Allergy Therapeutics Live Discussion

Totally_Wired 16 Jan 2020

RNS=Historic Allergy Therapeutics plc Half Year Trading Update & Notice of Results - Strong earnings and market share continues to grow - Record cash position reflecting continuous performance improvement 16 January 2020 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 2020 ahead of its Half Year Results to be announced on 4 March 2020. Financials Reported revenues for the six months ended 31 December 2019 are expected to have grown to £50.5m (2018: £46.7m) representing 9% growth on a constant currency basis (8% on reported basis). The Group is trading in line with Board expectations. Geographically, there was growth across all major countries with the best performances in Germany, Spain, Netherlands and Switzerland. Product wise, Pollinex Quattro and Venomil continued to progress well, along with Pollinex, driven by superior technology and a robust supply chain. The Group continued to gain market share in Germany.1 The cash balance at the end of December 2019 was £39.7m (31 December 2018: £31.6m) which includes the £3.2m received in settlement of legal costs relating to the litigation with Inflamax. On current assumptions, the Group will be able to fund the Grass MATA MPL Phase III trial currently planned for later this year from existing resources. Regulatory In reference to the Grass MATA MPL Phase III trial, the Group confirms that it is on track to start the screening for the first stage of the study during summer 2020, which will be executed in the USA and the EU. The design of this study in a stepwise approach (as communicated in November 2019) incorporates the lessons learned during the analysis of the Birch MATA MPL study. The Group has now completed and submitted its final report in relation to the Birch trial and is in dialogue with the correspondent regulatory authority with regards to that product. Finally, in reference to the development of its peanut vaccine, following the scale up process of pre-clinical materials, GMP batches for commercial development have now commenced. The Group has support from regulatory authorities to proceed to Phase I which will follow submission of the clinical trial application, including the GMP batch data package. Manuel Llobet, CEO at Allergy Therapeutics, stated: “This represents another six months of consistent growth reflecting the quality of our platform and our team. Despite an evolving regulatory environment, we continue to perform well and we have great confidence in our commercial abilities and clinical pipeline.” [link]

Totally_Wired 27 Nov 2019

In the Media Allergy Therapeutics Investor evening presentation A recording of CFO Nick Wykeman addressing investors at an event organised by Five Minute Pitch TV and Yellowstone Advisory. Allergy Therapeutics is listed on the London Stock Exchange and is a constitutent of the Alternative Investment Market (the AIM). It has a ticker LON: AGY. It develops, manufactures and distributes pharmaceuticals which combat a range of allergies. These include Hay-fever, Peanut, Birch and bee stings. Nick Discusses the companies operations, strategy and financials in the video. The video was recorded in October 2019 at an investor event organised by Yellowstone Advisory and Five Minute Pitch TV. [link]

Totally_Wired 26 Nov 2019

In the Media Allergy Therapeutics opts to split phase III grass allergy study over two pollen seasons Ian Lyall 07:29 Tue 26 Nov 2019 It has done so after consulting experts and taking on board feedback from its phase III Birch MATA MPL trial Allergy Therapeutics PLC (LON:AGY) said it is taking a “stepwise approach” to its upcoming phase III trial of its Grass MATA MPL vaccine for hay fever. Instead of embarking on one large study it will split the process in two – covering the 2020/2021 and 2021/2022 pollen seasons. This will allow Allergy to carry out an interim analysis of the data at the halfway stage. Allergy has opted to split the clinical assessment this way after consulting experts and taking on board feedback from its phase III Birch MATA MPL study. “The planning for our Grass MATA MPL phase III study is now completed and we look forward to starting this important trial,” Allergy chief executive Manuel Llobet said in a statement. Separately, Allergy said results from the group’s successful phase II trial of the grass pollen vaccine, which assessed the dose to be taken into phase III, were recently published in the World Allergy Organisation Journal. As the name suggests, Allergy Therapeutics, which is headquartered in Worthing, West Sussex and employs around 500 people, develops inoculations against common allergies. It has five products registered, as well as another five that are available on a named patient basis – this means they can only be prescribed by a doctor. It has a strong presence in Europe, with established operations in Germany, Italy, Spain, Austria, Switzerland, the Netherlands and the United Kingdom, while in other markets, it often makes its products available through distribution partners. [link]

Totally_Wired 26 Nov 2019

RNS=Historic 26 November 2019 Allergy Therapeutics plc Allergy Therapeutics announces update to Grass MATA MPL phase III clinical programme 26 November 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides an update on its Grass MATA MPL phase III study, due to start in Autumn 2020. Following further investigation of the phase III Birch MATA MPL study (B301), the upcoming Grass study will now take a stepwise approach, with two stages covering both the 2020/2021 and 2021/2022 pollen seasons, rather than the single large trial originally planned for the 2020/2021 season. The study’s stepwise approach has been designed with input from allergy experts. It enables a phase III-scale study to begin in the 2020/2021 season, followed by an interim review to gain insights into the trial, before continuing to the second part of the study. Results from the Group’s successful G205 phase II clinical study, which completed in 2018, evaluating the dose to be taken into phase III, were recently published in the World Allergy Organisation Journal. The paper “Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing” reports that the immunotherapy demonstrated a highly statistically significant (p<0.0001), monotonic dose response for all pre-specified models, which has enabled the Group to acquire agreement from regulatory authorities in Europe and the USA on a target dose for the phase III clinical programme. Manuel Llobet, CEO of Allergy Therapeutics, said: “The planning for our Grass MATA MPL phase III study is now completed and we look forward to starting this important trial.”

Totally_Wired 25 Nov 2019

RNS=Historic 25 November 2019 Allergy Therapeutics plc Result of Annual General Meeting 25 November 2019 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces that, at its Annual General Meeting held this morning, all resolutions were duly passed. [link]

Totally_Wired 26 Sep 2019

In the Media Five Minute Pitch TV [link]

jamesm 26 Sep 2019

Allergy Therapeutics Results Update Five Minute Pitch TV – 26 Sep 19 Allergy Therapeutics Financial Results Video - Five Minute Pitch TV AIM listed Allergy Thereapeutics announced full year results yesterday. We interviewed Manuel Llobet and Nick Wykeman who discuss the groups financials, strategy ...

Totally_Wired 26 Sep 2019

In the Media Allergy Therapeutics: Profitable, growing and with product pipeline not to be sneezed at Ian Lyall 13:46 Wed 25 Sep 2019 -Profitable allergy specialist developing new inoculations -Full-year results exceeded expectations -Strong pipeline of new products under development What the company does As the name suggests, Allergy Therapeutics PLC (LON:AGY), which is headquartered in Worthing, West Sussex and employs around 500 people, develops inoculations against common allergies. It has five products registered, as well as another five that are available on a named patient basis – this means they can only be prescribed by a doctor. It has a strong presence in Europe, with established operations in Germany, Italy, Spain, Austria, Switzerland, the Netherlands and the United Kingdom, while in other markets, it often makes its products available through distribution partners. Its Pollinex Quattro vaccine for the treatment of seasonal allergic rhinitis (hay fever) from grass, tree or ragweed pollen allergy is well-established in Europe. The company has been pouring money into making injections rather than tablets. This has two major benefits, both of which are linked. Firstly, injections tend to yield improved clinical results versus tablets. And they are preferred by physicians in places such as the US and Germany – some of the largest markets in the world. More via link below: [link]

Totally_Wired 26 Sep 2019

In the Media Hardman & Co Research Note: Allergy Therapeutics plc Continuing to gain market share 26 Sep 2019 / Corporate research By Dr Dorothea Hill, Dr Martin Hall, Dr Gregoire Pave Allergy Therapeutics (AGY) is a long-established specialist in the prevention, diagnosis and treatment of allergies. The Pollinex Quattro (PQ) platform, the ultra-short course subcutaneous allergy immunotherapy (AIT), continues to gain market share, despite its availability in the EU only on a “named-patient” basis. Several products are in clinical development, with the aim of moving the platform to full registration under the new regulatory frameworks in both the EU and the US. Management has the plan and resources to achieve the ultimate goal: to be the first to launch a fully-regulated subcutaneous immunotherapy product in the US market. Strategy: AGY is a fully-integrated pharmaceutical company focused on the treatment of allergies. There are three parts to its strategy: continued development of its European business via investment or opportunistic acquisitions; the US PQ opportunity; and further development of its pipeline. 2019 results: Underlying sales grew 8% to £73.7m (£68.3m) in a flat market, equating to a market share gain of ca.0.6ppts to 14.1%. The product profit margin (pre-R&D) increased 3.0ppts to 38.4% (35.4%). The net cash position was £25.0m, boosted subsequently by a $4.1m/£3.3m settlement of legal costs. R&D update: AGY is still analysing why the subjective primary endpoint in the Phase III Birch trial was not met, while there was a significant effect observed with the objective secondary endpoint. The findings will be used to tighten the US Phase III Grass MATA MPL trial protocol, due to start in 2H calendar 2020. Risks: The risks inherent in subjective clinical trial outcomes were clear in the Phase III Birch trial. However, AGY prudently included an objective secondary endpoint of activity, which will be used in EU regulatory discussions about the way forward, and to adjust the pending US trial protocol. Investment summary: The strong trading updates, coupled with positive settlement of the outstanding litigation, have seen some share price recovery from the low caused by the PQ Birch trial outcome in March. Despite the recovery to date, AGY is trading on an EV/sales of only 0.72x 2020E, reducing to 0.67x 2021E. In our view, this is too low for a company with a long and profitable product history, and well below the multiples commanded by direct competitors. Download the full report from the link below: [link]

Totally_Wired 25 Sep 2019

RNS=Historic Allergy Therapeutics plc Preliminary Results 25 September 2019 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 2019. Highlights Financial Highlights · 8% revenue growth (both reported and constant rate1) to £73.7m (2018: £68.3m) · 22% increase in pre-R&D operating profit to £11.3m (2018: £9.3m) as a result of sales growth and lower overhead cost growth · Strong cash balance of £27.4m at 30 June 2019 (2018: £15.5m) · Net profit of £3.5m for the year including Inflamax settlement of £6m (2018: Net loss of £7.5m) Operating Highlights · Good growth across key countries and products with 0.5point increase in market share2 in European business to 14.1% (2018:13.6%) · Scale up of VLP-based (virus like particle) Peanut product going well following encouraging initial discussions with regulatory authorities; Phase I trial due to commence next year · Successful Modified House Dust Mite Phase I safety trial · Primary endpoint of Birch MATA MPL Phase III trial not met but learnings being applied to clinical field-trial planning · Successful completion of legal action resulting in £6m settlement with costs recovered in 2020 Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: Allergy Therapeutics has traded well in 2019 with good sales growth, cost control and the favourable settlement of legal action delivering profitability for the year. Clinically, the unexpected failure of the Birch trial has been a disappointment, but we have learned from this outcome and will apply the lessons to our future clinical field-trials including the Grass MATA MPL Phase III trial. We are looking forward to the first in human peanut trial in the summer of next year. With our strong cash position, successful core products and exciting R&D pipeline, we look forward to the future with confidence." 1Constant 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. 2Market data and internal estimates for 12 months to 30 June 2019 for Allergy Therapeutics’ direct sales competitive markets excluding UK and Switzerland due to lack of competitor information. This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014. Analyst briefing and webcast today Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Chief Financial Officer, will host a meeting and webcast for analysts to provide an update on the Group, followed by a Q&A session, at 09.30am BST today at the offices of Panmure Gordon & Co, One New Change, London, EC4M 9AF. More via link below: [link]

Totally_Wired 06 Sep 2019

In the Media The slides used for the recent Shares Investor Evening are available via the link below: [link]

Totally_Wired 04 Sep 2019

In the Media Shares Investor Evening tonight

Totally_Wired 06 Aug 2019

In the Media Shares Investor Evening (London) Wednesday 4 September 2019 Join Shares and AJ Bell for an evening of investment inspiration and get to meet the decision-makers behind some of the UK’s fastest growing listed companies. The event on Wednesday 4 September 2019 in London will include: • An opportunity for you to talk directly with the directors and ask your questions about the companies’ core strengths and their short and long-term business strategy • Meet fellow investors and share your investing experience • Complimentary drinks and snacks More about the companies presenting: Allergy Therapeutics (AGY) is a pharmaceutical products company. It develops therapies for allergy based diseases, having its primary market in Germany. Belvoir Lettings (BLV) is uniquely positioned within the property sector, benefiting from the agility of a franchise business model compared with the larger corporate players, whilst providing our networks with the Central Office systems and support, not available to the smaller independent agents. CentralNic Group (CNIC) provides registry, registrar & enterprise services & strategic consultancy for new Top Level Domains (TLDs), Country Code TLD’s (ccTLDs) & Second-Level Domains (SLDs) and it is the owner & registrant for a portfolio of domain names. Open Orphan (ORPH) a European-focussed, rare and orphan drug consulting services platform. The Company will target the fragmented orphan drug services market in Europe [link]

Totally_Wired 11 Jul 2019

In the Media Allergy Therapeutics continues to trade ahead of expectations as it makes market share gains 11:20 11 Jul 2019 In a comprehensive update on trading, the group said net revenue for the year is expected to be £73.7mln, up 8% on last year, while cash at the end of June was £27.4mln [link]

Totally_Wired 11 Jul 2019

RNS=Historic 11 July 2019 Allergy Therapeutics plc Trading update - 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. Financials 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. Commercial 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. Pipeline 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. ENDS -