Merck Announces Second-Quarter 2012 Financial Results

Merck Announces Second-Quarter 2012 Financial Results

Merck & Co., Inc.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2012.

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the second quarter of $1.05 exclude acquisition-related costs and restructuring costs.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables below. Year-to-date results can be found in the attached tables.

"This quarter we delivered strong operational performance by focusing on growth and execution. We achieved top- and bottom-line growth by advancing our core strategy and maintaining momentum across our businesses," said Kenneth C. Frazier, chairman and chief executive officer of Merck. "The company remains focused on translating cutting-edge science into medically important products. We're seeing significant progress in the pipeline this year, and we expect six major filings over the next 18 months, including suvorexant for insomnia and odanacatib for osteoporosis. This focus on innovation and execution will drive long-term shareholder value."

Worldwide sales were $12.3 billion for the second quarter of 2012, an increase of 1 percent, or 5 percent excluding foreign exchange, compared with the second quarter of 2011. Sales also were unfavorably impacted by the arbitration settlement agreement with Johnson & Johnson discussed below.

The following table reflects sales of the company's top pharmaceutical products, as well as total sales of animal health and consumer care products.

Second-quarter pharmaceutical sales grew 2 percent to $10.6 billion, including a 3 percent negative impact due to foreign exchange. Adjusting pharmaceutical sales in the second quarter of 2011 to exclude sales of REMICADE (infliximab) and SIMPONI (golimumab) from the territories transferred to Johnson & Johnson through the settlement agreement, pharmaceutical sales would have increased 5 percent in the second quarter of 2012. The revenue increases largely reflect strong sales growth for JANUVIA (sitagliptin), VICTRELIS (boceprevir), JANUMET (sitagliptin/metformin hydrochloride), SINGULAIR (montelukast sodium), ISENTRESS (raltegravir) and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]. These increases were partially offset by expected declines in sales of COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide) as well as European austerity measures.

Sales from emerging markets accounted for approximately 18 percent of pharmaceutical sales in the second quarter. Growth in the emerging markets is being driven by diversified brands and core products like JANUVIA, JANUMET and ISENTRESS. China continues to be a key driver with 27 percent growth for the second quarter, including a 4 percent benefit from foreign exchange.

Worldwide sales of the combined diabetes franchise of JANUVIA/JANUMET, medicines that help lower blood sugar levels in adults with type 2 diabetes, grew 33 percent to $1.5 billion in the second quarter of 2012 driven by growth in all regions.

Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, grew 6 percent to $1.4 billion in the second quarter of 2012. The patent for SINGULAIR will expire in the U.S. in Aug. 2012 and in major European markets in Feb. 2013. The company expects a significant and rapid reduction in sales thereafter in those markets. SINGULAIR will retain marketing exclusivity in Japan until 2016.

Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, grew 2 percent to $1.1 billion in the second quarter driven by growth of ZETIA in the United States and VYTORIN outside of the United States.

Combined sales of REMICADE and SIMPONI, treatments for inflammatory diseases, declined 35 percent to $594 million for the second quarter of 2012. In Europe, Russia and Turkey, where Merck retained exclusive marketing rights, the combined sales of REMICADE and SIMPONI declined 3 percent for the second quarter of 2012, but excluding the impact of foreign exchange grew 6 percent. In July 2011, the company transferred exclusive marketing rights for REMICADE and SIMPONI to Johnson & Johnson in Canada, Central and South America, the Middle East, Africa and Asia Pacific.

ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, grew 18 percent to $398 million in the second quarter driven by strong growth in the emerging markets and the United States.

Global sales of Merck's antihypertensive medicines COZAAR and HYZAAR were down 17 percent to $337 million in the second quarter of 2012 due to the loss of marketing exclusivity in the United States and major European markets in 2010.

Sales recorded by Merck for GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus (HPV), increased 17 percent to $324 million for the quarter driven by vaccinations of males in the United States and the launch in Japan.

Sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster, grew 22 percent to $148 million in the quarter. The company continues to increase its promotional efforts for ZOSTAVAX in the United States.

Sales of VICTRELIS, the company's oral hepatitis C virus NS3/4A protease inhibitor, were $126 million in the quarter. VICTRELIS is approved in 43 countries and has launched in 23 of those markets.

Animal Health sales totaled $865 million for the second quarter of 2012, an 8 percent increase over the second quarter of 2011, including a 6 percent negative impact due to foreign exchange. Animal Health had strong performance in the United States and Asia Pacific, with growth led by increased sales of cattle and swine products. The division's products include pharmaceutical and vaccine products for the prevention, treatment and control of disease in all major farm and companion animal species.

Second-quarter global sales of Consumer Care were $552 million, an increase of 2 percent compared to the second quarter of 2011, including a 1 percent negative impact due to foreign exchange. The sales increase was primarily due to MiraLAX, CLARITIN and COPPERTONE.

Other revenues – primarily comprised of alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales – declined 26 percent to $333 million. The change was driven largely by lower revenue from AstraZeneca LP (AZLP) recorded by Merck, which declined 27 percent to $223 million, as well as by lower third-party manufacturing sales.

The costs detailed below totaled $9.7 billion on a GAAP basis during the second quarter of 2012 and include $1.7 billion of acquisition-related costs and restructuring costs.

The gross margin was 66.6 percent for the second quarter of 2012 and 64.7 percent for the second quarter of 2011, reflecting 10.6 and 12.0 percentage point unfavorable impacts, respectively, from the acquisition-related costs and restructuring costs noted above.

Marketing and administrative expenses, on a non-GAAP basis, were $3.2 billion in the second quarter of 2012, a decrease from $3.4 billion in the second quarter of 2011. The decrease was primarily due to ongoing productivity measures.

Research and development (R&D) expenses, on a non-GAAP basis, were $2.0 billion in the second quarter of 2012, an increase from $1.9 billion in the second quarter of 2011. The increase primarily reflects the $120 million upfront payment as part of the Endocyte Inc. transaction.

Equity income from affiliates was $142 million for the second quarter, which primarily reflects the performance of AZLP and Sanofi Pasteur MSD.

Other (income) expense, net was $103 million of expense in the second quarter of 2012, compared to $121 million of expense in the second quarter of 2011.

The company noted the following developments:

Merck continues to expect full-year 2012 non-GAAP EPS to be between $3.75 and $3.85 and the 2012 GAAP EPS range to be $2.04 to $2.30. The 2012 non-GAAP range excludes acquisition-related costs and costs related to restructuring programs.

Merck continues to expect full-year 2012 revenues to be at or near 2011 levels on a constant currency basis. At current exchange rates, sales would be affected unfavorably by approximately 6 percent for the third quarter and more than 3 percent for the full year.

In addition, the company expects full-year 2012 non-GAAP R&D expenses to be slightly higher than the 2011 level. The company now expects the full-year 2012 non-GAAP tax rate to be approximately 25 percent.

A reconciliation of anticipated 2012 EPS as reported in accordance with GAAP to non-GAAP EPS that excludes certain items is provided in the table below.

As of June 30, 2012, Merck had approximately 84,000 employees worldwide.

Investors are invited to a live audio webcast of Merck's second-quarter earnings conference call today at 8:00 a.m. EDT by visiting Merck's Internet site, . Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782. Journalists are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917. A replay of the call will be available starting at 11 a.m. EDT today for approximately one week. To listen to the replay, dial (404) 537-3406 or (855) 859-2056 and enter ID No. 91089609.

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit and connect with us on Twitter, Facebook and YouTube.

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2011 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ().

Merck is providing certain 2012 and 2011 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of the company's performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP. For a description of the items, see Table 2a including the related footnotes, attached to this release.

Net income attributable to Merck & Co., Inc.

Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS which may be different than the amount calculated by dividing the impact of the excluded items by the weighted average shares.

Includes expenses for the amortization of intangible assets and amortization of purchase accounting adjustments to inventories recognized as a result of mergers and acquisitions, as well as intangible asset impairment charges. Also includes integration and other costs associated with mergers and acquisitions.

Includes an estimated income tax (benefit) expense on the reconciling items. The second quarter of 2011 also includes the net favorable impact of approximately $700 million relating to the settlement of a federal income tax audit, as well as the favorable impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction of deferred tax liabilities on intangibles established in purchase accounting.