Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
- Earnings ahead of market expectations and market share continues to grow
- First meeting with regulatory authorities to prepare first in human trial for peanut allergy product
11 July 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2019 ahead of its Preliminary Results to be announced on 25 September 2019.
As previously announced, the Group now expects earnings for the full year 2019 to be ahead of market expectations. Net revenue is expected to be £73.7m (2018: £68.3m) representing 8% annual growth on a reported and constant currency basis reflective of strong performance. The Group is continuing to gain market share within its core markets in Europe and data for the key markets for the 12 months ending 31 March 2019 showed a 0.6 market share point increase1. Overheads are expected to be in line with market expectations.
The cash balance at the end of June 2019 was £27.4m (30 June 2018: £15.5m) which includes $7.6m (£6m) received before year end in settlement of litigation against Inflamax and three of its senior employees regarding a clinical trial, which ATL alleged was poorly run by Inflamax, as announced on 28 June 2019.
On current assumptions, the Group will be able to fund the Grass MATA MPL Phase III trial currently planned to start in autumn 2020 from existing resources. If the trial is successful, and subject to completion of the safety database, the Group will pursue regulatory filing in the US, opening up a potential market of approximately $2 billion.
In addition to the continued progress of its European business, the Group is exploring the potential distribution of its products in other markets, including China, and will provide an update when further information is available.
The Group had a good meeting with Swissmedic, the Swiss regulatory authority, to discuss the potential protocol for the first in human trial of its VLP-based (Virus-like Particle) Peanut product, due to start in H1 2020, and also continues to make good progress with the commercial scale-up process for this product. The Group is also looking to expand the VLP technology into other allergy areas.
Manuel Llobet, CEO at Allergy Therapeutics, stated: "Our strong, technically advanced and convenient product portfolio continues to perform well in the market and has facilitated 20 years of strong revenue growth. It is a testament to our patient-focused strategy that we continued to increase market share this year. We have made further progress on the pipeline portfolio and the Group's meeting with the Swiss regulatory authorities was an important milestone in the development of our exciting peanut product."
1Market data and internal estimates for 12 months to 31 March 2019, for the markets in which Allergy Therapeutics operates excluding Switzerland (competitor data not available)
This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.
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For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Erik Anderson, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia Manser
Stern Investor Relations, Inc.
+1 212 362 1200
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including aluminium free immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. Its broad pipeline of products in clinical development include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m2 of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which has achieved over 9% compound annual growth since formation, employs c.500 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.