Regulatory News:
Meda AB(STO:MEDAA):
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Group net sales reached SEK 3,375 million (2,944). At fixed currency
rates, sales increased 14%.
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EBITDA rose to SEK 1,151 million (1,119), corresponding to a 34.1%
margin (38.0).
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Operating profit amounted to SEK 618 million (650).
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Profit after tax amounted to SEK 370 million (373).
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Earnings per share reached SEK 1.24 (1.24).
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Cash earnings per share reached SEK 1.93 (1.99).
Highlights
Dymista approved by the FDA
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The US Food and Drug Administration (FDA) approved Dymista.
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Dymista is a new patented product for the treatment of seasonal
allergic rhinitis, which annually affects about 60 million patients in
the US. · Dymista has in several clinical studies consistently shown
rapid and more complete relief of symptoms compared with standard
treatment.
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Efficacy and safety were documented in studies with more than 4,000
patients, including a long-term study of more than 600 patients.CEO
STATEMENT
Sales increased by 14% to SEK 3,375 million. Key products in priority
areas showed good growth rates. As measured by organic growth, the
outcome was unchanged compared with 2011 – a significant improvement
over the fourth quarter last year.
There is a dividing line between pharmaceutical companies that have new
products and those that do not. Meda has a valuable pipeline of products
that are also close to market. A higher rate of investment in marketing
will help take advantage of these growth opportunities. Investments are
being made primarily in these areas:
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Dymista has the highest priority and clearly the greatest potential,
and was recent approved by the FDA. It has been quite some time since
a Swedish pharmaceutical company has had a drug with blockbuster
potential registered in the US. We are working very actively on the US
launch, scheduled for this fall. The registration process in other
markets is progressing as planned, and we are hoping for approval in
Europe next year.
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Initiatives in emerging markets continue.