“The Meda Group expects to achieve sales of about SEK 13,000 million and
an EBITDA of about SEK 4,200 million for full-year 2009.”
• The Group’s net sales reached SEK 13,178 million (10,675), a 23%
increase compared to the previous year.
• EBITDA rose 28% to SEK 4,387 million (3,425), thus yielding a
33.3% margin (32.1).
• Operating profit climbed to SEK 2,902 million (2,302).
• Profit after tax increased to SEK 1,537 million (954).
• Earnings per share reached SEK 5.09 (3.49).
• Cash earnings per share rose to SEK 9.95 (6.72).
• Proposed dividend per share: SEK 1.00 (0.75).
1) Including restructuring costs of SEK 131 million
2) Including restructuring costs of SEK 215 million
HIGHLIGHTS
Exceeded full-year forecast for 2009
• In its Q3 interim report Meda published the following forecast for
full-year 2009: "The Meda Group expects to achieve sales of about SEK
13,000 million and an EBITDA of about SEK 4,200 million.”
• The outcome was sales of SEK 13,178 million and EBITDA of SEK 4,387
million.
FDA accepts the New Drug Application for Retigabine for review
• The US Food and Drug Administration (FDA) and the European Medicines
Agency (EMEA) have accepted Retigabine’s New Drug Application (NDA) and
Marketing Authorization Application (MAA), respectively, for final
review.
In-licensing of exclusive rights to Xerese
• Xerese (treatment of cold sores) has been in-licensed from Medivir AB,
a Swedish research company.
• Xerese is the first topical treatment that is indicated to both reduce
the likelihood of cold sores and shorten their healing process. Xerese
is already approved by the FDA, and Meda’s exclusive rights cover the
US, Canada and Mexico.
In-licensing of exclusive rights to Ceplene
• Ceplene (remission maintenance therapy and prevention of relapse from
acute myeloid leukemia) has been in-licensed from EpiCept Corporation, a
US-based biopharmaceutical company. Meda's rights cover Europe and most
key Asian markets, including Japan, China, and Australia.
• There is currently no alternative treatment and a significant medical
need. The product will be launched on the European market in 2010.
SALES
January – December
Net sales for 2009 rose 23% to SEK 13,178 million (10,675). Currency
effects regarding like-for-like sales had a positive SEK 1,069 million
impact on sales compared to the previous year. Sales of the most
important products during the whole of 2009 were:
Astepro (allergic and non-allergic rhinitis treatment) had US sales
during the period of SEK 416 (45) million.
Astelin (allergic and non-allergic rhinitis treatment) totaled SEK 1,369
million (1,472). In the US, sales in local currency were down 21% to USD
162 million (206)—mainly due to the launch of the new Astepro product
that replaces Astelin.
Tambocor (cardiac arrhythmia treatment) amounted to SEK 921 million
(901), a 2% increase on the previous year. Annual sales in local
currency fell slightly compared with the previous year as a result of
price cuts in France.
Betadine (infection treatment) rose 13% to SEK 898 million (798). Sales
grew in the major southern-European markets, except for Spain, where
annual sales in local currency decreased.
Minitran (angina prevention) reached SEK 529 million (508).
Aldara (actinic keratosis treatment) totaled SEK 481 million (415), a
16% increase on the previous year.
Soma (muscle relaxant) amounted to SEK 449 million (314). Sales in local
currency were up 23%.
Zamadol (moderate to severe pain treatment) increased 4% to SEK 395
million (378).
Mestinon (treatment of myasthenia gravis, an autoimmune disease)
amounted to SEK 270 (79) million. Previous year's sales were
consolidated into the Meda Group as of September.
Novopulmon (budesonide Novolizer, asthma treatment) climbed 14% to SEK
206 million (180).
October – December
Net sales for Q4 2009 rose 3% to SEK 3,260 million (3,160). Currency
effects regarding like-for-like sales had a positive SEK 6 million
impact on sales compared to the previous year.
Sales of the most important products during the period were:
Astepro (allergic and non-allergic rhinitis treatment) had US sales
during the period of SEK 172 million. Astepro’s proportion of total
azelastine prescribed rose to about 39% in December. Market launch of
the new higher dosage of Astepro (0.15%) began in October. The product
has been favorably received in the market and already accounts a
majority of the Astepro prescribed.
Astelin (allergic and non-allergic rhinitis treatment) totaled SEK 287
million (423). In the US, sales in local currency were down 22% and
reached USD 40 million (51), primarily due to the launch of the new
Astepro product.
Tambocor (cardiac arrhythmia treatment) amounted to SEK 209 million
(231), a 10% decrease compared to the previous year.
Betadine (infection treatment) rose 7% to SEK 202 million (189). Italy
and Spain in particular reached high growth rates compared to the
previous year.
Minitran (angina prevention) reached SEK 141 million (128), an increase
of 10% after a strong Q4 in key southern European markets.
Aldara (actinic keratosis treatment) totaled SEK 122 million (125), a 2%
decrease on the previous year, primarily due to inventory reductions at
the wholesale level in Germany.
Soma (muscle relaxant) amounted to SEK 103 million (96). Sales in local
currency were up 17%.
Zamadol (moderate to severe pain treatment) increased 6% to SEK 102
million (96).
Mestinon (treatment of myasthenia gravis, an autoimmune disease)
increased 8% to SEK 70 million (65).
Novopulmon (budesonide Novolizer, asthma treatment) decreased 5% to SEK
52 million (55) due to lower sales to eastern European distributors.
In addition:
The FDA decided to accept the NDA for Retigabine for review, which
triggered a milestone payment of SEK 61 million to Meda during the
period. Retigabine has been documented for treatment of epilepsy and has
a different mechanism of action than current antiepileptic therapies on
the market. Valeant Pharmaceuticals International (Valeant), Meda’s
partner for Retigabine, has a global partnership agreement with
pharmaceutical company GlaxoSmithKline for the commercialization of
Retigabine. Meda is entitled to receive substantial royalties and
certain milestone payments from Valeant for Retigabine.
The US market launch of Onsolis started in Q4. Current Onsolis marketing
efforts are primarily focused on physician education and registration in
the REMS (Risk Evaluation and Mitigation Strategy) program, which is
progressing well. Given that competing fentanyl products do not
currently have a REMS program approved by FDA, sales for Onsolis are on
a low level. This is expected to change once similar REMS requirements
are put in place for these competing products.
Q4 sales of Optivar in the US market declined by 19% in local currency
to SEK 41 million after launch of a generic competitor.
PROFIT
Operating profit
Operating expenses for Q4 amounted to SEK 1,523 million. The increased
cost level compared with the previous quarter has several causes.
Marketing activities increased due to the US launches of Astepro (0.15%)
and Onsolis.
Since marketing efforts for important products focus increasingly on
specialists, Meda’s operations can be streamlined further. To this end,
the total number of employees in all positions in western Europe and the
US will be reduced by about 200 people. Thus, Meda has made provisions
for non-recurring restructuring costs of SEK 131 million in the fourth
quarter. At the same time Meda is increasing its efforts on Turkey,
Russia and Poland. The number of employees in the marketing organization
for these emerging markets will increase by 100. Operating profit for
January-December reached SEK 2,902 million (2,302), corresponding to a
26% increase.
EBITDA for 2009 was SEK 4,3871 million (3,4252), yielding a 33.3% margin
(32.1).
Operating profit for October–December reached SEK 626 million (476),
corresponding to a 32% increase.
EBITDA for the same period was SEK 1,0311 million (8092), yielding a
31.6% margin (25.6).
Financial items
The Group’s net financial items for January-December amounted to SEK
-618 million (-884). The average interest rate at 31 December 2009 was
3.9% (4.9).
Group profit after net financial items increased 61% to SEK 2,284
million (1,418) for the whole of 2009. The Group’s net financial items
for October–December were SEK –133 million (–271). The improvement
compared with Q4 2008 is mainly attributable to significantly lower
average interest rates and lower debt for Q4 2009. Group profit after
net financial items for the same period totaled SEK 493 million (205).
Net profit and earnings per share
Net profit for January–December rose 61% to SEK 1,537 million (954).
Group tax expense for January–December was SEK 747 million (464),
corresponding to a 32.7% tax rate (32.7).
Earnings per share for January–December reached SEK 5.09 (3.49).
Net profit for October–December rose to SEK 332 million (146).
Group tax expense for October–December totaled SEK 161 million (59),
corresponding to a 32.7% tax rate (28.8). Earnings per share for
October–December amounted to SEK 1.10 (0.52)
CASH FLOW
Cash flow from operating activities, before changes in working capital,
rose to SEK 3,087 million (2,003) for January–December. Implemented
restructuring measures had an adverse effect of SEK –132 million on cash
flow. Cash flow from changes in working capital was SEK 37 million
(–53). Cash flow from operating activities for January–December thus
rose to SEK 3,124 million (1,950). Tied-up working capital developed
positively in the fourth quarter and decreased by SEK 138 million. Cash
flow from operating activities thereby rose to SEK 961 million (468) for
Q4.
Cash flow from investing activities amounted to SEK –518 million
(–4,102) for the whole of 2009. In January, Meda paid the remaining
purchase consideration of SEK 107 million for the product portfolio
acquired from Roche in 2008. In conjunction with the FDA's approval of
Onsolis in July, a milestone of SEK 208 million was paid to BioDelivery
Sciences Inc., Meda's US development partner.
Cash flow from financing activities reached SEK –2,724 million (2,083).
Dividend of SEK 227 million was paid to Meda’s shareholders in May.
Cash earnings per share for January-December rose 48% to SEK 9.95
(6.72). Cash earnings per share for October–December rose 99% to SEK
3.06 (1.54).
FINANCING
Equity stood at SEK 13,664 million on 31 December compared to SEK 13,290
million at the year’s start, corresponding to SEK 45.2 (44.0) per share.
The equity/assets ratio rose to 41.4% from 37.1% at the start of the
year.
The Group’s net debt totaled SEK 13,467 million on 31 December, compared
to SEK 16,129 million at the year’s start. The SEK 2,662 million
reduction in net debt is primarily attributable to the Group’s cash flow.
In Q4, Meda issued a five-year bond loan of approximately SEK 4,300
million.
The bond proceeds were used to refinance the bridge facility of SEK
2,500 million from autumn 2008. The excess amount will strengthen Meda's
financial headroom. The new loan facility doubles Meda’s average debt
maturity from one and a half years to three years.
PARENT COMPANY Net sales for January-December reached SEK 3,643 million
(2,535), of which intra-Group sales represented SEK 2,912 million
(1,867).
Profit before appropriations and tax reached SEK 3,183 million (-66).
Net financial items were SEK 2,334 million (-552), which includes
dividends of SEK 2,723 million from subsidiaries.
Investments in intellectual property rights amounted to SEK 465 million
(2,102) in January-December. Investments in property, plant, and
equipment totaled SEK 0 million (0).
Financial non-current assets stood at SEK 20,432 million, compared to
SEK 20,853 million at year-end 2008.
AGREEMENTS AND KEY EVENTS
• FDA ACCEPTS THE NEW DRUG APPLICATION FOR RETIGABINE FOR REVIEW
The FDA has accepted the NDA for Retigabine for review. In addition, the
European Medicines Agency (EMEA) confirmed on November 17, 2009, that
the Marketing Authorization Application (MAA) is ready for MAA review.
Retigabine has been documented to treat epilepsy, and has a different
mechanism of action than current antiepileptic therapies on the market.
The product affects potassium channels in the central nervous system in
a new way.