SCHERING-PLOUGH 
By Transformed Company Delivers Solid Financial Performance, Continues to Advance Industry-Leading Late-Stage Pipeline
"Schering-Plough powered through to deliver a solid performance in the first quarter," said
"The people of Schering-Plough can take pride in executing a remarkable transformation of this company over the past six years of our Action Agenda, including the successful acquisition of Organon BioSciences," said Hassan. "They triumphed over the huge challenges we faced in '03 and '04, and then again in '08."
Looking ahead to the company's planned merger with Merck announced on
For the 2009 first quarter, Schering-Plough reported net income available to common shareholders of
GAAP net sales for the 2009 first quarter totaled
"We are gratified that we were able to drive both operational sales growth and reconciled earnings growth, in the midst of a severe global recession," said Hassan. "And at a time when regulatory approvals for new chemical entities are scarce, we achieved the first major market approval of SIMPONI (golimumab) - one of our 'Five Stars' - in
Schering-Plough's operations are becoming more efficient and cost-effective through the company's Productivity Transformation Program (PTP), launched in
Schering-Plough's transformation over the past six years is evidenced by the following achievements:
-- Building an industry-leading product pipeline, with six projects
designated "fast track" by the U.S. Food and Drug
Administration and 12 new entities in late-stage development, including
eight in Phase III and four in pre-registration;
-- Achieving greater geographic and product diversity, by expanding into
newer markets, adding new therapeutic areas, creating a leading global
animal health business, and growing the consumer business through
successful Rx-to-OTC switches;
-- Increasing the number of marketed products with sales above $1 billion
from none in 2003 to five in 2008 (REMICADE, NASONEX and TEMODAR - as
well as VYTORIN and ZETIA in the cholesterol joint venture);
-- Adding more than $12 billion to adjusted net sales, from $8.6 billion in
2003 to $20.8 billion in 2008;
-- Strengthening the company's financial position, going from negative
free cash flow of nearly $1 billion in 2003 to generating positive free
cash flow of more than $2 billion in 2008;
-- Successfully seeking, negotiating and integrating important and
value-creating transactions, such as the acquisition of Organon
BioSciences (OBS).
First Quarter 2009 Results
For the 2009 first quarter, Schering-Plough reported net income available to common shareholders of
GAAP net sales for the 2009 first quarter totaled
Net sales of the cholesterol franchise, which include sales of the cholesterol joint venture plus sales recorded by Schering-Plough in non-joint venture territories such as
Sales of Prescription Pharmaceuticals for the 2009 first quarter decreased 5 percent to
Sales of REMICADE increased 2 percent (22 percent operational growth offset by 20 percent unfavorable foreign exchange impact) to
Global sales of NASONEX, an inhaled nasal corticosteroid for allergies, totaled
Sales of TEMODAR, a treatment for certain types of brain tumors, increased 5 percent (16 percent operational growth offset by 11 percent unfavorable foreign exchange impact) to
Sales of PEGINTRON for hepatitis C decreased 4 percent (2 percent operational growth offset by 6 percent unfavorable foreign exchange impact) to
In women's health care, sales of FOLLISTIM/PUREGON, a fertility treatment, decreased 10 percent (1 percent operational decrease and 9 percent unfavorable foreign exchange impact) to
Global sales of CLARINEX, a nonsedating antihistamine, were
Sales of prescription CLARITIN were
Animal Health sales totaled
Consumer Health Care sales were
Overall, Schering-Plough shares in approximately 50 percent of the profits of the joint venture with Merck, although there are different profit-sharing arrangements for the cholesterol products in countries around the world. Schering-Plough records its share of the income from operations in "Equity income," which totaled
Schering-Plough does not record sales of its cholesterol joint venture and incurs substantial costs such as selling, general and administrative costs that are not reflected in "Equity income" and are borne by the overall cost structure of Schering-Plough. As a result, Schering-Plough's gross margin and ratios of selling, general and administrative (SG&A) expenses and R&D expenses as a percentage of sales do not reflect the benefit of the impact of the cholesterol joint venture's operating results.
Schering-Plough's gross margin on a GAAP basis was unfavorably affected by purchase accounting adjustments and totaled 68.2 percent for the 2009 first quarter as compared to 54.1 percent in the 2008 period. Excluding purchase accounting adjustments, the gross margin percentage increased to 71.0 percent for the first quarter of 2009 as compared to 68.9 percent for the first quarter of 2008, primarily due to a favorable impact from foreign exchange.
SG&A expenses were
Research and development spending for the 2009 first quarter totaled
Update on Merger with Merck
The previously announced merger with Merck remains on track. Merger pre-integration planning teams have been established at both Schering-Plough and Merck, and these teams have been meeting collaboratively in order to plan for a smooth and effective integration. Until the merger closes, both companies will continue to operate independently. The transaction is subject to approval by Schering-Plough and Merck shareholders and the satisfaction of customary closing conditions and regulatory approvals, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as clearance by the European Commission under the EC Merger Regulation and certain other foreign jurisdictions.
Recent Developments
The company also offered the following summary of recent significant developments that have previously been announced, including:
-- Responded to the FDA's complete response letter for SAPHRIS
(asenapine) sublingual tablets, which was received in January 2009.
SAPHRIS is under review for the acute treatment of schizophrenia in
adults and for the acute treatment of manic or mixed episodes associated
with bipolar I disorder in adults as monotherapy. (Announced Feb. 20,
2009)
-- Announced a license agreement between Nobilon, Schering-Plough's
human vaccine business unit, and the World Health Organization to
provide access to pandemic influenza vaccine manufacturing technology to
developing countries. (Announced Feb. 23)
-- Launched AFRIN PureSea(TM) Hydrating Nasal Rinse. (Announced March 3)
-- Received European Commission (EC) and FDA approvals for an intravenous
formulation of temozolomide, a chemotherapy treatment for certain
primary brain tumors, and received EC approval for a sachet packaging
presentation for TEMODAL Capsules. (Announced March 5)
-- Received FDA approval for expanded labeling for PEGINTRON and REBETOL
combination therapy allowing for retreatment of chronic hepatitis C
patients 3 years of age and older with compensated liver disease who
have failed prior therapy. (Announced March 11)
-- Reported on a Phase II study published in The Lancet of the
company's novel oral thrombin receptor antagonist (TRA), which
showed no increase in TIMI major and minor bleeding and was well
tolerated when given with standard platelet therapy. (Announced March
12)
-- Initiated the first-in-human clinical development program for a new
intranasal Live Attenuated Influenza Vaccine for annual seasonal use by
Nobilon, Schering-Plough's human vaccine business unit. (Announced
March 13)
-- Named a 2009 ENERGY STAR Partner of the Year by the U.S. Environmental
Protection Agency for outstanding energy management and reductions in
greenhouse gas emissions. (Announced March 30)
-- Reported on a study showing that early use of an investigational dose of
INTEGRILIN in patients with Acute Coronary Syndrome was not superior to
delayed provisional use. (Announced March 30)
-- Reported on the Dieter Luetticken Award 2008 for alternatives in animal
testing, sponsored by Intervet/Schering-Plough Animal Health.
(Announced April 7)
-- Gained approval in Canada for SIMPONI, the first once-monthly,
subcutaneous therapy for rheumatoid arthritis, psoriatic arthritis and
ankylosing spondylitis, marking the first approval in the world for this
innovative new product. (Announced April 13)
First Quarter 2009 Conference Call and Webcast
Schering-Plough will conduct a conference call today at
DISCLOSURE NOTICE: The information in this press release, the comments of Schering-Plough officers during the earnings teleconference/webcast on
A number of risks and uncertainties could cause results to differ materially from forward-looking statements, including, among other uncertainties, market viability of the company's (and the cholesterol joint venture's) marketed and pipeline products; market forces; economic factors such as interest rate and exchange rate fluctuations; the outcome of contingencies such as litigation and investigations; product availability; patent and other intellectual property protection; current and future branded, generic or over-the-counter competition; the regulatory process (including product approvals, labeling and post-marketing actions); scientific developments relating to marketed products or pipeline projects; media and societal reaction to such developments; and the ability of Schering-Plough and Merck to obtain governmental and self-regulatory organization approvals of the merger on the proposed terms and schedule. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. "Risk Factors" in the 2008 10-K, filed
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in
SCHERING-PLOUGH CORPORATION
U.S. GAAP report for the first quarter ended March 31 (unaudited):
(Amounts in millions, except per share figures)
First Quarter
2009 2008
Net sales $4,393 $4,657
Cost of sales 1/ 1,399 2,137
Selling, general and administrative 1,493 1,676
Research and development 804 880
Other expense/(income), net 88 95
Special, merger and acquisition-related
charges 2/ 75 23
Equity income (400) (517)
Income before income taxes 934 363
Income tax expense 129 49
Net income $805 $314
Preferred stock dividends 38 38
Net income available to common
shareholders $767 $276
Diluted earnings per common share $0.46 $0.17
Average shares outstanding - common
and participating - diluted 3/ 1,739 1,637
The company incurs substantial costs related to the cholesterol joint
venture, such as selling, general and administrative costs, that are not
reflected in "Equity income" and are borne by the overall cost structure
of Schering-Plough.
1/ Cost of sales for the three months ended March 31, 2009 includes
purchase accounting adjustments of $125 million and accelerated
depreciation of $2 million. For the three months ended March 31, 2008,
cost of sales includes purchase accounting adjustments of $688 million.
2/ Special, merger and acquisition-related charges relate to the
Productivity Transformation Program (PTP) and costs incurred related
to the proposed merger with Merck. For the three months ended March 31,
2009 and 2008, these charges were $75 million ($56 million for
severance costs and $19 million for merger costs) and $23 million
($8 million for severance costs and $15 million for integration-related
costs), respectively.
3/ For the three months ended March 31, 2009, the increase in average
shares outstanding is due to the preferred shares being dilutive under
accounting rules. For the three months ended March 31, 2008, the
preferred shares were anti-dilutive.
SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net Income Available to Common Shareholders
and Reported Diluted Earnings Per Common Share to As Reconciled Amounts for Net Income
Available to Common Shareholders and Diluted Earnings per Common Share
(Amounts in Millions, except per share figures)
To supplement its consolidated financial statements presented in accordance with accounting principles generally accepted in
"As Reconciled" amounts related to Net income available to common shareholders and Diluted earnings per common share are non-U.S. GAAP measures used by management in evaluating the performance of Schering-Plough's overall business. The effects of purchase accounting adjustments, special, merger and acquisition-related items and other specified items have been excluded from Net income available to common shareholders and Diluted earnings per common share as management of Schering-Plough does not consider these items to be indicative of continuing operating results. Schering-Plough believes that these "As Reconciled" performance measures contribute to a more complete understanding by investors of the overall results of the company and enhance investor understanding of items that impact the comparability of results between fiscal periods. Net income available to common shareholders and Diluted earnings per common share, as reported, are required to be presented under U.S. GAAP.
Three months ended March 31, 2009
(unaudited)
Special,
Purchase Merger and
Accounting Acquisition- Other As
As Adjust- Related Specified Reconciled
Reported ments Items Items (1)
Net sales $4,393 $- $- $- $4,393
Cost of sales 1,399 (125) (2) - 1,272
Selling, general
and administrative 1,493 (2) - - 1,491
Research and
development 804 (2) (2) - 800
Other expense/
(income), net 88 - - - 88
Special, merger and
acquisition-related
charges 75 - (75) - -
Equity income (400) - - - (400)
Income before
income taxes 934 129 79 - 1,142
Income tax expense/
(benefit) 129 (32) (7) - 168
Net income $805 $97 $72 $ - $974
Preferred stock dividends 38 - - - 38
Net income available to
common shareholders $767 $97 $72 $- $936
Diluted earnings per
common share $0.46 $0.56
Average shares
outstanding - common
and participating -
diluted 1,739 1,739
(1) "As Reconciled" to exclude purchase accounting adjustments, special,
merger and acquisition-related items and other specified items.
SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net Income Available to Common Shareholders
and Reported Diluted Earnings Per Common Share to As Reconciled Amounts
for Net Income
Available to Common Shareholders and Diluted Earnings per Common Share
(Amounts in Millions, except per share figures)
Three months ended March 31, 2008
(unaudited)
Purchase Special and
Accounting Acquisition- Other As
As Adjust- Related Specified Reconciled
Reported ments Items Items (1)
Net sales $4,657 $- $- $- $4,657
Cost of sales 2,137 (688) - - 1,449
Selling, general
and administrative 1,676 (1) - - 1,675
Research and
development 880 (2) - - 878
Other expense/
(income), net 95 - - 17 112
Special and acquisition-
related charges 23 - (23) - -
Equity income (517) - - - (517)
Income before income
taxes 363 691 23 (17) 1,060
Income tax expense/
(benefit) 49 (114) (2) 5 160
Net income $314 $577 $21 $(12) $900
Preferred stock dividends 38 - - - 38
Net income available to
common shareholders $276 $577 $21 $(12) $862
Diluted earnings per
common share $0.17 $0.53
Average shares
outstanding - common
and participating -
diluted 1,637 1,637
(1) "As Reconciled" to exclude purchase accounting adjustments, special
and acquisition-related items and other specified items.
SCHERING-PLOUGH CORPORATION
Reconciliation from Reported Net Income Available to Common Shareholders
and Reported Diluted Earnings Per Common Share to As Reconciled Amounts
for Net Income
Available to Common Shareholders and Diluted Earnings per Common Share
(Amounts in Millions)
"As Reconciled" amounts related to Net income available to common
shareholders and Diluted earnings per common share reflect the following
adjustments:
First Quarter
(unaudited)
2009 2008
Purchase accounting adjustments:
Amortization of intangibles in
connection with the acquisition of
Organon BioSciences (a) $118 $132
Depreciation related to the fair value
adjustment of fixed assets related to
the acquisition of Organon BioSciences (b) 11 8
Charge related to the fair value
adjustment to inventory related to the
acquisition of Organon BioSciences (a) - 551
Total purchase accounting adjustments, pre-tax 129 691
Income tax benefit 32 114
Total purchase accounting adjustments $97 $577
Special, merger and acquisition-related items:
Special, merger and integration-related
activities (a)/(d)/(e) $79 $23
Total special and acquisition-related
items, pre-tax 79 23
Income tax benefit 7 2
Total special, merger and
acquisition-related items $72 $21
Other specified items:
(Gain) on sale of manufacturing plant (c) $- $(17)
Total other specified items, pre-tax - (17)
Income tax expense - 5
Total other specified items $- $(12)
Total purchase accounting adjustments,
special and acquisition-related items
and other specified items $169 $586
(a) Included in Cost of sales
(b) Included in Cost of sales, Selling, general and administrative and
Research and development
(c) Included in Other expense/(income), net
(d) Included in Special, merger and acquisition-related charges
(e) Included in research and development
SCHERING-PLOUGH CORPORATION
Report for the period ended March 31 (unaudited):
GAAP Net Sales by Key Product
(Dollars in millions) First Quarter
2009 2008 %
PRESCRIPTION PHARMACEUTICALS $3,379 $3,557 (5%)
REMICADE 518 507 2%
NASONEX 306 307 -
TEMODAR 247 236 5%
PEGINTRON 216 225 (4%)
CLARINEX / AERIUS 174 213 (19%)
CLARITIN RX 132 128 3%
FOLLISTIM / PUREGON 131 145 (10%)
NUVARING 115 96 19%
AVELOX 109 142 (23%)
INTEGRILIN 76 74 3%
REBETOL 66 59 12%
CAELYX 61 74 (18%)
INTRON A 54 55 (3%)
PROVENTIL / ALBUTEROL CFC 54 50 7%
REMERON 50 68 (26%)
SUBUTEX / SUBOXONE 50 54 (7%)
ASMANEX 49 42 16%
ELOCON 41 45 (8%)
CERAZETTE 39 44 (10%)
NOXAFIL 39 34 15%
IMPLANON 37 38 (2%)
MERCILON 35 43 (19%)
LIVIAL 33 45 (26%)
ZEMURON 32 63 (49%)
MARVELON 31 37 (16%)
FORADIL 23 25 (8%)
Other Pharmaceuticals 661 708 (7%)
ANIMAL HEALTH 630 723 (13%)
CONSUMER HEALTH CARE 384 377 2%
OTC 232 209 11%
OTC CLARITIN 149 139 8%
MiraLAX 37 26 43%
Other OTC 46 44 3%
Foot Care 73 85 (14%)
Sun Care 79 83 (5%)
CONSOLIDATED GAAP NET SALES $4,393 $4,657 (6%)
NOTE: Additional information about U.S. and international sales for
specific products is available by calling the company or
visiting the Investor Relations Web site at
http://ir.schering-plough.com.
SCHERING-PLOUGH CORPORATION
Reconciliation of Non-U.S. GAAP Financial Measures
Adjusted net sales, defined as Net sales plus an assumed 50 percent of
global cholesterol joint venture net sales.
(Dollars in millions) Three months ended March 31,
(unaudited)
2009 2008 %
Net sales, as reported $4,393 $4,657 (6%)
50 percent of cholesterol joint venture
net sales a/ 466 607 (23%)
Adjusted net sales a/ $4,859 $5,264 (8%)
a/ Total Net sales of the cholesterol joint venture for the three months
ended March 31, 2009 and 2008 were $931 million and $1.2 billion,
respectively.
NOTE: Adjusted net sales, defined as net sales plus an assumed 50 percent
of global cholesterol joint venture net sales, is a non-U.S. GAAP
measure used by management in evaluating the performance of
Schering-Plough's overall business. Schering-Plough believes that
this performance measure contributes to a more complete
understanding by investors of the overall results of the company.
Schering-Plough provides this information to supplement the
reader's understanding of the importance to the company of its
share of results from the operations of the cholesterol joint
venture. Net sales (excluding the cholesterol joint venture net
sales) is required to be presented under U.S. GAAP. The cholesterol
joint venture's net sales are included as a component of income
from operations in the calculation of Schering-Plough's "Equity
income." Net sales of the cholesterol joint venture do not include
net sales of cholesterol products in non-joint venture territories.
SOURCE Schering-Plough Corporation
