Vectura Group Live Discussion

Matal 12 Sep 2018

Interim Accounts .Revenue up 1.4% to £79.9m This is the most important bit, an agreed partnership with one of the majors could be announced anytime soon and when it does, it’ll light a bonfire under GSK and provide lift off for VEC. Anticipated Major News flow 2018 -2019 Potential generics licensing deal, H2 2018 Open-Inhaled-Close Device As previously announced, Vectura has received feedback from the FDA that its Open-Inhale-Close device could be considered for use in an AB-rated substitutable generic drug-device combination for the GSK Ellipta® portfolio. This is a significant opportunity, with consensus analyst projections of global net sales of the Ellipta® products of approximately $3bn in the US by 2022. Device and formulation development with Vectura’s Open-Inhale-Close dry powder inhaler is continuing, with good progress being made in parallel with ongoing strategic partnering discussions. “we continue to make good progress in our open-inhale-closed program, which we talked about for the first time at the beginning of this year. This product is a potential multiproduct development for an AB-rated substitutable generic program addressing the currently strongly performing GSK Ellipta portfolio. Device and formulation development is progressing well, and there is continued interest in partnering this valuable Suite of potential assets”.

Matal 11 Sep 2018

Interim Accounts .Revenue up 1.4% to £79.9m Okay. So let’s turn to the royalties received from Novartis Ultibro and Seebri, the second-most important driver of the revenue growth on the inhaled side. Novartis continued to see growth for Ultibro, with total end market sales up 11.4 – 11.5%, driven by strong growth in particular in Europe of almost 9% and rest of the world growth of 25%. Ultibro is highly differentiated in the COPD arena and remains the only LAMA/LABA combination with demonstrated superiority versus ICS/LABA in terms of the exacerbations reduction the most serious asthma endpoint prior to mortality, of course. Ex Ultibro U.S. maintains its market leadership, despite now growing less strongly in the fast-growing LABA/LAMA market with multiple entrants, new entrants, most notably from Boehringer Europe. But you can see the impact to the sales for entry tapering off, and the rate of uptake for these new entrants is now slowing. Ultibro reported end market sales were over $500 million in the first – for the first time on an MAT basis and H1 this year. And combined Ultibro Seebri end market sales were close to 700 million growing at almost 10% MAT Q2 '18. Despite the lack of growth in Japan and the absence so far of meaningful revenues from the U.S. to date, we continue to see positive outlook for Ultibro and Seebri overall with combined percentage of revenue continuing to be close to $1 billion. Although it’s not my focus today, it will be remiss of me not to mention the further potential we see from Novartis triple therapy in asthma here in Europe with the program QVM149, with a Phase III European trials progressing well and due to report next year. So I touched on the major growth drivers on our inhaled business, so let me just say a couple of words on our other non-inhaled portfolio. As I said, for the first time, we’re providing more detail on these assets given the relatively broad and total size of these products to our business overall. The like-for-like comparison revenue showed a significant but a negative 17.4 reduction versus H1, as shown by the chart and as expected. The loss of the post patent expiry royalties for ADVATE, in particular, and also – along with a significant reduction in supply chain or reduction of – which benefited from a competitive lack of supply in H1 2017. Combined, these drove a 16.3% reduction in revenue between H1 and H2 last year, but you can see that between H2 and H1 this year, that decline is just 1.3%, which is a much normal decline when you take away those exceptional reductions. Moving now to R&D costs. As I mentioned, the introductory comments we certainly see a significant reduction in the R&D spend from GBP 31.4 million to GBP 25.3 million as a result of really 3 things. Number one, the refocused portfolio prioritization, aligned to our reinvestment strategy we announced in the beginning of the year. We’re also benefiting from the productivity investment initiatives we are implementing, but the third element is the phasing element to our spend, and we do expect further cost in particular for VR647 and 475 to flow through the P&L before the end of the year. And as a result of that, we are maintaining our R&D guidance for the full year of GBP 55 million to GBP 65 million. A key point I would like to make as well to make every asset to manage our total R&D spend. The majority of this investment is, in fact, recouped from our partners, as you can see from the numbers here. So a combination of licensing and milestones and development services essentially means our model allows us to recoup more than 50% of our total R&D costs from partners. This is a basic function of our model. And in fact, for the 12-month period up to the end of June this year, approximately 62% of R&D spend was effectively covered by partner revenues. So now I’d like to summarize our guidance for the rest of the year, which is largely unchanged based on continuing end market performance and visibility of forward orders. The board maintains its revenue growth outlook and expectations. As I said, we should see an acceleration in the growth rate partly driven by relatively weak comparative H2 performance in 2017. We expect higher second half R&D costs and maintain our guidance, as I just mentioned. And CapEx expected to be in the range of GBP 10 million to GBP 50 million as indicated previously. Having summarized the key progress to make from a financial perspective, we’ll focus the rest of the presentation on our pipeline and news flow for the rest of the year. And at this point, I’ll hand over firstly to Roger to start the updates on our overall pipeline progress. Roger? Roger Heerman, Vectura Group plc - EVP of Commercial & Business Development [2] Thank you, James, and good morning, everyone. My name is Roger Heerman. I’m the Executive Vice President of Commercial and Business Development here at Vectura. Over the course of my pharmaceutical industry career, I spent 15 years specifically working in the respiratory area, including the last 8.5 years here at Vectura. My pharmaceutical career started as a sales rep at GSK in the respiratory division selling ADVAIR in the U.S. I guess, you could say being here at Vectura today is bringing me full cycle on the life cycle of that product as generization of inhaled products in the U.S. market approaches. I’d like to start with giving a short overview of Vectura’s portfolio, which is aligned to the refocused reinvestment priorities announced at the start of this year. As you’re aware, in January, we announced our strategic investment priorities away from early-stage novel formulation device and partnering. These types of programs typically carry high molecular risks and extended periods of lower revenue. Today, we are now more focused on outlets with the highest likely value returns and lower molecular risks. You can see in the slide our large inhaled generics portfolio, where we continue to believe we have the wherewithal, capabilities, experience and expertise to be highly successful. This segment is characterized by high barriers to entry. And today, there are a few competitors entering this highly valuable U.S. market with AB-rated programs. Secondly, this portfolio reflects our increased focus in Vectura’s enhanced nebulized therapies. Following the approval of Breelib in Europe and the progress we’ve made with our own nebulized portfolio, we are further extending the leverage of this platform, announcing additional new programs, which Gonzalo will discuss in a few moments. Another area I would like to call your attention to is our potentially AB-rated substitutable generic products, which I will discuss a little bit further in the next couple of slides. As a final point on the pipeline, as you saw yesterday and as James mentioned earlier, the progress we’ve made with flutiform’s breath-actuated k-Haler device, the launch in Europe, initially in the U.K., with further launches anticipated across European countries in the coming months. We believe we are clearly at a tipping point for inhaled respiratory medications in the U.S. And I’m excited to spend the next few minutes reviewing the markets for generics and the progress we are making for with our development portfolio in the generics space. As I said, we remain committed to our belief that the respiratory market will behave like other disease areas. Generics will gain approval offering wider and more affordable access to these important medications for patients. We at Vectura are pleased to be in the leading group of companies developing and progressing these products. As you know, Vectura has already demonstrated the ability to develop and gain approval for generic products with our AirFluSal product in Europe. And as James mentioned in our earlier – in his earlier comments, we’ve also gained approval for our VR632 program of SYMBICORT generic in Europe with our partner Sandoz. So let’s spend a few minutes focusing on the U.S. market today. Reported U.S. sales of respiratory products of approximately $23 billion in 2017 with nearly 65 million inhalers sold in the key DPI and pMDI maintenance classes. However, less than 1% of all sales for generic products – they were less than 1% of all these sales were for generic products. And this is despite the fact that many of the underlying molecules in these products are long past their patent expiration. As you know, one of the key classes currently in focus is the ICS/LABA class. In this area, the 2 main competitors, ADVAIR and SYMBICORT, have seen declines in sales values as they battle for market share and as they have attempted to build a buffer against generic entry. As you can see in this slide, evaluate pharma reported sales of $2.1 billion for ADVAIR and $1.1 billion for SYMBICORT in 2017, which is down from $2.5 billion and $1.2 billion, respectively, in 2016. While we see the declines in value, the underlying volume of the ICS/LABA market remained stable at 35.8 million units. We remain confident in the value of the market based on the margin and volume available for generic products to capture once approved and launched. But our focus is not solely on VR315 or generic ADVAIR. Based on our experience, device and formulation expertise, we, along with partners, are well positioned to progress further generic products in the other current and emerging major classes in the inhaled respiratory space. Here, you can see the potential size of some of the products we believe Vectura is well positioned to progress. As James mentioned, the Ellipta range of products is estimated to be about GBP 3 billion by 2022. – tiotropium for Boehringer is currently at GBP 1.8 billion and the combination LABA/LAMA is expected to be about GBP 0.6 billion by 2024. These products provide significant additional opportunity for our generics business moving forward. So what progress are we making on the current and emerging GX development portfolio? On 315, we have already discussed the large market opportunity that remains despite the price erosion we’ve seen. With our partner Hikma, we are 1 of the 3 sponsors of programs under regulatory review. Recruitment is progressing on a key clinical study, and Hikma plans to submit data to the FDA in 2019, which could allow for potential launch in 2020. In terms of other programs, we announced last year at our Capital Markets Day the licensing of our VR2081, a generic of an existing major inhaled combination therapy for asthma and COPD in the U.S. using a pMDI. The development work on that program is progressing in line with our expectations. Our tiotropium program, VR410, that we licensed from – is progressing with ongoing formulation and development work, and we will conclude our technical feasibility and commercial opportunity to review in the second half of this year and look forward to providing more information on that program once that work is complete. Finally, as we highlighted this year – or earlier this year, our open inhaled close device platform, which we would target as substitutional genetics to the Ellipta range of products is continuing with device and formulation development, and good progress is being made with our strategic partnering discussions. As you can see, the market for inhaled generics means a significant opportunity. Vectura along with its partners is uniquely positioned to be one of the leaders in this area based on our formulation and device capabilities and expertise. And we look forward to continue to share our progress with the market going forward. With that, I would like to turn it over Gonzalo de Miquel, who will speak about our nebulized programs. Roger Heerman, Vectura Group plc - EVP of Commercial & Business Development [3] Thank you, Roger. Good morning, everyone. My name is Gonzalo de Miquel. I’m the Chief Medical Officer at Vectura. And for 20 years, I’ve worked in the respiratory drug development in the pharmaceutical industry in different companies. And I’ve been lucky enough to see some of the asthma drugs has been working on reaching the market and having patients to live better lives. There are many companies today spending hundreds, if not thousands of millions, developing new drugs for asthma and other disease. However, in spite of these huge investments, the asthma, for instance, remains a global health problem, affecting more than 235 million people worldwide. And only in the U.K., every 10 seconds, one person suffers a life-threatening asthma attack. So after so many years working in respiratory, I have come to the conclusion that it may sound a bit provocative, but I’m sure that most of my colleagues, my medical colleagues, would agree with it, which is that, although new therapies, new mechanism of action are needed, they are needed for treating just a few patients, a small group of patients. Because for the vast majority of patients suffering from asthma, the current available therapies aren’t good enough. Actually, many deaths and many life-threatening events could be avoided just by delivering these already available drugs to the right type of action at the – in the right month and also by ensuring a more compliant and more frequent and regular intake of these medications. This is really what I like about Vectura, this unique and very pragmatic approach to this global health problem. As we design and develop devices and formulations, specifically to optimize the drug amount delivered to the right site of action deeper into the lung, deeper into the small airways. So our devices are enabled with the flow and volume control technology that maximizes the dose delivered into the lung, decreasing the amount that is swallowed and then absorbed in the gut and then reaching the blood stream, causing secondary events. This more efficient delivery allows for a reduction in the viability of doses and also allows for a reduction in treatment times. In addition, we enhance our devices with e-technology and connectivity features to allow to improve adherence and compliance through apps and connections to laptops and smartphones. Actually, the effectiveness and the acceptability of our devices have already been proven with the recent approval and successful launch in Europe of Breelib with our handheld nebulizer and also through the results of our recent clinical studies. So as you will see in the next slides, we have a healthy portfolio going forward, based on these unique nebulized technology. So let me start first this portfolio review with our project VR647. VR647 is specifically developed to treat childhood asthma in the U.S., where the unmet medical need as high. As there are very few established approved products for available – for children with asthma, being nebulized the only inhaled steroid, which is approved for children under 4 years. So VR647 is looking to provide an alternative for this treatment to conventional nebulized therapy in children with asthma, offering a similar or better efficacy with a lower total steroid dose, shorter treatment times and a high-tech monitoring system to prove that the right dose has been effectively delivered. And I will come back to that because this is very important. Our market research tell us that in spite of the available generic budesonide in the U.S. market, VR647 profile supports a premium price over generics and price parity with – so it represents – 647 represents a significant marketable opportunity as the use of nebulized budesonide is widespread and stable. So as you might be aware, we recently reported on the results of our Phase II clinical trials for 647. We reported the methodology study with a mouthpiece and pharmacokinetic studies. Prior to that, a solid proof-of-concept study running 20 pediatric patients strongly suggested superior efficacy of our devices at a quarter of the conventional dose of budesonide versus standard nebulizer, giving us a very strong confidence to move forward. So what have been the results of the most recent Phase II trials? So let’s go first to the methodology or usability study. Traditionally, it was thought that – believed that young children below 4 years couldn’t use a mouthpiece effectively, particularly if it was connected with a breath-activated device. And we challenged that assumption. So we took 40 kids, 40 children aged 1 to 4 inclusive, and tested them with a mouthpiece to inhale a fixed volume of aerosol with our device 647. Our study demonstrates that more than 90% of children aged 2 and above could perfectly – were perfectly able to use the device with a mouthpiece, and most were able to do so already at the first attempt. It was a very intuitive maneuver and actually majority required more aid from parents or caregivers. So this was a very successful result for the program progression because it allowed us to determine the lowest age range in our Phase III program and also in our future label. So – but also because the mouthpiece is a much better, much more efficient system to deliver drugs into the lung than any other, like the facemasks. So in addition, we got a very positive feedback on one of the main concerns of parents and carers regarding the use of conventional nebulizers in young children, namely, if the kid has effectively taken the drug and how much has the kid will have taken. And because with conventional nebulizers, there is no way to know if the kid has taken the drug or the drug has been sprayed out into the lung area. So our unique nebulizers actually provide a real-time information on the dose delivered and on the remaining inhalations left to complete treatment. This is – this reassuring feedback was very highly appreciated by the health care providers, health care professionals involved in the study as well as the parents. So in the pharmacokinetic study, we showed that with the fraction of the dose, our technology can achieve similar exposure in the lung as a conventional nebulizer. This is vital because we want to prevent unnecessary exposures to steroids to kids and avoid adverse events. Additionally, because we need to deliver less drug with our technology, treatment times were reduced from the in-clinic delivery time of 6 to 7 minutes with the conventional nebulizer to 1 minutes to 2 minutes with our device. In the study, the nurse monitored very closely the delivery times and stopped the conventional nebulizer as soon as certain volume had been reached or certain remaining volume had been reached. However, at home, normally, the conventional nebulizers take between 10 and 15 minutes to complete. So if any of you have children, you will understand how difficult it is to make kids comply with treatments that require them staying still for 10 minutes or more twice a day every day over a long period of time. So you will appreciate the importance of this progress. So these results give us information we need to move to a Phase III study. But prior to that, we plan to meet with the FDA and discuss with them the Phase III program as quickly as possible. Rest assured that these results will be fully published in a peer-reviewed journal as soon as we can. And also, we will communicate them in the relevant scientific fora. So now let me move on – sorry – let me move on to our next wholly owned project, VR475. So while 647 aimed to deliver lesser drug – less drug with the same or better efficacy than the conventional nebulizer, VR475 aims to use our existing technology to deliver the same amount of drug but achieve better outcomes. So better efficacy outcomes, but with no impact on safety. In fact, the study we are conducting, which is ongoing, is designed to confirm that 475 reduces the frequency of exacerbations and improve the asthma control and the lung functions in adults and adults with severe asthma. And these are patients are – asthmatic patients that are uncontrolled despite the use of high doses of inhaled steroid and a second control medication. So doing so, VR475 will become an additional alternative step in the treatment of asthma of this patient before the expensive – before having to resort to expensive biologics or unsafe oral steroids. This program is focused in Europe, and the Phase III clinical trial is progressing well. We expect to see headline results by the end of this year. Partnering activities will progress once we have the clinical data results. So I have updated you on the progress we are making in 2 of our key budesonide programs, and we believe that opportunities do not stop here. To be on the proven device formulation development capabilities that Vectura is well known for, I’m very pleased to be able to talk today for the first time about the progress of our R&D strategy. We call this progress the VENT strategy, which stands for Vectura enhanced nebulized therapy strategy. Like with budesonide, we can use our proprietary technology even further, taking other existing drugs, approved drugs either for respiratory conditions or non-respiratory conditions, and repurpose them and reformulate them to improve and optimize their efficacy and safety profile, providing you more effective treatment for airways diseases with high unmet needs. So actually, there are many conditions in – with high unmet needs in the respiratory field. And there are great opportunities to improve this already existing therapies by delivering them better into the right site of action with our formulation and nebulization capabilities. So after further assessments, we have prioritized a number of conditions, amongst which we have the inhaled management of difficult-to-treat cardiopulmonary disease that, although rare, it can be life-threatening, and there are few available treatment options. We have also found inhaled treatment for the underlying inflammation in cystic fibrosis, for which there is no available anti-inflammatory today. And also for the prevention and treatment of pulmonary infections in transplanted immunocompromised patients, which are very susceptible to all kinds of infections. And here, there is a lot of opportunities as well. So these are 2 enhanced nebulized strategy are for us are like – very high likelihood of success because the drugs we are targeting are already proven to be safe and effective. This makes the development times shorter and also shorter time to realize the value. These untapped respiratory niche market represents a multibillion opportunity today, and each of these niche opportunities could easily deliver peak sales of above GBP 250 million each. So we’ve made headroom in our R&D budget, and we have already initiated development of some lead candidates. And I’m really excited by this really fine strategy. I hope in the next interactions we will be in a better position to give you more details of these assets on the progress of them. And with this, I would like to conclude my pipeline review and hand over to James Ward-Lilley. James Ward-Lilley, Vectura Group plc - CEO & Executive Director [4] Thank you, Gonzalo. Thank you, Roger. We’ll come back to these 2 gentlemen during the Q&A segment. Before I close, I’d like to quickly recap on the key messages I see from today’s presentation. First and foremost, we clearly see the business is regaining momentum, and that’s a positive outlook after what was a challenging '17. We see growth in H1 underpinned by the continued inhaled market performance. And importantly, a good step up in flutiform revenues to Vectura in particular and alignment normalization with market performance of flutiform. We’re also seeing, as Gonzalo and Roger have shown, a good progression in our refocus pipeline with the approval and continued development of key milestone catalysts for our generic portfolio and our focus in our unique nebulized platform is being increasingly validated. And we see particularly exciting prospects with a new series of enhanced assets that Gonzalo has just described. This really is doing what Vectura what does the best, leveraging its unique formulation device assets with the potential to significantly improve therapy for patients as well as providing potential for very meaningful returns to shareholders. We continue to demonstrate our focus on operational excellence, stepping up productivity, improving margins and creating capacity to do more of the same or to lower costs. And with revenue growth of cash-generative assets alongside operational excellence and tight financial management and capital allocation discipline, we continue and are able to build on our strong existing balance sheet. Vectura’s positive momentum is set to continue in H2. We look forward to a series of additional catalysts as we close the year and head into 2019. As mentioned, we continue to make good progress in our partnering discussions to the open-inhale-closed program device. And following the positive 647 results, our minds are now clearly focused on the VR475 Phase III results, which, as Gonzalo said, we expect to see the headline results for before the end of the year. As I said several times before and as mentioned by Gonzalo, we set a high bar as the endpoint for that Phase III study. But if successful, we believe this product device combination could make a very meaningful difference to the lives of severe asthmatic patients and that’s real alternative ahead of the fast-growing and very expensive biologics segment.

d_gaser 11 Sep 2018

Interim Accounts .Revenue up 1.4% to £79.9m Not a lot to say regarding these accounts ,other than they are better than this time last year .Still no signs of good news coming either this year ,and the company had an £11M loss,which is better than the £17m this time last year. Cash in the bank stands at £83.9m,against the £103.07m last year ,( £20m share’s buy back ) Not much change so looking for a better second half . BE HAPPY Dave RNS Number : 3394A Vectura Group plc 11 September 2018 This contains inside information Vectura Group plc Vectura regaining momentum with continued inhaled revenue and adjusted EBITDA growth Chippenham, UK - 11 September 2018: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”) announces its unaudited Interim Results for the six months ended 30 June 2018 and reiterates its current guidance for the full year. Financial & Operational Highlights H1 2018 £m H1 2017 £m % change Revenue1 79.9 78.8 1.4% Inhaled 64.7 60.4 7.1% Other (non-inhaled) 15.2 18.4 (17.4%) Gross profit 52.6 50.4 4.4% R&D expenditure (25.3) (31.4) 19.4% Operating loss (30.2) (41.3) 26.9% Basic loss per share (pence per share) (3.5) (5.6) 37.5% Adjusted EBITDA2 24.6 16.23 51.9% Cash and cash equivalents 83.9 90.5 (7.3%) Financial •Total reported revenue for the period of £79.9m up 1.4% (+2.1% constant exchange rates (CER)) o Inhaled portfolio revenue up 7.1%. Following H2 2017 de-stocking, flutiform® revenues to Vectura are normalising with revenue up 3.1% vs H1 and 6.1% vs H2 2017. o As expected, other (non-inhaled) portfolio revenues were down 17.4% due to non-recurrence of 2017 post patent royalties and lower product supply revenues. •Guidance for R&D costs of £55-65m for 2018 remains unchanged reflecting the Group’s refocussed portfolio prioritisation and initiatives to transform R&D productivity. R&D costs of £25.3m were 19.4% lower than H1 2017. The group anticipates a step up in phasing of R&D costs in H2 2018, principally related to VR475 and VR647. •Operating loss has reduced by £11.1m, mainly driven by a decrease of £8.1m of amortisation and lower R&D costs partially offset by exceptional items. •Adjusted EBITDA2 of £24.6m is up 51.9% vs H1 2017 benefiting from productivity initiatives, including good progress in procurement and supply chain, and R&D phasing, with operating margin before amortisation and exceptional items at 25.9%, vs 15.7% H1 2017. •Cash balance of £83.9m (December 2017: £103.7m) reflecting completion of share buyback programme, capital investment and annual cash flow phasing. Operational •Vectura Enhanced Nebulised Technology o Phase II pharmacokinetic and mouthpiece usability studies for VR647 support the progression of a Phase III programme. VR475 Phase III programme on track with headline results expected in Q4 2018. o Progressing a series of new pipeline projects with significant potential future value. •Inhaled Generics o VR315: recruitment is progressing on a repeat clinical study, Hikma anticipates being able to submit data to FDA in 2019, potential launch in 2020. o VR632 was approved in Europe, with launches planned in 2019. o Device and formulation development with Open-Inhale-Close dry powder inhaler is continuing, with good progress being made in strategic partnering discussions. Commenting on the interim results, James Ward-Lilley, Chief Executive Officer of Vectura, said: “Vectura is regaining momentum after a challenging 2017. Inhaled in-market growth is continuing with flutiform® stock levels normalising resulting in total inhaled Vectura revenues increasing 7.1% vs H1 2017. Our refocussed pipeline is making progress with Phase II VR647 results a key highlight in H1 2018. We have identified and are progressing a series of new pipeline projects, and we look forward to the read-out of the VR475 Phase III adult asthma study later this year. With positive in-market momentum and additional pipeline catalysts, we look forward to delivering against our strategy in the second half of 2018 and we maintain our full-year guidance.”

d_gaser 08 Sep 2018

Vectura declining SP GSK Ellipta product is not finding it very easy at the moment to gain market share ,Where as Novartis quickly taking market share thanks to the fact W.H.O gave them the gold standard last year, and that’s because, the Novartis product doesn’t contain steroids and is more affective .GSK are about to loose their dominance in this sector, once the FDA give some one clearance for a generic for an Advair product ,and if that company is us and our partner then the rewards will not be as great as we had first hopped ,had we done it in 2017, as those user’s will have been moved on to the new products by the time marketing is gained for a generic Advair in my opinion. Novartis are now the one to beat ,and as far as I know, only the new A/Z product can compete with it . If GSK loose their court battle with VEC then that will add further growth to VEC ,and reduce GSK over all profit margin .Novartis have a bigger stake here than GSK so to me if any body wanted to protect their market position,then it would be Novartis and not GSK . Just my thoughts BE HAPPY Dave

Matal 07 Sep 2018

Vectura declining SP The sp is obviously being manipulated to keep it low by being algo (bot) traded late in the day with the aim of keeping the sp well down. The trading patterns after the final bell show it up. Any real good news being reported would put an instant stop to it and the sp would recover to a more realistic level. The question is why? Either the algo trader is buying and selling to himself and making posssibly making profits out of the numerous tiny fractions involved or it’s precursor to an eventual low buy out offer with the additional expectation that the trading update due next Tuesday won’t be up to much… and it probably won’t. VEC need to be able to report they have agreed a partnership with one of the majors to develop a generic option for GSK’s upcoming Ellipta range. Imo… only that is what’s going to get this stock back on track anytime soon.

d_gaser 07 Sep 2018

Vectura declining SP Like you I have seen this S/P climb and fall over the years ,and as you say the rote set in with the merger .That leads me to believe either the market hasn’t got any confidence with the new board, or they don’t have confidence in the products we now have .Many will say it’s all about Advair ,but I disagree with that argument, yes it may have had some barring on fall in our price, but the new Novartis drugs are out taking over the growth predicted by most brokers. Before the merger it was predicted that around 60P had been priced in for the Advair product,but nothing for the Novartis products, as they had only just been launched, that means this is well over sold according to the statistics ,and has been for months ,but even so we have not seen any price adjustment, that leads me to think it has some thing to do with the company its self . Be Happy Dave

matthew.currall 07 Sep 2018

Vectura declining SP I’ve been a VEC shareholder for years and seen the share price increase from 50p to £1.70 and back down again. Ever since the merger last year we’ve seen the share price decline consistently. Can someone explain why we consistently trade at levels significantly below broker targets (currently targeting £1.40-70)? Why is the share price continuing to be under pressure? And what the chances are of achieving these broker targets in future? Thanks in advance.

d_gaser 26 Aug 2018

Positive findings for VR647 Phase II pharmacokinetic methodology studies Vectura Group announces positive findings from its VR647 Phase II pharmacokinetic and mouthpiece methodology studies Validating technology platforms and enabling progression of Phase III programme Chippenham, UK - 21 August 2018: Vectura successfully concludes two paediatric studies to support the potential use of VR647, its wholly-owned drug/device combination asset. The first study evaluated the pharmacokinetics of budesonide delivered using Vectura’s VR647 Inhalation System to paediatric asthma patients between four and eight years of age. The second study was a methodology study, designed to evaluate the ability of children from one to four years of age to use the VR647 Inhalation System with a mouthpiece. The pharmacokinetic and methodology studies suggests that the VR647 Inhalation System may reduce delivery times and potentially reduce steroid dose, versus marketed nebulised treatments in children with asthma. The trials investigated children across different age settings, and results from both studies provide high confidence in the programme, supporting the progression of VR647 to a Phase III programme. Pharmacokinetic Study This US study investigated 17 paediatric patients from four to eight years of age with symptoms suggestive of asthma. Pharmacokinetics were obtained for three different budesonide doses delivered with the VR647 Inhalation System and an approved 1mg budesonide dose delivered using a marketed nebuliser. Highlights: •Budesonide pharmacokinetics indicate that the VR647 Inhalation System can achieve the same lung deposition in children with a lower delivered dose than the marketed nebuliser delivery system without compromising exposure or safety. •Potential to reduce budesonide treatment time by 50% or more in children using the VR647 Inhalation System, compared with the marketed product tested. These results, subject to discussions with the FDA, will define the dosing regimens to be tested in the pivotal Phase III program to evaluate the efficacy and safety of VR647 Budesonide Inhalation Suspension delivered by the VR647 Inhalation System. Methodology study This study assessed the ability of 40 children from one to four years of age (inclusive) to use the VR647 Inhalation System successfully, with a mouthpiece to inhale a fixed volume of aerosol. The study also evaluated the impact of the age of the child on their need for hands-on support from a parent or caregiver. Highlights: •Despite the current belief that children under 4 years of age are unable to effectively use a mouthpiece, this trial demonstrates that children >2 years of age are able to use the VR647 Inhalation System with a mouthpiece. A mouthpiece is an efficient and convenient patient/nebuliser interface that allows a tight control of the breathing pattern with no loss of medication. Vectura is also developing a facemask for children under 2 years of age. Dr. Gonzalo de Miquel, Executive Vice President and Chief Medical Officer, Vectura, commented: “There are very few approved treatment options for children under 5 years of age. The results of these studies support Vectura’s confidence in our wholly-owned VR647 product as a more convenient treatment option for children. This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety. We look forward to outlining Phase III plans with the FDA at the end of the year.” Dr. Leonard Bacharier, Professor of Paediatrics and Medicine at Washington University School of Medicine, commented: “These studies provide very encouraging and positive data, as they demonstrate that the VR647 Inhalation System, with the mouthpiece, can easily be used by young children. The real-time feedback and inhalation control with the VR647 Inhalation System is a new way of treating asthmatic children with budesonide, and has the potential to improve compliance and efficacy in a patient population with limited therapy options.”

d_gaser 19 Jul 2018

Notice of Interim Results 18 July 2018 Vectura Group plc Notice of Interim Results Chippenham, UK, 18 July 2018: Vectura Group plc (LSE: VEC) (“Vectura” or the “Group”), an industry-leading inhaled product formulation, device design and development business, plans to announce its Interim Results for the 6 months ended 30 June 2018 on Tuesday 11 September 2018. James Ward-Lilley, Chief Executive Officer, will host a briefing for analysts at 9.30am on the morning of the results at the offices of Numis Securities Ltd., 10 Paternoster Square, London, EC4M 7LT. A live webcast of the meeting, with the presentation slides, will be available on Vectura’s website: [link] ENDS - BE HAPPY DAVE

Ripley94 26 Jun 2018

Topped up Thanks d-gaser i do not like the site at all , no favourites and can not find old posts .

d_gaser 25 Jun 2018

Topped up Hi Ripley94 how you getting on with the new site ? VEC in my opinion will not be sold even at this price ,plus the only company ever linked to them has now stated, they are not interested in VEC ,and if no body is interested in VEC at this price, then things really do look gloomy .The only up side so far is the fact that the company have said they will meet their earnings target for this six months, and hopefully for the full year, thanks to the new Novartis asthma drugs. keeping my fingers crossed that news might just kick start a revival. BE HAPPY DAVE

d_gaser 25 Jun 2018

Topped up Hi Andy how you getting on with the new site ? VEC in my opinion will not be sold soon even at this price ,plus the only company linked to them has now stated they are not interested,and if no body is interested in VEC at this price, then things really do look gloomy .The only up side is the company have said they will meet their earnings target for this six months and full year , thanks to new Novartis asthma drugs. Just keeping my fingers crossed it may kick start a revival. BE HAPPY DAVE

Ripley94 24 Jun 2018

Topped up VEC… XXXXX volatile on Friday were below March top up @ 77p

d_gaser 14 Jun 2018

Pulmatrix +Vecture dose trial for PURO200 COPD drug Pulmatri & Vecture dose-ranging Phase 1 clinical study of PUR0200 in COPD patients. Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole, an inhaled anti-fungal for patients with allergic bronchopulmonary aspergillosis (“ABPA”), and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and chronic obstructive pulmonary disease (“COPD”). In addition, Pulmatrix has partnered with Vectura Group plc to develop Pulmatrix’s drug candidate, PUR0200, for COPD for the U.S. market. Pulmatrix’s product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.www.4-traders.com/VECTURA-GROUP-PLC-4004743/news/Vectura-Pulmatrix-Announces-Publication-of-Results-from-a-Phase-1-Pharmacodynamic-Study-of-PUR0200-26762645

d_gaser 14 Jun 2018

Mylan also refused again! All though this is good news for VEC ,the fact that the FDA are being even more critical than usual about this drug doe’s mean VEC and Hikma have to ensure they don’t mess up this time as Trump has all ready said he want’s as many new generic products cleared as possible, as it costs the USA many hundreds of millions of $ using original manufactured drugs . Keep my fingers crossed BE HAPPY DAVE