Almirall 1st semester: excellent news in r & d and confirmed forecasts.

financial data highlights (rounded million €)

Eduardo Sanchiz, Consejero Delegado, comenta:

“We are very happy and proud of how the monotherapy aclidinio regulatory process has gone on both sides of the Atlantic. The result speaks very well of the work and the strength of the information submitted to the authorities.

In parallel, we are undertaking important work to prepare us for the new releases. We have established business partnerships that can provide a competitive position for our product in 80% of the world market of COPD, while we reinforce our market access and trade organizations.

In addition, the regulatory linaclotida in Europe for process runs its course and response we expect in the coming months.

“In summary, despite the difficulties in our domestic market, we reiterate our forecasts for 2012 and we are ready to start a period which could lead to a significant transformation of our business in the coming years”.

Approval of aclidinio and confirmation of forecasts for 2012

Net sales reached € 374.0 MM (- 12.3% vs. 2011) and are in line with forecasts, mainly due to legislative reforms in Spain and competition from generic for some products. International sales continue their good evolution with a growth of 3%, which means a 57% of total sales (compared with 48% in first half 2011).

Gross margin stood at € 230.5 MM, representing a 61.6% and is similar to the 2011 period, mainly due to the international expansion of Almirall.

Other income was € 47.5 MM (- 7.4%) and will grow significantly in the third quarter with the imputation of the landmarks associated with the approval of aclidinio in the United States and Europe.

The r & d expenses totalled € 77.7 temporarily MM, due to the progression of the studies in progress, but is expected to be similar to the figures for 2011 in absolute terms at end of year.

As anticipated, the expenses SG & A (sales, general and Administration) have continued to increase until a 4.1 per cent at € 184.5 MM, due to commercial investments related to aclidinio and linaclotida. He is expected that this growth in the coming quarters.

EBIT and EBITDA were € 17.9 MM (- 77.7%) and € 51.1 MM (- 54.0%), respectively.

The standard net result stood at € 27.0 MM (- 62.6%), while temporarily – as expected – below forecast, although it will improve in the third quarter due to the income derived from the adoption of aclidinio.

The free cash flow generated during the period remained positive at € 26.8 MM, although the investment activities have been higher than last year. It is worth mentioning that the amortization of the debt reached 119,9 mm €

Equity shows a solid balance sheet and accounts for more than 64% of the Total assets.

The General meeting of shareholders (May 4) approved a dividend of € 0.18 (rounded figure), which had a significant success since 96% of shareholders opted for new actions flexible. This has allowed Almirall to retain almost € 28 MM to further strengthen its balance sheet.

In summary, the results of the first half of Almirall were in line with expectations, with a solid balance sheet (net cash of € 5 MM) and recurring free cash flow generation. Financial forecasts to 2012 are confirmed.

Pipeline and regulatory update

Aclidinio monotherapy and your inhaler (Genuair ®) – both from the r & d Almirallpara chronic obstructive pulmonary disease (COPD), one of the key records of the company in 2012, has been approved by the FDA in the United States and by the European Commission in Europe.

Almirall respiratory franchise also boasts the combination aclidinio+formoterol currently in phase III development, whose results topline is expected to announce during 2013.

R & d compound own LAS41007 for skin cancer not melanoma has been discontinued due to its modest efficacy.

Sativex ®, which is already sold to treat spasticity in multiple sclerosis, is also in phase III for cancer pain.

Linaclotida, a unique opportunity for the irritable bowel syndrome with constipation (PRINCEZ) continues its regulatory course in Europe and expected response during 2012.

Growth platforms

Expected to launch your inhaler – both r & d Almirall – in the United States, Germany, United Kingdom and some Nordic countries before the end of the year and aclidinio monotherapy.

In the United States the brand will be Tudorza ® Pressair ® while in Europe the commercial names are Eklira ® Genuair ® and Bretaris ® Genuair ®.

Almirall has signed agreements on aclidinio with key companies such as Forest for the United States, Menarini for Europe, Kyorin in Japan and Daewoong at Korea. Agreements have also signed with Quintiles to United Kingdom and Germany. These agreements will provide a broad global reach in the area of respiratory covering geographies that represent more than 80% of worldwide sales of COPD, which will have a significant influence on the process of internationalization of Almirall. For the remaining 20%, Almirall is evaluating other options of agreements.

While Almirall prepares for the future deployment of aclidinio and linaclotida, the latest releases (Actickerall ®, Efficib ®, Sativex ® Toctino ® and Tesavel ®) grew almost 44 per cent and the dermatology franchise has continued to evolve as successfully with an increase of 8.5%.

In the first half of 2012, Sativex ® received the recommendation for approval in 10 additional European territories through the mutual recognition procedure and is expected to keep its deployment in new countries. Almirall owns the rights of marketing in Europe (except United Kingdom) and Mexico, where it has already launched the drug in Spain, Germany and Denmark.

New products to be launched in the third quarter included the co-promotion of the anticoagulant rivaroxaban in Spain.

In addition, Almirall is establishing a new subsidiary in Canada in order to have a direct presence to strengthen its activities in the North American geography and thus reinforce its international growth.

Almirall

Almirall is an international pharmaceutical company based on innovation and committed to health. With headquarters in Barcelona (Spain), Almirall researches, develops, produces and sells drugs r & d own and license, with the purpose of improving the health and well-being of people. The therapeutic areas in which concentrates its research resources are related to the treatment of asthma, COPD (chronic obstructive pulmonary disease), gastrointestinal disorders, psoriasis and other dermatological forms. Almirall drugs currently present in more than 70 countries. It has direct presence in Europe and Latin America through 12 subsidiaries.