Barcelona, 14th May 2018

Financial highlights (€ rounded million)2

'We are encouraged by the positive financial results of this first quarter of 2018 with a strong EBITDA and Net Income delivery. Dermatology in Europe continues to perform well, as we continue building our psoriasis franchise. In this regard, Skilarence® -recently launched with very positive initial feedback- will be continuing its roll out in other key European countries in H2, while the anticipated launch of tildrakizumab is on track for Q4 2018 or Q1 2019.

We expect this positive sales momentum to further build through 2018, enabling us to drive profit growth in the short-medium term and achieving the Guidance for 2018. We are executing in line with our strategic goals and I am confident that the company will create sustainable value for our shareholders.'

Peter Guenter, CEO.

Almirall, S.A. (ALM), the global pharmaceutical company based in Barcelona, has announced its Q1 2018 results.

Results summary.

  • Net Sales of €189.3 MM grew by 1.3% in CER, benefiting from new launches and a solid performance of the base business and despite last year's difficult comparable. Total Revenues reached €202 MM in Q1 2018 (-2.8% in CER).
  • Gross Profit growth of 4.6% in CER (€130.7 MM vs €128.2 MM in Q1 2017) reflected a constant currency gross margin improvement driven by product mix.
  • Research & Development costs were €18.6 MM in Q1, or 9.8% of Net Sales. We are targeting an investment of around 13% of Net Sales in the mid-to-long term.
  • Selling, General & Administrative expenses, excluding depreciation, declined by 4.3% in CER in Q1 2018. Resulting savings will be re-invested in growth.
  • EBITDA of €58 MM (+6.1% growth in CER) at close of Q1 2018, puts us on track to deliver our full-year Guidance.
  • Net Income of €30.9 MM experienced very strong growth of 59.6% in CER in comparison to Q1 2017.
  • Cash Flow from Operating Activities was €33.9 MM, while our Net Cash Position3decreased slightly at Q1 of 2018 (-€13.1MM), mainly related to the investment in new assets. Financial Debt came to a total of €150 MM, representing 7.4% of Total Assets.
  • Shareholders Equity represented 57.5% of Total Assets.

Building the psoriasis franchise. Strong performance of key brands.

Europe continues to be a key market in dermatology with sales of €45.4 MM, supported by the strong performance of key brands as Skilarence® and Ciclopoli®.

We are building our psoriasis franchise and remain encouraged by the positive launch of Skilarence®, the first and only European Commission approved fumaric acid ester (FAE) for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. In 2017, it was launched in UK, Germany, Sweden, Denmark and Norway. Skilarence® achieved close to 50% of Fumaderm® volumes by April and 35% of conventional market share4in Germany. Growth came from both switched and new patients, indicating renewed interest in fumarates as conventional treatment. We plan to launch Skilarence® in most other European countries in the coming quarters, including in Spain and Italy.

We are also preparing for the anticipated launch of tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. We submitted the regulatory filing in Europe at the beginning of 2017, and we hope to receive EU approval in Q4 2018, with subsequent launch shortly thereafter.

Sales of Ciclopoli®, the flagship Poli Group product for nail conditions, accounted for €11 MM, representing a growth of +20.4% vs. 2017. Market share of Ciclopoli® has been growing since Almirall acquired Poli Group in 2016, boosted by the strong efficacy of the product and the good performance of the sales team.

Another key brand performing strongly in the quarter is Sativex®, an endocannabinoid system modulator indicated as a treatment for patients with moderate to severe spasticity related to multiple sclerosis, generating sales of €7 MM (+29.6%).

Regarding Almirall US, the measures implemented in 2017-restructuring, strong cost control and new leadership team, among others- have started to take effect and profit has improved in comparison with Q4 2017. Nevertheless, the US market continues to be a complex environment in which to operate. We are focusing our efforts on improving our potential in medical dermatology and strengthening our portfolio, as demonstrated by the in-licensing of Athenex's KX2-391.

R&D progression.

Our focus remains firmly on offering an R&D pipeline with the best potential in the market. We are working on differentiated products that will cover unmet needs able to capture a significant market share, through targeting smart and breakthrough innovation, collaborating with external partners, and seeking differentiated New Chemical Entities (NCEs).

We currently have a total of 8 programs in our pipeline, including our first biologic, tildrakizumab. We have 3 products in phase III: P3058 (onychomycosis) in Europe; P3074 (androgenetic alopecia) in Europe and US, and KX2-391, recently added from our partnership with Athenex for the development and marketing in the US and Europe. KX2-391 is a first-in-class topical treatment of actinic keratosis and possibly other skin conditions that will strengthen Almirall's actinic keratosis franchise and dermatology market leadership. We expect phase III top-line data in Q3 2018.

We also have 1 program in phase II for Ichthyosis (PAT001) and 3 more programs in early development for rosacea (ADP13612), psoriasis (ADP12734) and atopic dermatitis (ADP12778).

Dividend Approval.

At the recent Annual General Meeting, held on May 10th 2018, a scrip dividend payment of €33 million euros or €0.19 per share was approved. The payment will be effective on June 1st and may be received in cash or in shares, at shareholders' discretion. The acquisition of a maximum of 5% of the company to be held as treasury shares was also approved at the Annual General Meeting.

Vision for the future.

Almirall continues to be focused on transforming its business strategy with the goal of becoming a global pharmaceutical leader focused on skin health, applying Science to provide solutions for healthcare professionals and patients. We continue to centre our efforts to support healthcare professionals in their continuing improvement, bringing our innovative solutions where they are needed.

M&A and in-licensing remain a priority. Our strong financial position will enable us to seek new growth opportunities aligned with our corporate strategy. Our smart investment focus will identify companies and/or assets in Europe and US, which generate shareholder value from the outset.

Guidance for 2018.

Guidance given on a CER basis.

Investor Calendar 2018.

  • H1 2018 Financial Results - 30th July 2018
  • Q3 2018 Financial Results - 12th November 2018

About Almirall

Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed.

The company, founded almost 75 years ago and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenues in 2017 were 755.8 million euros. More than 1,830 employees are devoted to Science.

For more information, please visit almirall.com

1CER (Constant Exchange Rates): Excluding the effects of exchange rate fluctuations

2IFRS 15 implemented

3Excluding Pension Plans

4Source: IMS SMART Psoriasis Systemic & Biologics database MAT Q2 2017 EU15

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Almirall SA published this content on 14 May 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 14 May 2018 07:27:05 UTC