |
|
— |
|
|
— |
|
|
— |
|
|
37 |
|
|
— |
|
|
— |
|
|
37 |
|
Issuances under employee stock purchase plan |
|
2 |
|
|
— |
|
|
90 |
|
|
— |
|
|
— |
|
|
— |
|
|
90 |
|
Issuances under equity incentive plans |
|
8 |
|
|
— |
|
|
92 |
|
|
— |
|
|
— |
|
|
— |
|
|
92 |
|
Stock-based compensation |
|
— |
|
|
— |
|
|
479 |
|
|
— |
|
|
— |
|
|
— |
|
|
479 |
|
Repurchases of common stock |
|
(26) |
|
|
— |
|
|
(73) |
|
|
— |
|
|
(1,675) |
|
|
— |
|
|
(1,748) |
|
Dividends declared ($1.89 per share)
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,431) |
|
|
— |
|
|
(2,431) |
|
Balance at September 30, 2019 |
|
1,266 |
|
|
$ |
1 |
|
|
$ |
2,870 |
|
|
$ |
117 |
|
|
$ |
17,616 |
|
|
$ |
132 |
|
|
$ |
20,736 |
|
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
September 30, |
|
|
2020 |
|
2019 |
Operating Activities: |
|
|
|
|
Net income (loss) |
|
$ |
(1,455) |
|
|
$ |
2,675 |
|
Adjustments to reconcile net income (loss) to net cash provided by
operating activities: |
|
|
|
|
Depreciation expense |
|
209 |
|
|
186 |
|
Amortization expense |
|
844 |
|
|
868 |
|
Stock-based compensation expense |
|
482 |
|
|
479 |
|
Acquired in-process research and development expenses |
|
5,792 |
|
|
4,251 |
|
Deferred income taxes |
|
(12) |
|
|
(796) |
|
Net unrealized (gain) loss from equity securities |
|
1,046 |
|
|
(312) |
|
Other |
|
210 |
|
|
199 |
|
Changes in operating assets and liabilities: |
|
|
|
|
Accounts receivable, net |
|
(334) |
|
|
33 |
|
Inventories |
|
(48) |
|
|
(35) |
|
Prepaid expenses and other |
|
22 |
|
|
(225) |
|
Accounts payable |
|
(134) |
|
|
(142) |
|
Income taxes payable |
|
(428) |
|
|
107 |
|
Accrued liabilities and other |
|
58 |
|
|
(724) |
|
Net cash provided by operating activities |
|
6,252 |
|
|
6,564 |
|
Investing Activities: |
|
|
|
|
Purchases of marketable debt securities |
|
(19,809) |
|
|
(24,057) |
|
Proceeds from sales of marketable debt securities |
|
12,367 |
|
|
4,522 |
|
Proceeds from maturities of marketable debt securities |
|
8,528 |
|
|
17,639 |
|
Acquisitions, including in-process research and development, net of
cash acquired |
|
(5,804) |
|
|
(4,251) |
|
Purchases of equity securities |
|
(388) |
|
|
(1,251) |
|
Capital expenditures |
|
(469) |
|
|
(622) |
|
Other |
|
(63) |
|
|
(228) |
|
Net cash used in investing activities |
|
(5,638) |
|
|
(8,248) |
|
Financing Activities: |
|
|
|
|
Proceeds from debt financing, net of issuance costs |
|
7,189 |
|
|
— |
|
Proceeds from issuances of common stock |
|
248 |
|
|
182 |
|
Repurchases of common stock |
|
(1,583) |
|
|
(1,644) |
|
Repayments of debt and other obligations |
|
(2,500) |
|
|
(2,750) |
|
Payments of dividends |
|
(2,591) |
|
|
(2,421) |
|
Other |
|
(124) |
|
|
(105) |
|
Net cash provided by (used in) financing activities |
|
639 |
|
|
(6,738) |
|
Effect of exchange rate changes on cash and cash
equivalents |
|
2 |
|
|
(44) |
|
Net change in cash and cash equivalents |
|
1,255 |
|
|
(8,466) |
|
Cash and cash equivalents at beginning of period |
|
11,631 |
|
|
17,940 |
|
Cash and cash equivalents at end of period |
|
$ |
12,886 |
|
|
$ |
9,474 |
|
See accompanying notes.
GILEAD SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial
Statements have been prepared in accordance with U.S. generally
accepted accounting principles for interim financial information.
The financial statements include all adjustments consisting of
normal recurring adjustments that the management of Gilead
Sciences, Inc. (“Gilead”, “we”, “our” or “us”) believes are
necessary for a fair presentation of the periods presented. These
interim financial results are not necessarily indicative of results
expected for the full fiscal year or for any subsequent interim
period.
The accompanying Condensed Consolidated Financial Statements
include the accounts of Gilead, our wholly-owned subsidiaries and
certain variable interest entities for which we are the primary
beneficiary. All intercompany transactions have been eliminated.
For consolidated entities where we own or are exposed to less than
100% of the economics, we record net income (loss) attributable to
noncontrolling interest in our Condensed Consolidated Statements of
Operations equal to the percentage of the economic or ownership
interest retained in such entities by the respective noncontrolling
parties.
We assess whether we are the primary beneficiary of a variable
interest entity (“VIE”) at the inception of the arrangement and at
each reporting date. This assessment is based on our power to
direct the activities of the VIE that most significantly impact the
VIE’s economic performance and our obligation to absorb losses or
the right to receive benefits from the VIE that could potentially
be significant to the VIE.
The accompanying Condensed Consolidated Financial Statements and
related Notes to Condensed Consolidated Financial Statements should
be read in conjunction with the audited Consolidated Financial
Statements and the related notes thereto for the year ended
December 31, 2019, included in our Annual Report on Form 10-K
filed with the U.S. Securities and Exchange
Commission.
Segment Information
We have one operating segment, which focuses on the discovery,
development and commercialization of innovative medicines in areas
of unmet medical need. Our Chief Executive Officer (“CEO”), as the
chief operating decision-maker, manages and allocates resources to
the operations of our company on an entity-wide basis. Managing and
allocating resources on an entity-wide basis enables our CEO to
assess the overall level of resources available and how to best
deploy these resources across functions and research and
development (“R&D”) projects based on unmet medical need and,
as necessary, reallocate resources among our internal R&D
portfolio and external opportunities to best support the long-term
growth of our business. See Note 2. Revenues for additional
information.
Significant Accounting Policies, Estimates and
Judgments
The preparation of these Condensed Consolidated Financial
Statements requires us to make estimates and judgments that affect
the reported amounts of assets, liabilities, revenues and expenses
and related disclosures. On an ongoing basis, we evaluate our
significant accounting policies and estimates. We base our
estimates on historical experience and on various market-specific
and other relevant assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources.
Estimates are assessed each period and updated to reflect current
information, such as the economic considerations related to the
impact that the recent coronavirus disease (“COVID-19”) could have
on our significant accounting estimates. Actual results could
differ materially from these estimates under different assumptions
or conditions.
Reclassification
Certain amounts for the three and nine months ended September 30,
2019 were reclassified to conform to the current period
presentation. Beginning in the second quarter of 2020, acquired
in-process research and development (“IPR&D”) expenses are
reported separately from Research and development expenses on our
Condensed Consolidated Statements of Operations. Acquired IPR&D
expenses reflect IPR&D impairments as well as the initial costs
of externally developed IPR&D projects, acquired directly in a
transaction other than a business combination, that do not have an
alternative future use, including upfront payments related to
various collaborations and the initial costs of rights to IPR&D
projects. Our Condensed Consolidated Statements of Cash Flows for
the nine months ended September 30, 2019, has been conformed to
separately present acquired IPR&D expenses.
Concentrations of Risk
We are subject to credit risk from our portfolio of cash
equivalents and marketable securities. Under our investment policy,
we limit amounts invested in such securities by credit rating,
maturity, industry group, investment type and issuer, except for
securities issued by the U.S. government. We are not exposed to any
significant concentrations of credit risk from our investment
portfolio. The goals of our investment policy, in order of
priority, are as follows: safety and preservation of principal and
diversification of risk; liquidity of investments sufficient to
meet cash flow requirements; and a competitive after-tax rate of
return.
We are also subject to credit risk from our accounts receivable
related to our product sales. Trade accounts receivable are
recorded net of allowances for wholesaler chargebacks related to
government and other programs, cash discounts for prompt payment
and credit losses. Estimates of our allowance for credit losses
consider a number of factors including existing contractual payment
terms, individual customer circumstances, historical payment
patterns of our customers, a review of the local economic
environment and its potential impact on expected future customer
payment patterns and government funding and reimbursement
practices. The majority of our trade accounts receivable arises
from product sales in the United States, Europe and Japan. Our
allowance for credit losses was $47 million as of
September 30, 2020 and January 1, 2020. There were no material
write-offs charged against the allowance for the three and nine
months ended September 30, 2020.
Recently Adopted Accounting Standards
In June 2016, the Financial Accounting Standards Board
(“FASB”) issued Accounting Standards Update No. 2016-13 “Financial
Instruments-Credit Losses: Measurement of Credit Losses on
Financial Instruments” and has since modified the standard with
several ASUs (collectively, “Topic 326”). Topic 326 requires
measurement and recognition of expected credit losses for financial
assets. On January 1, 2020, we adopted this standard using a
modified retrospective approach. The adoption did not have a
material impact on our Condensed Consolidated Financial Statements.
In connection with the adoption of Topic 326, we made an accounting
policy election to not measure an allowance for credit losses for
accrued interest receivable.
In November 2018, the FASB issued Accounting Standards Update
No. 2018-18 “Collaborative Arrangements (Topic 808): Clarifying the
Interaction between Topic 808 and Topic 606” (“ASU
2018-18”). ASU 2018-18 clarifies that certain transactions
between participants in a collaborative arrangement should be
accounted for under Topic 606, “Revenue from Contracts with
Customers” when the counterparty is a customer. In addition, the
update precludes an entity from presenting consideration from a
transaction in a collaborative arrangement as customer revenue if
the counterparty is not a customer for that transaction. On January
1, 2020, we adopted this standard and applied it retrospectively to
January 1, 2018 when we initially adopted Topic 606. The adoption
did not have an impact on our Condensed Consolidated Financial
Statements.
2. REVENUES
Disaggregation of Revenues
The following table disaggregates our product sales by product and
geographic region and disaggregates our royalty, contract and other
revenues by geographic region (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2020 |
|
Three Months Ended September 30, 2019 |
|
|
U.S. |
|
Europe |
|
Other Locations |
|
Total |
|
U.S. |
|
Europe |
|
Other Locations |
|
Total |
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atripla |
|
$ |
99 |
|
|
$ |
5 |
|
|
$ |
9 |
|
|
$ |
113 |
|
|
$ |
132 |
|
|
$ |
10 |
|
|
$ |
7 |
|
|
$ |
149 |
|
Biktarvy |
|
1,584 |
|
|
194 |
|
|
113 |
|
|
1,891 |
|
|
1,106 |
|
|
108 |
|
|
45 |
|
|
1,259 |
|
Complera/Eviplera |
|
26 |
|
|
35 |
|
|
9 |
|
|
70 |
|
|
40 |
|
|
45 |
|
|
8 |
|
|
93 |
|
Descovy |
|
424 |
|
|
49 |
|
|
35 |
|
|
508 |
|
|
256 |
|
|
63 |
|
|
44 |
|
|
363 |
|
Genvoya |
|
669 |
|
|
116 |
|
|
61 |
|
|
846 |
|
|
761 |
|
|
152 |
|
|
65 |
|
|
978 |
|
Odefsey |
|
309 |
|
|
116 |
|
|
12 |
|
|
437 |
|
|
317 |
|
|
111 |
|
|
8 |
|
|
436 |
|
Stribild |
|
27 |
|
|
13 |
|
|
2 |
|
|
42 |
|
|
63 |
|
|
18 |
|
|
13 |
|
|
94 |
|
Truvada |
|
492 |
|
|
6 |
|
|
11 |
|
|
509 |
|
|
688 |
|
|
14 |
|
|
19 |
|
|
721 |
|
Other HIV(1)
|
|
10 |
|
|
1 |
|
|
2 |
|
|
13 |
|
|
3 |
|
|
1 |
|
|
1 |
|
|
5 |
|
Revenue share – Symtuza(2)
|
|
82 |
|
|
34 |
|
|
2 |
|
|
118 |
|
|
68 |
|
|
36 |
|
|
— |
|
|
104 |
|
AmBisome |
|
18 |
|
|
58 |
|
|
35 |
|
|
111 |
|
|
9 |
|
|
57 |
|
|
33 |
|
|
99 |
|
Ledipasvir/Sofosbuvir(3)
|
|
36 |
|
|
11 |
|
|
37 |
|
|
84 |
|
|
54 |
|
|
14 |
|
|
56 |
|
|
124 |
|
Letairis |
|
78 |
|
|
— |
|
|
— |
|
|
78 |
|
|
121 |
|
|
— |
|
|
— |
|
|
121 |
|
Ranexa |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
31 |
|
|
— |
|
|
— |
|
|
31 |
|
Sofosbuvir/Velpatasvir(4)
|
|
170 |
|
|
74 |
|
|
86 |
|
|
330 |
|
|
282 |
|
|
118 |
|
|
116 |
|
|
516 |
|
Veklury |
|
785 |
|
|
60 |
|
|
28 |
|
|
873 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Vemlidy |
|
99 |
|
|
8 |
|
|
70 |
|
|
177 |
|
|
78 |
|
|
6 |
|
|
50 |
|
|
134 |
|
Viread |
|
3 |
|
|
8 |
|
|
21 |
|
|
32 |
|
|
7 |
|
|
15 |
|
|
35 |
|
|
57 |
|
Vosevi |
|
33 |
|
|
9 |
|
|
3 |
|
|
45 |
|
|
42 |
|
|
12 |
|
|
9 |
|
|
63 |
|
Yescarta |
|
85 |
|
|
51 |
|
|
2 |
|
|
138 |
|
|
86 |
|
|
32 |
|
|
— |
|
|
118 |
|
Zydelig |
|
8 |
|
|
9 |
|
|
— |
|
|
17 |
|
|
13 |
|
|
13 |
|
|
— |
|
|
26 |
|
Other(5)
|
|
39 |
|
|
20 |
|
|
2 |
|
|
61 |
|
|
42 |
|
|
(21) |
|
|
4 |
|
|
25 |
|
Total product sales |
|
5,076 |
|
|
877 |
|
|
540 |
|
|
6,493 |
|
|
4,199 |
|
|
804 |
|
|
513 |
|
|
5,516 |
|
Royalty, contract and other revenues |
|
24 |
|
|
60 |
|
|
— |
|
|
84 |
|
|
20 |
|
|
67 |
|
|
1 |
|
|
88 |
|
Total revenues |
|
$ |
5,100 |
|
|
$ |
937 |
|
|
$ |
540 |
|
|
$ |
6,577 |
|
|
$ |
4,219 |
|
|
$ |
871 |
|
|
$ |
514 |
|
|
$ |
5,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2020 |
|
Nine Months Ended September 30, 2019 |
|
|
U.S. |
|
Europe |
|
Other Locations |
|
Total |
|
U.S. |
|
Europe |
|
Other Locations |
|
Total |
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atripla |
|
$ |
275 |
|
|
$ |
17 |
|
|
$ |
19 |
|
|
$ |
311 |
|
|
$ |
387 |
|
|
$ |
52 |
|
|
$ |
33 |
|
|
$ |
472 |
|
Biktarvy |
|
4,346 |
|
|
528 |
|
|
314 |
|
|
5,188 |
|
|
2,868 |
|
|
229 |
|
|
71 |
|
|
3,168 |
|
Complera/Eviplera |
|
77 |
|
|
124 |
|
|
17 |
|
|
218 |
|
|
126 |
|
|
179 |
|
|
26 |
|
|
331 |
|
Descovy |
|
1,124 |
|
|
156 |
|
|
103 |
|
|
1,383 |
|
|
735 |
|
|
200 |
|
|
128 |
|
|
1,063 |
|
Genvoya |
|
1,927 |
|
|
376 |
|
|
183 |
|
|
2,486 |
|
|
2,222 |
|
|
522 |
|
|
229 |
|
|
2,973 |
|
Odefsey |
|
851 |
|
|
341 |
|
|
36 |
|
|
1,228 |
|
|
865 |
|
|
328 |
|
|
27 |
|
|
1,220 |
|
Stribild |
|
100 |
|
|
42 |
|
|
12 |
|
|
154 |
|
|
208 |
|
|
60 |
|
|
30 |
|
|
298 |
|
Truvada |
|
1,245 |
|
|
20 |
|
|
37 |
|
|
1,302 |
|
|
1,896 |
|
|
88 |
|
|
61 |
|
|
2,045 |
|
Other HIV(1)
|
|
24 |
|
|
4 |
|
|
21 |
|
|
49 |
|
|
23 |
|
|
3 |
|
|
11 |
|
|
37 |
|
Revenue share – Symtuza(2)
|
|
244 |
|
|
112 |
|
|
6 |
|
|
362 |
|
|
165 |
|
|
89 |
|
|
— |
|
|
254 |
|
AmBisome |
|
46 |
|
|
166 |
|
|
113 |
|
|
325 |
|
|
27 |
|
|
174 |
|
|
96 |
|
|
297 |
|
Ledipasvir/Sofosbuvir(3)
|
|
113 |
|
|
26 |
|
|
124 |
|
|
263 |
|
|
257 |
|
|
63 |
|
|
222 |
|
|
542 |
|
Letairis |
|
241 |
|
|
— |
|
|
— |
|
|
241 |
|
|
522 |
|
|
— |
|
|
— |
|
|
522 |
|
Ranexa |
|
9 |
|
|
— |
|
|
— |
|
|
9 |
|
|
205 |
|
|
— |
|
|
— |
|
|
205 |
|
Sofosbuvir/Velpatasvir(4)
|
|
646 |
|
|
253 |
|
|
330 |
|
|
1,229 |
|
|
731 |
|
|
428 |
|
|
341 |
|
|
1,500 |
|
Veklury |
|
785 |
|
|
60 |
|
|
28 |
|
|
873 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Vemlidy |
|
248 |
|
|
22 |
|
|
194 |
|
|
464 |
|
|
214 |
|
|
15 |
|
|
122 |
|
|
351 |
|
Viread |
|
10 |
|
|
27 |
|
|
100 |
|
|
137 |
|
|
28 |
|
|
57 |
|
|
119 |
|
|
204 |
|
Vosevi |
|
93 |
|
|
26 |
|
|
13 |
|
|
132 |
|
|
140 |
|
|
43 |
|
|
18 |
|
|
201 |
|
Yescarta |
|
283 |
|
|
144 |
|
|
7 |
|
|
434 |
|
|
275 |
|
|
59 |
|
|
— |
|
|
334 |
|
Zydelig |
|
24 |
|
|
30 |
|
|
1 |
|
|
55 |
|
|
36 |
|
|
42 |
|
|
1 |
|
|
79 |
|
Other(5)
|
|
124 |
|
|
54 |
|
|
6 |
|
|
184 |
|
|
119 |
|
|
96 |
|
|
12 |
|
|
227 |
|
Total product sales |
|
12,835 |
|
|
2,528 |
|
|
1,664 |
|
|
17,027 |
|
|
12,049 |
|
|
2,727 |
|
|
1,547 |
|
|
16,323 |
|
Royalty, contract and other revenues |
|
55 |
|
|
170 |
|
|
16 |
|
|
241 |
|
|
61 |
|
|
181 |
|
|
5 |
|
|
247 |
|
Total revenues |
|
$ |
12,890 |
|
|
$ |
2,698 |
|
|
$ |
1,680 |
|
|
$ |
17,268 |
|
|
$ |
12,110 |
|
|
$ |
2,908 |
|
|
$ |
1,552 |
|
|
$ |
16,570 |
|
|
|
|
|
|
|
________________________________ |
(1) |
Includes Emtriva and Tybost. |
(2) |
Represents our revenue from cobicistat (C), emtricitabine (FTC) and
tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a
fixed dose combination product commercialized by Janssen Sciences
Ireland UC. |
(3) |
Amounts consist of sales of Harvoni and the authorized generic
version of Harvoni sold by our separate subsidiary, Asegua
Therapeutics LLC. |
(4) |
Amounts consist of sales of Epclusa and the authorized generic
version of Epclusa sold by our separate subsidiary, Asegua
Therapeutics LLC. |
(5) |
Includes Cayston, Hepsera, Sovaldi and Tecartus. Europe product
sales included unfavorable adjustments recorded in 2019 for
statutory rebates related to sales of Sovaldi made in prior
years.
|
Revenues from Major Customers
The following table summarizes revenues from each of our customers
who individually accounted for 10% or more of our total revenues
(as a percentage of total revenues):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
AmerisourceBergen Corporation |
|
30 |
% |
|
21 |
% |
|
25 |
% |
|
21 |
% |
Cardinal Health, Inc. |
|
19 |
% |
|
21 |
% |
|
22 |
% |
|
21 |
% |
McKesson Corporation |
|
22 |
% |
|
23 |
% |
|
22 |
% |
|
21 |
% |
Revenues Recognized from Performance Obligations Satisfied in Prior
Periods
Revenues recognized from performance obligations satisfied in prior
years related to royalties for licenses of our intellectual
property were
$206 million
and
$618 million
for the three and nine months ended September 30, 2020,
respectively, and $201 million and $527 million for the three and
nine months ended September 30, 2019, respectively.
Variable consideration is included in the net sales price only to
the extent a significant reversal in the amount of cumulative
revenue recognized is not probable of occurring when the
uncertainty associated with the variable consideration is
subsequently resolved. Estimates are assessed each period and
updated to reflect current information. Changes in estimates for
variable consideration related to sales made in prior years
resulted in a $13 million and $94 million increase in revenues for
the three and nine months ended September 30, 2020, respectively,
and a $9 million and $309 million increase in revenues for the
three and nine months ended September 30, 2019,
respectively.
Contract Balances
Our contract assets, which consist of unbilled amounts primarily
from arrangements where the licensing of intellectual property is
the only or predominant performance obligation, totaled $186
million and $144 million as of September 30, 2020 and
December 31, 2019, respectively. Contract liabilities, which
generally result from receipt of advance payment before our
performance under the contract, were $103 million and
$45 million as of September 30, 2020 and
December 31, 2019. During the three and nine months ended
September 30, 2020 and 2019, revenue recognized that was included
in the contract liability balance as of the beginning of the
respective years was not material. Revenue expected to be
recognized in the future from contract liabilities as the related
performance obligations are satisfied is not expected to be
material in any one year.
3. FAIR
VALUE MEASUREMENTS
We determine the fair value of financial and non-financial assets
and liabilities using the fair value hierarchy, which establishes
three levels of inputs that may be used to measure fair value, as
follows:
•Level
1 inputs include quoted prices in active markets for identical
assets or liabilities;
•Level
2 inputs include observable inputs other than Level 1 inputs, such
as quoted prices for similar assets or liabilities; quoted prices
for identical or similar assets or liabilities in markets that are
not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full
term of the asset or liability. For our marketable securities, we
review trading activity and pricing as of the measurement date.
When sufficient quoted pricing for identical securities is not
available, we use market pricing and other observable market inputs
for similar securities obtained from various third-party data
providers. These inputs either represent quoted prices for similar
assets in active markets or have been derived from observable
market data; and
•Level
3 inputs include unobservable inputs that are supported by little
or no market activity and that are significant to the fair value of
the underlying asset or liability. Our Level 3 assets and
liabilities include those whose fair value measurements are
determined using pricing models, discounted cash flow methodologies
or similar valuation techniques and significant management judgment
or estimation.
Our financial instruments consist primarily of cash and cash
equivalents, marketable debt securities, accounts receivable,
foreign currency exchange contracts, equity securities, accounts
payable and short-term and long-term debt. Cash and cash
equivalents, marketable debt securities, certain equity securities
and foreign currency exchange contracts are reported at their
respective fair values in our Condensed Consolidated Balance
Sheets. Equity securities without readily determinable fair values
are recorded using the measurement alternative of cost less
impairment, if any, adjusted for observable price changes in
orderly transactions for identical or similar investments of the
same issuer. Short-term and long-term debt are reported at their
amortized costs in our Condensed Consolidated Balance Sheets. The
remaining financial instruments are reported in our Condensed
Consolidated Balance Sheets at amounts that approximate current
fair values.
The following table summarizes the types of assets and liabilities
measured at fair value on a recurring basis by level within the
fair value hierarchy (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
$ |
2,238 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,238 |
|
|
$ |
2,433 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,433 |
|
Certificates of deposit |
— |
|
|
2,136 |
|
|
— |
|
|
2,136 |
|
|
— |
|
|
3,517 |
|
|
— |
|
|
3,517 |
|
U.S. government agencies securities |
— |
|
|
71 |
|
|
— |
|
|
71 |
|
|
— |
|
|
1,081 |
|
|
— |
|
|
1,081 |
|
Non-U.S. government securities |
— |
|
|
220 |
|
|
— |
|
|
220 |
|
|
— |
|
|
174 |
|
|
— |
|
|
174 |
|
Corporate debt securities |
— |
|
|
7,525 |
|
|
— |
|
|
7,525 |
|
|
— |
|
|
9,204 |
|
|
— |
|
|
9,204 |
|
Residential mortgage and asset-backed securities |
— |
|
|
1,209 |
|
|
— |
|
|
1,209 |
|
|
— |
|
|
91 |
|
|
— |
|
|
91 |
|
Equity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity investment in Galapagos |
2,361 |
|
|
— |
|
|
— |
|
|
2,361 |
|
|
3,477 |
|
|
— |
|
|
— |
|
|
3,477 |
|
Money market funds |
11,430 |
|
|
— |
|
|
— |
|
|
11,430 |
|
|
7,069 |
|
|
— |
|
|
— |
|
|
7,069 |
|
Other publicly traded equity securities |
619 |
|
|
— |
|
|
— |
|
|
619 |
|
|
322 |
|
|
— |
|
|
— |
|
|
322 |
|
Deferred compensation plan |
200 |
|
|
— |
|
|
— |
|
|
200 |
|
|
171 |
|
|
— |
|
|
— |
|
|
171 |
|
Foreign currency derivative contracts |
— |
|
|
6 |
|
|
— |
|
|
6 |
|
|
— |
|
|
37 |
|
|
— |
|
|
37 |
|
Total |
$ |
16,848 |
|
|
$ |
11,167 |
|
|
$ |
— |
|
|
$ |
28,015 |
|
|
$ |
13,472 |
|
|
$ |
14,104 |
|
|
$ |
— |
|
|
$ |
27,576 |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation plan |
$ |
200 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
200 |
|
|
$ |
171 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
171 |
|
Foreign currency derivative contracts |
— |
|
|
50 |
|
|
— |
|
|
50 |
|
|
— |
|
|
8 |
|
|
— |
|
|
8 |
|
Total |
$ |
200 |
|
|
$ |
50 |
|
|
$ |
— |
|
|
$ |
250 |
|
|
$ |
171 |
|
|
$ |
8 |
|
|
$ |
— |
|
|
$ |
179 |
|
Changes in the fair value of equity securities resulted in net
unrealized losses of $964 million and $1,046 million for the three
and nine months ended September 30, 2020, respectively, and net
unrealized gains of $58 million and $312 million for the three and
nine months ended September 30, 2019, respectively, which were
included in Other income (expense), net on our Condensed
Consolidated Statements of Operations.
The following table summarizes the classification of our equity
securities in our Condensed Consolidated Balance Sheets (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Cash and cash equivalents |
$ |
11,430 |
|
|
$ |
7,069 |
|
Prepaid and other current assets |
986 |
|
|
319 |
|
Other long-term assets |
2,194 |
|
|
3,651 |
|
Total |
$ |
14,610 |
|
|
$ |
11,039 |
|
Our available-for-sale debt securities are classified as cash
equivalents, short-term marketable securities and long-term
marketable securities in our Condensed Consolidated Balance Sheets.
See Note 4. Available-For-Sale Debt Securities for additional
information.
See Note 6. Acquisitions, Collaborations and Other Arrangements for
additional information on our equity investment in Galapagos NV
(“Galapagos”).
Level 2 Inputs
We estimate the fair values of Level 2 instruments by taking into
consideration valuations obtained from third-party pricing
services. The pricing services utilize industry standard valuation
models, including both income-based and market-based approaches,
for which all significant inputs are observable, either directly or
indirectly, to estimate the fair value. These inputs include
reported trades of and broker/dealer quotes on the same or similar
securities, issuer credit spreads, benchmark securities,
prepayment/default projections based on historical data and other
observable inputs.
Substantially all of our foreign currency derivative contracts have
maturities within an 18-month time horizon and all are with
counterparties that have a minimum credit rating of A- or
equivalent by S&P Global Ratings, Moody’s Investors Service,
Inc. or Fitch Ratings, Inc. We estimate the fair values of these
contracts by taking into consideration the valuations obtained from
a third-party valuation service that utilizes an income-based
industry standard valuation model for which all significant inputs
are observable, either directly or indirectly. These inputs include
foreign currency exchange rates, London Interbank Offered Rates and
swap rates. These inputs, where applicable, are observable at
commonly quoted intervals.
The total estimated fair values of our aggregate short-term and
long-term debt, determined using Level 2 inputs based on their
quoted market values, were approximately $33.3 billion and $27.3
billion as of September 30, 2020 and December 31, 2019,
respectively, and the carrying values were $29.3 billion and $24.6
billion as of September 30, 2020 and December 31, 2019,
respectively.
4. AVAILABLE-FOR-SALE
DEBT SECURITIES
The following table summarizes our available-for-sale debt
securities (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
Amortized
Cost |
|
Gross
Unrealized
Gains |
|
Gross
Unrealized
Losses |
|
Estimated
Fair Value |
|
Amortized
Cost |
|
Gross
Unrealized
Gains |
|
Gross
Unrealized
Losses |
|
Estimated
Fair Value |
U.S. treasury securities |
|
$ |
2,225 |
|
|
$ |
13 |
|
|
$ |
— |
|
|
$ |
2,238 |
|
|
$ |
2,433 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,433 |
|
Certificates of deposit |
|
2,136 |
|
|
— |
|
|
— |
|
|
2,136 |
|
|
3,517 |
|
|
— |
|
|
— |
|
|
3,517 |
|
U.S. government agencies securities
|
|
71 |
|
|
— |
|
|
— |
|
|
71 |
|
|
1,081 |
|
|
— |
|
|
— |
|
|
1,081 |
|
Non-U.S. government securities |
|
220 |
|
|
— |
|
|
— |
|
|
220 |
|
|
174 |
|
|
— |
|
|
— |
|
|
174 |
|
Corporate debt securities |
|
7,506 |
|
|
20 |
|
|
(1) |
|
|
7,525 |
|
|
9,203 |
|
|
2 |
|
|
(1) |
|
|
9,204 |
|
Residential mortgage and asset-backed securities
|
|
1,207 |
|
|
2 |
|
|
— |
|
|
1,209 |
|
|
91 |
|
|
— |
|
|
— |
|
|
91 |
|
Total |
|
$ |
13,365 |
|
|
$ |
35 |
|
|
$ |
(1) |
|
|
$ |
13,399 |
|
|
$ |
16,499 |
|
|
$ |
2 |
|
|
$ |
(1) |
|
|
$ |
16,500 |
|
The following table summarizes the classification of our
available-for-sale debt securities in our Condensed Consolidated
Balance Sheets (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Cash and cash equivalents |
|
$ |
236 |
|
|
$ |
2,291 |
|
Short-term marketable securities |
|
11,089 |
|
|
12,721 |
|
Long-term marketable securities |
|
2,074 |
|
|
1,488 |
|
Total |
|
$ |
13,399 |
|
|
$ |
16,500 |
|
Accrued interest receivable excluded from both the fair value and
amortized cost basis of the available-for-sale debt securities was
$49 million and $37 million as of September 30, 2020 and
December 31, 2019, respectively, and is recorded in Prepaid
and other current assets on our Condensed Consolidated Balance
Sheets. There were no write-offs of accrued interest receivable
during the three and nine months ended September 30,
2020.
The following table summarizes our available-for-sale debt
securities by contractual maturity (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
|
Amortized Cost |
|
Fair Value |
Within one year |
|
$ |
11,292 |
|
|
$ |
11,325 |
|
After one year through five years |
|
1,991 |
|
|
1,992 |
|
After five years |
|
82 |
|
|
82 |
|
Total |
|
$ |
13,365 |
|
|
$ |
13,399 |
|
The following table summarizes our available-for-sale debt
securities in an unrealized loss position (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
12 Months or Greater |
|
Total |
|
|
Gross
Unrealized
Losses |
|
Estimated
Fair Value |
|
Gross
Unrealized
Losses |
|
Estimated
Fair Value |
|
Gross
Unrealized
Losses |
|
Estimated
Fair Value |
September 30, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
(1) |
|
|
$ |
1,042 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(1) |
|
|
$ |
1,042 |
|
December 31, 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
(1) |
|
|
$ |
1,866 |
|
|
$ |
— |
|
|
$ |
4 |
|
|
$ |
(1) |
|
|
$ |
1,870 |
|
We held a total of 208 positions which were in an unrealized loss
position as of September 30, 2020. The unrealized losses are
largely due to changes in interest rates. Aggregated gross
unrealized losses on available-for-sale corporate debt securities
were not material, and accordingly, no impairments were recognized
for the three and nine months ended September 30,
2020.
5. DERIVATIVE
FINANCIAL INSTRUMENTS
Our operations in foreign countries expose us to market risk
associated with foreign currency exchange rate fluctuations between
the U.S. dollar and various foreign currencies, primarily the Euro.
To manage this risk, we may hedge a portion of our foreign currency
exposures related to outstanding monetary assets and liabilities as
well as forecasted product sales using foreign currency exchange
forward or option contracts. In general, the market risk related to
these contracts is offset by corresponding gains and losses on the
hedged transactions. The credit risk associated with these
contracts is driven by changes in interest and currency exchange
rates and, as a result, varies over time. By working only with
major banks and closely monitoring current market conditions, we
seek to limit the risk that counterparties to these contracts may
be unable to perform. We also seek to limit our risk of loss by
entering into contracts that permit net settlement at maturity.
Therefore, our overall risk of loss in the event of a counterparty
default is limited to the amount of any unrealized gains on
outstanding contracts (i.e., those contracts that have a positive
fair value) at the date of default. We do not enter into derivative
contracts for trading purposes.
We hedge our exposure to foreign currency exchange rate
fluctuations for certain monetary assets and liabilities that are
denominated in a non-functional currency. The derivative
instruments we use to hedge this exposure are not designated as
hedges and, as a result, changes in their fair value are recorded
in Other income (expense), net on our Condensed Consolidated
Statements of Operations.
We hedge our exposure to foreign currency exchange rate
fluctuations for forecasted product sales that are denominated in a
non-functional currency. The derivative instruments we use to hedge
this exposure are designated as cash flow hedges and have
maturities of 18 months or less. Upon executing a hedging contract
and quarterly thereafter, we assess hedge effectiveness using
regression analysis. The unrealized gains or losses in Accumulated
other comprehensive income
(“AOCI”) are reclassified into product sales when the respective
hedged transactions affect earnings. The majority of gains and
losses related to the hedged forecasted transactions reported in
AOCI as of September 30, 2020 are expected to be reclassified
to product sales within 12 months.
The cash flow effects of our derivative contracts for the nine
months ended September 30, 2020 and 2019 were included within Net
cash provided by operating activities on our Condensed Consolidated
Statements of Cash Flows.
We had notional amounts on foreign currency exchange contracts
outstanding of $2.8 billion and $2.9 billion as of
September 30, 2020 and December 31, 2019,
respectively.
While all our derivative contracts allow us the right to offset
assets and liabilities, we have presented amounts on a gross basis.
The following table summarizes the classification and fair values
of derivative instruments in our Condensed Consolidated Balance
Sheets (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
|
Asset Derivatives |
|
Liability Derivatives |
|
|
Classification |
|
Fair Value |
|
Classification |
|
Fair Value |
Derivatives designated as hedges: |
|
|
|
|
|
|
|
|
Foreign currency exchange contracts
|
|
Prepaid and other current assets |
|
$ |
4 |
|
|
Other accrued liabilities |
|
$ |
(45) |
|
Foreign currency exchange contracts
|
|
Other long-term assets |
|
2 |
|
|
Other long-term obligations |
|
(5) |
|
Total derivatives designated as hedges |
|
|
|
6 |
|
|
|
|
(50) |
|
Derivatives not designated as hedges: |
|
|
|
|
|
|
|
|
Foreign currency exchange contracts
|
|
Prepaid and other current assets |
|
— |
|
|
Other accrued liabilities |
|
— |
|
Total derivatives not designated as hedges |
|
|
|
— |
|
|
|
|
— |
|
Total derivatives |
|
|
|
$ |
6 |
|
|
|
|
$ |
(50) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
|
Asset Derivatives |
|
Liability Derivatives |
|
|
Classification |
|
Fair Value |
|
Classification |
|
Fair Value |
Derivatives designated as hedges: |
|
|
|
|
|
|
|
|
Foreign currency exchange contracts
|
|
Prepaid and other current assets |
|
$ |
36 |
|
|
Other accrued liabilities |
|
$ |
(6) |
|
Foreign currency exchange contracts
|
|
Other long-term assets |
|
— |
|
|
Other long-term obligations |
|
(2) |
|
Total derivatives designated as hedges |
|
|
|
36 |
|
|
|
|
(8) |
|
Derivatives not designated as hedges: |
|
|
|
|
|
|
|
|
Foreign currency exchange contracts
|
|
Prepaid and other current assets |
|
1 |
|
|
Other accrued liabilities |
|
— |
|
Total derivatives not designated as hedges |
|
|
|
1 |
|
|
|
|
— |
|
Total derivatives |
|
|
|
$ |
37 |
|
|
|
|
$ |
(8) |
|
The following table summarizes the effect of our foreign currency
exchange contracts on our Condensed Consolidated Financial
Statements (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Derivatives designated as hedges: |
|
|
|
|
|
|
|
|
Gains (losses) recognized in AOCI
|
|
$ |
(52) |
|
|
$ |
69 |
|
|
$ |
(28) |
|
|
$ |
98 |
|
Gains reclassified from AOCI into product sales
|
|
$ |
12 |
|
|
$ |
31 |
|
|
$ |
57 |
|
|
$ |
96 |
|
Derivatives not designated as hedges: |
|
|
|
|
|
|
|
|
Gains (losses) recognized in Other income (expense),
net
|
|
$ |
(13) |
|
|
$ |
40 |
|
|
$ |
(10) |
|
|
$ |
29 |
|
From time to time, we may discontinue cash flow hedges and, as a
result, record related amounts in Other income (expense), net on
our Condensed Consolidated Statements of Operations. There were no
discontinuances of cash flow hedges for the three and nine months
ended September 30, 2020 and 2019.
As of September 30, 2020 and December 31, 2019, we only
held foreign currency exchange contracts. The following table
summarizes the potential effect of offsetting our foreign currency
exchange contracts on our Condensed Consolidated Balance Sheets (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Amounts Not Offset
on our Condensed
Consolidated Balance Sheets |
|
|
Description |
|
Gross Amounts
of Recognized
Assets/Liabilities |
|
Gross Amounts
Offset on our
Condensed
Consolidated
Balance Sheets |
|
Amounts of Assets/Liabilities Presented
on our Condensed Consolidated
Balance Sheets |
|
Derivative
Financial
Instruments |
|
Cash Collateral
Received/
Pledged |
|
Net Amount
(Legal Offset) |
As of September 30, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets |
|
$ |
6 |
|
|
$ |
— |
|
|
$ |
6 |
|
|
$ |
(6) |
|
|
$ |
— |
|
|
$ |
— |
|
Derivative liabilities |
|
$ |
(50) |
|
|
$ |
— |
|
|
$ |
(50) |
|
|
$ |
6 |
|
|
$ |
— |
|
|
$ |
(44) |
|
As of December 31, 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Derivative assets |
|
$ |
37 |
|
|
$ |
— |
|
|
$ |
37 |
|
|
$ |
(6) |
|
|
$ |
— |
|
|
$ |
31 |
|
Derivative liabilities |
|
$ |
(8) |
|
|
$ |
— |
|
|
$ |
(8) |
|
|
$ |
7 |
|
|
$ |
— |
|
|
$ |
(1) |
|
6. ACQUISITIONS, COLLABORATIONS AND OTHER
ARRANGEMENTS
We continue to pursue acquisitions, licensing and strategic
collaborations and other similar arrangements including equity
investments with third parties for the development and
commercialization of certain products and product candidates. These
arrangements may include non-refundable upfront payments, expense
reimbursements or payments by us for options to acquire certain
rights, contingent obligations by us for potential development and
regulatory milestone payments and/or sales-based milestone
payments, royalty payments, revenue or profit-sharing arrangements
and cost-sharing arrangements.
Acquisitions
Forty Seven, Inc. (“Forty Seven”)
On April 7, 2020, we acquired all of the then issued and
outstanding common stock of Forty Seven, a clinical-stage
immuno-oncology company focused on developing therapies targeting
cancer immune evasion pathways and specific cell targeting
approaches, for a price of $95.50 per share in cash, for total
consideration of $4.7 billion, net of acquired cash. As a result,
Forty Seven became our wholly-owned subsidiary. Forty Seven’s lead
program, magrolimab, is an investigational monoclonal antibody in
clinical development for the treatment of myelodysplastic syndrome,
acute myeloid leukemia, non-Hodgkin lymphoma and solid
tumors.
We accounted for the transaction as an asset acquisition since the
lead asset, magrolimab, represented substantially all the fair
value of the gross assets acquired. At the acquisition date, we
recorded a $4.5 billion charge representing an acquired IPR&D
asset with no alternative future use in Acquired in-process
research and development expenses on our Condensed Consolidated
Statements of Operations. In connection with this acquisition, we
recorded $202 million of assets acquired primarily consisting of
deferred tax assets. Liabilities assumed were not material. During
the three months ended June 30, 2020, we also recorded share-based
compensation expense of $144 million related to the cash settlement
of unvested Forty Seven employee stock awards attributable to
post-acquisition services, which was primarily recorded in Research
and development expenses on our Condensed Consolidated Statements
of Operations.
Immunomedics, Inc. (“Immunomedics”)
On September 13, 2020, we entered into an agreement and plan of
merger (“Agreement and Plan of Merger”) to acquire Immunomedics, a
company focused on the development of antibody-drug conjugate
(“ADC”) technology. Immunomedics researches and develops
biopharmaceutical products, particularly antibody-based products
for patients with solid tumors and blood cancers, and manufactures
and markets Trodelvy. Trodelvy, a Trop-2-directed ADC, developed by
Immunomedics is the first ADC that the U.S. Food and Drug
Administration (“FDA”) approved for the treatment of adult patients
with metastatic triple-negative breast cancer.
On September 24, 2020, under the terms of the Agreement and Plan of
Merger, we commenced a tender offer (“Offer”) to acquire all of the
outstanding shares of common stock of Immunomedics for
approximately $21 billion (at a price of $88.00 per share), net in
cash, without interest and subject to any withholding of
taxes.
In an event subsequent to September 30, 2020, on October 23, 2020,
we completed the Offer for all outstanding shares of common stock
of Immunomedics and accepted all shares validly tendered and not
withdrawn as of the expiration time of the Offer. Following the
Offer, we also acquired all remaining shares not tendered at Offer
pursuant to the merger contemplated by the Agreement and Plan of
Merger. As a result, the acquisition was completed and Immunomedics
became a wholly owned subsidiary of Gilead. The financial results
of Immunomedics will be included in our consolidated financial
results for the year ending December 31, 2020 from the date of
completion of the acquisition. We financed the acquisition with the
majority of the proceeds from the September 2020 senior unsecured
notes offering, an additional $1.0 billion borrowing under a new
senior unsecured term loan facility and the balance with cash on
hand. See Note 9. Debt and Credit Facilities for additional
information.
Our acquisition of Immunomedics will be accounted for as a business
combination using the acquisition method of accounting in the
fourth quarter of 2020. Given the recent timing of the transaction
close, we are in the process of estimating fair values of
the assets acquired and liabilities assumed in the business
combination.
As a result, we are currently unable to provide preliminary
allocation of purchase consideration based on the acquisition date
fair values of the assets acquired and liabilities assumed as well
as other related information, but we will disclose such information
in our Annual Report on Form 10-K for the year ending December 31,
2020.
Collaborations and Other Arrangements
Arcus Biosciences, Inc. (“Arcus”)
On May 29, 2020, we acquired 2.2 million shares of the common
stock of Arcus, a publicly traded oncology-focused
biopharmaceutical company, for approximately $61 million in a
secondary equity offering.
Separately, on May 27, 2020, we entered into a transaction
with Arcus, which included entry into an option, license and
collaboration agreement (the “Collaboration Agreement”) and a
common stock purchase agreement and an investor rights agreement
(together, the “Stock Purchase Agreements”).
Upon closing of the Collaboration Agreement and Stock Purchase
Agreements, on July 13, 2020, we made an upfront payment of $175
million and acquired approximately 6 million additional shares
of Arcus’ common stock for $200 million in accordance with the
terms of the Collaboration Agreement and the Stock Purchase
Agreements. Of the total $391 million initial cash payments made
under the agreements and direct transactional costs, we recorded
$135 million as an equity investment, which was calculated based on
Arcus’ closing stock price of $22.67 on the closing date of the
transaction. As a result, combined with our existing share
holdings, we own 8.2 million shares of Arcus, representing
approximately 13% of the issued and outstanding voting stock of
Arcus immediately following the closing of the transaction. We
recorded our equity investments in Arcus in Other long-term assets
on our Condensed Consolidated Balance Sheets as the investments are
subject to contractual lock-up provisions for a period up to 2
years from the closing date of the agreements, subject to certain
conditions. We account for our equity investment in Arcus at fair
value with changes in fair value recognized in Other income
(expense), net for each reporting period. The remaining $256
million was attributed to the acquired license and option rights of
$175 million representing IPR&D assets with no alternative
future use, $65 million of an issuance premium for the equity
purchase and $16 million of direct transactional costs. These
amounts were expensed as Acquired in-process research and
development expenses during the three months ended September 30,
2020 on our Condensed Consolidated Statements of
Operations.
Gilead has the right to opt-in to all current and future
investigational product candidates that emerge from Arcus’ research
portfolio for the ten years following the closing of the
transaction. Upon our exercise of an option for a program, unless
Arcus opts out according to the terms of the Collaboration
Agreement, the companies will co-develop and share global
development costs and co-commercialize and share profits in the
U.S. We will obtain exclusive rights to commercialize any optioned
programs outside of the U.S., subject to any rights of Arcus’
existing partners, for which we will pay to Arcus tiered royalties
ranging from the high teens to the low twenties on net
sales.
Under the Collaboration Agreement, subject to certain limited
exceptions, we are required to provide $100 million to Arcus
on the second anniversary of the agreement and may pay an
additional $100 million at our option on each of the fourth, sixth,
and eighth anniversaries of the agreement, unless terminated early,
as ongoing research and development support to extend our
collaboration term to up to 10-years. Accordingly, during the three
months ended September 30, 2020, we recorded a $100 million charge
representing the contractually committed payment in Acquired
in-process research and development expenses on our Condensed
Consolidated Statements of Operations.
Under the Collaboration Agreement, we will potentially provide up
to $1.2 billion in opt-in and milestone payments with respect to
current clinical product candidates, if and when such payments are
triggered under the Collaboration Agreement.
Under the Stock Purchase Agreements, we have the right to purchase
additional shares of Arcus from Arcus over the next five years, up
to a maximum of 35% of the outstanding voting stock. We are subject
to a three-year standstill restricting our ability to acquire
voting stock of Arcus exceeding more than 35% of the then issued
and outstanding voting stock of Arcus, subject to certain
exceptions. Additionally, we agreed not to dispose of any equity
securities of Arcus prior to the second anniversary of the closing
of the Stock Purchase Agreements without the prior consent of
Arcus, subject to certain exceptions.
Pionyr Immunotherapeutics, Inc. (“Pionyr”)
On June 19, 2020, we entered into a transaction with Pionyr, a
privately held company pursuing novel biology in the field of
immuno-oncology, which included entry into two separate merger
agreements, one contemplating the initial acquisition of 49.9%
equity interest in Pionyr, and the other providing us the exclusive
option, subject to certain terms and conditions, to acquire the
remaining outstanding capital stock of Pionyr (together, the
“Pionyr Merger and Option Agreements”) and a research and
development service agreement.
On July 13, 2020, we closed the transaction with Pionyr and paid
$269 million in cash and accrued an additional $6 million payable,
subject to certain customary adjustments, to Pionyr’s shareholders
in accordance with the terms of the Pionyr Merger and Option
Agreements. We account for our investment in Pionyr using the
equity method of accounting because our equity interest provides us
with the ability to exercise significance influence over Pionyr.
Our investment in Pionyr, consisting of the transaction price noted
above and transaction costs, exceeded our pro-rata portion of
Pionyr's net assets at transaction closing. We determined that the
resulting basis difference primarily relates to Pionyr’s IPR&D
which has no alternative future use and that Pionyr is not a
business as defined in ASC 805, “Business Combinations.” As a
result, we immediately recorded a charge for this basis difference
of $215 million in Acquired in-process research and development
expenses on our Condensed Consolidated Statements of Operations
during the three months ended September 30, 2020.
The estimated fair value of our exclusive option to acquire the
remaining outstanding capital stock of Pionyr is approximately $70
million based on a probability weighted option pricing model and
recorded in Other long-term assets on our Condensed Consolidated
Balance Sheet. From the first anniversary of the closing date, we
may choose to exercise our exclusive option to purchase the
remaining equity interest from Pionyr’s current shareholders for a
$315 million option exercise fee and up to $1.2 billion in
potential future milestone payments upon achievement of certain
development and regulatory milestones, in each case subject to
certain negotiated adjustments. Such option to purchase will expire
following the earliest occurrence of specified events, including
the delivery of data following completion of certain Phase 1b
trials by Pionyr.
Under the research and development service agreement, we made an
initial cash funding of $80 million and recorded a charge in
Acquired in-process research and development expenses on our
Condensed Consolidated Statements of Operations during the three
months ended September 30, 2020. We will provide additional
payments of up to $115 million to Pionyr upon achievement of
certain development milestones.
Tizona Therapeutics, Inc. (“Tizona”)
On July 17, 2020, we entered into a transaction with Tizona, a
privately held company developing cancer immunotherapies, which
included entry into two separate merger agreements, one
contemplating the initial acquisition of a 49.9% equity interest in
Tizona, and the other providing us the exclusive option, subject to
certain terms and conditions, to acquire the remaining outstanding
capital stock of Tizona (together, the “Tizona Merger and Option
Agreements”) and a development agreement.
On August 25, 2020, we closed the transaction with Tizona and paid
$302 million in cash to Tizona’s shareholders in accordance with
the terms of the Tizona Merger and Option Agreements. We account
for our investment in Tizona using the equity method of accounting
because our equity interest provides us with the ability to
exercise significance influence over Tizona. Our investment in
Tizona, consisting of the transaction price noted above and
transaction costs, exceeded our pro-rata portion of Tizona’s net
assets at transaction closing. We determined that the resulting
basis difference primarily relates to Tizona’s IPR&D with no
alternative future use and that Tizona is not a business as defined
in ASC 805, “Business Combinations.” As a result, during the three
months ended September 30, 2020, we immediately recorded this basis
difference of $272 million in Acquired in-process research and
development expenses on our Condensed Consolidated Statements of
Operations.
The estimated fair value of our exclusive option to acquire Tizona
is approximately $41 million based on a probability weighted option
pricing model and recorded in Other long-term assets on our
Condensed Consolidated Balance Sheet. From the first anniversary of
the closing date, we may choose to exercise our exclusive option to
purchase the remaining equity interest from Tizona’s current
shareholders for up to $1.3 billion, including an option fee and
potential future milestone payments upon achievement of certain
development and regulatory milestones, in each case subject to
certain negotiated adjustments. Such option to purchase will expire
following the earliest occurrence of specified events, including
the delivery of data following completion of certain Phase 1b
trials by Tizona.
Under the development agreement, we committed to provide funding to
Tizona of $115 million, which was recorded in Acquired in-process
research and development expenses on our Condensed Consolidated
Statements of Operations during the three months ended September
30, 2020.
Tango Therapeutics, Inc. (“Tango”)
On August 17, 2020, we entered into a transaction with Tango, a
privately held company pursuing innovative targeted immune evasion
therapies for patients with cancer through its proprietary,
CRISPR-enabled functional genomics target discovery platform, which
included entry into an amended and restated research collaboration
and license agreement and a stock purchase agreement (together, the
“Collaboration and Stock Purchase Agreements”).
Upon entering into this transaction, we made an upfront payment of
$125 million and a $20 million equity investment in Tango,
representing approximately 7% of the issued and outstanding voting
stock of Tango immediately following the transaction, in accordance
with the terms of the Collaboration and Stock Purchase Agreements.
During the three months ended September 30, 2020, we recorded the
$125 million upfront expense in Acquired in-process research and
development expenses on our Condensed Consolidated Statements of
Operations. Our equity investment in Tango is recorded at cost less
impairment, if any, adjusted for observable price changes in
orderly transactions for identical or similar investments of
Tango.
Under the Collaboration and Stock Purchase Agreements, Gilead has
the right to option up to 15 programs over the seven-year
collaboration for up to $410 million per program in opt-in,
extension and milestone payments. The parties will equally split
profits and losses, as well as development costs in the U.S., for
the products that Tango opts to co-develop and co-promote. We will
provide Tango milestone payments and royalties on sales outside of
the U.S. For products that Tango does not opt to co-develop and
co-promote, we will pay Tango up to low double digit tiered
royalties on net sales.
Jounce Therapeutics, Inc. (“Jounce”)
On September 1, 2020, we entered into a transaction with Jounce, a
publicly traded company developing novel cancer immunotherapies,
which included entry into license, registration rights and stock
purchase agreements (together, “License and Stock Purchase
Agreement”). In an event subsequent to September 30, 2020, in
October 2020, we closed this transaction and made a total payment
of $120 million in accordance with the terms of the License and
Stock Purchase Agreement and recorded $56 million as an equity
investment, representing approximately 14% of the issued and
outstanding voting stock of Jounce immediately following the
transaction, which was calculated based on Jounce’s closing stock
price of $10.06 on the closing date of the transaction. In
addition, we will provide up to $685 million in future potential
clinical, regulatory and commercial milestone payments upon
achievement of certain milestones, and pay Jounce royalties ranging
from high single digit to mid-teens based upon worldwide sales,
subject to certain adjustments.
Galapagos
In August 2019, we closed an option, license and collaboration
agreement (the “Collaboration Agreement”) and a subscription
agreement (the “Subscription Agreement”), each with Galapagos,
pursuant to which the parties entered into a global collaboration
that covers Galapagos’ current and future product portfolio (other
than filgotinib). Upon closing, we paid $5.1 billion for the
license and option rights and 6.8 million new ordinary shares
of Galapagos at a subscription price of €140.59 per share. As a
result, combined with our then existing share holdings, we owned
13.6 million ordinary shares of Galapagos, representing
approximately 22% of the issued and outstanding voting securities
of Galapagos at the closing of the Collaboration Agreement and
Subscription Agreement. The parties also amended certain terms
relating to the development and commercialization of filgotinib
pursuant to the license and collaboration agreement previously
entered into between Gilead and Galapagos in 2015.
We have elected the fair value option to account for our equity
investment in Galapagos whereby the investment is marked to market
through earnings in each reporting period based on the market price
of Galapagos shares. We believe the fair value option best reflects
the underlying economics of the investment. The $1.1 billion
equity investment, which included an issuance discount of $63
million calculated based on Galapagos’ closing stock price on the
date of closing of the Subscription Agreement and the subscription
price of €140.59 per share, and our existing equity investment in
Galapagos was recorded in Other long-term assets on our Condensed
Consolidated Balance Sheets as our equity investment in Galapagos
is subject to contractual lock-up provisions for a period up to 5
years from the closing date of the Subscription Agreement. The
remaining $3.9 billion of the payment was recorded in Acquired
in-process research and development expenses on our Condensed
Consolidated Statements of Operations.
During the three months ended September 30, 2020, as the initial
contractual lock-up provision for certain Galapagos shares will
expire in August 2021, the corresponding equity investment balance
of $505 million was reclassified to Prepaid and other current
assets from Other long-term assets on our Condensed Consolidated
Balance Sheets. During the three months ended September 30, 2020,
we recorded a pre-tax unrealized loss of $923 million related
to our investment in Galapagos in Other income (expense), net on
our Condensed Consolidated Statement of Operations due to a decline
in Galapagos’ stock price. See Note 3. Fair Value Measurements for
additional information.
Gadeta B.V. (“Gadeta”)
In July 2018, we entered into a collaboration arrangement with
Gadeta and made a purchase of equity in Gadeta from Gadeta’s
shareholders. We determined that Gadeta was a VIE, and we were its
primary beneficiary because we had the power to direct the
activities of Gadeta that most significantly impact its economic
performance. Upon the initial consolidation of Gadeta, we recorded
$82 million to Noncontrolling interest, primarily reflecting
acquired intangible assets related to IPR&D on our Condensed
Consolidated Balance Sheets.
During the three months ended September 30, 2020, we effectively
terminated the agreement with Gadeta. Upon the effective
termination, we ceased to have a controlling interest and
deconsolidated this VIE by removing the related net assets and
noncontrolling interest of $82 million from our Condensed
Consolidated Balance Sheets. The net loss from the deconsolidation
was not material.
Other Arrangements
During the three and nine months ended September 30, 2020 and 2019,
we entered into several collaborative, equity investments and
licensing arrangements as well as other similar arrangements that
we do not consider to be individually material. We recorded upfront
collaboration expenses related to these arrangements of $7 million
and $129 million for the three and nine months ended September 30,
2020, respectively, and $40 million and $331 million for the three
and nine months ended September 30, 2019, respectively, within
Acquired in-process research and development expenses on our
Condensed Consolidated Statements of Operations. Cash payments made
related to our equity investments for the three and nine months
ended September 30, 2020 were $36 million and $61 million,
respectively, and totaled $15 million and $119 million for the
three and nine months ended September 30, 2019, respectively, which
were primarily recorded within Prepaid and other current assets and
Other long-term assets on our Condensed Consolidated Balance
Sheets.
Under the financial terms of these arrangements, we may be required
to make payments upon achievement of developmental, regulatory and
commercial milestones, which could be significant. Future milestone
payments, if any, will be reflected in our Condensed Consolidated
Statements of Operations when the corresponding events become
probable. In addition, we may be required to pay significant
royalties on future sales if products related to these arrangements
are commercialized. The payment of these amounts, however, is
contingent upon the occurrence of various future events, which have
a high degree of uncertainty of occurrence.
7. OTHER
FINANCIAL INFORMATION
Inventories
The following table summarizes our Inventories (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Raw materials |
|
$ |
1,061 |
|
|
$ |
1,348 |
|
Work in process |
|
182 |
|
|
170 |
|
Finished goods |
|
710 |
|
|
549 |
|
Total
|
|
$ |
1,953 |
|
|
$ |
2,067 |
|
|
|
|
|
|
Reported as: |
|
|
|
|
|