Highlights include:
• Adjusted diluted EPS of .32 and .97 for the three and nine months ended September 30, 2009, compared to .23 and .52 for the same prior year periods;
• Total revenues of $1.26 billion for the three months ended September 30, 2009;
• Total revenues of $3.74 billion for the nine months ended September 30, 2009;
• On a GAAP basis, a loss per diluted share of .13 for the three months ended September 30, 2009;
• On a GAAP basis, earnings per diluted share of .29 for the nine months ended September 30, 2009.
Mylan's Chairman and CEO Robert J. Coury said, "I am particularly pleased with these results in light of the fact that they were achieved through higher volumes, market growth, and multiple new product launches across the globe and not from any one product. This is clearly indicative of the efficient, globally diverse business model that we've created and is reflective of our operators' continued exemplary execution that has led to the accelerated realization of our integration-related synergies."
Coury continued: "We are increasing the range of our full year 2009 adjusted diluted EPS guidance to $1.24 - $1.28, and we are confident that this momentum will continue into 2010 and enable us to once again deliver the revenue and earnings performance growth that we envision."
Mylan previously had three reportable segments, "Generics," "Specialty" and "Matrix." The Matrix segment had consisted of Matrix Laboratories Limited, which had been a publicly traded Indian Company in which Mylan held a 71.2% ownership stake. Beginning this quarter, Mylan has re-evaluated its segment disclosure. Following the acquisition of approximately 24% of the remaining interest in Matrix and the related de-listing, Mylan will report two segments, "Generics" and "Specialty". The former Matrix Segment is included within the Generics Segment. Information for earlier periods has been recast for comparability.
Total revenues for the quarter ended September 30, 2009 were $1.26 billion compared to $1.66 billion for the three months ended September 30, 2008. Included in total revenues for the three months ended September 30, 2008, was $455.0 million of revenue related to the Company's sale of the product rights of Bystolic™. Excluding this, total revenues increased by $62.2 million or 5.2% over the same prior year period.
Generics revenues, which are derived from sales in North America, Europe, the Middle East and Africa (collectively, EMEA), and Asia Pacific were $1.12 billion in the current quarter, compared to $1.08 billion in the same prior year period.
Total revenues from North America were $502.5 million for the three months ended September 30, 2009, compared to $460.3 million for the same prior year period, representing an increase of 9.2%.
Revenues from products launched in North America subsequent to September 30, 2008, and increased volume were primarily responsible for the increase in revenues, partially offset by unfavorable pricing as a result of additional generic competition on certain products. New products contributed revenues of approximately $60.0 million.
Total revenues from EMEA were $417.6 million in the current quarter, compared to $422.1 million in the same prior year period, a decrease of 1.1%. On a constant currency basis, EMEA revenues increased by approximately 7% over the prior year period. Higher revenues in France, EMEA's largest market, and the U.K. served to offset lower revenue in Germany. In France, revenues increased as a result of higher volumes and new product launches, while prior period revenues in the U.K. were negatively impacted by excess supply that existed in the market at that time.
Sales in Asia Pacific are derived from Mylan's operations in Australia, India, Japan and New Zealand. Asia Pacific revenues were $237.0 million in the current quarter, compared to $226.6 million in the same prior year period, an increase of 4.6%. On a constant currency basis, sales increased approximately 10%, with increased sales in Japan and India offsetting lower revenues in Australia. Also contributing to the increase in Asia Pacific revenues are higher third-party sales of active pharmaceutical ingredients (API). API is also sold to Mylan subsidiaries in conjunction with the Company's vertical integration strategy.
Specialty, consisting of Mylan's Dey business, which focuses on the development, manufacture and marketing of specialty pharmaceuticals in the respiratory and severe allergy markets, reported third party revenues of $150.9 million, an increase of 20.3% from third party revenues of $125.4 million for the three months ended September 30, 2008. Perforomist® Solution, Dey's Formoterol Fumarate Inhalation Solution (Perforomist Solution), and Dey's EpiPen® Auto-Injector (EpiPen Auto-Injector), were the primary drivers of the increase in revenues.
Consolidated gross profit for the three months ended September 30, 2009, was $505.0 million and gross margins were 39.9%, compared to gross profit of $911.1 million and gross margins of 55.0% in the same prior year period, which included the impact of the sale of Bystolic. Gross profit in both periods is negatively impacted by certain purchase accounting related items totaling $71.8 million and $105.4 million for the quarters ended September 30, 2009 and 2008, which consisted primarily of incremental amortization related to purchased intangible assets. Excluding these amounts from both periods and the impact of Bystolic from the prior year, gross margins were 45.6% in the current year compared to 46.7% in the prior.
Earnings from operations were $61.3 million for the three months ended September 30, 2009, compared to $560.8 million for the same prior year period. During the three months ended September 30, 2009, the Company recorded net unfavorable litigation charges of $114.3 million. Included in this amount was a one time, non-recurring, charge of $121.0 million ($83.0 million after-tax) related to the previously announced settlement of an investigation by the U.S. Department of Justice concerning calculations of Medicaid drug rebates. Excluding litigation, as well as the impact of the Bystolic revenue in 2008 and the purchase accounting related items in both periods, as mentioned above, earnings from operations were $247.4 million compared to $211.3 million, an increase of $36.1 million or 17.1% over the prior year. This increase in operating income in the current quarter is due to increased sales and gross profit, as well as lower R&D and SG&A expense. R&D expense decreased by $4.9 million in the current quarter, primarily in Generics, and is reflective of certain restructuring activities undertaken by the Company with respect to the previously announced rationalization and optimization of the global manufacturing and research and development platforms. SG&A expense decreased by $16.0 million in the quarter primarily due to lower costs, including temporary staffing and consulting, related to the integration of the former Merck Generics business, with the majority of such costs having been incurred in the prior year. Additionally, both SG&A and R&D expense in the current quarter were favorably impacted by the effect of the stronger U.S. dollar.
Total revenues for the nine months ended September 30, 2009 were $3.74 billion compared to $3.93 billion for the same prior year period. Included in total revenues were other revenues of $61.1 million in the current year compared to $493.8 million in the same prior year period. The prior year includes $468.1 million related to the sale of Bystolic. Excluding this, other revenue increased by $35.5 million in the current year, primarily the result of approximately $26.0 million of incremental revenue resulting from the cancellation of certain product development agreements.
Net revenues for the nine months ended September 30, 2009, were $3.68 billion compared to $3.44 billion in the same prior year period, an increase of $239.2 million or 7.0%. On a constant currency basis, year-over-year revenue growth would have been approximately 14%.
Generics revenues were $3.41 billion in the nine months ended September 30, 2009, compared to $3.16 billion in the same prior year period.
Total revenues from North America were $1.64 billion for the nine months ended September 30, 2009, compared to $1.31 billion for the same prior year period, representing an increase of 24.7%. This increase was the result of new product revenue of approximately $297.0 million, mainly Divalproex Sodium Extended-Release tablets, Mylan's version of Abbott Laboratories' Depakote® ER, and Levetiracetam, Mylan's version of UCB Pharma's Keppra®, and higher volumes, partially offset by unfavorable pricing.
Mylan's Fentanyl Transdermal System (Fentanyl), Mylan's AB-rated generic alternative to Duragesic®, continued to contribute significantly to both revenue and gross profit despite the entrance into the market of additional generic competition. Sales of Fentanyl have remained relatively strong primarily due to Mylan's ability to continue to be a stable and reliable source of supply to the market.
Total revenues from EMEA were $1.18 billion in the current nine month period, compared to $1.27 billion in the prior year period, a decrease of 7.2%. On a constant currency basis, EMEA revenues would have increased by approximately 5%. Increased revenues in France and Italy, and a full nine months of revenue contribution from the Central and Eastern European businesses acquired in June 2008, served to offset lower revenues brought about by continued pricing pressures in certain European markets, primarily in Germany.
Total revenues in Asia Pacific were $692.2 million in the current nine month period, compared to $678.8 million in the prior year period, an increase of 2.0%. On a constant currency basis, sales in the current year increased by approximately 15%. The increase in Asia Pacific was primarily realized by Mylan's Japanese and Indian subsidiaries, and higher sales of API. These increases were partially offset by lower sales in Australia, which were negatively impacted by the government price reduction of 25% that took place in the third quarter of 2008.
Specialty reported third party revenue of $353.0 million, an increase of $44.6 million or 14.4% from third party revenues of $308.5 million for the nine months ended September 30, 2008. Increased sales of the EpiPen Auto-Injector and Perforomist Solution in the current year were partially offset by lower sales of DuoNeb® as a result of the unfavorable impact of generic competition, which first entered the market in 2007.
Consolidated gross profit for the nine months ended September 30, 2009, was $1.56 billion and gross margins were 41.7%, compared to gross profit of $1.68 billion and gross margins of 42.6% in the same prior year period. Excluding Bystolic and the effect of certain purchase accounting related items described above, which totaled $210.2 million and $335.7 million for the nine months ended September 30, 2009 and 2008, gross margin was 47.3% in the current year period, compared to 44.5% in the prior year period.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. For more information, please visit www.mylan.com .
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