Merck reports non-GAAP EPS of $0.83 for first-quarter 2010

Merck & Co., Inc. (NYSE: MRK) today announced financial results for the first quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the first quarter of $0.83, which excludes purchase accounting adjustments, merger-related expenses and restructuring costs, as well as a tax charge related to the recently enacted health care reform legislation. First-quarter GAAP EPS was $0.09.

“And our expanded worldwide presence and broader product portfolio now provides many more individuals with access to the valuable and diverse set of health care solutions Merck provides than they did just a few months ago.”

Worldwide sales for the first quarter of 2010 were $11.4 billion. Net income for the first quarter was $299 million. Foreign exchange for the quarter favorably affected global sales performance by 4 percent.

A reconciliation of EPS as reported in accordance with GAAP to EPS, excluding certain items, is provided in the table that follows. The first quarter of 2009 GAAP results below reflect legacy Merck on a stand-alone basis.

Select Business Highlights

• The company has been moving rapidly to complete integration actions and remains on track to achieve its synergy target of $3.5 billion of annual savings in 2012.
• Eight of Merck's top 10 product families saw growth during the quarter, carrying forward the momentum seen in the fourth quarter of 2009 performance. International sales of Merck's pharmaceutical and vaccine products reported overall strong growth of 10 percent for the first quarter of 2010, including the favorable impact of foreign exchange. For example, JANUVIA reported growth outside the United States of 60 percent for the first quarter compared to the 13 percent reported by the U.S. market.
• sanofi-aventis exercised its option to combine Merial with Intervet/Schering-Plough in a new equally-owned joint venture with Merck during the quarter. Subject to antitrust reviews and other customary closing conditions, this new joint venture will offer a broader portfolio of animal health products and services in pharmaceuticals and biologics, as well as the ability to capitalize on growth opportunities in all fields and countries around the world. Merck expects the transaction to close in the first quarter of 2011.
• The passage of health care reform in March will result in greater access to coverage and important market reforms that begin this year with more significant changes and improvements beginning in 2014. Merck, like many companies, will begin to incur costs related to the health care reform legislation starting in 2010. These costs include increased Medicaid rebates and a one-time charge related to taxes on retiree medical benefits. In addition, the company estimates that the net unfavorable sales impact related to the passage of this legislation will be approximately $170 million in 2010 and approximately $300 million to $350 million in 2011.
• Merck will hold its R & D Day and Business Briefing on Tuesday, May 11.

First-Quarter Financial Results

The following supplemental combined first-quarter 2009 non-GAAP sales are adjusted to reflect a full quarter of legacy Merck and legacy Schering-Plough combined results. This supplemental information is provided to enhance investors' understanding of the company's products and overall business performance and should be considered in addition to, but not in lieu of, sales recorded in accordance with GAAP.

The company's financial performance for the first quarter of 2010 discussed below reflects both legacy Schering-Plough and legacy Merck results. The increases noted are largely due to the inclusion of legacy Schering-Plough operations.

Materials and production costs were $5.2 billion for the first quarter of 2010, compared to $1.3 billion for the first quarter of 2009. The first quarter of 2010 includes $2.3 billion of additional costs related to the amortization of purchase accounting adjustments to inventories and to intangible assets recognized as a result of the merger. The first quarters of 2010 and 2009 include $57 million and $22 million, respectively, for costs associated with restructuring programs. The gross margin was 54.3 percent for the first quarter of 2010, reflecting a 21.1 percentage point unfavorable impact from the purchase accounting adjustments and restructuring costs noted above. In 2009, gross margin was 75.2 percent for the first quarter, reflecting a 0.4 percentage point unfavorable impact due to restructuring costs.

Marketing and administrative expenses were $3.2 billion for the first quarter of 2010. Costs for the first quarter include $80 million of merger-related costs. Marketing and administrative costs were $1.6 billion for the first quarter of 2009.

Research and development expenses were $2.0 billion for the first quarter of 2010, which included $27 million of charges for in-process research and development impairments. Expenses for 2009 were $1.2 billion for the quarter which included $88 million of costs for restructuring activities.

Restructuring costs, primarily related to employee separations, were $288 million for the first quarter of 2010, compared with $64 million for the first quarter of 2009. The increase for the first quarter of 2010 is largely associated with the merger restructuring program.

Total overall costs associated with the company's global restructuring programs included in materials and production, research and development, and restructuring costs were $351 million and $175 million for the first quarters of 2010 and 2009, respectively, primarily comprised of employee separations and accelerated depreciation.

Equity income from affiliates was $138 million in the first quarter of 2010. Equity income from affiliates no longer reflects any contribution from the Merck/Schering-Plough partnership or from Merial Limited.

Other (income) expense, net was $168 million of expense in the first quarter of 2010 compared with $67 million of income in the first quarter of 2009 primarily reflecting higher interest expense and lower interest income as a result of the merger. Additionally in the first quarter of 2010, the company recorded higher exchange losses primarily due to the impact of the Venezuelan currency devaluation, as well as income on the settlement of certain disputed royalties.

The effective tax rate of 46.4 percent for the first quarter of 2010 reflects the impact of a one-time charge of $147 million, or approximately 24 percentage points, associated with a change in tax law that requires taxation of the prescription drug subsidy of the company's retiree health benefit plans which was enacted in the first quarter of 2010 as part of U.S. health care reform legislation. In addition, the effective tax rate was impacted by purchase accounting adjustments and restructuring charges. Excluding these items, the non-GAAP effective tax rate was 23 percent for the quarter.

Financial Targets

For 2010, Merck is targeting a non-GAAP EPS range of $3.27 to $3.41, excluding certain items, and a 2010 GAAP EPS range of $1.15 to $1.50. The 2010 non-GAAP guidance excludes purchase accounting adjustments, restructuring and merger-related costs, a pretax gain from AstraZeneca's asset option exercise, and the first-quarter tax charge related to the recently enacted health care reform legislation. EPS and other financial targets assume for 2010 that Merck retains full rights to REMICADE and SIMPONI in the applicable markets.

A reconciliation of anticipated 2010 EPS as reported in accordance with GAAP to non-GAAP EPS that excludes certain items is provided in the table that follows:

Merck said it expects full-year 2010 revenue to be between $45.4 billion and $46.4 billion, including the impact of the recently passed health care reform legislation. For the full year 2010, the increased Medicaid rebates (including Managed Medicaid) and other impacts are expected to reduce revenue by approximately $170 million, which includes a first-quarter 2010 impact of approximately $33 million.

Non-GAAP research and development expense, which excludes joint ventures, is anticipated to be approximately $8.3 billion to $8.7 billion for the full year of 2010. This guidance excludes the portion of the restructuring costs and any in-process R & D impairment charges included in research and development expense in 2010.

Merck's consolidated non-GAAP 2010 tax rate is estimated to be approximately 22 percent to 24 percent.

Merck continues to target a high single-digit non-GAAP EPS compound annual growth rate for the combined company from 2009 to 2013 when compared to Merck 2009 non-GAAP EPS. As the company has previously said, the longer-term targets are applicable regardless of the assumptions made for the REMICADE and SIMPONI business.

Product Performance

The sales figures discussed below for legacy Schering-Plough products are reported on a GAAP basis, which represents sales for the first quarter of 2010 only.

Bone, Respiratory, Immunology and Dermatology

Worldwide sales of SINGULAIR (montelukast sodium), a once-a-day oral medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, were $1.2 billion for the first quarter of 2010, representing a 10 percent increase compared with the first quarter of 2009.

Sales of REMICADE (infliximab) were $674 million for the first quarter of 2010. REMICADE is a treatment for inflammatory diseases which is marketed in countries outside the United States (except in Japan and certain other Asian markets). In addition, SIMPONI (golimumab), a once-monthly, subcutaneous treatment for certain inflammatory diseases, has been launched in Canada, Germany, Denmark, Hungary and Norway; launches in other international markets are planned.

Global sales of NASONEX (mometasone furoate monohydrate), nasal spray, an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, were $320 million for the first quarter of 2010.

Global sales of CLARINEX (desloratadine), a nonsedating antihistamine, were $174 million for the first quarter of 2010.

Cardiovascular

Global sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin) were $534 million and $477 million, respectively, for the first quarter of 2010.

Diabetes and Obesity

JANUVIA (sitagliptin), Merck's DPP-4 inhibitor for the treatment of type 2 diabetes, recorded worldwide sales of $511 million during the first quarter of 2010, representing a 24 percent increase compared with same quarter in 2009. JANUMET (sitagliptin/metformin hydrochloride), a single tablet that targets all three key defects of type 2 diabetes, achieved worldwide sales of $201 million during the quarter, an increase of 56 percent compared with the first quarter 2009. The JANUVIA/JANUMET combined franchise had sales of $712 million during the first quarter of 2010, an increase of 32 percent compared to the same quarter in 2009.

Infectious Disease

ISENTRESS (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, reported worldwide sales of $232 million for the first quarter of 2010, an increase of 57 percent compared with the first quarter of 2009.

Worldwide sales of PEGINTRON (peginterferon alfa-2b) for chronic hepatitis C were $186 million for the first quarter of 2010.

Mature Brands

Merck's mature brands are human health pharmaceutical products that are approaching the expiration of their marketing exclusivity or are no longer protected by patents in developed markets, but continue to be a core part of the company's offering in other markets around the world.

Global sales of Merck's antihypertensive medicines, COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide), were $782 million for the first quarter of 2010, representing a 7 percent decrease compared with the first quarter of 2009. The company anticipates a significant decline in future COZAAR/HYZAAR sales since these medicines lost marketing exclusivity in the United States in April and in major European markets during the first quarter.

Neuroscience and Ophthalmology

Global sales of MAXALT (rizatriptan benzoate), Merck's tablet for the treatment of acute migraine, were $135 million for the first quarter of 2010, a 1 percent increase from the same quarter last year.

Oncology

Sales of TEMODAR (temozolomide), a treatment for certain types of brain tumors, were $274 million the first quarter of 2010. In March, Merck reached an agreement with a generic manufacturer regarding a U.S. generic version of TEMODAR pending the resolution of Merck's appeal to the Federal Circuit concerning the patent. Under the agreement, a generic product will not be marketed until the Federal Circuit either upholds the lower court's decision or August 2013, subject to certain conditions.

Vaccines

Total sales as recorded by Merck of its cervical cancer vaccine, GARDASIL (human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant), were $233 million for the first quarter of 2010, an 11 percent decline from the same quarter in 2009.

ZOSTAVAX (zoster vaccine live), the company's vaccine to help prevent shingles (herpes zoster), recorded sales of $95 million in the United States for the first quarter of 2010 compared with $75 million for the first quarter of 2009. Customers will experience backorders, or periods where they are unable to place orders, for ZOSTAVAX throughout 2010 and possibly into 2011. Due to supply constraints, no international launches or immunization programs outside of the United States are currently planned for this year or 2011.

Worldwide sales of Merck's other viral vaccines, which include VARIVAX (varicella virus vaccine live), M-M-R II (measles, mumps and rubella virus vaccine live) and PROQUAD (measles, mumps, rubella and varicella virus vaccine live), as recorded by Merck, were $319 million for the first quarter of 2010, an increase of 27 percent compared with the same period a year earlier.

U.S. vaccine sales for the first quarter of 2010 benefited from inventory build-up during the quarter.

Women's Health and Endocrine

Global sales of NUVARING (etonogestrel/ethinyl estradiol vaginal ring), a contraceptive product, were $135 million for the first quarter of 2010.

Sales of FOLLISTIM/PUREGON (follitropin beta injection), a fertility treatment, were $134 million for the first quarter of 2010.

Product Performance - Animal Health

Animal Health sales totaled $709 million for the first quarter of 2010, reflecting continued strong performance among companion animal and poultry products. Animal Health includes pharmaceutical and vaccine products for the prevention, treatment and control of disease in all major farm and companion animal species.

Product Performance - Consumer Care

Consumer Care sales were $379 million for the first quarter of 2010, which reflect strong demand for foot care products and the expansion of DR. SCHOLL'S Custom Fit Orthotics in the United States. ZEGERID OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), a product for treating frequent heartburn, was launched in the United States late in the first quarter.

Select Company Data

As of March 31, Merck had approximately 95,000 employees worldwide.