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3-Nov-2008
Quarterly Report
Sales
Worldwide sales were $5.94 billion for the third quarter of 2008, a decline of
2% compared with the third quarter of 2007, primarily attributable to a 6%
unfavorable effect from volume, partially offset by a 4% favorable effect from
foreign exchange. The revenue decline in the third quarter largely reflects
lower sales of Fosamax for the treatment and prevention of osteoporosis.
Fosamaxand Fosamax Plus D lost market exclusivity for substantially all
formulations in the United States in February 2008 and April 2008, respectively.
Also contributing to the decline were lower sales of vaccines, including
Zostavax, a vaccine to help prevent shingles (herpes zoster), RotaTeq, a vaccine
to help protect against rotavirus gastroenteritis in infants and children, and
Haemophilus influenzae type b ("HIB") and hepatitis vaccines. Revenue was also
negatively impacted by lower sales of Zocor, the Company's statin for modifying
cholesterol which lost U.S. market exclusivity in 2006, and lower revenue from
the Company's relationship with AstraZeneca LP ("AZLP"). These declines were
partially offset by higher sales of Januvia and Janumet for the treatment of
type 2 diabetes, Isentress for the treatment of HIV infection and Cozaar/Hyzaar*
for the treatment of hypertension.
Worldwide sales were $17.82 billion for the first nine months of 2008, a decline
of 1% compared with the first nine months of 2007, primarily attributable to a
4% unfavorable effect from volume and a 1% unfavorable effect from price
changes, offset by a 4% favorable effect from foreign exchange. The revenue
decline for the first nine months of 2008 reflects lower sales of Fosamax,
decreased revenues from the Company's relationship with AZLP, lower sales of
Zocor and lower sales of vaccines, including hepatitis and HIB vaccines.
Partially offsetting these declines were higher sales of Januvia and Janumet,
Isentress, Cozaar/Hyzaar, RotaTeq and Singulair, a medicine indicated for the
chronic treatment of asthma and the relief of symptoms of allergic rhinitis.
* Cozaar and Hyzaar are registered trademarks of E.I. duPont de Nemours &
Company, Wilmington, Delaware.
Sales of the Company's products were as follows:
Three Months Ended Nine Months Ended
September 30, September 30,
($ in millions) 2008 2007 2008 2007
Pharmaceutical:
Singulair $ 1,029.3 $ 1,018.1 $ 3,214.6 $ 3,111.9
Cozaar/Hyzaar 888.3 813.6 2,676.3 2,458.8
Fosamax 353.9 725.2 1,234.8 2,253.0
Januvia 378.5 184.6 984.4 415.3
Cosopt/Trusopt 208.6 196.8 627.4 575.0
Zocor 157.2 217.8 513.1 654.2
Maxalt 136.4 125.0 388.3 341.5
Propecia 107.9 99.2 320.6 292.8
Arcoxia 96.8 76.1 294.1 245.2
Vasotec/Vaseretic 82.1 119.5 271.5 368.5
Proscar 80.9 89.6 251.9 328.0
Janumet 100.7 18.6 231.5 42.9
Emend 68.2 48.9 193.3 143.6
Other pharmaceutical (1) 519.1 575.4 1,734.2 1,980.2
Vaccine and infectious disease product
sales included in the Pharmaceutical
segment (2) 596.7 456.8 1,686.1 1,328.1
Pharmaceutical segment revenues 4,804.6 4,765.2 14,622.1 14,539.0
Vaccines (3) and Infectious Diseases:
Gardasil 401.0 418.4 1,117.1 1,141.3
RotaTeq 134.5 171.3 502.4 375.4
Zostavax 11.2 61.2 150.8 150.7
ProQuad/M-M-R II/Varivax 430.4 428.5 973.8 1,018.1
Hepatitis vaccines 36.2 68.4 107.9 219.5
Other vaccines 80.6 96.5 222.8 284.6
Primaxin 187.6 185.6 591.5 568.4
Cancidas 147.9 135.2 457.4 403.2
Isentress 107.3 5.4 231.1 11.9
Crixivan/Stocrin 68.5 72.3 222.8 229.9
Invanz 71.1 49.5 197.0 137.4
Other infectious disease 6.3 0.5 9.6 0.8
Vaccine and infectious disease product
sales included in the Pharmaceutical
segment (2) (596.7 ) (456.8 ) (1,686.1 ) (1,328.1 )
Vaccines and Infectious Diseases segment
revenues 1,085.9 1,236.0 3,098.1 3,213.1
Other segment (4) 21.2 44.9 65.3 125.6
Total segment revenues 5,911.7 6,046.1 17,785.5 17,877.7
Other (5) 32.2 28.0 32.4 77.1
$ 5,943.9 $ 6,074.1 $ 17,817.9 $ 17,954.8
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(1) Other pharmaceutical primarily includes sales of other human pharmaceutical products and revenue from the Company's relationship with AZLP primarily relating to sales of Nexium, as well as Prilosec. Revenue from AZLP was $375.2 million and $416.3 million for the third quarter of 2008 and 2007, respectively, and was $1,235.7 million and $1,438.2 million for the first nine months of 2008 and 2007, respectively.
(2) Sales of vaccine and infectious disease products by non-U.S. subsidiaries are included in the Pharmaceutical segment.
(3) These amounts do not reflect sales of vaccines sold in most major European markets through the Company's joint venture, Sanofi Pasteur MSD, the results of which are reflected in Equity income from affiliates. These amounts do, however, reflect supply sales to Sanofi Pasteur MSD.
(4) Includes other non-reportable human and animal health segments.
(5) Other revenues are primarily comprised of miscellaneous corporate revenues, sales related to divested products or businesses and other supply sales not included in segment results.
Sales by product are presented net of discounts and returns. The provision for discounts includes indirect customer discounts that occur when a contracted customer purchases directly through an intermediary wholesale purchaser, known
as chargebacks, as well as indirectly in the form of rebates owed based upon
definitive contractual agreements or legal requirements with private sector and
public sector (Medicaid and Medicare Part D) benefit providers, after the final
dispensing of the product by a pharmacy to a benefit plan participant. These
discounts, in the aggregate, reduced revenues by $529.7 million and $492.4
million for the three months ended September 30, 2008 and 2007, respectively,
and by $1,581.7 million and $1,536.1 million for the nine months ended
September 30, 2008 and 2007, respectively. Inventory levels at key wholesalers
for each of the Company's major pharmaceutical products are generally less than
one month.
Pharmaceutical Segment Revenues
Sales of the Pharmaceutical segment increased 1% for both the third quarter and
first nine months of 2008 to $4.80 billion and $14.62 billion, respectively,
compared with the corresponding periods of 2007. These results reflect growth of
Januvia, Janumet, Isentress and Cozaar/Hyzaar, offset by declines in Fosamax,
Zocor and supply sales to AZLP.
Worldwide sales for Singulair were $1.03 billion for the third quarter of 2008,
representing an increase of 1% over the third quarter of 2007. Sales for the
first nine months of 2008 reached $3.21 billion, a 3% increase over the
comparable prior year period. Sales in the third quarter and first nine months
of 2008 reflect the continued demand for asthma and seasonal and perennial
allergic rhinitis medications. Sales performance for the quarter and
year-to-date period benefited from higher sales outside the United States,
including the positive effect of foreign exchange and volume growth in Europe
and Japan. Sales performance in the United States also reflects the impact of
the switch of a competing allergic rhinitis product to over-the-counter status
in the United States in early 2008, the timing and public reaction to the U.S.
Food and Drug Administration ("FDA") early communication regarding a very
limited number of post-marketing adverse event reports which created uncertainty
in the marketplace, and a shorter and milder spring allergy season. Singulair
continues to be the number one prescribed branded product in the U.S.
respiratory market.
Global sales of Cozaar and Hyzaar were $888.3 million for the third quarter of
2008, an increase of 9% compared with the third quarter of 2007. Sales for the
first nine months of 2008 were $2.68 billion, an increase of 9% compared with
the first nine months of 2007. The increase in both periods was driven in part
by the positive effect of foreign exchange and strong performance of Hyzaar in
Japan (marketed as Preminent). Cozaar and Hyzaar are among the leading medicines
in the growing angiotensin receptor blocker class.
Global sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout
the European Union ("EU") and as Fosamac in Japan) were $353.9 million for the
third quarter of 2008 and were $1.23 billion for the first nine months of 2008,
representing declines of 51% and 45%, respectively, over the comparable prior
year periods of 2007. Since substantially all formulations of these medicines
have lost U.S. market exclusivity, the Company is experiencing a significant
decline in sales in the United States within the Fosamax franchise and the
Company expects such declines to continue.
Global sales of Januvia, Merck's dipeptidyl peptidase-4 ("DPP-4") inhibitor for
the treatment of type 2 diabetes, were $378.5 million in the third quarter of
2008 compared with $184.6 million for the third quarter of 2007. Sales for the
first nine months of 2008 were $984.4 million compared with $415.3 for the first
nine months of 2007. Januvia was approved by the FDA in October 2006 and by the
European Commission ("EC") in March 2007. Januvia continues to be the second
leading branded oral anti-diabetic agent in terms of new prescription share.
DPP-4 inhibitors represent a class of prescription medications that improve
blood sugar control in patients with type 2 diabetes by enhancing a natural body
system called the incretin system, which helps to regulate glucose by affecting
the beta cells and alpha cells in the pancreas.
In September 2008, new data analyses from five new studies were presented at the
44thAnnual Meeting of the European Association for the Study of Diabetes. These
data showed initial combination therapy with Januvia and metformin provided
improvements in blood sugar levels as measured by A1C (a measure of a person's
average blood glucose over a two-month to three-month period) over two years of
treatment and was generally well tolerated. Also presented at the meeting was a
separate, new pooled analysis of 6,139 patients that showed that Januvia was
generally well tolerated in clinical trials up to two years in duration. Three
additional studies further demonstrated the safety and efficacy profile of
Januvia as an add-on to other oral diabetes treatments and efficacy when
analyzed based on different baseline characteristics.
Global sales of Janumet, Merck's oral antihyperglycemic agent that combines
sitagliptin (Merck's DPP-4 inhibitor, Januvia) with metformin in a single tablet
to target all three key defects of type 2 diabetes, were $100.7 million for the
third quarter of 2008 compared with $18.6 million for the third quarter of 2007.
Sales for the first nine months of 2008 were $231.5 million compared with
$42.9 million for the same period of 2007. Janumet, launched in the United
States in April 2007, was approved, as an adjunct to diet and exercise, to
improve blood sugar control in adult patients with type 2
diabetes who are not adequately controlled on metformin or sitagliptin alone, or
in patients already being treated with the combination of sitagliptin and
metformin. In February 2008, Merck received FDA approval to market Janumet as an
initial treatment for type 2 diabetes. In July 2008, Janumet was approved for
marketing in the EU, Iceland and Norway.
Worldwide sales of Zocor, Merck's statin for modifying cholesterol, declined 28%
in the third quarter of 2008 compared with the third quarter of 2007 and 22% for
the first nine months of 2008 over the corresponding period of 2007 reflecting
the continuing impact of the loss of U.S. market exclusivity in June 2006.
Other Pharmaceutical segment products experiencing growth in the third quarter
and first nine months of 2008 compared with the same periods of 2007 include
Arcoxia for the treatment of arthritis and pain, Emend for the prevention of
acute and delayed nausea and vomiting associated with moderately and highly
emetogenic cancer chemotherapy, as well as for the treatment of post-operative
nausea and vomiting, Maxalt to treat migraine pain, Cosopt to treat elevated
intraocular pressure in patients with open-angle glaucoma or ocular
hypertension, and Propecia for male pattern hair loss.
In September 2008, Merck confirmed that the EC adopted the recommendation of the
European Medicines Agency to approve Arcoxia 90 mg once daily as a new treatment
for ankylosing spondylitis, maintain the 90 mg dose for rheumatoid arthritis,
and modify the contraindications and warnings sections of the label for treating
and monitoring patients with hypertension. In Europe, Arcoxia is indicated for
the treatment of osteoarthritis (30 mg or 60 mg), rheumatoid arthritis (90 mg)
and acute gouty arthritis (120 mg). National approval procedures to implement
the new indication and prescribing information are underway in the 27 member
states of the EU. Arcoxia is approved and launched in 69 countries in Europe,
Latin America and the Asia-Pacific region.
In October 2008, Merck terminated its Phase II/III clinical study evaluating
Zolinza in combination with paclitaxel and carboplatin in patients with Stage
IIIB or Stage IV non-small cell lung cancer. The decision follows the
recommendations of an independent Data Safety Monitoring Board ("DSMB"), which
met on October 14, 2008 for a pre-planned interim analysis of the study. The
DSMB recommended that the study, which had completed Phase II enrollment, be
discontinued due to a lack of improvement in progression-free survival and a
higher incidence of serious adverse experiences and discontinuations of therapy
in the Zolinza plus carboplatin and paclitaxel arm. Merck currently remains
blinded to the data and will evaluate the data once it has been fully analyzed.
As lung cancer is a leading cause of cancer deaths worldwide, Merck is committed
to further researching Zolinza in combination with other chemotherapy agents.
Also in October 2008, the patent that provided U.S. market exclusivity for
Trusopt and Cosoptexpired. The Company expects significant declines in U.S.
sales of these products.
During the first quarter of 2008, Merck divested its remaining ownership of
Aggrastat in foreign markets to Iroko Pharmaceuticals.
Also during the first quarter of 2008, the Company and AZLP entered into an
agreement with Ranbaxy Laboratories Ltd. ("Ranbaxy") to settle patent litigation
with respect to esomeprazole (Nexium)which provides that Ranbaxy will not bring
its generic esomeprazole product to market in the United States until May 27,
2014.
Vaccines and Infectious Diseases Segment Revenues
Sales of the Vaccines and Infectious Diseases segment declined 12% to
$1.09 billion in the third quarter of 2008 from $1.24 billion in the third
quarter of 2007 primarily due to lower sales of Zostavax, Gardasil, RotaTeq,
hepatitis and HIB vaccines, partially offset by sales of Isentress. Sales for
the first nine months of 2008 declined 4% to $3.10 billion from $3.21 billion
for the first nine months of 2007 primarily due to lower sales of hepatitis and
HIB vaccines, Gardasil and other viral vaccines, which include Varivax, M-M-R II
and ProQuad, partially offset by sales of Isentress and growth in RotaTeq.
The following discussion of vaccine and infectious disease product sales
includes total vaccine and infectious disease product sales, the aggregate
majority of which are included in the Vaccines and Infectious Diseases segment
and the remainder, representing sales of these products by non-U.S.
subsidiaries, are included in the Pharmaceutical segment. These amounts do not
reflect sales of vaccines sold in most major European markets through Sanofi
Pasteur MSD ("SPMSD"), the Company's joint venture with Sanofi Pasteur, the
results of which are reflected in Equity income from affiliates (see "Selected
Joint Venture and Affiliate Information" below). Supply sales to SPMSD are
reflected in Vaccines and Infectious Diseases segment revenues.
Worldwide sales of the Company's cervical cancer vaccine Gardasil, as recorded
by Merck, were $401.0 million for the third quarter of 2008, a decline of 4%
compared with the third quarter of 2007 and were $1.12 billion for the first
nine months of 2008, a decline of 2% over the comparable period of 2007. Sales
performance reflects lower sales
domestically, partially offset by growth outside the United States. Sales growth
outside the United States was aided by the adoption of school-based programs in
all Canadian provinces, which was the primary driver of a $34 million increase
in sales in Canada in the third quarter of 2008 compared with the third quarter
of 2007. Based on market research, the third quarter 2008 performance for
Gardasil in the United States was driven by a generally consistent monthly
vaccination rate among 19 to 26 year old women over the past year, and while the
annual vaccination rate of the remaining 13 to 18 year olds increased, the
overall number of first dose vaccinations declined because of the early success
in vaccinating this age group following launch. Also, utilization during the
back to school season appears to have been tempered by media coverage over the
summer on post-marketing reports. Gardasil, the world's top-selling HPV vaccine
and only HPV vaccine available for use in the United States, currently is
indicated for girls and women nine through 26 years of age for the prevention of
cervical, vulvar and vaginal cancers, precancerous or dysplastic lesions, and
genital warts caused by HPV types 6, 11, 16 and 18.
In September 2008, the FDA approved Gardasil for the prevention of vulvar and
vaginal cancers caused by HPV types 16 and 18. The approval is based on data
from a combined analysis of three studies that demonstrated the efficacy and
safety of Gardasil in more than 15,000 patients.
In June 2008, the FDA issued a complete response letter regarding the
supplemental biologics license application ("sBLA") for the use of Gardasil in
women ages 27 through 45. The agency issued the letter to advise that it has
completed its review of the submission and that there are issues that preclude
approval of the supplement within the expected review timeframe. Merck
discussed with the FDA their questions related to this application and responded
to the agency in July 2008. The agency has informed the Company that the
response was a class 2 response, which typically undergo a six month review. The
letter does not affect current indications for Gardasilin females aged nine
through 26. Clinical studies to evaluate the safety and efficacy of Gardasilin
males 16 to 26 years of age continue and the Company expects to submit to the
FDA an application to support an indication for males nine to 26 years of age in
2008.
RotaTeq, Merck's vaccine to help protect against rotavirus gastroenteritis in
infants and children, achieved worldwide sales as recorded by Merck of
$134.5 million for the third quarter of 2008, a decline of 21% compared with the
third quarter of 2007. In the third quarter of 2007, the Company recorded
$51 million in revenue as a result of a government purchase for the U.S. Centers
for Disease Control and Prevention ("CDC") stockpile. Sales were $502.4 million
for the first nine months of 2008, an increase of 34% compared with the first
nine months of 2007. The increase for the year-to-date period was driven largely
by the continued uptake in the United States and successful launches around the
world. Sales in the first nine months of 2008 included purchases of $54 million
to support the CDC stockpile compared with $51 million in the first nine months
of 2007.
In October 2008, Merck announced that RotaTeq has been awarded pre-qualification
status by the World Health Organization ("WHO"). WHO pre-qualification allows
for expanded access to RotaTeq and provides a greater opportunity to help
protect millions of babies from rotavirus gastroenteritis. Because RotaTeq is
pre-qualified by the WHO, the vaccine is eligible for procurement by the Pan
American Health Organization, UNICEF and other United Nations' agencies for use
in national vaccination programs. RotaTeq is the only ready-to-use oral liquid
rotavirus vaccine to receive WHO pre-qualification. Merck has committed to
providing RotaTeq to the Global Alliance for Vaccines and Immunization-eligible
countries at prices at which it does not profit.
Also in October 2008, data on RotaTeq were presented at the 48th Interscience
Conference on Antimicrobial Agents and Chemotherapy / Infectious Diseases
Society of America 46th Annual Meeting in Washington, D.C. that showed RotaTeq
reduced rotavirus-related hospitalizations and emergency room visits combined by
100% during the 2007 and 2008 rotavirus seasons (January through May of each
year) in an observational study in the United States. The large, national,
post-licensure observational study was based on a review of health insurance
claims data from approximately 61,000 infants in the United States.
Additionally, in October 2008, the CDC Advisory Committee on Immunization
Practices ("ACIP") voted unanimously to recommend that adults ages 19 to 64 with
asthma receive pneumococcal polysaccharide vaccine ("PPSV23"), known as
Pneumovax 23 (Pneumococcal Vaccine Polyvalent). Merck is the sole supplier of
Pneumovax 23 in the United States. The ACIP based this recommendation on study
data that showed an increased risk of pneumococcal disease among people with
asthma. Pneumococcal diseases are caused by common bacteria and can lead to
potentially serious bacterial infections of the lungs (pneumonia), lining of the
brain (meningitis) and blood (bacteremia). The ACIP also voted to recommend that
people aged 19 through 64 years who smoke cigarettes should receive PPSV23 as
well as smoking-cessation counseling. This recommendation is the first time the
ACIP has recommended a vaccine specifically for people who smoke.
As previously disclosed, the Company has resolved an issue related to the bulk
manufacturing process for the Company's varicella zoster virus
("VZV")-containing vaccines. The Company is manufacturing bulk varicella and is
producing doses of Varivax and Zostavax. The Company has received regulatory
approvals in the United States and certain other markets
to increase its manufacturing capacity for VZV-containing vaccines. ProQuad, the
Company's combination vaccine that helps protect against measles, mumps, rubella
and chickenpox, one of the VZV-containing vaccines, is currently not available
for ordering; however, orders have been transitioned, as appropriate, to M-M-R
II and Varivax. Total sales as recorded by Merck for ProQuad were $259.9 million
for the first nine months of 2007.
Merck's sales of Varivax, the Company's vaccine for the prevention of chickenpox
(varicella), were $336.7 million for the third quarter of 2008 compared with
$284.3 million for the third quarter of 2007 and were $710.6 million for the
first nine months of 2008 compared with $585.1 million for the first nine months
of 2007. Varivax is currently the only vaccine available in the United States to
help protect against chickenpox due to the unavailability of ProQuad. Merck's
sales of M-M-R II, a vaccine to help protect against measles, mumps, and
rubella, were $93.9 million for the third quarter of 2008 compared with
$75.3 million for the third quarter of 2007 and were $253.7 million for the
first nine months of 2008 compared with $173.1 million for the first nine months
of 2007. Sales of Varivax and M-M-R II were affected by the unavailability of
ProQuad. Combined sales of ProQuad, M-M-R II and Varivax in the third quarter of
2008 were comparable with sales for the third quarter of 2007 and declined in
the first nine months of 2008 compared with the corresponding period of 2007.
Sales of Zostavax, the Company's vaccine to help prevent shingles (herpes
zoster), as recorded by Merck were $11.2 million for the third quarter of 2008
as compared with $61.2 million in the third quarter of 2007. Sales in the
quarter were impacted by bulk vaccine supply issues that caused delays in the
fulfillment of customer orders. Merck expects to fill the customer back orders
that existed at the end of the third quarter by the end of 2008. Sales of
Zostavax for the first nine months of 2008 of $150.8 million were comparable
with sales for same period a year ago. The Company currently anticipates
launching Zostavax outside the United States beyond 2009.
The Company has been working to resolve manufacturing issues related to its
HIB-containing vaccines, PedvaxHIB and Comvax since December 2007. The Company
has resolved the original issue related to equipment sterilization, but has
identified another unrelated manufacturing process change that will require a
regulatory filing. Merck anticipates that PedvaxHIB and Comvax will return to
the U.S. market in mid-2009. Additionally, Merck anticipates the pediatric
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