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| MRK > SEC Filings for MRK > Form 10-Q on 4-May-2009 | All Recent SEC Filings |
4-May-2009
Quarterly Report
* 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
March 31,
($ in millions) 2009 2008
Pharmaceutical:
Singulair $ 1,057.2 $ 1,103.8
Cozaar/Hyzaar 839.2 846.9
Januvia 411.1 272.1
Fosamax 261.3 469.8
Zocor 137.4 179.1
Maxalt 133.2 121.6
Janumet 128.5 58.4
Cosopt/Trusopt 121.1 201.3
Propecia 102.8 105.0
Arcoxia 81.3 93.4
Vasotec/Vaseretic 77.1 95.7
Proscar 72.1 85.0
Emend 69.2 59.6
Other pharmaceutical (1) 469.4 589.9
Vaccine and infectious disease product sales included in the
Pharmaceutical segment (2) 524.7 529.8
Pharmaceutical segment revenues 4,485.6 4,811.4
Vaccines(3) and Infectious Diseases:
Gardasil 262.0 390.4
ProQuad/M-M-R II/Varivax 252.0 225.6
RotaTeq 134.4 190.1
Zostavax 75.2 73.5
Hepatitis vaccines 34.5 33.9
Other vaccines 55.5 72.6
Primaxin 164.5 202.6
Isentress 148.1 46.5
Cancidas 138.7 148.9
Invanz 61.7 55.5
Crixivan/Stocrin 49.1 75.3
Other infectious disease 8.7 0.5
Vaccine and infectious disease product sales included in the
Pharmaceutical segment (2) (524.7 ) (529.8 )
Vaccines and Infectious Diseases segment revenues 859.7 985.6
Other segment revenues(4) 11.1 25.0
Total segment revenues 5,356.4 5,822.0
Other (5) 28.8 0.1
$ 5,385.2 $ 5,822.1
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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 $355.7 million and $404.7 million for the first quarter of 2009 and 2008, 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 $496.9 million and
$547.5 million for the three months ended March 31, 2009 and 2008, 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 decreased 7% for the first quarter of 2009,
to $4.49 billion, compared with the corresponding period of 2008. These results
reflect declines in Fosamax, Cosopt, Trusopt, Singulair, Zocor and lower supply
sales to AZLP, partially offset by growth in Januvia, Janumet and Isentress. In
addition, foreign exchange negatively impacted sales in the first quarter of
2009 as compared with the first quarter of 2008.
Worldwide sales for Singulair were $1.06 billion for the first quarter of 2009,
representing a decrease of 4% over the first quarter of 2008. Sales performance
was largely driven by declines in the United States reflecting the impact of
public reaction to the U.S. Food and Drug Administration's ("FDA") early
communication regarding a very limited number of post marketing adverse event
reports in early 2008 which created uncertainty in the marketplace. The FDA
updated its early communication in January 2009 notifying prescribers and
patients that its safety review of clinical trial data and post marketing
adverse events was not yet complete. Singulair continues to be the number one
prescribed branded product in the U.S. respiratory market.
Global sales of Cozaar and Hyzaar were $839.2 million for the first quarter of
2009, a decrease of 1% compared with the first quarter of 2008. The decline was
driven in part by the unfavorable effect of foreign exchange, partially offset
by the strong performance of Hyzaar in Japan (marketed as Preminent). Cozaar and
Hyzaar are among the leading medicines in the angiotensin receptor blocker
class.
Global sales of Januvia, Merck's dipeptidyl peptidase-4 ("DPP-4") inhibitor for
the treatment of type 2 diabetes, were $411.1 million in the first quarter of
2009 compared with $272.1 million for the first quarter of 2008. Januvia
continues to be the second leading branded oral anti-diabetic agent in terms of
new prescription share in the United States. 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.
Worldwide 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 $128.5 million for the
first quarter of 2009 compared with $58.4 million for the first quarter of 2008.
Janumet was initially 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.
Global sales for Fosamax and Fosamax Plus D (marketed as Fosavance throughout
the European Union ("EU") and as Fosamac in Japan) were $261.3 million for the
first quarter of 2009, representing a decline of 44% over the first quarter of
2008. 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.
Worldwide sales of Zocor declined 23% in the first quarter of 2009 compared with
the first quarter of 2008. Zocor lost U.S. market exclusivity in June 2006 and
has also lost market exclusivity in most international markets.
Sales of Cosopt and Trusopt were $121.1 million for the first quarter of 2009, a
decline of 40% compared with the first quarter of 2008. The patent that provided
U.S. market exclusivity for Cosopt and Trusopt expired in October 2008.
During the first quarter of 2009, Merck divested its U.S. marketing rights to
the Timopticfranchise to Aton Pharma, Inc. The Timoptic franchise includes
ophthalmic products to treat elevated intraocular pressure in patients with
ocular hypertension or open-angle glaucoma.
Vaccines and Infectious Diseases Segment Revenues
Sales of the Vaccines and Infectious Diseases segment declined 13% to
$859.7 million in the first quarter of 2009 primarily due to lower sales of
Gardasil, RotaTeq and Primaxin, partially offset by higher sales of Isentress
and Varivax.
The following discussion of vaccine and infectious disease product sales
includes total vaccine and infectious disease product sales, the 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, however, are
reflected in Vaccines and Infectious Diseases segment revenues.
Worldwide sales of Gardasil, as recorded by Merck, were $262.0 million for the
first quarter of 2009, a decline of 33% compared with the first quarter of 2008.
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. Sales performance was primarily driven by a decline in
the United States reflecting the continued challenges in penetrating the 19 to
26 year-old age group. Also, despite new vaccinations in the 11 to 18 year-old
age group, the strong cumulative penetration in this cohort has led to a lower
overall number of first-doses and corresponding declines in second and
third-dose vaccinations.
In December 2008, the Company submitted a supplemental biologics license
application ("sBLA") for the use of Gardasil in males which has been accepted by
the FDA. The Company expects FDA action in the fourth quarter of 2009. In
January 2009, the FDA issued a second complete response letter regarding the
sBLA for the use of Gardasil in women ages 27 though 45. The agency completed
its review of the response that Merck provided in July 2008 to the FDA's first
complete response letter issued in June 2008 and has recommended that Merck
submit additional data when the 48 month study has been completed. The initial
sBLA included data collected through an average of 24 months from enrollment
into the study, which is when the number of pre-specified endpoints had been
met. Following a review of the final results of the study, Merck anticipates
providing a response to the FDA in the fourth quarter of 2009. The letter does
not affect current indications for Gardasil in females ages nine through 26 nor
does the letter relate to the sBLA for the use of Gardasil in males.
The Company has received regulatory approvals in the United States and certain
other markets to increase its manufacturing capacity for VZV-containing
vaccines. The Company is manufacturing bulk varicella and is producing doses of
Varivax and Zostavax. The Company is working to ensure adequate market supply
and sufficient inventory of Varivax and to build stable supply and inventory for
Zostavax. 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 $10.1 million for the first quarter of 2008.
Merck's sales of Varivax, the Company's vaccine for the prevention of chickenpox
(varicella), were $191.4 million for the first quarter of 2009 compared with
$148.7 million for the first quarter of 2008. 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 $61.7 million for the first
quarter of 2009 compared with $66.9 million for the first quarter of 2008.
Combined sales of ProQuad, M-M-R II and Varivax in the first quarter of 2009
were 12% higher than sales for the first quarter of 2008.
RotaTeq achieved worldwide sales as recorded by Merck of $134.4 million for the
first quarter of 2009, a decline of 29% compared with the first quarter of 2008.
In the first quarter of 2008, the Company recorded $41 million in revenue as a
result of a government purchase for the U.S. Centers for Disease Control and
Prevention's Strategic National Stockpile. RotaTeq is experiencing moderate
impact from competition in the United States, with a greater impact in the
public sector.
Sales of Zostavax, the Company's vaccine to help prevent shingles (herpes
zoster), as recorded by Merck, were $75.2 million for the first quarter of 2009
as compared with $73.5 million in the first quarter of 2008. Sales performance
in the first quarter of 2009 was affected by the clearing of backorders at the
end of 2008 and a continued limited supply. During the first quarter of 2009,
Merck cleared all remaining 2008 backorders for Zostavax and the Company expects
to return to normal shipping times in mid-2009.
Sales of Primaxin in the first quarter of 2009 were $164.5 million, a decline of
19% compared with the first quarter of 2008 reflecting limited supply
constraints and competitive pressures. The patent that provides U.S. market
exclusivity for Primaxin expires in September 2009. After such time, the Company
expects a significant decline in U.S. sales of this product.
Worldwide sales for Isentress were $148.1 million in the first quarter of 2009
compared with $46.5 million for the first quarter of 2008. In October 2007, the
FDA granted Isentress accelerated approval for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection in
treatment-experienced adult patients who have evidence of viral replication and
HIV-1 strains resistant to multiple antiretroviral agents. Isentress is the
first medicine to be approved in the class of antiretroviral drugs called
integrase inhibitors. Isentress works by inhibiting the insertion of HIV DNA
into human DNA by the integrase enzyme. Inhibiting integrase from performing
this essential function limits the ability of the virus to replicate and infect
new cells. The Company is also seeking U.S. marketing approval of Isentress in
combination with other HIV medicines for treatment in adult patients who are
previously untreated (naïve) for HIV. In December 2008, Merck announced that the
FDA had accepted the supplemental New Drug Application ("sNDA") filing for
Isentress tablets for standard review. Merck expects FDA action in July 2009.
Costs, Expenses and Other
As previously disclosed, in October 2008, the Company announced a global
restructuring program (the "2008 Restructuring Program") to reduce its cost
structure, increase efficiency, and enhance competitiveness. As part of the 2008
Restructuring Program, the Company expects to eliminate approximately 7,200
positions - 6,800 active employees and 400 vacancies - across all areas of the
Company worldwide by the end of 2011. About 40% of the total reductions will
occur in the United States. As part of the 2008 Restructuring Program, the
Company is streamlining management layers by reducing its total number of senior
and mid-level executives globally by approximately 25%. As of March 31, 2009,
the Company has eliminated approximately 2,800 positions in connection with this
program, comprised of employee separations and the elimination of contractors
and vacant positions. Merck is rolling out a new, more customer-centric selling
model designed to provide Merck with a meaningful competitive advantage and help
physicians, patients and payers improve patient outcomes. The Company is now
operating its new commercial selling models in the United States and other
markets around the world. The Company also will make greater use of outside
technology resources, centralize common sales and marketing activities, and
consolidate and streamline its operations. Merck's manufacturing division will
further focus its capabilities on core products and outsource non-core
manufacturing. Also, Merck is expanding its access to worldwide external science
through a basic research global operating strategy, which is designed to provide
a sustainable pipeline and is focused on translating basic research productivity
into late-stage clinical success. To increase efficiencies, basic research
operations will consolidate work in support of a given therapeutic area into one
of four locations. This will provide a more efficient use of research facilities
and result in the closure of three basic research sites located in Tsukuba,
Japan; Pomezia, Italy; and Seattle by the end of 2009.
Separation costs are accounted for under Financial Accounting Standards Board
("FASB") Statement No. 112, Employers' Accounting for Postemployment Benefits -
an amendment of FASB Statement No. 5 and 43 ("FAS 112"), and FASB Statement
No. 146, Accounting for Costs Associated with Exit or Disposal Activities ("FAS
146"). In connection with the 2008 Restructuring Program, separation costs under
the Company's existing severance programs worldwide were accounted for under FAS
112 and recorded in the third quarter of 2008 to the extent such costs were
probable and estimable. The Company commenced accruing costs related to one-time
termination benefits offered to employees under the 2008 Restructuring Program
in the fourth quarter of 2008 as that is when the necessary criteria under FAS
146 was met. The Company recorded total pretax restructuring costs of $174.6
million ($124.3 million after-tax) for the first quarter of 2009 related to the
2008 Restructuring Program. These costs were comprised primarily of accelerated
depreciation and separation costs recorded in Materials and production, Research
and development and Restructuring costs (see Note 3 to the consolidated
financial statements). The Company anticipates that total costs for 2009 will be
in the range of $400 million to $600 million. The 2008 Restructuring Program is
expected to be completed by the end of 2011 with the total pretax costs
estimated to be $1.6 billion to $2.0 billion. The Company estimates that
two-thirds of the cumulative pretax costs will result in future cash outlays,
primarily from employee separation expense. Approximately one-third of the
cumulative pretax costs are non-cash, relating primarily to the accelerated
depreciation of facilities to be closed or divested. Merck expects the 2008
Restructuring Program to yield cumulative pretax savings of $3.8 billion to
$4.2 billion from 2008 to 2013.
The 2008 Restructuring Program was put into place prior to the pending merger
with Schering-Plough and does not reflect any potential impacts of the merger.
In November 2005, the Company announced a global restructuring program (the
"2005 Restructuring Program") designed to reduce the Company's cost structure,
increase efficiency and enhance competitiveness which was substantially complete
at the end of 2008.
Materials and production costs were $1.33 billion for the first quarter of 2009,
an increase of 8% compared with the first quarter of 2008. Included in the first
quarter of 2009 and 2008 were costs associated with restructuring activities of
$22.2 million and $14.9 million, respectively, primarily accelerated
depreciation. (See Note 3 to the consolidated financial statements).
Gross margin was 75.2% in the first quarter of 2009 compared with 78.7% in the
first quarter of 2008, which reflect 0.4 and 0.3 percentage point unfavorable
impacts, respectively, relating to costs associated with restructuring
activities. The gross margin decline is primarily attributable to the fixed cost
base in vaccine production being spread over a lower production unit volume,
higher discards, as well as changes in product mix due to the loss of marketing
exclusivity for higher-margin products Fosamax and Cosopt/Trusopt in 2008.
Marketing and administrative expenses were $1.63 billion for the first quarter
of 2009, a decline of 12% compared with the first quarter of 2008. Expenses for
the first quarter of 2008 include the impact of reserving an additional
$40 million solely for future legal defense costs for Fosamaxlitigation. In
addition to lower expenses for future legal defense costs, the decline in
marketing and administrative expenses also reflects the Company's efforts to
reduce its cost base which has resulted in reductions in the U.S. and European
sales forces, as well as reductions in administrative expenses. The Company has
incurred separation costs associated with these sales force reductions that are
reflected in Restructuring costs as discussed above.
Research and development expenses were $1.22 billion for the first quarter of
2009, an increase of 14% compared with the first quarter of 2008. Expenses in
the first quarter of 2009 reflect $88.1 million of costs related to the 2008
Restructuring Program, primarily accelerated depreciation. Research and
development expenses in 2009 compared with 2008 also reflect an increase in
development spending in support of the continued advancement of the research
pipeline, including investments in late-stage clinical trials.
In April 2009, Merck announced it is delaying the filing of the U.S. application
for telcagepant (MK-0974), one of the Company's investigational calcitonin
gene-related peptide ("CGRP") receptor antagonists for the treatment of acute
migraine. The Company no longer expects to file a New Drug Application ("NDA")
with the FDA in 2009, and will provide an updated timeline once additional
information is available. The decision was based on findings from a Phase IIa
exploratory study in which a small number of patients taking telcagepant twice
daily for three months for the prevention of migraine were found to have marked
elevations in liver transaminases. The daily dosing regimen in the prevention
study was different than the dosing regimen used in Phase III studies in which
telcagepant was intermittently administered in one or two doses to treat
. . .
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