REG - Allergy Therapeutics - Half Year Trading Update & Notice of Results

Allergy TherapeuticsAnnouncement

13/01/2022 07:00

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RNS Number : 2762Y  Allergy Therapeutics PLC  13 January 2022

 

Allergy Therapeutics plc

("Allergy Therapeutics", "ATL" or the "Group")

 

 

Half Year Trading Update 2022 and Notice of Results

 

-     VLP Peanut IND application submitted to FDA with a protocol enabling
Phase I  trial (named PROTECT); expected results in H1 2023 ahead of original
Q4 2023 data readout

-     IMP VLP Peanut batch manufactured and ready for start of upcoming
PROTECT trial

-     Strategic streamlining of products to focus on SCIT and innovative
allergy treatments

-     Strong cash position to support Grass MATA MPL pivotal Phase III
field studies and Phase I VLP Peanut PROTECT trial

-     Phase III Grass MATA MPL trial on track to start Q3 2022 following
impressive results from exploratory field trial

 

 

13 January 2022 Allergy Therapeutics plc (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, today
provides a trading update for the six months ended 31 December 2021 ahead of
its Half Year Results to be announced on 3 March 2022.

 

Financials

 

Reported revenues for the six months ended 31 December 2021 are expected to be
£48.7m (2020: £54.0m), representing a 10% reduction on a reported basis
(down 5% on constant currency basis). This  is primarily due to the
previously disclosed strategic streamlining of non-differentiated older
products to maintain focus on short course subcutaneous immunotherapy (SCIT)
and innovative allergy treatments. On this revised basis revenues have
increased 3% on a like for like product and phasing basis (on constant
currency basis).

 

Revenues were also affected by phasing, headwinds in Germany and the
continuing effect of COVID-19 in Italy and Germany. However Spain, the Group's
second most important market, saw a double-digit growth in sales, while the
Netherlands, UK and Rest of World (RoW) also grew strongly. There was
double-digit growth for key products Pollinex, Venomil and Acarovac (on
constant currency basis).

 

Reported revenue for the year is likely to be down on the 2021 financial year
by an upper single digit percentage, but through planned cost reductions in
the second half of the year, the Board remains confident that market consensus
for the operating profit pre R&D this financial year will be achieved.

 

The Group has continued to generate good cash conversion, with a strong cash
balance at the end of December 2021 of £41.4m (31 December 2020: £48.3m).

 

On current internal assumptions and as previously communicated, the Group will
be able to fund the Grass MATA MPL Phase III trial (G306), as well as the VLP
Peanut Phase I PROTECT trial, from existing resources with a small amount of
additional debt.

 

 

Regulatory

 

The Group has successfully submitted the Investigational New Drug (IND)
application for VLP Peanut to the US Food and Drug Administration (FDA).
Following consultation with experts in the field, the IND application includes
a protocol for the upcoming Phase I PROTECT trial, moving the planned
paediatric and adolescent arms into a future Phase II trial. As a result,
topline data from the Phase I PROTECT trial, in adult patients, would be
anticipated in H1 2023, ahead of the original intended Q4 2023 data readout.

 

Furthermore, the batch of investigational medicinal product (IMP) intended for
use in the upcoming Phase I PROTECT trial has been successfully manufactured,
tested and released. This product aims to revolutionise the peanut allergy
market as a treatment that has the potential to provoke a disease-modifying
effect and to bring a significant positive impact to the lives of patients and
families affected by peanut allergy, and to health systems. The market for
peanut allergies is expected to be around $8bn worldwide.

 

Following the outcome of the Grass MATA MPL exploratory field trial in October
2021 which showed efficacy of 36.8% in an extended posology, the Group is now
on track to begin the Grass MATA MPL pivotal Phase III trial (G306) in the
autumn of this calendar year.

 

Manuel Llobet, CEO at Allergy Therapeutics, stated: "2022 is going to be a
pivotal year for Allergy Therapeutics with the VLP Peanut Phase I PROTECT
trial and MATA MPL Phase III trial (G306) commencing during the calender year.
We continue to be very encouraged by the data and the clinical progress
supporting these highly innovative product trials. The Group has continued to
perform and I am encouraged by our response to the challenges from what
continues to be a tough environment. Our focus on providing innovative allergy
treatments to patients in need, as well as delivering a strong, differentiated
R&D pipeline remains key to our strategy. We are confident in the Group's
commercial capabilities despite being cautious due to COVID-related
uncertainties and we look forward to reporting the significant progress
expected in our clinical pipeline."

 

 

This announcement contains inside information for the purposes of Article 7 of
Regulatory (EU) No596/2014.

 

- ENDS -

 

 

 

 

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

Rupert Dearden, Corporate Broking

 

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / David Daley / Davide Salvi

allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)

 

Stern Investor Relations, Inc.

+1 212 362 1200

Christina Tartaglia

christina@sternir.com (mailto: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
(http://www.allergytherapeutics.com) .

 

 

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