Allergy Therapeutics Live Discussion

Totally_Wired 06 Mar 2019

In the Media Allergy Therapeutics sees first-half sales, profits jump ahead of “pivotal” year 12:10 06 Mar 2019 Allergy has a slew of data due to be published in the coming months, while key studies of its grass and peanut allergy jabs are due to kick off later in the year . Allergy Therapeutics PLC (LON:AGY) shares rose on Wednesday as the firm enjoyed another six months of revenue and market share growth and ended 2018 with plenty of money in the bank ahead of what will be a “pivotal” year for the drug developer. The Worthing-based company, which, as the name suggests, develops vaccines against common allergies, saw turnover rise 10.6% to £46.7mln in the six months ended 31 December, up from £42.2mln a year earlier. Allergy Therapeutics sees first-half sales, profits jump ahead of “pivotal” year

Totally_Wired 06 Mar 2019

In the Media Strong operating performance driving market share 06 Mar 2019 / Corporate research By Dr Dorothea Hill 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. 2019 is expected to deliver progress in several areas, notably PQ Birch, for which top-line Phase III data are due in 1Q’19. Later this year, AGY will commence the pivotal Phase III trial for PQ Grass which will support both an EU and US registration package. Meanwhile, the ‘in-market’ performance of AGY’s products is exceptional, with further market share gains. 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. Interim results: Operating performance in 1H’19 was particularly strong with underling sales rising 10.6% and underlying EBIT up 70.8%, benefiting from the second-half weighting of certain marketing and R&D investment. From a competitive standpoint, AGY saw further market share gains in Europe. Trial updates: Calendar 2019 will be characterised by a strong clinical trial programme. Pivotal will be results from the Phase III PQ Birch trial due by the end of March. Later in the year, AGY expects to commence the important EU and US registration trials for PQ Grass. Risks: AGY’s primary risk lies in the timings of the regulatory approval process, mostly outside of its control, related to the PQ Birch immunotherapy and the European TAV process for full approval. Ongoing trials do represent a risk, but this is limited by the products’ use on a named-patient basis. Investment summary: AGY is approaching an exciting period. It has a clear vision, is gaining market share from competitors, and is leading the race to have its subcutaneous-administered products fully approved and regulated as biologicals – first in Europe and then in the US, where the regulators are demanding change. Read-out from the EU Phase III PQ Birch trial is imminent and will provide the next major value inflection point. Full report can be downloaded from a link found on the summary page: [link] Strong operating performance driving market share

Totally_Wired 06 Mar 2019

Interim Results Video with CEO Manuel Hadn’t seen it until now, I’ll stick it in the 'In The Media ’ section. cheers

Totally_Wired 06 Mar 2019

In the Media Allergy Therapeutics celebrating 20 years of growth and innovation (Video Interview) 08:38 06 Mar 2019 Allergy Therapeutics PLC’s (LON:AGY) CEO Manuel Llobet and chief financial officer Nick Wykeman discuss with Proactive London’s Andrew Scott the group’s results for the six months to December 2018. The company saw turnover rise 10.6% to £46.7mln in the period, up from £42.2mln a year earlier. 2019 is Allergy’s 20th anniversary since they spun out of GlaxoSmithKline. Allergy Therapeutics celebrating 20 years of growth and innovation

Totally_Wired 06 Mar 2019

Interim Results Video with CEO Manuel From the Interim Results: Outlook This calendar year is set to be pivotal for Allergy Therapeutics particularly with the Grass MATA MPL Phase III trial due to start in the second half of the calendar year which will help to provide us with the platform to potentially expand into the highly attractive US market. The Board and management team expect that net sales will continue to grow in line with market expectations in the second half of the year and have great confidence in the future of the business. The gross margin is expected to be lower in the second half as the first half of the year was boosted by additional production in the manufacturing facility to build up stocks before the Brexit deadline date of 29 March 2019. Volumes through the factory are likely to be lower in second half. As planned, research and development costs are expected to double in the second half of the year compared to the first half, reflecting the period of higher activity of the Grass MATA MPL Phase III field trial as well as the start of the oral therapy trials. Other costs for the full year are expected to be in line with market expectations due to phasing and Brexit costs. As noted in the Group Risks section of the 2018 Annual Report, management has taken action to try and mitigate the impact of Brexit, though the Group expects sales would be impacted in the event of a hard Brexit. The Group is well positioned to continue to grow the European business while developing the pipeline for the US market and the food allergy field. We look forward to the future with confidence. Interim Results (Continued)

Totally_Wired 06 Mar 2019

Interim Results Video with CEO Manuel 06 March 2019 Allergy Therapeutics plc (“Allergy Therapeutics” or “the Group”) Interim Results for the six months ended 31 December 2018 Continued good sales growth and strong operating profit Pipeline progressing well with PQ Birch results due Q1 and house dust mite results due in H1 Highlights Financial highlights · Revenue increased by 10.6% (both reported and constant rate*) to £46.7m (H1 2018: £42.2m) · 27% growth in pre-R&D operating profit to £15.7m (H1 2018: £12.3m) largely as a result of investment in the commercial business last year and a higher gross margin · R&D expenditure lower at £5.0m (H1 2018: £5.9m) due to lower level of activity · Cash balance of £31.6m (30 June 2018: £15.5m) · Oversubscribed equity raise of £10.6m gross in July 2018 to support the development of the Group’s clinical pipeline Operational highlights · Increased market share in Germany to 14.5%** (2018: 13.7%) · Breadth of portfolio demonstrated by strong performance from ultra-short course products as well as venom and modified allergen house dust mite therapies · Completion of PQ Birch Phase III trial, with data readout expected before the end of Q1 2019 · Scale up of Polyvac Peanut progressing well with intention to begin first in human trial in 2019 · Modified allergen house dust mite Phase I trial completed last patient last treatment with readout expected in H1 2019 Interim Results

jamesm 06 Mar 2019

Interim Results Video with CEO Manuel Investors update from allergy below:

Pharma_Giles 06 Mar 2019

PQBirch301 - Outcome Wasn’t really expecting the trial results in this RNS but at least we have a little more clarity… Still blinded and sounds like a CRO issue (although was expecting the company to point to a collating data delay). All will be revealed this month. - they may be collating birch pollen data to help results? Still confident the results should be favourable… "PQ Birch Phase III trial will read out before the end of Q1 2019. The delay has been caused by a longer than expected time needed by the Group’s trial service providers to audit, review and consolidate data from the field trial. Allergy Therapeutics remains blinded to the data package and management looks forward to receiving the data

Totally_Wired 16 Feb 2019

In the Media Unusual for Proactive to issue one of their Overview/Big Picture articles on no news! Allergy Therapeutics delivers “stronger than expected” first-half growth as it awaits PQ Birch trial data 15:54 15 Feb 2019 Allergy Therapeutics is a long-established specialist in the prevention, diagnosis and treatment of allergies Develops treatments for common allergies Market share is growing More than £30mln in the bank Phase III readout of PQ Birch trial (Q1 19) the next major inflection point What it 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. Its most commonly prescribed vaccines are used to treat pollen-related allergies, particularly allergies to grasses and trees. 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 already 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. As a result, they are preferred by physicians in places such as the US and Germany – some of the largest markets in the world. How it’s doing The company recently revealed another year of revenue and market share growth as it ended 20128 financially well-resourced. turnover grew by 10.6% in the 12 months ended December 31, with the main contributions to sales coming from Germany, Austria, Switzerland and the Netherlands. Its most popular products were the group’s ultra-short course, aluminium-free treatments such as Pollinex and Pollinex Quattro (pollen) as well as Acarovac (dust mite) and Venomil (wasp sting). At the period-end, the company had cash of £31.6mln, up from £25.8mln. The figures were in line with market forecasts. "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,” said chief executive Manuel Llobet. Blue sky Significant progress is expected in the clinic this year. Top-line results from the Phase III trial of its PQ Birch jab are expected in the first quarter, while a read-out from a Phase I assessment of Acarovac is expected sometime in the next six months. Meetings with the US Food & Drug Administration and the German regulator in relation to its PQ Grass trials are scheduled for the first three months of 2019. On top of that, a phase III trial of its PQ Grass vaccine is pencilled in for the second half of the year. “The group is making good progress across its clinical pipeline, with a number of key developments anticipated for the first half of this year,” said CEO Llobet. What analysts say “AGY is approaching an exciting period,” said Hardman & co analyst Martin Hall. “It has a clear vision, is gaining market share from competitors, and is leading the race to have its subcutaneous-administered products fully approved and regulated as biologicals – first in Europe and then in the US, where the regulators are demanding change. “Read-out from the EU Phase III PQ Birch trial in 1Q’19 will provide the next major value inflection point.” Speaking after the recent first-half results, City broker finnCap added: “The six-month trading update to 31 December 2018 demonstrates stronger-than-expected growth. “The stock trades at a c.65% discount to its peer group in terms of EV/Sales as the market anxiously awaits the Phase III PQ Birch data.” [link]

Aberdeen_investor 11 Feb 2019

PQBirch301 - Outcome Thanks

Totally_Wired 05 Feb 2019

Financial Calendar November 2019 AGM (TBC) September 2019 Full Year Results (TBC) July 2019 Trading Update (TBC) 06 March 2019 Half Year Results [link]

Pharma_Giles 26 Jan 2019

PQBirch301 - Outcome As promised (on LSE site) I’ll summarise but like I say the information is in the public domain, although not always easy to find if you don’t design clinical trials. Just to point out if you followed IMM last year, I posted why their Phase III trial would be very unlikely to hit statistical significance (link below). The numbers/assumptions all turned out to be accurate but just want to mention that with IMM (and most other P3 studies) the trial design was very different to PQBirch301, in that they used a “responder analysis”. This is where you define a “responder” based on a pre-defined, clinically meaningful, reduction from baseline in the score. You can then compare the proportion of responders on active vs placebo as your primary outcome measure – but dropouts can be an issue (if not accounted for – link below to my post). Why raise funds now? Market Discussions The recent interview was very positive, the impression that was given was the results would be excellent and that it’s basically a “done deal”… I hope the results are as good as everyone is expecting them to be, but just an honest question… please don’t shoot me down for asking this… If the management are so confident, why dilute existing share holders now to raise funds? It’s not like there was a massive waiting time till the results of the clinical trials are released so why raise funds now?… Most modern P3 studies use this “responder” trial design but AGY can’t really do that here. Patients are likely to be asymptomatic at the start of the evaluation period - thus can’t be defined as a “responder” based on a predefined reduction from baseline (there are other ways but I won’t go into that here). PQBirch301 is therefore somewhat old school in its design (but acceptable). They simply compare the mean combined symptom and medication score (CSMS) on placebo vs active, over the birch pollen season. This allows for a much great chance of reaching statistical significance, and gets over many of the hurdles I pointed out in my IMM posts. The CSMS is the EAACI recommended endpoint for pivotal studies with allergens. Briefly, CSMS is the sum of daily symptom score (dSS) + daily medication score (dMS). dSS is comprised of six individual symptom scores: four nasal symptoms (itchy nose, sneezing, runny nose, blocked nose) and two ocular symptoms (itchy/red eyes, watery eyes), all rated on a scale of 0-3. The dSS can be calculated as a mean of all non-missing daily SS during the pollen season (range 0-18) divided by the number of individual symptoms (6 symptoms). This way the dSS can range from 0-3. The dMS is based on the following scores: 0 = no rescue medication,1 = antihistamines, 2 = nasal corticosteroids, 3 = oral corticosteroids, again calculated as the average of the daily MS during the pollen season. Consequently, the dMS has a range from 0-3. The CSMS, which is dSS + dMS, hence has a range from 0-6. The mean CSMS will most likely be calculated from the sum of all daily CSMS during the birch pollen season divided by the number of days in the birch pollen season. For assessment of efficacy, the respective mean CSMS of the active and placebo groups will be compared. From the data available, in the public domain, the likely placebo CSMS will be around 1.5 (range 1.3 – 1.7). This sounds low but is an accurate estimate from what we know. In order for the PQBirch301 trial to reach a successful outcome, we need to see at least an 18- 20% reduction from this placebo score. Assuming 1.5 as the placebo response, we would need our active arm to be <= to 1.2. Importantly however we will see very narrow standard errors (SE) around these point estimates (SE’s <0.08), which lends itself to gaining a highly statistically significant result. To evaluate the chances of reaching this difference you can look at the PQ Birch Phase II program. At the dose being used in PQBirch301 (27 300 SU cumulative) – the improvement from placebo was 32.3%, and indeed at every dose above 5000SU (7 separate groups) this was consistently > 20% improvement from placebo. The P2 program however did use the total symptom score (TSS), and used a conjunctival provocation test (CPT). It’s worth noting that the symptom component of the CSMS is likely to be the main driver for the actual total score. If we consider the 1.5 for placebo roughly 0.9 will be from symptoms vs 0.6 from the medication component (again based on information in the public domain and these are rough estimates). If we consider some of the potential issues (e.g. insufficient birch pollen – which could mean no symptoms in the placebo group) AGY could use a modified ITT as their primary population for analysis (also known as mITT or mFAS) i.e exclude patients from the primary analysis set who were exposed to <80 grains/m3 per 24 hours in any week for example, They can’t change their primary and secondary endpoints but can adapt their primary population for analysis (must be predefined in the SAP), and as long as they do this before unblinding If they don’t pre-define as a mFAS it simply becomes a subgroup analysis of the full FAS. The may wish to do something like this if new information has come to light during the study, or at least prior to database lock (unblinding). Hope the top-line summary is helpful but like I say by all accounts, and based on probability, this specific trial should yield a successful outcome given the drug has a well proven mechanism of action, and a decent P2 program to establish dose and efficacy. Unlike other studies the trial design doesn’t look like it will throw up too many hurdles either. Good luck and time will tell of course…

d_gaser 16 Jan 2019

Six month update, turn over up 10% ,cash in hand £31.6m 0700 +000: Trading Update & Notice of Results RNS Number : 1965N Allergy Therapeutics PLC 16 January 2019 Allergy Therapeutics plc (“Allergy Therapeutics” or the “Group”) 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 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 Erik Anderson, Corporate Broking Consilium Strategic Communications +44 20 3709 5700 Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia Manser [email protected] Stern Investor Relations, Inc. +1 212 362 1200 Christina Tartaglia [email protected] 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 double digit 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. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com. END TSTLFFLFLEIELIA

d_gaser 04 Dec 2018

Is this a take over? 4m shares change hands today Black rock say they have purchased, 5.5 Last week Black rock said they now hold 636,168,6164 shares rand the Resulting situation on the date on which the threshold was crossed meant Blackrock held 5.33% from a of N/A position . Today another 4,098,835 shares have been purchased, but by whom, unfortunately we won’t know that until we get a RNS ,but this confirms some body is building a position in AGY .More shares have changed hands over the past 4 weeks, than have in the last 6 months of normal trading ,(average 126K per week) Keeping fingers crossed BE HAPPY DAVE

d_gaser 28 Nov 2018

Is this a take over ?over 6 million Buys/sells against 160k average It appears that either some one is selling out or some body is building a large position with a view to a take over see link regarding true value and market opinion. www.marketbeat.com/stocks/LON/AGY/price-target/