TIDMAGY
RNS Number : 0099T
Allergy Therapeutics PLC
15 July 2020
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
Trading Update
- Strong 2020 performance despite COVID-19 challenge
- Earnings above market expectations
- Net revenue of GBP78.2million representing 6% annual growth
- Strong cash balance of GBP37.0 million
- Phase I Peanut program fully funded from existing resources
- Licencing deal signed for new oral treatment, ImmunoBON
- COVID-19 diagnostic facility approved by Spanish authorities
15 July 2020 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 2020 ahead of its Preliminary Results to be announced on 23
September 2020.
Financials
The Group now expects earnings for the full year 2020 to be
ahead of market expectations as announced on 24 June 2020. Net
revenue is expected to be GBP78.2million (2019: GBP73.7million)
representing 6% annual growth (7% growth on a constant currency
basis) reflective of a very robust performance in challenging
circumstances. Operating efficiencies and timing of the research
and development spend have led to strong overall performance with
the Group likely to report a significant, positive net income for
the year. Due to the Group's strong performance, the Executive
Management has taken the decision to repay all UK furlough monies
claimed back to the government.
The cash balance at 30 June 2020 was GBP37.0 million (30 June
2019: GBP27.4 million). The Group's total bank loan debt was GBP3.8
million (30 June 2019: GBP2.4 million).
Based on current assumptions, the Group expects to be able to
fully fund the upcoming Grass MATA MPL pilot and pivotal Phase III
field studies and the Phase I Peanut programme with existing cash
resources and a small amount of additional debt.
Response to COVID-19 and Commercial Update
The Group has coped well with the challenge presented by
COVID-19. After an initial decline, sales improved and have only
been moderately affected due to patients not visiting clinics and
hospitals. Trading in Southern Europe has been more heavily
impacted than in Northern Europe, owing to the greater number of
allergy clinics located within hospitals in Southern Europe. The
sales and marketing team across Europe has responded rapidly to
provide broad support to doctors, hospitals and patients.
Encouragingly, the easing of restrictions is reflected in the final
month of the year, with sales returning to previous levels.
From the beginning of the COVID-19 outbreak, the Group has taken
steps to ensure the safety of its employees. This was achieved, in
part, by implementing social distancing measures within the Group's
operations and splitting vital functions into separate teams to
minimise the risk of workers becoming ill and slowing production
and transport across the continent. Throughout the COVID-19
situation, the Group has maintained a constant supply of its
products across all markets with no disruption in the supply chain.
All areas of the business have reacted well to the challenges of
COVID-19, with approximately two-thirds of staff working remotely.
Clear communication with internal and external stakeholders and a
strong collaborative approach in line with the Group's values and
behaviours, have helped to ensure minimum disruption.
COVID -19 Diagnostic Facility
In response to the urgent need to increase the global capacity
to diagnose infected COVID-19 patients, the Group has invested
capital into expanding its microbiological diagnostic facilities in
Spain, by incorporating an RT-PCR based SARS-COV-2 diagnostic test
into its portfolio. The RT-PCR technique can detect a fragment of
RNA (the genetic material) derived from the SARS-COV-2 virus to
determine if the patient is currently infected.
The Group's expanded microbiology facilities in Alcalá, named AT
Immunolab, have been authorised by Spanish Health Authorities and
will provide support in this healthcare crisis helping healthcare
providers and patients in this difficult situation. The project has
been set up in a significantly accelerated timeframe and received
financing from the Centre for the Development of Industrial
Technology and the Technology Fund, from the Ministry of Science,
Innovation and Universities of Spain. AT Immunolab began SARS-COV-2
testing in the first week of July and, at full capacity, is
expected be able to perform 200,000 tests a year.
Pipeline
Previously communicated R&D plans continue to be executed
and the Grass MATA MPL clinical programme is expected to start next
month as planned, with the pilot field study in about 150 adults to
be recruited in the US and Europe. The study will implement
COVID-19 related procedures, flexibility and strategies to minimise
the impact of COVID-19. Limited impact on clinical operations or
regulatory activities is expected.
The Group has signed a knowledge-sharing agreement with Saiba
AG, owners of the virus-like particle (VLP) platform currently
licensed to Allergy Therapeutics for allergy indications, to assist
with the development of Saiba's COVID-19 vaccine candidates. The
agreement has the potential to benefit the Group in the future, by
supplying pre-clinical and clinical data using the same novel VLP
platform to support the Group's peanut vaccine candidate
programme.
The Group has also signed a commercial agreement with Biomedical
International R+D GmbH for the exclusive rights to ImmunoBON, a
patented protein-based oral treatment which was developed to
replicate the reduction in incidence of allergy as seen by those
who live on a farm with livestock, the so-called "farm effect". In
a preclinical study programme, the immunogenicity of the protein
formulation with the selected ligands was proven, as well as the
capacity to prevent allergic sensitisation(1-5) . At the scientific
congress of the European Academy of Allergy and Clinical Immunology
in June 2020, two poster presentations demonstrated that the
product significantly reduced allergic symptoms in a mouse model(6)
, and also among patients in a double-blind placebo controlled
pilot study(7) when compared to placebo treatment. Additionally, a
recently completed study in an allergen exposure chamber (European
Centre for Allergy Research Foundation, Berlin, Germany) revealed
significant improvement in allergy symptoms in house dust mite
allergic patients (data on file).The product will initially be
available in Germany with roll out across the rest of Europe to
follow.
Manuel Llobet, CEO at Allergy Therapeutics , stated: "Our focus
during the COVID-19 pandemic has been the safety and well-being of
all of our employees, partners and customers and I am proud of our
robust and rapid response to the challenges presented during this
time. When the outbreak started in Europe, we made a commitment as
a group to leverage our strengths. Our business has put in place
new efficiencies, highlighting our resilience and agility in times
of change and we are thriving as a result. Our plans to develop a
strong R&D pipeline remains on track and our two recently
signed agreements with partners provides exciting new opportunities
for our VLP technology and our oral treatment offerings for allergy
patients. I am especially proud of our team and would like to thank
them for their unwavering commitment and desire to drive the
business forward."
This announcement contains inside information for the purposes
of Article 7 of Regulatory (EU) No596/2014.
-S -
For further information, please contact:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
Panmure Gordon
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
James Stearns, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Ashley Tapp / Olivia
Manser
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
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 11,000m(2) 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 .
References:
1. Roth-Walter et al. The Major Cow Milk Allergen Bos d 5
Manipulates T-Helper Cells Depending on Its Load with
Siderophore-Bound Iron. PLoS ONE 9(8): e104803
2. Roth-Walter et al. Bet v 1 from Birch Pollen Is a
Lipocalin-like Protein Acting as Allergen Only When Devoid of Iron
by Promoting Th2 Lymphocytes. J. Biol. Chem. 2014,
289:17416-17421
3. Hufnagl et al. Retinoic acid prevents immunogenicity of milk
lipocalin Bos d 5 through binding to its immunodominant T-cell
epitope. Scientific Reports 2018; 8:1598
4. Hufnagl et al. Retinoic acid-loading of the major birch
pollen allergen Bet v 1 may improve specific allergen
immunotherapy: In silico, in vitro and in vivo data in BALB/c mice.
Allergy. 2020;00:1-5
5. Roth-Walter et al. Cow milk protein beta-lactoglobulin
confers resilience against allergy by 1 targeting complexed iron
into immune cells. JACI 2020, in press (available as Journal
pre-proof) doi.org/10.1016/j.jaci.2020.05.023
6. Afify et al. Dietary supplementation with a new immune tablet
reduces antigen presentation and allergic symptoms in a
poly-sensitization BALB/c model. EAACI poster #1414, 2020
7. Bartosik et al. Dietary supplementation with a new immune
tablet ameliorates human symptom load during birch pollen season:
lower B-cell numbers yet with higher intracellular iron. EAACI
poster #1213, 2020
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END
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