Press Release
Abbott Reports Strong Sales and Earnings Growth in Third Quarter; Again Raises Full-Year Earnings Outlook
Worldwide Sales Increased 17.6 Percent
Adjusted EPS Growth of 17.9 Percent (GAAP EPS up 50.0
Percent)
Company Raises Earnings-Per-Share Outlook for 2008
Double-Digit Sales Growth Reported in Each Major Global Business
XIENCE V™ U.S. Launch Exceeding Expectations
October 15, 2008
More information regarding Abbott's Investor Relations
resources:
Abbott Park, Illinois — Abbott (NYSE: ABT)
today announced financial results for the third quarter ended September 30,
2008.
- Diluted earnings per share, excluding specified items, were $0.79, above
Abbott's previously announced guidance range of $0.76 - $0.78, reflecting 17.9
percent growth. Diluted earnings per share under Generally Accepted Accounting
Principles (GAAP) were $0.69, up 50.0
percent.
- Today, Abbott is raising its guidance for full-year 2008 adjusted earnings
per share to $3.31 - $3.33 from $3.24 - $3.28, excluding specified items.
Projected earnings per share under GAAP is $3.23 - $3.25.
- Worldwide sales increased 17.6 percent to $7.5
billion, including a favorable 4.7 percent
effect of exchange rates.
- Worldwide pharmaceutical sales increased 16.7 percent driven by
double-digit growth in HUMIRA®, TriCor®, Niaspan® and Kaletra®. Global HUMIRA
sales exceeded $1.2 billion; Abbott now expects
full-year 2008 global HUMIRA sales of more than $4.4
billion.
- Worldwide medical products sales increased 25.2
percent, driven by 15.3 percent growth in
global diagnostics sales, and 57.9 percent growth
in global vascular sales following the U.S. approval and successful launch of
XIENCE V during the quarter. Drug-eluting stent
(DES) franchise sales were $305 million.
- Worldwide nutritional products sales increased 14.5
percent led by 22.2 percent growth in
international nutritionals, with continued strength in emerging markets.
- The Abbott board of directors has recently approved a new $5 billion share repurchase program. Last year, Abbott
returned more than $3 billion to shareholders
through dividends and share repurchase, and is on track to exceed this level in
2008.
"All of Abbott's businesses are performing exceptionally well, ahead of
expectations," said Miles D. White, chairman and chief executive officer,
Abbott. "Abbott remains well-positioned, with strong core growth
franchises, including our emerging vascular business, which is rapidly becoming
a significant contributor to Abbott's growth."
The following is a summary of third-quarter 2008
sales.
Sales Summary -
Quarter Ended 9/30/08 |
3Q08
($ millions) |
% Change
vs. 3Q07 |
Impact of Exchange
on % Change |
Total Sales |
$7,498 |
17.6 |
4.7 |
| Total U.S. Sales |
$3,683 |
17.9 |
. . . |
| Total International Sales |
$3,815 |
17.3 |
9.2 |
Worldwide Pharmaceutical Sales |
$4,121 |
16.7 |
4.8 |
| U.S. Pharmaceuticals |
$2,135 |
12.6 |
. . . |
| International Pharmaceuticals |
$1,986 |
21.5 |
10.3 |
Worldwide Nutritional Sales |
$1,262 |
14.5 |
2.6 |
| U.S. Nutritionals |
$633 |
7.8 |
. . . |
| International Nutritionals |
$629 |
22.2 |
5.5 |
Worldwide Diagnostics Sales |
$911 |
15.3 |
7.5 |
| U.S. Diagnostics |
$231 |
14.7 |
. . . |
| International Diagnostics |
$680 |
15.5 |
10.0 |
Worldwide Vascular Sales |
$636 |
57.9 |
5.4 |
| U.S. Vascular |
$376 |
87.2 |
. . . |
| International Vascular |
$260 |
28.8 |
10.7 |
Other Sales |
$568 |
2.9 |
4.1 |
Note: See "Consolidated Statement of Earnings" for more
information.
The following is a summary of sales for the first nine
months of 2008.
Sales Summary -
Nine Months Ended 9/30/08 |
9M08
($ millions) |
% Change
vs. 9M07 |
Impact of Exchange
on % Change |
Total Sales |
$21,577 |
15.4 |
5.4 |
| Total U.S. Sales |
$10,135 |
9.2 |
. . . |
| Total International Sales |
$11,442 |
21.6 |
10.7 |
Worldwide Pharmaceutical Sales |
$12,098 |
15.9 |
5.6 |
| U.S. Pharmaceuticals |
$5,957 |
8.3 |
. . . |
| International Pharmaceuticals |
$6,141 |
24.4 |
11.8 |
Worldwide Nutritional Sales |
$3,606 |
12.7 |
3.1 |
| U.S. Nutritionals |
$1,823 |
5.2 |
. . . |
| International Nutritionals |
$1,783 |
21.5 |
6.7 |
Worldwide Diagnostics Sales |
$2,679 |
16.5 |
8.2 |
| U.S. Diagnostics |
$668 |
10.0 |
. . . |
| International Diagnostics |
$2,011 |
18.9 |
11.2 |
Worldwide Vascular Sales |
$1,578 |
26.6 |
5.6 |
| U.S. Vascular |
$809 |
21.2 |
. . . |
| International Vascular |
$769 |
32.9 |
12.0 |
Other Sales |
$1,616 |
6.9 |
4.5 |
Note:See "Consolidated Statement of Earnings" for more
information.
The following is a summary of Abbott's third-quarter
2008 sales for selected products.
Quarter Ended 9/30/08
(dollars in millions) |
U.S.
Sales |
Percent
Change
vs. 3Q07 |
Rest of
World |
Percent
Change
vs. 3Q07 |
Global
Sales |
Percent
Change
vs. 3Q07 |
Pharmaceutical Products |
| HUMIRA |
$577 |
35.1 |
$627 |
67.0a |
$1,204 |
50.0 |
| Kaletra |
$128 |
(6.4) |
$259 |
28.4b |
$387 |
14.4 |
| TriCor |
$334 |
11.1 |
. . . |
. . . |
$334 |
11.1 |
| Depakote |
$290 |
(19.1) |
$27 |
7.1 |
$317 |
(17.4) |
| Lupron |
$149 |
n/m |
$72 |
11.8c |
$221 |
n/m |
| Ultane/Sevorane |
$47 |
(3.0) |
$153 |
10.0d |
$200 |
6.6 |
| Niaspan |
$194 |
16.2 |
. . . |
. . . |
$194 |
16.2 |
| Synthroid |
$106 |
(3.5) |
$23 |
14.6 |
$129 |
(0.7) |
| Biaxin (clarithromycin) |
$3 |
n/m |
$112 |
(8.3)e |
$115 |
(11.9) |
Nutritional Products |
| Pediatric Nutritionals |
$319 |
(2.0) |
$349 |
25.9f |
$668 |
10.8 |
| Adult Nutritionals |
$304 |
20.4 |
$280 |
17.8g |
$584 |
19.1 |
Medical Products |
| Coronary Stents |
$248 |
262.3 |
$135 |
42.8h |
$383 |
135.0 |
| Abbott Diabetes Care |
$145 |
(0.7) |
$210 |
19.3i |
$355 |
10.2 |
| Other Coronary |
$70 |
1.7 |
$84 |
13.2j |
$154 |
7.7 |
| Endovascular |
$58 |
(7.8) |
$41 |
24.4k |
$99 |
3.1 |
| |
|
| a |
Without the positive impact of exchange of 16.8
percent, HUMIRA sales increased 50.2
percent internationally. |
| b |
Without the positive impact of exchange of 10.4
percent, Kaletra sales increased 18.0
percent internationally. |
| c |
Without the positive impact of exchange of 10.7
percent, Lupron sales increased 1.1
percent internationally. |
| d |
Without the positive impact of exchange of 8.0
percent, Sevorane sales increased 2.0
percent internationally. |
| e |
Without the positive impact of exchange of 7.9
percent, clarithromycin sales decreased 16.2
percent internationally. |
| f |
Without the positive impact of exchange of 4.6
percent, Pediatric Nutritionals sales increased 21.3 percent internationally. |
| g |
Without the positive impact of exchange of 6.6
percent, Adult Nutritionals sales increased 11.2
percent internationally. |
| h |
Without the positive impact of exchange of 11.9
percent, Coronary Stent sales increased 30.9
percent internationally. |
| i |
Without the positive impact of exchange of 11.2
percent, Abbott Diabetes Care sales increased 8.1
percent internationally. |
| j |
Without the positive impact of exchange of 9.4
percent, Other Coronary sales increased 3.8
percent internationally. |
| k |
Without the positive impact of exchange of 10.3
percent Endovascular sales increased 14.1
percent internationally. |
| n/m = Not meaningful |
The following is a summary of Abbott's first nine months
of 2008 sales for selected products.
Nine Months Ended 9/30/08
(dollars in millions) |
U.S.
Sales |
Percent
Change
vs. 9M07 |
Rest of
World |
Percent
Change
vs. 9M07 |
Global
Sales |
Percent
Change
vs. 9M07 |
Pharmaceutical Products |
| HUMIRA |
$1,504 |
33.9 |
$1,666 |
69.0 a |
$3,170 |
50.3 |
| Kaletra |
$361 |
(6.2) |
$734 |
29.2b |
$1,095 |
14.9 |
| Depakote |
$1,017 |
(2.7) |
$78 |
13.8 |
$1,095 |
(1.7) |
| TriCor |
$886 |
7.3 |
. . . |
. . . |
$886 |
7.3 |
| Ultane/Sevorane |
$135 |
(9.7) |
$454 |
11.0c |
$589 |
5.5 |
| Niaspan |
$565 |
17.7 |
. . . |
. . . |
$565 |
17.7 |
| Biaxin (clarithromycin) |
$11 |
n/m |
$485 |
(3.7)d |
$496 |
(5.4) |
| Lupron |
$231 |
n/m |
$208 |
12.9e |
$439 |
n/m |
| Synthroid |
$315 |
(3.2) |
$67 |
23.7 |
$382 |
0.7 |
Nutritional Products |
| Pediatric Nutritionals |
$935 |
2.9 |
$984 |
24.3f |
$1,919 |
12.9 |
| Adult Nutritionals |
$866 |
8.7 |
$800 |
18.1g |
$1,666 |
13.0 |
Medical Products |
| Abbott Diabetes Care |
$415 |
(0.9) |
$601 |
21.4h |
$1,016 |
11.2 |
| Coronary Stents |
$402 |
75.4 |
$386 |
48.5i |
$788 |
61.1 |
| Other Coronary |
$226 |
(4.6) |
$262 |
17.1j |
$488 |
5.9 |
| Endovascular |
$181 |
(10.1) |
$121 |
27.4k |
$302 |
2.0 |
| |
|
| a |
Without the positive impact of exchange of 17.9
percent, HUMIRA sales increased 51.1
percent internationally. |
| b |
Without the positive impact of exchange of 11.1
percent, Kaletra sales increased 18.1
percent internationally. |
| c |
Without the positive impact of exchange of 9.1
percent, Sevorane sales increased 1.9
percent internationally. |
| d |
Without the positive impact of exchange of 9.3
percent, clarithromycin sales decreased 13.0
percent internationally. |
| e |
Without the positive impact of exchange of 11.5
percent, Lupron sales increased 1.4
percent internationally. |
| f |
Without the positive impact of exchange of 5.5
percent, Pediatric Nutritionals sales increased 18.8 percent internationally. |
| g |
Without the positive impact of exchange of 8.1
percent, Adult Nutritionals sales increased 10.0
percent internationally. |
| h |
Without the positive impact of exchange of 12.3
percent, Abbott Diabetes Care sales increased 9.1
percent internationally. |
| i |
Without the positive impact of exchange of 13.3
percent, Coronary Stents sales increased 35.2
percent internationally. |
| j |
Without the positive impact of exchange of 10.3
percent, Other Coronary sales increased 6.8
percent internationally. |
| k |
Without the positive impact of exchange of 12.2
percent, Endovascular sales increased 15.2
percent internationally. |
| n/m = Not meaningful |
Business Highlights
-
TCT Data Presentations - At this week's Transcatheter Cardiovascular
Therapeutics (TCT) meeting, presented results from a new meta-analysis of its
XIENCE V™ drug-eluting stent clinical trials,
SPIRIT II and SPIRIT
III, which showed XIENCE V outperformed Boston Scientific's TAXUS® in
key efficacy and safety endpoints out to two years. We also presented new
two-year data from our ABSORB trial, which demonstrated that our bioabsorbable
drug-eluting stent successfully treated coronary artery disease and absorbed
within two years.
-
Similac® Enhancements - In September, announced the launch of an
innovative infant nutrition product and new consumer packaging. Similac Advance
EarlyShield™ is the only infant formula that has a unique blend of prebiotics,
nucleotides and antioxidants - nutrients found in breast milk. Similac®
SimplePac™ is Abbott's most significant packaging redesign of baby formula
powder containers.
-
HUMIRA® Psoriasis Data - In September, presented data at the
European Academy of Dermatology and Venereology (EADV) Congress demonstrating
more psoriasis patients achieved efficacy when they received continuous
treatment with HUMIRA (adalimumab) versus interrupted treatment. Additional
analysis showed HUMIRA effectively treats adult patients with psoriasis
regardless of age, duration of disease, diagnosis of psoriatic arthritis or
recent systemic therapy.
-
Patient Side Point-of-Care Testing - In August, announced patient
side, point-of-care testing - where diagnostic testing is conducted at or near
the site of the patient - enabling doctors to make decisions on patients
presenting with chest pain up to 20 minutes faster than those whose lab tests
are evaluated by a standard lab, according to a study that appeared in the
peer-reviewed journal Annals of Emergency Medicine.
-
AstraZeneca Relationship Expanded - In August, announced an
agreement with AstraZeneca to promote AstraZeneca's CRESTOR® (rosuvastatin
calcium), a medication used along with diet to reduce high cholesterol. Abbott
will obtain the non-exclusive right to promote CRESTOR alongside AstraZeneca in
the United States, excluding Puerto Rico.
-
Post-Approval Study of XIENCE V - In July, announced the start of
the XIENCE V USA post-approval study. The XIENCE V USA study will evaluate the safety and
effectiveness of the XIENCE V drug-eluting stent
in 5,000 patients in a real-world clinical setting out to five years.
-
XIENCE V Approved in United States - On July 2, received FDA
approval and launched XIENCE V, which
demonstrated superiority to TAXUS in two randomized, controlled clinical
trials. Abbott's application included safety and efficacy data from SPIRIT III
clinical trials, which met its primary endpoints and demonstrated the
superiority of XIENCE V over the previous market
leader, TAXUS.
Abbott raises guidance for full-year earnings per
share
Based on the company's continued strong results year-to-date, and the
outlook for the remainder of the year, Abbott is raising its earnings-per-share
forecast for the full-year 2008 to $3.31 - $3.33 from $3.24 - $3.28, excluding
specified items. Abbott's original guidance range for 2008, provided in
January, was $3.20 - $3.25.
Abbott continues to forecast net specified items for the full-year 2008 of
$0.08 per share, primarily associated with cost reduction initiatives and
acquired in-process R&D, offset by favorable items including the gain
related to the conclusion of the TAP joint venture, a favorable settlement of a
prior year's tax audits, and the gain on the sale of an equity investment, and
the gain on sale of Abbott's spine business, which is forecast to occur in the
fourth quarter. Including these specified items, projected earnings per share
under GAAP would be $3.23 - $3.25 for the full-year 2008.
Abbott declares quarterly dividend; double-digit
increase over prior year
On September 12, 2008, the board of directors of Abbott declared the
company's quarterly common dividend of 36 cents per share, a 10.8 percent
increase over the prior year. The cash dividend is payable November 15, 2008, to shareholders of record at the
close of business on October 15, 2008. This marks
the 339th consecutive dividend paid by Abbott since 1924.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs more than
68,000 people and markets its products in more than 130 countries.
Abbott will webcast its live third-quarter earnings conference call through
its Investor Relations Web site at www.abbottinvestor.com at 8 a.m. Central
time today. An archived edition of the call will be available after 11 a.m.
Central time.
Private Securities Litigation Reform Act of 1995 - A
Caution Concerning Forward-Looking Statements
Some statements in this news release may be forward-looking statements for
the purposes of the Private Securities Litigation Reform Act of 1995. We
caution that these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially from those
indicated. Economic, competitive, governmental, technological and other factors
that may affect Abbott's operations are discussed in Item 1A, "Risk
Factors," to our Annual Report on Securities and Exchange Commission Form
10-K for the year ended Dec. 31, 2007, and in Item 1A, "Risk Factors,"
to Abbott's Quarterly Report on Securities and Exchange Commission Form 10-Q
for the quarter ended June 30, 2008, and are incorporated by reference. Abbott
undertakes no obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments.
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
Third Quarter Ended September 30, 2008 and 2007
(unaudited) |
| |
2008 |
2007 |
Percent
Change |
| Net Sales |
$ 7,497,660,000 |
$ 6,376,706,000 |
17.6 |
| Cost of products sold |
3,352,869,000 |
2,864,030,000 |
17.1 |
| Research and development |
680,360,000 |
640,718,000 |
6.2 |
| Selling, general and administrative |
2,067,914,000 |
1,945,404,000 |
6.3 |
| Total Operating Cost and Expenses |
6,101,143,000 |
5,450,152,000 |
11.9 |
| |
|
|
|
| Operating earnings |
1,396,517,000 |
926,554,000 |
50.7 |
| |
|
|
|
| Net interest expense |
69,701,000 |
106,224,000 |
(34.4) |
| Net foreign exchange (gain) loss |
17,156,000 |
4,959,000 |
n/m |
(Income) from TAP Pharmaceutical Products Inc.
joint venture |
. . . |
(114,084,000) |
(100.0) |
| Other (income) expense, net 1) |
(63,376,000) |
36,036,000 |
n/m |
| Earnings before taxes |
1,373,036,000 |
893,419,000 |
53.7 |
| Taxes on earnings |
288,424,000 |
176,414,000 |
63.5 |
| |
|
|
|
| Net Earnings |
$ 1,084,612,000 |
$ 717,005,000 |
51.3 |
| |
|
|
|
Net Earnings Excluding Specified Items,
as described below 2) |
$ 1,235,553,000 |
$ 1,046,437,000 |
18.1 |
| |
|
|
|
| Diluted Earnings Per Common Share |
$ 0.69 |
$ 0.46 |
50.0 |
| |
|
|
|
Diluted Earnings Per Common Share,
Excluding Specified Items, as described below 2) |
$ 0.79 |
$ 0.67 |
17.9 |
| |
|
|
|
Average Number of Common Shares Outstanding
Plus Dilutive Common Stock Options and Awards |
1,563,730,000 |
1,557,758,000 |
|
| |
|
| 1 |
Other (income) expense, net in 2008 includes primarily ongoing contractual
payments from Takeda associated with the conclusion of the TAP joint venture.
Other (income) expense, net, in 2007 is primarily associated with Abbott's
ownership of Boston Scientific stock. |
| 2 |
2008 Net Earnings Excluding Specified Items excludes after-tax charges of
$151 million, or $0.10 per share, for cost
reduction initiatives, related primarily to actions announced in August 2008 to
streamline global manufacturing operations, reduce overall costs, and improve
efficiencies in Abbott's core diagnostic business.
2007 Net Earnings Excluding Specified Items excludes after-tax charges of $111 million, or $0.07 per share, for a contract
termination and other litigation, $79 million, or
$0.05 per share, for reestablishment of suspended depreciation and amortization
expense on the long-term assets of the core laboratory diagnostics business,
$56 million, or $0.04 per share, for acquisition
integration, and other, $21 million, or $0.01 per
share, for fair value loss adjustments related to Boston Scientific stock, and
$62 million, or $0.04 per share, for cost
reduction initiatives. |
NOTE: See attached questions and answers section for further explanation of
Consolidated Statement of Earnings line items. |
| n/m = Percent change is not meaningful. |
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
Nine Months Ended September 30, 2008 and 2007
(unaudited) |
| |
2008 |
2007 |
Percent
Change |
| Net Sales |
$ 21,577,284,000 |
$ 18,692,887,000 |
15.4 |
| Cost of products sold |
9,433,641,000 |
8,260,366,000 |
14.2 |
| Research and development |
1,957,180,000 |
1,843,248,000 |
6.2 |
| Acquired in-process research and development |
97,256,000 |
. . . |
n/m |
| Selling, general and administrative |
6,138,264,000 |
5,528,729,000 |
11.0 |
| Total Operating Cost and Expenses |
17,626,341,000 |
15,632,343,000 |
12.8 |
| |
| Operating earnings |
3,950,943,000 |
3,060,544,000 |
29.1 |
| |
| Net interest expense |
246,200,000 |
355,245,000 |
(30.7) |
| Net foreign exchange (gain) loss |
37,849,000 |
16,058,000 |
135.7 |
(Income) from TAP Pharmaceutical Products Inc.
joint venture |
(118,997,000) |
(376,442,000) |
(68.4) |
| Other (income) expense, net 1) |
(384,189,000) |
78,960,000 |
n/m |
| Earnings before taxes |
4,170,080,000 |
2,986,723,000 |
39.6 |
| Taxes on earnings |
825,587,000 |
583,436,000 |
41.5 |
| |
| Net Earnings |
$ 3,344,493,000 |
$ 2,403,287,000 |
39.2 |
| |
Net Earnings Excluding Specified Items,
as described below 2) |
$ 3,531,274,000 |
$ 2,976,580,000 |
18.6 |
| |
| Diluted Earnings Per Common Share 2) |
$ 2.14 |
$ 1.54 |
39.0 |
| |
Diluted Earnings Per Common Share,
Excluding Specified Items, as described below |
$ 2.26 |
$ 1.91 |
18.3 |
| |
Average Number of Common Shares Outstanding
Plus Dilutive Common Stock Options and Awards |
1,559,686,000 |
1,559,074,000 |
|
| |
|
| 1 |
Other (income) expense, net, in 2008 includes a gain of $94 million in connection with the closing of the TAP
Pharmaceutical Products Inc. joint venture transaction and gains of $63 million from the sale of equity investments in
Millennium Pharmaceuticals and Boston Scientific. These items have been treated
as specified items. The remainder of Other (income) expense, net, is primarily
related to ongoing contractual payments from Takeda associated with the
conclusion of the TAP joint venture. Other (income) expense, net, in 2007 is
primarily associated with Abbott's ownership of Boston Scientific stock. |
| 2 |
2008 Net Earnings Excluding Specified Items excludes a tax-free gain of
$94 million, or $0.06 per share, recorded on the
closing of the TAP joint venture transaction, a reduction in income taxes of
$30 million, or $0.02 per share, relating to the
settlement of an IRS audit, and an after-tax gain of $49
million, or $0.03 per share, relating to sales of equity investments in
Millennium Pharmaceuticals and Boston Scientific. These items were offset by
after-tax charges of $76 million, or $0.05 per share, for acquired in-process
research and development relating to technology investments, $225 million, or $0.14 per share, for cost reduction
initiatives, and $59 million, or $0.04 per share
for acquisition integration, TAP separation and other.
2007 Net Earnings Excluding Specified Items excludes after-tax charges of $164 million, or $0.11 per share, for acquisition
integration, $111 million, or $0.07 per share,
for a contract termination and other litigation, $41
million, or $0.03 per share, for fair value loss adjustments, net of
realized gains, related to Boston Scientific stock, $34
million, or $0.02 per share, for write-down of Omnicef inventory, $19 million, or $0.01 per share, for transaction and
separation costs relating to the terminated sale of the core laboratory
diagnostics business, and $204 million, or $0.13 per share, for cost reduction
initiatives and other. |
NOTE: See attached questions and answers section for further explanation of
Consolidated Statement of Earnings line items. |
| n/m = Percent change is not meaningful. |
Questions & Answers
| Q1) |
What drove the 16.7 percent increase in global pharmaceutical sales in
the quarter? |
| A1) |
U.S. pharmaceutical sales increased 12.6
percent, reflecting double-digit growth for HUMIRA, TriCor and Niaspan.
U.S. HUMIRA sales increased more than 35 percent,
as strong market demand continued across the three major market segments of
rheumatology, gastroenterology and dermatology. Based on the strength of HUMIRA
and the outlook for global growth, Abbott now expects HUMIRA sales of more than
$4.4 billion in 2008.
Also in the quarter, Abbott's lipid franchise performed well, with growth
outpacing the overall cholesterol market and both Niaspan and TriCor achieving
double-digit growth. Niaspan increased 16.2
percent with sales of $194 million. TriCor
sales increased more than 11 percent with sales of $334 million.
International pharmaceutical sales increased 21.5
percent, including a 10.3 percent
favorable impact from exchange. Better-than-expected international growth was
driven by HUMIRA, which increased 67.0 percent,
and Kaletra, which grew 28.4 percent, driven by
continued success of the tablet launch in international markets. Synthroid,
Lupron and Sevorane also contributed to reported international growth, as well
as a number of other established products.
|
| Q2) |
What drove the 25.2 percent increase in
global medical products sales and strong international nutritional products
sales? |
| A2) |
Medical products sales increased 25.2
percent, reflecting 15.3 percent growth in
global diagnostics sales and 57.9 percent growth
in worldwide vascular. Each of Abbott's major diagnostic segments – molecular,
point of care, and the core immunochemistry business – delivered double-digit
growth.
Abbott Vascular achieved record sales of $636
million, driven by drug-eluting stent (DES) franchise sales of $305 million, which more than doubled sequentially from
the second quarter, exceeding the company's previous guidance. The substantial
increase in vascular sales this quarter was due to the U.S. approval and
successful launch of XIENCE V beginning July 2. Xience V is now
the market-leading DES in the U.S. The XIENCE platform, which includes a
private-label version of XIENCE V called Promus,
has captured more than 50 percent of U.S. market.
Market conditions for coronary stents continue to improve in the U.S., with
U.S. percutaneous coronary intervention (PCI) volumes up versus the third
quarter 2007 and DES penetration rates steadily increasing to more than 70 percent.
Worldwide nutritional products sales were led by 22.2
percent growth in international nutritionals, including a 5.5 percent favorable impact from exchange, with
continued strong growth in key emerging markets, including Latin America and
Asia, where Abbott is opening a new state-of-the art nutritionals manufacturing
facility in Singapore beginning in early 2009.
|
| Q3) |
How did specified items affect reported results? |
| A3) |
Specified items impacted third-quarter results as follows:
| |
3Q08 |
| (dollars in millions, except earnings-per-share) |
Earnings |
|
| |
Pre-tax |
After-tax |
EPS |
| As reported |
$1,373 |
$1,085 |
$0.69 |
| Adjusted for specified items: |
|
|
|
| Cost reduction initiatives |
$191 |
$151 |
$0.10 |
| As adjusted |
$1,564 |
$1,236 |
$0.79 |
Cost reduction initiatives are related primarily to actions announced in August
2008 to streamline global manufacturing operations, reduce overall costs, and
improve efficiencies in Abbott's core diagnostic business. Charges related to
this action were in line with the previous forecast.
The pre-tax impact of the remaining specified items by Consolidated Statement
of Earnings line item is as follows (dollars in millions):
| |
3Q08 |
| |
Cost of
Products
Sold |
R&D |
SG&A |
| As reported |
$3,353 |
$680 |
$2,068 |
| Adjusted for specified items: |
|
|
|
| Cost reduction initiatives |
$165 |
$6 |
$20 |
| As adjusted |
$3,188 |
$674 |
$2,048 |
|
Q4) |
What drove the strong investment spending in the quarter? |
| A4) |
Combined investment in R&D and SG&A was up 13.6 percent, excluding specified items. The strong
growth in SG&A included new and ongoing promotional initiatives across
multiple businesses, including spending to support the numerous new product
approvals this year. Growth in R&D expense reflected continued investment
in our broad-based pipeline, including early-to-mid-stage opportunities across
a number of therapeutic areas, such as oncology, immunology, hepatitis C, neuroscience and our bioabsorbable stent
program.
|
| Q5) |
How does the third-quarter gross margin ratio compare to the company's
guidance? |
| A5) |
The gross margin ratio before and after specified items is shown below
(dollars in millions):
| |
3Q08 |
Cost of
Products
Sold |
Gross
Margin |
Gross
Margin % |
| As reported |
$3,353 |
$4,145 |
55.3% |
| Adjusted for specified items: |
|
|
|
| Cost reduction initiatives and other |
($165) |
$165 |
2.2% |
| As adjusted |
$3,188 |
$4,310 |
57.5% |
The adjusted gross margin ratio was 57.5 percent,
at the high-end of our previous forecast range of 57.0 to 57.5 percent for the quarter. The gross margin ratio
for the fourth quarter is forecasted to be approximately 59.0 percent.
|
| Q6) |
What was the tax rate in the quarter? |
| A6) |
The tax rate this quarter, excluding specified items, was 21.0 percent, in line with our forecasted rate. The
year-to-date tax rate for 2008, excluding specified items, was 21.0 percent, also in line with our previous forecast.
As a reminder, the third quarter and year-to-date tax rate does not include the
benefit of the U.S. R&D tax credit since it was enacted in the fourth
quarter.
|
| Q7) |
What are some near-term opportunities in Abbott's broad-based
pipeline? |
| A7) |
Abbott's late-stage pipeline has been very productive this year, generating
eight new regulatory approvals to date in 2008, with two additional approvals
expected in the fourth quarter. Highlights of the near-term opportunities
include:
-
HUMIRA
- Psoriasis – Launched in Europe and the U.S. in the first-quarter 2008.
- RA Japan – Launched in June 2008.
- Psoriasis Japan – Indication filed, under regulatory review.
- Ulcerative colitis – Currently in Phase III
development.
-
TRILIPIX™ – We expect a fourth-quarter approval of
TRILIPIX, Abbott's next-generation fenofibrate. To support TRILIPIX, Abbott has
executed the largest clinical program to date to evaluate the efficacy and
safety of a fibrate in combination with statins. Development also continues on
a fixed-dose combination of TRILIPIX and CRESTOR to address all three lipid
parameters in a single pill. We plan to submit a New Drug Application for this
fixed-dose combination in the second half of 2009.
-
Controlled-Release Vicodin – We expect a fourth-quarter
approval of this new branded pain medication. When approved, this product will
be the first extended release formulation of hydrocodone with
acetaminophen.
-
Flutiform – Flutiform, a combination asthma treatment in
Phase III development, is targeted for a first-quarter 2009 NDA filing.
-
ABT-874 – In Immunology, Abbott's anti-IL-12/23 biologic,
ABT-874, has demonstrated promising results in early studies for Crohn's
disease and psoriasis. Abbott moved ABT-874 into Phase III development for
psoriasis in December 2007.
-
Diabetes Care Pipeline – The FreeStyle Freedom Lite
no-calibration meter was launched internationally last year and was launched in
the United States in the first quarter of 2008. Abbott's FreeStyle Navigator
Continuous Glucose Monitoring System was launched in Europe last year and was
approved and launched in the United States in the first quarter of 2008. Also
in development is a fully-integrated blood glucose monitoring system combining
a meter, test strips and lancing capabilities in one device.
-
XIENCE V in Japan – Recently submitted a
marketing authorization license application in Japan to gain approval for XIENCE V to treat coronary artery disease. The
application for XIENCE V consisted of safety and
efficacy data from the SPIRIT III clinical trial,
including data from a Japanese patient population.
-
Core Laboratory Diagnostics – In April, Abbott introduced
the ARCHITECT i1000SR immunochemistry analyzer in the United States,
expanding its ARCHITECT family of diagnostic instrument systems for clinical
laboratories. In 2009, we plan to introduce the ARCHITECT c4000™, a
clinical chemistry analyzer designed for small-to-medium-sized labs. The
c4000 is compatible with the i1000, which will allow seamless
integration of clinical chemistry and immunoassay testing on one platform.
|
| Q8) |
What are some early and mid-stage opportunities in Abbott's broad-based
pipeline? |
| A8) |
With the recent productivity of the late-stage pipeline, Abbott is now
focused on advancing leading-edge scientific discoveries from its
early-to-mid-stage development pipeline across the company, where we continue
to advance a number of compounds that have breakthrough potential.
Our pharmaceutical pipeline has increased in size, novelty and number of phase
transitions. This year, Phase I or Phase II trial initiations are nearly double 2007
levels. We continue to focus our investment to discover new treatments across a
spectrum of therapeutic areas. Select highlights include:
-
Oncology
- Abbott's Oncology pipeline includes targeted therapies that represent
promising, unique scientific approaches to treating cancer. Our collaboration
with Genentech to develop two Abbott-discovered compounds including a
multi-targeted kinase inhibitor and Bcl-2 family protein antagonist, continues
to progress.
- Oncology compounds in Abbott's pipeline that are not part of the
collaboration include: a PARP-inhibitor, which prevents DNA repair in cancer
cells, enhancing the effectiveness of current cancer therapies; an oral
anti-mitotic in Phase II for non-small cell lung
cancer and neuroblastoma; and a biologic anti-tumor agent with a novel
mechanism of action.
-
Neuroscience
- Abbott is conducting innovative research in neuroscience, where we've
developed compounds that target receptors in the brain that help regulate pain,
mood, memory and other neurological functions to address conditions, such as
attention deficit hyperactivity disorder, Alzheimer's disease and
schizophrenia. Our work in neuroscience is focused on several promising
investigational platforms including NNRs, H3, Calpain and TRPV1, among
others.
- Abbott is also working to advance compounds that have the potential to meet
the market need for a non-opioid pain therapy.
-
Immunology
- Abbott's scientific experience with the anti-TNF biologic HUMIRA serves as
a strong foundation for our continuing research in immunology. Products in
development for the treatment of immune-mediated diseases are designed to
selectively inhibit proteins that are responsible for inflammation. In addition
to our work with IL-12/23, we are working to advance development of our early
discovery programs, including oral therapies for rheumatoid arthritis, JAK
kinase and P38, as well as other potential biologic targets.
- Additionally, our proprietary DVD-ig technology represents a promising
approach that could lead to combination biologic therapies.
-
Hepatitis C
- Abbott's antiviral program is focused on the treatment of hepatitis C, a disease that affects more than 170
million people worldwide. Abbott has two active hepatitis C programs including our partnership with
Enanta Pharmaceuticals to develop protease inhibitors as well as an internal
polymerase program.
-
Bioabsorbable Drug-Eluting Stent
- At the TCT meeting this week, Abbott presented encouraging two-year data
from the world's first clinical trial for a fully-bioabsorbable DES to treat
coronary artery disease. The bioabsorbable DES is designed to be slowly
metabolized by the body and completely absorbed over time.
|
Financial:
John Thomas
Larry Peepo
Tina Ventura |
(847) 938-2655
(847) 935-6722
(847) 935-9390 |
Media:
Melissa Brotz
Scott Stoffel |
(847) 935-3456
(847) 936-9502 |