|Almirall begins the transformation|
Barcelona, 7h May 2013
Financial highlights (€ rounded million)
Eduardo Sanchiz, Chief Executive Officer, commented:
"Financial results in Q1 were in line with our expectations and on track to achieve the yearly guidance. Sales improvement will become apparent in the second half of the year given the effect of the reforms implemented in Spain in 2012 together with the increasing acceleration of the new products sales, especially aclidinium.
Almirall's good momentum continues in 2013 based on the rollout of aclidinium, linaclotide, Sativex®, and dermatology products in key markets and the company's international expansion, together with positive R&D news.
We expect more than 30 country launches in 2013 of these three assets and this will require our continued strong focus on execution to maximize the value for all stakeholders.
In the R&D arena, successful phase III aclidinium + formoterol combo pivotal studies will support the regulatory filing submissions in Europe and the United States in 2013, meaning one step closer for Almirall towards achieving an innovative global respiratory franchise around aclidinium and the Genuair® inhaler, our own R&D device.
We remain fully focused on the transformational opportunity that we start this year".
Barcelona, 7th May 2013.- Almirall, the international pharmaceutical company based in Barcelona, announced results for the first quarter 2013.
Financial guidance 2013 confirmed
Total Revenues reached € 198,3 MM (-10.2%), including Net Sales of € 170,3 MM and Other Income of € 28,0 MM mainly associated with Eklira®.
Net Sales stood at € 170,3 MM (-14.9% vs. 2012) impacted -as expected- by Spanish reforms and generic competition, but will progressively improve over the year driven by accelerating new product sales, especially aclidinium.
Gross Profit reached € 110,0 MM and represents a margin of 64.6%, a strong improvement vs. 61.9% in 2012 due to the new mix of proprietary products, especially aclidinium. We expect improvements in gross profit to be sustainable going forward.
As anticipated, R&D expenses, at € 28.3 MM vs. 38,0 MM in the same period last year, came back to more normal levels after reaching a peak level in 2012 driven by the aclidinium+formoterol combo trials.
SG&A (Selling, general and administrative) expenses grew 14.3% to € 104.9 MM, as per the continuous commercial efforts in supporting Almirall's new platforms of growth. Lower increase is expected at the end of the year vs. 2012.
EBIT and EBITDA were € 3.5 MM (-76.5%) and € 20.1 MM (-35.8%), respectively.
Normalized Net Income was € 10.2 MM (-44.3%), in line with guidance, due to investment in new product launches.
Almirall now holds a solid cash position of € 35.9 MM.
Equity shows a solid balance sheet and amounts to 70.4% of Total Assets.
The Annual General Meeting (May 3rd ) approved a scrip dividend of € 0.15 (rounded figure).
Pipeline and regulatory update
Leading the respiratory franchise is now the combination of aclidinium + formoterol BID1 for chronic obstructive pulmonary disease (COPD) which showed recent positive phase III results in two different pivotal studies in Europe (ACLIFORM COPD) and the US (AUGMENT COPD). Indeed both studies confirmed safety and efficacy and will support the regulatory filing submissions in the said territories in Q4 2013. This successful completion of both pivotal studies mean that Almirall is one step closer towards achieving an innovative global respiratory franchise around aclidinium and the Genuair® inhaler, Almirall's own R&D device.
A proprietary derma compound, LAS41008 for psoriasis, as well as Sativex® in oncological pain, are also undergoing phase III. Top line results are expected in both cases during 2014.
Abediterol's (OD LABA2) development, combined with an inhaled corticosteroid, for the treatment of asthma and COPD, is entering phase IIb and ready to be partnered worldwide (ex-US).
In addition, a MABA3 for COPD that could be the trigger to a triple combination is entering the clinical phase in 2013.
Transformative potential of growth
Linaclotide, for moderate to severe irritable bowel syndrome with constipation(IBS-c), is the first drug approved by the European regulatory authorities for this condition. It is already available in Germany and later this month it will be in the UK. Besides, its rollout will be continue throughout 2013.
Almirall expects more than 30 launches of Eklira®, Constella® and Sativex® during 2013.
Dermatology products coming from own R&D efforts are a main source of future growth. The area continues very good evolution contributing almost 20% to Almirall's business.
Investor Calendar 2013 –
The company was founded in 1943 and is headquartered in Barcelona, Spain. The stock is traded in the Spanish stock exchange (ticker: ALM).
For more information please visit www.almirall.com