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MRK > SEC Filings for MRK > Form 10-Q on 4-May-2009All Recent SEC Filings

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Form 10-Q for MERCK & CO INC


4-May-2009

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
Merger Agreement with Schering-Plough Corporation In March 2009, Merck and Schering-Plough Corporation ("Schering-Plough") announced that their Boards of Directors unanimously approved a definitive merger agreement under which Merck and Schering-Plough will combine in a stock and cash transaction. The transaction will be structured as a "reverse merger" in which Schering-Plough, renamed Merck, will continue as the surviving public corporation. Under the terms of the agreement, each issued and outstanding share of Schering-Plough common stock will be converted into the right to receive a combination of $10.50 in cash and 0.5767 of a share of the combined company. Each Merck share will automatically be converted into a share of the combined company. The cash portion of the consideration will be funded with a combination of existing cash, the sale or redemption of short-and long-term investments and the issuance of debt. Upon completion of the merger, each issued and outstanding share of Schering-Plough 6% Mandatory Convertible Preferred Stock not converted in accordance with the preferred stock designations shall remain outstanding as one share of 6% Mandatory Convertible Preferred Stock of the newly combined company having designations, preferences, qualifications, limitations and other rights identical to those of the Schering-Plough 6% Mandatory Convertible Preferred Stock. The transaction remains subject to Merck and Schering-Plough shareholder approvals and the satisfaction of customary closing conditions and regulatory approvals. The transaction is expected to close in the fourth quarter of 2009.
Operating Results
Sales
Worldwide sales were $5.39 billion for the first quarter of 2009, a decline of 8% compared with the first quarter of 2008, primarily attributable to a 6% unfavorable effect from volume and a 3% unfavorable effect from foreign exchange, partially offset by a 1% favorable effect from price changes. The revenue decline in the first quarter largely reflects lower sales of Fosamax for the treatment and prevention of osteoporosis. Fosamax and 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 Gardasil, a vaccine to help prevent cervical, vulvar and vaginal cancers, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18, lower sales of Cosopt and Trusopt, ophthalmic products which lost U.S. market exclusivity in October 2008, and a decline in sales of RotaTeq, a vaccine to help protect against rotavirus gastroenteritis in infants and children. Revenue was also negatively impacted by lower revenue from the Company's relationship with AstraZeneca LP ("AZLP") and lower sales of Singulair, a medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, Zocor, the Company's statin for modifying cholesterol, and Primaxin for the treatment of bacterial infections. These declines were partially offset by higher sales of Januviaand Janumet for the treatment of type 2 diabetes and Isentress, an antiretroviral therapy for the treatment of HIV infection.

* Cozaar and Hyzaar are registered trademarks of E.I. duPont de Nemours & Company, Wilmington, Delaware.

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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

(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

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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

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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.

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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.

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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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