dna-10q_0207.htm
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
________________________
FORM
10-Q
________________________
(Mark
One)
|
|
þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the quarterly period ended June 30, 2007
|
|
or
|
o
|
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: 1-9813
GENENTECH,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction of incorporation or organization)
|
94-2347624
(I.R.S.
Employer Identification Number)
|
1 DNA
Way, South San Francisco,
California 94080-4990
(Address
of principal executive offices and Zip Code)
(650) 225-1000
(Registrant’s
telephone number, including area code)
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 þ No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer þ
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No þ
Indicate
the number of shares outstanding of each of the issuer’s classes of Common
Stock, as of the latest practicable date.
Class
|
Number
of Shares Outstanding
|
Common
Stock $0.02 par value
|
1,053,031,880 Outstanding
at July 26, 2007
|
GENENTECH,
INC.
TABLE
OF CONTENTS
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Page
No.
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Item
1.
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3
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3
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4
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5
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6-14
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15
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Item
2.
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16-39
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Item
3.
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40
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Item
4.
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40
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Item
1.
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41
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Item
1A.
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41-53
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Item
2.
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53
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Item
4.
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54
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Item
6.
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54
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55
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In
this report, “Genentech,” “we,” “us,” and “our” refer to Genentech,
Inc. “Common Stock” refers to Genentech’s Common Stock, par value $0.02 per
share, “Special Common Stock” refers to Genentech’s callable putable common
stock, par value $0.02 per share, all of which was redeemed by Roche Holdings,
Inc. (RHI) on June 30, 1999.
We
own or have rights to various copyrights, trademarks, and trade names used
in
our business, including the following: Activase® (alteplase, recombinant)
tissue-plasminogen activator; Avastin® (bevacizumab) anti-VEGF antibody;
Cathflo® Activase® (alteplase for catheter clearance); Herceptin® (trastuzumab)
anti-HER2 antibody; Lucentis® (ranibizumab, rhuFab V2) anti-VEGF antibody
fragment; Nutropin® (somatropin [rDNA origin] for injection) growth hormone;
Nutropin AQ® and Nutropin AQ Pen® (somatropin [rDNA origin] for injection)
liquid formulation growth hormone; Omnitarg™ (pertuzumab) HER dimerization
inhibitor; Pulmozyme® (dornase alfa, recombinant) inhalation solution; Raptiva®
(efalizumab) anti-CD11a antibody; and TNKase® (tenecteplase) single-bolus
thrombolytic agent. Rituxan® (rituximab) anti-CD20 antibody is a registered
trademark of Biogen Idec Inc.; Tarceva® (erlotinib) is a trademark of OSI
Pharmaceuticals, Inc.; and Xolair® (omalizumab) anti-IgE antibody is a trademark
of Novartis AG. This report also includes other trademarks, service marks,
and
trade names of other companies.
GENENTECH,
INC.
(In
millions, except per share amounts)
(Unaudited)
|
|
Three
Months
|
|
|
Six
Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales (including amounts from related parties:
three
months—2007–$256; 2006–$75;
six
months—2007–$522; 2006–$133)
|
|
$ |
2,443
|
|
|
$ |
1,810
|
|
|
$ |
4,773
|
|
|
$ |
3,454
|
|
Royalties
(including amounts from related parties:
three
months—2007–$296; 2006–$207;
six
months—2007–$557; 2006–$373)
|
|
|
484
|
|
|
|
316
|
|
|
|
903
|
|
|
|
602
|
|
Contract
revenue (including amounts from related parties:
three
months—2007–$34; 2006–$34;
six
months—2007–$104; 2006–$63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating revenue
|
|
|
3,004
|
|
|
|
2,199
|
|
|
|
5,847
|
|
|
|
4,185
|
|
Costs
and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales (including amounts for related parties:
three
months—2007–$140; 2006–$65;
six
months—2007–$265; 2006–$115)
|
|
|
429
|
|
|
|
284
|
|
|
|
821
|
|
|
|
546
|
|
Research
and development (including amounts for related parties:
three
months—2007–$79; 2006–$65;
six
months—2007–$147; 2006–$117)
(including
amounts in contract revenue:
three
months—2007–$60; 2006–$51;
six
months—2007–$106; 2006–$87)
|
|
|
603
|
|
|
|
390
|
|
|
|
1,213
|
|
|
|
764
|
|
Marketing,
general and administrative
|
|
|
532
|
|
|
|
471
|
|
|
|
1,023
|
|
|
|
912
|
|
Collaboration
profit sharing (including amounts for a related party:
three
months—2007–$49; 2006–$48;
six
months—2007–$96; 2006–$91)
|
|
|
277
|
|
|
|
259
|
|
|
|
529
|
|
|
|
485
|
|
Recurring
charges related to redemption
|
|
|
26
|
|
|
|
26
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|
|
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52
|
|
|
|
52
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|
Special
items: litigation related
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total
costs and expenses
|
|
|
1,880
|
|
|
|
1,444
|
|
|
|
3,664
|
|
|
|
2,786
|
|
Operating
income
|
|
|
1,124
|
|
|
|
755
|
|
|
|
2,183
|
|
|
|
1,399
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense), net
|
|
|
75
|
|
|
|
121
|
|
|
|
149
|
|
|
|
174
|
|
Interest
expense
|
|
|
(17 |
) |
|
|
(18 |
) |
|
|
(35 |
) |
|
|
(37 |
) |
Total
other income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Income
before taxes
|
|
|
1,182
|
|
|
|
858
|
|
|
|
2,297
|
|
|
|
1,536
|
|
Income
tax provision
|
|
|
|
|
|
|
|
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|
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|
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Net
income
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Earnings
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Basic
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
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Diluted
|
|
$ |
|
|
|
$ |
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$ |
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$ |
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Shares
used to compute basic earnings per share
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Shares
used to compute diluted earnings per share
|
|
|
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|
See
Notes to Condensed Consolidated Financial Statements.
GENENTECH,
INC.
(In
millions)
(Unaudited)
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities
|
|
|
|
|
|
|
Net
income
|
|
$ |
1,453
|
|
|
$ |
952
|
|
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
215
|
|
|
|
199
|
|
Employee
stock-based compensation
|
|
|
203
|
|
|
|
149
|
|
Deferred
income taxes
|
|
|
(103 |
) |
|
|
(85 |
) |
Deferred
revenue
|
|
|
(29 |
) |
|
|
2
|
|
Litigation-related
liabilities
|
|
|
26
|
|
|
|
26
|
|
Excess
tax benefit from stock-based compensation arrangements
|
|
|
(127 |
) |
|
|
(90 |
) |
Gain
on sales of securities available-for-sale and other, net
|
|
|
(12 |
) |
|
|
(69 |
) |
Write-down
of securities available-for-sale and other
|
|
|
4
|
|
|
|
–
|
|
Loss
on property and equipment dispositions
|
|
|
30
|
|
|
|
–
|
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
Receivables
and other current assets
|
|
|
(115 |
) |
|
|
(184 |
) |
Inventories
|
|
|
(180 |
) |
|
|
(174 |
) |
Investments
in trading securities
|
|
|
(72 |
) |
|
|
(15 |
) |
Accounts
payable, other accrued liabilities, and other long-term
liabilities
|
|
|
|
|
|
|
|
|
Net
cash provided by operating activities
|
|
|
1,425
|
|
|
|
916
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities
|
|
|
|
|
|
|
|
|
Purchases
of securities available-for-sale
|
|
|
(465 |
) |
|
|
(898 |
) |
Proceeds
from sales of securities available-for-sale
|
|
|
335
|
|
|
|
419
|
|
Proceeds
from maturities of securities available-for-sale
|
|
|
261
|
|
|
|
126
|
|
Capital
expenditures
|
|
|
(475 |
) |
|
|
(538 |
) |
Change
in other intangible and long-term assets
|
|
|
(8 |
) |
|
|
|
|
Net
cash used in investing activities
|
|
|
(352 |
) |
|
|
(874 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities
|
|
|
|
|
|
|
|
|
Stock
issuances
|
|
|
276
|
|
|
|
187
|
|
Stock
repurchases
|
|
|
(666 |
) |
|
|
(540 |
) |
Excess
tax benefit from stock-based compensation arrangements
|
|
|
|
|
|
|
|
|
Net
cash used in financing activities
|
|
|
(263 |
) |
|
|
(263 |
) |
Net
increase (decrease) in cash and cash equivalents
|
|
|
810
|
|
|
|
(221 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Supplemental
cash flow data
|
|
|
|
|
|
|
|
|
Cash
paid during the period for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$ |
31
|
|
|
$ |
35
|
|
Income
taxes
|
|
|
806
|
|
|
|
498
|
|
Non-cash
investing and financing activities
|
|
|
|
|
|
|
|
|
Capitalization
of construction in progress related to financing lease
transactions
|
|
|
101
|
|
|
|
61
|
|
See
Notes to Condensed Consolidated Financial Statements.
GENENTECH,
INC.
(In
millions)
(Unaudited)
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
2,060
|
|
|
$ |
1,250
|
|
Short-term
investments
|
|
|
1,135
|
|
|
|
1,243
|
|
Accounts
receivable—product sales (net of allowances:
2007–$105;
2006–$92; including amounts from related parties:
2007–$68;
2006–$57)
|
|
|
1,068
|
|
|
|
965
|
|
Accounts
receivable—royalties (including amounts from related
parties:
2007–$379;
2006–$316)
|
|
|
514
|
|
|
|
453
|
|
Accounts
receivable—other (including amounts from related parties:
2007–$103;
2006–$150)
|
|
|
177
|
|
|
|
248
|
|
Inventories
|
|
|
1,365
|
|
|
|
1,178
|
|
Deferred
tax assets
|
|
|
272
|
|
|
|
278
|
|
Prepaid
expenses and other current assets
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
6,699
|
|
|
|
5,704
|
|
Long-term
marketable debt and equity securities
|
|
|
1,883
|
|
|
|
1,832
|
|
Property,
plant and equipment, net
|
|
|
4,563
|
|
|
|
4,173
|
|
Goodwill
|
|
|
1,315
|
|
|
|
1,315
|
|
Other
intangible assets
|
|
|
427
|
|
|
|
476
|
|
Restricted
cash and investments
|
|
|
788
|
|
|
|
788
|
|
Other
long-term assets
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and stockholders’ equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable (including amounts to related parties:
2007
and 2006–$7)
|
|
$ |
361
|
|
|
$ |
346
|
|
Deferred
revenue
|
|
|
52
|
|
|
|
62
|
|
Taxes
payable
|
|
|
124
|
|
|
|
111
|
|
Other
accrued liabilities (including amounts to related
parties:
2007–$164;
2006–$136)
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
1,989
|
|
|
|
2,010
|
|
Long-term
debt
|
|
|
2,307
|
|
|
|
2,204
|
|
Deferred
revenue
|
|
|
180
|
|
|
|
199
|
|
Litigation-related
and other long-term liabilities
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
Stockholders’
equity
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
21
|
|
|
|
21
|
|
Additional
paid-in capital
|
|
|
10,624
|
|
|
|
10,091
|
|
Accumulated
other comprehensive income
|
|
|
205
|
|
|
|
204
|
|
Retained
earnings (accumulated deficit), since June 30, 1999
|
|
|
|
|
|
|
(838 |
) |
Total
stockholders’ equity
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity
|
|
$ |
|
|
|
$ |
|
|
See
Notes to Condensed Consolidated Financial Statements.
GENENTECH,
INC.
(Unaudited)
Note
1.
|
Summary
of Significant Accounting
Policies
|
Basis
of Presentation
We
prepared the Condensed Consolidated Financial Statements following the
requirements of the United States (U.S.) Securities and Exchange Commission
for
interim reporting. As permitted under those rules, certain footnotes or other
financial information that are normally required by U.S. generally accepted
accounting principles (GAAP) can be condensed or omitted. The information
included in this Quarterly Report on Form 10-Q should be read in conjunction
with the Consolidated Financial Statements and accompanying notes included
in
our Annual Report on Form 10-K for the year ended December 31, 2006. In the
opinion of management, the financial statements include all adjustments,
consisting only of normal and recurring adjustments, considered necessary for
the fair presentation of our financial position and operating
results.
Revenue,
expenses, assets, and liabilities can vary during each quarter of the year.
Therefore, the results and trends in these interim financial statements may
not
be the same as those expected for the full year or any future
period.
Principles
of Consolidation
The
consolidated financial statements include the accounts of Genentech and all
wholly owned subsidiaries. Material intercompany accounts and transactions
have
been eliminated.
Use
of Estimates and Reclassifications
The
preparation of financial statements in conformity with GAAP requires management
to make judgments, assumptions, and estimates that affect the amounts reported
in our Condensed Consolidated Financial Statements and accompanying notes.
Actual results could differ materially from those estimates.
Certain
reclassifications of prior period amounts have been made to our Condensed
Consolidated Financial Statements to conform to the current period
presentation.
Recent
Accounting Pronouncements
On
January 1, 2007, we adopted Emerging Issues Task Force (EITF) Issue No. 06-2,
“Accounting for Sabbatical Leave and Other Similar Benefits
Pursuant to FASB Statement No. 43, Accounting for Compensated
Absences” (EITF 06-2). Prior to the adoption of EITF 06-2, we
recorded a liability for a sabbatical leave when the employee vested in the
benefit, which was only at the end of a six-year service period. Under EITF
06-2, we accrue an estimated liability for a sabbatical leave over the requisite
six-year service period, as the employee’s services are rendered. Upon our
adoption of EITF 06-2, we recorded an adjustment to retained earnings
(accumulated deficit) of $26 million, net of tax, as a cumulative effect of
a
change in accounting principle.
We
adopted the provisions of Financial Accounting Standards Board (FASB)
Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes” (FIN 48), on January 1, 2007. Implementation of FIN 48 did
not result in a cumulative adjustment to retained earnings (accumulated
deficit). The total amount of unrecognized tax benefits as of the date of
adoption was $147 million. Of this total, $112 million represents the
amount of unrecognized tax benefits that, if recognized, would favorably affect
our effective income tax rate in any future period. As a result of the
implementation of FIN 48, we reclassified $147 million of unrecognized tax
benefits from current liabilities to long-term liabilities as of December 31,
2006 in the accompanying Condensed Consolidated Balance Sheets.
We
file income tax returns in the U.S. federal jurisdiction and various state
and
international jurisdictions. The Internal Revenue Service (IRS) is examining
our
U.S. federal income tax returns for 2002 through 2004. As of June 30, 2007,
the
IRS has not proposed any adjustments. We are also under
examination by several state jurisdictions. As of June 30, 2007, no material
adjustments related to these audits have been proposed.
We
accrue tax-related interest and penalties and include such expenses with income
tax expense in the Condensed Consolidated Statements of Income. We recognized
approximately $2 million and $4 million in tax-related interest expense during
the second quarter and first six months of 2007, respectively, and had
approximately $10 million of tax-related interest accrued at January 1, 2007.
Interest amounts are net of tax benefit. No penalties have been
accrued.
Revenue
Recognition
We
recognize revenue from the sale of our products, royalties earned, and contract
arrangements. Our revenue arrangements that contain multiple elements are
divided into separate units of accounting if certain criteria are met, including
whether the delivered element has stand-alone value to the customer and whether
there is objective and reliable evidence of the fair value of the undelivered
items. The consideration we receive is allocated among the separate units based
on their respective fair values, and the applicable revenue recognition criteria
are applied to each of the separate units. Advance payments received in excess
of amounts earned are classified as deferred revenue until earned.
The
Avastin Patient Assistance Program is a voluntary program that enables eligible
patients who have received 10,000 milligrams of Avastin in a 12-month period
to
receive free Avastin in excess of the 10,000 milligrams during the remainder
of
the 12-month period. Based on the current wholesale acquisition cost, 10,000
milligrams is valued at $55,000 in gross revenue. We defer a portion of our
gross Avastin product sales revenue to reflect our estimate of the commitment
to
supply free Avastin to patients who elect to enroll in the program. To calculate
our deferred revenue, we estimate the number of patients who will receive free
Avastin and the amount of free Avastin that we expect them to receive. Based
on
those estimates, we defer a portion of Avastin revenue on product vials sold
through normal commercial channels. The deferred revenue is recognized as free
Avastin vials are delivered.
Earnings
Per Share
Basic
earnings per share (EPS) are computed based on the weighted-average number
of
shares of our Common Stock outstanding. Diluted earnings per share are computed
based on the weighted-average number of shares of our Common Stock and other
dilutive securities.
The
following is a reconciliation of the numerators and denominators of the basic
and diluted earnings per share computations (in millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
747
|
|
|
$ |
531
|
|
|
$ |
|
|
|
$ |
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding used to compute basic earnings per
share
|
|
|
1,053
|
|
|
|
1,053
|
|
|
|
1,053
|
|
|
|
1,054
|
|
Effect
of dilutive stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding and dilutive securities used to compute diluted
earnings per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
employee stock options to purchase approximately 35 million and 34 million
shares of our Common Stock were excluded from the computation of diluted EPS
for
the second quarter and first six months of 2007, respectively, because the
effect would have been anti-dilutive.
Comprehensive
Income
Comprehensive
income comprises net income and other comprehensive income (OCI). OCI includes
certain changes in stockholders’ equity that are excluded from net income.
Specifically, we include in OCI changes in the estimated fair value of
derivatives designated as effective cash flow hedges, and unrealized gains
and
losses on our securities available-for-sale. In accordance with our adoption
of
Statement of Financial Accounting Standards (FAS) No. 158,
“Employers’ Accounting for Defined Benefit
Pension and Other Postretirement Plans – an amendment of FASB Statements No. 87,
88, 106, and 132(R),” in 2006, the gains or losses and
prior service costs or credits that arise during the period, but are not
recognized as components of net periodic benefit cost, have been recognized
in
other comprehensive income.
The
components of accumulated other comprehensive income, net of taxes, were as
follows (in millions):
|
|
|
|
|
|
|
Net
unrealized gains on securities available-for-sale
|
|
$ |
204
|
|
|
$ |
214
|
|
Net
unrealized gains (losses) on cash flow hedges
|
|
|
7
|
|
|
|
(4 |
) |
Post-retirement
benefit obligation
|
|
|
(6 |
) |
|
|
(6 |
) |
Accumulated
other comprehensive income
|
|
$ |
|
|
|
$ |
|
|
The
activity in comprehensive income, net of income taxes, was as follows (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
747
|
|
|
$ |
531
|
|
|
$ |
1,453
|
|
|
$ |
952
|
|
Decrease
in unrealized gains on securities available-for-sale
|
|
|
(14 |
) |
|
|
(43 |
) |
|
|
(10 |
) |
|
|
(40 |
) |
Increase
(decrease) in unrealized gains on cash flow hedges
|
|
|
|
|
|
|
(19 |
) |
|
|
|
|
|
|
(20 |
) |
Comprehensive
income, net of income taxes
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Derivative
Instruments
Our
derivative instruments, designated as cash flow hedges, consist of foreign
currency exchange options and marketable equity collars. At June 30, 2007,
estimated net gains expected to be reclassified from accumulated OCI to “other
income, net” during the next year are $8 million.
Note
2.
|
Employee
Stock-Based Compensation
|
Stock-Based
Compensation Expense under FAS 123R
Employee
stock-based compensation expense was calculated based on awards ultimately
expected to vest and has been reduced for estimated forfeitures. FAS No. 123(R),
“Share-Based Payment” (FAS 123R), requires
forfeitures to be estimated at the time of grant and revised, if necessary,
in
subsequent periods if actual forfeitures differ from those
estimates.
Employee
stock-based compensation expense recognized under FAS 123R was as follows
(in millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
$ |
16
|
|
|
$ |
–
|
|
|
$ |
33
|
|
|
$ |
–
|
|
Research
and development
|
|
|
39
|
|
|
|
34
|
|
|
|
77
|
|
|
|
67
|
|
Marketing,
general and administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
employee stock-based compensation expense
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
As
of June 30, 2007, total compensation cost related to unvested stock options
not
yet recognized was $667 million, which is expected to be
allocated to expense and production costs over a weighted-average period of
30 months.
The
carrying value of inventory on our Condensed Consolidated Balance Sheets as
of
June 30, 2007 and 2006 includes employee stock-based compensation costs of
$75
million and $33 million, respectively. During the second quarter and first
six
months of 2007, $16 million and $33 million, respectively, of previously
capitalized employee stock-based compensation costs were recognized in cost
of
sales. Substantially all of the products sold during the first six months of
2006 were manufactured in previous periods when we did not include employee
stock-based compensation expense in our production costs.
Valuation
Assumptions
The
employee stock-based compensation expense recognized under FAS 123R was
determined using the Black-Scholes option valuation model. Option valuation
models require the input of subjective assumptions, and these assumptions can
vary over time. The weighted-average assumptions used were as
follows:
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
|
4.8 |
% |
|
|
4.9 |
% |
|
|
4.7 |
% |
|
|
4.8 |
% |
Dividend
yield
|
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected
volatility
|
|
|
27.0 |
% |
|
|
29.0 |
% |
|
|
27.0 |
% |
|
|
29.0 |
% |
Expected
term (years)
|
|
|
4.6
|
|
|
|
4.2
|
|
|
|
4.6
|
|
|
|
4.2
|
|
Due
to the redemption of our Special Common Stock in June 1999 by Roche Holdings,
Inc. (RHI), there is limited historical information available to support our
estimate of certain assumptions required to value our employee stock options
and
the stock issued under our employee stock purchase plan. In developing our
estimate of expected term, we have determined that our historical stock option
exercise experience is a relevant indicator of future exercise patterns. We
also
take into account other available information, including industry averages.
We
primarily base our determination of expected volatility on our assessment of
the
implied volatility of our Common Stock. Implied volatility is the volatility
assumption inherent in the market prices of a company’s traded
options.
Note
3.
|
Condensed
Consolidated Financial Statement
Detail
|
Inventories
The
components of inventories were as follows (in millions):
|
|
|
|
|
|
|
Raw
materials and supplies
|
|
$ |
123
|
|
|
$ |
116
|
|
Work
in process
|
|
|
883
|
|
|
|
818
|
|
Finished
goods
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
|
|
|
$ |
|
|
We
are a party to various legal proceedings, including patent infringement
litigation and licensing and contract disputes, and other matters.
On
October 4, 2004, we received a subpoena from the U.S. Department of Justice,
requesting documents related to the promotion of Rituxan, a prescription
treatment now approved for five indications. We are cooperating with the
associated investigation, which is both civil and criminal in nature, and
through counsel we are having discussions with government representatives about
the status of their investigation and Genentech’s views on this matter. The
government has called, and may continue to call, former and current Genentech
employees to appear before a grand jury in connection with this investigation.
The outcome of this matter cannot be determined at this time.
On
July 29, 2005, a former Genentech employee, whose employment ended in April
2005, filed a qui tam complaint under seal in the United States District Court
for the District of Maine against Genentech and Biogen Idec Inc., alleging
violations of the False Claims Act and retaliatory discharge of employment.
On
December 20, 2005, the United States filed notice of its election to decline
intervention in the lawsuit. The complaint was subsequently unsealed and we
were
served on January 5, 2006. Genentech filed a motion to dismiss the complaint
and
on December 14, 2006, the Magistrate Judge assigned to the case issued a
Recommended Decision on that motion, which is subject to review by the District
Court Judge. The Magistrate Judge recommended that the False Claims Act portion
of the complaint be dismissed, leaving as the only remaining claim against
Genentech the plaintiff’s retaliatory discharge claim. Plaintiff, Biogen Idec,
and Genentech each subsequently filed objections with the District Court Judge
concerning certain aspects of the Magistrate Judge’s Recommended Decision. On
July 24, 2007, the District Court Judge affirmed the dismissal of both claims
relating to the False Claims Act but denied Genentech’s motion to dismiss
plaintiff’s federal retaliatory discharge claim and granted plaintiff’s motion
for leave to file a Second Amended Complaint asserting an additional state
law
employment claim. The outcome of this matter cannot be determined at this
time.
We
and the City of Hope National Medical Center (COH) are parties to a 1976
agreement related to work conducted by two COH employees, Arthur Riggs and
Keiichi Itakura, and patents that resulted from that work, which are referred
to
as the “Riggs/Itakura Patents.” Since that time, we have entered into license
agreements with various companies to manufacture, use, and sell the products
covered by the Riggs/Itakura Patents. On August 13, 1999, the COH filed a
complaint against us in the Superior Court in Los Angeles County, California,
alleging that we owe royalties to the COH in connection with these license
agreements, as well as product license agreements that involve the grant of
licenses under the Riggs/Itakura Patents. On June 10, 2002, a jury voted to
award the COH approximately $300 million in compensatory damages. On June 24,
2002, a jury voted to award the COH an additional $200 million in punitive
damages. Such amounts were accrued as an expense in the second quarter of 2002
and are included in the accompanying Condensed Consolidated Balance Sheets
in
“litigation-related and other long-term liabilities” at June 30, 2007 and
December 31, 2006. We filed a notice of appeal of the verdict and damages awards
with the California Court of Appeal. On October 21, 2004, the California Court
of Appeal affirmed the verdict and damages awards in all respects. On November
22, 2004, the California Court of Appeal modified its opinion without changing
the verdict and denied Genentech’s request for rehearing. On November 24, 2004,
we filed a petition seeking review by the California Supreme Court. On February
2, 2005, the California Supreme Court granted that petition. The appeal to
the
California Supreme Court has been fully briefed, and we are waiting to be
assigned an oral argument date. The amount of cash paid, if any, or the timing
of such payment in connection with the COH matter will depend on the outcome
of
the California Supreme Court’s review of the matter. It may take longer than one
year to resolve the matter.
We
recorded accrued interest and bond costs related to the COH trial judgment
of
$13 million for the second quarter of 2007 and $14 million for the second
quarter of 2006, and $26 million for the first six months of 2007 and $27
million for the first six months of 2006. In conjunction with the COH judgment,
we posted a surety bond and were required to pledge cash and investments of
$788
million at June 30, 2007 and December 31, 2006 to secure the bond. These amounts
are reflected in “restricted cash and investments” in the accompanying Condensed
Consolidated Balance Sheets. We expect that we will continue to incur interest
charges on the judgment and service fees on the surety bond each quarter through
the process of appealing the COH trial results.
On
April 11, 2003, MedImmune, Inc. filed a lawsuit against Genentech, COH, and
Celltech R & D Ltd. in the U.S. District Court for the Central District of
California (Los Angeles). The lawsuit relates to U.S. Patent No. 6,331,415
(the
Cabilly patent) that we co-own with COH and under which MedImmune and other
companies have been licensed and are paying royalties to us. The lawsuit
includes claims for violation of antitrust, patent, and unfair competition
laws.
MedImmune is seeking a ruling that the Cabilly patent is invalid and/or
unenforceable, a determination that MedImmune does not owe royalties under
the
Cabilly patent on sales of its Synagis® antibody product, an injunction to
prevent us from enforcing the Cabilly patent, an award of actual and exemplary
damages, and other relief. On January 14, 2004 (amending a December 23, 2003
order), the U.S. District Court granted summary judgment in our favor on all
of
MedImmune’s antitrust and unfair competition claims. On April 23, 2004, the
District Court granted our motion to dismiss all remaining claims in the case.
On October 18, 2005, the U.S. Court of Appeals for the Federal Circuit affirmed
the judgment of the District Court in all respects. MedImmune filed a petition
for certiorari with the United States Supreme Court on November 10, 2005,
seeking review of the decision to dismiss certain of its claims. The Supreme
Court granted MedImmune’s petition, and the oral argument of this case before
the Supreme Court occurred on October 4, 2006. On January 9, 2007, the Supreme
Court issued a decision reversing the Federal Circuit’s decision and remanding
the case to the lower courts for further proceedings in connection with the
patent and contract claims. The trial of this matter has been scheduled for
June
23, 2008. The outcome of this matter cannot be determined at this
time.
On
May 13, 2005, a request was filed by a third party for reexamination of the
Cabilly patent. The request sought reexamination on the basis of non-statutory
double patenting over U.S. Patent No. 4,816,567. On July 7, 2005, the U.S.
Patent and Trademark Office (Patent Office) ordered reexamination of the Cabilly
patent. On September 13, 2005, the Patent Office mailed an initial non-final
Patent Office action rejecting the claims of the Cabilly patent. We filed our
response to the Patent Office action on November 25, 2005. On December 23,
2005,
a second request for reexamination of the Cabilly patent was filed by another
third party, and on January 23, 2006, the Patent Office granted that request.
On
June 6, 2006, the two reexaminations were merged into one proceeding. On August
16, 2006, the Patent Office mailed a non-final Patent Office action in the
merged proceeding, rejecting the claims of the Cabilly patent based on issues
raised in the two reexamination requests. We filed our response to the Patent
Office action on October 30, 2006. On February 16, 2007, the Patent Office
mailed a final Patent Office action rejecting all 36 claims of the Cabilly
patent. We responded to the final Patent Office action on May 21, 2007 and
requested continued reexamination. On May 31, 2007, the Patent Office granted
the request for continued reexamination, and in doing so withdrew the finality
of the February 2007 Patent Office action and agreed to treat our May 21, 2007
filing as a response to a first Patent Office action. The Cabilly patent, which
expires in 2018, relates to methods that we and others use to make certain
antibodies or antibody fragments, as well as cells and DNA used in these
methods. We have licensed the Cabilly patent to other companies and derive
significant royalties from those licenses. The claims of the Cabilly patent
remain valid and enforceable throughout the reexamination and appeals processes.
Because the above-described proceeding is ongoing, the outcome of this matter
cannot be determined at this time.
In
2006, we made development decisions involving our humanized anti-CD20 program,
and our collaborator, Biogen Idec, disagreed with certain of our development
decisions related to humanized anti-CD20 products. Under our 2003 collaboration
agreement with Biogen Idec, we believe that we are permitted under the agreement
to proceed with further trials of certain humanized anti-CD20 antibodies, and
Biogen Idec disagreed with our position. The disputed issues have been submitted
to arbitration. In the arbitration, Biogen Idec filed motions for a preliminary
injunction and summary judgment seeking to stop us from proceeding with certain
development activities, including planned clinical trials. On April 20, 2007,
the arbitration panel denied both Biogen Idec’s motion for a preliminary
injunction and Biogen Idec’s motion for summary judgment. Resolution of the
arbitration could require that both parties agree to certain development
decisions before moving forward with humanized anti-CD20 antibody clinical
trials, and possibly clinical trials of other collaboration products, including
Rituxan, in which case we may have to alter or cancel planned trials in order
to
obtain Biogen Idec’s approval. The hearing of this matter is scheduled to begin
in June 2008. We expect a final decision by the arbitrators by
approximately the end of 2008 unless the parties are able to resolve the matter
earlier through settlement discussions or otherwise. The outcome of this matter
cannot be determined at this time.
Note
5.
|
Relationship
with Roche Holdings, Inc. and Related Party
Transactions
|
Roche
Holdings, Inc.’s Ability to Maintain Percentage Ownership Interest in
Our Stock
We
issue shares of Common Stock in connection with our stock option and stock
purchase plans, and we may issue additional shares for other purposes. Our
affiliation agreement with RHI provides, among other things, that with respect
to any issuance of our Common Stock in the future, we will repurchase a
sufficient number of shares so that immediately after such issuance, the
percentage of our Common Stock owned by RHI will be no lower than 2% below
the
“Minimum Percentage” (subject to certain conditions). The Minimum Percentage
equals the lowest number of shares of Genentech Common Stock owned by RHI since
the July 1999 offering (to be adjusted in the future for dispositions of shares
of Genentech Common Stock by RHI as well as for stock splits or stock
combinations) divided by 1,018,388,704 (to be adjusted in the future for stock
splits or stock combinations), which is the number of shares of Genentech Common
Stock outstanding at the time of the July 1999 offering, adjusted for stock
splits. We have repurchased shares of our Common Stock since 2001. The
affiliation agreement also provides that upon RHI’s request, we will repurchase
shares of our Common Stock to increase RHI’s ownership to the Minimum
Percentage. In addition, RHI will have a continuing option to buy stock from
us
at prevailing market prices to maintain its percentage ownership interest.
Under
the terms of the affiliation agreement, RHI’s Minimum Percentage is 57.7%, and
RHI’s ownership percentage is to be no lower than 55.7%. At June 30, 2007, RHI’s
ownership percentage was 55.8%.
Related
Party Transactions
We
enter into transactions with our related parties, Roche Holding AG and
affiliates (Roche) and Novartis AG and other Novartis affiliates (Novartis).
The
accounting policies that we apply to our transactions with our related parties
are consistent with those applied in transactions with independent third
parties.
In
our royalty and supply arrangements with related parties, we are the principal,
as defined under EITF Issue No. 99-19, “Reporting Revenue Gross as
a Principal versus Net as an Agent” (EITF 99-19), because we bear
the manufacturing risk, general inventory risk, and the risk to defend our
intellectual property. For circumstances in which we are the principal in the
transaction, we record the transaction on a gross basis in accordance with
EITF
99-19. Otherwise, our transactions are recorded on a net basis.
Roche
Under
our existing arrangements with Roche, including our licensing and marketing
agreements, we recognized the following amounts (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales to Roche
|
|
$ |
253
|
|
|
$ |
73
|
|
|
$ |
516
|
|
|
$ |
131
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Roche
|
|
$ |
283
|
|
|
$ |
207
|
|
|
$ |
538
|
|
|
$ |
373
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Roche
|
|
$ |
30
|
|
|
$ |
21
|
|
|
$ |
60
|
|
|
$ |
40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Roche
|
|
$ |
137
|
|
|
$ |
64
|
|
|
$ |
258
|
|
|
$ |
113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development (R&D) expenses incurred on joint development projects
with Roche
|
|
$ |
70
|
|
|
$ |
53
|
|
|
$ |
128
|
|
|
$ |
95
|
|
R&D
expenses are partially reimbursable to us by Roche. In addition, these amounts
include R&D expenses resulting from the net settlement of amounts we owed to
Roche on R&D expenses that Roche incurred on joint development projects,
less amounts reimbursable to us by Roche on these
respective projects.
Novartis
Based
on information available to us at the time of filing this Form 10-Q, we believe
that Novartis holds approximately 33.3 percent of the outstanding voting shares
of Roche Holding AG. As a result of this ownership, Novartis is deemed to have
an indirect beneficial ownership interest under FAS 57, “Related
Party Disclosures,” of more than 10 percent of our voting
stock.
We
have an agreement with Novartis Pharma AG (a wholly owned subsidiary of Novartis
AG) under which Novartis Pharma AG has the exclusive right to develop and market
Lucentis outside the U.S. for indications related to diseases or disorders
of
the eye. As part of this agreement, the parties will share the cost of certain
of our ongoing development expenses for Lucentis. Novartis Pharma AG makes
royalty payments to us on sales of Lucentis outside the U.S.
We,
along with Novartis Pharma AG, are co-developing Xolair in the U.S., and we
and
Novartis are co-promoting Xolair in the U.S. We record all sales and cost of
sales in the U.S., and Novartis markets the product in and records all sales
and
cost of sales in Europe. We and Novartis share the resulting U.S. and European
operating profits, respectively, according to prescribed profit sharing
percentages, and our U.S. and European profit sharing expenses are recorded
as
collaboration profit sharing expense.
Under
our existing arrangements with Novartis, we recognized the following amounts
(in millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales to Novartis
|
|
$ |
3
|
|
|
$ |
2
|
|
|
$ |
6
|
|
|
$ |
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Novartis
|
|
$ |
13
|
|
|
$ |
–
|
|
|
$ |
19
|
|
|
$ |
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Novartis
|
|
$ |
4
|
|
|
$ |
13
|
|
|
$ |
44
|
|
|
$ |
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Novartis
|
|
$ |
3
|
|
|
$ |
1
|
|
|
$ |
7
|
|
|
$ |
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects with
Novartis
|
|
$ |
9
|
|
|
$ |
12
|
|
|
$ |
19
|
|
|
$ |
22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
profit sharing expense to Novartis
|
|
$ |
49
|
|
|
$ |
48
|
|
|
$ |
96
|
|
|
$ |
91
|
|
Contract
revenue in the first six months of 2007 included a $30 million milestone payment
from Novartis Pharma AG for European Union approval of Lucentis for the
treatment of neovascular (wet) age-related macular degeneration.
R&D
expenses are partially reimbursable to us by Novartis. In addition, these
amounts include R&D expenses resulting from the net settlement of amounts we
owed to Novartis on R&D expenses that Novartis incurred on joint development
projects, less amounts reimbursable to us by Novartis on
these respective projects.
The
effective income tax rate was 37% in the second quarter and in the first six
months of 2007, compared to 38% in the second quarter and in the first six
months of 2006. The decrease in the income tax rate is primarily due to the
extension of the federal R&D tax credit and an increase in the domestic
manufacturing deduction in 2007.
On
August 2, 2007, we acquired 100% of the shares of Tanox, Inc., a publicly held
company based in Houston, Texas, specializing in the discovery of
biotherapeutics based on monoclonal antibody technology, for $20 per share
for a
total cash value of approximately $919 million, including estimated transaction
costs. We expect to complete the purchase price allocation for this acquisition
pending the receipt of final asset appraisals and the completion of certain
other analyses in the third quarter of 2007.
The
Board of Directors and Stockholders of Genentech, Inc.
We
have reviewed the condensed consolidated balance sheet of Genentech, Inc. as
of
June 30, 2007, and the related condensed consolidated statements of income
for
the three-month and six-month periods ended June 30, 2007 and 2006, and the
condensed consolidated statements of cash flows for the six-month periods ended
June 30, 2007 and 2006. These financial statements are the responsibility of
the
Company’s management.
We
conducted our review in accordance with the standards of the Public Company
Accounting Oversight Board (United States). A review of interim financial
information consists principally of applying analytical procedures and making
inquiries of persons responsible for financial and accounting matters. It is
substantially less in scope than an audit conducted in accordance with the
standards of the Public Company Accounting Oversight Board, the objective of
which is the expression of an opinion regarding the financial statements taken
as a whole. Accordingly, we do not express such an opinion.
Based
on our review, we are not aware of any material modifications that should be
made to the condensed consolidated financial statements referred to above for
them to be in conformity with U.S. generally accepted accounting
principles.
We
have previously audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), the consolidated balance sheet
of
Genentech, Inc. as of December 31, 2006, and the related consolidated statements
of income, stockholders’ equity, and cash flows for the year then ended, not
presented herein, and in our report dated February 5, 2007, we expressed an
unqualified opinion on those consolidated financial statements including an
explanatory paragraph relating to the change in method of accounting for
stock-based compensation in accordance with guidance provided in Statement
of
Financial Accounting Standards No. 123(R), “Share-based Payment.” In our
opinion, the information set forth in the accompanying condensed consolidated
balance sheet as of December 31, 2006, is fairly stated, in all material
respects, in relation to the consolidated balance sheet from which it has been
derived.
Palo
Alto, California
July
20, 2007,
except
for Note 7, as to which the date is
August
2, 2007
GENENTECH,
INC.
FINANCIAL
REVIEW
Overview
The
information included in this Quarterly Report on Form 10-Q should be read in
conjunction with the Consolidated Financial Statements and accompanying notes
included in our Annual Report on Form 10-K for the year ended December 31,
2006.
The
Company
Genentech
is a leading biotechnology company that discovers, develops, manufactures,
and
commercializes biotherapeutics for significant unmet medical needs. We
commercialize multiple biotechnology products, and also receive royalties from
companies that are licensed to market products based on our
technology.
Major
Developments in the Second Quarter of 2007
We
primarily earn revenue and income and generate cash from product sales and
royalty revenue. In the second quarter of 2007, our total operating revenue
was
$3,004 million, an increase of 37% from $2,199 million in the second quarter
of
2006. Our net income for the second quarter of 2007 was $747 million, an
increase of 41% from $531 million in the second quarter of 2006. In the first
six months of 2007, our total operating revenue was $5,847 million, an increase
of 40% from $4,185 million in the first six months of 2006. Our net income
for
the first six months of 2007 was $1,453 million, an increase of 53% from $952
million in the first six months of 2006.
In
June 2007, we submitted two supplemental Biologic License Applications (sBLAs)
with the United States (U.S.) Food and Drug Administration (FDA) for the use
of
Herceptin in combination with a chemotherapy regimen containing doxorubicin,
cyclophosphamide, and Taxotere and in combination with a non-anthracycline
chemotherapy regimen consisting of Taxotere and carboplatin based on data from
the BCIRG-006 trial.
On
June 26, 2007, we entered into a collaboration agreement with Abbott
Laboratories for the global research, development, and commercialization of
two
of Abbott’s investigational anti-cancer, small molecule compounds: ABT-263 and
ABT-869. ABT-263 is currently in Phase I clinical trials and we, in
collaboration with Abbott, are planning to initiate Phase II trials with
ABT-869 in solid tumor types in the second half of 2007.
During
the second quarter of 2007, we achieved four manufacturing milestones: (i)
we
received FDA licensure of our Oceanside, California manufacturing facility
to
produce bulk Avastin, (ii) we received approval for a new aseptic fill-finish
line in South San Francisco, California; (iii) we broke ground on our E. coli
production facility in Singapore, and (iv) we achieved mechanical completion
of
our second manufacturing facility in Vacaville, California, for which we
continue to anticipate licensure in 2009.
On
August 2, 2007, we acquired 100% of the shares of Tanox, Inc. for $20 per share
for a total cash value of approximately $919 million, including estimated
transaction costs. We expect to complete the purchase price allocation for
this
acquisition pending the receipt of final asset appraisals and the completion
of
certain other analyses in the third quarter of 2007.
Our
Strategy and Goals
As
announced in 2006, our business objectives for the years 2006 through 2010
include bringing at least 20 new molecules into clinical development, bringing
at least 15 major new products or indications onto the market, becoming the
number one U.S. oncology company in sales, and achieving certain financial
growth measures. These
objectives
are reflected in our revised Horizon 2010 strategy and goals summarized on
our
website at www.gene.com/gene/about/corporate/growthstrategy.
Economic,
Industry-wide, and Other Factors
Our
strategy and goals are challenged by economic and industry-wide factors that
affect our business. Key factors that affect our future growth are discussed
below:
-
We
face significant competition in the diseases of interest to us from
pharmaceutical companies and biotechnology companies. The introduction
of new
competitive products or follow-on biologics, and/or new information about
existing products or pricing decisions by us or our competitors, may result
in
lost market share for us, reduced utilization of our products, lower prices,
and/or reduced product sales, even for products protected by
patents.
-
Our
long-term business growth depends upon our ability to continue to successfully
develop and commercialize important novel therapeutics to treat unmet medical
needs, such as cancer, as well as our ability to in-license product
candidates. We recognize that the successful development of biotherapeutics
is
highly difficult and uncertain, and that it will be challenging for us
to
continue to discover and develop innovative treatments. Our business requires
significant investment in research and development (R&D) over many years,
often for products that fail during the R&D process. Once a product
receives FDA approval, it remains subject to ongoing FDA regulation, including
changes to the product label, new or revised regulatory requirements for
manufacturing practices, written advisement to physicians, and/or product
recalls or withdrawals.
-
Our
near-term growth will depend on our ability to execute on recent product
approvals, including Lucentis for the treatment of neovascular (wet)
age-related macular degeneration (AMD) and Avastin for the treatment of
non-small cell lung cancer, and to successfully obtain FDA approvals for
potential new indications for our existing products such as Avastin for
the
treatment of metastatic breast cancer and anti-CD20 molecules for the
treatment of immunological disorders.
-
Our
business model requires appropriate pricing and reimbursement for our
products, to offset the costs and risks of drug development. The pricing
of
our products has received negative press coverage and public scrutiny.
We will
continue to meet with patient groups, payers, and other stakeholders in
the
healthcare system to understand their issues and concerns. The reimbursement
environment for our products may change in the future and become more
challenging.
-
As
the Medicare and Medicaid programs are the largest payers for our products,
rules related to coverage and reimbursement continue to represent an important
issue for our business. New regulations related to hospital and physician
payment continue to be implemented annually. To date, we have not seen
any
detectable effects of the new rules on our product sales.
-
Intellectual
property protection of our products is crucial to our business. Loss of
effective intellectual property protection on one or more products could
result in lost sales to competing products and may negatively affect our
sales, royalty revenue, and operating results. We are often involved in
disputes over contracts and intellectual property, and we work to resolve
these disputes in confidential negotiations or litigation. We expect legal
challenges in this area to continue. We plan to continue to build upon
and
defend our intellectual property position.
-
Manufacturing
biotherapeutics is difficult and complex, and requires facilities specifically
designed and validated to run biotechnology production processes. The
manufacture of a biotherapeutic requires developing and maintaining a process
to reliably manufacture and formulate the product at an appropriate scale,
obtaining regulatory approval to manufacture the product, and is subject
to
changes in regulatory requirements or standards that may require modifications
to the manufacturing process. Additionally, we may have an excess of available
capacity, which could lead to an idling of a portion of our manufacturing
facilities and incurring unabsorbed or idle plant charges, or other excess
capacity charges, resulting in an increase in our cost of
sales.
-
Our
ability to attract and retain highly qualified and talented people in all
areas of the company, and our ability to maintain our unique culture, will
be
critical to our success over the long-term. We are working diligently across
the company to make sure that we successfully hire, train, and integrate
new
employees into the Genentech culture and environment.
Marketed
Products
We
commercialize in the U.S. the biotechnology products listed below:
Avastin
(bevacizumab) is an anti-VEGF humanized antibody approved for use in combination
with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients
with first- or second-line metastatic cancer of the colon or rectum. It is
also
approved for use in combination with carboplatin and paclitaxel chemotherapy
for
the first-line treatment of unresectable, locally advanced, recurrent or
metastatic non-squamous, non-small cell lung cancer.
Rituxan
(rituximab) is an anti-CD20 antibody that we commercialize with Biogen
Idec, Inc. It is approved for:
-
The
treatment of patients with relapsed or refractory, low-grade or follicular,
CD20-positive, B-cell non-Hodgkin’s lymphoma, including retreatment and bulky
disease;
-
The
first-line treatment of patients with diffuse large B-cell, CD20-positive,
non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide,
doxorubicin, vincristine, and prednisone) or other anthracycline-based
chemotherapy;
-
The
first-line treatment of patients with follicular, CD20-positive, B-cell
non-Hodgkin’s lymphoma in combination with cyclophosphamide, vincristine, and
prednisone (CVP) chemotherapy regimens;
-
The
treatment of low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma in
patients with stable disease or who achieve a partial or complete response
following first-line treatment with CVP chemotherapy;
and
-
Use
in combination with methotrexate for reducing signs and symptoms
in adult
patients with moderately to severely active rheumatoid arthritis
(RA) who have
had an inadequate response to one or more tumor necrosis factor antagonist
therapies.
Herceptin
(trastuzumab) is a humanized anti-HER2 antibody approved for use as
an
adjuvant treatment of node-positive breast cancer as part of a treatment
regimen
containing doxorubicin, cyclophosphamide, and paclitaxel for patients who
have
tumors that overexpress the human epidermal growth factor receptor 2 (HER2)
protein. It is also approved for use as a first-line therapy in combination
with
paclitaxel and as a single agent in second- and third-line therapy for patients
with HER2-positive metastatic breast cancer.
Lucentis
(ranibizumab) is an anti-VEGF antibody fragment approved for the treatment
of
neovascular (wet) age-related macular degeneration.
Xolair
(omalizumab) is a humanized anti-IgE antibody, which we commercialize with
Novartis Pharma AG (Novartis). Xolair is approved for adults and adolescents
(age 12 or older) with moderate to severe persistent asthma
who
have a positive skin test or in vitro reactivity to a perennial aeroallergen
and
whose symptoms are inadequately controlled with inhaled
corticosteroids.
Tarceva
(erlotinib), which we commercialize with OSI Pharmaceuticals, Inc., is
a
small-molecule tyrosine kinase inhibitor of the HER1/epidermal growth factor
receptor (EGFR) signaling pathway. Tarceva is approved for the treatment of
patients with locally advanced or metastatic non-small cell lung cancer after
failure of at least one prior chemotherapy regimen. It is also approved,
in combination with gemcitabine chemotherapy, for the first-line treatment
of patients with locally advanced, unresectable, or metastatic pancreatic
cancer.
Nutropin
(somatropin [rDNA origin] for injection) and Nutropin AQ are
growth hormone products approved for the treatment of growth hormone deficiency
in children and adults, growth failure associated with chronic renal
insufficiency prior to kidney transplantation, short stature associated with
Turner syndrome, and long-term treatment of idiopathic short
stature.
Activase
(alteplase, recombinant) is a tissue plasminogen activator (t-PA) approved
for the treatment of acute myocardial infarction (heart attack), acute ischemic
stroke (blood clots in the brain) within three hours of the onset of symptoms,
and acute massive pulmonary embolism (blood clots in the lungs).
TNKase
(tenecteplase) is a modified form of t-PA approved for the treatment of
acute myocardial infarction (heart attack).
Cathflo
Activase (alteplase, recombinant) is a t-PA approved in adult and pediatric
patients for the restoration of function to central venous access devices that
have become occluded due to a blood clot.
Pulmozyme
(dornase alfa, recombinant) is an inhalation solution of deoxyribonuclease
(rhDNase) I, approved for the treatment of cystic fibrosis.
Raptiva
(efalizumab) is a humanized anti-CD11a antibody approved for the treatment
of
chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are
candidates for systemic therapy or phototherapy.
Licensed
Products
We
receive royalty revenue from various licensees, including significant royalty
revenue from Roche Holding AG and affiliates (Roche) on sales of:
See
Note 4, “Contingencies,” in the Notes to Condensed Consolidated Financial
Statements of Part I, Item 1 of this Form 10-Q for information regarding certain
patent-related legal proceedings.
Available
Information
The
following information is found on our website at www.gene.com, or can be
obtained free of charge by contacting our Investor Relations Department at
(650)
225-1599 or sending an e-mail message to
investor.relations@gene.com:
-
Our
annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
on
Form 8-K, and all amendments to those reports as soon as reasonably
practicable after such material is electronically filed with the Securities
and Exchange Commission;
-
Our
policies related to corporate governance, including our Principles of
Corporate Governance, Good Operating Principles, and our Code of Ethics,
which
apply to our Chief Executive Officer, Chief Financial Officer, and senior
financial officials; and
Critical
Accounting Policies and the Use of Estimates
The
accompanying discussion and analysis of our financial condition and results
of
operations are based on our Condensed Consolidated Financial Statements and
the
related disclosures, which have been prepared in accordance with U.S. generally
accepted accounting principles (GAAP). The preparation of these Condensed
Consolidated Financial Statements requires management to make estimates,
assumptions, and judgments that affect the reported amounts in our Condensed
Consolidated Financial Statements and accompanying notes. These estimates form
the basis for making judgments about the carrying values of assets and
liabilities. We base our estimates and judgments on historical experience and
on
various other assumptions that we believe to be reasonable under the
circumstances, and we have established internal controls related to the
preparation of these estimates. Actual results and the timing of the results
could differ materially from these estimates.
We
believe the following policies to be critical to understanding our financial
condition, results of operations, and expectations for 2007, because these
policies require management to make significant estimates, assumptions, and
judgments about matters that are inherently uncertain.
Contingencies
We
are currently, and have been, involved in certain legal proceedings, including
patent infringement litigation. We are also involved in licensing and contract
disputes, and other matters. See Note 4, “Contingencies,” in the Notes to
Condensed Consolidated Financial Statements of Part I, Item 1 of this Form
10-Q
for further information on these matters. We assess the likelihood of any
adverse judgments or outcomes for these legal matters as well as potential
ranges of probable losses. We record an estimated loss as a charge to income
if
we determine that, based on information available at the time, the loss is
probable and the amount of loss can be reasonably estimated. Included in
“litigation-related and other long-term liabilities” in the accompanying
Condensed Consolidated Balance Sheet at June 30, 2007 is $751 million, which
represents our estimate of the costs for the current resolution of the City
of
Hope National Medical Center (COH) matter. The nature of these matters is highly
uncertain and subject to change; as a result, the amount of our liability for
certain of these matters could exceed or be less than the amount of our current
estimates, depending on the final outcome of these matters. An outcome of such
matters that is different from previously estimated could have a material effect
on our financial position or our results of operations in any one
quarter.
Revenue
Recognition – Avastin U.S. Product Sales
In
February 2007, we launched the Avastin Patient Assistance Program, which is
a
voluntary program that enables eligible patients who have received 10,000
milligrams of Avastin in a 12-month period to receive free Avastin in excess
of
the 10,000 milligrams during the remainder of the 12-month period. Based on
the
current wholesale acquisition cost, the 10,000 milligrams is valued at $55,000
in gross revenue. Eligible patients include those who are being treated for
an
FDA-approved indication and who meet the household income criteria for this
program. The program is available for eligible patients who enroll regardless
of
whether they are insured. We defer a portion of our gross Avastin product sales
revenue to reflect our estimate of the commitment to supply free Avastin to
those patients who elect to enroll in the program.
In
order to make our estimate of the amount of free Avastin to be provided to
patients under the program, we need to estimate several factors, most notably:
the number of patients who are currently being treated for FDA-approved
indications and the start date for their treatment regimen, the extent to which
doctors and patients may elect to enroll in the program, the number of patients
who will meet the financial eligibility requirements of the program, and the
duration and extent of treatment for the FDA-approved indications, among other
factors. We have based our
enrollment
assumptions on physician surveys and other information that we consider
relevant. We will continue to update our estimates in each reporting period
as
new information becomes available. If the actual results underlying this
deferred revenue accounting vary significantly from our estimates, we will
need
to make adjustments to these estimates, which could have a material effect
on
revenue and earnings in the period of adjustment. Based on these estimates,
we
defer a portion of Avastin revenue on product vials sold through normal
commercial channels. The deferred revenue will be recognized as free Avastin
vials are delivered. In the first six months of 2007, we deferred a net amount
of approximately $3 million of our Avastin sales, resulting in a total deferred
revenue liability in connection with the Avastin Patient Assistance Program
of
$12 million in our Condensed Consolidated Balance Sheet at June 30,
2007.
Product
Sales Allowances
Revenue
from U.S. product sales is recorded net of allowances and accruals for rebates,
healthcare provider contractual chargebacks, prompt-pay sales discounts, product
returns, and wholesaler inventory management allowances, all of which are
established at the time of sale. Sales allowances and accruals are based
on estimates of the amounts earned or to be claimed on the related sales.
The amounts reflected in our Condensed Consolidated Statements of Income as
product sales allowances have been relatively consistent at approximately six
to
eight percent of gross sales. In order to prepare our Condensed Consolidated
Financial Statements, we are required to make estimates regarding the amounts
earned or to be claimed on the related product sales.
Definitions
for the product sales allowance types are as follows:
-
Rebate
allowances and accruals comprise both direct and indirect rebates. Direct
rebates are contractual price adjustments payable to direct customers,
mainly
to wholesalers and specialty pharmacies that purchase products directly
from
us. Indirect rebates are contractual price adjustments payable to healthcare
providers and organizations such as clinics, hospitals, pharmacies, Medicaid,
and group purchasing organizations that do not purchase products directly
from
us;
-
Wholesaler
inventory management allowances are credits granted to wholesalers for
compliance with various contractually defined inventory management programs.
These programs were created to align purchases with underlying demand for
our
products and to maintain consistent inventory levels, typically at two
to
three weeks of sales depending on the product; and
We
believe that our estimates related to product returns allowances and wholesaler
inventory management payments are not material amounts, based on the historical
levels of credits and allowances as a percentage of product sales. We believe
that our estimates related to healthcare provider contractual chargebacks and
prompt-pay sales discounts do not have a high degree of estimation complexity
or
uncertainty, as the related amounts are settled within a short period of time.
We consider rebate allowances and accruals to be the only estimations that
involve material amounts and require a higher degree of subjectivity and
judgment necessary. As a result of the uncertainties involved in estimating
rebate allowances and accruals, there is a likelihood that materially different
amounts could be reported under different conditions or using different
assumptions.
Our
rebates are based on definitive agreements or legal requirements (such as
Medicaid). These rebates are primarily estimated using historical and other
data, including patient usage, customer buying patterns, applicable
contractual
rebate
rates, and contract performance by the benefit providers. Direct rebates are
accrued at the time of sale and recorded as allowances against trade accounts
receivable; indirect (including Medicaid) rebates are accrued at the time of
sale and recorded as liabilities. Rebate estimates are evaluated quarterly
and
may require changes to better align our estimates with actual results. As part
of this evaluation, we review changes to Medicaid legislation, changes to state
rebate contracts, changes in the level of discounts, and significant changes
in
product sales trends. Although rebates are accrued at the time of sale, rebates
are typically paid out, on average, up to six months after the sale. We believe
that our rebate allowances and accruals estimation process provides a high
degree of confidence in the amounts established and that the annual allowance
amounts provided for would not vary by more than approximately 3% based on
our
estimate that our changes in rebate allowances and accruals estimates related
to
prior years have not exceeded 3%. To illustrate our sensitivity to changes
in
the rebate allowances and accruals process, as much as a 10% change in our
annualized rebate allowances and accruals provision experienced to date in
2007
(which is in excess of three times the level of variability that we reasonably
expect to observe for rebates) would have an approximate $18 million effect
on
our income before taxes (or approximately $0.01 per share after taxes). The
total rebate allowances and accruals recorded in our Condensed Consolidated
Balance Sheet were $61 million as of June 30, 2007.
All
of the aforementioned categories of allowances and accruals are evaluated
quarterly and adjusted when trends or significant events indicate that a change
in estimate is appropriate. Such changes in estimate could materially affect
our
results of operations or financial position; however, to date they have not
been
material. It is possible that we may need to adjust our estimates in future
periods. As of June 30, 2007, our Condensed Consolidated Balance Sheet reflected
estimated product sales allowance reserves and accruals totaling approximately
$158 million.
Royalties
For
substantially all of our agreements with licensees, we estimate royalty revenue
and royalty receivables in the period the royalties are earned, which is in
advance of collection. Our estimates of royalty revenue and receivables in
those
instances are based on communication with some licensees, historical
information, forecasted sales trends, and collectibility. Differences between
actual royalty revenue and estimated royalty revenue are adjusted for in the
period in which they become known, typically the following quarter. If the
collectibility of a royalty amount is doubtful, royalty revenue is not recorded.
In the case of a receivable related to previously recognized royalty revenue
that is subsequently determined to be uncollectible, the receivable is reserved
for in the period in which the circumstances that make collectibility doubtful
are determined. Historically, adjustments to our royalty receivables have not
been material to our consolidated financial condition or results of
operations.
We
have confidential licensing agreements with a number of companies on U.S. Patent
No. 6,331,415 (the Cabilly patent), under which we receive royalty revenue
on
sales of products that are covered by the patent. The Cabilly patent, which
expires in 2018, relates to methods that we and others use to make certain
antibodies or antibody fragments, as well as cells and DNA used in these
methods. The U.S. Patent and Trademark Office (Patent Office) is performing
a
reexamination of the patent and on February 16, 2007 issued a final Patent
Office action rejecting all 36 claims of the Cabilly patent. We responded to
the
final Patent Office action on May 21, 2007 and requested continued
reexamination. On May 31, 2007, the Patent Office granted the request for
continued reexamination, and in so doing withdrew the finality of the February
2007 Patent Office action and agreed to treat our May 21, 2007 filing as a
response to a first Patent Office action. The claims of the patent remain valid
and enforceable throughout the reexamination and appeals processes. See also
Note 4, “Contingencies,” in the Notes to Condensed Consolidated Financial
Statements of Part I, Item 1 of this Form 10-Q for further information on our
Cabilly patent reexamination.
Cabilly
patent royalties are generally due 60 days after the end of the quarter.
Additionally, we pay COH a percentage of our Cabilly patent royalty revenue
60
days after the quarter in which we receive payments from our licensees. As
of
June 30, 2007, our Condensed Consolidated Balance Sheet included Cabilly patent
receivables totaling approximately $48 million and the related COH payable
totaling approximately $18 million.
Income
Taxes
Income
tax provision is based on income before taxes and is computed using the
liability method. Deferred tax assets and liabilities are determined based
on
the difference between the financial statement and tax basis of assets
and
liabilities
using tax rates projected to be in effect for the year in which the differences
are expected to reverse. Significant estimates are required in determining
our
provision for income taxes. Some of these estimates are based on interpretations
of existing tax laws or regulations. Various internal and external factors
may
have favorable or unfavorable effects on our future effective income tax rate.
These factors include, but are not limited to, changes in tax laws, regulations
and/or rates, changing interpretations of existing tax laws or regulations,
changes in estimates of prior years’ items, past and future levels of R&D
spending, acquisitions, and changes in overall levels of income before
taxes.
On
January 1, 2007, we adopted the provisions of Financial Accounting Standards
Board (FASB) Interpretation No. 48, “Accounting for
Uncertainty in Income Taxes” (FIN 48). As a result of the
implementation of FIN 48, we evaluated our income tax position and reclassified
$147 million of unrecognized tax benefits from current liabilities to long-term
liabilities as of January 1, 2007, and we also reclassified the balance as
of
December 31, 2006, for consistency, in the accompanying Condensed Consolidated
Balance Sheets.
Inventories
Inventories
may include currently marketed products manufactured under a new process or
at
facilities awaiting regulatory licensure. These inventories are capitalized
based on management’s judgment of probable near-term regulatory licensure. The
valuation of inventory requires us to estimate the value of inventory that
may
expire prior to use or that may fail to be released for commercial sale. The
determination of obsolete inventory requires us to estimate the future demands
for our products, and in the case of pre-approval inventories, to estimate
the
regulatory approval date for the product or for the licensure of either the
manufacturing facility or the new manufacturing process. We may be required
to
expense previously capitalized inventory costs upon a change in our estimate,
due to, among other potential factors, the denial or delay of approval of a
product or the licensure of either a manufacturing facility or a new
manufacturing process by the necessary regulatory bodies, or new information
that suggests that the inventory will not be saleable.
Employee
Stock-Based Compensation
Under
the provisions of Statement of Financial Accounting Standards (FAS) No.
123(R), “Share-Based Payment” (FAS 123R),
employee stock-based compensation is estimated at the date of grant based on
the
employee stock award’s fair value using the Black-Scholes option-pricing model
and is recognized as expense ratably over the requisite service period in a
manner similar to other forms of compensation paid to employees. The
Black-Scholes option-pricing model requires the use of certain subjective
assumptions. The most significant of these assumptions are our estimates of
the
expected volatility of the market price of our stock and the expected term
of
the award. Due to the redemption of our Special Common Stock in June 1999
(Redemption) by Roche Holdings, Inc. (RHI), there is limited historical
information available to support our estimate of certain assumptions required
to
value our stock options. When establishing an estimate of the expected term
of
an award, we consider the vesting period for the award, our recent historical
experience of employee stock option exercises (including forfeitures), the
expected volatility, and a comparison to relevant peer group data. As required
under the accounting rules, we review our valuation assumptions at each grant
date, and, as a result, our valuation assumptions used to value employee
stock-based awards granted in future periods may change. See also Note 2,
“Employee Stock-Based Compensation,” in the Notes to Condensed Consolidated
Financial Statements of Part I, Item 1 of this Form 10-Q for further
information.
Results
of Operations
(In
millions, except per share amounts)
|
|
Three
Months
Ended
June 30,
|
|
|
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$ |
2,443
|
|
|
$ |
1,810
|
|
|
|
35 |
% |
|
$ |
4,773
|
|
|
$ |
3,454
|
|
|
|
38 |
% |
Royalties
|
|
|
484
|
|
|
|
316
|
|
|
|
53
|
|
|
|
903
|
|
|
|
602
|
|
|
|
50
|
|
Contract
revenue
|
|
|
|
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
33
|
|
Total
operating revenue
|
|
|
|
|
|
|
|
|
|
|
37
|
|
|
|
|
|
|
|
|
|
|
|
40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
429
|
|
|
|
284
|
|
|
|
51
|
|
|
|
821
|
|
|
|
546
|
|
|
|
50
|
|
Research
and development
|
|
|
603
|
|
|
|
390
|
|
|
|
55
|
|
|
|
1,213
|
|
|
|
764
|
|
|
|
59
|
|
Marketing,
general and administrative
|
|
|
532
|
|
|
|
471
|
|
|
|
13
|
|
|
|
1,023
|
|
|
|
912
|
|
|
|
12
|
|
Collaboration
profit sharing
|
|
|
277
|
|
|
|
259
|
|
|
|
7
|
|
|
|
529
|
|
|
|
485
|
|
|
|
9
|
|
Recurring
charges related to redemption
|
|
|
26
|
|
|
|
26
|
|
|
|
–
|
|
|
|
52
|
|
|
|
52
|
|
|
|
–
|
|
Special
items: litigation-related
|
|
|
|
|
|
|
|
|
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
(4 |
) |
Total
costs and expenses
|
|
|
|
|
|
|
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
|
1,124
|
|
|
|
755
|
|
|
|
49
|
|
|
|
2,183
|
|
|
|
1,399
|
|
|
|
56
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income, net
|
|
|
75
|
|
|
|
121
|
|
|
|
(38 |
) |
|
|
149
|
|
|
|
174
|
|
|
|
(14 |
) |
Interest
expense
|
|
|
(17 |
) |
|
|
(18 |
) |
|
|
(6 |
) |
|
|
(35 |
) |
|
|
(37 |
) |
|
|
(5 |
) |
Total
other income, net
|
|
|
|
|
|
|
|
|
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
(17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
before taxes
|
|
|
1,182
|
|
|
|
858
|
|
|
|
38
|
|
|
|
2,297
|
|
|
|
1,536
|
|
|
|
50
|
|
Income
tax provision
|
|
|
|
|
|
|
|
|
|
|
33
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
Net
income
|
|
$ |
|
|
|
$ |
|
|
|
|
41
|
|
|
$ |
|
|
|
$ |
|
|
|
|
53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
|
|
|
$ |
|
|
|
|
42
|
|
|
$ |
|
|
|
$ |
|
|
|
|
53
|
|
Diluted
|
|
$ |
|
|
|
$ |
|
|
|
|
43
|
|
|
$ |
|
|
|
$ |
|
|
|
|
53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales as a % of product sales
|
|
|
18 |
% |
|
|
16 |
% |
|
|
|
|
|
|
17 |
% |
|
|
16 |
% |
|
|
|
|
Research
and development as a % of operating revenue
|
|
|
20
|
|
|
|
18
|
|
|
|
|
|
|
|
21
|
|
|
|
18
|
|
|
|
|
|
Marketing,
general and administrative as a % of operating revenue
|
|
|
18
|
|
|
|
21
|
|
|
|
|
|
|
|
17
|
|
|
|
22
|
|
|
|
|
|
Pretax
operating margin
|
|
|
37
|
|
|
|
34
|
|
|
|
|
|
|
|
37
|
|
|
|
33
|
|
|
|
|
|
Effective
income tax rate
|
|
|
37
|
|
|
|
38
|
|
|
|
|
|
|
|
37
|
|
|
|
38
|
|
|
|
|
|
________________________
Percentages
in this table and throughout management’s discussion and analysis of financial
condition and results of operations may reflect rounding
adjustments.
Total
Operating Revenue
Total
operating revenue increased 37% in the second quarter of 2007 and 40% in the
first six months of 2007 from the comparable periods in 2006. These increases
were primarily due to higher product sales and royalty revenue, and are further
discussed below.
Total
Product Sales
(In
millions)
|
|
Three
Months
|
|
|
|
|
|
Six
Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
U.S. product sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avastin
|
|
$ |
564
|
|
|
$ |
423
|
|
|
|
33 |
% |
|
$ |
1,097
|
|
|
$ |
821
|
|
|
|
34 |
% |
Rituxan
|
|
|
582
|
|
|
|
526
|
|
|
|
11
|
|
|
|
1,117
|
|
|
|
1,003
|
|
|
|
11
|
|
Herceptin
|
|
|
329
|
|
|
|
320
|
|
|
|
3
|
|
|
|
640
|
|
|
|
610
|
|
|
|
5
|
|
Lucentis
|
|
|
209
|
|
|
|
10
|
|
|
|
*
|
|
|
|
420
|
|
|
|
10
|
|
|
|
*
|
|
Xolair
|
|
|
120
|
|
|
|
105
|
|
|
|
14
|
|
|
|
231
|
|
|
|
200
|
|
|
|
16
|
|
Tarceva
|
|
|
102
|
|
|
|
103
|
|
|
|
(1 |
) |
|
|
203
|
|
|
|
196
|
|
|
|
4
|
|
Nutropin
products
|
|
|
94
|
|
|
|
98
|
|
|
|
(4 |
) |
|
|
185
|
|
|
|
185
|
|
|
|
–
|
|
Thrombolytics
|
|
|
67
|
|
|
|
62
|
|
|
|
8
|
|
|
|
135
|
|
|
|
121
|
|
|
|
12
|
|
Pulmozyme
|
|
|
55
|
|
|
|
47
|
|
|
|
17
|
|
|
|
107
|
|
|
|
96
|
|
|
|
11
|
|
Raptiva
|
|
|
|
|
|
|
|
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
Total
U.S. product sales(1)
|
|
|
2,149
|
|
|
|
1,716
|
|
|
|
25
|
|
|
|
4,186
|
|
|
|
3,285
|
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
product sales to collaborators
|
|
|
|
|
|
|
|
|
|
|
213
|
|
|
|
|
|
|
|
|
|
|
|
247
|
|
Total
product sales
|
|
$ |
|
|
|
$ |
|
|
|
|
35
|
|
|
$ |
|
|
|
$ |
|
|
|
|
38
|
|
______________________
*
|
Calculation
not meaningful.
|
(1)
|
The
totals may not appear to sum due to
rounding.
|
Total
product sales increased 35% in the second quarter and 38% in the first six
months of 2007 from the comparable periods in 2006. Total U.S. product sales
increased 25% to $2,149 million in the second quarter and
27% to $4,186 million in the first six months of 2007 from the comparable
periods in 2006. This increase in U.S. sales over the comparable periods was
due
to higher sales across most products, in particular higher sales of our oncology
products and sales of Lucentis. Increased U.S. sales volume accounted for 86%,
or $371 million, of the increase in U.S. net product sales in the second quarter
of 2007, and 87%, or $786 million, of the increase in the first six months
of
2007. Changes in net U.S. sales prices across the portfolio accounted for most
of the remaining increase in net U.S. product sales in the second quarter and
first six months of 2007.
Our
references below to market adoption and penetration, as well as patient share,
are derived from our analyses of market tracking studies and surveys that we
undertake with physicians. We consider these tracking studies and surveys
indicative of trends and information with respect to our direct customers’
buying patterns. We use statistical analyses to extrapolate the data that we
obtain, and as such, the adoption, penetration, and patient share data
presented herein represents estimates. Limitations in sample size and the
timeliness in receiving and analyzing this data result in inherent margins
of
error; thus, where presented, we have rounded our percentage estimates to the
nearest 5%.
Avastin
Net
U.S. sales of Avastin increased 33% to $564 million in the
second quarter and 34% to $1,097 million in the first six months of 2007 from
the comparable periods in 2006. Net U.S. sales in the first six months of 2007
excluded $3 million of revenue that we deferred in connection with our Avastin
Patient Assistance Program. There have been no price increases on
Avastin.
The
increases in sales were primarily a result of increased use of Avastin in
metastatic non-small cell lung cancer (NSCLC), approved on October 11, 2006,
and, to a lesser extent, in metastatic breast cancer (mBC), an unapproved
use of Avastin. Among first-line metastatic NSCLC patients, we estimate that
Avastin penetration was approximately 30% in the second quarter of 2007, an
increase from the adoption rate in the second quarter of 2006. With respect
to
dose, use of the 15mg/kg/every-three-weeks dose remained at approximately 75%,
consistent with the first quarter of 2007. However, our tracking study for
the
second quarter of 2007 was fielded prior to the presentation of the results
from
the Roche-sponsored Phase III BO17704 study at the American Society of Clinical
Oncology in June 2007. The BO17704 study evaluated two different doses of
Avastin in combination with gemcitabine and cisplatin chemotherapy compared
to
chemotherapy alone in patients with previously untreated, advanced NSCLC. This
study evaluated a 15mg/kg/every-three-weeks dose of Avastin (the dose approved
in the U.S. for use in combination with carboplatin and paclitaxel) and a
7.5mg/kg/every-three-weeks dose of Avastin (a dose not approved for use in
the
U.S.). Both doses met the primary endpoint of prolonging progression-free
survival (PFS) compared to chemotherapy alone. Although the study was not
designed to compare the Avastin doses, a similar treatment effect in PFS was
observed between the two arms. We expect the results of the BO17704 study to
lead to some level of increased adoption of Avastin at the lower dose of
7.5mg/kg/every-three-weeks. Efficacy data from other clinical studies conducted
by any party in the U.S. or internationally (such as AVADO, Roche’s study
evaluating two doses of Avastin in first-line mBC), showing or perceived to
be
showing a similar or an improved treatment benefit at a lower dose or shorter
duration of therapy, could further negatively affect future sales of
Avastin.
In
mBC, we estimate that Avastin use slightly increased in the second quarter
of
2007 compared to the second quarter of 2006, and use was essentially flat
compared to the first quarter of 2007. In first-line metastatic colorectal
cancer (CRC), we estimate that penetration, duration of treatment, and dosing
remained flat in the second quarter of 2007 compared to the second quarter
of
2006. In combined second- and third-line CRC, we estimate that Avastin
penetration decreased in the second quarter of 2007 compared to the second
quarter of 2006, due to increased competition, and was flat compared to the
first quarter of 2007. We believe that Avastin sales growth for the second
half
of 2007 will depend on increased penetration in the first-line treatment of
metastatic NSCLC and the extent to which physicians prescribe Avastin at its
approved dose.
Rituxan
Net
U.S. sales of Rituxan increased 11% to $582 million in the
second quarter and 11% to $1,117 million in the first six months of 2007 from
the comparable periods in 2006. It remains difficult to precisely determine
the
sales split between Rituxan use in oncology and immunology settings, since
many
treatment centers treat both types of patients. However, based on our
market research, we believe that the sales growth resulted from increased
use of Rituxan in treating rheumatoid arthritis (RA), approved on February
28,
2006, and the use of Rituxan following first-line therapy in indolent
non-Hodgkin’s lymphoma (NHL), including areas of unapproved uses. We estimate
that Rituxan’s overall adoption rate in combined markets of NHL, including areas
of unapproved use, and chronic lymphocytic leukemia (CLL), an unapproved use,
remained flat in the first half of 2007 and throughout 2006. Also contributing
to the increase in product sales were price increases effective on March 29,
2006, October 5, 2006, and March 26, 2007.
Herceptin
Net
U.S. sales of Herceptin increased 3% to $329 million in
the second quarter and 5% to $640 million in the first six months of 2007 from
the comparable periods in 2006. The increases in product sales resulted
primarily from price increases effective on March 26, 2006, October 3, 2006,
and
March 29, 2007. Also contributing to the growth in sales was increased use
of
Herceptin in the treatment of adjuvant (early-stage) HER2-positive breast
cancer, approved on November 16, 2006. We estimate that Herceptin’s penetration
in adjuvant HER2-positive breast cancer patients was over 70% in the second
quarter of 2007, an increase from the adoption rate in the second quarter of
2006.
Lucentis
Lucentis
was approved by the FDA for the treatment of neovascular (wet) age-related
macular degeneration (AMD) on June 30, 2006. Net U.S. sales were $209 million
in
the second quarter of 2007 and $211 million in the first quarter of 2007. New
patient share in the second quarter of 2007 was approximately 55%, consistent
with the first quarter of 2007. We believe that sales growth will depend on
continued dosing of existing patients beyond the first year of therapy and
to a lesser extent on increased penetration in newly diagnosed patients
(including gains against the unapproved use of Avastin in this setting). Over
the longer term, growth may also be affected by the duration of
treatment.
Xolair
Net
U.S. sales of Xolair increased 14% to $120 million in the
second quarter and 16% to $231 million in the first six months of 2007 from
the
comparable periods in 2006. The sales growth was primarily driven by increased
penetration in the asthma market and, to a lesser extent, price increases
effective on April 4, 2006 and October 17, 2006. We believe that sales in the
first six months of 2007 were modestly affected by the FDA’s request that
we strengthen the existing warning of the potential risk for anaphylaxis in
patients receiving Xolair by adding a boxed warning to the product label and
implementing a Risk Minimization Action Plan (RiskMAP), including providing
a
medication guide for patients. We and Novartis, our co-promotion collaborator,
agreed on a new U.S. label and RiskMAP with the FDA that emphasize the incidence
of anaphylaxis and instruct physicians that patients should be closely observed
for an appropriate period of time after Xolair administration. We believe this
update to the label and RiskMAP will not have a significant effect on the way
that specialists prescribe Xolair.
Tarceva
Net
U.S. sales of Tarceva decreased 1% to $102 million in the
second quarter and increased 4% to $203 million in the first six months of
2007
from the comparable periods in 2006. Returns and return reserve requirements
were higher than normal in the second quarter of 2007. We estimate that
Tarceva’s overall penetration in NSCLC remained flat in the first six months of
2007 relative to the same period in 2006. Duration of therapy in second-line
NSCLC increased in the first six months of 2007 compared to the same period
in
2006. We estimate that Tarceva’s penetration in first-line pancreatic cancer in
the second quarter of 2007 remained flat compared to the second quarter of
2006. Sales results were primarily affected by price increases
effective on November 14, 2006 and May 1, 2007, and, to a lesser extent,
increases in duration of therapy. Future sales growth in NSCLC will depend
on
increases in duration of therapy and penetration, particularly against
chemotherapy within select second-line NSCLC patient subsets.
Nutropin
Products
Combined
net U.S. sales of our Nutropin products decreased 4% to
$94 million in the second quarter and remained flat at
$185 million in the first six months of 2007 from the comparable periods in
2006. The decrease from the second quarter of 2006 was due to lower sales
volume, partially resulting from the loss of managed care product placement
due
to pricing. The volume decrease was partially offset by price increases
effective on March 1, 2007.
Thrombolytics
Combined
net U.S. sales of our three thrombolytic products—Activase, Cathflo Activase,
and TNKase—increased 8% to $67 million in the second quarter and 12% to
$135 million in the first six months of 2007 from the comparable periods in
2006. The increases were primarily due to growth in Cathflo Activase sales
in
the catheter clearance market and increased Activase sales in the acute ischemic
stroke market, partially offset by lower sales of TNKase. Also contributing
to
the increases in product sales were price increases effective on February 14,
2006, July 6, 2006, and January 18, 2007.
Pulmozyme
Net
U.S. sales of Pulmozyme increased 17% to $55 million in
the second quarter and 11% to $107 million in the first six months of 2007
from
the comparable periods in 2006. The increases reflected price increases
effective on June 29, 2006 and May 31, 2007, and, to a lesser extent, increased
penetration in certain patient segments.
Raptiva
Net
U.S. sales of Raptiva increased 23% to $27 million in the
second quarter and 19% to $51 million in the first six months of 2007 from
the
comparable periods in 2006. The growth in sales was primarily due to increased
penetration in hand and foot psoriasis patients and, to a lesser extent, price
increases effective on August 10, 2006 and May 31, 2007.
Sales
to Collaborators
Product
sales to collaborators, for use in non-U.S. markets, increased 213% to
$294 million in the second quarter and 247% to $587
million in the first six months of 2007 from the comparable periods in 2006.
The
increases were primarily due to more favorable Herceptin pricing terms that
were
part of the new supply agreement with Roche signed in the third quarter of
2006
and higher sales of Herceptin, Avastin, and Rituxan to Roche. The favorable
Roche Herceptin pricing terms will continue through the end of
2008.
For
the full year 2007, we expect sales to collaborators to approximately double
relative to 2006 levels.
Royalties
Royalty
revenue increased 53% to $484 million in the second
quarter and 50% to $903 million in the first six months of 2007 from the
comparable periods in 2006. The increases were primarily due to higher sales
by
Roche of our Herceptin, Avastin, and Rituxan products. Of the overall royalties
received, royalties from Roche represented approximately 58% in the second
quarter and 60% in the first six months of 2007 compared to approximately 65%
in
the second quarter and 62% in the first six months of 2006. The increases were
also due to an acceleration of royalties in the second quarter of 2007, as
discussed below. Royalties from other licensees included royalty revenue on
our
patent licenses, including our Cabilly patent as discussed below.
In
June 2007, we entered into a transaction with an existing licensee to license
from them the right to co-develop and commercialize certain molecules. In
exchange, we released the licensee from its obligation to make certain royalty
payments to us that would have otherwise been owed over the
three-and-a-half-year period ending June 2010, and that period may be extended
contingent upon certain events as defined in the agreement. We estimate that
the
fair value of the royalty revenue owed to us over the three-and-a-half-year
period, less any amount recognized in the first quarter of 2007, was
approximately $65 million, and this amount was recognized as royalty revenue
in
the second quarter of 2007. We also recognized a similar amount as
R&D expense for the purchase of the new license, and thus the second quarter
net earnings per share (EPS) effect of entering into this new collaboration
was
not significant.
We
have confidential licensing agreements with a number of companies on U.S. Patent
No. 6,331,415 (the Cabilly patent) under which we receive royalty revenue on
sales of products that are covered by the patent. The Cabilly patent expires
in
December 2018. The net pretax contributions related to the Cabilly patent were
as follows (in millions):
|
|
Three
Months
Ended
June 30, 2007
|
|
|
Six
Months
Ended
June 30, 2007
|
|
Royalty
revenue
|
|
$ |
46
|
|
|
$ |
108
|
|
|
|
|
|
|
|
|
|
|
Gross
expenses(1)
|
|
$ |
27
|
|
|
$ |
57
|
|
|
|
|
|
|
|
|
|
|
Net
of tax effect of Cabilly patent on diluted EPS
|
|
$ |
0.01
|
|
|
$ |
0.03
|
|
______________________
(1)
|
Gross
expenses include COH’s share of royalty revenue and royalty cost of sales
on our U.S. product sales
|
See
also Note 4, “Contingencies,” in the Notes to Condensed Consolidated Financial
Statements of Part I, Item 1 of this Form 10-Q for further information on our
Cabilly patent reexamination.
Cash
flows from royalty income include revenue denominated in foreign currencies.
We
currently purchase simple foreign currency put option contracts (options) and
forwards to hedge these foreign currency cash flows. These options and forwards
are due to expire between 2007 and 2009.
For
the full year 2007, we expect royalty revenue to increase more than 30% over
the
2006 level of $1,354 million; however, royalties are difficult to forecast
because of the number of licensees and products involved, and potential
licensing and intellectual property disputes.
Contract
Revenue
Contract
revenue increased 5% to $77 million in the second quarter
and 33% to $171 million in the first six months of 2007 from the comparable
periods in 2006. The increase in the first six months of 2007 was primarily
due
to recognition of a $30 million milestone payment from Novartis for European
Union approval of Lucentis for the treatment of patients with AMD and higher
reimbursements from Roche related to R&D efforts on Avastin. See “Related
Party Transactions” below for more information on contract revenue from Roche
and Novartis.
Contract
revenue varies each quarter and is dependent on a number of factors, including
the timing and level of reimbursements from ongoing development efforts,
milestones, and opt-in payments received, and new contract arrangements. For
the
full year 2007, we expect contract revenue to be relatively flat compared to
$290 million in 2006.
Cost
of Sales
Cost
of sales as a percentage of product sales was 18% in the second quarter and
17%
in the first six months of 2007 compared to 16% in the second quarter and first
six months of 2006. The increases were due to the recognition of employee
stock-based compensation expense of $16 million in the second quarter and $33
million in the first half of 2007, related to products sold for which employee
stock-based compensation expense was previously capitalized as part of inventory
costs, and to higher volume of lower margin sales to collaborators. Cost of
sales as a percentage of product sales was favorably affected by U.S. product
sales mix (increased sales of our higher margin products, primarily Lucentis,
Avastin, and Herceptin in the first half of 2007) and a price increase on sales
of Herceptin to Roche.
Research
and Development
Research
and development (R&D) expenses increased 55% to
$603 million in the second quarter and 59% to $1,213
million in the first six months of 2007 from the comparable periods in 2006.
A
significant portion of the increases in R&D expenses was due to an increase
in up-front, in-licensing expense for new collaborations. The higher levels
of
expenses
also reflected increased development activity across our entire product
portfolio, including increased spending on clinical trials, post-marketing
studies, and clinical manufacturing expenses (notably for Rituxan, Avastin,
Xolair, and Herceptin), and early-stage projects, as well as higher research
expenses due to increased headcount and headcount-related expenses in support
of
new molecular entities.
R&D
as a percentage of operating revenue was 20% in the second
quarter and 21% in the first six months of 2007 compared to 18% in the second
quarter and first six months of 2006.
The
major components of R&D expenses were as follows (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
Research
and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
development (including post-marketing)
|
|
$ |
387
|
|
|
$ |
301
|
|
|
|
29 |
% |
|
$ |
799
|
|
|
$ |
584
|
|
|
|
37 |
% |
Research
|
|
|
128
|
|
|
|
75
|
|
|
|
71
|
|
|
|
195
|
|
|
|
149
|
|
|
|
31
|
|
In-licensing
(up-front and ongoing fees)
|
|
|
|
|
|
|
|
|
|
|
529
|
|
|
|
|
|
|
|
|
|
|
|
606
|
|
Total
R&D
|
|
$ |
|
|
|
$ |
|
|
|
|
55
|
|
|
$ |
|
|
|
$ |
|
|
|
|
59
|
|
Marketing,
General and Administrative
Marketing,
general and administrative (MG&A) expenses increased 13% to
$532 million in the second quarter and 12% to $1,023
million in the first six months of 2007 from the comparable periods in 2006.
The
increases were primarily due to: (i) an increase in corporate expenses,
including charitable donations and losses on property and equipment disposals,
(ii) an increase in royalty expense, primarily to Biogen Idec resulting from
higher Roche sales of Rituxan, and (iii) an increase in marketing and sales
expense primarily in support of Herceptin (adjuvant setting), Rituxan (RA
setting), and post-launch activities related to Lucentis.
MG&A
as a percentage of operating revenue was 18% in the second quarter and 17%
in
the first six months of 2007 compared to 21% in the second quarter and 22%
in
the first six months of 2006.
Collaboration
Profit Sharing
Collaboration
profit sharing expenses increased 7% to $277 million in
the second quarter and 9% to $529 million in the first six months of 2007 from
the comparable periods in 2006 due to higher sales of Rituxan, Xolair, and
Tarceva and the related profit sharing expenses.
The
following table summarizes the amounts resulting from the respective profit
sharing collaborations for the periods presented (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
Rituxan profit sharing expense
|
|
$ |
188
|
|
|
$ |
173
|
|
|
|
9 |
% |
|
$ |
354
|
|
|
$ |
325
|
|
|
|
9 |
% |
U.S.
Tarceva profit sharing expense
|
|
|
49
|
|
|
|
48
|
|
|
|
2
|
|
|
|
96
|
|
|
|
91
|
|
|
|
5
|
|
Total
Xolair profit sharing expense
|
|
|
|
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
Total
collaboration profit sharing expense
|
|
$ |
|
|
|
$ |
|
|
|
|
7
|
|
|
$ |
|
|
|
$ |
|
|
|
|
9
|
|
Currently,
our most significant collaboration profit sharing agreement is with Biogen
Idec,
with whom we co-promote Rituxan in the U.S. Under the collaboration agreement,
Biogen Idec granted us a worldwide license to develop, commercialize, and market
Rituxan in multiple indications. In exchange for these worldwide rights, Biogen
Idec has co-promotion rights in the U.S. and a contractual arrangement under
which we share a portion of the pretax U.S. co-promotion profits of Rituxan
and
royalty revenue on sales of Rituxan by collaborators. In June 2003, we amended
and restated the collaboration agreement with Biogen Idec to include the
development and commercialization of one or more anti-CD20 antibodies targeting
B-cell disorders, in addition to Rituxan, for a broad range of
indications.
Under
the amended and restated collaboration agreement, our share of the current
pretax U.S. co-promotion profit sharing formula is approximately 60% of
operating profits, and Biogen Idec’s share is approximately 40% of operating
profits. For each calendar year or portion thereof following the approval date
of the first new anti-CD20 product, after a period of transition, our share
of
the pretax U.S. co-promotion profits will change to approximately 70% of
operating profits, and Biogen Idec’s share will be approximately 30% of
operating profits.
Collaboration
profit sharing expense, exclusive of R&D expenses, related to Biogen Idec
for the periods ended June 30, 2007 and 2006 consisted of the following (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales, net
|
|
$ |
582
|
|
|
$ |
525
|
|
|
|
11 |
% |
|
$ |
1,117
|
|
|
$ |
1,002
|
|
|
|
11 |
% |
Combined
commercial and manufacturing costs and expenses
|
|
|
|
|
|
|
|
|
|
|
26
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
Combined
co-promotion profits
|
|
$ |
|
|
|
$ |
|
|
|
|
7
|
|
|
$ |
|
|
|
$ |
|
|
|
|
9
|
|
Amount
due to Biogen Idec for their share of co-promotion profits – included in
collaboration profit sharing expense
|
|
$ |
188
|
|
|
$ |
173
|
|
|
|
9 |
% |
|
$ |
354
|
|
|
$ |
325
|
|
|
|
9 |
% |
Biogen
Idec’s relative share of combined commercial costs determines the amount shown
as collaboration profit sharing expense, exclusive of R&D
expenses.
Revenue
and expenses related to our collaboration with Biogen Idec separately included
the following (in millions):
|
|
Three
Months
Ended
June 30,
|
|
|
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Biogen Idec (R&D reimbursement)
|
|
$ |
34
|
|
|
$ |
23
|
|
|
|
48 |
% |
|
$ |
55
|
|
|
$ |
39
|
|
|
|
41 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty
expense on sales of Rituxan to Roche and Zenyaku and other patent
costs –
included in MG&A expense
|
|
$ |
51
|
|
|
$ |
45
|
|
|
|
13 |
% |
|
$ |
107
|
|
|
$ |
80
|
|
|
|
34 |
% |
Recurring
Charges Related to Redemption
We
recorded recurring charges related to the June 1999 Redemption and push-down
accounting. These charges were $26 million in the second quarters of 2007 and
2006, and $52 million in the first six months of 2007 and 2006, and comprised
the amortization of Redemption-related intangible assets in the periods
presented.
On
June 30, 1999, RHI exercised its option to cause us to redeem all of our Special
Common Stock held by stockholders other than RHI. The Redemption was reflected
as the purchase of a business, which under GAAP required push-down accounting
to
reflect in our financial statements the amounts paid for our stock in excess
of
our net book value.
Special
Items: Litigation-Related
We
recorded accrued interest and bond costs related to the COH trial judgment
of
$13 million for the second quarter of 2007 and $14 million for the second
quarter of 2006, and $26 million for the first six months of 2007 and $27
million for the first six months of 2006. We expect that we will continue to
incur interest charges on the judgment and service fees on the surety bond
each
quarter through the process of appealing the COH trial results. The amount
of
cash to be paid, if any, or the timing of such payment in connection with the
COH matter will depend on the outcome of the California Supreme Court’s review.
It may take longer than one year to resolve this matter. See Note
4,
“Contingencies,” in the Notes to the Condensed Consolidated Financial Statements
of Part I, Item 1 of this Form 10-Q for further information regarding our
litigation.
Operating
Income
Operating
income was $1,124 million in the second quarter of 2007, a 49% increase from
the
second quarter of 2006, and $2,183 million in the first six months of 2007,
a
56% increase from the comparable period in 2006. Our operating income as a
percentage of operating revenue (pretax operating margin) was 37% in the second
quarter of 2007 and 34% in the second quarter of 2006, and was 37% in the first
six months of 2007 and 33% in the first six months of 2006.
Other
Income (Expense)
The
components of “other income (expense)” were as follows (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
Other
Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gains
on sales of biotechnology equity securities, net
|
|
$ |
4
|
|
|
$ |
66
|
|
|
|
(94 |
)% |
|
$ |
12
|
|
|
$ |
69
|
|
|
|
(83 |
)% |
Write-downs
of biotechnology debt and equity securities
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(4 |
) |
|
|
–
|
|
|
|
–
|
|
Interest
income
|
|
|
70
|
|
|
|
54
|
|
|
|
30
|
|
|
|
140
|
|
|
|
103
|
|
|
|
36
|
|
Interest
expense
|
|
|
(17 |
) |
|
|
(18 |
) |
|
|
(6 |
) |
|
|
(35 |
) |
|
|
(37 |
) |
|
|
(5 |
) |
Other
miscellaneous income
|
|
|
|
|
|
|
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
|
|
(50 |
) |
Total
other income, net
|
|
$ |
|
|
|
$ |
|
|
|
|
(44 |
) |
|
$ |
|
|
|
$ |
|
|
|
|
(17 |
) |
Other
income, net decreased 44% to $58 million in the second quarter of 2007 and
17%
to $114 million in the first six months of 2007 over the comparable periods
in
2006. Gains on sales of biotechnology equity securities, net were lower
resulting from approximately $63 million in gains from sales of certain of
our
biotechnology equity investments in the second quarter of 2006. Interest income
increased primarily due to higher yields and higher average cash balances in
the
second quarter and first six months of 2007 from the comparable periods in
2006.
For the full year 2007, we expect other income, net to be approximately 80%
of
2006 levels, although this may vary with fluctuations in interest rates and
unexpected gains or losses from our biotechnology equity portfolio.
Income
Tax Provision
The
effective income tax rate was 37% in the second quarter and first six months
of
2007, compared to 38% in the second quarter and first six months of 2006. The
decrease in the income tax rate was primarily due to the extension of the
federal R&D tax credit and an increase in the domestic manufacturing
deduction in 2007.
We
adopted the provisions of FIN 48 on January 1, 2007. Implementation of FIN
48
did not result in any adjustment to our Condensed Consolidated Statements of
Income or a cumulative adjustment to retained earnings (accumulated deficit).
As
a result of the implementation of FIN 48, we reclassified $147 million of
unrecognized tax benefits from current liabilities to long-term liabilities
as
of January 1, 2007, and we also reclassified the balance as of December 31,
2006, for consistency, in the accompanying Condensed Consolidated Balance
Sheets, none of which would have been considered due in 2007 in the presentation
of our Contractual Obligations table in our Annual Report on Form 10-K for
the
year ended December 31, 2006.
Liquidity
and Capital Resources
(In
millions)
|
|
|
|
|
|
|
Unrestricted
cash, cash equivalents, short-term investments, and long-term marketable
debt and equity securities
|
|
$ |
5,078
|
|
|
$ |
4,325
|
|
Net
receivable equity hedge instruments
|
|
|
|
|
|
|
|
|
Total
unrestricted cash, cash equivalents, short-term investments, long-term
marketable debt and equity securities, and equity hedge
instruments
|
|
$ |
|
|
|
$ |
|
|
Working
capital
|
|
|
4,710
|
|
|
$ |
3,694
|
|
Current
ratio
|
|
3.4:1
|
|
|
2.8:1
|
|
Total
unrestricted cash, cash equivalents, short-term investments, and long-term
marketable securities, including the fair value of the equity hedge instruments,
were approximately $5.1 billion at June 30, 2007, an increase of $741 million
from December 31, 2006. This increase primarily reflects cash generated from
operations and cash increases from stock option exercises, partially offset
by
cash used for repurchases of our Common Stock and capital expenditures. To
mitigate the risk of market value fluctuation, certain of our biotechnology
marketable equity securities are hedged with zero-cost collars and forward
contracts, which are carried at fair value. See Note 4, “Investment Securities
and Financial Instruments,” in the Notes to the Consolidated Financial
Statements of Part II, Item 8 of our Form 10-K for the year ended December
31, 2006 for further information regarding activity in our marketable investment
portfolio and derivative instruments.
See
“Our affiliation agreement with Roche Holdings, Inc. could adversely affect
our
cash position” among other risk factors below in Part II, Item 1A, “Risk
Factors,” of this Form 10-Q and Note 4, “Contingencies,” in the Notes to
Condensed Consolidated Financial Statements of Part I, Item 1 of this Form
10-Q
for factors that could negatively affect our cash position.
Cash
Provided by Operating Activities
Cash
provided by operating activities is primarily driven by increases in our net
income. However, operating cash flows differ from net income as a result of
non-cash charges or differences in the timing of cash flows and earnings
recognition. Significant components of cash provided by operating activities
were as follows:
Our
“accounts receivable—product sales” was $1,068 million at June 30, 2007, an
increase of $103 million from December 31, 2006. The increase was primarily
due
to higher product sales of Avastin and higher sales of Herceptin and Avastin
to
Roche. The average collection period of our “accounts receivable—product sales”
as measured in days’ sales outstanding (DSO) was 40 days for the second quarter
2007 compared to 33 days in the second quarter of 2006 and 42 days in the first
quarter of 2007. The increase from the second quarter of 2006 was primarily
due
to the extended payment terms of approximately 100 days that we offered certain
wholesalers in conjunction with the launch of Lucentis on June 30, 2006. This
program ended on June 30, 2007 and was revised so that extended payment terms
for Lucentis will continue through March 31, 2008. Under the revised program,
extended payment terms of approximately 60 additional days will be offered
through September 30, 2007 and then extended payment terms of approximately
30
additional days will be offered through March 31, 2008. Due to the shorter
payment terms under the revised program, we expect a slight decrease in our
DSO
during the second half of 2007.
Our
inventory balance was $1,365 million at June 30, 2007, an increase of $187
million from December 31, 2006. The increase was primarily due to finished
goods
of our Herceptin and Avastin products, as well as bulk campaign production
of
our Avastin product. In the first six months of 2007, we capitalized into
inventory $40 million of non-cash employee stock-based compensation costs
pursuant to FAS 123R, and recognized $33 million of previously capitalized
employee stock-based compensation costs in cost of sales.
Accounts
payable, other accrued liabilities, and other long-term liabilities increased
$132 million in the first six months of 2007. This increase was mainly due
to
increases in accrued royalties, taxes payable, accrued
marketing
expenses,
and other liabilities, which were mainly due to the growth in the business,
partially offset by decreases in accrued compensation due to payments made
during the first six months of 2007.
Cash
Used in Investing Activities
Cash
used in investing activities was primarily related to capital expenditures
and
purchases, sales, and maturities of investments. Capital expenditures were
$475
million during the first six months of 2007 compared to $538 million during
the
first six months of 2006. Capital expenditures in the first six months of 2007
included ongoing construction of our second manufacturing facility in Vacaville,
California, leasehold improvements for newly constructed
buildings on our South San Francisco, California campus, and purchase of
equipment and information systems.
Cash
Used in Financing Activities
Cash
used in financing activities was primarily related to activities under our
employee stock plans and our stock repurchase program. We used cash for stock
repurchases of $666 million during the first six months of 2007 and $540 million
during the first six months of 2006 pursuant to our stock repurchase program
approved by our Board of Directors. We also received $276 million during the
first six months of 2007 and $187 million during the first six months of 2006
related to stock option exercises and stock issuances under our employee stock
plans. The excess tax benefits from stock-based compensation arrangements were
$127 million in the first six months of 2007 and $90 million in the first six
months of 2006.
Under
a stock repurchase program approved by our Board of Directors in December 2003
and most recently extended in April 2007, we are authorized to repurchase up
to
100 million shares of our Common Stock for an aggregate price of up to $8.0
billion through June 30, 2008. In this program, as in previous stock repurchase
programs, purchases may be made in the open market or in privately negotiated
transactions from time to time at management’s discretion. We also may engage in
transactions in other Genentech securities in conjunction with the repurchase
program, including certain derivative securities. As of June 30, 2007, we have
not engaged in any such transactions. We intend to use the repurchased stock
to
offset dilution caused by the issuance of shares in connection with our employee
stock plans. Although there are currently no specific plans for the shares
that
may be purchased under the program, our goals for the program are (i) to address
provisions of our affiliation agreement with RHI related to maintaining RHI’s
minimum ownership percentage, (ii) to make prudent investments of our cash
resources, and (iii) to allow for an effective mechanism to provide stock for
our employee stock plans. See below in “Relationship with Roche Holdings, Inc.”
for more information on RHI’s minimum ownership percentage.
We
have entered into Rule 10b5-1 trading plans to repurchase shares in the open
market during those periods each quarter when trading in our stock is restricted
under our insider trading policy. The current trading plan covered approximately
four million shares and expired on June
30, 2007.
Our
shares repurchased during the first six months of 2007 were as follows
(shares in millions):
|
|
Total
Number of
Shares
Purchased
|
|
|
Average
Price
Paid
per
Share
|
|
January
1–31, 2007
|
|
|
3.0
|
|
|
$ |
87.33
|
|
February
1–28, 2007
|
|
|
0.9
|
|
|
|
86.54
|
|
March
1–31, 2007
|
|
|
0.6
|
|
|
|
82.33
|
|
April
1–30, 2007
|
|
|
0.8
|
|
|
|
82.14
|
|
May
1–31, 2007
|
|
|
1.4
|
|
|
|
79.65
|
|
June
1–30, 2007
|
|
|
|
|
|
|
|
|
Total
|
|
|
8.0
|
|
|
$ |
83.16
|
|
As
of June 30, 2007, 70 million shares had been purchased under our stock
repurchase program for $5.0 billion, and a maximum of 30 million additional
shares may be purchased under the program through June 30, 2008.
Off-Balance
Sheet Arrangements
We
have certain contractual arrangements that create potential risk for us and
are
not recognized in our Condensed Consolidated Balance Sheets. We believe there
have been no significant changes in the off-balance sheet arrangements disclosed
in our Annual Report on Form 10-K for the year ended December 31, 2006 that
have
or are reasonably likely to have a material current or future effect on our
financial condition, changes in financial condition, revenue or expenses,
results of operations, liquidity, capital expenditures, or capital
resources.
Contractual
Obligations
During
the first six months of 2007, we believe that there have been no significant
changes in our payments due under contractual obligations, as disclosed in
our
Annual Report on Form 10-K for the year ended December 31, 2006, except as
noted
above in “Income Tax Provision.”
Contingencies
We
are party to various legal proceedings, including patent infringement litigation
and licensing and contract disputes, and other matters. See Note 4,
“Contingencies,” in the Notes to Condensed Consolidated Financial Statements of
Part I, Item 1 of this Form 10-Q for further information.
Relationship
with Roche Holdings, Inc.
Roche
Holdings, Inc.’s Ability to Maintain Percentage Ownership Interest in Our
Stock
We
issue shares of Common Stock in connection with our stock option and stock
purchase plans, and we may issue additional shares for other purposes. Our
affiliation agreement with RHI provides, among other things, that with respect
to any issuance of our Common Stock in the future, we will repurchase a
sufficient number of shares so that immediately after such issuance, the
percentage of our Common Stock owned by RHI will be no lower than 2% below
the
“Minimum Percentage” (subject to certain conditions). The Minimum Percentage
equals the lowest number of shares of Genentech Common Stock owned by RHI since
the July 1999 offering (to be adjusted in the future for dispositions of shares
of Genentech Common Stock by RHI as well as for stock splits or stock
combinations) divided by 1,018,388,704 (to be adjusted in the future for stock
splits or stock combinations), which is the number of shares of Genentech Common
Stock outstanding at the time of the July 1999 offering, as adjusted for stock
splits. We have repurchased shares of our Common Stock since 2001 (see
discussion above in “Liquidity and Capital Resources”). The affiliation
agreement also provides that, upon RHI’s request, we will repurchase shares of
our Common Stock to increase RHI’s ownership to the Minimum Percentage. In
addition, RHI will have a continuing option to buy stock from us at prevailing
market prices to maintain its percentage ownership interest. Under the terms
of
the affiliation agreement, RHI’s Minimum Percentage is 57.7% and RHI’s ownership
percentage is to be no lower than 55.7%. At June 30, 2007, RHI’s ownership
percentage was 55.8%.
Related
Party Transactions
We
enter into transactions with our related parties, Roche Holding AG and
affiliates (Roche) and Novartis AG and other Novartis affiliates (Novartis).
The
accounting policies that we apply to our transactions with our related parties
are consistent with those applied in transactions with independent third
parties, and all related party agreements are negotiated on an arm’s-length
basis.
In
our royalty and supply arrangements with related parties, we are the principal,
as defined under Emerging Issues Task Force (EITF) Issue No. 99-19,
“Reporting Revenue Gross as a Principal versus
Net as an Agent” (EITF 99-19), because we bear the manufacturing
risk, general inventory risk, and the risk to defend our intellectual property.
For circumstances in which we are the principal in the transaction, we record
the transaction on a gross basis in accordance with EITF 99-19. Otherwise our
transactions are recorded on a net basis.
Roche
Under
our existing arrangements with Roche, including our licensing and marketing
agreement, we recognized the following amounts (in
millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales to Roche
|
|
$ |
253
|
|
|
$ |
73
|
|
|
$ |
516
|
|
|
$ |
131
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Roche
|
|
$ |
283
|
|
|
$ |
207
|
|
|
$ |
538
|
|
|
$ |
373
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Roche
|
|
$ |
30
|
|
|
$ |
21
|
|
|
$ |
60
|
|
|
$ |
40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Roche
|
|
$ |
137
|
|
|
$ |
64
|
|
|
$ |
258
|
|
|
$ |
113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects with Roche
|
|
$ |
70
|
|
|
$ |
53
|
|
|
$ |
128
|
|
|
$ |
95
|
|
R&D
expenses are partially reimbursable to us by Roche. In addition, these amounts
include R&D expenses resulting from the net settlement of amounts that we
owed to Roche for R&D expenses that Roche incurred on joint development
projects, less amounts reimbursable to us by Roche on these respective
projects.
Novartis
Based
on information available to us at the time of filing this Form 10-Q, we believe
that Novartis holds approximately 33.3 percent of the outstanding voting shares
of Roche Holding AG. As a result of this ownership, Novartis is deemed to have
an indirect beneficial ownership interest under FAS 57, “Related
Party Disclosures,” of more than 10 percent of our voting
stock.
We
have an agreement with Novartis Pharma AG (a wholly owned subsidiary of Novartis
AG) under which Novartis Pharma AG has the exclusive right to develop and market
Lucentis outside the U.S. for indications related to diseases or disorders
of
the eye. As part of this agreement, the parties will share the cost of certain
of our ongoing development expenses for Lucentis. Novartis Pharma AG makes
royalty payments to us on sales of Lucentis outside the U.S.
We,
along with Novartis Pharma AG, are co-developing Xolair in the U.S., and we
and
Novartis are co-promoting Xolair in the U.S. We record all sales and cost of
sales in the U.S., and Novartis markets the product in and records all sales
and
cost of sales in Europe. We and Novartis share the resulting U.S. and European
operating profits according to prescribed profit sharing percentages, and our
U.S. and European profit sharing expenses are recorded as collaboration profit
sharing expense.
Under
our existing arrangements with Novartis, we recognized the following amounts
(in millions):
|
|
Three
Months
Ended
June 30,
|
|
|
Six
Months
Ended
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales to Novartis
|
|
$ |
3
|
|
|
$ |
2
|
|
|
$ |
6
|
|
|
$ |
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Novartis
|
|
$ |
13
|
|
|
$ |
–
|
|
|
$ |
19
|
|
|
$ |
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Novartis
|
|
$ |
4
|
|
|
$ |
13
|
|
|
$ |
44
|
|
|
$ |
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Novartis
|
|
$ |
3
|
|
|
$ |
1
|
|
|
$ |
7
|
|
|
$ |
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects
with
Novartis
|
|
$ |
9
|
|
|
$ |
12
|
|
|
$ |
19
|
|
|
$ |
22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
profit sharing expense to Novartis
|
|
$ |
49
|
|
|
$ |
48
|
|
|
$ |
96
|
|
|
$ |
91
|
|
Contract
revenue in the first six months of 2007 included a $30 million milestone payment
from Novartis Pharma AG for European Union approval of Lucentis for the
treatment of AMD.
R&D
expenses are partially reimbursable to us by Novartis. In addition, these
amounts include R&D expenses resulting from the net settlement of amounts
that we owed to Novartis for R&D expenses that Novartis incurred on
joint development projects, less amounts reimbursable to us by Novartis on
these respective projects.
Stock
Options
Option
Program Description
Our
employee stock option program is a broad-based, long-term retention program
that
is intended to attract and retain talented employees and to align stockholder
and employee interests. Our program primarily consists of our 2004 Equity
Incentive Plan (the Plan), a broad-based plan under which stock options,
restricted stock, stock appreciation rights, and performance shares and units
may be granted to employees, directors, and other service providers.
Substantially all of our employees participate in our stock option program.
In
the past, we granted options under our amended and restated 1999 Stock Plan,
1996 Stock Option/Stock Incentive Plan, our amended and restated 1994 Stock
Option Plan, and our amended and restated 1990 Stock Option/Stock Incentive
Plan. Although we no longer grant options under these plans, exercisable options
granted under these plans are still outstanding.
All
stock option grants are made with the approval of the Compensation Committee
of
the Board of Directors or an authorized delegate.
General
Option Information
Summary
of Option Activity
(Shares
in millions)
|
|
|
|
|
|
|
|
|
Shares
Available
for
Grant
|
|
|
|
|
|
Weighted-Average
Exercise
Price
|
|
December
31, 2005
|
|
|
83.7
|
|
|
|
82.8
|
|
|
$ |
46.64
|
|
Grants
|
|
|
(17.5 |
) |
|
|
17.5
|
|
|
|
79.85
|
|
Exercises
|
|
|
–
|
|
|
|
(9.5 |
) |
|
|
30.42
|
|
Cancellations
|
|
|
|
|
|
|
(2.5 |
) |
|
|
62.09
|
|
December
31, 2006
|
|
|
68.7
|
|
|
|
88.3
|
|
|
$ |
54.53
|
|
Grants
|
|
|
(0.8 |
) |
|
|
0.8
|
|
|
|
81.99
|
|
Exercises
|
|
|
–
|
|
|
|
(6.5 |
) |
|
|
31.35
|
|
Cancellations
|
|
|
|
|
|
|
(1.6 |
) |
|
|
74.07
|
|
June
30, 2007 (Year to Date)
|
|
|
|
|
|
|
|
|
|
$ |
56.27
|
|
In-the-Money
and Out-of-the-Money Option Information
(Shares
in millions)
|
|
|
|
|
|
|
|
|
|
As
of June 30, 2007
|
|
|
|
|
Weighted-Average
Exercise
Price
|
|
|
|
|
|
Weighted-Average
Exercise
Price
|
|
|
|
|
|
Weighted-Average
Exercise
Price
|
|
In-the-Money
|
|
|
40
|
|
|
$ |
34.13
|
|
|
|
7
|
|
|
$ |
51.56
|
|
|
|
47
|
|
|
$ |
36.66
|
|
Out-of-the-Money(1)
|
|
|
|
|
|
$ |
85.88
|
|
|
|
|
|
|
$ |
81.99
|
|
|
|
|
|
|
$ |
82.89
|
|
Total
Options Outstanding
|
|
|
48
|
|
|
|
|
|
|
|
33
|
|
|
|
|
|
|
|
81
|
|
|
|
|
|
(1)
|
Out-of-the-money
options are those options with an exercise price equal to or greater
than
the fair market value of Genentech Common Stock, $75.66, at the close
of
business on June 29, 2007.
|
Dilutive
Effect of Options
Grants,
net of cancellations, as a percentage of outstanding shares were
(0.08%) for the first six months of 2007,
1.43% for the year ended December 31, 2006, and 1.70% for
the year ended December 31, 2005.
Equity
Compensation Plan Information
Our
stockholders have approved all of our equity compensation plans under which
options are outstanding.
******
This
report contains forward-looking statements regarding our Horizon 2010 strategy
of bringing 20 new molecules into clinical development, bringing at least 15
major new products or indications onto the market, becoming the number one
U.S.
oncology company in sales, and achieving certain financial growth measures;
licensure of a manufacturing facility; the timing of clinical trials for
ABT-869; physicians decisions with respect Avastin dosing;
Avastin, Lucentis and Tarceva sales growth; the effect of a new label and
RiskMAP on the use of Xolair; sales to collaborators; royalty and contract
revenue; other income, net; days of sales outstanding; and purchase price
allocation for the acquisition of Tanox.
These
forward-looking statements involve risks and uncertainties, and the cautionary
statements set forth below and those contained in “Risk Factors” in this Form
10-Q identify important factors that could cause actual results to differ
materially from those predicted in any such forward-looking statements. Such
factors include, but are not limited to, difficulty in enrolling patients in
clinical trials; additional time requirements for data analysis;
efficacy
data
concerning any of our products which shows or is perceived to show similar
or
improved treatment benefit at a lower dose or shorter duration of therapy;
BLA
preparation and decision making; FDA actions or delays; failure to obtain FDA
approval; difficulty in obtaining materials from suppliers; unexpected safety,
efficacy or manufacturing issues for us or our contractors/collaborators; the
ability to supply product and meet demand for our products; product withdrawals;
competition; pricing decisions by us or our competitors; our ability to protect
our proprietary rights; the outcome of, and expenses associated with, litigation
or legal settlements; increased cost of sales; variations in collaborator sales
and expenses; actions by Roche Holdings, Inc. that are adverse to our interests;
decreases in third party reimbursement rates; and new accounting pronouncements
or guidance. We disclaim and do not undertake any obligation to update or revise
any forward-looking statement in this Form 10-Q.
Our
market risks at June 30, 2007 have not changed materially from those discussed
in Item 7A of our Form 10-K for the year ended December 31, 2006 on file with
the U.S. Securities and Exchange Commission.
See
also Note 1, “Summary of Significant Accounting Policies—Derivative Instruments”
in the Notes to Condensed Consolidated Financial Statements in Part I, Item
1 of
this Form 10-Q.
Evaluation
of Disclosure Controls and Procedures: Our principal executive
and financial officers reviewed and evaluated our disclosure controls and
procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the
period covered by this Form 10-Q. Based on that evaluation, our principal
executive and financial officers concluded that our disclosure controls and
procedures are effective in timely providing them with material information
related to Genentech, as required to be disclosed in the reports that we file
under the Exchange Act of 1934.
Changes
in Internal Controls over Financial Reporting: There were no changes in our
internal control over financial reporting that occurred during our last fiscal
quarter that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
PART
II—OTHER INFORMATION
See
Note 4, “Contingencies,” in the Notes to Condensed Consolidated Financial
Statements of Part I, Item 1 of this Form 10-Q for a description of legal
proceedings as well as certain other matters.
See
also Item 3 of our Annual Report on Form 10-K for the year ended December 31,
2006 and Part II, Item 1 of our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2007.
This
Form 10-Q contains forward-looking information based on our current
expectations. Because our actual results may differ materially from any
forward-looking statements that we make or that are made on our behalf, this
section includes a discussion of important factors that could affect our actual
future results, including, but not limited to, our product sales, royalties,
contract revenue, expenses, net income, and earnings per share.
The
successful development of biotherapeutics is highly uncertain and requires
significant expenditures and time.
Successful
development of biotherapeutics is highly uncertain. Products that appear
promising in research or development may be delayed or fail to reach later
stages of development or the market for several reasons, including:
-
Failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals. Among other things, such delays may be caused by slow enrollment
in
clinical studies; extended length of time to achieve study endpoints;
additional time requirements for data analysis or Biologic License Application
(BLA) preparation; discussions with the United States (U.S.) Food and Drug
Administration (FDA); FDA requests for additional preclinical or clinical
data; analyses or changes to study design; or unexpected safety, efficacy,
or
manufacturing issues.
Success
in preclinical and early clinical trials does not ensure that large-scale
clinical trials will be successful. Clinical results are frequently susceptible
to varying interpretations that may delay, limit, or prevent regulatory
approvals. The length of time necessary to complete clinical trials and to
submit an application for marketing approval for a final decision by a
regulatory authority varies significantly and may be difficult to predict.
If
our large-scale clinical trials are not successful, we will not recover our
substantial investments in the product.
Factors
affecting our research and development (R&D) productivity and the amount of
our R&D expenses include, but are not limited to:
-
The
number of products entering into development from late-stage research.
For
example, there is no guarantee that internal research efforts will succeed
in
generating a sufficient number of product candidates that are ready to
move
into development or that will be available for in-licensing on terms
acceptable to us and permitted under the anti-trust laws.
-
Our
ability to in-license projects of interest to us and the timing and amount
of
related development funding or milestone payments for such licenses. For
example, we may enter into agreements requiring us to pay a significant
up-front fee for the purchase of in-process R&D, which we may record as an
R&D expense.
-
Charges
incurred in connection with expanding our product manufacturing capabilities,
as described in “Difficulties or delays in product manufacturing or in
obtaining materials from our suppliers, or difficulties in accurately
forecasting manufacturing capacity needs, could harm our business and/or
negatively affect our financial performance.”
We
may be unable to obtain or maintain regulatory approvals for our
products.
We
are subject to stringent regulation with respect to product safety and efficacy
by various international, federal, state, and local authorities. Of particular
significance are the FDA’s requirements covering R&D, testing,
manufacturing, quality control, labeling, and promotion of drugs for human
use.
A biotherapeutic cannot be marketed in the U.S. until it has been approved
by
the FDA, and then can be marketed for only the indications approved by the
FDA.
As a result of these requirements, the length of time, the level of
expenditures, and the laboratory and clinical information required for approval
of a BLA or New Drug Application are substantial and can require a number of
years. In addition, even if our products receive regulatory approval, they
remain subject to ongoing FDA regulation, including, for example, changes to
the
product label, new or revised regulatory requirements for manufacturing
practices, written advisements to physicians, and/or a product recall or
withdrawal.
We
may not obtain necessary regulatory approvals on a timely basis, if at all,
for
any of the products we are developing or manufacturing, or we may not maintain
necessary regulatory approvals for our existing products, and all of the
following could have a material adverse effect on our business:
-
Loss
of, or changes to, previously obtained approvals, including those resulting
from post-approval safety or efficacy issues.
In
addition, the current regulatory framework could change or additional
regulations could arise at any stage during our product development or
marketing, which may affect our ability to obtain or maintain approval of our
products or require us to make significant expenditures to obtain or maintain
such approvals.
We
face competition.
We
face competition from pharmaceutical companies and biotechnology
companies.
The
introduction of new competitive products or follow-on biologics, and/or new
information about existing products or pricing decisions by us or our
competitors, may result in lost market share for us, reduced utilization of
our
products, lower prices, and/or reduced product sales, even for products
protected by patents.
Avastin: Avastin
competes in metastatic colorectal cancer (CRC) with Erbitux®
(Imclone/Bristol-Myers Squibb), which is an EGFR-inhibitor approved for the
treatment of irinotecan refractory or intolerant metastatic CRC patients; and
with Vectibix™ (Amgen), which is indicated for the treatment of patients with
EGFR-expressing metastatic CRC who have disease progression on or following
fluoropyrimidine-, oxaliplatin-, and irinotecan- containing regimens. In
addition, Avastin competes with Nexavar® (sorafenib, Bayer Corporation/Onyx
Pharmaceuticals, Inc.), Sutent® (sunitinib malate, Pfizer, Inc.), and Torisel®
(Wyeth) for the treatment of patients with advanced renal cell carcinoma (an
unapproved use of Avastin).
Avastin
could face competition from products in development that currently do not have
regulatory approval. Amgen initiated head-to-head clinical trials comparing
AMG
706 and Avastin in non small cell lung cancer (NSCLC) and metastatic breast
cancer (mBC). There
are also ongoing head-to-head clinical trials comparing both Sutent®
and
AZD2171 (AstraZeneca) to Avastin. Additionally, there are more than 65
molecules that target VEGF inhibition, and over 130 companies are developing
molecules that, if successful in clinical trials, may compete with
Avastin.
Rituxan: Rituxan’s
current competitors in hematology-oncology include Bexxar® (GlaxoSmithKline
[GSK]) and Zevalin® (Biogen Idec Inc.), both of which are radioimmunotherapies
indicated for the treatment of patients with relapsed or refractory low-grade,
follicular or transformed B-cell non-Hodgkin’s lymphoma (NHL). Other potential
competitors include Campath® (Bayer Corporation/Genzyme) in relapsed chronic
lymphocytic leukemia (CLL) (an unapproved use of Rituxan), Velcade®
(Millennium Pharmaceuticals, Inc.), which is indicated for multiple myeloma
and
more recently, mantle cell lymphoma (both unapproved uses of Rituxan) and
Revlimid® (Celgene), which is indicated for multiple myeloma and myelodysplastic
syndromes (both unapproved uses of Rituxan).
Rituxan’s
current competitors in rheumatoid arthritis (RA) include Enbrel® (Amgen/Wyeth),
Humira® (Abbott Laboratories), Remicade® (Johnson & Johnson), Orencia®
(Bristol-Myers Squibb), and Kineret® (Amgen). These products are approved for
use in a broader RA patient population than the approved population for Rituxan.
In addition, molecules in development that, if successful in clinical trials,
may compete with Rituxan in RA include: Actemra™, an anti-interleukin-6
receptor being developed by Chugai and Roche; Cimzia™ (certolizumab pegol), an
anti-TNF antibody being developed by UCB; and CNTO 148 (golimumab), an anti-TNF
antibody being developed by Centocor, Inc.
Rituxan
may face future competition in both hematology-oncology and RA from Humax CD20™
(Ofatumumab), an anti-CD20 antibody being co-developed by Genmab and
GSK. Genmab and GSK announced their plans to file for approval and launch
of Humax™ in the fourth quarter of 2008 for monotherapy use in refractory
CLL and monotherapy use in Rituxan refractory NHL. In addition, we are aware
of
other anti-CD20 molecules in development that, if successful in clinical trials,
may compete with Rituxan.
Herceptin: Herceptin
faces competition in the relapsed metastatic setting from Tykerb® (lapatinib
ditosylate), manufactured by GSK. On March 13, 2007, the FDA approved Tykerb®,
in combination with capecitabine, for the treatment of patients with advanced
or
metastatic breast cancer whose tumors overexpress HER2 and who have received
prior therapy, including an anthracycline, a taxane, or Herceptin. We believe
that lapatinib use is primarily within its labeled indication in the later
lines
of mBC; as a result, the impact on Herceptin in the second quarter of 2007
was limited.
Lucentis: We
are aware that retinal specialists are currently using Avastin to treat the
wet
form of age-related macular degeneration (AMD), an unapproved use for Avastin,
which results in significantly less revenue to us per treatment compared to
Lucentis. We expect Avastin use to continue in this setting. Additionally,
the
National Eye Institute announced plans to fund a head-to-head trial of Avastin
and Lucentis in this setting. Lucentis also competes with Macugen® (Pfizer/OSI
Pharmaceuticals), and with Visudyne® (Novartis) alone, in combination with
Lucentis, in combination with Avastin, or in combination with the off-label
steroid triamcinolone in wet AMD. In addition, if successful in clinical trials,
VEGF-Trap-Eye, a vascular endothelial growth factor blocker being developed
by
Bayer Corporation and Regeneron, may compete with Lucentis.
Xolair: Xolair
faces competition from other asthma therapies, including inhaled
corticosteroids, long-acting beta agonists, combination products such as
fixed-dose inhaled corticosteroids/long-acting beta agonists and leukotriene
inhibitors, as well as oral corticosteroids and immunotherapy.
Tarceva: Tarceva
competes with the chemotherapy agents Taxotere® (Sanofi-Aventis) and Alimta®
(Eli Lilly and Company), both of which are indicated for the treatment of
relapsed non-small cell lung cancer (NSCLC). Recent increases in the off-label
use of Avastin in combination with chemotherapy in second-line NSCLC have also
had an impact in this setting. In front-line pancreatic cancer, Tarceva
primarily competes with Gemzar® (Eli Lilly) monotherapy and Gemzar® in
combination with other chemotherapeutic agents. Tarceva could also face
competition in the future from products in late-phase development, such as
Erbitux® (Bristol-Myers Squibb) and Xeloda® (Roche), which currently do not have
regulatory approval for use in NSCLC or pancreatic cancer.
Nutropin: Nutropin
faces competition in the growth hormone market, from other companies currently
selling growth hormone products. Nutropin’s current competitors are Genotropin®
(Pfizer), Norditropin® (Novo Nordisk), Humatrope® (Eli Lilly and Company),
Tev-Tropin® (Teva Pharmaceutical Industries Ltd.), and Saizen® (Serono, Inc.).
In addition, follow-on biologics that are not therapeutically equivalent (not
substitutable) for current growth hormone products are beginning to enter the
market. Omnitrope® (Sandoz), a biologic similar to Genotropin®, launched in
January 2007. In March 2007, Cangene received an approvable letter from the
FDA
for its growth hormone Accretropin™ as a biologic similar to Humatrope®.
Valtropin® (LG Life Sciences along with its partner Biopartners) also received
FDA approval in April 2007 as a biologic similar to Humatrope® for three
indications: short stature associated with growth hormone deficiency and Turner
Syndrome in pediatrics, and growth hormone deficiency in adults. Furthermore,
as
a result of multiple competitors, we have experienced, and may continue to
experience, a loss of patient share and increased competition for managed care
product placement. Obtaining placement on the preferred product lists of managed
care companies may require that we further discount the price of
Nutropin.
Thrombolytics: Our
thrombolytic products face competition in the acute myocardial infarction
market, with sales of TNKase and Activase affected by the adoption by physicians
of mechanical reperfusion strategies. We expect that the use of mechanical
reperfusion, in lieu of thrombolytic therapy for the treatment of acute
myocardial infarction, will continue to grow. TNKase, for acute myocardial
infarction, also faces competition from Retavase® (PDL BioPharma Inc.), which
engages in competitive price discounting.
Pulmozyme: Pulmozyme
currently faces competition from the use of hypertonic saline, an inexpensive
approach to clearing the lungs of cystic fibrosis patients.
Raptiva: Raptiva
competes with established therapies for moderate-to-severe psoriasis, including
oral systemics such as methotrexate and cyclosporin as well as ultraviolet
light
therapies. In addition, Raptiva competes with biologic agents Amevive®
(Astellas), Enbrel® (Amgen), and Remicade® (Centocor). Raptiva also competes
with the
biologic
agent Humira® (Abbott), which is currently used off-label in the psoriasis
market. Abbott is expecting FDA approval of Humira® for the treatment of
psoriasis in the first quarter of 2008.
In
addition to the commercial and late-stage development products listed above,
there are numerous products in earlier stages of development at other
biotechnology and pharmaceutical companies that, if successful in clinical
trials, may compete with our products.
Decreases
in third-party reimbursement rates may affect our product sales, results of
operations, and financial condition.
Sales
of our products will depend significantly on the extent to which reimbursement
for the cost of our products and related treatments will be available to
physicians from government health administration authorities, private health
insurers, and other organizations. Third-party payers and government health
administration authorities increasingly attempt to limit and/or regulate the
reimbursement of medical products and services, including branded prescription
drugs. Changes in government legislation or regulation, such as the Medicare
Act, or changes in private third-party payers’ policies toward reimbursement for
our products may reduce reimbursement of our products’ costs to physicians.
Decreases in third-party reimbursement for our products could reduce physician
usage of the products and may have a material adverse effect on our product
sales, results of operations, and financial condition.
Difficulties
or delays in product manufacturing or in obtaining materials from our suppliers,
or difficulties in accurately forecasting manufacturing capacity needs, could
harm our business and/or negatively affect our financial
performance.
Manufacturing
biotherapeutics is difficult and complex, and requires facilities specifically
designed and validated for this purpose. It can take longer than five years
to
design, construct, validate, and license a new biotechnology manufacturing
facility. We currently produce our products at our manufacturing facilities
located in South San Francisco, Vacaville, and Oceanside, California and through
various contract-manufacturing arrangements. Maintaining an adequate supply
to
meet demand for our products depends on our ability to execute on our production
plan. Any significant problem in the operations of our or our contractors’
manufacturing facilities could result in cancellation of shipments; loss of
product in the process of being manufactured; a shortfall, stock-out, or recall
of available product inventory; or unplanned increases in production costs,
any
of which could have a material adverse effect on our business. A number of
factors could cause significant production problems or interruptions,
including:
-
Damage
to a facility, including our warehouses and distribution facilities, due
to
natural disasters, including, but not limited to, earthquakes, as our South
San Francisco, Vacaville, and Oceanside facilities are located in areas
where
earthquakes have occurred;
-
Implementation
and integration of our new enterprise resource planning system, including
the
portions related to manufacturing and
distribution.
In
addition, there are inherent uncertainties associated with forecasting future
demand, especially for newly introduced products of ours or of those for whom
we
produce products, and as a consequence we may have inadequate capacity to meet
our own actual demands and/or the actual demands of those for whom we produce
products. Alternatively, we may have an excess of available capacity, which
could lead to an idling of a portion of our manufacturing facilities and
incurring unabsorbed or idle plant charges, or other excess capacity charges,
resulting in an increase in our cost of sales.
Furthermore,
certain of our raw materials and supplies required for the production of our
principal products, or products that we make for others, are available only
through sole-source suppliers (the only recognized supplier available to us)
or
single-source suppliers (the only approved supplier for us among other sources),
and we may not be able to obtain such raw materials without significant delay
or
at all. If such sole-source or single-source suppliers were to limit or
terminate production or otherwise fail to supply these materials for any reason,
such failures could also have a material adverse effect on our product sales
and
our business.
Because
our manufacturing processes and those of our contractors are highly complex
and
are subject to a lengthy FDA approval process, alternative qualified production
capacity may not be available on a timely basis or at all. Difficulties or
delays in our or our contractors’ manufacturing and supply of existing or new
products could increase our costs, cause us to lose revenue or market share,
damage our reputation, and result in a material adverse effect on our product
sales, financial condition, and results of operations.
Protecting
our proprietary rights is difficult and costly.
The
patent positions of pharmaceutical and biotechnology companies can be highly
uncertain and involve complex legal and factual questions. Accordingly, we
cannot predict with certainty the breadth of claims allowed in companies’
patents. Patent disputes are frequent and may ultimately preclude the
commercialization of products. We have in the past been, are currently, and
may
in the future be involved in material litigation and other legal proceedings
related to our proprietary rights, such as the Cabilly reexamination (discussed
in Note 4, “Contingencies,” in the Notes to Condensed Consolidated Financial
Statements of Part I, Item 1 of this Form 10-Q)and disputes in connection with
licenses granted to or obtained from third parties. Such litigation and other
legal proceedings are costly in their own right and could subject us to
significant liabilities with third parties, including the payment of
significant royalty expenses, the loss of significant royalty income, or other
expenses or losses. Furthermore, an adverse decision or ruling could
force us to either obtain third-party licenses at a material cost or cease
using
the technology or commercializing the product in dispute. An adverse decision
or
ruling with respect to one or more of our patents or other intellectual property
rights could cause us to incur a material loss of royalties and other revenue
from licensing arrangements that we have with third parties, and could
significantly interfere with our ability to negotiate future licensing
arrangements.
The
presence of patents or other proprietary rights belonging to other parties
may
lead to our termination of the R&D of a particular product, or to a loss of
our entire investment in the product and subject us to infringement
claims.
If
there is an adverse outcome in our pending litigation or other legal actions,
our business may be harmed.
Litigation
and other legal actions to which we are currently or have been subjected relate
to, among other things, our patent and other intellectual property rights,
licensing arrangements and other contracts with third parties, and product
liability. We cannot predict with certainty the eventual outcome of pending
proceedings, which may include an injunction against the development,
manufacture, or sale of a product or potential product, or a judgment with
significant monetary award including the possibility of punitive damages, or
a
judgment that certain of our patent or other intellectual property rights are
invalid or unenforceable. Furthermore, we may have to incur substantial expense
in these proceedings, and such matters could divert management’s attention from
ongoing business concerns.
Our
activities related to the sale and marketing of our products are subject to
regulation under the U.S. Federal Food, Drug, and Cosmetic Act and other federal
statutes. Violations of these laws may be punishable by criminal and/or civil
sanctions, including fines and civil monetary penalties, as well as the
possibility of exclusion from federal healthcare programs (including Medicare
and Medicaid). In 1999, we agreed to pay $50 million to settle a federal
investigation related to our past clinical, sales, and marketing activities
associated with human growth hormone. We are currently being investigated by
the
Department of Justice with respect to our promotional practices, and may in
the
future be investigated for our promotional practices related to any of our
products. If the government were to bring charges against us or convict us
of
violating these laws, or if we were subject to third-party litigation related
to
the same promotional practices, there could be a material adverse effect on
our
business, including our financial condition and results of
operations.
We
are subject to various U.S. federal and state laws pertaining to healthcare
fraud and abuse, including anti-kickback and false claims laws. Anti-kickback
laws make it illegal for a prescription drug manufacturer to solicit, offer,
receive, or pay any remuneration in exchange for, or to induce, the referral
of
business, including the purchase or prescription of a particular drug. Due
to
the breadth of the statutory provisions and the absence of guidance in the
form
of regulations or court decisions addressing some of our practices, it is
possible that our practices might be challenged under anti-kickback or similar
laws. False claims laws prohibit anyone from knowingly and willingly presenting,
or causing to be presented for payment to third-party payers (including Medicare
and Medicaid), claims for reimbursed drugs or services that are false or
fraudulent, claims for items or services not provided as claimed, or claims
for
medically unnecessary items or services. Violations of fraud and abuse laws
may
be punishable by criminal and/or civil sanctions, including fines and civil
monetary penalties, as well as the possibility of exclusion from federal
healthcare programs (including Medicare and Medicaid). If a court were to find
us liable for violating these laws, or if the government were to allege against
us or convict us of violating these laws, there could be a material adverse
effect on our business, including our stock price.
Other
factors could affect our product sales.
Other
factors that could affect our product sales include, but are not limited
to:
-
Our
pricing decisions, including a decision to increase or decrease the price
of a
product, the pricing decisions of our competitors, as well as our Avastin
Patient Assistance Program, which is a voluntary program that enables eligible
patients who have received 10,000 milligrams of Avastin in a 12-month period
to receive free Avastin in excess of the 10,000 milligrams during the
remainder of the 12-month period.
-
Efficacy
data from clinical studies conducted by any party in the U.S. or
internationally, showing or perceived to show a similar or an improved
treatment benefit at a lower dose or shorter duration of therapy, could
cause
the sales of our products to decrease.
-
Our
distribution strategy, including the termination of, or change in, an existing
arrangement with any major wholesalers who supply our
products.
Any
of these factors could have a material adverse effect on our sales and results
of operations.
Our
results of operations are affected by our royalty and contract revenue, and
sales to collaborators.
Royalty
and contract revenue, and sales to collaborators in future periods, could vary
significantly. Major factors affecting these revenues include, but are not
limited to:
-
The
expiration or termination of existing arrangements with other companies
and
Roche, which may include development and marketing arrangements for our
products in the U.S., Europe, and other countries.
-
The
expiration or invalidation of our patents or licensed intellectual property.
For example, patent litigations, interferences, oppositions, and other
proceedings involving our patents often include claims by third parties
that
such patents are invalid, unenforceable, or unpatentable. If a court, patent
office, or other authority were to determine that a patent (including,
for
example, the Cabilly patent) under which we receive royalties and/or other
revenue is invalid, unenforceable, or unpatentable, that determination
could
cause us to suffer a loss of such royalties and/or revenue, and could cause
us
to incur other monetary damages.
We
may be unable to manufacture certain of our products if there is BSE
contamination of our bovine source raw material.
Most
biotechnology companies, including Genentech, have historically used bovine
source raw materials to support cell growth in our production processes. Bovine
source raw materials from within or outside the U.S. are subject to public
and
regulatory scrutiny because of the perceived risk of contamination with the
infectious agent that causes bovine spongiform encephalopathy (BSE). Should
such
BSE contamination occur, it would likely negatively affect our ability to
manufacture certain products for an indefinite period of time (or at least
until
an alternative process is approved), negatively affect our reputation, and
could
result in a material adverse effect on our product sales, financial condition,
and results of operations.
We
may be unable to retain skilled personnel and maintain key
relationships.
The
success of our business depends, in large part, on our continued ability to
(i)
attract and retain highly qualified management, scientific, manufacturing,
and
sales and marketing personnel, (ii) successfully integrate large numbers of
new
employees into our corporate culture, and (iii) develop and maintain important
relationships with leading research and medical institutions and key
distributors. Competition for these types of personnel and relationships is
intense. We cannot be sure that we will be able to attract or retain skilled
personnel or maintain key relationships, or that the costs of retaining such
personnel or maintaining such relationships will not materially
increase.
Our
affiliation agreement with Roche Holdings, Inc. could adversely affect our
cash
position.
Our
affiliation agreement with Roche Holdings, Inc. (RHI) provides that we establish
a stock repurchase program designed to maintain RHI’s percentage ownership
interest in our Common Stock based on an established Minimum Percentage. For
more information on our stock repurchase program, see “Liquidity and Capital
Resources—Cash Used in Financing Activities” above. For information on the
Minimum Percentage, see Note 5, “Relationship with Roche Holdings, Inc. and
Related Party Transactions,” in the Notes to Condensed Consolidated Financial
Statements in Part I, Item 1 of this Form 10-Q.
RHI’s
ownership percentage is diluted by the exercise of stock options to purchase
shares of our Common Stock by our employees and the purchase of shares of our
Common Stock through our employee stock purchase plan. See Note 2, “Employee
Stock-Based Compensation,” in the Notes to Condensed Consolidated Financial
Statements in Part I, Item 1 of this Form 10-Q for information regarding
employee stock plans. In order to maintain RHI’s Minimum Percentage, we
repurchase shares of our Common Stock under the stock repurchase program. While
the dollar amounts associated with future stock repurchase programs cannot
currently be determined, future stock repurchases could have a material adverse
effect on our liquidity, credit rating, and ability to access additional capital
in the financial markets.
Our
affiliation agreement with Roche Holdings, Inc. could limit our ability to
make
acquisitions.
Our
affiliation agreement with RHI contains provisions that:
-
Require
the approval of the directors designated by RHI to make any acquisition
or any
sale or disposal of all or a portion of our business representing 10 percent
or more of our assets, net income, or revenue.
-
Require
us to establish a stock repurchase program designed to maintain RHI’s
percentage ownership interest in our Common Stock based on an established
Minimum Percentage. For information regarding the Minimum Percentage, see
Note
5, “Relationship with Roche Holdings, Inc. and Related Party Transactions,” in
the Notes to Condensed Consolidated Financial Statements in Part I, Item
1 of
this Form 10-Q.
These
provisions may have the effect of limiting our ability to make
acquisitions.
Future
sales of our Common Stock by Roche Holdings, Inc. could cause the price of
our
Common Stock to decline.
As
of June 30, 2007, RHI owned 587,189,380 shares of our Common Stock, or 55.8
percent of our outstanding shares. All of our shares owned by RHI are eligible
for sale in the public market subject to compliance with the applicable
securities laws. We have agreed that, upon RHI’s request, we will file one or
more registration statements under the Securities Act of 1933 in order to permit
RHI to offer and sell shares of our Common Stock. Sales of a substantial number
of shares of our Common Stock by RHI in the public market could adversely affect
the market price of our Common Stock.
Roche
Holdings, Inc., our controlling stockholder, may seek to influence our business
in a manner that is adverse to us or adverse to other stockholders who may
be
unable to prevent actions by Roche Holdings, Inc.
As
our majority stockholder, RHI controls the outcome of most actions requiring
the
approval of our stockholders. Our bylaws provide, among other things, that
the
composition of our Board of Directors shall consist of at least three directors
designated by RHI, three independent directors nominated by the Nominations
Committee, and one Genentech executive officer nominated by the Nominations
Committee. Our bylaws also provide that RHI will have the right to obtain
proportional representation on our Board until such time that RHI owns less
than
five percent of our stock. Currently, three of our directors—Mr. William Burns,
Dr. Erich Hunziker, and Dr. Jonathan K. C. Knowles—also serve as officers and
employees of Roche Holding Ltd and its affiliates. As long as RHI owns in excess
of 50 percent of our Common Stock, RHI directors will be two of the three
members of the Nominations Committee. Our certificate of incorporation includes
provisions related to competition by RHI affiliates with Genentech, offering
of
corporate opportunities, transactions with interested parties, intercompany
agreements, and provisions limiting the liability of specified employees. We
cannot assure that RHI will not seek to influence our business in a manner
that
is contrary to our goals or strategies or the interests of other stockholders.
Moreover, persons who are directors and/or officers of Genentech and who are
also directors and/or officers of RHI may decline to take action in a manner
that might be favorable to us but adverse to RHI.
Additionally,
our certificate of incorporation provides that any person purchasing or
acquiring an interest in shares of our capital stock shall be deemed to have
consented to the provisions in the certificate of incorporation related to
competition with RHI, conflicts of interest with RHI, the offer of corporate
opportunities to RHI, and intercompany agreements with RHI. This deemed consent
might restrict our ability to challenge transactions carried out in compliance
with these provisions.
We
may incur material product liability costs.
The
testing and marketing of medical products entail an inherent risk of product
liability. Liability exposures for biotherapeutics could be extremely large
and
pose a material risk. Our business may be materially and adversely affected
by a
successful product liability claim or claims in excess of any insurance coverage
that we may have.
Insurance
coverage is increasingly more difficult and costly to obtain or
maintain.
While
we currently have a certain amount of insurance to minimize our direct exposure
to certain business risks, premiums are generally increasing and coverage is
narrowing in scope. As a result, we may be required to assume more risk in
the
future or make significant expenditures to maintain our current levels of
insurance. If we are subject to third-party claims or suffer a loss or damages
in excess of our insurance coverage, we will incur the cost of the portion
of
the retained risk. Furthermore, any claims made on our insurance policies may
affect our ability to obtain or maintain insurance coverage at reasonable
costs.
We
are subject to environmental and other risks.
We
use certain hazardous materials in connection with our research and
manufacturing activities. In the event that such hazardous materials are stored,
handled, or released into the environment in violation of law or any permit,
we
could be subject to loss of our permits, government fines, or penalties and/or
other adverse governmental or private
actions.
The levy of a substantial fine or penalty, the payment of significant
environmental remediation costs, or the loss of a permit or other authorization
to operate or engage in our ordinary course of business could materially
adversely affect our business.
We
also have acquired, and may continue to acquire in the future, land and
buildings as we expand our operations. Some of these properties are
“brownfields” for which redevelopment or use is complicated by the presence or
potential presence of a hazardous substance, pollutant, or contaminant. Certain
events that could occur may require us to pay significant clean-up or other
costs in order to maintain our operations on those properties. Such events
include, but are not limited to, changes in environmental laws, discovery of
new
contamination, or unintended exacerbation of existing contamination. The
occurrence of any such event could materially affect our ability to continue
our
business operations on those properties.
Fluctuations
in our operating results could affect the price of our Common
Stock.
Our
operating results may vary from period to period for several reasons,
including:
-
The
amount and timing of sales to customers in the U.S. For example, sales
of a
product may increase or decrease due to pricing changes, fluctuations in
distributor buying patterns, or sales initiatives that we may undertake
from
time to time.
Our
integration of new information systems could disrupt our internal operations,
which could decrease our revenue and increase our
expenses.
Portions
of our information technology infrastructure may experience interruptions,
delays, or cessations of service or produce errors. As part of our enterprise
resource planning efforts, we are implementing new information systems, but
we
may not be successful in implementing all of the new systems, and transitioning
data and other aspects of the process could be expensive, time consuming,
disruptive, and resource intensive. Any disruptions that may occur in the
implementation of new systems or any future systems could adversely affect
our
ability to report in an accurate
and
timely manner the results of our consolidated operations, financial position,
and cash flows. Disruptions to these systems also could adversely affect our
ability to fulfill orders and interrupt other operational processes. Delayed
sales, lower margins, or lost customers resulting from these disruptions could
adversely affect our financial results.
Our
stock price, like that of many biotechnology companies, is
volatile.
The
market prices for securities of biotechnology companies in general have been
highly volatile and may continue to be highly volatile in the future. In
addition, the market price of our Common Stock has been and may continue to
be
volatile.
The
following factors may have a significant effect on the market price of our
Common Stock:
Our
effective income tax rate may vary significantly.
Various
internal and external factors may have favorable or unfavorable effects on
our
future effective income tax rate. These factors include but are not limited
to
changes in tax laws, regulations, and/or rates; changing interpretations of
existing tax laws or regulations; changes in estimates of prior years’ items;
past and future levels of R&D spending; acquisitions; and changes in overall
levels of income before taxes.
To
pay our indebtedness will require a significant amount of cash and may adversely
affect our operations and financial results.
As
of June 30, 2007, we had approximately $2.0 billion of long-term debt. Our
ability to make payments on and to refinance our indebtedness, including our
long-term debt obligations, and to fund planned capital expenditures, R&D,
as well as stock repurchases and expansion efforts will depend on our ability
to
generate cash in the future. This risk, to a certain extent, is subject to
general economic, financial, competitive, legislative, regulatory, and other
factors that are and will remain beyond our control. Additionally, our
indebtedness may increase our vulnerability to general adverse economic and
industry conditions, and require us to dedicate a substantial portion of our
cash flow from operations to payments on our indebtedness, which would reduce
the availability of our cash flow to fund working capital, capital expenditures,
R&D, expansion efforts, and other general corporate purposes, and limit our
flexibility in planning for, or reacting to, changes in our business and the
industry in which we operate.
Accounting
pronouncements may affect our future financial position and results of
operations.
Under
Financial Accounting Standards Board Interpretation No. 46R (FIN 46R), a
revision to FIN 46, “Consolidation of Variable Interest
Entities,” we are required to assess new business
development collaborations as
well
as reassess, upon certain events, some of which are outside our control, the
accounting treatment of our existing business development collaborations based
on the nature and extent of our variable interests in the entities, as well
as
the extent of our ability to exercise influence over the entities, with which
we
have such collaborations. Our continuing compliance with FIN 46R may result
in
our consolidation of companies or related entities with which we have a
collaborative arrangement, and this may have a material effect on our financial
condition and/or results of operations in future periods.
Under
a stock repurchase program approved by our Board of Directors in December 2003
and most recently extended in April 2007, we are authorized to repurchase up
to
100 million shares of our Common Stock for an aggregate price of up to $8.0
billion through June 30, 2008. In this program, as in previous stock repurchase
programs, purchases may be made in the open market or in privately negotiated
transactions from time to time at management’s discretion. We also may engage in
transactions in other Genentech securities in conjunction with the repurchase
program, including certain derivative securities. As of June 30, 2007, we have
not engaged in any such transactions. We intend to use the repurchased stock
to
offset dilution caused by the issuance of shares in connection with our employee
stock plans. Although there are currently no specific plans for the shares
that
may be purchased under the program, our goals for the program are (i) to address
provisions of our affiliation agreement with Roche Holdings, Inc. (RHI) related
to maintaining RHI’s minimum ownership percentage, (ii) to make prudent
investments of our cash resources, and (iii) to allow for an effective mechanism
to provide stock for our employee stock plans. See Note 5, “Relationship with
Roche Holdings, Inc. and Related Party Transactions,” in the Notes to Condensed
Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for more
information on RHI’s minimum ownership percentage.
We
have entered into Rule 10b5-1 trading plans to repurchase shares in the open
market during those periods each quarter when trading in our stock is restricted
under our insider trading policy. The current trading plan covered approximately
four million shares and expired on June 30, 2007.
Our
shares repurchased during the second quarter of 2007 were as follows (shares
in millions):
|
|
Total
Number of
Shares
Purchased
|
|
|
Average
Price Paid
per
Share
|
|
|
Total
Number of Shares
Purchased
as Part
of
Publicly
Announced
Plans
or Programs
|
|
|
Maximum
Number of
Shares
that May Yet
Be
Purchased
Under
the Plans
or
Programs
|
|
April
1–30, 2007
|
|
|
0.8
|
|
|
$ |
82.14
|
|
|
|
|
|
|
|
May
1–31, 2007
|
|
|
1.4
|
|
|
|
79.65
|
|
|
|
|
|
|
|
June
1–30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
3.5
|
|
|
$ |
78.84
|
|
|
|
70
|
|
|
|
30
|
|
The
par value method of accounting is used for Common Stock repurchases. The excess
of the cost of shares acquired over the par value is allocated to additional
paid-in capital with the amounts in excess of the estimated original sales
price
charged to accumulated deficit.
At
our Annual Meeting of Stockholders held on April 20, 2007, two matters were
voted upon. A description of each matter and a tabulation of the votes for
each
of the matters follows:
1.
|
To
elect seven director nominees to hold office until the 2008 Annual
Meeting
of Stockholders or until their successors are duly elected and
qualified:
|
|
|
|
|
|
|
|
|
|
|
|
Herbert
W. Boyer, Ph.D.
|
|
|
899,987,204
|
|
|
|
116,486,921
|
|
William
M. Burns
|
|
|
869,665,794
|
|
|
|
146,808,331
|
|
Erich
Hunziker, Ph.D.
|
|
|
869,667,962
|
|
|
|
146,806,163
|
|
Jonathan
K. C. Knowles, Ph.D.
|
|
|
869,674,066
|
|
|
|
146,800,059
|
|
Arthur
D. Levinson, Ph.D.
|
|
|
904,232,619
|
|
|
|
112,241,506
|
|
Debra
L. Reed
|
|
|
997,540,812
|
|
|
|
18,933,313
|
|
Charles
A. Sanders, M.D.
|
|
|
998,034,537
|
|
|
|
18,439,588
|
|
2.
|
To
ratify Ernst & Young LLP as our independent registered public
accounting firm for 2007.
|
|
|
|
|
|
|
1,011,122,963
|
|
5,004,278
|
|
346,884
|
Exhibit
No.
|
Description
|
Location
|
15.1
|
Letter
regarding Unaudited Interim Financial Information.
|
Filed
herewith
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as
amended
|
Filed
herewith
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as
amended
|
Filed
herewith
|
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant to
18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
Furnished
herewith
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
GENENTECH,
INC.
|
Date:
|
|
|
|
|
|
|
Arthur
D. Levinson, Ph.D.
Chairman
and Chief Executive Officer
|
|
|
|
|
|
|
|
|
Date:
|
|
|
|
|
|
|
David
A. Ebersman
Executive
Vice President and
Chief
Financial Officer
|
|
|
|
|
|
|
|
|
Date:
|
|
|
|
|
|
|
Robert
E. Andreatta
Controller
and Chief Accounting Officer
|