Mylan Reports Adjusted Diluted EPS of $0.33 for the Quarter Ended March 31, 20092009 Adjusted Diluted EPS Guidance Range Revised Upward to
$1.00 - $1.10
from
$0.90 to $1.10
PITTSBURGH, April 30 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL)
today announced its financial results for the three months ended March 31,
2009.
Financial Highlights
- Adjusted diluted EPS, which excludes the impact of certain purchase
accounting items as well as other non-cash and/or non-recurring items
as detailed below, was $0.33 for the three months ended March 31,
2009, compared to $0.09 for the same prior year period;
- Total revenues of $1.21 billion for the three months ended March 31,
2009, an increase of $135.5 million over the same prior year period;
- On a GAAP basis, the company reported diluted EPS of $0.23 for the
three months ended March 31, 2009, compared to a loss per share of
$1.47 in the same prior year period, which included a non-cash
goodwill impairment charge of $385.0 million related to the Specialty
Segment.
Mylan's Vice Chairman and CEO Robert J. Coury commented: "Our performance
this quarter continues to demonstrate the value we have always envisioned from
the combination of the strategic global assets we pulled together. As a result
of the momentum that we created in 2008, which has carried over into 2009, and
the strength that we continue to see in our underlying business, we are
raising the lower end of our 2009 adjusted diluted EPS guidance by $0.10. The
mid-point of this newly adjusted range of $1.00 to $1.10 represents a 31%
increase over last year's adjusted EPS of $0.80."
Coury continued: "The outstanding execution on our stated objectives
remains our primary focus. Operational excellence at Mylan has become a way of
life for each and every one of our employees, and I believe you will continue
to see the benefits of their ongoing discipline and exceptional commitment."
Financial Summary
Total revenues for the quarter ended March 31, 2009, increased by $135.5
million, or 13%, to $1.21 billion, from $1.07 billion in the same prior year
period. Increased revenues were realized by all three of Mylan's reportable
segments, Generics, Specialty and Matrix, as further discussed below.
Excluding the unfavorable effect of the stronger U.S. dollar, year-over-year
revenue growth would have been approximately 23%.
Also included in total revenues for the current quarter are other revenues
of $41.6 million, which increased by $29.5 million from the same prior year
period. This increase is primarily the result of the acceleration of the
recognition of revenue related to certain product development arrangements
that had been previously deferred.
Generics revenues, which are derived from sales in North America, Europe,
the Middle East and Africa (collectively, EMEA) and Asia Pacific were $1.03
billion in the current quarter, compared to $906.7 million in the same prior
year period.
Total revenues from North America were $586.0 million for the three months
ended March 31, 2009, compared to $388.8 million for the same prior year
period, representing an increase of $197.2 million, or 51%.
New product launches 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. In the current quarter,
new products launched in the U.S. contributed revenues of $185.2 million,
primarily consisting of Divalproex Sodium Extended-release and Paroxetine
Extended-release.
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 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 $332.9 million in the current quarter,
compared to $389.0 million in the same prior year period, a decrease of $56.1
million, or 14%. This decrease was driven mainly by the effects of foreign
currency translation, primarily reflecting the weakening of the Euro versus
the U.S. dollar. Excluding the unfavorable effect of the stronger U.S. dollar,
EMEA revenues were consistent with the prior year period. Increased sales in
France, EMEA's largest market, as the result of new product launches, helped
to offset revenue decreases in Germany and the United Kingdom, the second and
third largest markets. Also contributing to EMEA revenues were sales from the
Central and Eastern European businesses, which Mylan acquired from Merck KGaA
in June 2008.
Asia Pacific revenues were $109.0 million in the current quarter, compared
to $128.9 million in the same prior year period, a decrease of $19.8 million,
or 15%. Sales in Asia Pacific are derived from Mylan's operations in
Australia, Japan and New Zealand. Excluding the effect of a weaker Australian
dollar versus the U.S. dollar, the decrease in sales would have been
approximately 3%. A government-mandated price reduction in Australia, which
went into effect in July 2008, was primarily responsible for the decrease in
sales. Helping to offset the unfavorable pricing in Australia were increased
volumes and new product launches in that country, as well as higher sales in
Japan.
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 sales of $79.4
million, compared to $77.1 million for the three months ended March 31, 2008.
Perforomist®, Dey's Formoterol Fumarate Inhalation Solution, was the primary
driver of the increase in revenues in the current quarter. Increased revenues
from EpiPen®, Dey's Epinephrine auto-injector, were more than offset by
lower sales of DuoNeb®, which continues to experience the unfavorable impact
of generic competition, which first entered the market in 2007.
Matrix reported third-party revenues of $102.6 million for the three
months ended March 31, 2009, compared to $87.6 million for the same prior year
period, representing an increase of $15.0 million, or 17%. Excluding the
unfavorable effect of a stronger U.S. dollar, year-over-year revenue growth
would have been approximately 44%. This is the result of the strengthening of
the U.S. dollar versus the Indian rupee and the Euro, the functional currency
of Matrix's European distribution business.
Matrix's revenues increased primarily as a result of higher sales of
anti-retroviral (ARV) finished dosage form (FDF) products. Current quarter
revenues included sales of first-line ARV products, which were launched
subsequent to March 31, 2008, and higher sales of second-line ARV products,
which Matrix first launched in late calendar year 2007.
Gross profit for the three months ended March 31, 2009, was $525.7 million
and gross margins were 43.5%. Excluding certain purchase accounting items,
gross margins would have been 49.1%. Gross margins in the same prior year
period, also adjusted to exclude certain purchase accounting items, would have
been 43.6%. This increase was due primarily to a more favorable product mix,
including the impact of new product launches.
Gross margins in the current quarter were negatively impacted by certain
purchase accounting items of approximately $68.2 million, which consisted
primarily of amortization related to purchased intangible assets and the
amortization of the inventory step-up associated with the acquisition of the
former Merck Generics business. In the same prior year period, gross margins
were negatively impacted by similar items, which amounted to approximately
$118.1 million.
Earnings from operations were $227.3 million for the three months ended
March 31, 2009, compared to a loss from operations of $371.5 million in the
same prior year period, which included a non-cash goodwill impairment charge
of $385.0 million. Excluding purchase accounting items from both periods, as
well as the non-cash impairment charge from the prior year, earnings from
operations would have been $295.5 million in the current quarter, compared to
$131.6 million in the prior year.
The 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.
Additionally, earnings from operations in the current quarter include
approximately $28.5 million of incremental revenue resulting from the
acceleration of the recognition of revenue related to certain product
development arrangements as discussed above.
SG&A expense was higher in the prior year primarily as a result of more
activity associated with the integration of the former Merck Generics
business, while the timing of certain 2009 development projects was favorable
to current quarter R&D. Additionally, in the current year, SG&A and R&D were
both impacted by the favorable effect of the stronger U.S. dollar and by
synergies realized as a result of the company's ongoing restructuring
initiatives. The company's previously announced plans to optimize and
rationalize its global manufacturing and R&D platforms have contributed to the
decrease in operating expenses, particularly R&D.
Interest expense for the current quarter totaled $85.0 million, compared
to $96.5 million for the three months ended March 31, 2008. This decrease is
primarily the result of reduced market interest rates on our floating-rate
debt and debt repayments made during calendar year 2008.
EBITDA for the quarter ended March 31, 2009, which is defined as net
income (loss) (excluding the non-controlling interest and income from equity
method investees) plus income taxes, interest expense, depreciation and
amortization, was $327.9 million. After adjusting for certain non-recurring or
non-cash items as further discussed below, adjusted EBITDA was $326.1 million.
Non-GAAP Financial Measures
Mylan is disclosing non-GAAP financial measures when providing financial
results. Primarily due to acquisitions, Mylan believes that an evaluation of
its ongoing operations (and comparisons of its current operations with
historical and future operations) would be difficult if the disclosure of its
financial results were limited to financial measures prepared only in
accordance with accounting principles generally accepted in the U.S. (GAAP).
In addition to disclosing its financial results determined in accordance with
GAAP, Mylan is disclosing non-GAAP results that exclude items such as
amortization expense and other costs directly associated with the acquisitions
as well as certain other non-recurring and non-cash expenses and revenue in
order to supplement investors' and other readers' understanding and assessment
of the company's financial performance because the company's management uses
these measures internally for forecasting, budgeting and measuring its
operating performance. In addition, the company believes that including EBITDA
and supplemental adjustments applied in presenting adjusted EBITDA is
appropriate to provide additional information to investors to demonstrate the
company's ability to comply with financial debt covenants (which are
calculated using a measure similar to adjusted EBITDA) and assess the
company's ability to incur additional indebtedness. Whenever Mylan uses such a
non-GAAP measure, it will provide a reconciliation of non-GAAP financial
measures to the most closely applicable GAAP financial measure. Investors and
other readers are encouraged to review the related GAAP financial measures and
the reconciliation of non-GAAP measures to their most closely applicable GAAP
measure set forth below and should consider non-GAAP measures only as a
supplement to, not as a substitute for or as a superior measure to, measures
of financial performance prepared in accordance with GAAP.
Below is a reconciliation of GAAP net earnings attributable to Mylan Inc.
and diluted GAAP EPS to adjusted net earnings attributable to Mylan Inc. and
adjusted diluted EPS for the three months ended March 31, 2009:
Three months
ended
March 31, 2009
(in millions except per share amounts) --------------
GAAP net earnings attributable to Mylan Inc.
& diluted GAAP EPS $106.1 $0.23
Purchase accounting related amortization (1) 68.2
Litigation settlements, net (2.1)
Non-cash interest expense 10.2
Integration and other non-recurring items (2) (4.4)
Tax effect of the above items (3) (28.2)
-----
Adjusted net earnings attributable to Mylan Inc.&
adjusted diluted EPS (4) $149.8 $0.33
====== =====
(1) This amount, which is included in cost of sales, consists primarily
of amortization expense related to purchased intangible assets as
well as amortization of the inventory step-up related to the
acquisition of the former Merck Generics business.
(2) Integration and other non-recurring items include charges principally
related to the acquisition and integration of the former Merck
Generics business (e.g., non-recurring professional and consulting
fees and other non-recurring expenses) as well as certain
restructuring charges, more than offset by non-recurring revenue
items. Non-recurring revenue items of $28.5 million, consisting
primarily of the acceleration of the recognition of revenue related
to certain product development agreements, are included in other
revenue on the statement of operations. Additionally, integration and
other non-recurring expenses of $7.4 million are included in cost of
sales, $13.1 million are included in SG&A and $3.6 million are
included in R&D.
(3) The tax effect is calculated assuming an annual adjusted effective
tax rate for the resulting adjusted earnings, and results in an
effective tax rate on adjusted earnings of 30% including the impact
of tax synergies.
(4) Adjusted diluted EPS and GAAP diluted EPS for the three months ended
March 31, 2009, were calculated under the "if-converted method" which
assumes conversion of the company's preferred stock into a maximum of
152.8 million shares of common stock and excludes the preferred
dividend from the calculation. The "if-converted" method was more
dilutive to adjusted diluted EPS and GAAP diluted EPS by
approximately $0.05 per share and $0.002 per share, respectively.
Below is a reconciliation of GAAP net earnings attributable to Mylan Inc.
to adjusted EBITDA for the three months ended March 31, 2009:
Three months
ended
(in millions) March 31, 2009
--------------
GAAP net earnings attributable to Mylan Inc. $106.1
Add/(Deduct):
Net earnings attributable to the
noncontrolling interest 3.0
Income from equity method investees (0.8)
Income taxes 37.5
Interest expense 85.0
Depreciation & amortization 97.1
----
EBITDA 327.9
Add/(Deduct) Adjustments:
Non-cash stock-based compensation expense 8.4
Litigation settlements, net (2.1)
Integration and other non-recurring items (8.1)
Adjusted EBITDA $326.1
======
Conference Call
Mylan will host a conference call and live webcast today, Thursday, April
30, 2009, at 10:00 a.m. ET, in conjunction with the release of its financial
results. The dial-in number to access the April 30 call is 877.440.5788 or
719.325.4858 for international callers. A replay, available for approximately
seven days, will be available at 888.203.1112 or 719.457.0820 for
international callers with access pass code 9657848. To access a live webcast
of the call, please log on to Mylan's Web site (www.mylan.com) at least 15
minutes before the event is to begin to register and download or install any
necessary software.
About Mylan
Mylan Inc., which provides products to customers in more than 140
countries and territories, ranks among the leading diversified generic and
specialty pharmaceutical companies in the world. The company maintains one of
the industry's broadest -- and highest quality -- product portfolios,
supported by a robust product pipeline; owns a controlling interest in the
world's third largest active pharmaceutical ingredient manufacturer; and
operates a specialty business focused on respiratory and allergy therapies.
For more information, please visit www.mylan.com.
Forward Looking Statements
This press release includes statements that constitute "forward-looking
statements", including with regard to the company's future operations and its
earnings expectations. These statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Because
such statements inherently involve risks and uncertainties, actual future
results may differ materially from those expressed or implied by such
forward-looking statements. Factors that could cause or contribute to such
differences include, but are not limited to: challenges, risks and costs
inherent in business integrations and in achieving anticipated synergies; the
effect of any changes in customer and supplier relationships and customer
purchasing patterns; general market perception of the acquisition of the
former Merck Generics business; the ability to attract and retain key
personnel; changes in third-party relationships; the impacts of competition;
changes in economic and financial conditions of the company's business;
uncertainties and matters beyond the control of management; inherent
uncertainties involved in the estimates and judgments used in the preparation
of financial statements, and the providing of estimates of financial measures,
in accordance with GAAP and related standards. These cautionary statements
should be considered in connection with any subsequent written or oral
forward-looking statements that may be made by the company or by persons
acting on its behalf and in conjunction with its periodic SEC filings. In
addition, please refer to the cautionary statements and risk factors set forth
in the company's Annual Report on Form 10-K, as amended, for the fiscal year
ended Dec. 31, 2008, and in its other filings with the SEC. Further,
uncertainties or other circumstances, or matters outside of the company's
control between the date of this release and the date that its Form 10-Q for
the quarter ended March 31, 2009 is filed with the SEC could potentially
result in adjustments to reported results. The company undertakes no
obligation to update statements herein for revisions or changes after the date
of this release.
Mylan Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited; in thousands, except per share amounts)
Three Months Ended
March 31, 2009 March 31, 2008
-------------- --------------
As Adjusted*
Revenues:
Net revenues $1,168,362 $1,062,413
Other revenues 41,555 12,048
------ ------
Total revenues 1,209,917 1,074,461
Cost of sales 684,184 724,240
------- -------
Gross profit 525,733 350,221
------- -------
Operating expenses:
Research and development 58,836 83,844
Impairment loss on goodwill - 385,000
Selling, general and administrative 239,556 252,913
------- -------
Total operating expenses 298,392 721,757
------- -------
Earnings (loss) from operations 227,341 (371,536)
Interest expense 85,002 96,479
Other income, net 4,189 6,961
----- -----
Earnings (loss) before income taxes and
noncontrolling interest 146,528 (461,054)
Income tax provision (benefit) 37,454 (47,121)
------ -------
Net earnings (loss) before noncontrolling
interest 109,074 (413,933)
Net earnings (loss) attributable to the
noncontrolling interest 3,016 (2,042)
----- ------
Net earnings (loss) attributable to Mylan
Inc. before preferred dividends 106,058 (411,891)
Preferred dividends 34,759 34,718
------ ------
Net earnings (loss) attributable to Mylan
Inc. common shareholders $71,299 $(446,609)
======= =========
Earnings (loss) per common share attributable
to Mylan Inc.:
Basic $0.23 $(1.47)
===== ======
Diluted $0.23 $(1.47)
===== ======
Weighted average common shares outstanding:
Basic 304,578 304,181
======= =======
Diluted 458,049 304,181
======= =======
* Adjusted to reflect the adoption of FSP APB No. 14-1
Mylan Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited; in thousands)
March 31, 2009 December 31, 2008
-------------- -----------------
As Adjusted*
Assets:
Current assets:
Cash and cash equivalents $453,062 $557,147
Restricted cash 40,021 40,309
Available-for-sale securities 40,371 42,260
Accounts receivable, net 1,080,319 1,164,613
Inventories 1,018,603 1,065,990
Other current assets 279,876 304,354
------- -------
Total current assets 2,912,252 3,174,673
Intangible assets, net 2,313,960 2,453,161
Goodwill 2,995,642 3,161,580
Other non-current assets 1,674,790 1,620,445
--------- ---------
Total assets $9,896,644 $10,409,859
========== ===========
Liabilities:
Current liabilities $1,339,983 $1,544,650
Long-term debt 4,964,569 5,078,937
Other non-current liabilities 942,864 999,431
------- -------
Total liabilities 7,247,416 7,623,018
Noncontrolling interest 31,450 29,108
Mylan Inc. shareholders' equity 2,617,778 2,757,733
--------- ---------
Total liabilities and shareholders'
equity $9,896,644 $10,409,859
========== ===========
* Adjusted to reflect the adoption of FSP APB No. 14-1
SOURCE Mylan Inc.
04/30/2009
CONTACT: Michael Laffin (Media), +1-724-514-1968, or Dan Crookshank
(Investors), +1-724-514-1813
/Web Site: http://www.mylan.com
(MYL)