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Abbott Reports 15.5 Percent Sales Growth in First Quarter- Double-Digit Sales Growth in Both Pharmaceuticals and Medical Products -
ABBOTT PARK, Ill., April 18 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced financial results for the first quarter ended March 31, 2007. -- Abbott's diluted earnings per share, excluding specified items, were
$0.55, including results from Discontinued Operations, ahead of
Abbott's previously announced guidance range of $0.51 to $0.53, which
also included Discontinued Operations. Higher TAP joint venture income,
resulting from a favorable outcome in a patent dispute, impacted
earnings per share by $0.02. Abbott is raising its full-year ongoing
earnings-per-share guidance. Diluted earnings per share under Generally
Accepted Accounting Principles (GAAP) were $0.45.
-- Worldwide sales increased 15.5 percent to $5.3 billion, including the
impact of acquisitions and a favorable 2.5 percent effect of exchange
rates.
-- Worldwide pharmaceutical sales increased 16.6 percent, including U.S.
sales growth of 16.8 percent, driven by strong growth in HUMIRA, as
well as the first full quarter of sales from the Kos Pharmaceuticals
acquisition. International pharmaceutical sales increased 16.4 percent,
including the impact of exchange, led by double-digit growth of
Kaletra(R) and more than 60 percent growth of HUMIRA. Abbott continues
to expect 2007 global sales of HUMIRA to exceed $2.7 billion.
-- Medical Products sales increased 13.9 percent, including $420 million
from Abbott Vascular and double-digit growth in International
Nutritionals and Abbott Molecular. In March, Abbott presented U.S.
clinical trial data on its XIENCE(TM) V drug-eluting stent system and
remains on track to file for U.S. regulatory approval in the second
quarter of this year.
"Our businesses continue to perform well and our outlook remains strong," said Miles D. White, chairman and chief executive officer, Abbott. "Our late- stage pipeline is generating significant opportunities across our diverse portfolio, giving us great confidence in our future." The following is a summary of first-quarter 2007 sales for each of Abbott's major operating divisions. Impact of
Sales Summary - 1Q07 % Change Exchange on
Quarter Ended 3/31/07 ($ millions) vs. 1Q06 % Change
Total Sales $5,290 15.5 2.5
Total U.S. Sales $2,763 10.3 ---
Total International Sales $2,527 21.8 5.5
Worldwide Pharmaceutical Sales $3,373 16.6 2.8
U.S. Pharmaceuticals $1,692 16.8 ---
International Pharmaceuticals (AI) $1,681 16.4 5.6
Worldwide Nutritional Sales $1,002 (12.3)(a) 1.0
U.S. Nutritionals (Ross) $565 (25.3)(a) ---
International Nutritionals (ANI) $437 13.4 2.9
Worldwide Vascular Sales $420 407.9 (b) 2.7
U.S. Vascular $244 360.2 (b) ---
International Vascular $176 492.9 (b) 7.4
(a) Reflects completion of U.S. co-promotion of Synagis in 2006.
Excluding this impact, U.S. Nutritionals increased 6.0 percent and
Worldwide Nutritionals increased 9.1 percent.
(b) Includes the impact of the Guidant vascular acquisition.
Note: See "Consolidated Statement of Earnings" for more information.
The following is a summary of Abbott's first-quarter 2007 sales for selected products. Quarter Ended 3/31/07 Percent Percent Percent
(dollars in millions) U.S. Change Rest of Change Global Change
Sales vs. 1Q06 World vs. 1Q06 Sales vs. 1Q06
Pharmaceutical Products
HUMIRA $289 32.4 $282 62.2 (a) $571 45.6
Depakote $305 33.4 $21 22.2 $326 32.6
Kaletra $117 (2.4) $183 14.5 (b) $300 7.2
Biaxin (clarithromycin) $7 (85.2) $217 9.5 (c) $224 (9.9)
TriCor $223 8.7 --- --- $223 8.7
Ultane/Sevorane $48 (41.3) $126 0.7 (d) $174 (16.0)
Omnicef $161 12.5 --- --- $161 12.5
Niaspan $142 n/a --- --- $142 n/a
Synthroid $112 0.5 $17 14.6 $129 2.2
Nutritional Products
Pediatric Nutritionals $292 7.1 $235 17.9 $527 11.6
Adult Nutritionals $261 2.8 $201 8.6 (e) $462 5.3
Medical Products
Abbott Diabetes Care $131 (5.8) $154 14.5 (f) $285 4.1
Coronary Stents $85 n/m $75 n/m $160 n/m
Other Coronary $90 n/m $72 n/m $162 n/m
Endovascular $69 76.9 $29 107.1 $98 84.9
TAP Pharmaceutical Products
(not consolidated in
Abbott's sales)
Prevacid $573 (7.1) --- --- $573 (7.1)
Lupron $165 (1.8) --- --- $165 (1.8)
(a) Without the positive impact of exchange of 13.0 percent, HUMIRA sales
increased 49.2 percent internationally.
(b) Without the positive impact of exchange of 6.8 percent, Kaletra sales
increased 7.7 percent internationally.
(c) Without the positive impact of exchange of 4.7 percent, clarithromycin
sales increased 4.8 percent internationally.
(d) Without the positive impact of exchange of 4.7 percent, Sevorane sales
decreased 4.0 percent internationally.
(e) Without the positive impact of exchange of 3.8 percent, Adult
Nutritionals sales increased 4.8 percent internationally.
(f) Without the positive impact of exchange of 7.6 percent, Abbott
Diabetes Care sales increased 6.9 percent internationally.
n/a = Percent change is not applicable due to the acquisition of Niaspan
in the fourth-quarter 2006.
n/m = Percent change is not meaningful.
Business Highlights
-- Global Regulatory Submission for HUMIRA(R) in Psoriasis - Abbott
recently submitted HUMIRA for U.S. and European regulatory approval to
treat psoriasis, a chronic autoimmune disease affecting the skin.
During the quarter, Abbott presented new Phase III psoriasis data that
demonstrated that nearly three out of four psoriasis patients
experienced a significant reduction in disease signs when treated with
HUMIRA. The study also showed that patients are significantly less
likely to have their disease signs worsen if they maintain treatment
with HUMIRA. These data are consistent with results from an earlier
Phase III trial presented in 2006. Both of these studies formed the
basis of the global submissions.
-- HUMIRA Crohn's Disease Approval and Launch - Abbott received U.S. Food
and Drug Administration (FDA) approval for HUMIRA to treat Crohn's
disease, the fourth disease state indication for HUMIRA. Crohn's
disease is a serious chronic, inflammatory disease of the
gastrointestinal tract with onset typically before age 40. Abbott also
expects European regulatory approval for Crohn's disease in the second
quarter of 2007.
-- Biologics Manufacturing Plant in Puerto Rico - In April, Abbott
announced the official opening of its new state-of-the-art biologics
manufacturing facility in Puerto Rico to support the long-term supply
of HUMIRA and other future biologics. The new facility received FDA
approval in February to produce HUMIRA.
-- XIENCE(TM) V SPIRIT Data - In March, Abbott presented data from its
U.S. pivotal drug-eluting stent trial, SPIRIT III, demonstrating
superiority of its XIENCE V everolimus-eluting stent system over the
TAXUS(R) paclitaxel-eluting coronary stent system with respect to the
study's primary endpoint of in-segment late loss and a secondary
endpoint of reduction in major adverse cardiac events (MACE) after nine
months. This was the first time that superiority for MACE was
demonstrated in a head-to-head trial of two drug-eluting stents. Abbott
also presented one-year data from its SPIRIT II European trial, which
also demonstrated superiority to TAXUS in MACE.
-- Bioabsorbable Stent Data - Abbott presented six-month clinical
follow-up data from ABSORB, the world's first clinical trial of a fully
bioabsorbable drug-eluting coronary stent system. Results from the
first 30 patients in the study demonstrated an encouraging efficacy and
safety profile, with no stent thrombosis and a low MACE rate.
-- New Niaspan(R) Tablet Approval - In April, Abbott received FDA approval
of a new film-coated Niaspan extended-release prescription tablet.
Niaspan is the most widely prescribed therapy for raising HDL or "good"
cholesterol and is the most effective drug to raise HDL with proven
outcomes of 25 to 35 percent on average.
-- Divestiture of Core Laboratory Diagnostics Business - On January 18,
2007, Abbott announced an agreement to divest its core laboratory
diagnostics business, including the Abbott Diagnostics Division and
Abbott Point of Care, to General Electric for $8.13 billion in cash.
The transaction has received U.S. Federal Trade Commission approval and
is subject to customary closing conditions, including regulatory
approvals.
-- Launch of FreeStyle Lite(TM) System - In April, Abbott received FDA
clearance to market the FreeStyle Lite blood glucose monitoring system.
The newest offering in the FreeStyle(R) product line features no
required coding and automatic calibration, manual steps needed by most
meters prior to using a new vial of test strips. This system provides
results in an average of five seconds using the world's smallest blood
sample size.
-- Increase in Quarterly Dividend - In February, the Board of Directors
approved a 10.2 percent increase in Abbott's quarterly dividend to
32.5 cents per share. This is the 35th consecutive year that Abbott has
increased its quarterly dividend payout.
Abbott raises full-year earnings-per-share guidance
Abbott is raising its earnings-per-share guidance, excluding specified items, for the full-year 2007 to $2.79 to $2.85, as a result of the higher than expected TAP joint venture income this quarter. Abbott is confirming guidance for the second quarter of $0.67 to $0.69 per share, as previously forecasted, also excluding specified items. Guidance for the full year and second quarter reflects the announced sale of Abbott's core laboratory diagnostics business and includes both the results of this business while owned by Abbott and the redeployment of proceeds after closing the transaction. This guidance also reflects a lower tax rate than previously forecasted and a more conservative financial planning assumption for Omnicef. See Q&A Answer 10 for additional information. Abbott forecasts a net gain from specified items for the full-year 2007 of $1.97 per share, which includes a projected gain of approximately $2.25 per share related to the sale of the core laboratory diagnostics business offset by charges of $0.28 per share, primarily associated with acquisition integration, cost reduction initiatives and a fair value adjustment to Boston Scientific stock and related gain-sharing aspect of the stock purchase (See Q&A Answer 7). Including these net specified items, projected earnings per share under GAAP would be $4.76 to $4.82 for the full-year 2007. The impact of the gain on sale will be reflected in the quarter in which closing occurs. Abbott forecasts specified items, other than the projected gain on the sale of the core laboratory diagnostics business, for the second-quarter 2007 of approximately $0.09 per share, as previously forecasted, primarily associated with acquisition integration and cost reduction initiatives. Including these specified items, projected earnings per share under GAAP would be $0.58 to $0.60 for the second-quarter 2007. These forecasts exclude any one-time costs associated with the sale of the core laboratory diagnostics business, which will be provided at a later date. Abbott declares quarterly dividend On February 16, 2007, the board of directors of Abbott increased the company's quarterly common dividend to 32.5 cents per share, an increase of 10.2 percent. The cash dividend is payable May 15, 2007, to shareholders of record at the close of business on April 13, 2007. This marks the 35th consecutive year that Abbott has increased its dividend payout and the 333rd consecutive dividend paid by Abbott since 1924. About Abbott Abbott 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 65,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ . Abbott will webcast its live first-quarter earnings conference call through its Investor Relations Web site at http://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, 2006, and are incorporated by reference. We undertake 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
First Quarter Ended March 31, 2007 and 2006
(unaudited)
Percent
2007 2006 Change
Net Sales $5,290,284,000 $4,580,465,000 15.5
Cost of products sold 2,176,695,000 1,759,583,000 23.7
Research and
development 578,374,000 438,579,000 31.9
Selling, general and
administrative 1,657,030,000 1,339,542,000 23.7
Total Operating Cost
and Expenses 4,412,099,000 3,537,704,000 24.7
Operating earnings 878,185,000 1,042,761,000 (15.8)
Net interest expense 124,514,000 34,948,000 256.3
Net foreign exchange
(gain) loss 4,851,000 (810,000) n/m
(Income) from TAP
Pharmaceutical
Products Inc. joint
venture (146,632,000) (101,311,000) 44.7
Other (income) expense,
net 124,461,000 (3,435,000) n/m a)
Earnings from Continuing
Operations Before Taxes 770,991,000 1,113,369,000 (30.8)
Taxes on earnings from
Continuing Operations 129,542,000 264,809,000 (51.1)
Earnings from Continuing
Operations 641,449,000 848,560,000 (24.4)
Earnings from Discontinued
Operations, net of taxes 56,088,000 16,323,000 n/m b)
Net Earnings $697,537,000 $864,883,000 (19.3)
Earnings from Continuing
Operations Excluding
Specified Items, as
described below $828,578,000 $865,951,000 (4.3) c)
Earnings from Discontinued
Operations Excluding
Specified Items, as
described below 25,529,000 16,323,000 56.4 b) d)
Diluted Earnings Per Common
Share from:
Continuing Operations $0.41 $0.55 (25.5)
Discontinued Operations $0.04 $0.01 n/m b) d)
Total $0.45 $0.56 (19.6)
Diluted Earnings Per Common
Share, Excluding Specified
Items described below, from:
Continuing Operations $0.53 $0.56 (5.4) c)
Discontinued Operations $0.02 $0.01 n/m b) d)
Total $0.55 $0.57 (3.5)
Average Number of Common
Shares Outstanding Plus
Dilutive Common Stock
Options and Awards 1,558,234,000 1,537,695,000
a) Other (income) expense, net in 2007 is primarily related to a fair
value adjustment of Abbott's investment in Boston Scientific (BSX)
stock partially offset by the fair value adjustment for the related
gain-sharing aspect of the BSX stock purchase (See Q&A Answer 7).
b) Earnings from Discontinued Operations, net of taxes and Diluted
Earnings Per Common Share from Discontinued Operations, Excluding
Specified Items, reflect the reclassification of results of the core
laboratory diagnostics business to Discontinued Operations. (See Q&A
Answer 1 for additional detail.)
c) 2007 Earnings from Continuing Operations Excluding Specified Items
excludes after-tax charges of $57 million, or $0.04 per share, for
acquisition integration, $75 million, or $0.05 per share, related to
fair value adjustments of Abbott's investment in Boston Scientific
stock and related gain-sharing aspect, and $55 million, or $0.03 per
share, for cost reduction initiatives and other.
2006 Earnings from Continuing Operations Excluding Specified Items
excludes after-tax charges of $17 million, or $0.01 per share,
primarily related to cost reduction and integration activities.
d) 2007 Earnings from Discontinued Operations Excluding Specified Items
excludes $30 million, or $0.02 per share after-tax benefit of suspended
depreciation and amortization of the long-term assets of discontinued
operations.
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) How are the results of the core laboratory diagnostics business being
reported?
A1) In accordance with GAAP, financial results from the core laboratory
diagnostics business have been excluded from Continuing Operations and
are reported as Discontinued Operations as a result of the pending
divestiture by Abbott. Beginning this quarter, the comparable
prior-year quarter also reflects this reporting. As a result, the line
items of the Consolidated Statement of Earnings reflect Continuing
Operations and are on a comparable basis for 2006 and 2007. See Q&A
Answer 13 for additional information on the impact of the pending
divestiture on prior year's sales results.
Q2) What drove double-digit medical products sales growth?
A2) Medical Products sales growth of 13.9 percent was led by Abbott
Vascular, which achieved sales of $420 million, up significantly from
the prior year, including the contribution from the Guidant
acquisition. Strong performance in Abbott Vascular was driven by
international sales of the XIENCE V drug-eluting stent, as well as
continued growth in bare metal stents. Continued double-digit sales
growth in International Nutritionals and Abbott Molecular contributed
to the strong performance in the quarter. Partially offsetting this
growth was an expected decline in U.S. nutritional sales, consistent
with previous forecasts and reflecting the completion of the
co-promotion of Synagis in the U.S. during 2006.
Q3) What drove double-digit pharmaceutical sales growth?
A3) U.S. pharmaceutical sales growth of 16.8 percent included the
contribution from the Kos Pharmaceuticals acquisition, completed in
December 2006. In addition to Kos, growth was led by HUMIRA, which
increased more than 32 percent in the United States. HUMIRA
prescription trends are strong, with growth of more than 40 percent
compared to the prior year. HUMIRA continued to gain market share in
both the rheumatology and dermatology self-injectable biologics
markets. In the quarter, Abbott received FDA approval for HUMIRA in
Crohn's disease, and recently submitted its global regulatory filing
for the treatment of psoriasis. Abbott continues to expect 2007 global
sales of HUMIRA to exceed $2.7 billion. Double-digit growth of
Depakote and Omnicef also contributed to U.S. sales growth in the
quarter.
Sales of Abbott's international pharmaceuticals increased 16.4 percent
during the quarter, including a 5.6 percent favorable impact from
exchange. International growth was favorably impacted by the continued
strength of HUMIRA, with sales up more than 60 percent and
double-digit growth of Kaletra based on the continued strength of the
international launch of Kaletra tablets.
Q4) What drove the strong double-digit increase in R&D and SG&A this
quarter?
A4) The strong investment spending this quarter supported a number of
future growth initiatives across Abbott's businesses.
On a reported basis, R&D investment increased more than 30 percent
this quarter, including specified items and the impact from the
Guidant and Kos acquisitions. Strong growth reflects continuing
investment in our pharmaceutical and medical products pipelines,
including HUMIRA, ABT-335, ABT-874, controlled-release Vicodin and
XIENCE V.
Reported SG&A expense increased almost 24 percent this quarter, also
including specified items and the impact from the Guidant and Kos
acquisitions. Strong growth was driven by new and ongoing promotional
initiatives, including new indications for HUMIRA and the continuing
international launch of XIENCE V.
Q5) How does the first-quarter gross margin profile compare to the prior
year?
A5) The gross margin from Continuing Operations before and after specified
items is shown below (dollars in millions):
1Q07 1Q06
Cost of Gross Cost of Gross
Products Gross Margin Products Gross Margin
Sold Margin % Sold Margin %
As reported $2,176 $3,114 58.9% $1,760 $2,821 61.6%
Adjust for specified
items:
Acquisition
integration ($23) $23 0.4% - - -
Cost reduction
initiatives
and other ($56) $56 1.1% ($11) $11 0.2%
As adjusted $2,097 $3,193 60.4% $1,749 $2,832 61.8%
The first-quarter 2007 gross margin ratio was consistent with guidance
provided last quarter. We are forecasting steady improvement in the
gross margin ratio throughout the year. The comparison to the prior
year has been impacted by the expected reduction in the contribution
from Synagis in the United States this quarter, as well as generic
competition for Biaxin XL in the United States. As a reminder, U.S.
co-promotion for Synagis ended in 2006.
Q6) Why did Net Interest Expense increase from the prior year?
A6) Net Interest Expense increased over the prior year primarily as a
result of debt related to the Guidant vascular and Kos Pharmaceuticals
acquisitions.
Q7) How did specified items affect reported results from Continuing
Operations?
A7) Specified items impacted first-quarter Earnings from Continuing
Operations as follows (dollars in millions, except earnings-per-share
data):
1Q07 1Q06
Earnings Earnings
Pre- After- Pre- After-
tax tax EPS tax tax EPS
As reported, Continuing
Operations $771 $641 $0.41 $1,113 $849 $0.55
Adjusted for specified items:
Acquisition integration $71 $57 $0.04 - - -
Fair value adjustment for BSX
stock and related gain-sharing
aspect $124 $75 $0.05 - - -
Cost reduction initiatives and
other $70 $55 $0.03 $23 $17 $0.01
As adjusted, Continuing
Operations $1,036 $828 $0.53 $1,136 $866 $0.56
The first-quarter 2007 specified items below are primarily related to
integration costs associated with 2006 acquisitions and continuing
cost reduction initiatives in global manufacturing operations, all as
previously forecasted; and a fair value adjustment for the Boston
Scientific (BSX) stock and related gain-sharing aspect of the BSX
stock purchase. In accordance with a newly issued accounting standard,
SFAS 159, Abbott's investment in BSX stock is being accounted for at
fair value. The unrealized loss, or decline in value of BSX stock
prior to January 1, 2007, remains in retained earnings. Subsequent
changes to the fair value of the BSX investment are required to be
reflected in the income statement, which will be tracked as a
specified item, along with any related realized gains/losses on
disposition of this stock. As a result, at the end of the
first-quarter 2007, Abbott adjusted its 64.6 million BSX shares to a
fair value of approximately $14 per share. As a reminder, Abbott is
required to dispose of these shares by October 21, 2008.
The pre-tax impact of the specified items by Consolidated Statement of
Earnings line item is as follows (dollars in millions):
1Q07
Cost of Other
Products (Income)/
Sold R&D SG&A Expense
As reported, Continuing Operations $2,176 $579 $1,657 $124
Adjusted for specified items:
Acquisition integration $23 $4 $44 -
Fair value adjustment for BSX stock
and related gain-sharing aspect - - - $124
Cost reduction initiatives and other $56 - $14 -
As adjusted, Continuing Operations $2,097 $575 $1,599 $ -
Q8) How did specified items affect reported results for Discontinued
Operations?
A8) Specified items impacted first-quarter earnings from Discontinued
Operations, net of taxes, as follows (dollars in millions, except
earnings-per-share data):
1Q07 1Q06
Earnings Earnings
After- After-
Tax EPS Tax EPS
As reported, Discontinued Operations $56 $0.04 $16 $0.01
Adjusted for specified items:
Suspension of depreciation and
amortization $30 $0.02 - -
As adjusted, Discontinued Operations $26 $0.02 $16 $0.01
The suspension of depreciation and amortization in Discontinued
Operations reflects the fact that, under GAAP (SFAS 144), once an
agreement to divest a business has been reached, depreciation and
amortization expense on the related long-term assets is suspended.
This benefit has been reflected as a specified item to better reflect
the underlying results of this business.
Q9) What was the tax rate in the quarter?
A9) The tax rate for continuing operations this quarter, excluding
specified items, was 20.0 percent, lower than our previous forecast.
The tax rate this quarter reflects favorable trends in the mix of
income across the various tax jurisdictions. We expect to sustain this
lower tax rate throughout 2007 and going forward. The reported tax
rate is reconciled to the ongoing rate below (dollars in millions):
1Q07
Pre-tax Income Tax
Income Tax Rate
As reported, Continuing Operations $771 $129 16.8%
Acquisition integration $71 $14 20.0%
Fair value adjustment for BSX stock
and related gain-sharing aspect $124 $49 39.8%
Cost reduction initiatives and other $70 $15 20.0%
Continuing Operations, excluding
specified items $1,036 $207 20.0%
Q10) How does the lower 2007 tax rate affect 2007 earnings-per-share
guidance?
A10) As indicated above, the lower tax rate is expected to be sustainable
in 2007 and going forward. Abbott is now assuming this rate in its
increased full-year earnings-per-share guidance, but is now also
reflecting a more conservative financial planning assumption for
Omnicef in its forecasts for 2007 and beyond. If sales of Omnicef
exceed assumptions in the current forecasts, this would provide
either additional spending capacity or the potential for additional
earnings.
Q11) What are some near-term opportunities in Abbott's broad-based
pipeline?
A11) Abbott is making significant progress across a number of late-stage
programs in its broad-based pipeline, including:
-- HUMIRA
- Crohn's disease - On February 27, Abbott received U.S. FDA
approval, with European approval expected in the second-quarter
2007.
- Psoriasis - On April 2, Abbott announced its submission for
global regulatory approval.
- Juvenile RA - Abbott plans to submit for regulatory approval in
the second-quarter 2007.
- Ulcerative colitis - Entered into Phase III development in 2006.
-- XIENCE V Drug-eluting Stent - Abbott expects to submit XIENCE V
for U.S. approval in the second quarter of 2007, on track for a
U.S. launch in the first half of 2008. As a reminder, XIENCE V was
launched in Europe and Asia in 2006. Abbott has additional
next-generation drug-eluting stents in development, including a
bioabsorbable drug-eluting stent.
-- Controlled-release Vicodin - Abbott is developing a
controlled-release form of its pain brand, Vicodin, which is
currently in Phase III development. Abbott plans to submit for
regulatory approval in the second half of 2007.
-- New Coated Niaspan Tablet - In April, Abbott received U.S. FDA
approval for the new coated Niaspan tablet, a leading therapy for
raising HDL cholesterol.
-- Simcor - Abbott expects to file for regulatory approval of Simcor,
a combination therapy to address both HDL and LDL cholesterol, in
the second quarter.
-- ABT-335 - Abbott's next-generation fenofibrate is currently in
Phase III development both as a stand-alone therapy and in
combination with CRESTOR. Regulatory submission for the
stand-alone therapy is expected in the second half of 2007.
-- ABT-335 or TriCor/CRESTOR - Abbott's combination therapy of TriCor
or ABT-335 with CRESTOR is in Phase III development. This
single-pill combination therapy will address all three lipid
parameters: HDL, LDL and triglycerides.
-- 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 and will enter Phase III development for
psoriasis later this year.
-- Diabetes Care Pipeline - On April 16, Abbott received U.S. FDA
approval for the FreeStyle Lite blood glucose monitor that
improves convenience for people with diabetes. Abbott's FreeStyle
Navigator Continuous Glucose Monitoring System remains under
active U.S. FDA review. Beyond the FreeStyle Navigator, a fully
integrated blood glucose monitoring system combining a meter, test
strips and lancing capabilities in one device is also in
development. Abbott continues to update and refresh its FreeStyle
and Precision product lines.
-- m2000 Molecular Diagnostics System - Abbott expects to receive
U.S. FDA approval for the m2000 automated instrument system as
well as the RealTime HIV-1 viral load test in the second quarter
of this year. The real-time PCR hepatitis B assay was recently
approved in Europe, expanding the m2000 system's growing menu of
tests and completing the menu for infectious disease assays in
Europe.
Q12) What contributed to TAP joint venture income this quarter?
A12) Income from the TAP joint venture of $147 million was above previous
forecasts due largely to a favorable outcome reached this quarter in
a Lupron patent dispute. This contributed $0.02 per share to earnings
this quarter. As a result, Abbott is raising its ongoing
earnings-per-share guidance for the full-year 2007.
Q13) How does the announced divestiture of the core laboratory diagnostics
business impact total sales reported in 2006?
A13) The following schedule details Abbott's total sales as they were
reported in 2006, details the business to be divested, and provides
the resulting total sales from Continuing Operations (dollars in
millions):
As
Previously Discontinued Continuing
1Q06 Reported Operations Operations
Total Sales $5,183 $603 $4,580
U.S. Sales $2,674 $169 $2,505
International Sales $2,509 $434 $2,075
2Q06
Total Sales $5,501 $666 $4,835
U.S. Sales $2,750 $173 $2,577
International Sales $2,751 $493 $2,258
3Q06
Total Sales $5,574 $670 $4,904
U.S. Sales $2,846 $179 $2,667
International Sales $2,728 $491 $2,237
4Q06
Total Sales $6,218 $704 $5,514
U.S. Sales $3,264 $182 $3,082
International Sales $2,954 $522 $2,432
Full-Year 2006
Total Sales $22,476 $2,643 $19,833
U.S. Sales $11,534 $703 $10,831
International Sales $10,942 $1,940 $9,002
Website: http://www.abbott.com/ |
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