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Almirall's European Dermatology business continued to be the driving force behind Almirall's strong performance in the first nine months of 2023, with a growth rate of 15.9% underpinned by the success of Ilumetri and other recently launched products.
Good performance of Key products in Europe: strong year-on-year growth of Ilumetri (psoriasis) across geographies; Wynzora (psoriasis) sales gaining traction, reinforced by recent country launches; and Klisyri (actinic keratosis) rollout driving its favourable uptake.
Lebrikizumab (EBGLYSS) received positive CHMP opinion for marketing authorisation in patients with moderate-to-severe atopic dermatitis; EU approval is usually expected within two months of the CHMP's positive opinion.
Pipeline development: based on the large field study data of tirbanibulin, the company submitted a supplementary New Drug Application (sNDA) in August 2023 and expects approval and a subsequent launch in H2 2024.
The additional funds obtained from the capital increase executed in June allowed Almirall to take strategic steps to expand its capabilities. In the third quarter Almirall completed the acquisition of the rights of Prometax in Spain, highly synergetic with Almirall’s existing neurology business in Spain. In parallel, the company continues to explore other opportunities for early and mid-stage assets. Almirall is on track to meet mid-single net sales digit growth (vs. initial low- to mid-single guidance) and continues to expect total EBITDA between €165 MM - €180 MM.
Summary of Results
- Net Sales reached €674.6 MM, a +6.4% year-on-year increase driven by good performance of the dermatology portfolio in Europe.
- Total EBITDA was €138.2 MM, consistent with expectations and reflecting the lower contribution from Other Income due to AstraZeneca / Covis milestones compared to 9M 2022.
- SG&A (Selling, General and Administrative) investment was €316.7 MM, 2.5% higher than last year, as expected. This increase reflects the company's ongoing investments in the pre-marketing ramp-up for lebrikizumab, as well as its investments in the recent launches of Wynzora and Klisyri in the US and EU, and the rollout of Ilumetri.
- Gross Margin of 64.9% was in line with expectations and reflects the impact of high input costs and inflation affecting some material purchases.
- R&D investment was €78.4 MM, reaching 11.6% of Net Sales. R&D expenses are expected to normalise for the full year in the range of 12% of Net Sales.
- Almirall finished the first 9 months of 2023 with a favourable balance sheet and solid liquidity position at 0.2x Net Debt to EBITDA.
Carlos Gallardo Piqué, Chairman and CEO of Almirall commented: Almirall has delivered a consistently strong operational performance throughout the first nine months of 2023, and we are pleased to modestly upgrade our Net Sales guidance for the year. As we gear up for the lebrikizumab launch, we're embarking on a transformative journey for our company. The expected EMA approval, following the positive CHMP opinion, is just around the corner.
We maintain confidence in the positive trajectory of our growth drivers as we continue to support their success. Moreover, we have strategically utilised the additional capital from our recent capital increase to strengthen our portfolio, while we continue to explore other opportunities to enhance our R&D portfolio. This reflects our commitment to advancing innovation in dermatology and positions us favourably to realise our ambition of becoming a leading dermatology company, paving the way in medical dermatology by providing innovative solutions that profoundly impact patients' lives.”