Genentech Announces Second Quarter 2008 Results
2008-07-14 15:02:00
SOUTH SAN FRANCISCO, Calif.–(EMWNews)–Genentech, Inc. (NYSE: DNA) today announced financial results for the
second quarter of 2008. Key results for the second quarter of 2008
include:
-
U.S. product sales of $2,351 million, a 9 percent increase from U.S.
product sales of $2,149 million in the second quarter of 2007.
-
Non-GAAP operating revenue of $3,232 million1,
an 8 percent increase from operating revenue of $3,004 million in the
second quarter of 2007; GAAP operating revenue of $3,236 million, an 8
percent increase from operating revenue of $3,004 million in the
second quarter of 2007.
-
Non-GAAP net income of $871 million, a 4 percent increase from $834
million in the second quarter of 20071; GAAP
net income of $782 million, a 5 percent increase from $747 million in
the second quarter of 2007.
-
Non-GAAP earnings per share of $0.82, a 5 percent increase from $0.78
in the second quarter of 20071; GAAP earnings
per share of $0.73, a 4 percent increase from $0.70 in the second
quarter of 2007.
Reconciliations between non-GAAP and GAAP earnings per share for second
quarters of 2008 and 2007 are provided in the following table:
|
Non-GAAP Diluted EPS |
Employee Stock-Based Compensation Expense |
Net Charges related to Redemption, Acquisition and Special Items |
Reported GAAP Diluted EPS |
Q2 2008 |
$0.82 |
($0.06) |
($0.02) |
$0.73 |
Q2 2007 |
$0.78 |
($0.06) |
($0.02) |
$0.70 |
Note: Amounts may not sum due to rounding.
The company is currently forecasting that full-year 2008 non-GAAP
earnings are likely to be in the range of $3.40 to $3.50 per share,
revised from $3.35 to $3.45 per share.1
Product Sales and Royalty Revenue
Information on product sales for the three months ended June 30, 2008
and 2007, are provided in the following tables (dollars in millions):
Three Months
Ended June 30, |
|||
2008 |
2007 |
% Change |
|
Rituxan® |
$651 |
$582 |
12% |
Avastin®+ |
650 |
564 |
15 |
Herceptin® |
338 |
329 |
3 |
Lucentis® |
216 |
209 |
3 |
Xolair® |
129 |
120 |
8 |
Tarceva® |
119 |
102 |
17 |
Nutropin® Products |
89 |
94 |
(5) |
Thrombolytics |
68 |
67 |
1 |
Pulmozyme® |
63 |
55 |
15 |
Raptiva® |
28 |
27 |
4 |
Total U.S. product sales ++ |
$2,351 |
$2,149 |
9 |
|
|||
Net product sales to collaborators |
185 |
294 |
(37) |
Total product sales ++ |
$2,536 |
$2,443 |
4 |
+ Second quarter 2008 Avastin U.S. product sales results include a net
deferral of approximately $1 million in conjunction with the company’s
Avastin Patient Assistance Program. The net deferral related to the
program in the second quarter of 2007 was not significant.
++ Amounts may not sum due to rounding.
Non-GAAP royalty revenue for the second quarter of 2008 was $625
million, a 29 percent increase over the second quarter of 2007.1
Excluding the impact of a collaboration agreement in the second quarter
of 2007, which resulted in one-time royalty revenue of approximately $65
million in that quarter, non-GAAP royalty revenue in the second quarter
of 2008 increased 49 percent. GAAP royalty revenue of $629 million in
the second quarter of 2008 increased 30 percent over the second quarter
of 2007. The increase was primarily due to growth in ex-U.S. sales of
Genentech’s products by collaborators and related foreign exchange
benefits of the weak dollar.
Total Costs and Expenses
Information on costs and expenses including cost of sales (COS),
research and development (R&D) and marketing, general and administrative
(MG&A) expenses for the three months ended June 30, 2008 and 2007, are
provided in the following tables (dollars in millions)2:
Three Months
Ended June 30, |
|||
2008 |
2007 |
% Change |
|
non-GAAP2 |
|||
COS |
$423 |
$413 |
2% |
R&D |
611 |
564 |
8 |
MG&A |
518 |
485 |
7 |
GAAP |
|||
COS |
441 |
429 |
3 |
R&D |
649 |
603 |
8 |
MG&A |
559 |
532 |
5 |
Reported non-GAAP and GAAP COS for the second quarter of 2008 both
include a charge of approximately $50 million, related to failed lots
from a manufacturing start-up campaign at one of Genentech’s facilities.
Three Months
Ended June 30, |
||
2008 |
2007 |
|
non-GAAP2 |
||
COS as a % of product sales |
17% |
17% |
R&D as a % of operating revenue |
19% |
19% |
MG&A as a % of operating revenue |
16% |
16% |
GAAP |
||
COS as a % of product sales |
17% |
18% |
R&D as a % of operating revenue |
20% |
20% |
MG&A as a % of operating revenue |
17% |
18% |
Other Financial Items
The non-GAAP and GAAP income tax rates of 40 percent for the second
quarter of 2008 include a $33 million settlement with the Internal
Revenue Service related to prior years that was resolved in the second
quarter of 2008.
Clinical Development
Genentech announced that enrollment was completed in seven Phase II and
Phase III studies during the second quarter of 2008. These studies
included two combination Phase III studies for Avastin®
(bevacizumab) and Tarceva® (erlotinib) in
first-line and second-line metastatic non-squamous non-small cell lung
cancer (NSCLC) and a Phase II study for Trastuzumab-DM1 in HER2-positive
metastatic breast cancer patients who have progressed on HER2-directed
therapy.
Genentech also announced that, with its collaborator Abbott, it
initiated a Phase II trial of ABT-869, a VEGFR targeted kinase
inhibitor, in combination with chemotherapy for patients with advanced
NSCLC. In addition, Genentech initiated a Phase III combination study
(BETH) of Avastin and Herceptin®
(Trastuzumab) for patients with adjuvant HER2-positive breast cancer.
Webcast
Genentech will be offering a live webcast of a discussion by Genentech
management of its financial and other business results on Monday, July
14, 2008, at 1:45 p.m. Pacific Time (PT). The live webcast may be
accessed on Genentech’s website at http://www.gene.com.
This webcast will be available via the website until 5:00 p.m. PT on
August 4, 2008. A telephonic audio replay of the webcast will be
available beginning at 4:45 p.m. PT on July 14, 2008 through 4:45 p.m.
PT on July 21, 2008. Access numbers for this replay are: 1-800-642-1687
(U.S./Canada) and 1-706-645-9291 (international); conference ID number
is 49949746.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with significant unmet medical needs. The
company has headquarters in South San Francisco, California and is
listed on the New York Stock Exchange under the symbol DNA. For
additional information about the company, please visit http://www.gene.com.
About Genentech’s Commitment to Patient Access
Genentech is committed to patients having access to our therapies.
Through its Genentech Access Solutions program, the company provides
patients and healthcare providers with coverage and reimbursement
support, patient assistance and informational resources. Patient
assistance support is for those eligible patients in the United States
who do not have insurance coverage or who cannot afford their
out-of-pocket co-pay costs. Since 1985, when its first product was
approved, Genentech has donated approximately $1 billion in free
medicine to uninsured patients through the Genentech®
Access to Care Foundation (GATCF) and other product donation programs.
Since 2005, Genentech has also donated more than $140 million to various
independent, non-profit organizations that provide financial assistance
to eligible patients who cannot access needed medical treatment due to
co-pay costs.
For information on Genentech’s latest
business and product development events please refer to http://www.gene.com/gene/news/press-releases/index.jsp.
This press release contains a forward-looking statement regarding
expected growth in non-GAAP earnings per share for 2008. Such a
statement is a prediction and involves risks and uncertainties such that
actual results may differ materially. Such risks and uncertainties
include, but are not limited to, the need for additional data, data
analysis or clinical studies; the results of clinical trials; Biologics
License Application preparation and decision making; U.S. Food and Drug
Administration (FDA) actions or delays; failure to obtain or maintain
FDA approval; difficulty in obtaining materials from suppliers;
unexpected safety, efficacy or manufacturing issues for us or our
contract/collaborator manufacturers; product withdrawals; competition;
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; 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; our cost of sales,
other expenses and indebtedness; variations in collaborator sales and
expenses; fluctuations in contract revenue and royalties; actions by
Roche that are adverse to our interests; decreases in third party
reimbursement rates; and changes in accounting or tax laws or the
application or interpretation of such laws. Please also refer to
Genentech’s periodic reports filed with the Securities and Exchange
Commission. Genentech disclaims, and does not undertake, any obligation
to update or revise forward-looking statements in this press release.
1 Genentech’s non-GAAP royalty revenue and
operating revenue for the second quarter of 2008 exclude recognition of
deferred royalty revenue associated with the acquisition of Tanox, Inc.
of $4 million. In the second quarter of 2008, GAAP royalty revenue and
GAAP operating revenue were $629 million and $3,236 million,
respectively. Genentech’s non-GAAP net income and non-GAAP earnings per
share exclude the after-tax impact of certain items associated with the
acquisition of Tanox, Inc. (including recurring recognition of deferred
royalty revenue and recurring amortization of intangible assets);
recurring charges related to the 1999 redemption of Genentech’s stock by
Roche Holdings, Inc.; litigation-related and similar special items; and
employee stock-based compensation expense. The differences in non-GAAP
and GAAP amounts are reconciled in the accompanying tables and on http://www.gene.com.
2 Genentech’s second quarter 2008 non-GAAP
reported COS, R&D and MG&A expenses exclude the effects of employee
stock-based compensation expense of $18 million, $38 million, and $41
million, respectively. Second quarter 2007 non-GAAP reported COS, R&D
and MG&A expenses exclude the effects of employee stock-based
compensation expense of $16 million, $39 million, and $47 million,
respectively. The differences in non-GAAP and GAAP amounts are
reconciled in the accompanying tables and on http://www.gene.com.
GENENTECH, INC. |
||||||||||||||||
CONSOLIDATED STATEMENTS OF INCOME |
||||||||||||||||
(In millions, except per share amounts) |
||||||||||||||||
(Unaudited) |
||||||||||||||||
|
|
|
||||||||||||||
Three Months |
Six Months |
|||||||||||||||
Ended June 30, |
Ended June 30, |
|||||||||||||||
2008 |
2007 |
2008 |
2007 |
|||||||||||||
Revenues: |
||||||||||||||||
Product sales |
$ |
2,536 |
$ |
2,443 |
$ |
4,915 |
$ |
4,773 |
||||||||
Royalties |
629 |
484 |
1,244 |
903 |
||||||||||||
Contract revenue |
|
71 |
|
|
77 |
|
|
140 |
|
|
171 |
|
||||
Total operating revenues |
3,236 |
3,004 |
6,299 |
5,847 |
||||||||||||
|
||||||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of sales (includes employee stock-based compensation expense: three months–2008–$18; 2007–$16; six months–2008–$41; 2007–$33) |
441 |
429 |
831 |
821 |
||||||||||||
Research and development (includes employee stock-based compensation expense: three months–2008–$38; 2007–$39; six months–2008–$80; 2007–$77) |
649 |
603 |
1,266 |
1,213 |
||||||||||||
Marketing, general and administrative (includes employee stock-based compensation expense: three months–2008–$41; 2007–$47; six months–2008–$87; 2007–$93) |
559 |
532 |
1,076 |
1,023 |
||||||||||||
Collaboration profit sharing |
313 |
277 |
592 |
529 |
||||||||||||
Recurring charges related to redemption and acquisition |
43 |
26 |
86 |
52 |
||||||||||||
Special items: litigation-related |
|
2 |
|
|
13 |
|
|
(300 |
) |
|
26 |
|
||||
Total costs and expenses |
2,007 |
1,880 |
Genentech, Inc. Pecquet, 650-467-7078 650-225-1034 |
|
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