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Q3 results: Almirall prepares for future growth

Barcelona, 14 November 2011

  • On track to achieve profit guidance.  
  • Strong balance sheet, estimated net cash by year end.  
  • Excellent free cash flow generation.  
  • Aclidinium bromide monotherapy submitted for approval in EU and US and its combination with formoterol has started phase III.  
  • Linaclotide submitted for approval in EU.  
  • Six recent product launchescontributing to rejuvenate Almirall’s portfolio.

Financial highlights (€ rounded million)

YTD Sep 2011

YTD Sep 2010

Variation

Net Sales

591.9

676.5

(12.5%)

EBIT

101.1

146.8

(31.1%)

EBITDA

148.0

192.8

(23.2%)

Normalized Net income

93.7

121.9

(23.1%)

 Free Cash Flow

94.8

79.1

19.8%

Eduardo Sanchiz, Chief Executive Officer, said:

"In a challenging environment we maintainsolid financial fundamentals. We are highly focusedon cost management and in the growth of ourInternational business.

The recent corporate development agreements are accelerating their contribution to our revenuesas a new product cycle is unfolding and rejuvenating our portfolio.

Now is time to ensure that the anticipatedforthcoming launches (aclidinium and linaclotide), with unprecedented sales potential for Almirall, are optimally promoted.

To take Almirall to the next level our mid-term planning is focused upon dealing withthe currentmarket challenges and ensuring thatwe leverage the potential of our different growth platforms.”

Barcelona, 14th November 2011.–  Almirall, the international pharmaceutical company based in Barcelona(Spain), announced results as of September 30, 2011.

Financial Results

Almirall is on track to attain its profit guidance in a challenging environment.

Salesreached € 591.9 MM still reflecting the impact of the 2010 reforms and generic competition. The core international business is growing well.

Gross Profit stood at € 371.0 MM and represents a margin of 62.7%. It has significantlyimproved by 110bps, mainly driven by the greater proportion of proprietary drugs sold.

R&D Expenseswere € 97.3 MM, representing 16.4% of sales and already reflecting the start of the phase III of aclidinium bromide + formoterol combination for COPD1treatment.

SG&A(Selling, general and administrative) expenses were € 250.0 MM and this is on trackto achieve the targeted € 7 MM savings this year.

Normalized Net Incomeof€ 93.7 MM iswithin guidance.

The strong financial fundamentals continue. Almirallmaintainsa very solid balance sheetwith intact net leverage capacity and the company estimates net cash by yearend.

The solid Free Cash Flow generated during the period reached € 94.8 MM and has improved by 20% vs. the same previous period of 2010.

Almirall’s financial performance during the first three quarters is progressing within expectations andthe company expects to achieve the profit guidance announced in October.

Pipeline with significant upside

Almirall’s pipeline is on track and progressing as expected with newsflow delivered as planned.

Aclidinium bromide monotherapyin the Almirall’s Genuair® inhaler, a novel, 2-step, patient friendly, has been presented forregistration in the USand EU for moderate to severe COPD.

Linaclotide,a pan-European first-in-class opportunity in the IBS-C2 indication with high unmet needs in which no specific treatments have been approved by the EMA3 yet, has also been submitted for approval in Europe in Q3 2011.

Both submissions have been validated and regulatory feedback is expected during 2012.

Almirall’s respiratory franchise continues to evolve.The phase III combination of aclidinium bromide + formoterol BID4in COPD has started with clinical trials conducted globally to satisfy requirements from both, European and North American regulatory authorities.

Two additional compounds are progressing in phase III: LAS41007 for non melanoma skin cancer and Sativex® in oncological pain.

Almirall’s growth platforms

Recent product launches like Tesavel®, Efficib®, Actikerall®, Sativex®, Silodyx® and Toctino®, are evolving positively and contributing to the rejuvenation of Almirall’s portfolio, adding to accumulated sales more than € 34 MM as of the end of Q3. This contribution is expected to accelerate and will be reinforced by the forthcoming launch of Solaraze® in Spainbefore the end of this year.

There are ongoing price and reimbursement conversations with authorities for Toctino® which roll-out Almirall plans to continue during 2012.

Sativex®has already been launched by Almirall in Spain, Germanyand Denmarkand four additional countries, Austria, CzechRepublic, Italyand Swedenwill be added during 2012. A second Mutual Recognition Procedure (MRP)5wave is expected before the end of 2011. Almirall holds EU commercial rights for the product except in UK.

The expected regulatory feedback for aclidinium bromide and linaclotide, that target areas with unmet needs and offer differentiation vs. current therapies, represents a new possibility for patients and physicians as well as an unprecedented commercial opportunity for Almirall.
It is estimated that these medicines could reach the market during the first half 2013 and could provide significant transformation to the company and to its International footprint.

Strategic considerations

Almirall’s strategic priorities include:

  • Drive growth of recent product additions, as well as preparing effectively for launch of the key three growth platforms (aclidinium bromide, linaclotide and Sativex®).  
  • Preparing the organization for growth, realigning teams to reach the next level whilst maintaining a continuous cost focus.  
  • Managing the P&L transition in the current challenging environment whilst ensuring appropriate investment to leverage potential transformational opportunities.

Notes: 1COPD: Chronic Obstructive Pulmonary Disease 2IBS-C: Irritable Bowel Syndrome with Constipation 3EMA: European Medicines Agency 4BID: twice daily 5MRP: The Marketing Authorisation for a medicine in a European member state acting as ReferenceMemberStatederives in an approval procedure extended to other state members.

Disclaimer This document includes only summary information and does not intend to be comprehensive. Facts, figures and opinions contained herein, other than historical, are "forward-looking statements". These statements are based on currently available information and on best estimates and assumptions believed to be reasonable by the Company. These statements involve risks and uncertainties beyond the Company's control. Therefore, actual results may differ materially from those stated by such forward-looking statements. The Company expressly disclaims any obligation to review or update any forward-looking statements, targets or estimates contained in this document to reflect any change in the assumptions, events or circumstances on which such forward-looking statements are based unless so required by applicable law.
 

About Almirall Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercializes its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.

Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, psoriasis and other dermatological conditions.

Almirall’s products are currently present in over 70 countries while it has direct presence in Europeand Latin Americathrough 12 affiliates. For further information please visit: www.almirall.com

More information:

Ketchum Pleon (media):

Sonia San Segundo/Mónica Escusa Tel. +34 91 788 32 00 sonia.sansegundo@ketchumpleon.com monica.escusa@ketchumpleon.com

Investor Relations (investors and analysts):

Jordi Molina Tel. +34 93 291 3087 jordi.molina@almirall.com

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