2012 results in line with guidance; positioning Almirall for transformative growth from 2013
Barcelona, 25th February 2013
- 2012 results in line with guidance
- Total revenues increase over 3% and international sales grow at 5%
- Eklira® is launched in 2012 in the US and three European countries
- Preparing for first Constella® launches in H1 2013
- Scrip dividend proposal of ¿ 0.15* per share
Financial highlights (¿ rounded million)
|
2012 |
2011 |
Variation | |
|
Total Revenues |
900.2 |
873.1 |
3.1% |
|
682.9 |
768.4 |
(11.1%) |
|
217.3 |
104.7 |
107.5% |
|
EBITDA |
124.0 |
160.1 |
(22.5%) |
|
Normalized Net income |
77.8 |
97.9 |
(20.5%) |
|
Eduardo Sanchiz, Chief Executive Officer, commented: |
"2012 has been a historical year for Almirall. Through important regulatory news and partnership agreements, we have set the foundations towards entering an important growth period while delivering on the financial guidance that we provided for the year and paying down the remaining debt.
Total revenues are up by 3% from the previous year while our international sales now represent 60% of total and are growing by 5%.
Mid-year approvals for aclidinium bromide in Europe and the US allowed us to launch it under the brand name Eklira® /Bretaris® Genuair® in three European markets before the end of the year and as Tudorza¿ Pressair¿ in the US. These activities allow us to enter the COPD (chronic obstructive pulmonary disease) market that accounts for more than $9 B worldwide.
We also received in November approval by the EMA of Constella® to treat patients afflicted by IBS-c (irritable bowel syndrome with constipation).
With these two assets plus Sativex we prepare, together with our partners, to perform more than 30 product launches in 2013. This will represent a major undertaking for Almirall and will require significant investments in order to maximize the products´ potential.
We have extended the reach of Eklira® through partnerships made during 2012 in Europe, Korea, Canada and Australia/New Zealand. Also through partnerships we have strengthened our new products portfolio by gaining rights to linaclotide and Sativex® in Mexico
In summary, we look forward to 2013 as an inflexion year and a year of strong product launch execution. We are enthusiastic about it and determined to leverage the opportunities in our portfolio to accelerate our mid and long term growth."
*rounded figure Barcelona, 25th February 2013 .- Almirall, the international pharmaceutical company based in Barcelona (Spain), announced results for the year ended December 31st, 2012.
Guidance delivered while Total Revenues increase
Total Revenues rose to ¿ 900.2 MM, increasing by 3.1% and driven by Other Income of ¿ 217.3 MM due to the booking of milestones mainly associated with aclidinium's monotherapy approval in the US and the EU.
Net Sales reached ¿ 682.9 MM (-11.1% vs. 2011) due to the impact of Spanish healthcare reforms and generic competition. International sales grew at 5% vs. 2011 and now represent near 60% of sales.
Gross Profit stood at ¿ 420.7 MM, -11.9% vs. 2011, which represents a limited gross margin erosion despite the ongoing pressures in Spain.
R&D Expenses were ¿ 159.5 MM, driven by the progress of our proprietary respiratory franchise, and increased by 10% to over 23% of sales.
SG&A (Selling, general and administrative) expenses were ¿ 420.5 MM, showing a significant increase of 23.5% vs. 2011 due to the major investment in Eklira®'s rollout as it was launched in three EU markets in H2 2012.
EBIT and EBITDA were ¿ 56.0 MM (-42.2%) and ¿ 124.0 MM (-22.5%), respectively.
Net Income reached ¿ 76.4 MM (-9.3%) and Normalized Net Income stood at ¿ 77.8 MM (-20.5%) in line with guidance.
The company expects a return to sales growth in 2013 while Normalized Net Income will be impacted due to investments in new products launches. Rapid growth is envisaged thereafter.
Almirall is now debt free as all financial debt was paid down during 2012.
Solid Free Cash Flow of ¿ 36.4 MM was generated during the period.
Equity has continued to increase and now totals 68.1% of Total Assets.
The Board will propose to the Annual General Meeting (May 3rd) a scrip dividend of ¿ 0.15 (rounded figure) per share. Shareholders will have the opportunity to take dividend either in cash or shares.
Positioning for transformative growth
Aclidinium monotherapy is sold under the trademarks Eklira® Genuair®/ Bretaris® Genuair® in Europe and Tudorza¿ Pressair¿in the US and presents a significant opportunity for Almirall in a growing COPD market currently worth in the order of $9 B. As of the end of 2012 the medicine was launched in the US, the UK, Germany and Denmark.
Linaclotide, the first IBS-c drug approved by the European regulatory authorities, is expected to begin its rollout in H1 2013 under the brand name Constella® indicated for moderate to severe IBS-c, a prevalent disease.
Sativex®'s roll out continues on track for spasticity in multiple sclerosis.
Almirall expects more than 30 launches of Eklira®, Constella® and Sativex® during 2013.
Dermatology is showing a very good evolution representing almost 20% of net sales in 2012 and growing at 8%.
The company also started in 2012 the co-promotion in Spain of rivaroxaban, an innovative anticoagulant for stroke prevention in atrial fibrillation, under the name Xarelto®.
Additionally, Almirall set up a new affiliate in Canada in order to have direct presence to reinforce activities in the North American geography and therefore enhance its international growth. Thus the company now counts on 14 affiliates and has direct market capabilities in 22 countries.
Corporate development continues
During 2012, Almirall's corporate development focus has continued.
The aclidinium franchise has been partnered to Forest in Canada, Grupo Menarini in Europe, Australia and New Zealand while Daewoong acquired rights on development and commercialisation for Korea.
It was also announced that rights for commercialising Constella® and Sativex® had been extended to Almirall for Mexico.
Almirall also became part of the share capital of AB-Biotics, a biotech company specialized in pharmacogenetics tests. From early 2013 on, both companies are commercialising Neurofarmagen in Spain, an innovative DNA test to be used in psychiatry and neurology.
R&D pipeline
Almirall's respiratory franchise is now led by the combination aclidinium + formoterol whose phase III BID1 trials in COPD continue, read out anticipated in Q2 2013.
Two other compounds are progressing in phase III: LAS41008 for psoriasis and Sativex® in oncological pain. In boht cases, top line results are expected in 2014.
Abediterol's development (OD LABA2), 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, the stepping stone to the triple combination is a MABA3 for COPD which is expected to enter clinical phase in H1 2013.
Financial Calendar 2013 and AGM .¿
| 3rd May 2013 7th May 2013 (Prev. 6th May) |
AGM Q1 Results |
|
29th July 2013 |
Q2/H1 Results |
|
11th November 2013 |
Q3 Results |
Notes: 1 BID: twice daily 2 OD LABA: Once Daily Long Acting Beta Agonist 3 MABA: Muscarinic acetylcholine receptor antagonist and beta 2 adrenoceptor agonist
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 a pharmaceutical company committed to provide valuable medicines through our own R&D efforts, which exceeded 23% on sales in 2012, together with external partnerships, licenses and collaborations. Through seeking innovative medicines we aim to become a relevant player in respiratory and dermatology diseases with also a strong interest in gastroenterology and pain. With more than 3000 employees in 22 countries, Almirall generated total revenues of 900 million in 2012.
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
| For more information: | Investors Relations contact: |
| Ketchum | Almirall |
| Sonia San Segundo/Alejandra Ríos | Jordi Molina |
| sonia.sansegundo@ketchum.com | jordi.molina@almirall.com |
| Tel.: 00 34 91 788 32 00 | Tel.: 00 34 93 291 30 87 |
Press release