Almirall’s year to date results 2014: In line with guidance

• Solid growth in Sales and Total Revenues
• Platforms of Growth represent 47.5% of Net Sales after growing 74.9% vs Q3 2013
• Acceleration of Net Sales (19.6%) and EBITDA growth (80.4%)
• Duaklir^® (aclidinium bromide/formoterol fumarate) recommended for approval in Europe to treat COPD
• Transaction with AstraZeneca successfully completed

Financial highlights (€ rounded million)

Eduardo Sanchiz, Chief Executive Officer, commented:

“Performance for September YTD has been strong and in line with our guidance for the year, showing high teens growth in sales and very significant profits growth, all driven primarily by respiratory and dermatology together with our other platforms of growth, gastroenterology and pain.

We see now, effective on November 1^st, a significant evolution in Almirall´s strategy through our strategic respiratory agreement with AstraZeneca. This deal will allow to maximize the value of our respiratory portfolio and for Almirall to be able to obtain over the years a revenue stream linked to its performance. At the same time, the proceeds from this operation will help us to better focus in specialty areas and particularly in dermatology, where we are taking further efforts to become a top global player.”

Almirall, the global pharmaceutical company based in Barcelona, announced year to date 2014 results.

Continued growth acceleration – Highlights

Total Revenues:   €654.1 MM (+7.0%) 

Net Sales of €611.5 MM (+19.6%) 

Other Income of €42.6 MM (-57.5%). Lower trends were as anticipated and reflect smaller contributions to R&D expenses and lower milestones from partners.

Gross Profit:   €429.8 MM (70.3% of Net Sales) improving significantly versus the same period of 2013 driven by a more favorable mix of proprietary sales and Aqua Pharmaceutical’s consolidation.

R&D expenses of €80.1 MM decline by 11.7% vs the same period of last year, representing 13.1% of sales.

SG&A expenses reached €349.1 MM (+3.5%).

EBIT and EBITDA jumped to €43.1 MM and €107.0 MM (+80.4%), as a consequence of Net Sales acceleration

Net Income and Normalized Net Income were €42.9MM and 43.9MM, 96.8% and 101.4% respectively higher than in Sept YTD 2013.

Shareholders Equity represented 52% of Total Assets.

Performance year to date has been strong and consistent with the yearly guidance.

Platforms of Growth

In Q3 Almirall’s growth continued to be driven by a strong focus in respiratory and dermatology followed by gastroenterology and pain.

Eklira^®, has grown to €93.4MM (+53.3%), representing 15.3% of our net sales.

Our Dermatology franchise grew 83.4% to €181.9MM following the consolidation of Aqua Pharmaceuticals (+6% excluding Aqua), and it has now become our number one therapeutic area in terms of sales.

In Rx dermatology, Almirall is already number 1 in Germany, number 5 in Europe, and within the first 10 in the US for dermatology prescriptions.

Gastroenterology and Pain are also areas of additional interest to Almirall which are represented by two first-in-class brands: Constella^® and Sativex^®.

Constella^®, for the treatment of irritable bowel syndrome with constipation, is now present in 11 countries including Mexico where it was recently launched (under the brand Linzess^®); additionally, Constella^® has been successfully launched in Spain during Q3. 

Sativex^®, indicated for spasticity in Multiple Sclerosis, is now available through Almirall in 11 European countries. As of the end of Q3 2014, Sativex^® growth was 127.0% vs the same period last year. At the beginning of 2015, it is anticipated that top line phase III data will read out for a second indication (cancer pain) for which Almirall holds the European commercial rights ex-UK.

In summary, our Platforms of Growth (Eklira^®, Constella^®, Sativex^® and the derma franchise) increased by 74.9% and now represents 47.5% of total sales (vs 32.5% in H1 2013).

Strategic transaction with AstraZeneca

Almirall announced on November 3^rd that the transaction to transfer to AstraZeneca the rights of Almirall’s respiratory franchise was completed after all closing conditions were satisfied. AstraZeneca will now own the rights for the development and commercialisation of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira^® (aclidinium); Duaklir^®, the combination of aclidinium with formoterol (LAMA/LABA) that has received a positive opinion from the CHMP in the EU and is being developed in the US; LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in Phase II; an M3 antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and Phase I (LAS190792); and multiple pre-clinical programmes. Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, also transfers to AstraZeneca.

This transaction includes an upfront cash consideration of $875 million and, additionally, up to $1.22 billion related to development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments.

Almirall’s Newsflow

In July, our subsidiary Aqua Pharmaceuticals announced approval from the U.S. Food and Drug Administration (FDA) of the NDA for ACTICLATE™ (doxycycline hyclate USP) Tablets, 150 mg and 75 mg, thereby continuing Aqua’s leadership in medical dermatology and oral antibiotics for acne.

In September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the regulatory approval of Duaklir^® Genuair^® (aclidinium bromide/formoterol fumarate) in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).