Meda AB (publ) - Interim report, January-June 2011

Meda AB (publ) - Interim report, January-June 2011

 


  · Group net sales reached SEK 6,177 million (5,986). At fixed currency
rates, sales increased 14%.

  · EBITDA rose to SEK 2,319 million (2,191[1]), corresponding to a
37.5% margin (36.6). At fixed currency rates, EBITDA increased 17%.

  · Operating profit amounted to SEK 1,345 million (1,348 [1]).

  · Profit after tax totaled SEK 753 million (1,039). Excluding
non-recurring effects, profit after tax totaled SEK 753 million (731
[2]).

  · Earnings per share reached SEK 2.49 (3.44). Excluding non-recurring
effects, earnings per share totaled SEK 2.49 (2.42 [2]).

  · Cash earnings per share rose to SEK 5.10 (4.93).

Highlights

Meda and Valeant enter partnership

  · Meda licensed the exclusive rights to Elidel (pimecrolimus 1% cream)
and Xerese (acyclovir and hydrocortisone cream) to Valeant in North
America. The companies will collaborate on development of the products.

  · Meda received an initial USD 76 million and is also eligible for
long-term double-digit royalties on sales of Zovirax cream and ointment
(treatment of cold sores and genital herpes), Xerese, and Elidel, and on
their respective future product development in North America. Up to the
end of 2012, Meda estimats to receive milestone payments and royalties
of about USD 130 million, and royalty payments of at least USD 120
million are expected from 2013 to 2015.

Potiga (ezogabine) receives FDA approval

  · The US Food and Drug Administration (FDA) approved Potiga for
treatment of epilepsy.

  · The FDA approval triggered a milestone payment to Meda of USD 6
million. Meda is also entitled to receive royalties of 7% on net sales
and other milestone payments related to future development of the
product. GlaxoSmithKline is responsible for global commercialization.

Progress for Dymista

  · New study results for Dymista were presented at this year's European
Academy of Allergy and Clinical Immunology (EAACI) meeting. The results
from three randomized placebo-controlled parallel group studies with
more than 2,200 patients showed that Dymista represents a breakthrough
in the treatment of allergic rhinitis. Compared with current standard
therapy, Dymista:
1) was more effective while retaining a positive safety profile.
2) provided significantly faster clinically relevant alleviation of
symptoms to a greater number of patients.
3) was very effective in reducing eye symptoms associated with allergic
rhinoconjunctivitis.

  · The new drug application (NDA) for Dymista was submitted to the FDA
in early April. The FDA has determined that the application is
sufficiently complete to permit a substantive review.

  · The European NDA for Dymista is expected to be submitted to the
authorities concerned by the end of 2011.

Zyclara and Acnex NDAs submitted in Europe

  · The NDA for patented dermatology products Acnex (clindamycin and
tretinoin) and Zyclara (imiquimod 3.75% cream) have been submitted to
European regulatory authorities.

  · Acnex (treatment of mild to severe acne) is formulated for use once
a day. More than 4,000 patients were enrolled in clinical studies.
Zyclara (treatment of actinic keratosis) can be administered once per
day and expands treatment options to more skin areas. More than 1,400
patients were enrolled in seven clinical studies.

CEO'S COMMENTS

We are pleased to say that several important steps have been taken to
secure good future growth in the company. Several significant
acquisitions were made to strengthen our position in OTC drugs. We will
continue on this path and build positions in this area with respect to
products and markets. These are important initiatives that will help the
company grow. The acquisition of Elidel is complete and reflects
increased focus on dermatology. We chose to license the North American
rights to Valeant. That partnership also includes Xerese and Zovirax.
Through this agreement, Meda will be able to earn considerable royalties
in the future. This agreement also means that we can focus Meda's
resources on the allergy area, which is our highest priority area in the
US, and that we can launch Dymista with full force.

Positive news on several products was presented in recent months:

  · The NDA for Dymista in the US was submitted to the FDA, and we
expect to submit an NDA in Europe before the end of the year.
  · NDAs for Zyclara and Acnex have been submitted to the European
regulatory authorities. These products will strengthen Meda's position
in dermatology in Europe.
  · Sublinox was approved in Canada and the product will be
commercialized through Meda's joint venture with Valeant. Meda
consolidates sales.
  · Potiga was approved in the US and Europe, and GlaxoSmithKline began
launching in some markets in Europe. Meda is entitled to 6-8% in
royalties in these territories.

Emerging Markets continues its positive performance, and we have
resolved to invest further in these markets. New subsidiaries are being
established in China, Brazil, Romania, and Australia.

Conditions are now very good for successfully growing the business.

Anders Lönner

Group President and CEO

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[1] Excluding non-recurring revenue of SEK 429 million in Q2 2010.

 [2]Excluding non-recurring revenue of SEK 429 million in Q2 2010 and
its related tax effect.

For more information, contact

Anders Larnholt,            
                                                                        
Phone        +46 8-630 19 62
VP Corporate Development and Investor
Relations                                                      +46
709-458 878

REVIEW REPORT

We have reviewed this report for the period 1 January 2011 to 30 June
2011 for Meda AB (publ). The board of directors and the CEO are
responsible for the preparation and presentation of this interim report
in accordance with IAS 34 and the Swedish Annual Accounts Act.  Our
responsibility is to express a conclusion on this interim report based
on our review.

We conducted our review in accordance with the Swedish Standard on
Review Engagements SÖG 2410, Review of Interim Report Performed by the
Independent Auditor of the Entity.  A review consists of making
inquiries, primarily of persons responsible for financial and accounting
matters, and applying analytical and other review procedures. A review
is substantially less in scope than an audit conducted in accordance
with International Standards on Auditing (ISA) and other generally
accepted auditing standards in Sweden. The procedures performed in a
review do not enable us to obtain assurance that we would become aware
of all significant matters that might be identified in an audit.
 Accordingly, we do not express an audit opinion.

Based on our review, nothing has come to our attention that causes us to
believe that the interim report is not prepared, in all material
respects, in accordance with IAS 34 and the Swedish Annual Accounts Act,
regarding the Group, and with the Swedish Annual Accounts Act, regarding
the Parent Company.

Stockholm, 3 August 2011

PricewaterhouseCoopers AB

Göran
Tidström                                                                
                                                                        
         
Authorized Public
Accountant                                                              
                                                          

Auditor in
charge                                                                  
         

FORWARD-LOOKING STATEMENTS

This report is not an offer to sell or a solicitation to buy shares in
Meda. This report also contains certain forward-looking statements with
respect to certain future events and Meda's potential financial
performance. These forward-looking statements can be identified by the
fact that they do not relate only to historical or current facts and may
sometimes include words such as “may”, “will”, “seek”, “anticipate”,
“expect”, “estimate”, “intend”, “plan”, “forecast”, “believe”, or other
words of similar meaning. These forward-looking statements reflect the
current expectations on future events of the management at the time such
statements are made, but are made subject to a number of risks and
uncertainties. In the event such risks or uncertainties materialize,
Meda's results could be materially affected. The risks and uncertainties
include, but are not limited to, risks associated with the inherent
uncertainty of pharmaceutical research and product development,
manufacturing and commercialization, the impact of competitive products,
patents, legal challenges, government regulation and approval, Meda's
ability to secure new products for commercialization and/or development,
and other risks and uncertainties detailed from time to time in Meda
AB's interim or annual reports, prospectuses, or press releases.
Listeners and readers are cautioned that no forward-looking statement is
a guarantee of future performance and that actual results could differ
materially from those contained in the forward-looking statement. Meda
does not intend or undertake to update any such forward-looking
statements.