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| BAX > SEC Filings for BAX > Form 10-Q on 31-Oct-2008 | All Recent SEC Filings |
31-Oct-2008
Quarterly Report
RESULTS OF OPERATIONS
NET SALES
Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
BioScience $ 1,354 $ 1,099 23% $ 3,949 $ 3,440 15%
Medication Delivery 1,157 1,047 11% 3,386 3,076 10%
Renal 593 560 6% 1,749 1,638 7%
Transition services to
Fenwal Inc. 47 44 7% 133 100 33%
Total net sales $ 3,151 $ 2,750 15% $ 9,217 $ 8,254 12%
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Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
International $ 1,879 $ 1,539 22% $ 5,525 $ 4,708 17%
United States 1,272 1,211 5% 3,692 3,546 4%
Total net sales $ 3,151 $ 2,750 15% $ 9,217 $ 8,254 12%
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Foreign currency fluctuations benefited sales growth by 6 and 7 percentage points in the three- and nine-month periods ended September 30, 2008, respectively, principally due to the weakening of the U.S. Dollar relative to the Euro in both periods.
Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
Total net sales $ 3,151 $ 2,750 15% $ 9,217 $ 8,254 12 %
Pre-divestiture sales
of Transfusion
Therapies products
(included in
BioScience segment
through the
February 28, 2007
divestiture date) - - N/A - 79 (100 %)
Transition services to
Fenwal Inc.
(subsequent to the
February 28, 2007
divestiture date) 47 44 7% 133 100 33 %
Total net sales
excluding Transfusion
Therapies $ 3,104 $ 2,706 15% $ 9,084 $ 8,075 12 %
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Net sales excluding Transfusion Therapies (TT) increased 15% and 12% in the
three- and nine-month periods ended September 30, 2008 (including a 6 percentage
point favorable impact from foreign currency fluctuations for both the three-
and nine-month periods ended September 30, 2008). Management believes that net
sales and sales growth excluding TT facilitates a more meaningful analysis of
the company's net sales growth due to the divestiture of this business in 2007.
See Note 3 for further information regarding the divestiture of the TT business.
BioScience
Net sales in the BioScience segment increased 23% and 15% for the three- and
nine-month periods ended September 30, 2008 (including a 6 and 7 percentage
point favorable impact from foreign currency fluctuations in the three- and
nine-month periods ended September 30, 2008, respectively).
The following is a summary of sales by significant product line.
Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
Recombinants $ 516 $ 432 19% $ 1,460 $ 1,251 17 %
Plasma Proteins 338 246 37% 889 714 25 %
Antibody Therapy 307 245 25% 908 705 29 %
Regenerative Medicine 104 82 27% 307 251 22 %
Transfusion Therapies - - N/A - 79 (100 %)
Other 89 94 (5% ) 385 440 (13 %)
Total net sales $ 1,354 $ 1,099 23% $ 3,949 $ 3,440 15 %
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Recombinants
The primary driver of sales growth in the Recombinants product line during the
third quarter and first nine months of 2008 was increased sales volume of
recombinant factor VIII therapies. Factor VIII products are used in the
treatment of hemophilia A, which is a bleeding disorder caused by a deficiency
in blood clotting factor VIII. Sales growth was fueled by the continuing
adoption by customers of the advanced recombinant therapy, ADVATE
(Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM, with
strong patient conversion in both the United States and international markets,
and increased demand for new dosage forms that reduce both the volume of drug
and infusion time required for hemophilia patients needing high doses of factor
VIII.
Plasma Proteins
Plasma Proteins include specialty therapeutics, such as FEIBA, an anti-inhibitor
coagulant complex, and ARALAST (alpha 1-proteinase inhibitor (human)) for the
treatment of hereditary emphysema, plasma-derived hemophilia treatments and
albumin. Sales growth in the third quarter and first nine months of 2008 was
driven by growth across all plasma protein products, including albumin, FEIBA,
plasma-derived factor VIII and ARALAST, as a result of strong demand and pricing
improvements, primarily for albumin, as well as the timing of international
tenders.
Antibody Therapy
Higher sales of IGIV (immune globulin intravenous), which is used in the
treatment of immune deficiencies, fueled sales growth during the third quarter
and first nine months of 2008, with increased volume, continuing improvements in
pricing in the United States, and continuing customer conversions to the liquid
formulation of the product. Because it does not need to be reconstituted prior
to infusion, the higher-yielding liquid formulation offers added convenience for
clinicians and patients.
Regenerative Medicine
This product line principally includes plasma-based and non-plasma-based
biosurgery products for hemostasis (the stoppage of bleeding) and wound-sealing.
Growth in the third quarter and first nine months of 2008 was driven by
increased sales volume of the company's portfolio of fibrin sealant products,
FLOSEAL, COSEAL and TISSEEL.
Transfusion Therapies
The Transfusion Therapies product line included products and systems for use in
the collection and preparation of blood and blood components. See Note 3 for
information regarding the company's February 28, 2007 sale of substantially all
of the assets and liabilities of this business.
Other
Other BioScience products primarily consist of vaccines and sales of plasma to
third parties. The decrease in sales in this product line in the third quarter
of 2008 was primarily due to the impact of lower milestone revenue associated
with the development of a candidate pandemic vaccine and a seasonal influenza
vaccine for the U.S. government. The decrease in sales in this product line in
the first nine months of 2008 was primarily due to the transfer of marketing and
distribution rights for recombinant FIX (BeneFIX) back to Wyeth effective
June 30, 2007. Sales of BeneFIX were approximately $110 million through the
June 30, 2007 transition date. Also contributing to the decrease in sales in the
year-to-date period were significant shipments of candidate H5N1 influenza
vaccine to various governments worldwide in the first quarter of 2007. Partially
offsetting these declines in the first nine months of 2008 were strong
international sales of FSME Immun (for the prevention of tick-borne
encephalitis), due to both volume and pricing improvements. Sales of vaccines
may fluctuate from period to period based on the seasonal nature of demand,
timing of government tenders and new supply agreements.
Medication Delivery
Net sales in the Medication Delivery segment increased 11% and 10% for the
three- and nine-month periods ended September 30, 2008 (including a 5 percentage
point favorable impact from foreign currency fluctuations for both the three-
and nine-month periods ended September 30, 2008).
The following is a summary of sales by significant product line.
Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
IV Therapies $ 403 $ 346 16% $ 1,182 $ 1,012 17 %
Global Injectables 403 372 8% 1,164 1,114 4 %
Infusion Systems 235 207 14% 684 624 10 %
Anesthesia 112 111 1% 333 296 13 %
Other 4 11 (64% ) 23 30 (23 %)
Total net sales $ 1,157 $ 1,047 11% $ 3,386 $ 3,076 10 %
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IV Therapies
This product line principally consists of intravenous (IV) solutions and
nutritional products. Growth for the third quarter and first nine months of 2008
was principally driven by increased demand for IV therapy products in Europe,
Latin America, and Asia, and strong international sales of nutritional products.
Also impacting sales growth in the third quarter and first nine months of 2008
were pricing improvements for IV therapy products in the United States.
Global Injectables
This product line primarily consists of the company's pharmaceutical company
partnering business, enhanced packaging, premixed drugs and generic injectables.
Sales growth in the third quarter and first nine months of 2008 was driven by
strong international sales in the pharmacy-compounding business, partially
offset by lower sales of generic injectables. In the year-to-date period, lower
sales of generic injectables was principally driven by the transfer of marketing
and distribution rights for generic propofol back to Teva Pharmaceutical
Industries Ltd. effective July 1, 2007. Sales of propofol totaled approximately
$35 million in the first nine months of 2007.
Infusion Systems
Sales growth in the third quarter and first nine months of 2008 was driven by
increased revenues relating to COLLEAGUE infusion pumps which remain in use as
the remediation plan is executed and increased sales of disposable tubing sets
used in the administration of IV solutions. Refer to Note 4 and the "Certain
Regulatory Matters" section below for additional information related to the
COLLEAGUE infusion pump.
Anesthesia
Sales in this product line in the third quarter of 2008 benefited from strong
international sales of SUPRANE (desflurane, USP) and sevoflurane. However, sales
growth of SUPRANE in the United States in the third quarter of 2008 was
negatively impacted by wholesaler purchasing patterns. Sales growth in the first
nine months of 2008 was driven by the launch of sevoflurane in additional
geographic markets and strong global sales of SUPRANE.
Renal
Net sales in the Renal segment increased 6% and 7% for the three- and nine-month
periods ended September 30, 2008 (including a 7 and 8 percentage point favorable
impact from foreign currency fluctuations in the three- and nine-month periods
ended September 30, 2008, respectively).
The following is a summary of sales by significant product line.
Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
PD Therapy $ 480 $ 448 7% $ 1,404 $ 1,310 7 %
HD Therapy 113 112 1% 345 328 5 %
Total net sales $ 593 $ 560 6% $ 1,749 $ 1,638 7 %
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PD Therapy
Peritoneal dialysis, or PD Therapy, is a home dialysis treatment for end-stage
renal disease. PD Therapy uses the peritoneal membrane, or abdominal lining, as
a natural filter to remove waste from the bloodstream. Excluding the impact of
foreign currency, sales were flat in the third quarter and declined slightly in
the first nine months of 2008, as increased numbers of patients in Asia
(particularly in China), the United States, and Central and Eastern Europe were
more than offset by the loss of a government tender in Mexico in the first
quarter of 2008. Increased penetration of PD Therapy products continues to be
strong in emerging markets, where many people with end-stage renal disease are
currently under-treated.
HD Therapy
Hemodialysis, or HD Therapy, is another form of end-stage renal disease dialysis
therapy that is generally performed in a hospital or outpatient center. In HD
Therapy, the patient's blood is pumped outside the body to be cleansed of wastes
and fluid using a machine and an external filter, also known as a dialyzer. The
favorable impact of foreign currency fluctuations in the third quarter and first
nine months of 2008 were partially offset by lower saline sales.
Transition Services to Fenwal Inc.
Net sales in this category represents revenues associated with manufacturing,
distribution and other services provided by the company to Fenwal Inc. (Fenwal)
subsequent to the divestiture of the TT business on February 28, 2007. See Note
3 for further information.
GROSS MARGIN AND EXPENSE RATIOS
Three months ended Nine months ended
September 30, September 30,
2008 2007 Change 2008 2007 Change
Gross margin 48.3% 50.0% (1.7 pts ) 49.1% 48.9% 0.2 pts
Marketing and
administrative
expenses 21.6% 24.1% (2.5 pts ) 22.0% 22.6% (0.6 pts )
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Gross Margin
The gross margin in both the third quarter and the first nine months of 2008
benefited from continued customer conversion to ADVATE and the liquid
formulation of IGIV, manufacturing efficiencies and improved volumes and pricing
for certain plasma protein and other products.
Included in the company's gross margin in 2008 were charges of $125 million
related to COLLEAGUE infusion pumps (with $72 million recorded in the third
quarter and $53 million recorded in the first quarter) and a $19 million charge
in the first quarter related to the company's recall of its heparin products in
the United States. These charges decreased the gross margin by 2.3 percentage
points in the third quarter and 1.6 percentage points in the year-to-date
period. Refer to Note 4 for further information on these charges. Also
negatively impacting the gross margin in both periods were increased raw
material costs.
Marketing and Administrative Expenses
The decline in the marketing and administrative expense ratios for the third
quarter and first nine months of 2008 was principally due to leverage from
higher sales, stronger cost controls and the impact of the third quarter 2007
charge of $56 million to establish reserves related to the average wholesale
pricing (AWP) litigation, partially offset by an increase in stock compensation
costs and spending related to certain marketing programs, particularly in the
BioScience segment.
RESEARCH AND DEVELOPMENT
Three months ended Nine months ended
September 30, Percent September 30, Percent
(in millions) 2008 2007 change 2008 2007 change
Research and
development (R&D)
expenses $230 $203 13% $642 $539 19%
As a percent of sales 7.3% 7.4% 7.0% 6.5%
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R&D expenses increased during the third quarter and first nine months of 2008 with strong growth in spending on R&D projects across all three of the company's businesses, particularly BioScience, reflecting the company's
commitment to accelerate R&D investments. Foreign currency fluctuations also
contributed to the increase in R&D expenses in both periods.
Included in R&D expenses in the third quarter of 2008 was a $12 million
in-process R&D (IPR&D) charge related to an in-licensing agreement with Innocoll
Pharmaceuticals Ltd. (Innocoll) to market and distribute Innocoll's gentamicin
surgical implant in the United States upon receipt of regulatory approval.
Included in R&D expenses in the third quarter of 2007 was a $25 million IPR&D
charge related to a collaboration for the development of a next-generation home
HD machine with HHD, LLC, and a $10 million IPR&D charge related to an
in-licensing arrangement with Halozyme Therapeutics, Inc. (Halozyme). The nine
months ended September 30, 2007 also included an $11 million IPR&D charge
relating to the acquisition of certain assets of MAAS Medical, LLC (MAAS
Medical). Refer to Note 2 for additional information regarding the company's
in-licensing agreement with Innocoll and the 2007 Annual Report for a discussion
of the company's R&D pipeline, arrangements with HHD, LLC and Halozyme and the
acquisition of MAAS Medical.
2007 RESTRUCTURING CHARGE
During 2007, the company recorded a restructuring charge of $70 million
principally associated with the consolidation of certain commercial and
manufacturing operations outside of the United States. Based upon a review of
current and future capacity needs, the company decided to integrate several
facilities in order to reduce the company's cost structure and optimize the
company's operations.
Included in the charge was $17 million related to asset impairments and
$53 million for cash costs, principally pertaining to severance and other
employee-related costs. The reserve for cash costs is expected to be
substantially utilized by the end of 2009. Refer to Note 4 for further
information, including reserve utilization through September 30, 2008. The
company believes that the reserves are adequate. However, adjustments may be
recorded in the future as the programs are completed. Cash expenditures are
being funded with cash generated from operations.
NET INTEREST EXPENSE
Net interest expense was $20 million and $6 million in the third quarters of
2008 and 2007, respectively, and $62 million and $10 million for the nine months
ended September 30, 2008 and 2007, respectively. The increased expense was
driven by lower interest rates and higher average debt levels, principally due
to the December 2007 issuance of $500 million of senior unsecured notes and the
May 2008 issuance of $500 million of senior unsecured notes. The increase in net
interest expense for the nine months ended September 30, 2008 was also driven by
lower average cash balances.
OTHER EXPENSE, NET
Other expense, net was $32 million and $21 million in the third quarters of 2008
and 2007, respectively, and $36 million and $28 million for the nine-month
periods ended September 30, 2008 and 2007, respectively. Other expense, net in
both periods included amounts relating to foreign exchange, minority interests
and equity method investments. Included in other expense, net for the three and
nine months ended September 30, 2008 was a third quarter 2008 charge of
$31 million associated with the discontinuation of the company's CLEARSHOT
pre-filled syringe program. Also included in other expense, net for the nine
months ended September 30, 2008 and 2007 was income recognized in the first
quarter of 2007 related to the divestiture of the TT business, which included a
gain on the sale of the TT business of $58 million less related charges of
$35 million, and $16 million of income in the first quarter of 2008 related to
the finalization of the net assets transferred in the TT divestiture. See Note 3
for further information on the TT business divestiture and Note 4 for further
information on the CLEARSHOT charge.
PRE-TAX INCOME
Refer to Note 8 for a summary of financial results by segment. The following is
a summary of significant factors impacting the segments' financial results.
BioScience
Pre-tax income increased 18% and 21% for the three- and nine-month periods ended
September 30, 2008, respectively. The primary drivers of the increase in both
periods were the continued customer conversion to ADVATE and the liquid
formulation of IGIV, improved pricing of certain plasma protein products,
manufacturing
efficiencies and the favorable impact of foreign currency fluctuations.
Partially offsetting this growth was higher spending on new marketing programs
and increased R&D spending related to product development and milestone payments
to partners.
Medication Delivery
Pre-tax income decreased 48% and 22% for the three- and nine-month periods ended
September 30, 2008, respectively. The improvements in product mix, with
increased sales of certain higher-margin products such as SUPRANE, sevoflurane
and nutritional products, as well as the favorable impact of foreign currency
fluctuations, were more than offset by the impact of special charges and
increased spending on R&D. The nine months ended September 30, 2008 included
$125 million of charges related to the COLLEAGUE infusion pump (with $72 million
recorded in the third quarter and $53 million recorded in the first quarter), a
third quarter 2008 charge of $31 million related to the discontinuation of the
CLEARSHOT pre-filled syringe program and a first quarter 2008 charge of $19
million related to the company's recall of its heparin products in the United
States. See Note 4 for further information about these charges.
Renal
Pre-tax income decreased 5% and 12% for the three- and nine-month periods ended
September 30, 2008, respectively. The decrease in both periods was principally
due to the loss of a PD tender in Mexico, and increased spending on new product
development, including a next-generation home HD machine, partially offset by
the favorable impact of foreign currency fluctuations.
Other
Certain items are maintained at the company's corporate level and are not
allocated to the segments. These items primarily include net interest expense,
certain foreign currency fluctuations and the majority of the foreign currency
and interest rate hedging activities, stock compensation expense, income and
expense related to certain non-strategic investments, corporate headquarters
costs, certain employee benefit plan costs, certain nonrecurring gains and
losses, IPR&D charges and income related to the manufacturing, distribution and
other transition agreements with Fenwal. Refer to Note 8 for a reconciliation of
segment pre-tax income to income before income taxes per the consolidated income
statements. The significant factors impacting these other items are described
below.
Refer to the discussion above regarding net interest expense, the 2007
restructuring charge, the AWP charge and IPR&D charges.
The increase in stock compensation expense in the quarter and year-to-date
period was principally due to changes in the company's stock compensation
programs, including the granting of performance share units beginning in 2007
and an amendment to the company's employee stock purchase plan effective
January 1, 2008. Refer to the 2007 Annual Report for further information
regarding these changes.
The increase in other corporate expenses, net in the first nine months of 2008
was primarily driven by increased legal and other costs held at corporate and
the impact of the income in the first quarter of 2007 related to the divestiture
of the TT business, partially offset by income in the first quarter of 2008
related to the finalization of the net assets transferred in the divestiture of
the TT business. Refer to Note 3 for further information regarding the
divestiture of the TT business.
INCOME TAXES
The company's effective income tax rates were 15.4% and 18.2% in the third
quarters of 2008 and 2007, respectively, and were 18.1% and 19.1% in the
nine-month periods ended September 30, 2008 and 2007, respectively.
The effective tax rates in the third quarters and first nine months of 2008 and
2007 were impacted by reductions of $29 million and $57 million, respectively,
of valuation allowances on net operating loss carryforwards in foreign
jurisdictions due to profitability improvements, and $14 million and
$84 million, respectively, of additional U.S. income tax expense related to
foreign earnings which are no longer considered indefinitely reinvested outside
of the United States because management planned to remit these earnings to the
United States in the foreseeable future. Also impacting the tax rate in the
2007 year-to-date period was the extension of tax incentives and the settlement
of tax audits in jurisdictions outside of the United States.
INCOME AND EARNINGS PER DILUTED SHARE
Net income was $472 million and $395 million for the three months ended
September 30, 2008 and 2007, respectively, and $1,445 million and $1,229 million
for the nine months ended September 30, 2008 and 2007, respectively. Net income
per diluted share was $0.74 and $0.61 for the three months ended September 30,
2008 and 2007, respectively, and $2.26 and $1.87 for the nine months ended
September 30, 2008 and 2007, respectively. The significant factors and events
contributing to the changes are discussed above.
CRITICAL ACCOUNTING POLICIES
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