Mylan reports improved financial results for 2009

    PITTSBURGH -- Mylan Inc. has announced its financial results for the three and twelve months ended December 31, 2009.

    Financial Highlights
• Adjusted diluted earnings per share (EPS) of .33 and $1.30 for the three and twelve months ended December 31, 2009, compared to .26 and .80 for the same prior year periods;
• Total revenues of $1.35 billion for the three months ended December 31, 2009;
• Total revenues of $5.09 billion for the year ended December 31, 2009;

    Mylan's Chairman and CEO Robert J. Coury said, "I'm pleased to report very strong fourth quarter results capping off another extremely successful year, our second full year of operating the New Mylan. With that said, we are reaffirming our 2010 guidance of $1.50 to $1.70, which I fully expect will translate into an industry-leading EPS growth rate over the 2008 to 2010 period. I anticipate that this strong growth will continue, and we are projecting revenues in excess of $8.5 billion in 2013, representing a top-line CAGR of 15%, from 2010. We are also projecting EPS in excess of $2.75 in 2013, which represents a CAGR of 20%. Additionally, I fully expect we will be able to deliver EPS in excess of $2 in 2011. We also anticipate generating cumulative operating cash flows of approximately $4 billion by the end of 2013. With that said, we expect to continue to lead the sector in EPS growth, which we believe will benefit all shareholders and other stakeholders."

    Total revenues for the quarter ended Dec. 31, 2009 increased $148.7 million, or 12% to $1.35 billion from $1.20 billion in the same prior year period. Revenues in the current quarter were favorably impacted by the effect of foreign currency translation, reflecting a weaker U.S. dollar. Translating current year revenues at prior year exchange rates would have resulted in operational year-over-year revenue growth, excluding foreign currency, of $70.3 million, or approximately 6%.

    Generics revenues, which are derived from sales in North America, Europe, the Middle East and Africa (collectively, EMEA), and Asia Pacific were $1.29 billion in the current quarter, compared to $1.13 billion in the same prior year period.

    Total revenues from North America were $545.0 million for the three months ended December 31, 2009, compared to $561.7 million for the same prior year period, representing a decrease of 3%. Prior year revenues included a substantial contribution from levetiracetam, which was launched by Mylan in November 2008. Additional generic competition on levetiracetam entered the market in mid-January 2009.

    Helping to offset some of the effect of this additional competition were products launched in North America subsequent to December 31, 2008, which contributed revenues of approximately $81 million, including lansoprazole delayed-release ("lansoprazole DR") capsules, 15 mg and 30 mg, the generic version of Tap Pharmaceuticals' proton pump inhibitor Prevacid(R) DR Capsules.

    Sales in Asia Pacific are derived from Mylan's operations in India, Australia, Japan and New Zealand. Asia Pacific revenues were $309.1 million in the current quarter, compared to $232.3 million in the same prior year period, an increase of 33%. Excluding foreign currency, calculated as described above, operational sales increased approximately 20%, primarily driven by increased sales in Japan and India. 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 our 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 total revenues of $87.5 million for the current quarter, an increase of 8% from $81.2 million for the three months ended December 31, 2008, led by Perforomist(R) Solution, Dey's Formoterol Fumarate Inhalation Solution (Perforomist Solution). Sales of Dey's EpiPen(R) Auto-Injector were consistent on a year over year basis and, as has been previously noted, fourth quarter sales of the EpiPen Auto-Injector are seasonally the lowest.

    Consolidated gross profit for the three months ended December 31, 2009, was $516.0 million and gross margins were 38.2%, compared to gross profit of $394.7 million and gross margins of 32.8% in the same prior year period. Gross profit in both periods is negatively impacted by certain purchase accounting related items totaling $72.4 million and $145.6 million for the quarters ended December 31, 2009 and 2008, which consisted primarily of incremental amortization related to purchased intangible assets and step-up in inventory. Excluding these amounts from both periods, gross margins were 43.5% in the current year compared to 44.9% in the prior.

    Earnings from operations were $60.0 million for the three months ended December 31, 2009, compared to $34.6 million for the same prior year period.

    Total revenues for the year ended December 31, 2009 were $5.09 billion compared to $5.14 billion for the prior year. Included in total revenues in the prior year was other revenue of $468.1 million of previously deferred revenue related to the sale of our rights in Bystolic(TM). Excluding other revenue from both years, net revenue increased by $384.2 million, or 8% from $4.63 billion in the prior year to $5.02 billion in 2009.

    Generics revenues were $4.70 billion in the year ended December 31, 2009, compared to $4.29 billion in the prior year.  

 

    Total revenues from North America were $2.18 billion for the year ended December 31, 2009, compared to $1.87 billion for the prior year, representing an increase of 16%. This increase was the result of new product revenue of approximately $322.5 million, mainly Divalproex Sodium Extended-Release tablets, Mylan's version of Abbott Laboratories' Depakote(R) ER.

    With headquarters in Pittsburgh, Mylan maintains a large production facility in Morgantown. Mylan is the 11th largest private company in West Virginia in 2009, according to data released by Workforce West Virginia.

    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, visitwww.mylan.com .

Mylan Receives Approval for Generic Version of GoLytely

    PITTSBURGH -- Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely(R) laxative.

    Polyethylene Glycol 3350 and Electrolytes for Oral Solution had U.S. sales of approximately $14 million for the 12 months ending Sept. 30, according to IMS Health. Mylan's version is available for immediate shipment.

    Currently, Mylan has 141 ANDAs pending U.S. Food and Drug Administration approval representing $87.9 billion in annual brand sales, according to IMS. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, according to IMS.

    With headquarters in Pittsburgh, Mylan maintains a large production facility in Morgantown. Mylan is the 11th largest private company in West Virginia in 2009, according to data recently released by Workforce West Virginia.

    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, visit www.mylan.com .

Mylan announces third quarter, first nine months results

PITTSBURGH  -- Mylan Inc.  today announced its financial results for the three and nine months ended September 30, 2009.

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  .

Mylan Declares Quarterly Preferred Stock Dividend

PITTSBURGH -- Mylan Inc. (NASDAQ: MYL) has announced that in accordance with its 2.139 million preferred stock issuance, the company has declared its quarterly dividend of $16.25 per share (based on the annual dividend rate of 6.5% and a liquidation preference of $1,000.00 per share) payable on Nov. 16, 2009, to holders of preferred stock of record as of Nov. 1, 2009.

With headquarters in Pittsburgh, Mylan maintains a large production facility in Morgantown. Mylan is the 11th largest private company in West Virginia in 2009, according to data recently released by Workforce West Virginia.

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 .

Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax® Sprinkle Capsules

PITTSBURGH -- Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil's anticonvulsant Topamax® Sprinkle Capsules, 15 mg and 25 mg. For the 12 months ending June 30, 2009, Topiramate Capsules (Sprinkle) had U.S. sales of approximately $58 million for the same strengths, according to IMS Health. Mylan has launched this product.

Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales, according to IMS Health.


With headquarters in Pittsburgh, Mylan maintains a large production facility in Morgantown. Mylan is the 11th largest private company in West Virginia in 2009, according to data recently released by Workforce West Virginia.

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.