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Allergy Therapeutics PLC (AGY)     

banjomick - 01 Feb 2016 13:59

logo.png

Mission Statement
To create a sustainable, fast-growing and profitable global speciality pharmaceutical business with a substantial franchise in the allergy sector by developing innovative, patented, registered therapies for both the treatment and prevention of allergy-related conditions.

Chart.aspx?Provider=Intra&Code=AGY&Size=460&Skin=RedWhite&Scale=0&Type=2&Cycle=MINUTE1&Layout=Intra;IntraDate&E&Ind=VOLMA(60);&Layout=Intra;IntraDate&E=UK&YFormat=&XCycle=Hour2&Fix=1&SV=0Chart.aspx?Provider=EODIntra&Code=AGY&Size=460&Skin=BlackBlue&Type=2&Scale=0&Span=YEAR1&MA=&EMA=&OVER=&IND=VOLMA;&XCycle=&XFormat=&Layout=2Line;Default;Price;HisDate&SV=0

NEWS

19th Jul 2018 Proposed placing and subscription to raise up to £10.6 million
13th Jul 2018 Hardman & Co Research
12th Jul 2018 Trading update
25th Jun 2018 Positive data of Pollinex Quattro Grass vaccine
29th May 2018 Positive data with house-dust mite immunotherapy
21st May 2018 Positive top-line results from Grass Ph II study
14th May 2018 Publication of MCT Adjuvant Data
07th Mar 2018 Hardman Research: Clinical development towards submission
07th Mar 2018 Interim Results for the six months ended 31 December 2017


VIDEO/AUDIO
21st May 2018 Allergy Therapeutics on track for phase III grass pollen trial in 2019
September 2017 5 minute pitch
09th May 2016 Allergy Therapeutics boss excited by PQBirch204 Phase II data
08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable
18th Feb 2016 Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019
14th Jan 2016 Allergy Therapeutics boss says the firm is outperforming its competitors

EVENTS
27 11 2018 AGM (tentative)
03 10 2018 Shares Investor Evening (London)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)


WEBSITES

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C_Allergy_logo.pngpl_logo.svg

Teomed-Bencard.pngbencard_adjuvant_systems.png

banjomick - 19 Jul 2018 08:31 - 141 of 159

19 July 2018
Allergy Therapeutics plc

Proposed placing and subscription to raise up to £10.6 million


Allergy Therapeutics plc (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces a placing and subscription of up to 40,000,000 new ordinary shares of 0.1 pence each in the capital of the Company ("New Shares"), representing up to approximately 6.7% of the Company's existing ordinary share capital, to raise up to £10.6 million.

Highlights

· Placing and subscription of up to 40,000,000 New Shares in the Company ("Placing and Subscription"), representing up to approximately 6.7% of the Company's existing ordinary share capital, at a price of 26.5 pence per New Share ("Issue Price") to raise up to approximately £10.6 million before expenses.

· The Company intends to use the Placing and Subscription proceeds to expand the planned Phase III PQ Grass Trial, part fund the Acarovac Phase II Trial and continue to progress its diversified pipeline.

· Revenue for the financial year ended 30 June 2018 is expected to be £68.3 million (2017: £64.1 million). This represents a 6.6% annual growth on a reported basis and 3.5% on a constant currency basis despite the unusually weak pollen season in 2017. The Company is also continuing to gain market share within its core markets in Europe and data for the key markets for the 9 months ended 31 March 2018 showed an increase of 0.7 of a market share point[1].

The Placing is being conducted through an accelerated bookbuilding process (the "Bookbuild") which will commence immediately in accordance with the terms and conditions set out in Appendix I to this Announcement.

Panmure Gordon (UK) Limited ("Panmure Gordon") is acting as Financial Adviser, Nominated Adviser and Corporate Broker in respect of the Placing.

Manuel Llobet, Chief Executive Officer, stated:

"Allergy Therapeutics is poised for a transformational period of growth both with our marketed products and our R&D pipeline. With this planned funding, we hope to expand our planned Phase III PQ Grass trial, scheduled to start in H2 2019, including a project to analyse pollen trends in the US to maximise the exposure of patients to grass pollen. We also intend to support the Acarovac Phase II trial and, looking further out, further progress our diversified pipeline of patient friendly, convenient to use products including Polyvac Peanut."

Background to the Placing and Subscription

Allergy Therapeutics is an international commercial biotechnology company focused 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 eight major European countries and via distribution agreements in an additional fourteen 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.

In a trading update for the year ended 30 June 2018, the Company reported that revenues for the year are expected to be in line with market expectations at £68.3 million (2017: £64.1 million). This performance represents 6.6% annual growth on a reported basis and 3.5% on a constant currency basis which reflects a strong performance during an unusually weak pollen season in 2017. The Group is continuing to gain market share within its core markets in Europe and data for the key markets for the nine months ended 31 March 2018 showed an increase of 0.7 of a market share point[2].

The Company is making continual advances across all three of its major strategic objectives; profitably expanding the existing European business; preparing for product entry into the US market; and developing a strong product pipeline.

The European business of Allergy Therapeutics has grown at a CAGR of 10% over the last 19 years from its flexible and varied product portfolio. Recently, the Company reported annual growth of 3.5% and increased its market share by 0.7 of a market share point[3] which is the result of:

· Innovative, convenient and patient-friendly (short-course) products;

· Increased regulatory requirements which has resulted in 40% of all the products that were on the market and submitted for the TAV process dropping out and no longer being allowed to be sold in Germany[4];

· Focused investment across the business;

· Strength of a broad portfolio with modified house dust mite and venom SCIT; and

· Scaling-up to drive technological and geographical expansion.



The Directors believe that the US allergy immunotherapy market is estimated to be valued at $2 billion and, of that market, estimated peak grass sales could be $300-400 million. There are no registered injected products and adherence levels to treatments are as low as 15%[5]. The changing US regulatory landscape provides an opportunity for Allergy Therapeutics. New United States Pharmacopeia ("USP") and US Food and Drug Administration ("FDA") regulations are moving to pharmaceutical grade, centrally manufactured, single allergen treatments. Existing products in the market are long courses of treatment with between 50-100 injections with efficacy in 6-12 months. Allergy Therapeutics can offer a short course treatment of 4-6 injections with efficacy in three weeks for a four shot treatment plan.

Allergy Therapeutics is progressing its Birch Phase III trial for Europe, the results of which are expected in Q3 2018. The Phase III field trial in Europe recruited 582 patients from 59 centres in Germany, Austria, Poland and Sweden. The trial is a double blind placebo controlled trial and is pivotal for approval in Germany. If the trial is successful and approved, the next step is expected to lead to a market authorisation.

On 21 May 2018, the Company announced positive top-line results from its grass modified allergen tyrosine absorbed MPL Phase II dose ranging study. The trial met its primary endpoint of establishing a dose-response relationship and a Phase III dose. The trial, conducted on 447 patients in 50 sites in Germany, Austria and Poland, measured four aspects of eye symptoms to generate a total symptom score.

Acarovac, the Company's Mite MPL house dust mite product, is currently undergoing its Phase I trial with the results expected in H1 2019. Acarovac is a short-course product that can be used to address the potential market of $3 billion[6] worldwide with only Europe partially covered already. In the Company's preclinical pipeline, its Polyvac peanut product offers a potential solution to the $8 billion[7] worldwide food allergy market. The single dose of VLP combined with recombinant peanut allergen successfully protects against anaphylaxsis when challenged with peanut. Polyvac Peanut received positive results from its pre-clinical research and pre-clinical development has been progressing according to plan with important product differentiation demonstrated. The Company signed a manufacturing contract for scale-up of the Polyvac product with the aim of having the first trial in humans in 2019.


Reasons for the Placing and Subscription and Use of Proceeds


The Directors believe that Allergy Therapeutics has the opportunity to accelerate growth across its three pillars of growth outlined above. Allergy Therapeutics is seeking to raise up to £10.6 million via the Placing and Subscription, earmarked for investment by the Company in:

· expanding the planned Phase III PQ Grass trial, scheduled to start in H2 2019. The Phase III trial will entail an increase in the number of patients recruited to the study, the introduction of a vaccinated placebo arm (following the completion of the trial, to reduce the overall cost of the potential safety database), and an additional project to analyse pollen trends in the US to maximise the exposure of patients to grass pollen;

· part funding of the Acarovac Phase II trial (balance of funding for trial from CDTI to start, subject to contract, in 2019); and

· ensuring continued progress on a diversified pipeline, including developing the Polyvac Peanut product.


Details of the Placing and Subscription ***More details via link below***

http://www.moneyam.com/action/news/showArticle?id=6058111

banjomick - 26 Jul 2018 12:40 - 142 of 159

TR-1: Standard form for notification of major holdings

http://www.moneyam.com/action/news/showArticle?id=6067980

banjomick - 26 Jul 2018 12:56 - 143 of 159

Their 'Financial Calendar' wasn't working for some time but all okay now:

31 07 2018 Trading update (tentative)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)
27 11 2018 AGM (tentative)

https://www.allergytherapeutics.com/investor-relations/financial-calendar/

banjomick - 27 Jul 2018 23:38 - 144 of 159

17:26----TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARES

http://www.moneyam.com/action/news/showArticle?id=6070179

banjomick - 04 Aug 2018 11:37 - 145 of 159

The Placing Roadshow slides from July 2018

https://www.allergytherapeutics.com/media/1319/placing-slides-july-2018.pdf

banjomick - 08 Aug 2018 08:47 - 146 of 159

08 August 2018
Allergy Therapeutics plc

Notice of Preliminary Results

8 August 2018 Allergy Therapeutics (AIM:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, will issue its preliminary results for the year ended 30 June 2018 on Wednesday 26 September 2018.

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Chief Financial Officer, will hold a presentation and conference call for analysts on the day of results at 10:30am BST at the offices of Panmure Gordon & Co, One New Change, London, EC4M 9AF.

Please contact Consilium Strategic Communications for further details.

http://www.moneyam.com/action/news/showArticle?id=6082995

banjomick - 05 Sep 2018 14:20 - 147 of 159

One week after the Preliminary Results are released AGY are taking part in this event:

03 10 2018 Shares Investor Evening (London)

banjomick - 26 Sep 2018 09:51 - 148 of 159

Allergy Therapeutics plc

Preliminary Results

26 September 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces preliminary results for the year ended 30 June 2018.

Financial highlights

· 6.6% revenue growth increase in actual terms to £68.3m (2017: £64.1m)

· 3.5%1 revenue growth at constant currency2 to £66.4m (2017: £64.1m)

· One point increase to 14%3 in market share in European business (2017: 13%)

· 10% compound annual growth in net sales over 19 years since the company formed

· 26% increase in operating profit4 (pre-R&D) to £9.3m (2017: £7.4m)

· Cash at 30 June £15.5m (2017: £22.1m) prior to the July 2018 fundraising of £10.2m net of expenses


Operational highlights

· Successful completion of the Phase II PQ Grass (G205) in May, allowing progression to a pivotal trial for US registration. The Phase III PQ Birch (B301) study has completed and top line data are now expected by the end of the year

· Good pipeline progress, including initiation of Acarovac Phase I trial (data readout expected H1 2019) and positive pre-clinical Polyvac peanut work, with first in-human trials expected in 2019

· Completion of £10.6m (gross) oversubscribed placing in July 2018



Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "2018 was a solid year for Allergy Therapeutics as we made important progress in key areas across the Company. We generated continued growth despite a low pollen season in our core business, with constant currency revenue growth of 3.5%1, driving additional gains in market share and a 26% increase in pre-R&D operating profit4. We also achieved significant clinical success in the year, with the positive Phase II PQ Grass in May and we now expect headline data from the Phase III PQ Birch study by the end of the year. With progress towards the US market, a pipeline of exciting clinical and pre-clinical assets, and a robust balance sheet, we look to the future with confidence in our growth prospects."


1 Percentage based on figures in thousands (2018: £66.369m, 2017:£ 64.139m)

2 Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements.

3 Market data and internal estimates for 12 months to 30 June 2018 for Allergy Therapeutics' direct sales competitive markets excluding UK and Switzerland due to lack of competitor information.

4 Operating profit (pre R&D) is calculated by adding back R&D expenditure for the year to the operating loss of the year to arrive at an operating profit (pre R&D) of £9.3m (2017: £7.4m)

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

- ENDS -

Analyst briefing today

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Chief Financial Officer, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 10.30 BST today at the offices of Panmure Gordon & Co, One New Change, London, EC4M 9AF. Dial-in details are: +44 (0) 207 192 8000. Conference ID: 9583215.

http://www.moneyam.com/action/news/showArticle?id=6142192

banjomick - 26 Sep 2018 10:57 - 149 of 159

Increased Market Share and Revenues at Allergy Therapeutics
26th September 2018

Allergy Therapeutics plc (LON:AGY) today released Preliminary Results for the year ended 30th June 2018. European market share for their products has increased by 1% to 14%, whilst revenues have grown by 6.6% to £68.3m (2017:£64.1m).

Below is a video interview with Manuel Llobet and Nick Wykeman, who discuss the results in detail and explore the drivers behind the company’s growth.

Video Interview: Allergy Therapeutics Preliminary Results:

http://www.fmp-tv.co.uk/2018/09/26/increased-market-share-and-revenues-at-allergy-therapeutics/

banjomick - 26 Sep 2018 11:02 - 150 of 159

Allergy Therapeutics outperforming the market "significantly" in latest financial year-Video interview (another one!)
10:08 26 Sep 2018


Allergy Therapeutics plc's (LON:AGY) Nick Wykeman and Manuel Llobet tell Proactive the company has continued to take market share and is "outperforming the market significantly" as the firm releases its figures for the latest financial year.

The group said the year to the end of June was one of strong progress made against its strategic objectives of expanding in Europe, preparing for entry into the US market, and making clinical progress with the group's lead assets.

Despite a low pollen season, revenue rose 6.6% to £68.3mln from £64.1mln the year before, albeit helped by currency movements; on a constant currency (CC) basis, revenue growth was 3.5%.

http://www.proactiveinvestors.co.uk/companies/stocktube/10614/allergy-therapeutics-outperforming-the-market-significantly-in-latest-financial-year-10614.html

banjomick - 27 Sep 2018 08:47 - 151 of 159

Hardman & Co: 2018 full-year results: solid growth

http://www.moneyam.com/action/news/showArticle?id=6144455

banjomick - 16 Oct 2018 22:58 - 152 of 159

Video from the Shares Investor Evening earlier this month:

https://www.sharesmagazine.co.uk/video/nick-wykeman-fd-allergy-therapeutics-agy-2

banjomick - 24 Oct 2018 00:18 - 153 of 159

23 October 2018
Allergy Therapeutics plc

ANNUAL FINANCIAL REPORT 2018 AND NOTICE OF 2018 ANNUAL GENERAL MEETING

Allergy Therapeutics plc has today published the following documents:

· Annual Report for the year ended 30 June 2018 ("Annual Report"); and


· Notice of 2018 Annual General Meeting ("Notice of Meeting");



Each of these documents is available electronically on the Company's website at
www.allergytherapeutics.com


A hard copy of the Annual Report and Notice of Meeting is anticipated to be posted to shareholders on 23 October 2018.

https://www.moneyam.com/action/news/showArticle?id=6178705

banjomick - 24 Oct 2018 09:04 - 154 of 159

Director/PDMR Shareholding

24 October 2018 - Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that Manuel Llobet, Chief Executive Officer and Nick Wykeman, Chief Financial Officer, have today purchased 50,000 and 150,000 ordinary shares, respectively, of 0.1 pence each in the Company ("Ordinary Shares"), at a price of 17.5 pence per Ordinary Share.

Furthermore, Peter Jensen, Non-Executive Chairman, has today purchased 20,000 Ordinary Shares at a price of 18 pence per Ordinary Share. Following the dealings, the interests of Manuel Llobet, Nick Wykeman and Peter Jensen in the issued share capital of the Company are set out below:

https://www.moneyam.com/action/news/showArticle?id=6178890

banjomick - 08 Nov 2018 08:55 - 155 of 159

08 November 2018
Allergy Therapeutics plc


Directorate Change

8 November 2018 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces the appointment of Mr Scott Leinenweber to the Company's Board as a Non-Executive Director, nominated by Abbott Laboratories, Inc. ("Abbott", NYSE: ABT) in replacement of Mr Jeff Barton who retires from the Board, both effective after close of business 7 November 2018.


Scott Leinenweber currently serves as Vice President of Investor Relations and Licensing & Acquisitions at Abbott. During his time in this role, he has been the lead spokesman with investors and served as lead for Abbott's M&A activities in the Medical Devices, Diagnostics, Pharmaceuticals and Nutritionals business segments. Scott started his career at Abbott as a financial analyst in 1997, before moving into product management, sales and marketing roles across Abbott's businesses. Mr Leinenweber holds a degree in finance from the University of Wisconsin-Oshkosh and a Masters of Business Administration from the Marquette University, Graduate School of Business.



Peter Jensen, Chairman of Allergy Therapeutics, commented: "We are pleased to welcome Scott to the Board. He brings extensive investor relations and marketing experience, particularly in the United States, which will be valuable to our Company as we continue to execute our global strategy. We also wish to take this opportunity to thank Jeff for his contribution and support to Allergy Therapeutics since February 2017."


Scott Michael Leinenweber, aged 47, is, or has been, a director or partner of the following companies or partnerships during the past five years:

Current Directorships and Partnerships
Abbott Healthcare Private Limited (an Indian subsidiary of Abbott Laboratories)

Past Directorships and Partnerships in the previous five years
None

https://www.moneyam.com/action/news/showArticle?id=6199006

banjomick - 12 Nov 2018 12:13 - 156 of 159

Allergy Therapeutics to present at Jefferies 2018 London Healthcare Conference

12 November 2018 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that Manuel Llobet, CEO, and Nick Wykeman, CFO, will attend the Jefferies Healthcare Conference in London on Wednesday 14 November 2018.

Nick Wykeman, CFO, will lead an investor presentation at 15.20 GMT on Wednesday 14 November.

https://www.moneyam.com/action/news/showArticle?id=6203440


Conference website:

http://www.jefferies.com/OurFirm/Conferences/325/433

banjomick - 27 Nov 2018 09:45 - 157 of 159

AGM Trading Update


Sales continue to grow strongly with market share gains


27 November 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides an AGM trading and regulatory update ahead of its Half Year Results to be announced in March 2019.

Financials


The Group continues to perform well with revenues up strongly from the prior year in most markets and sales in line with market expectations for the year. The Group continues to gain market share in Europe, particularly in Germany.1

Regulatory update

The Group continues to prepare for the upcoming PQ Grass pivotal Phase III trial that can allow for US registration. An end of Phase II meeting with the FDA has now been confirmed for January 2019 and good progress is being made regarding the Phase III trial protocol. Further to previous updates, top line results from the PQ Birch (B301) Phase III trial for Europe are now expected in Q1 2019. Allergy Therapeutics remains blinded to the data package and looks forward to the disclosure of the data.

The Worthing site recently completed a successful MHRA audit with no critical findings illustrating the quality of the Group's supply chain.


AGM voting results

The company will announce the results of the AGM voting later today.



Manuel Llobet, CEO at Allergy Therapeutics, stated: "Our revenue growth reflects the quality of our products, the strength of our supply chain and our sales and marketing team. We are pleased that we have continued to make headway this year both in market share and in the progress of our pipeline."


1Insight Health Data

https://www.moneyam.com/action/news/showArticle?id=6221475

banjomick - 16 Jan 2019 09:51 - 158 of 159

16 January 2019
Allergy Therapeutics plc

Trading Update & Notice of Results

Sales continue to grow strongly

Strong cash position sustained by good performance


16 January 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunology vaccines, today provides a trading update for the six months ended 31 December 2018 ahead of its Half Year Results to be announced on 6 March 2019.

Financials

The Group is trading in line with Board expectations. Reported revenues for the six months ended 31 December 2018 are expected to be £46.7m (2017: £42.2m) representing 10.6% growth on both a reported and constant currency basis. In terms of geography, the main contributors to this strong sales growth are Germany, Austria, Switzerland and Netherlands. Spain has continued to grow well despite the withdrawal of all bacterial products across the market. In terms of product mix, this growth is being driven primarily by the Group's ultra-short course, aluminium-free treatments (Pollinex and Pollinex Quattro) as well as Acarovac and Venomil. The Group continues to gain market share in Germany1 and again achieved number one position in this market for the month of October 2018 (the Group's busiest month of the year) for the second year running2.

The cash balance at the end of December 2018 was £31.6m (31 December 2017: £25.8m).

Regulatory

The Group continues to make good progress with the peanut allergy vaccine outsourced manufacturing scale up and the Acarovac Phase I trial for dust mite allergies. The first in-human trials for the Polyvac peanut product are expected to start in 2019, and data from the Acarovac Phase I trial is expected in H1 2019. As announced in December 2018, the top line results of the PQ Birch Phase III trial will be announced in Q1 2019. Meetings with the FDA and the German regulator, the Paul-Ehrlich-Institut (PEI), in relation to the PQ Grass trials are scheduled for Q1 2019.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "This is another period of revenue growth and continued gain in market share for Allergy Therapeutics, in line with our mid and long-term strategy. The Group is also making good progress across its clinical pipeline, with a number of key developments anticipated for the first half of this year. We see momentum in the business and look forward to updating the market at our interim results."

1Insight Health Data November 2018

2 Insight Health Data October 2018


https://www.moneyam.com/action/news/showArticle?id=6278405

banjomick - 17 Jan 2019 10:28 - 159 of 159

Edit:

WITH THE CLOSURE OF MONEY AM THERE IS NO POINT IN ADDING TO THIS THREAD
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